PHAT on Nasdaq

Phathom Pharmaceuticals, Inc.

In its 2026 annual report the company says: “We are a commercial-stage biopharmaceutical company focused on commercializing and developing novel treatments for gastrointestinal, or GI, diseases.”3 It is headquartered in Florham Park, New Jersey.1 Its shares trade on Nasdaq under the symbol PHAT.1

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Last updated Oct 21, 2026.

Overview

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  • TickerPHAT on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersFlorham Park, New Jersey1
  • Incorporated inDE2
  • Business address100 Campus Drive,, Suite 102, Florham Park, Nj 079322
  • Filer categoryNon-accelerated filer, Smaller reporting company2

We are a commercial-stage biopharmaceutical company focused on commercializing and developing novel treatments for gastrointestinal, or GI, diseases. Our approved products, VOQUEZNA®, VOQUEZNA® DUAL PAK® and VOQUEZNA® TRIPLE PAK®, contain vonoprazan, an oral small molecule potassium-competitive acid blocker, or PCAB. PCABs are a novel class of molecules that block acid secretion in the stomach. VOQUEZNA is the only PCAB currently approved for marketing and sale in the United States.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

87.1%Gross margin4
-91.4%Operating margin4
-126.3%Net margin4
216.9%Revenue growth, 20254
-$167.0MFree cash flow4

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue7¢$22.6M
  • Research and development10¢$32.8M
  • Selling, general and admin83¢$279.7M

Out of $175.1M in revenue.4 The company lost money this year.

Financial statements

Revenue564$175.1M in 2025
0$50.0M$100.0M$150.0M$200.0M2022: $0$020222023: $682.0K$682.0K20232024: $55.3M$55.3M2024+8001%2025: $175.1M$175.1M2025+217%
Gross profit564$152.5M in 2025
0$50.0M$100.0M$150.0M$200.0M2022: $0$020222023: $515.0K$515.0K20232024: $47.3M$47.3M2024+9080%2025: $152.5M$152.5M2025+223%
Operating income789564-$160.0M in 2025+51% since 2019
-$300.0M-$200.0M-$100.0M02019: -$106.2M-$106.2M20192020: -$125.7M-$125.7M2020+18%2021: -$135.1M-$135.1M2021+7%2022: -$172.4M-$172.4M2022+28%2023: -$167.3M-$167.3M2023−3%2024: -$277.5M-$277.5M2024+66%2025: -$160.0M-$160.0M2025−42%
Net income789564-$221.2M in 2025−13% since 2019
-$400.0M-$300.0M-$200.0M-$100.0M02019: -$255.1M-$255.1M20192020: -$129.1M-$129.1M2020−49%2021: -$143.9M-$143.9M2021+11%2022: -$197.7M-$197.7M2022+37%2023: -$201.6M-$201.6M2023+2%2024: -$334.3M-$334.3M2024+66%2025: -$221.2M-$221.2M2025−34%

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

Period ending2025-12-312024-12-31
Product revenue, net$175.1M$55.3M
Cost of revenue$22.6M$8.0M
Gross Profit$152.5M$47.3M
Research and development$32.8M$34.1M
Selling, general and administrative$279.7M$290.7M
Total operating expenses$312.5M$324.7M
Loss from operations-$160.0M-$277.5M
Interest income$7.0M$15.2M
Interest expense-$68.1M-$72.0M
Other expense, net-$190.0K-$8.0K
Total other expense-$61.3M-$56.9M
Net loss and comprehensive loss-$221.2M-$334.3M
Net loss per share, basic-$3.03-$5.29
Net loss per share, diluted-$3.03-$5.29
Weighted-average shares of common stock outstanding, basic72.9M shares63.2M shares
Weighted-average shares of common stock outstanding, diluted72.9M shares63.2M shares

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Corporate structure

Phathom Pharmaceuticals, 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 Phathom Pharmaceuticals, Inc.

  • BlackRock Filed SCHEDULE 13G on Phathom Pharmaceuticals, Inc., latest Jul 29, 2026 (4 filings since Oct 21, 2024)
  • MILLENNIUM MANAGEMENT LLC Filed SCHEDULE 13G/A on Phathom Pharmaceuticals, Inc., latest Jul 20, 2026 (6 filings since Aug 13, 2025)
  • Frazier Life Sciences Public Fund, L.P. Filed SCHEDULE 13D/A on Phathom Pharmaceuticals, Inc., latest Nov 4, 2025 (7 filings since May 5, 2023)
  • Carlyle Group Filed SCHEDULE 13G/A on Phathom Pharmaceuticals, Inc., latest Aug 28, 2025 (3 filings since Mar 9, 2023)
  • JENNISON ASSOCIATES LLC Filed SCHEDULE 13G/A on Phathom Pharmaceuticals, Inc., latest Jun 9, 2025 (3 filings since Nov 4, 2024)
  • Prudential Financial Filed SCHEDULE 13G/A on Phathom Pharmaceuticals, Inc., latest Jun 6, 2025 (3 filings since Nov 5, 2024)
  • Takeda Pharmaceutical Company Filed SC 13D/A on Phathom Pharmaceuticals, Inc., latest Apr 10, 2024 (4 filings since Nov 12, 2021)
  • Invesco Filed SC 13G/A on Phathom Pharmaceuticals, Inc., latest Feb 9, 2024 (3 filings since Feb 10, 2022)
  • Medicxi Growth I LP Filed SC 13G/A on Phathom Pharmaceuticals, Inc., latest Jan 26, 2024 (2 filings since Jan 31, 2023)
  • Avidity Partners Management LP Filed SC 13G/A on Phathom Pharmaceuticals, Inc., latest Feb 14, 2023 (2 filings since Feb 14, 2022)
  • James E. Flynn Filed SC 13G/A on Phathom Pharmaceuticals, Inc., latest Feb 10, 2023 (2 filings since Sep 23, 2022)
  • Janus Henderson Group Ltd. Filed SC 13G/A on Phathom Pharmaceuticals, Inc., latest Feb 9, 2023 (2 filings since Feb 10, 2022)
  • Phathom Pharmaceuticals, Inc. Florham Park, New Jersey

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

What it owns

What Phathom Pharmaceuticals, 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$4.5M4 Dec 31, 2025$4.3M4 Dec 31, 2024+5.1%
Accumulated depreciation$3.5M4 Dec 31, 2025$2.8M4 Dec 31, 2024+22.3%
Property and equipment, net$1.1M4 Dec 31, 2025$1.5M4 Dec 31, 2024−27.9%
Operating-lease assets (leased space)$2.6M4 Dec 31, 2025$613.0K4 Dec 31, 2024+324.6%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$130.0M4 Dec 31, 2025$297.3M4 Dec 31, 2024−56.3%

Inventory

ItemLatestA year beforeChange
Inventory, total$5.5M4 Dec 31, 2025$3.2M4 Dec 31, 2024+72.0%
Raw materials$4.1M4 Dec 31, 2025$1.7M4 Dec 31, 2024+134.9%
Finished goods$1.5M4 Dec 31, 2025$1.5M4 Dec 31, 2024−1.5%

Properties, in its own words

Our corporate offices are located in leased offices in Buffalo Grove, Illinois, and Florham Park, New Jersey. We believe that our facilities are adequate to meet our current needs, and that suitable additional alternative spaces will be available in the future on commercially reasonable terms, if required.

For additional information, see Note 4, Lease Commitments included in Item 15 of this Annual Report on Form 10-K.

Item 2 of the 10-K filed Feb 26, 2026.3

Leadership

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

Board members and other officers (16)

Timeline

  1. Sep 29, 20268-K Other events33
  2. Jul 30, 20268-K Results of operations34
  3. Jun 23, 20268-K Other events35
  4. May 21, 20268-K Shareholder vote36
  5. Apr 30, 20268-K Results of operations37
  6. Feb 26, 20268-K Results of operations38
  7. Jan 8, 20268-K Other events39
  8. Jan 7, 20268-K Results of operations40
  9. Nov 4, 20258-K Other events41
  10. Oct 30, 20258-K Results of operations42
  11. Oct 27, 20258-K Other events43
  12. Oct 6, 20258-K Executive or director change44
  13. Apr 3, 2025New chief executive Steven L. Basta becomes CEO12
  14. Jul 2, 2020New chief executive Terrie Curran becomes CEO13
  15. Oct 24, 2019New chief executive David A. Socks becomes CEO14

Calendar

Coming up

  1. Oct 29, 2026 · Before the openReports results for the quarter ending Sep/2026 A year earlier it reported ($0.28) a share, on Oct 30, 2025.45

When it reported results

  1. Jul 30, 2026Reported quarterly or annual results34
  2. Apr 30, 2026Reported quarterly or annual results37
  3. Feb 26, 2026Reported quarterly or annual results38
  4. Jan 7, 2026Reported quarterly or annual results40
  5. Oct 30, 2025Reported quarterly or annual results42
  6. Aug 7, 2025Reported quarterly or annual results46
  7. May 1, 2025Reported quarterly or annual results47
  8. Mar 6, 2025Reported quarterly or annual results48

Drug trials and FDA: coming up

  1. Oct 20, 2027Phase 3 trial readout expected Phase 3 trial of Vonoprazan in Symptomatic Non-erosive Gastroesophageal Reflux Disease: primary completion expected Oct 20, 2027 (ClinicalTrials.gov NCT07752407).49

Drug trials and FDA: recently

  1. Sep 11, 2026Phase 2 trial completed Phase 2 trial of Vonoprazan in Eosinophilic Esophagitis: primary completion Sep 11, 2026, no results posted yet (ClinicalTrials.gov NCT06851559).50
  2. Jul 17, 2024FDA approval FDA approved Voquezna (vonoprazan fumarate) (NDA 218710).51
  3. Nov 1, 2023FDA approval FDA approved Voquezna (vonoprazan fumarate), a new molecular entity (NDA 215151).52

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

325 filings to the SEC since October 2021: 6 annual reports, 17 quarterly reports, 71 major events, 145 insider forms, 48 large holders, 38 other. The latest 20:

  1. Oct 8, 20264 EDGAR
  2. Sep 29, 20268-K EDGAR
  3. Sep 8, 20264 EDGAR
  4. Jul 30, 202610-Q EDGAR
  5. Jul 30, 20268-K EDGAR
  6. Jul 29, 2026SCHEDULE 13G EDGAR
  7. Jul 20, 2026SCHEDULE 13G/A EDGAR
  8. Jul 16, 20264 EDGAR
  9. Jun 23, 20268-K EDGAR
  10. May 27, 20264 EDGAR
  11. May 21, 20264 EDGAR
  12. May 21, 20264 EDGAR
  13. May 21, 20264 EDGAR
  14. May 21, 20264 EDGAR
  15. May 21, 20264 EDGAR
  16. May 21, 20264 EDGAR
  17. May 21, 20264 EDGAR
  18. May 21, 20268-K EDGAR
  19. Apr 30, 202610-Q EDGAR
  20. Apr 30, 20268-K EDGAR

The 325 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

52 open-market trades by officers, directors and large owners since October 2021: 22 buys and 30 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Nov 3, 2025Breedlove Robert CharlesPrincipal Accounting OfficerSale524$13.51$7.1KForm 4
Sep 5, 2025Breedlove Robert CharlesPrincipal Accounting OfficerSale461$12.09$5.6KForm 4
Jul 16, 2025Breedlove Robert CharlesPrincipal Accounting OfficerSale1,692$8.36$14.1KForm 4
May 21, 2025Topper James NDirectorBuy3,780$3.86$14.6KForm 4
May 14, 2025Topper James NDirectorBuy6,300$3.32$20.9KForm 4
May 13, 2025Topper James NDirectorBuy1,120$3.16$3.5KForm 4
May 12, 2025Topper James NDirectorBuy12,601$3.04$38.3KForm 4
May 9, 2025Topper James NDirectorBuy35,602$3.22$114.5KForm 4
May 7, 2025Parikh AsitDirectorBuy5,000$2.40$12.0KForm 4
May 6, 2025Parikh AsitDirectorBuy5,000$2.60$13.0KForm 4
Apr 7, 2025Henderson MollyCFO and CBOSale3,678$4.55$16.7KForm 4
Mar 13, 2025Parikh AsitDirectorBuy10,000$4.42$44.2KForm 4
Jan 21, 2025Henderson MollyCFO and CBOSale6,583$6.59$43.4KForm 4
Jan 21, 2025Nabulsi AzmiChief Operating OfficerSale7,886$6.59$52.0KForm 4
Jan 21, 2025Curran TerriePresident and Chief ExecutiveSale19,109$6.59$125.9KForm 4
Dec 19, 2024Nabulsi AzmiChief Operating OfficerSale1,118$8.00$8.9KForm 4
Dec 19, 2024Henderson MollyCFO and CBOSale1,291$8.00$10.3KForm 4
Dec 13, 2024KARBE FRANKDirectorBuy12,500$7.93$99.1KForm 4
Dec 13, 2024Parikh AsitDirectorBuy10,000$8.12$81.2KForm 4
Jul 15, 2024Nabulsi AzmiChief Operating OfficerSale10,901$11.72$127.8KForm 4

All 52 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
2025Steven Basta60$525.0K$7.0M69
2025Terrie Curran$184.0K$4.9M69
2025Sanjeev Narula65$131.4K$3.6M69
2025Azmi NabulsiM.D., M.P.H.$219.8K$2.7M69
2025Anne Marie Cook64$261.5K$2.1M69
2024Former President and Chief Executive Officer$708.1K$3.6M69
2024Former Chief Operating Officer$569.0K$1.6M69

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
Frazier Life Sciences Management, L.P.12,466,489$135.3M2.9%No change
Medicxi Ventures Management (Jersey) Ltd7,464,572$81.0M45.6%No change
BlackRock, Inc.4,525,129$49.1M0.0%+463,133
Invesco Ltd.4,029,731$43.7M0.0%−292,329
Carlyle Group Inc.3,496,808$37.9M0.4%No change
Millennium Management LLC3,375,834$36.6M0.0%−647,075
Vanguard Capital Management LLC2,656,944$28.8M0.0%+73,308
Franklin Resources Inc1,970,828$21.4M0.0%+976,324
NEA Management Company, LLC1,960,169$21.3M1.3%No change
683 Capital Management, LLC1,850,000$20.1M1.9%No change
Goldman Sachs Group Inc1,778,032$19.3M0.0%+1,151,836
State Street Corp1,586,323$17.2M0.0%+199,433
Catalys Pacific, LLC1,493,854$16.2M7.1%No change
Nomura Asset Management International Inc.1,462,738$15.9M0.0%+257,369
Geode Capital Management, LLC1,315,687$14.3M0.0%−12,358
Wasatch Advisors LP1,307,247$14.2M0.1%−33,669
Ensign Peak Advisors, Inc1,051,913$11.4M0.0%−575,893
Propel Bio Management, LLC1,050,358$11.4M6.0%+209,086
Point72 Asset Management, L.P.1,022,193$11.1M0.0%New
Vanguard Portfolio Management LLC796,631$8.6M0.0%+130,602
SummitTX Capital, L.P.789,550$8.6M0.2%−206,335
Hsbc Holdings PLC709,695$7.7M0.0%New
Marshall Wace, Llp666,090$7.2M0.0%−194,602
EcoR1 Capital, LLC625,000$6.8M0.3%No change
Perceptive Advisors LLC532,000$5.8M0.1%−393,000

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

SEC filer profile

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

  • Name on EDGARPhathom Pharmaceuticals, Inc.1
  • CIK0001783183
  • Employer ID (EIN)82-41515743
  • Filer statusNon-accelerated filer not 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 address100 Campus Drive,, Suite 102, Florham Park, NJ 079321
  • Phone(877) 742-84661
  • Shares outstanding80,900,934 as of Jul 27, 202611
  • Public float$555.5M as of Jun 30, 20253
  • AuditorErnst & Young LLP, Iselin, New Jersey PCAOB ID 42; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceJul 26, 20191
  • Filings490 in all: 4 (195), 8-K (99), 3 (24), 10-Q (21), SC 13G/A (20), SC 13D/A (15), SC 13G (13), SCHEDULE 13G/A (10)1
    All 42 form types

    424B5 (8), DEFA14A (8), 10-K (7), DEF 14A (7), CORRESP (6), UPLOAD (6), S-8 (5), ARS (4), SCHEDULE 13G (4), SEC STAFF LETTER (4), 4/A (3), EFFECT (3), SCHEDULE 13D/A (3), 10-Q/A (2), DRSLTR (2), S-3 (2), SC 13D (2), 10-K/A (1), 3/A (1), 424B4 (1), 5 (1), 8-A12B (1), CERT (1), DRS (1), DRS/A (1), FWP (1), PRE 14A (1), S-1 (1), S-1/A (1), S-1MEF (1), S-3ASR (1), SC TO-C (1), SC TO-I (1), SC TO-I/A (1)

  • Latest filingsAnnual report (10-K) Feb 26, 2026
    Quarterly report (10-Q) Jul 30, 2026
    Proxy statement (DEF 14A) Apr 7, 2026
    Latest 8-K (8-K) Sep 29, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per sharePHATThe Nasdaq Global Select Market

From the cover page of the 10-K filed Feb 26, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Phathom Pharmaceuticals, Inc. names in Item 1A of its 10-K filed Feb 26, 2026: 75 risks under these headings, as written.3

  • Risks Related to Our Limited Operating History, Financial Position and Capital Requirements
  • We have a limited operating history as a commercial company, which may make it difficult to evaluate the success of our business to date and to assess our future viability.
  • We have incurred significant operating losses since inception and may never achieve or maintain profitability.
  • We may require substantial additional financing to achieve our goals, finance our operations or meet our financial obligations, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could materially adversely affect our business.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • Risks Related to Commercialization of VOQUEZNA, VOQUEZNA TRIPLE PAK, VOQUEZNA DUAL PAK and Any Future Product Candidates
  • We currently rely entirely on the commercial success of our VOQUEZNA products, which depends upon the degree of market acceptance of such products by physicians, patients, healthcare payers and others in the medical community.
  • We may lack the necessary expertise, personnel and resources to successfully commercialize VOQUEZNA, VOQUEZNA DUAL PAK, and VOQUEZNA TRIPLE PAK and any future product candidates that may receive regulatory approval, on our own or together with collaborators.
  • As a commercial-stage company with FDA-approved products, we are subject to ongoing regulatory obligations and failure to comply with these requirements or changes in regulatory rules could materially adversely affect our business or result in significant additional expense.
  • The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. If we are found or alleged to have improperly promoted off-label uses, we may become subject to significant liability.
  • Successful commercialization of our current products or any future product candidate, will depend in part on the extent to which private health insurers or governmental authorities provide and maintain coverage with adequate reimbursement levels and without onerous utilization management requirements. Failure to obtain or maintain favorable pricing and adequate coverage and reimbursement policies for our products could limit our ability to market those products and decrease our ability to generate revenue at the levels and on the timelines we expect.
  • If we fail to comply with reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, results of operations and prospects.
The other 63 risks
  • Competition in the markets for our approved products is expected to increase, and we may also face competition with respect to any product candidates we may develop, in each case which could materially adversely affect our business, results of operations and prospects.
  • If the market opportunities for our approved products, including VOQUEZNA, or for any future product candidates we may develop, are smaller than we expect, our business, results of operations and prospects could be adversely affected.
  • If our efforts to develop, maintain and effectively deploy sales, marketing and distribution capabilities are unsuccessful, we may not be able to successfully commercialize our approved products or any product candidates we may develop and generate revenues at the levels and on the timing we expect.
  • Our future growth may depend, in part, on our ability to operate in foreign markets, particularly Europe and Canada, where we would be subject to additional regulatory burdens and other risks and uncertainties.
  • Risks Related to the Development and Regulatory Approval of Product Candidates
  • Our future growth depends on our ability to develop vonoprazan for additional indications or formulations and to successfully develop or acquire additional product candidates.
  • Clinical development is lengthy, expensive and uncertain, and delays or failures in our clinical trials could limit our ability to obtain additional regulatory approvals and adversely affect our business.
  • Obtaining regulatory approval for product candidates, including additional indications or formulations of approved products, is subject to extensive regulation and is costly, time-consuming and uncertain.
  • We may not be successful in our efforts to expand our pipeline by pursuing and developing vonoprazan for additional indications and formulations. We may decide not to pursue additional indications or formulations, at all or we may expend our limited resources to pursue a particular indication or formulation for vonoprazan and fail to capitalize on indications or formulations or other product candidates for which there may be a greater likelihood of success or that may be more profitable.
  • We enrolled patients in Europe in our Erosive GERD and H. pylori trials with VOQUEZNA, and the FDA accepted data from those sites as part of the basis for approval of VOQUEZNA, VOQUEZNA Dual Pak and VOQUEZNA Triple Pak. However, the FDA and other comparable foreign regulatory authorities may not accept data from future trials conducted outside the United States.
  • Interim, top-line and preliminary data from clinical trials that we or others 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. Even if final data from a clinical trial are positive, such results may not be replicated or confirmed in subsequent clinical trials.
  • Disruptions at the FDA and other government agencies caused by funding shortages, staffing limitations, government shutdowns or policy changes could delay regulatory review and approval processes and adversely affect our business.
  • Risks Related to Our Reliance on Third Parties
  • We rely on the Takeda License to provide us rights to develop and commercialize vonoprazan in the United States, Europe, and Canada. If the license agreement is terminated, we would lose our rights to develop and commercialize vonoprazan.
  • We rely on third parties to conduct our clinical trials. Any failure by a third party to conduct the clinical trials according to GCPs and other requirements and in a timely manner may delay or prevent our ability to seek or obtain additional regulatory approvals for vonoprazan and regulatory approvals for any future product candidates.
  • We currently rely on, and expect to rely on for the foreseeable future, Evonik and Catalent for the manufacture of vonoprazan drug substance and drug product for commercial sale and any clinical development, and we expect to rely on Sandoz for commercial supplies of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK and the amoxicillin and clarithromycin in those products. This reliance on third parties increases the risk that we will not have sufficient quantities of finished product which could have a material adverse impact on our business, results from operation and prospects.
  • Our reliance on third parties, including Sandoz, Catalent and Evonik, 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.
  • The loss of, or significant reduction in business from, one or more of our major customers could significantly reduce our revenue, earnings or other operating results.
  • We may seek to enter into collaborations, licenses and other similar arrangements and may not be successful in doing so, and even if we are, we may not realize the benefits of such relationships.
  • Risks Related to Our Business Operations 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.
  • Our indebtedness may limit our flexibility in operating our business and adversely affect our financial health and competitive position, and all of our obligations under our indebtedness are secured by substantially all of our assets, excluding our licensed intellectual property and certain other assets. If we default on these obligations, our lenders could foreclose on our assets.
  • Our Revenue Interest Financing Agreement could limit cash flow available for our operations and expose us to risks that could adversely affect our business, financial condition and results of operations.
  • Our future growth and ability to compete depends on retaining our key personnel and recruiting additional qualified personnel.
  • We are subject to various foreign, federal, and state healthcare laws and regulations, and our failure to comply with these laws and regulations could result in significant fines, damages and penalties and harm our results of operations and financial condition.
  • Enacted and future legislation and healthcare reform measures may increase the difficulty, cost and uncertainty for us of commercializing vonoprazan and any future product candidates and may adversely affect pricing, reimbursement and patient access.
  • We and any of our third-party manufacturers or suppliers may use potent chemical agents and hazardous materials, and any claims relating to improper handling, storage or disposal of these materials could be time consuming or costly.
  • U.S. legislation, sanctions, trade restrictions and other foreign regulatory requirements could adversely impact the supply of material from foreign CROs and CMOs to us or our ability to secure government commitments to purchase potential therapies.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our products.
  • We and others are subject to ongoing adverse event reporting obligations for our approved products and any failure to comply with these requirements could result in regulatory action that would materially harm our business.
  • Compliance with applicable data protection, privacy and security laws, regulations, standards and other requirements involves significant expenditure and resources, and any actual or perceived failures by us, our partners or vendors to comply could adversely affect our business, results of operations, and financial condition.
  • Our internal information systems, or those of any of our CROs, contract manufacturers, service providers, other contractors or consultants or potential future collaborators, may fail or suffer cybersecurity incidents or breaches, which could result in a material disruption of our product development programs.
  • Our business may be affected by the evolving regulatory framework for AI Technologies
  • Our employees and independent contractors, including consultants, vendor, principal investigators and CROs, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • 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 impair our ability to compete in domestic and international markets. We could face criminal liability and other serious consequences for violations, which could harm our business.
  • We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management.
  • Risks Related to Our Intellectual Property
  • Our success depends on our ability to protect our intellectual property and our proprietary technologies.
  • If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties, including our rights in vonoprazan licensed from Takeda, or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
  • If the scope of any patent protection or non-patent regulatory exclusivity we obtain is not sufficiently broad, or if we lose or fail to obtain any of our patent protection or non-patent regulatory exclusivity, our ability to prevent our competitors from commercializing similar or identical product candidates would be adversely affected.
  • The patent protection and patent prosecution for vonoprazan or any future product candidates may be dependent on third parties.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties. Claims by third parties that we infringe their proprietary rights may result in liability for damages or prevent or delay our developmental and commercialization efforts.
  • We may not be successful in obtaining or maintaining necessary rights to our current products and any future product candidates through acquisitions and in-licenses.
  • We may be involved in lawsuits to protect or enforce our future patents or the patents of our current and future licensors, which could be expensive, time consuming and unsuccessful. Further, our future issued patents or the patents of our current and future licensors could be found invalid or unenforceable if challenged in court.
  • Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common shares to decline.
  • Derivation or interference proceedings may be necessary to determine priority of inventions, and an unfavorable outcome may require us to cease using the related technology or to attempt to license rights from the prevailing party.
  • Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our future patent applications or those of our current and future licensors and the enforcement or defense of our future issued patents or those of our current and future licensors.
  • Changes in U.S. patent law, or laws in other countries, could diminish the value of patents in general, thereby impairing our ability to protect our current products and any future product candidates.
  • We may be subject to claims challenging the inventorship or ownership of our future patents, the patents of our current and future licensors, or other intellectual property.
  • Patent terms may be inadequate to protect our competitive position on VOQUEZNA and any future product candidates for an adequate amount of time.
  • If we do not obtain patent term extension for any future product candidates, our business may be materially harmed.
  • We may not be able to protect our intellectual property rights throughout our licensed territories.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by regulations and governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • We may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • Any collaboration arrangements that we have or may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our products.
  • Intellectual property discovered through government funded programs may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S. manufacturers.
  • Risks Related to Our Common Stock
  • The trading price of the shares of our common stock has been, and is likely to continue to be, highly volatile, and purchasers of our common stock could incur substantial losses.
  • Our executive officers, directors and principal stockholders, if they choose to act together, have the ability to control or significantly influence all matters submitted to stockholders for approval. Furthermore, many of our current directors were appointed by our principal stockholders.
  • We do not currently intend to pay dividends on our common stock, and, consequently, your ability to achieve a return on your investment will depend on appreciation, if any, in the price of our common stock.
  • We have ceased to qualify as a smaller reporting company in 2026, and as a result we are subject to increased reporting, compliance and internal control requirements, which may increase our costs and strain management resources.
  • Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management.
  • Our amended and restated certificate of incorporation and amended and restated bylaws provide 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.
  • Our ability to use net operating loss, or NOL, carryforwards and other tax attributes may be limited.
  • Changes in tax laws may materially adversely affect our financial condition, results of operations and cash flows.

Legal proceedings

We are not currently subject to any material legal proceedings. From time to time, we may be involved in legal proceedings or subject to claims incident to the ordinary course of business. Regardless of the outcome, such proceedings or claims can have an adverse impact on us because of defense and settlement costs, diversion of resources and other factors, and there can be no assurances that favorable outcomes will be obtained.

The opening of Item 3, Legal Proceedings.3

Sources

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