Clindamycin Phosphate

Business development: Secures royalty economic interests in two early stage partnered assets through XOMA Royalty’s announced expected acquisition of LAVA Therapeutics. Company acquisitions: •Completed XOMA Royalty’s acquisitions of Turnstone Biologics and HilleVax; • announced acquisitions of LAVA Therapeutics and Mural Oncology; • acted as structuring agent for XenoTherapeutics’ acquisition of ESSA Pharma. Key Pipeline advancements: • Zevra Therapeutics submitted a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) seeking marketing approval for arimoclomol as a treatment for Niemann-Pick Type C; • Rezolute Bio reconfirmed its expectations to announce topline data in December from its Phase 3 ersodetug trial in patients with congenital hyperinsulinism (HI) and announced alignment with FDA on streamlined design for ongoing Phase 3 trial of ersodetug in tumor HI; •Gossamer Bio expects topline results from PROSERA, its Phase 3 trial of seralutunib in pulmonary atrial hypertension (PAH), in February 2026. Cash receipts: In the first nine months of 2025, XOMA Royalty received $43.9 million in royalties and milestones from its partners, including $14.3 million from royalties during the third quarter. EMERYVILLE, Calif., Nov. 12, 2025 (GLOBE NEWSWIRE) -- XOMA Royalty Corporation (NASDAQ: XOMA), the biotech royalty aggregator, reported its 2025 third quarter and year to date financial results and highlighted recent actions that have the potential to deliver additional shareholder value. “We continue to execute on innovative ways to increase optionality within our portfolio while maintaining a healthy cash balance and limiting dilution to our shareholders,” stated Owen Hughes, Chief Executive Officer of XOMA Royalty. “Growing royalty receipts reflect solid commercial execution on the part of our partners. We look forward to several clinical readouts over the coming months and quarters that, if positive, can meaningfully shape our business trajectory.” Royalty and Milestone Acquisitions CompanyAsset and Transaction DetailLAVA TherapeuticsXOMA Royalty will secure an economic interest in PF-08046052, which is being developed by Pfizer, and JNJ-89853413, which is being developed by Johnson & Johnson, upon closing its acquisition of LAVA. Company Acquisitions CompanyTransaction DetailsTurnstone BiologicsXOMA Royalty acquired Turnstone for $0.34 in cash per share of Turnstone common stock plus one non-transferable contingent value right (CVR). HilleVaxXOMA Royalty acquired HilleVax for a cash payment of $1.95 per share plus a non-transferable CVR that entitles holders to receive certain potential payments. LAVA TherapeuticsXOMA Royalty will acquire LAVA for (i) an initial cash amount per share of $1.04 plus (ii) a non-transferable CVR per share representing the right to receive certain cash payments, including (A) the previously announced rights to receive, among other things, 75% of the net proceeds related to LAVA’s two partnered assets plus 75% of any net proceeds from any out license or sale of LAVA’s unpartnered programs, plus (B) a new right to receive up to approximately $0.23 per CVR depending on the final determination after closing of certain potential liabilities.Mural OncologyXOMA Royalty will acquire Mural Oncology through its wholly owned subsidiary XRA 5 Corp. for between $2.035 and $2.24 in cash per share. The acquisition is expected to close in the fourth quarter of 2025.1,2XenoTherapeutics Acquisition of ESSA PharmaXOMA Royalty acted as structuring agent for XenoTherapeutics’ completed acquisition of ESSA Pharma. Pipeline Partner Updates through November 10, 2025 PartnerEventRezoluteIn September, Rezolute announced it had achieved alignment with FDA on a significantly streamlined clinical development path for its ongoing Phase 3 study (upLIFT) of ersodetug for the treatment of tumor HI. Topline results are expected in the second half of 2026.3TakedaThe first patient was dosed in Takeda’s Phase 3 clinical trial investigating mezagitamab as a treatment for adults with IgA Nephropathy.Zevra TherapeuticsOn July 28, Zevra announced it had submitted an MAA to EMA for the evaluation of arimoclomol for the treatment of Niemann-Pick Disease Type C (NPC)4.Gossamer BioActivated first clinical site for the global, registrational Phase 3 SERANATA study examining seralutinib in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) in the fourth quarter of 20255.Daré BiosciencesAnnounced positive interim safety and efficacy results from its ongoing Phase 3 clinical trial evaluating the contraceptive effectiveness, safety, and acceptability of Ovaprene®, an investigational monthly, hormone-free intravaginal contraceptive.6 Anticipated Partner Events of Note through Mid-2026 PartnerEventRezoluteAnnounces topline data in December 20257 from sunRIZE Phase 3 clinical trial, which is investigating ersodetug in infants and children with congenital HI.Gossamer BioPublishes topline results from the Phase 3 PROSERA Study evaluating seralutinib in Functional Class II and III PAH patients5.Daré BioscienceMakes DARE to PLAY™ Sildenafil Cream available commercially via prescription in the fourth quarter of 2025 as a compounded drug under Section 503B of the Federal Food, Drug, and Cosmetic Act.8Commences one of two registrational Phase 3 clinical trials investigating Sildenafil Cream, 3.6%, for the treatment of female sexual arousal disorder9. Discussions with FDA regarding endpoint assessment for Phase 3 clinical studies of Sildenafil Cream, 3.6% continue8.Day One BiopharmaceuticalsPer the Day One conference call held on November 4, 2025, Ipsen, Day One’s partner outside the U.S., expects to receive EMA regulatory decision on its application to commercialize tovorafenib in the European Union. 1 https://investors.xoma.com/news-events/press-releases/detail/482/mural-oncology-announces-entry-into-agreement-to-be 2 http://ml.globenewswire.com/Resource/Download/538d82a8-0fae-4d41-8687-71845b9b67c2 3 https://ir.rezolutebio.com/news/detail/361/rezolute-announces-alignment-with-fda-on-streamlined-design-for-ongoing-phase-3-trial-of-ersodetug-in-tumor-hyperinsulinism 4 https://investors.zevra.com/news-releases/news-release-details/zevra-therapeutics-submits-marketing-authorization-application 5 https://ir.gossamerbio.com/news-releases/news-release-details/gossamer-bio-announces-third-quarter-2025-financial-results-and 6 https://ir.darebioscience.com/news-releases/news-release-details/positive-interim-phase-3-results-highlight-potential-ovaprener 7 https://ir.rezolutebio.com/news/detail/366/rezolute-reports-first-quarter-fiscal-2026-financial-results-and-provides-business-update 8 https://ir.darebioscience.com/news-releases/news-release-details/dare-bioscience-reports-second-quarter-2025-financial-results 9 https://ir.darebioscience.com/news-releases/news-release-details/dare-bioscience-announces-phase-3-plans-sildenafil-cream-36 Third Quarter and Year to Date 2025 Financial Results Tom Burns, Chief Financial Officer of XOMA Royalty, commented, “In the first nine months of 2025, we have received $43.9 million in cash from partners, of which $30.3 million were royalty payments related to commercial sales and $13.6 million in milestone payments and fees. In the third quarter, we received $14.3 million in cash from our partners’ commercial sales. With well-executed commercialization efforts by our partners and the emergence of new commercial opportunities from within our portfolio, XOMA Royalty has the potential to become a self-sustaining entity from royalties alone over the near term.” Income and Revenue: Income and revenue for the three and nine months ended September 30, 2025, were $9.4 million and $38.4 million, respectively, as compared with $7.2 million and $19.8 million for the corresponding periods of 2024. The increase in both periods presented was primarily driven by increased income related to VABYSMO and OJEMDA. Research and Development (R&D) Expenses: R&D expenses for the three and nine months ended September 30, 2025, were $69 thousand and $1.4 million, respectively, compared with $0.8 million and $2.0 million for each of the corresponding periods of 2024. R&D expenses in the first quarter of 2025 and the three- and nine-month periods of 2024 were related to the clinical trial costs incurred subsequent to XOMA Royalty’s acquisition of Kinnate in April 2024 related to KIN-3248 and the associated wind-down activities. General and Administrative (G&A) Expenses: G&A expenses for the three and nine months ended September 30, 2025, were $9.7 million and $25.7 million, respectively, as compared with $8.0 million and $27.5 million for the corresponding periods of 2024. The increase of $1.7 million for the three months ended September 30, 2025, as compared to the same period in 2024, was primarily due to an increase in business development and deal-related costs, partially offset by a decrease in stock-based compensation expense. For the nine months ended September 30, 2025, the decrease of $1.8 million, as compared to the same period in 2024, was primarily due to costs related to exit packages for Kinnate senior leadership in the second quarter of 2024 and a decrease in stock-based compensation expense, partially offset by an increase in business development and deal-related costs. XOMA Royalty’s G&A expenses included non-cash stock-based compensation expenses during the three and nine months ended September 30, 2025, of $1.8 million and $5.4 million, respectively, as compared to $2.6 million and $8.1 million for the corresponding periods of 2024. The 2024 periods reflect non-cash stock-based compensation related to the appointment of Mr. Hughes to full-time Chief Executive Officer and issuance of performance stock units. Credit Losses on Purchased Receivables: During the nine months ended September 30, 2024, XOMA Royalty recorded one-time, non-cash credit losses on purchased receivables associated with the Aronora and Agenus assets. To date, there have been no credit losses in 2025. Amortization of Intangible Assets: Amortization of intangible assets relates to the IP acquired in the Company’s acquisitions of Pulmokine in November 2024 and the mezagitamab economics from the BioInvent transaction in May 2025. Amortization of non-cash intangible assets were $0.9 million and $2.1 million for the three and nine months ended September 30, 2025. Gains on Acquisitions: In the third quarter of 2025, XOMA Royalty recorded gains on acquisitions of $17.9 million for HilleVax and $1.8 million for Turnstone. Interest Expense: For the three and nine months ended September 30, 2025, interest expense was $3.3 million and $10.0 million, respectively, as compared with $3.5 million and $10.4 million for the corresponding periods of 2024. Interest expense relates to the Blue Owl Loan established in December 2023. Other Income, net: For the three and nine months ended September 30, 2025, other income, net was $0.7 million and $8.5 million, respectively, as compared with $1.9 million and $5.9 million for the corresponding periods of 2024. Net Income: XOMA Royalty reported net income of $14.1 million and $25.6 million for the three and nine months ended September 30, 2025, as compared to net losses of $17.2 million and $9.9 million in the corresponding periods of 2024. Cash Position: On September 30, 2025, XOMA Royalty had cash and cash equivalents of $130.6 million, including $85.4 million in restricted cash. The restricted cash balance included $43.3 million related to the assumed HilleVax lease, $39.9 million reserved to fund the Mural acquisition, and $2.2 million related to the Blue Owl Loan. Cash and cash equivalents of $106.4 million as of December 31, 2024, included $4.8 million in restricted cash related to the Blue Owl Loan. In the third quarter of 2025, XOMA Royalty received $14.3 million in cash receipts from royalties and commercial payments and paid $1.4 million in dividends on the XOMA Royalty Perpetual Preferred stocks. In the first nine months of 2025, XOMA Royalty received $43.9 million in cash receipts, including $30.3 million in royalties and commercial payments and $13.6 million in milestone payments and fees. During the first nine months of 2025, XOMA Royalty deployed $25.0 million to acquire additional assets for its royalty and milestone portfolio, repurchased approximately 108,510 shares of its common stock for a cost of $2.4 million, and paid $4.1 million in dividends on the XOMA Royalty Perpetual Preferred stocks. About XOMA Royalty CorporationXOMA Royalty is a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health. XOMA Royalty acquires the potential future economics associated with pre-commercial and commercial therapeutic candidates that have been licensed to pharmaceutical or biotechnology companies. When XOMA Royalty acquires the future economics, the seller receives non-dilutive, non-recourse funding they can use to advance their internal drug candidate(s) or for general corporate purposes. The Company has an extensive and growing portfolio of assets (asset defined as the right to receive potential future economics associated with the advancement of an underlying therapeutic candidate). For more information about the Company and its portfolio, please visit www.xoma.com or follow XOMA Royalty Corporation on LinkedIn. Forward-Looking Statements/Explanatory NotesCertain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding the timing and amount of potential commercial payments to XOMA Royalty and other developments related to VABYSMO® (faricimab-svoa), OJEMDA™ (tovorafenib), MIPLYFFA™ (arimoclomol), XACIATO™ (clindamycin phosphate) vaginal gel 2%, IXINITY® [coagulation factor IX (recombinant)], DSUVIA® (sufentanil sublingual tablet), and Sildenafil Cream, 3.6%; the potential occurrences of the events listed under “Anticipated 2025 Events of Note”; the anticipated timings of regulatory filings and approvals related to assets in XOMA Royalty’s portfolio; and the potential of XOMA Royalty’s portfolio of partnered programs and licensed technologies generating substantial milestone and royalty proceeds over time. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,” “will”, “would,” “could” or “should,” the negative of these terms or similar expressions. These forward-looking statements are not a guarantee of XOMA Royalty’s performance, and you should not place undue reliance on such statements. These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry, including those related to the fact that our product candidates subject to out-license agreements are still being developed, and our licensees may require substantial funds to continue development which may not be available; we do not know whether there will be, or will continue to be, a viable market for the products in which we have an ownership or royalty interest; and if the therapeutic product candidates to which we have a royalty interest do not receive regulatory approval, our third-party licensees will not be able to market them. Other potential risks to XOMA Royalty meeting these expectations are described in more detail in XOMA Royalty's most recent filing on Form 10-Q and in other filings with the Securities and Exchange Commission. Consider such risks carefully when considering XOMA Royalty's prospects. Any forward-looking statement in this press release represents XOMA Royalty's beliefs and assumptions only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA Royalty disclaims any obligation to update any forward-looking statement, except as required by applicable law. EXPLANATORY NOTE: Any references to “portfolio” in this press release refer strictly to milestone and/or royalty rights associated with a basket of drug products in development. Any references to “assets” in this press release refer strictly to milestone and/or royalty rights associated with individual drug products in development. As of the date of this press release, the commercial assets in XOMA Royalty’s milestone and royalty portfolio are VABYSMO® (faricimab-svoa), OJEMDA™ (tovorafenib), MIPLYFFA™ (arimoclomol), XACIATO™ (clindamycin phosphate) vaginal gel 2%, IXINITY® [coagulation factor IX (recombinant)], and DSUVIA® (sufentanil sublingual tablet). All other assets in the milestone and royalty portfolio are investigational compounds. Efficacy and safety have not been established. There is no guarantee that any of the investigational compounds will become commercially available. XOMA ROYALTY CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (in thousands, except share and per share amounts) Three Months Ended September 30, Nine Month Ended September 30, 2025 2024 2025 2024 Income and Revenues: Income from purchased receivables under the EIR method$6,962 $5,423 $19,039 $9,985 Income from purchased receivables under the cost recovery method 1,857 1,040 9,125 1,910 Revenue from contracts with customers 225 25 9,250 6,050 Revenue recognized under units-of-revenue method 307 709 978 1,828 Total income and revenues 9,351 7,197 38,392 19,773 Operating expenses: Research and development 69 817 1,431 2,011 General and administrative 9,734 8,020 25,682 27,485 Credit losses on purchased receivables - 14,000 - 23,000 Amortization of intangible assets 878 - 2,077 - Total operating expenses 10,681 22,837 29,190 52,496 Income (Loss) from operations (1,330) (15,640) 9,202 (32,723) Other income (expense) Gains on acquisitions 18,004 - 18,004 19,316 Change in fair value of embedded derivative related to RPA - - - 8,100 Interest expense (3,301) (3,493) (10,004) (10,446) Other income, net 727 1,890 8,456 5,900 Net income$14,100 $(17,243) $25,658 $(9,853) Income tax expense$(49) $- $(49) $- Net income (loss)$14,051 $(17,243) $25,609 $(9,853) Net income (loss) available to (attributable to) common stockholders, basic$8,981 $(18,611) $15,192 $(13,957) Basic net income per share available to common stockholders$0.74 $(1.59) $1.26 $(1.20) Weighted average shares used in computing basic net income per share available to common stockholders 12,137 11,712 12,038 11,645 Net income (loss) available to (attributable to) common stockholders, diluted$12,683 $(18,611) $21,505 $(13,957) Diluted net income per share available to common stockholders$0.70 $(1.59) $1.20 $(1.20) Weighted average shares used in computing diluted net income per share available to common stockholders 18,141 11,712 17,932 11,645 XOMA ROYALTY CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) (in thousands, except share and per share amounts) September 30, December 31, 2025 2024 ASSETS Current assets: Cash and cash equivalents$45,189 $101,654 Short-term restricted cash 45,288 1,330 Investment in equity securities 1,521 3,529 Trade and other receivables, net 3,573 1,839 Short-term royalty and commercial payment receivables under the EIR method 13,269 14,763 Short-term royalty and commercial payment receivables under the cost recovery method 900 413 Prepaid expenses and other current assets 967 2,076 Total current assets 110,707 125,604 Long-term restricted cash 40,076 3,432 Property and equipment, net 24 32 Operating lease right-of-use assets 272 319 Long-term royalty and commercial payment receivables under the EIR method 4,678 4,970 Long-term royalty and commercial payment receivables under the cost recovery method 57,864 55,936 Exarafenib milestone asset 3,500 3,214 Investment in warrants 595 - Intangible assets, net 44,556 25,909 Other assets - long term 879 1,861 Total assets$263,151 $221,277 LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable$2,654 $1,053 Accrued and other liabilities 4,134 5,752 Contingent consideration under RPAs, AAAs, and CPPAs - 3,000 Operating lease liabilities 2,508 446 Unearned revenue recognized under units-of-revenue method 1,320 1,361 Preferred stock dividend accrual 1,368 1,368 Current portion of long-term debt 14,345 11,394 Contingent value rights liabilities - current portion 1,976 - Total current liabilities 28,305 24,374 Unearned revenue recognized under units-of-revenue method – long-term 3,473 4,410 Exarafenib milestone contingent consideration 3,500 3,214 Long-term operating lease liabilities 20,678 483 Long-term debt 94,382 106,875 Contingent value rights liabilities - long-term 4,807 - Deferred tax liability 49 - Total liabilities 155,194 139,356 Convertible preferred stock, $0.05 par value, 5,003 shares authorized, issued and outstanding as of September 30, 2025 and December 31, 2024 20,019 20,019 Stockholders’ equity: 8.625% Series A cumulative, perpetual preferred stock, $0.05 par value, 984,000 shares authorized, issued and outstanding as of September 30, 2025 and December 31, 2024 49 49 8.375% Series B cumulative, perpetual preferred stock, $0.05 par value, 3,600 shares authorized, 1,600 shares issued and outstanding as of September 30, 2025 and December 31, 2024 — — Common stock, $0.0075 par value, 277,333,332 shares authorized, 12,310,300 and 11,952,377 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively 92 90 Additional paid-in capital 1,301,542 1,298,747 Accumulated other comprehensive income 121 73 Accumulated deficit (1,213,866) (1,237,057) Total stockholders’ equity 87,938 61,902 Total liabilities, convertible preferred stock and stockholders’ equity$263,151 $221,277 XOMA ROYALTY CORPORATIONCONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(unaudited)(in thousands) Nine Months Ended September 30, 2025 2024 Cash flows from operating activities: Net income$25,609 $(9,853)Adjustments to reconcile net income to net cash provided by (used in) operating activities: Adjustment for income from EIR method purchased receivables 627 (9,985)Stock-based compensation expense 5,358 8,136 Gains on acquisitions (18,004) (19,316)Credit losses on purchased receivables — 23,000 Gain on sale of equity securities (3,663) — Income tax expense 49 — Common stock contribution to 401(k) 141 118 Amortization of intangible assets 2,077 — Depreciation 8 8 Accretion of long-term debt discount and debt issuance costs 1,136 996 Non-cash lease expense 47 45 Change in fair value of equity securities (1,230) (624)Change in fair value of available-for-sale debt securities classified as cash equivalents 49 104 Change in fair value of derivatives 10 — Changes in assets and liabilities: Trade and other receivables, net (1,187) (41)Prepaid expenses and other assets 1,839 (72)Accounts payable and accrued liabilities (3,248) (1,348)Operating lease liabilities (268) (185)Unearned revenue recognized under units-of-revenue method (978) (1,828)Net cash provided by (used in) operating activities 8,372 (10,845) Cash flows from investing activities: Net cash acquired in Kinnate acquisition — 18,926 Net cash, cash equivalents and restricted cash acquired in Turnstone acquisition 3,943 — Net cash, cash equivalents and restricted cash acquired in HilleVax acquisition 46,832 — Payments of consideration under RPAs, AAAs, and CPPAs (8,000) (37,000)Receipts under RPAs, AAAs, and CPPAs 3,139 26,263 Payment for BioInvent contract-based intangible asset (20,725) — Payment of contingent consideration related to Kinnate IP asset (550) — Purchase of property and equipment — (17)Purchase of equity securities (99) — Sale of equity securities 6,999 — Net cash used in investing activities 31,539 8,172 Cash flows from financing activities: Principal payments – debt (10,598) (6,902)Debt issuance costs and loan fees paid in connection with long-term debt (80) (740)Payment of preferred stock dividends (4,104) (4,104)Repurchases of common stock (2,395) (13)Proceeds from exercise of options and other share-based compensation 3,422 4,127 Taxes paid related to net share settlement of equity awards (2,019) (2,429)Net cash used in financing activities (15,774) (10,061) Net increase (decrease) in cash, cash equivalents, and restricted cash 24,137 (12,734)Cash, cash equivalents, and restricted cash at the beginning of the period 106,416 159,550 Cash, cash equivalents, and restricted cash at the end of the period$130,553 $146,816 Supplemental Cash Flow Information: Cash paid for interest$11,906 $9,985 Cash paid for taxes$277 $— Non-cash investing and financing activities: Accrual of contingent value rights liability in the Turnstone acquisition$1,110 $— Accrual of contingent value rights liability in the HilleVax acquisition$5,673 $— Right-of-use assets obtained in exchange for operating lease liabilities in the HilleVax acquisition$22,525 $— Relative fair value basis reduction of right-of-use assets in the HilleVax acquisition$(22,525) $— Transaction costs in connection with the Turnstone acquisition included in accounts payable$92 $— Transaction costs in connection with the HilleVax acquisition included in accounts payable and accrued expenses$449 $— Excise tax accrual due to stock repurchases$24 $— Preferred stock dividend accrual$1,368 $1,368 Estimated fair value of the Exarafenib milestone asset$— $2,922 Estimated fair value of the Exarafenib milestone contingent consideration$— $2,922 Right-of-use assets obtained in exchange for operating lease liabilities in the Kinnate acquisition$— $824 Relative fair value basis reduction of rights-of-use assets in the Kinnate acquisition$— $(824)Accrual of contingent consideration under the Affitech CPPA$— $3,000 Accrual of contingent consideration under the LadRX AAA$— $1,000 Investor contact:Media contact:Juliane SnowdenKathy VincentXOMA Royalty CorporationKV Consulting & Management+1-646-438-9754kathy@kathyvincent.com juliane.snowden@xoma.com

SAN DIEGO, Oct. 06, 2025 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a biopharmaceutical company with a sole focus of closing the gap in women's health between promising science and real solutions, today announced the receipt of a $4.0 million non-dilutive funding installment under its multi-year grant agreement to support development of DARE-LARC1, the contraception-focused use case of Daré’s intelligent drug delivery system (DARE-IDDS) platform. This brings the total received to approximately $41.8 million of the up to approximately $49 million in committed grant funding for nonclinical development, IND-enabling studies, and preparation for submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA). DARE-LARC1 is a preclinical-stage investigational, long-acting reversible contraceptive (LARC) utilizing a next-generation programmable drug delivery device to administer levonorgestrel, the active pharmaceutical ingredient in a number of FDA-approved birth control methods, for an extended period without requiring day-to-day effort. The underlying DARE-IDDS platform has broader potential across multibillion-dollar markets, including obesity, diabetes, and other chronic conditions that require precise, programmable, and/or long-term dosing. Daré is currently exploring strategic partnering discussions to expand evaluation of the platform’s use beyond reproductive health. “This funding milestone will help advance what we believe is one of the most promising smart drug delivery technologies in development today,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “With non-dilutive capital covering early development, we are not only progressing a novel contraceptive, but also laying the foundation for a versatile, programmable drug delivery device platform across high-value therapeutic areas.” DARE-IDDS: A Next-Generation Drug Delivery Platform1 Originally developed at the Massachusetts Institute of Technology by renowned inventors Dr. Robert Langer and Dr. Michael Cima, clinical proof of concept was validated with an earlier prototype in a prior human study in osteoporosis patients, establishing the feasibility of long-term, programmable drug release via an implantable device.2 Since acquiring the technology, Daré has advanced the design by enhancing electronics, battery performance, and precision dosing, guided by therapeutic use cases and user feedback. The result is a programmable, wirelessly controlled device capable of delivering up to hundreds of individualized doses over months or years, without recharging or surgical replacement. Key Platform Features: Precision Dosing: Controlled release via programmable micro-reservoirs Extended Duration: Monthly to multi-year dosing capability from a single device No External Power Required: Implant-grade battery designed to last up to 20 years Remote Programmability: Schedules and dosing parameters adjustable wirelessly in real time Smartphone Integration: Custom mobile apps for user and clinician interface Upgradable Firmware: Software updates extend lifecycle without device removal Broad Market Potential While the initial focus is DARE-LARC1 for contraception, the flexible DARE-IDDS platform supports integration with GLP-1 analogs, anti-obesity medications, hormone therapies for areas such as diabetes, breast cancer, and infertility, and neurologic disease treatments such as for Parkinson’s disease. “Beyond reproductive health, this platform has the potential to dramatically improve patient adherence, reduce treatment burden, and lower healthcare system costs in areas that today rely on frequent injections or daily oral dosing,” added Johnson. Looking Ahead Daré is eligible for additional non-dilutive funding for the DARE-LARC1 program of up to approximately $7.1 million, contingent on achieving technical and other milestones specified in the grant agreement, and is actively exploring strategic collaborations to expand the investigation of the DARE-IDDS platform into additional therapeutic categories. The company expects to continue to provide updates on program progress and partnership activity. 1 DARE-IDDS is an investigational device in preclinical development. It has not been approved or cleared for clinical investigation in humans or for any use in humans. The platform features described in this press release are based on the results of technological proof-of-concept studies. 2 Farra et al., Science Translational Medicine, 22 Feb 2012, Vol 4, Issue 122. Available at: https://www.science.org/doi/10.1126/scitranslmed.3003276 About Daré Bioscience Daré Bioscience is a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority. Daré believes that innovation does not have to start from scratch. The company’s goal is to bring to market as soon as practicable innovative evidence-based solutions that address decades of unmet needs in women’s health and enhance outcomes and convenience, primarily in the areas of contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health and menopause. The potential products Daré identifies, in many cases, already have clinical proof of concept or existing safety data for the active ingredient that the company leverages. This provides optionality and flexibility, in many cases, in how Daré seeks to bring solutions to market in ways designed to optimize access for women in a fiscally responsible manner. The first FDA-approved product to emerge from Daré’s portfolio of women’s health product candidates is XACIATO™ (clindamycin phosphate) vaginal gel 2%, a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Visit www.xaciato.com for information about XACIATO. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil citrate, the active ingredient in an oral erectile dysfunction drug for men, to treat female sexual arousal disorder (FSAD); and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. To learn more about Daré’s full portfolio of women’s health product candidates and mission to deliver differentiated therapies for women, please visit www.darebioscience.com. Daré Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma and Daré's CEO has been honored as one of Fierce Pharma’s Most Influential People in Biopharma for Daré’s contributions to innovation and advocacy in the women’s health space. Daré may announce material information about its finances, products and product candidates, clinical trials and other matters using the Investors section of its website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Daré will use these channels to distribute material information about the company and may also use social media to communicate important information about the company, its finances, products and product candidates, clinical trials and other matters. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts in the Investors section of its website and to follow these X (formerly Twitter) accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted in the Investors section of Daré’s website. Forward-Looking Statements Daré cautions you that all statements, other than statements of historical facts, contained in this press release, 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,” “plan,” “potential,” “positioned,” “pursue,” “explore,” “seek,” “should,” “would,” “project,” “target,” “objective,” “on track,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to DARE-LARC1’s potential to demonstrate safety and effectiveness as a long-acting reversible contraceptive product, the potential utilization of the DARE-IDDS platform in future products for the treatment of a broad range of diseases and conditions, the therapeutic and market potential of products utilizing the DARE-IDDS platform, if approved, the potential for Daré to enter into strategic collaborations relating to the DARE-IDDS platform, and the potential for Daré to receive additional funding under the grant agreement relating to DARE-LARC1. As used in this press release, “first-in-category” is a forward-looking statement relating to the potential of a product candidate to represent a new category of product if it were to receive marketing approval for the indication for which it is being developed because Daré believes it would address a need in women’s health that is not being met by existing FDA-approved products. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: Daré’s ability to achieve the technical and other milestones required to receive additional funding under the grant agreement relating to DARE-LARC1; the potential that no definitive agreements result from discussions regarding potential strategic collaborations for the DARE-IDDS platform; DARE-LARC1 is in preclinical development and results from preclinical studies or early clinical trials are not necessarily predictive of future clinical results; Daré’s ability to raise additional capital when and as needed to execute its business strategy and continue as a going concern; Daré’s dependence on grants and other financial awards from governmental entities and a private foundation; limitations on Daré’s ability to raise additional capital through sales of its common stock or other equity securities due to restrictions under SEC and Nasdaq rules and regulations or contractual limitation; Daré’s inexperience, as a company, in and lack of infrastructure for commercializing products; Daré’s reliance on Section 503B-registered outsourcing facilities and other third parties to bring DARE to PLAY™ Sildenafil Cream and other solutions to market as compounded drugs or as consumer health products and facilitate access to such products and the risk that those third parties do not perform as expected; the risk that the FDA could stop permitting Section 503B-registered outsourcing facilities to compound the drug substances in the proprietary formulations Daré intends to bring or brings to market; the degree of market demand and acceptance for the products Daré brings to market; Daré’s reliance on third parties to manufacture and conduct clinical trials and preclinical studies of its product candidates and commercialize XACIATO™ (clindamycin phosphate) vaginal gel 2% and future FDA-approved products, if any; the risk that the current regulatory pathway known as the FDA’s 505(b)(2) pathway for drug product approval in the U.S. is not available for a product candidate as Daré anticipates; Daré’s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay in starting, conducting and completing clinical trials of a product candidate and the inherent uncertainty of outcomes of clinical trials; Daré’s ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to meet established clinical endpoints, to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety and efficacy of its product candidates; Daré’s dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; the risks that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate and that interim data or results from a particular clinical study do not necessarily predict the final results for that study; the risk that the FDA, other regulatory authorities, members of the scientific or medical communities or investors may not accept or agree with Daré’s interpretation of or conclusions regarding data from clinical studies of its product candidates; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré anticipates, or that the duration of a study or number of study subjects must be significantly greater than anticipated; the loss of, or inability to attract, key personnel; the risk that developments by competitors make Daré’s products or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and/or commercial collaborators; failure of Daré’s products or product candidates, if approved, to gain market acceptance or obtain adequate coverage, pricing and reimbursement from third-party payors; Daré’s ability to retain its licensed rights to develop and commercialize a product or product candidate; Daré’s ability to satisfy the monetary obligations and other requirements in connection with its exclusive, in-license agreements covering the critical patents and related intellectual property related to its products and product candidates; Daré’s ability to adequately protect or enforce its, or its licensor’s, intellectual property rights; the lack of patent protection for the active ingredients in certain of Daré’s product candidates which could expose its products to competition from other formulations using the same active ingredients; product liability claims; governmental investigations or actions relating to Daré’s products or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; the effects of macroeconomic conditions, geopolitical events, and major changes and disruptions in U.S. government policies and operations on Daré’s ability to raise additional capital or on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; Daré’s ability to maintain compliance with Nasdaq’s continued listing requirements and continue to have its common stock listed on The Nasdaq Capital Market; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; cybersecurity incidents or similar events that compromise Daré’s technology systems or those of third parties on which it relies and/or significantly disrupt Daré’s business; and disputes or other developments concerning Daré’s intellectual property rights. Daré’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Daré’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including Daré’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Daré undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Contacts: Daré Bioscience Investor Relations innovations@darebioscience.com Source: Daré Bioscience, Inc.