Several biotechnology and pharmaceutical names posted notable gains in after-hours trading on Monday, driven by clinical trial updates, regulatory progress, and investor anticipation ahead of key data releases.Alumis Inc. (ALMS) surged 17.33% to $9.75, adding $1.44 after announcing that topline data from its Phase 3 ONWARD clinical program evaluating envudeucitinib in patients with moderate-to-severe plaque psoriasis will be reported on January 6, 2026. The company also confirmed it will host a conference ...

Core Insights - Femasys Inc. has received FDA 510(k) clearance for its FemVue Controlled device, which integrates FemVue and FemChec technologies to enhance fallopian tube evaluation and improve workflow efficiency [1][2] Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally, with a patent-protected portfolio of therapeutic and diagnostic products [3] - The company is actively commercializing its lead product innovations in the U.S. and key international markets, including FemaSeed and FemVue [3] Product Details - The FemVue Controlled device is designed for controlled delivery of saline and air as contrast media during ultrasound imaging to evaluate fallopian tube status, enabling multiple clinical uses in one solution [2] - Femasys' fertility portfolio includes FemaSeed, which is over twice as effective as traditional intrauterine insemination (IUI) with a comparable safety profile [3] Recent Developments - FemBloc, a non-surgical permanent birth control method, received full regulatory approval in Europe, the UK, and New Zealand in 2025, with commercialization planned through strategic partnerships [4] - The FemChec product provides an ultrasound-based test to confirm procedural success, demonstrating compelling effectiveness and high satisfaction rates in initial clinical trials [4]

Financial Performance - Sales for the three months ended September 30, 2025, were $729,394, up 31.4% from $554,908 in the same period of 2024[21] - Net loss for the nine months ended September 30, 2025, was $14.68 million, compared to a net loss of $13.69 million for the same period in 2024, indicating a 7.2% increase in losses[21] - The company reported a net loss per share of $0.10 for the three months ended September 30, 2025, compared to $0.24 for the same period in 2024[21] - For the nine months ended September 30, 2025, total revenue reached $1,479,926, up 41.2% from $1,047,532 in the prior year[54] - U.S. sales for the nine months ended September 30, 2025, were $1,015,168, up from $755,082 in 2024, representing a 34.4% increase[54] - International sales for the nine months ended September 30, 2025, were $464,758, compared to $292,450 in 2024, marking a 58.8% increase[54] - Total sales for the nine months ended September 30, 2025, were $1,479,926, an increase from $1,047,532 in the same period of 2024, reflecting a 41.2% year-over-year growth[100] Assets and Liabilities - Total assets increased to $16.29 million as of September 30, 2025, from $12.45 million as of December 31, 2024, representing a 30.5% growth[16] - Total current liabilities rose to $10.54 million as of September 30, 2025, compared to $8.58 million as of December 31, 2024, reflecting a 22.8% increase[19] - Total stockholders' equity increased to $4.56 million as of September 30, 2025, from $2.30 million as of December 31, 2024, a growth of 97.8%[19] - The accumulated deficit as of September 30, 2025, was $141,875,839, with expectations of continued losses and negative operating cash flows for at least the next twelve months[39] Cash Flow and Financing - Cash and cash equivalents increased to $4.57 million as of September 30, 2025, from $3.45 million as of December 31, 2024, a growth of 32.4%[16] - The company reported a net cash used in operating activities of $14,505,325 for the nine months ended September 30, 2025, compared to $14,369,440 for the same period in 2024, indicating a slight increase in cash outflow of about 0.9%[30] - The company raised $7,998,826 from the issuance of common stock, accompanying warrants, and pre-funded warrants in August 2025 financing[30] - The company generated proceeds of $4,510,001 from the issuance of common stock in June 2025 financing[30] - The company executed a promissory note with AFCO for $367,450 in July 2025, with a monthly installment of $31,672 at an interest rate of 7.44%[58] - The company entered into a definitive agreement for the issuance of senior secured convertible notes in November 2025, with an aggregate principal amount of $12,000,000, convertible into 16,378,563 common shares at a conversion price of $0.73 per share[102] Expenses - Research and development expenses decreased to $5.76 million for the nine months ended September 30, 2025, from $6.05 million in 2024, a reduction of 4.5%[21] - Interest expense for the nine months ended September 30, 2025, was $1.48 million, up from $1.16 million in the same period of 2024, an increase of 27.5%[21] - Share-based compensation expense for the nine months ended September 30, 2025, was $723,722, compared to $310,004 for the same period in 2024, representing an increase of approximately 133.3%[30] - The company reported total operating expenses of $13,876,592 for the nine months ended September 30, 2025, compared to $13,758,269 in 2024, indicating a slight increase of 0.9%[100] Stock and Shareholder Information - The company issued 10,434,586 shares of common stock in connection with August 2025 financing, net of issuance costs, raising approximately $7,068,694[24] - The weighted average number of shares used in computing net loss per share increased to 41,015,196 in 2025 from 22,232,799 in 2024, indicating a significant increase in share dilution[94] - The company granted 1,599,915 stock options during the nine months ended September 30, 2025, with an average exercise price of $1.08[82] - The company issued 49,247 shares under its Employee Stock Purchase Plan (ESPP) for a fair value of $40,875 during the nine months ended September 30, 2025, compared to 12,081 shares for $10,390 in the same period of 2024[88] Regulatory and Market Developments - The company aims to obtain FDA approval for its FemBloc product candidate, which is critical for future commercialization efforts[10] - The company has received regulatory approvals for its products in multiple regions, including the U.S., EU, UK, Canada, and Australia, enhancing its market presence[1] - The company announced strategic distribution partnerships for FemBloc in Spain and the France/Benelux region in March and September 2025, respectively[32] - The company received FDA approval in November 2025 for its investigational device exemption supplement to proceed with the final phase of the pivotal clinical trial for FemBloc[32]

Financial Performance - Sales increased by $174,486, or 31.4%, to $729,394 for Q3 2025 compared to $554,908 for Q3 2024, primarily due to sales of FemBloc[8] - Net loss was $4,194,821, or ($0.10) per share for Q3 2025, compared to a net loss of $5,408,860, or ($0.24) per share for Q3 2024[8] - Cash and cash equivalents as of September 30, 2025, was approximately $4.6 million, with an accumulated deficit of approximately $141.9 million[8] Research and Development - Research and development expenses decreased by $921,219, or 40.0%, to $1,382,022 for Q3 2025 compared to $2,303,241 for Q3 2024, primarily due to commercialization of development products into inventory[8] Assets and Funding - Total assets increased to $16,290,153 as of September 30, 2025, compared to $12,445,002 as of December 31, 2024[10] - The company announced a definitive agreement for the issuance of $12 million in secured convertible notes, with total potential funding of $58 million if all warrants are exercised[4] Market Expansion - Regulatory approvals for the complete FemBloc System were secured in the U.K. and New Zealand, expanding access across Europe and the Asia-Pacific region[3] - The company received initial commercial orders from distribution partners in Spain and France, indicating early momentum in market expansion[3] - The company announced a partnership with Kebomed to commercialize FemBloc in France and the Benelux region[4] Operational Outlook - The company expects its current cash and cash equivalents will be sufficient to fund ongoing operations into September 2026[8]

Core Insights - Femasys Inc. has achieved significant regulatory milestones, including FDA IDE approval for the final pivotal trial of FemBloc, which positions the company for potential U.S. FDA approval [3][5][19] - The company secured $12 million in financing, enhancing its balance sheet and extending its cash runway, with total potential funding of $58 million if all warrants are exercised [5][7] - Sales for the third quarter of 2025 increased by 31.4% to $729,394, driven primarily by FemBloc sales, while R&D expenses decreased significantly [6][12] Regulatory Approvals - Femasys received regulatory approvals for the complete FemBloc System in the U.K. and New Zealand, expanding access to this non-surgical permanent birth control option [3][5][19] - Initial commercial orders have been received from distribution partners in Spain and France, indicating early momentum in the European market [3][5] Financial Performance - For the third quarter of 2025, sales increased by $174,486 to $729,394 compared to the same period in 2024, primarily due to FemBloc [6] - R&D expenses decreased by 40.0% to $1,382,022, reflecting a shift towards commercialization and reduced costs [6] - The net loss for the third quarter was $4,194,821, or ($0.10) per share, an improvement from a net loss of $5,408,860, or ($0.24) per share, in the prior year [6] Cash Position - As of September 30, 2025, Femasys had approximately $4.6 million in cash and cash equivalents, with an accumulated deficit of approximately $141.9 million [7] - The company expects its current cash position, bolstered by recent financing, to fund operations into September 2026 [7] Strategic Partnerships - Femasys announced a partnership with Kebomed to commercialize FemBloc in France and the Benelux region, enhancing its distribution capabilities [5] - A partnership with Medical Electronic Systems LLC was established to provide the FemSperm™ Analysis Kit, further expanding the company's product offerings [5]

Core Insights - Femasys Inc. has announced a significant initial order valued at approximately $500,000 for the commercial launch of FemBloc in France and the Benelux region, marking continued expansion in key European markets [1][2] - FemBloc is a non-surgical permanent contraceptive solution that addresses a significant unmet need in women's reproductive health, utilizing a patented delivery system to occlude fallopian tubes without the risks associated with surgical procedures [2][4] Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally, with a broad patent-protected portfolio of products [3] - The company is actively commercializing its lead product innovations in the U.S. and key international markets, including FemSeed and FemVue, which have shown high effectiveness and patient satisfaction [3] Product Details - FemBloc is the first and only non-surgical, in-office alternative to surgical sterilization, receiving full regulatory approval in Europe, the UK, and New Zealand in 2025 [4] - The product is designed to be cost-effective, convenient, and significantly safer than traditional surgical options, with no anesthesia, incisions, or recovery time required [2][4] Strategic Partnerships - Femasys has partnered with Kebomed, a leading distributor in Europe, to facilitate the introduction of FemBloc in France and the Benelux region, reflecting a strategic approach to market access and women's healthcare advancement [2][6] - Kebomed has a strong presence across Europe and has been focused on women's health, enhancing its portfolio through partnerships with innovators in minimally invasive gynecology [6][7]

Core Insights - Femasys Inc. has received FDA Investigational Device Exemption (IDE) approval to continue enrollment in the final phase of the FINALE pivotal trial for FemBloc, a non-surgical permanent birth control solution, marking a significant step towards potential U.S. Pre-Market Approval (PMA) [1][2] - The company has secured $12 million in senior secured convertible notes, with total potential proceeds of $58 million if all warrants are exercised, indicating strong investor confidence in Femasys' mission to enhance women's health [1][2] Company Developments - The successful completion of Part A of the FINALE trial allows Femasys to advance to Part B, which is crucial for obtaining U.S. FDA approval for FemBloc [1][2] - The financing from institutional and accredited investors will be utilized to refinance existing debt and support the commercialization of Femasys' fertility and permanent birth control portfolio [1][2] Product Information - FemBloc is a first-of-its-kind, non-surgical solution for permanent birth control that uses a patented delivery system to create natural scar tissue in the fallopian tubes, providing a safer and more convenient alternative to surgical sterilization [2][8] - The product has already received regulatory approval in Europe, the UK, and New Zealand, with commercialization efforts underway in select European countries [8] Financial Details - The convertible notes bear an interest rate of 8.5% per annum and have a 10-year maturity, convertible into approximately 16.38 million shares of common stock at a conversion price of $0.73 per share, which is a 15% premium to the stock's closing price prior to the agreement [3][4] - The accompanying warrants include multiple classes with exercise prices ranging from $0.81 to $1.10 per share, potentially generating additional proceeds of up to $46 million if exercised for cash [3][4] Market Position - Femasys aims to redefine women's reproductive care with FemBloc, addressing a significant unmet need in the market for permanent birth control options, which currently only includes surgical sterilization in the U.S. [2][8] - The company is positioned to create long-term value for shareholders in a multi-billion-dollar market by introducing innovative solutions in women's health [2][8]

Core Insights - Femasys Inc. has initiated a post-market surveillance clinical study for its FemBloc Permanent Birth Control, marking a significant step in its European commercialization strategy under the EU Medical Device Regulation [1][2][3] Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally, with a patent-protected portfolio of therapeutic and diagnostic products [4] - The company is actively commercializing its lead product innovations in the U.S. and key international markets, including the FemBloc and FemaSeed [4] Product Details - FemBloc is a non-surgical solution for permanent birth control that uses a patented delivery system to occlude fallopian tubes without the need for anesthesia or incisions, thus avoiding surgical risks [3][5] - The product has received full regulatory approval in Europe, the UK, and New Zealand, and is positioned to meet the strong demand for safe and accessible permanent birth control options among women [5] Clinical Study and Compliance - The post-market surveillance study aims to monitor the safety and performance of FemBloc in real-world settings, complying with the rigorous requirements of the EU MDR [2][3] - The study has received approval from multiple Ethics Committees and adheres to ISO 14155:2020 for Good Clinical Practice [2] Market Potential - FemBloc addresses a significant unmet need in women's reproductive health, with no comparable alternatives currently available, indicating a broad global market potential [3][5] - The company aims to build a foundation for broader physician adoption and reimbursement through the generation of real-world data from the clinical study [3]

Core Insights - Femasys Inc. will showcase its innovative fertility solutions at the ASRM 2025 Scientific Congress & Expo in San Antonio, Texas from October 25-29 [1][4] - The company is highlighting its next-generation artificial insemination solution, FemaSeed, which has demonstrated more than double the pregnancy rates of traditional intrauterine insemination (IUI) in cases of low male sperm count [2][5] - Femasys has expanded its FemaSeed portfolio to include various kits that enable gynecologists to perform sperm preparation and offer FemaSeed directly in their practices [3] Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally [5] - The company has a patent-protected portfolio of therapeutic and diagnostic products, including FemaSeed and FemVue, aimed at improving reproductive health [5] - Femasys has received regulatory approvals for its products in multiple regions, including the U.S., Europe, UK, Canada, Israel, Australia, and New Zealand [2][6] Product Highlights - FemaSeed is positioned as a safe, accessible, and cost-effective alternative to IUI, particularly for patients with low male sperm count [2] - The FemBloc product, a non-surgical permanent birth control solution, received full regulatory approval in Europe, the UK, and New Zealand in 2025 [6] - The FemChec diagnostic product provides an ultrasound-based test to confirm procedural success for FemBloc [6]

Core Insights - Femasys Inc. has partnered with Kebomed to commercialize FemBloc Permanent Birth Control in France and the Benelux region, significantly enhancing market access for this innovative product [1][2] - The collaboration is a key part of Femasys' European growth strategy following the recent CE mark approval for FemBloc, which is the only non-surgical permanent birth control option available [1][4] Company Overview - Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women globally, with a patent-protected portfolio of products [3] - The company's lead product innovations include FemBloc and FemaSeed, with clinical data showing FemaSeed is over twice as effective as traditional IUI [3] Product Details - FemBloc is a non-surgical solution for permanent birth control that uses a patented delivery system to occlude fallopian tubes, offering a safer and more cost-effective alternative to surgical sterilization [2][4] - The product has received full regulatory approval in Europe, the UK, and New Zealand, with ongoing efforts for U.S. FDA approval through the FINALE pivotal trial [4] Strategic Partnership - Kebomed, a leading independent distributor of medical devices in Europe, will leverage its established infrastructure and expertise in women's health to drive the adoption of FemBloc [2][6] - The partnership aims to unlock significant growth potential in key European markets, particularly in France, which represents the largest market opportunity for FemBloc [2][6]