Private company
Third Harmonic Bio, Inc.
In its 2025 annual report the company says: “We are a biopharmaceutical company focused on advancing the next wave of medicine for dermal, respiratory, and gastrointestinal inflammatory diseases. We are developing THB335, our next-generation, potent and selective, oral small-molecule inhibitor of KIT, a cell surface receptor that serves as the master regulator of mast cell function and survival.”3 It is headquartered in San Francisco, California.1
Last updated Oct 21, 2026.
Overview
- IndustryPharmaceutical Preparations1
- HeadquartersSan Francisco, California1
- Incorporated inDE2
- Business address1700 Montgomery Street, Suite 210, San Francisco, Ca 941112
- Filer category, Emerging growth company2
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We are a biopharmaceutical company focused on advancing the next wave of medicine for dermal, respiratory, and gastrointestinal inflammatory diseases. We are developing THB335, our next-generation, potent and selective, oral small-molecule inhibitor of KIT, a cell surface receptor that serves as the master regulator of mast cell function and survival. Early clinical studies have demonstrated that KIT inhibition has the potential to address the treatment of a broad range of mast cell-mediated inflammatory diseases, and that a titratable, oral small molecule inhibitor may provide an attractive therapeutic profile against this target. Our initial focus is on developing an oral KIT inhibitor to treat chronic spontaneous urticaria (CSU). THB335 maintains the nonclinical pharmacology and selectivity profile of THB001, our first-generation product candidate, with structural modifications that a…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
| Fiscal year | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|
| Research and development | $15.7M4 | $24.4M5 | $24.0M6 | $36.5M6 | ||
| Operating expenses | $19.0M4 | $37.7M5 | $44.0M6 | $58.9M6 | ||
| Operating income | -$19.0M4 | -$37.7M5 | -$44.0M6 | -$58.9M6 | ||
| Income before tax | -$29.6M4 | -$35.2M5 | -$30.8M6 | -$45.5M6 | ||
| Net income | -$29.6M4 | -$35.2M5 | -$30.8M6 | -$45.5M6 | ||
| Earnings per share | -$7.324 | $2.455 | $0.786 | $1.096 | ||
| Earnings per share (diluted) | -$7.324 | $2.455 | $0.786 | $1.096 | ||
| Shares (weighted, basic) | 4.0M shares4 | 14.4M shares5 | 39.6M shares6 | 41.7M shares6 | ||
| Shares (weighted, diluted) | 4.0M shares4 | 14.4M shares5 | 39.6M shares6 | 41.7M shares6 |
| Fiscal year | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|
| Cash | $128.3M4 | $288.9M5 | $269.1M6 | $285.1M6 | ||
| Current assets | $129.2M4 | $292.8M5 | $272.4M6 | $290.5M6 | ||
| Property, plant and equipment | $04 | $35.0K5 | $169.0K6 | $130.0K6 | ||
| Total assets | $129.2M4 | $298.7M5 | $277.7M6 | $294.6M6 | ||
| Accounts payable | $1.8M4 | $2.1M5 | $1.8M6 | $1.9M6 | ||
| Current liabilities | $5.7M4 | $5.7M5 | $5.4M6 | $7.1M6 | ||
| Total liabilities | $5.7M4 | $9.6M5 | $8.6M6 | $9.5M6 | ||
| Retained earnings | -$48.2M4 | -$83.4M5 | -$114.2M6 | -$159.7M6 | ||
| Shareholders’ equity | -$18.4M4 | -$46.7M5 | $289.1M6 | $269.1M6 | $285.1M6 | |
| Shares outstanding | 4.2M shares4 | 39.4M shares5 | 40.1M shares6 | 44.9M shares6 | 45.1M shares6 |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
| Fiscal year | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|
| Cash from operations | -$15.7M4 | -$34.9M5 | -$20.4M6 | -$34.5M6 | ||
| Stock-based compensation | $510.0K4 | $4.8M5 | $9.6M6 | $11.1M6 | ||
| Capital spending | $04 | $36.0K5 | $169.0K6 | $10.0K6 | ||
| Free cash flow | -$15.7M | -$35.0M | -$20.6M | -$34.5M | ||
| Cash from investing | $04 | -$36.0K5 | -$169.0K6 | -$10.0K6 | ||
| Cash from financing | $135.7M4 | $196.0M5 | $799.0K6 | $50.5M6 | ||
| Dividend per share | $0.004 | $0.005 | $0.005 | $0.006 |
Corporate structure
Third Harmonic Bio, 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 Third Harmonic Bio, Inc.
- Nantahala Capital Management, LLC Filed SCHEDULE 13G/A on Third Harmonic Bio, Inc., latest Nov 14, 2025 (2 filings since May 15, 2025)
- EcoR1 Capital, LLC Filed SCHEDULE 13G/A on Third Harmonic Bio, Inc., latest May 15, 2025 (3 filings since Sep 13, 2023)
- FMR LLC Filed SCHEDULE 13G/A on Third Harmonic Bio, Inc., latest May 12, 2025 (2 filings since Feb 12, 2025)
- BIOTECHNOLOGY VALUE FUND L P Filed SCHEDULE 13G/A on Third Harmonic Bio, Inc., latest Apr 16, 2025 (4 filings since Sep 26, 2022)
- BML Investment Partners, L.P. Filed SCHEDULE 13G on Third Harmonic Bio, Inc., latest Feb 14, 2025
- GENERAL ATLANTIC, L.P. Filed SCHEDULE 13D/A on Third Harmonic Bio, Inc., latest Feb 13, 2025 (3 filings since Sep 28, 2022)
- RA CAPITAL MANAGEMENT, L.P. Filed SC 13G/A on Third Harmonic Bio, Inc., latest Nov 14, 2024 (4 filings since Sep 26, 2022)
- T. Rowe Price Investment Management, Inc. Filed SC 13G on Third Harmonic Bio, Inc., latest Nov 14, 2024
- ORBIMED ADVISORS LLC Filed SC 13D/A on Third Harmonic Bio, Inc., latest Nov 12, 2024 (2 filings since Sep 28, 2022)
- Atlas Venture Fund XI, L.P. Filed SC 13D/A on Third Harmonic Bio, Inc., latest Nov 5, 2024 (2 filings since Sep 29, 2022)
- TCG Crossover GP II, LLC Filed SC 13G on Third Harmonic Bio, Inc., latest Sep 27, 2024
- Stonepine Capital Management, LLC Filed SC 13G/A on Third Harmonic Bio, Inc., latest Feb 13, 2024 (2 filings since Jan 19, 2023)
- Third Harmonic Bio, Inc. 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 Third Harmonic Bio, 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
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, before depreciation | $214.0K6 Dec 31, 2024 | $204.0K6 Dec 31, 2023 | +4.9% |
| Accumulated depreciation | $84.0K6 Dec 31, 2024 | $35.0K6 Dec 31, 2023 | +140.0% |
| Property and equipment, net | $130.0K6 Dec 31, 2024 | $169.0K6 Dec 31, 2023 | −23.1% |
| Operating-lease assets (leased space) | $3.0M6 Dec 31, 2024 | $3.8M6 Dec 31, 2023 | −19.2% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $285.1M6 Dec 31, 2024 | $269.1M6 Dec 31, 2023 | +5.9% |
Properties, in its own words
As of December 31, 2024, we lease office space at 130 Prospect Street in Cambridge, Massachusetts, which is where our corporate headquarters are located, and which consists of 10,356 rentable square feet. We also lease office space at 1700 Montgomery Street in San Francisco, California, which consists of 4,703 rentable square feet. We believe our current office space is sufficient to meet our office needs until the expiration of the leases in 2028.
Item 2 of the 10-K filed Mar 27, 2025.3
Leadership
Who has led Third Harmonic Bio, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
Chief operating officer
- Chief executive officerNatalie C. Holles Sep 14, 2022 to now10
- Chief financial officerChristopher M. Murphy Jan 9, 2024 to now11
- Chief financial officerRobert Ho Sep 14, 2022 to Mar 8, 202312
- Chief operating officerJennifer Dittman Jan 17, 2025 to now13
Board members and other officers (14)
- Chief Scientific OfficerChristopher Dinsmore May 20, 2024 to now14
- Chief Development Oper OfficerJennifer Dittman May 20, 2024 to now15
- Chief Scientific OfficerAdrian S. Ray Sep 14, 2022 to Mar 8, 202316
- Chief Medical OfficerEdward R. Conner Sep 14, 2022 to now17
- Chief Administrative OfficerJulie Person Sep 14, 2022 to now18
- Board memberGeoff McDonough Mar 28, 2024 to now19
- Board memberDavid P. Bonita Sep 14, 2022 to now20
- Board memberHans Martin Seidel Sep 14, 2022 to now21
- Board memberMark T. Iwicki Sep 14, 2022 to now22
- Board memberMichael Gladstone Sep 14, 2022 to now23
- Board memberNatalie C. Holles Sep 14, 2022 to now10
- Board memberRobert J. Perez Sep 14, 2022 to Mar 8, 202324
- Board memberShao-Lee Lin Sep 14, 2022 to Oct 27, 202225
- Board memberThomas P. Soloway Sep 14, 2022 to now26
Timeline
- Jul 31, 20258-K Listing notice or transfer; Change to shareholders' rights27
- Jul 21, 20258-K Listing notice or transfer; Change to shareholders' rights; Executive or director change28
- Jun 12, 20258-K Regulation FD disclosure29
- Jun 11, 20258-K Shareholder vote30
- Apr 22, 20258-K Executive or director change31
- Apr 14, 20258-K Results of operations; Other events32
- Mar 27, 20258-K Results of operations33
- Mar 11, 20258-K Regulation FD disclosure34
- Feb 11, 20258-K Results of operations; Exit or restructuring costs; Regulation FD disclosure35
- Nov 7, 20248-K Results of operations36
- Aug 8, 20248-K Results of operations37
- Jun 7, 20248-K Executive or director change; Shareholder vote38
- Sep 14, 2022New chief executive Natalie C. Holles becomes CEO10
Calendar
When it reported results
- Apr 14, 2025Reported quarterly or annual results32
- Mar 27, 2025Reported quarterly or annual results33
- Feb 11, 2025Reported quarterly or annual results35
- Nov 7, 2024Reported quarterly or annual results36
- Aug 8, 2024Reported quarterly or annual results37
- May 15, 2024Reported quarterly or annual results39
- Mar 26, 2024Reported quarterly or annual results40
- Nov 9, 2023Reported 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
220 filings to the SEC since October 2021: 3 annual reports, 8 quarterly reports, 29 major events, 97 insider forms, 30 large holders, 53 other. The latest 20:
- Nov 14, 2025SCHEDULE 13G/A EDGAR
- Aug 14, 20254 EDGAR
- Aug 14, 20254 EDGAR
- Aug 14, 20254 EDGAR
- Aug 14, 20254 EDGAR
- Aug 14, 20254 EDGAR
- Aug 14, 20254 EDGAR
- Aug 14, 20254 EDGAR
- Aug 11, 202515-12G EDGAR
- Jul 31, 2025EFFECT EDGAR
- Jul 31, 20258-K EDGAR
- Jul 31, 2025S-8 POS EDGAR
- Jul 31, 2025S-8 POS EDGAR
- Jul 31, 2025S-8 POS EDGAR
- Jul 31, 2025S-8 POS EDGAR
- Jul 31, 2025POS AM EDGAR
- Jul 31, 202525 EDGAR
- Jul 21, 20258-K EDGAR
- Jun 12, 20258-K EDGAR
- Jun 11, 20258-K EDGAR
The 220 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
19 open-market trades by officers, directors and large owners since October 2021: 4 buys and 15 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Nov 8, 2024 | Conner Edward R.Chief Medical Officer | Sale | 2,117 | $15.00 | $31.8K | Form 4 |
| Oct 29, 2024 | BVF INC/IL | Sale | 1,000,000 | $14.30 | $14.3M | Form 4 |
| Oct 28, 2024 | Conner Edward R.Chief Medical Officer | Sale | 2,673 | $15.00 | $40.1K | Form 4 |
| Sep 19, 2024 | Conner Edward R.Chief Medical Officer | Sale | 4,790 | $15.00 | $71.8K | Form 4 |
| Sep 19, 2024 | Person JulieCHIEF ADMINISTRATIVE OFFICER | Sale | 9,497 | $14.29 | $135.7K | Form 4 |
| Sep 18, 2024 | Person JulieCHIEF ADMINISTRATIVE OFFICER | Sale | 503 | $14.00 | $7.0K | Form 4 |
| Jun 26, 2024 | Person JulieCHIEF ADMINISTRATIVE OFFICER | Sale | 10,000 | $12.46 | $124.6K | Form 4 |
| Jun 7, 2024 | Dittman JenniferChief Operating Officer | Sale | 494 | $14.17 | $7.0K | Form 4 |
| May 20, 2024 | Dittman JenniferChief Operating Officer | Sale | 1,042 | $14.00 | $14.6K | Form 4 |
| May 16, 2024 | Dittman JenniferChief Operating Officer | Sale | 23,578 | $14.04 | $331.0K | Form 4 |
| May 9, 2024 | Holles Natalie C.CEO | Sale | 20,222 | $12.18 | $246.3K | Form 4 |
| Apr 11, 2024 | Holles Natalie C.CEO | Sale | 13,558 | $12.19 | $165.3K | Form 4 |
| Apr 4, 2024 | Person JulieCHIEF ADMINISTRATIVE OFFICER | Sale | 1,107 | $10.00 | $11.1K | Form 4 |
| Dec 5, 2023 | Person JulieCHIEF ADMINISTRATIVE OFFICER | Sale | 12,863 | $10.30 | $132.5K | Form 4 |
| Dec 5, 2023 | Conner Edward R.Chief Medical Officer | Sale | 4,790 | $10.03 | $48.0K | Form 4 |
| Dec 20, 2022 | BIOTECHNOLOGY VALUE FUND II LP | Buy | 214,063 | $4.11 | $879.8K | Form 4 |
| Sep 19, 2022 | OrbiMed Capital GP VII LLCDirector | Buy | 300,000 | $17.00 | $5.1M | Form 4 |
| Sep 19, 2022 | Bonita David PDirector | Buy | 300,000 | $17.00 | $5.1M | Form 4 |
| Sep 19, 2022 | Atlas Venture Associates XI, LLC10% owner | Buy | 300,000 | $17.00 | $5.1M | Form 4 |
From Forms 4 filed with the SEC.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- Nantahala Capital Management, LLCSCHEDULE 13G/A, 2 filings May 15, 2025 to Nov 14, 202542
- EcoR1 Capital, LLCSCHEDULE 13G/A, 3 filings Sep 13, 2023 to May 15, 202543
- FMR LLCSCHEDULE 13G/A, 2 filings Feb 12, 2025 to May 12, 202544
- BIOTECHNOLOGY VALUE FUND L PSCHEDULE 13G/A, 4 filings Sep 26, 2022 to Apr 16, 202545
- BML Investment Partners, L.P.SCHEDULE 13G, 1 filing Feb 14, 202546
- GENERAL ATLANTIC, L.P.SCHEDULE 13D/A, 3 filings Sep 28, 2022 to Feb 13, 202547
- RA CAPITAL MANAGEMENT, L.P.SC 13G/A, 4 filings Sep 26, 2022 to Nov 14, 202448
- T. Rowe Price Investment Management, Inc.SC 13G, 1 filing Nov 14, 202449
- ORBIMED ADVISORS LLCSC 13D/A, 2 filings Sep 28, 2022 to Nov 12, 202450
- Atlas Venture Fund XI, L.P.SC 13D/A, 2 filings Sep 29, 2022 to Nov 5, 202451
- TCG Crossover GP II, LLCSC 13G, 1 filing Sep 27, 202452
- Stonepine Capital Management, LLCSC 13G/A, 2 filings Jan 19, 2023 to Feb 13, 202453
- Bain Capital Life Sciences Investors, LLCSC 13G/A, 2 filings Sep 29, 2022 to Feb 14, 202354
- Novartis Institutes for BioMedical Research, Inc.SC 13G, 1 filing Feb 8, 202355
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.
SEC filer profile
How Third Harmonic Bio, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARThird Harmonic Bio, Inc.1
- CIK0001923840
- Employer ID (EIN)83-45535033
- 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 address1700 Montgomery Street, Suite 210, San Francisco, CA 941111
- Phone20972724571
- Shares outstanding45,127,797 as of May 2, 20259
- Public float$298.5M as of Jun 28, 20243
- AuditorDeloitte & Touche LLP, Morristown, NJ PCAOB ID 34; no auditor attestation of internal control over financial reporting3
- On EDGAR sinceMay 16, 20221
- Filings220 in all: 4 (76), 8-K (29), 3 (20), 144 (11), SC 13G (9), 10-Q (8), SC 13G/A (7), S-8 (4)1
All 37 form types
S-8 POS (4), SCHEDULE 13G/A (4), 10-K (3), ARS (3), CORRESP (3), DEF 14A (3), DEFA14A (3), EFFECT (3), SC 13D (3), SCHEDULE 13G (3), DRS/A (2), SC 13D/A (2), SCHEDULE 13D/A (2), SEC STAFF LETTER (2), UPLOAD (2), 15-12G (1), 25 (1), 4/A (1), 424B4 (1), 8-A12B (1), CERT (1), DRS (1), DRSLTR (1), POS AM (1), PRE 14A (1), S-1 (1), S-1/A (1), S-1MEF (1), S-3 (1)
- Latest filingsAnnual report (10-K) Mar 27, 2025
Quarterly report (10-Q) May 8, 2025
Proxy statement (DEF 14A) Apr 25, 2025
Latest 8-K (8-K) Jul 31, 2025
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.0001 per share | THRD | The Nasdaq Stock Market LLC |
From the cover page of the 10-K filed Mar 27, 2025 (Section 12(b) of the Exchange Act).3
Risk factors and legal proceedings
The risks Third Harmonic Bio, Inc. names in Item 1A of its 10-K filed Mar 27, 2025: 68 risks under these headings, as written.3
- Risks Related to Our Financial Position, Limited Operating History and Need for Additional Capital
- We have a limited operating history, have not completed any clinical trials beyond Phase 1, and have no product candidates approved for commercial sale. We have a history of significant net losses since our inception and expect to continue to incur significant losses for the foreseeable future.
- We have never generated revenue, may never generate any revenue from product sales and may never be profitable.
- Subject to our strategic review process, we will need substantial additional funds to pursue our business objectives, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development programs, commercialization efforts or other operations.
- Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or nonperformance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations, and its financial condition and results of operations.
- We had a material weakness in our internal control over financial reporting in the past, and cannot assure you there will not be material weaknesses or significant deficiencies in our internal control over financial reporting in the future. If we fail to maintain effective internal control, we may not be able to accurately report our financial results or file our periodic reports in a timely manner, which may cause investors to lose confidence in our reported financial information and may lead to a decline in the market price of our common stock.
- Risks Related to Discovery, Development and Commercialization
- Our future performance is substantially dependent on the success of THB335 as well as our ability to identify and develop future product candidates.
- If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of THB335 or any future product candidates may be delayed and, as a result, our stock price may decline and you may lose all or part of your investment.
- Drug development is a lengthy and expensive process, and the outcome of clinical testing is inherently uncertain, and results of earlier studies and trials may not be predictive of future trial results. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of THB335 or any future product candidates.
- Results of nonclinical studies and early clinical trials may not be predictive of results of clinical trials.
- Preliminary, topline or 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.
The other 57 risks
- Our clinical trials may reveal significant adverse events not seen in our nonclinical studies and may result in a safety profile that could inhibit regulatory approval or market acceptance of THB335 or any future product candidates.
- Clinical trials of THB335 or any oral future KIT inhibitor product candidates may not uncover all possible AEs that patients may experience.
- If we experience delays or difficulties in enrolling patients in our ongoing or planned clinical trials, our receipt of necessary regulatory approval could be delayed or prevented.
- We face competition from entities that have made substantial investments into the rapid development of novel treatments for allergic and inflammatory diseases, including large and specialty pharmaceutical and biotechnology companies developing novel treatments and technology platforms. If these companies develop technologies or product candidates more rapidly than we do or their technologies are more effective, our ability to develop and successfully commercialize, if approved, product candidates may be adversely affected.
- THB335 and any oral future KIT inhibitor product candidates may not achieve adequate market acceptance among physicians, patients, healthcare third-party payors and others in the medical community necessary for commercial success, if approved, and we may not generate any future revenue from the sale or licensing of product candidates.
- The market opportunities for THB335 or any of our oral future KIT inhibitor product candidates, if approved, may be limited to certain smaller patient subsets and may be smaller than we estimate them to be.
- If in the future we are unable to establish U.S. or global sales and marketing capabilities or enter into agreements with third parties to sell and market THB335 or any oral future KIT inhibitor product candidates, we may not be successful in commercializing our product candidates if they are approved and we may not be able to generate any revenue.
- If THB335 or any oral future KIT inhibitor product candidates receives marketing approval and we or others later identify undesirable side effects caused by the product candidate, our ability to market and derive revenue from the product candidates could be compromised.
- Risks Related to Our Business and Operations
- Subject to our strategic review process, we may in the future expand our development, clinical and regulatory capabilities and operations as we grow our Company, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
- Our future performance depends on our ability to retain key employees and to attract, retain and motivate qualified employees and manage our human capital.
- Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
- Our business depends on the efficient and uninterrupted operation of our information technology systems and those of our third-party CROs, CDMOs, or other vendors, contractors or consultants, may fail or suffer security breaches, cyber-attacks, loss or leakage of data and other disruptions, which could result in a material disruption of our development programs, compromise sensitive information related to our business or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affecting our business.
- Our business entails a significant risk of product liability and our ability to obtain sufficient insurance coverage could have a material and adverse effect on our business, financial condition, results of operations and prospects.
- Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
- If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be affected adversely.
- We, or the third parties on whom we depend, may be adversely affected by natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
- Changes in tax laws or regulations that are applied adversely to us may have a material adverse effect on our business, cash flow, financial condition or results of operations.
- Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
- Risks Related to Our Reliance on Third Parties
- We rely, and intend to continue to rely, on third parties to conduct our clinical trials and perform all of our research and nonclinical studies. If these third parties do not satisfactorily carry out their contractual duties, fail to comply with applicable regulatory requirements or do not meet expected deadlines, our development programs may be delayed or subject to increased costs or we may be unable to obtain regulatory approval, each of which may have an adverse effect on our business, financial condition, results of operations and prospects.
- We may, in the future, enter into collaborations with third parties for the discovery, development and commercialization of product candidates, if approved. If those collaborations are not successful, we may not be able to capitalize on the market potential of THB335 or any oral future KIT inhibitor product candidates.
- We rely on third-party manufacturers and suppliers, including foreign manufacturers, to supply components of THB335 or any oral future KIT inhibitor product candidates. The loss of our third-party manufacturers or suppliers, or our or their failure to comply with applicable regulatory requirements or to supply sufficient quantities at acceptable quality levels or prices, or at all, would materially and adversely affect our business.
- Risks Related to Intellectual Property
- If we are not able to obtain, maintain and enforce patent protection for our technologies or product candidates, development and commercialization, if approved, of THB335 or any oral future KIT inhibitor product candidates may be adversely affected.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- If we breach our license agreements, it could have a material adverse effect on our commercialization efforts for any oral future KIT inhibitor product candidates.
- Our intellectual property licensed from various third parties may be subject to retained rights.
- Our strategy of obtaining rights to key technologies through in-licenses may not be successful.
- Other companies or organizations may challenge our or our licensors’ patent rights or may assert patent rights that prevent us from developing and commercializing our products.
- We may not be able to protect our intellectual property rights throughout the world.
- We, our licensors or collaborators, or any future strategic partners may need to resort to litigation to protect or enforce our patents, if and when granted, or other proprietary rights, all of which could be costly, time consuming, delay or prevent the development and commercialization of THB335 or any oral future KIT inhibitor product candidates, or put our patents, if and when granted, and other proprietary rights at risk.
- Intellectual property litigation could cause us to spend substantial resources and distract our employees from their normal responsibilities.
- We may be subject to claims that we or our employees or consultants have wrongfully used or disclosed alleged trade secrets of our employees’ or consultants’ former employers or their clients. These claims may be costly to defend and if we do not successfully do so, we may be required to pay monetary damages and may lose valuable intellectual property rights or employees.
- Patent terms may be insufficient to protect our competitive position on THB335 or any oral future KIT inhibitor product candidates for an adequate amount of time.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be harmed.
- Changes in U.S. patent and ex-U.S. patent laws could diminish the value of patents in general, thereby impairing our ability to protect our products.
- Risks Related to Government Regulation
- The regulatory approval process is highly uncertain, and we may be unable to obtain, or may be delayed in obtaining, U.S. or foreign regulatory approval and, as a result, unable to commercialize THB335 or any oral future KIT inhibitor product candidates. Even if we believe our development plans are successful, regulatory authorities may not agree that they provide adequate data on safety or efficacy.
- Even if we receive regulatory approval for THB335 or any oral future KIT inhibitor product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, THB335 or any future product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal. We may also be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products.
- Our operations and relationships with healthcare providers, healthcare organizations, customers and third-party payors will be subject to applicable anti-bribery, anti-kickback, fraud and abuse, transparency and other healthcare and privacy laws and regulations, which could expose us to, among other things, enforcement actions, criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
- We are subject to stringent and changing obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse business consequences.
- We may face difficulties from legislative and regulatory reform measures.
- Even if we are able to commercialize THB335 or any of our oral future KIT inhibitor product candidates, such product candidate may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which would harm 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 impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can harm our business.
- Governments outside the United States tend to impose strict price controls, which may adversely affect our revenue, if any.
- Risks Related to Our Common Stock
- An active and liquid trading market for our common stock may never be sustained and you may not be able to resell your shares of common stock at or above the purchase price, if at all.
- Our quarterly and annual operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline.
- The market price of our common stock may be volatile, and you could lose all or part of your investment.
- A sale of a substantial number of shares of our common stock may cause the price of our common stock to decline.
- Our principal stockholders and management own a significant percentage of our common stock and will be able to control matters subject to stockholder approval.
- 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 or smaller reporting companies will make our common stock less attractive to investors.
- If we fail to maintain proper and effective internal controls over financial reporting our ability to produce accurate and timely financial statements could be impaired.
- Anti-takeover provisions in our charter documents and under Delaware law could prevent or delay an acquisition of us, which may be beneficial to our stockholders, and may prevent attempts by our stockholders to replace or remove our current management.
- The exclusive forum provisions in our organizational documents may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers, or employees, or the underwriters of any offering giving rise to such claim, which may discourage lawsuits with respect to such claims.
- Because we do not anticipate paying any dividends on our capital stock for the foreseeable future, capital appreciation, if any, will be your sole source of gain and you may never obtain a return on your investment.
- General Risk Factors
- If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline.
- We will continue to incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives and corporate governance practices.
- Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
- We may be subject to securities litigation, which is expensive and could divert management attention.
Legal proceedings
From time to time, we may be involved in legal proceedings arising in the ordinary course of business. We are not presently a party to any legal proceedings that, in the opinion of management, would have a material adverse effect on our business. Regardless of the outcome, litigation can have an adverse impact on us due to defense and settlement costs, diversion of management resources, negative publicity and reputational harm.
The opening of Item 3, Legal Proceedings.3
Sources
The numbers on this page point here. Each one links to the record it came from.
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- 12SEC EDGARRobert Ho, Chief financial officer
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- 19SEC EDGARGeoff McDonough, Board member
- 20SEC EDGARDavid P. Bonita, Board member
- 21SEC EDGARHans Martin Seidel, Board member
- 22SEC EDGARMark T. Iwicki, Board member
- 23SEC EDGARMichael Gladstone, Board member
- 24SEC EDGARRobert J. Perez, Board member
- 25SEC EDGARShao-Lee Lin, Board member
- 26SEC EDGARThomas P. Soloway, Board member
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- 29SEC EDGARRegulation FD disclosure
- 30SEC EDGARShareholder vote
- 31SEC EDGARExecutive or director change
- 32SEC EDGARResults of operations; Other events
- 33SEC EDGARResults of operations
- 34SEC EDGARRegulation FD disclosure
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- 36SEC EDGARResults of operations
- 37SEC EDGARResults of operations
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