Sign in

SEPN on Nasdaq

Septerna, Inc.

American pharmaceutical preparations company based in South San Francisco1

In its 2026 annual report the company says: “We own various U.S. federal trademark filings, including a registered trademark, and possess proprietary trademark rights in our name and logo that we use in connection with the operation of our business.”7 Its shares trade on Nasdaq under the symbol SEPN.1

Price unavailable

Last updated Oct 21, 2026.

Overview

Compare with Protagonist Therapeutics, Inc, Aquestive Therapeutics, Inc. or CUMBERLAND PHARMACEUTICALS INC, or pick any stock.

  • TickerSEPN on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersSouth San Francisco, California1
  • Incorporated inDE2
  • Business address250 East Grand Avenue, Suite 65, South San Francisco, Ca 940802
  • Filer category, Emerging growth company2
  • Legal formCorporation

See how the biggest companies compare on our leaderboards

Financials

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

Key numbers, fiscal 2025

-148.6%Operating margin3
-106.4%Net margin3
4174.5%Revenue growth, 20253
-12.8%Return on equity3
$109.7MFree cash flow3

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development100¢$97.6M
  • Income tax0¢$12.0K

Out of $46.0M in revenue.3 The company lost money this year.

Where each dollar of operating cash went, fiscal 2025

  • Capital spending0¢$518.0K
  • Kept or used elsewhere100¢$109.7M

Out of $110.2M of cash from operations.3

Financial statements

Revenue43$46.0M in 2025+30331% since 2023
0$20.0M$40.0M$60.0M2023: $151.0K$151.0K20232024: $1.1M$1.1M2024+612%2025: $46.0M$46.0M2025+4175%
Operating income43-$68.3M in 2025
-$100.0M-$75.0M-$50.0M-$25.0M0$25.0M2023: $2.1M$2.1M20232024: -$80.8M-$80.8M20242025: -$68.3M-$68.3M2025−15%
Net income43-$48.9M in 2025
-$80.0M-$60.0M-$40.0M-$20.0M0$20.0M2023: $4.2M$4.2M20232024: -$71.8M-$71.8M20242025: -$48.9M-$48.9M2025−32%

Every line of the income statement as filed: the last 3 fiscal years, latest first.3

Period ending2025-12-312024-12-312023-12-31
Revenue$46.0M$1.1M
Research and development$97.6M$65.3M
General and administrative$29.2M$16.6M
Gain on sale of non-financial asset-$12.5M$0
Total operating expenses$114.2M$81.9M
Loss from operations-$68.3M-$80.8M
Interest income$19.5M$8.6M
Other expense, net-$100.0K-$90.0K
Total other income, net$19.4M$8.5M
Loss before provision (benefit) for income taxes-$48.9M-$72.3M-$48.9M
Provision (benefit) for income taxes$12.0K-$498.0K
Net loss-$48.9M-$71.8M
Net loss per share, basic-$1.10-$7.26
Net loss per share, diluted-$1.10-$7.26
Weighted-average shares outstanding, basic44.3M shares9.9M shares
Weighted-average shares outstanding, diluted44.3M shares9.9M shares
Net unrealized gain on marketable securities$561.0K$56.0K
Total other comprehensive income$561.0K$56.0K
Comprehensive loss-$48.3M-$71.7M

Compare Septerna, Inc. with another company

Corporate structure

Septerna, 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 Septerna, Inc.

  • Septerna, Inc. South San Francisco, California

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

What it owns

What Septerna, 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$8.8M3 Dec 31, 2025$8.0M3 Dec 31, 2024+9.6%
Accumulated depreciation$4.4M3 Dec 31, 2025$2.9M3 Dec 31, 2024+48.6%
Property and equipment, net$4.4M3 Dec 31, 2025$5.1M3 Dec 31, 2024−12.9%
Operating-lease assets (leased space)$21.5M3 Dec 31, 2025$23.6M3 Dec 31, 2024−8.9%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$120.7M3 Dec 31, 2025$238.2M3 Dec 31, 2024−49.3%
Marketable securities, current$270.4M3 Dec 31, 2025$112.7M3 Dec 31, 2024+139.8%
Marketable securities, non-current$157.6M3 Dec 31, 2025$69.9M3 Dec 31, 2024+125.5%
Debt securities available for sale$480.3M3 Dec 31, 2025$273.2M3 Dec 31, 2024+75.8%

Properties, in its own words

Our corporate headquarters are located in South San Francisco, California, where we lease and occupy approximately 44,819 square feet of combined office, research and laboratory space at 250 East Grand Avenue, South San Francisco, California 94080. The current term of our lease expires in July 2032.

We believe that our existing facilities are adequate for our current needs and for the foreseeable future. To meet the future needs of our business, we may lease additional or alternate space. We believe that suitable additional or substitute space at commercially reasonable terms will be available as needed to accommodate any future expansion of our operations.

Item 2 of the 10-K filed Mar 9, 2026.7

Leadership

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

Chief executive

  1. Jeffrey Finer2024–now

President

  1. Jeffrey Finer2024–2025
  2. Elizabeth Bhatt2025–now

Chief financial officer

  1. Ran Xiao2024
  2. Gil M. Labrucherie2025–now

Chief operating officer

  1. Elizabeth Bhatt2024–now
2025
Board members and other officers (14)

Timeline

  1. Aug 25, 20268-K Regulation FD disclosure; Other events25
  2. Aug 10, 20268-K Results of operations26
  3. Jun 30, 20268-K Shareholder vote27
  4. May 11, 20268-K Results of operations28
  5. Apr 13, 20268-K Regulation FD disclosure29
  6. Mar 9, 20268-K Results of operations30
  7. Mar 2, 20268-K Regulation FD disclosure; Other events31
  8. Jan 12, 20268-K Regulation FD disclosure32
  9. Jan 8, 20268-K Regulation FD disclosure33
  10. Nov 10, 20258-K Results of operations34
  11. Sep 29, 20258-K Executive or director change; Regulation FD disclosure35
  12. Sep 3, 20258-K Regulation FD disclosure36
  13. Oct 24, 2024New chief executive Jeffrey Finer becomes CEO8

Calendar

Coming up

  1. Nov 9, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.09) a share, on Nov 10, 2025.37

When it reported results

  1. Aug 10, 2026Reported quarterly or annual results26
  2. May 11, 2026Reported quarterly or annual results28
  3. Mar 9, 2026Reported quarterly or annual results30
  4. Nov 10, 2025Reported quarterly or annual results34
  5. Aug 11, 2025Reported quarterly or annual results38
  6. May 15, 2025Reported quarterly or annual results39
  7. Mar 27, 2025Reported quarterly or annual results40
  8. Nov 20, 2024Reported quarterly or annual results41

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

Filings

168 filings to the SEC since October 2021: 2 annual reports, 6 quarterly reports, 26 major events, 79 insider forms, 12 large holders, 1 private raises, 42 other. The latest 20:

  1. Oct 1, 2026144 EDGAR
  2. Oct 1, 2026144 EDGAR
  3. Sep 10, 20264 EDGAR
  4. Sep 3, 20263 EDGAR
  5. Sep 3, 20264 EDGAR
  6. Aug 25, 20268-K EDGAR
  7. Aug 14, 2026SCHEDULE 13D/A EDGAR
  8. Aug 14, 20264 EDGAR
  9. Aug 14, 20264 EDGAR
  10. Aug 14, 2026SCHEDULE 13G/A EDGAR
  11. Aug 13, 20264 EDGAR
  12. Aug 12, 2026144 EDGAR
  13. Aug 12, 2026144 EDGAR
  14. Aug 12, 2026144 EDGAR
  15. Aug 11, 2026144 EDGAR
  16. Aug 10, 202610-Q EDGAR
  17. Aug 10, 20268-K EDGAR
  18. Aug 5, 20264 EDGAR
  19. Jul 17, 20264 EDGAR
  20. Jul 15, 2026144 EDGAR

The 168 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

33 open-market trades by officers, directors and large owners since October 2021: 17 buys and 16 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 1, 2026Long Daniel D.SVP, Drug DiscoverySale3,333$37.83$126.1KForm 4
Aug 12, 2026Shah Rajeev M.DirectorSale1,493,000$42.50$63.5MForm 4
Aug 12, 2026Third Rock Ventures GP VI, L.P.10% ownerSale147,200$50.27$7.4MForm 4
Aug 11, 2026Bhatt ElizabethPresident and COOSale25,000$44.00$1.1MForm 4
Aug 3, 2026Long Daniel D.SVP, Drug DiscoverySale3,334$34.47$114.9KForm 4
Jul 15, 2026Bhatt ElizabethPresident and COOSale4,000$33.99$136.0KForm 4
Jul 1, 2026Long Daniel D.SVP, Drug DiscoverySale3,333$34.36$114.5KForm 4
Jun 29, 2026Shaikhly SamiraChief People OfficerSale2,178$35.18$76.6KForm 4
Jun 22, 2026Long Daniel D.SVP, Drug DiscoverySale15,000$35.51$532.6KForm 4
Jun 12, 2026Shaikhly SamiraChief People OfficerSale6,250$35.08$219.2KForm 4
Jun 1, 2026Shaikhly SamiraChief People OfficerSale5,935$28.92$171.7KForm 4
May 26, 2026Shaikhly SamiraChief People OfficerSale11,798$30.06$354.6KForm 4
Apr 15, 2026Bhatt ElizabethPresident and COOSale4,000$24.34$97.4KForm 4
Mar 2, 2026Shaikhly SamiraChief People OfficerSale70,453$28.10$2.0MForm 4
Feb 18, 2026Bhatt ElizabethPresident and COOSale4,000$28.96$115.9KForm 4
Nov 10, 2025Long Daniel D.SVP, Drug DiscoverySale3,501$18.06$63.2KForm 4
Mar 7, 2025Ezekowitz AlanDirectorBuy13,319$6.93$92.3KForm 4
Mar 6, 2025Ezekowitz AlanDirectorBuy41,355$6.00$248.1KForm 4
Mar 5, 2025Ezekowitz AlanDirectorBuy37,835$5.82$220.2KForm 4
Mar 4, 2025Ezekowitz AlanDirectorBuy7,491$6.35$47.6KForm 4

All 33 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
2025Gil M. LabrucherieCFA, J.D.$479.5K$3.2M47
2025Jeffrey FinerM.D., Ph.D$635.0K$2.9M47
2025Liz BhattM.S., M.B.A58$500.0K$1.6M47
2024Chief Executive Officer$550.2K$4.7M47
2024President and Chief Operating Officer$449.6K$1.6M47

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$73.5M 2023–2023
Money received by yearMoney received by year, 2023–2023: $73.5M in all. Private raises (Form D) $73.5M.$0$20M$40M$60M$80M2023 · Private raises (Form D): $73.5M2023
Figures by year
YearPrivate raises (Form D)Total
2023$73.5M$73.5M

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. Jun 28, 2023Raised $73.5 million in a private offering of equity48 Form D: $150 million offered in all 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 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Ra Capital Management, L.P.6,995,858$234.3M2.0%No change
Trv Gp V, LLC6,215,591$208.2M41.8%No change
Driehaus Capital Management LLC4,433,058$148.5M0.9%+37,486
Trv Gp Vi, LLC4,211,659$141.0M60.7%No change
Samsara Biocapital, LLC3,149,128$105.5M8.7%No change
Goldman Sachs Group Inc3,062,766$102.6M0.0%+156,339
BlackRock, Inc.1,932,088$64.7M0.0%+109,914
Siren, L.L.C.1,900,000$63.6M1.3%−100,000
Avoro Capital Advisors LLC1,337,500$44.8M0.4%No change
Jupiter Topco LLC1,307,500$43.7M0.0%New
Vanguard Capital Management LLC1,221,673$40.9M0.0%+24,711
Primecap Management Co/ca/1,167,382$39.1M0.0%+118,548
First Light Asset Management, LLC963,260$32.3M2.0%+230,400
ADAR1 Capital Management, LLC940,747$31.5M1.5%−149,071
Geode Capital Management, LLC679,163$22.8M0.0%+34,017
State Street Corp652,630$21.9M0.0%+21,183
Loomis Sayles & Co L P624,752$20.9M0.0%New
Casdin Capital, LLC553,268$18.5M0.9%No change
Catalio Capital Management, LP536,152$18.0M3.4%+241,792
Algert Global LLC397,487$13.3M0.2%+376,452
Kalehua Capital Management LLC389,088$13.0M4.2%No change
Balyasny Asset Management L.P.350,442$11.7M0.0%+113,763
Longaeva Partners L.P.298,171$10.0M0.3%+223,604
Soleus Capital Management, L.P.275,000$9.2M0.3%No change
Vanguard Portfolio Management LLC230,184$7.7M0.0%+35,141

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

SEC filer profile

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

  • Name on EDGARSepterna, Inc.1
  • CIK0001984086
  • Employer ID (EIN)84-38914407
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company7
  • Incorporated inDelaware7
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address250 East Grand Avenue, Suite 65, South San Francisco, CA 940801
  • Phone650-338-35331
  • Shares outstanding46,676,947 as of Aug 5, 20266
  • Public float$363.3M as of Jun 30, 20257
  • AuditorErnst & Young LLP, San Mateo, California PCAOB ID 42; no auditor attestation of internal control over financial reporting7
  • On EDGAR sinceJul 13, 20231
  • Filings168 in all: 4 (60), 8-K (26), 3 (19), 144 (15), 10-Q (6), SCHEDULE 13G/A (6), CORRESP (4), S-8 (3)1
    All 29 form types

    10-K (2), ARS (2), DEF 14A (2), DEFA14A (2), S-1/A (2), SC 13G (2), SCHEDULE 13G (2), UPLOAD (2), 424B4 (1), 8-A12B (1), CERT (1), D (1), DRS (1), DRS/A (1), DRSLTR (1), EFFECT (1), S-1 (1), S-1MEF (1), S-3ASR (1), SC 13D (1), SCHEDULE 13D/A (1)

  • Latest filingsAnnual report (10-K) Mar 9, 2026
    Quarterly report (10-Q) Aug 10, 2026
    Proxy statement (DEF 14A) Apr 30, 2026
    Latest 8-K (8-K) Aug 25, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareSEPNThe Nasdaq Global Market

From the cover page of the 10-K filed Mar 9, 2026 (Section 12(b) of the Exchange Act).7

Risk factors and legal proceedings

The risks Septerna, Inc. names in Item 1A of its 10-K filed Mar 9, 2026: 72 risks under these headings, as written.7

  • Risks Related to Limited Operating History, Financial Position and Capital Requirements
  • We have a limited operating history and have incurred significant operating losses since our inception and expect to incur significant losses for the foreseeable future.
  • We will require substantial additional funding in order to finance our operations. If we are unable to raise additional capital when needed on acceptable terms, or at all, we may be forced to delay, reduce, or terminate certain of our research and product development programs, future commercialization efforts or other operations.
  • We have never generated revenue from product sales and may never be profitable.
  • Risks Related to Discovery, Development and Regulatory Approval of Product Candidates
  • We are early in our development efforts, and as a result it will be years before we commercialize a product candidate, if ever. If we are unable to identify and advance product candidates through preclinical studies and clinical trials, obtain marketing approval and ultimately commercialize them, or experience significant delays in doing so, our business will be materially harmed.
  • Preclinical and clinical drug development is a lengthy and expensive process, with uncertain timelines and outcomes. If preclinical studies or clinical trials of our product candidates are prolonged or delayed, we may be unable to obtain required regulatory approvals, and therefore be unable to commercialize our therapeutic candidates or any of our future therapeutic candidates on a timely basis or at all.
  • We may encounter substantial delays in the commencement, enrollment or completion of our planned clinical trials or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, which could prevent us from commercializing any product candidates we determine to develop on a timely basis, if at all.
  • Serious adverse events, undesirable side effects or other unexpected properties of our product candidates may be identified during development or after approval, which could lead to the discontinuation of our clinical development programs, refusal by regulatory authorities to approve our product candidates or, if discovered following marketing approval, revocation of marketing authorizations or limitations on the use of our product candidates, any of which would limit the commercial potential of such product candidate.
  • Our product candidates are subject to extensive regulation and compliance obligations, which is costly and time-consuming and which may cause unanticipated delays or prevent the receipt of the required approvals to commercialize our product candidates.
  • Enrollment and retention of patients 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, which could adversely affect our business, operating results and prospects.
  • Even if we receive regulatory approval of any product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
The other 62 risks
  • If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of our therapeutics may be delayed and, as a result, our stock price may decline.
  • Results of preclinical studies and early clinical trials on any of our product candidates may not be predictive of results of future clinical trials.
  • We may expend our limited resources to pursue a particular product candidate and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • Our proprietary Native Complex Platform® is based on novel technologies that are unproven and may not result in approvable or marketable products, which exposes us to unforeseen risks and makes it difficult for us to predict the time and cost of product development and potential for regulatory approval, and we may not be successful in our efforts to expand our development portfolio of product candidates.
  • Preliminary, topline and interim data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • We may develop our product candidates in combination with other therapies, which would expose us to additional risks.
  • Risks Related to Commercialization, Marketing and Competition
  • We currently have no marketing and sales organization and have no experience as a company in commercializing products, and we may invest significant resources to develop these capabilities. If we are unable to establish marketing, sales or distribution capabilities or enter into agreements with third parties to market and sell our products, we may not be able to generate product revenue.
  • Even if any of our product candidates receive marketing approval, such product candidate may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success, in which case we may not generate significant revenues or become profitable.
  • Even if we are able to commercialize any product candidate, the third-party payor coverage and reimbursement status of newly-approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for our product candidates could limit our ability to market those products and decrease our ability to generate revenue.
  • We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than us.
  • EU drug marketing and reimbursement regulations may materially affect our ability to market and receive coverage for our products in the EU Member States.
  • Obtaining and maintaining marketing approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining marketing approval of our product candidates in other jurisdictions.
  • Our future growth may depend, in part, on our ability to commercialize products in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
  • If the market opportunities for any of our product candidates are smaller than we estimate, even assuming approval of a product candidate, our revenue may be adversely affected, and our business may suffer.
  • Risks Related to Business Operation and Industry
  • Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
  • We expect to expand our organization, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • We are highly dependent on the services of our senior management team and if we are not able to retain these members of our management team and recruit and retain additional management, clinical and scientific personnel, our business will be harmed.
  • Our employees, independent contractors, principal investigators, CROs, consultants, vendors and collaboration partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Changes in U.S. and international trade policies, particularly with respect to China, may adversely impact our business and operating results.
  • Clinical trial and product liability lawsuits against us could divert our resources, could cause us to incur substantial liabilities and could limit commercialization of any product candidates we may develop.
  • If we or any contract manufacturers and suppliers we engage 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.
  • Our future ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
  • We have and may in the future engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management.
  • We have conducted and may continue to conduct, clinical trials for our product candidates outside of the United States, and we may do so for our other product candidates. However, conducting trials outside of the United States exposes us to additional risks, which could materially harm our business.
  • If our information systems or data, or those of third parties with whom we work, are or were compromised, we could experience adverse consequences from such compromises, such as damage to our reputation, significant financial and legal exposure, or other adverse effects to our business.
  • Risks Related to Government Regulatory and Legal Requirements
  • Disruptions at the FDA, SEC and other U.S. government agencies caused reduction in staffing, by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, or otherwise prevent those agencies from performing normal business functions on which the operation of business may relay, which could negatively impact our business.
  • We may not be able to obtain orphan drug designation or exclusivity for our product candidates for which we seek such a designation or exclusivity, and even if we do, that designation may not provide an expedited development or regulatory review or approval process and any orphan drug exclusivity we may receive for approved products may not prevent the FDA or the EMA from approving other competing products.
  • While we may in the future seek designations for our product candidates with the FDA, EMA and other comparable foreign regulatory authorities that are intended to confer benefits such as a faster development process, an accelerated regulatory pathway or regulatory exclusivity, there can be no assurance that we will successfully obtain such designations. In addition, even if one or more of our product candidates are granted such designations, we may not be able to realize the intended benefits of such designations.
  • We are subject to stringent and evolving U.S. and foreign laws, rules, regulations, policies, industry standards, contractual requirements, and other obligations related to data protection, privacy, and security. Our actual or perceived failure to comply with such obligations could adversely affect our business.
  • Our use of new and evolving technologies, such as artificial intelligence, may present risks and challenges that can impact our business, including by posing cybersecurity and other risks to our confidential and/or proprietary information, including personal information, and as a result we may be exposed to reputational harm and liability.
  • Healthcare legislative reform measures may have a negative impact on our business and results of operations.
  • Our relationships with customers, physicians, and third-party payors may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, other healthcare laws and regulations and health data privacy and security laws and regulations, contractual obligations and self-regulatory schemes. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • Legislation or other changes in U.S. tax law may have a material adverse effect on our business, cash flow, financial condition, or results of operations.
  • A decline in the federal budget, changes in spending or budgetary priorities of the U.S. government, a prolonged U.S. government shutdown or delays in contract awards may significantly and adversely affect our future revenues, cash flow and financial results.
  • The U.S. Congress, the Trump administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business
  • We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Compliance with these legal standards could hinder our ability to compete in certain markets. We can face criminal liability and other serious consequences for violations, which can harm our business.
  • Risks Related to Third Party Relationships
  • We currently rely on, and may continue to depend on, collaborations with third parties for the discovery, development and commercialization of our product candidates. If any of these collaborations are not successful, we may not be able to capitalize on the market potential of those product candidates.
  • We rely on third-party manufacturers, CROs, CMOs, and suppliers to supply, develop and test components of our product candidates. The loss of our third-party manufacturers, CROs, CMOs, or suppliers, their failure to comply with applicable regulatory requirements or to supply sufficient quantities at acceptable quality levels or prices, or at all, or changes in methods of product candidate manufacturing, development or formulation would materially and adversely affect our business.
  • We have entered into a collaboration agreement, and may in the future enter into additional collaboration agreements and strategic alliances to maximize the potential of our structure-based drug discovery platform and product candidates, and we may not realize the anticipated benefits of such collaborations or alliances. We expect to form collaborations in the future with respect to our product candidates, but may be unable to do so or to realize the potential benefits of such transactions, which may cause us to alter or delay our development and commercialization plans.
  • The manufacturing of our product candidates is complex, and our third-party manufacturers may encounter difficulties in production. If we or any of our third-party manufacturers encounter such difficulties, our ability to provide supply of our product candidates for clinical trials, our ability to obtain marketing approval, or our ability to provide patients supply of our products, if approved, could be delayed or stopped.
  • We intend to rely on third parties to conduct, supervise and monitor our preclinical studies and clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business.
  • We currently depend and in the future may continue to depend on single- or limited-source suppliers for some of the components and materials used in the product candidates we may develop.
  • Risks Related to Intellectual Property
  • If we are unable to obtain, maintain, defend and enforce patent or other intellectual property protection for our current or any future 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 be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • If we are sued for infringing intellectual property rights of third parties, such litigation could be costly and time consuming and could prevent or delay us from developing or commercializing our product candidates.
  • Our technology licensed from various third parties may be subject to retained rights.
  • We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration date of a third-party patent, which might adversely affect our ability to develop and market our products.
  • We may not be successful in obtaining or maintaining necessary rights to our product candidates through acquisitions and in-licenses.
  • We may be involved in lawsuits to protect or enforce our patents, which could be expensive, time consuming and unsuccessful. Further, our issued patents could be found invalid or unenforceable if challenged in court.
  • We may be subject to claims that we or our employees have misappropriated the intellectual property, including confidential information, know-how or trade secrets, of a third-party, or claiming ownership of what we regard as our own intellectual property.
  • We may license intellectual property rights from third parties. Such licenses may be subject to early termination if we fail to comply with our obligations in our licenses with third parties, which could result in the loss of rights or technology that are material to our business.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business.
  • If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be materially harmed.
  • Confidentiality agreements with employees and third parties may not prevent unauthorized disclosure of our trade secrets and other proprietary information. If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Our intellectual property rights do not necessarily protect against all potential threats to our business.
  • If our trademarks and trade names 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.
  • Rights to improvements to our product candidates may be held by third parties.
  • Risks Related to Ownership of Our Common Stock
  • We do not know whether a market will be sustained for our common stock or what the market price of our common stock will be, and, as a result, it may be difficult for you to sell your shares of our common stock.
  • The market price of our common stock may be volatile, which could result in substantial losses for investors purchasing shares.
  • Future sales, or the perception of future sales, of our common stock in the public market by existing stockholders could cause our stock price to fall.
  • We are an “emerging growth company” and a “smaller reporting company,” and the reduced reporting requirements applicable to emerging growth companies and smaller reporting companies may make our common stock less attractive to investors.

Legal proceedings

From time to time, we may become involved in or be subject to legal proceedings, claims and litigation arising from the ordinary course of business. We are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are probable to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on our business, financial condition, results of operations and prospects because of defense and settlement costs, diversion of management resources and other factors.

The opening of Item 3, Legal Proceedings.7

Sources

The numbers on this page point here. Each one links to the record it came from.

  1. 1
  2. 2
  3. 3
  4. 4
  5. 5
  6. 6
  7. 7
  8. 8
  9. 9
  10. 10
  11. 11
  12. 12
  13. 13
  14. 14
  15. 15
  16. 16
  17. 17
  18. 18
  19. 19
  20. 20
  21. 21
  22. 22
  23. 23
  24. 24
  25. 25
  26. 26
  27. 27
  28. 28
  29. 29
  30. 30
  31. 31
  32. 32
  33. 33
  34. 34
  35. 35
  36. 36
  37. 37
  38. 38
  39. 39
  40. 40
  41. 41
  42. 42
  43. 43
  44. 44
  45. 45
  46. 46
  47. 47
  48. 48