Private company
Apogee Therapeutics, Inc.
Biological products company1
In its 2026 annual report the company says: “We are a clinical stage biotechnology company advancing optimized, novel biologics with the potential for differentiated efficacy and dosing in the largest inflammatory and immunology markets, including for the treatment of atopic dermatitis, asthma, eosinophilic esophagitis, chronic obstructive pulmonary disease, and other I&I indications.”4 It is headquartered in San Francisco, California.1
Last updated Oct 21, 2026.
Overview
- IndustryBiological Products, (No Diagnostic Substances)1
- HeadquartersSan Francisco, California1
- Business address1 Letterman Drive, Building B, San Francisco, Ca3
- Filer categoryLarge accelerated filer3
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We are a clinical stage biotechnology company advancing optimized, novel biologics with the potential for differentiated efficacy and dosing in the largest inflammatory and immunology (“I&I”) markets, including for the treatment of atopic dermatitis (“AD”), asthma, eosinophilic esophagitis (“EoE”), chronic obstructive pulmonary disease (“COPD”), and other I&I indications. Our antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties.4 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Key numbers, fiscal 2025
Financial statements
| Fiscal year | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|
| Research and development | $68.4M2 | $167.9M2 | $214.7M2 | |
| Operating expenses | $93.0M2 | $216.9M2 | $285.6M2 | |
| Operating income | -$93.0M2 | -$216.9M2 | -$285.6M2 | |
| Income before tax | -$84.0M2 | -$182.1M2 | -$255.6M2 | |
| Income tax | $02 | $18.0K2 | $278.0K2 | |
| Net income | -$84.0M2 | -$182.1M2 | -$255.8M2 | |
| Earnings per share | -$3.362 | -$3.302 | -$4.222 | |
| Earnings per share (diluted) | -$3.362 | -$3.302 | -$4.222 | |
| Shares (weighted, basic) | 25.0M shares2 | 55.2M shares2 | 60.7M shares2 | |
| Shares (weighted, diluted) | 25.0M shares2 | 55.2M shares2 | 60.7M shares2 |
| Fiscal year | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|
| Cash | $151.9M8 | $118.3M2 | $141.8M2 | $131.5M2 |
| Current assets | $152.1M8 | $398.4M9 | $529.7M2 | $741.4M2 |
| Property, plant and equipment | $377.0K9 | $2.0M2 | $5.7M2 | |
| Total assets | $152.1M8 | $401.4M9 | $754.0M2 | $937.1M2 |
| Accounts payable | $418.0K8 | $2.1M9 | $1.1M2 | $1.2M2 |
| Current liabilities | $10.0M8 | $20.6M9 | $28.6M2 | $27.9M2 |
| Total liabilities | $10.0M8 | $21.5M9 | $37.2M2 | $33.3M2 |
| Retained earnings | -$39.8M8 | -$123.8M9 | -$305.9M2 | -$561.8M2 |
| Shares outstanding | 0 shares8 | 48.3M shares9 | 58.1M shares2 | 68.4M shares2 |
Corporate structure
Apogee Therapeutics, Inc. sits at the top of its group. 1 entity on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Apogee Therapeutics, Inc.
- Venrock Healthcare Capital Partners III, L.P. Filed SCHEDULE 13D/A on Apogee Therapeutics, Inc., latest Sep 8, 2026 (2 filings since Jul 28, 2023)
- Fairmount Funds Management LLC Filed SCHEDULE 13D/A on Apogee Therapeutics, Inc., latest Sep 3, 2026 (8 filings since Jul 21, 2023)
- FMR LLC Filed SCHEDULE 13G/A on Apogee Therapeutics, Inc., latest Jul 8, 2026 (5 filings since Aug 10, 2023)
- T. Rowe Price Investment Management, Inc. Filed SCHEDULE 13G/A on Apogee Therapeutics, Inc., latest Jul 8, 2026 (3 filings since Mar 6, 2026)
- Wellington Management Company Filed SCHEDULE 13G/A on Apogee Therapeutics, Inc., latest Jul 8, 2026 (6 filings since Oct 4, 2024)
- VANGUARD GROUP INC Filed SCHEDULE 13G/A on Apogee Therapeutics, Inc., latest Mar 26, 2026 (2 filings since Jan 30, 2026)
- RTW INVESTMENTS, LP Filed SCHEDULE 13G/A on Apogee Therapeutics, Inc., latest Feb 17, 2026 (2 filings since Feb 14, 2025)
- DRIEHAUS CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G/A on Apogee Therapeutics, Inc., latest Nov 14, 2025 (2 filings since Nov 14, 2024)
- BlackRock Filed SCHEDULE 13G/A on Apogee Therapeutics, Inc., latest Jul 16, 2025 (3 filings since Oct 22, 2024)
- Deep Track Capital, LP Filed SC 13G/A on Apogee Therapeutics, Inc., latest Nov 14, 2024 (3 filings since Jul 24, 2023)
- RA CAPITAL MANAGEMENT, L.P. Filed SC 13G/A on Apogee Therapeutics, Inc., latest Nov 14, 2024 (2 filings since Feb 14, 2024)
- ACCESS INDUSTRIES MANAGEMENT, LLC Filed SC 13G/A on Apogee Therapeutics, Inc., latest Nov 4, 2024 (2 filings since Nov 3, 2023)
- Apogee Therapeutics, 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 Apogee Therapeutics, 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 |
|---|---|---|---|
| Accumulated depreciation | $1.6M2 Dec 31, 2025 | $189.0K2 Dec 31, 2024 | +750.8% |
| Property and equipment, net | $5.7M2 Dec 31, 2025 | $2.0M2 Dec 31, 2024 | +190.4% |
| Operating-lease assets (leased space) | $8.7M2 Dec 31, 2025 | $11.4M2 Dec 31, 2024 | −23.6% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $131.5M2 Dec 31, 2025 | $141.8M2 Dec 31, 2024 | −7.2% |
| Marketable securities, current | $598.6M2 Dec 31, 2025 | $378.9M2 Dec 31, 2024 | +58.0% |
| Marketable securities, non-current | $172.7M2 Dec 31, 2025 | $210.4M2 Dec 31, 2024 | −17.9% |
Properties, in its own words
We maintain a corporate headquarters in Waltham, Massachusetts, laboratory and office space in Boston, Massachusetts, office space in San Francisco, California and otherwise operate virtually in the United States. Our corporate headquarters in Waltham, Massachusetts, consists of 1,087 square feet of leased office space under a lease agreement that expires in September 2026. We also lease a laboratory facility located in Boston, Massachusetts, which consists of 17,685 square feet of R&D laboratories and office space under a lease agreement that expires in November 2026, with the option to extend for one year. In September 2024, the Company entered into a lease agreement for 15,710 square feet of office space in San Francisco, California. The lease expires in September 2029 with two one-year options to extend. We believe these arrangements support our current needs. If we require additional space, we believe that we will be able to obtain such space on acceptable, commercially reasonable terms.
Item 2 of the 10-K filed Mar 2, 2026.4
Leadership
Who has led Apogee Therapeutics, Inc., and when. Pick a name to see everywhere that person has worked.
- Chief executive officerMichael Thomas Henderson Jul 13, 2023 to now11
- Chief financial officerJane Henderson Jul 13, 2023 to now12
Board members and other officers (10)
- Chief Medical OfficerCarl Dambkowski Jul 13, 2023 to now13
- Board memberLisa Bollinger May 30, 2024 to now14
- Board memberAndrew Gottesdiener Jul 13, 2023 to now15
- Board memberJennifer A. Fox Jul 13, 2023 to now16
- Board memberMichael Thomas Henderson Jul 13, 2023 to now11
- Board memberNimish P. Shah Jul 13, 2023 to now17
- Board memberWilliam A. Jones Jr. Jul 13, 2023 to now18
- Board memberPeter Evan Harwin Jul 17, 2023 to now19
- Board memberTomas Kiselak Jul 17, 2023 to now19
- Board memberMark C. McKenna Aug 21, 2023 to now20
Former names
- Apogee Therapeutics, LLCApr 28, 2023 to Jun 12, 20233
Timeline
- Sep 3, 20268-K Ended a material agreement; Completed an acquisition or sale; Listing notice or transfer21
- Aug 11, 20268-K Executive or director change; Shareholder vote22
- Aug 10, 20268-K Results of operations23
- Jun 22, 20268-K Entered a material agreement24
- Jun 22, 20268-K Entered a material agreement; Shareholder vote; Regulation FD disclosure25
- Jun 12, 20268-K Shareholder vote26
- May 27, 20268-K Regulation FD disclosure; Other events27
- May 27, 20268-K Entered a material agreement; Regulation FD disclosure28
- May 11, 20268-K Results of operations29
- Apr 24, 20268-K Executive or director change30
- Mar 25, 20268-K Entered a material agreement31
- Mar 23, 20268-K Regulation FD disclosure; Other events32
- Jul 13, 2023New chief executive Michael Thomas Henderson becomes CEO11
Calendar
Coming up
- Around Nov 9, 2026Next results, estimated About a quarter after its last report. The company hasn't announced the date.
When it reported results
- Aug 10, 2026Reported quarterly or annual results23
- May 11, 2026Reported quarterly or annual results29
- Nov 10, 2025Reported quarterly or annual results33
- Aug 11, 2025Reported quarterly or annual results34
- May 12, 2025Reported quarterly or annual results35
- Mar 3, 2025Reported quarterly or annual results36
- Nov 12, 2024Reported quarterly or annual results37
- Aug 12, 2024Reported quarterly or annual results38
Drug trials and FDA: coming up
- Nov 2026Phase 2 trial readout expected Phase 2 trial of APG777 in Atopic Dermatitis: primary completion expected Nov 2026 (ClinicalTrials.gov NCT06395948).39
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar
Filings
316 filings to the SEC since October 2021: 3 annual reports, 10 quarterly reports, 40 major events, 128 insider forms, 40 large holders, 95 other. The latest 20:
- Sep 14, 202615-12G EDGAR
- Sep 8, 2026SCHEDULE 13D/A EDGAR
- Sep 3, 20264 EDGAR
- Sep 3, 20264 EDGAR
- Sep 3, 20264 EDGAR
- Sep 3, 20264 EDGAR
- Sep 3, 20264 EDGAR
- Sep 3, 20264 EDGAR
- Sep 3, 20264 EDGAR
- Sep 3, 20264 EDGAR
- Sep 3, 2026POSASR EDGAR
- Sep 3, 2026S-8 POS EDGAR
- Sep 3, 2026S-8 POS EDGAR
- Sep 3, 2026S-8 POS EDGAR
- Sep 3, 2026S-8 POS EDGAR
- Sep 3, 2026S-8 POS EDGAR
- Sep 3, 20268-K EDGAR
- Sep 3, 2026SCHEDULE 13D/A EDGAR
- Sep 3, 20264 OWNERSHIP DOCUMENT EDGAR
- Aug 11, 20268-K EDGAR
The 316 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
66 open-market trades by officers, directors and large owners since October 2021: 3 buys and 63 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Aug 5, 2026 | Dambkowski CarlChief Medical Officer | Sale | 5,500 | $134.17 | $737.9K | Form 4 |
| Jul 8, 2026 | HENDERSON MICHAEL THOMASChief Executive Officer | Sale | 20,000 | $133.63 | $2.7M | Form 4 |
| Jul 1, 2026 | Dambkowski CarlChief Medical Officer | Sale | 5,500 | $132.74 | $730.1K | Form 4 |
| Jun 22, 2026 | Dambkowski CarlChief Medical Officer | Sale | 26,400 | $132.60 | $3.5M | Form 4 |
| Jun 22, 2026 | HENDERSON MICHAEL THOMASChief Executive Officer | Sale | 80,000 | $132.54 | $10.6M | Form 4 |
| Jun 10, 2026 | HENDERSON MICHAEL THOMASChief Executive Officer | Sale | 20,000 | $83.38 | $1.7M | Form 4 |
| Jun 3, 2026 | Dambkowski CarlChief Medical Officer | Sale | 5,500 | $78.71 | $432.9K | Form 4 |
| May 13, 2026 | HENDERSON MICHAEL THOMASChief Executive Officer | Sale | 20,000 | $82.09 | $1.6M | Form 4 |
| May 6, 2026 | Dambkowski CarlChief Medical Officer | Sale | 5,500 | $84.14 | $462.8K | Form 4 |
| May 1, 2026 | Henderson JaneChief Financial Officer | Sale | 2,000 | $82.04 | $164.1K | Form 4 |
| Apr 16, 2026 | Henderson JaneChief Financial Officer | Sale | 2,000 | $90.00 | $180.0K | Form 4 |
| Apr 8, 2026 | HENDERSON MICHAEL THOMASChief Executive Officer | Sale | 20,000 | $82.58 | $1.7M | Form 4 |
| Apr 1, 2026 | Dambkowski CarlChief Medical Officer | Sale | 5,500 | $84.84 | $466.6K | Form 4 |
| Apr 1, 2026 | Henderson JaneChief Financial Officer | Sale | 2,000 | $85.01 | $170.0K | Form 4 |
| Mar 25, 2026 | Henderson JaneChief Financial Officer | Sale | 2,000 | $85.00 | $170.0K | Form 4 |
| Mar 11, 2026 | HENDERSON MICHAEL THOMASChief Executive Officer | Sale | 20,000 | $74.78 | $1.5M | Form 4 |
| Mar 4, 2026 | Dambkowski CarlChief Medical Officer | Sale | 5,500 | $71.06 | $390.8K | Form 4 |
| Mar 2, 2026 | Henderson JaneChief Financial Officer | Sale | 2,000 | $70.22 | $140.4K | Form 4 |
| Feb 11, 2026 | HENDERSON MICHAEL THOMASChief Executive Officer | Sale | 20,000 | $63.35 | $1.3M | Form 4 |
| Feb 4, 2026 | Dambkowski CarlChief Medical Officer | Sale | 5,500 | $65.79 | $361.9K | Form 4 |
All 66 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.
- Venrock Healthcare Capital Partners III, L.P.SCHEDULE 13D/A, 2 filings Jul 28, 2023 to Sep 8, 202640
- Fairmount Funds Management LLCSCHEDULE 13D/A, 8 filings Jul 21, 2023 to Sep 3, 202641
- FMR LLCSCHEDULE 13G/A, 5 filings Aug 10, 2023 to Jul 8, 202642
- T. Rowe Price Investment Management, Inc.SCHEDULE 13G/A, 3 filings Mar 6, 2026 to Jul 8, 202643
- Wellington Management CompanySCHEDULE 13G/A, 6 filings Oct 4, 2024 to Jul 8, 202644
- VANGUARD GROUP INCSCHEDULE 13G/A, 2 filings Jan 30, 2026 to Mar 26, 202645
- RTW INVESTMENTS, LPSCHEDULE 13G/A, 2 filings Feb 14, 2025 to Feb 17, 202646
- DRIEHAUS CAPITAL MANAGEMENT LLCSCHEDULE 13G/A, 2 filings Nov 14, 2024 to Nov 14, 202547
- BlackRockSCHEDULE 13G/A, 3 filings Oct 22, 2024 to Jul 16, 202548
- Deep Track Capital, LPSC 13G/A, 3 filings Jul 24, 2023 to Nov 14, 202449
- RA CAPITAL MANAGEMENT, L.P.SC 13G/A, 2 filings Feb 14, 2024 to Nov 14, 202450
- ACCESS INDUSTRIES MANAGEMENT, LLCSC 13G/A, 2 filings Nov 3, 2023 to Nov 4, 202451
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 |
|---|---|---|---|---|
| 2025 | Chief Executive Officer | $700.0K | $1.3M52 | |
| 2025 | Chief Financial Officer | $540.0K | $855.9K52 | |
| 2025 | Chief Medical Officer | $540.0K | $855.9K52 | |
| 2024 | Chief Executive Officer | $661.5K | $13.2M52 | |
| 2024 | Chief Financial Officer | $525.0K | $5.1M52 | |
| 2024 | Chief Medical Officer | $525.0K | $5.1M52 | |
| 2023 | Chief Executive Officer | $564.8K | $8.7M52 | |
| 2023 | Chief Medical Officer | $477.1K | $4.2M52 |
SEC filer profile
How Apogee Therapeutics, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARApogee Therapeutics, Inc.1
- CIK0001974640
- Employer ID (EIN)93-49586654
- Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company4
- Incorporated inDelaware4
- 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 address1 Letterman Drive, Building B, San Francisco, CA1
- Phone650-394-52301
- Shares outstanding55,998,605 Voting Common Stock shares; 13,486,642 Nonvoting Common Stock shares as of Feb 23, 20264
- Public float$1.8B as of Jun 30, 20254
- AuditorErnst & Young LLP, Boston, Massachusetts PCAOB ID 42; it also attests to the company’s internal control over financial reporting4
- On EDGAR sinceApr 28, 20231
- Filings318 in all: 4 (113), 8-K (40), 144 (34), SCHEDULE 13G/A (13), 10-Q (10), 3 (10), DEFA14A (9), SC 13G (8)1
All 39 form types
CORRESP (6), SC 13G/A (6), SCHEDULE 13D/A (6), 3/A (5), S-8 (5), S-8 POS (5), 424B5 (4), UPLOAD (4), 10-K (3), ARS (3), DEF 14A (3), SCHEDULE 13G (3), 424B4 (2), DRS (2), EFFECT (2), S-1 (2), S-1/A (2), S-1MEF (2), SC 13D (2), SC 13D/A (2), SEC STAFF LETTER (2), 15-12G (1), 25-NSE (1), 8-A12B (1), CERT (1), DEFM14A (1), DRS/A (1), DRSLTR (1), POSASR (1), PREM14A (1), S-3ASR (1)
- Latest filingsAnnual report (10-K) Mar 2, 2026
Quarterly report (10-Q) Aug 10, 2026
Proxy statement (DEF 14A) Apr 24, 2026
Latest 8-K (8-K) Sep 3, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.00001 per share | APGE | The Nasdaq Global Market |
From the cover page of the 10-K filed Mar 2, 2026 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks Apogee Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 2, 2026: 69 risks under these headings, as written.4
- We are a clinical stage biotechnology company with a limited operating history, we are currently conducting clinical trials, and we have no products approved for commercial sale, which may make it difficult for you to evaluate our current business and likelihood of success and viability.
- We will require substantial additional capital to finance our operations in the future. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our development programs or future commercialization efforts.
- We have incurred significant losses since inception, and we expect to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future. We have no products approved for sale, have not generated any revenue from our programs and may never generate revenue or become profitable.
- We face competition from entities that have developed or may develop programs for the diseases addressed by our product candidates.
- Our programs are in clinical and preclinical stages of development and may fail in development or suffer delays that materially and adversely affect their commercial viability. If we or our current or future collaborators are unable to complete development of, or commercialize our product candidates or experience significant delays in doing so, our business will be materially harmed.
- We are substantially dependent on the success of our product candidates, zumilokibart, APG279, APG273, APG990, APG333 and APG808 and our ongoing and anticipated trials may not be successful.
- If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of our product candidates may be delayed and our expenses may increase and, as a result, our stock price may decline.
- Our approach to the discovery and development of our programs is unproven, and we may not be successful in our efforts to build a pipeline of product candidates with commercial value.
- Preclinical and clinical development involves a lengthy and expensive process that is subject to delays and with uncertain outcomes, and results of earlier studies and trials may not be predictive of future clinical trial results. If our preclinical studies and clinical trials are not sufficient to support regulatory approval of any of our programs, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of such program.
- We anticipate developing certain product candidates for use in combination with one or more of our other product candidates, and regulatory or safety issues with combination therapies may delay or prevent development and approval of our product candidates.
- If we encounter difficulties enrolling patients in our current and future clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
- 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.
The other 57 risks
- Our current and future clinical trials or those of our future collaborators may reveal significant adverse events or undesirable side effects not seen in our preclinical studies and may result in a safety profile that could halt clinical development, inhibit regulatory approval or limit commercial potential or market acceptance of any of our product candidates.
- We may expend our limited resources to pursue a particular program and fail to capitalize on programs that may be more profitable or for which there is a greater likelihood of success.
- Any approved products resulting from our current programs or any future program may not achieve adequate market acceptance among clinicians, patients, healthcare third-party payors and others in the medical community necessary for commercial success and we may not generate any future revenue from the sale or licensing of such products.
- Certain of our programs may compete with our other programs, which could negatively impact our business and reduce our future revenue.
- We are conducting and may conduct future clinical trials for our programs at sites outside the United States, and the FDA may not accept data from trials conducted in such locations.
- We rely on collaborations and licensing arrangements with third parties, including our collaboration with Paragon. If we are unable to maintain these collaborations or licensing arrangements, or if these collaborations or licensing arrangements are not successful, our business could be negatively impacted.
- We currently rely, and plan to rely in the future, on third parties to conduct and support our preclinical studies and clinical trials. If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our product candidates.
- Our reliance on foreign CMOs may expose us to supply chain disruption, delays in our clinical development programs, regulatory risks and increased costs, which may have a material adverse effect on our business, financial condition, results of operations and prospects.
- We currently rely and expect to rely in the future on the use of third-party facilities and on third parties to manufacture and test our product candidates, and we may rely on third parties to produce and process our products, if approved. Our business could be adversely affected if we are unable to use third-party manufacturing suites or testing facilities or if the third-party manufacturers encounter difficulties in production.
- We intend to deliver our product candidates via a pre-filled syringe, autoinjector or other drug delivery device presentation that will have its own regulatory, development, supply and other risks.
- Risks Related to Our Business and Operations
- In order to successfully implement our plans and strategies, we will need to grow the size of our organization and we may experience difficulties in managing this growth.
- We are highly dependent on our key personnel and anticipate hiring new key personnel. If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
- 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 employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, CMOs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
- Our internal information technology systems, or those of any of our CROs, manufacturers, other contractors or consultants, third party service providers, or potential future collaborators, may fail or suffer security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data or personal data, which could result in additional costs, loss of revenue, significant liabilities, harm to our brand and material disruption of our operations.
- We are subject to stringent and changing laws, regulations and standards, and contractual obligations relating to privacy, data protection, and data security. The actual or perceived failure to comply with such obligations could lead to government enforcement actions (which could include civil or criminal penalties), fines and sanctions, private litigation and/or adverse publicity and could negatively affect our operating results and business.
- If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
- We may be subject to adverse legislative or regulatory tax changes that could negatively impact our financial condition.
- We may acquire businesses or products, or form strategic alliances, in the future, and may not realize the benefits of such acquisitions.
- We maintain our cash at financial institutions, often in balances that exceed federally-insured limits. The failure of financial institutions could adversely affect our ability to pay our operational expenses or make other payments.
- Risks Related to Intellectual Property
- Our ability to protect our patents and other proprietary rights is uncertain, exposing us to the possible loss of competitive advantage.
- We may not be successful in obtaining or maintaining necessary rights to our programs through acquisitions and in-licenses.
- We may be subject to patent infringement claims or may need to file claims to protect our intellectual property, which could result in substantial costs and liability and prevent us from commercializing our potential products.
- We may be subject to claims that we have wrongfully hired an employee from a competitor or that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
- Changes to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
- Obtaining and maintaining patent protection depends on compliance with various procedural, document submissions, 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.
- We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products.
- We may become subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
- Patent terms may be inadequate to protect our competitive position on our programs for an adequate amount of time.
- Our technology licensed from various third parties may be subject to retained rights.
- Risks Related to Government Regulation
- The regulatory approval processes of the FDA and other comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable. If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for our product candidates, we will not be able to commercialize, or will be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially impaired.
- Disruptions at the FDA and other government agencies could negatively affect the review and approval of our regulatory submissions, which could negatively impact our business.
- We may not be able to meet requirements for the chemistry, manufacturing and control of our product candidates.
- Our programs for which we intend to seek approval as biologics may face competition sooner than anticipated.
- Even if we receive regulatory approval of our product candidates, we will be subject to extensive ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
- We may face difficulties from healthcare legislative reform measures.
- Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties.
- Even if we are able to commercialize any product candidates, due to potential unfavorable pricing regulations and/or third-party coverage/access and reimbursement policies, we may not be able to realize access to products or appropriate pricing, which would seriously 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. 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 and/or our ability to gain access to our products, if any.
- If we decide to pursue a Fast Track Designation by the FDA, it may not lead to a faster development or regulatory review or approval process.
- Risks Related to Our Common Stock
- 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 price of our stock has fluctuated in the past and may continue to be volatile, and you could lose all or part of your investment.
- Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant influence over matters subject to stockholder approval.
- A sale of a substantial number of shares of our common stock may cause the market price of our common stock to drop significantly, even if our business is doing well.
- Provisions in our amended and restated certificate of incorporation and amended and restated bylaws and Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the market price of our common stock.
- Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware and the federal district courts of the United States will be the exclusive forums for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes.
- Because we do not anticipate paying any dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.
- 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.
- 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.
- General Risk Factors
- We may become exposed to costly and damaging liability claims, either when testing our programs in the clinic or at the commercial stage, and our product liability insurance may not cover all damages from such claims.
- Litigation costs and the outcome of litigation could have a material adverse effect on our business.
- If securities or industry analysts do not publish research or reports, or if they publish adverse or misleading research or reports, regarding us or our business, 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 continue to be required to devote substantial time to new compliance initiatives and corporate governance practices.
- 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.
- Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
- Our business could be adversely affected by economic downturns, inflation, increases in interest rates, natural disasters, public health crises, political crises, geopolitical events, such as the conflict between Russia and Ukraine, and Israel and Hamas or other macroeconomic conditions, which could have a material and adverse effect on our results of operations and financial condition.
Legal proceedings
We are not party to any material legal proceedings at this time. From time to time, we may become involved in various legal proceedings that arise in the ordinary course of our business. 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, and there can be no assurances that favorable outcomes will be obtained.
The opening of Item 3, Legal Proceedings.4
Sources
The numbers on this page point here. Each one links to the record it came from.
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- 14SEC EDGARLisa Bollinger, Board member
- 15SEC EDGARAndrew Gottesdiener, Board member
- 16SEC EDGARJennifer A. Fox, Board member
- 17SEC EDGARNimish P. Shah, Board member
- 18SEC EDGARWilliam A. Jones Jr., Board member
- 19SEC EDGARPeter Evan Harwin, Board member
- 20SEC EDGARMark C. McKenna, Board member
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- 23SEC EDGARResults of operations
- 24SEC EDGAREntered a material agreement
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- 26SEC EDGARShareholder vote
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- 29SEC EDGARResults of operations
- 30SEC EDGARExecutive or director change
- 31SEC EDGAREntered a material agreement
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