New Risk • Jul 21
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$19m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Shareholders have been substantially diluted in the past year (86% increase in shares outstanding). Market cap is less than US$10m (US$9.87m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$12m net loss in 3 years). Revenue is less than US$5m (US$2.4m revenue). New Risk • Jul 17
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.21m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$19m free cash flow). Shareholders have been substantially diluted in the past year (86% increase in shares outstanding). Market cap is less than US$10m (US$9.21m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$12m net loss in 3 years). Share price has been volatile over the past 3 months (15% average weekly change). Revenue is less than US$5m (US$2.4m revenue). Major Estimate Revision • May 15
Consensus revenue estimates decrease by 30%, EPS upgraded The consensus outlook for fiscal year 2026 has been updated. 2026 revenue forecast fell from US$5.41m to US$3.77m. EPS estimate increased from -US$0.313 to -US$0.227 per share. Medical Equipment industry in the US expected to see average net income growth of 13% next year. Consensus price target down from US$3.67 to US$3.17. Share price fell 16% to US$0.36 over the past week. New Risk • May 13
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$12m Forecast net loss in 3 years: US$9.6m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$19m free cash flow). Shareholders have been substantially diluted in the past year (122% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$9.6m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Revenue is less than US$5m (US$2.4m revenue). Market cap is less than US$100m (US$22.8m market cap). Reported Earnings • May 11
First quarter 2026 earnings released: EPS: US$0.013 (vs US$0.23 loss in 1Q 2025) First quarter 2026 results: EPS: US$0.013 (up from US$0.23 loss in 1Q 2025). Revenue: US$424.9k (up 25% from 1Q 2025). Net income: US$846.1k (up US$6.74m from 1Q 2025). Revenue is forecast to grow 56% p.a. on average during the next 3 years, compared to a 7.9% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has increased by 23% per year but the company’s share price has fallen by 16% per year, which means it is significantly lagging earnings. Announcement • May 07
Femasys Inc. Enables OB/GYNs to Deliver First-Line Fertility Treatment with Initial Commercial Use of Femaseed Femasys Inc. announced the first revenue-generating commercial use of its fertility portfolio in the OBGYN setting, led by FemaSeed as a first-line infertility treatment. The procedure was supported by FemSperm, enabling in-office sperm preparation and advancing the shift of fertility care to women’s primary physician, where earlier intervention can improve access and outcomes. Infertility impacts an estimated 10 million women in the United States, yet fewer than 1% receive care at specialized fertility centers, highlighting a significant gap in treatment access. This disparity is further underscored by recent CDC data showing U.S. fertility rates declined to record lows in 2025, continuing a long-term downward trend. By enabling fertility care within the OBGYN setting, where most women already receive care, Femasys is addressing this unmet need with earlier access to intervention at a meaningfully lower cost and reduced procedural complexity than IVF. This approach enables OBGYNs to offer a new in-office fertility treatment option, supporting practice growth while shifting the care pathway toward more timely, cost-efficient, and patient-centered treatment. FemaSeed Complete is a comprehensive first-line fertility solution designed for use in the OB/GYN office. It combines FemaSeed intratubal insemination (ITI) with FemSperm, providing an integrated approach to sperm preparation and insemination in a single in-office visit. By streamlining the procedural workflow and eliminating the need for external lab processing or referrals, FemaSeed Complete is designed to expand access to cost-effective fertility care and support earlier intervention in the patient journey. Femasys’ fertility portfolio includes FemaSeed Intratubal Insemination (ITI), a groundbreaking first-step infertility treatment; FemSperm, a CLIA waived sperm preparation and analysis product line; and FemVue, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrate that FemaSeed achieved more than double the pregnancy rate of traditional IUI, with a comparable safety profile and high patient and practitioner satisfaction. FemBloc permanent birth control is the first and only non-surgical, in-office alternative to centuries-old surgical sterilization that received full regulatory approval in Europe in June 2025, the UK in August 2025, and New Zealand in September 2025. Commercialization of this highly cost-effective, convenient and significantly safer approach will be completed through strategic partnerships in select European countries. Alongside FemBloc, the FemChec diagnostic product provides an ultrasound-based test to confirm procedural success. Published data from initial clinical trials demonstrated compelling effectiveness, five-year safety, and high patient and practitioner satisfaction. For U.S. FDA approval, enrollment in the FINALE pivotal trial (NCT05977751) is ongoing. Announcement • May 05
Femasys Inc., Annual General Meeting, Jun 24, 2026 Femasys Inc., Annual General Meeting, Jun 24, 2026. Location: 3950 johns creek court, suite 100, suwanee, georgia 30024, United States Announcement • Apr 24
Femasys Launches FemaSeed® Complete for OB/GYNs at ACOG 2026 Femasys Inc. announced the commercial launch of FemaSeed Complete, a comprehensive fertility solution that enables OB/GYNs to perform first-line insemination entirely within their own practices. An estimated 10 million women in the United States experience infertility, yet fewer than half access care, and only a very small percentage ultimately undergo IVF. At the same time, U.S. fertility rates declined again in 2025 to a record low, underscoring the growing need for earlier intervention and expanded access to care. While more than 40,000 OB/GYNs are accessible to patients, infertility specialists—fewer than 2,000 nationwide—are typically accessed by referral and concentrated in a declining number of centers, limiting access to treatment. By enabling first-line treatment in the OB/GYN office, FemaSeed Complete is positioned to expand access to care and substantially increase the addressable market. The Company will showcase its portfolio of novel, in-office women’s reproductive health solutions at booth #524 at the ACOG Clinical and Scientific Meeting, taking place May 1–3, 2026 at the Walter E. Washington Convention Center in Washington, D.C. FemaSeed Complete is a comprehensive first-line fertility solution designed for use in the OB/GYN office. It combines FemaSeed intratubal insemination (ITI) with FemSperm, providing an integrated approach to sperm preparation and insemination in a single in-office visit. By streamlining the procedural workflow and eliminating the need for external lab processing or referrals, FemaSeed Complete is designed to expand access to cost-effective fertility care and support earlier intervention in the patient journey. Femasys’ fertility portfolio includes FemaSeed Intratubal Insemination (ITI), a groundbreaking first-step infertility treatment; FemSperm, a CLIA waived sperm preparation and analysis product line; and FemVue, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrate that FemaSeed achieved more than double the pregnancy rate of traditional IUI, with a comparable safety profile and high patient and practitioner satisfaction. FemBloc permanent birth control is the first and only non-surgical, in-office alternative to centuries-old surgical sterilization that received full regulatory approval in Europe in June 2025, the UK in August 2025, and New Zealand in September 2025. Commercialization of this highly cost-effective, convenient and significantly safer approach will be completed through strategic partnerships in select European countries. Alongside FemBloc, the FemChec diagnostic product provides an ultrasound-based test to confirm procedural success. Published data from initial clinical trials demonstrated compelling effectiveness, five-year safety, and high patient and practitioner satisfaction. For U.S. FDA approval, enrollment in the FINALE pivotal trial (NCT05977751) is ongoing. Major Estimate Revision • Apr 15
Consensus revenue estimates increase by 17% The consensus outlook for revenues in fiscal year 2026 has improved. 2026 revenue forecast increased from US$4.61m to US$5.41m. Forecast losses expected to reduce from -US$0.363 to -US$0.313 per share. Medical Equipment industry in the US expected to see average net income growth of 12% next year. Consensus price target of US$3.67 unchanged from last update. Share price rose 7.8% to US$0.43 over the past week. Reported Earnings • Apr 04
Full year 2025 earnings released: US$0.47 loss per share (vs US$0.84 loss in FY 2024) Full year 2025 results: US$0.47 loss per share (improved from US$0.84 loss in FY 2024). Revenue: US$2.29m (up 41% from FY 2024). Net loss: US$18.6m (loss narrowed 1.0% from FY 2024). Revenue is forecast to grow 53% p.a. on average during the next 3 years, compared to a 8.1% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has increased by 14% per year but the company’s share price has fallen by 27% per year, which means it is significantly lagging earnings. Announcement • Apr 01
Femasys Inc. Appoints John Canning as Chief Operating Officer, Effective March 30, 2026 On April 1, 2026, Femasys Inc. announced the hiring and appointment of John Canning as its Chief Operating Officer, effective March 30, 2026. Mr. Canning is an accomplished medical device executive with more than 25 years of experience leading global operations and technology organizations within complex medical device companies. He brings a track record of scaling organizations, advancing product pipelines, and driving operational excellence across key functions to support commercial growth and product adoption. Prior to joining Femasys, Mr. Canning served as Chief Operating Officer and Chief Technology Officer at Terumo Aortic, where he led global operations and technology functions, advancing the company’s endovascular product pipeline and improving operational performance. He was instrumental in Terumo’s acquisition of Bolton Medical, where he previously served as Chief Operating Officer. He began his career in manufacturing leadership roles at Medtronic Vascular, a global leader in interventional medical technologies. Announcement • Mar 21
Femasys Inc. announced that it has received $12 million in funding On March 20, 2026, Femasys Inc. closed the transaction. Announcement • Mar 18
Femasys Inc. Appoints Dr. Kenneth D. Eichenbaum to Board of Directors Femasys Inc. announced the appointment of Kenneth D. Eichenbaum, M.D., M.S.E., to its Board of Directors. Dr. Eichenbaum is a board-certified anesthesiologist with clinical affiliations at Corewell Health William Beaumont University Hospital and Trinity Health Oakland Hospital, bringing deep clinical expertise and strategic insight developed through more than 20 years of evaluating biotechnology and medical device companies and advising investment firms. He completed a fellowship at Stanford University Medical Center and earned his M.D. from the Icahn School of Medicine at Mount Sinai, with additional degrees in engineering from the University of Pennsylvania and in finance from The Wharton School. Femasys Inc. also announced the departure of Joshua Silverman from the Board of Directors. His capital markets perspective and strategic counsel supported Femasys during a period of important growth and development. Announcement • Mar 11
Femasys Inc Initiates Pivotal Trial Enrollment For FemBloc Non-Surgical Permanent Birth Control Femasys Inc. announced the initiation of patient enrollment in the FINALE pivotal clinical trial evaluating FemBloc. This milestone follows U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to advance the study based on positive clinical data generated in its earlier phase. FemBloc has already received regulatory approvals and is being commercialized in Europe and other select countries outside the United States as a non-surgical alternative to the surgical procedures currently used for permanent birth control. Completion of the FINALE study is expected to support a future U.S. regulatory submission. Permanent birth control is one of the most widely used contraceptive methods worldwide, yet current options require surgery, anesthesia, abdominal incisions, and recovery time, introducing procedural risks and increasing healthcare costs. FemBloc is a first-of-its-kind, non-surgical solution designed to address this unmet need in women’s reproductive health. Using a patented delivery system, FemBloc places a proprietary blended polymer into both fallopian tubes, where it safely degrades and forms natural scar tissue for permanent occlusion. By eliminating the complexities associated with surgical sterilization, FemBloc has the potential to expand access to permanent contraception while reducing the burden on healthcare systems. Millions of women worldwide undergo surgical procedures for permanent birth control each year, highlighting the need for a non-surgical alternative. Announcement • Feb 24
Femasys Inc. Receives AMA CPT Editorial Panel Approval for New Category III CPT Code for FemSeed Intratubal Insemination Femasys Inc. announced that it has received notice from the American Medical Association (AMA) CPT Editorial Panel approving a new, unique Category III Current Procedural Terminology (CPT) code covering the use of FemaSeed for intratubal insemination (ITI), a procedure that delivers sperm directly into the fallopian tube where conception occurs. The approved Category III CPT code is expected to be issued publicly by the AMA with an effective date of January 1, 2027. Approval of this Category III CPT code represents an important step in advancing the reimbursement strategy for FemaSeed to support broader clinical adoption, provider utilization, and expanded patient access to this first-step infertility treatment option. FemaSeed is a next-generation artificial insemination solution that enhances fertilization by precisely delivering sperm to the fallopian tube, the natural site of conception. Developed to bridge the gap between traditional intrauterine insemination (IUI), which often has low success rates, and in vitro fertilization (IVF), which is costly and invasive, FemaSeed offers a safe, effective, accessible, and cost-efficient first-line, in-office treatment option. In its pivotal clinical trial (NCT0468847), conducted in the challenging setting of low male sperm count, FemaSeed achieved more than double the pregnancy rates of IUI. FemaSeed is authorized for use in the U.S., Europe, UK, Canada, and Israel. Announcement • Jan 16
Nasdaq Grants Femasys 180-Day Extension to Gain Compliance with Listing Rules As previously reported, on July 16, 2025, Femasys Inc. (the “Company”) received a notice from The Nasdaq Stock Market (“Nasdaq”) that the Company is not in compliance with Nasdaq’s Listing Rule 5550(a)(2), as the minimum bid price of the Company’s common stock has been below $1.00 per share for 30 consecutive business days (the “Minimum Bid Price Requirement”). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company had a period of 180 calendar days from July 16, 2025, or until January 12, 2026, to regain compliance with the Minimum Bid Price Requirement. On January 12, 2026, the Company submitted a request to Nasdaq for a 180-day extension to regain compliance with the Minimum Bid Price Requirement. The Company indicated to Nasdaq that it had demonstrated more than $5 million in stockholders’ equity as of December 31, 2025, and provided notice of its intention to cure the deficiency during the extended compliance period by effecting a reverse stock split, if necessary, and in sufficient time to evidence a closing bid price of at least $1.00 per share for a minimum of ten consecutive business days prior to the expiration of the extended compliance period. On January 13, 2026, the Company received a letter from Nasdaq advising that the Company had been granted a 180-day extension to July 13, 2026 to regain compliance with the Minimum Bid Price Requirement, in accordance with Nasdaq Listing Rule 5810(c)(3)(A). The Company intends to continue actively monitoring the closing bid price for the Company’s common stock between now and July 13, 2026, and will consider available options to resolve the deficiency, including effecting a reverse stock split as stated above, and regain compliance with the Minimum Bid Price Requirement. Breakeven Date Change • Dec 31
Forecast to breakeven in 2028 The 3 analysts covering Femasys expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$1.38m in 2028. Average annual earnings growth of 59% is required to achieve expected profit on schedule. Announcement • Dec 18
Femasys Inc. Secures U.S. FDA Clearance for Next-Generation FemVue Diagnostic Device Femasys Inc. announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its FemVue Controlled device, an innovative diagnostic solution designed for controlled contrast delivery to evaluate fallopian tube status. The next-generation FemVue Controlled device integrates features of the Company's original FemVue and FemChec technologies into a single FDA-cleared product, enabling multiple clinical uses while streamlining manufacturing and practice workflows. New Risk • Nov 21
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$20m Forecast net loss in 3 years: US$2.8m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (29% average weekly change). Shareholders have been substantially diluted in the past year (155% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$2.8m net loss in 3 years). Revenue is less than US$5m (US$2.1m revenue). Market cap is less than US$100m (US$46.7m market cap). Major Estimate Revision • Nov 21
Consensus revenue estimates decrease by 26%, EPS upgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from US$3.70m to US$2.73m. EPS estimate increased from -US$0.57 to -US$0.51 per share. Medical Equipment industry in the US expected to see average net income growth of 15% next year. Consensus price target of US$4.50 unchanged from last update. Share price fell 3.2% to US$0.80 over the past week. Reported Earnings • Nov 17
Third quarter 2025 earnings: EPS exceeds analyst expectations while revenues lag behind Third quarter 2025 results: US$0.10 loss per share (improved from US$0.24 loss in 3Q 2024). Revenue: US$729.4k (up 31% from 3Q 2024). Net loss: US$4.19m (loss narrowed 22% from 3Q 2024). Revenue missed analyst estimates by 46%. Earnings per share (EPS) exceeded analyst estimates by 13%. Revenue is forecast to grow 64% p.a. on average during the next 3 years, compared to a 8.4% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has increased by 8% per year but the company’s share price has fallen by 10% per year, which means it is significantly lagging earnings. Announcement • Oct 22
Femasys Inc. Announces Initiation of Post-Market Surveillance Study for Fembloc Permanent Birth Control in Europe Femasys Inc. announced the commencement of a post-market surveillance (PMS) clinical study for its CE-marked FemBloc Permanent birth Control. This study is being conducted in accordance with the European Union Medical Device Regulation (EU MDR 2017/745) and numerous thought leaders throughout the region. This PMS study is a key component of Femasys' long-term commitment to monitor the safety and performance of its products in real-world settings while complying with the rigorous post-market requirements introduced under the MDR framework (Annex XIV Part B). The study has received approval from multiple Ethics Committees and is being carried out in compliance with ISO 14155:2020 for Good Clinical Practice and applicable national regulations. Announcement • Oct 19
Femasys Inc. Announces Retirement of Daniel Currie as Chief Operating Officer, Effective as of December 15, 2025 Femasys Inc. announced that On October 13, 2025, Daniel Currie, Chief Operating Officer informed the Company of his decision to retire from the Company, effective as of December 15, 2025. Mr. Currie will remain in his current role with the Company until his departure. Mr. Currie’s decision to retire follows more than 20 years of dedicated service, having joined the Company in March 2004, and is based on personal health considerations, a desire to focus on family and the next chapter of his life. New Risk • Oct 03
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 20% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (20% average weekly change). Shareholders have been substantially diluted in the past year (93% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$5.9m net loss in 3 years). Revenue is less than US$5m (US$1.9m revenue). Market cap is less than US$100m (US$17.8m market cap). Announcement • Sep 11
Femasys Inc. Expands FemSperm™? Product Line with New Insemination Prep Kit to Broaden Gynecology-Based Access to FemSeed Femasys Inc. announced the introduction of its FemSperm Insemination Prep Kit, designed to fully enable gynecologists to perform FemaSeed Intratubal Insemination. The kit includes customized components, such as sperm washing for specific use with the FemSperm Setup kit to optimize sperm preparation for FemaSeed procedures. By providing a streamlined, in-office solution, the company is creating the foundation for gynecologist-driven adoption of FemaSeed as a first-step fertility treatment, broadening patient access to alternatives ahead of IVF and strengthening its long-term revenue growth strategy. With the availability of the FemSperm product family, gynecologists can now perform sperm preparation and offer FemaSeed Intratabal Insemination directly within their practices. FemaSeed is a next-generation artificial sterilization solution that enhances natural fertilization by delivering sperm precisely to the fallopian tube, the site of conception. Positioned as a true first step in the fertility journey, FemaSeed offers a safe, accessible, and cost-effective alternative to intrauterine insemination (IUI). Femasys' fertility portfolio includes FemaSeed®? Intratubal Insemin®?, a first-step infertility treatment and FemVue®?, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrates FemaSeed is over twice as effective as traditional IUI, with a comparable safety profile, and high patient and practitioner satisfaction.emBloc®? permanent birth control is the first and only non-surgical, in-office alternative to centuries-old surgical sterilization that received full regulatory approval in Europe in June of 2025, United Kingdom in August 2025, and New Zealand in September 2025. Commercialization of this highly cost-effective, convenient and significantly safer approach will be completed through strategic partnerships in select European countries. Alongside FemBloc, the FemChec®?, diagnostic product provides an ultrasound-based test to confirm procedural success. Published data from initial clinical trials demonstrated compelling effectiveness, five-year safety, and high patient and practitioners satisfaction. For U.S. FDA approval, enrollment in the FinalE pivotal trial (NCT05977751) is on-going. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to difference include, among others: ability to obtain regulatory approvals for FemBloc product candidate; develop and advance current FemBloc product candidate and successfully enroll and complete the clinical trial; the ability of clinical trial to demonstrate safety and effectiveness of product candidate and other positive results; estimates regarding the total addressable market for products and product candidate; ability to commercialize products and product candidate, ability to establish, maintain, grow or increase sales and revenues, or the effect of delays in commercializing products, including FemaSeed; business model and strategic plans for products, technologies and business, including implementation there of; and those other risks and uncertainties described in the section titled "R&A". Announcement • Sep 08
Femasys Secures Regulatory Approval for Fembloc Permanent Birth Control in New Zealand Femasys Inc. announced it has received approval from the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) for its FemBloc Permanent Birth Control. This approval confirms that FemBloc meets the country’s standards for safety, quality, and effectiveness, and represents an important milestone in Femasys’ global expansion strategy to make this revolutionary non-surgical permanent birth control option available to women worldwide. New Zealand represents a strategically important healthcare market in the Asia-Pacific region, with a strong focus on advancing women’s health and equitable access to innovative treatments. Under its publicly funded healthcare system, technologies that improve outcomes and reduce costs have a clear pathway to adoption. Securing MEDSAFE approval not only validates FemBloc’s safety and effectiveness but also enables Femasys to provide women in New Zealand with access to a groundbreaking, non-surgical permanent birth control option. FemBloc is a first-of-its-kind, non-surgical solution for permanent birth control, addressing a significant unmet need in women’s reproductive health. It uses a patented delivery system to place a proprietary blended polymer into both fallopian tubes, which safely degrades and forms natural scar tissue for permanent occlusion. In contrast to surgical sterilization, FemBloc eliminates the risks of anesthesia, infection, and recovery downtime, making it safer, more accessible, and significantly more cost-effective. Announcement • Aug 26
Femasys Inc. has completed a Follow-on Equity Offering in the amount of $7.985276 million. Femasys Inc. has completed a Follow-on Equity Offering in the amount of $7.985276 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 10,434,586
Price\Range: $0.36
Discount Per Security: $0.0252
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 11,750,000
Price\Range: $0.3599
Discount Per Security: $0.025193
Security Name: Common Warrants
Security Type: Equity Warrant
Securities Offered: 22,184,586 Announcement • Aug 21
Femasys Announces FemSperm™ Kit to Activate Gynecologists and Advance FemaSeed® Fertility Platform Femasys Inc. announced the introduction of its FemSperm Setup Kit, the first in a planned family of products designed to fully enable gynecologists for FemaSeed Intratubal Insemination. The setup kit includes customized components, such as a pre-configured centrifuge to optimize sperm preparation for use with FemaSeed. By providing a streamlined, in-office solution, Femasys is establishing the foundation for gynecologist-driven adoption of FemaSeed as a first-step fertility treatment, expanding patient access to alternatives ahead of IVF and advancing the Company’s commercialization strategy. FemaSeed is a next-generation artificial insemination solution that enhances natural fertilization by precisely delivering sperm to the fallopian tube, the site of conception. Positioned as a true first step in the fertility journey, FemaSeed offers safe, accessible, and cost-effective alternative to intrauterine insemination (IUI). In its pivotal trial, FemaSeed established more than double the pregnancy rates compared to IUI in cases of low male sperm count. As an affordable, less invasive, lower-risk option before IVF, FemaSeed is authorized for use in the U.S., Europe, UK, Canada, Israel, Australia and New Zealand. New Risk • Aug 12
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$20m free cash flow). Shareholders have been substantially diluted in the past year (47% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$21m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Revenue is less than US$5m (US$1.9m revenue). Market cap is less than US$100m (US$25.3m market cap). Reported Earnings • Aug 11
Second quarter 2025 earnings: EPS exceeds analyst expectations while revenues lag behind Second quarter 2025 results: US$0.16 loss per share (improved from US$0.21 loss in 2Q 2024). Revenue: US$409.3k (up 85% from 2Q 2024). Net loss: US$4.59m (loss narrowed 2.1% from 2Q 2024). Revenue missed analyst estimates by 65%. Earnings per share (EPS) exceeded analyst estimates by 1.5%. Revenue is forecast to grow 59% p.a. on average during the next 3 years, compared to a 8.2% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has increased by 3% per year but the company’s share price has fallen by 24% per year, which means it is significantly lagging earnings. Announcement • Jul 20
Femasys Receives Notice from Nasdaq Due to Non-Compliance with the Minimum Bid Price Requirement On July 16, 2025, Femasys Inc. (the ‘Company’) received a notice from The Nasdaq Stock Market (‘Nasdaq’) that the Company is not in compliance with Nasdaq’s Listing Rule 5550(a)(2), as the minimum bid price of the Company’s common stock has been below $1.00 per share for 30 consecutive business days (the ‘Minimum Bid Price Requirement’). The notification of noncompliance has no immediate effect on the listing or trading of the Company’s common stock on The Nasdaq Capital Market. The Company has 180 calendar days, or until January 12, 2026, to regain compliance with the Minimum Bid Price Requirement. To regain compliance, the minimum bid price of the Company’s common stock must meet or exceed $1.00 per share for a minimum of ten consecutive business days during this 180-calendar day grace period. In the event the Company does not regain compliance with the Minimum Bid Price Requirement by January 12, 2026, the Company may be eligible for an additional 180-calendar day compliance period if it meets all other initial listing standards for The Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and provides written notice of its intention to cure the bid deficiency during the second compliance period, by effecting a reverse stock split, if necessary. If the Company does not regain compliance with the Minimum Bid Price Requirement by the end of the compliance period (or the second compliance period, if applicable), the Company’s common stock will become subject to delisting. In the event that the Company receives notice that its common stock is being delisted, the Nasdaq listing rules permit the Company to appeal a delisting determination by the Staff to a hearings panel. The Company intends to monitor the closing bid price of its common stock and may, if appropriate, consider available options to regain compliance with the Minimum Bid Price Requirement, including initiating a reverse stock split. However, there can be no assurance that the Company will be able to regain compliance with the Minimum Bid Price Requirement or will otherwise be in compliance with other Nasdaq Listing Rules. Announcement • Jul 02
Femasys, Inc. Achieves Australian and New Zealand Regulatory Approvals for Femaseed®? for First-Line Infertility Treatment and Femvue Diagnostic Femasys Inc. announced the achievement of regulatory approvals in Australia and New Zealand for its next-generation infertility solutions: FemaSeed®? for first-line intratubal insemination treatment and FemVue®? for diagnostic evaluation. Major Estimate Revision • Jun 26
Consensus revenue estimates increase by 16% The consensus outlook for revenues in fiscal year 2025 has improved. 2025 revenue forecast increased from US$5.30m to US$6.13m. Forecast losses expected to reduce from -US$0.635 to -US$0.607 per share. Medical Equipment industry in the US expected to see average net income growth of 13% next year. Consensus price target of US$7.25 unchanged from last update. Share price rose 12% to US$0.98 over the past week. Announcement • Jun 18
Femasys, Inc. Appoints Kelley Nicholas as Chief Commercial Officer Femasys Inc. announced on June 17, 2025, the appointment of Kelley Nicholas as Chief Commercial Officer (CCO). Ms. Nicholas will be responsible for leading the execution and optimization of Femasys’ commercial strategy to drive revenue growth across its entire portfolio, with a particular focus on expanding the U.S. infertility market and building key international partners. Ms. Nicholas has over 25 years of industry experience, including two decades leading high-performing commercial teams. She has a strong record of driving revenue growth, expanding markets, and leading transformative strategies in the medical device and biotechnology sectors. Prior to joining Femasys, Ms. Nicholas served as Head of Sales at NeuroPace, where she spearheaded a commercial overhaul that dramatically accelerated revenue, profitability, and stock performance. In her role as Global Vice President of Marketing at Hologic, she restructured the commercial organization and revamped product development, launch effectiveness, and global commercialization which led to top line revenue growth across all business units. Kelley’s leadership experience spans global healthcare companies like Medtronic, Baxter, Intuitive Surgical and Covidien where she led multiple go-to-market strategy transformations and organizational scale-ups which contributed to the successful commercialization of disruptive technologies. She is known for building energized, accountable teams, and aligning strategic vision with execution to deliver sustainable growth. Ms. Nicholas holds a BS in Health Science and Physical Therapy from the University of Missouri and a master’s in business administration from Washington University. Announcement • Jun 11
Femasys Inc. announced that it has received $1.45 million in funding On June 10, 2025, Femasys Inc., closed the transaction. The transaction included participation from 6 investors. New Risk • Jun 06
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 46% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Shareholders have been substantially diluted in the past year (46% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$12m net loss in 3 years). Revenue is less than US$5m (US$1.7m revenue). Market cap is less than US$100m (US$25.9m market cap). Announcement • May 25
Femasys Receives Written Notice from Nasdaq Regarding Non-Compliance with the Minimum Market Value of Listed Securities Requirement On May 19, 2025, Femasys Inc. received a written notice (the ‘Notice’) from The Nasdaq Stock Market LLC (‘Nasdaq’) that for the last 30 consecutive business days, the Market Value of Listed Securities (‘MVLS’) for the Company’s common stock was below the minimum $35.0 million requirement for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(b)(2) (the ‘Minimum MVLS Requirement’). Additionally, the Company does not meet either of the alternative Nasdaq continued listing standards under Nasdaq Listing Rule 5550(b)(2): (i) stockholders’ equity of at least $2.5 million or (ii) net income of $500,000 in the most recently completed fiscal year, or in two of the three most recently completed fiscal years. The Notice has no immediate effect on the listing of the Company’s common stock and the Company’s common stock will continue to be listed on Nasdaq under the symbol ‘FEMY.’ In accordance with Nasdaq Listing Rule 5810(c)(3)(C), the Company has a period of 180 calendar days, or until November 17, 2025, to regain compliance with the Minimum MVLS Requirement. If at any time before November 17, 2025, the MVLS of the Company’s common stock closes at $35.0 million or more for a minimum of 10 consecutive business days, Nasdaq will provide the Company with a written confirmation of compliance with the Minimum MVLS Requirement. If the Company does not regain compliance with the Minimum MVLS Requirement by November 17, 2025, Nasdaq will provide written notification to the Company that its Common Stock is subject to delisting. At that time, the Company may appeal the delisting determination to a Nasdaq hearings panel. The Company intends to actively monitor the MVLS of its Common Stock between now and November 17, 2025, and will consider its available options to regain compliance with the Minimum MVLS Requirement. There can be no assurance that the Company will regain compliance with the Minimum MVLS Requirement or maintain compliance with any of the other Nasdaq continued listing requirements. Major Estimate Revision • May 15
Consensus revenue estimates fall by 39% The consensus outlook for revenues in fiscal year 2025 has deteriorated. 2025 revenue forecast decreased from US$8.65m to US$5.30m. Forecast losses increased from -US$0.557 to -US$0.635 per share. Medical Equipment industry in the US expected to see average net income growth of 13% next year. Consensus price target down from US$9.00 to US$7.25. Share price fell 7.0% to US$1.07 over the past week. Price Target Changed • May 11
Price target decreased by 8.3% to US$8.25 Down from US$9.00, the current price target is an average from 4 analysts. New target price is 678% above last closing price of US$1.06. Stock is down 12% over the past year. The company is forecast to post a net loss per share of US$0.56 next year compared to a net loss per share of US$0.85 last year. Reported Earnings • May 09
First quarter 2025 earnings: EPS and revenues miss analyst expectations First quarter 2025 results: US$0.23 loss per share (further deteriorated from US$0.17 loss in 1Q 2024). Revenue: US$341.3k (up 26% from 1Q 2024). Net loss: US$5.90m (loss widened 64% from 1Q 2024). Revenue missed analyst estimates by 70%. Earnings per share (EPS) also missed analyst estimates by 15%. Revenue is forecast to grow 55% p.a. on average during the next 3 years, compared to a 8.1% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has increased by 3% per year but the company’s share price has fallen by 11% per year, which means it is significantly lagging earnings. Announcement • Apr 29
Femasys Inc., Annual General Meeting, Jun 25, 2025 Femasys Inc., Annual General Meeting, Jun 25, 2025. Location: 3950 johns creek court, suite 100, suwanee, georgia 30024, United States Major Estimate Revision • Apr 03
Consensus revenue estimates decrease by 16% The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from US$10.3m to US$8.65m. EPS estimate unchanged at -US$0.557 per share. Medical Equipment industry in the US expected to see average net income growth of 16% next year. Consensus price target of US$9.00 unchanged from last update. Share price fell 7.9% to US$1.23 over the past week. New Risk • Apr 02
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 23% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Less than 1 year of cash runway based on free cash flow trend (-US$20m free cash flow). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$13m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (23% increase in shares outstanding). Revenue is less than US$5m (US$1.6m revenue). Market cap is less than US$100m (US$33.4m market cap). Reported Earnings • Mar 28
Full year 2024 earnings: EPS and revenues miss analyst expectations Full year 2024 results: US$0.84 loss per share. Revenue: US$1.63m (up 52% from FY 2023). Net loss: US$18.8m (loss widened 32% from FY 2023). Revenue missed analyst estimates by 40%. Earnings per share (EPS) also missed analyst estimates by 5.9%. Revenue is forecast to grow 52% p.a. on average during the next 3 years, compared to a 7.8% growth forecast for the Medical Equipment industry in the US. New Risk • Mar 27
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Less than 1 year of cash runway based on free cash flow trend (-US$18m free cash flow). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$21m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Revenue is less than US$5m (US$1.3m revenue). Market cap is less than US$100m (US$34.8m market cap). Price Target Changed • Mar 20
Price target increased by 9.1% to US$9.00 Up from US$8.25, the current price target is an average from 4 analysts. New target price is 473% above last closing price of US$1.57. Stock is down 13% over the past year. The company is forecast to post a net loss per share of US$0.80 next year compared to a net loss per share of US$0.93 last year. Announcement • Mar 13
Femasys Announces FemBloc Delivery System Approval in Europe Femasys Inc. announced Conformité Européene (CE) mark certification under European Union Medical Device Regulation (EU MDR) as the first regulatory approval in the world for the FemBloc delivery system for non-surgical female permanent birth control. For the FemBloc blended polymer, an integral part of the FemBloc permanent birth control, the Company has successfully completed an expedited G12 Special MDR Audit for Class III devices and the Notified Body has recommended for CE mark approval pending the final stages of European Medical Agency (EMA) review, with potential approval expected mid-2025. About Permanent Birth Control: In the 1800’s, surgical sterilization (tubal ligation) was first performed and evolved to be performed laparoscopically, becoming the most commonly used contraceptive method worldwide. Despite the progress made in the last century, unintended pregnancies continue to rise and present a significant personal burden for individuals, as well as a major public health issue in the United States and globally. Due to the invasive nature of surgical sterilization, women may be utilizing temporary/reversible methods to avoid the reported risks, which include infection, minor or major bleeding, injury to nearby organs, anesthesia-related events, and even death. Along with the various surgical risks, some patients may not qualify as good surgical candidates due to obesity or medical comorbidities. For over 100 years, there has been stagnant innovation for permanent contraception which has resulted in a significant unmet need for women seeking an alternative to surgical sterilization. Announcement • Feb 25
Femasys Inc. Announces Peer-Reviewed Publication of Positive Safety and Efficacy Results from FemBloc Permanent Birth Control Clinical Trials Femasys Inc. announced the peer-reviewed publication of positive data from its initial clinical trials of FemBloc® permanent birth control in the Journal of Gynecology & Reproductive Medicine (JGRM), a leading peer-reviewed journal covering gynecology and reproductive medicine. The publication entitled, "FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes" includes positive data from three initial clinical trials (Clinicaltrials.gov NCT03067272, NCT03433911, and NCT04273594). The pregnancy rate for FemBloc subjects, who met trial eligibility and were determined bilaterally occluded after a confirmation test three months post-FemBloc was 0% (95% UCB: 0.057; n=0/51). In contrast to historic surgical sterilization, the FemBloc approach offers a non-surgical, more accessible in-office alternative with fewer risks, contraindications, and substantially lower cost. Participants are being enrolled in the finalE pivotal clinical trial (NCT05977751) for U.S. approval. Peer-reviewed publication of positive data of FemBloc have demonstrated compelling effectiveness and five-year safety with high satisfaction from both patients and practitioners. Announcement • Feb 11
Femasys Inc. Announces UK Regulatory Approvals for FemaSeed for Female Infertility Treatment and Two Diagnostic Devices Femasys Inc. announced the receipt of the Medicines & Healthcare products Regulatory Agency (MHRA) approvals for the FemaSeed Intratubal Insemination product for female infertility treatment and two diagnostic devices, FemVue for tubal evaluation and FemCerv for cervical cancer detection. Announcement • Feb 04
Femasys Announces Israeli Regulatory Approvals for Femaseed® for Female Infertility Treatment and Two Diagnostic Devices Femasys Inc. announced the receipt of the Israeli Medical Device Division of the Ministry of Health’s (AMAR) approvals for the FemaSeed® Intratubal Insemination product for female infertility treatment and two diagnostic devices, FemVue® for tubal evaluation and FemCerv® for cervical cancer detection. Announcement • Jan 30
Femasys Inc. Announces Notices of Intention to Grant for Two New European Patent Applications Covering Use of FemBloc Permanent Birth Control Femasys Inc. announced the European Patent Office issued notices of Intention to Grant for two EU Patent Applications, EPO Application Nos. 24170531.8 and 18751753.7, which will have anticipated expirations in 2039 and 2038, respectively. FemBloc plans to pursue additional patent applications to further strengthen its existing portfolio protecting FemBloc permanent birth control, along with its other products, including FemaSeed, FemVue, FemCath and FemCerv. Announcement • Jan 16
Femasys Inc. Announces Notice of Allowance for New U.S. Patent Application Covering Use of FemaSeed® for Female Infertility Treatment Femasys Inc. announced the United States Patent and Trademark Office issued a Notice of Allowance for U.S. Patent Application 18/443,798 further strengthening Femasys' intellectual property position and coverage for the Company's infertility therapeutic product FemaSeed® Intratubal Insemination. Femasys expects the resulting patent, when issued, will have an anticipated expiration in 2044 at the earliest. Femasys intends to continue to prosecute additional patent applications to further enhance its existing patent portfolio protecting FemaSeed along with FemBlocpermanent birth control, the Company’s late-stage product candidate, in addition to the Company’s other existing available diagnostic products, FemVue, FemCath, and FemCerv. Announcement • Nov 26
Femasys Inc. Announces Peer-Reviewed Publication of Positive Data from Prospective, Multicenter Pivotal Trial of FemSeed® Infertility Treatment Femasys Inc. announced the peer-reviewed publication of positive data from its pivotal trial of FemaSeed intratubal insemination (ITI) in the Journal of Gynecology & Reproductive Medicine (JGRM), a leading peer-reviewed journal covering gynecology and reproductive medicine. The publication titled, ‘FemaSeed directional intratubal artificial insemination for couples with male-factor or unexplained infertility associated with low male sperm count,’ includes positive data from the pivotal trial (Clinicaltrials.gov NCT04968847). The trial met its primary endpoint with a pregnancy rate per subject of 26.3% (95% CI: 13.443.1%; n=10/38) and 17.5% per cycle (95% LCB: 7.6%, 95% CI: 5.729.4%; n=10/57), which was significantly higher than the performance goal of 7% based on the historical control (one-sided P=0.041). Safety reports were consistent with IUI. The vast majority of subjects stated they would probably or definitely recommend FemaSeed, and investigator satisfaction was similarly high. Targeted intratubal insemination of washed spermatozoa using the FemaSeed ITI device is a safe artificial insemination technique that demonstrated high effectiveness for couples with male-factor/unexplained infertility associated with low male sperm count. Delivery of washed spermatozoa directly into the utero-tubal ostium and fallopian tube without catheterization likely increases sperm-oocyte interaction, suggestive of improved efficiency over conventional intrauterine insemination particularly for male-factor infertility. Reported Earnings • Nov 14
Third quarter 2024 earnings: EPS and revenues miss analyst expectations Third quarter 2024 results: US$0.24 loss per share. Revenue: US$554.9k (up 127% from 3Q 2023). Net loss: US$5.41m (loss widened 35% from 3Q 2023). Revenue missed analyst estimates by 18%. Earnings per share (EPS) also missed analyst estimates by 20%. Revenue is forecast to grow 63% p.a. on average during the next 3 years, compared to a 8.3% growth forecast for the Medical Equipment industry in the US. Major Estimate Revision • Nov 13
Consensus revenue estimates fall by 17% The consensus outlook for revenues in fiscal year 2024 has deteriorated. 2024 revenue forecast decreased from US$2.57m to US$2.15m. Forecast losses increased from -US$0.752 to -US$0.803 per share. Medical Equipment industry in the US expected to see average net income growth of 20% next year. Consensus price target of US$8.25 unchanged from last update. Share price fell 8.0% to US$1.03 over the past week. Announcement • Sep 11
Femasys Inc. Receives U.S. FDA Clearance to Market FemChec, an Innovative Diagnostic Solution for Fallopian Tube Check Femasys Inc. announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for FemChec, an innovative diagnostic solution for checking the fallopian tubes, designed for controlled delivery of contrast for confirmation of tubal status. Major Estimate Revision • Aug 15
Consensus revenue estimates fall by 40% The consensus outlook for revenues in fiscal year 2024 has deteriorated. 2024 revenue forecast decreased from US$4.14m to US$2.47m. Forecast losses increased from -US$0.652 to -US$0.752 per share. Medical Equipment industry in the US expected to see average net income growth of 17% next year. Consensus price target down from US$10.00 to US$8.75. Share price was steady at US$1.06 over the past week. New Risk • Aug 11
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$15m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$15m free cash flow). Revenue is less than US$1m (US$950k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$12m net loss in 3 years). Share price has been volatile over the past 3 months (14% average weekly change). Shareholders have been diluted in the past year (47% increase in shares outstanding). Market cap is less than US$100m (US$20.7m market cap). Reported Earnings • Aug 09
Second quarter 2024 earnings: EPS and revenues miss analyst expectations Second quarter 2024 results: US$0.21 loss per share. Net loss: US$4.68m (loss widened 62% from 2Q 2023). Revenue missed analyst estimates by 71%. Earnings per share (EPS) also missed analyst estimates by 29%. Revenue is forecast to grow 57% p.a. on average during the next 3 years, compared to a 8.2% growth forecast for the Medical Equipment industry in the US. Announcement • Jun 10
Femasys Inc., Annual General Meeting, Jul 12, 2024 Femasys Inc., Annual General Meeting, Jul 12, 2024. Location: 3950 johns creek court, suite 100, georgia 30024, suwanee United States Major Estimate Revision • May 16
Consensus revenue estimates decrease by 17%, EPS upgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$5.02m to US$4.14m. EPS estimate increased from -US$0.69 to -US$0.652 per share. Medical Equipment industry in the US expected to see average net income growth of 18% next year. Consensus price target of US$10.00 unchanged from last update. Share price was steady at US$1.29 over the past week. Price Target Changed • May 12
Price target increased by 8.1% to US$10.00 Up from US$9.25, the current price target is an average from 4 analysts. New target price is 726% above last closing price of US$1.21. Stock is up 62% over the past year. The company is forecast to post a net loss per share of US$0.65 next year compared to a net loss per share of US$0.93 last year. New Risk • May 10
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$13m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$13m free cash flow). Shareholders have been substantially diluted in the past year (86% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$13m net loss in 3 years). Share price has been volatile over the past 3 months (14% average weekly change). Revenue is less than US$5m (US$1.0m revenue). Market cap is less than US$100m (US$28.1m market cap). Reported Earnings • May 10
First quarter 2024 earnings: EPS exceeds analyst expectations while revenues lag behind First quarter 2024 results: US$0.17 loss per share. Net loss: US$3.60m (loss widened 22% from 1Q 2023). Revenue missed analyst estimates by 74%. Earnings per share (EPS) exceeded analyst estimates by 17%. Revenue is forecast to grow 54% p.a. on average during the next 3 years, compared to a 8.1% growth forecast for the Medical Equipment industry in the US. Major Estimate Revision • Apr 04
Consensus revenue estimates fall by 13% The consensus outlook for revenues in fiscal year 2024 has deteriorated. 2024 revenue forecast decreased from US$5.79m to US$5.02m. Forecast losses increased from -US$0.627 to -US$0.69 per share. Medical Equipment industry in the US expected to see average net income growth of 16% next year. Consensus price target up from US$9.25 to US$9.75. Share price rose 23% to US$1.81 over the past week. Reported Earnings • Mar 31
Full year 2023 earnings: EPS exceeds analyst expectations while revenues lag behind Full year 2023 results: US$0.93 loss per share. Net loss: US$14.2m (loss widened 25% from FY 2022). Revenue missed analyst estimates by 8.9%. Earnings per share (EPS) exceeded analyst estimates by 1.8%. Revenue is forecast to grow 55% p.a. on average during the next 3 years, compared to a 7.9% growth forecast for the Medical Equipment industry in the US. Announcement • Mar 07
Femasys Completes the First In-Office Commercial Procedure with the FDA-Cleared FemaSeed Infertility Solution Femasys Inc. announced the first commercial procedure using its FemaSeed intratubal insemination product. FDA-Cleared FemaSeed is a revolutionary approach to enhancing fertilization, as a cost-effective primary therapeutic choice that carries notably reduced risks compared to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). Engineered to precisely deliver sperm into the fallopian tube, the site of conception, FemaSeed enables reliable and safe fertilization. New Risk • Feb 09
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Shareholders have been substantially diluted in the past year (83% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$15m net loss in 3 years). Revenue is less than US$5m (US$1.1m revenue). Market cap is less than US$100m (US$25.3m market cap). Announcement • Feb 06
Femasys Inc. Appoints Richard Spector as Chief Commercial Officer Femasys Inc. announced the appointment of Richard Spector to chief commercial officer (CCO), effective February 2024. Mr. Spector has 25 years of experience spanning a continuum of commercial stages at both public and private medical device and biopharmaceutical companies. Mr. Spector brings over 25 years of experience leading public and private biotechnology companies through various stages of commercialization. His expertise ranges from leading functional efforts in sales and marketing, key opinion leader strategy, product/brand development, and reimbursement strategy, to strategic efforts such as product planning, alliance management, cross functional team management and interfacing with investors and analysts. Most recently, Mr. Spector was chief commercial officer at Qlibrium (formally Cam-Med Inc.), a medical device company innovating on-body, wearable devices with the first electrochemical and microfluidic technology platform for therapeutic areas as such as oncology, diabetes, autoimmune, and in vitro fertilization (IVF). At Qlibrium, Mr. Spector led sales, marketing and partner development functions from early-stage to commercial launch as well as revamped and launched all marketing materials and campaigns to drive awareness and patient flow, including campaigns with Johnson & Johnson (J&J), Boeing and NASA. Prior to this, Mr. Spector was at Insulet Corporation as senior director, strategic alliances, where he negotiated and managed over a dozen business development deals with pharmaceutical and device companies and at OvaScience Inc. (acquired by Millendo Therapeutics Inc.) as the vice president, of global sales and partner development for their global fertility products. He was also in leadership positions at other Women’s Health companies, including NeoMatrix Inc. (acquired by Halo Health Systems), Advanced Radiation Therapy, LLC (acquired by Best Medical International Inc.) and Cytyc Surgical Products, LLC (acquired by Hologic Inc.). Mr. Spector has a Bachelor of Science degree in Business Administration and Marketing from California State University in Sacramento, CA. Announcement • Jan 26
Femasys Inc. Begins Fembloc Pivotal Trial Enrollment At UC Davis Medical Center, A Hub for Innovation and Groundbreaking Research in Health Care for Women Femasys Inc. announced that it has activated enrollment for its pivotal FemBloc® trial at University of California, Davis (“UC Davis”) Medical Center in Sacramento, California. The FemBloc Intratubal Occlusion for TranscervicAL Permanent Birth Control (the “FINALE” trial) is being conducted to investigate the safety and efficacy of its investigational permanent birth control candidate, FemBloc®. The FDA-approved, multi-center trial is designed to address the high unmet need that exists for women seeking permanent birth control, for whom elective surgery currently remains the only option. Femasys is creating accessible innovative options for women, as exemplified by its lead product candidate, FemBloc®, in late-stage clinical development for permanent birth control, and its United States Food and Drug Administration (FDA)-cleared product, FemaSeed®, for infertility treatment that is also approved in Canada. The Company is also commercializing complementary diagnostic products, FemVue®, FemCath® and FemCerv®, all of which were internally developed through its in-house R&D and manufacturing capabilities, with regulatory approvals in the U.S., Canada and other ex-U.S. territories. Announcement • Jan 23
Femasys Inc. Begins Fembloc Pivotal Trial Enrollment At University of Utah Femasys Inc. announced that it has activated enrollment for its pivotal FemBloc trial at another academic site, University of Utah Hospital in Salt Lake City, Utah. The FemBloc Intratubal Occlusion for TranscervicAL Permanent Birth Control (the “FINALE” trial) is being conducted to investigate the safety and efficacy of its investigational permanent birth control candidate, FemBloc®. The FDA-approved, multi-center trial is designed to help women seeking permanent birth control, for whom elective surgery currently remains the only option. Femasys is creating accessible innovative options for women, as exemplified by its lead product candidate, FemBloc® in late-stage clinical development for permanent birth control and its United States Food and Drug Administration (FDA)-cleared product, FemaSeed® for infertility treatment that is also approved in Canada. The Company is also commercializing complementary diagnostic products, FemVue®, FemCath® and FemCerv®, all of which were internally developed through its in-house R&D and manufacturing capabilities, with regulatory approvals in the U.S., Canada and other ex-U.S. territories. Announcement • Dec 15
Femasys Inc. Begins FemBloc Pivotal Trial Enrollment at Stanford Medicine Femasys Inc. announced that it has activated enrollment for its pivotal FemBloc® trial at Stanford Medicine in Palo Alto, California. The FemBloc Intratubal Occlusion for TranscervicAL Permanent Birth Control (the “FINALE” trial) is being conducted to investigate the safety and efficacy of its investigational permanent birth control candidate, FemBloc. The FDA-approved, multi-center trial is designed to address the high unmet need that exists for women seeking permanent birth control, for whom elective surgery currently remains the only option. Femasys is creating accessible innovative options for women, as exemplified by its lead product candidate, FemBloc, in late-stage clinical development for permanent birth control, and its United States Food and Drug Administration (FDA)-cleared product, FemaSeed®, for infertility treatment that is also approved in Canada. The Company is also commercializing complementary diagnostic products, FemVue®, FemCath® and FemCerv®, all of which were internally developed through its in-house R&D and manufacturing capabilities, with regulatory approvals in the U.S., Canada and other ex-U.S. territories. Announcement • Nov 23
Femasys Inc. announced that it has received $6.85 million in funding from PharmaCyte Biotech, Inc. and other investors On November 22, 2023, Femasys Inc. closed the transaction. The company received $1,850,000 in its second and final tranche. The company received funding pursuant to Regulation D in the transaction from 4 investors. Announcement • Nov 22
Femasys Inc. Appoints Joshua Silverman as Director The Board of Directors (the ‘Board’) of Femasys Inc. appointed Joshua Silverman as director of the Company effective November 21, 2023. There are no family relationships between Mr. Silverman and any Company director or executive officer, and no arrangements or understandings between Mr. Silverman and any other person pursuant to which he was selected as a director, other than the Securities Purchase Agreement. Mr. Silverman was appointed to the Board pursuant to the board nomination right granted to PharmaCyte Biotech Inc. (‘PharmaCyte’) under the Securities Purchase Agreement, dated November 21, 2023 (the ‘Securities Purchase Agreement’), by and among the Company, PharmaCyte and the other purchasers party thereto, which agreement is described in and filed as an exhibit to Current Report on Form 8-K filed with the SEC on November 15, 2023. Joshua Silverman serves as the interim Chief Executive Officer, President and Director of PharmaCyte Biotech. He is the Co-Founder and Managing Member of Parkfield Funding LLC and is a former Principal and Managing Partner of Iroquois Capital Management, LLC. Previously, he served as Co-Chief Investment Officer of Iroquois from 2003 until 2016 and Co-Chief Investment Officer of Vertical Ventures, LLC from 2000 to 2003. Mr. Silverman served as Assistant Press Secretary to The President of The United States. Mr. Silverman also serves on the boards of directors of Ayro Inc., MYMD Pharmaceuticals Inc., Petros Pharmaceuticals Inc. and Synaptogenix Inc. Mr. Silverman received his B.A. from Lehigh University. New Risk • Nov 19
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 83% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (46% average daily change). Shareholders have been substantially diluted in the past year (83% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$15m net loss in 3 years). Revenue is less than US$5m (US$1.1m revenue). Market cap is less than US$100m (US$20.9m market cap). Reported Earnings • Nov 17
Third quarter 2023 earnings: EPS and revenues miss analyst expectations Third quarter 2023 results: US$0.27 loss per share (further deteriorated from US$0.25 loss in 3Q 2022). Net loss: US$4.00m (loss widened 34% from 3Q 2022). Revenue missed analyst estimates by 35%. Earnings per share (EPS) also missed analyst estimates by 16%. Revenue is forecast to grow 64% p.a. on average during the next 3 years, compared to a 7.8% growth forecast for the Medical Equipment industry in the US. Major Estimate Revision • Nov 16
Consensus revenue estimates fall by 11% The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from US$1.36m to US$1.20m. Forecast losses increased from -US$0.893 to -US$0.953 per share. Medical Equipment industry in the US expected to see average net income growth of 22% next year. Consensus price target down from US$10.00 to US$9.00. Share price fell 17% to US$1.01 over the past week. New Risk • Nov 16
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 3.5% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$11m free cash flow). Share price has been highly volatile over the past 3 months (46% average daily change). Earnings are forecast to decline by an average of 3.5% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$20m net loss in 3 years). Shareholders have been diluted in the past year (41% increase in shares outstanding). Revenue is less than US$5m (US$1.2m revenue). Market cap is less than US$100m (US$15.5m market cap). Announcement • Oct 29
Femasys Inc. Successfully Completes the Stage 2 European Union (EU) Medical Device Regulation Femasys Inc. announced that it has successfully completed the Stage 2 European Union (EU) Medical Device Regulation (MDR 2017/745) onsite audit resulting in zero nonconformances and no findings. This is the final audit phase in the MDR designation process that was conducted by TUV SUD America Inc., a recognized Auditing Organization and Notified Body. Successful completion of both Stage 1 and Stage 2 MDR audits confirms Femasys is compliant in all areas of MDR and may progress to issuance of the MDR certification, allowing for Femasys’ products to secure CE Marking. Femasys is creating accessible innovative options for women, as exemplified by its lead product candidate, FemBloc in late-stage clinical development for permanent birth control and its United States Food and Drug Administration (FDA)-cleared product, FemaSeed for infertility treatment that is also approved in Canada. The Company is also commercializing complementary diagnostic products, FemVue, FemCath and FemCerv, all of which were internally developed through its in-house R&D and manufacturing capabilities, with regulatory approvals in the U.S., Canada and other ex-U.S. territories. Announcement • Sep 01
Femasys Inc. Obtains Medical Device Establishment License from Health Canada Femasys Inc. has obtained a Medical Device Establishment License ("MDEL") from Health Canada (License Number 24825). The MDEL license is issued by Health Canada's Regulatory Operations and Enforcement Branch (ROEB) to companies for the activities of manufacturing, importing and distributing and selling of medical devices for human use in Canada. This license allows Femasys to directly sell its four products, FemaSeed(R), FemVue(R), FemCath(R) and FemCerv(R), approved in Canada. More information on Femasys' approved products in Canada (FemaSeed, FemVue, FemCath and FemCerv) is below: About FemaSeed(R) FemaSeed is a first-of-its-kind infertility solution in late-stage clinical development in the U.S. for directional intrauterine insemination that delivers sperm to the fallopian tube where conception occurs. It is intended to augment natural fertilization as a first-line infertility treatment option that is less invasive and more affordable than in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). About FemVue(R) FemVue is the first FDA-cleared product that creates natural contrast to allow for real time evaluation of the fallopian tubes with ultrasound in the GYN's office that is safer and less costly than the alternative radiology exam. About FemCath(R) FemCath is the first FDA-cleared product that allows for selective evaluation of the fallopian tubes by using in conjunction with FemVue. The baseline ultrasound-based diagnostic test is essential prior to any infertility treatment, including therapeutic solution FemaSeed. About FemCerv(R) FemCerv is the first FDA-cleared product that allows for the capture and protection of a comprehensive endocervical tissue sample in a virtually pain-free procedure for diagnosis of cervical cancer. New Risk • Aug 12
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 14% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$11m free cash flow). Share price has been highly volatile over the past 3 months (40% average weekly change). Earnings are forecast to decline by an average of 14% per year for the foreseeable future. Market cap is less than US$10m (US$6.48m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$22m net loss in 3 years). Shareholders have been diluted in the past year (28% increase in shares outstanding). Revenue is less than US$5m (US$1.2m revenue). Announcement • Aug 11
Femasys Inc. Designates Daniel Currie as its Chief Operating Officer Femasys Inc. announced that it has designated Daniel Currie, the Company’s Senior Vice President, as its Chief Operating Officer. Mr. Currie, 59, has served as Senior Vice President, Operations since 2009, and Vice President, Operations since 2004. Mr. Currie has over 30 years of operational experience in the medical device industry, including assignments at early stage and large established companies. He worked closely with research and development teams, implemented and managed quality systems, spearheaded compliance and complaint handling systems at CIBA Vision Corporation. As head of Quality at Novoste Corporation, he oversaw and was directly involved in design and manufacturing controls, quality auditing (including FDA), evaluating and managing subcontractor operations, managing validation systems and performing product evaluations and testing. In addition, Mr. Currie was responsible for evaluating facilities outside the United States capable of manufacturing class III medical devices. Once the site was selected, Mr. Currie co-managed a team to establish full manufacturing operations. Mr. Currie is a graduate of Georgia Southern University with a BBA in Economics. Reported Earnings • Aug 11
Second quarter 2023 earnings: EPS and revenues miss analyst expectations Second quarter 2023 results: US$0.22 loss per share. Revenue: US$320.5k (up 5.7% from 2Q 2022). Net loss: US$2.89m (loss widened 9.8% from 2Q 2022). Revenue missed analyst estimates by 12%. Earnings per share (EPS) also missed analyst estimates by 10.0%. Revenue is forecast to grow 61% p.a. on average during the next 3 years, compared to a 7.8% growth forecast for the Medical Equipment industry in the US. Announcement • Jun 28
Femasys Inc. Announces FDA Approval of its IDE for the Pivotal Clinical Trial of FemBloc Permanent Birth Control, A Non-Surgical Alternative for Women Femasys Inc. announced the approval of an Investigational Device Exemption (IDE) from the United States Food and Drug Administration (FDA) to evaluate the safety and efficacy of FemBloc, a first-of-its-kind, non-surgical, non-implant, in-office solution for permanent birth control in a pivotal clinical trial (the "FINALE" trial). FemBloc is intended to be a safer option for women by eliminating the need for anesthesia, incisions, and permanent implants. FemBloc has the potential to offer women a convenient and reliable option for permanent birth control. FemBloc along with FemaSeed(R) localized directional insemination for infertility represent the two lead product candidates of the Company and if approved will provide therapeutic solutions to compliment the Company's existing marketed diagnostic products, FemVue(R) for fallopian tube assessment by ultrasound which can be used in conjunction with FemCath(R), an intrauterine catheter for selective evaluation of the fallopian tubes, and FemCerv(R), an endocervical sampler for cervical cancer diagnosis that is the first product of the technology platform for tissue sampling. FemaSeed, FemCerv, and FemCath have received product approval in Canada. Announcement • Jun 16
Femasys Inc. Announces Management Changes Femasys Inc. announced that it has appointed Mr. Keith J. Kendall and Mr. Alistair Milnes to its board of directors. Messrs. Kendall and Milnes will be replacing Mr. John Dyett, who currently serves as Co-CEO of Salem Partners, LLC and Salem Partners Wealth Management, LLC and Mr. John Adams, formerly served as CEO and President of Adams Respiratory Therapeutics, who both have served as members of Femasys’ board of directors for over eight years. Mr. Kendall will also replace Mr. Dyett as Audit Committee Chair. Keith J. Kendall serves as Founder and Chief Executive Officer at KSquared Strategic Advisors, a firm that provides strategic, corporate development and capital markets advisory services. Previously, he served as Chief Executive Officer and President of Aquestive Therapeutics, a commercial-stage, biopharmaceutical drug delivery company and prior to that served as their Chief Operating Officer and Chief Financial Officer. Mr. Kendall has served in various business leadership positions for blue-chip companies such as Hewlett Packard Financial Services, including serving the role of Vice President and Managing Director of the Americas, and held a number of positions with AT&T Capital Corporation, including President of AT&T Credit Corporation and NCR Credit Corporation. Mr. Kendall received his B.S. from St. John’s University and an M.B. A from Pace University. Alistair Milnes serves as Chief Operating Officer at Bicycle Therapeutics, a clinical-stage biopharmaceutical company, and previously served as Vice President, Human Resources and Communications there. Previously, he provided independent human resources consulting services, and also served as a Strategic Advisor at Rio Tinto with a focus on transformation, people and communications, and in roles of increasing responsibility at Gazprom Marketing & Trading Ltd., including serving as Director of Global Human Resources and Communications. Mr. Milnes received his B.A. from Edinburgh Napier University. Announcement • Jun 09
Femasys' FemCath Intrauterine Catheter Receives Product Approval in Canada Femasys Inc. announced that Health Canada, the Public Health Agency of Canada, has granted product approval of FemCath, the first intrauterine catheter that allows for selective evaluation of a fallopian tube with contrast. FemCath is used in conjunction with Femasys' FemVue device for an ultrasound-based diagnostic test as part of an infertility evaluation. Femasys' diagnostic products are to be used prior to performing any infertility treatment, such as artificial insemination with Femasys' FemaSeed product, which was approved by Health Canada in April of this year. Femasys' other biomedical solutions in development, FemaSeed and FemBloc, utilize the same delivery platform for directed delivery of other materials. FemaSeed and femBloc are not yet approved in the United States, but FemaSeed is already approved in Canada. In the case of FemaSeed, sperm is delivered directly to the tube where conception occurs and for FemaSeed, a proprietary degradable biopolymer is delivered to both tubes for nonsurgical permanent birth control. About FemCath is the first FDA-cleared product that allows for selective evaluation of the fallopian tubes in conjunction with the FemVue device. The ultrasound-based diagnostic test is part of an infertility evaluation, which is essential prior to any infertility treatment, including with other biomedical solution, FemaSeed, approved in Canada and in development in the U.S. About FemCath: FemaSeed is the first FDA-clearing product that allows for selective evaluate the fallopian tube where conception occurs and forFemBloc, a proprietary degradable Biopolymer is delivered to both tube for nonsurgical permanent birth control; About FemCath: FemVue is the first FDA- Cleared product that creates natural saline and air contrast and enables safe, reliable, and real-time evaluation of the fallopian tubes with ultrasound. When performed with a uterine cavity assessment, a more comprehensive exam can be achieved from the comfort of the GYN's office. 
