Ritonavir

FDA briefing document submitted April 24, 2025 in support of a meeting to align on pathway for tivoxavir marboxil (TXM, bird flu/seasonal flu) including potential for accelerated approval utilizing the “Animal Rule” Additional briefing document in support of a meeting to align on ratutrelvir for COVID - including Long COVID - to be submitted to regulatory authorities in Q2 2025 Cash runway to support planned operations into Q1 2026 NEWTOWN, Pa., May 15, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”), a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respiratory viral diseases, today reported financial results for the quarter ended March 31, 2025 and provided recent business highlights, with updates to the Company’s investigational programs including lead product candidate, tivoxavir marboxil (TXM) in development for bird flu and seasonal flu, and ratutrelvir in development for acute treatment of COVID, with potential to prevent COVID-rebound and Long COVID. “Traws continues to make excellent progress this year with its two proprietary, investigational oral, small molecule antivirals for bird flu/seasonal flu and COVID. Identifying opportunities to accelerate the path to approval is core to Traws’ strategy. We are preparing to interact with regulatory authorities in the coming months regarding both of our antiviral programs,” said Iain D. Dukes, D.Phil, Interim CEO of Traws Pharma. “We have submitted briefing materials to the FDA for our tivoxavir marboxil program, in preparation for a meeting to discuss the potential for accelerated approval under the FDA Animal Rule. In addition, Traws intends to seek regulatory input on the use of ratutrelvir in acute treatment/rebound prevention and Long COVID. We look forward to providing an update on our progress with these discussions over the next quarter.” “Viral diseases are an important medical problem with high morbidity and mortality. The standard approach to viral disease has been vaccines. In my view, vaccine use is waning dramatically due to the fast development of resistance and potential regulatory hurdles for new approvals. Antiviral agents can be used to address an existing infection and virus spread, especially in cases where vaccines do not yet exist or are not sufficiently effective or utilized. We believe that Traws’ programs are each poised to make important progress in the coming months, supported by potent antiviral activity in well accepted preclinical tests and animal models, and promising pharmacokinetic profiles from Phase 1 studies, that could enable differentiated activity,” added Robert Redfield, MD, Chief Medical Officer at Traws Pharma and former Director of the U.S. Centers for Disease Control and Prevention (CDC) and Senior Visiting Fellow, Biosecurity and Public Health Policy, Asian Studies Center at the Heritage Foundation. Recent Highlights and Anticipated Milestones: Product Development Tivoxavir Marboxil (TXM, Bird flu and seasonal flu)A single-dose, investigational CAP-dependent endonuclease inhibitor Intended Indication: Treatment or prevention of H5N1 bird flu and seasonal fluU.S. Market Opportunity: Estimated to be a multi-billion dollar market opportunity, including, in the short-term, potential stockpiling1,2Current Status: Preparations are underway to finalize the development plan and move forward on the path to approvalRecent Updates (including International Conference for Antiviral Research (ICAR 2025) data): Briefing package submitted to FDA on April 24, 2025, for a meeting to discuss the potential for accelerated approval under the FDA Animal Rule, per a meeting request submitted March 21, 2025Topline data from a non-human primate challenge study showed that a single, oral dose of TXM significantly reduced viral burden and pathology in the lung with no weight loss compared to untreated controls, two key measures of antiviral activity in preclinical flu modelsTopline data from a ferret challenge study showed that a single, oral dose of TXM increased the proportion of surviving animals and lowered the viral burden and pathology in lungs and nasal tissues; ferrets are widely accepted as an animal model for evaluating influenza treatmentsPhase 1 data showed that TXM maintained plasma blood levels above the EC90 for approximately three weeks after a single oral dose, with good overall tolerability; these data support the use of TXM as a single-dose treatment Next Steps: Bird flu: Provide an update on FDA discussions regarding the Animal Rule: Q2 2025Bird flu/Seasonal flu: Finalize the development plan and move forward on the path to approvalBird flu/Seasonal flu: Finalize formulation and CMC scale-up Ratutrelvir (COVID)A ritonavir-independent investigational oral Main protease (Mpro) inhibitor designed to be administered as a single dose, with potential for once-daily, 10-day dosing Intended Indication: Treatment of acute COVID infection, with potential to reduce the risk of COVID rebound and Long COVIDU.S. Market Opportunity: Estimated to be a multi-billion dollar market opportunity3,4Current Status: Preparations are underway for regulatory briefings and Phase 2 studiesRecent Updates (primarily from the International Conference for Antiviral Research (ICAR 2025)): Preclinical studies of ratutrelvir show potent suppression of resistant virusPharmacokinetic (PK) results provide support for ratutrelvir as a ritonavir-independent agent based on data showing that drug metabolism is not induced by 10-days of treatment at 600 mg/day and that trough blood plasma levels are maintained at four times the EC90Phase 1 data show good overall tolerability at all doses tested, with attractive (PK) Next Steps: Submit a briefing package to regulatory authorities in Q2 2025 for the use of ratutrelvir in acute treatment/rebound prevention and Long COVID Legacy Programs: Traws is seeking partnership opportunities for its legacy oncology assets (narazaciclib and rigosertib) Corporate Updates Management Updates: Iain D. Dukes, D. Phil was named Interim CEO, following the retirement of Werner Cautreels, PhD, on March 31, 2025. With the expansion Dr. Dukes’ responsibilities, Jack Stover, an independent director, was named Chairman of Traws Board on April 15, 2025. Financial Results: Cash, cash equivalents and short-term investments: As of March 31, 2025, the Company had cash, cash equivalents, and short-term investments of approximately $15.9 million, compared to approximately $21.3 million as of December 31, 2024. The Company believes its cash and cash equivalents will be sufficient to support ongoing operations into Q1 2026. Revenue for the quarter ended March 31, 2025, was $57 thousand, compared to $56 thousand for the comparable period in 2024. Research and development (R&D) expense for the quarter ended March 31, 2025, totaled $2.5 million, compared to $1.9 million for the comparable period in 2024. This increase of $0.6 million primarily relates to an increase in expenses related to our virology programs, partially offset by a decrease in expenses related to the oncology program. General and administrative (G&A) expense for the quarter ended March 31, 2025, totaled $2.8 million, compared to $3.4 million for the comparable period in 2024. This decrease of $0.6 million was primarily attributable to a decrease in consulting fees, partially offset by an increase in expenses attributable to severance expenses. Net Income (loss): The net income for the quarter ended March 31, 2025 was $21.5 million, driven by the change in fair value of warrant liability of $26.5 million associated with the December 2024 financing. As a result, the net income for the quarter ended March 31, 2025 was $2.17 per basic common share and $2.09 per diluted common share. This compares to a net loss of $5.0 million, or a net loss of $5.92 per basic and diluted common share, for the quarter ended March 31, 2024. Shares Outstanding: Traws had 5,564,315 shares of common stock outstanding as of May 13, 2025. About Tivoxavir Marboxil Tivoxavir marboxil (TXM) is an investigational oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose for the treatment of bird flu and seasonal influenza. It has potent in vitro activity against a range of influenza strains in preclinical studies, including a human isolate of the highly pathogenic avian flu H5N1 (bird flu). Consistent, positive preclinical data from three animal species indicate that a single dose of TXM demonstrated a therapeutic effect against H5N1 bird flu. Seasonal influenza represents an estimated multi-billion dollar antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders1,2, with upside potential from potential pandemic flu outbreaks including H5N1 bird flu. We believe that these data support further development of tivoxavir marboxil as a treatment for bird flu. About Ratutrelvir Ratutrelvir is an investigational oral, small molecule Mpro (3CL protease) inhibitor designed to be a broadly acting treatment for COVID-19 that is used without ritonavir. It has demonstrated in vitro activity against a range of COVID-19 strains. Preclinical and Phase 1 studies show that ratutrelvir does not require co-administration with a metabolic inhibitor, such as ritonavir, which could avoid ritonavir-associated drug-drug interactions5, and potentially enable wider patient use. Phase 1 data also show that ratutrelvir’s pharmacokinetic (PK) profile demonstrated maintenance of target blood plasma levels approximately 13 times above the EC50 using the target Phase 2 dosing regimen of 600 mg/day for ten days, which may also reduce the likelihood of clinical rebound and, consequently, reduce the risk for Long COVID6. Industry data indicate that COVID treatment represents a potential multi-billion dollar market opportunity3,4. Source information: Per link TRAW data on filePfizer.com 10K report 2024, Feb 27, 2025Merck & Co 10K, Feb 25 2025https://ascpt-onlinelibrary-wiley-com.libproxy1.nus.edu.sg/doi/pdf/10.1002/cpt.2646Carly Herbert et al. (2025) Clinical Infectious Diseases. https://doi-org.libproxy1.nus.edu.sg/10.1093/cid/ciae539 About Traws Pharma, Inc. Traws Pharma is a clinical stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. Traws integrates antiviral drug development, medical intelligence and regulatory strategy to meet real world challenges in the treatment of viral diseases. We are advancing novel investigational oral small molecule antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health: bird flu and seasonal influenza, and COVID-19. Tivoxavir marboxil is in development as a single dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease (CEN). Ratutrelvir is in development as a ritonavir-independent COVID treatment, targeting the Main protease (Mpro or 3CL protease). For more information, please visit www.trawspharma.com and follow us on LinkedIn. Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, benefits, effectiveness, safety, and the clinical and regulatory plans for tivoxavir marboxil and ratutrelvir. The Company has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “preliminary”, “encouraging”, “approximately” or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Traws’ clinical trials, Traws’ interactions with the FDA and similar foreign regulators, collaborations, market conditions, regulatory requirements and pathways for approval, the extent of the spread and threat of the bird flu, the ongoing need for improved therapy to reduce the frequency of clinical rebound and the concomitant risk for Long COVID, and those discussed under the heading “Risk Factors” in Traws’ filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent required by law. Traws Pharma Contact:Nora BrennanTraws Pharma, Inc.nbrennan@trawspharma.com www.trawspharma.com Investor Contact:Bruce Mackle LifeSci Advisors, LLC646-889-1200bmackle@lifesciadvisors.com Traws Pharma, Inc.Condensed Consolidated Balance Sheets(unaudited) March 31, December 31, 2025 2024Assets Current assets: Cash and cash equivalents $15,937,000 $21,338,000 Tax incentive and other receivables 1,654,000 1,765,000 Prepaid expenses and other assets 1,265,000 1,848,000 Total current assets 18,856,000 24,951,000 Property and equipment, net 9,000 10,000 Other assets 198,000 1,000 Total assets $19,063,000 $24,962,000 Liabilities and stockholders’ equity (deficit) Current liabilities: Accounts payable $7,656,000 $8,186,000 Accrued expenses and other liabilities 2,519,000 3,121,000 Deferred revenue 226,000 226,000 Total current liabilities 10,401,000 11,533,000 Deferred revenue, non-current 2,508,000 2,565,000 Warrant liabilities 154,000 42,494,000 Total liabilities 13,063,000 56,592,000 Stockholders’ equity (deficit): Series C Preferred stock, $0.01 par value, 5,000,000 shares authorized, 7,440 shares issued and 7,398 shares outstanding at March 31, 2025 and December 31, 2024 — — Common stock, $0.01 par value, 250,000,000 shares authorized, 5,075,390 and 3,650,731 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively 50,000 36,000 Additional paid in capital 633,633,000 617,530,000 Accumulated deficit (627,664,000) (649,154,000)Accumulated other comprehensive loss (19,000) (42,000)Total stockholders’ equity (deficit) 6,000,000 (31,630,000)Total liabilities and stockholders’ equity (deficit) $19,063,000 $24,962,000 Traws Pharma, Inc.Condensed Consolidated Statements of Operations (unaudited) Three Months Ended March 31, 2025 2024Revenue $57,000 $56,000 Operating expenses: Research and development 2,506,000 1,912,000 General and administrative 2,754,000 3,356,000 Total operating expenses 5,260,000 5,268,000 Loss from operations (5,203,000) (5,212,000)Change in fair value of warrant liability 26,513,000 — Other income, net 180,000 229,000 Net income (loss) $21,490,000 $(4,983,000)Net income (loss) attributable to common stockholders, basic and diluted $15,083,000 $(4,983,000)Weighted-average shares of common stock outstanding, basic 6,965,927 841,738 Net income (loss) per share of common stock, basic $2.17 $(5.92)Weighted-average shares of common stock outstanding, diluted 7,215,125 841,738 Net income (loss) per share of common stock, diluted $2.09 $(5.92)Net income (loss) attributable to Series C Preferred stockholders, basic and diluted $6,407,000 $— Weighted-average shares of Series C Preferred outstanding, basic and diluted 7,398 — Net income (loss) per share of Series C Preferred, basic and diluted $866.04 $—

Creates commercial opportunity in the estimated up to $4.5 billion compounded hormone therapy market, enabling women to access an evidence-based solution Four on-market products will accelerate revenue generation and provide path to profitability Daré expects to start recording revenue in the 4th quarter of this year Conference call today at 4:30 p.m. ET to discuss the further expanded business strategy to commercialize multiple solutions in 2025 and 2026 2025 and 2026 Milestones Sildenafil Cream, 3.6% an investigational topical formulation of sildenafil being developed to treat female sexual arousal disorder, targeting availability via prescription as a Section 503B compounded drug this year DARE-HRT1 an investigational monthly intravaginal hormone therapy being developed to treat the vasomotor symptoms of menopause, targeting availability via prescription as a Section 503B compounded drug next year Vaginal probiotics, designed to restore a healthy vaginal microbiome, targeting availability as branded consumer health products this year Ovaprene®, a novel, investigational hormone-free monthly intravaginal contraceptive; enrollment ongoing in pivotal Phase 3 contraceptive efficacy study; data safety monitoring board interim assessment scheduled for July 2025 SAN DIEGO, May 13, 2025 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority, today reported financial results for the quarter ended March 31, 2025 and provided a company update. “The first quarter of 2025 has been marked by distractions and disruptions for the overall healthcare and biotech sector. I am proud that Daré is uniquely positioned to cut through the noise and deliver value to all of our stakeholders – women, healthcare providers, and investors. Today, biopharmaceutical companies with relatively low risk assets, a competitive advantage and a path toward near-term revenue are positioned to offer upside. We believe that is Daré today,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “Women's health is ripe for returns because it has been underfunded and fragmented – and with our recently announced expanded business strategy, we believe we are uniquely positioned to deliver value and returns to all of our stakeholders, with a business model that is nimble, allowing us to rapidly commercialize multiple products via multiple channels. We are no longer only seeking FDA approval; we are leveraging a dual path strategy where we commercialize via 503B compounding while continuing to seek FDA approval. We are also taking steps toward launching certain solutions as branded consumer health products that do not require a prescription.” “To our knowledge, we are the only publicly traded company focused solely on developing therapeutic products for a broad range of conditions affecting women – contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health and menopause. And, to our knowledge, we are the only publicly traded company leveraging all available paths to bring evidence-based solutions to market, reflecting where and how women are getting and paying for their care – as an FDA-approved treatment, as a compounded product, as a consumer health product that does not require a prescription – available via telehealth, online, or via an in-person visit with her healthcare provider. Our portfolio is compelling and over the next months we look forward to providing updates regarding strategic partnerships and collaborations to facilitate access to Daré on-market brands for women across multiple channels,” said Ms. Johnson. Therapeutic Development Pipeline Highlights Ovaprene®, a novel, investigational hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer HealthCare. Pivotal Phase 3 contraceptive efficacy study ongoing across the United States; an up to $10.7 million foundation non-dilutive grant announced in November 2024 supported addition of 5 new investigator sites in the first quarter of 2025. Review of interim data by the study's data safety monitoring board, an independent group of experts which evaluates the safety and integrity of the study, scheduled for July 2025. 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. If successful, Daré expects the study to support the submission of a premarket approval application for Ovaprene to the FDA, as well as regulatory filings in Europe and other countries worldwide, to allow for marketing approvals of Ovaprene. Sildenafil Cream, 3.6%, a proprietary, investigational cream formulation of sildenafil, the active ingredient in an oral erectile dysfunction drug for men, for topical on-demand administration to treat female sexual arousal disorder (FSAD). Continued interactions with the FDA regarding planned Phase 3 study; Phase 3 study design, development, and collaboration strategy updates expected throughout 2025. Daré is targeting submission of additional information requested by the FDA, along with the protocol and statistical analysis plan for the Phase 3 study, to the FDA by the end of the second quarter of 2025. DARE-HPV, a proprietary, investigational fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert for the treatment of human papillomavirus (HPV)-related cervical diseases. Conducting activities necessary to enable submission of an IND application to the FDA for a Phase 2, randomized, placebo-controlled, double-blind clinical study of DARE-HPV for clearance of high-risk HPV infection in women. Supported with up to $10 million milestone-based non-dilutive award announced October 2024. Financial Highlights for the Quarter ended March 31, 2025 Cash position: at March 31, 2025, cash and cash equivalents of approximately $10.3 million, and working capital deficit of approximately $9.4 million. General and administrative expenses: $2.3 million in 1Q-2025 as compared to $2.7 million in 1Q-2024, with the current quarter’s decrease primarily attributable to decreases in stock-based compensation expense, professional services expense and personnel costs. Research and development expenses: $2.3 million in 1Q-2025 as compared to $3.4 million in 1Q-2024, a 31% decrease compared to Q1-2024. The current quarter’s decrease is primarily attributable to decreases in manufacturing costs related to Ovaprene, costs related to development activities for Sildenafil Cream, and costs related to development activities for preclinical stage programs. We encourage investors to review the more detailed discussion of our financial statements, our financial condition, liquidity, capital resources, and risk factors in our quarterly report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC today. Conference Call Daré will host a conference call and live webcast today, May 13, 2025, at 4:30 p.m. Eastern Time to review financial results for the quarter ended March 31, 2025 and to provide a company update. To access the conference call via phone, dial (646) 307-1963 (U.S.) or (800) 715-9871 (toll free). The conference ID number for the call is 3461324. The live webcast can be accessed under “Presentations, Events & Webcasts" in the Investors section of the company's website at http://ir.darebioscience.com. Please log in approximately 5-10 minutes prior to the call to register and to download and install any necessary software. The webcast will be archived under the same section of the company's website and available for replay until May 27, 2025. 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, 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, 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,” “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 Daré’s go-to-market strategies; Daré’s plans and timing for making its proprietary formulations available by prescription in the U.S. as compounded drugs via Section 503B of Federal Food, Drug, and Cosmetic Act (FDCA) and for launching branded consumer health products; the market opportunity for those products and their ability to gain market acceptance; expected timing of revenue from sales and that such sales will provide a path to profitability for Daré; plans and expectations with respect to Daré’s product candidates, including clinical development plans, trial design, timelines, costs, milestones, targeted indications, clinical trials and results, regulatory strategy, and U.S. Food and Drug Administration (FDA) communications, submissions and review of applications; the clinical potential of and market opportunities for Daré’s product candidates; potential strategic partnerships and third-party collaborations; expectations regarding existing collaborations; and the amount and timing of Daré’s receipt of funds under grant agreements. 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 raise additional capital when and as needed to execute its business strategy and continue as a going concern; the risk of delisting of Daré’s common stock from Nasdaq; 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 enter into and maintain third-party collaborations to facilitate access to the solutions Daré intends to bring to market as compounded drugs or consumer health products and Daré’s reliance on those third parties; the performance of Section 503B-registered outsourcing facilities and other third parties on which Daré will rely to execute its expanded business strategy; 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 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 achieve the product development and other milestones required for it to receive payments under its subaward and grant agreements; the potential for termination of the subaward and grant agreements before Daré receives additional payments; the limits on Daré’s ability to sell stock under its equity line arrangement at times it may desire to raise additional capital; 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; the loss of, or inability to attract, key personnel; 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, 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 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 products 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: Daré Bioscience Investor Relations innovations@darebioscience.com Source: Daré Bioscience, Inc. Source: Daré Bioscience, Inc.