8-K
Femasys Inc (FEMY)
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): July 13, 2021
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, 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 July 13, 2021, 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 is incorporated herein by reference. Representatives of the Company will use the presentation in various meetings with investors, analysts and other parties from time to time. The information in this Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, or incorporated by reference in any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, except as shall be expressly set forth by specific reference in such filing.
| Item 9.01 | Financial Statements and Exhibits. |
|---|
(d) Exhibits.
| Exhibit No. | Description |
|---|---|
| 99.1 | Femasys Inc. Investor Presentation July 2021 |
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: July 13, 2021
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:[email protected] [email protected]