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FEMY on Nasdaq

FEMASYS INC

FEMASYS INC is a leading biomedical innovator.1 It is headquartered in Suwanee, Georgia.1 Its shares trade on Nasdaq under the symbol FEMY.1

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Last updated Oct 21, 2026.

Overview

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  • TickerFEMY on Nasdaq1
  • IndustrySurgical & Medical Instruments & Apparatus1
  • HeadquartersSuwanee, Georgia1
  • Incorporated inDE2
  • Business address3950 Johns Creek Court, Suite 100, Suwanee, Ga 300242
  • Filer categoryNon-accelerated filer, Smaller reporting company, Emerging growth company2
  • Legal formCorporation

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We are a leading biomedical innovator, addressing significant unmet needs in women’s health worldwide, with a broad patent-protected portfolio of disruptive, accessible, in-office therapeutic and diagnostic products. The Company is a U.S. manufacturer that has received global regulatory approvals for its product portfolio, which is currently being commercialized in the U.S. and key international markets. FemaSeed ® Intratubal Insemination, a groundbreaking first-step infertility treatment delivering sperm directly to the site of conception, is U.S. FDA-cleared and approved in Europe, United Kingdom (UK), Canada, Israel, Australia and New Zealand. A peer-reviewed publication of positive data from its pivotal clinical trial of FemaSeed demonstrated effectiveness and safety with high satisfaction from both patients and practitioners. FemSperm ® , which includes setup, preparation and analys…3 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

-767.0%Operating margin4
-812.3%Net margin4
40.8%Revenue growth, 20254
-317.4%Return on equity4
-$19.2MFree cash flow4

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Regions

United States brought in 61% of the revenue FEMASYS INC broke down this way in fiscal 2025.

  1. United States$1.4M461%up 30% from 2024
  2. Outside the United States$899.8K439%up 62% from 2024
Regions by year
Regions20242025
United States$1.1M$1.4M
Outside the United States$555.6K$899.8K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue10¢$872.4K
  • Research and development90¢$7.6M
  • Income tax0¢$1.3K

Out of $2.3M in revenue.4 The company lost money this year.

Financial statements

Revenue56784$2.3M in 2025+121% since 2020
0$1.0M$2.0M$3.0M2020: $1.0M$1.0M20202021: $1.2M$1.2M2021+14%2022: $1.2M$1.2M2022+2%2023: $1.1M$1.1M2023−11%2024: $1.6M$1.6M2024+52%2025: $2.3M$2.3M2025+41%
Gross profit56$764.3K in 2022+4% since 2020
0$250.0K$500.0K$750.0K$1.0M2020: $731.4K$731.4K20202021: $809.3K$809.3K2021+11%2022: $764.3K$764.3K2022−6%
Operating income56784-$17.6M in 2025+154% since 2020
-$20.0M-$15.0M-$10.0M-$5.0M02020: -$6.9M-$6.9M20202021: -$8.3M-$8.3M2021+20%2022: -$11.6M-$11.6M2022+39%2023: -$14.5M-$14.5M2023+25%2024: -$17.8M-$17.8M2024+23%2025: -$17.6M-$17.6M2025−1%
Net income56784-$18.6M in 2025+169% since 2020
-$20.0M-$15.0M-$10.0M-$5.0M02020: -$6.9M-$6.9M20202021: -$7.5M-$7.5M2021+9%2022: -$11.4M-$11.4M2022+51%2023: -$14.2M-$14.2M2023+25%2024: -$18.8M-$18.8M2024+32%2025: -$18.6M-$18.6M2025−1%

Every line of the income statement as filed: the last 2 fiscal years, latest first.4

Period ending2025-12-312024-12-31
Sales$2.3M$1.6M
Cost of sales (excluding depreciation expense)$872.4K$544.9K
Research and development$7.6M$8.2M
Sales and marketing$4.4M$4.0M
General and administrative$6.6M$6.3M
Depreciation and amortization$342.0K$297.3K
Total operating expenses$19.0M$18.9M
Loss from operations-$17.6M-$17.8M
Interest income$101.8K$582.4K
Change in fair value of conversion option liability$503.0K$0
Change in fair value of warrants liabilities$731.0K$0
Interest expense-$1.9M-$1.6M
Other expense-$482.6K$0
Total other expense, net-$1.0M-$1.0M
Loss before income taxes-$18.6M-$18.8M
Income tax expense$1.3K$9.6K
Net loss-$18.6M-$18.8M
Net loss attributable to common stockholders, basic-$18.6M-$18.8M
Net loss attributable to common stockholders, diluted-$18.6M-$18.8M
Net loss per share attributable to common stockholders, basic (in Dollars per share)-$0.47-$0.85
Net loss per share attributable to common stockholders, diluted (in Dollars per share)-$0.47-$0.85
Weighted-average common shares and pre-funded warrants outstanding- basic (in Shares)39.5M shares22.3M shares
Weighted-average common shares and pre-funded warrants outstanding- Diluted (in Shares)39.5M shares22.3M shares

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Corporate structure

FEMASYS INC sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of FEMASYS INC

  • FEMASYS INC Suwanee, Georgia

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What FEMASYS INC reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Machinery and equipment$3.1M4 Dec 31, 2025$2.9M4 Dec 31, 2024+7.3%
Furniture and fixtures$417.9K4 Dec 31, 2025$417.9K4 Dec 31, 20240%
Leasehold improvements$1.2M4 Dec 31, 2025$1.2M4 Dec 31, 20240%
Construction in progress$897.9K4 Dec 31, 2025$762.4K4 Dec 31, 2024+17.8%
Property and equipment, before depreciation$5.7M4 Dec 31, 2025$5.3M4 Dec 31, 2024+6.8%
Accumulated depreciation$3.8M4 Dec 31, 2025$3.7M4 Dec 31, 2024+1.7%
Property and equipment, net$1.9M4 Dec 31, 2025$1.6M4 Dec 31, 2024+18.8%
Operating-lease assets (leased space)$1.3M4 Dec 31, 2025$1.8M4 Dec 31, 2024−28.2%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$9.3M4 Dec 31, 2025$3.5M4 Dec 31, 2024+168.5%

Intangibles and goodwill

ItemLatestA year beforeChange
Finite-lived intangibles, gross$1.9M4 Dec 31, 2025$1.8M4 Dec 31, 2024+6.5%
Accumulated amortization$1.7M4 Dec 31, 2025$1.7M4 Dec 31, 2024+2.7%
Finite-lived intangibles, net$134.9K4 Dec 31, 2025$65.9K4 Dec 31, 2024+104.7%

Inventory

ItemLatestA year beforeChange
Inventory, total$5.7M4 Dec 31, 2025$3.0M4 Dec 31, 2024+88.4%
Raw materials$2.1M4 Dec 31, 2025$1.3M4 Dec 31, 2024+57.4%
Work in process$1.3M4 Dec 31, 2025$982.6K4 Dec 31, 2024+28.9%
Finished goods$2.4M4 Dec 31, 2025$754.8K4 Dec 31, 2024+219.7%

Properties, in its own words

Properties.

We lease our facility in Suwanee, Georgia which, together with our research and development, controlled environment room and office space, currently totals approximately 41,000 square feet. As of December 31, 2025, our monthly rent payment was $52,614 and is subject to increases on an annual basis. Our lease expires in April 2029, and we have the option to extend the term for one consecutive term of five years, subject to certain terms and conditions.

Item 2 of the 10-K filed Mar 31, 2026.3

Leadership

Who has led FEMASYS INC, and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Kathy Lee-Sepsick2021–now

Chief financial officer

  1. Dov Elefant2022–now

Chief operating officer

  1. Daniel Scott Currie2024–2026
  2. John Charles Canning2026–now
2025
Board members and other officers (16)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerJeremy R. Sippos named Aug 20, 202630
  • Executive OfficerJohn R. Canninng named Aug 20, 202630
  • DirectorCharles Larsen named Nov 22, 2023 to Aug 20, 202630
  • DirectorJoshua Silverman named Nov 22, 2023 to Nov 14, 202531

Timeline

  1. Aug 14, 20268-K Results of operations32
  2. Aug 11, 20268-K Entered a material agreement; Unregistered sale of shares33
  3. Jun 24, 20268-K Other events34
  4. Jun 24, 20268-K Shareholder vote35
  5. Jun 5, 20268-K Change to shareholders' rights; Bylaws or fiscal year changed36
  6. Jun 4, 20268-K Regulation FD disclosure37
  7. May 13, 20268-K Regulation FD disclosure38
  8. May 8, 20268-K Results of operations39
  9. Apr 29, 20268-K Shareholder vote40
  10. Apr 1, 20268-K Executive or director change; Other events41
  11. Mar 31, 20268-K Results of operations42
  12. Mar 20, 20268-K Entered a material agreement; Unregistered sale of shares; Executive or director change43
  13. Jun 17, 2021New chief executive Kathy Lee-Sepsick becomes CEO11

Calendar

Coming up

  1. Nov 13, 2026Reports results for the quarter ending Sep/202644

When it reported results

  1. Aug 14, 2026Reported quarterly or annual results32
  2. May 8, 2026Reported quarterly or annual results39
  3. Mar 31, 2026Reported quarterly or annual results42
  4. Nov 14, 2025Reported quarterly or annual results45
  5. Aug 8, 2025Reported quarterly or annual results46
  6. May 8, 2025Reported quarterly or annual results47
  7. Mar 27, 2025Reported quarterly or annual results48
  8. Nov 12, 2024Reported quarterly or annual results49

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

286 filings to the SEC since October 2021: 8 annual reports, 15 quarterly reports, 93 major events, 85 insider forms, 11 large holders, 4 private raises, 70 other. The latest 20:

  1. Oct 15, 2026SCHEDULE 13G EDGAR
  2. Sep 29, 2026424B3 EDGAR
  3. Sep 28, 2026EFFECT EDGAR
  4. Sep 3, 2026S-3 EDGAR
  5. Aug 31, 2026SCHEDULE 13G EDGAR
  6. Aug 20, 2026D EDGAR
  7. Aug 17, 2026SCHEDULE 13D EDGAR
  8. Aug 14, 2026SCHEDULE 13G EDGAR
  9. Aug 14, 202610-Q EDGAR
  10. Aug 14, 20268-K EDGAR
  11. Aug 11, 20264 EDGAR
  12. Aug 11, 20264 EDGAR
  13. Aug 11, 20264 EDGAR
  14. Aug 11, 20264 EDGAR
  15. Aug 11, 20264 EDGAR
  16. Aug 11, 20264 EDGAR
  17. Aug 11, 20263 EDGAR
  18. Aug 11, 20264 EDGAR
  19. Aug 11, 20264 EDGAR
  20. Aug 11, 20264 EDGAR

The 286 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

5 open-market trades by officers, directors and large owners since October 2021: 5 buys and 0 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 7, 2026Mifek Jeffrey GeraldChief Clinical-Medical AffairsBuy3,125$3.20$10.0KForm 4
Aug 7, 2026Sipos Jeremy AlexanderChief Technology OfficerBuy3,125$3.20$10.0KForm 4
Aug 7, 2026Canning John CharlesChief Operating OfficerBuy4,375$3.20$14.0KForm 4
Aug 7, 2026Elefant DovChief Financial OfficerBuy15,625$3.20$50.0KForm 4
Aug 7, 2026Lee-Sepsick KathyChief Executive OfficerBuy15,625$3.20$50.0KForm 4

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Kathy Lee-SepsickPresident and Chief Executive Officer58$542.0K$1.1M58
2025Dov ElefantChief Financial Officer58$432.6K$743.3K58
2025Daniel CurrieChief Operating Officer$384.0K$638.8K58
2024Kathy Lee-SepsickPresident and Chief Executive Officer58$542.0K$800.3K58
2024Dov ElefantChief Financial Officer58$432.6K$605.8K58
2024Daniel CurrieChief Operating Officer$400.7K$529.3K58

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Aug 10, 2026Raised $30 million in a private offering of equity Form D: 41 investors so far Form D
  2. Nov 7, 2025Raised $8 million in a private offering of debt Form D: $12 million offered in all Form D
  3. Jun 2, 2025Raised $1.4 million in a private offering of equity Form D: 6 investors so far Form D
  4. Nov 14, 2023Raised $6.8 million in a private offering of debt Form D: 4 investors so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Dauntless Investment Group, LLC1,867,987$7.8M13.5%New
Vanguard Capital Management LLC62,232$260.1K0.0%New
Jane Street Group, LLC52,511$219.5K0.0%New
Geode Capital Management, LLC30,920$129.3K0.0%New
UBS Group AG18,777$78.5K0.0%New
Citadel Advisors LLC16,921$70.7K0.0%New
Vanguard Fiduciary Trust Co12,492$52.2K0.0%New
Osaic Holdings, Inc.2,397$10.0K0.0%New
BlackRock, Inc.1,784$7.5K0.0%New
Northwestern Mutual Wealth Management Co1,000$4.2K0.0%New
Arax Advisory Partners900$3.8K0.0%New
Whittier Trust Co Of Nevada Inc794$3.1K0.0%New
Trust Co Of Toledo Na /oh/87$3640.0%New
IFP Advisors, Inc50$2090.0%New
Barclays PLC8$330.0%New
SBI Securities Co., Ltd.7$290.0%New
Morgan Stanley3$130.0%New

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How FEMASYS INC is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARFEMASYS INC1
  • CIK0001339005
  • Employer ID (EIN)11-37134993
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)3841 Surgical & Medical Instruments & Apparatus1
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
  • Business address3950 Johns Creek Court, Suite 100, Suwanee, GA 300241
  • Phone770-500-39101
  • Shares outstanding8,375,027 as of Aug 13, 202610
  • Public float$29.9M as of Jun 30, 20253
  • AuditorKPMG LLP, Atlanta, Georgia PCAOB ID 185; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceSep 15, 20051
  • Filings340 in all: 8-K (98), 4 (75), 3 (24), 10-Q (16), D (15), CORRESP (12), 424B3 (9), EFFECT (8)1
    All 35 form types

    S-8 (8), UPLOAD (8), DEF 14A (7), SCHEDULE 13G (7), 10-K (5), S-3 (5), DEFA14A (4), 10-K/A (3), 424B5 (3), ARS (3), PRE 14A (3), REGDEX (3), S-1 (3), S-1/A (3), 3/A (2), D/A (2), DRS (2), DRSLTR (2), SCHEDULE 13G/A (2), 424B4 (1), 8-A12B (1), 8-K/A (1), CERT (1), DRS/A (1), S-3/A (1), SC 13D (1), SCHEDULE 13D (1)

  • Latest filingsAnnual report (10-K) Mar 31, 2026
    Quarterly report (10-Q) Aug 14, 2026
    Proxy statement (DEF 14A) Apr 30, 2026
    Latest 8-K (8-K) Aug 14, 2026

Securities registered for trading

ClassSymbolExchange
Common stock, par value $0.001FEMYNASDAQ

From the cover page of the 10-K filed Mar 31, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks FEMASYS INC names in Item 1A of its 10-K filed Mar 31, 2026: 73 risks under these headings, as written.3

  • Risks Related to Our Financial Position and Need for Additional Capital
  • We have incurred significant operating losses since inception, we expect to incur operating losses in the future and we may not be able to achieve or sustain profitability. We have limited history operating as a commercial company.
  • We need substantial additional funding and may be unable to raise capital when needed, which could force us to delay or reduce our commercialization efforts or product development programs.
  • There is substantial doubt about our ability to continue as a going concern.
  • There are risks associated with our convertible notes and warrants that could adversely affect our business and financial condition.
  • Our financial results may fluctuate significantly and may not fully reflect the underlying performance of our business.
  • We have received deficiency notices from Nasdaq relating to our non-compliance with Nasdaq's continued listing requirements and our common stock could become subject to delisting from Nasdaq if we fail to regain compliance.
  • Risks Related to Discovery and Development
  • Enrollment and retention of subjects in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control.
  • Our current U.S. product candidate, FemBloc is in late-stage of development. Our U.S. product candidate may fail in development or suffer delays that adversely affect its commercial viability. If we fail to obtain or maintain FDA approval to market and sell our FemBloc our business will be materially harmed.
  • As we evolve from a company that is primarily involved in clinical development to a company that is also involved in commercialization, we may encounter difficulties in expanding our operations successfully.
  • We are significantly dependent on the FDA’s permission to market our FemBloc system, as well as market acceptance in the United States for it, and our failure to receive FDA authorization to market the FemBloc system or the failure of it to gain such market acceptance would negatively impact our business.
The other 63 risks
  • Interim, “topline,” and preliminary data from our clinical trials that we announce or publish from time to time may change as more data become available and are subject to confirmation, audit, and verification procedures that could result in material changes in the final data.
  • If patients or healthcare practitioners are not willing to change current practices to adopt our permanent birth control solution or artificial insemination solution, our products may fail to gain increased market acceptance, and our business will be adversely affected.
  • If we are unable to achieve and maintain adequate levels of coverage or reimbursement for our permanent birth control solution or any other products we seek to commercialize, our commercial success may be severely hindered.
  • Third-party payors and healthcare practitioners who do not cover or use our permanent birth control solution or other women’s healthcare devices may require additional clinical data prior to adopting or maintaining coverage of our products.
  • The training required for healthcare practitioners to use our artificial insemination solution and permanent birth control solution could reduce the market acceptance of our products.
  • We currently compete and will in the future continue to compete against other companies, some of which have longer operating histories, more established products or greater resources than we do, which may prevent us from achieving increased market penetration and improved operating results.
  • Our long-term growth depends on our ability to enhance our artificial insemination solution, permanent birth control solution and women-specific medical product solutions, expand our indications and develop and commercialize additional products.
  • Our results of operations could be materially harmed if we are unable to accurately forecast customer demand for our artificial insemination solution, permanent birth control solution, and women-specific medical products and manage our inventory.
  • We manufacture and assemble components for our products and U.S. product candidate, and a loss or degradation in the performance of our manufacturing capabilities could have a material adverse effect on our business, financial condition and results of operations.
  • We rely on a limited number of third-party suppliers for components for our products, as well as the sterilization of certain of our products, and a loss or degradation in performance of these suppliers could have a material adverse effect on our business, financial condition and results of operations.
  • Performance issues, service interruptions or price increases by our shipping carriers could adversely affect our business and harm our reputation and ability to provide our services on a timely basis.
  • Consolidation in the healthcare industry or group purchasing organizations could lead to demands for price concessions, which may affect our ability to sell our products at prices necessary to support our current business strategies.
  • We have limited experience marketing and selling our women-specific medical product solutions, and if we are unable to expand, manage and maintain our direct sales and marketing organization we may not be able to generate revenue growth.
  • To successfully market and sell our artificial insemination product, permanent birth control system, and women specific medical product solutions in markets outside of the United States, we must address many international business risks with which we have limited experience.
  • We plan to rely on our own direct sales force in North America for our women-specific medical products, which may result in higher fixed costs than our competitors and may slow our ability to reduce costs in the face of a sudden decline in demand for our products.
  • We face the risk of product liability claims that could be expensive, divert management’s attention and harm our reputation and business. We may not be able to maintain adequate product liability insurance.
  • If the quality of our artificial insemination product, permanent birth control system, and women-specific medical product solutions does not meet the expectations of healthcare practitioners or patients, then our brand and reputation or our business could be adversely affected.
  • If we choose to acquire new and complementary businesses, products or technologies, we may be unable to complete these acquisitions or to successfully integrate them in a cost-effective and non-disruptive manner.
  • Risks Related to Managing Growth and Employee Matters
  • We face risks related to health epidemics and outbreaks, which could significantly disrupt our commercialization activities and clinical trials, and could have an adverse impact on our business.
  • Failure of a key information technology system, process or site could have an adverse effect on our business.
  • If our facilities are damaged or become inoperable, we will be unable to continue to research, develop, manufacture and supply our products and, as a result, there will be an adverse effect on our business until we are able to secure a new facility and rebuild our inventory.
  • Our ability to maintain our competitive position depends on our ability to attract and retain senior management and other highly qualified personnel.
  • We will need to grow the size of our organization, and we may experience difficulties in managing this growth.
  • The increasing use of social media platforms presents new risks and challenges.
  • Risks Related to Government Regulation
  • Our products and operations are subject to extensive government regulation and oversight both in the United States and abroad, and our failure to comply with applicable requirements could harm our business.
  • We may not receive the necessary approvals, granted de novo classifications, or clearances for our FemBloc system or future devices and expanded indications, and failure to timely obtain these marketing authorizations would adversely affect our ability to grow our business.
  • Modifications to our products may require us to obtain new PMA approvals or approvals of a PMA supplement, and if we market modified products without obtaining necessary approvals, we may be required to cease marketing or recall the modified products until required approvals are obtained for the United States.
  • Failure to comply with post-marketing regulatory requirements could subject us to enforcement actions, including substantial penalties, and might require us to recall or withdraw a product from the market.
  • Our products must be manufactured in accordance with federal and state regulations, and we or any of our suppliers could be forced to recall our products or terminate production if we fail to comply with these regulations.
  • If treatment guidelines for permanent birth control or other women healthcare treatments change or the standard of care evolves, we may need to redesign and seek new marketing authorization from the FDA for one or more of our products.
  • The misuse or off-label use of our products may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory bodies if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.
  • Our products may cause or contribute to adverse medical events or be subject to failures or malfunctions that we are required to report to the FDA, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition and results of operations. The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on us.
  • If we do not obtain and maintain international regulatory registrations or approvals for our products, we will be unable to market and sell our products outside of United States.
  • Legislative or regulatory reforms in the United States or the European Union may make it more difficult and costly for us to obtain regulatory approvals, grants or clearances for our products or to manufacture, market or distribute our products after clearance or approval is obtained.
  • We are subject to certain federal, state and foreign fraud and abuse laws, health information privacy and security laws and transparency laws, which, if violated, could subject us to substantial penalties. Additionally, any challenge to or investigation into our practices under these laws could cause adverse publicity and be costly to respond to, and thus could harm our business.
  • Inadequate funding for the FDA, the SEC and other government agencies, including from government shut downs, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Compliance with ever evolving federal, state, and foreign laws relating to handling of information about individuals involves significant expenditure and resources, and any failure by us or our vendors to comply may result in significant liability, negative publicity, and/or an erosion of trust, and could materially adversely affect our business, results of operations, and financial condition.
  • Healthcare policy changes, including recently enacted legislation reforming the U.S. healthcare system, could harm our business, financial condition and results of operations.
  • Our business involves the use of hazardous materials, and we must comply with environmental laws and regulations, which may be expensive and restrict how we do business.
  • We are subject to anti-bribery, anti-corruption, and anti-money laundering laws, including the U.S. Foreign Corrupt Practices Act, as well as export control laws, customs laws, sanctions laws and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial measures and legal expenses, which could adversely affect our business, results of operations and financial condition.
  • We bear the risk of warranty claims on our products.
  • Risks Related to Intellectual Property Matters
  • If we are unable to adequately protect our intellectual property rights, or if we are accused of infringing on the intellectual property rights of others, our competitive position could be harmed or we could be required to incur significant expenses to enforce or defend our rights.
  • Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.
  • Litigation or other proceedings or third-party claims of intellectual property infringement could require us to spend significant time and money and could prevent us from developing or selling our products or affect our stock price.
  • Third parties may assert ownership or commercial rights to inventions we develop.
  • We may be unable to enforce our intellectual property rights throughout the world.
  • Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.
  • U.S. patent laws could diminish the value of patents in general and may limit our ability to obtain, defend and/or enforce our patents.
  • Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time.
  • If our trademarks or trade names are denied by regulatory authorities or are not adequately protected, we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • Risks Related to Our Common Stock
  • We are a “smaller reporting company” and an “emerging growth company” and the reduced disclosure requirements applicable to “smaller reporting companies” may make our common stock less attractive to investors.
  • Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
  • We incur significant costs as a result of being a public company, which may adversely affect our business, financial condition and results of operations.
  • We are obligated to develop and maintain proper and effective internal controls over financial reporting and any failure to maintain the adequacy of these internal controls may adversely affect investor confidence in our Company and, as a result, the value of our common stock.
  • Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
  • Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.
  • General Risk Factors
  • Adverse developments affecting the financial services industry could adversely affect our current and projected business operations and our financial condition and results of operations.
  • Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.
  • Our internal computer systems, or those of any of our Contract Research Organizations (“CROs”), manufacturers, other contractors, consultants, existing or future collaborators, may fail or suffer security or data privacy breaches or other unauthorized or improper access to, use of or destruction of our proprietary and confidential data, employee data or personal data, which could result in additional costs, significant liabilities, harm to our reputation and material disruption of our operations.
  • The estimates of market opportunity and forecasts of market growth that we provide may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business may not grow at similar rates, or at all.
  • Our employees, independent contractors, consultants, commercial partners, collaborators and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Our ability to use our net operating losses and research and development credit carryforwards to offset future taxable income may be subject to certain limitations.

Legal proceedings

Legal Proceedings.

We are not currently a party to any legal proceedings the outcome of which we believe, if determined adversely to us, would individually or in the aggregate have a material adverse effect on our business, operating results or financial condition. We have received, and may from time to time receive, letters from third parties alleging patent infringement, violation of employment practices or trademark infringement, and we may in the future participate in litigation to defend ourselves. We cannot predict the results of any such disputes, and despite the potential outcomes, the existence thereof may have an adverse material impact on us due to diversion of management time and attention as well as the financial costs related to resolving such disputes.

The opening of Item 3, Legal Proceedings.3

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