Daré Bioscience and Theramex Announce Co-Development and Licensing Agreement for a Potential Biodegradable Long-Acting Contraceptive Implant
Daré Bioscience (NASDAQ: DARE) and Theramex have entered into a co-development and licensing agreement for Casea S, a potential first-in-category biodegradable contraceptive implant. The product is designed to release contraceptive medication over 18-24 months before dissolving, eliminating the need for surgical removal.
A fully-funded Phase 1 trial is currently ongoing, conducted by FHI 360, investigating pharmacokinetics, removability, safety, and tolerability. Daré has received a royalty-free, exclusive license to the US patents for Casea S. There are currently no development costs for either company due to foundation grant funding.
If Phase 1 results are positive, Daré will be responsible for conducting the Phase II study in the US. Future Phase II and III study funding will be shared between both companies, with terms to be determined based on market opportunity in their respective regions.
Daré Bioscience (NASDAQ: DARE) e Theramex hanno stipulato un accordo di co-sviluppo e licenza per Casea S, un potenziale impianto contraccettivo biodegradabile di prima categoria. Il prodotto è concepito per rilasciare farmaci contraccettivi per un periodo di 18-24 mesi prima di dissolversi, eliminando la necessità di rimozione chirurgica.
Attualmente è in corso uno studio di Fase 1 completamente finanziato, condotto da FHI 360, che indaga sulla farmacocinetica, sulla rimuovibilità, sulla sicurezza e sulla tollerabilità. Daré ha ricevuto una licenza esclusiva, senza diritti d'autore, per i brevetti statunitensi di Casea S. Attualmente non ci sono costi di sviluppo per entrambe le aziende grazie ai finanziamenti concessi da fondazioni.
Se i risultati della Fase 1 saranno positivi, Daré sarà responsabile della conduzione dello studio di Fase II negli Stati Uniti. I finanziamenti per i futuri studi di Fase II e III saranno condivisi tra le due aziende, con termini da determinare in base alle opportunità di mercato nelle rispettive regioni.
Daré Bioscience (NASDAQ: DARE) y Theramex han firmado un acuerdo de co-desarrollo y licencia para Casea S, un potencial implante anticonceptivo biodegradable de primera categoría. El producto está diseñado para liberar medicamentos anticonceptivos durante 18-24 meses antes de disolverse, eliminando la necesidad de extracción quirúrgica.
Actualmente se está llevando a cabo un ensayo de Fase 1 completamente financiado, realizado por FHI 360, que investiga la farmacocinética, la removibilidad, la seguridad y la tolerancia. Daré ha recibido una licencia exclusiva y sin regalías para las patentes estadounidenses de Casea S. Actualmente no hay costos de desarrollo para ninguna de las empresas gracias a la financiación de fundaciones.
Si los resultados de la Fase 1 son positivos, Daré será responsable de llevar a cabo el estudio de Fase II en los EE. UU. La financiación para los futuros estudios de Fase II y III se compartirá entre ambas empresas, con términos que se determinarán en función de las oportunidades del mercado en sus respectivas regiones.
다레 바이오사이언스 (NASDAQ: DARE)와 테라멕스는 카세아 S에 대한 공동 개발 및 라이센스 계약을 체결했습니다. 이는 첫 번째 카테고리의 생분해성 피임 임플란트입니다. 이 제품은 18-24개월 동안 피임 약물을 방출한 후 용해되어 외과적 제거의 필요성을 없애도록 설계되었습니다.
현재 FHI 360에 의해 수행되는 완전 자금 지원의 1상 시험이 진행 중이며, 약물의 약동학, 제거 가능성, 안전성 및 내약성을 조사하고 있습니다. 다레는 카세아 S의 미국 특허에 대한 로열티 없는 독점 라이센스를 받았습니다. 현재 두 회사 모두 재단 기부금 덕분에 개발 비용이 없습니다.
1상 결과가 긍정적이면 다레는 미국에서 2상 연구를 수행할 책임이 있습니다. 향후 2상 및 3상 연구 자금은 두 회사 간에 공유되며, 각각의 지역에서의 시장 기회에 따라 조건이 결정됩니다.
Daré Bioscience (NASDAQ: DARE) et Theramex ont conclu un accord de co-développement et de licence pour Casea S, un potentiel implant contraceptif biodégradable de première catégorie. Le produit est conçu pour libérer des médicaments contraceptifs pendant 18 à 24 mois avant de se dissoudre, éliminant ainsi le besoin d'une intervention chirurgicale.
Un essai de phase 1 entièrement financé est actuellement en cours, mené par FHI 360, qui étudie la pharmacocinétique, la possibilité de retrait, la sécurité et la tolérance. Daré a reçu une licence exclusive et sans redevance pour les brevets américains de Casea S. Actuellement, il n'y a pas de coûts de développement pour les deux entreprises en raison du financement par des fondations.
Si les résultats de la phase 1 sont positifs, Daré sera responsable de la conduite de l'étude de phase II aux États-Unis. Le financement des futures études de phase II et III sera partagé entre les deux entreprises, avec des conditions à déterminer en fonction des opportunités de marché dans leurs régions respectives.
Daré Bioscience (NASDAQ: DARE) und Theramex haben eine Co-Entwicklungs- und Lizenzvereinbarung für Casea S getroffen, ein potenzielles, erstmals in seiner Kategorie auftretendes biologisch abbaubares Verhütungsimplantat. Das Produkt ist so konzipiert, dass es über einen Zeitraum von 18-24 Monaten Verhütungsmittel abgibt, bevor es sich auflöst und die Notwendigkeit einer chirurgischen Entfernung entfällt.
Derzeit läuft eine vollständig finanzierte Phase-1-Studie, die von FHI 360 durchgeführt wird und die Pharmakokinetik, Entfernbarkeit, Sicherheit und Verträglichkeit untersucht. Daré hat eine lizenzfreie, exklusive Lizenz für die US-Patente von Casea S erhalten. Derzeit fallen für beide Unternehmen aufgrund von Fördergeldern keine Entwicklungskosten an.
Wenn die Ergebnisse der Phase 1 positiv sind, wird Daré für die Durchführung der Phase-II-Studie in den USA verantwortlich sein. Die Finanzierung zukünftiger Phase-II- und III-Studien wird zwischen beiden Unternehmen geteilt, wobei die Bedingungen basierend auf den Marktchancen in ihren jeweiligen Regionen festgelegt werden.
- Fully funded Phase 1 trial with no current development costs
- Royalty-free, exclusive US patent license acquired
- Non-dilutive funding structure preserves shareholder value
- Potential first-in-category product addressing unmet market need
- Future Phase II and III studies will require significant funding commitment
- Development success contingent on positive Phase 1 results
- Cost-sharing terms for future development not yet determined
Insights
This strategic partnership represents a significant development for Daré Bioscience, particularly given its modest market cap of
- A foundation-funded Phase 1 study eliminating immediate development costs
- A royalty-free, exclusive US patent license providing long-term value
- Risk-sharing arrangement for future development costs based on market opportunity assessment
The biodegradable technology of Casea S addresses a important market gap in long-acting contraceptives. Current implanted contraceptives require surgical removal, which creates both cost barriers and patient hesitation. The 18-24 month duration hits a sweet spot in the market - long enough to be convenient but short enough to align with family planning timeframes.
The external validation through foundation funding is particularly significant for a small-cap biotech, as it provides credibility and reduces development risk. The shared development cost structure for Phase II/III studies indicates confidence from both parties in the commercial potential, while allowing Daré to maintain significant upside without immediate capital requirements.
From a strategic perspective, this partnership with Theramex, a global women's health specialist, provides valuable commercialization infrastructure and expertise. The risk-mitigated development pathway, coupled with the potential first-in-category status, positions Casea S as a significant value driver for Daré, especially considering their current market capitalization.
Ongoing Phase 1 study is funded by a foundation grant
Daré received a royalty-free, exclusive license to the US patents
SAN DIEGO and LONDON, Feb. 20, 2025 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in innovation for the health and wellbeing of women, and Theramex, a leading, global specialty pharmaceutical company dedicated to women and their health, announced today that they entered into a co-development and licensing agreement for a potential first-in-category biodegradable contraceptive implant called Casea S recently acquired by Theramex.
“We are thrilled that Theramex selected Daré as its development partner for this potentially disruptive long-acting, minimally-invasive contraceptive candidate. The fully funded ongoing Phase 1 study is external validation of this important technology, and enables Daré and Theramex to make future development decisions based on results of the study,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “The in-license of these US patents to add to our portfolio is another example of how we leverage non-dilutive funding to advance first-in-category product candidates, and this collaboration with Theramex is a testament to our development track record in women’s health.”
“We are excited to partner with Daré to develop Casea S, a potential first-in-category contraceptive candidate for women,” said Rob Stewart, CEO of Theramex. “A biodegradable implant for contraception resonates with what we hear from women as does the idea that she can make that choice every 18-24 months as to whether it is right for her. With its innovative design, Casea S would only require a single surgery visit, offering a more convenient, reversible alternative to existing long-acting contraceptive methods that would enable women to take control of their reproductive health with confidence.”
Casea S is designed to control release of a well-characterized contraceptive for a set period of time (18-24 months) before dissolving. It is designed to provide women with a long-acting, minimally-invasive contraceptive method that will not require surgical removal by a healthcare provider, which would improve convenience and could eliminate one of the barriers to use associated with existing implanted contraceptives.
FHI 360 is conducting a fully-funded Phase 1 trial to investigate pharmacokinetics, removability, safety and tolerability of Casea S with support from a foundation grant (ClinicalTrials.gov ID: NCT05174884).
Daré received a royalty-free, exclusive, fully paid up, sublicensable license to the US patents Theramex recently acquired for Casea S. Given that the product candidate is in an ongoing Phase 1 study that is funded by a grant, there are no development costs for Daré or Theramex at this time. If Daré determines that the results from the study are positive, it would be responsible for conducting the Phase II study in the US, and funding for such study and for a future Phase III study in the US will be shared by Daré and Theramex on terms to be agreed upon by the parties, taking into account the size of the opportunity for Casea S in their respective markets.
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, sexual health, pelvic pain, fertility, infectious diseases, and menopause.
The first FDA-approved product to emerge from Daré’s portfolio of women’s health product candidates is XACIATO™ (clindamycin phosphate) vaginal gel
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.
About Theramex
Theramex is a leading global specialty pharmaceutical company dedicated to women and their health. Theramex supports women of all ages by providing a broad portfolio of innovative and established brands covering contraception, fertility, menopause, and osteoporosis. Theramex’s vision is to be a lifetime partner for women and the healthcare professionals who treat them, and is committed to listening to and understanding its patients, serving their needs, and offering effective healthcare solutions that care for and support women through different stages of their lives.
For further information about Theramex, please contact:
info@theramex.com
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 the potential future development of Casea S and its potential to be a first-in-category product, and that funding for future studies of Casea S may be shared between Daré and Theramex. As used in this press release, “first-in-category” is a forward-looking statement relating to the potential of a product candidate if it were to receive marketing approval for the use 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: the risk that the results of the ongoing Phase I study of Casea S may not be positive; 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; the inherent uncertainty of outcomes of clinical trials; 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 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:
Daré Bioscience Investor Relations
innovations@darebioscience.com
Theramex
info@theramex.com
Source: Daré Bioscience, Inc.
FAQ
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