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8-K

Femasys Inc (FEMY)

8-K 2022-08-02 For: 2022-08-02
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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): August 2, 2022

Femasys Inc.

(Exact name of registrant as specified in its charter)

Delaware 001-40492 11-3713499
(State or other jurisdiction<br><br> <br>of incorporation) (Commission<br><br> <br>File Number) (IRS Employer<br><br> <br>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 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 August 2, 2022, 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 August 2022

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: August 2, 2022



Exhibit 99.1

Disrupting Convention in Women’s Health Through Continuous Innovation  August 2022  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: $28.5M  (as of 6/30/22)     Cash: $21.8M  (as of 3/31/22)  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  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   Intellectual Property Portfolio with >150 Patents Globally  Cash Runway of at Least 12 Months  4


Key Leadership   Experienced biotechnology and medical device professionals  Kathy Lee-Sepsick  President, CEO, Founder  25+ years of experience  Jeffery Marcus, MD   Chief Medical Advisor  25+ years of experience  Dan Currie  Sr. VP, Operations  30+ years of experience  Jeremy Sipos  VP, Research & Development  20+ years of experience  Lexy Kelley, MD  VP, Medical & Clinical Affairs  14+ 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


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  Investigational for artificial insemination  Investigational for permanent birth control  Commercially Available for fallopian tube assessment  (2022)  No special skillset and no capital equipment  No cannulation of tube  Patents issued and pending  No anesthesia and no incisions


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  Commercially Available  Investigational  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  Endometrial biopsy  Commercially Available for cervix assessment   (2022)  R & D for uterine cavity assessment  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 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 struggle   with infertility  Despite advancements, there have been no new affordable options in decades.  13  https://www.cdc.gov/nchs/nsfg/key_statistics/i-keystat.htm


FemaSeed: Low Cost for the Front End of Infertility Treatment  FemaSeed  $$  Traditional IUI  $  IVF  $$$$$  Artificial Insemination  ✔  ✔  Directed sperm delivery   (into fallopian tube where conception occurs)  ✔  No ovulation stimulation  optional  optional  No embryo transfer   ✔  ✔  Minimal training  ✔  ✔  14


FemaSeed Localized Directional Insemination in Development  There’s been limited advancements and continuous demand for less costly options  Undirected sperm delivery to cavity (IUI) is first-line treatment despite low success rates  First and only approach delivering sperm where conception occurs  15


Summary:  Study Design: multi-center, unblinded, prospective study  # Subjects: 792 subject cycles Primary Effectiveness Endpoint:  pregnancy rate by 7 weeks post procedure  Interim Analysis Planned  Summary:  Study Design: multi-center (7 U.S. sites), prospective post-market study   # Subjects: 23 (45 tubes)   Study Objective: observation of saline-air contrast to assess selective tubal infusion  Results:   89% (40/45) had contrast enter tube combined with sustained flow or exit into peritoneal cavity   No serious safety events reported  Evaluated Delivery Effectiveness  FemaSeed de Novo Clinical Trial for Grant/ Clearance  SITE RECRUITMENT UNDERWAY  Early Clinical  (completed)  Pivotal Trial: Safety & Effectiveness(IDE Approved April 2021)  16  1st Subject Treated July 2021  ✔  INTERIM DATE EXPECTED Q4 2022


The Unmet Need for Women: Options for 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

The Unmet Need for Women: Options for Infertility  17  For more than 20 years, current approaches to infertility treatment has 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 Products: Diagnostic Test Prior to Infertility Treatment, 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  When paired with FemCath allows for selective tubal evaluation   FemVue creates saline-air contrast that travels through the fallopian tube(s) when open  18

Companion Products: Diagnostic Test Prior to Infertility Treatment, 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., Europe, Canada, Japan, other  When paired with FemCath allows for selective tubal evaluation   FemVue creates saline-air contrast that travels through the fallopian tube(s) when open  18


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.


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 Coil Implant/ Clip  ✔  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   96% physicians assessed procedure to be extremely/ 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  Goals:  n=50 subjects receive two confirmation tests to allow selection of ultrasound or radiology test  Evaluate adequacy of improvements to procedures, products and training  Goals:  IDE approval of study design(multi-center, unblinded prospective study);   First-mover advantage utilizing previous FDA approved third-party study designs:  primary endpoint of pregnancy rate at 1 year post confirmation test  safety follow-up 2-5 years post-market  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  (on-going)  Stage III: Pivotal  (pending)  25  ✔  ✔  ENROLLMENT COMPLETION EXPECTED Q3 2022  FILE IDE EXPECTED Q1 2023


165  27  53  8  2  2  3  5  12  1  FemBloc Treatment  (90 days)  FemBloc: Majority AEs Were Mild and Occurred at Time of Procedure (n = 183 subjects)  Patients are being followed for 5 years, with first subjects approaching 5-year follow-up  94% AEs related to device/ procedure occurred within 7 days of procedure  75% AEs mild  No SAEs  26

165  27  53  8  2  2  3  5  12  1  FemBloc Treatment  (90 days)  FemBloc: Majority AEs Were Mild and Occurred at Time of Procedure (n = 183 subjects)  Patients are being followed for 5 years, with first subjects approaching 4-year follow-up  94% AEs related to device/ procedure occurred within 7 days of procedure  75% AEs mild  No SAEs  26


Bleeding/Spotting (41.5%)  Pain/Cramps (38%)  Other  28%  10.3%  2.1%  1.1%  24.8%  8.9%  4.3%  1.1%  1.8%  *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:   4.3 for FemBloc treatment and 3.0 for confirmation  27


The Unmet Need for Women: Options for Family Planning  28  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  72M Reproductive Aged Women  Most Invasive/ Most Reliable  Least Invasive / Least Reliable  29  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.   30


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  31


FemBloc Has Potential to be a Game-Changer for Women  32  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

FemBloc Has Potential to be a Game-Changer for Women  32  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 in practice  Clear path to reimbursement   For the Patient  For the Physician


Femasys is Prepared for Execution  33  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


34  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


Expanded Collection   Chamber  FemCerv: Diagnostic Cervical Screening Solution   First cervical tissue sampler designed to improve tissue quality and quantity that is expected to be an improvement over the existing standard of care  1  Advantages:  Captures a 360° tissue sample allowing for comprehensive analysis  Reduces risk of sample contamination   Designed to be a relatively pain-free procedure (“mild” to “no discomfort” reported by patients)  Similar collection modality for other related applications  2  Collected sample  35


Abstract 2014, Femasys Inc. Sponsor.  FemCerv: Post-Market Clinical Data Supports Product Advantages  Study Conclusion  Endocervical curettage 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.  36


Commercial Strategy (U.S.) for our Technologies  37  I. Infertility Focus  II. GYN Focus  1,300 Reproductive Endocrinologists (450 practices)  > 40,000 Gynecologists in office practices  Product Offering  FemVue  FemCath (2022)  + FemaSeed  (Supports commercial footprint)  FemVue  FemCath (2022)  (Supports expanded commercial effort)  FemCerv (2022)  + FemBloc  Product Offering  + FemaSeed


Upcoming Anticipated Milestones / Events  Near term expected valuation inflection points creating accretive value for investors  38  2022  Q3  Q4  FemBloc    publication   from early    studies  Complete   FemBloc    enrollment   stage II study  Interim data   from FemaSeed   de novo pivotal   trial   Q1  Q2  2023  File FemBloc    IDE for pivotal    trial to support   PMA approval  Complete FemaSeed enrollment de novo pivotal trial  Q3  Q4  File FemEMB    submission    with FDA


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  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   Intellectual Property Portfolio with >150 Patents Globally  Cash Runway of at least 12 months  39


Disrupting Convention in Women’s Health Through Continuous Innovation  August 2022  Corporate Presentation  Investors: Chuck Padala  IR@femasys.com  Contact:   Media: Karissa Cross  Media@femasys.com   40  03333 R00