Private company
Tourmaline Bio, Inc.
In its 2025 annual report the company says: “We are a late-stage clinical biotechnology company focused on developing transformative medicines that dramatically improve the lives of patients with life-altering immune and inflammatory diseases. Our initial product candidate is pacibekitug (also known as TOUR006), a fully human monoclonal antibody that selectively binds to interleukin-6, a key proinflammatory cytokine involved in the pathogenesis of many autoimmune and inflammatory disorders.”3 It is headquartered in New York, New York.1
Last updated Oct 20, 2026.
Overview
- IndustryBiological Products, (No Diagnostic Substances)1
- HeadquartersNew York, New York1
- Incorporated inDE2
- Business address27 West 24Th Street, Suite 702, New York, Ny 100102
- Filer category, Emerging growth company2
See how the biggest companies compare on our leaderboards
We are a late-stage clinical biotechnology company focused on developing transformative medicines that dramatically improve the lives of patients with life-altering immune and inflammatory diseases. In doing so, we seek to identify and develop medicines that have the potential to establish new standards-of-care in areas of high unmet medical need.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 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|
| Research and development | $15.3M4 | $34.2M5 | $17.5M6 | $32.4M7 | $67.0M7 | ||
| Operating expenses | $47.5M5 | $19.7M6 | $45.4M7 | $89.7M7 | |||
| Operating income | -$22.7M4 | -$47.5M5 | -$19.7M6 | -$45.4M7 | -$89.7M7 | ||
| Income tax | $04 | $05 | $06 | $07 | $07 | ||
| Net income | -$22.7M4 | -$47.8M5 | -$19.7M6 | -$42.1M7 | -$73.2M7 | ||
| Earnings per share | -$1.645 | -$22.466 | -$8.877 | -$2.897 | |||
| Earnings per share (diluted) | -$1.645 | -$22.466 | -$8.877 | -$2.897 | |||
| Shares (weighted, basic) | 29.1M shares5 | 877.0K shares6 | 4.7M shares7 | 25.3M shares7 | |||
| Shares (weighted, diluted) | 29.1M shares5 | 877.0K shares6 | 4.7M shares7 | 25.3M shares7 |
| Fiscal year | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|
| Cash | $17.6M4 | $18.6M5 | $8.3M6 | $140.7M7 | $30.5M7 | ||
| Current assets | $150.8M4 | $246.5M5 | $8.3M6 | $208.9M7 | $268.8M7 | ||
| Property, plant and equipment | $4.8M5 | $81.0K6 | $85.0K7 | $55.0K7 | |||
| Goodwill | $07 | ||||||
| Intangible assets | $07 | ||||||
| Total assets | $152.8M4 | $251.4M5 | $9.1M6 | $210.3M7 | $309.0M7 | ||
| Accounts payable | $2.6M5 | $401.0K6 | $1.1M7 | $3.6M7 | |||
| Current liabilities | $3.4M4 | $8.0M5 | $1.4M6 | $5.0M7 | $8.9M7 | ||
| Total liabilities | $4.8M4 | $8.6M5 | $1.7M6 | $5.3M7 | $8.9M7 | ||
| Retained earnings | -$90.8M5 | -$19.9M6 | -$62.1M7 | -$135.3M7 | |||
| Shareholders’ equity | -$17.1M4 | -$38.1M5 | -$226.0K6 | -$19.7M7 | $205.0M7 | $300.1M7 | |
| Shares outstanding | 7.1M shares4 | 39.8M shares5 | 867.5K shares6 | 20.3M shares7 | 25.6M shares7 | 25.7M shares7 |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
| Fiscal year | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|
| Cash from operations | -$19.2M4 | -$40.0M5 | -$6.5M6 | -$28.1M7 | -$77.3M7 | ||
| Depreciation and amortization | $623.0K5 | $1.4M5 | |||||
| Stock-based compensation | $3.8M5 | $195.0K6 | $5.8M7 | $6.6M7 | |||
| Capital spending | $1.3M4 | $2.4M5 | $68.0K6 | $56.0K7 | $9.0K7 | ||
| Free cash flow | -$20.5M | -$42.4M | -$6.5M | -$28.1M | -$77.3M | ||
| Cash from investing | -$96.4M5 | -$5.1M6 | $3.8M7 | -$194.3M7 | |||
| Share buybacks | $07 | $4.0K7 | |||||
| Cash from financing | $137.4M5 | $19.9M6 | $156.7M7 | $161.3M7 |
Corporate structure
Tourmaline 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 Tourmaline Bio, Inc.
- RA CAPITAL MANAGEMENT, L.P. Filed SCHEDULE 13G/A on Tourmaline Bio, Inc., latest Nov 14, 2025 (5 filings since Jul 6, 2023)
- BlackRock Filed SCHEDULE 13G/A on Tourmaline Bio, Inc., latest Oct 17, 2025 (3 filings since Oct 22, 2024)
- Avoro Capital Advisors LLC Filed SCHEDULE 13G/A on Tourmaline Bio, Inc., latest Aug 14, 2025 (2 filings since Nov 14, 2024)
- QVT Financial LP Filed SCHEDULE 13G/A on Tourmaline Bio, Inc., latest Aug 14, 2025 (2 filings since May 15, 2025)
- Blue Owl Capital Filed SCHEDULE 13G/A on Tourmaline Bio, Inc., latest Feb 14, 2025 (3 filings since Feb 14, 2024)
- Deep Track Capital, LP Filed SC 13G/A on Tourmaline Bio, Inc., latest Nov 14, 2024 (2 filings since Oct 27, 2023)
- VIKING GLOBAL INVESTORS LP Filed SC 13G/A on Tourmaline Bio, Inc., latest Nov 14, 2024 (2 filings since Feb 14, 2022)
- Pfizer Filed SC 13G/A on Tourmaline Bio, Inc., latest Mar 15, 2024 (2 filings since Oct 27, 2023)
- CITADEL ADVISORS LLC Filed SC 13G/A on Tourmaline Bio, Inc., latest Feb 14, 2024 (3 filings since Feb 14, 2022)
- Hydra LLC Filed SC 13G/A on Tourmaline Bio, Inc., latest Feb 14, 2024 (2 filings since Nov 6, 2023)
- Blackstone Holdings II L.P. Filed SC 13G/A on Tourmaline Bio, Inc., latest Feb 9, 2024 (2 filings since Feb 11, 2022)
- TCG Crossover GP I, LLC Filed SC 13G on Tourmaline Bio, Inc., latest Feb 9, 2024
- Tourmaline Bio, Inc. New York, New York
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Tourmaline 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 | $132.0K7 Dec 31, 2024 | $123.0K7 Dec 31, 2023 | +7.3% |
| Accumulated depreciation | $77.0K7 Dec 31, 2024 | $38.0K7 Dec 31, 2023 | +102.6% |
| Property and equipment, net | $55.0K7 Dec 31, 2024 | $85.0K7 Dec 31, 2023 | −35.3% |
| Operating-lease assets (leased space) | $212.0K7 Dec 31, 2024 | $362.0K7 Dec 31, 2023 | −41.4% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $30.5M7 Dec 31, 2024 | $140.7M7 Dec 31, 2023 | −78.3% |
| Marketable securities, current | $227.8M7 Dec 31, 2024 | $62.2M7 Dec 31, 2023 | +266.1% |
| Marketable securities, non-current | $36.6M7 Dec 31, 2024 | $07 Dec 31, 2023 | |
| Debt securities available for sale | $287.8M7 Dec 31, 2024 | $66.8M7 Dec 31, 2023 | +330.6% |
| Long-term investments | $36.6M7 Dec 31, 2024 |
Intangibles and goodwill
| Item | Latest | A year before | Change |
|---|---|---|---|
| Goodwill | $07 Oct 19, 2023 | ||
| Intangible assets, net (excluding goodwill) | $07 Oct 19, 2023 |
Properties, in its own words
We lease approximately 3,274 square feet of office space at 27 West 24th Street, Suite 702, New York, New York, 10010, which serves as our corporate headquarters. The lease expires on February 28, 2026. We believe that our current facilities are adequate to meet our ongoing needs, and that, if we require additional space, we will be able to obtain additional facilities on commercially reasonable terms.
Item 2 of the 10-K filed Mar 13, 2025.3
Leadership
Who has led Tourmaline Bio, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
- Chief executive officerSandeep Chidambar Kulkarni Oct 23, 2023 to now10
- Chief executive officerScott Requadt Feb 2, 2022 to Feb 3, 202311
- Chief financial officerRyan F. Robinson Oct 23, 2023 to now12
- Chief financial officerMary Kay Fenton May 6, 2021 to Jul 6, 202313
Board members and other officers (23)
- Chief Technology OfficerSusan Dana Jones Oct 23, 2023 to now14
- CBO, GC and SecretaryW. Bradford Middlekauff Oct 23, 2023 to now15
- Chief Medical OfficerYung H. Chyung Oct 23, 2023 to Oct 23, 202316
- Chief Technology OfficerMichael Zdanowski May 6, 2021 to Feb 3, 202317
- Chief Medical OfficerNancy Krieger May 6, 2021 to Feb 3, 202318
- OfficerScott Requadt May 6, 2021 to May 6, 202119
- Chief Scientific OfficerSuzanne Ildstad May 6, 2021 to Aug 23, 202220
- Board memberAaron Kantoff Oct 23, 2023 to now21
- Board memberCaley Castelein Oct 23, 2023 to now22
- Board memberCariad Chester Oct 23, 2023 to Oct 23, 202323
- Board memberParvinder Thiara Oct 23, 2023 to now24
- Board memberSandeep Chidambar Kulkarni Oct 23, 2023 to now10
- Board memberClay B. Siegall Dec 15, 2023 to now25
- Board memberKaren L. Smith May 17, 2022 to Jun 14, 202326
- Board memberFrancois Nader May 6, 2021 to Jun 14, 202327
- Board memberGaurav Shah May 6, 2021 to Jun 14, 202328
- Board memberGeoffrey Mackay May 6, 2021 to Jun 14, 202329
- Board memberMark McDade May 6, 2021 to now30
- Board memberNicholas Galakatos May 6, 2021 to May 6, 202131
- Board memberSandip Agarwala May 6, 2021 to Jun 14, 202332
- Board memberSapna Srivastava May 6, 2021 to now33
- Board memberScott Requadt May 6, 2021 to Feb 3, 202319
- Board memberSuzanne Ildstad May 6, 2021 to Jun 14, 202320
Former names
- Talaris Therapeutics, Inc.Oct 7, 2020 to Oct 18, 20232
Timeline
- Oct 28, 20258-K Ended a material agreement; Completed an acquisition or sale; Listing notice or transfer34
- Sep 12, 20258-K Executive or director change35
- Sep 9, 20258-K Entered a material agreement; Regulation FD disclosure36
- Aug 13, 20258-K Results of operations37
- Jun 9, 20258-K Regulation FD disclosure38
- Jun 6, 20258-K Shareholder vote39
- May 20, 20258-K Regulation FD disclosure; Other events40
- May 2, 20258-K Results of operations41
- Mar 13, 20258-K Results of operations42
- Dec 10, 20248-K Regulation FD disclosure; Other events43
- Dec 10, 20248-K Regulation FD disclosure44
- Nov 7, 20248-K Results of operations45
- Oct 23, 2023New chief executive Sandeep Chidambar Kulkarni becomes CEO10
- Feb 2, 2022New chief executive Scott Requadt becomes CEO11
Calendar
When it reported results
- Aug 13, 2025Reported quarterly or annual results37
- May 2, 2025Reported quarterly or annual results41
- Mar 13, 2025Reported quarterly or annual results42
- Nov 7, 2024Reported quarterly or annual results45
- Aug 8, 2024Reported quarterly or annual results46
- May 13, 2024Reported quarterly or annual results47
- Mar 19, 2024Reported quarterly or annual results48
- Jan 24, 2024Reported quarterly or annual results49
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
293 filings to the SEC since October 2021: 4 annual reports, 12 quarterly reports, 51 major events, 123 insider forms, 35 large holders, 68 other. The latest 20:
- Nov 14, 2025EFFECT EDGAR
- Nov 14, 2025EFFECT EDGAR
- Nov 14, 2025SCHEDULE 13G/A EDGAR
- Nov 7, 202515-12G EDGAR
- Oct 28, 20254 EDGAR
- Oct 28, 20254 EDGAR
- Oct 28, 20254 EDGAR
- Oct 28, 20254 EDGAR
- Oct 28, 20254 EDGAR
- Oct 28, 20254 EDGAR
- Oct 28, 20254 EDGAR
- Oct 28, 20254 EDGAR
- Oct 28, 20254 EDGAR
- Oct 28, 20254 EDGAR
- Oct 28, 20254 EDGAR
- Oct 28, 20253 OWNERSHIP DOCUMENT EDGAR
- Oct 28, 2025S-8 POS EDGAR
- Oct 28, 2025S-8 POS EDGAR
- Oct 28, 2025S-8 POS EDGAR
- Oct 28, 2025S-8 POS EDGAR
The 293 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
50 open-market trades by officers, directors and large owners since October 2021: 22 buys and 28 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Aug 21, 2024 | Kulkarni Sandeep ChidambarCEO | Buy | 1,779 | $14.85 | $26.4K | Form 4 |
| Aug 16, 2024 | Kulkarni Sandeep ChidambarCEO | Buy | 5,221 | $13.79 | $72.0K | Form 4 |
| Jan 29, 2024 | MCDADE MARKDirector | Buy | 100,000 | $32.50 | $3.2M | Form 4 |
| Nov 17, 2023 | Kulkarni Sandeep ChidambarCEO | Buy | 4,000 | $16.99 | $68.0K | Form 4 |
| Nov 17, 2023 | Thiara ParvinderDirector | Buy | 1,000 | $17.31 | $17.3K | Form 4 |
| Oct 27, 2023 | Castelein CaleyDirector | Buy | 15,800 | $14.55 | $229.9K | Form 4 |
| Oct 26, 2023 | Kulkarni Sandeep ChidambarCEO | Buy | 5,000 | $12.25 | $61.2K | Form 4 |
| Oct 25, 2023 | Castelein CaleyDirector | Buy | 4,200 | $12.07 | $50.7K | Form 4 |
| Oct 25, 2023 | Thiara ParvinderDirector | Buy | 2,000 | $12.12 | $24.2K | Form 4 |
| Oct 24, 2023 | Kulkarni Sandeep ChidambarCEO | Buy | 4,650 | $10.68 | $49.7K | Form 4 |
| Oct 24, 2023 | KANTOFF AARONDirector | Buy | 7,500 | $11.86 | $89.0K | Form 4 |
| Oct 24, 2023 | Thiara ParvinderDirector | Buy | 5,000 | $10.66 | $53.3K | Form 4 |
| Jun 14, 2023 | Ildstad SuzanneDirector | Sale | 12,942 | $2.49 | $32.2K | Form 4 |
| Jun 13, 2023 | Ildstad SuzanneDirector | Sale | 14,208 | $2.56 | $36.4K | Form 4 |
| Jun 12, 2023 | Ildstad SuzanneDirector | Sale | 16,870 | $2.59 | $43.7K | Form 4 |
| Jun 9, 2023 | Ildstad SuzanneDirector | Sale | 25,419 | $2.46 | $62.5K | Form 4 |
| Jun 8, 2023 | Ildstad SuzanneDirector | Sale | 40,642 | $2.48 | $100.8K | Form 4 |
| Jun 7, 2023 | Ildstad SuzanneDirector | Sale | 75,001 | $2.39 | $179.3K | Form 4 |
| Jun 6, 2023 | Ildstad SuzanneDirector | Sale | 25,549 | $2.53 | $64.6K | Form 4 |
| Jun 5, 2023 | Ildstad SuzanneDirector | Sale | 7,841 | $2.52 | $19.8K | Form 4 |
All 50 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.
- RA CAPITAL MANAGEMENT, L.P.SCHEDULE 13G/A, 5 filings Jul 6, 2023 to Nov 14, 202550
- BlackRockSCHEDULE 13G/A, 3 filings Oct 22, 2024 to Oct 17, 202551
- Avoro Capital Advisors LLCSCHEDULE 13G/A, 2 filings Nov 14, 2024 to Aug 14, 202552
- QVT Financial LPSCHEDULE 13G/A, 2 filings May 15, 2025 to Aug 14, 202553
- Blue Owl CapitalSCHEDULE 13G/A, 3 filings Feb 14, 2024 to Feb 14, 202554
- Deep Track Capital, LPSC 13G/A, 2 filings Oct 27, 2023 to Nov 14, 202455
- VIKING GLOBAL INVESTORS LPSC 13G/A, 2 filings Feb 14, 2022 to Nov 14, 202456
- PfizerSC 13G/A, 2 filings Oct 27, 2023 to Mar 15, 202457
- CITADEL ADVISORS LLCSC 13G/A, 3 filings Feb 14, 2022 to Feb 14, 202458
- Hydra LLCSC 13G/A, 2 filings Nov 6, 2023 to Feb 14, 202459
- Blackstone Holdings II L.P.SC 13G/A, 2 filings Feb 11, 2022 to Feb 9, 202460
- TCG Crossover GP I, LLCSC 13G, 1 filing Feb 9, 202461
- BML Investment Partners, L.P.SC 13G/A, 3 filings Apr 27, 2023 to Feb 7, 202462
- Longitude Capital Partners III, LLCSC 13D/A, 1 filing Oct 30, 202363
- Qiming U.S. Healthcare GP II, LLCSC 13D/A, 2 filings Feb 28, 2022 to Oct 30, 202364
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.
| Year | Executive | Age | Salary | Total pay |
|---|---|---|---|---|
| 2024 | Ryan Robinson | 37 | $434.0K | $1.4M65 |
| 2024 | Sandeep KulkarniM.D. | 43 | $585.0K | $848.2K65 |
| 2024 | Brad MiddlekauffJ.D. | 63 | $425.0K | $582.2K65 |
| 2023 | Chief Executive Officer and Director | $114.1K | $2.1M65 |
SEC filer profile
How Tourmaline 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 EDGARTourmaline Bio, Inc.1
- CIK0001827506
- Employer ID (EIN)83-23773523
- 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)2836 Biological Products, (No Diagnostic Substances)1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address27 West 24Th Street, Suite 702, New York, NY 100101
- Phone646-481-98321
- Shares outstanding25,692,268 as of Aug 1, 20259
- Public float$294.0M as of Jun 28, 20243
- AuditorDeloitte & Touche LLP, Morristown, New Jersey PCAOB ID 34; no auditor attestation of internal control over financial reporting3
- On EDGAR sinceOct 7, 20201
- Filings346 in all: 4 (108), 8-K (53), 3 (28), SC 13G (16), 10-Q (14), SC 13G/A (14), CORRESP (8), 425 (7)1
All 47 form types
4/A (6), EFFECT (6), S-8 (6), S-8 POS (6), UPLOAD (6), SCHEDULE 13G/A (5), 10-K (4), 144 (4), DEF 14A (4), DEFA14A (4), SEC STAFF LETTER (4), ARS (3), S-4/A (3), SC 14D9/A (3), SC TO-T/A (3), SC14D9C (3), 424B5 (2), POS AM (2), S-3 (2), SC 13D (2), SC 13D/A (2), 15-12G (1), 25-NSE (1), 424B3 (1), 424B4 (1), 8-A12B (1), 8-K/A (1), CERT (1), D (1), DRS (1), DRS/A (1), DRSLTR (1), S-1 (1), S-1/A (1), S-4 (1), SC 14D9 (1), SC TO-C (1), SC TO-T (1), SCHEDULE 13G (1)
- Latest filingsAnnual report (10-K) Mar 13, 2025
Quarterly report (10-Q) Aug 13, 2025
Proxy statement (DEF 14A) Apr 21, 2025
Latest 8-K (8-K) Oct 28, 2025
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, $0.0001 par value per share | TRML | The Nasdaq Global Select Market |
From the cover page of the 10-K filed Mar 13, 2025 (Section 12(b) of the Exchange Act).3
Risk factors and legal proceedings
The risks Tourmaline Bio, Inc. names in Item 1A of its 10-K filed Mar 13, 2025: 62 risks under these headings, as written.3
- Risks Related to Our Financial Condition and Capital Needs
- We have a limited operating history and no history of commercializing products which may make it difficult for an investor to evaluate the success of our business to date and to assess our future viability.
- We have incurred net losses every year since our inception and have no source of product revenue. We expect to continue to incur significant operating losses and may never become profitable.
- Our business is highly dependent on the success of pacibekitug as well as any other potential future product candidates. If we are unable to successfully complete clinical development of, obtain regulatory approval for, or commercialize, pacibekitug or any other potential future product candidates, or if we experience delays in doing so, our business will be materially harmed.
- We will need significant additional capital to proceed with the development and commercialization of pacibekitug and any potential future product candidates and our other operations. We may not be able to access sufficient capital on acceptable terms, if at all, and, as a result, we may be required to delay, scale back or discontinue development of such product candidates or other operations.
- We will incur additional costs and increased demands upon management as a result of complying with the laws and regulations applicable to public companies.
- Once we are no longer an emerging growth company, a smaller reporting company, or otherwise no longer qualify for applicable exemptions, we will be subject to additional laws and regulations affecting public companies that will increase our costs and the demands on management and could harm our operating results.
- Risks Related to Our Dependence on Third Parties
- We may not be able to obtain and maintain the relationships with third parties that are necessary to develop, commercialize and manufacture pacibekitug and any potential future product candidates.
- We rely completely on CDMOs for the manufacture and testing of pacibekitug and any potential future product candidates under cGMP, and we are subject to many manufacturing risks, any of which could substantially increase our costs and limit supply of any potential product candidates and any future products. Additionally, any difficulties in the transfer of drug substance or drug product to or from clinical sites or manufacturing facilities could materially adversely affect our business, financial condition, and results of operations.
- As of December 31, 2024, our manufacturing and testing of bulk drug substance for pacibekitug currently takes place in the U.S. through a global CDMO with facilities around the world. Our manufacturing and testing of drug product for pacibekitug occurs in facilities in Austria and the U.S. Our drug product is packaged in Germany and the U.S. A significant disruption in the operation of these manufacturing facilities, a trade war or political unrest could materially adversely affect our business, financial condition and results of operations.
- We may seek to establish BD Arrangements, and, if we are not able to establish them on commercially reasonable terms, or at all, we may have to alter our development and commercialization plans.
The other 52 risks
- We have no experience in sales, marketing and distribution and may have to enter into agreements with third parties to perform these functions, which could prevent us from successfully commercializing pacibekitug or any potential future product candidates.
- We, our CROs, our CDMOs, our service providers, our current and potential future partners or other third parties with whom we work, could experience a security incident, system disruption or failure, data loss, cyberattack, or similar event that could compromise our systems and data (or those of the third parties with whom we work), result in material disruptions to our business operations, lead to regulatory investigations or actions, litigation, fines and penalties, affect our reputation, revenue or profits, or otherwise harm our business.
- Risks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates
- Pacibekitug and any other of our future product candidates must undergo rigorous clinical trials before seeking regulatory approvals, and clinical trials may be delayed, suspended or terminated at any time for many reasons, any of which could delay or prevent regulatory approval and, if approval is granted, commercialization of our product candidates.
- If clinical trials of pacibekitug or any potential future product candidates fail to timely initiate, enroll, complete, or produce positive results or to demonstrate safety and efficacy to the satisfaction of the FDA or comparable health authorities or sufficiently demonstrate differentiation from other approved therapies or therapies in development, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
- We may not be able to file INDs, IND amendments, or clinical trial applications (“CTAs”) to commence clinical trials on the timelines we expect, and even if we are able to, the FDA or comparable health authorities may not permit us to proceed.
- If we experience delays or difficulties in the enrollment of patients in clinical trials, development of pacibekitug, or any potential future product candidates, may be delayed or prevented, which would have a material adverse effect on our business.
- Success in preclinical studies or earlier-stage clinical trials for pacibekitug, or evidence from published observations, clinical studies, or other literature for other anti-IL-6 or anti-IL-6 receptor agents, may not be indicative of such results in future or ongoing clinical trials for pacibekitug.
- Preliminary, initial, or interim results from clinical trials that we announce, present, or publish from time to time may change as more data and information become available (or are updated based upon audit, validation and verification procedures of the data/information commonly performed for clinical trials) that could result in material changes in the final trial results.
- Pacibekitug may cause undesirable side effects or adverse events or have other properties or safety risks, which could terminate further development of this product candidate, result in a lack of product approval by the FDA or other regulatory authorities, delay the timing (and/or increase the cost) of a product approval by the FDA or other regulatory authorities, lead to a restrictive product label that significantly limits prescribing of an approved product, delay or preclude reimbursement by payors, or significantly limit or preclude the commercialization of pacibekitug.
- Pacibekitug is a product candidate within the IL-6 inhibitor and IL-6R inhibitor class and may be adversely impacted by results for other members in the class, which could delay, terminate or increase the cost of development of pacibekitug, delay or prevent approval by the FDA or other regulatory authorities, lead to a restrictive product label that significantly limits prescribing, delay or preclude reimbursement by payors, or significantly limit or preclude the commercialization of pacibekitug.
- We face significant competition from other biotechnology and pharmaceutical companies targeting immune and inflammatory disease indications. Our operating results will suffer if we fail to compete effectively.
- If the market opportunities for pacibekitug and any potential future product candidates are smaller than we estimate or if any approval that we obtain is based on a narrower definition of the patient population, then our revenue potential and ability to achieve profitability will be adversely affected.
- We may not successfully identify new product candidates to expand our development pipeline.
- Risks Related to the Marketing and Commercialization of Our Product Candidates
- Even if any of our current or future product candidates receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
- Even if we obtain approval to market pacibekitug or other potential future product candidates, these products may become subject to unfavorable pricing regulations, reimbursement practices from third-party payors or healthcare reform initiatives in the U.S. and abroad, which could harm our business.
- Even if we are able to obtain regulatory approval for pacibekitug or any of our future product candidates, we may receive an undesirable label, including, but not limited to, a black boxed warning, which could impede our ability to successfully commercialize pacibekitug or any of our future product candidates or compete successfully.
- Our estimates of market opportunity and forecasts of market growth may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business may not grow at similar rates, or at all.
- Product liability lawsuits against us could cause us to incur substantial liabilities and to limit development and commercialization of any products that we may develop.
- Risks Related to Government Regulation
- The regulatory approval processes of the FDA and comparable foreign health authorities are lengthy and inherently unpredictable. Our inability to obtain regulatory approval for pacibekitug would substantially harm our business.
- Inadequate funding for the FDA, the SEC and other government agencies, including from government shutdowns, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
- Our failure to obtain health authority approval in foreign jurisdictions would prevent us from marketing pacibekitug or any potential future product candidates outside the U.S.
- Even if pacibekitug and any potential future product candidates receive regulatory approval, they will still face extensive ongoing regulatory requirements, which may result in significant expenses, and may still face future development and regulatory difficulties.
- Healthcare reform may negatively impact our ability to profitably sell pacibekitug and any potential future product candidates, if approved.
- Our current and future relationships with investigators, healthcare professionals, customers, and third-party payors will be subject to applicable anti-kickback, fraud and abuse, transparency, and other healthcare laws and regulations, which, if violated, could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens, and diminished profits and future earnings.
- Changes in tax laws or regulations could adversely affect our business and financial condition.
- Our ability to use our U.S. net operating loss carryforwards and certain other U.S. tax attributes may be limited.
- Future changes in financial accounting standards or practices may cause adverse and unexpected revenue fluctuations and adversely affect our reported results of operations.
- Risks Related to Our Business Operations, Employee Matters and Managing Growth
- Our internal control over financial reporting may not meet the standards required by Section 404 of the Sarbanes-Oxley Act, and failure to achieve and maintain effective internal control over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act, could have a material adverse effect on our business and share price.
- We have previously identified material weaknesses in our internal control over financial reporting. If we identify additional material weaknesses in the future or otherwise fail to maintain effective internal control over financial reporting, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect our business.
- We expect to expand our clinical development, manufacturing and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, including significant growth in the number of our employees, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
- We must attract and retain highly skilled employees in order to succeed. If we are not able to retain our current management team or to continue to attract and retain qualified scientific, technical and business personnel, our business may suffer.
- Our Executive Severance and Change in Control Plan with certain of our executive officers may require us to pay severance benefits to any of those persons who are terminated in connection with a change in control of us or otherwise, which could harm our financial condition or results.
- Our international operations may expose us to business, regulatory, political, operational, financial, pricing and reimbursement risks associated with doing business outside of the U.S.
- Our business could be materially and adversely affected in the future by the effects of disease outbreaks, epidemics, and pandemics.
- Unfavorable domestic or global economic conditions could adversely affect our business, financial condition, results of operations, or cash flows.
- Our operations are vulnerable to interruption by fire, earthquake, power loss, telecommunications failure, terrorist activity and other events beyond our control, which could harm our business.
- We and the third parties with whom we contract use and generate materials that may expose us to material liability.
- We may be exposed to litigation, including stockholder litigation, which could have an adverse effect on our business and operations.
- Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
- Risks Related to Our Intellectual Property
- Our success depends in significant part upon our ability to obtain and maintain intellectual property protection for our products and technologies.
- We are dependent on patents, know-how and technology, both our own and licensed from others. In particular, we are dependent on our license agreements with Pfizer and Lonza. Any termination, or reduction or narrowing, of these licenses could result in the loss of significant rights and could harm our ability to commercialize pacibekitug and any potential future product candidates.
- We may be unable to obtain intellectual property rights or technologies necessary to develop and commercialize pacibekitug or any potential future product candidates.
- We could lose the ability to continue the development, manufacture, and commercialization of pacibekitug or any potential future product candidates if we breach any license agreement with service providers and vendors related to those product candidates.
- We may become involved in lawsuits or other proceedings to protect or enforce our intellectual property rights, which could be expensive, time-consuming and unsuccessful, and have a material adverse effect on the success of our business.
- Third parties may initiate legal proceedings against us alleging that we infringe their intellectual property rights or we may initiate legal proceedings against third parties to challenge the validity or scope of the third-party intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
- Reliance on third parties requires us to share our proprietary information, which increases the possibility that such information will be misappropriated or disclosed.
- We may not be able to protect our intellectual property rights throughout the world.
- Risks Related to Our Common Stock
- The market price of our common stock is expected to be volatile, and the market price of the common stock may drop.
- Provisions in our charter documents and under Delaware law could make an acquisition of us more difficult and may discourage any takeover attempts stockholders may consider favorable, and may lead to entrenchment of management.
- Our bylaws provide that the Court of Chancery of the State of Delaware is 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 other employees.
- We do not anticipate that we will pay any cash dividends in the foreseeable future.
Legal proceedings
From time to time, we may become involved in legal proceedings arising from the ordinary course of business. For additional information regarding legal proceedings, see Note 13 “Commitments and Contingencies—Litigation” to our audited financial statements included elsewhere in this Report. We believe there are currently no pending legal proceedings to which we or our property are subject that could have a material adverse effect on our financial position, results of operations or cash flows.
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.
- 1
- 2
- 3
- 4
- 5
- 6
- 7
- 8
- 9
- 10
- 11
- 12
- 13
- 14
- 15
- 16
- 17
- 18SEC EDGARNancy Krieger, Chief Medical Officer
- 19SEC EDGARScott Requadt, Officer
- 20
- 21SEC EDGARAaron Kantoff, Board member
- 22SEC EDGARCaley Castelein, Board member
- 23SEC EDGARCariad Chester, Board member
- 24SEC EDGARParvinder Thiara, Board member
- 25SEC EDGARClay B. Siegall, Board member
- 26SEC EDGARKaren L. Smith, Board member
- 27SEC EDGARFrancois Nader, Board member
- 28SEC EDGARGaurav Shah, Board member
- 29SEC EDGARGeoffrey Mackay, Board member
- 30SEC EDGARMark McDade, Board member
- 31SEC EDGARNicholas Galakatos, Board member
- 32SEC EDGARSandip Agarwala, Board member
- 33SEC EDGARSapna Srivastava, Board member
- 34
- 35SEC EDGARExecutive or director change
- 36
- 37SEC EDGARResults of operations
- 38SEC EDGARRegulation FD disclosure
- 39SEC EDGARShareholder vote
- 40
- 41SEC EDGARResults of operations
- 42SEC EDGARResults of operations
- 43
- 44SEC EDGARRegulation FD disclosure
- 45SEC EDGARResults of operations
- 46
- 47
- 48
- 49
- 50
- 51
- 52
- 53
- 54
- 55
- 56
- 57
- 58
- 59
- 60
- 61
- 62
- 63
- 64
- 65