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Tuesday, May 21, 2024

Daré Secures $22M for Women-Centric Drug Pipeline

BIOPHARMA: XOMA Agreement Advances Phase 3 Programs

LA JOLLA – Biopharma leader Daré Bioscience, Inc. (Nasdaq: DARE) scored $22 million in financing from biotech royalty aggregator XOMA to help advance two key first-in-category drugs in its pipeline, in a deal that propels the company’s mission to create innovative therapeutics designed specifically for women.

“Daré’s agreement with XOMA allows us to focus on advancing our Phase 3 first-in-category investigational products, including Ovaprene, a potential first FDA-approved hormone-free intravaginal monthly contraceptive, and Sildenafil Cream, 3.6% (the active ingredient in Viagra), a potential first FDA-approved treatment for female sexual arousal disorder, through key catalysts,” President and CEO Sabrina Martucci Johnson told the Business Journal.

Sabrina Martucci Johnson
President & CEO
Daré Bioscience

The deal includes future net royalty and net milestone payments based on net sales of Daré’s already FDA-approved gel XACIATO (licensed with Organon) for patients 12 and older with bacterial vaginosis, along with minority interest net payments for future revenue from the company’s current Phase 3 candidates, Ovaprene and Sildenafil Cream.

“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.”

Brad Sitko
Chief Investment Officer

“Disruptive Products’ Advancing in Clinical Trials

The company’s Ovaprene contraceptive candidate is under a license agreement with Bayer HealthCare for U.S. commercial rights. In that agreement – which the two companies entered in 2020 – Daré may be entitled to up to $310 million in commercial milestone payments plus tiered royalties on net sales in the double-digits.

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Daré, along with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH), started enrolling patients in Ovaprene’s Phase 3 clinical study last December, with broad recruitment currently underway.

“Non-hormonal contraception represents a significant commercial market opportunity, and there are currently no monthly, hormone-free contraceptives approved by the FDA,” added Martucci Johnson. “Ovaprene has the potential to be a disruptive product in the contraceptive category and an important option for women who cannot use hormone-based birth control products or prefer not to do so.”
Meanwhile, Daré is planning the Phase 3 study of its investigational Sildenafil Cream which it says would be the first-ever Phase 3 pivotal study of a drug candidate targeting arousal disorder in women. It comes after the company reported milestone positive results last summer following the review of its Phase 2b study data on the potential treatment.

Variety of Funding Sources Fuel R&D

The new $22 million royalty payment from XOMA comes after receiving a series of funds from various sources. Last year, the company stated it got $4.7 million in nondilutive grant funding from the NIH and the Bill & Melinda Gates Foundation. Daré stated it also completed a $7 million registered direct offering last September with a $12 million royalty-backed financing structure last December, under which it received $5 million at closing. In 2022, Daré reports it got $24.1 million in non-dilutive funding, including a $10 million cashout from the license agreement with Organon for XACIATO. The company also states it received an additional $13.3 million in grant funding from the NIH and Bill & Melinda Gates Foundation, along with a research and development cash rebate of $800,000 from the Australian government for clinical work back in 2021.

The company’s enterprise value is hovering around $22.5 million with a market cap of $31.57 million. Q1 2024 financial results will be released on May 14, but its 2023 full year review revealed it’s sitting on $10.5 million in cash and cash equivalents with a total revenue of $2.8 million. General and administrative expenses were reportedly $12.1 million, which the company expects to reduce to $10 million this year. Its research and development expenses reportedly came in at $21.5 million, down from $30 million the year before.

Launched in 2015, Daré is still relatively young. The name comes from the Italian word “dare” which means “to give.” In English, it means “to be bold”. Before its founding, Martucci Johnson served as President of WomanCare Global Trading, CFO/CAO of the California Institute for Biomedical Research, CFO/COO of Cypress Bioscience, Inc. (Nasdaq: CYPB) and held marketing and sales positions with Advanced Tissue Sciences. She began her biotech career as a research scientist with Baxter Healthcare.

Looking ahead, she and her company are committed to developing other potential therapies for menopause symptoms, sexual pain, HPV-related conditions, pre-term birth and infertility, and creating other novel contraceptives.

“It’s difficult to call out any one program in addition to Ovaprene and Sildenafil Cream as we think about the next 5 years, but – big picture – we are looking forward to transforming women’s health by continuing to advance our diverse portfolio of innovative product candidates, and by doing so deliver value for all Daré stakeholders.”

Daré Bioscience, Inc.
FOUNDED: 2015 as Daré Bioscience Operations
PRESIDENT & CEO: Sabrina Martucci Johnson
BUSINESS: biopharma
NOTABLE: President & CEO Sabrina Martucci Johnson was named one of FiercePharma’s Most Influential People in Biopharma in 2023.


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