Sildenaifl Citrate

Organon, a global women’s healthcare company, initiated XACIATO™ commercial activities in the fourth quarter of 2023 XOMA further expands its late-stage portfolio with synthetic royalty and milestone interests in two additional women’s health assets: Ovaprene®, an investigational potential first-in-category Phase 3 hormone-free monthly intravaginal contraceptive, and Sildenafil Cream, 3.6%, a potential first-in-category Phase 3-ready candidate for female sexual arousal disorder Bayer HealthCare holds the exclusive rights to U.S. commercialization of Ovaprene® XOMA provided $22 million upfront as non-dilutive royalty capital solution to Daré Bioscience EMERYVILLE, Calif., April 30, 2024 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA) announced today it has acquired an economic interest in three women’s health assets - XACIATO™ (clindamycin phosphate) vaginal gel 2%, Ovaprene®, and Sildenafil Cream, 3.6% - from Daré Bioscience, Inc., for an upfront payment of $22 million. XACIATO™ is approved by the U.S. Food and Drug Administration (FDA) for the treatment of bacterial vaginosis (BV) in females 12 years of age and older. In 2022, Daré entered into a license agreement with Organon, which initiated XACIATO™ commercial marketing activities in the fourth quarter of 2023. “XACIATO™, an important therapy, becomes the fifth commercial asset in XOMA’s royalty portfolio, and our royalty monetization transaction with Daré also adds two first-in-category Phase 3 royalty assets that have the potential to create additional value for our shareholders. Each of the three assets represents a meaningful advance in the women’s health category that has typically been under-represented and has significant growth potential,” stated Brad Sitko, Chief Investment Officer at XOMA. “XOMA structured an attractive, non-dilutive royalty capital solution that provides Daré with additional financial resources to advance its pipeline through key catalysts and aligns with its stockholders, enabling them to participate in the future value created by XACIATO™, Ovaprene®, and Sildenafil Cream.” Under the terms of the agreement, XOMA will receive the remaining royalties related to XACIATO™ not already included in Daré’s December 2023 royalty-backed financing agreement, which equates to low to high single-digit royalties on net sales. XOMA also is entitled to potential milestone payments based on the commercial success of XACIATO. Additionally, XOMA has acquired an interest in a potential milestone and a low single-digit synthetic royalty on Ovaprene®, as well as a low single-digit synthetic royalty on Sildenafil Cream, 3.6%. Upon achieving a pre-specified return threshold, XOMA will make upside-sharing milestone payments to Daré. AdvisorsGibson, Dunn & Crutcher LLP served as XOMA’s legal advisor, while Daré was advised by Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. TD Cowen, a division of TD Securities, acted as exclusive financial advisor to Daré. About XACIATO™ (clindamycin phosphate) vaginal gel 2%XACIATO vaginal gel is a prescription medicine used to treat bacterial vaginal infections in females 12 years of age and older, which is under a global license agreement with Organon. For more information, including important safety information, please visit www.xaciato.com. About Ovaprene®Ovaprene® is a novel investigational hormone-free monthly intravaginal contraceptive designed to be an easy-to use monthly option and prevent pregnancy by releasing a locally acting, non-hormonal agent, which impedes sperm motility, and physically blocks sperm from entering the cervical canal with its unique knitted polymer barrier. The novel combination of these complementary approaches has the potential to produce efficacy consistent with existing short-acting hormone birth control options (pills, patches, vaginal ring), without the use of hormones. U.S. commercial rights to Ovaprene® are under a license agreement with Bayer. About Sildenafil Cream, 3.6%Sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, is the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra® for the treatment of erectile dysfunction in men. Sildenafil Cream is an investigational, proprietary cream formulation of sildenafil designed for topical administration to the vulvar-vaginal tissue on demand to increase genital blood flow and provide improvements in the female genital arousal response, while avoiding systemic side effects observed with oral formulations of sildenafil. About XOMA CorporationXOMA is a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health. XOMA acquires the potential future economics associated with pre-commercial therapeutic candidates that have been licensed to pharmaceutical or biotechnology companies. When XOMA 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 the Company 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 and other developments related to XACIATO™, Ovaprene®, and Sildenafil Cream, 3.6%. 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’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; if the therapeutic product candidates to which we have a royalty interest do not receive regulatory approval, and our third-party licensees will not be able to market them. Other potential risks to XOMA meeting these expectations are described in more detail in XOMA's most recent filing on Form 10-K and in other filings with the Securities and Exchange Commission. Consider such risks carefully when considering XOMA's prospects. Any forward-looking statement in this press release represents XOMA'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 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, all assets in XOMA’s milestone and royalty portfolio, except VABYSMO® (faricimab), OJEMDA™ (tovorafenib), XACIATO™ (clindamycin phosphate) vaginal gel 2%, IXINITY® [coagulation factor IX (recombinant)], and DSUVIA® (sufentanil sublingual tablet), 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 Investor ContactXOMA Media ContactJuliane SnowdenKathy VincentXOMA CorporationKV Consulting & Management+1 646-438-9754+1 310-403-8951juliane.snowden@xoma.comkathy@kathyvincent.com

$22 million of non-dilutive capital at close provides significant capital to achieve objectives Upon achieving a pre-specified return threshold, XOMA will make upside-sharing milestone payments to Daré representing 50% of the future payments otherwise payable to XOMA Transaction allows Daré to focus on advancing Phase 3 first-in-category investigational products Ovaprene®, a potential first FDA-approved hormone-free intravaginal monthly contraceptive, and Sildenafil Cream, 3.6%, a potential first FDA-approved treatment for female sexual arousal disorder through key catalysts Previously announced royalty financing remains outstanding, bringing royalty-based capital committed to $34 million SAN DIEGO, April 30, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced it has closed a royalty monetization transaction with XOMA (US) LLC. Daré received $22 million in gross proceeds at close and, following a pre-specified total return to XOMA, XOMA will make upside-sharing milestone payments to Daré equal to 50% of all remaining cash flows sold to XOMA under the transaction. “This monetization of future net royalty and net milestone payments based on net sales of XACIATO™ (clindamycin phosphate) vaginal gel 2% under our license agreement with Organon, along with a low single digit minority interest in net payments related to future revenue from our Phase 3 candidates, Ovaprene and Sildenafil Cream, accelerates potential cash flows from the future commercial success of XACIATO and such product candidates, providing us with non-dilutive capital at an opportune time to drive shareholder value through the continued advancement of Ovaprene and Sildenafil Cream, both of which are first-in-category and represent large market opportunities,” said Sabrina Martucci Johnson, President and Chief Executive Officer of Daré Bioscience. “Importantly, this transaction ensures that Daré and our shareholders have the opportunity to participate meaningfully in XACIATO economics as commercialization progresses. The structure of these agreements also underscores the significant potential of Ovaprene and Sildenafil Cream, with Daré retaining the significant majority of future economics and the ability to achieve attractive margins through retained net sales and all commercial milestones. This transaction exemplifies our commitment to being creative, collaborative and opportunistic in seeking capital at an attractive cost to advance our potential first-in-category Phase 3 candidates to deliver value for all Daré stakeholders.” The transaction involves the sale of (a) the remaining royalties and potential milestones based on net sales of XACIATO payable to Daré under its global license agreement with Organon after deducting (i) all amounts due on such royalties and milestone payments to third-party licensors, and (ii) all payments owed by Daré under its existing royalty interest financing agreement with United in Endeavour, LLC, (b) 25% of the potential $20 million payment due to Daré under its license agreement with Bayer relating to Ovaprene, in the event Bayer, in its sole discretion, elects to make the payment1, and (c) a 4% synthetic royalty on net sales of Ovaprene and a 2% synthetic royalty on net sales of Sildenafil Cream, subject to an automatic decrease to 2.5% and 1.25%, respectively, as described below. Once XOMA achieves a pre-specified total return on its investment, XOMA will pay to Daré 50% of each successive $22 million that XOMA receives under the transaction agreements, and, once XOMA achieves another pre-specified total return on its investment, the synthetic royalty rates on net sales of Ovaprene and Sildenafil Cream will automatically decrease to 2.5% and 1.25%, respectively, which, after taking into account the $11 million payments to Daré after XOMA achieves the initial pre-specified total return, results in a lower effective royalty rate. TD Cowen, a division of TD Securities, acted as exclusive financial advisor to Daré Bioscience on the transaction. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. served as Daré’s legal advisor while XOMA was advised by Gibson, Dunn & Crutcher LLP. Additional information regarding the transaction is available in Daré’s Current Report on Form 8-K filed with the Securities and Exchange Commission today. 1 - Daré retains 75% of the potential $20 million payment and has no downstream obligations with respect to such payment. About Daré Bioscience Daré Bioscience is a biopharmaceutical company committed to advancing innovative products for women’s health. The company’s mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women's health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, vaginal health, reproductive health, menopause, sexual health and fertility. 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. Organon commenced U.S. marketing of XACIATO in the fourth quarter of 2023. 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, the active ingredient in Viagra®, 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 XACIATO, Daré’s full portfolio of women’s health product candidates, and Daré’s 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 2022. In 2023, Daré's CEO was 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 Bioscience placed #1 in the Small Company category of the San Diego Business Journal’s 2023 Best Places to Work Awards. Daré may announce material information about its finances, product 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, product 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,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “objective,” 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 Daré’s use of proceeds from its transaction with XOMA, potential ongoing milestone payments from XOMA, the potential for lower effective synthetic royalty rates on net sales of Ovaprene and Sildenafil Cream, Daré’s expectation that proceeds from the transaction will provide sufficient capital to advance Ovaprene and Sildenafil Cream through key catalysts, the continued advancement of Ovaprene and Sildenafil Cream, the potential market opportunity for Ovaprene and Sildenafil Cream, if approved, and Daré’s ability to deliver value for all Daré stakeholders. In addition, as used in this press release, the description of a product candidate as “first-in-category” is a forward-looking statement relating to the potential of the candidate to represent a new category of product if it were to receive marketing approval for the indication for which Daré is developing it. 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 raise additional capital when and as needed to advance its product candidates, execute its business strategy and continue as a going concern; 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; 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 risk 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; 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; the loss of, or inability to attract, key personnel; the effects of macroeconomic conditions, geopolitical events, public health emergencies, and major disruptions in government operations on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; the risk that developments by competitors make Daré’s product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and/or commercial collaborators; failure of Daré’s product or product candidates, if approved, to gain market acceptance or obtain adequate coverage or reimbursement from third-party payers; 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 product 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 product or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; 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: Media and Investors on behalf of Daré Bioscience, Inc:Camilla White / Simona KormanikovaDentons Global AdvisorsDareBioscience@dentonsglobaladvisors.com / 1.212.466.6450 Source: Daré Bioscience, Inc.