-- Multi-Product Distribution Agreement Marks Continued Commercial Momentum in Europe --ATLANTA, Feb. 03, 2026 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced today a new strategic distribution partnership with OR Consulting to support the commercial launch of its product portfolio in Switzerland. The agreement includes FemBloc Permanent Birth Control, Fe ...

Several biotech and healthcare stocks posted notable gains in after-hours trading on Friday, driven by regulatory developments, financing updates, and investor sentiment.Atossa Therapeutics, Inc. (ATOS) rose 12.98% to $0.69, up $0.080 after announcing that the U.S. Food and Drug Administration's Office of Orphan Products Development granted Orphan Drug Designation to (Z)-endoxifen for the treatment of Duchenne muscular dystrophy. The designation marks a significant milestone for the company's pipeline.Immu ...

ATLANTA, Jan. 14, 2026 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY) (“Femasys” or the “Company”), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, today announced that on January 13, 2026, it received notification from The Nasdaq Stock Market LLC ("Nasdaq") that Nasdaq approved the Company's request for an additional 180-calendar day extension to regain compliance with the minimum closing bid price requirement ...

Core Insights - Femasys Inc. has announced a partnership with Refuah Health Center to enhance the adoption of FemaSeed, a fertility treatment, within community-based healthcare settings [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 [4] - The company’s lead product, FemaSeed, is a next-generation artificial insemination solution that has shown over double the pregnancy rates compared to traditional intrauterine insemination (IUI) in cases of low male sperm count [3][4] Product Details - FemaSeed is designed to deliver sperm directly to the fallopian tube, providing a safe, accessible, and cost-effective first-line treatment option before in vitro fertilization (IVF) [3] - The product is authorized for use in multiple regions, including the U.S., Europe, UK, Canada, and Israel [3] Partnership Impact - The collaboration with Refuah Health Center aims to expand patient access to FemaSeed, thereby increasing its utilization as a first-line approach in infertility treatment [1][2] - Refuah Health Center, a Federally Qualified Community Health Center, emphasizes providing evidence-based options to streamline the fertility journey for patients [7]

Core Insights - Several biotechnology and pharmaceutical companies experienced significant stock price increases in after-hours trading due to clinical trial updates, regulatory advancements, and investor anticipation for upcoming data releases [1] Company Updates - Alumis Inc. (ALMS) saw a surge of 17.33% to $9.75, gaining $1.44 after announcing that topline data from its Phase 3 ONWARD clinical program for envudeucitinib in moderate-to-severe plaque psoriasis will be reported on January 6, 2026, along with a conference call to discuss the results [2] - Genelux Corp. (GNLX) climbed 10.92% to $3.86, up $0.38, following interim results from ongoing trials evaluating Olvi-Vec in patients with progressive small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) [3] - Bright Minds Biosciences Inc. (DRUG) rose 8.42% to $86.75, gaining $6.74, and announced a conference call on January 6, 2026, to report topline results from its Phase 2 trial of BMB-101 in patients with drug-resistant Absence Seizures [4] - Context Therapeutics Inc. (CNTX) shares increased by 8.36% to $1.68, adding $0.13, despite no specific news released [4] - BioAtla, Inc. (BCAB) gained 3.95% to $0.44, up $0.017, after announcing a special purpose vehicle transaction to advance ozuriftamab vedotin in a Phase 3 study for oropharyngeal squamous cell carcinoma, receiving $5 million in initial funding [5] - Femasys Inc. (FEMY) added 7.09% to $0.6223, up $0.04, with no new updates reported [5] - Acumen Pharmaceuticals, Inc. (ABOS) jumped 11.62% to $2.21, gaining $0.23, also without new corporate updates [6] - Alpha Tau Medical Ltd. (DRTS) rose 5.36% to $5.50, up $0.28, after submitting the first module of its pre-market approval application to the FDA for Alpha DaRT in treating recurrent cutaneous squamous cell carcinoma [7]

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]