FEMASYS INC Stock Price, News & Analysis

Femasys (NASDAQ: FEMY), a biomedical company focused on women's health, has announced a combined public offering and private placement to raise $4.5 million in gross proceeds. The public offering consists of 3.6 million shares at $0.85 per share, while the private placement includes 1.69 million shares priced at $0.85 for institutional investors and $1.02 for directors and officers. The underwriter has a 30-day option to purchase an additional 540,000 shares. The company plans to use the proceeds for commercial expansion, product development, corporate purposes, capital expenditures, and working capital. Both offerings are expected to close around June 2, 2025, with Jones serving as the sole book-running manager and placement agent.

Femasys (NASDAQ: FEMY), a biomedical company focused on women's health, has announced plans for a public offering of common stock alongside a concurrent private placement. The company will grant underwriters a 30-day option to purchase up to an additional 15% of shares from the public offering. Current institutional stockholders, directors, and officers have shown interest in participating in the private placement.

Jones will serve as the sole book-running manager for the public offering and placement agent for the private placement. Femasys plans to use the proceeds for commercial expansion, product development, corporate purposes, capital expenditures, and working capital. The public offering will be made through a previously filed S-3 Registration Statement, while the private placement will rely on Securities Act exemptions.

Femasys (NASDAQ: FEMY) reported Q1 2025 financial results and corporate updates. Sales increased 25.9% to $341,264, driven by FemaSeed's 78% quarter-over-quarter growth in the U.S. The company secured European approval for the FemBloc delivery system, marking progress toward full system approval for non-surgical permanent birth control. Key developments include UK and Israeli regulatory approvals for FemaSeed, partnership with CNY Fertility's eleven centers, and distribution agreements in Spain. However, net loss widened to $5.9 million ($0.23 per share) from $3.6 million ($0.17 per share) year-over-year. R&D expenses increased 67.6% to $3.0 million. With $3.8 million in cash, Femasys expects funding through early Q3 2025.

Femasys Inc. (NASDAQ: FEMY) reported financial results for 2024 and provided corporate updates. Key highlights include FemBloc® permanent birth control system approval in Europe and new distribution partnerships in Spain. The company's sales increased 52.0% to $1.63 million in 2024, while net loss widened to $18.82 million ($0.85 per share).

Notable achievements include partnerships with CNY Fertility, HRC Fertility, and Boston IVF for FemaSeed® distribution, along with UK and Israeli regulatory approvals. R&D expenses rose 14.0% to $8.22 million. The company ended 2024 with $3.5 million in cash and raised an additional $5.4 million post-year-end, expecting to fund operations into Q3 2025.

Femasys (NASDAQ: FEMY) has announced a strategic partnership with CNY Fertility, a national provider of fertility services, to offer its FemaSeed intratubal insemination product across CNY's network of 11 locations. The partnership aims to expand access and market share for Femasys's first-line infertility treatment option.

CNY Fertility, recognized as a prominent infertility group in the United States, will integrate FemaSeed into their comprehensive fertility solutions portfolio. This collaboration aligns with CNY Fertility's mission to provide affordable, high-quality fertility treatments while expanding treatment options for patients seeking to grow their families.

Femasys Inc. (FEMY) has secured its first global distribution partnerships for FemBloc®, a non-surgical permanent birth control solution, in Spain. The company has partnered with Comercial Medico Quirurigca, SA (CMQ) for northern Spain and Durgalab for the southern region.

These partnerships represent Femasys's first EU distributors and mark the initial global commercialization of FemBloc®. Both distribution partners have previous experience with Conceptus Essure product, positioning them strategically for marketing FemBloc® as a new advancement in non-surgical permanent birth control.

Femasys Inc. (FEMY) has achieved a significant milestone with the CE mark certification for its FemBloc® delivery system, marking the world's first regulatory approval for non-surgical female permanent birth control under European Union Medical Device Regulation (EU MDR).

The company has also completed an expedited G12 Special MDR Audit for the FemBloc blended polymer, a important component of the permanent birth control system. The Notified Body has recommended CE mark approval, pending final European Medical Agency (EMA) review, with potential approval anticipated by mid-2025.

FemBloc represents a revolutionary alternative to traditional surgical permanent contraception, offering a safer and more accessible option. The company is preparing for a potential market launch in select European countries while continuing enrollment in their FDA IDE approved final pivotal clinical trial for U.S. approval.

Femasys (NASDAQ: FEMY) has announced the publication of positive clinical trial results for FemBloc®, its permanent birth control solution, in the Journal of Gynecology & Reproductive Medicine. The prospective, multi-center trials demonstrated compelling effectiveness and five-year safety data for the in-office therapeutic product.

The trials showed high satisfaction rates among both patients and practitioners, supporting FemBloc's potential as a non-surgical alternative to traditional sterilization procedures. The peer-reviewed publication represents a significant milestone in Femasys's mission to provide safer, more accessible permanent contraception options.

Femasys Inc. (NASDAQ: FEMY) has received regulatory approvals from the UK's Medicines & Healthcare products Regulatory Agency (MHRA) for three products: FemaSeed®, an intratubal insemination product for female infertility treatment, FemVue® for tubal evaluation, and FemCerv® for cervical cancer detection.

These UK approvals follow previous clearances and approvals in the United States, Europe, Canada, and Israel, marking an important expansion of Femasys' global market presence. The company focuses on providing innovative, accessible in-office therapeutic and diagnostic solutions for women's health needs.