8-K
Femasys Inc (FEMY)
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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): March 31, 2023
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)) |
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Securities registered pursuant to Section 12(b) of the Exchange Act:
| Title of each class | Trading<br><br> <br>Symbol(s) | Name of each 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 |
|---|
On March 31, 2023, 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 March 2023 |
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: March 31, 2023 |
Exhibit 99.1
Disrupting Convention in Women’s Health Through Continuous Innovation March 2023 Corporate Presentation 1
Forward-Looking Statements 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 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 patient population with the potential to benefit from treatment with any product candidates the Company may develop 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. 2
Femasys: At-a-Glance Who We Are Financial Information Femasys is a biomedical company aiming to meet women’s needs worldwide with a novel suite of products and product candidates that include minimally invasive, in-office technologies for reproductive health. Headquarters: Suwanee, GA Nasdaq: FEMY IPO date: June 2021 Market Cap: $13.7M (as of 03/30/23) Cash: $13.0M (as of 12/31/22) 3
Investment Highlights Biomedical Company Disrupting the Approaches to Women’s Health with Proprietary Diagnostic and Device Solutions in Development Addressing Multi-Billion Dollar Global Market Opportunities in Infertility and Permanent Birth Control With Differentiated and Improved Approaches Clear Reimbursement Path with Limited Competition Yields Improved Patient Care and Health Economics 4 Intellectual Property Portfolio with >150 Patents Globally Cash Runway into Q1 2024 Woman-Founded and Led, Experienced Leadership Team with Concentrated Development Expertise Commercial-Readiness Based on In-House CMC and Device Infrastructure; Audited Systems Allow for Risk Mitigation Supply Chain Control; No Reliance on Third-Party Manufacturing Mission Differentiator Foundation
Key Leadership Experienced biotechnology and medical device professionals Brian Drumheller VP, Quality 30+ years of experience Dan Currie SVP, Operations 30+ years of experience Jeremy Sipos VP, Research & Development 20+ years of experience Christine Thomas SVP, Regulatory & Clinical Affairs 20+ years of experience Terrell Pruitt VP, Manufacturing 25+ years of experience Edward Evantash, MD Chief Medical Officer 20+ years of experience Mary An Merchant, JD, PhD VP Counsel, Intellectual Property 25+ years of experience Dov Elefant Chief Financial Officer 25+ years of experience 5 Kathy Lee-Sepsick President, CEO, Founder 25+ years of experience
FemVue®️ Contrast-Generating Device FemCath™️ Selective Delivery Catheter FemaSeed® Localized Directional Insemination FemBloc® Permanent Birth Control and Ultrasound Occlusion Confirmation FemCerv® Endocervical Tissue Sampler FemaSeed® FemBloc® Product Candidates Localized Directional Insemination Research Preclinical Stage ISafety Stage IIValidation Stage IIIPivotal DeNovo Clinical Study PMA Clinical Study Our Technologies in Development and Approved are Complimentary TREATMENT TREATMENT Permanent Birth Control and Ultrasound Occlusion Confirmation FemEMB™ DIAGNOSTIC Endometrial Tissue Sampler Research Preclinical FemVue®️ Contrast-Generating Device FemCath™️ Selective Delivery Catheter Commercially Available Products FemCerv® Endocervical Tissue Sampler DIAGNOSTIC DIAGNOSTIC DIAGNOSTIC 6
Strong Global Intellectual Property Portfolio Our Patent Estate Encompasses Utility and Design >150 patents globally Directional Delivery (dual or single) to Fallopian Tubes Biopolymer Composition for Tubal Occlusion Contrast Generating Ultrasound Visible Tissue Sampling for Cancer Detection FemBloc, FemaSeed, FemCath FemBloc FemVue FemCerv FemChec 7
Our Technologies Provide a Continuum of Care In-office, minimally invasive solutions Shared delivery platforms leverage existing skill sets 8
Femasys Unique In-Office Platform Technologies: Delivery Directed to Fallopian Tubes 9 I. Products isolate opening of fallopian tube(s) for precise delivery of materials Selective catheter for sperm Dual catheters for biopolymer Selective catheter for contrast Stage: Investigational for artificial insemination Stage: Investigational for permanent birth control No special skillset and no capital equipment No cannulation of tube Patents issued and pending No anesthesia and no incisions Stage: Commercially Available
Femasys Unique In-Office Platform Technologies:Diagnostic Contrast for Ultrasound 10 II. Products generate natural contrast for ultrasound evaluation of fallopian tubes Assess patency for infertility diagnosis Assess occlusion post FemBloc Stage: Commercially Available Stage: Investigational for confirmation test Safe and affordable No radiation or x-ray contrast dye No referral and saves time Patents issued and pending
Femasys Unique In-Office Platform Technologies:Tissue Sampling for Cancer Diagnosis 11 III. Products collect and contain comprehensive sample to maximize quality & quantity Endocervical curettage for cervical cancer diagnosis Endometrial biopsy for uterine cancer diagnosis Stage: Commercially Available Stage: R & D Coming Soon Safe and reliable 360° tissue capture Virtually pain free Patents issued
12 FemaSeed® Localized Artificial Insemination Developing the first and only first-line approach designed to deliver sperm directly where conception occurs Designed to be more affordable than assisted reproduction Companion Diagnostics FemVue® and FemCath™ Includes first in-office ultrasound diagnosis of fallopian tubes for infertility Infertility Focused Portfolio
Infertility: Unmet Need (U.S. only) >10M women struggle with infertility1 ~ 40-50% is due to male factor2 Despite advancements, there have been no new affordable options in decades. 13 https://www.cdc.gov/nchs/nsfg/key_statistics/i-keystat.htm Kumar N, et al. (2015) Trends of male factor infertility, an important cause of infertility: A review of literature. J Hum Reprod Sci. 8(4): 191–196. doi: 10.4103/0974-1208.170370: 10.4103/0974-1208.170370. Levine H, et al. (2023) Temporal trends in sperm count: a systematic review and meta-regression analysis of samples collected globally in the 20th and 21st centuries. Human Reproduction Update, Vol.29, No.2, pp. 157–176, 2023 Sperm counts worldwide have declined by >50%3
FemaSeed: Low Cost for Front-End of Infertility Treatment FemaSeed $$ Traditional IUI $ IVF/ ICSI* $$$$$ Artificial Insemination ✔ ✔ Directed sperm delivery (into fallopian tube where conception occurs) ✔ No ovulation stimulation optional optional No embryo transfer ✔ ✔ Minimal training ✔ ✔ 14 For couples with male infertility, treatment with IVF/ ICSI is advised given the low success rates for IUI *CDC (2016), >90% of couples with male factor infertility use Intracytoplasmic Sperm Injection (ICSI).
FemaSeed Localized Directional Insemination in Development There’s been limited advancements and continuous demand for less costly options First and only approach delivering sperm directly where conception occurs in the fallopian tube 15 Undirected sperm delivery to cavity (IUI) is first-line treatment despite low success rates
Summary: Study Design: prospective, multi-center, unblinded, single arm Study Population: male factor infertility Sample Size: up to 214 subjects contributing 214 FemaSeed cycles Primary Effectiveness Endpoint: Pregnancy Rate Trial Designed to Expedite Clinical Program Advancement FemaSeed de Novo Clinical Trial for Market Approval SITE RECRUITMENT UNDERWAY Pivotal Trial(IDE Approved October 2022) 16 To Evaluate Safety and Effectiveness
The Unmet Need in Infertility 17 For more than 20 years, current approaches to infertility treatment have been limited during the initial stage of therapeutic care, but with the advancement of FemaSeed, we believe a next generation intrauterine procedure may have the opportunity to truly change this traditional paradigm. - Michael Glassner, MD Founding Partner and Medical Director of Main Line Fertility & Reproductive Medicine
Companion Diagnostics: Test Prior to Infertility Treatments, including FemaSeed Diagnostic performed prior to any infertility procedures Can be combined with uterine cavity evaluation (standard of care) On-line training and support available for new customers Physician locator available on patient website Reimbursed using existing codes First In-office, Ultrasound Approach for Fallopian Tube Evaluation Commercially Available: U.S., Japan, and other FemVue creates saline-air contrast that travels through the fallopian tube(s) when open 18 First Intrauterine Catheter for Selective Tubal Evaluation
FemVue: Compelling Patient Testimonials 19 Being aware that there are many reasons why women have issues conceiving, FemVue is one easy procedure that can assist in finding out why it may have been difficult. As such, I highly recommend any woman who has tried for months or years to conceive to get the FemVue procedure. It is a procedure that will get you immediate results for you and your doctor to discuss the next steps of making your dreams come true. After a month of completing successful medical procedures including FemVue, my husband and I conceived our first child. - FemVue Patient Testimonial - FemVue Patient Testimonial
Fertility Enabling Market Opportunity (U.S.) Near-Term Target Market $800M Total Market Expansion Opportunity $2B Total Includes women choosing IUI and required tubal diagnosis Intrauterine Insemination (IUI) Diagnosis / Drugs Discussion Only IVF (~200k cycles/ year)* >10M Infertile Women Most Expensive Least Expensive 20 *Centers for Disease Control and Prevention. 2019 Assisted Reproductive Technology Fertility Clinic and National Summary Report. US Dept of Health and Human Services; 2021.
FemBloc® Permanent Birth Control First and only non-surgical, in-office, permanent birth control option in development with the potential to be the safest and most natural approach at half the cost of the long-standing surgical alternative 21 Contraception Focused Portfolio Companion Diagnostics FemChec® and FemCath™ Includes first in-office ultrasound diagnosis of fallopian tubes for confirmation of procedure success
Since surgical tubal ligation has been performed since the 1880’s and remains the most common option for women who want permanent birth control. Permanent Birth Control Alternatives: Unmet Need (U.S. only) >13M women no longer intend to have children >12M use non-permanent birth control, long-term 800,000 women choose surgical tubal ligation as a form of permanent birth control every year* More than 100 years of stagnant innovation for permanent birth control 22 *Frattarelli 2007
*6% failure rate for laparoscopic sterilization (tubal ligation) and 5% failure rate for hysteroscopic sterilization (Essure), reported in published study as higher than expected (Fertility and Sterility, 2022) Essure® is a registered trademark of Bayer Healthcare (Conceptus) and, as of December 2018, no longer a marketed solution. FemBloc: Expected Competitive Advantages Over Existing or Previous Birth Control Options On-Market Solutions Off-Market FemBloc Surgical Tubal Ligation* IUD (Reversible) Essure®* Permanent ✔ ✔ ✔ Office Procedure ✔ ✔ Some No Special Capital Equipment ✔ ✔ No Anesthesia ✔ ✔ No Permanent Implant (coil/ clip) ✔ No Surgery (risks/ cost) ✔ ✔ No Hormones ✔ ✔ ✔ One-Time Treatment Cost ✔ ✔ Multiple IUDs ✔ Worldwide Applicability ✔ Varies ✔ 23
Companion ultrasound procedure exclusive to FemBloc - confirms procedure success Occlusion Confirmation No Permanent Implant – Scar Tissue Closes Tubal Lumen FemBloc Treatment FemBloc Permanent Birth Control in Development The first and only non-surgical, in-office approach Balloon at tubal opening without cannulation Biopolymer is designed to be expelled within 3 months 3 Months Blockage Biopolymer solidifies Biopolymer degrades Saline-air contrast confirms blockage 24
Summary: n=183 subjects being followed for 5 years Patients found procedures highly tolerable Physicians found procedure to be extremely simple or very simple 99% physicians assessed easier than tubal ligation surgery Summary: n=93 subjects received planned hysterectomy Subset with histopathology demonstrating biopolymer tissue reactions No serious safety events reported Summary: n=45 subjects being followed for 5 years Subjects received two confirmation tests (ultrasound and radiology) Continued safety established; no serious AEs Continued patient tolerability and physician ease of use established Goals: IDE approval of study design(prospective, multi-center, unblinded, single-arm study) Investigational plan utilizes previous FDA approved third-party study designs: Primary Endpoint: pregnancy rate at 1-year post confirmation test Safety Follow-Up: 2-5 years post-market Establish Safety & Effectivenessof FemBloc Selection of ConfirmationTest for Pivotal No Serious AEs Reported Evaluated Delivery &Biopolymer Effectiveness FemBloc Clinical Studies for Pre-Market Approval (PMA) SITE RECRUITMENT UNDERWAY Early Clinical Stage I: Safety Stage II: Validation Stage III: Pivotal (pending) 25 ✔ ✔ IDE Submitted Q1 2023 ✔
212 28 57 12 2 3 3 18 21 FemBloc Treatment (>90 days) FemBloc: Majority AEs Were Mild and Occurred at Time of Procedure (N = 228 subjects from Stage I & II) Patients are being followed for 5 years, with first subjects completed 5-year follow-up 89% AEs related to device/ procedure occurred within 7 days of procedure 75% AEs mild No SAEs 26 Investigators rated extremely or very satisfied for 96% of FemBloc procedures
Bleeding/Spotting (61%) Pain/Cramps (57%) Other 41% 13.6% 3.9% 2.6% 36% 13.6% 7.5% 3.9% 1.3% *Visual Analog Scale (VAS) from 0-10 was used, where 10 was the highest measure of pain/discomfort. FemBloc: Most Common Reported AEs (>1%) Were Related to Bleeding/Spotting or Pelvic Pain/Cramping Mean pain/ discomfort score* out of 10 as reported by patient in-office with no anesthesia: 4.6 for FemBloc treatment and 3.4 for confirmation 27
215 28 57 12 2 2 3 18 13 FemBloc Treatment (>90 days) FemBloc: Majority AEs Were Mild and Occurred at Time of Procedure (N = 228 subjects from Stage I & II) Patients are being followed for 5 years, with first subjects completed 5-year follow-up 91% AEs related to device/ procedure occurred within 7 days of procedure 75% AEs mild No SAEs 28 Investigators rated extremely or very satisfied for 96% of FemBloc procedures
Bleeding/Spotting (59%) Pain/Cramps (55%) Other 40% 13.1% 3.5% 2.6% 34.5% 13.5% 7% 3.9% 1.3% *Visual Analog Scale (VAS) from 0-10 was used, where 10 was the highest measure of pain/discomfort. FemBloc: Most Common Reported AEs (>1%) Were Related to Bleeding/Spotting or Pelvic Pain/Cramping Mean pain/ discomfort score* out of 10 as reported by patient in-office with no anesthesia: 4.6 for FemBloc treatment and 3.4 for confirmation 29
The Unmet Need for Women: Options for Family Planning 30 Although tubal ligation has been performed for over a century, women will benefit from an in-office approach that avoids the risks and discomforts associated with incisions, general anesthesia and surgery. FemBloc may expand much needed options for women seeking permanent contraception. - Paul Blumenthal, MD, MPH Professor Emeritus and Director of the Stanford Program for International Reproductive Education and Services (SPIRES) at Stanford University’s School of Medicine
Permanent Birth Control Market Opportunity (U.S.) Near-Term Target Market $2B Annual Market Expansion Opportunity $20B Total Includes women (and partners) choosing permanent birth control annually (~1.3M)1,2 Includes women using non-permanent options but are candidates (>12M)3 Hormones Condoms Tubal Ligation Surgery >13M Reproductive Aged Women NO Longer Intend Children Most Invasive/ Most Reliable Least Invasive / Least Reliable 31 Frattarelli 2007 Eisenberg ML 2009 Daniels K. NCHS Data Brief, no 388. 2020
FemBloc: Improved Health Economics Permanent One-Time Cost Breakdown Pre-Op $6,000* Facility Anesthesia Post-Op Cost of FemBloc System Anesthesia Physician / Practice Est < ½ cost of Tubal Ligation Physician In-office procedure expands practice services Can perform multiple procedures in same room Quick to perform; ease of room turnover Patient resumes normal activities FemBloc Efficiencies *Planned Parenthood 2019, https://www.plannedparenthood.org/learn/birth-control;Doximity 2019; U.S. Bureau of Labor Statistics, 2019. 32
In-office procedure FemBloc Treatment Category covered (ACA) Cat III code approved 2 FemBloc: Clear Reimbursement Path 3 reimbursable visits 1+ Days 3 Months In-office/ TeleVisit(required for permanent birth control) Counseling/Eligibility Existing CPT codes 1 In-office test (ultrasound) Cat III code approved FemBloc Confirmation 3 33
FemBloc Has Potential to be a Game-Changer for Women 34 Large Market Unmet Need Designed with Patient and Physician in Mind Growing demand with overturn of Roe v. Wade Only surgical tubal ligation available (costly, difficult to access, lower effectiveness rate) In-office, convenient and quick Safe, non-implant approach No cost through ACA In-office technique leverages existing skill set Easy to incorporate into practice Clear path to reimbursement For the Patient For the Physician
Femasys is Prepared for Execution 35 Clear Clinical Path to FDA Approval Clear Reimbursement Pathway Commercial Expertise Full manufacture facility with ability to scale and transfer MFG Ready Sales Ready Building commercial infrastructure before salesforce with FDA cleared products for GYNs
36 FemCerv® Diagnostic for Cervical Cancer First endocervical biopsy designed for comprehensive tissue sampling with minimal contamination First endometrial biopsy in development with the potential to capture comprehensive tissue sample FemEMB™ Diagnostic for Uterine Cancer Coming Soon
Cervical Cancer: Unmet Need (U.S. only) Inadequate cervical cancer screening remains a significant problem with persistent health inequities across the entire spectrum of cervical cancer care. 1 37 1 (https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2021/04/updated-cervical-cancer-screening-guidelines) 2 Obstet Gynecol. 2017 December ; 130(6): 1218–1225. doi:10.1097/AOG.0000000000002330. >3M women undergo colposcopic evaluation each year for abnormal screening cytology.2 Endocervical curettage (ECC) has been increasingly incorporated in the colposcopy-biopsy examination.
FemCerv: Competitive Advantages Over Existing Options FemCerv Kevorkian Curette Endocervical Brush Relatively pain-free ✔ Protects sample against cross contamination ✔ Collects a comprehensive, 360o sample ✔ High sample adequacy ✔ ✔ ✔ Ease of use ✔ ✔ ✔ 38 The incidence of stage IV cervical cancer in the U.S. is increasing.* *Francoeur et. al, International Journal of Gynecologic Cancer (2022).
Expanded Collection Chamber FemCerv: Post-Market Clinical Data Supports Product Advantages 1 2 Collected sample 39 Study Conclusion Endocervical curettage (tissue sampling) for the routine investigation of patients with abnormal cervical cytology was successfully conducted with the FemCerv Endocervical Sampler. Device typically provided adequate samples for histological evaluation. Device’s rounded tapered tip was easy to insert in most patients. Procedure was well tolerated by almost all patients, who experienced mild or no discomfort. Endocervical Curettage with the FemCerv Endocervical Sampler* *Marcus, et al. Endocervical Curettage with the FemCerv Endocervical Sampler. JMIG. 2013 https://doi.org/10.1016/j.jmig.2013.08.362
U.S. Commercial Strategy: Planning for Commercial Readiness 40 Initial Focus on Infertility Specialists + Added Focus on Gynecologists Product Candidates FemaSeed FemBloc FemVue Available FemCath Available FemCerv Available FDA Cleared Diagnostic Products Commercial-ready capacity for production; in-house manufacturing already in-place ~1,700 ~40,000
Upcoming Anticipated Milestones / Events Near term expected valuation inflection points creating accretive value for investors 41 2024 Q1 Q2 Begin FemBloc pivotal trial enrollment Q1 Q2 2023 FDA IDE for FemBloc pivotal trial to support PMA approval Complete FemaSeed enrollment de novo pivotal trial Q3 Q4 File FemEMB submission with FDA U.S. Launch FemaSeed FemBloc interim analysis
Investment Highlights Biomedical Company Disrupting the Approaches to Women’s Health with Proprietary Diagnostic and Device Solutions in Development Addressing Multi-Billion Dollar Global Market Opportunities in Infertility and Permanent Birth Control With Differentiated and Improved Approaches Clear Reimbursement Path with Limited Competition Yields Improved Patient Care and Health Economics 42 Intellectual Property Portfolio with >150 Patents Globally Cash Runway into Q1 2024 Woman-Founded and Led, Experienced Leadership Team with Concentrated Development Expertise Commercial-Readiness Based on In-House CMC and Device Infrastructure; Audited Systems Allow for Risk Mitigation Supply Chain Control; No Reliance on Third-Party Manufacturing Mission Differentiator Foundation
Disrupting Convention in Women’s Health Through Continuous Innovation March 2023 Corporate Presentation Investors: IR@femasys.com Contact: Media: Media@femasys.com 43 03333 R03