Full Press Release Details
Disrupting Convention in Women's Health Through Continuous Innovation October
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: $13.3M (as of 9/30/22) Cash: $19.1M (as of 6/30/22) 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 of at Least 12 Months 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 Michael Meier VP, Sales & Marketing 20+ 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 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 Kathy Lee-Sepsick President, CEO, Founder 25+ years of experience
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 In Q4 2022
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
infertility ~ 40-50% is due to male factor 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. Sperm counts worldwide have declined by >50%
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
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 New Trial Design to Expedite Clinical Program Advancement FemaSeed de Novo
Clinical Trial for Market Approval 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 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. - 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) Early Clinical Stage I: Safety Stage II: Validation Stage III: Pivotal (pending) 25 IDE EXPECTED Q1 2023
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 = 229 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