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FTH on Nasdaq

Faeth Therapeutics, Inc.

In its 2026 annual report the company says: “We are a clinical-stage biotechnology company focused on improving outcomes for cancer patients through multi-node inhibition of critical oncogenic pathways.”3 It is headquartered in Austin, Texas.1 Its shares trade on Nasdaq under the symbol FTH.1

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Last updated Oct 21, 2026.

Overview

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  • TickerFTH on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersAustin, Texas1
  • Incorporated inDE2
  • Business address701 Tillery Street #12 #1010, Austin, Tx 787022
  • Filer category, Emerging growth company2
  • Legal formCorporation

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We are a clinical-stage biotechnology company focused on improving outcomes for cancer patients through multi-node inhibition of critical oncogenic pathways. On February 17, 2026, we completed the acquisition of Faeth Therapeutics, a clinical-stage biotechnology company developing multi-node therapies that target tumor metabolism and signaling. The Acquisition brought Faeth's lead asset, PIKTOR, a proprietary investigational all-oral combination of serabelisib and sapanisertib that inhibits multiple nodes of the PI3K/AKT/mTOR pathway, into our pipeline. In connection with the Acquisition, we received $200 million in gross proceeds from a private placement financing, or the 2026 Private Placement, from a broad syndicate of investors, including several leading life sciences funds, including B Group Capital, Balyasny Asset Management, Columbia Threadneedle Investments, Cormorant Asset Manag…3 From its latest annual report

Financials

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

Financial statements

Operating income45678-$22.3M in 2025+15% since 2020
-$60.0M-$40.0M-$20.0M02020: -$19.5M-$19.5M20202021: -$37.5M-$37.5M2021+93%2022: -$50.2M-$50.2M2022+34%2023: -$37.1M-$37.1M2023−26%2024: -$32.6M-$32.6M2024−12%2025: -$22.3M-$22.3M2025−32%
Net income45678-$21.1M in 2025+5% since 2020
-$60.0M-$40.0M-$20.0M02020: -$20.1M-$20.1M20202021: -$36.8M-$36.8M2021+83%2022: -$48.6M-$48.6M2022+32%2023: -$34.1M-$34.1M2023−30%2024: -$30.2M-$30.2M2024−12%2025: -$21.1M-$21.1M2025−30%

Every line of the income statement as filed: the last 2 fiscal years, latest first.8

Period ending2025-12-312024-12-31
Research and development$11.0M$18.6M
General and administrative$11.3M$13.0M
Long-lived asset impairment$0$951.0K
Total operating expenses$22.3M$32.6M
Loss from operations-$22.3M-$32.6M
Interest income$1.2M$2.5M
Interest expense-$32.0K-$90.0K
Other expense, net-$4.0K-$3.0K
Net loss-$21.1M-$30.2M
Net loss per common share, basic-$16.72-$24.01
Net loss per common share, diluted-$16.72-$24.01
Weighted-average number of shares used in computing net loss per common share, basic1.3M shares1.3M shares
Weighted-average number of shares used in computing net loss per common share, diluted1.3M shares1.3M shares
Net loss attributable to common stockholders-$21.1M-$30.2M
Unrealized gain on marketable securities$14.0K$196.0K
Total other comprehensive income$14.0K$196.0K
Total comprehensive loss-$21.1M-$30.0M

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Corporate structure

Faeth Therapeutics, 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 Faeth Therapeutics, Inc.

  • Faeth Therapeutics, Inc. Austin, Texas

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

What it owns

What Faeth Therapeutics, 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
Property and equipment, before depreciation$622.0K8 Dec 31, 2025$1.9M8 Dec 31, 2024−67.5%
Accumulated depreciation$540.0K8 Dec 31, 2025$1.5M8 Dec 31, 2024−63.9%
Property and equipment, net$82.0K8 Dec 31, 2025$417.0K8 Dec 31, 2024−80.3%
Finance-lease assets$1.0K8 Dec 31, 2025$163.0K8 Dec 31, 2024−99.4%
Operating-lease assets (leased space)$1.3M8 Dec 31, 2025$2.8M8 Dec 31, 2024−53.9%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$8.7M8 Dec 31, 2025$10.0M8 Dec 31, 2024−13.3%
Marketable securities, current$12.5M8 Dec 31, 2025$31.3M8 Dec 31, 2024−60.1%

Properties, in its own words

We have leased office and laboratory space in Boston, Massachusetts pursuant to a lease that expires in September 2026. We also lease office and laboratory space in Rockville, Maryland at 1405 Research Blvd, Suite 125, which serves as our principal executive office. The Rockville research operations were wound down in connection with the 2024 Restructuring, and the space is currently used on a limited basis for administrative purposes. The lease expires in 2027. We believe that our current facilities are adequate to meet our ongoing needs, and that, if we require additional space, we will be able to obtain additional facilities on commercially reasonable terms.

Item 2 of the 10-K filed Mar 30, 2026.3

Leadership

Who has led Faeth Therapeutics, Inc., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. John Celebi2021–2025
  2. Anand Kiran Parikh2026–now

President

  1. John Celebi2021–2025
  2. Christopher Gerry2025–2026
  3. Anand Kiran Parikh2026–now

Chief financial officer

  1. Erin Colgan2022–2024
  2. Brian C. Stephenson2026–now

Chief operating officer

  1. Anand Kiran Parikh2026–now
2025
Board members and other officers (21)

Former names

  • Sensei Biotherapeutics, Inc.Nov 12, 2020 to Jun 16, 20262

Timeline

  1. Sep 17, 20268-K Executive or director change36
  2. Aug 4, 20268-K Results of operations37
  3. Jul 23, 20268-K Executive or director change38
  4. Jun 18, 20268-K Entered a material agreement; Other events39
  5. Jun 16, 2026New chief executive Anand Kiran Parikh becomes CEO11
  6. Jun 15, 20268-K Ended a material agreement; Executive or director change; Bylaws or fiscal year changed40
  7. Jun 10, 20268-K Executive or director change; Bylaws or fiscal year changed; Shareholder vote41
  8. May 22, 20268-K Other events42
  9. May 21, 20268-K Other events43
  10. May 15, 20268-K Results of operations44
  11. Apr 16, 20268-K Executive or director change45
  12. Apr 15, 20268-K Financial statements and exhibits46
  13. Mar 30, 20268-K Results of operations47
  14. Feb 3, 2021New chief executive John Celebi becomes CEO12

Calendar

Coming up

  1. Nov 13, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($3.62) a share, on Nov 14, 2025.48

When it reported results

  1. Aug 4, 2026Reported quarterly or annual results37
  2. May 15, 2026Reported quarterly or annual results44
  3. Mar 30, 2026Reported quarterly or annual results47
  4. Nov 14, 2025Reported quarterly or annual results49
  5. Aug 5, 2025Reported quarterly or annual results50
  6. May 6, 2025Reported quarterly or annual results51
  7. Mar 28, 2025Reported quarterly or annual results52
  8. Nov 14, 2024Reported quarterly or annual results53

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

Filings

336 filings to the SEC since October 2021: 7 annual reports, 15 quarterly reports, 74 major events, 166 insider forms, 25 large holders, 1 private raises, 48 other. The latest 20:

  1. Sep 17, 20268-K EDGAR
  2. Sep 15, 20264 EDGAR
  3. Sep 15, 20263 EDGAR
  4. Aug 14, 2026SCHEDULE 13G/A EDGAR
  5. Aug 14, 2026SCHEDULE 13G/A EDGAR
  6. Aug 14, 2026SCHEDULE 13G EDGAR
  7. Aug 14, 2026SCHEDULE 13G/A EDGAR
  8. Aug 11, 2026144 EDGAR
  9. Aug 4, 20268-K EDGAR
  10. Aug 4, 202610-Q EDGAR
  11. Jul 28, 20263 EDGAR
  12. Jul 23, 20264 EDGAR
  13. Jul 23, 20264 EDGAR
  14. Jul 23, 20268-K EDGAR
  15. Jul 1, 20264 EDGAR
  16. Jun 26, 20264 EDGAR
  17. Jun 24, 20264 EDGAR
  18. Jun 24, 20264 EDGAR
  19. Jun 23, 20263 EDGAR
  20. Jun 23, 2026SCHEDULE 13G EDGAR

The 336 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

112 open-market trades by officers, directors and large owners since October 2021: 94 buys and 18 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jul 1, 2026STEPHENSON BRIAN CChief Financial OfficerBuy5,000$23.50$117.5KForm 4
Jun 30, 2026STEPHENSON BRIAN CChief Financial OfficerBuy7,803$24.25$189.2KForm 4
Jun 29, 2026STEPHENSON BRIAN CChief Financial OfficerBuy831$23.34$19.4KForm 4
Jun 26, 2026STEPHENSON BRIAN CChief Financial OfficerBuy6,250$24.95$155.9KForm 4
Jun 24, 2026STEPHENSON BRIAN CChief Financial OfficerBuy9,391$26.13$245.4KForm 4
Jun 23, 2026STEPHENSON BRIAN CChief Financial OfficerBuy9,230$24.36$224.8KForm 4
Jun 22, 2026Parikh Anand KiranPresident and CEOBuy2,806$19.76$55.4KForm 4
Jun 22, 2026STEPHENSON BRIAN CChief Financial OfficerBuy8,183$22.13$181.1KForm 4
Jun 1, 2026Cambrian BioPharma Inc10% ownerSale25,000$20.02$500.5KForm 4
Jun 1, 2026Peyer James10% ownerSale25,000$20.02$500.5KForm 4
Apr 7, 2026ICS OPPORTUNITIES II LLC10% ownerBuy1,108$33.38$37.0KForm 4
Apr 7, 2026ICS OPPORTUNITIES II LLC10% ownerSale8,151$31.01$252.8KForm 4
Apr 6, 2026ICS OPPORTUNITIES II LLC10% ownerBuy1,104$31.02$34.2KForm 4
Apr 6, 2026ICS OPPORTUNITIES II LLC10% ownerSale1,259$31.05$39.1KForm 4
Apr 2, 2026ICS OPPORTUNITIES II LLC10% ownerBuy2,003$35.01$70.1KForm 4
Apr 2, 2026ICS OPPORTUNITIES II LLC10% ownerSale7,666$32.12$246.2KForm 4
Apr 1, 2026MILLENNIUM MANAGEMENT LLC10% ownerBuy6,175$34.49$213.0KForm 4
Apr 1, 2026MILLENNIUM MANAGEMENT LLC10% ownerSale1,150$31.65$36.4KForm 4
Mar 31, 2026MILLENNIUM MANAGEMENT LLC10% ownerBuy6,005$28.16$169.1KForm 4
Mar 31, 2026MILLENNIUM MANAGEMENT LLC10% ownerSale1,591$25.49$40.6KForm 4

All 112 trades can be filtered by person here when JavaScript is on.

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
2025John Celebi$481.9K$1.3M65
2025Edward van der HorstPh.D.$357.1K$749.2K65
2025Stephanie Krebs$346.4K$730.7K65
2025Christopher W. GerryPresident and General Counsel$398.2K$434.6K65
2025Josiah CraverSVP, Finance$372.6K$409.7K65
2024Former President and Chief Executive Officer$535.6K$1.2M65
2024Former Chief Scientific Officer$400.0K$667.7K65
2024Former Chief Business Officer$385.0K$584.4K65

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$348.9M 2026–2026
Money received by yearMoney received by year, 2026–2026: $348.9M in all. Private raises (Form D) $348.9M.$0$100M$200M$300M$400M2026 · Private raises (Form D): $348.9M2026
Figures by year
YearPrivate raises (Form D)Total
2026$348.9M$348.9M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Feb 17, 2026Raised $348.9 million in a private offering of equity66 Form D: 104 investors so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 45. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Montanova Capital, LLC2,020,103$50.5M1.1%+1,985,554
Avoro Capital Advisors LLC1,444,039$36.1M0.3%New
Baker Bros. Advisors LP1,286,411$32.2M0.2%New
Balyasny Asset Management L.P.1,042,198$26.1M0.0%+1,025,993
Ra Capital Management, L.P.722,020$18.1M0.2%New
Vivo Capital, LLC722,020$18.1M1.6%No change
Logos Global Management LP722,020$18.1M0.8%+692,020
Fairmount Funds Management LLC722,020$18.1M1.2%New
Caligan Partners LP629,467$15.7M0.8%+503,465
B Group, Inc.610,169$15.3M8.7%New
Trails Edge Capital Partners, LP515,335$12.9M2.0%+390,335
Franklin Resources Inc494,516$12.4M0.0%+361,010
Octagon Capital Advisors LP361,010$9.0M0.8%New
ADAR1 Capital Management, LLC361,010$9.0M0.4%New
Cormorant Asset Management, LP1,028,242$7.7M0.4%+722,020
Marshall Wace, Llp206,508$5.2M0.0%+140,778
Boxer Capital Management, LLC180,505$4.5M0.3%New
Patient Square Capital LP175,050$4.4M0.7%New
Alyeska Investment Group, L.P.144,404$3.6M0.0%New
Affinity Asset Advisors, LLC144,404$3.6M0.2%New
Boothbay Fund Management, LLC133,643$3.3M0.1%+107,519
AWM Investment Company, Inc.111,343$2.8M0.2%New
Richmond Investment Services, LLC79,731$2.0M0.6%New
Ikarian Capital, LLC35,386$884.6K0.1%+29,035
UBS Group AG21,541$538.5K0.0%+17,012

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

SEC filer profile

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

  • Name on EDGARFaeth Therapeutics, Inc.1
  • CIK0001829802
  • Employer ID (EIN)83-18633853
  • 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)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address701 Tillery Street #12 #1010, Austin, TX 787021
  • Mailing address1405 Research Blvd, Suite 125, Rockville, MD 208501
  • Phone512-200-29821
  • Shares outstanding25,840,425 as of Jul 30, 202610
  • Public float$7.1M as of Jun 30, 20253
  • AuditorDeloitte & Touche LLP, Baltimore, Maryland PCAOB ID 34; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceNov 12, 20201
  • Filings445 in all: 4 (197), 8-K (83), 3 (30), 10-Q (17), 4/A (13), DEFA14A (9), 144 (8), CORRESP (7)1
    All 39 form types

    SC 13D/A (7), SCHEDULE 13G (7), 10-K (6), S-8 (6), DEF 14A (5), ARS (4), SC 13G/A (4), SCHEDULE 13G/A (4), EFFECT (3), S-3/A (3), SC 13G (3), UPLOAD (3), 10-K/A (2), 3/A (2), 424B5 (2), 8-A12B (2), PRE 14A (2), S-3 (2), SC 13D (2), 424B4 (1), 8-K/A (1), CERT (1), D (1), DRS (1), DRS/A (1), DRSLTR (1), S-1 (1), S-1/A (1), S-1MEF (1), S-3ASR (1), SEC STAFF LETTER (1)

  • Latest filingsAnnual report (10-K) Mar 30, 2026
    Quarterly report (10-Q) Aug 4, 2026
    Proxy statement (DEF 14A) Apr 27, 2026
    Latest 8-K (8-K) Sep 17, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.0001 par value per shareSNSEThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 30, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Faeth Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 30, 2026: 72 risks under these headings, as written.3

  • Risks Related to Our Financial Position
  • We have a limited operating history and have incurred significant losses in every year since our inception. We expect to continue to incur losses over the next several years and may never achieve or maintain profitability.
  • Our operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
  • We will need substantial additional funding to complete the development of our product candidates. A failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development or commercialization efforts.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • Our business could be adversely affected by economic downturns, inflation, increases in interest rates, natural disasters, public health crises such as pandemics, political crises, geopolitical events, or other macroeconomic conditions, which have in the past and may in the future negatively impact our business and financial performance.
  • Risks Related to the Development of our Product Candidates
  • Our development efforts are in the early stages. If we are unable to advance our product candidates through clinical development, obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.
  • The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.
  • Our business is highly dependent on the success of our product candidates that we advance into the clinic, particularly PIKTOR. All of our product candidates, including PIKTOR, will require significant additional preclinical, clinical and manufacturing development before we may be able to seek regulatory approval for and launch a product commercially and we may not be successful in our efforts.
  • While emerging clinical data from third parties has provided evidence supporting the multi-node inhibition concept for the PI3K/AKT/mTOR pathway, there is no guarantee that PIKTOR’s specific approach will produce comparable clinical results, and earlier approvals for third party drugs in this class could limit our commercial opportunity.
  • If the clinical trials of any of our product candidates fail to demonstrate safety and efficacy to the satisfaction of the FDA or other comparable regulatory authorities, or do not otherwise produce favorable results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
The other 62 risks
  • Clinical trials are difficult to design and implement, can be lengthy and expensive, involve uncertain outcomes and may not ultimately be successful.
  • Negative outcomes or data integrity failures by competitors in the oncology space could adversely affect our business, reputation, and the regulatory and commercial environment in which we operate.
  • We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or have a greater likelihood of success.
  • Success in preclinical studies or clinical trials may not be predictive of results in future clinical trials.
  • We were not involved in the early development of PIKTOR; therefore, we are dependent on third parties having accurately generated, collected, interpreted and reported data from certain preclinical and clinical trials of PIKTOR.
  • Interim topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patients are enrolled and additional data become available, and are subject to audit and verification procedures that could result in material changes in the final data.
  • The cross-trial comparisons we present regarding PIKTOR’s safety and efficacy profile relative to other PI3K/AKT/mTOR pathway agents are subject to significant limitations and may not be predictive of PIKTOR’s relative performance in future controlled studies.
  • We depend on timely enrollment of patients in our clinical trials for our product candidates. If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • The market opportunities for certain of our product candidates may be limited to those patients who are ineligible for or have failed prior treatments and, therefore, may be small, and our projections regarding the size of the addressable market may be incorrect.
  • Our projections of addressable market opportunity for PIKTOR are based on estimates and assumptions that may prove incorrect, and the actual commercial opportunity may be substantially smaller than we expect.
  • Adverse side effects or other safety risks associated with our product candidates could delay or preclude approval, cause us to suspend or discontinue clinical trials, cause us to abandon product candidates, could limit the commercial profile of an approved label, or could result in significant negative consequences following any potential marketing approval.
  • Even if we complete the necessary preclinical studies and clinical trials, the marketing approval process is expensive, time-consuming and uncertain and may prevent us or any future collaboration partners from obtaining approvals for the commercialization of any other product candidate we develop.
  • Risks Related to Manufacturing and our Dependence on Third Parties
  • We currently rely, and expect to continue to rely, on third parties to conduct, supervise, and monitor our preclinical studies and clinical trials. If those third parties do not perform satisfactorily, including failing to meet deadlines for the completion of such clinical trials or failing to comply with regulatory requirements, we may be unable to obtain regulatory approval for our product candidates.
  • Certain of our current and future product candidates will be evaluated in combination with third-party drugs, and we will have limited or no control over the supply, regulatory status, or regulatory approval of such drugs.
  • We currently rely on CMOs for the production of PIKTOR and we expect to rely on CMOs for our other product candidates. This reliance on CMOs increases the risk that we will not have sufficient quantities of such materials, product candidates, or any therapies that we may develop and commercialize, or that such supply will not be available to us at an acceptable cost, which could delay, prevent, or impair our development or commercialization efforts.
  • Because we rely on a limited number of suppliers for the raw materials used in our drug candidates, any delay, shortage or interruption in the supply of such raw materials or contamination in our manufacturing process could lead to delays in the manufacture and supply of our drug candidates.
  • Our employees, principal investigators, CROs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
  • Risks Related to Regulatory Approval of our Product Candidates and Other Legal Compliance Matters
  • If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for our product candidates, we will not be able to commercialize, or will be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially impaired.
  • Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not guarantee that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
  • Even if we receive regulatory approval for any of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, our product candidates, if approved, could be subject to post-market study requirements, marketing and labeling restrictions, and even recall or market withdrawal if unanticipated safety issues are discovered following approval. In addition, we may be subject to penalties or other enforcement action if we fail to comply with regulatory requirements.
  • If we are unable to successfully validate, develop and obtain regulatory approval for any required companion diagnostic tests for our product candidates or experience significant delays in doing so, we may fail to obtain approval or may not realize the full commercial potential of these product candidates.
  • Our relationships with customers, healthcare professionals, and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to significant penalties, including criminal sanctions, administrative civil penalties, exclusion from government healthcare programs, contractual damages, reputational harm and diminished profits and future earnings.
  • Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.
  • We are subject to the U.K. Bribery Act 2010, or the Bribery Act, the U.S. Foreign Corrupt Practices Act of 1977, as amended, or the FCPA, and other anti-corruption laws, as well as export control laws, import and customs laws, trade and economic sanctions laws and other laws governing our operations.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • Risks Related to the Commercialization of our Product Candidates
  • If we are unable to establish sales, marketing and distribution capabilities for our product candidates, or enter into sales, marketing and distribution agreements with third parties, we may not be successful in commercializing our product candidates, if approved.
  • We operate in a rapidly changing industry and face significant competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
  • Even if any of our product candidates receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
  • Coverage and adequate reimbursement may not be available for our current or any future product candidates, which could make it difficult for us to sell profitably, if approved.
  • Our business, operational and financial goals may not be attainable if the market opportunities for our products are smaller than we expect. Our internal research and third-party estimates may not accurately reflect the market opportunities for PIKTOR or our other product candidates today or in the future.
  • Inadequate funding for the FDA, the SEC and other government agencies 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.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain effective patent protection for our technology and product candidates, or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets
  • We may not identify relevant patents or may incorrectly interpret the relevance, scope or expiration of a patent, which might adversely affect our ability to develop and market our products.
  • Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • Third-party claims or litigation alleging infringement of patents or other proprietary rights, or seeking to invalidate our patents or other proprietary rights, may delay or prevent our development and commercialization efforts.
  • We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
  • We may develop or license intellectual property for which development was funded or otherwise assisted by, the U.S. government and/or government agencies, such as the National Institutes of Health, for development of our technology and product candidates. Failure to meet our own obligations to future licensors or upstream licensors, including such government agencies, may result in the loss of our rights to such intellectual property, which could harm our business.
  • We may become involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
  • If we fail to comply with our obligations in the agreements under which we license intellectual property and other rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
  • We may be subject to claims challenging the inventorship of our patent filings and other intellectual property.
  • Any trademarks we may obtain may be infringed or successfully challenged, resulting in harm to our business.
  • Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • We may not be able to protect our intellectual property rights throughout the world, which could impair our business.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural requirements, document submissions, fee payment and other requirements imposed by governmental patent agencies. Our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Risks Related to our Business Operations
  • We will be required to expand our development and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • Our future success depends on our ability to retain key members of senior management and to attract, retain and motivate qualified personnel.
  • Following the Acquisition, certain of our employees who previously worked at a private company are now subject to public company compliance obligations, and any failure to comply with these obligations could expose us to regulatory risk and reputational harm.
  • If we engage in future acquisitions or strategic collaborations, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities and subject us to other risks.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
  • Risks Related to our Securities and our Status as a Public Company
  • The trading price of our common stock may be volatile, and you could lose all or part of your investment.
  • Our business and operations could be negatively affected by any securities litigation or stockholder activism, which could cause us to incur significant expense, hinder execution of business and growth strategies and impact our share price.
  • A significant portion of our total outstanding shares may be sold into the market, which could cause the market price of our common stock to drop significantly, even if our business is doing well.
  • If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud.
  • We are an “emerging growth company” and a “smaller reporting company,” and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies will make our shares of common stock less attractive to investors.
  • We do not anticipate paying any cash dividends on our common stock in the foreseeable future.
  • Changes in tax law could adversely affect our business and financial condition.
  • Our ability to use our net operating losses to offset future taxable income may be subject to certain limitations.
  • We have incurred and expect to continue incurring significantly increased costs as a result of operating as a company whose common stock is publicly traded, and our management will be required to devote substantial time to new compliance initiatives.
  • Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware and, to the extent enforceable, the federal district courts of the United States of America, 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.
  • Insiders have substantial influence over us and could cause us to take actions that may not be, or refrain from taking actions that may be, in our best interest or in the best interest of our stockholders.
  • Risks Related to the Acquisition

Legal proceedings

We are not currently a party to any material legal proceedings. From time to time, we may become involved in other litigation or legal proceedings relating to claims arising from the ordinary course of business.

The opening of Item 3, Legal Proceedings.3

Sources

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