Exhibit 99.1
Disrupting Convention in Women’s Health Through Continuous Innovation September
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 focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including FemaSeed® an FDA-cleared infertility treatment, FemBloc® a lead late-clinical stage product candidate
for permanent birth control, and FDA-cleared, innovative diagnostic products. Headquarters: Suwanee, GA Nasdaq: FEMY IPO date: June 2021 Market Cap: $22.3M (as of 09/26/23) Cash: $10.7M (as of 06/30/23) 3
Investment Highlights Differentiator 4 Develop disruptive approaches for
women’s health Address multi-billion-dollar global market opportunities in permanent birth control and infertility Clear reimbursement path with limited competition Improved patient care and health economics Intellectual property
portfolio with >150 patents globally Cash runway into Q2 2024 Woman-founded and led, experienced leadership team Commercial-readiness with in-house CMC and device manufacturing Global regulatory approvals, including the U.S., Japan,
and Canada Mission Foundation
Key Leadership Experienced biotechnology and medical device
professionals Brian Drumheller VP, Quality 30+ years of experience Dan Currie Chief Operating Officer 30+ years of experience Jeremy Sipos VP, Research & Development 20+ years of experience Christine Thomas SVP, Regulatory
& Clinical 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
FemBloc® Product Candidate Research Preclinical Stage ISafety Stage
IIValidation Stage IIIPivotal Our Technologies Provide a Continuum of Care Permanent Birth Control and Ultrasound Occlusion Confirmation 6 In-office, minimally invasive solutions that share delivery platforms. Commercially Available
Products Commercially Available Products FemaSeed® Treatment Intratubal Insemination FemVue® Diagnostic Contrast-Generating Device FemCath® Diagnostic Selective Delivery Catheter FemCerv® Diagnostic Endocervical Tissue
Sampler Treatment Clinical Trial
Femasys Portfolio of Products 7 Initial Focus on Infertility Specialists +
Added Focus on Gynecologists ~1,700 (U.S.) ~40,000 (U.S.) Product U.S. Commercial Ex-US Commercial Primary Detailing Target Secondary Detailing Target FemaSeed NOW FDA CLEARED ✔ (Canada) REI GYN FemVue ✔ ✔ (Japan,
Canada, Hong Kong, UAE) REI GYN FemCath ✔ ✔ (Canada) REI GYN FemCerv ✔ ✔ (Canada) GYN GYN Onc FemBloc Est 2027 Est 2027 GYN —
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 8 *New U.S. patent application for FemBloc allowed with anticipated expiration in 2039 at the earliest.
FemaSeed® Intratubal Artificial Insemination 9 Innovative first-line
infertility treatment designed to deliver sperm directly where conception occurs Designed to be more affordable than assisted reproduction Complementary Diagnostics FemVue® and FemCath® First in-office ultrasound evaluation of fallopian
tubes for infertility diagnosis Infertility Focused Portfolio FDA-Cleared in U.S. and Approved in Canada
Infertility: Unmet Need (U.S. only) >10M women struggle with
infertility1 Birth rate fell 4% in 2020 (largest single year decrease in 50 years)2 Despite advancements, there have been no new affordable options in decades. 10 https://www.cdc.gov/nchs/nsfg/key_statistics/i-keystat.htm Hamilton, et
al. (2021) Births: Provisional Data for 2020. U.S. Department of Health and Human Services • Centers for Disease Control and Prevention, National Center for Health Statistics, National Vital Statistics System. Report No.
12. https://www.pewtrusts.org/en/research-and-analysis/issue-briefs/2022/12/the-long-term-decline-in-fertility-and-what-it-means-for-state-budgets 43 U.S. states have recorded lowest fertility rate in last three decades3
FemaSeed: Low Cost for Front-End of Infertility
Treatment FemaSeed $$ Traditional IUI $ IVF/ ICSI* $$$$$ Artificial Insemination ✔ ✔ Intratubal sperm delivery (into fallopian tube where conception occurs) ✔ Ovulation stimulation optional optional ✔ No egg retrieval, no
egg freezing ✔ ✔ Minimal training ✔ ✔ 11 There have been limited advancements and continuous demand for less costly options. *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 Intratubal Insemination An innovative treatment for infertility
designed to deliver sperm directly to where conception occurs, in a woman’s fallopian tube. 12 Undirected sperm delivery to cavity (IUI) is first-line treatment despite low success rates Video will open in browser window.
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 FemaSeed Ongoing Clinical Trial for Male Infertility Factor SITE RECRUITMENT
UNDERWAY Clinical Trial(IDE Approved October 2022) 13 To Evaluate Safety and Effectiveness ~ 40-50% of infertility is due to male factor1 Sperm counts worldwide have declined by >50%2 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
The Unmet Need in Infertility: Compelling Testimonials 14 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 FemaSeed Physician Testimonial FemVue Patient Testimonials 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.
First In-office, Ultrasound Approach for Fallopian Tube Evaluation FemVue
creates saline-air contrast that travels through the fallopian tube(s) when open 15 First Intrauterine Catheter for Selective Tubal Evaluation Complimentary Diagnostics: test prior to infertility treatments, including FemaSeed Approved
in U.S., Japan, and Canada Video will open in browser window.
Diagnosis Discussion Drugs IUI IVF Infertility Addressable Market (U.S.
only) 16 Least Costly Most Costly seek evaluation & treatment (1.4M IUI) FemVue/FemCath FemaSeed $2B total 4.3M seek evaluation only Market Expansion for FemaSeed $800M total Immediate Addressable 4.8M seek evaluation &
treatment (~1M cycles/yr IUI*) >10M women struggle with infertility *Centers for Disease Control and Prevention. 2019 Assisted Reproductive Technology Fertility Clinic and National Summary Report. US Dept of Health and Human Services;
2021.
Competitive Options: Price Comparison 17 IUI Intrauterine
Insemination FemaSeed $500-$4,000 total per cycle including ultrasound monitoring, and optional ovulation drugs2 + device per cycle above IUI cost Average Total
Cost 1https://www.fertilityiq.com/iui-or-artificial-insemination/the-cost-of-iui 2Parenthood, Planned. “What Is Intrauterine Insemination (IUI)?” Planned Parenthood,
https://www.plannedparenthood.org/learn/pregnancy/fertility-treatments/what-iui. 3Ravitsky, 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. IVF/ ICSI In vitro fertilization / intracytoplasmic sperm injection $30,000 total per cycle, including ultrasound monitoring, ovulation drugs, egg extraction and freezing3 Population If
insurance, covered under IUI codes (service, sperm washing) Insurance with positive coverage policy typically covers 3-6 cycles Required prior to IVF/ ICSI in many coverage policies Infertile Women/ Couples Seeking Treatment Subset of
Infertile (After 1-3 IUI cycles or as indicated) Intratubal Insemination Reimbursement 14/20 covered states that have fertility insurance coverage, include IVF
FemBloc® Permanent Birth Control 18 First and only non-surgical, in-office,
permanent birth control option in late-stage clinical development with the potential to be the safest and most natural approach at substantially less cost than the long-standing surgical alternative Companion Diagnostics FemChec® and
FemCath® First in-office ultrasound diagnosis of fallopian tubes for confirmation of procedure success Contraception Focused Portfolio
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 19 *Frattarelli 2007
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 ✔ 20 *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)
No Permanent Implant – Scar Tissue Closes Tubal Lumen FemBloc
Treatments 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 Biopolymer
solidifies 21 Video will open in browser window. Biopolymer degrades
Companion ultrasound test (FemChec® and FemCath®) exclusive to FemBloc -
confirms procedure success Occlusion Confirmation FemBloc Permanent Birth Control in Development 3 Months Blockage Biopolymer degrades Saline-air contrast confirms blockage 22 Video will open in browser window.
Completed Earlier FemBloc Supportive Studies (N=321) Stage I: Safety FemBloc
Clinical Studies for Pre-Market Approval (PMA) 23 Stage III: Pivotal Clinical Trial (IDE approved June 2023; currently enrolling) FINALE Trial Design: Prospective, multi-center, open-label, single-arm study Roll-in study design to begin
with enrollment of 50 women for a clinical readout primarily of preliminary safety data prior to enrolling remaining subjects. Primary Endpoint: pregnancy rate at 1-year after FemBloc use for permanent birth control (N=401) Secondary
Endpoints: safety and various in-office assessments Safety Follow-Up: 2-5 years post-market Interim analysis planned after 300 women have used FemBloc for permanent birth control for 1-year. Selection of Confirmation Test for
Pivotal Stage II: Validation Early Clinical Long-Term Safety with No Serious AEs Reported Evaluated Delivery & Biopolymer 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 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
61% 8% 16% 3% 0.5% 0.5% 0.8% 5% 4% FemBloc Treatment (>90
days) FemBloc: Majority AEs 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 No SAEs 24 Investigators rated extremely or very satisfied for 96% of FemBloc procedures
Bleeding/Spotting (59%) Pain/Cramps
(55%) 40% 13.1% 3.5% 2.6% 34.5% 13.5% 7% *Long-Acting Contraceptive Comparison (Bayer, Mirena IFU, August 2022) reported most common adverse events (>5%) as: 71% bleeding related 66% reproductive system and breast disorders 23%
abdominal/pelvic pain 16% headache/migraine 8 % back pain 7% skin and subcutaneous disorders 6% depression FemBloc: Most Common Reported AEs (>5%)(N = 228 subjects from Stage I & II) Mean pain/discomfort score (visual analog
scale) out of 10 as reported by patient in-office with no anesthesia: 4.6 for FemBloc Treatment and 3.4 for Confirmation 25
The Unmet Need for Women: Options for Family Planning 26 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 Addressable Market (U.S.
only) 27 Pills Condoms Injectable/Ring/Patch IUDs Tubal Ligation Least Invasive / Least Reliable Most Invasive / Most Reliable $20B Total Includes women using non-permanent options but are candidates (>12M)3 Market Expansion
Opportunity $2B Annual Near-Term Target Market Includes women (and partners) choosing permanent birth control annually (~1.3M) 1,2 >13M Reproductive Aged Women NO Longer Intend Children 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.
28
In-office procedure FemBloc Treatments Category covered (ACA) Cat III code
approved FemBloc: Clear U.S. Reimbursement Path Reimbursable Visits In-office/ TeleVisit(required for permanent birth control) Counseling/Eligibility Existing CPT codes In-office test (ultrasound) Cat III code approved FemBloc
Confirmation 29 NO COST TO PATIENT
30 FemCerv® Diagnostic for Cervical Cancer First endocervical biopsy
designed for comprehensive tissue sampling with minimal contamination that is virtually pain free Cancer Diagnostic Portfolio FDA-Cleared in U.S. and Approved in Canada
Expanded Collection Chamber FemCerv Endocervical Tissue
Sampler 1 2 Collected sample 31 Video will open in browser window. The incidence of stage IV cervical cancer in the U.S. is increasing.* *Francoeur et. al, International Journal of Gynecologic Cancer (2022). 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.
Femasys is Prepared for Execution 32 Clear Regulatory & Clinical Path to
FDA Approval Clear Reimbursement Pathway Commercial Expertise Full manufacture facility with ability to scale and transfer MFG Ready Sales Ready Built infrastructure prior to commercial salesforce with FDA-cleared diagnostic products
Recently Achieved & Upcoming Anticipated Milestones Near term expected
valuation inflection points creating accretive value for investors 33 2024 Q2 Complete FemaSeed enrollment for male infertility factor trial Q3 2023 FemBloc pivotal trial enrollment initiated Q4 Q1 Commercialize infertility
portfolio of products in U.S. FemaSeed FDA 510(k) clearance achieved Top line data for FemaSeed male infertility factor trial Achieve CE mark for FemaSeed, FemVue, FemCath and FemCerv Q3 Complete FemBloc Part A pivotal trial
enrollment
Investment Highlights Differentiator 34 Develop disruptive approaches for
women’s health Address multi-billion-dollar global market opportunities in permanent birth control and infertility Clear reimbursement path with limited competition Improved patient care and health economics Intellectual property
portfolio with >150 patents globally Cash runway into Q2 2024 Woman-founded and led, experienced leadership team Commercial-readiness with in-house CMC and device manufacturing Global regulatory approvals, including the U.S., Japan,
and Canada Mission Foundation
Disrupting Convention in Women’s Health Through Continuous Innovation September
2023 Corporate Presentation Investors: IR@femasys.com Contact: Media: Media@femasys.com 35 03333 R07