UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 1-A
REGULATION A OFFERING STATEMENT
UNDER THE SECURITIES ACT OF 1933
OMB APPROVAL
FORM 1-A
OMB Number: 3235-0286
Estimated average burden hours per response: 608.0
1-A: Filer Information
Issuer CIK
0001401914
Issuer CCC
XXXXXXXX
DOS File Number
Offering File Number
Is this a LIVE or TEST Filing?
LIVE
TEST
Would you like a Return Copy?
Notify via Filing Website only?
Since Last Filing?
Submission Contact Information
Name
Phone
E-Mail Address
1-A: Item 1. Issuer Information
Issuer Infomation
Exact name of issuer as specified in the issuer's
charter
Dare Bioscience, Inc.
Jurisdiction of Incorporation / Organization
DELAWARE
Year of Incorporation
2005
CIK
0001401914
Primary Standard Industrial Classification Code
PHARMACEUTICAL PREPARATIONS
I.R.S. Employer Identification Number
99-2600308
Total number of full-time employees
21
Total number of part-time employees
3
Contact Infomation
Address of Principal Executive Offices
Address 1
3655 NOBEL DRIVE
Address 2
SUITE 260
City
SAN DIEGO
State/Country
CALIFORNIA
Mailing Zip/ Postal Code
92122
Phone
858-926-7655
Provide the following information for the person the
Securities
and Exchange Commission's staff should call in
connection with any
pre-qualification review of the offering
statement.
Name
Edwin Astudillo
Address 1
Address 2
City
State/Country
Mailing Zip/ Postal Code
Phone
Provide up to two e-mail addresses to which
the
Securities and
Exchange Commission's staff may send any comment
letters relating to
the offering statement. After qualification of
the offering
statement, such e-mail addresses are not required to
remain active.
Financial Statements
Use the financial statements for the most recent period
contained in
this offering statement to provide the following
information about
the issuer. The following table does not include
all of the line
items from the financial statements. Long Term Debt
would include
notes payable, bonds, mortgages, and similar
obligations. To
determine "Total Revenues" for all companies
selecting "Other" for
their industry group, refer to Article
5-03(b)(1) of Regulation
S-X. For companies selecting "Insurance",
refer to Article 7-04 of
Regulation S-X for calculation of "Total
Revenues" and paragraphs 5
and 7 of Article 7-04 for "Costs and
Expenses Applicable to
Revenues".
Industry Group (select one)
Banking
Insurance
Other
Balance Sheet Information
Cash and Cash Equivalents
$
23075261.00
Investment Securities
$
0.00
Total Investments
$
Accounts and Notes Receivable
$
0.00
Loans
$
Property, Plant and Equipment (PP&E):
$
1657255.00
Property and Equipment
$
Total Assets
$
30748574.00
Accounts Payable and Accrued Liabilities
$
4169793.00
Policy Liabilities and Accruals
$
Deposits
$
Long Term Debt
$
5674277.00
Total Liabilities
$
27890671.00
Total Stockholders' Equity
$
2857903.00
Total Liabilities and Equity
$
30748574.00
Statement of Comprehensive Income Information
Total Revenues
$
6517.00
Total Interest Income
$
Costs and Expenses Applicable to Revenues
$
0.00
Total Interest Expenses
$
Depreciation and Amortization
$
1100091.00
Net Income
$
-11957556.00
Earnings Per Share - Basic
$
-1.18
Earnings Per Share - Diluted
$
-1.18
Name of Auditor (if any)
Haskell & White LLP
Outstanding Securities
Common Equity
Name of Class (if any) Common Equity
Common Stock
Common Equity Units Outstanding
14289502
Common Equity CUSIP (if any):
23666P200
Common Equity Units Name of Trading Center or Quotation Medium (if any)
Nasdaq Capital Market
Preferred Equity
Preferred Equity Name of Class (if any)
N/A
Preferred Equity Units Outstanding
0
Preferred Equity CUSIP (if any)
000000000
Preferred Equity Name of Trading Center or Quotation Medium (if any)
None
Debt Securities
Debt Securities Name of Class (if any)
N/A
Debt Securities Units Outstanding
0
Debt Securities CUSIP (if any):
000000000
Debt Securities Name of Trading Center or Quotation Medium (if any)
None
1-A: Item 2. Issuer Eligibility
Issuer Eligibility
Check this box to certify that all of the following statements
are true for the issuer(s)
Organized under the laws of the United States or Canada, or any
State, Province, Territory or possession thereof, or the District
of Columbia.
Principal place of business is in the United States or Canada.
Not a development stage company that either (a) has no specific
business plan or purpose, or (b) has indicated that its business
plan is to merge with an unidentified company or companies.
Not an investment company registered or required to be
registered under the Investment Company Act of 1940.
Not issuing fractional undivided interests in oil or gas rights,
or a similar interest in other mineral rights.
Not issuing asset-backed securities as defined in Item 1101 (c)
of Regulation AB.
Not, and has not been, subject to any order of the Commission
entered pursuant to Section 12(j) of the Exchange Act (15 U.S.C.
78l(j)) within five years before the filing of this offering
statement.
Has filed with the Commission all the reports it was required to
file, if any, pursuant to Rule 257 during the two years immediately
before the filing of the offering statement (or for such shorter
period that the issuer was required to file such reports).
1-A: Item 3. Application of Rule 262
Application Rule 262
Check this box to certify that, as of the time of this filing,
each person described in Rule 262 of Regulation A is either not
disqualified under that rule or is disqualified but has received a
waiver of such disqualification.
Check this box if "bad actor" disclosure under Rule 262(d) is
provided in Part II of the offering statement.
1-A: Item 4. Summary Information Regarding the Offering and Other
Current or Proposed Offerings
Summary Infomation
Check the appropriate box to indicate whether you are
conducting
a Tier 1 or Tier 2 offering
Tier1
Tier2
Check the appropriate box to indicate whether the
financial statements
have been audited
Unaudited
Audited
Types of Securities Offered in this Offering Statement
(select
all that apply)
Equity (common or preferred stock)
Option, warrant or other right to acquire another security
Security to be acquired upon exercise of option, warrant or other right to acquire security
Does the issuer intend to offer the securities on a
delayed or continuous basis pursuant to Rule 251(d)(3)?
Yes
No
Does the issuer intend this offering to last more than
one year?
Yes
No
Does the issuer intend to price this offering after
qualification
pursuant to Rule 253(b)?
Yes
No
Will the issuer be conducting a best efforts offering?
Yes
No
Has the issuer used solicitation of interest
communications in
connection with the proposed offering?
Yes
No
Does the proposed offering involve the resale of
securities by
affiliates of the issuer?
Yes
No
Number of securities offered
4854000
Number of securities of that class outstanding
0
The information called for by this item below may be omitted if
undetermined at the time of filing or submission, except that if a
price range has been included in the offering statement, the midpoint
of that range must be used to respond. Please refer to Rule 251(a)
for the definition of "aggregate offering price" or "aggregate sales"
as used in this item. Please leave the field blank if undetermined at
this time and include a zero if a particular item is not applicable
to the offering.
Price per security
$
5.0000
The portion of the aggregate offering price
attributable to securities being offered on behalf of the issuer
$
24270000.00
The portion of the aggregate offering price
attributable to securities being offered on behalf of selling
securityholders
$
0.00
The portion of the aggregate offering price
attributable to all the securities of the issuer sold pursuant to a
qualified offering statement within the 12 months before the
qualification of this offering statement
$
0.00
The estimated portion of aggregate sales attributable
to securities that may be sold pursuant to any other qualified
offering statement concurrently with securities being sold under
this offering statement
$
0.00
Total (the sum of the aggregate offering price and
aggregate sales in the four preceding paragraphs)
$
24270000.00
Anticipated fees in connection with this offering and names of
service providers
1-A: Item 5. Jurisdictions in Which Securities are to be Offered
Jurisdictions in Which Securities are to be Offered
Using the list below, select the jurisdictions in which
the
issuer intends to offer the securities
Selected States and Jurisdictions
ALABAMA
ALASKA
ARIZONA
ARKANSAS
CALIFORNIA
COLORADO
CONNECTICUT
DELAWARE
FLORIDA
GEORGIA
HAWAII
IDAHO
ILLINOIS
INDIANA
IOWA
KANSAS
KENTUCKY
LOUISIANA
MAINE
MARYLAND
MASSACHUSETTS
MICHIGAN
MINNESOTA
MISSISSIPPI
MISSOURI
MONTANA
NEBRASKA
NEVADA
NEW HAMPSHIRE
NEW JERSEY
NEW MEXICO
NEW YORK
NORTH CAROLINA
NORTH DAKOTA
OHIO
OKLAHOMA
OREGON
PENNSYLVANIA
RHODE ISLAND
SOUTH CAROLINA
SOUTH DAKOTA
TENNESSEE
TEXAS
UTAH
VERMONT
VIRGINIA
WASHINGTON
WEST VIRGINIA
WISCONSIN
WYOMING
DISTRICT OF COLUMBIA
PUERTO RICO
Using the list below, select the jurisdictions in which the
securities are to be offered by underwriters, dealers or sales
persons or check the appropriate box
None
Same as the jurisdictions in which the issuer intends
to offer the securities
Selected States and Jurisdictions
ALABAMA
ALASKA
ARIZONA
ARKANSAS
CALIFORNIA
COLORADO
CONNECTICUT
DELAWARE
FLORIDA
GEORGIA
HAWAII
IDAHO
ILLINOIS
INDIANA
IOWA
KANSAS
KENTUCKY
LOUISIANA
MAINE
MARYLAND
MASSACHUSETTS
MICHIGAN
MINNESOTA
MISSISSIPPI
MISSOURI
MONTANA
NEBRASKA
NEVADA
NEW HAMPSHIRE
NEW JERSEY
NEW MEXICO
NEW YORK
NORTH CAROLINA
NORTH DAKOTA
OHIO
OKLAHOMA
OREGON
PENNSYLVANIA
RHODE ISLAND
SOUTH CAROLINA
SOUTH DAKOTA
TENNESSEE
TEXAS
UTAH
VERMONT
VIRGINIA
WASHINGTON
WEST VIRGINIA
WISCONSIN
WYOMING
DISTRICT OF COLUMBIA
PUERTO RICO
1-A: Item 6. Unregistered Securities Issued or Sold Within One
Year
Unregistered Securities Issued or Sold Within One Year
None
Unregistered Securities Issued
As to any unregistered securities issued by the issuer of any of
its predecessors or affiliated issuers within one year before the
filing of this Form 1-A, state:
(a)Name of such issuer
Dare Bioscience, Inc.
(b)(1) Title of securities issued
Common Stock
(2) Total Amount of such securities issued
1260000
(3) Amount of such securities sold by or for the
account of any person who at the time was a director, officer,
promoter or principal securityholder of the issuer of such
securities, or was an underwriter of any securities of such issuer.
0
(c)(1) Aggregate consideration for which the securities
were issued and basis for computing the amount thereof.
$2,857,479 in cash proceeds; computed by totaling the cash proceeds received by the issuer in exchange for the shares issued
(2) Aggregate consideration for which the securities
listed in (b)(3) of this item (if any) were issued and the basis
for computing the amount thereof (if different from the basis
described in (c)(1)).
Unregistered Securities Act
(d) Indicate the section of the Securities Act or
Commission rule or regulation relied upon for exemption from the
registration requirements of such Act and state briefly the facts
relied upon for such exemption
4(a)(2) of the Securities Act of 1933, as amended, and Rule 506(c) of Regulation D promulgated thereunder. Securities sold solely to an accredited investor.
An
offering statement pursuant to Regulation A relating to these securities has been filed with the Securities and Exchange Commission.
Information contained in this Preliminary Offering Circular is subject to completion or amendment. These securities may not be sold nor
may offers to buy be accepted before the offering statement filed with the Commission is qualified. This Preliminary Offering Circular
shall not constitute an offer to sell or the solicitation of an offer to buy nor may there be any sales of these securities in any state
in which such offer, solicitation or sale would be unlawful before registration or qualification under the laws of any such state. We
may elect to satisfy our obligation to deliver a Final Offering Circular by sending you a notice within two business days after the completion
of our sale to you that contains the URL where the Final Offering Circular or the offering statement in which such Final Offering Circular
was filed may be obtained.
Preliminary
Offering Circular, dated November 25, 2025
Best
Efforts Offering of up to 4,854,000 Investor Units, each Investor Unit Consisting of One Share of Series A Convertible Preferred Stock,
which is Convertible into Two Shares of Common Stock, and Two Warrants, each to Purchase One Share of Common Stock
Up
to 9,708,000 Shares of Common Stock Issuable Upon Conversion of the Series A Preferred Stock and up to 9,708,000 Shares of Common Stock
Issuable Upon Exercise of the Warrants, in each case, that are part of the Investor Units
Agent
Unit Warrants to Purchase up to 145,620 Agent Units, each Agent Unit Consisting of One Share of Series A Convertible Preferred Stock,
which is Convertible into Two Shares of Common Stock, and Two Warrants, each to Purchase One Share of Common Stock
Up
to 145,620 Shares of Series A Convertible Preferred Stock Issuable Upon Exercise of the Agent Unit Warrants and up to 291,240 Shares
of Common Stock Issuable Upon Conversion of such Shares of Series A Preferred Stock
Up
to 291,240 Warrants Issuable Upon Exercise of the Agent Unit Warrants and up to 291,240 Shares of Common Stock Issuable Upon Exercise
of such Warrants
Daré
Bioscience, Inc. (the “Company,” “Daré,” “we,” “our” or “us”) is offering
up to 4,854,000 units (each, an “Investor Unit” and collectively the “Investor Units”), each consisting of one
share of our Series A Convertible Preferred Stock (“Series A Preferred Stock”), and two warrants, each to purchase one share
of our common stock (“Investor Warrants”). Each Investor Unit will be sold at an offering price of $5.00, for a maximum offering
amount of $24,270,000 worth of Investor Units.
At
any time after issuance, each share of our Series A Preferred Stock is convertible into two shares of our common stock at the option
of the holder thereof, subject to customary adjustments in the event of stock dividends, stock splits, reorganizations or similar events.
At any time after issuance, we will have the right to force the conversion of our then outstanding Series A Preferred Stock upon the
occurrence of any of the following events: (i) a change in control of the Company, (b) if the price of our common stock closes at or
above $4.50 per share, subject to customary adjustments in the event of stock dividends, stock splits, reorganizations or similar events,
for any 10 trading days out of any 30 consecutive trading day period, and (c) if we consummate a firm commitment public offering of common
stock for gross proceeds of at least $15.0 million at an offering price per share equal to or greater than $4.50, subject to customary
adjustments in the event of stock dividends, stock splits, reorganizations or similar events. Our Series A Preferred Stock and our common
stock differ in other characteristics including voting rights. See “Description of Securities Being Offered” beginning on
page 24 for additional information.
The
Investor Warrants are exercisable at any time after issuance through the 36-month anniversary of their date of issuance at an exercise
price of $4.00 per share of common stock, subject to customary adjustments in the event of stock dividends, stock splits, reorganizations
or similar events.
This
offering circular also relates to the 9,708,000 shares of our common stock issuable upon conversion of the Series A Preferred Stock that
are part of the Investor Units and the 9,708,000 shares of common stock issuable upon exercise of the Investor Warrants.
The
shares of our Series A Preferred Stock and the Investor Warrants that are part of the Investor Units are immediately separable and will
be issued separately, but must be purchased together as an Investor Unit in this offering. The Investor Units have no stand-alone rights
and will not be certificated or issued as stand-alone securities.
The
minimum investment amount per investor is $250 or a minimum of 50 Investor Units, subject to our right to accept a lesser amount.
Our
common stock is listed on The Nasdaq Capital Market under the symbol “DARE.” On November 24, 2025, the closing price of our
common stock was $1.79 per share. There is no existing trading market for the Investor Units, Series A Preferred Stock or the
Investor Warrants, and we do not expect one to develop. None of the Investor Units, Series A Preferred Stock or the Investor Warrants
are currently listed on any exchange or quoted in any automated dealer quotation system or other over-the-counter market, and we do not
intend to seek a listing or quotation for any of them. The offering price of the Investor Units is not related to, nor may it reflect,
the market price of our common stock after this offering.
This
offering is being conducted on a “best efforts” basis. This offering will terminate at the earliest of (i) the date on which
the maximum offering amount of Investor Units has been sold, (ii) the date that is one year after the date on which the offering statement
of which this offering circular forms a part is qualified by the U.S. Securities and Exchange Commission (the “SEC”) and
(iii) the date on which we determine to terminate this offering, which we may do in our sole discretion at any time and for any reason
or no reason. Notwithstanding the termination of this offering, the offering statement on Form 1-A of which this offering circular forms
a part will remain qualified in accordance with Rule 251(d)(3)(i)(F) of Regulation A until the date on which all of the warrants to purchase
shares of our common stock issued in this offering and underlying the Agent Unit Warrants have been exercised.
We
intend to complete multiple closings in this offering on a rolling basis. Until a closing occurs, funds delivered by potential investors
will be kept in an escrow account maintained at Wilmington Trust, N.A., the escrow agent for this offering. If a potential investor’s
subscription is accepted, the funds they delivered into escrow will be delivered to us and the shares of Series A Preferred Stock and
Investor Warrants they subscribed to purchase will be issued to them at a subsequent closing. If a subscription is not accepted, or if
no closing occurs or if funds remain in the escrow account upon termination of this offering without any corresponding closing, the funds
deposited in the escrow account will be promptly returned to the applicable investors, without deduction or interest. See “Plan
of Distribution” on page 28.
We
have engaged Digital Offering, LLC (“Digital Offering” or the “lead selling agent”), a broker-dealer registered
with the SEC and a member of the Financial Industry Regulatory Authority (“FINRA”) and of the Securities Investor Protection
Corporation (“SIPC”), as the lead selling agent for this offering. The lead selling agent is selling our Investor Units in
this offering on a best efforts basis and is not required to sell any specific number or dollar amount of Investor Units. The lead selling
agent is not purchasing the Investor Units. In addition, the lead selling agent may engage one or more sub-agents or selected dealers
to assist in its marketing efforts (the lead selling agent, together with dealers collectively, the “selling agents”).
This
offering circular also relates to (i) 145,620 warrants (the “Agent Unit Warrants”) to purchase up to 145,620 units (the “Agent
Units”) issuable to the selling agents, each Agent Unit consisting of one share of our Series A Preferred Stock and two warrants,
each to purchase one share of our common stock, (ii) up to 145,620 shares of our Series A Preferred Stock issuable upon exercise of the
Agent Unit Warrants and up to 291,240 shares of our common stock issuable upon conversion of such shares of Series A Preferred Stock,
and (iii) up to 291,240 warrants (the “Agent Common Warrants”) issuable upon exercise of the Agent Unit Warrants and up to
291,240 shares of common stock issuable upon exercise of the Agent Common Warrants.
ii
Investing
in our securities involves a high degree of risk. See the “Risk Factors” section beginning on page 16 of this offering circular.
Price
to Public
Selling
Agent Commissions(2)
Proceeds
to Daré(3)
Offering
Price Per Investor Unit(1)
$
5.00
$
0.36
$
4.64
Maximum
Amount of Investor Units Offered
$
24,270,000
$
1,759,575
$
22,510,425
4,854,000
Shares of Series A Preferred Stock Contained in the Investor Units
—
—
—
9,708,000
Shares of Common Stock Issuable upon Conversion of Series A Preferred Stock Contained in the Investor Units(4)
—
—
—
9,708,000
Investor Warrants Contained in the Investor Units
—
—
—
9,708,000
Shares of Common Stock Issuable upon Exercise of Investor Warrants(4)
—
—
$
38,832,000
145,620
Agent Unit Warrants(5)
—
—
$
910,125
145,620
Shares of Series A Preferred Stock Contained in the Agent Unit Warrants
—
—
—
291,240
Shares of Common Stock Issuable upon Conversion of Series A Preferred Stock Contained in the Agent Unit Warrants
—
—
—
291,240
Agent Warrants Contained in the Agent Unit Warrants
—
—
—
291,240
Shares of Common Stock Issuable upon Exercise of Agent Warrants
—
—
$
1,164,960
Total
$
24,270,000
$
1,759,575
$
63,417,510
(1)
Represents
the offering price for one Investor Unit.
(2)
We
will pay to Digital Offering a placement fee equal to 7.25% of the offering price per Investor
Unit. We will also issue Agent Unit Warrants to Digital Offering to purchase that number
of Agent Units equal to 3% of the total number of Investor Units sold in this offering. The
Agent Unit Warrants and the securities comprising and underlying the Agent Units Warrants
will not be transferable for a period of six months after the date of commencement of sales
in this offering (in compliance with FINRA Rule 5110(e)(1)), and the Agent Unit Warrants
will expire on the five year anniversary of the date of commencement of sales in this offering.
The exercise price per Agent Unit Warrant will be $6.25, which equals 125% of the offering
price of the Investor Units. The Agent Units issuable upon exercise of the Agent Unit Warrants
will consist of one share of our Series A Preferred Stock and two warrants, each to purchase
one share of our common stock at an exercise price of $4.00 per share, subject to customary
adjustments in the event of stock dividends, stock splits, reorganizations or similar events.
In addition, we paid Digital Offering a $25,000 consulting fee and will reimburse Digital
Offering for up to $85,000 of its reasonable, out-of-pocket, and documented fees and expenses
incurred in connection with this offering, $25,000 of which has been paid to date. See “Plan
of Distribution” for more information regarding the compensation payable to Digital
Offering in connection with this offering.
(3)
Before
deducting $296,569 of estimated offering expenses payable by Daré. See “Plan
of Distribution.”
(4)
No
additional consideration or placement fees will be paid in connection with the issuance of
shares of common stock upon conversion of the Series A Preferred Stock or upon exercise of
the Investor Warrants.
(5)
The
value of the Agent Unit Warrants is based on the number of Agent Unit Warrants multiplied
by the $6.25 exercise price per Agent Unit Warrant. The actual value of the Agent Unit Warrants
utilizing an options pricing model may be different from the value indicated in the table.
The
SEC does not pass upon the merits of or give its approval to any securities offered or the terms of the offering, nor does it pass upon
the accuracy or completeness of any offering circular or other solicitation materials. These securities are offered pursuant to an exemption
from registration with the SEC; however, the SEC has not made an independent determination that the securities offered are exempt from
registration.
Generally,
no sale may be made to you in this offering if the aggregate purchase price you pay is more than 10% of the greater of your annual income
or net worth. Different rules apply to accredited investors and non-natural persons. Before making any representation that your investment
does not exceed applicable thresholds, we encourage you to review Rule 251(d)(2)(i)(c) of Regulation A. For general information on investing,
we encourage you to refer to www.investor.gov.
This
offering circular follows the disclosure format of Part I of Form S-1 pursuant to the general instructions of Part II(a)(1)(ii) of Form
1-A.
Sales
of these securities will commence on approximately [●], 2025.
You
should carefully read this offering circular, any offering circular supplement that we subsequently authorize for use in connection with
the offering of the securities described herein, the information and documents incorporated herein by reference and the additional information
under the heading “Where You Can Find More Information” before making an investment decision. You should rely only on the
information we have provided or incorporated by reference in this offering circular, or in any offering circular supplement that we subsequently
authorize for use in connection with the offering of the securities described herein. Neither we, nor the selling agents, have authorized
anyone to provide you with information different from that contained or incorporated by reference in this offering circular. If anyone
provides you with different or inconsistent information, you should not rely on it. You should assume that the information in this offering
circular, or any related offering circular supplement, is accurate only as of the date set forth on the cover page of any such document
or any earlier date as of which such information is given, as applicable, and that any information we have incorporated herein by reference
is accurate only as of the date set forth on the cover page of any such document containing such information or any earlier date as of
which such information is given, as applicable, regardless of the time of delivery of this offering circular, or such offering circular
supplement, or any sale of a security. Our business, financial condition, results of operations and prospects may have changed since
that date.
Neither
we, nor the selling agents, are offering to sell or seeking offers to purchase these securities in any jurisdiction where the offer or
sale is not permitted. We have not done anything that would permit this offering or possession or distribution of this offering circular
in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who
come into possession of this offering circular must inform themselves about, and observe any restrictions relating to, the offering of
the securities hereunder and the distribution of this offering circular outside the United States.
The
representations, warranties and covenants made by us in any agreement that is identified as an exhibit in Part III of this offering circular
or to any document incorporated by reference in this offering circular were made solely for the benefit of the parties to such agreement,
including, in some cases, for the purpose of allocating risk among the parties to such agreements, and should not be deemed to be a representation,
warranty or covenant to you. Moreover, such representations, warranties or covenants were accurate only as of the date when made. Accordingly,
such representations, warranties and covenants should not be relied on as accurately representing the current state of our affairs.
To
the extent there are inconsistencies between the information in this offering circular, any related offering circular supplement, and
any documents incorporated by reference herein or therein, the document with the most recent date will control.
Unless
the context otherwise requires, “Daré,” the “Company,” “we,” “us,” “our”
and similar terms refer to Daré Bioscience, Inc. and its subsidiaries.
This
offering circular contains forward-looking statements that are subject to a number of risks and uncertainties, many of which are beyond
our control. Please read “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements.”
Market,
Industry, and Other Data
Unless
otherwise indicated, information contained in this offering circular or in any document incorporated by reference in this offering circular
concerning our industry and the markets in which we operate, including our general expectations and market position, market opportunity
and market size, is based on information from various sources, including peer reviewed journals, formal presentations at medical society
meetings and third-parties commissioned by us or our licensors to provide market research and analysis, and is subject to a number of
assumptions and limitations. Although we are responsible for all of the disclosure contained in this offering circular, and in any document
incorporated by reference in this offering circular, and we believe the information from industry publications and other third-party
sources included herein and therein is reliable, such information is inherently imprecise. Information that is based on estimates, forecasts,
projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ
materially from events and circumstances that are assumed in this information. The industry in which we operate is subject to a high
degree of uncertainty and risk due to a variety of factors, including those described in the section captioned “Risk Factors.”
Numerical
figures included in this offering circular have been subject to rounding adjustments. Accordingly, numerical figures shown as totals
in various tables may not be arithmetic aggregations of the figures that precede them.
Trademarks
and Trade Names
We
own or have rights to various trademarks, service marks, and trade names that we use in connection with the operation of our business.
This offering circular may also contain trademarks, service marks, and trade names of third parties, which are the property of their
respective owners. Our use or display of third parties’ trademarks, service marks, trade names, or products in this offering circular
is not intended to, and does not imply, a relationship with or endorsement or sponsorship by us. Solely for convenience, the trademarks,
service marks, and trade names referred to in this offering circular may appear without the ®, TM, or SM symbols, but such references
are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right
of the applicable licensor to these trademarks, service marks, and trade names.
This
offering circular and the documents incorporated by reference herein contains forward-looking statements that involve substantial risks
and uncertainties. All statements, other than statements of historical facts, contained herein and therein, including statements regarding
our strategy, future operations, future financial position, projected revenue, funding and expenses, prospects, plans and objectives
of management, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,”
“may,” “will,” “estimate,” “continue,” “anticipate,” “design,”
“intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,”
“seek,” “pursue,” “should,” “would,” “accelerate,” “project,”
“target,” “aim,” or the negative version of these words and similar expressions.
Forward-looking
statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements
to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements,
including those factors described in the section titled “Risk Factors” in this offering circular and elsewhere herein. Given
these uncertainties, you should not place undue reliance on any forward-looking statement. The following factors are among those that
may cause such differences:
●
Inability
to raise additional capital, under favorable terms or at all, or generate sufficient revenue
from our Section 503B compounding and consumer health products business strategies to fund
our operating needs and continue as a going concern;
●
Dependence
on grants and other financial awards from governmental entities and a private foundation
to advance the development of several of our product candidates;
●
Inexperience,
as a company, in and lack of infrastructure for commercializing products;
●
Reliance
on third parties to execute our operating plan and business strategy, including to commercialize
or assist us in commercializing products and conduct or assist us in conducting clinical
and nonclinical studies of our product candidates, and delays or difficulties in establishing
and maintaining agreements with third parties on a timely basis or on acceptable terms, or
at all, and obtaining expected performance from third parties;
●
The
number and scope of product development programs we pursue;
●
Difficulties
or delays in commencement or completion, or the termination or suspension, of our current
or planned clinical or preclinical studies;
●
Clinical
trial outcomes and results of preclinical development;
●
Failure
to complete development of our product candidates or submit and obtain United States Food
and Drug Administration, or FDA, or foreign regulatory authority approval for our product
candidates on projected timelines or budgets, or at all;
●
Challenges
and delays in obtaining timely supplies of our product candidates, including their components
as well as the finished product, in the quantities needed in accordance with current good
manufacturing practices, our specifications and other applicable requirements;
●
The
removal of sildenafil citrate or any other bulk drug substance needed to compound the compounded
drugs that we seek to make available under Section 503B of the Federal Food, Drug, and Cosmetic
Act, or FDCA, from the FDA’s list of bulk drug substances that can be compounded under
Section 503B;
●
The
degree of market demand and acceptance achieved by any product we or one of our licensees
or collaborators brings to market;
●
A
change in the laws or regulations related to compounded drugs under Section 503B of the FDCA
or consumer health products;
●
Termination
by a collaborator of our respective out-license agreements for commercialization of XACIATO®
(clindamycin phosphate) vaginal gel 2%, or XACIATO, and Ovaprene®, or, in the case of
Ovaprene, a decision by the collaborator not to make the license grant fully effective following
its review of the results of the ongoing pivotal clinical trial of Ovaprene;
2
●
The
timing and amount of future royalty, milestone or other payments to us, if any, under our
out-license agreement for Ovaprene, and of upside-sharing milestone payments from XOMA under
our traditional and synthetic royalty purchase agreements, if any;
●
The
terms and conditions of any future strategic collaborations relating to our product candidates;
●
Coverage
and reimbursement levels for XACIATO and any future product by government health care programs,
private health insurance companies and other third-party payors;
●
Our
loss of, or inability to attract, key personnel;
●
A
change in the FDA’s prior determination that the Center for Devices and Radiological
Health would lead the review of a premarket approval application for potential marketing
approval of Ovaprene;
●
A
change in regulatory requirements for our product candidates, including the development pathway
pursuant to Section 505(b)(2) of the FDCA, or the FDA’s 505(b)(2) pathway;
●
Unfavorable
differences between preliminary, interim or topline clinical study data reported by us and
final study results;
●
Communication
from the FDA or another regulatory authority, including a complete response letter, that
such agency does not accept or agree with our assumptions, estimates, calculations, conclusions
or analyses of clinical or nonclinical study data regarding a product candidate, or that
such agency interprets or weighs the importance of study data differently than we have in
a manner that negatively impacts the candidate’s prospects for regulatory approval
in a timely manner, or at all;
●
Failure
to select product candidates that capitalize on the most scientifically, clinically or commercially
promising or profitable indications or therapeutic areas within women’s health including
due to our limited financial resources;
●
Loss
or impairment of our in-licensed rights to develop and commercialize our products and product
candidates;
●
The
timing and amount of our payment and other obligations under our in-license and acquisition
agreements for our products and product candidates;
●
Developments
by our competitors that make any product or potential product we develop less competitive
or obsolete;
●
Unfavorable
or unanticipated macroeconomic factors, geopolitical events or conflicts, public health emergencies,
or natural disasters;
●
Weak
interest in women’s health relative to other healthcare sectors from the investment
community or from pharmaceutical companies and other potential development and commercialization
collaborators;
●
Cyber-attacks,
security breaches or similar events compromising our technology systems and data, our financial
resources and other assets, or the technology systems and data of third parties on which
we rely;
●
Difficulty
in introducing branded products in a market made up of generic products;
●
Inability
to adequately protect or enforce our, or our licensor’s, intellectual property rights;
●
Lack
of patent protection for the active ingredients in XACIATO and certain of the products and
potential products we develop that expose them to competition from other formulations using
the same active ingredients;
●
Higher
risk of failure associated with product candidates in preclinical stages of development that
may lead investors to assign them little to no value and make these assets difficult to fund;
●
Disputes
or other developments concerning our intellectual property rights;
●
Actual
and anticipated fluctuations in our quarterly or annual operating results or results that
differ from investors’ expectations for such results;
3
●
Failure
to maintain the listing of our common stock on the Nasdaq Capital Market or another nationally
recognized exchange;
●
Price
and volume fluctuations in the stock market, and in our stock in particular, which could
cause investors to experience losses and subject us to securities class-action litigation;
●
Development
of safety, efficacy or quality concerns related to our products or product candidates (or
third-party products or product candidates that share similar characteristics or drug substances),
whether or not scientifically justified, leading to delays in or discontinuation of product
development, product recalls or withdrawals, diminished sales, and/or other significant negative
consequences;
●
Product
liability claims or governmental investigations;
●
Changes
in government laws and regulations in the United States and other jurisdictions, including
laws and regulations governing the research, development, approval, clearance, manufacturing,
supply, distribution, pricing and/or marketing of our products, product candidates and related
intellectual property, health care information and data privacy and security laws, transparency
laws and fraud and abuse laws, and the enforcement thereof affecting our business; and
●
Increased
costs as a result of operating as a public company, and substantial time devoted by our management
to compliance initiatives and corporate governance practices.
In
addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These
statements are based upon information available to us as of the date made, and while we believe such information forms a reasonable basis
for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted
an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and
investors are cautioned not to unduly rely upon these statements.
All
forward-looking statements in this offering circular are current only as of the date of this offering circular. We do not undertake any
obligation to publicly update any forward-looking statement to reflect events or circumstances after the date on which any statement
is made or to reflect the occurrence of unanticipated events, except as required by law.
4
OFFERING
CIRCULAR SUMMARY
This
summary provides an overview of information appearing elsewhere in this offering circular and highlights the key aspects of this offering.
This summary does not contain all the information you should consider prior to investing in our securities. You should read this entire
offering circular and in the documents incorporated by reference herein, including the factors described under the section titled “Risk
Factors” of this offering circular, before making an investment decision. Unless otherwise stated, references in this offering
circular to particular years, quarters, months or periods refer to our fiscal years ending December 31 and the associated quarters, months
and periods of those fiscal years. Unless the context otherwise requires, references to “Daré” the “Company,”
“we,” “us,” and “our” in this offering circular refer to collectively to Daré Bioscience,
Inc. and its wholly-owned subsidiaries.
Business
Overview
We
are a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world
solutions. Every innovation we advance is based in advanced science and backed by rigorous, peer-reviewed research. From contraception
to menopause, pelvic pain to fertility, vaginal health to infectious disease, we’re closing critical gaps in care using science
that serves her needs.
For
decades, women have been told to “wait it out” or “live with it,” while innovations that could improve their
quality of life languish in the regulatory or funding pipeline.
With
growing awareness around menopause, sexual health, and vaginal health, the conversation is shifting. However, access to real, evidence-based
solutions continues to lag. Daré was founded to change that. As a female-led health biotech company, we are accelerating the development
of credible, science-based solutions that meet the high standards of clinical rigor – randomized, controlled trials; validated
endpoints; peer-reviewed publications; and current Good Manufacturing Practice (cGMP) requirements.
We
regularly hear from healthcare providers, researchers, and women themselves about the urgent need for expanded access to evidenced-based
and convenient options. Our goal is to fulfill that need by bringing innovative products to market as soon as practicable, whether as
FDA-approved therapies or through alternative regulatory pathways that enable earlier availability, such as Section 503B compounding.
Through a pipeline of investigational products and near-commercial, alternative pathway products, we aim to close persistent gaps in
care and deliver clinically meaningful advances that redefine standards in women’s health.
In
March 2025, we announced an expansion of our business model to include a dual-path approach to bringing new products to market. For select
proprietary formulations, we are pursuing both traditional FDA approval and earlier market access via outsourcing facilities registered
under Section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA), which may compound and distribute certain drugs without patient-specific
prescriptions. We believe this strategy allows us to respond to clinician and patient demand for timely access while continuing to generate
the data necessary to seek FDA approval and support long-term value creation. In addition to prescription-based offerings — both
FDA-approved products and compounded drugs— we intend to bring to market select consumer health products that do not require a
physician’s prescription, where appropriate based on product profile and market opportunity.
Beginning
in the fourth quarter of 2025, we expect to initiate commercialization of DARE to PLAY™ Sildenafil Cream, which we also refer to
as DARE to PLAY, a first-of-its-kind, topically applied formulation of sildenafil designed to improve female sexual arousal. The product
will be made available in the United States through a Section 503B-registered outsourcing facility – a pathway that enables us
to deliver clinically credible solutions directly to women through licensed prescribers and telehealth platforms. DARE to PLAY will address
an area of women’s health that has been historically underserved and stigmatized, and be a first-of-its-kind product in that, to
our knowledge, there are no other topical cream sildenafil products manufactured in accordance with cGMP requirements and supported by
clinical data demonstrating increased genital blood flow within 10-15 minutes of application and improvements in arousal sensations using
clinically validated and FDA-reviewed endpoints. We believe the product’s positioning – science-backed, evidence-driven,
and female-focused – sets a new benchmark for credibility in the female sexual wellness category.
Following
DARE to PLAY, we plan to expand our commercial portfolio with the introduction of our DARE to RESTORE™ product line, vaginal probiotic
products designed to support vaginal microbiome balance. These offerings, which will not require a physician’s prescription, align
with our broader vision to integrate clinically credible, evidence-based products into women’s health routines, including select
consumer health products.
5
Our
near-term commercial initiatives are designed not only to drive revenue but also to create a self-reinforcing ecosystem for growth. The
commercial experience, brand awareness, and provider engagement generated through these products can position us to efficiently introduce
additional pipeline candidates, including potential future FDA-approved products. By pursuing a balanced strategy that integrates short-term
commercial execution with long-term R&D investment, we aim to reduce reliance on dilutive capital and build a financially sustainable
model for innovation in women’s health.
We
are pursuing a capital-efficient path to commercialization that leverages targeted direct-to-consumer and healthcare professional marketing
initiatives to build awareness of our women’s health portfolio, including digital campaigns, webinars, social media education,
and advocacy programs. We do not have sales, marketing or distribution infrastructure, and currently, we do not intend to build our own
sales force or marketing and distribution infrastructure. However, reflecting the shift in our business model, we have been and will
be allocating resources to support commercial execution activities, including third-party manufacturing, market preparation, and strategic
partnerships.
Our
diverse portfolio of proprietary programs, assembled through acquisitions, exclusive in-licenses, and collaborations, targets product
categories we believe represent meaningful opportunities to improve women’s health and quality of life. These include contraception,
sexual health, pelvic pain, fertility, infectious disease, vaginal health, and menopause.
Our
business is subject to a number of risks common to biopharmaceutical companies and the process of developing, obtaining regulatory approvals
for, and commercializing prescription drug and drug/device products in the United States and in foreign jurisdictions, is inherently
uncertain, and requires the expenditure of substantial financial resources without any guarantee of success. See our discussion of many
of these risks under the sections entitled “Risk Factors” in the reports incorporated by reference into this offering circular.
Section
503B Compounding
As
discussed above, we are working to bring to market select proprietary formulations via Section 503B-registered outsourcing facilities.
In assessing which of our proprietary formulations are candidates for Section 503B compounding, in addition to the drug substance(s)
being on the FDA’s interim Category 1 list of bulk drug substances, we take into account whether we believe the formulation is
ready for cGMP manufacturing at scale to meet potential demand and that the data from nonclinical and clinical studies of the formulation
to date will be compelling to healthcare providers. We do not believe bringing those proprietary formulations to market via Section 503B
compounding will negatively impact the regulatory process or commercial opportunity for an FDA-approved product utilizing the same proprietary
formulation.
To
execute our Section 503B compounding strategy, among other things, we have entered into and will need to maintain arrangements with one
or more 503B-registered outsourcing facilities and other third parties with marketing, sales or distribution capabilities in the Section
503B market, and we intend to expand our collaborations, including by establishing relationships with telehealth platforms. We intend
to focus our resources on provider-to-provider education about disease state and our proprietary formulations, leveraging online resources,
including web-based ordering platforms and collaborations with telehealth platforms and other third parties. We do not plan to establish
marketing, sales or distribution capabilities in order to bring our proprietary formulations to market under Section 503B.
When
we use the term “Section 503B compounding” or “Section 503B,” we refer to the production and supply of compounded
drugs by Section 503B-registered outsourcing facilities without patient-specific prescriptions in accordance with Section 503B of the
FDCA.
DARE
to PLAY™ Sildenafil Cream
Our
proprietary topical cream formulation of sildenafil will be our first product to market under Section 503B. The compounded drug will
be branded as DARE to PLAY Sildenafil Cream. We expect to have DARE to PLAY Sildenafil Cream to become available by prescription in the
U.S. in December 2025 and to begin recording revenue from sales thereof in the fourth quarter of 2025, however, we do not expect the
amount of such revenue, if any, to be material during 2025. Because we are in the early stages of executing against our Section 503B
compounding strategy and, as an organization, we have no experience in or infrastructure for commercializing products, the amount of
potential revenue we may generate during 2026 remains uncertain. We anticipate needing to invest no more than $1.0 million to launch
DARE to PLAY Sildenafil Cream in 2025, which has been and will be utilized to support a 503B-registered outsourcing facility with technology-transfer
activities specific to DARE to PLAY Sildenafil Cream, activate an awareness campaign, and facilitate access to DARE to PLAY Sildenafil
Cream as an option for providers and women.
6
DARE
to RECLAIM™ estradiol progesterone intravaginal ring
We
are also taking action to bring our estradiol progesterone intravaginal ring to market under Section 503B. The compounded product will
be branded as DARE to RECLAIM estradiol progesterone intravaginal ring. We are targeting to have DARE to RECLAIM estradiol progesterone
intravaginal ring available, and to begin recording revenue from sales thereof, in early 2027. Because we are in the early stages of
executing against our Section 503B compounding strategy and, as an organization, we have no experience in or infrastructure for commercializing
products, the amount of potential revenue we may generate during 2027 remains uncertain. There are no FDA-approved products that provide
estradiol and progesterone together in a non-oral monthly form.
Consumer
Health Products - DARE to RESTORE™
We
are also working to bring to market a line of consumer health products branded as the DARE to RESTORE family of products, designed to
support vaginal microbiome balance. We have sourced vaginal probiotics from Europe that we are targeting to make available in the U.S.
in the first quarter of 2026.
When
we use the term “consumer health products,” we refer to consumer health products that can be obtained without a physician’s
prescription, unless the context otherwise requires.
Similar
to our plans with respect to our Section 503B business strategy, we do not plan to establish marketing, sales or distribution capabilities
in order to commercialize consumer health products, but rather we plan to pursue a capital-efficient path to market that leverages targeted
direct-to-consumer and healthcare professional marketing initiatives to build awareness, including digital campaigns, webinars, social
media education, and advocacy programs, as well as identify and enter into strategic agreements and collaborations with third parties
with marketing, sales or distribution capabilities in the consumer health products market.
Product
Candidates
Our
product candidates are in various stages of development, from pre-clinical through a pivotal Phase 3 clinical study, and will require
review and approval from the FDA, or a comparable foreign regulatory authority, prior to being marketed and sold. The most clinically
advanced product candidates we are developing are: Ovaprene®, an investigational, hormone-free, monthly intravaginal contraceptive
currently being evaluated in a pivotal Phase 3 clinical study, whose U.S. commercial rights are under a license agreement with Bayer
HealthCare LLC, or Bayer; Sildenafil Cream, 3.6%, or Sildenafil Cream, an investigational cream formulation of sildenafil, the active
ingredient in Viagra®, for topical administration for the treatment of female sexual arousal disorder, or FSAD; DARE-HRT1, an intravaginal
ring designed to deliver combination menopausal hormone therapy, bio-identical 17β-estradiol and progesterone together, continuously
over a 28-day period for the treatment of moderate to severe vasomotor symptoms, also known as hot flashes; DARE-VVA1, an investigational
formulation of tamoxifen in a soft gelatin capsule for intravaginal administration as a hormone-free alternative to estrogen-based therapies
for the treatment of moderate-to-severe dyspareunia, or pain during sexual intercourse; and DARE-HPV, an investigational, proprietary
fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert for the treatment of genital human papillomavirus (HPV)
infection in women as well as treatment of cervical intraepithelial neoplasia (also known as cervical dysplasia), and other HPV-related
pathologies. See ITEM 1. BUSINESS in Part I of our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC
on March 31, 2025 and “—Recent Events—Product Candidate Updates,” below, for additional information regarding
our product candidates.
XACIATO®
The
first FDA-approved product to emerge from our portfolio is XACIATO® (clindamycin phosphate) vaginal gel 2%, or XACIATO (pronounced
zah-she-AH-toe). We achieved FDA approval of XACIATO three years after acquiring rights to the program. XACIATO was approved by the FDA
in December 2021 as a single-dose prescription medication for the treatment of bacterial vaginosis in females 12 years of age and older.
In 2022, we licensed exclusive worldwide rights to develop, manufacture and commercialize XACIATO to an affiliate of Organon & Co.,
Organon International GmbH, or Organon. In January 2024, Organon announced that XACIATO was available nationwide in the U.S. In April
2024, we sold our rights to all royalty and potential milestone payments based on net sales of XACIATO under our agreement with Organon,
net of our obligations to certain third parties, to XOMA (US) LLC, or XOMA, until XOMA receives a specified return on its investment,
after which we will share equally in the royalty and milestone payments earned on net sales of XACIATO from Organon. See Note 3 “Strategic
Agreements” and Note 8 “Royalty Purchase Agreements” to the condensed consolidated financial statements included in
our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025 filed with the SEC on November 13, 2025 (“Q3
10-Q”), for information regarding our exclusive license agreement with Organon and our royalty purchase agreements with XOMA, respectively.
7
Recent
Events
Product
Candidate Updates
Ovaprene®
Enrollment
is ongoing in our pivotal Phase 3 multi-center, single arm, non-comparative clinical study of Ovaprene to evaluate its effectiveness
as a contraceptive along with its safety and acceptability (ClinicalTrials.gov ID: NCT06127199). We intend to maintain active recruitment
at five study sites, supported by grant funding we received in November 2024, We currently anticipate enrollment will be completed in
2026, and plan to provide further updates regarding anticipated enrollment and study completion targets next year.
In
July 2025, the study’s data safety monitoring board (DSMB), an independent group of experts which evaluates the safety and integrity
of the study, conducted a planned interim analysis and recommended the study continue without modification. No new safety or tolerability
concerns were identified. At the time of the interim analysis, approximately 9% of the women treated in the study had experienced a pregnancy.
Approximately 17% of participants discontinued the study due to vaginal odor, the most commonly reported product-related adverse event.
No serious safety concerns were identified, and overall tolerability was favorable. As of the interim analysis, approximately 115 participants
were ongoing or had completed the study. The target enrollment is approximately 250 participants completing approximately 12 months of
use. The primary objective of the study is to assess the typical use pregnancy rate over 13 menstrual cycles, or the estimated Pearl
Index for Ovaprene. Secondary objectives are to assess Ovaprene’s 13-cycle use cumulative pregnancy rate, safety, acceptability,
product fit/ease of use, and assessments of vaginal health.
The
Phase 3 study is being conducted, in part, under our Cooperative Research and Development Agreement, or CRADA, with the U.S. Department
of Health and Human Services (HHS), as represented by the Eunice Kennedy Shriver National Institute of Child Health and Human Development’s
(NICHD), part of the U.S. National Institutes of Health (NIH), and within the Contraceptive Clinical Trials Network (CCTN). In the first
quarter of 2025, due to uncertainty regarding the future NICHD budget for the CRADA following U.S. federal policy changes and executive
orders, we and NICHD agreed to pause recruitment of new participants at all 15 of the CCTN study sites then following enrolled participants
to help ensure the CCTN sites would remain active for continued follow-up with those participants. We will not resume recruitment of
participants at the CCTN sites. CCTN sites with ongoing subjects are expected to remain open to complete follow-up visits with those
participants.
Sildenafil
Cream, 3.6%
We
seek to advance Sildenafil Cream into the first of two anticipated Phase 3 clinical studies to support a new drug application to the
FDA for the indication of treatment of female sexual arousal disorder (FSAD) in premenopausal women utilizing the 505(b)(2) regulatory
pathway.
In
April 2025, we received additional input and information requests from the FDA regarding our patient reported outcomes (PRO) psychometrics
for the Phase 3 study. The PRO psychometrics analysis has bearing on efficacy endpoint selection and the statistical analysis plan for
the Phase 3 study. We submitted additional requested information to the FDA in the second quarter of 2025. Pending additional feedback
from the FDA, the timing of which is uncertain, and alignment with the FDA on the protocol and statistical analysis plan, we cannot determine
whether our prior estimate of capital required to conduct the Phase 3 studies is appropriate. As a result, we do not anticipate initiating
the first Phase 3 study in 2025 and cannot at this time reasonably predict when the study will commence.
Other
Development Programs
We
continue to work on the development of our other clinical and preclinical-stage programs, including conducting activities necessary to
enable submission of an investigational new drug, or IND, application to the FDA for a pivotal Phase 3 clinical study of DARE-HRT1, activities
in preparation for a Phase 2 randomized, double-blinded, placebo-controlled, dose-finding clinical study of DARE-VVA1 based on our FDA-cleared
IND relating to DARE-VVA1 and the anticipated study, and activities necessary to enable submission of an IND application to the FDA for
a Phase 2 clinical study of DARE-HPV in the United States.
8
Nasdaq
Listing
On
July 24, 2025, we received a letter from the Nasdaq Office of General Counsel confirming that we had demonstrated compliance with the
stockholders’ equity requirement in Nasdaq Listing Rule 5550(b)(1), or the Stockholders’ Equity Rule, and that we are therefore
in compliance with the Nasdaq Capital Market’s continued listing requirements. We are subject to a mandatory monitoring period
of one-year from July 24, 2025, and if, within that one-year period, the Nasdaq Listing Qualifications Staff determines that we are out
of compliance with the Stockholders’ Equity Rule, the Staff will issue a delist determination letter and we will have an opportunity
to request a new hearing with Nasdaq’s Hearing Panel. Notwithstanding Nasdaq Listing Rule 5810(c)(2), we will not be permitted
to provide a plan of compliance to the Staff with respect to such non-compliance, the Staff will not be permitted to grant additional
time for us to regain compliance, and we will not be afforded a cure period pursuant to Nasdaq Listing Rule 5810(c)(3). Until we regained
compliance with the Stockholders Equity Rule, we had not been in compliance with Nasdaq Listing Rule 5550(b) since August 2024. See the
risk factor titled, There is no assurance that we will continue satisfying the listing requirements of the Nasdaq Capital Market, in
the section titled “Risk Factors,” below.
Receipt
of Payments Under 2021 DARE-LARC1 Grant Agreement
In
July and October 2025, we received payments of $6.0 million and $4.0 million, respectively, from the Gates Foundation, or the Foundation,
under the agreement we entered into in June 2021 to support the development of DARE-LARC1, our preclinical-stage long-acting reversible
personal contraceptive system, through nonclinical proof-of-principle studies and other IND-enabling work to allow for the submission
of an IND application with the FDA. For a discussion of this agreement, see Note 10 “Grant Awards” to the condensed consolidated
financial statements included in our Q3 10-Q. Taking into account these payments, we have received a cumulative total of approximately
$41.8 million of the up to approximately $49.0 million in potential funding under the grant agreement.
Summary
of Risk Factors
We
are subject to numerous risks that make an investment in our securities speculative or risky. Below is a summary of the principal factors
that make an investment in our securities speculative or risky. This summary does not address all the risks we face. We urge investors
to carefully review and consider the additional discussion of the risks summarized in this risk factor summary, and other risks that
we face, which can be found below under the heading “Risk Factors,” together with other information in this offering circular
and the information incorporated by reference herein, before making investment decisions regarding our securities.
●
We
will need to raise substantial additional capital to continue our operations, execute our
business strategy and remain a going concern, and we may not be able to raise adequate capital
on a timely basis, on favorable terms, or at all. Raising additional capital may cause substantial
dilution to our stockholders, restrict our operations or require us to relinquish rights
in our technologies or product candidates and their future revenue streams.
●
If
we fail to maintain compliance with the continued listing requirements of the Nasdaq Capital
Market, our common stock could be delisted, which could, among other things, limit demand
for our common stock, substantially impair our ability to raise additional capital and have
an adverse effect on the market price of, and the efficiency of the trading market for, our
common stock.
●
We
have a limited operating history, a history of significant losses from operations, and expect
significant losses from operations, net losses and negative cash flows from operations to
continue for the foreseeable future, which, together with our limited financial resources,
make it difficult to assess our prospects.
●
Because
we are in the early stages of executing against our Section 503B compounding and consumer
health products strategy and, as an organization, we have no experience in or infrastructure
for commercializing products, the amount of potential revenue we may generate remains uncertain.
In addition, our Section 503B compounding strategy and commercializing consumer health products
subjects us to new regulations and potential liability.
●
All
of our product candidates are investigational, require the conduct and successful completion
of clinical studies and nonclinical work, and may never complete development or be submitted
for or receive regulatory approval. The FDA’s approval of XACIATO is not predictive
of favorable development or marketing approval outcomes for our product candidates.
9
●
Clinical
development is a lengthy and expensive process with an inherently uncertain outcome. Failure
to successfully complete clinical trials and nonclinical activities and obtain regulatory
approval to market and sell our product candidates on our anticipated timelines at reasonable
costs to us, or at all, particularly Ovaprene and Sildenafil Cream, could have a material
adverse effect on our business, operating results and financial condition.
●
The
regulatory approval processes of the FDA and comparable foreign authorities are expensive,
lengthy, time-consuming, and inherently unpredictable. If we are not able to obtain regulatory
approvals for our product candidates, our ability to generate product revenue will be materially
impaired.
●
We
rely on in-license agreements with third parties for rights to develop and commercialize
XACIATO and our product candidates. The loss or impairment of our rights under these agreements
could disrupt or require us to discontinue development or commercialization activities, or
impair our rights to receive payments from our sublicensees, which could have a material
adverse effect on our operations and business prospects and viability.
●
Strategic
collaborations are a key part of our strategy and our existing strategic collaborations are
important to our business. If we are unable to maintain existing strategic collaborations
or establish new ones, or if they are not successful, we may require substantial additional
capital to develop and commercialize our products and product candidates and our business
and prospects may be materially harmed.
●
Delays
and disruptions in the supply and manufacturing of our product candidates could postpone
the initiation of or interrupt our clinical studies, extend the timeframe and cost of development
of our product candidates, delay potential regulatory approvals and adversely impact the
commercialization of any approved products.
●
We
have no manufacturing, sales, marketing or distribution infrastructure. We depend heavily
on, and expect to continue to rely on, the performance of third parties, including third
parties for the compounding and distribution of DARE to PLAY, strategic collaborators, contract
manufacturers and suppliers, clinical research organizations, medical institutions, and scientific,
medical, regulatory and other consultants and advisors. Failure of these third parties to
perform as expected could result in substantial delays, increased costs or failures of our
Section 503B compounding strategy and our product development programs, delayed or unsuccessful
commercialization of any FDA-approved products, and the need for significant additional capital.
●
Due
in part to our limited financial and human resources, we may fail to effectively execute
our product development, regulatory submission and commercialization plans in accordance
with communicated timelines, or at all.
●
The
commercial success of XACIATO is outside of our control and will depend on Organon’s
efforts and capabilities and a variety of factors, many of which currently are unknown or
uncertain, and if commercialization of XACIATO is not successful, our reputation, business
and prospects may suffer.
●
Our
product candidates, if approved for commercial sale, and DARE to PLAY, DARE to RECLAIM, DARE
to RESTORE will face intense competition and may fail to achieve the degree of market acceptance
necessary for commercial success. Our business, operating results and financial condition
will suffer if we, or our commercial collaborators, fail to compete effectively.
●
Failure
to successfully obtain coverage and adequate reimbursement for XACIATO and any future products
from government health care programs and other third-party payors would diminish our ability,
or that of a commercial collaborator, to generate net product revenue or net sales. If out-of-pocket
costs for products we develop are deemed by women to be unaffordable, a commercial market
may never develop.
●
We
have a relatively small number of employees and if we fail to attract and retain key personnel
our business may materially suffer.
●
We
may not be successful in our efforts to identify and acquire or in-license additional product
candidates or technologies, which may limit our growth potential.
●
If
we and our licensors are unable to obtain and maintain sufficient intellectual property protection,
competitors could develop and commercialize or make available products similar or identical
to ours, which could significantly limit the commercial potential of our products and product
candidates and materially harm our business, financial condition, results of operations,
and prospects.
10
●
Most
of the products we are developing utilize active pharmaceutical ingredients that are not
proprietary to us or our licensors and the patents and patent applications owned by us and
our licensors intended to protect our products and product candidates relate to specific
formulations, processes, methods of delivery, and/or uses, which may not afford sufficient
protection against competitors.
●
Volatility
in the financial markets, geopolitical conflicts and events, natural disasters, public health
emergencies , international trade policies, and other macroeconomic factors may negatively
impact our business, financial condition and results and our stock price, including by increasing
the cost and timelines for our clinical development programs or making it more difficult
or costly to raise additional capital when needed.
●
Product
liability lawsuits against us could cause us to incur substantial liabilities and divert
management attention from our business.
●
The
price of our common stock has been and may continue to be highly volatile and such volatility
may be related or unrelated to our performance and operating results. Volatility in our stock
price may subject us to increased risk of securities litigation, including class-action lawsuits,
which could be expensive and divert management attention.
●
Future
dilution to our existing stockholders from sales and issuances of our common stock to raise
additional capital, or the market’s expectation that such sales may occur, could adversely
affect our stock price even if our business is doing well.
●
We
have been subject to a cyber-related crime and our controls and security measures may not
be successful in preventing other cybersecurity incidents in the future. Cyber-attacks, security
breaches, loss of data and other disruptions to our information technology systems or those
of our strategic collaborators or third-party service providers could compromise sensitive
or confidential information related to our business, delay or prevent us from accessing critical
information, subject us to significant financial loss, or expose us to liability, any of
which could adversely affect our business and our reputation.
Corporate
Information
We
were incorporated in Delaware in December 2005. Until July 2017, our corporate name was Cerulean Pharma Inc., or Cerulean. In July 2017,
Cerulean completed a business combination with Daré Bioscience Operations, Inc., at which time we changed our name to “Daré
Bioscience, Inc.” and began to focus on development of innovative, investigational products in women’s health. We and our
wholly-owned subsidiaries operate in one business segment.
Our
principal executive offices are located at 3655 Nobel Drive, Suite 260, San Diego, California 92122, and our telephone number at that
address is (858) 926-7655. Our website is located at https://www.darebioscience.com. The information contained on, or that can be accessed
through, our website is not a part of this prospectus. We have included our website address in this offering circular solely as an inactive
textual reference.
Implications
of Being a Smaller Reporting Company
We
qualify as a “smaller reporting company” under the rules promulgated under the Securities Act of 1933, as amended (the “Securities
Act”) and the Securities Exchange Act of 1934, as amended (the “Exchange Act”). As a result, we have chosen, and may
continue to choose, to take advantage of certain scaled disclosure requirements available specifically to smaller reporting companies.
We will remain a smaller reporting company until the last day of the fiscal year in which the aggregate market value of our common stock
held by non-affiliated persons and entities, or our public float, is greater than $250 million as of the last business day of our most
recently completed second fiscal quarter, or the last day of the fiscal year in which we have at least $100 million in revenue and at
least $700 million in public float as of the last business day of our most recently completed second fiscal quarter.
Continuing
Reporting Requirements Under Regulation A
We
are required to file periodic and other reports with the SEC pursuant to Section 13 of the Exchange Act. Our continuing reporting obligations
under Regulation A are deemed to be satisfied as long as we comply with our reporting requirements under Section 13 of the Exchange Act.
11
THE
OFFERING
Securities
Offered
We
are offering on a “best efforts” basis up to 4,854,000 Investor Units. Each Investor
Unit consists of one share of our Series A Preferred Stock and two Investor Warrants. Each
Investor Unit is being offered at an offering price of $5.00.
The
shares of our Series A Preferred Stock and the Investor Warrants that are part of the Investor Units are immediately separable and
will be issued separately, but must be purchased together as an Investor Unit in this offering.
This
offering circular also relates to the 9,708,000 shares of our common stock issuable upon conversion of the Series A Preferred Stock
that are part of the Investor Units and the 9,708,000 shares of common stock issuable upon exercise of the Investor Warrants.
Minimum
Investment
The
minimum investment amount per investor is $250 or a minimum of 50 Investor Units, subject
to our right to accept a lesser amount.
Terms
of Series A Preferred Stock
Ranking.
Our Series A Preferred Stock will rank, as to rights upon our liquidation, dissolution, or
winding up, senior to our common stock. The terms of our Series A Preferred Stock will not
limit our ability to (i) incur indebtedness or (ii) issue additional equity securities that
are senior in rank to our Series A Preferred Stock as to dividend or distribution rights
and rights upon our liquidation, dissolution or winding up.
Dividends.
Holders of our Series A Preferred Stock will not be entitled to receive any dividends.
Stated
Value. Each share of our Series A Preferred Stock has an initial stated value of $5.00,
subject to customary adjustments in the event of stock dividends, stock splits, reorganizations
or similar events affecting our Series A Preferred Stock.
Liquidation
Preference. The liquidation preference for each share of our Series A Preferred Stock
is $5.00 per share, subject to customary adjustments in the event of stock dividends, stock
splits, reorganizations or similar events. Upon our liquidation, dissolution or winding up,
to the extent we have the cash available, holders of shares of our Series A Preferred Stock
will be entitled to receive the liquidation preference with respect to their shares of Series
A Preferred Stock.
Optional
Conversion. Each share of our Series A Preferred Stock is convertible into two shares
of our common stock at the option of the holder at any time, subject to customary adjustments
in the event of stock dividends, stock splits, reorganizations or similar events. Notwithstanding
the foregoing, Nasdaq Listing Rules impose certain limitations on the conversion of our Series
A Preferred Stock if such conversion will result in a change of control of the company. See
“Description of Securities Being Offered” beginning on page 24 for additional
information.
Forced
Conversion. If at any time after issuance, any of the following events occurs, we will
have the right to require the holders of our Series A Preferred Stock to convert all, or
any portion of, their shares of our Series A Preferred Stock into shares of our common stock: (a) a change in control, (b) if the closing price of our common stock
is at or above $4.50 per share (subject to customary adjustments in the event of stock dividends,
stock splits, reorganizations or similar events) for any 10 trading days out of any 30 consecutive
trading day period, or (c) if we consummate a firm commitment public offering of our common
stock resulting in gross proceeds of at least $15.0 million at an offering price per share
equal to or greater than $4.50 (subject to customary adjustments in the event of stock dividends,
stock splits, reorganizations or similar events). Notwithstanding the foregoing, Nasdaq Listing
Rules impose certain limitations on the conversion of our Series A Preferred Stock if such
conversion will result in a change of control of the company. See “Description of Securities
Being Offered” beginning on page 24 for additional information.
12
Company
Call Option. Commencing on the third anniversary of the initial closing of this offering
and continuing indefinitely thereafter, we will have a right to call for redemption the outstanding
shares of our Series A Preferred Stock at a per share call price equal to the lesser of (i)
the stated value per share plus a non-compounded rate of return calculated at 8% per annum,
and (ii) 200% of the stated value per share, subject to customary adjustments in the event
of stock dividends, stock splits, reorganizations or similar events.
Voting
Rights. Except as required by law, our Series A Preferred Stock has no voting rights.
No
Redemption Right. Our Series A Preferred Stock has no maturity date, and we are not required
to redeem any of our Series A Preferred Stock at any time. Accordingly, unless converted
into shares of our common stock or we exercise our call option, our Series A Preferred Stock
will remain outstanding indefinitely.
Terms
of Investor Warrants
The
Investor Warrants are exercisable at any time after issuance through the 36-month anniversary
of their date of issuance at an exercise price of $4.00 per share of common stock, subject
to customary adjustments in the event of stock dividends, stock splits, reorganizations or
similar events. Notwithstanding the foregoing, Nasdaq Listing Rules impose certain limitations
on the exercise of the Investor Warrants if such exercise will result in a change of control
of the company. See “Description of Securities Being Offered” beginning on page
24 for additional information.
Investment
Perks:
In
recognition of investors who share our mission to advance women’s health innovation,
we intend to offer to eligible investors in this offering certain non-financial perks and
benefits (“Investor Perks”). Investor Perks are not investment returns and do
not affect the terms or value of the securities being offered. All Investor Perks are subject
to availability, applicable laws and regulations, and fulfillment conditions. We reserve
the right to modify or discontinue any Investor Perk at any time prior to fulfillment. See
“Plan of Distribution—Investor Perks” beginning on page 28 for further
details.
Selling
Agent; Best Efforts Offering
We
have engaged Digital Offering to serve as our lead selling agent to assist in the placement
of the Investor Units in this offering on a “best efforts” basis. Digital Offering
is not required to sell any specific number or dollar amount of Investor Units. We will pay
to Digital Offering a placement fee equal 7.25% of the offering price per Investor Unit sold
in this offering. See “Plan of Distribution” beginning on page 28 for further
details.
Agent
Unit Warrants
We
will issue Agent Unit Warrants to Digital Offering to purchase that number of Agent Units
equal to 3% of the total number of Investor Units sold in this offering. The Agent Unit Warrants
and the securities comprising and underlying the Agent Units Warrants will not be transferable
for a period of six months after the date of commencement of sales in this offering (in compliance
with FINRA Rule 5110(e)(1)), and the Agent Unit Warrants will expire on the five year anniversary
of the date of commencement of sales in this offering. The exercise price per Agent Unit
Warrant will be $6.25, which equals 125% of the offering price of the Investor Units. The
Agent Units issuable upon exercise of the Agent Unit Warrants will consist of one share of
our Series A Preferred Stock and two warrants, each to purchase one share of our common stock
at an exercise price of $4.00 per share, subject to customary adjustments in the event of
stock dividends, stock splits, reorganizations or similar events.
13
Restrictions
on Investment Amount
Generally,
no sale may be made to you in this offering if the aggregate purchase price you pay is more
than 10% of the greater of your annual income or net worth. Different rules apply to accredited
investors and non-natural persons. Before making any representation that your investment
does not exceed applicable thresholds, we encourage you to review Rule 251(d)(2)(i)(c) of
Regulation A. For general information on investing, we encourage you to refer to www.investor.gov.
Capital
Stock Outstanding Immediately After this Offering(1)
Immediately
after this offering, assuming we sell all the Investor Units offered hereby, our issued and
outstanding capital stock will consist of 14,289,502 shares of common stock and 4,854,000
shares of Series A Preferred Stock. The foregoing assumes that no shares of Series A Preferred
Stock or Investor Warrants issued to investors are converted or exercised, respectively,
and that no Agent Units Warrants are exercised.
Use
of Proceeds
If
we raise the maximum amount contemplated in this offering, we estimate our net proceeds,
after deducting estimated offering expenses payable by us, will be approximately $22.2
million, and excluding any proceeds that we may receive upon the cash exercise of the Investor
Warrants, the Agent Unit Warrants or the Agent Common Warrants. We intend to use the net
proceeds for working capital and general corporate purposes. See “Use of Proceeds”
on page 34.
Closings
of the Offering
We
intend to complete multiple closings for this offering on a rolling basis until the maximum
offering amount is raised or this offering is terminated. Until we complete a closing, the
amounts invested by investors in this offering will be kept in an escrow account maintained
at Wilmington Trust, N.A.
We
intend to have the initial closing on a date mutually determined by us and the lead selling agent. In determining when to have the
initial closing, we and the lead selling agent will take into account the number of investors with funds deposited in the escrow
account that have cleared the requisite anti-money laundering, know your client and background check procedures, and the total amount
of funds held in escrow pending the initial closing (although no minimum amount of funds is required to conduct the initial or any
subsequent closing). Following the initial closing, we expect to have closings monthly.
Investors
should expect to wait approximately 30 days and no longer than 45 days before we accept or reject their subscriptions. An investor’s
subscription is binding and irrevocable and an investor will not have the right to withdraw their subscription or receive a return
of their investment funds unless we reject their subscription or we terminate this offering before accepting their subscription.
You will receive a confirmation of your investment promptly following the closing in which you participate.
If
there are no closings, if your subscription is rejected or if funds remain in the escrow account upon termination of this offering
without any corresponding closing, the funds so deposited in the escrow account will be promptly returned to the applicable investors,
without deduction and without interest.
You
may not subscribe to purchase the securities offered hereby before the date that the offering statement of which this offering circular
forms a part is qualified by the SEC. Before such date, you may only make non-binding indications of your interest to purchase securities
in the offering.
See
“Plan of Distribution” beginning on page 28 for further details.
Termination
of the Offering
This
offering will terminate at the earliest of (i) the date on which the maximum offering amount
of Investor Units has been sold, (ii) the date that is one year after the date on which the
offering statement of which this offering circular forms a part is qualified by the SEC and
(iii) the date on which we determine to terminate this offering, which we may do in our sole
discretion at any time for any reason or no reason. Notwithstanding the termination of this
offering, the offering statement on Form 1-A of which this offering circular forms a part
will remain qualified in accordance with Rule 251(d)(3)(i)(F) of Regulation A until the date
on which all of the warrants to purchase shares of our common stock issued in this offering
and underlying the Agent Unit Warrants have been exercised.
14
No
Market for Series A Preferred Stock or Investor Warrants
There
is no existing trading market for the Investor Units, Series A Preferred Stock or the Investor
Warrants, and we do not expect one to develop. None of the Investor Units, Series A Preferred
Stock or the Investor Warrants are currently listed on any exchange or quoted in any automated
dealer quotation system or other over-the-counter market, and we do not intend to seek a
listing or quotation for any of them. The offering price of the Investor Units is not related
to, nor may it reflect, the market price of our common stock after this offering.
Common
Stock Listing
Our
common stock is listed on The Nasdaq Capital Market under the symbol “DARE.”
Dividend
Policy
We
do not anticipate that we will declare or pay dividends in the foreseeable future on our
Series A Preferred Stock or our common stock. Any future determination to declare dividends
would be subject to the discretion of our board of directors and would depend upon various
factors, including our results of operations, financial condition and liquidity requirements,
restrictions that may be imposed by applicable law and our contracts and other factors deemed
relevant by our board of directors.
Risk
Factors
See
the “Risk Factors” section beginning on page 16 and the other information included
herein for a discussion of factors to consider before deciding to invest in our securities.
(1)
Our issued and outstanding capital stock immediately after this offering is based on 13,929,502 shares of our common stock and zero shares
of our preferred stock outstanding as of September 30, 2025 and excludes, as of that date, the following:
●
1,409,042
shares of our common stock issuable upon the exercise of outstanding stock options with a
weighted average exercise price of $9.41 per share awarded under our stock incentive plans;
●
540,043
shares of our common stock available for future grant under our 2022 Stock Incentive Plan;
and
●
1,268,572
shares of our common stock issuable upon the exercise of outstanding warrants with a weighted
average exercise price of $7.49 per share; and
●
360,000
shares of our common stock issued after September 30, 2025 pursuant to our equity line arrangement
with Lincoln Park Capital Fund, LLC (“Lincoln Park”).
Except
as otherwise indicated, all information in this offering circular reflects and assumes:
●
no
exercise of any Investor Warrants;
●
no
conversion of any shares of Series A Preferred Stock issued as part of the Investor Units;
●
no
exercise of any Agent Unit Warrants (and therefore no issuance or conversion of any shares
of Series A Preferred Stock issuable upon exercise of the Agent Units Warrants or issuance
or exercise of any Agent Common Warrants issuable upon exercise of the Agent Units Warrants);
●
no
issuance, exercise or settlement of stock-based awards under our equity incentive plans;
and
●
no
sales of any shares of our common stock under our sales agreement with Stifel, Nicolaus &
Company, Incorporated, as sales agent, dated as of March 31, 2023 (“ATM sales agreement”)
or under our equity line arrangement with Lincoln Park.
15
RISK
FACTORS
Investment
in our securities involves a high degree of risk and uncertainty. Before deciding to purchase our securities, you should carefully read
and consider the risks and uncertainties described below and in Item 1A. Risk Factors of Part I of our Annual Report on Form 10-K for
the year ended December 31, 2024 filed with the SEC on March 31, 2025 (“2024 10-K”), as well as the other information and
documents contained in or incorporated by reference into this offering circular. The risks and uncertainties described in our 2024 10-K
are incorporated by reference into this offering circular. See the section titled “Where You Can Find Additional Information,”
below. Each of these risk and uncertainties could materially and adversely affect our business, financial condition, results of operations
and prospects, and could result in a partial or complete loss of your investment. Additional risks and uncertainties not presently known
to us or that we currently believe are immaterial may also significantly impair our business and prospects.
Risks
Related to Our Financial Position and Capital Needs
We
will need to raise substantial additional capital to continue our operations and execute our business strategy, and we may not be able
to raise adequate capital on a timely basis, on favorable terms, or at all.
We
have a history of losses from operations, we expect significant losses from operations, net losses and negative cash flows from operations
for at least the next several years. At September 30, 2025, we had an accumulated deficit of approximately $187.2 million, cash and cash
equivalents of approximately $23.1 million, and working capital of approximately $3.8 million, and we had a net loss of approximately
$12.0 million and negative cash flows from operations of approximately $11.3 million for the nine months ended September 30, 2025. A
majority of our cash and cash equivalents at September 30, 2025 represented funds received under grant agreements that may be applied
solely toward direct costs for the funded project under those grant agreements, other than an approximately 5% to 22% indirect cost allowance,
and as of September 30, 2025, our deferred grant funding liability was approximately $14.6 million, substantially all of which consisted
of funds intended to support the DARE-LARC1 program, the Ovaprene Phase 3 clinical study, and the DARE-HPV program. For more information
about these grant agreements, see “—Contractual Obligations and Other Commitments—Grant Agreements” in Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations of Part I of our Quarterly Report on Form
10-Q for the quarterly period ended September 30, 2025 filed with the SEC on November 13, 2025 (“3Q 10Q”), Note 2 “Basis
of Presentation and Summary of Significant Accounting Policies—Grant Funding” to our consolidated financial statements in
our 2024 10-K, and Note 10 “Grant Awards—Other Non-Dilutive Grant Funding” to the condensed consolidated financial
statements in our 3Q 10Q, all of which is incorporated herein by reference. See the section titled “Information Incorporated By
Reference,” below.
We
will require additional capital to advance the development programs in our pipeline that are not currently being supported by non-dilutive
grant or other award funding, to enable further investment across our entire portfolio of product candidates, and to support our long-term
operating plans. We will continue to evaluate and may pursue various capital raising options, including sales of equity, debt financings,
government or other grant funding, collaborations, structured financings, and commercial collaborations or other strategic transactions.
Our ability to obtain additional capital, and the timing and terms thereof, depend on various factors, many aspects of which are not
entirely within our control, and there can be no assurance that capital will be available when needed or, if available, on terms favorable
to us and our stockholders. Raising additional capital may cause substantial dilution to our stockholders, restrict our operations or
require us to relinquish rights in our technologies or product candidates and their future revenue streams. If we cannot raise capital
when needed, on favorable terms or at all, we will need to reevaluate our planned operations and may need to delay, scale back or eliminate
some or all of our product candidate programs and/or reduce expenses. For example, in recent years, due to our limited capital resources,
we have focused our resources primarily on the advancement of Ovaprene and Sildenafil Cream, unless a program has been supported by grant
or other non-dilutive funding, and we have delayed R&D activities for other programs. If we become unable to continue as a going
concern, we may have to liquidate our assets, and might realize significantly less than the values at which they are carried on our financial
statements, and our stockholders may lose all or part of their investment in our common stock.
16
Because
we are in the early stages of executing against our Section 503B compounding and consumer health products business strategies and, as
an organization, we have no experience in or infrastructure for commercializing products, both the timing and amount of potential revenue
we may generate remain uncertain. As a result, we may continue to incur significant losses from operations and negative cash flows from
operations for the next several years, and may never generate sufficient revenues to finance our operations or achieve profitability.
We expect our operating expenses will increase substantially in the future as we continue to develop and seek FDA approval for our product
candidates and expand our capabilities to support our 503B compounding and consumer health business strategies. Our future capital requirements
are difficult to predict because they will depend on many factors that are highly variable and difficult to predict, including, but not
limited to, those discussed in the risk factors in Part I, Item 1A of our 2024 10-K under “Risks Related to Our Financial Position
and Capital Needs.” See also the risk factor titled “We will need to raise substantial additional capital to continue our
operations and execute our business strategy, and we may not be able to raise adequate capital on a timely basis, on favorable terms,
or at all,” in Item 1A of Part I of our 2024 10-K.
We
have a limited operating history, a history of significant losses from operations, and expect significant losses from operations, net
losses and negative cash flows from operations to continue for the foreseeable future, which, together with our limited financial resources,
make it difficult to assess our prospects.
We
have a limited operating history upon which to evaluate our business and prospects. The success of our business is highly speculative
and developing FDA-approved drugs is a lengthy and expensive undertaking and involves substantial risk. We cannot accurately determine
the duration and completion costs of our development programs, or if, when and to what extent we will generate revenue from any products
we develop. Other than XACIATO, we have not obtained any regulatory approvals for any of our product candidates, commercialized any of
our product candidates or generated any product revenue. We have not been profitable since we commenced operations and may never achieve
profitability. We devote significant resources to licensing or otherwise acquiring the rights to our product candidates and to research
and development activities for them. We have a history of significant operating losses. We must raise additional capital to finance our
operations and remain a going concern and adequate additional capital may not be available to us on a timely basis, or at all.
Disruptions
at the FDA, NIH, SEC and other government agencies, including due to lack of funding, changes in leadership, significant personnel turnover,
or diminished staffing, could delay or disrupt clinical and preclinical development and potential marketing approval of our product candidates
and hinder our ability to raise additional capital.
Considerable
uncertainty exists regarding how federal government policy changes and budget decisions will unfold, including the regulatory and spending
priorities of the new U.S. presidential administration and Congress, and what challenges potential policy changes and budget reductions
will present for us and our industry generally. Measures being implemented by the current U.S. presidential administration have already
had a significant impact federal regulatory agencies, such as by reducing funding to or restructuring such agencies. For example, in
2025 the U.S. presidential administration began terminating federal government employees and federal agencies were directed to develop
plans for large-scale reductions in force and reorganization. As a result, agencies throughout the federal government may experience
mass layoffs, as well as a significant number of voluntary departures. The impact of these changes at federal government agencies with
which we interact is uncertain at this time, however, mass layoffs and large-scale voluntary departures, in particular at the FDA, NIH,
ARPA-H and SEC, could adversely impact our company, and we cannot predict what further measures will be implemented in future. If the
FDA experiences significant workforce reduction or turnover, the agency may be unlikely to meet its application review goals or be available
for timely interactions regarding our product development plans, which could delay our ability to advance clinical development of our
product candidates or obtain marketing approvals. The ability of the FDA to review and approve new product applications or take action
with respect to other regulatory matters can be affected by a variety of factors, including funding levels, ability to accept the payment
of user fees, ability to hire and retain key personnel, and statutory, regulatory and policy changes. Disruptions at the FDA may delay
meetings and other communications with or on-site inspections by agency staff necessary to progress development of our product candidates
and may slow the time necessary for acceptance, review and approval of applications to commence clinical studies or to market a new product
in the U.S. By way of further example, disruptions at the NIH, including its various institutes and centers, such as NICHD, could delay
or prevent providing or processing new grant awards to fund research and development activities and disrupt staff’s work and other
activities or funding under active grant/cooperative agreements.
17
In
addition, U.S. government shutdowns that caused federal agencies to halt non-essential operations occurred three times in the past decade.
Political polarization among lawmakers may lead to a higher frequency and longer duration of government shutdowns in the future. Any
future federal government shutdown could prevent or delay staff at federal agencies from performing key functions that may adversely
affect our business. For example, a U.S. government shutdown could (i) prevent and significantly delay the FDA, NIH, SEC and other regulatory
agencies from hiring and retaining personnel and conducting their regular activities, (ii) result in agency restructuring or significant
reductions in funding, leadership changes, workforce reduction or employee turnover, (iii) significantly impact the ability of these
agencies to timely review and process our regulatory submissions and may impede our access to additional capital needed to maintain or
expand our operations.
Risks
Related to Ownership of Our Securities
Raising
additional capital may cause substantial dilution to our stockholders, restrict our operations or require us to relinquish rights in
our technologies or product candidates and their future revenue streams.
As
discussed above, we may seek to raise additional capital through a variety of means. Raising capital through the issuance of shares of
our common stock, or securities convertible into or exercisable for our common stock, may depress our stock price and substantially dilute
our existing stockholders. The terms of securities issued may include liquidation or other preferences that may materially adversely
affect the rights of our existing stockholders. Debt and other structured financings, if available, would increase our fixed payment
obligations and may involve covenants requiring us to maintain specified financial ratios or a specified cash balance, or limiting or
restricting our ability to take specific actions, such as incurring additional debt, acquiring, selling or licensing intellectual property
rights, and making capital expenditures, or impose other operating restrictions that could adversely impact our ability to operate our
business and pursue our strategic objectives. We could also be required to meet certain milestones in connection with a debt financing
and the failure to achieve such milestones by certain dates may force us to relinquish rights to some of our technologies, product candidates
or products, or otherwise agree to terms unfavorable to us. In addition, we may forego part or all of potentially valuable streams of
future payments (e.g., milestone and/or royalty revenue) to raise immediate capital to fund our operations and advance our development
programs, such as in the case of our royalty interest financing agreement with United in Endeavour, LLC, and our royalty purchase agreements
with XOMA (US) LLC. Moreover, the lower our cash balance when we seek to raise additional capital, the more difficult, costly or dilutive
to our existing stockholders it may be for us to raise additional capital.
We
may be required to seek additional capital through arrangements with collaborators at an earlier stage of development or commercialization
of our technologies, product candidates or products than otherwise would be desirable, in which case we may grant rights to our technologies,
product candidates or products on terms that may not be as favorable to us or grant rights that we would otherwise prefer to retain.
If we raise capital through new collaborations, strategic alliances or other similar types of arrangements, we may relinquish valuable
rights to future revenue streams. Licensing agreements likely would significantly reduce our control over the development or commercialization
of the licensed technology, product candidates or products, and our collaborators may become unable or unwilling to devote adequate resources
to realize their full potential value. If we obtain funding through grants from governmental entities or private organizations, such
parties may impose restrictions on our rights to technologies, product candidates or products developed with such funding, obtain rights
to license such technologies, product candidates or products to third parties (e.g., if we are unable or unwilling to commercialize a
product or make it available to certain patient populations in a timely manner or at certain prices), or require future royalty or other
payments if such technologies, product candidates or products are commercialized.
We
have relied heavily on sales of our common stock to fund our operations, and our ability to obtain additional capital through stock sales
or other securities offerings may be more costly or dilutive to our stockholders than in the past, or may not be available to us at all.
Our ability to raise additional capital may be limited by a low trading volume, stock price and market capitalization, as well as by
laws, regulations and market conditions.
We
have relied heavily on our ability to raise capital by selling shares of our common stock. For example, from January 1, 2025 through
September 30, 2025, we raised an aggregate of approximately $19.6 million in net proceeds from sales of our common stock. Our ability
to raise additional capital through sales of our common stock or other securities offerings will depend on several factors, many of which
may not be in our favor, including the trading volume and volatile trading price of our common stock, our relatively low public float
and market capitalization, our potential inability maintain compliance with the listing requirements of the Nasdaq Capital Market, unfavorable
financial market conditions, and the other risks and uncertainties. If we are unable to raise additional capital through the offering
and sale of shares of our common stock, or securities convertible into or exercisable for our common stock, on a timely basis or on acceptable
terms, or at all, we may seek additional capital through other third-party sources that require us to relinquish valuable rights in our
intellectual property, technologies, product candidates or future revenue streams, or that subject us to restrictive covenants, operational
restrictions or security interests in our assets, or we may need to delay, scale back or eliminate some or all of our development programs,
reduce other expenses, file for bankruptcy, reorganize, merge with another entity, or cease operations.
18
Using
a shelf registration statement to conduct an equity offering to raise capital generally takes less time and is less expensive than other
means, such as conducting an offering under a Form S-1 registration statement. We currently have a shelf registration statement effective,
however, our ability to raise capital under a shelf registration statement is, and may continue to be, limited by, among other things,
current and future SEC rules and regulations impacting the eligibility of smaller companies to use Form S-3 for primary offerings of
securities. For example, we currently are subject to the “baby shelf rule.” This means that we may use our shelf registration
statement to raise additional funds only to the extent that the aggregate market value of securities sold by us or on our behalf pursuant
to Instruction I.B.6. of Form S-3 during the 12 calendar months immediately prior to, and including, the intended sale does not exceed
one-third of the aggregate market value of our public float, calculated in accordance with the instructions to Form S-3. Based on the
aggregate market value of our public float as of the date of this offering circular and on the aggregate market value of securities sold
by us or on our behalf pursuant to Instruction I.B.6. of Form S-3 during the 12 calendar months immediately prior to the date of this
offering circular, we are unable to raise capital under our shelf registration. If our ability to offer securities under our shelf registration
statement is limited, including by the baby shelf rule, we may choose to conduct an offering of our securities under an exemption from
registration under the Securities Act or under a Form S-1 registration statement. We would expect either of these alternatives to take
more time and be a more expensive method of raising additional capital relative to using our shelf registration statement.
In
addition, under SEC rules and regulations, our common stock must be listed and registered on a national securities exchange in order
to use a Form S-3 registration statement (1) for a primary offering, if our public float is not at least $75.0 million as of a date within
60 days prior to the date of filing the Form S-3 or a re-evaluation date, whichever is later, and (2) to register the resale of our securities
by persons other than us (i.e., a resale offering). While our common stock is currently listed on the Nasdaq Capital Market, there can
be no assurance that we can maintain such listing. See, “Although our common stock is currently listed on the Nasdaq Capital Market,
there is no assurance that we will continue satisfying the listing requirements of the Nasdaq Capital Market,” below.
Our
ability to raise capital on a timely basis through the issuance and sale of equity securities may also be limited by Nasdaq’s stockholder
approval requirement for any transaction that is not a public offering (as defined in Nasdaq listing rules). For transactions other than
public offerings, Nasdaq requires stockholder approval prior to the issuance or potential issuance of common stock (or securities convertible
into or exercisable for common stock) at a price per share that is less than the “Minimum Price” if the issuance (together
with sales by our officers, directors and substantial shareholders (as defined in Nasdaq listing rules)) would equal 20% or more of our
common stock outstanding before the issuance. Under Nasdaq rules, the “Minimum Price” means a price that is the lower of
(i) the Nasdaq official closing price immediately preceding the signing of the binding agreement; or (ii) the average Nasdaq official
closing price of the common stock for the five trading days immediately preceding the signing of the binding agreement. In addition,
certain prior sales of securities by us may be aggregated with any offering we may propose at a price that is less than the Minimum Price
and which is not considered a public offering by Nasdaq, further limiting the amount we could raise in the offering. Under Nasdaq rules,
stockholder approval is also required prior to the issuance of securities when the issuance or potential issuance will result in a change
of control of our company. Even if a public offering under Nasdaq rules is not subject to the 20% limitation described above, it may
involve publicly announcing the proposed transaction, which often has the effect of depressing the market price of a company’s
stock and could result in a reduced offering price. Accordingly, our existing investors may suffer greater dilution if we seek to raise
additional capital through such a public offering of our securities.
Obtaining
stockholder approval is a costly and time-consuming process. If we must obtain stockholder approval for a potential transaction, we would
expect to spend substantial additional money and resources. In addition, seeking stockholder approval would delay our receipt of otherwise
available capital, which may materially and adversely affect our ability to execute our business plan, and there is no guarantee our
stockholders ultimately would approve a proposed transaction.
19
Although
our common stock is currently listed on the Nasdaq Capital Market, there is no assurance that we will continue satisfying the listing
requirements of the Nasdaq Capital Market.
Our
common stock is listed on the Nasdaq Capital Market. To maintain our listing we are required to satisfy continued listing requirements,
including the requirements commonly referred to as the minimum bid price rule and with either the stockholders’ equity rule or
the market value of listed securities rule. The minimum bid price rule requires that the closing bid price of our common stock be at
least $1.00 per share, and the stockholders’ equity rule requires that our stockholders’ equity be at least $2.5 million,
or, alternatively, that the market value of our listed securities be at least $35 million or that we have net income from continuing
operations of $500,000 in the most recently completed fiscal year or in two of the three most recently completed fiscal years.
We
were not in compliance with the stockholders’ equity rule or the market value of listed securities rule from August 2024 until
July 24, 2025, and we were not in compliance with the minimum bid price rule from July 2023 until July 2024 and from December 2022 until
January 2023. Although we regained compliance with the applicable rule in each instance, but there can be no assurance that we will continue
to satisfy those or other continued listing requirements and maintain the listing of our common stock on the Nasdaq Capital Market.
When
Nasdaq confirmed that we regained compliance with the stockholders’ equity rule on July 24, 2025, Nasdaq also informed us that,
pursuant to Nasdaq Listing Rule 5815(d)(4)(B), we will be subject to a mandatory panel monitor for a period of one year from July 24,
2025, and that if, within that one-year period, the Nasdaq Listing Qualifications Staff, or the Staff, determines that we are out of
compliance with the stockholders’ equity rule, the Staff will issue a delist determination letter and we will have an opportunity
to request a new hearing with Nasdaq’s Hearings Panel. Notwithstanding Nasdaq Listing Rule 5810(c)(2), we will not be permitted
to provide a plan of compliance to the Staff with respect to such non-compliance, the Staff will not be permitted to grant additional
time for us to regain compliance, and we will not be afforded a cure period pursuant to Nasdaq Listing Rule 5810(c)(3). The foregoing
would limit our ability to regain compliance with the stockholders’ equity rule, and increases the likelihood that our common stock
may be delisted, in the event we were to become non-compliant with the stockholders’ equity rule during the one-year monitoring
period.
The
suspension or delisting of our common stock, or the commencement of delisting proceedings, for whatever reason, could, among other things,
substantially impair our ability to raise additional capital; result in the loss of interest from institutional investors, the loss of
confidence in our company by investors and employees, and in fewer financing, strategic and business development opportunities; and result
in potential breaches of agreements under which we made representations or covenants relating to our compliance with applicable listing
requirements. Claims related to any such breaches, with or without merit, could result in costly litigation, significant liabilities
and diversion of our management’s time and attention and could have a material adverse effect on our financial condition, business
and results of operations. In addition, the suspension or delisting of our common stock, or the commencement of delisting proceedings,
for whatever reason, may materially impair our stockholders’ ability to buy and sell shares of our common stock and could have
an adverse effect on the market price of, and the efficiency of the trading market for, our common stock.
If
we fail to attract or maintain securities analysts to publish research on our business or if they publish or convey negative evaluations
of our business, the price of our stock could decline.
The
trading market for our common stock relies in part on the research and reports that industry or financial analysts publish about us or
our business. We do not have any control over these analysts. If one or more of the analysts covering our business downgrade their evaluations
of our stock, the price of our common stock could decline. As of the date of this offering circular, to our knowledge, four analysts
cover our company. If one or more of these analysts cease coverage or fail to regularly publish reports on our business, we could lose
visibility in the financial markets, which in turn could cause our common stock price or trading volume to decline.
Risks
Related to This Offering
There
is no public market for any of the Investor Units, the shares of Series A Preferred Stock or the Investor Warrants being offered in this
offering.
There
is no existing trading market for the Investor Units, Series A Preferred Stock or the Investor Warrants, and we do not expect one to
develop. None of the Investor Units, Series A Preferred Stock or the Investor Warrants are currently listed on any exchange or quoted
in any automated dealer quotation system or other over-the-counter market, and we do not intend to seek a listing or quotation for any
of them. With no trading market, it may be extremely difficult or impossible for you to resell your Series A Preferred Stock or Investor
Warrants if you should desire to do so. In addition, there can be no assurance that, in the event you are able to find a purchaser for
your Series A Preferred Stock or Investor Warrants, that you will be able to resell such securities at the price you paid in this offering.
Prospective investors who require liquidity in their investment should not rely upon the Series A Preferred Stock or Investor Warrants
being offered in this offering as a short-term component of their return on investment.
20
This
is a fixed price offering and the fixed offering price may not accurately represent the current value of our company or our assets at
any particular time. Therefore, the purchase price you pay for the Investor Units may not be supported by the value of our assets at
the time of your purchase.
This
is a fixed price offering, which means that the offering price for the Investor Units is fixed and will not vary based on the underlying
value of our assets at any time. The offering price has not been based on appraisals of any assets we own or may own, or of our company
as a whole, nor do we intend to obtain such appraisals. Therefore, the offering price may not be supported by the current value of our
company or our assets at any particular time. See the section titled “Determination of Offering Price,” below.
We
have broad discretion in the use of the net proceeds from this offering and may not use them effectively.
Our
management will have broad discretion in the application of the net proceeds from this offering. Because of the number and variability
of factors that will determine our use of the net proceeds from this offering, their ultimate use may vary substantially from their currently
intended use. Our management might spend the proceeds in ways with which you and other investors do not agree, or in ways that do not
improve our financial condition, operating results, or market value, which could compromise our ability to pursue our business strategy
and adversely affect the value of your investment and the market price of our common stock. Pending their use, we may invest the net
proceeds from this offering in short-term, investment-grade, interest-bearing securities. These investments may not yield a favorable
return to our stockholders. See the section titled “Use of Proceeds,” below.
Holders
of shares of our Series A Preferred Stock and Investor Warrants will have no rights as common stockholders until such holders convert
or exercise such shares or warrants, respectively, and acquire shares of our common stock.
If
you hold shares of our Series A Preferred Stock or Investor Warrants you will have no rights with respect to the shares of our common
stock underlying such shares and warrants, such as voting rights, unless and until you acquire the shares of our common stock issuable
upon conversion or exercise of such shares and warrants, respectively. Upon conversion or exercise of shares of our Series A Preferred
Stock or Investor Warrants, respectively, you will be entitled to exercise the rights of a common stockholder only as to matters for
which the record date occurs after the date on which the shares are deemed issued upon such conversion or exercise, as applicable.
The
Investor Warrants are speculative in nature.
The
Investor Warrants do not confer any rights of common stock ownership on their holders, such as voting rights or the right to receive
dividends, but rather merely represent the right to acquire shares of our common stock at a fixed price. Moreover, following this offering,
the market value of the Investor Warrants is uncertain and there can be no assurance that the market price of our common stock will equal
or exceed the exercise price of the Investor Warrants, and consequently, whether it will ever be profitable for holders to exercise the
Investor Warrants.
This
offering is being conducted on a “best efforts” basis and no minimum amount of securities is required to be sold.
The
selling agent has agreed to use its reasonable best efforts to sell the Investor Units in this offering. The selling agent has no obligation
to buy any of the Investor Units from us or to arrange for the purchase or sale of any specific number or dollar amount of the Investor
Units. There is no required minimum number of Investor Units that must be sold as a condition to closing this offering. Because there
is no minimum offering amount required as a condition to closing this offering, the actual offering amount, selling agent fees and net
proceeds to us are not presently determinable and may be substantially less than the maximum amounts described in this offering circular.
We may sell fewer than all of the Investor Units offered hereby, which may significantly reduce the amount of net proceeds received by
us, and investors in this offering will not receive a refund. No assurance can be given to you that any funds will be invested in this
offering other than your own or that we will have sufficient funds to execute our business plan or satisfy our working capital requirements
and you will bear the risk that we will be unable to secure the funds necessary to meet our current and anticipated financial obligations.
21
We
may terminate this offering at any time.
We
reserve the right to terminate this offering at any time and for any reason or no reason, regardless of the number of Investor Units
sold. There is no minimum offering amount that we must raise in this offering before we complete a closing. We may close on any funds
that we receive. An investor’s subscription is binding and irrevocable and an investor will not have the right to withdraw their
subscription or receive a return of their investment funds unless we reject their subscription or we terminate this offering before accepting
their subscription. Potential investors should be aware that there can be no assurance that any funds other than their funds will be
invested in this offering.
If
you purchase Investor Units in this offering, your interest will be immediately diluted to the extent of the difference between the offering
price per Investor Unit and the adjusted net tangible book value per share of our common stock after this offering.
The
offering price per Investor Unit in this offering is $5.00. Each Investor Unit consists of one share of Series A Preferred Stock, which
is convertible into two shares of our common stock, and two Investor Warrants, each to purchase one share of our common stock at a per
share exercise price of $4.00, in each case, subject to customary adjustments in the event of stock dividends, stock splits, reorganizations
or similar events. The effective purchase price per share of common stock issuable upon conversion of each share of Series A Preferred
Stock is $2.50. After giving effect to the sale of all the Investor Units in this offering for an aggregate offering amount of $24.3
million, assuming no exercise of any of the Investor Warrants or Agent Unit Warrants, and after deducting the selling agent’s fees
and estimated offering expenses payable by us, you would suffer immediate dilution of $1.44 per share in the pro forma as adjusted net
tangible book value of our common stock. See the section titled “Dilution,” below.
If
you purchase our securities in this offering, you may experience future dilution as a result of future financings.
We
will issue additional shares of our common stock or other equity or convertible debt securities in order to raise additional capital.
Future investors in such financings may have rights superior to investors in this offering, and the effective price per share at which
we sell shares of common stock in future financings may be at a higher or lower effective price per share of common stock than the effective
price per share of common stock in this offering.
We
may issue equity or debt securities that are senior to our Series A Preferred Stock as to distributions and in liquidation, which could
materially adversely affect the value of our Series A Preferred Stock.
We
may issue equity or debt securities, which could include issuances of other series of preferred stock and/or senior secured debt securities.
In the event of our liquidation, holders of equity or debt securities that rank senior to our Series A Preferred Stock would receive
a distribution of our available assets before distributions to holders of our Series A Preferred Stock and our common stock. Any shares
of preferred stock, if issued, may have a preference with respect to distributions and upon liquidation that is senior to the preference
of our Series A Preferred Stock, which could further limit our ability to make distributions to holders of our Series A Preferred Stock
and our common stock. Because our decision to issue securities and the terms of such securities in future offerings will depend on market
conditions and other factors beyond our control, we cannot predict or estimate the amount, timing or nature of our future offerings.
Further, market conditions could require us to accept less favorable terms for the issuance of our securities in the future. Thus, you
will bear the risk of our future offerings reducing the value of the securities offered in this offering.
The
subscription agreement that investors will execute in connection with this offering has an exclusive forum selection provision that requires
disputes be resolved in state or federal courts in the State of Delaware, regardless of convenience or cost to you, the investor.
The
subscription agreement that investors will execute to purchase Investor Units requires any claims against us based on the subscription
agreement to be brought in a state or federal court of competent jurisdiction in the State of Delaware. By purchasing Investor Units,
investors consent to the jurisdiction of the state courts located within the State of Delaware. Investors located outside the State of
Delaware may have difficulty bringing any legal claim against us due to geographic limitations and may find it difficult and costly to
respond to claims. Although we believe the provision benefits us by providing increased consistency in the application of Delaware law
in the types of lawsuits to which it applies and in limiting our litigation costs, the forum selection provision may limit investors’
ability to bring claims in judicial forums that they find favorable to such disputes, may increase investors’ costs of bringing
suit and may discourage lawsuits with respect to such claims. Alternatively, if a court were to find the provision inapplicable to a
particular claim or unenforceable, we may incur additional costs associated with resolving such matters in other jurisdictions, which
could adversely affect our business, financial condition or results of operations. This exclusive forum provision would not apply to
suits brought to enforce a duty or liability created by federal securities laws or any other claim for which the U.S. federal courts
have exclusive jurisdiction.
22
Investors
in this offering may not be entitled to a jury trial with respect to claims arising under the subscription agreement, which could result
in less favorable outcomes to the plaintiff(s) bringing any such claim.
Investors
in this offering will be bound by the terms of the subscription agreement they sign in connection with their investment, which includes
a provision under which investors waive the right to a jury trial of any claim they may have against us arising out of or relating to
the agreement other than those arising under the federal securities laws.
If
we oppose a jury trial demand based on the jury trial waiver, we expect that a court will determine whether the waiver is enforceable
based on the facts and circumstances of that case in accordance with the applicable law and that a court will consider whether the visibility
of the jury trial waiver provision within the agreement was sufficiently prominent such that a party knowingly, intelligently and voluntarily
waived the right to a jury trial. We believe that the jury trial provision is sufficiently prominent in the subscription agreement. You
should consult legal counsel regarding the jury waiver provision before signing the subscription agreement.
If
you bring a claim against us arising out of or relating to the subscription agreement (other than a claim arising under the federal securities
laws), you may not be entitled to a jury trial with respect to such claim, which may limit and discourage claims against us. If a claim
is brought against us under the subscription agreement and it is not subject to a jury trial, it would be conducted under different procedures
and may result in outcomes that differ from those that may have resulted if the claim was heard by a jury, including outcomes that could
be less favorable to you.
Investors
electing to pay for their Investor Units with a credit card may impact the return on their investment.
Investors
in this offering have the option of paying for their investment with a credit card. Interest or other fees you may incur related to using
that form of payment may increase the effective purchase price of the Investor Units you purchase in this offering. For example, you
may incur interest on unpaid card balances, and credit card interest rates can be high, more than 20% in certain cases. The cost of using
a credit card may also increase if you do not make the minimum monthly card payments and incur late fees. Using a credit card is a relatively
new form of payment for the purchase of securities and will subject you to risks inherent in this form of payment, including that, if
you fail to make a credit card payment (e.g. minimum monthly payments), you risk damaging your credit score and payment by credit card
may be more susceptible to abuse than other forms of payment. Moreover, where a third-party payment processor is used, as is the case
in this offering, your recovery options in the case of disputes may be limited. The increased costs due to transaction fees and interest
may reduce the return on your investment.
The
SEC’s Office of Investor Education and Advocacy issued an Investor Alert dated February 14, 2018 entitled: Credit Cards and Investments
– A Risky Combination, which explains these and other risks you may want to consider before using a credit card to pay for your
investment.
23
DESCRIPTION
OF SECURITIES BEING OFFERED
Authorized
Capital
We
are authorized to issue up to 240,000,000 shares of common stock, $0.0001 per value per share, and up to 5,000,000 shares of preferred
stock, $0.01 par value per share. As of November 12, 2025, we had outstanding 14,289,229 shares of common stock and no shares of preferred
stock. The issued and outstanding shares of common stock are duly authorized, validly issued, fully paid and nonassessable.
The
following is a brief description of the rights of our common stock and Series A Preferred Stock. The description is qualified in its
entirety by reference to, and should be read in conjunction with, our Restated Certificate of Incorporation (as amended to date, including
the Certificate of Correction of the Certificate of Amendment of our Restated Certificate dated June 21, 2024, our “certificate
of incorporation”), the Certificate of Designations of Preferences, Rights and Limitations of Series A Convertible Preferred Stock
dated [●] (the “Series A Preferred Stock certificate of designation”), our Third Amended and Restated By-laws (as amended,
our “bylaws”), and the applicable provisions of the Delaware General Corporation Law (the “DGCL”). Our certificate
of incorporation and bylaws are filed as exhibits to our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and
the Series A Preferred Stock certificate of designation will be filed as an exhibit to the offering statement on Form 1A of which this
offering circular forms a part. See the section titled, “Where You Can Find More Information,” below.
Common
Stock
Voting
Rights. Each holder of our common stock is entitled to one vote for each share on all matters submitted to a vote of the stockholders,
including the election of directors. Our stockholders do not have cumulative voting rights. When a quorum is present at any meeting,
generally any matter other than the election of directors to be voted upon by the stockholders at such meeting will be decided by the
vote of the holders of shares of stock having a majority in voting power of the votes cast by the holders of all of the shares of stock
present or represented at the meeting and voting affirmatively or negatively on such matter (or if there are two or more classes or series
of stock entitled to vote as separate classes, then in the case of each such class or series, the holders of a majority in voting power
of the shares of stock of that class or series present or represented at the meeting and voting affirmatively or negatively on such matter),
except when a different or minimum vote is required by applicable law, our certificate of incorporation or bylaws, in which case such
different or minimum vote will be the applicable vote on the matter. When a quorum is present at any meeting, any election by stockholders
of directors will be determined by a plurality of the votes cast by the stockholders entitled to vote on the election.
Dividend
Rights. Subject to preferences that may apply to any then outstanding shares of preferred stock, holders of our common stock are
entitled to receive dividends, if any, as may be declared from time to time by our board of directors out of legally available funds.
Liquidation
Rights. In the event of our liquidation, dissolution or winding up, holders of our common stock will be entitled to share ratably
in the net assets legally available for distribution to stockholders after the payment of all of our debts and other liabilities and
the satisfaction of any liquidation preference granted to the holders of any then outstanding shares of preferred stock.
No
Preemptive Rights. Holders of our common stock have no preemptive, conversion, subscription or other rights, and there are no redemption
or sinking fund provisions applicable to our common stock.
Fully
Paid and Non-assessable. All of our outstanding shares of common stock are, and the shares of common stock issuable upon conversion
of the Series A Preferred Stock and upon exercise of the Investor Warrants will be, fully paid and nonassessable.
Rights
of Preferred Stock May be Senior to Rights of Common Stock. Our board of directors has the authority, without further action by our
stockholders, to issue up to 5,000,000 shares of preferred stock in one or more series and to fix the rights, preferences, privileges
and restrictions thereof. These rights, preferences and privileges could include dividend rights, conversion rights, voting rights, terms
of redemption, and liquidation preferences, any or all of which may be greater than the rights of the holders of our common stock.
Series
A Preferred Stock
On
[●], 2025, we filed the Series A Preferred Stock certificate of designation with the Delaware Secretary of State. We designated
a total of 4,999,620 shares of our preferred stock as our Series A Preferred Stock. Our Series A Preferred Stock has following voting
powers, designations, preferences and relative rights, qualifications, limitations or restrictions:
24
Voting
Rights. Except as required by law, our Series A Preferred Stock has no voting rights.
Ranking.
Our Series A Preferred Stock will rank, as to rights upon our liquidation, dissolution, or winding up, senior to our common stock. The
terms of our Series A Preferred Stock will not limit our ability to (i) incur indebtedness or (ii) issue additional equity securities
that are senior in rank to our Series A Preferred Stock as to dividend or distribution rights and rights upon our liquidation, dissolution
or winding up.
Stated
Value. Each share of our Series A Preferred Stock has an initial stated value of $5.00, subject to customary adjustments in the event
of stock dividends, stock splits, reorganizations or similar events affecting our Series A Preferred Stock.
Dividend
Rights. Holders of our Series A Preferred Stock will not be entitled to receive any dividends.
Liquidation
Preference. The liquidation preference for each share of our Series A Preferred Stock is $5.00 per share, subject to customary adjustments
in the event of stock dividends, stock splits, reorganizations or similar events affecting our Series A Preferred Stock. Upon a liquidation,
dissolution or winding up of our company, to the extent we have the cash available, holders of shares of our Series A Preferred Stock
will be entitled to receive the liquidation preference with respect to their shares of Series A Preferred Stock.
Company
Call Option. Commencing on the third anniversary of the initial closing of this offering and continuing indefinitely thereafter,
we will have a right to call for redemption the outstanding shares of our Series A Preferred Stock at a per share call price equal to
the lesser of (i) the stated value per share plus a non-compounded rate of return calculated at 8% per annum, and (ii) 200% of the stated
value per share, subject to customary adjustments in the event of stock dividends, stock splits, reorganizations or similar events affecting
our Series A Preferred Stock. To exercise the call right, we will notify each holder of record of the then outstanding shares of our
Series A Preferred Stock that we will redeem all or a part of outstanding shares on a date that is no earlier than 20 and no later than
60 days after the date of notice. If less than all the outstanding shares are to be redeemed, we will redeem the shares on a pro rata
basis, selection by lot or in such other equitable manner we determine.
Conversion
at Option of Holder. At any time after issuance, each share of our Series A Preferred Stock is convertible into two shares of our
common stock at the option of the holder thereof, subject to customary adjustments in the event of stock dividends, stock splits, reorganizations
or similar events.
Forced
Conversion. If at any time after issuance, any of the following events occurs, we will have the right to require the holders of our
Series A Preferred Stock to convert all, or any portion of, their shares of our Series A Preferred Stock into shares of our common stock:
(a) a change in control, (b) if the closing price of our common stock is at or above $4.50 per share, subject to customary adjustments
in the event of stock dividends, stock splits, reorganizations or similar events, for any 10 trading days out of any 30 consecutive trading
day period, or (c) if we consummate a firm commitment public offering of our common stock resulting in gross proceeds of at least $15.0
million at an offering price per share equal to or greater than $4.50, subject to customary adjustments in the event of stock dividends,
stock splits, reorganizations or similar events.
Limitations
on Conversion. Notwithstanding the conversion rights described above, to the extent prohibited by applicable rules of The Nasdaq
Stock Market LLC or any other national securities exchange or trading market on which our capital stock is listed, we will not issues
shares of our common stock upon conversion of shares of our Series A Preferred Stock if such issuance will result in a change of control
of the Company, unless we obtain stockholder approval of such issuance in accordance with such applicable rules.
No
Redemption Right. Our Series A Preferred Stock has no maturity date, and we are not required to redeem any of our Series A Preferred
Stock at any time. Accordingly, unless converted into shares of our common stock or we exercise our call option, our Series A Preferred
Stock will remain outstanding indefinitely.
Fully
Paid and Non-assessable. The shares of our Series A Preferred Stock issued in this offering will be fully paid and nonassessable.
Investor
Warrants
Each
Investor Warrant is exercisable for one share of our common stock at an exercise price of $4.00 per share of common stock, subject to
customary adjustments in the event of stock dividends, stock splits, reorganizations or similar events. The Investor Warrants will be
exercisable at any time after issuance through the 36-month anniversary of their date of issuance. Notwithstanding the foregoing, to
the extent prohibited by applicable rules of The Nasdaq Stock Market LLC or any other national securities exchange or trading market
on which our capital stock is listed, we will not issues shares of our common stock upon exercise of an Investor Warrant if such issuance
will result in a change of control of the Company, unless we obtain stockholder approval of such issuance in accordance with such applicable
rules.
25
Anti-Takeover
Effect Provisions
Certain
provisions in our certificate of incorporation and bylaws may have an anti-takeover effect, including:
Classified
Board. We have a classified board of directors with three-year staggered terms, which may delay the ability of stockholders to change
the composition of a majority of our board of directors.
Number
of Directors. The number of directors on our board of directors is established by our board of directors from time to time, which
may delay the ability of stockholders to change the composition of a majority of our board of directors.
No
Cumulative Voting. Our stockholders cannot cumulate their votes in the election of directors, which limits the ability of minority
stockholders to elect director candidates.
Filling
of Vacancies. Our board of directors has the exclusive right to elect a director to fill any vacancy or newly created directorship.
Removing
Directors. A director may be removed only for cause and only by the affirmative vote of at least 75% of the votes which all the stockholders
would be entitled to cast in any annual election of directors or class of directors.
Prohibition
on Written Consent. Our stockholders are prohibited from acting by written consent, which forces stockholder action to be taken at
an annual or special meeting of our stockholders.
Calling
Special Meetings. Special meetings of our stockholders may be called only by our board of directors, the chair of our board of directors
or our chief executive officer, which may delay the ability of our stockholders to force consideration of a proposal or to take action,
including the removal of directors.
Advance
Notice Procedures. Stockholders must comply with the advance notice procedures in our bylaws to nominate candidates to our board
of directors and to propose matters to be acted upon at a stockholders’ meeting, which may discourage or deter a potential acquirer
from soliciting proxies to elect its own slate of directors or otherwise attempting to obtain control of us.
Supermajority
Provisions. The affirmative vote of the holders of at least 75% of the votes which all the stockholders would be entitled to cast
in any annual election of directors or class of directors is required to amend or repeal, or to adopt any provision inconsistent with,
certain provisions in our certificate of incorporation that relate to, among other matters, the classification of our board of directors,
the number of our directors, the removal of our directors, the filling of vacancies on our board of directors, the prohibition on our
stockholders to act by written consent, and the calling of special meetings of our stockholders.
Bylaw
Amendments. Our board of directors, by majority vote, may amend, alter or repeal our bylaws and may adopt new bylaws. Our stockholders
may not adopt, amend, alter or repeal our bylaws or adopt any provision inconsistent therewith, unless such action is approved, in addition
to any vote required by our certificate of incorporation, by the affirmative vote of holders of at least 75% of the votes that all the
stockholders would be entitled to cast in any annual election of directors or class of directors, and the affirmative vote of holders
of at least 75% of the votes that all the stockholders would be entitled to cast in any annual election of directors or class of directors
is required to amend or repeal, or to adopt any provision inconsistent with, the foregoing. These provisions may inhibit the ability
of an acquirer from amending our certificate of incorporation or bylaws to facilitate a hostile acquisition and may allow our board of
directors to take additional actions to prevent a hostile acquisition.
Preferred
Stock. Our board of directors can determine to issue shares of preferred stock and to determine the price and other terms of those
shares, including preferences and voting rights, without stockholder approval, which could significantly dilute the ownership of a hostile
acquirer.
Additional
Authorized Shares of Capital Stock. The shares of authorized common stock and preferred stock available for issuance under our certificate
of incorporation could be issued at such times, under such circumstances, and with such terms as to delay or impede a change in control.
26
In
addition, we are subject to Section 203 of the DGCL, which, subject to certain exceptions, prohibits a Delaware corporation from engaging
in any “business combination” with any “interested stockholder” for three years following the date that such
stockholder became an interested stockholder, unless: (i) before such date, the board of directors of the corporation approved either
the business combination or the transaction that resulted in the stockholder becoming an interested stockholder; (ii) on consummation
of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85%
of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the number
of shares outstanding those shares owned (a) by persons who are directors and also officers and (b) by employee stock plans in which
employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a
tender or exchange offer; or (iii) on or after such date, the business combination is approved by the board of directors and authorized
at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66 2⁄3% of the
outstanding voting stock not owned by the interested stockholder.
The
term “business combination” generally includes mergers or consolidations resulting in a financial benefit to the interested
stockholder. The term “interested stockholder” generally means any person, other than the corporation and any direct or indirect
majority-owned subsidiary of the corporation, who, together with affiliates and associates, owns (or owned within three years prior to
the determination of interested stockholder status) 15% or more of the outstanding voting stock of the corporation.
Exclusive
Forum. Our bylaws provides that, unless we consent in writing to the selection of an alternative forum, the Delaware Court of Chancery
shall, to the fullest extent permitted by law, be the sole and exclusive forum for: (a) any derivative action or proceeding brought on
behalf of our company, (b) any action asserting a claim of breach of a fiduciary duty owed by any of our current or former directors,
officers, other employees, agents or stockholders to us or to our Company’s stockholders, including, without limitation, a claim
alleging the aiding and abetting of such a breach of fiduciary duty, (c) any action to interpret, apply, enforce or determine the validity
of our certificate of incorporation or bylaws (including any right, obligation or remedy thereunder), (d) any action as to which the
DGCL confers jurisdiction on the Delaware Court of Chancery, and (e) any action asserting a claim governed by the internal affairs doctrine.
Our bylaws also provide that, unless we consent in writing to the selection of an alternative forum, the federal district courts of the
United States shall, to the fullest extent permitted by law, be the sole and exclusive forum for the resolution of any complaint asserting
a cause of action arising under the Securities Act of 1933, as amended. Our bylaws also provide that any person or entity purchasing
or otherwise acquiring or holding any interest in any of our securities shall be deemed to have notice of and consented to the foregoing.
Listing
& Holders
Our
common stock is listed on the NASDAQ Capital Market under the symbol “DARE.” There is no existing trading market for the
Investor Units, Series A Preferred Stock or the Investor Warrants, and we do not expect one to develop. None of the Investor Units, Series
A Preferred Stock or the Investor Warrants are currently listed on any exchange or quoted in any automated dealer quotation system or
other over-the-counter market, and we do not intend to seek a listing or quotation for any of them.
As
of November 18, 2025, we had approximately 32 stockholders of record. The number of stockholders of record is based upon the actual number
of holders registered on our books at such date. A substantially greater number of holders of our common stock are “street name”
or beneficial holders, whose shares are held by banks, brokers and other financial institutions.
Transfer
Agent and Registrar
The
transfer agent and registrar for our common stock is Equiniti Trust Company LLC. We will serve as the transfer agent and registrar for
our Series A Preferred Stock and the Investor Warrants.
27
PLAN
OF DISTRIBUTION
We
are offering on a “best efforts” basis up to 4,854,000 Investor Units at an offering price of $5.00 per Investor Unit, for
a maximum offering amount of $24,270,000 worth of Investor Units. Each Investor Unit consists of one share of our Series A Preferred
Stock and two Investor Warrants. The minimum investment amount per investor is $250 or a minimum of 50 Investor Units, subject to our
right to accept a lesser amount. The shares of our Series A Preferred Stock and the Investor Warrants that are part of the Investor Units
are immediately separable and will be issued separately but must be purchased together as an Investor Unit. The Investor Units have no
stand-alone rights and will not be certificated or issued as stand-alone securities. See “Description of Securities Being Offered”
beginning on page 24 for information regarding our Series A Preferred Stock, the Investor Warrants and the shares of our common stock
issuable upon conversion and exercise of the Series A Preferred Stock and Investor Warrants, respectively.
We
intend to market the Investor Units using both online and offline means. Online marketing may take the form of contacting potential investors
through electronic media, television broadcast advertising and posting this offering circular or “testing the waters” materials
on an online investment platform. All advertising will direct investors to the online investment platform. This offering circular may
be downloaded by prospective investors from [●], a landing page on our website that relates to this offering.
This
offering will terminate at the earliest of (i) the date on which the maximum offering amount of Investor Units has been sold, (ii) the
date that is one year after the date on which the offering statement of which this offering circular forms a part is qualified by the
SEC, and (iii) the date on which we determine to terminate this offering, which we may do in our sole discretion at any time and for
any reason or no reason.
We
intend to complete multiple closings for this offering on a rolling basis until the maximum offering amount is raised or this offering
is terminated. Until we complete a closing, the amounts invested by investors in this offering will be kept in an escrow account maintained
at Wilmington Trust, N.A.
We
intend to have the initial closing on a date mutually determined by us and the lead selling agent. In determining when to have the initial
closing, we and the lead selling agent will take into account the number of investors with funds deposited in the escrow account that
have cleared the requisite anti-money laundering, know your client and background check procedures, and the total amount of funds held
in escrow pending the initial closing (although no minimum amount of funds is required to conduct the initial or any subsequent closing).
Following the initial closing, we expect to have closings monthly.
Investors
should expect to wait approximately 30 days and no longer than 45 days before we accept or reject their subscriptions. An investor’s
subscription is binding and irrevocable and an investor will not have the right to withdraw their subscription or receive a return of
their investment funds unless we reject their subscription or we terminate this offering before accepting their subscription. You will
receive a confirmation of your investment promptly following the closing in which you participate.
At
each closing, the funds deposited into escrow by investors whose subscriptions have been accepted by us will be distributed to us and
the shares of Series A Preferred Stock and Investor Warrants will be issued to the investors participating in such closing. If there
are no closings, if your subscription is rejected or if funds remain in the escrow account upon termination of this offering without
any corresponding closing, the funds so deposited in the escrow account will be promptly returned to the applicable investors, without
deduction and without interest. See “—Procedures for Subscribing,” below.
You
may not subscribe to purchase the securities offered hereby before the date that the offering statement of which this offering circular
forms a part is qualified by the SEC. Before such date, you may only make non-binding indications of your interest to purchase securities
in the offering.
There
is no minimum offering amount that we must raise in this offering before we complete a closing. We may close on any funds that we receive.
Potential investors should be aware that there can be no assurance that any funds other than their funds will be invested in this offering.
28
Engagement
of Digital Offering
We
entered into an engagement letter with Digital Offering dated June 22, 2025, pursuant to which it agreed to act as the lead managing
selling agent for this offering and to use its best efforts to sell the Investor Units in this offering. However, Digital Offering made
no commitment to purchase, and is under no obligation to purchase or to arrange for the sale of, any specific number or dollar amount
of the Investor Units offered hereby. Digital Offering is an “underwriter” of this offering within the meaning of Section
2(a)(11) of the Securities Act. We paid Digital offering a consulting fee of $25,000 upon signing of the engagement letter. The term
of the engagement began on June 22, 2025 and will end on the earliest of: (a) the date that engagement letter is terminated in accordance
with its terms, (b) June 30, 2026, and (c) the date that this offering is terminated.
The
engagement provides that Digital Offering will create a selling group for this offering comprised of broker-dealers who are registered
with the SEC and who are Financial Industry Regulatory Authority (“FINRA”) members and/or rely on soliciting dealers who
are FINRA members to participate in placing a portion of the Investment Units offered hereby (such broker-dealers, FINRA members, soliciting
dealers, and other members of the selling group, the “selling group members”). No selling group member made or will make
any commitment to purchase, and no selling group member is or will be under any obligation to purchase or to arrange for the sale of,
any specific number or dollar amount of the Investor Units offered hereby. Digital Offering will be responsible for the payment of all
compensation payable to, and all costs and expenses incurred for, all selling group members, and will be permitted to allocate the placement
fees and Agent Unit Warrants payable to Digital Offering to the selling group members in its discretion. As of the date the offering
statement of which this offering circular is a part was initially filed with the SEC, we have been advised that Digital Offering has
not retained any selling group members.
In
addition to the engagement letter described above, we plan to enter into a selling agency agreement with Digital Offering prior to the
commencement of this offering.
Selling
Agents’ Placement Fees
Digital
Offering will be entitled to a placement fee of 7.25% of the gross proceeds received by us from the sale of Investor Units in this offering.
Assuming we sell the maximum offering amount of Investor Units, the aggregate placement fees payable to Digital Offering would be $1,759,575.
The table below shows the placement fees payable to Digital Offering on a per-Investor Unit basis.
Per
Investor Unit
Public
offering price
$
5.00
Placement
fee payable to Digital Offering
$
0.36
Proceeds
to us, before expenses
$
4.64
Selling
Agent’s Warrants
We
will also issue Agent Unit Warrants to Digital Offering to purchase that number of Agent Units equal to 3% of the total number of Investor
Units sold in this offering. The Agent Unit Warrants and the securities comprising and underlying the Agent Units Warrants will not be
transferable for a period of six months after the date of commencement of sales in this offering (in compliance with FINRA Rule 5110(e)(1))
and the Agent Unit Warrants will expire five years after the date of commencement of sales in this offering.
The
exercise price per Agent Unit Warrant will be $6.25, which equals 125% of the offering price of the Investor Units. The Agent Units issuable
upon exercise of the Agent Unit Warrants will consist of one share of our Series A Preferred Stock and two warrants, each to purchase
one share of our common stock at an exercise price of $4.00 per share, subject to customary adjustments in the event of stock dividends,
stock splits, reorganizations or similar events.
The
Agent Unit Warrants will provide for cashless exercise in the event there is not a qualified offering statement covering the securities
underlying the Agent Units Warrants, and immediate “piggyback” registration rights, with a duration of seven years from the
date of commencement of sales in this offering (in compliance with FINRA Rule 5110(g)(8)(D)), with respect to the registration of the
shares of common stock underlying the shares of Series A Preferred Stock and the warrants that are part of the Agent Unit Warrants.
This
offering circular also relates to the Agent Unit Warrants, the shares of our Series A Preferred Stock and warrants issuable upon exercise
of the Agent Unit Warrants, and the shares of our common stock issuable upon conversion of such shares of Series A Preferred Stock and
upon exercise of such warrants (collectively, the “Agent Securities”).
The
Agent Securities have been deemed compensation by FINRA and are therefore subject to a 180-day lock-up pursuant to Rule 5110(e)(1) of
FINRA. The selling agents and their permitted assignees under such rule, may not exercise, sell, transfer, assign, pledge, or hypothecate
any of the Agent Securities, nor will the selling agents or any of their permitted assignees engage in any hedging, short sale, derivative,
put, or call transaction that would result in the effective economic disposition of the Agent Securities for a period of 180 days from
the date of commencement of sales in this offering, except that they may be transferred, in whole or in part, by operation of law or
by reason of our reorganization, or to any selling group member and their respective officers, partners or registered representatives
if the Agent Securities so transferred remain subject to the foregoing lock-up restrictions for the remainder of the time period.
29
Offering
Expenses
We
are responsible for all expenses we incur relating to this offering, including all filing fees relating to the qualification of the offering
statement of which this offering circular is a part and the filing of offering materials with FINRA, and the fees and expenses of our
accountants and legal counsel.
We
will reimburse Digital Offering for up to $85,000 of its reasonable, out-of-pocket, and documented fees and expenses incurred in connection
with this offering, $25,000 of which has been paid to date, which will, in compliance with FINRA Rule 5110(g)(4)(a), be reimbursed to
us to the extent not actually incurred.
Subscription
Processing
We
engaged EquiDeFi, Ltd. (“EquideFi”) to create and maintain the online subscription processing platform for this offering.
After the offering statement of which this offering circular is a part is qualified by the SEC, this offering will be conducted, in part,
using EquiDeFi’s online subscription processing platform accessible at [●]. At that website investors will be able to access,
review, execute and deliver subscription agreements and pay for the Investor Units they purchase through a third-party processor by ACH
debit transfer, wire transfer or credit card.
We
will pay EquiDeFi a $6,000 set-up fee and a $2,500 monthly account maintenance fee.
If
investors elect to pay for their Investor Units with a credit card (including through a digital wallet – e.g., Apple Pay or Google
Pay) or by ACH or wire transfer, we will pay a credit card processing fee of 4.0% of such investor’s investment amount plus $0.30
per transaction and an ACH or wire transfer fee of 0.5% of such investor’s investment amount plus $5.00 per transfer. We will also
be responsible for fees related to chargebacks and failed payments.
Indemnification
We
have agreed to indemnify Digital Offering, selling group members and controlling persons of the foregoing against losses, damages and
liabilities to which such parties may become subject which are related to or result from the performance of their services in connection
with this offering. If such indemnification is for any reason held unenforceable, we agreed to contribute to the losses, damages and
liabilities for which such indemnification is held unenforceable.
Our
Relationship with the Lead Selling Agent
From
time to time in the future, Digital Offering may provide various advisory, investment and commercial banking and other services to us
in the ordinary course of business, for which it may receive customary fees and commissions. However, we have no present arrangements
with Digital Offering for any future services. During the past five years, Digital Offering had not provided any services to us or our
affiliates.
In
the ordinary course of their various business activities, Digital Offering and its affiliates may make or hold a broad array of investments
and actively trade debt and equity securities (or related derivative securities) and financial instruments (including bank loans) for
their own account and for the accounts of their customers, and such investment and securities activities may involve our securities.
Digital Offering and its affiliates may also make investment recommendations and/or publish or express independent research views in
respect of such securities, or recommend to clients that they acquire, long and/or short positions in such securities.
Investment
Limitations & How to Calculate Net Worth
In
order to purchase Investor Units and before funds to purchase Investor Units may be accepted, potential investors will be required to
represent, to our satisfaction, that either (a) they are an “accredited investor” as defined under Rule 501 of Regulation
D under the Securities Act, or (b) their investment amount is not more than 10% of the greater of their annual income or net worth. In
the case of fiduciary accounts, net worth and/or income suitability requirements may be satisfied by the beneficiary of the account or
by the fiduciary, if the fiduciary, directly or indirectly, provides the funds to purchase the Investor Units. The investment limitations
are imposed by law, not by us. Before making any representation that your investment does not exceed 10% of the greater of you annual
income or net worth, we encourage you to review Rule 251(d)(2)(i)(C) of Regulation A. For general information on investing, we encourage
you to refer to www.investor.gov.
30
Net
worth is defined as the difference between your total assets and total liabilities. This calculation must exclude the value of your primary
residence and may exclude any indebtedness secured by your primary residence (up to an amount equal to the value of your primary residence).
Rule
501 of Regulation D under the Securities Act defines an “accredited investor” as:
●
a
natural person who has individual net worth, or joint net worth with the person’s spouse,
that exceeds $1 million at the time of the purchase, excluding the value of the primary residence
of such person;
●
a
natural person with income exceeding $200,000 in each of the two most recent years or joint
income with a spouse exceeding $300,000 for those years and a reasonable expectation of the
same income level in the current year;
●
a
trust with assets in excess of $5 million, not formed for the specific purpose of acquiring
the securities offered, whose purchase is directed by a sophisticated person;
●
a
business in which all the equity owners are accredited investors;
●
an
employee benefit plan, within the meaning of the Employee Retirement Income Security Act,
if a bank, insurance company, or registered investment adviser makes the investment decisions,
or if the plan has total assets in excess of $5 million;
●
a
bank, insurance company, registered investment company, business development company, or
small business investment company;
●
a
charitable organization, corporation, or partnership, not formed for the specific purpose
of acquiring the securities offered, with total assets exceeding $5 million; and
●
a
director, executive officer, or general partner of the company selling the securities, or
any director, executive officer, or general partner of a general partner of that company.
Procedures
for Subscribing
General
You
may not subscribe to purchase Investor Units in this offering prior to the date this offering is qualified by the SEC. Before such date,
you may only make non-binding indications of your interest to purchase Investor Units.
Procedures
for subscribing directly through our website
Below
is a summary of the subscription procedure through our website:
1.
Go
to the [●] and click on the “Invest Now” button.
2.
Complete,
execute and deliver a subscription agreement (a form of which is filed as an exhibit to the
offering statement of which this offering circular is a part).
3.
Deliver
funds directly by wire, debit card, credit card or electronic funds transfer via ACH to the
escrow account (see “—Escrow Account and Right to Review and Accept or Reject
Subscriptions,” below).
4.
Once
funds or documentation are received an automated anti-money laundering (“AML”)
check will be performed to verify the identity and status of the investor.
5.
After
the AML check, an investor will electronically receive, review, execute and deliver to us
a subscription agreement. Investors must complete, execute and deliver a subscription agreement
in order to invest. The subscription agreement will include a representation by the investor
to the effect that, if the investor is not an “accredited investor,” the investor
is investing an amount that does not exceed the greater of 10% of the investor’s annual
income or 10% of the investor’s net worth (see “—Investment Limitations
& How to Calculate Net Worth,” above).
Escrow
Account and Our Right to Review and Accept or Reject Subscriptions
We
intend to complete multiple closings in this offering on a rolling basis. If you desire to invest in this offering, you will be required
to complete, execute and deliver a subscription agreement and deliver the purchase price for the Investment Units you desire to purchase
into an escrow account maintained by Wilmington Trust, N.A., the escrow agent for this offering.
31
Once
you submit the subscription agreement and deliver the purchase price for the Investment Units you desire to purchase into escrow, you
may not revoke or change your subscription or request any portion of such purchase price be returned to you.
All
funds delivered to the escrow account will be held in escrow until your subscription is reviewed and we decide whether to accept or reject
it. We have the right to review and accept or reject a subscription in whole or in part, for any reason or for no reason. If we confirm
that your subscription is complete and we decide to accept it, at a subsequent closing, we will countersign your subscription agreement,
the funds you delivered into the escrow account for your investment will be transferred to us and the shares of Series A Preferred Stock
and Investor Warrants that comprise the Investor Units you subscribed to purchase will be issued to you. If your subscription is rejected
or if a closing does not occur after you have delivered your funds into escrow, your subscription will be cancelled and the funds you
delivered into escrow will be returned to you promptly, without deduction and without interest.
Investor
Perks
In
recognition of investors who share our mission to advance women’s health innovation, we intend to offer to eligible investors in
this offering certain non-financial perks and benefits (“Investor Perks”). Investor Perks are not investment returns and
do not affect the terms or value of the securities being offered. All Investor Perks are subject to availability, applicable laws and
regulations, and the fulfillment conditions described below. As described below, we reserve the right to modify or discontinue any Investor
Perk at any time prior to fulfillment.
Investor
Perk Tiers
The
table below describes the Investor Perks we intend to offer to investors who subscribe to purchase Investor Units in this offering and
the minimum amount required to be invested in this offering to be eligible to receive the applicable Investor Perk.
Investment
Amount
Description
of Perk
$250
or more
●
“Over Being Overlooked™” pin recognizing participation in Daré’s mission.
$500
or more
●
All perks at the $250 tier.
● “Over Being Overlooked™” T-shirt or tote bag.
$1,000
or more
●
All perks at lower tiers.
● Invitation to a virtual DARE to PLAY™ Launch event with Daré leadership.
● Voucher for one complimentary 30 gram tube of DARE to PLAY™ Sildenafil Cream.
$2,500
or more
●
All perks at lower tiers.
● Invitation to attend in-person an investor-only roundtable with Daré’s CEO and scientific advisors.
● Voucher for a complimentary bundle of DARE to PLAY™ Sildenafil Cream and DARE to RESTORE™ probiotic.
$5,000
or more
●
All perks at lower tiers.
● Invitation to attend in-person a Women’s Health Innovation Summit hosted by Daré.
● Limited-edition framed “We’re Over Being Overlooked™” print signed by Daré’s
leadership.
$10,000
or more
●
All perks at lower tiers.
● Recognition as a “Because women’s health is not niche – it’s non-negotiable” Advocate
on Daré’s corporate website and in select annual communications (optional).
Investor
Perks – General Terms & Conditions
By
accepting any Investor Perk, you, the investor, agree to the following terms & conditions:
Daré
will seek to coordinate timely delivery and access to the listed perks; however, timing and availability may be subject to logistical,
operational, or third-party constraints.
Daré
is of the opinion that these Investor Perks do not have any cash value and do not alter the sales price or cost basis of the securities
offered hereby. Rather, they are promotional in nature and intended to thank investors for supporting Daré’s mission and
growth. Nonetheless, investors are strongly encouraged to consult their personal tax advisors to determine any potential tax consequences
arising from the receipt of such Investor Perks in connection with their investment.
32
Daré
reserves the right to modify, substitute, or discontinue any Investor Perk at its discretion. Investor Perks are non-transferable unless
otherwise noted and may be subject to additional eligibility or participation requirements at the time of fulfillment.
Investors
must complete applicable documents and applications by applicable deadlines to be eligible for the Investor Perks.
Investor
Perks may include access to and/or attendance at certain events, experiences, or activities (collectively, the “Events”),
as designated by Daré in its sole discretion. Unless expressly stated in writing, the Investor Perks includes only admission to
the Events and do not include transportation, lodging, meals, insurance, or other incidental expenses. Investors are solely responsible
for all costs and expenses associated with attending the Events, including airfare, hotel accommodations, ground transportation, meals,
personal expenses, and travel insurance. Daré does not reimburse or advance funds for such costs and has no liability for any
travel-related issues or expenses. Investors assume all risks associated with travel to and attendance at the Events. To the maximum
extent permitted by law, investors release Daré from all liability relating to travel, participation in the Events, or inability
to participate.
Participation
in the Events is voluntary. If investors are unable or unwilling to attend the Events for any reason—including travel issues, illness,
scheduling conflicts, visa issues, or force majeure—the applicable Investor Perk is deemed forfeited in its entirety. No alternate
Investor Perk, cash equivalent, substitution, refund, or credit will be provided.
Any
product-related perk (e.g., the voucher for a complimentary 30 gram tube of DARE to PLAY™ Sildenafil Cream or the DARE to RESTORE™
probiotic) will be fulfilled following commercial availability and is subject to product availability, applicable prescribing and dispensing
regulations and requirements and, if applicable, must be fulfilled through a licensed pharmacy partner.
The
Investor Perks are personal to the investor and may not be transferred, assigned, substituted, or sold without Daré’s prior
written consent.
INVESTORS
ARE SOLELY RESPONSIBLE FOR ANY AND ALL FEDERAL, STATE, LOCAL, FOREIGN, OR OTHER TAXES, FEES, OR GOVERNMENTAL CHARGES ASSOCIATED WITH
ACCEPTANCE OR USE OF INVESTOR PERKS. DARÉ HAS NO OBLIGATION TO PAY, REIMBURSE, GROSS-UP, OR OTHERWISE SATISFY ANY SUCH TAX OBLIGATIONS
ON BEHALF OF INVESTORS.
Certain
Provisions in the Subscription Agreement
Forum
Selection Provision
The
subscription agreement that investors will execute in connection with this offering includes a forum selection provision that requires
any claims against us based upon or arising out of the subscription agreement to be brought in a state or federal court of competent
jurisdiction in the State of Delaware. Although we believe the provision benefits us by providing increased consistency in the application
of Delaware law in the types of lawsuits to which it applies and in limiting our litigation costs, to the extent it is enforceable, the
forum selection provision may limit investors’ ability to bring claims in judicial forums that they find favorable to such disputes
and may discourage lawsuits with respect to such claims. Section 22 of the Securities Act creates concurrent jurisdiction for federal
and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder.
We believe that the exclusive forum provision applies to claims arising under the Securities Act, but there is uncertainty as to whether
a court would enforce such a provision in this context. Section 27 of the Exchange Act creates exclusive federal jurisdiction over all
suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder. As a result, the
exclusive forum provision will not apply to suits brought to enforce any duty or liability created by the Exchange Act or any other claim
for which the federal courts have exclusive jurisdiction. Investors will not be deemed to have waived our compliance with federal securities
laws and the rules and regulations promulgated thereunder. See the risk factor titled, “The subscription agreement that investors
will execute in connection with this offering has an exclusive forum selection provision that requires disputes be resolved in state
or federal courts in the State of Delaware, regardless of convenience or cost to you, the investor,” in “RISK FACTORS—Risks
Related to this Offering,” above.
33
Jury
Trial Waiver
The
subscription agreement that investors will sign in connection with this offering includes a provision pursuant to which investors waive
the right to a jury trial for any claim they may have against us arising out of or relating to the agreement, other than claims arising
under federal securities laws. If we oppose a jury trial demand based on the waiver, we expect that a court will determine whether the
waiver is enforceable based on the facts and circumstances of that case in accordance with applicable law. You should consult legal counsel
regarding the jury waiver provision before signing the subscription agreement. See the risk factor titled, “Investors in this offering
may not be entitled to a jury trial with respect to claims arising under the subscription agreement, which could result in less favorable
outcomes to the plaintiff(s) bringing any such claim,” in “RISK FACTORS—Risks Related to this Offering,” above.
Offer
Restrictions Outside the United States
Other
than in the United States, no action has been taken by us or the lead selling agent that would permit a public offering of the securities
offered by this offering circular in any jurisdiction where action for that purpose is required. The securities offered by this offering
circular may not be offered or sold, directly or indirectly, nor may this offering circular or any other offering material or advertisements
in connection with the offer and sale of any such securities be distributed or published in any jurisdiction, except under circumstances
that will result in compliance with the applicable rules and regulations of that jurisdiction. Persons who have possession of this offering
circular are advised to inform themselves about and to observe any restrictions relating to this offering and the distribution of this
offering circular. This offering circular does not constitute an offer to sell or a solicitation of an offer to buy any securities offered
by this offering circular in any jurisdiction in which such an offer or a solicitation is unlawful.
USE
OF PROCEEDS
Assuming
we sell all $24,270,000 of Investment Units offered hereby, we estimate that the net proceeds to us from this offering will be approximately
$22,213,856, after deducting the selling agent’s commissions and estimated offering expenses payable by us, and without taking
into account any credit card, ACH or wire transfer fees that we may pay in connection with investors’ subscriptions.
In
addition, we would receive up to an aggregate of approximately (a) $38,832,000 from the exercise of the Investor Warrants, (b) $910,125
from the exercise of the Agent Unit Warrants, and (c) $1,164,960 from the exercise of the Agent Common Warrants, in each case, assuming
the exercise in full of all such warrants for cash, for which no assurances can be given.
We
have no current specific plan for the net proceeds from this offering and we will retain broad discretion over their use. We currently
intend to use the net proceeds from this offering for working capital and general corporate purposes. We may also use a portion of the
net proceeds to acquire or invest in technologies and products or product candidates, although we have no current plans, commitments
or agreements with respect to any acquisitions as of the date of this offering circular. Pending the use of net proceeds from this offering,
we plan to invest the net proceeds in short-term interest-bearing investment-grade securities, certificates of deposit or government
securities.
While
our ongoing Section 503B compounding and consumer health product initiatives are designed to drive near-term revenue, because we are
in the early stages of executing against our Section 503B compounding and consumer health products business strategies and, as an organization,
we have no experience in or infrastructure for commercializing products, both the timing and amount of potential revenue we may generate
remain uncertain, and we expect to require significant additional funding in the future, together with the net proceeds from this offering,
to execute against our business strategy and to continue to advance the development of, and seek regulatory approval for, our product
candidates. Our determination as to when we will seek additional capital in the future and the amount of additional capital that we will
need will be based on our evaluation of the progress we make in executing against our business strategy and our research and development
programs, changes to the scope and focus of those programs, changes in grant funding for certain of those programs, and projection of
future costs, revenues, and rates of expenditure. While we may seek to obtain additional capital through one or more equity offerings,
debt financings, government or other grant funding, or other third-party funding transactions, including potential strategic alliances
and licensing or collaboration agreements, or structured financings such as royalty monetization transactions, we cannot provide any
assurance that adequate additional capital will be available on favorable terms, if at all. The unavailability or inadequacy of additional
capital in the future when and as needed could force us to modify, curtail, delay, or suspend some or all aspects of our current planned
operations, including by delaying, postponing, or canceling clinical trials or limiting the number of clinical trial sites of one or
more of our product candidates.
34
The
following table below sets forth the estimated net proceeds assuming the sale of 25%, 50%, 75% and 100% of the 4,854,000 Investment Units
offered hereby and does not reflect any credit card, ACH or wire transfer fees that we may pay in connection with investors’ subscriptions.
25%
50%
75%
100%
No.
of Investment Units sold
1,213,500
2,427,000
3,640,500
4,854,000
Gross
proceeds
$
6,067,500
$
12,135,000
$
18,202,500
$
24,270,000
Selling
agent commissions
$
439,894
$
879,788
$
1,319,681
$
1,759,575
Other
offering expenses payable by us
$
296,569
$
296,569
$
296,569
$
296,569
Net
proceeds
$
5,331,037
$
10,958,644
$
16,586,250
$
22,213,856
Notwithstanding
the foregoing, we and the selling agent are offering the Investment Units on a “best efforts” basis and we are not required
to sell any specific number or dollar amount of Investment Units in this offering. As such, we and the selling agent may sell less than
the maximum number of Investment Units offered hereby, and we may receive net proceeds of less than the least amount set forth above.
DILUTION
The
offering price per Investor Unit in this offering is $5.00. Each Investor Unit consists of one share of Series A Preferred Stock, which
is convertible into two shares of our common stock, and two Investor Warrants, each to purchase one share of our common stock at a per
share exercise price of $4.00, in each case, subject to customary adjustments in the event of stock dividends, stock splits, reorganizations
or similar events. The effective purchase price per share of common stock issuable upon conversion of each share of Series A Preferred
Stock is $2.50.
If
you purchase Investor Units in this offering, your ownership interest in our common stock will be diluted immediately to the extent of
the difference between the effective purchase price per share of common stock issuable upon conversion of each share of Series A Preferred
Stock and the as adjusted net tangible book value per share of our common stock after this offering.
Our
net tangible book value on September 30, 2025 was approximately $2.9 million, or approximately $0.21 per share. Net tangible book value
per share is determined by dividing our net tangible book value, which consists of tangible assets less total liabilities, by the number
of shares of our common stock outstanding on that date. Dilution per share to purchasers of Investor Units in this offering represents
the amount by which the effective purchase price per share of common stock issuable upon conversion of each share of Series A Preferred
Stock exceeds the as adjusted net tangible book value per share of our common stock after this offering.
After
giving effect to the sale of all 4,854,000 Investor Units in this offering at an offering price of $5.00 per Investor Unit for gross
proceeds of $24.3 million, after deducting the estimated commissions and estimated offering expenses payable by us, and assuming no exercise
of any Investor Warrants or Agent Unit Warrants, our as adjusted net tangible book value as of September 30, 2025 would have been approximately
$25.1 million, or $1.06 per share of common stock. This represents an immediate increase in as adjusted net tangible book value of $0.85
per share of common stock to existing stockholders and immediate dilution of $1.44 per share of common stock to purchasers of Investor
Units in this offering based on the effective purchase price of $2.50 per share of common stock issuable upon conversion of each share
of Series A Preferred Stock that is part of each Investor Unit. The following table illustrates this dilution on a per share of common
stock basis:
Effective
purchase price per share of common stock issuable upon conversion of each share of Series A Preferred Stock that is a part of each
Investor Unit
$
2.50
Net
tangible book value per share as of September 30, 2025
$
0.21
Increase
in net tangible book value per share attributable to the net proceeds from this offering
$
0.85
As
adjusted net tangible book value per share as of September 30, 2025, after giving effect to this offering
$
1.06
Dilution
per share to purchasers of Investor Units in this offering
$
1.44
35
The
above discussion and table are based on 13,929,502 shares of our common stock and zero shares of our preferred stock issued and outstanding
as of September 30, 2025 and excludes, as of that date, the following:
●
1,409,042
shares of our common stock issuable upon the exercise of outstanding stock options with a
weighted average exercise price of $9.41 per share awarded under our stock incentive plans;
●
540,043
shares of our common stock available for future grant under our 2022 Stock Incentive Plan;
and
●
1,268,572
shares of our common stock issuable upon the exercise of outstanding warrants with a weighted
average exercise price of $7.49 per share; and
●
360,000
shares of our common stock issued after September 30, 2025 pursuant to our equity line arrangement
with Lincoln Park.
To
the extent that any outstanding stock options or warrants are exercised, new stock-based awards are issued under our 2022 Equity Incentive
Plan, or we issue additional shares of common stock or securities convertible or exercisable into shares of common stock in the future,
including pursuant to our “at the market” offering program or our equity line arrangement with Lincoln Park or in connection
with other capital raising transactions, there will be further dilution to investors in this offering. We may choose to raise additional
capital at any time even if we believe we have sufficient funds for our current or future operating plans.
DETERMINATION
OF OFFERING PRICE
In
accordance with Rule 253(b) of the Securities Act, we intend to set the offering price per Investor Unit, and the exercise price of the
Investor Warrant, after the qualification by the SEC of the offering statement of which this offering circular is a part.
Our
common stock is listed on The Nasdaq Capital Market under the symbol “DARE.” On [●], 2025, the date on which this offering
circular was qualified by the SEC, the closing price of our common stock was $[●] per share. The Investor Units consist of one
share of our Series A Preferred Stock, which is convertible into two shares of our common stock, and two Investor Warrants, each to purchase
one share of our common stock at an exercise price of $4.00 per share, in each case, subject to customary adjustments in the event of
stock dividends, stock splits, reorganizations or similar events. The offering price of each Investor Unit was determined by us and the
lead sales agent. Although the market price of our common stock was considered in determining the offering price of each Investor Unit
and the per share exercise price of the Investor Warrant, neither the offering price nor the exercise price is related to, nor may it
reflect, the market price of our common stock after this offering. Other factors considered in determining the offering price of each
Investor Unit and the per share exercise price of the Investor Warrant include (i) our history and prospects and the history of and prospects
for the industry in which we compete; (ii) our past and present financial performance; (iii) our prospects for future earnings; (iv)
the general condition of the securities markets at the time this offering commences; and (v) other factors we and the lead sales agent
deemed relevant.
DIVIDEND
POLICY
We
have not paid cash dividends on our common stock and we do not anticipate paying cash dividends on our common stock in the foreseeable
future. We also do not anticipate that we will pay cash dividends on our Series A Preferred Stock in the foreseeable future. Instead,
we anticipate that all of our earnings, if any, will be used for the operation and growth of our business. Any future determination to
declare cash dividends will be made at the discretion of our board of directors, subject to applicable laws and contractual limitations,
and will depend on our financial condition, results of operations, capital requirements, general business conditions and other factors
that our board of directors may deem relevant.
36
EXECUTIVE
OFFICERS AND DIRECTORS
Executive
Officers
Set
forth below are the names, ages, offices held, tenure, and certain biographical information of each of our executive officers as of November
14, 2025.
Name
Age
Offices
Executive
Officer Since
Sabrina
Martucci Johnson
59
Chief
Executive Officer, President, Secretary and Director
July
2017
MarDee
Haring-Layton
49
Chief
Accounting Officer
January
2024
Sabrina
Martucci Johnson. Ms. Johnson is a life sciences executive committed to advancing improvements in women’s healthcare. She has
served as our Chief Executive Officer since July 2017, following the completion of the business combination transaction through which
the private company that conducted the business we currently conduct, which we refer to as Private Daré, became a public company.
She co-founded Private Daré in 2015 and served as its President and Chief Executive Officer since its inception until the completion
of the foregoing transaction. From May 2015 to July 2017, Ms. Johnson served as the Chief Financial Officer of the California Institute
for Biomedical Research (now part of The Scripps Research Institute) served as President of WomanCare Global Trading, a specialty pharmaceutical
company in female reproductive healthcare with commercial product distribution in over 100 countries, from October of 2014 to May of
2015, and served as its Chief Financial Officer and Chief Operating Officer from July 2013 to October 2014. Ms. Johnson provided financial
consulting services to the WomanCare Global family of companies, including the United Kingdom-based non-profit division, from November
2012 to July 2013. From 2002 until its sale in 2010, Ms. Johnson served as Chief Financial Officer of Cypress Bioscience, Inc., a publicly-traded
pharmaceutical company, and in addition served as its Chief Operating Officer from 2008 until its sale in 2010. Ms. Johnson began her
career in the biotechnology industry as a research scientist with Baxter Healthcare, Hyland Division, working on their recombinant factor
VIII program, and later held marketing and sales positions with Advanced Tissue Sciences and Clonetics Corporation. Ms. Johnson currently
serves on the board of directors of ATAI Life Sciences, a publicly-traded clinical-stage biopharmaceutical company aiming to transform
the treatment of mental health disorders, and of Biocom California, where she serves as Chair.
She
also serves on the Emerging Companies Section Governing Board of the Biotechnology Innovation Organization. Additionally, Ms. Johnson
serves on the Board of Advisors of Tulane University School of Science & Engineering, emeritus, and on the Newcomb Institute Dean’s
Advisory Council. Ms. Johnson is also past co-president of Women Give San Diego, which funded non-profit organizations serving women
and girls in San Diego, and formerly served on the board of Planned Parenthood of the Pacific Southwest, Athena San Diego, and formerly
served as the Chair of the University of California San Diego (UCSD) Librarian’s Advisory Board. Ms. Johnson was formerly on the
board of directors of Aethlon Medical, Inc., a publicly-traded company developing immunotherapeutic technologies to combat infectious
disease and cancer. Ms. Johnson has a Masters of International Management degree with honors from the American Graduate School of International
Management (Thunderbird), a MSc. in Biochemical Engineering from the University of London, University College London and a BSc. in Biomedical
Engineering from Tulane University, where she graduated magna cum laude. Ms. Johnson’s leadership has been honored by Ernst &
Young Entrepreneur of the Year (Pacific Southwest Region), Fierce Pharma’s Most Influential People in Biopharma, and inclusion
on the Medicine Maker Power List and Endpoints Women in Biopharma. Our Board believes that Ms. Johnson is qualified to serve as our Chief
Executive Officer and as a member of our Board due to her leadership experience in life sciences, women’s reproductive healthcare,
development and commercial distribution of healthcare products, capital raises, and her experience as an officer in life sciences and
women’s reproductive healthcare non-profit and for-profit companies, including publicly traded companies.
MarDee
Haring-Layton. Ms. Haring-Layton joined Daré in January 2018 and has served as our Chief Accounting Officer since January
2024 where she is responsible for oversight of accounting and finance, including our financial and SEC reporting and internal controls.
From October 2018 until January 2024, Ms. Haring-Layton served as our Vice President of Accounting & Finance. From 2010 until 2017,
Ms. Haring-Layton served as Chief Financial Officer of e.Digital Corporation, a publicly traded IP licensing and development company.
Earlier in her career, Ms. Haring-Layton held corporate accounting positions at public companies and provided consulting services for
several biotechnology companies. She began her career with Deloitte, LLP. Ms. Haring-Layton has a Bachelor of Science in Business Administration
(Accounting) from San Diego State University.
37
Directors
Set
forth below are the names, ages, board committee assignments, tenure, class, and certain biographical information of each of the members
of our board of directors as of November 14, 2025. In accordance with our restated certificate of incorporation and by-laws, our board
of directors is divided into three classes, with one class of directors standing for election each year, for a three-year term.
Name
Age
Committees
Director
Since
Class**
Jessica
D. Grossman, M.D.
53
Audit,
Nominating & Corporate Governance
April
2018
I
Susan
L. Kelley, M.D.
71
Nominating
& Corporate Governance*
October
2014
I
Sabrina
Martucci Johnson
59
None
July
2017
III
Gregory
W. Matz, CPA
66
Audit*,
Nominating & Corporate Governance
September
2018
II
William
H. Rastetter, Ph.D.
77
Compensation*
January
2014***
II
Robin
J. Steele, J.D., L.L.M.
69
Audit,
Compensation
July
2017
II
*
Committee
chairperson
**
The
terms of our Class I, II and III directors ends at our annual meeting of our stockholders to be held in 2027, 2028 and 2026, respectively.
***
Dr.
Rastetter has served as Chair of our Board since July 2019.
Ms.
Johnson’s biographical information is included above in the section titled “Executive Officers.”
Jessica
D. Grossman, M.D. Dr. Grossman currently serves as the Chief Executive Officer of IgGenix, a company developing first-in-class therapies
for people limited by food allergies and other severe allergic conditions. From 2015 to 2020, Dr. Grossman served as Chief Executive
Officer of Medicines360. Medicines360 is a global non-profit women’s health pharmaceutical company that developed the FDA-approved
contraceptive IUD LILETTA® (52-mg levonorgestrel-releasing intrauterine system). From 2011 to 2014, Dr. Grossman served on the board
of directors of Medicines360, and from 2014 to 2018 she served as Chair of AlliancePartners360, a wholly owned subsidiary of Medicines360
that serves the non-profit, public benefit mission of Medicines360 of expanding access to medicines for women regardless of their socioeconomic
status, insurance coverage, or geographic location. From 2013 to 2014, Dr. Grossman served as President and Founding Chief Executive
Officer of Sense4Baby, Inc. Dr. Grossman served as a Medical Director at Ethicon Endo-Surgery, part of the Johnson & Johnson family
of companies, from 2010 to 2013. From 2008 to 2010, Dr. Grossman was the Founder and Chief Executive Officer of JG Limited LLC, a consulting
company providing services to medical technology companies and non-profit organizations in the areas of clinical and commercial strategy.
From 2005 to 2008, Dr. Grossman was Founder and President of Gynesonics, an early-stage medical device company focused on minimally invasive
solutions for women’s health which developed the first intrauterine ultrasound-guided radiofrequency ablation device for fibroid
tumors. Dr. Grossman holds numerous patents, has published several peer-reviewed articles and conducted research at the Beth Israel Deaconess
Medical Center, one of the teaching hospitals of Harvard Medical School. Dr. Grossman received her M.D. from Thomas Jefferson University,
Jefferson Medical College. Our Board believes that Dr. Grossman is qualified to serve on our Board due to her extensive experience in
women’s health, her executive leadership experience with several life science companies, and her experience with product development
and commercialization.
Susan
L. Kelley, M.D. Dr. Kelley has been developing drugs in oncology and immunology for over 35 years. Dr. Kelley currently serves on
the board of directors of A2 Biotherapeutics. From February 2021 until June 2025, she served on the board of directors of IDEAYA Biosciences,
Inc., and from 2019 until its acquisition by Ono Pharmaceutical Co., Ltd. in June 2024, she served on the board of directors of Deciphera
Pharmaceuticals, Inc. From 2011 until its acquisition by Merck & Co. in 2020, she served on the board of directors of ArQule, Inc.,
and from 2016 until its acquisition by Merck & Co. in 2019, she served on the board of directors of Immune Design Corp. She was a
director at VBL Therapeutics, Ltd. from 2018 until 2020. From 2008 to 2011, Dr. Kelley served as Chief Medical Officer of the Multiple
Myeloma Research Consortium and its sister organization, the Multiple Myeloma Research Foundation. Previously, Dr. Kelley held positions
at Bayer Healthcare Pharmaceuticals and Bayer-Schering Pharma, including Vice President, Global Clinical Development and Therapeutic
Area Head—Oncology, where she led the Bayer team responsible for the development and worldwide regulatory approval of Nexavar®
(sorafenib). Prior to joining Bayer, Dr. Kelley worked at Bristol-Myers Squibb in Oncology and Immunology drug development ultimately
serving as Executive Director, Oncology Clinical Research, at the Bristol-Myers Squibb Pharmaceutical Research Institute. Dr. Kelley
was a Fellow in Medical Oncology and Clinical Fellow in Medicine at Dana-Farber Cancer Institute, Harvard Medical School, and a Fellow
in Medical Oncology and Pharmacology at Yale University School of Medicine. Dr. Kelley also serves as an Entrepreneur-in-Residence at
Yale University’s Yale Ventures. Dr. Kelley received her M.D. from Duke University School of Medicine. Our Board believes that
Dr. Kelley is qualified to serve on our Board due to her experience in life sciences and clinical development and her experience as a
director of life sciences companies.
38
Gregory
W. Matz, CPA. Mr. Matz currently serves on the board of One Stop Systems, Inc., a publicly-traded company focused on high-performance
edge computing. Mr. Matz retired as the Senior Vice President and Chief Financial Officer for The Cooper Companies in November 2016.
Additionally, he served as the company’s Chief Risk Officer. The Cooper Companies is a publicly traded, global medical device company
that operates through two business units, CooperVision and CooperSurgical. He previously was the Vice President and Chief Financial Officer
for CooperVision from May 2010 to December 2011. Prior to joining the company Mr. Matz held key management roles in finance and marketing
at Agilent Technologies and Hewlett Packard. He began his career at KPMG and is a CPA with an active certification. Mr. Matz graduated
from the University of San Francisco with a Bachelor of Science in Business and the University of Pennsylvania, The Wharton School’s
Advanced Management Program. Mr. Matz is also a National Association of Corporate Directors (NACD) Board Leadership Fellow and has earned
the NACD Directorship Certification credential. In addition, Mr. Matz achieved the NACD/Carnegie Mellon University CERT Certification
in Cybersecurity Oversight. Our Board believes Mr. Matz’s experience as a chief financial officer and chief risk officer of a company
within the women’s health industry and his corporate experience and skills in financial functions, including planning, reporting,
and audit, in risk management, in managing internal growth and in capital markets and corporate strategy qualifies him to serve as a
member of our Board and to fill the important role of “audit committee financial expert.”
William
H. Rastetter, Ph.D. Dr. Rastetter has served as Chair of our Board since July 2019. He also currently serves as Chairman of the board
of directors of Neurocrine Biosciences, Inc. and of Fate Therapeutics, Inc., as a member of the board of directors of Regulus Therapeutics,
Inc., and of Iambic, Inc., a private company using AI to design and develop medicinal agents. Dr. Rastetter serves as an advisor to the
venture capital firm, Illumina Ventures. Dr. Rastetter is co-founder and Chairman of the non-profit, San Diego Squared, that focuses
on preparing students from underserved communities for careers in STEM. Dr. Rastetter co-founded Receptos, Inc., a biopharmaceutical
company, where he previously held the roles of Acting Chief Executive Officer from 2009 to 2010, and Director and Chairman of the board
of directors from 2009 to 2015. Dr. Rastetter served on the board of Illumina, Inc., a leading public genomic technology company, from
1998 until January 2016, and as Chairman from 2005 to 2016. Dr. Rastetter served as a founding director of Grail, Inc. (2016) and as
its interim CEO and Chairman (2017-2018), and continued as a director until its acquisition by Illumina, Inc. in 2021. Dr. Rastetter
was a Partner at the venture capital firm of Venrock Associates from 2006 to 2013. Prior to his tenure with Venrock, Dr. Rastetter was
Executive Chairman of Biogen Idec Inc. and was previously Chairman and Chief Executive Officer of Idec Pharmaceuticals. Prior to Idec,
he was Director of Corporate Ventures at Genentech, Inc. Dr. Rastetter held various faculty positions at the Massachusetts Institute
of Technology and Harvard University and is an Alfred P. Sloan Fellow. Dr. Rastetter holds a S.B. from the Massachusetts Institute of
Technology and received his M.A. and Ph.D. from Harvard University. Our Board believes that Dr. Rastetter is qualified to serve on our
Board due to his extensive experience in the biotechnology industry, his broad leadership experience with several public and private
biotechnology companies, and his experience with financial matters.
Robin
J. Steele, J.D., LL.M. Ms. Steele has worked as an executive and board member in the life sciences industry for over 30 years. She
also currently serves on the boards of directors of Nacuity Pharmaceuticals, Inc., Coagulant Therapeutics and Ancient Organics Bioscience,
Inc. From 2021 to 2024, Ms. Steele served on the board of directors of Ocuterra Therapeutics, Inc. From 2004 to 2014, she served as Senior
Vice President, General Counsel and Secretary of InterMune, Inc., a publicly-traded biopharmaceutical company. From 1998 to 2003, Ms.
Steele served as Vice President of Legal Affairs for Elan Pharmaceuticals, a publicly traded pharmaceutical company. Ms. Steele received
a B.A. from the University of Colorado, a J.D. from the University of California, Hastings College of the Law, and an LL.M. in Taxation
from New York University School of Law. Ms. Steele earned the National Association of Corporate Directors (NACD) Directorship Certification
credential in 2021. Our Board believes that Ms. Steele is qualified to serve on our Board due to her expertise in legal matters and corporate
governance, her prior experience as general counsel of a public company and her involvement as a board member and advisor for a number
of private life science companies.
39
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The
table below sets forth certain information, as of November 12, 2025, regarding the beneficial ownership of our common stock for (1) each
person, or group of affiliated persons, known by us to be the beneficial owner of more than 5% of our outstanding common stock, (2) each
of our directors, (3) each of our named executive officers and (4) all of our current directors and executive officers as a group.
We
have determined beneficial ownership in accordance with applicable SEC rules, and the information reflected in the table below is not
necessarily indicative of beneficial ownership for any other purpose. Under applicable SEC rules, beneficial ownership includes any shares
of common stock as to which a person has sole or shared voting power or investment power and any shares of common stock which the person
has the right to acquire within 60 days after the date set forth in the paragraph above through the exercise of any option, warrant or
right or through the conversion of any convertible security. Unless otherwise indicated in the footnotes to the table below and subject
to community property laws where applicable, we believe, based on the information furnished to us and on SEC filings, that each of the
persons named in table below has sole voting and investment power with respect to the shares indicated as beneficially owned.
The
information set forth in the table below is based on 14,289,229 shares of our common stock issued and outstanding on November 12, 2025.
In computing the number of shares of common stock beneficially owned by a person and the percentage ownership of that person, we deemed
to be outstanding all shares of common stock subject to options, warrants, rights or other convertible securities held by that person
that are currently exercisable or will be exercisable within 60 days after such date. We did not deem these shares outstanding, however,
for the purpose of computing the percentage ownership of any other person. Except as otherwise noted, the address for each person listed
in the table below is c/o Daré Bioscience, Inc., 3655 Nobel Drive, Suite 260, San Diego, California, 92122.
Name
Number
of Shares Beneficially
Owned
Percentage
Beneficially
Owned
5%
Stockholders
Law
Custodial Inc.(1)
1,409,167
9.9
%
Named
Executive Officers and Directors
Sabrina
Martucci Johnson(2)
328,219
2.3
%
MarDee
Haring-Layton(3)
68,208
*
Lisa
Walters-Hoffert(4)
36,959
*
Jessica
D. Grossman, M.D.(5)
19,832
*
Susan
L. Kelley, M.D.(6)
20,164
*
Gregory
W. Matz(7)
19,874
*
William
H. Rastetter, Ph.D.(8)
21,023
*
Robin
J. Steele(9)
40,530
*
All
Directors and Executive Officers as a Group (7 persons)(10)
517,850
3.5
%
*
Less
than 1%
(1)
The
address of Law Custodial Inc. is 6/F, Wings Building, 110-116 Queen’s Road Central,
Central, Hong Kong. The number of shares beneficially owned is as of October 6, 2025 and
is based on information set forth in a Schedule 13G filed by Law Custodial Inc. with the
SEC on October 6, 2025.
(2)
Includes
248,046 shares of common stock issuable upon exercise of stock options. The outstanding shares
are held by The Vincent S. Johnson and Sabrina M. Johnson Family Trust dated February 14,
2005. Ms. Johnson is the co-trustee of such trust and has shared investment and dispositive
power over such shares.
(3)
Consists
of 68,208 shares of common stock issuable upon exercise of stock options.
(4)
Ms.
Walters-Hoffert was our former Chief Financial Officer. She resigned from that position effective
January 26, 2024. The shares are held by The Lisa Walters-Hoffert Survivor’s Trust
dated October 31, 2002. Ms. Walters-Hoffert is the trustee of such trust and has sole investment
and dispositive power over such shares.
(5)
Consists
of 19,832 shares of common stock issuable upon exercise of stock options.
(6)
Consists
of 20,164 shares of common stock issuable upon exercise of stock options.
(7)
Includes
19,832 shares of common stock issuable upon exercise of stock options. The outstanding shares
are held by the Matz Trust Dated December 20, 1999. Mr. Matz is the co-trustee of such trust
and has shared investment and dispositive power over such shares.
40
(8)
Includes
20,164 shares of common stock issuable upon exercise of stock options. The outstanding shares
are held by William and Marisa Rastetter Trustees of the Rastetter Family Trust U/A Dated
09/02/2010. Dr. Rastetter is the co-trustee of such trust and has shared investment and dispositive
power over such shares.
(9)
Includes
20,015 shares of common stock issuable upon exercise of stock options. The outstanding shares
are held by the Robin J. Steele Trust DTD 1/30/2015. Ms. Steele is the trustee of such trust
and has sole investment and dispositive power over such shares.
(10)
Includes
416,261 shares of common stock issuable upon exercise of stock options. The members of this
group are our two executive officers (Ms. Johnson and Ms. Haring-Layton) and our five non-employee
directors (Drs. Grossman, Kelley, and Rastetter, Mr. Matz, and Ms. Steele).
LEGAL
MATTERS
The
validity of the securities offered by this offering circular will be passed upon for us by Sheppard, Mullin, Richter & Hampton, LLP,
San Diego, California. Bevilacqua PLLC, Washington, DC is acting as counsel to the lead sales agent in this offering.
INDEPENDENT
REGISTERED PUBLIC ACCOUNTING FIRM
Haskell
& White LLP, an independent registered public accounting firm, has audited our consolidated financial statements included in our
Annual Report on Form 10-K for the year ended December 31, 2024, as set forth in its report (which report includes an explanatory paragraph
regarding the existence of substantial doubt about our ability to continue as a going concern), which is incorporated by reference in
this offering circular and the information statement of which it forms a part. Our financial statements are incorporated by reference
in reliance on Haskell & White LLP’s report, given on the authority of said firm as experts in accounting and auditing.
DISCLOSURE
OF COMMISSION POSITION ON
INDEMNIFICATION
FOR SECURITIES ACT LIABILITIES
As
permitted under Delaware law, we have entered into indemnification agreements with our officers and directors that provide that we will
indemnify the directors and officers for certain expenses, including attorneys’ fees, judgments, fines and settlement amounts incurred
by such director or officer in any action or proceeding arising out of their service as a director and/or officer. The term of the indemnification
is for the officer’s or director’s lifetime. Our restated certificate of incorporation and our by-laws provide that we will
indemnify each of our directors and officers to the fullest extent permitted by the Delaware General Corporation Law. We have also purchased
a directors’ and officers’ liability insurance policy that insures our directors and officers against the cost of defense,
settlement, or payment of a judgment under certain circumstances. Insofar as indemnification for liabilities arising under the Securities
Act may be permitted to our director and officers, we have been advised that in the opinion of the SEC such indemnification is against
public policy as expressed in the Securities Act and is, therefore, unenforceable.
INFORMATION
INCORPORATED BY REFERENCE
The
SEC allows us to “incorporate by reference” information into this offering circular, which means we can disclose important
information to you by referring you to documents that we previously submitted or filed on EDGAR. The information incorporated by reference,
which includes important information about us and our financial condition, is deemed to be part of this offering circular, except for
any information superseded by information in this offering circular or incorporated by reference subsequent to the date of this offering
circular. This offering circular incorporates by reference the information from the documents set forth below that we previously filed
with the SEC.
Item
7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
of Part II of our 2024
10-K, Item 2. Management’s Discussion and Analysis of Financial Condition and Results
of Operations of Part I of our Quarterly Report on Form
10-Q for the quarterly period ended March 31, 2025 filed with the SEC on May 13, 2025
(“1Q 10Q”), Item 2. Management’s Discussion and Analysis of Financial Condition
and Results of Operations of Part I of our Quarterly Report on Form
10-Q for the quarterly period ended June 30, 2025 filed with the SEC on August 14, 2025
(“2Q 10Q”), and Item 2. Management’s Discussion and Analysis of Financial
Condition and Results of Operations of Part I of our Quarterly Report on Form
10-Q for the quarterly period ended September 30, 2025 filed with the SEC on November
13, 2025 (“3Q 10Q”);
41
●
Item
8. Financial Statements and Supplementary Data of Part II of our 2024
10-K and Item 1. Condensed Consolidated Financial Statements (Unaudited) of Part I of
our 3Q
10-Q;
●
The
section titled “Corporate
Governance” beginning on page 10 of our definitive proxy statement filed with the
SEC on April 24, 2025 (“2025 proxy statement”);
Our
2024 10-K, 1Q 10Q, 2Q 10Q, 3Q 10Q and 2025 proxy statement can be accessed at https://ir.darebioscience.com/financial-information
and on the SEC’s website at https://www.sec.gov. The information set forth on our website is not part of this offering circular.
We have included our website address in this offering circular solely as an inactive textual reference. Similarly, the information on
the SEC’s website is not part of this offering circular, and any references to the SEC’s website or any other website are
inactive textual references only.
You
may request a copy of any of the documents containing information incorporated by reference into this offering circular, at no cost,
by writing or telephoning us at: Daré Bioscience, Inc., Attention: Corporate Secretary, 3655 Nobel Drive, Suite 260, CA 92122,
(858) 926-7655.
WHERE
YOU CAN FIND ADDITIONAL INFORMATION
This
offering circular is part of an offering statement on Form 1-A that we filed with the SEC. In accordance with the SEC rules and regulations,
this offering circular omits information contained in the offering statement. You should review the information in the offering statement
and the schedules and/or exhibits thereto for further information about us and the securities being offered in this offering. Statements
in this offering circular regarding any document we filed as an exhibit or schedule to the offering statement or that we otherwise filed
with the SEC are not intended to be comprehensive and are qualified by reference to such documents. You should review the document to
evaluate these statements.
We
are subject to the reporting requirements of the Exchange Act and file annual, quarterly and current reports, proxy statements and other
information with the SEC. The SEC maintains a website that contains reports, proxy and information statements and other information regarding
issuers, such as our company, that file documents electronically with the SEC. Our SEC filings are available to the public at the SEC’s
website address at https://www.sec.gov. The information on the SEC’s website is not part of this offering circular, and any references
to the SEC’s website or any other website are inactive textual references only.
We
also maintain a website at https://ir.darebioscience.com/financial-information from which you can access our SEC filings. The
information set forth on our website is not part of this offering circular. We have included our website address in this offering circular
solely as an inactive textual reference.
42
PART
III – EXHIBITS
Exhibits
not filed or furnished herewith are incorporated by reference to exhibits previously filed with the SEC, as reflected in the table below.
Incorporated
by Reference
Exhibit
Number
Description
of Exhibit
Form
File
No.
Filing
Date
Exhibit
No.
Filed
Herewith
UNDERWRITING
AGREEMENT
1.1#
Selling
Agency Agreement, between Daré Bioscience, Inc. and Digital Offering, LLC
Consent
of Sheppard, Mullin, Richter & Hampton LLP (included in Exhibit 12.1)
OPINION
RE LEGALITY
12.1#
Opinion
of Sheppard, Mullin, Richter & Hampton LLP
#
To
be filed by amendment.
+
Portions
of this exhibit have been redacted in compliance with Regulation S-K Item 601(b)(10). The omitted information is not material and
would likely cause competitive harm to the Company if publicly disclosed.
Δ
Confidential
treatment has been requested or granted to certain confidential information contained in this exhibit.
*
Management
contract or compensatory plan or arrangement
§
All
schedules (or similar attachments) have been omitted from this filing pursuant to Item 601(b)(2) of Regulation S-K. The registrant
will furnish copies of any schedules to the Securities and Exchange Commission upon request.
47
SIGNATURES
Pursuant
to the requirements of Regulation A, the issuer certifies that it has reasonable grounds to believe that it meets all of the requirements
for filing on Form 1-A and has duly caused this offering statement to be signed on its behalf by the undersigned, thereunto duly authorized,
in the City of San Diego, State of California, on November 25, 2025.
Daré
Bioscience, Inc.
By:
/s/
Sabrina Martucci Johnson
Sabrina
Martucci Johnson
Chief
Executive Officer and President
POWER
OF ATTORNEY
Each
of the undersigned directors of Daré Bioscience, Inc. hereby constitutes and appoints Sabrina Martucci Johnson and MarDee Haring-Layton
and each of them, as such person’s true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution,
for such person and in such person’s name, place, and stead, in any and all capacities, to sign any and all amendments to this
offering statement, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities
and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform
each and every act and thing requisite and necessary to be done in connection therewith and about the premises, as fully to all intents
and purposes as such person might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents,
or any of them, or their or such person’s substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
This
offering statement has been signed by the following persons in the capacities and on the dates indicated:
Signature
Title
Date
/s/
Sabrina Martucci Johnson
Chief
Executive Officer, President, Secretary,
November
25, 2025
Sabrina
Martucci Johnson
and
Director
/s/
MarDee Haring-Layton
Chief
Accounting Officer
November
25, 2025
MarDee
Haring-Layton
/s/
Jessica D. Grossman
Director
November
25, 2025
Jessica
D. Grossman, M.D.
/s/
Susan L. Kelley
Director
November
25, 2025
Susan
L. Kelley, M.D.
/s/
Gregory W. Matz
Director
November
25, 2025
Gregory
W. Matz, CPA
/s/
William H. Rastetter
Director
November
25, 2025
William
H. Rastetter, Ph.D.
/s/
Robin J. Steele
Director
November
25, 2025
Robin
J. Steele, J.D., L.L.M.
48
Exhibit
11.1
CONSENT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We
consent to the incorporation by reference in the Offering Statement on Form 1-A of Daré Bioscience, Inc. (the “Company”)
of our audit report dated March 31, 2025, relating to our audits of the Company’s consolidated financial statements as of December
31, 2024 and 2023, and for each of the years then ended, included in the Company’s Annual Report on Form 10-K for the fiscal year
ended December 31, 2024.
Our
report dated March 31, 2025 contains an explanatory paragraph that states the Company has recurring losses from operations and is dependent
on additional financing to fund operations. These conditions raise substantial doubt about the Company’s ability to continue as
a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
We
also consent to the reference to us under the heading “Experts” in this Offering Statement.