WINT on OTC
WINDTREE THERAPEUTICS INC /DE/
In its 2025 annual report the company says: “We are a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases.”3 It is headquartered in Warrington, Pennsylvania.1 Its shares trade on OTC under the symbol WINT.1
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Last updated Oct 21, 2026.
Overview
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- TickerWINT on OTC1
- IndustryBiological Products, (No Diagnostic Substances)1
- HeadquartersWarrington, Pennsylvania1
- Incorporated inDE2
- Business address2600 Kelly Road, Suite 100, Warrington, Pa 189762
- Filer categoryNon-accelerated filer, Smaller reporting company2
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We are a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases. Our portfolio of product candidates includes istaroxime, a Phase 2 candidate that inhibits the sodium-potassium ATPase and also activates sarco endoplasmic reticulum Ca2+ -ATPase 2a, or SERCA2a, for acute heart failure and/or associated cardiogenic shock; preclinical SERCA2a activators for heart failure; rostafuroxin for the treatment of hypertension in patients with a specific genetic profile; and a preclinical atypical protein kinase C iota, or aPKCi, inhibitor (topical and oral formulations), being developed for potential application in rare and broad oncology indications. We also have a licensing business model with partnership out-licenses currently in place.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 2019
Where the money goes
Where each dollar of revenue went, fiscal 2019
- Research and development50¢$12.7M
- Selling, general and admin48¢$12.4M
- Interest2¢$495.0K
Out of $198.0K in revenue.54 The company lost money this year.
Financial statements
| Fiscal year | 2018 | 2019 |
|---|---|---|
| Revenue | $1.8M5 | $198.0K5 |
| Cost of revenue | ||
| Research and development | $10.6M5 | $12.7M4 |
| Selling, general and admin | $7.4M5 | $12.4M4 |
| Operating expenses | ||
| Operating income | -$16.2M5 | -$24.9M4 |
| Interest | $1.4M5 | $495.0K4 |
| Income before tax | ||
| Income tax | ||
| Net income | -$20.5M5 | -$27.5M4 |
| Earnings per share | -$7.749 | |
| Earnings per share (diluted) | -$7.749 | |
| Shares (weighted, basic) |
| Fiscal year | 2018 | 2019 |
|---|---|---|
| Cash | $11.2M5 | $22.6M4 |
| Current assets | $25.7M5 | $23.9M4 |
| Property, plant and equipment | ||
| Goodwill | ||
| Intangible assets | ||
| Total assets | $119.4M5 | $119.0M4 |
| Accounts payable | ||
| Current liabilities | $20.6M5 | $7.8M4 |
| Long-term debt | ||
| Total liabilities | $51.3M5 | $44.0M4 |
| Retained earnings | ||
| Shareholders’ equity | $68.1M4 | $74.9M6 |
| Shares outstanding | 32.1M shares5 | 13.7M shares4 |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Corporate structure
WINDTREE THERAPEUTICS INC /DE/ 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 WINDTREE THERAPEUTICS INC /DE/
- ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G/A on WINDTREE THERAPEUTICS INC /DE/, latest Feb 14, 2025 (2 filings since Nov 14, 2024)
- James E. Flynn Filed SC 13G/A on WINDTREE THERAPEUTICS INC /DE/, latest Nov 14, 2024 (2 filings since Feb 1, 2024)
- Lind Global Fund II LP Filed SC 13G/A on WINDTREE THERAPEUTICS INC /DE/, latest Nov 14, 2024 (3 filings since Apr 28, 2023)
- Lincoln Park Capital Fund, LLC Filed SC 13G/A on WINDTREE THERAPEUTICS INC /DE/, latest Feb 14, 2024 (2 filings since Apr 24, 2023)
- Krishna Duvvuri Filed SC 13G on WINDTREE THERAPEUTICS INC /DE/, latest Nov 13, 2023
- James Huang Filed SC 13D/A on WINDTREE THERAPEUTICS INC /DE/, latest May 17, 2023 (4 filings since Feb 9, 2023)
- Center Laboratories, Inc. Filed SC 13G/A on WINDTREE THERAPEUTICS INC /DE/, latest Jan 10, 2022
- WINDTREE THERAPEUTICS INC /DE/ Warrington, Pennsylvania
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What WINDTREE THERAPEUTICS INC /DE/ 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 | $3.9M10 Dec 31, 2024 | $3.9M10 Dec 31, 2023 | +0.3% |
| Accumulated depreciation | $3.8M10 Dec 31, 2024 | $3.7M10 Dec 31, 2023 | +2.2% |
| Property and equipment, net | $111.0K10 Dec 31, 2024 | $183.0K10 Dec 31, 2023 | −39.3% |
| Operating-lease assets (leased space) | $1.1M10 Dec 31, 2024 | $1.4M10 Dec 31, 2023 | −27.2% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $1.8M10 Dec 31, 2024 | $4.3M10 Dec 31, 2023 | −58.8% |
Intangibles and goodwill
| Item | Latest | A year before | Change |
|---|---|---|---|
| Goodwill | $010 Dec 31, 2023 | $3.1M11 Dec 31, 2022 | −100.0% |
| Indefinite-lived intangibles (excluding goodwill) | $24.1M10 Dec 31, 2024 | $25.2M10 Dec 31, 2023 | −4.4% |
Properties, in its own words
We maintain our principal executive offices at 2600 Kelly Road, Suite 100, Warrington, Pennsylvania 18976-3622. Our premises include corporate administration, research and drug development, clinical operations, regulatory affairs, and quality.
We also maintain a location in Taipei, Taiwan consisting of approximately 1,317 square feet of office space, where we oversee certain manufacturing development and preclinical activities occurring at a university in Taiwan related to our cardiovascular drug product candidates. We believe our current facilities are adequate for our needs in 2025.
Item 2 of the 10-K filed Apr 15, 2025.3
Leadership
Who has led WINDTREE THERAPEUTICS INC /DE/, and when. Pick a name to see everywhere that person has worked.
Chair
Chief financial officer
Chief operating officer
- Chief executive officerCraig Fraser Feb 2, 2016 to now12
- Chief executive officerW. Thomas Amick Sep 8, 2009 to Feb 13, 201313
- Chief executive officerRobert J. Capetola Jan 5, 2006 to Dec 16, 200814
- ChairW. Thomas Amick Jan 23, 2012 to Jan 23, 201215
- PresidentCraig Fraser Feb 3, 2016 to now16
- PresidentRobert J. Capetola Jan 5, 2006 to Dec 16, 200814
- Chief financial officerJohn A. Tattory Feb 17, 2015 to Feb 3, 202317
- Chief operating officerEric Curtis Mar 19, 2020 to Aug 25, 202318
- Chief operating officerChristopher Schaber Jan 5, 2006 to Jan 5, 200619
Board members and other officers (36)
- VP, Controller, & CAOJamie McAndrew Sep 5, 2023 to Sep 5, 202320
- SVP, Gen Counsel, & Corp SecMary B. Templeton Esq. Feb 12, 2014 to May 27, 202021
- SVP, Chief Development OfficerSteven Simonson Nov 6, 2014 to now22
- VP, Quality OperationsMichael L. Magee May 7, 2012 to Mar 31, 201523
- Senior VP, R&DRussell Clayton Sep 22, 2011 to Mar 10, 201424
- VP, Principal Acct OfficerJohn A. Tattory Aug 26, 2010 to Mar 10, 201425
- Executive VP & Legal CounselDavid L. Lopez Jan 5, 2006 to Feb 9, 201126
- Sr VP, Business DevelopmentDeni M. Zodda Phd. Jan 5, 2006 to Jan 5, 200627
- Dir, Finance and ControllerKathleen A. McGowan Jan 5, 2006 to Jan 8, 200828
- SVP, Sales and MarketingMark G. Osterman Jan 5, 2006 to Jan 5, 200629
- Sr VP, Chief Medical OfficerRobert-Md Segal Jan 5, 2006 to Feb 9, 201130
- SVP, Manufacturing OperationsCharles F. Katzer Jan 20, 2006 to Feb 9, 201031
- Senior VP, Human ResourcesKathy Cole Feb 1, 2006 to Mar 31, 201532
- Board memberLeanne M. Kelly Jan 14, 2025 to now33
- Board memberAndrew Albert Kucharchuk Aug 5, 2025 to now34
- Board memberJed Latkin Aug 14, 2024 to now35
- Board memberSaundra L. Pelletier Aug 14, 2024 to now36
- Board memberMark Strobeck Jun 28, 2023 to Aug 25, 202337
- Board memberEvan Loh Feb 5, 2021 to Feb 5, 202138
- Board memberLeslie J. Williams Feb 5, 2021 to Aug 25, 202339
- Board memberRobert A. Scott Feb 9, 2021 to Aug 25, 202340
- Board memberDaniel E. Geffken Apr 26, 2019 to Aug 29, 202341
- Board memberBrian D. Schreiber Dec 31, 2018 to Feb 5, 202142
- Board memberCraig Fraser Feb 2, 2016 to now12
- Board memberJoseph M. Mahady Jan 4, 2013 to Feb 5, 202143
- Board memberJohn R. Leone Nov 14, 2012 to Feb 5, 202144
- Board memberBruce Peacock Sep 20, 2010 to Feb 5, 202145
- Board memberRobert J. Capetola Jan 5, 2006 to Dec 16, 200814
- Board memberAntonio Esteve Phd. Jun 19, 2006 to Jun 12, 201246
- Board memberHerbert H. McDade Jun 19, 2006 to Dec 22, 201047
- Board memberMarvin E. Rosenthale Jun 19, 2006 to Aug 8, 201648
- Board memberMax Link Jun 19, 2006 to Jun 12, 201249
- Board memberW. Thomas Amick Jun 19, 2006 to Oct 11, 201150
- General counselDiane Carman Jul 6, 2021 to Mar 2, 202351
- General counselDavid L. Lopez Aug 1, 2011 to Aug 1, 201152
- General counselMary B. Templeton Esq. Sep 22, 2011 to Mar 28, 201353
Former names
Timeline
- Jul 22, 20268-K Entered a material agreement54
- Jan 7, 20268-K Executive or director change55
- Dec 2, 20258-K New debt or obligation; Unregistered sale of shares56
- Oct 16, 20258-K New debt or obligation; Unregistered sale of shares57
- Oct 6, 20258-K Entered a material agreement58
- Sep 8, 20258-K Executive or director change59
- Sep 2, 20258-K Shareholder vote60
- Aug 20, 20258-K Listing notice or transfer61
- Aug 8, 20258-K Other events62
- Aug 5, 20258-K Regulation FD disclosure63
- Aug 4, 20258-K Executive or director change64
- Jul 24, 20258-K Entered a material agreement; New debt or obligation; Unregistered sale of shares65
- Feb 2, 2016New chief executive Craig Fraser becomes CEO12
- Sep 8, 2009New chief executive W. Thomas Amick becomes CEO13
- Jan 5, 2006New chief executive Robert J. Capetola becomes CEO14
Calendar
When it reported results
- May 16, 2025Reported quarterly or annual results66
- Apr 15, 2025Reported quarterly or annual results67
- Nov 27, 2024Reported quarterly or annual results68
- Aug 20, 2024Reported quarterly or annual results69
- Apr 17, 2024Reported quarterly or annual results70
- Nov 9, 2023Reported quarterly or annual results71
- Aug 7, 2023Reported quarterly or annual results72
- May 15, 2023Reported quarterly or annual results73
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
279 filings to the SEC since October 2021: 6 annual reports, 13 quarterly reports, 96 major events, 50 insider forms, 15 large holders, 99 other. The latest 20:
- Jul 22, 20268-K EDGAR
- Apr 1, 2026NT 10-K EDGAR
- Jan 7, 20268-K EDGAR
- Dec 2, 20258-K EDGAR
- Nov 21, 2025424B3 EDGAR
- Nov 19, 202510-Q EDGAR
- Nov 14, 2025NT 10-Q EDGAR
- Nov 13, 2025424B3 EDGAR
- Oct 24, 2025S-1 EDGAR
- Oct 16, 20258-K EDGAR
- Oct 6, 20258-K EDGAR
- Sep 8, 20258-K EDGAR
- Sep 2, 20258-K EDGAR
- Aug 20, 20258-K EDGAR
- Aug 19, 202510-Q EDGAR
- Aug 14, 2025NT 10-Q EDGAR
- Aug 11, 2025ARS EDGAR
- Aug 8, 2025DEF 14A EDGAR
- Aug 8, 20258-K EDGAR
- Aug 5, 20253 EDGAR
The 279 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
20 open-market trades by officers, directors and large owners since October 2021: 19 buys and 1 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Oct 8, 2024 | Fraser CraigPresident and CEO | Buy | 5,431 | $0.91 | $4.9K | Form 4 |
| Sep 27, 2023 | Fraser CraigPresident and CEO | Buy | 2,500 | $1.02 | $2.5K | Form 4 |
| Sep 26, 2023 | Fraser CraigPresident and CEO | Buy | 2,500 | $0.90 | $2.2K | Form 4 |
| Apr 26, 2023 | Fraser CraigPresident and CEO | Buy | 1,497 | $1.77 | $2.6K | Form 4 |
| Apr 25, 2023 | Fraser CraigPresident and CEO | Buy | 1,315 | $1.89 | $2.5K | Form 4 |
| Jul 27, 2022 | Fraser CraigPresident and CEO | Buy | 2,500 | $0.38 | $950 | Form 4 |
| Jul 26, 2022 | Hamill John P.SVP & CFO | Buy | 3,000 | $0.37 | $1.1K | Form 4 |
| Jul 26, 2022 | Fraser CraigPresident and CEO | Buy | 2,500 | $0.37 | $925 | Form 4 |
| Jun 30, 2022 | Fraser CraigPresident and CEO | Buy | 4,500 | $0.43 | $1.9K | Form 4 |
| Jun 29, 2022 | Fraser CraigPresident and CEO | Buy | 7,000 | $0.42 | $2.9K | Form 4 |
| Mar 16, 2022 | Fraser CraigPresident and CEO | Buy | 2,000 | $0.98 | $2.0K | Form 4 |
| Mar 15, 2022 | Simonson StevenSVP, Chief Medical Officer | Buy | 5,000 | $1.00 | $5.0K | Form 4 |
| Mar 15, 2022 | Fraser CraigPresident and CEO | Buy | 3,000 | $0.98 | $2.9K | Form 4 |
| Dec 30, 2021 | Center Laboratories, Inc.10% owner | Buy | 1,239,088 | $1.60 | $2.0M | Form 4 |
| Dec 30, 2021 | Bioengine Capital Inc.10% owner | Sale | 1,239,088 | $1.60 | $2.0M | Form 4 |
| Nov 19, 2021 | Fraser CraigPresident and CEO | Buy | 930 | $1.60 | $1.5K | Form 4 |
| Nov 18, 2021 | Fraser CraigPresident and CEO | Buy | 930 | $1.61 | $1.5K | Form 4 |
| Oct 22, 2021 | Fraser CraigPresident and CEO | Buy | 3,000 | $1.90 | $5.7K | Form 4 |
| Oct 19, 2021 | Huang JamesDirector | Buy | 50,000 | $1.90 | $95.0K | Form 4 |
| Oct 19, 2021 | Fraser CraigPresident and CEO | Buy | 3,000 | $1.91 | $5.7K | 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/A, 2 filings Nov 14, 2024 to Feb 14, 202574
- James E. FlynnSC 13G/A, 2 filings Feb 1, 2024 to Nov 14, 202475
- Lind Global Fund II LPSC 13G/A, 3 filings Apr 28, 2023 to Nov 14, 202476
- Lincoln Park Capital Fund, LLCSC 13G/A, 2 filings Apr 24, 2023 to Feb 14, 202477
- Krishna DuvvuriSC 13G, 1 filing Nov 13, 202378
- James HuangSC 13D/A, 4 filings Feb 9, 2023 to May 17, 202379
- Center Laboratories, Inc.SC 13G/A, 1 filing Jan 10, 202280
Executive pay
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
| Year | Executive | Age | Salary | Total pay |
|---|---|---|---|---|
| 2024 | Craig E. Fraser | $568.4K | $583.3K81 | |
| 2024 | Steven G. SimonsonM.D. | $458.1K | $468.4K81 | |
| 2024 | Eric Curtis | $401.4K | $411.5K81 | |
| 2024 | Jed Latkin | $46.4K | $69.0K81 | |
| 2023 | Former President and CEO | $557.3K | $693.6K81 | |
| 2023 | Senior VicePresident and CMO | $438.1K | $491.7K81 |
SEC filer profile
How WINDTREE THERAPEUTICS INC /DE/ is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARWINDTREE THERAPEUTICS INC /DE/1
- CIK0000946486
- Employer ID (EIN)94-31719433
- 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)2836 Biological Products, (No Diagnostic Substances)1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address2600 Kelly Road, Suite 100, Warrington, PA 189761
- Phone21548893001
- Shares outstanding33,708,784 as of Nov 14, 20258
- Public float$1.9M as of Jun 28, 20243
- AuditorEisnerAmper LLP, Philadelphia, Pennsylvania PCAOB ID 274; no auditor attestation of internal control over financial reporting3
- On EDGAR sinceMay 15, 19961
- Filings1,785 in all: 4 (503), 8-K (434), 5 (88), 10-Q (73), SC 13G/A (67), 3 (60), 424B3 (45), S-8 (36)1
All 64 form types
SC 13G (36), 424B5 (32), CORRESP (31), DEF 14A (29), UPLOAD (26), S-3 (24), 10-K (23), EFFECT (21), PRE 14A (20), 10QSB (17), 4/A (16), 8-K/A (16), CT ORDER (14), D (13), 10-K/A (12), SC 13D/A (12), ARS (10), NT 10-Q (10), S-1 (10), S-1/A (10), SC 13D (10), S-3/A (9), NT 10-K (7), 10KSB (6), DEFA14A (6), PRER14A (5), DEF 14C (4), FWP (4), REGDEX (4), 10-Q/A (3), 10KSB/A (3), 5/A (3), SD (3), 10QSB/A (2), 424B4 (2), 8-A12G (2), DEFR14A (2), PRE 14C (2), S-4/A (2), SEC STAFF LETTER (2), 10KSB40 (1), 25-NSE (1), 8-A12B (1), CERT (1), D/A (1), DEL AM (1), NO ACT (1), NT 10-Q/A (1), POS AM (1), PREM14A (1), PRER14C (1), RW (1), S-1MEF (1), S-3MEF (1), S-4 (1), SCHEDULE 13G/A (1)
- Latest filingsAnnual report (10-K) Apr 15, 2025
Quarterly report (10-Q) Nov 19, 2025
Proxy statement (DEF 14A) Aug 8, 2025
Latest 8-K (8-K) Jul 22, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, $0.001 par value | WINT | Nasdaq |
From the cover page of the 10-K filed Apr 15, 2025 (Section 12(b) of the Exchange Act).3
Risk factors and legal proceedings
The risks WINDTREE THERAPEUTICS INC /DE/ names in Item 1A of its 10-K filed Apr 15, 2025: 75 risks under these headings, as written.3
- Information concerning the shares of our common stock and related share prices in these risk factors has been adjusted to reflect the 1-for-18 reverse split of our common stock that was made effective on April 19, 2024 and the 1-for-50 reverse split of our common stock that was made effective on February 20, 2025.
- Risks Related to Our Finances and Capital Requirements
- Our current cash position, losses, negative cash flows from operations, and accumulated deficit raise substantial doubt about our ability to continue as a going concern absent obtaining adequate new debt or equity financings. Our ability to continue as a going concern requires that we obtain sufficient funding to finance our operations in the near term.
- We have incurred significant operating losses since inception, we expect to incur operating losses in the future, and we may not be able to achieve or sustain profitability.
- We have incurred indebtedness, which could adversely affect our operating flexibility and financial condition.
- We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development programs, or other operations.
- As a result of our failure to timely file our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2024 with the SEC, we are currently ineligible to file new registration statements on Form S-3, which may impair our ability to raise capital in a timely manner or at all.
- Our strategy to expand our pipeline on our own, through acquisitions of early-stage product candidates, or through research partnerships, may not be successful.
- Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
- Unstable market and economic conditions may have serious adverse consequences on our business, financial condition, and stock price.
- Our business could be adversely affected by economic downturns, changes in inflation and interest rates, changes in trade policy, political crises, geopolitical events, such as the ongoing war between Russia and Ukraine and the war involving Israel, or other macroeconomic conditions, which may in the future negatively impact our business and financial performance.
- Natural disasters, including those resulting from significant climate change, could adversely affect our business and our third-party partners’ businesses.
The other 64 risks
- Adverse developments affecting the financial services industry, including events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our business, financial condition or results of operations.
- Due to the significant resources required to develop our product candidates, we must prioritize development of certain product candidates and/or certain disease indications. We may expend our limited resources on candidates or indications that do not yield a successful product and fail to capitalize on other product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
- We have a significant amount of intangible assets recorded on our consolidated balance sheets which may lead to potentially significant impairment charges.
- If we fail to maintain proper and effective internal control over financial reporting, our ability to produce accurate and timely financial statements could be impaired, investors may lose confidence in our financial reporting and the trading price of our common stock may decline.
- Risks Related to our Development Activities and Regulatory Approval of our Product Candidates
- We are substantially dependent on the success of our lead product candidate istaroxime. To the extent that our clinical development of istaroxime is not successful, our business, financial condition, and results of operations may be materially adversely affected and the price of our common stock may decline.
- Clinical development involves a lengthy and expensive process with an uncertain outcome, and results of preclinical studies and early clinical trials are not necessarily predictive of future results. In addition, our assumptions about why certain of our product candidates are worthy of future development and potential approval are based on data primarily collected by other companies. Our product candidates may not have favorable results in later clinical trials, if any, or receive regulatory approval on a timely basis, if at all.
- Delays in clinical trials are common and have many causes, and any delay could result in increased costs to us and jeopardize or delay our ability to continue development activities, including our ability to obtain trial results, regulatory approval and commence product sales or allow for competition to emerge.
- We have conducted, and may in the future conduct, clinical trials for our product candidates at clinical sites located in the U.S. and outside of the U.S. If the FDA and other foreign equivalents raise concerns about certain of the clinical sites based on location and regulatory environment, they may not accept data from such trials, in which case our development plans will be delayed, which could materially harm our business.
- Our business may be adversely affected by a pandemic, epidemic, or outbreak of an infectious disease.
- Use of our product candidates could be associated with side effects, adverse events or other properties or safety risks, which could delay or preclude approval, cause us to suspend or discontinue clinical trials, abandon a product candidate, limit the commercial profile of an approved label or result in other significant negative consequences that could severely harm our business, prospects, operating results and financial condition.
- Our product candidates are subject to extensive regulation and compliance, which is costly and time consuming, and such regulation may cause unanticipated delays or prevent the receipt of the required approvals to commercialize our product candidates.
- Although we have multiple product candidates or potential indications of those candidates in our clinical pipeline, we may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on other product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
- Even though some of our product candidates have Fast Track designation, the FDA may not approve them at all or any sooner than other product candidates that do not have Fast Track designation.
- Although we may pursue expedited regulatory programs for a product candidate or an indication, it may not qualify for expedited development or, if it does qualify for expedited development, it may not actually lead to a faster development or regulatory review or approval process.
- We may not be able to obtain or maintain Orphan Drug exclusivity for our product candidates.
- Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
- Even if we receive regulatory approval for any product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, our product candidates, if approved, could be subject to labeling and other restrictions on marketing or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our product candidates, when and if any of them are approved.
- If we fail to obtain and maintain regulatory approval in foreign jurisdictions, our market opportunities will be limited.
- If the FDA or other applicable regulatory authorities approve generic products with claims that compete with our product candidates, it could reduce our sales of our product candidates if approved.
- Even if we receive regulatory approval for any of our product candidates, we may not be able to successfully commercialize the product and the revenue that we generate from its sales, if any, may be limited.
- The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. If we are found or alleged to have improperly promoted any of our products, if approved, for off-label uses, we may become subject to significant liability.
- We currently have no sales and marketing organization. If we are unable to establish satisfactory sales and marketing capabilities or secure a sales and marketing partner, we may not successfully commercialize any of our product candidates.
- The successful commercialization of our product candidates, if approved, will depend in part on the extent to which hospitals and hospital systems, governmental authorities and health insurers establish coverage, adequate reimbursement levels and favorable pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our product candidates, if approved, could limit our ability to market those product candidates and decrease our ability to generate revenue.
- Disruptions at the FDA and other government agencies caused by funding shortages, staffing limitations or global health concerns could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new products and services from being developed or commercialized in a timely manner, which could negatively impact our business.
- Changes in 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 functions.
- Risks Related to Our Reliance on Third Parties
- We rely on third parties, primarily outside of the U.S., to conduct many of our preclinical studies and clinical trials. Any failure by a third party to conduct the clinical trials according to good clinical practices, or GCPs, and other requirements and in a timely and quality manner may delay or prevent our ability to seek or obtain regulatory approval for or commercialize our product candidates.
- We currently do not have a back-up facility for our contract manufacturing organization, or CMO, for our drug product candidates, or our suppliers of API. If the parties we depend on for supplying our APIs and manufacturing our drug product candidates do not supply these products in a timely and quality manner, it may delay or impair our ability to execute our development plans for our current and potential pipeline products.
- Our product candidates are temperature sensitive and may have other attributes that lead to limited shelf life. These attributes may pose risks to supply, inventory and waste management and increased cost of goods.
- We plan to rely on third parties, some of which are located outside the U.S., to manufacture our drug product candidates, which exposes us to risks that may affect our ability to maintain supplies of our clinical materials, and subject us to uncertainty associated with the international political climate, and could potentially delay or cease our research and development activities, as well as eventual regulatory approval and commercialization of our drug product candidates.
- Our ability to manufacture our product candidates depends upon receiving adequate supplies and related services, which may be difficult or uneconomical to procure.
- We are dependent on Lee’s (HK) and Zhaoke for the successful development and commercialization of our KL4 surfactant products. If Lee’s (HK) and Zhaoke do not devote sufficient resources to the development of those product candidates, are unsuccessful in their efforts, or chooses to terminate their agreement with us, the potential licensing revenue will not materialize.
- Risks Related to our Business and Operations
- Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
- Our acquisition of Varian’s assets may divert resources away from existing operations or expose us to liabilities, which could adversely affect our business, results of operations and financial condition.
- Our new corporate strategy may not be successful.
- We are continually evaluating our business strategy and may modify this strategy to respond to developments in our business and other factors, and any such modification, if not successful, could have a material adverse effect on our business, financial condition, and results of operations.
- Our industry is highly competitive, and we have less capital and resources than many of our competitors, which may give them an advantage in developing and marketing products similar to ours or make our product candidates obsolete.
- The political and healthcare policy and reimbursement environment is becoming more challenging for pharmaceutical companies and manufacturers and may adversely affect our business.
- We depend upon key employees and consultants in a competitive market for skilled personnel. If we or our strategic partners or collaborators are unable to attract and retain key personnel, it could adversely affect our ability to develop and market our product candidates.
- If our business development activities are unsuccessful, our business could suffer, and our financial performance could be adversely affected.
- We may seek to enter into licensing transactions, collaboration arrangements, and other similar transactions and strategic opportunities, and may not be successful in doing so, and even if we are, we may not realize the benefits of such relationships.
- We could be adversely affected by any interruption, including from breaches in cybersecurity, in our ability to conduct business at our current location.
- The failure to prevail in litigation or the costs of litigation, including securities class actions, product liability claims and patent infringement claims, could harm our financial performance and business operations.
- Risks Related to Government Regulation
- Our activities are subject to various and complex laws and regulations, and we are susceptible to a changing regulatory environment. Violations or allegations of violations of these laws may result in large civil and criminal penalties, debarment from participating in government programs, diversion of management time, attention and resources and may otherwise have a material adverse effect on our business, financial condition and results of operations.
- Failure in our information technology systems could disrupt our operations and cause the loss of confidential information and business opportunities.
- We face risks related to our collection and use of data, including personal information, which could result in investigations, inquiries, litigation, fines, legislative and regulatory action and negative press about our privacy and data protection practices.
- Healthcare reform measures in the U.S., as well as the general tightening of drug reimbursement pathways and levels of reimbursement globally, are expected to add additional pressure to achieve financial expectations for our product candidates, if approved.
- Our international operations subject us to additional regulatory oversight in foreign jurisdictions, as well as economic, social, and political uncertainties, which could cause a material adverse effect on our business, financial position, and operating results.
- If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates, if approved.
- Our employees and independent contractors, including principal investigators, CROs, consultants and vendors, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
- We are subject to anti-bribery, anti-corruption, and anti-money laundering laws, including the U.S. Foreign Corrupt Practices Act, in which violations of these laws could result in substantial penalties and prosecution.
- We and any of our third-party manufacturers or suppliers may use potent chemical agents and hazardous materials, and any claims relating to improper handling, storage or disposal of these materials could be time consuming or costly.
- We may change or diversify the nature of our business from biotechnology to include a sector that may provide revenue opportunities in the near future, which could expose us to new risks and uncertainties.
- Risks Related to Intellectual Property Matters
- If we cannot protect our intellectual property, others could use our technology in competitive products. Even if we obtain patents to protect our product candidates, those patents may not be sufficiently broad, or they may expire and others could then compete with us.
- Intellectual property rights of third parties could limit our ability to develop and market our product candidates.
- We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
- We rely on agreements containing obligations regarding intellectual property, confidentiality and noncompetition provisions that could be breached and may be difficult to enforce.
- Patents covering our product candidates could be found invalid or unenforceable if challenged in court or before administrative bodies in the U.S. or abroad.
- Third parties may assert ownership or commercial rights to inventions we develop.
- Litigation or other proceedings or third-party claims of intellectual property infringement could require us to spend significant time and money and could prevent us from selling our product candidates or affect our stock price.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position could be harmed.
- We may be unable to enforce our intellectual property rights throughout the world.
- Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.
- Changes in U.S. patent laws may limit our ability to obtain, defend and/or enforce our patents.
Legal proceedings
We are not aware of any pending legal actions that would, if determined adversely to us, have a material adverse effect on our business and operations.
We may be subject to other legal proceedings and claims in the ordinary course of business. We cannot predict the results of any such disputes, and despite the potential outcomes, the existence thereof may have an adverse material impact on us due to diversion of management time and attention as well as the financial costs related to resolving such disputes.
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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- 15SEC EDGARW. Thomas Amick, Chair
- 16SEC EDGARCraig Fraser, President
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- 18SEC EDGAREric Curtis, Chief operating officer
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- 24SEC EDGARRussell Clayton, Senior VP, R&D
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- 33SEC EDGARLeanne M. Kelly, Board member
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- 35SEC EDGARJed Latkin, Board member
- 36SEC EDGARSaundra L. Pelletier, Board member
- 37SEC EDGARMark Strobeck, Board member
- 38SEC EDGAREvan Loh, Board member
- 39SEC EDGARLeslie J. Williams, Board member
- 40SEC EDGARRobert A. Scott, Board member
- 41SEC EDGARDaniel E. Geffken, Board member
- 42SEC EDGARBrian D. Schreiber, Board member
- 43SEC EDGARJoseph M. Mahady, Board member
- 44SEC EDGARJohn R. Leone, Board member
- 45SEC EDGARBruce Peacock, Board member
- 46SEC EDGARAntonio Esteve Phd., Board member
- 47SEC EDGARHerbert H. McDade, Board member
- 48SEC EDGARMarvin E. Rosenthale, Board member
- 49SEC EDGARMax Link, Board member
- 50SEC EDGARW. Thomas Amick, Board member
- 51SEC EDGARDiane Carman, General counsel
- 52SEC EDGARDavid L. Lopez, General counsel
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- 54SEC EDGAREntered a material agreement
- 55SEC EDGARExecutive or director change
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- 58SEC EDGAREntered a material agreement
- 59SEC EDGARExecutive or director change
- 60SEC EDGARShareholder vote
- 61SEC EDGARListing notice or transfer
- 62SEC EDGAROther events
- 63SEC EDGARRegulation FD disclosure
- 64SEC EDGARExecutive or director change
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