EX-99.1 2 brhc10026833_ex99-1.htm EXHIBIT 99.1

Exhibit 99.1

     Transforming Women’s Healthcare  ©2021 Femasys Inc.  Corporate PresentationJuly 2021 
 

   Forward Looking Statements  2  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 anyforward-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. 
 

             Clear Reimbursement Path with Improved Patient Care & Health EconomicsWoman Founded and Led, Experienced Leadership Team with Concentrated Development ExpertiseIn-House CMC & Device Infrastructure & 100+ Patents Filed GloballySupported by Leading Strategic (Medtronic) & Institutional Investors  Highlights      Multi-Billion Dollar Global Market Opportunities in Reproductive Health    Biomedical Company Developing Novel Solutions Providing Significant Clinical Impact to Address Severely Underserved Areas in Women’s Health  3  Unwavering commitment to advancing women’s health 
 

   Key LeadershipExperienced biotechnology and medical device developers        Kathy Lee-SepsickPresident, CEO, Founder                25+ years of experience  Todd CreechChief Financial Advisor  20+ years of experience  Jeffery Marcus, MDChief Medical Advisor  25+ years of experience  Dan CurrieSr. VP, Operations          30+ years of experience  4  Lexy Kelley, MDVP, Medical & Clinical Affairs  14+ years of experience  Terrell PruittVP, Manufacturing  25+ years of experience  Gary ThompsonVP, Finance & Administration  30+ years of experience 
 

   Addressable Market Opportunities in Reproductive Health (U.S.)                    Temporary Contraception  End Risk of PregnancyFemBloc®Permanent Birth ControlPotential to be safest and most natural approach at half the cost    >13M Women$20B+ Market Potential      Fertility    FemaSeed™Localized Directional InseminationFirst and only approach delivering sperm where conception occursFemVue®Patency EvaluationFirst in-office ultrasound approach>9M Women$2B+ Market Potential      FemChec®Occlusion ConfirmationFirst in-office ultrasound approach  5 
 

 Proprietary Delivery Platform 
 

                             Simple Office Proceduresfor local directional delivery of materials to fallopian tubes  Dual Delivery  Single Delivery  Common minimally invasive technique(i.e., intrauterine catheters, IUD)  Delivery Type / Product  NO ANESTHESIA AND NO INCISIONSNO SPECIAL SKILL SET AND NO CAPITAL EQUIPMENTNO CANNULATION OF TUBE  FemaSeed        FemBloc  Delivery System Removed  Biopolymer*      * Proprietary tissue adhesive, patent pending  7 
 

                     Deliver saline-air contrastfor tubal evaluation  Patency  Screening Type / Product  NO RADIATION NO X-RAY DYENO REFERRAL TO RADIOLOGY CENTER  FemVue      FemChec  8  Occlusion  Ultrasound Based Diagnostic Productsfor use with therapeutic solutions  Balloon catheter insertedcommon technique 
 

       Strong IP Portfolio>100 patents filed globally  Directional Delivery (dual or single) to Fallopian Tubes  FemBloc, FemaSeed, Drug Delivery  Utility & Design Encompassing    Biopolymer Composition for Tubal Occlusion  FemBloc    Contrast Generating Ultrasound Visible  FemVue / FemChec    Tissue Sampling for cancer detection  FemCerv* / FemEMB  *    Biopsy Product  Indication  Research  Pre-Clinical  Clinical Study  US Approval  CE Mark  Anticipated Milestones  FemCerv®  Endocervical Tissue Sampler      N/A  ✓  ✓  Commercialization 2022                                            9 
 

     Permanent Birth Control(Product Candidate)  FemBloc    10 
 

           Ultrasound procedure with FemChec  Confirmation    No Permanent Implant – Scar Tissue Closes Tubal Lumen  Balloon at tubal opening without  cannulation  Biopolymer expels within 3 months                  Biopolymer can expel with menstruation  11  Treatment  FemBloc Permanent Birth ControlFirst and only non-surgical approach 
 

                           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 Cost  ✔  ✔  Multiple IUDs    ✔  Worldwide Applicability  ✔  Some  ✔        On-Market Solutions  12  Off-Market  Essure® is a registered trademark of Bayer Healthcare (Conceptus) and, as of December 2018, no longer a marketed solution.  Potential Competitive Advantage 
 

             Tubal Ligation Surgery  Hormones  Condoms  Least Invasive/ Least Reliable  *Includes partners that choose vasectomy                              Most Invasive/ Most Reliable  13  Market Opportunity (U.S.)  72 M Reproductive Aged Women  Near-Term Target Market$2B AnnualIncludes women (and partners) choosing permanent birth control annually (~1.3M)  Market Expansion Opportunity$20B TotalIncludes women using non-permanent options but are candidates (>12M) 
 

 In-office visit(required for permanent birth control)  In-office procedure  In-office ultrasound procedure  Counseling/Eligibility  FemChec Confirmation      Existing CPT codes  Category covered (ACA)Cat III code approved  FemBloc Treatment    1 2    3                Cat III code approved  14  Clear Reimbursement Path3 reimbursable office visits 
 

   Confidential © 2021 | 15  Improved Health Economics    PhysicianSurgical Tubal Ligation FemBloc* Planned Parenthood 2019, https://www.plannedparenthood.org/learn/birth-control; Doximity 2019; U.S. Bureau of Labor Statistics, 2019.    Facility Anesthesia Pre-Op Post-Op                      Est < ½ cost of          Tubal Ligation            Cost of FemBloc System                  Physician/ Practice      0  1000  2000  3000  4000  5000  6000  Amount in $  43,000 GYNs in U.S.Permanent One-Time Cost Breakdown$6,000*      In-office procedure expands practice services  FemBloc Efficiencies    Can perform multiple procedures in same room    Quicker to perform and resume normal activities         
 

   Confidential © 2021 | 16          n=183 subjects being followed for 5 yearsPatients found procedures highly tolerable96% physicians assessed procedure to be extremely/ very simple99% physicians assessed easier than tubal ligation surgery  Stage IIIPivotal(pending)Safety & Effectiveness of FemBloc  Summary:  Goals:  IDE approval of study design (multi-center, two arm, unblinded prospective study)Previous FDA approved third- party study design:  primary endpoint of pregnancy rate at 1 year post confirmation testsafety follow-up 2-5 years post-market  PMA Clinical StudiesTrial stages to pivotal for FDA approval        Stage IIValidation(on-going)Selection of Confirmation Test for Pivotal  n=50 subjects receive two confirmation tests to allow selection of FemChec ultrasound or radiology testEvaluate adequacy of improvements to procedures, products and training  Goals:    Stage ISafety(enrollment completed Feb 2019)No Serious AEs Reported  Early Clinical(completed)Evaluated Delivery & Biopolymer Effectiveness  n=93 subjects received planned hysterectomySubset with histopathology demonstrating biopolymer tissue reactionsNo serious safety events reported  Summary:   
 

   Confidential © 2021 | 17    No SAEs    94% AEs related to device/ procedure occurred within 7 days of procedure    75% AEs mild                    123  16  48  2  37  8  5  2  1 4  1 7  5  5  3  6Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Day 8-90  0  20  40  60  80  120100  140  160  180  Day of FemBloc Treatment  Day 1  Number of AEs Reported        Mild    Moderate    Severe      165      27      53      8          2 2          3 5      12      1  Day of Confirmation (90 days)  Majority AEs Occurred at Time of Proceduren=183 subjects    Patients are being followed for 5 years, with first subjects approaching 4 year follow-up 
 

   Confidential © 2021 | 18  Most Common AEs Reported (>1%)          2752502252001751501251007550250  Vaginal Bleeding  Spotting  Post Procedure Bleeding  Uterine Bleeding  Pelvic Pain  Uterine Cramps  Cramps/ Abdominal  Abdominal Bloating  Nausea  Number of AEs Reported          Mean pain/ discomfort score* as reported by patient:4.3 for FemBloc treatment and 3.0 for FemChec confirmation                                                                                                              Bleeding/Spotting (41.5%)      Pain/Cramps (38%)          Other  28%                          24.8%            10.3%                    2.1% 1.1%        8.9%  4.3%  1.1% 1.8%  *Visual Analog Scale (VAS) from 0-10 was used. 
 

   Transforming Women’s Health with Novel SolutionsFirst and only non-surgical, in-office permanent birth control option        Contraception Product Portfolio  Indication  Research  Pre-  PMA Clinical Studies      USApproval  CEMark  Anticipated Milestones        Clinical  Stage I Safety  Stage II Validation  Stage III Pivotal        FemBloc®  Permanent Birth Control                Complete enrollment for validation study second half 2021Combined IDE submission for PMA clinical trial anticipated first half 2022 followed by commencement of trial  FemChec®  Occlusion Confirmation                      19 
 

     Localized Directional Insemination(Product Candidate)  FemaSeed    20 
 

           Potential Competitive Advantage    1st line treatment despite low success rates    Undirected sperm delivery to cavity    Opportunity for First Line AlternativeLimited advancements - continuous demand for less costly options  First and only approach delivering sperm where conception occursIUI oldest technique in reproductive medicine  Egg  Sperm delivered to tube where conception occurs          Ovulation generally occurs on one side  Space created by balloon  FemaSeed          21 
 

         FDA clearance for single intrauterine directional delivery device for different indication  Post-market study (n=15 subjects) with 93% contrast delivery into fallopian tube  FemBloc stage I safety data supports localized directional delivery  Commercial  1,300 reproductive endocrinologists at 450 practices  FemaSeed Clinical to MarketNo direct competitors in product category    Prospective, Multi-Center, Single-Arm (n=792)    Clinical Trial(IDE approval received April 2021)    Early Support(Completed)    Primary Effectiveness Endpoint:Confirmed clinical pregnancy with fetal heartbeat at 7 weeks post FemaSeed procedure  22  Site recruitment underway  Interim Analysis:  Occurs at midpoint of data set  Hire direct sales force for U.S., distribution partners for international  Initially target customers for FemVue (50 practices currently)  8 states represent over 50% practices and 60% of assisted reproductive cycles  Summary:  Goals: 
 

   FemVue Saline-Air DeviceFirst Ultrasound Approach for In-Office Fallopian Tube Evaluation      Diagnostic prior to infertility treatments(e.g. FemaSeed)Can be combined with saline evaluation of uterine cavity (standard of care)On-line training and new customer supportPhysician locator available on patient websiteReimbursed using existing codes  Uses standard ultrasound to evaluate tubes for patency (open)  Commercially Available(U.S., Europe, Canada, Japan)      23 
 

       *Includes partners that choose vasectomy                    Most Expensive          Market Opportunity (U.S.)  >9M Infertile Women  Near-Term Target Market$800M TotalIncludes women choosing IUI and required tubal diagnosis  Market Expansion Opportunity$2B TotalIncludes women currently seeking evaluation and treatment  IVF(~200k/ year)  Intrauterine Insemination (IUI)  Sperm  Diagnosis / Drugs    Discussion Only          Least Expensive  24 
 

   First-Line Approaches for Women to Seek CareIn-office products for the treatment of infertility        Fertility Product Portfolio  Indication  Research  Pre- Clinical  De novo Clinical Study  USApproval  CEMark  Anticipated Milestones  FemaSeed™  Localized Directional Insemination            IDE approval received from FDA in April 2021Anticipated commencement of de novo clinical trial third quarter of 2021 and completion in second half of 2022  FemVue®  Infertility Diagnosis      N/A  ✓  ✓  Expand commercialization                                  25 
 

                         2021  Q3  Q4  1H  2H  Commencement of de novo clinical trial for FemaSeed  Complete enrollment for FemBloc stage II study  Interim analysis FemaSeedSubmission of IDE for FemBloc stage III PMA trial      Complete enrollment for FemaSeed de novo trialCommencement of PMA trial for FemBloc  Upcoming Anticipated Milestones  Near term expected valuation inflection points creating accretive value for investors      2022  26 
 

   Transforming Women’s Healthcare    Corporate PresentationJuly 2021  Contact:IR@femasys.com Media@femasys.com