Private company
IGM Biosciences, Inc.
In its 2025 annual report the company says: “We are a biotechnology company that has historically been focused on the development of IgM antibodies for the treatment of cancer and autoimmune and inflammatory diseases. We have created a portfolio of patents and patent applications, know-how and trade secrets directed to our platform technology and we retain worldwide commercial rights to all of our product candidates, other than those being developed in partnership with Sanofi and the intellectual property related thereto.”5 It is headquartered in Mountain View, United States.2
Last updated Oct 20, 2026.
Overview
- IndustryPharmaceutical Preparations2
- HeadquartersMountain View, United States2
- Incorporated inDE4
- Business address325 E Middlefield Road, Mountain View, Ca 940434
- Filer categoryNon-accelerated filer, Smaller reporting company4
- Legal formCorporation2
- LEI5493008XCQES2N0VY9692
- StatusActive2
- LEI statusLapsed (not renewed)2
- Registered addressc/o THE CORPORATION TRUST COMPANY, CORPORATION TRUST CENTER 1209 ORANGE ST, 19801 Wilmington, United States2
- Registered withDivision of Corporations, Department of State, 23487882
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We are a biotechnology company that has historically been focused on the development of IgM antibodies for the treatment of cancer and autoimmune and inflammatory diseases. IgM antibodies have inherent properties that we believe may enable them to bind more strongly to targets on the surface of cells than comparable IgG antibodies.5 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 2024
Financial statements
| Fiscal year | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|---|
| Research and development | $8.6M6 | $19.0M7 | $35.3M8 | $65.0M9 | $127.0M10 | $179.3M3 | $215.5M3 | $160.9M3 |
| Operating expenses | $165.3M10 | $229.0M3 | $265.6M3 | $211.3M3 | ||||
| Operating income | -$11.1M6 | -$22.8M7 | -$44.5M8 | -$83.3M9 | -$165.3M10 | -$228.0M3 | -$263.5M3 | -$208.6M3 |
| Income before tax | -$165.2M10 | -$221.1M3 | -$245.7M3 | -$195.8M3 | ||||
| Income tax | $06 | $07 | $07 | $07 | $010 | $03 | $678.0K3 | $03 |
| Net income | -$11.1M6 | -$22.7M7 | -$43.1M8 | -$81.4M9 | -$165.2M10 | -$221.1M3 | -$246.4M3 | -$195.8M3 |
| Earnings per share | -$2.659 | -$4.9310 | -$5.323 | -$4.713 | -$3.243 | |||
| Earnings per share (diluted) | -$2.659 | -$4.9310 | -$5.323 | -$4.713 | -$3.243 | |||
| Shares (weighted, basic) | 33.5M shares10 | 41.5M shares3 | 52.3M shares3 | 60.5M shares3 | ||||
| Shares (weighted, diluted) | 33.5M shares10 | 41.5M shares3 | 52.3M shares3 | 60.5M shares3 |
| Fiscal year | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|---|
| Cash | $432.0K6 | $1.9M7 | $35.9M8 | $241.1M9 | $133.3M10 | $121.2M3 | $112.5M3 | $26.5M3 |
| Current assets | $2.4M6 | $231.1M7 | $373.3M8 | $240.7M9 | $438.4M10 | $347.6M3 | $193.6M3 | |
| Property, plant and equipment | $28.5M9 | $33.5M10 | $38.2M3 | $32.5M3 | ||||
| Total assets | $4.0M6 | $261.4M7 | $408.6M8 | $298.1M9 | $513.5M10 | $423.4M3 | $265.7M3 | |
| Accounts payable | $5.6M9 | $2.5M10 | $1.3M3 | $983.0K3 | ||||
| Current liabilities | $8.9M6 | $8.9M7 | $17.2M8 | $27.8M9 | $44.7M10 | $42.5M3 | $37.6M3 | |
| Total liabilities | $8.9M6 | $21.1M7 | $26.8M8 | $53.2M9 | $226.2M10 | $220.2M3 | $217.5M3 | |
| Retained earnings | -$353.7M9 | -$574.8M10 | -$821.2M3 | -$1.0B3 | ||||
| Shareholders’ equity | -$40.5M7 | -$65.8M8 | $240.2M9 | $381.8M10 | $244.9M3 | $287.3M3 | $203.2M3 | $48.2M3 |
| Shares outstanding | 438.1K shares6 | 24.1M shares7 | 25.5M shares7 |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
| Fiscal year | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 |
|---|---|---|---|---|---|---|---|---|
| Cash from operations | -$10.4M6 | -$20.0M7 | -$45.1M8 | -$67.9M9 | -$125.0M10 | -$5.9M3 | -$192.2M3 | -$153.0M3 |
| Stock-based compensation | $25.9M10 | $44.7M3 | $46.5M3 | $38.3M3 | ||||
| Capital spending | $385.0K6 | $788.0K7 | $2.3M8 | $17.5M9 | $13.2M10 | $10.2M3 | $12.4M3 | $5.9M3 |
| Free cash flow | -$10.7M | -$20.8M | -$47.5M | -$85.4M | -$138.2M | -$16.1M | -$204.6M | -$158.8M |
| Cash from investing | $15.5M10 | -$225.6M3 | $68.4M3 | $64.2M3 | ||||
| Cash from financing | $2.5M10 | $219.4M3 | $115.1M3 | $2.4M3 |
Corporate structure
IGM Biosciences, 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 IGM Biosciences, Inc.
- GLAZER CAPITAL, LLC Filed SCHEDULE 13G/A on IGM Biosciences, Inc., latest Nov 13, 2025 (2 filings since Jul 9, 2025)
- BAKER BROS. ADVISORS LP Filed SCHEDULE 13D/A on IGM Biosciences, Inc., latest Aug 18, 2025 (5 filings since Apr 5, 2022)
- Topsoe Holding A/S Filed SCHEDULE 13D/A on IGM Biosciences, Inc., latest Aug 18, 2025 (2 filings since Jul 19, 2023)
- Redmile Group, LLC Filed SCHEDULE 13D/A on IGM Biosciences, Inc., latest Aug 15, 2025 (5 filings since Apr 5, 2022)
- PRICE T ROWE ASSOCIATES INC /MD/ Filed SCHEDULE 13G/A on IGM Biosciences, Inc., latest Feb 14, 2025 (7 filings since Feb 14, 2022)
- FMR LLC Filed SC 13G/A on IGM Biosciences, Inc., latest Nov 12, 2024 (2 filings since Feb 9, 2024)
- Invus Global Management, LLC Filed SC 13G/A on IGM Biosciences, Inc., latest Aug 2, 2024
- Artal International S.C.A. Filed SC 13G/A on IGM Biosciences, Inc., latest Feb 9, 2024 (3 filings since Feb 11, 2022)
- IGM Biosciences, Inc. Mountain View, California, United States
Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What IGM Biosciences, 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 | $61.8M3 Dec 31, 2024 | $58.8M3 Dec 31, 2023 | +5.1% |
| Accumulated depreciation | $29.3M3 Dec 31, 2024 | $20.6M3 Dec 31, 2023 | +42.3% |
| Property and equipment, net | $32.5M3 Dec 31, 2024 | $38.2M3 Dec 31, 2023 | −15.0% |
| Operating-lease assets (leased space) | $38.5M3 Dec 31, 2024 | $35.8M3 Dec 31, 2023 | +7.7% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $26.5M3 Dec 31, 2024 | $112.5M3 Dec 31, 2023 | −76.5% |
Properties, in its own words
We lease approximately 95,900 square feet of office, laboratory and manufacturing space in Mountain View, California and office and laboratory space in Doylestown, PA. These leases have expiration dates ranging from December 2025 through June 2032. We believe that our facilities are adequate to meet our needs for the immediate future, and that, should it be needed, suitable additional space will be available on commercially reasonable terms to accommodate any such expansion of our operations.
Item 2 of the 10-K filed Mar 6, 2025.5
Leadership
Who has led IGM Biosciences, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
- Chief executive officerMary Beth Harler Oct 4, 2024 to now15
- Chief executive officerFred Schwarzer Sep 17, 2019 to Oct 4, 202416
- PresidentFred Schwarzer Sep 17, 2019 to now16
- Chief financial officerMisbah Tahir Sep 17, 2019 to now17
Board members and other officers (17)
- Head, Research & AutoimmunityMary Beth Harler Apr 23, 2024 to now18
- Chief Commercial OfficerGeorge Gauthier Apr 26, 2021 to Dec 1, 202319
- Chief Medical OfficerChris H. Takimoto Aug 3, 2021 to now20
- Chief Scientific OfficerBruce Keyt Sep 17, 2019 to now21
- Board memberMary Beth Harler Oct 4, 2024 to now15
- Board memberChristina Teng Topsoe Sep 17, 2019 to now22
- Board memberFelix Baker Sep 17, 2019 to now23
- Board memberFred Schwarzer Sep 17, 2019 to now16
- Board memberJakob Haldor Topsoe Sep 17, 2019 to now24
- Board memberJeremy Green Sep 17, 2019 to now25
- Board memberJulian Baker Sep 17, 2019 to now23
- Board memberJulie Hambleton Sep 17, 2019 to now26
- Board memberKelvin Neu Sep 17, 2019 to Sep 17, 201927
- Board memberL.p. 667 Sep 17, 2019 to now23
- Board memberM. Kathleen Behrens Sep 17, 2019 to now28
- Board memberMichael D. Loberg Sep 17, 2019 to Oct 3, 202329
- Board memberWilliam Strohl Sep 17, 2019 to now30
Named in SEC Form D filings
People the company listed in its private-offering notices.
Former names
- Palingen, Inc.Jul 16, 2010 to Jul 16, 20104
Timeline
- Aug 14, 20258-K Completed an acquisition or sale; Listing notice or transfer; Change to shareholders' rights32
- Jul 1, 20258-K Entered a material agreement; Executive or director change; Regulation FD disclosure33
- Jun 11, 20258-K Listing notice or transfer34
- May 29, 20258-K Entered a material agreement; Ended a material agreement35
- May 8, 20258-K Ended a material agreement; Regulation FD disclosure36
- Mar 6, 20258-K Exit or restructuring costs37
- Jan 10, 20258-K Results of operations; Exit or restructuring costs; Regulation FD disclosure38
- Nov 8, 20248-K Exit or restructuring costs39
- Nov 8, 20248-K Results of operations40
- Oct 4, 2024New chief executive Mary Beth Harler becomes CEO15
- Oct 3, 20248-K Exit or restructuring costs; Executive or director change41
- Aug 14, 20248-K Results of operations42
- Jul 5, 20248-K Regulation FD disclosure43
- Sep 17, 2019New chief executive Fred Schwarzer becomes CEO16
- Aug 25, 1993Founded IGM Biosciences, Inc. is founded2
Calendar
When it reported results
- Jan 10, 2025Reported quarterly or annual results38
- Nov 8, 2024Reported quarterly or annual results40
- Aug 14, 2024Reported quarterly or annual results42
- May 8, 2024Reported quarterly or annual results44
- Mar 7, 2024Reported quarterly or annual results45
- Jan 8, 2024Reported quarterly or annual results46
- Nov 13, 2023Reported quarterly or annual results47
- Aug 3, 2023Reported quarterly or annual results48
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
469 filings to the SEC since October 2021: 5 annual reports, 12 quarterly reports, 39 major events, 311 insider forms, 27 large holders, 1 private raises, 74 other. The latest 20:
- Nov 13, 2025SCHEDULE 13G/A EDGAR
- Aug 25, 202515-12G EDGAR
- Aug 18, 2025SCHEDULE 13D/A EDGAR
- Aug 18, 20254 EDGAR
- Aug 18, 2025SCHEDULE 13D/A EDGAR
- Aug 15, 2025SCHEDULE 13D/A EDGAR
- Aug 15, 20254 OWNERSHIP DOCUMENT EDGAR
- Aug 14, 2025EFFECT EDGAR
- Aug 14, 2025EFFECT EDGAR
- Aug 14, 2025EFFECT EDGAR
- Aug 14, 2025EFFECT EDGAR
- Aug 14, 2025EFFECT 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 14, 20254 EDGAR
The 469 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
120 open-market trades by officers, directors and large owners since October 2021: 22 buys and 98 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Jul 23, 2025 | Tahir MisbahCHIEF FINANCIAL OFFICER | Sale | 8,741 | $1.27 | $11.1K | Form 4 |
| Jul 23, 2025 | Harler Mary BethChief Executive Officer | Sale | 14,501 | $1.27 | $18.4K | Form 4 |
| Jul 23, 2025 | Decker Lisa LynnCHIEF BUSINESS OFFICER | Sale | 4,409 | $1.27 | $5.6K | Form 4 |
| Jun 16, 2025 | Weber StevenPRINCIPAL ACCOUNTING OFFICER | Sale | 486 | $1.20 | $583 | Form 4 |
| Jun 16, 2025 | Tahir MisbahCHIEF FINANCIAL OFFICER | Sale | 1,522 | $1.20 | $1.8K | Form 4 |
| Jun 16, 2025 | Harler Mary BethChief Executive Officer | Sale | 1,522 | $1.20 | $1.8K | Form 4 |
| Jun 16, 2025 | Decker Lisa LynnCHIEF BUSINESS OFFICER | Sale | 951 | $1.20 | $1.1K | Form 4 |
| May 14, 2025 | Weber StevenPRINCIPAL ACCOUNTING OFFICER | Sale | 1,865 | $1.12 | $2.1K | Form 4 |
| Mar 14, 2025 | Weber StevenPRINCIPAL ACCOUNTING OFFICER | Sale | 1,701 | $1.23 | $2.1K | Form 4 |
| Mar 14, 2025 | Tahir MisbahCHIEF FINANCIAL OFFICER | Sale | 7,329 | $1.23 | $9.0K | Form 4 |
| Mar 14, 2025 | Harler Mary BethChief Executive Officer | Sale | 7,329 | $1.23 | $9.0K | Form 4 |
| Mar 14, 2025 | Decker Lisa LynnCHIEF BUSINESS OFFICER | Sale | 4,512 | $1.23 | $5.5K | Form 4 |
| Jan 15, 2025 | Weber StevenPRINCIPAL ACCOUNTING OFFICER | Sale | 1,122 | $1.70 | $1.9K | Form 4 |
| Dec 16, 2024 | Weber StevenPRINCIPAL ACCOUNTING OFFICER | Sale | 539 | $7.48 | $4.0K | Form 4 |
| Dec 16, 2024 | Decker Lisa LynnCHIEF BUSINESS OFFICER | Sale | 1,063 | $7.48 | $8.0K | Form 4 |
| Dec 16, 2024 | Harler Mary BethChief Executive Officer | Sale | 1,708 | $7.48 | $12.8K | Form 4 |
| Dec 16, 2024 | Tahir MisbahCHIEF FINANCIAL OFFICER | Sale | 1,708 | $7.48 | $12.8K | Form 4 |
| Sep 13, 2024 | Weber StevenPRINCIPAL ACCOUNTING OFFICER | Sale | 469 | $11.54 | $5.4K | Form 4 |
| Sep 13, 2024 | Takimoto Chris HCHIEF MEDICAL OFFICER | Sale | 1,487 | $11.54 | $17.2K | Form 4 |
| Sep 13, 2024 | Tahir MisbahCHIEF FINANCIAL OFFICER | Sale | 1,487 | $11.54 | $17.2K | Form 4 |
All 120 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.
- GLAZER CAPITAL, LLCSCHEDULE 13G/A, 2 filings Jul 9, 2025 to Nov 13, 202549
- BAKER BROS. ADVISORS LPSCHEDULE 13D/A, 5 filings Apr 5, 2022 to Aug 18, 202550
- Topsoe Holding A/SSCHEDULE 13D/A, 2 filings Jul 19, 2023 to Aug 18, 202551
- Redmile Group, LLCSCHEDULE 13D/A, 5 filings Apr 5, 2022 to Aug 15, 202552
- PRICE T ROWE ASSOCIATES INC /MD/SCHEDULE 13G/A, 7 filings Feb 14, 2022 to Feb 14, 202553
- FMR LLCSC 13G/A, 2 filings Feb 9, 2024 to Nov 12, 202454
- Invus Global Management, LLCSC 13G/A, 1 filing Aug 2, 202455
- Artal International S.C.A.SC 13G/A, 3 filings Feb 11, 2022 to Feb 9, 202456
Money raised
Private offerings the company reported to the SEC on Form D.
- Jun 26, 2023Raised $22.5 million in a private offering of equity Form D: 1 investor so far Form D
SEC filer profile
How IGM Biosciences, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARIGM Biosciences, Inc.1
- CIK0001496323
- Employer ID (EIN)77-03491945
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company5
- Incorporated inDelaware5
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address325 E Middlefield Road, Mountain View, CA 940431
- Phone650-965-78731
- Shares outstanding34,388,419 Common Stock shares; 25,386,983 Nonvoting Common Stock shares as of Feb 28, 20255
- Public float$50.7M as of Jun 28, 20245
- AuditorDeloitte & Touche LLP, San Francisco, California PCAOB ID 34; no auditor attestation of internal control over financial reporting5
- On EDGAR sinceJul 16, 20101
- Filings710 in all: 4 (448), 8-K (55), 3 (21), 10-Q (18), SC 13D/A (15), 144 (14), EFFECT (11), SC 13G/A (11)1
All 50 form types
CORRESP (8), S-8 (8), S-8 POS (8), UPLOAD (8), 10-K (6), 424B5 (6), DEF 14A (6), POS AM (5), S-3 (5), DEFA14A (4), SC 13G (4), 4/A (3), FWP (3), PRE 14A (3), SC 13D (3), SC TO-I/A (3), SCHEDULE 13D/A (3), SCHEDULE 13G/A (3), 8-K/A (2), ARS (2), D (2), S-1/A (2), 10-K/A (1), 15-12G (1), 25-NSE (1), 3/A (1), 424B3 (1), 424B4 (1), 8-A12B (1), CERT (1), DRS (1), DRS/A (1), DRSLTR (1), S-1 (1), SC 14D9 (1), SC 14D9/A (1), SC TO-C (1), SC TO-I (1), SC TO-T (1), SC TO-T/A (1), SC14D9C (1), SCHEDULE 13G (1)
- Latest filingsAnnual report (10-K) Mar 6, 2025
Quarterly report (10-Q) Jul 31, 2025
Proxy statement (DEF 14A) Apr 26, 2024
Latest 8-K (8-K) Aug 14, 2025
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.01 per share | IGMS | The Nasdaq Global Select Market |
From the cover page of the 10-K filed Mar 6, 2025 (Section 12(b) of the Exchange Act).5
Risk factors and legal proceedings
The risks IGM Biosciences, Inc. names in Item 1A of its 10-K filed Mar 6, 2025: 75 risks under these headings, as written.5
- Unless the context otherwise requires, any references to or discussion of "product candidates" in these Risk Factors refer to the IgM antibodies we are developing under the Sanofi Agreement or any product candidates that we may otherwise pursue in the future, if any. Further, unless the context otherwise requires, any references to or discussion of "clinical trials" or "clinical development" in these Risk Factors refer to any such clinical trials or clinical development that we may in the future conduct in connection with the Sanofi Agreement or may otherwise pursue in the future, if any.
- Risks Related to Our Business and the Development and Commercialization of Our Product Candidates
- Our only ongoing IgM-related efforts relate to the targets we are developing under the Sanofi Agreement, and we have not completed the development of any product candidates. If we are unable to discover and develop product candidates, advance product candidates through clinical development, obtain regulatory approval and commercialize one or more of our product candidates, our business will be materially adversely affected and we may never generate any product revenue.
- Our activities to evaluate and pursue potential strategic alternatives may not result in any definitive transaction or enhance stockholder value.
- If we fail to achieve the expected financial and operational benefits of our recent cash preservation activities, our business and financial results may be harmed.
- The use of engineered IgM antibodies is a novel and unproven therapeutic approach and our discovery and research programs may never lead to a marketable product.
- Following the 2025 Restructuring, we may decide not to develop product candidates through the IgM platform outside of the Sanofi Agreement. If, in the future, we do pursue such product candidates, we may not be successful in our efforts.
- In the future we may seek approval from the FDA or comparable foreign regulatory authorities through the use of expedited approval pathways, such as Fast Track designation and Breakthrough Therapy designation, orphan drug designation, or accelerated approval. Even if we receive accelerated approval from the FDA or comparable regulatory authorities, if our confirmatory clinical trials do not verify clinical benefit, or if we do not comply with rigorous post-marketing requirements, the FDA or such other regulatory authorities may seek to withdraw accelerated approval.
- Product candidates we may develop may have undesirable side effects that may delay or prevent marketing approval or, if approval is received, require them to be taken off the market, require them to include new safety warnings, contraindications or precautions, or otherwise limit their sales. No regulatory agency has made a determination that any of our product candidates are safe or effective for use by the general public for any indication.
- We face significant competition from entities that have developed or may develop product candidates for the treatment of diseases that we are initially targeting, including companies developing novel treatments and technology platforms. If our competitors develop and market products that are more effective, safer or less expensive than our product candidates, our commercial opportunities will be negatively impacted.
- We and our third-party manufacturers have encountered and may continue to encounter difficulties in the production of product candidates, and supply chain shortages have limited and may continue to limit access to raw materials and other supplies. Should we encounter any such difficulties, our ability to manufacture drug substance or supply our product candidates for preclinical studies or future clinical trials or, if approved, for commercial sale, could be further delayed or halted entirely.
- We may expend our limited resources to pursue product candidates or indications that do not yield a successful product and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
The other 63 risks
- Clinical trials are expensive, time consuming and difficult to design and implement and may fail to demonstrate adequate safety and efficacy of our product candidates. Furthermore, the results of previous preclinical studies and clinical trials may not be predictive of future results, and the results of any clinical trials may not satisfy the requirements of the FDA or comparable foreign regulatory authorities or provide the basis for regulatory approval.
- Interim, preliminary or topline data from any 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.
- If clinical trials for any product candidates that we may develop are prolonged, delayed or stopped, we may be unable to seek or obtain regulatory approval and commercialize our product candidates on a timely basis, or at all, which would require us to incur additional costs and delay our receipt of any product revenue.
- If we experience delays or difficulties in the enrollment of patients in clinical trials, including because of competition for patients, we will be unable to complete these trials on a timely basis, if at all.
- We face risks related to health epidemics and other outbreaks, such as COVID-19, which could significantly disrupt our operations or otherwise result in material adverse impacts to us.
- Material changes in methods of product candidate manufacturing or formulation may result in the need to perform new clinical trials, which would require additional costs and cause delay.
- The design or execution of our future clinical trials may not support regulatory approval.
- Even if any of our product candidates receive regulatory approval, the approved products may not achieve broad market acceptance among physicians, patients, the medical community and third-party payors, in which case revenue generated from their sales would be limited.
- We may be unsuccessful, in obtaining or may be unable to maintain the benefits associated with, orphan drug designation for current or future product candidates that we may develop. If our competitors are able to obtain orphan product exclusivity for their products in specific indications, we may not be able to have competing products approved in those indications by the applicable regulatory authority for a significant period of time.
- Even if we obtain FDA approval of any of our product candidates, we may never obtain approval or commercialize such products outside of the United States, which would limit our ability to realize their full market potential.
- Reimbursement decisions by third-party payors may have an adverse effect on pricing and market acceptance. If reimbursement is not available or is not sufficient for our products, it is less likely that our products will be widely used.
- If the market opportunities for any product that we develop are smaller than we believe they are, our revenue may be adversely affected and our business may suffer.
- Development of product candidates in combination with other therapies could expose us to additional risks.
- Even if we receive regulatory approval to commercialize any of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which will result in significant additional expense.
- If any product liability lawsuits are successfully brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.
- Any product candidates for which we may seek approval may face competition sooner than anticipated.
- Foreign governments tend to impose strict price controls, which may adversely affect our future profitability.
- Current and future legislation may increase the difficulty and cost for us to commercialize our product candidates, if approved, and affect the prices we may obtain.
- Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
- Our business may become subject to economic, political, regulatory and other risks associated with international operations.
- Our business and current and future relationships with customers and third-party payors in the United States and elsewhere will be subject, directly or indirectly, to applicable federal and state anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens, and diminished profits and future earnings.
- Our employees, independent contractors, principal investigators, consultants 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 adversely affected.
- Risks Related to Our Financial Position and Need for Additional Capital
- We have incurred significant losses since inception and anticipate that we will continue to incur losses for the foreseeable future. We have no products approved for commercial sale, and to date we have not generated any revenue or profit from product sales. We may never achieve or sustain profitability.
- Drug development is a highly speculative undertaking and involves a substantial degree of uncertainty. We have never generated any revenue from product sales and may never be profitable. Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve a number of objectives.
- We will require substantial additional funding to finance our operations, which may not be available to us on acceptable terms, or at all, and, if not available, may require us to delay, scale back or cease our product development programs or operations.
- Unstable market and economic conditions may have serious adverse consequences on our business and financial condition.
- Risks Related to Managing Our Growth and Operations
- Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
- We may need to grow our organization, and we may experience difficulty in managing this growth, which could disrupt our operations.
- Security breaches, loss of data and other disruptions could compromise sensitive information related to our business or protected health information or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.
- We are subject to stringent and changing obligations related to privacy, data protection 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.
- Our operations are vulnerable to interruption by catastrophic events, which could harm our business and financial condition.
- Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
- Changes in the U.S. taxation of international business activities or the adoption of other tax reform policies could materially impact our business, results of operations and financial condition.
- Acquisitions or joint ventures could increase our capital requirements, disrupt our business, cause dilution to our stockholders, cause us to incur debt or assume contingent liabilities and otherwise harm our business.
- Adverse events or perceptions affecting the financial services industry could adversely affect our operating results, financial condition and prospects.
- Risks Related to Our Dependence on Third Parties
- We have in the past and may in the future rely on third parties to manufacture and deliver our product candidates and provide other services. Any failure by one of these third parties to manufacture and deliver acceptable product candidates and provide other services for us pursuant to our specifications and regulatory standards may delay or impair our ability to initiate or complete our future clinical trials, obtain and maintain regulatory approvals or commercialize approved products.
- We have in the past and may in the future rely on third parties to monitor, support, conduct and oversee our preclinical studies and clinical trials and, in some cases, to maintain regulatory files for product candidates. We may not be able to obtain regulatory approval for, or commercialize, our product candidates, or we may miss expected deadlines, if we are not able to maintain or
- secure agreements with such third parties on acceptable terms, if these third parties do not perform their services as contractually required, or if these third parties fail to timely transfer any regulatory information held by them to us.
- We rely on third parties for various operational and administrative aspects of our business, including for certain cloud-based software platforms, which impact our financial, operational and research activities. If any of these third parties fail to provide timely, accurate and ongoing service or if the technology systems and infrastructure suffer outages that we are unable to mitigate, our business may be adversely affected.
- Strategic partnerships may be important to us. We will face significant competition in seeking new strategic partners.
- If we are unable to maintain strategic partnerships, or if these strategic partnerships are not successful, our business could be adversely affected.
- Risks Related to Our Intellectual Property
- Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties.
- 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 United States-based companies. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-United States manufacturers.
- If we fail to comply with our obligations under any license, collaboration or other intellectual property-related agreements, we may be required to pay damages and could lose intellectual property rights that may be necessary for developing, commercializing and protecting our current or future technologies or product candidates or we could lose certain rights to grant sublicenses.
- Our patents covering one or more of our products or product candidates could be found invalid or unenforceable if challenged.
- Our intellectual property rights will not necessarily provide us with competitive advantages.
- We may become involved in lawsuits to protect or enforce our patents and trade secrets, which could be expensive, time consuming and unsuccessful.
- Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.
- If we do not obtain protection under the Hatch-Waxman amendments and similar foreign legislation for extending the term of patents covering each of our product candidates, our business may be materially harmed.
- If we are unable to protect the confidentiality of our trade secrets and proprietary information, the value of our technology and products could be adversely affected.
- We may be subject to claims that we or our employees or consultants have wrongfully used or disclosed alleged trade secrets or other proprietary information of our employees’ or consultants’ former employers or their clients.
- 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.
- We may be subject to claims challenging the inventorship of our patents and other intellectual property.
- Patent protection and patent prosecution for some of our product candidates may be dependent on, and the ability to assert patents and defend them against claims of invalidity may be maintained by, third parties.
- Changes in patent laws, patent regulations, or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
- We may not be able to protect our intellectual property rights throughout the world.
- We will need to obtain FDA approval for any proposed product candidate names, and any failure or delay associated with such approval may adversely affect our business.
- Risks Related to Ownership of Our Securities
- The market price of our common stock may be volatile, which could result in substantial losses for our securityholders.
- An active trading market for our common stock may not continue to be developed or sustained, and as a result it may be difficult for you to sell your shares of our common stock.
- We are controlled by a concentrated group of stockholders, whose interests in our business may conflict with yours.
- The dual class structure of our common stock may limit your ability to influence corporate matters and may limit your visibility with respect to certain transactions.
- Sales of substantial amounts of our common stock in the public markets, or the perception that such sales could occur, could cause the market price of our common stock to decline significantly, even if our business is doing well.
Legal proceedings
From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. We are not currently a party to any material legal proceedings. Regardless of outcome, litigation can have an adverse impact on us due to defense and settlement costs, diversion of management resources, negative publicity, reputational harm and other factors.
The opening of Item 3, Legal Proceedings.5
Sources
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- 21SEC EDGARBruce Keyt, Chief Scientific Officer
- 22SEC EDGARChristina Teng Topsoe, Board member
- 23SEC EDGARFelix Baker, Board member
- 24SEC EDGARJakob Haldor Topsoe, Board member
- 25SEC EDGARJeremy Green, Board member
- 26SEC EDGARJulie Hambleton, Board member
- 27SEC EDGARKelvin Neu, Board member
- 28SEC EDGARM. Kathleen Behrens, Board member
- 29SEC EDGARMichael D. Loberg, Board member
- 30SEC EDGARWilliam Strohl, Board member
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