Private company
Galera Therapeutics, Inc.
American pharmaceutical preparations company based in Malvern1
In its 2026 annual report the company says: “We are a biopharmaceutical company that historically was focused on developing a portfolio of small molecule superoxide dismutase (SOD) mimetics to improve radiotherapy in cancer, primarily by reducing one of the most common side effects of radiotherapy, severe oral mucositis (SOM).”4
Last updated Oct 21, 2026.
Overview
- IndustryPharmaceutical Preparations1
- HeadquartersMalvern, Pennsylvania1
- Incorporated inDE2
- Business address101 Lindenwood Drive, Suite 225, Malvern, Pa 193552
- Filer categoryNon-accelerated filer, Smaller reporting company2
- Legal formCorporation
See how the biggest companies compare on our leaderboards
We are a biopharmaceutical company that historically was focused on developing a portfolio of small molecule superoxide dismutase (SOD) mimetics to improve radiotherapy in cancer, primarily by reducing one of the most common side effects of radiotherapy, severe oral mucositis (SOM). In October 2025 we sold our assets related to avasopasem and rucosopasem and all other dismutase mimetics assets to Biossil, Inc. (Biossil), a privately-held company based in Toronto, Canada. In connection with selling these assets, we assigned and Biossil assumed all rights and obligations under the Royalty Agreement with Blackstone Life Sciences (Blackstone), as described below. We received consideration from Biossil in the form of an upfront payment of $3.5 million and are eligible to receive further payments upon the achievement of future regulatory and commercial milestones and we received contingent val…4 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Financial statements
| Fiscal year | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|---|
| Research and development | $42.3M5 | $54.8M6 | $52.4M7 | $31.0M8 | $24.1M9 | $3.2M10 | $349.0K10 | |
| Operating income | -$50.7M5 | -$70.6M6 | -$73.4M7 | -$51.2M8 | -$49.3M9 | -$20.2M10 | -$2.5M10 | |
| Interest | $3.0M5 | $4.9M6 | $7.2M7 | $11.6M8 | $11.4M9 | $010 | $010 | |
| Income before tax | -$80.5M7 | -$62.3M8 | -$59.1M9 | -$19.2M10 | $149.0M10 | |||
| Income tax | -$9.0K5 | -$16.0K6 | $07 | $70.0K8 | $09 | -$203.0K10 | $010 | |
| Net income | -$51.9M5 | -$74.2M6 | -$80.5M7 | -$62.2M8 | -$59.1M9 | -$19.0M10 | $149.0M10 | |
| Earnings per share | -$1.339 | -$0.3410 | $0.6410 | |||||
| Earnings per share (diluted) | -$1.339 | -$0.3410 | $0.6410 | |||||
| Shares (weighted, basic) | 44.5M shares9 | 54.6M shares10 | 98.5M shares10 | |||||
| Shares (weighted, diluted) | 44.5M shares9 | 54.6M shares10 | 98.5M shares10 |
| Fiscal year | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|---|
| Cash | $18.4M5 | $15.9M6 | $19.9M7 | $4.3M8 | $18.3M9 | $8.3M10 | $6.4M10 | |
| Current assets | $117.6M5 | $77.9M6 | $77.4M7 | $38.5M8 | $21.6M9 | $10.0M10 | $7.1M10 | |
| Property, plant and equipment | $527.0K7 | $438.0K8 | $71.0K9 | $09 | ||||
| Goodwill | $881.0K7 | $881.0K8 | $881.0K9 | $09 | ||||
| Total assets | $123.4M5 | $84.1M6 | $83.3M7 | $44.0M8 | $26.1M9 | $10.1M10 | $7.2M10 | |
| Accounts payable | $5.0M7 | $3.6M8 | $1.4M9 | $1.3M10 | $265.0K10 | |||
| Current liabilities | $9.7M5 | $14.0M6 | $12.9M7 | $13.4M8 | $5.0M9 | $1.7M10 | $645.0K10 | |
| Total liabilities | $53.8M5 | $78.0M6 | $141.3M7 | $153.2M8 | $157.3M9 | $153.8M10 | $645.0K10 | |
| Retained earnings | -$316.1M7 | -$378.3M8 | -$437.4M9 | -$456.4M10 | -$307.3M10 | |||
| Shareholders’ equity | $69.6M6 | $6.1M7 | -$58.0M8 | -$109.2M9 | -$131.2M10 | -$148.0M10 | $4.0M10 | |
| Shares outstanding | 24.8M shares5 | 25.0M shares6 | 26.5M shares7 | 28.5M shares8 | 54.4M shares9 | 75.5M shares10 | 75.5M shares10 | 75.5M shares10 |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
| Fiscal year | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|---|
| Cash from operations | -$46.7M5 | -$59.5M6 | -$68.0M7 | -$43.4M8 | -$44.8M9 | -$12.1M10 | -$6.0M10 | |
| Depreciation and amortization | $778.0K7 | $114.0K8 | $259.0K9 | $20.0K10 | $010 | |||
| Stock-based compensation | $7.2M7 | $7.2M8 | $5.6M9 | $2.5M10 | $410.0K10 | |||
| Capital spending | $633.0K5 | $457.0K6 | $283.0K7 | $25.0K8 | $59.0K9 | $09 | ||
| Free cash flow | -$47.3M | -$60.0M | -$68.2M | -$43.5M | -$44.9M | -$12.1M | ||
| Cash from investing | $5.2M7 | $24.0M8 | $27.3M9 | -$46.0K10 | $3.5M10 | |||
| Cash from financing | $66.7M7 | $3.9M8 | $31.5M9 | $2.2M10 | $635.0K10 |
Corporate structure
Galera Therapeutics, Inc. sits at the top of its group. 3 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Galera Therapeutics, Inc.
- Ikarian Capital, LLC Filed SCHEDULE 13G/A on Galera Therapeutics, Inc., latest Aug 14, 2026 (2 filings since Feb 14, 2025)
- Parvinder S. Hyare Filed SCHEDULE 13D on Galera Therapeutics, Inc., latest Jun 11, 2026
- Emerald Bioventures, LLC Filed SCHEDULE 13D/A on Galera Therapeutics, Inc., latest May 29, 2026 (2 filings since Apr 27, 2026)
- Nancy T. Chang Filed SCHEDULE 13D on Galera Therapeutics, Inc., latest Apr 10, 2026
- Rochel Soffer Filed SC 13G on Galera Therapeutics, Inc., latest May 16, 2024
- Yair Schneid Filed SC 13G/A on Galera Therapeutics, Inc., latest May 16, 2024 (3 filings since Jan 17, 2024)
- ALPHA PHARMA Investments LLC Filed SC 13G on Galera Therapeutics, Inc., latest Apr 16, 2024
- Altamont Pharmaceutical Holdings, LLC Filed SC 13G/A on Galera Therapeutics, Inc., latest Apr 3, 2024 (2 filings since Nov 13, 2023)
- Sofinnova Venture Partners IX, L.P. Filed SC 13D/A on Galera Therapeutics, Inc., latest Feb 20, 2024 (2 filings since Feb 6, 2023)
- SECTORAL ASSET MANAGEMENT INC Filed SC 13G/A on Galera Therapeutics, Inc., latest Feb 14, 2024 (2 filings since Feb 13, 2023)
- GSA CAPITAL PARTNERS LLP Filed SC 13G on Galera Therapeutics, Inc., latest Jan 2, 2024
- Blackstone Holdings I/II GP L.L.C. Filed SC 13D/A on Galera Therapeutics, Inc., latest Dec 4, 2023 (3 filings since Feb 11, 2022)
- Galera Therapeutics, Inc. Malvern, Pennsylvania
- Galera Labs, LLC Subsidiary · Missouri, United States
- Nova Pharmaceuticals Operating, LLC Subsidiary · Delaware, United States
Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Galera 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 |
|---|---|---|---|
| Property and equipment, before depreciation | $09 Dec 31, 2024 | $530.0K9 Dec 31, 2023 | −100.0% |
| Accumulated depreciation | $09 Dec 31, 2024 | $459.0K9 Dec 31, 2023 | −100.0% |
| Property and equipment, net | $09 Dec 31, 2024 | $71.0K9 Dec 31, 2023 | −100.0% |
| Operating-lease assets (leased space) | $09 Dec 31, 2024 | $1.2M9 Dec 31, 2023 | −100.0% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $6.4M10 Dec 31, 2025 | $8.3M10 Dec 31, 2024 | −23.1% |
Intangibles and goodwill
| Item | Latest | A year before | Change |
|---|---|---|---|
| Goodwill | $09 Dec 31, 2024 | $881.0K9 Dec 31, 2023 | −100.0% |
| Indefinite-lived intangibles (excluding goodwill) | $09 Dec 31, 2024 | $2.3M9 Dec 31, 2023 | −100.0% |
Properties, in its own words
Our principal office is located at 101 Lindenwood Drive, Suite 225, Malvern, Pennsylvania 19355, where we lease office space under a month-to-month lease.
Item 2 of the 10-K filed Mar 19, 2026.4
Leadership
Who has led Galera Therapeutics, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
Chief operating officer
- Chief executive officerMel Sorensen Nov 6, 2019 to now14
- PresidentMel Sorensen Nov 6, 2019 to now14
- Chief financial officerChris Degnan Nov 6, 2019 to Mar 14, 202315
- Chief operating officerRobert A. Beardsley Nov 6, 2019 to Feb 28, 202316
Board members and other officers (14)
- Chief Medical OfficerEugene P. Kennedy Sep 2, 2022 to Feb 28, 202317
- OfficerJennifer Evans Stacey Oct 12, 2021 to Feb 28, 202318
- Chief Commercial OfficerMark Bachleda Oct 12, 2021 to Mar 20, 202319
- Chief Scientific OfficerDennis Riley Feb 4, 2020 to Feb 4, 202020
- Chief Business OfficerArthur Fratamico Nov 6, 2019 to Jan 28, 202121
- Chief Accounting OfficerJoel F. Sussman Nov 6, 2019 to now22
- Chief Medical OfficerJon T. Holmlund Nov 6, 2019 to Mar 2, 202223
- Board memberNancy T. Chang Jan 2, 2025 to now24
- Board memberLinda West Apr 2, 2020 to Jul 5, 202325
- Board memberEmmett Cunningham Nov 6, 2019 to Jun 16, 202326
- Board memberJason Fuller Nov 6, 2019 to Nov 8, 201927
- Board memberKevin G. Lokay Nov 6, 2019 to now28
- Board memberLawrence M. Alleva Nov 6, 2019 to now29
- Board memberMel Sorensen Nov 6, 2019 to now14
Named in SEC Form D filings
People the company listed in its private-offering notices.
- DirectorMichael R. Friedman named Jan 13, 2025 to Jan 14, 202530
Subsidiaries and ownership
Subsidiaries (Exhibit 21)
- Galera Labs, LLC Missouri, United States3
- Nova Pharmaceuticals Operating, LLC Delaware, United States3
The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.
Timeline
- Aug 4, 20268-K Entered a material agreement; Completed an acquisition or sale; Listing notice or transfer31
- Jul 31, 20268-K Unregistered sale of shares; Regulation FD disclosure32
- Jul 13, 20268-K Change to shareholders' rights; Bylaws or fiscal year changed33
- Jul 7, 20268-K Other events34
- May 19, 20268-K Other events35
- May 15, 20268-K Bylaws or fiscal year changed36
- May 11, 20268-K Shareholder vote37
- Apr 14, 20268-K Entered a material agreement; Unregistered sale of shares; Change in control38
- Apr 9, 20268-K Other events39
- Apr 3, 20268-K Other events40
- Feb 18, 20268-K Bylaws or fiscal year changed41
- Feb 12, 20268-K Executive or director change42
- Nov 6, 2019New chief executive Mel Sorensen becomes CEO14
Calendar
When it reported results
- Aug 14, 2024Reported quarterly or annual results43
- May 13, 2024Reported quarterly or annual results44
- Mar 28, 2024Reported quarterly or annual results45
- Nov 14, 2023Reported quarterly or annual results46
- Oct 31, 2023Reported quarterly or annual results47
- Aug 14, 2023Reported quarterly or annual results48
- Aug 10, 2023Reported quarterly or annual results49
- May 11, 2023Reported quarterly or annual results50
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
211 filings to the SEC since October 2021: 5 annual reports, 14 quarterly reports, 56 major events, 67 insider forms, 30 large holders, 2 private raises, 37 other. The latest 20:
- Aug 14, 2026SCHEDULE 13G/A EDGAR
- Aug 7, 2026EFFECT EDGAR
- Aug 5, 20264 EDGAR
- Aug 5, 20264 EDGAR
- Aug 5, 20264 EDGAR
- Aug 5, 20264 EDGAR
- Aug 5, 20264 EDGAR
- Aug 5, 20264 EDGAR
- Aug 4, 202615-12G EDGAR
- Aug 4, 2026POS AM EDGAR
- Aug 4, 2026S-8 POS EDGAR
- Aug 4, 2026S-8 POS EDGAR
- Aug 4, 20268-K EDGAR
- Jul 31, 20268-K EDGAR
- Jul 13, 2026DEFA14C EDGAR
- Jul 13, 20268-K EDGAR
- Jul 7, 2026DEFA14C EDGAR
- Jul 7, 20268-K EDGAR
- Jul 2, 2026DEFM14C EDGAR
- Jun 11, 2026SCHEDULE 13D EDGAR
The 211 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
22 open-market trades by officers, directors and large owners since October 2021: 14 buys and 8 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Nov 20, 2025 | Sorensen MelPresident and CEO | Sale | 70,000 | $0.02 | $1.4K | Form 4 |
| Dec 30, 2024 | CHANG NANCY TDirector | Buy | 7,644,932 | $0.07 | $535.1K | Form 4 |
| Aug 16, 2024 | Sorensen MelPresident and CEO | Sale | 67,015 | $0.07 | $4.7K | Form 4 |
| Apr 19, 2024 | Schneid Yair10% owner | Buy | 100,000 | $0.19 | $19.0K | Form 4 |
| Apr 18, 2024 | Schneid Yair10% owner | Buy | 547,600 | $0.20 | $108.3K | Form 4 |
| Apr 17, 2024 | Schneid Yair10% owner | Buy | 1,814,657 | $0.22 | $403.1K | Form 4 |
| Mar 28, 2024 | Altamont Pharmaceutical Holdings, LLC10% owner | Sale | 693,076 | $0.15 | $104.0K | Form 4 |
| Mar 27, 2024 | Altamont Pharmaceutical Holdings, LLC10% owner | Sale | 306,924 | $0.17 | $52.2K | Form 4 |
| Mar 26, 2024 | Altamont Pharmaceutical Holdings, LLC10% owner | Sale | 2,000,000 | $0.20 | $400.0K | Form 4 |
| Mar 25, 2024 | Altamont Pharmaceutical Holdings, LLC10% owner | Sale | 780,000 | $0.22 | $171.6K | Form 4 |
| Mar 22, 2024 | Altamont Pharmaceutical Holdings, LLC10% owner | Sale | 20,000 | $0.23 | $4.6K | Form 4 |
| Feb 8, 2024 | Schneid Yair10% owner | Buy | 150,000 | $0.17 | $25.5K | Form 4 |
| Feb 7, 2024 | Schneid Yair10% owner | Buy | 175,000 | $0.17 | $29.8K | Form 4 |
| Feb 6, 2024 | Schneid Yair10% owner | Buy | 25,000 | $0.20 | $5.0K | Form 4 |
| Feb 5, 2024 | Schneid Yair10% owner | Buy | 97,402 | $0.18 | $17.5K | Form 4 |
| Jan 30, 2024 | Schneid Yair10% owner | Buy | 335,000 | $0.18 | $60.3K | Form 4 |
| Jan 29, 2024 | Schneid Yair10% owner | Buy | 150,000 | $0.18 | $27.0K | Form 4 |
| Jan 11, 2024 | Altamont Pharmaceutical Holdings, LLC10% owner | Sale | 400,000 | $0.23 | $92.0K | Form 4 |
| Mar 16, 2023 | Bachleda MarkChief Commercial Officer | Buy | 11,000 | $2.25 | $24.8K | Form 4 |
| Mar 13, 2023 | Degnan ChrisChief Financial Officer | Buy | 10,000 | $1.96 | $19.6K | Form 4 |
All 22 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.
- Ikarian Capital, LLCSCHEDULE 13G/A, 2 filings Feb 14, 2025 to Aug 14, 202651
- Parvinder S. HyareSCHEDULE 13D, 1 filing Jun 11, 202652
- Emerald Bioventures, LLCSCHEDULE 13D/A, 2 filings Apr 27, 2026 to May 29, 202653
- Nancy T. ChangSCHEDULE 13D, 1 filing Apr 10, 202654
- Rochel SofferSC 13G, 1 filing May 16, 202455
- Yair SchneidSC 13G/A, 3 filings Jan 17, 2024 to May 16, 202456
- ALPHA PHARMA Investments LLCSC 13G, 1 filing Apr 16, 202457
- Altamont Pharmaceutical Holdings, LLCSC 13G/A, 2 filings Nov 13, 2023 to Apr 3, 202458
- Sofinnova Venture Partners IX, L.P.SC 13D/A, 2 filings Feb 6, 2023 to Feb 20, 202459
- SECTORAL ASSET MANAGEMENT INCSC 13G/A, 2 filings Feb 13, 2023 to Feb 14, 202460
- GSA CAPITAL PARTNERS LLPSC 13G, 1 filing Jan 2, 202461
- Blackstone Holdings I/II GP L.L.C.SC 13D/A, 3 filings Feb 11, 2022 to Dec 4, 202362
- Novo Holdings A/SSC 13G/A, 2 filings Feb 2, 2022 to Jun 28, 202363
- James E. FlynnSC 13G, 1 filing Feb 28, 202364
- CITADEL ADVISORS LLCSC 13G/A, 2 filings Dec 27, 2021 to Feb 14, 202265
- Novartis Bioventures LtdSC 13G/A, 1 filing Feb 11, 202266
- Rosalind Advisors, Inc.SC 13G, 1 filing Feb 11, 202267
- ADAGE CAPITAL PARTNERS GP, L.L.C.SC 13G/A, 1 filing Feb 10, 202268
- Orin HirschmanSC 13G/A, 1 filing Oct 20, 202169
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 | J. Mel SorensenM.D., | 69 | $619.5K | $747.8K70 |
| 2025 | Joel Sussman | 77 | $336.0K | $408.1K70 |
| 2024 | President and Chief Executive Officer | $619.5K | $633.3K70 | |
| 2024 | Chief Accounting OfficerTreasurer and Secretary | $336.0K | $349.4K70 |
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) $5.6M
Figures by year
| Year | Private raises (Form D) | Total |
|---|---|---|
| 2024 | $5.6M | $5.6M |
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.
SEC filer profile
How Galera 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 EDGARGalera Therapeutics, Inc.1
- CIK0001563577
- Employer ID (EIN)46-14548984
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
- Incorporated inDelaware4
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address101 Lindenwood Drive, Suite 225, Malvern, PA 193551
- Phone610-725-15001
- Shares outstanding160,429,783 as of May 12, 202613
- Public float$1.5M as of Jun 30, 20254
- AuditorKPMG LLP, Philadelphia, Pennsylvania PCAOB ID 185; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceDec 10, 20121
- Filings373 in all: 4 (115), 8-K (76), 3 (34), 10-Q (20), SC 13G/A (18), SC 13G (16), 425 (12), 10-K (7)1
All 45 form types
D (7), DEF 14A (7), CORRESP (4), DEFA14A (4), DRS/A (3), EFFECT (3), SC 13D/A (3), SCHEDULE 13D (3), UPLOAD (3), 144 (2), 8-A12B (2), ARS (2), DEFA14C (2), DRSLTR (2), PRE 14A (2), S-8 (2), S-8 POS (2), SC 13D (2), SEC STAFF LETTER (2), 15-12G (1), 25-NSE (1), 4/A (1), 424B4 (1), 424B5 (1), 5 (1), 8-K/A (1), CERT (1), DEFM14C (1), DRS (1), NT 10-Q (1), POS AM (1), S-1 (1), S-1/A (1), S-3 (1), SCHEDULE 13D/A (1), SCHEDULE 13G (1), SCHEDULE 13G/A (1)
- Latest filingsAnnual report (10-K) Mar 19, 2026
Quarterly report (10-Q) May 14, 2026
Proxy statement (DEF 14A) Apr 20, 2026
Latest 8-K (8-K) Aug 4, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, | GRTX |
From the cover page of the 10-K filed Mar 19, 2026 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks Galera Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 19, 2026: 40 risks under these headings, as written.4
- Risks Related to Our Financial Position and Capital Needs
- We have incurred significant operating losses since our inception and anticipate that we will incur continued losses for the foreseeable future.
- Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidate.
- Risks Related to the Discovery and Development of Our Product Candidate
- We are heavily dependent on the success of our product candidate, tilarginine, which has not received regulatory approval. If development of our product candidate is unsuccessful, we may be unable to obtain required regulatory approvals and be unable to commercialize our product candidate on a timely basis, if at all.
- We rely, and will continue to rely, on third parties to conduct our clinical trials for our product candidate, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials.
- Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials.
- Our product candidate may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval or result in significant negative consequences following marketing approval, if any.
- The biopharmaceutical industries are subject to extensive regulatory obligations and policies that may be subject to significant and abrupt change, including due to judicial challenges, election cycles, and resulting regulatory updates and changes in policy priorities.
- Risks Related to Competition, Retaining Key Employees and Managing Growth
- Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
- Risks Related to Intellectual Property
The other 32 risks
- If we are unable to adequately protect our proprietary technology and product candidate, if the scope of the patent protection obtained is not sufficiently broad, or if the terms of our patents are insufficient to protect our product candidate for an adequate amount of time, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our product candidate may be materially impaired.
- We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful.
- Our commercial success depends significantly on our ability to operate without infringing upon the intellectual property rights of third parties.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position may be harmed.
- Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our existing and future product candidates and processes.
- If we do not obtain patent term extensions in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation with respect to our product candidate, thereby potentially extending the term of marketing exclusivity for such product candidate, our business may be harmed.
- Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, 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.
- If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
- We may not be able to adequately protect our intellectual property rights throughout the world.
- 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 product candidate.
- Patent terms may be inadequate to protect our competitive position on our product candidate for an adequate amount of time.
- Intellectual property rights do not necessarily address all potential threats to our business.
- We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of their former employers or other third parties.
- Our intellectual property agreements with third parties may be subject to disagreements over contract interpretation, which could narrow the scope of our rights to the relevant intellectual property or technology.
- Risks Related to the Nova Acquisition
- Our stockholders may not realize a benefit from our acquisition (the "Nova Acquisition") of Nova Pharmaceuticals, Inc. ("Nova") commensurate with the ownership dilution they may experience in connection with the Nova Acquisition upon conversion of preferred stock issued in connection therewith.
- Other Risks Related to Our Business
- The successful commercialization of our product candidate will depend in part on the extent to which third-party payors, including governmental authorities and private health insurers, provide coverage and adequate reimbursement levels, as well as implement pricing policies favorable for our product candidate.
- Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations, customers and others will be subject to applicable healthcare regulatory laws, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens, and diminished profits and future earnings.
- Unfavorable U.S. and global economic conditions could adversely affect our business, financial condition or results of operations.
- Our business and operations may suffer in the event of information technology system failures, cyberattacks or deficiencies in our cybersecurity.
- Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business, results of operations, and financial condition.
- Violations of or liabilities under environmental, health and safety laws and regulations could subject us to fines, penalties or other costs that could have a material adverse effect on the success of our business.
- Insurance policies are expensive and protect us only from some business risks, which leaves us exposed to uninsured liabilities.
- Our employees and independent contractors, including consultants, vendors, and any third parties we may engage in connection with development and commercialization may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could harm our business.
- We or the third parties upon whom we depend may be adversely affected by natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
- Our ability to use our net operating losses to offset future taxable income is subject to certain limitations.
- Risks Related to Our Common Stock
- Our common stock is currently quoted on the OTCQB Market, which may have an unfavorable impact on our stock price and liquidity.
- Our directors, officers and principal stockholders own a significant percentage of our stock and, if they choose to act together, are able to exercise influence over matters submitted to stockholders for approval.
- We are a “smaller reporting company” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.
- Provisions in our amended and restated certificate of incorporation and amended and restated bylaws and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
- Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.
- The price of our common stock is likely to be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock.
- Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in dilution of the percentage ownership of our stockholders and could cause our common stock price to fall.
Legal proceedings
From time to time, we may be involved in claims and proceedings arising in the course of our business. The outcome of any such claim or proceeding, regardless of the merits, is inherently uncertain.
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.
- 1
- 2
- 3
- 4
- 5
- 6
- 7
- 8
- 9
- 10
- 11
- 12
- 13
- 14
- 15
- 16
- 17
- 18SEC EDGARJennifer Evans Stacey, Officer
- 19
- 20
- 21
- 22
- 23
- 24SEC EDGARNancy T. Chang, Board member
- 25SEC EDGARLinda West, Board member
- 26SEC EDGAREmmett Cunningham, Board member
- 27SEC EDGARJason Fuller, Board member
- 28SEC EDGARKevin G. Lokay, Board member
- 29SEC EDGARLawrence M. Alleva, Board member
- 30
- 31
- 32
- 33
- 34SEC EDGAROther events
- 35SEC EDGAROther events
- 36SEC EDGARBylaws or fiscal year changed
- 37SEC EDGARShareholder vote
- 38
- 39SEC EDGAROther events
- 40SEC EDGAROther events
- 41SEC EDGARBylaws or fiscal year changed
- 42SEC EDGARExecutive or director change
- 43
- 44
- 45
- 46
- 47
- 48
- 49
- 50
- 51
- 52
- 53
- 54
- 55
- 56
- 57
- 58
- 59
- 60
- 61
- 62
- 63
- 64
- 65
- 66
- 67
- 68
- 69
- 70
- 71