8-K
Femasys Inc (FEMY)
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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): February 28, 2022
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,<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 February 28, 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 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<br><br> <br>No. | Description |
|---|---|
| 99.1 | Femasys Inc. Investor Presentation February 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: February 28, 2022 |
Exhibit 99.1
Disrupting Convention in Women’s Health Through Continuous Innovation February 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: FEMYIPO date: June 2021 Market Cap: $35.16 M(as of 2/22/22) Cash: $27.28 M(as of 9/30/21) 3
Investment Highlights Biomedical Company Disrupting the Approaches to Women’s Health with Proprietary Diagnostic and Device Solutions in DevelopmentAddressing Multi-Billion Dollar Global Market Opportunities in Infertility and Permanent Birth Control With Differentiated and Improved ApproachesClear Reimbursement Path with Limited Competition Yields Improved Patient Care and Health EconomicsWoman-Founded and Led, Experienced Leadership Team with Concentrated Development ExpertiseIn-House CMC and Device Infrastructure; 130+ Patents Filed Globally$33 million from recent IPO; early investment from Medtronic 4
Our Product Pipeline Infertility Products and Product Candidates Contraception Product Candidate Biopsy Product Research Preclinical De Novo Clinical Study Approval PMA Clinical Studies Approval Stage ISafety Stage IIValidation Stage IIIPivotal Research Preclinical Research Preclinical Research Preclinical THERAPEUTIC FemaSeed® Localized Artificial Insemination DIAGNOSTIC FemVue®️ Contrast-Generating Device FemCath™️ Selective Delivery Catheter FemBloc® Permanent Birth Control and Ultrasound Occlusion Confirmation FemCerv® Endocervical Tissue Sampler 5
Broadly Applicable Proprietary Platform Technologies Our portfolio of products and product candidates address various underserved areas of the reproductive and gynecological market providing solutions for OB/GYNS 6
Our Novel Biomedical Procedures in Development: Simple and In-Office Specified, precise delivery to fallopian tubes (i.e., biomedical material, sperm or therapeutic agents) No anesthesia and no incisionsNo special skillset and no capital equipmentNo cannulation of tubePatents issued and pending Common minimally invasive technique(i.e., intrauterine catheters, IUD) Dual Placement Single Placement 7
Our Companion Ultrasound-Based Diagnostics: Simple and In-Office Balloon catheter insertedcommon technique Deliver saline-air contrast for tubal evaluation Occlusion Patency No RadiationNo X-Ray DyeNo Referral to Radiology Center Contrast generation for screening and occlusion confirmation for use with our novel biomedical procedures 8 Real-time imaging result
Strong Global IP Portfolio Our Patent Estate Encompasses Utility and Design 130+ patents ISSUED globally; OVER 40 pending 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 Occlusion Confirmation for FemBloc 9
FemBloc® Permanent Birth Control + Ultrasound Occlusion Confirmation 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 alternativeFirst in-office ultrasound approach for confirmation of procedure success 10
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 11
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 Cost ✔ ✔ Multiple IUDs ✔ Worldwide Applicability ✔ Varies ✔ 12
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 13
Summary:n=183 subjects being followed for 5 years Patients found procedures highly tolerable 96% physicians assessed procedure to be extremely/ very simple99% physicians assessed easier than tubal ligation surgery Summary:n=93 subjects received planned hysterectomy Subset with histopathology demonstrating biopolymer tissue reactionsNo serious safety events reported Goals:n=50 subjects receive two confirmation tests to allow selection of ultrasound or radiology testEvaluate 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 testsafety 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) 14 ✔ ✔
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 15
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 16
Permanent Birth Control Market Opportunity (U.S.) Near-Term Target Market $2B Annual Market Expansion Opportunity $20 B Total Includes women (and partners) choosing permanent birth control annually (~1.3M) Includes women using non-permanent options but are candidates (>12M) Hormones Condoms Tubal Ligation Surgery 72 M Reproductive Aged Women Most Invasive/ Most Reliable Least Invasive / Least Reliable 17
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 servicesCan perform multiple procedures in same roomQuick to perform; ease of room turnoverPatient resumes normal activities FemBloc Efficiencies Planned Parenthood 2019, https://www.plannedparenthood.org/learn/birth-control;Doximity 2019; U.S. Bureau of Labor Statistics, 2019. 18
In-office procedure FemBloc Treatment Category covered (ACA)Cat III code approved 2 FemBloc: Clear Reimbursement Path 3 reimbursable office visits 1+ Days 3 Months In-office visit(required for permanent birth control) Counseling/Eligibility Existing CPT codes 1 In-office ultrasound procedure Cat III code approved FemBloc Confirmation 3 19
FemaSeed® Localized Artificial Insemination Developing the first and only first-line approach designed to deliver sperm where conception occursDesigned to be more affordable than assisted reproductionIncludes first in-office ultrasound diagnosis of fallopian tubes for infertility Companion Diagnostics FemVue® and FemCath™ 20
Infertility: Unmet Need (U.S. only) More than 9 million struggle with infertility Despite advancements, there have been no new affordable options in decades. 21
FemaSeed: Expected Competitive Advantages Over Existing Infertility Options FemaSeed Traditional IUI IVF Artificial Insemination ✔ ✔ Sperm delivered to egg infallopian tube (where conception occurs) ✔ ✔ Stimulation drugs optional ✔ ✔ Low procedure cost ✔ ✔ Minimal training ✔ ✔ 22
FemaSeed Localized Directional Insemination in Development Limited advancements - 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 23
FemVue® Diagnostic Evaluation of Fallopian Tubes Commercially Available FemCath™ Selective Fallopian Tube Contrast Placement Commercially Available First diagnostic to allow for selective evaluation of a fallopian tube with contrast First diagnostic that creates natural contrast for an in-office ultrasound approach Companion Diagnostics for FemaSeed® Localized Directional Insemination Procedure 24
FemVue Saline-Air Device (used prior to FemaSeed Procedure) Diagnostic performed prior to infertility proceduresCan be combined with saline evaluation of uterine cavity (standard of care)On-line training and support available for new customersPhysician locator available on patient websiteReimbursed using existing codes First In-office, Ultrasound Approach for Fallopian Tube Evaluation Commercially Available: U.S., Europe, Canada, Japan When paired with FemCath allows for selective tubal evaluation Saline-Air contrast travels through the fallopian tube when open 25
Summary:Study Design: multi-center, unblinded, prospective study# Subjects: 792 subject cycles Primary Effectiveness Endpoint:pregnancy rate by 7 weeks post procedureInterim 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 infusionResults: 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) 26 1st Subject Treated July 2021
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) >9M Infertile Women Most Expensive Least Expensive 27
FemaSeed Potential Market Penetration U.S. Commercial Strategy Goals: No Advancement for Decades and Limited Competition in the Infertility Product Category 1,300 reproductive endocrinologists at 450 practices Hire direct sales force for U.S., distribution partners for internationalInitially target customers for FemVue (50 practices currently)8 states represent over 50% practices and 60% of assisted reproductive cycles Prospective Targets 28
FemCerv® Diagnostic/Cervical Cancer Sampling First endocervical biopsy designed for comprehensive tissue sampling with minimal contamination FDA Approved Commercialization Pending 29
Expanded Collection Chamber FemCerv: Diagnostic Cervical Screening Solution First cervical tissue sampler designed to improve tissue quality and quantity 1 Designed for minimal contaminationAllows for comprehensive tissue samplingDesigned to minimize patient discomfort 2 Collected sample 30
Our Strategy: Targeting Ob/Gyns With Product Solutions Throughout the Continuum of Female Care Addressing facets of care that have had negligible advancement over decades to create improved patient care and improved physician treatment options Procedures for Infertility/Permanent Birth Control Diagnostic Evaluation Occlusion Confirmation for FemBloc and FemCerv FemVue and FemCath FemaSeed and FemBloc Diagnostic Confirmation and Ongoing Care 31
Our Strategy: Targeting Ob/Gyns With Product Solutions Throughout the Continuum of Female Care U.S. Commercial Strategy Goals: Limited In-Office Advancements for Gynecologic Care Leaves Antiquated Options In Key Areas 41,000 U.S. Gynecologists in office practices Expand infertility sales force for GYN in-office call pointInitially target customers for already commercialized product linesDirect in U.S, distribution partners international, to provide breadth of product solutions including diagnostics and therapeutics Prospective Targets 32
Upcoming Anticipated Milestones / Events Near term expected valuation inflection points creating accretive value for investors 33 2022 Q1 Q2 Q3 Q4 CFO appointment 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
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 34
Investment Highlights 35 Biomedical Company Disrupting the Approaches to Women’s Health with Proprietary Diagnostic and Device Solutions in DevelopmentAddressing Multi-Billion Dollar Global Market Opportunities in Infertility and Permanent Birth Control With Differentiated and Improved ApproachesClear Reimbursement Path with Limited Competition Yields Improved Patient Care and Health EconomicsWoman-Founded and Led, Experienced Leadership Team with Concentrated Development ExpertiseIn-House CMC and Device Infrastructure; 130+ Patents Filed Globally$33 million from recent IPO; early investment from Medtronic
Disrupting Convention in Women’s Health Through Continuous Innovation February 2022 Corporate Presentation Investors: Chuck PadalaIR@femasys.com Contact: Media: Sky StriarMedia@femasys.com 36