ACXP on Nasdaq
Acurx Pharmaceuticals, Inc.
In its 2026 annual report the company says: “Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. Our approach is to develop antibiotic candidates with a Gram-positive selective spectrum that block the active site of the Gram positive specific bacterial enzyme deoxyribonucleic acid polymerase IIIC, inhibiting DNA replication and leading to Gram-positive bacterial cell death.”4 It is headquartered in Wilmington, United States.2 Its shares trade on Nasdaq under the symbol ACXP.2
Price unavailable
Last updated Oct 21, 2026.
Overview
- TickerACXP on Nasdaq2
- IndustryPharmaceutical Preparations2
- HeadquartersWilmington, United States2
- Incorporated inDE3
- Business address259 Liberty Avenue, Staten Island, Ny 103053
- Filer categoryNon-accelerated filer, Smaller reporting company, Emerging growth company3
- Legal formCorporation2
- LEI5493006KI0IEUHE1UK562
- StatusActive2
- LEI statusIssued and current2
- Registered addressc/o CORPORATION SERVICE COMPANY, 251 LITTLE FALLS DRIVE, 19808 Wilmington, United States2
- Registered withDivision of Corporations, Department of State, 64845772
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Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. Our approach is to develop antibiotic candidates with a Gram-positive selective spectrum (“GPSS®”) that block the active site of the Gram positive specific bacterial enzyme deoxyribonucleic acid (“DNA”) polymerase IIIC (“pol IIIC”), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Our research and development (“R&D”) pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile (“C. difficile ”), methicillin-resistant Staphylococcus aureus (“MRSA”), vancomycin resistant Enterococcus (“VRE”) and drug-resistant Streptococcus pneumoniae (“DRSP”) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen).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
Every line of the income statement as filed: the last 2 fiscal years, latest first.5
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Research and Development | $1.8M | $5.4M |
| General and Administrative | $6.3M | $8.7M |
| TOTAL OPERATING EXPENSES | $8.1M | $14.1M |
| OPERATING LOSS | -$8.1M | -$14.1M |
| Interest Income | $125.4K | $20.1K |
| NET LOSS | -$8.0M | -$14.1M |
| Basic net loss per common share | -$5.32 | -$17.45 |
| Diluted net loss per common share | -$5.32 | -$17.45 |
| Weighted average common shares outstanding basic | 1.5M shares | 808.2K shares |
| Weighted average common shares outstanding diluted | 1.5M shares | 808.2K shares |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 5 fiscal years (annual) or 5 quarters (quarterly), latest first.5
| Period ending | 2025-12-31 | 2025-09-30 | 2024-12-31 | 2023-12-31 | 2021-06-30 |
|---|---|---|---|---|---|
| Cash | $7.6M | $3.7M | |||
| Other Receivable | $48.4K | $51.1K | |||
| Prepaid Expenses | $85.0K | $100.1K | |||
| TOTAL ASSETS | $7.7M | $3.9M | |||
| Accounts Payable and Accrued Expenses | $2.4M | $3.2M | |||
| TOTAL CURRENT LIABILITIES | $2.4M | $3.2M | |||
| TOTAL LIABILITIES | $2.4M | $3.2M | |||
| Common Stock; $0.001 par value, 250,000,000 shares authorized, 2,348,113 shares issued and outstanding at December 31, 2025 and 200,000,000 shares authorized, 851,534 shares issued and outstanding at December 31, 2024 | $2.3K | $852 | |||
| Additional Paid-In Capital | $80.6M | $67.9M | |||
| Accumulated Deficit | -$75.3M | -$67.3M | |||
| TOTAL SHAREHOLDERS' EQUITY | $5.3M | $615.1K | $4.7M | ||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $7.7M | $3.9M | |||
| Preferred stock, par value | $0.00 | $0.00 | $0.00 | ||
| Preferred stock, shares authorized (in shares) | 10.0M shares | 10.0M shares | 10.0M shares | ||
| Preferred Stock, shares issued (in shares) | 0 shares | 0 shares | |||
| Preferred stock, shares outstanding (in shares) | 0 shares | 0 shares | |||
| Common stock, par value | $0.00 | $0.00 | $0.00 | ||
| Common stock, authorized (in shares) | 250.0M shares | 250.0M shares | 200.0M shares | 250.0M shares | |
| Common stock, Issued (in shares) | 2.3M shares | 851.5K shares | |||
| Common stock, outstanding (in shares) | 2.3M shares | 851.5K shares |
| Period ending | 2025-12-31 | 2025-09-30 | 2024-12-31 | 2023-12-31 | 2021-06-30 |
|---|---|---|---|---|---|
| Cash | $7.6M | $3.7M | |||
| Other Receivable | $48.4K | $51.1K | |||
| Prepaid Expenses | $85.0K | $100.1K | |||
| TOTAL ASSETS | $7.7M | $3.9M | |||
| Accounts Payable and Accrued Expenses | $2.4M | $3.2M | |||
| TOTAL CURRENT LIABILITIES | $2.4M | $3.2M | |||
| TOTAL LIABILITIES | $2.4M | $3.2M | |||
| Common Stock; $0.001 par value, 250,000,000 shares authorized, 2,348,113 shares issued and outstanding at December 31, 2025 and 200,000,000 shares authorized, 851,534 shares issued and outstanding at December 31, 2024 | $2.3K | $852 | |||
| Additional Paid-In Capital | $80.6M | $67.9M | |||
| Accumulated Deficit | -$75.3M | -$67.3M | |||
| TOTAL SHAREHOLDERS' EQUITY | $5.3M | $615.1K | $4.7M | ||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $7.7M | $3.9M | |||
| Preferred stock, par value | $0.00 | $0.00 | $0.00 | ||
| Preferred stock, shares authorized (in shares) | 10.0M shares | 10.0M shares | 10.0M shares | ||
| Preferred Stock, shares issued (in shares) | 0 shares | 0 shares | |||
| Preferred stock, shares outstanding (in shares) | 0 shares | 0 shares | |||
| Common stock, par value | $0.00 | $0.00 | $0.00 | ||
| Common stock, authorized (in shares) | 250.0M shares | 250.0M shares | 200.0M shares | 250.0M shares | |
| Common stock, Issued (in shares) | 2.3M shares | 851.5K shares | |||
| Common stock, outstanding (in shares) | 2.3M shares | 851.5K shares |
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.5
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net Loss | -$8.0M | -$14.1M |
| Share-Based Compensation | $1.2M | $2.6M |
| Share-Based Payments to Vendors | $322.3K | $833.7K |
| Other Receivable | $2.7K | $78.0K |
| Prepaid Expenses | $15.1K | $5.7K |
| Accounts Payable and Accrued Expenses | -$408.8K | $200.4K |
| Net Cash Used in Operating Activities | -$6.8M | -$10.4M |
| Reverse Stock Split fractional share adjustment | -$1.0K | |
| Proceeds from Warrant Inducement, net of issuance costs | $2.5M | |
| Proceeds from Warrant Exercise | $1.4M | $210.2K |
| Proceeds from issuance of common stock in connection with equity line of credit purchase agreement, net of issuance costs | $3.8M | |
| Proceeds from 2025 March Registered Direct Offering, net of issuance costs | $889.4K | |
| Proceeds from 2025 January Registered Direct Offering, net of issuance costs | $2.1M | |
| Proceeds from At-the-Market Offering, net of issuance costs | $6.4M | |
| Net Cash Provided by Financing Activities | $10.6M | $6.6M |
| Net Increase/(Decrease) in Cash | $3.8M | -$3.8M |
| Share-Based Compensation to settle accrued compensation (Note 5) | $413.1K | |
| 2025 Equity Line of Credit Purchase Agreement costs (Commitment shares)(Note 4) | $360.0K | |
| 2025 Warrant Inducement Financing costs (Note 4) | $4.6M |
No quarter-by-quarter statement was filed.
Corporate structure
Acurx Pharmaceuticals, 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 Acurx Pharmaceuticals, Inc.
- ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G/A on Acurx Pharmaceuticals, Inc., latest Nov 14, 2025 (5 filings since Feb 14, 2023)
- Acurx Pharmaceuticals, Inc. Wilmington, Delaware, United States
Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Acurx Pharmaceuticals, 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.
Properties, in its own words
Our headquarters is located in Staten Island, New York, where we lease a total of approximately 150 square feet of office.
Item 2 of the 10-K filed Mar 12, 2026.4
Leadership
Who has led Acurx Pharmaceuticals, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
- Chief executive officerDavid P. Luci Jun 24, 2021 to now12
- PresidentDavid P. Luci Jun 24, 2021 to now12
- Chief financial officerRobert G. Shawah Jun 24, 2021 to now13
Board members and other officers (6)
- Board memberCarl Sailer Jun 24, 2021 to now14
- Board memberDavid P. Luci Jun 24, 2021 to now12
- Board memberJack H. Dean Jun 24, 2021 to now15
- Board memberJames J. Donohue Jun 24, 2021 to now16
- Board memberJoseph C. Scodari Jun 24, 2021 to now17
- Board memberRobert J. Deluccia Jun 24, 2021 to now18
Named in SEC Form D filings
People the company listed in its private-offering notices.
- DirectorThomas H. Harrison named Jan 17, 2025 to Apr 29, 202619
Former names
- Acurx Pharmaceuticals, LLCApr 3, 2018 to Jun 23, 20213
Timeline
- Apr 16, 20268-K Entered a material agreement; Unregistered sale of shares; Other events20
- Mar 9, 20268-K Executive or director change; Other events21
- Sep 22, 20258-K Bylaws or fiscal year changed22
- Sep 19, 20258-K Shareholder vote23
- Jul 31, 20258-K Change to shareholders' rights; Bylaws or fiscal year changed; Other events24
- Jul 17, 20258-K Shareholder vote25
- Jun 20, 20258-K Entered a material agreement; Unregistered sale of shares; Other events26
- May 13, 20258-K Results of operations27
- May 8, 20258-K Entered a material agreement; Unregistered sale of shares28
- Mar 28, 20258-K Listing notice or transfer29
- Mar 18, 20258-K Results of operations30
- Mar 10, 20258-K Entered a material agreement; Unregistered sale of shares; Other events31
- Jun 24, 2021New chief executive David P. Luci becomes CEO12
- Jul 19, 2017Founded Acurx Pharmaceuticals, Inc. is founded2
Calendar
Coming up
- Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($1.23) a share, on Nov 12, 2025.32
When it reported results
- May 13, 2025Reported quarterly or annual results27
- Mar 18, 2025Reported quarterly or annual results30
- Nov 13, 2024Reported quarterly or annual results33
- Aug 9, 2024Reported quarterly or annual results34
- May 15, 2024Reported quarterly or annual results35
- Mar 18, 2024Reported quarterly or annual results36
- Nov 14, 2023Reported quarterly or annual results37
- Aug 14, 2023Reported quarterly or annual results38
Drug trials and FDA: coming up
- Sep 29, 2027Phase 2 trial readout expected Phase 2 trial of Ibezapolstat in Clostridium Difficile Infection Recurrence: primary completion expected Sep 29, 2027 (ClinicalTrials.gov NCT07513285).39
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar
Filings
200 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 34 major events, 42 insider forms, 5 large holders, 5 private raises, 94 other. The latest 20:
- Sep 17, 2026EFFECT EDGAR
- Sep 17, 2026424B3 EDGAR
- Sep 8, 2026S-1 EDGAR
- Sep 1, 2026ARS EDGAR
- Sep 1, 2026DEFA14A EDGAR
- Sep 1, 2026DEF 14A EDGAR
- Aug 13, 202610-Q EDGAR
- May 12, 2026424B3 EDGAR
- May 12, 2026424B3 EDGAR
- May 11, 2026EFFECT EDGAR
- May 11, 2026EFFECT EDGAR
- May 11, 202610-Q EDGAR
- May 7, 2026CORRESP EDGAR
- May 7, 2026CORRESP EDGAR
- May 7, 2026UPLOAD EDGAR
- May 7, 2026UPLOAD EDGAR
- May 4, 2026S-1 EDGAR
- May 4, 2026S-1 EDGAR
- Apr 29, 2026D EDGAR
- Apr 22, 20264 OWNERSHIP DOCUMENT EDGAR
The 200 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
12 open-market trades by officers, directors and large owners since October 2021: 12 buys and 0 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Jan 6, 2025 | Scodari Joseph CDirector | Buy | 24,631 | $1.02 | $25.1K | Form 4 |
| Jan 6, 2025 | Sailer CarlDirector | Buy | 24,631 | $1.02 | $25.1K | Form 4 |
| Jan 6, 2025 | LUCI DAVID PPresident and CEO | Buy | 49,261 | $1.02 | $50.2K | Form 4 |
| Jan 6, 2025 | Donohue James J.Director | Buy | 9,852 | $1.02 | $10.0K | Form 4 |
| Jan 6, 2025 | DELUCCIA ROBERT JDirector | Buy | 49,261 | $1.02 | $50.2K | Form 4 |
| Jan 6, 2025 | DEAN JACK HDirector | Buy | 9,852 | $1.02 | $10.0K | Form 4 |
| Jul 27, 2022 | Sailer CarlDirector | Buy | 19,737 | $3.80 | $75.0K | Form 4 |
| Jul 27, 2022 | DELUCCIA ROBERT JDirector | Buy | 19,737 | $3.80 | $75.0K | Form 4 |
| Jul 27, 2022 | LUCI DAVID PPresident and CEO | Buy | 19,737 | $3.80 | $75.0K | Form 4 |
| Nov 23, 2021 | Sailer CarlDirector | Buy | 5,161 | $4.84 | $25.0K | Form 4 |
| Nov 19, 2021 | DELUCCIA ROBERT JDirector | Buy | 5,034 | $4.90 | $24.7K | Form 4 |
| Nov 19, 2021 | LUCI DAVID PPresident and CEO | Buy | 5,200 | $4.80 | $25.0K | 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, 5 filings Feb 14, 2023 to Nov 14, 202540
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 | Robert J. DeLuccia Executive Chairman | 81 | $550.0K | $771.7K41 |
| 2025 | David P. Luci President and Chief Executive Officer | 59 | $550.0K | $729.4K41 |
| 2025 | Robert G. Shawah Chief Financial Officer | $400.0K | $503.5K41 | |
| 2024 | Robert J. DeLuccia Executive Chairman | 81 | $539.2K | $1.5M41 |
| 2024 | David P. Luci President and Chief Executive Officer | 59 | $537.5K | $1.4M41 |
| 2024 | Robert G. Shawah Chief Financial Officer | $395.8K | $907.5K41 |
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) $14.3M
Figures by year
| Year | Private raises (Form D) | Total |
|---|---|---|
| 2026 | $4.6M | $4.6M |
| 2025 | $9.8M | $9.8M |
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.
- Apr 15, 2026Raised $4.6 million in a private offering of securities19 Form D: 5 investors so far Form D
- Jun 17, 2025Raised $4 million in a private offering of securities42 Form D: 1 investor so far Form D
- May 8, 2025Filed a private offering of equity43 Form D: $12 million offered in all Form D
- Mar 10, 2025Raised $3.4 million in a private offering of securities44 Form D: 6 investors so far Form D
- Jan 7, 2025Raised $2.4 million in a private offering of securities45 Form D: 12 investors so far Form D
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 | 31,099 | $48.2K | 0.0% | No change |
| Geode Capital Management, LLC | 26,411 | $40.9K | 0.0% | +1,592 |
| Vanguard Fiduciary Trust Co | 16,205 | $25.1K | 0.0% | No change |
| Jane Street Group, LLC | 15,727 | $24.4K | 0.0% | −38,915 |
| Prospect Financial Services LLC | 13,785 | $21.4K | 0.0% | No change |
| Morgan Stanley | 7,500 | $11.6K | 0.0% | +1,000 |
| Integrated Wealth Concepts LLC | 4,729 | $7.3K | 0.0% | New |
| Tower Research Capital LLC (TRC) | 2,744 | $4.3K | 0.0% | +1,713 |
| Wells Fargo & Company/mn | 2,300 | $3.6K | 0.0% | No change |
| Westside Investment Management, Inc. | 1,650 | $2.6K | 0.0% | No change |
| Lanark Financial, Inc. | 1,500 | $2.3K | 0.0% | No change |
| Barclays PLC | 281 | $436 | 0.0% | −99 |
| Cornerstone Planning Group LLC | 167 | $245 | 0.0% | No change |
| Osaic Holdings, Inc. | 100 | $155 | 0.0% | No change |
| Group One Trading LLC | 95 | $147 | 0.0% | −150 |
| BlackRock, Inc. | 60 | $93 | 0.0% | No change |
| Caitong International Asset Management Co., Ltd | 23 | $36 | 0.0% | New |
| SBI Securities Co., Ltd. | 6 | $9 | 0.0% | No change |
| UBS Group AG | 3 | $5 | 0.0% | −6,309 |
| NewEdge Advisors, LLC | 0 | $0 | 0.0% | New |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Acurx Pharmaceuticals, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARAcurx Pharmaceuticals, Inc.1
- CIK0001736243
- Employer ID (EIN)82-37335674
- Filer statusNon-accelerated filer 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 address259 Liberty Avenue, Staten Island, NY 103051
- Phone917-533-14691
- Shares outstanding5,269,921 as of Aug 13, 202611
- Public float$13.7M as of Jun 30, 20254
- AuditorCohnReznick LLP, Parsippany, NJ PCAOB ID 596; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceApr 3, 20181
- Filings243 in all: 4 (51), 8-K (36), 10-Q (16), CORRESP (14), EFFECT (14), S-1 (13), UPLOAD (13), 424B3 (10)1
All 35 form types
3 (8), D (7), 424B5 (6), DEF 14A (6), DEFA14A (6), S-8 (6), 10-K (5), ARS (4), D/A (3), PRE 14A (3), FWP (2), S-1/A (2), S-3 (2), SC 13D (2), SC 13G (2), 424B4 (1), 8-A12B (1), CERT (1), DRS (1), DRS/A (1), DRSLTR (1), POS AM (1), RW (1), S-3/A (1), SC 13G/A (1), SCHEDULE 13G (1), SCHEDULE 13G/A (1)
- Latest filingsAnnual report (10-K) Mar 12, 2026
Quarterly report (10-Q) Aug 13, 2026
Proxy statement (DEF 14A) Sep 1, 2026
Latest 8-K (8-K) Apr 16, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, $0.001 par value per share | ACXP | Nasdaq |
From the cover page of the 10-K filed Mar 12, 2026 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks Acurx Pharmaceuticals, Inc. names in Item 1A of its 10-K filed Mar 12, 2026: 54 risks under these headings, as written.4
- Risks Relating to Our Business
- We are a clinical-stage company and have a limited operating history, which may make it difficult to evaluate our current business and predict our future performance.
- We have incurred significant net losses in each period since our inception and anticipate that we will continue to incur net losses in for the foreseeable future and may never achieve or maintain profitability.
- Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern.
- We may need substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
- Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
- We are reliant on the success of our lead product candidate, ibezapolstat, which we are developing for the treatment of CDI. If we are unable to commercialize ibezapolstat, or experience significant delays in doing so, our business will be materially harmed.
- If serious adverse or inappropriate side effects are identified during the development of ibezapolstat or any other product candidate, we may need to abandon or limit our development of that product candidate.
- Ibezapolstat or our other product candidates may never achieve sufficient market acceptance even if we obtain regulatory approval.
- We are exposed to product liability, and non-clinical and clinical liability risks which could place a substantial financial burden upon us, should lawsuits be filed against us.
- Our current and future operations substantially depend on our management team and our ability to hire other key personnel, the loss of any of whom could disrupt our business operations.
- Our failure to complete or meet key milestones relating to the development of our technologies and proposed products and formulations would significantly impair our financial condition.
The other 43 risks
- We will compete with larger and better capitalized companies, and competitors in the drug development or pharmaceutical industries may develop competing products which outperform or supplant our proposed products.
- We may not be able to effectively manage our growth and expansion or implement our business strategies, in which case our business and results of operations may be materially and adversely affected.
- A pandemic, epidemic, or outbreak of an infectious disease, such as the COVID-19 pandemic, could materially and adversely affect our business.
- Global, market and economic conditions may negatively impact our business, financial condition and share price.
- Climate change or legal, regulatory or market measures to address climate change may negatively affect our business, results of operations, cash flows and prospects.
- The insurance coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for new or current products could limit our ability to market those products and decrease our ability to generate revenue.
- Because results of preclinical studies and early clinical trials are not necessarily predictive of future results, any product candidate we advance may not have favorable results in later clinical trials or receive regulatory approval. Moreover, interim, “top-line,” and preliminary data from our clinical trials that we announce or publish may change, or the perceived product profile may be negatively impacted, as more patient data or additional endpoints (including efficacy and safety) are analyzed.
- Risks Related to Regulatory Approval
- If clinical trials of our lead product candidate fail to demonstrate safety and efficacy to the satisfaction of the FDA, or the EMA, or do not otherwise produce favorable results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete the development and commercialization of ibezapolstat or any other product candidate.
- If we experience any of a number of possible unforeseen events in connection with our clinical trials, potential marketing approval or commercialization of our product candidates could be delayed or prevented.
- If we experience delays or difficulties in the enrollment of patients in our clinical trials, our receipt of necessary marketing approvals could be delayed or prevented.
- We may be unable to obtain regulatory approval in the United States or foreign jurisdictions and, as a result, be unable to commercialize our product candidates and our ability to generate revenue will be materially impaired.
- Even if we obtain regulatory approvals, our marketed drugs will be subject to ongoing regulatory oversight. If we or our collaborators or contractors fail to comply with continuing U.S. and foreign requirements, our approvals, if obtained, could be limited or withdrawn, we could be subject to other penalties, and our business would be seriously harmed.
- Our product candidates for which we obtain approval may face competition sooner than anticipated.
- Risks associated with operating in foreign countries could materially adversely affect our product development should we elect to extend development outside the U.S.
- Our results of operations may be adversely affected by current and potential future healthcare legislative and regulatory actions.
- Risks Related to Our Dependence on Third Parties
- If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product candidates, we may not be successful in commercializing ibezapolstat or any other product candidate if and when such product candidates are approved.
- We contract with third parties for the manufacture of our product candidates for preclinical studies and our ongoing clinical trials, and expect to continue to do so for additional clinical trials and ultimately for commercialization. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or drugs or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
- If ultimate users of our product candidates are unable to obtain adequate reimbursement from third-party payers, or if new restrictive legislation is adopted, market acceptance of our proposed products may be limited and we may not achieve material revenues.
- Our relationships with future customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
- Risks Related to Intellectual Property
- We may be involved in lawsuits to protect or enforce our patents.
- Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
- We may need to license certain intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
- If we are unable to adequately protect or enforce our rights to intellectual property or secure rights to third-party patents, we may lose valuable rights, experience reduced market share, assuming any, or incur costly litigation to enforce, maintain or protect such rights.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- Risks Related to Our Common Stock
- Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.
- Provisions in our corporate charter documents 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.
- We are an “emerging growth company,” and a “smaller reporting company” and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies and smaller reporting companies will make our common stock less attractive to investors.
- The price of our stock may be volatile, and you could lose all or part of your investment.
- Our largest stockholders will exercise significant influence over our company for the foreseeable future, including the outcome of matters requiring stockholder approval.
- 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.
- General Risk Factors
- The requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract and retain qualified board members.
- Cyber incidents or attacks directed at us could result in information theft, data corruption, operational disruption and/or financial loss.
- We may fail to comply with evolving privacy and data protection laws, which could adversely affect our business, results of operations and financial condition.
- Our issuance of additional capital stock in connection with potential future financings, acquisitions, investments, our stock incentive plans or otherwise will dilute all other stockholders.
- Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
- There may be limitations on the effectiveness of our internal controls, and a failure of our control systems to prevent error or fraud may materially harm us.
- The estimates and judgments we make, or the assumptions on which we rely, in preparing our financial statements could prove inaccurate.
- Failure to comply with the United States Foreign Corrupt Practices Act could subject us to penalties and other adverse consequences.
- Litigation may adversely affect our business, financial condition and results of operations.
- If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business.
- If securities or industry analysts do not publish research or reports about our business, or they publish negative reports about our business, our share price and trading volume could decline.
- Delaware law contains anti-takeover provisions that could deter takeover attempts that could be beneficial to our stockholders.
- Our certificate of incorporation and our bylaws provide that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
Legal proceedings
From time to time, we may become involved in litigation or other legal proceedings. We are not currently a party to any litigation or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
The opening of Item 3, Legal Proceedings.4
Sources
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- 14SEC EDGARCarl Sailer, Board member
- 15SEC EDGARJack H. Dean, Board member
- 16SEC EDGARJames J. Donohue, Board member
- 17SEC EDGARJoseph C. Scodari, Board member
- 18SEC EDGARRobert J. Deluccia, Board member
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- 22SEC EDGARBylaws or fiscal year changed
- 23SEC EDGARShareholder vote
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- 25SEC EDGARShareholder vote
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- 27SEC EDGARResults of operations
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- 29SEC EDGARListing notice or transfer
- 30SEC EDGARResults of operations
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- 32NasdaqNasdaq calendar
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