8-K
Femasys Inc (FEMY)
View as plain text
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 29, 2024
Femasys Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-40492 | 11-3713499 |
|---|---|---|
| (State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
| 3950 Johns Creek Court,<br> Suite 100<br><br> <br>Suwanee, Georgia | 30024 | |
| --- | --- | |
| (Address of principal executive offices) | (Zip Code) |
(770) 500-3910
(Registrant’s telephone number, including area code)
n/a
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| --- | --- |
Securities registered pursuant to Section 12(b) of the Exchange Act:
| Title of each class | Trading<br><br> <br>Symbol(s) | Name of each<br><br> <br>exchange<br><br> <br>on which registered |
|---|---|---|
| Common Stock, par value $0.001 per share | FEMY | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
| Item 7.01 | Regulation FD Disclosure Other Events |
|---|
On October 29, 2024, Femasys Inc. (the “Company”) posted on its website an updated slide presentation, which is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein. Representatives of the Company will use the presentation in various meetings with investors, analysts and other parties from time to time.
The information furnished in this Item 7.01 and Exhibit 99.1 attached hereto is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, except as may be expressly set forth by specific reference in such filing.
The Company expressly disclaims any obligation to update or revise any of the information contained in the corporate presentation.
| Item 9.01 | Financial Statements and Exhibits. |
|---|---|
| (d) | Exhibits. |
| --- | --- |
| Exhibit<br><br> <br>No. | Description |
| --- | --- |
| 99.1 | Femasys Inc. Corporate Presentation dated October 2024. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Femasys Inc. | ||
|---|---|---|
| By: | /s/ Kathy Lee-Sepsick | |
| Names: Kathy Lee-Sepsick | ||
| Title: Chief Executive Officer | ||
| Date: October<br><br> 29, 2024 |
Exhibit 99.1
Investor presentation October 2024 NASDAQ: FEMY Disrupting Convention in Women’s Reproductive Health Through Continuous Innovation
This Presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to our business, operations and financial conditions, including but not limited to current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, results of clinical trials and other future conditions. Words such as, but not limited to, "anticipate", "believe", "could", "estimate", "expect", "intend", "may", "plan", "potential", "predict", "project", "should", "will", "would" or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes, identify forward-looking statements. These forward-looking statements reflect management's beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this Presentation and are subject to risks and uncertainties. Moreover, the Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for management to predict all risks, nor can the Company assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The Company qualifies all of the forward-looking statements in this Presentation by these cautionary statements. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. Statements contained herein are made as of the date of this Presentation unless stated otherwise, and neither this Presentation, nor any sale of securities, shall under any circumstances create an implication that the information contained herein is correct as of any time after such date or that the information will be updated or revisited to reflect information that subsequently becomes available or changes occurring after that date hereof. Certain information contained in this Presentation relates to or is based on statistical and other industry and market data obtained from independent industry publications and research, surveys and studies conducted by independent third parties as well as the Company's own estimates. The market data used in this Presentation involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such data. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. The Company's estimates of the total addressable market of the patient population with the potential to benefit from treatment with any products and product candidates the Company may develop, our ability to commercialize our products and product candidates, or the effect of delays in commercializing include several key assumptions based on its industry knowledge, industry publications and third-party research, which may be based on a small sample size and may fail to accurately reflect the addressable patient population. While the Company believes that its internal assumptions are reasonable, no independent source has verified such assumptions. This Presentation contains trademarks, trade names, or service marks belonging to other entities. The Company does not intend the use or display of other parties' trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of, or by these other parties. NASDAQ: FEMY 2 Forward Looking Statements
Femasys Overview NASDAQ: FEMY 3 Empowering Women & Enabling Choice Femasys is committed to providing women with revolutionary products as they seek solutions throughout their reproductive journey. Technological advancements in female reproductive health are long overdue, driving our focus to develop in-office, accessible, and innovative options. MAIN AREAS OF FOCUSInfertility FemaSeed® Intratubal Insemination FemVue® Contrast-Generating Device Contraception FemBloc® Permanent Birth Control Cancer Diagnostic FemCerv® Endocervical Tissue Sampler
Investment Highlights NASDAQ: FEMY 4 Mission Develop disruptive broad portfolio of products for women’s health Address multi-billion-dollar global market opportunities Infertility therapeutic and diagnostic Permanent birth control Improve patient care and health economics Differentiator Minimal competition with well defined reimbursement strategies Commercial-readiness with in-house CMC and device manufacturing Achieved global regulatory approvals, including U.S., Europe, Japan, and Canada Foundation Woman-founded and led, experienced leadership team Intellectual property portfolio with >180 patents globally Cash runway into July 2025 Six commercial-stage products and one in late-stage clinical trial NASDAQ: FEMY (IPO June 2021) Stock Price(as of 10/28/24) $1.33 Share Count 22.2M Market Capitalization(as of 10/28/24) $29.6M Cash (as of 06/30/24) $13.5M
Key Leadership Kathy Lee-Sepsick President, CEO, Founder 30+ years of experience Terumo Medical, Novoste, Salumedica Dov Elefant Chief Financial Officer 30+ years of experience Cellectar Biosciences, Akari Therapeutics, Lev Pharmaceuticals, EpiCept James Liu, MD Chief Medical Officer 40+ years of experience Chair, Dept OB/ GYN University Heath System, Chair Dept Reproductive Biology at Case Western, and Division Head University of Cincinnati Richard Spector Chief Commercial Officer 25+ years of experience Quilibrium, Insulet, OvaScience, NeoMatrix, Cytyc Surgical Dan Currie Chief Operating Officer 30+ years of experience Ciba Vision, Novoste, Salumedica Christine Thomas SVP, Regulatory & Clinical 20+ years of experience GE Healthcare, Boston Scientific, Smiths Medical, RTI Surgical NASDAQ: FEMY 5
Commercially Available Products for Infertility Treatment Intratubal Insemination Diagnostic Contrast-Generating Device Diagnostic Selective Delivery Catheter Diagnostic Endocervical Tissue Sampler Diagnostic Controlled Contrast-Generating Device Office-based, minimally invasive solutions utilizing shared delivery platforms Product Candidate Research Preclinical Stage I Safety Clinical Trial Stage II Validation Stage III Pivotal NASDAQ: FEMY 6 Solutions for Women Through the Continuum of Care
Infertility-Focused Portfolio Intratubal Artificial Insemination FDA-cleared, innovative first-line infertility treatment for directed sperm delivery Positive topline results announced NASDAQ: FEMY 7 Tubal Diagnosis with Ultrasound FDA-cleared, first in-office ultrasound evaluation of fallopian tubes
NASDAQ: FEMY 8 No Affordable infertility Options Introduced in Decades Key Trends: 43 U.S. states have recorded lowest fertility rate in last three decades4 9.14 million women have received infertility services at some time in their lives5 NOTES: 1. 2. 3. 4. https://www.cdc.gov/nchs/nsfg/key_statistics/i-keystat.htm. Kumar N, et al. (2015) 5. Levine H. et al. (2023) Centers for Disease Control and Prevention (2019) Chandra A, et al. (2014) ~10M women in the U.S. struggle with infertility1 ~50% due to male factor2 Sperm counts worldwide have declined by >50%3
4.3M seek evaluation only DISCUSSION DIAGNOSIS DRUGS IUI IVF ~200k cycles/ year ~1M cycles/ year Centers for Disease Control and Prevention. 2019 Assisted Reproductive Technology Fertility Clinic and National Summary Report. US Dept of Health and Human Services; 2021. NASDAQ: FEMY 9 Patient Journey (U.S.) FemaSeed and FemVue Provide Next Generation Options
Natural contrast flows in tube Allows for selective evaluation when needed Video will open in browser window. Intended Population: Baseline diagnostic test for infertility and prior to insemination (Note: blocked tubes are a silent factor affecting 1 in 3 infertile women) NASDAQ: FEMY 10 Safe Cost-Effective Time Saving Infertility Portfolio: from Diagnosis to Treatment
Delivers sperm to site of conception NO CATHETERIZATION Video will open in browser window. Intended Population: Infertile women/ couples Patients desiring insemination, including same sex couples & single women NASDAQ: FEMY 11 Requires at least one open fallopian tube (FemVue can confirm first) Safe Cost-Effective Enhance Fertilization Infertility Portfolio: from Diagnosis to Treatment
Vagina Cervix Uterus FemaSeed IUI Fallopian Tube NASDAQ: FEMY 12 *Femasys proprietary market research (100 reproductive endocrinologists). Advantages from Market Research 92% of Survey Respondents had Favorable Impression of FemaSeed* ” It’s angle toward the opening (ostia) is the most critical finding that I am impressed with that allows sperm to be the closest to the egg. - Reproductive Endocrinologist HCP* ” It’s an interesting concept for women who have unilateral disease [blocked tube]. - Reproductive Endocrinologist HCP* Delivery to fallopian tube makes sense with low “ “ “ ” count [sperm] cases to improve efficacy. - Reproductive Endocrinologist HCP* FemaSeed Overcomes the Last Barrier to Natural Fertilization
FemaSeed Offers Significant Competitive Advantages NASDAQ: FEMY 13 Assisted Reproductive Approaches Artificial Insemination IVF ICSI IUI No surgery No egg retrieval or storage No required injections Delivery to fallopian tubes (site of conception) NA NA Cost-effective Minimal safety risks Low male sperm count efficacy Single fallopian tube solution NA NA Widespread accessibility Varies Varies
FemaSeed Top Line Data from Pivotal Trial Demonstrates Significant Progress in Fertility Treatment NASDAQ: FEMY 14 Trial Results 26.3% pregnancy rate for women with male factor/ unexplained infertility More than double pregnancy rate when compared to historic intrauterine insemination (IUI) for similar patient population (17.5% FemaSeed vs 6.7% IUI per cycle) Majority of women who became pregnant did so after first FemaSeed procedure No new safety concerns; all AEs consistent with IUI Trial Design (NCT 04966847); enrollment completed Q4 2023 Prospective, unblinded pivotal trial evaluating the safety and efficacy of FemaSeed Primary endpoint: 3-week pregnancy rate Safety: 7-week follow-up period post FemaSeed
Commercialization Strategy in U.S. Initial Focus Expanded Focus ~40,000 Gynecologists ~1,700 Infertility Specialists Limited Market Release Focused regions and targeted audience Focused sales and marketing efforts Monitoring, evaluation and iterative improvement NASDAQ: FEMY 15 Expanded Market Release Wider distribution and geographical expansion Targeted marketing and sales strategies Education and training Expanded product offerings Customer support, feedback collection, and monitoring market performance
NASDAQ: FEMY 16 FemaSeed Priced to Support First-Line Treatment Option Infertile Women/Couples Seeking Treatment IUI Intrauterine Insemination Intratubal Insemination $500-$4,0001 total per cycle including ultrasound monitoring, and optional ovulation drugs2 + device per cycle above IUI cost Insurance with positive coverage policy typically covers 3-6 cycles Required prior to IVF/ ICSI in many coverage policies Patient out-of-pocket charge for ITI, If insurance, ancillary services covered under existing codes Subset of Infertile (After 1-3 IUI cycles or as indicated) IVF/ICSI In vitro fertilization / intracytoplasmic sperm injection $30,000 total per cycle, including ultrasound monitoring, ovulation drugs, egg extraction and freezing3 14/20 covered states that have fertility insurance coverage, include IVF Population Average Total Cost Reimbursement NOTES: https://www.fertilityiq.com/iui-or-artificial-insemination/the-cost-of-iui Parenthood, Planned. “What Is Intrauterine Insemination (IUI)?” Planned Parenthood, https://www.plannedparenthood.org/learn/pregnancy/fertility-treatments/what-iui. Ravitsky, et al. The forgotten men: rising rates of male infertility urgently require new approaches for its prevention, diagnosis and treatment. Biology of Reproduction, 2019, 101(5), 872-874. Data on file with Femasys Market Research4 N=1,000 infertile women 85% of women would have preferred FemaSeed instead of IUI 88% of women would have preferred FemaSeed prior to IVF More than 7 in 10 women were extremely or very likely to consider FemaSeed
FemaSeed has Significant Potential Revenue Opportunity Immediate addressable market Immediate expansion Future expansion ~ 1 million* IUI cycles/ yr ~$1 B market opportunity 4.8 million women seek evaluation & treatment 4.3 million women seek evaluation only Expansion opportunity *Centers for Disease Control and Prevention. 2019 Assisted Reproductive Technology Fertility Clinic and National Summary Report. US Dept of Health and Human Services; 2021. NASDAQ: FEMY 17
In-Office Sterilization First and only non-surgical, in-office, permanent birth control option In late-stage clinical development with on-going pivotal trial Potential to be the safest and most natural approach at substantially less cost than the long-standing surgical alternative NASDAQ: FEMY 18
Lack of Innovation in Last Century for Permanent Birth Control >13M Women in the U.S. no longer intend to have children 800,000 women choose surgical tubal ligation as a form of permanent birth control every year* >12M use non-permanent birth control long-term $2B NASDAQ: FEMY 19 annual market opportunity $20B total market expansion *Frattarelli 2007
FemBloc Permanent Birth Control & Confirmation Test Biopolymer designed to expel within 3 months Balloon positioned at tubal opening Biopolymer solidifies Biopolymer degrades leaving tissue in-growth to block tubes Video will open in browser window. Video will open in browser window. Ultrasound-Based Confirmation Test (to ensure success) Safe • Convenient -Office • Lower Cost NASDAQ: FEMY 20 In
FemBloc Clinical Studies for Pre-Market Approval (PMA) Stage III: FINALE Pivotal Clinical Trial Trial Design (IDE approved June 2023; currently enrolling) Prospective, multi-center, open-label, single-arm study ⎼ Roll-in study design (50 subjects in part A for safety) ⎼ Endpoints: Primary: pregnancy rate at 1-year after using FemBloc (N=401) Secondary: safety and various in-office assessments Additional Analysis: ⎼ 2-5 years post-market for safety ⎼ Interim analysis: after 300 women have relied on FemBloc for 1-year Completed Earlier FemBloc Supportive Studies (N=321) Early Clinical (N=93) Stage I: Safety (N=183); IDE approved Stage II: Validation (N=45); IDE approved Evaluated Delivery & Biopolymer No Serious AEs Reported; 5-year follow-up for safety Selection of Confirmation Test for Pivotal; 5-year follow-up for safety NASDAQ: FEMY 21
FemBloc Safety Profile (N = 228 subjects from Stage I & II; 5-year follow-up on-going) 215 28 57 12 18 0 50 100 150 200 250 Day of Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 FemBloc Treatment Day 8-90 Day of Confirmation Number of AEs Reported 8% 16% 3% 5% 4% 5 0.5% 0.5% 0.8% Timing of AEs No SAEs 91% AEs related to device/procedure occurred within 7 days of procedure Other Key Findings: Investigator Rating: ⎼ 96% extremely or very satisfied with FemBloc Most common AEs: ⎼ 59% bleeding/ spotting ⎼ 55% pain/ cramps Mean pain score per visual analog scale (0-10): ⎼ 4.6 FemBloc ⎼ 3.4 confirmation test NASDAQ: FEMY 22
FemBloc Improves Health Economics 0 1000 2000 3000 4000 5000 6000 Cost Breakdown Compared to Alternative $6,000* Amount in $ Pre-Op Facility Anesthesia Post-Op Cost of FemBloc System Anesthe Physician / Practice FemBloc estimate < ½ cost of surgery Physician Surgical Tubal Ligation FemBloc NO COST TO PATIENT (covered under Affordable Care Act) FemBloc Efficiencies In-office procedure expands practice services Can perform multiple procedures in same room Quick to perform; ease of room turnover Patient immediately resumes normal activities *Planned Parenthood 2019, https://www.plannedparenthood.org/learn/birth-control; Doximity 2019; U.S. Bureau of Labor Statistics, 2019. NASDAQ: FEMY 23
FemBloc Offers Significant Competitive Advantages Permanent Birth Control Temporary Surgical Sterilization (94% effective*) Essure® No longer marketed (95% effective*) IUD Permanent Office procedure Some No special capital equipment No anesthesia No implant (coil/clip) No surgery (risks/cost) No hormones Coverage in place/anticipated Worldwide accessibility Varies Off Market *Fertility and Sterility, 2022 NASDAQ: FEMY 24
Milestones Q1 Top line data for FemaSeed pivotal clinical trial (LOCAL) Inflection points that create value for investors NASDAQ: FEMY 25 Initial commercial team on-boarded Limited market release of infertility product portfolio in North America Achieve CE mark for infertility product portfolio Expand market release of infertility product portfolio to additional regions in North America Q2 Q3 Q4 ACHIEVED ACHIEVED ACHIEVED
Investment Highlights NASDAQ: FEMY 26 Mission Develop disruptive broad portfolio of products for women’s health Address multi-billion-dollar global market opportunities Infertility therapeutic and diagnostic Permanent birth control Improve patient care and health economics Differentiator Minimal competition with well defined reimbursement strategies Commercial-readiness with in-house CMC and device manufacturing Achieved global regulatory approvals, including U.S., Europe, Japan, and Canada Foundation Woman-founded and led, experienced leadership team Intellectual property portfolio with >180 patents globally Cash runway into July 2025 Six commercial-stage products and one in late-stage clinical trial
Contact Details Investor Relations: IR@femasys.com Media Inquiries: PR@femasys.com