DCOY on Nasdaq
Decoy Therapeutics Inc.
In its 2026 annual report the company says: “We are a pre-clinical stage biotechnology company focused on advancing our pipeline of peptide conjugate therapeutics engineered through our proprietary IMP 3 ACT™ platform. Our IMP 3 ACT™ platform represents a paradigm shift in peptide conjugate drug discovery and manufacturing, leveraging machine learning and artificial intelligence tools alongside high-speed synthesis techniques to rapidly engineer, optimize and manufacture peptide conjugates that target serious unmet medical needs.”3 It is headquartered in Houston, Texas.1 Its shares trade on Nasdaq under the symbol DCOY.1
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Last updated Oct 21, 2026.
Overview
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- TickerDCOY on Nasdaq1
- IndustryPharmaceutical Preparations1
- HeadquartersHouston, Texas1
- Incorporated inDE2
- Business address2450 Holcombe Blvd, Suite J-608, Houston, Tx 770212
- Filer categoryNon-accelerated filer, Smaller reporting company2
- Legal formCorporation
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We are a pre-clinical stage biotechnology company focused on advancing our pipeline of peptide conjugate therapeutics engineered through our proprietary IMP 3 ACT™ platform. Our IMP 3 ACT™ platform represents a paradigm shift in peptide conjugate drug discovery and manufacturing, leveraging machine learning ("ML") and artificial intelligence ("AI") tools alongside high-speed synthesis techniques to rapidly engineer, optimize and manufacture peptide conjugates that target serious unmet medical needs. Peptide conjugates are emerging as a major therapeutic drug modality, with the potential to transform multiple therapeutic areas. Utilizing our novel IMP 3 ACT platform that increases the drug development speed and reduce the complexity of variant synthesis, we aim to build a robust portfolio of novel peptide conjugate therapeutics, initially focusing on infectious diseases and oncology, with…3 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Key numbers, fiscal 2022
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.11
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Acquired in-process research and development | $8.5M | $0 |
| Research and development | $368.2K | $770.0K |
| General and administrative | $3.7M | $5.0M |
| Total operating expenses | $12.6M | $5.7M |
| Loss from operations | -$12.6M | -$5.7M |
| Interest income and other, net | $95.5K | $158.5K |
| Net loss | -$12.5M | -$5.6M |
| Loss attributable to common stockholders | -$12.5M | -$5.6M |
| Net loss per share attributable to common stockholders - basic | -$129 | -$70 |
| Net loss per share attributable to common stockholders - diluted | -$129 | -$70 |
| Total net loss per share - basic | -$129.10 | -$69.54 |
| Total net loss per share - diluted | -$129.10 | -$69.54 |
| Weighted-average number of common shares used in net loss per share attributable to common stockholders - basic | 97.0K shares | 80.2K shares |
| Weighted-average number of common shares used in net loss per share attributable to common stockholders - diluted | 97.0K shares | 80.2K shares |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 5 fiscal years (annual) or 6 quarters (quarterly), latest first.11
| Period ending | 2026-02-28 | 2025-12-31 | 2025-08-31 | 2024-12-31 | 2024-05-31 |
|---|---|---|---|---|---|
| Cash, cash equivalents, and restricted cash | $10.7M | $2.4M | |||
| Prepaid expenses and other current assets | $275.2K | $553.0K | |||
| Total current assets | $11.0M | $3.0M | |||
| Property and equipment, net | $40.6K | $0 | |||
| Other assets | $31.0K | $35.4K | |||
| Total assets | $11.1M | $3.0M | |||
| Accounts payable | $940.6K | $937.0K | |||
| Accrued expenses and other current liabilities | $859.4K | $352.4K | |||
| Deferred revenue | $3.2M | $0 | |||
| Notes payable | $0 | $221.9K | |||
| Due to related party | $139.8K | $0 | |||
| Other current liability | $2.3K | $0 | |||
| Total current liabilities | $5.2M | $1.5M | |||
| Total liabilities | $5.2M | $1.5M | |||
| Common stock of $0.0001 par value; 100,000,000 shares authorized; 531,968 and 8,006 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively | $53 | $1 | |||
| Additional paid-in capital | $100.3M | $83.4M | |||
| Accumulated deficit | -$94.4M | -$81.9M | |||
| Total stockholders' equity | $5.9M | $1.5M | |||
| Total liabilities, and stockholders' equity | $11.1M | $3.0M | |||
| Common stock, par value (in dollar per share) | $0.00 | $0.00 | $0.00 |
| Period ending | 2026-02-28 | 2025-12-31 | 2025-08-31 | 2024-12-31 | 2024-05-31 | 2023-12-31 |
|---|---|---|---|---|---|---|
| Cash, cash equivalents, and restricted cash | $10.7M | $2.4M | ||||
| Prepaid expenses and other current assets | $275.2K | $553.0K | ||||
| Total current assets | $11.0M | $3.0M | ||||
| Property and equipment, net | $40.6K | $0 | ||||
| Other assets | $31.0K | $35.4K | ||||
| Total assets | $11.1M | $3.0M | ||||
| Accounts payable | $940.6K | $937.0K | ||||
| Accrued expenses and other current liabilities | $859.4K | $352.4K | ||||
| Deferred revenue | $3.2M | $0 | ||||
| Notes payable | $0 | $221.9K | ||||
| Due to related party | $139.8K | $0 | ||||
| Other current liability | $2.3K | $0 | ||||
| Total current liabilities | $5.2M | $1.5M | ||||
| Total liabilities | $5.2M | $1.5M | ||||
| Common stock of $0.0001 par value; 100,000,000 shares authorized; 531,968 and 8,006 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively | $53 | $1 | ||||
| Additional paid-in capital | $100.3M | $83.4M | ||||
| Accumulated deficit | -$94.4M | -$81.9M | ||||
| Total stockholders' equity | $5.9M | $1.5M | $5.3M | |||
| Total liabilities, and stockholders' equity | $11.1M | $3.0M | ||||
| Common stock, par value (in dollar per share) | $0.00 | $0.00 | $0.00 |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Every line of the cash flow as filed: the last 2 fiscal years, latest first.11
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net Income (Loss) | -$12.5M | -$5.6M |
| Depreciation, amortization and impairment | $7.2K | $4.4K |
| Equity-based compensation | $219.1K | $273.7K |
| Change in fair value of warrant liability | -$6.5K | $0 |
| In-process research and development expense | $8.5M | $0 |
| Prepaid expenses and other current assets | $419.6K | $492.5K |
| Accounts payable | -$1.2M | $334.1K |
| Accrued expenses | -$298.9K | -$54.3K |
| Net cash used in operating activities | -$4.8M | -$4.5M |
| Issuance of promissory loan in connection with asset acquisition | -$577.0K | $0 |
| Cash received from asset acquisition, net of cash paid | $1.3M | $0 |
| Net cash provided by investing activities | $764.7K | $0 |
| Proceeds from issuance of equity securities, net | $12.6M | $1.5M |
| Payments on note payable | -$221.9K | -$466.5K |
| Net cash provided by financing activities | $12.3M | $1.1M |
| Net increase (decrease) in cash, cash equivalents , and restricted cash | $8.3M | -$3.5M |
| Cash paid for interest | $5.8K | $10.6K |
| Preferred stock issued for in-process research and development technology | $4.3M | $0 |
| Accrued issuance costs for public offering | $185.0K | $0 |
| Settlement of promissory loans in connection with asset acquisition | $577.0K | $0 |
| Prepaid expense financed by note payable | $0 | $398.7K |
No quarter-by-quarter statement was filed.
Corporate structure
Decoy Therapeutics 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 Decoy Therapeutics Inc.
- ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G on Decoy Therapeutics Inc., latest Aug 14, 2026 (3 filings since Feb 14, 2024)
- CVI Investments, Inc. Filed SCHEDULE 13G/A on Decoy Therapeutics Inc., latest Feb 17, 2026 (2 filings since Nov 18, 2025)
- INTRACOASTAL CAPITAL, LLC Filed SCHEDULE 13G on Decoy Therapeutics Inc., latest Nov 14, 2025
- C/M CAPITAL PARTNERS, LP Filed SCHEDULE 13G on Decoy Therapeutics Inc., latest Oct 14, 2025
- Elvin Sanghwan Lee Filed SC 13D on Decoy Therapeutics Inc., latest Oct 27, 2023
- Lind Global Fund II LP Filed SC 13G/A on Decoy Therapeutics Inc., latest Feb 13, 2023 (2 filings since Apr 29, 2022)
- Lincoln Park Capital Fund, LLC Filed SC 13G on Decoy Therapeutics Inc., latest Apr 27, 2022
- Sio Capital Management, LLC Filed SC 13G/A on Decoy Therapeutics Inc., latest Feb 10, 2022
- Decoy Therapeutics Inc. Houston, Texas
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Decoy 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
Real estate and locations
| Item | Latest | A year before | Change |
|---|---|---|---|
| Countries it operates in | 111 Dec 31, 2025 |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $10.7M11 Dec 31, 2025 | $2.4M11 Dec 31, 2024 | +339.9% |
Properties, in its own words
Our principal executive offices are in the Texas Medical Center in Houston, Texas, under a month-to-month lease. Currently, this facility consists of approximately 300 square feet and accommodates our general and administrative activities. We also maintain a facility at One Broadway, 14th Floor, Cambridge, MA 02142. Additionally, we lease laboratory space at 45-18 Ct Square W, Long Island City, NY 11101. Neither company owns any physical property, plants, or laboratories.
Item 2 of the 10-K filed Mar 31, 2026.3
Leadership
Who has led Decoy Therapeutics Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
Chief operating officer
- Chief executive officerWilliam K. McVicar Jul 27, 2017 to Jun 18, 201812
- Chief executive officerChristoph H. Westphal Jan 28, 2015 to Nov 8, 201613
- PresidentWilliam K. McVicar Apr 12, 2017 to Jun 18, 201814
- PresidentChristoph H. Westphal Jan 28, 2015 to Nov 8, 201613
- PresidentMarina Hahn Jan 28, 2015 to Nov 20, 201515
- Chief financial officerScott Jordan Jul 23, 2019 to Sep 12, 201916
- Chief financial officerMark J. Rosenblum Sep 12, 2019 to now17
- Chief financial officerJohn P. McCabe Jan 20, 2017 to Jun 18, 201818
- Chief operating officerKatharine Lindemann Sep 9, 2015 to Jan 20, 201719
Board members and other officers (26)
- Chief Scientific OfficerBarbara Louise Hibner Nov 24, 2025 to now20
- Chief Business OfficerPeter Klaus Marschel Nov 24, 2025 to now21
- ControllerPao-Yu Chuang Jul 23, 2019 to Sep 12, 201922
- Chief Business OfficerScott Jordan Sep 13, 2019 to Feb 18, 202023
- VP, Investor RelationsElizabeth Woo Jan 28, 2015 to Jan 19, 201824
- VP Program ManagementJennifer Cermak Jan 28, 2015 to Jan 28, 201525
- VP of Finance & TreasurerJohn P. McCabe Jan 28, 2015 to Nov 7, 201626
- Board memberPatricia G. Gauthier Jul 31, 2026 to now27
- Board memberJonathan I. Lieber Jun 22, 2020 to now28
- Board memberArnold C. Hanish Jul 23, 2019 to now29
- Board memberBruce J. McCreedy Jr. Jul 23, 2019 to Feb 22, 202430
- Board memberJonathan P. Northrup Jul 23, 2019 to Mar 25, 202031
- Board memberPaul Lammers Jul 23, 2019 to now32
- Board memberTess Burleson Jul 23, 2019 to now33
- Board memberWilliam K. McVicar Jan 19, 2018 to now34
- Board memberRoger D. Tung Nov 6, 2017 to Jul 26, 201835
- Board memberMichelle Stacy Mar 8, 2016 to Jul 26, 201836
- Board memberChristoph H. Westphal Jan 28, 2015 to Jul 27, 201713
- Board memberJohn Sculley Jan 28, 2015 to Jul 12, 201637
- Board memberMarc D. Kozin Jan 28, 2015 to Jul 26, 201838
- Board memberPeter Barton Hutt Jan 28, 2015 to Jul 26, 201839
- Board memberStuart A. Randle Jan 28, 2015 to Jul 26, 201840
- Board memberRoderick Mackinnon Mar 3, 2015 to Jul 27, 201741
- Board memberJeffrey D. Capello Apr 10, 2015 to Jul 27, 201742
- Board memberRobert J. Perez Sep 9, 2015 to Jul 27, 201743
- General counselRobert Hadfield Jan 28, 2015 to Jan 20, 201744
Named in SEC Form D filings
People the company listed in its private-offering notices.
- Chief Executive Officer, PresidentDavid J. Arthur named May 5, 2022 to Dec 27, 202445
Former names
Timeline
- Sep 23, 20268-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure46
- Sep 15, 20268-K Shareholder vote47
- Jul 15, 20268-K Shareholder vote48
- Jun 29, 20268-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure49
- May 19, 20268-K Director nominations; Other events50
- Apr 2, 20268-K Other events51
- Mar 5, 20268-K Change to shareholders' rights; Bylaws or fiscal year changed; Other events52
- Feb 25, 20268-K Shareholder vote53
- Jan 8, 20268-K Bylaws or fiscal year changed; Other events54
- Jan 2, 20268-K Shareholder vote55
- Jan 2, 20268-K Listing notice or transfer56
- Dec 19, 20258-K Shareholder vote; Regulation FD disclosure57
- Jul 27, 2017New chief executive William K. McVicar becomes CEO12
- Jan 28, 2015New chief executive Christoph H. Westphal becomes CEO13
Calendar
Coming up
- Nov 13, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($21.73) a share, on Nov 14, 2025.58
When it reported results
- Jul 31, 2025Reported quarterly or annual results59
- Jan 17, 2025Reported quarterly or annual results60
- Aug 10, 2023Reported quarterly or annual results61
- Nov 10, 2022Reported quarterly or annual results62
- Aug 15, 2022Reported quarterly or annual results63
- May 12, 2022Reported quarterly or annual results64
- Mar 10, 2022Reported quarterly or annual results65
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
262 filings to the SEC since October 2021: 7 annual reports, 15 quarterly reports, 75 major events, 64 insider forms, 12 large holders, 3 private raises, 86 other. The latest 20:
- Oct 7, 2026S-1 EDGAR
- Sep 23, 20268-K EDGAR
- Sep 15, 20268-K EDGAR
- Sep 2, 20264 EDGAR
- Sep 2, 20264 EDGAR
- Sep 2, 20264 EDGAR
- Sep 2, 20264 EDGAR
- Sep 2, 20264 EDGAR
- Sep 2, 20264 EDGAR
- Sep 2, 20264 EDGAR
- Sep 2, 20264 EDGAR
- Sep 2, 20264 EDGAR
- Sep 2, 20264 EDGAR
- Aug 14, 2026SCHEDULE 13G EDGAR
- Aug 12, 202610-Q EDGAR
- Aug 4, 2026DEFA14A EDGAR
- Aug 4, 2026DEF 14A EDGAR
- Jul 31, 20263 EDGAR
- Jul 24, 2026PRE 14A EDGAR
- Jul 17, 2026EFFECT EDGAR
The 262 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
11 open-market trades by officers, directors and large owners since October 2021: 10 buys and 1 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Dec 30, 2025 | HANISH ARNOLD CDirector | Sale | 27 | $0.64 | $17 | Form 4 |
| Nov 20, 2025 | HANISH ARNOLD CDirector | Buy | 5,000 | $0.75 | $3.8K | Form 4 |
| Nov 20, 2025 | Rosenblum Mark JChief Financial Officer | Buy | 20,000 | $0.80 | $16.0K | Form 4 |
| Jun 7, 2022 | Burleson TessDirector | Buy | 27,700 | $0.18 | $5.0K | Form 4 |
| Jun 7, 2022 | Lieber Jonathan IDirector | Buy | 37,500 | $0.19 | $7.1K | Form 4 |
| Jun 6, 2022 | McVicar William K.Director | Buy | 26,553 | $0.19 | $5.0K | Form 4 |
| Jun 3, 2022 | HANISH ARNOLD CDirector | Buy | 28,000 | $0.18 | $5.0K | Form 4 |
| May 31, 2022 | Rosenblum Mark JChief Financial Officer | Buy | 28,000 | $0.18 | $5.0K | Form 4 |
| May 26, 2022 | Arthur David J.Chief Executive Officer | Buy | 43,900 | $0.18 | $7.9K | Form 4 |
| Mar 3, 2022 | Rosenblum Mark JChief Financial Officer | Buy | 76,246 | $0.39 | $29.7K | Form 4 |
| Mar 3, 2022 | Arthur David J.Chief Executive Officer | Buy | 139,488 | $0.39 | $54.4K | Form 4 |
From Forms 4 filed with the SEC.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- ARMISTICE CAPITAL, LLCSCHEDULE 13G, 3 filings Feb 14, 2024 to Aug 14, 202666
- CVI Investments, Inc.SCHEDULE 13G/A, 2 filings Nov 18, 2025 to Feb 17, 202667
- INTRACOASTAL CAPITAL, LLCSCHEDULE 13G, 1 filing Nov 14, 202568
- C/M CAPITAL PARTNERS, LPSCHEDULE 13G, 1 filing Oct 14, 202569
- Elvin Sanghwan LeeSC 13D, 1 filing Oct 27, 202370
- Lind Global Fund II LPSC 13G/A, 2 filings Apr 29, 2022 to Feb 13, 202371
- Lincoln Park Capital Fund, LLCSC 13G, 1 filing Apr 27, 202272
- Sio Capital Management, LLCSC 13G/A, 1 filing Feb 10, 202273
Funding
Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.
- Private raises (Form D) $8.3M
Figures by year
| Year | Private raises (Form D) | Total |
|---|---|---|
| 2023 | $6.0M | $6.0M |
| 2022 | $2.3M | $2.3M |
Private raises
Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026. Change is in shares since the quarter before.
| Fund | Shares | Value | Share of the fund | Change |
|---|---|---|---|---|
| Vanguard Capital Management LLC | 4,034 | $29.0K | 0.0% | New |
| Tower Research Capital LLC (TRC) | 256 | $1.8K | 0.0% | −765 |
| UBS Group AG | 25 | $180 | 0.0% | −521 |
| Caitong International Asset Management Co., Ltd | 2 | $14 | 0.0% | New |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Decoy 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 EDGARDecoy Therapeutics Inc.1
- CIK0001615219
- Employer ID (EIN)46-50873393
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company3
- Incorporated inDelaware3
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address2450 Holcombe Blvd, Suite J-608, Houston, TX 770211
- Phone346-772-03461
- Shares outstanding655,185 as of Aug 12, 20269
- Public float$1.9M as of Jun 30, 20253
- AuditorErnst & Young LLP, Houston, Texas PCAOB ID 42; no auditor attestation of internal control over financial reporting3
- On EDGAR sinceAug 6, 20141
- Filings741 in all: 4 (233), 8-K (166), 10-Q (35), 3 (34), CORRESP (26), 425 (20), UPLOAD (17), DEF 14A (16)1
All 45 form types
424B5 (14), DEFA14A (13), 10-K (12), EFFECT (12), SC 13G/A (12), 4/A (11), S-1/A (11), SC 13G (11), S-8 (9), SC 13D (8), 8-K/A (7), S-1 (7), S-3 (7), SC 13D/A (6), 424B3 (5), PRE 14A (5), 3/A (4), CT ORDER (4), D (4), FWP (4), SCHEDULE 13G (4), 10-K/A (3), 424B4 (3), 5 (2), S-1MEF (2), S-3/A (2), S-4/A (2), 10-Q/A (1), 8-A12B (1), CERTNAS (1), DFAN14A (1), DRS (1), DRS/A (1), DRSLTR (1), RW (1), S-4 (1), SCHEDULE 13G/A (1)
- Latest filingsAnnual report (10-K) Mar 31, 2026
Quarterly report (10-Q) Aug 12, 2026
Proxy statement (DEF 14A) Aug 4, 2026
Latest 8-K (8-K) Sep 23, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $ 0.0001 | DCOY | The Nasdaq Stock Market LLC |
From the cover page of the 10-K filed Mar 31, 2026 (Section 12(b) of the Exchange Act).3
Risk factors and legal proceedings
The risks Decoy Therapeutics Inc. names in Item 1A of its 10-K filed Mar 31, 2026: 47 risks under these headings, as written.3
- Risks Related to our Business
- Nasdaq may delist our securities from trading on its exchange, which could limit investors’ ability to make transactions in our securities and subject us to additional trading restrictions.
- Our financial condition raises substantial doubt regarding our ability to continue as a going concern.
- We have never generated revenue from product sales and all of our potential product candidates are currently in the pre-clinical stage, and we may continue to incur significant losses for the foreseeable future and never generate revenue from product sales.
- Because we have yet to generate revenue from product sales on which to evaluate our potential for future success and to determine if we will be able to execute our business plan, it is difficult to evaluate our prospects and the likelihood of success or failure of our business.
- Because early-stage drug development requires major capital investment, as we continue to incur operating losses, we will need to raise additional capital or form strategic partnerships to support our research and development activities in the future.
- We may become involved in securities class action litigation that could divert management’s attention and harm our business and insurance coverage may not be sufficient to cover all costs and damages.
- Risks Related to the Discovery, Development and Commercialization of Potential Product Candidates
- If any strategic alliances on which we depend are unsuccessful or are terminated, we may be unable to develop or commercialize certain potential product candidates and we may be unable to generate revenues from our development programs.
- Since we expect to rely on third parties to conduct, supervise and monitor any future clinical trials, if those third parties fail to perform in a satisfactory manner and one that meets applicable regulatory, scientific and safety requirements, it may materially harm our business.
- Because the approach we are taking to discover and develop drugs is novel, including the usage of AI, it may never lead to marketable products.
- If we do not succeed in our efforts to identify or discover additional potential product candidates, your investment may be lost.
The other 36 risks
- Because our future commercial success depends on gaining regulatory approval for our products, we cannot generate revenue without obtaining approvals.
- We may be unable to demonstrate safety and efficacy of our potential product candidates to the satisfaction of regulatory authorities, or we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our potential product candidates.
- Even if the FDA grants breakthrough therapy designation for one or more of our potential product candidates, the designation may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that our potential product candidates will receive marketing approval, and FDA may rescind the designation if it determines the product candidate no longer meets the qualifying criteria for breakthrough therapy.
- Our potential product candidates may cause adverse effects or have other properties that could delay or prevent their regulatory approval or limit the scope of any approved label or market acceptance.
- Following regulatory approval for a product candidate, we will still face extensive regulatory requirements, and the approved product may face future development and regulatory difficulties.
- We may not succeed in obtaining or maintaining necessary rights to drug compounds and processes for our development pipeline through acquisitions and in-licenses.
- Our product development programs are in the preclinical stage and we face significant competition from major companies who have developed or are developing vaccines or treatments for the diseases we are targeting, and if we fail to gain market share because our competitors develop and successfully commercialize vaccines or treatments, our business and future prospects could be materially and adversely affected.
- We have limited experience in conducting and managing the preclinical development activities and clinical trials necessary to obtain approvals for marketing our potential product candidates, including approval by the FDA.
- Risks Related to Our Operations and Industry
- If we cannot obtain or protect intellectual property rights related to our future products and potential product candidates, we may not be able to compete effectively in our markets.
- If third-party intellectual property infringement claims are asserted against us, it may prevent or delay our development and commercialization efforts and have a material adverse effect on our business and future prospects.
- We may in the future be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.
- We may need to obtain additional licenses to intellectual property rights from third parties.
- We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
- Because we face significant competition from other biotechnology and pharmaceutical companies, our operating results will suffer if we fail to compete effectively.
- Our business could be negatively impacted by cybersecurity threats and other security threats and disruptions.
- Failure of our information technology infrastructure to operate effectively could adversely affect our business.
- The commercial success of our potential product candidates will depend upon the acceptance of these potential product candidates by the medical community, including physicians, patients and healthcare payors.
- Disruptions at the FDA, the SEC and other U.S. government agencies or comparable foreign regulatory authorities 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, which could negatively impact our business and our timelines.
- If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our potential product candidates, we may be unable to generate any revenues from product sales.
- If we obtain approval to commercialize any approved products outside of the United States, a variety of risks associated with international operations could materially adversely affect our business.
- If we lose key management or scientific personnel, cannot recruit qualified employees, directors, officers, or other personnel or experience increases in our compensation costs, our business may materially suffer.
- Any relationships with customers and third-party payors may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws and health information privacy and security laws. If we are unable to comply, or have not fully complied with such laws, we could face criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
- Because we will face potential product liability as we further develop potential product candidates and more so if we can commercialize any product candidate, if claims are brought against us, we may incur substantial liability and costs.
- If we fail to comply with applicable laws and regulations, including 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 our business.
- Our ability to use our net operating losses and tax credits to offset future taxable income and income tax liabilities may be limited.
- Business interruptions resulting from natural disasters and adverse weather events could cause delays in research and development of our potential product candidates.
- Risks Related to Ownership of our Common Stock
- The price of our common stock may fluctuate substantially.
- Future sales of a significant number of our shares of common stock in the public markets, or the perception that such sales could occur, could depress the market price of our shares of our common stock or cause our stock price to decline.
- We do not currently intend to pay dividends on our common stock, and any return to investors is expected to come, if at all, only from potential increases in the price of our common stock.
- If we were deemed to be an investment company under the Investment Company Act of 1940, as amended (the “1940 Act”), applicable restrictions could make it impractical for us to continue our business as contemplated and could have a material adverse effect on our business, financial condition and results of operations.
- We are a “smaller reporting company” and are able to avail ourselves of reduced disclosure requirements applicable to smaller reporting companies, which could make our common stock less attractive to investors.
- Our certificate of incorporation, our bylaws, and Delaware law may have anti-takeover effects that could discourage, delay, or prevent a change in control, which may cause our stock price to decline.
- Financial reporting obligations of being a public company in the U.S. are expensive and time-consuming, and our management is required to devote substantial time to compliance matters.
- General Risk Factors
- If securities or industry analysts do not publish research or reports, or publish unfavorable research or reports about our business, our stock price and trading volume may decline.
- Changes in tax laws or exposure to additional income tax liabilities could have a material impact on our business, results of operations, financial condition and cash flows.
- Additional indirect taxes in various jurisdictions could materially adversely affect our business, financial condition, results of operations, and prospects.
Legal proceedings
We are not currently a party to any legal proceedings the outcome of which we believe, if determined adversely to us, would individually or in the aggregate, have a material adverse effect on our business, financial condition, or results of operations. From time to time, we may become involved in legal proceedings arising in the ordinary course of business.
The opening of Item 3, Legal Proceedings.3
Sources
The numbers on this page point here. Each one links to the record it came from.
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- 14SEC EDGARWilliam K. McVicar, President
- 15SEC EDGARMarina Hahn, President
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- 22SEC EDGARPao-Yu Chuang, Controller
- 23SEC EDGARScott Jordan, Chief Business Officer
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- 27SEC EDGARPatricia G. Gauthier, Board member
- 28SEC EDGARJonathan I. Lieber, Board member
- 29SEC EDGARArnold C. Hanish, Board member
- 30SEC EDGARBruce J. McCreedy Jr., Board member
- 31SEC EDGARJonathan P. Northrup, Board member
- 32SEC EDGARPaul Lammers, Board member
- 33SEC EDGARTess Burleson, Board member
- 34SEC EDGARWilliam K. McVicar, Board member
- 35SEC EDGARRoger D. Tung, Board member
- 36SEC EDGARMichelle Stacy, Board member
- 37SEC EDGARJohn Sculley, Board member
- 38SEC EDGARMarc D. Kozin, Board member
- 39SEC EDGARPeter Barton Hutt, Board member
- 40SEC EDGARStuart A. Randle, Board member
- 41SEC EDGARRoderick Mackinnon, Board member
- 42SEC EDGARJeffrey D. Capello, Board member
- 43SEC EDGARRobert J. Perez, Board member
- 44SEC EDGARRobert Hadfield, General counsel
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- 47SEC EDGARShareholder vote
- 48SEC EDGARShareholder vote
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- 50SEC EDGARDirector nominations; Other events
- 51SEC EDGAROther events
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- 53SEC EDGARShareholder vote
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- 55SEC EDGARShareholder vote
- 56SEC EDGARListing notice or transfer
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- 58NasdaqNasdaq calendar
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