Overview
- TickerCNSP on Nasdaq2
- IndustryPharmaceutical Preparations2
- HeadquartersHouston, United States2
- Incorporated inNV3
- Business address2100 West Loop South, Suite 900, Houston, Tx 770273
- Filer categoryNon-accelerated filer, Smaller reporting company3
- Legal formCorporation2
- LEI529900FDJ7WGF2Q7UN442
- StatusActive2
- LEI statusIssued and current2
- Registered addressc/o Corporation Service Company, 112 North Curry Street, 89703 Carson City, United States2
- Registered withBusiness Center (Secretary of State), E0354342017-02
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Chimeric antigen receptor T-cell (“CAR-T”) therapy has achieved durable remissions in subsets of hematologic malignancies.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.10
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| General and administrative | $6.2M | $5.6M |
| Research and development | $9.8M | $9.3M |
| Total operating expenses | $16.0M | $14.9M |
| Loss from operations | -$16.0M | -$14.9M |
| Other expense | -$2.6K | $0 |
| Interest income | $153.8K | $60.3K |
| Interest expense | -$15.2K | -$16.1K |
| Total other income (expense) | $136.0K | $44.1K |
| Net loss | -$15.9M | -$14.9M |
| Loss per share - basic | -$35.75 | -$466.89 |
| Loss per share - diluted | -$35.75 | -$466.89 |
| Weighted average shares outstanding - basic | 443.4K shares | 31.8K shares |
| Weighted average shares outstanding - diluted | 443.4K shares | 31.8K 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.10
| Period ending | 2025-12-31 | 2025-11-30 | 2025-07-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|---|---|
| Cash and cash equivalents | $7.2M | $6.5M | |||
| Deferred offering costs | $45.5K | $20.6K | |||
| Subscription receivable | $0 | $882.5K | |||
| Prepaid expenses and other current assets | $856.3K | $1.3M | |||
| Total current assets | $8.1M | $8.7M | |||
| Prepaid expenses, net of current portion | $503.0K | $36.4K | |||
| Property and equipment, net | $17.7K | $6.0K | |||
| Total noncurrent assets | $520.7K | $42.4K | |||
| Total Assets | $8.6M | $8.7M | |||
| Accounts payable and accrued expenses | $3.8M | $2.2M | |||
| Notes payable | $328.6K | $326.1K | |||
| Total current liabilities | $4.1M | $2.5M | |||
| Total Liabilities | $4.1M | $2.5M | |||
| Preferred stock, $0.001 par value, 5,000,000 shares authorized and 0 shares issued and outstanding | $0 | $0 | |||
| Common stock, $0.001 par value, 300,000,000 shares authorized and 632,516 and 117,796 shares issued and outstanding, respectively | $633 | $118 | |||
| Additional paid-in capital | $104.8M | $90.6M | |||
| Accumulated deficit | -$100.3M | -$84.4M | |||
| Total Stockholders' Equity (Deficit) | $4.5M | $6.2M | -$4.4M | ||
| Total Liabilities and Stockholders' Equity (Deficit) | $8.6M | $8.7M | |||
| Preferred stock, par value | $0.00 | $0.00 | |||
| Preferred stock, shares authorized | 5.0M shares | 5.0M shares | 416.7K shares | 5.0M shares | |
| Preferred stock, shares issued | 0 shares | 0 shares | |||
| Preferred stock, shares outstanding | 0 shares | 0 shares | |||
| Common stock, par value | $0.00 | $0.00 | |||
| Common stock, shares authorized | 300.0M shares | 300.0M shares | 25.0M shares | 300.0M shares | |
| Common stock, shares issued | 632.5K shares | 117.8K shares | |||
| Common stock, shares outstanding | 632.5K shares | 117.8K shares |
| Period ending | 2025-12-31 | 2025-11-30 | 2025-07-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|---|---|
| Cash and cash equivalents | $7.2M | $6.5M | |||
| Deferred offering costs | $45.5K | $20.6K | |||
| Subscription receivable | $0 | $882.5K | |||
| Prepaid expenses and other current assets | $856.3K | $1.3M | |||
| Total current assets | $8.1M | $8.7M | |||
| Prepaid expenses, net of current portion | $503.0K | $36.4K | |||
| Property and equipment, net | $17.7K | $6.0K | |||
| Total noncurrent assets | $520.7K | $42.4K | |||
| Total Assets | $8.6M | $8.7M | |||
| Accounts payable and accrued expenses | $3.8M | $2.2M | |||
| Notes payable | $328.6K | $326.1K | |||
| Total current liabilities | $4.1M | $2.5M | |||
| Total Liabilities | $4.1M | $2.5M | |||
| Preferred stock, $0.001 par value, 5,000,000 shares authorized and 0 shares issued and outstanding | $0 | $0 | |||
| Common stock, $0.001 par value, 300,000,000 shares authorized and 632,516 and 117,796 shares issued and outstanding, respectively | $633 | $118 | |||
| Additional paid-in capital | $104.8M | $90.6M | |||
| Accumulated deficit | -$100.3M | -$84.4M | |||
| Total Stockholders' Equity (Deficit) | $4.5M | $6.2M | -$4.4M | ||
| Total Liabilities and Stockholders' Equity (Deficit) | $8.6M | $8.7M | |||
| Preferred stock, par value | $0.00 | $0.00 | |||
| Preferred stock, shares authorized | 5.0M shares | 5.0M shares | 416.7K shares | 5.0M shares | |
| Preferred stock, shares issued | 0 shares | 0 shares | |||
| Preferred stock, shares outstanding | 0 shares | 0 shares | |||
| Common stock, par value | $0.00 | $0.00 | |||
| Common stock, shares authorized | 300.0M shares | 300.0M shares | 25.0M shares | 300.0M shares | |
| Common stock, shares issued | 632.5K shares | 117.8K shares | |||
| Common stock, shares outstanding | 632.5K shares | 117.8K 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.10
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$15.9M | -$14.9M |
| Stock-based compensation | $187.7K | $839.0K |
| Depreciation | $3.9K | $3.3K |
| Common stock issued for license agreement | $0 | $596.3K |
| Loss (gain) on disposal of fixed assets | $2.6K | -$190 |
| Prepaid expenses and other current assets | $302.8K | -$60.0K |
| Accounts payable and accrued expenses | $1.5M | -$3.6M |
| Net cash used in operating activities | -$13.8M | -$17.1M |
| Purchase of property and equipment | -$18.2K | -$4.2K |
| Net cash used in investing activities | -$18.2K | -$4.2K |
| Payments of deferred offering costs | -$64.1K | -$66.8K |
| Payments on notes payable | -$297.6K | -$300.8K |
| Stock repurchased during stock split rounding | -$2.0K | $0 |
| Proceeds from subscription receivable | $882.5K | $0 |
| Proceeds from exercise of warrants | $3.6K | $21.3K |
| Proceeds from sale of common stock | $14.0M | $23.4M |
| Net cash provided by financing activities | $14.6M | $23.0M |
| Net change in cash and cash equivalents | $739.6K | $5.9M |
| Cash paid for interest | $15.3K | $13.6K |
| Cash paid for income taxes | $0 | $0 |
| Prepaid expense financed with note payable | $360.2K | $326.1K |
| Reclassification of deferred offering costs to equity | $39.2K | $249.0K |
| Common stock issued for subscription receivable | $0 | $882.5K |
| Stock issued for stock split rounding | $0 | $2 |
No quarter-by-quarter statement was filed.
Corporate structure
CNS 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 CNS Pharmaceuticals, Inc.
- Ikarian Capital, LLC Filed SCHEDULE 13G/A on CNS Pharmaceuticals, Inc., latest Aug 14, 2026 (2 filings since Apr 17, 2026)
- Stonepine Capital Management, LLC Filed SCHEDULE 13G/A on CNS Pharmaceuticals, Inc., latest May 15, 2026 (3 filings since Nov 4, 2025)
- ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G/A on CNS Pharmaceuticals, Inc., latest Nov 14, 2025 (5 filings since Feb 14, 2023)
- Cortice Biosciences, Inc. Filed SC 13D on CNS Pharmaceuticals, Inc., latest Aug 2, 2024
- Robert Forster Filed SC 13G on CNS Pharmaceuticals, Inc., latest Jul 2, 2024 (2 filings since Jun 25, 2024)
- Waldemar Priebe Filed SC 13G on CNS Pharmaceuticals, Inc., latest Aug 1, 2023
- CNS Pharmaceuticals, Inc. Houston, Texas, 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 CNS 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.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, net | $17.7K10 Dec 31, 2025 | $6.0K10 Dec 31, 2024 | +194.8% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $7.2M10 Dec 31, 2025 | $6.5M10 Dec 31, 2024 | +11.4% |
Properties, in its own words
Our corporate and executive offices are located in a leased facility in Houston, Texas. We believe our facilities are sufficient to meet our current needs and that suitable space will be available as and when needed. We do not own any real property.
Item 2 of the 10-K filed Mar 31, 2026.4
Leadership
Who has led CNS Pharmaceuticals, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
- Chief executive officerRami Levin Jan 2, 2026 to now13
- Chief executive officerJohn M. Climaco Nov 8, 2019 to Jan 2, 202614
- PresidentRami Levin Jan 2, 2026 to now13
- Chief financial officerSteve O'Loughlin Mar 4, 2026 to now15
Board members and other officers (11)
- Chief Technology OfficerEric Faulkner Mar 4, 2026 to now16
- Board memberRami Levin Jan 2, 2026 to now13
- Board memberMichal Fisher Aug 18, 2026 to now17
- Board memberAmy Mahery Feb 6, 2024 to now18
- Board memberFaith L. Charles Jan 4, 2023 to now19
- Board memberBettina M. Cockroft May 9, 2023 to now20
- Board memberAndrzej Andraczke Nov 8, 2019 to Oct 12, 202321
- Board memberCarl Anthony Evans Nov 8, 2019 to Apr 10, 202422
- Board memberJeffry R. Keyes Nov 8, 2019 to now23
- Board memberJerzy Gumulka Nov 8, 2019 to now24
- Board memberJohn M. Climaco Nov 8, 2019 to now14
Timeline
- Oct 2, 20268-K Executive or director change; Shareholder vote25
- Jul 2, 20268-K Regulation FD disclosure26
- May 4, 20268-K Entered a material agreement; Unregistered sale of shares; Executive or director change27
- Mar 11, 20268-K Regulation FD disclosure28
- Mar 2, 20268-K Executive or director change29
- Feb 17, 20268-K Executive or director change30
- Jan 2, 2026New chief executive Rami Levin becomes CEO13
- Dec 17, 20258-K Executive or director change31
- Nov 21, 20258-K Executive or director change; Bylaws or fiscal year changed; Shareholder vote32
- Jul 22, 20258-K Change to shareholders' rights; Bylaws or fiscal year changed; Other events33
- Jul 15, 20258-K Regulation FD disclosure34
- May 15, 20258-K Entered a material agreement35
- Apr 9, 20258-K Regulation FD disclosure36
- Nov 8, 2019New chief executive John M. Climaco becomes CEO14
- Jul 27, 2017Founded CNS Pharmaceuticals, Inc. is founded2
Calendar
Coming up
- Nov 13, 2026Reports results for the quarter ending Sep/202637
When it reported results
- May 16, 2024Reported quarterly or annual results38
- Apr 1, 2024Reported quarterly or annual results39
- Nov 15, 2023Reported quarterly or annual results40
- Aug 14, 2023Reported quarterly or annual results41
- May 15, 2023Reported quarterly or annual results42
- Aug 15, 2022Reported quarterly or annual results43
- May 16, 2022Reported quarterly or annual results44
- Mar 3, 2022Reported quarterly or annual results45
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
280 filings to the SEC since October 2021: 9 annual reports, 15 quarterly reports, 72 major events, 71 insider forms, 14 large holders, 1 private raises, 98 other. The latest 20:
- Oct 2, 20268-K EDGAR
- Aug 25, 2026DEFA14A EDGAR
- Aug 21, 2026DEF 14A DEFINITIVE NOTICE AND PROXY STATEMENT EDGAR
- Aug 18, 20264 EDGAR
- Aug 18, 20264 EDGAR
- Aug 18, 20263 EDGAR
- Aug 14, 2026SCHEDULE 13G/A EDGAR
- Aug 12, 202610-Q FORM 10-Q FOR JUN 2026 EDGAR
- Jul 2, 20268-K EDGAR
- May 26, 2026EFFECT EDGAR
- May 26, 2026424B3 424B3 PROSPECTUS EDGAR
- May 22, 2026CORRESP EDGAR
- May 22, 2026UPLOAD EDGAR
- May 20, 20264 EDGAR
- May 19, 2026D EDGAR
- May 19, 2026S-3 FORM S-3 REGISTRATION STATEMENT EDGAR
- May 15, 2026SCHEDULE 13G/A EDGAR
- May 14, 202610-Q FORM 10-Q FOR MAR 2026 EDGAR
- May 4, 20268-K EDGAR
- Apr 30, 202610-K/A AMENDMENT #1 TO FORM 10-K EDGAR
The 280 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
31 open-market trades by officers, directors and large owners since October 2021: 14 buys and 17 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| May 18, 2026 | Fisher MichalDirector | Buy | 2,000 | $5.00 | $10.0K | Form 4 |
| May 18, 2026 | Charles Faith L.Director | Buy | 7,100 | $4.79 | $34.0K | Form 4 |
| Feb 1, 2024 | Gumulka JerzyDirector | Buy | 33,333 | $0.30 | $10.0K | Form 4 |
| Feb 1, 2024 | Evans Carl AnthonyDirector | Buy | 33,333 | $0.30 | $10.0K | Form 4 |
| Feb 1, 2024 | Downs ChristopherChief Financial Officer | Buy | 66,666 | $0.30 | $20.0K | Form 4 |
| Feb 1, 2024 | Climaco John MChief Executive Officer | Buy | 166,666 | $0.30 | $50.0K | Form 4 |
| Aug 22, 2023 | Downs ChristopherChief Financial Officer | Buy | 27,000 | $1.27 | $34.3K | Form 4 |
| Aug 16, 2023 | Climaco John MChief Executive Officer | Buy | 2,750 | $1.80 | $5.0K | Form 4 |
| Apr 19, 2023 | Gumulka JerzyDirector | Buy | 2,500 | $1.70 | $4.2K | Form 4 |
| Apr 17, 2023 | Downs ChristopherChief Financial Officer | Buy | 3,100 | $3.20 | $9.9K | Form 4 |
| Apr 12, 2023 | Climaco John MChief Executive Officer | Buy | 15,000 | $0.69 | $10.3K | Form 4 |
| Apr 10, 2023 | Gumulka JerzyDirector | Buy | 7,173 | $0.74 | $5.3K | Form 4 |
| Mar 28, 2023 | Priebe Waldemar10% owner | Sale | 10,000 | $1.04 | $10.4K | Form 4 |
| Mar 27, 2023 | Priebe Waldemar10% owner | Sale | 5,000 | $1.09 | $5.5K | Form 4 |
| Mar 24, 2023 | Priebe Waldemar10% owner | Sale | 5,000 | $1.08 | $5.4K | Form 4 |
| Mar 23, 2023 | Priebe Waldemar10% owner | Sale | 10,000 | $1.08 | $10.8K | Form 4 |
| Mar 22, 2023 | Priebe Waldemar10% owner | Sale | 5,000 | $1.08 | $5.4K | Form 4 |
| Mar 21, 2023 | Priebe Waldemar10% owner | Sale | 5,000 | $1.10 | $5.5K | Form 4 |
| Mar 20, 2023 | Priebe Waldemar10% owner | Sale | 5,000 | $1.08 | $5.4K | Form 4 |
| Mar 17, 2023 | Priebe Waldemar10% owner | Sale | 5,000 | $1.13 | $5.7K | Form 4 |
All 31 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 Apr 17, 2026 to Aug 14, 202646
- Stonepine Capital Management, LLCSCHEDULE 13G/A, 3 filings Nov 4, 2025 to May 15, 202647
- ARMISTICE CAPITAL, LLCSCHEDULE 13G/A, 5 filings Feb 14, 2023 to Nov 14, 202548
- Cortice Biosciences, Inc.SC 13D, 1 filing Aug 2, 202449
- Robert ForsterSC 13G, 2 filings Jun 25, 2024 to Jul 2, 202450
- Waldemar PriebeSC 13G, 1 filing Aug 1, 202351
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 | John ClimacoFormer Chief Executive Officer | $580.0K | $1.2M52 | |
| 2025 | Christopher DownsSenior Vice President – Finance, (Former Chief Financial Officer) | $450.0K | $728.8K52 | |
| 2025 | Sandra SilbermanFormer Chief Medical Officer | $495.0K | $720.8K52 | |
| 2024 | John ClimacoFormer Chief Executive Officer | $525.0K | $1.1M52 | |
| 2024 | Christopher DownsSenior Vice President – Finance, (Former Chief Financial Officer) | $340.0K | $621.0K52 | |
| 2024 | Sandra SilbermanFormer Chief Medical Officer | $200.0K | $361.6K52 |
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) $22.5M
Figures by year
| Year | Private raises (Form D) | Total |
|---|---|---|
| 2026 | $22.5M | $22.5M |
Private raises
Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026. Change is in shares since the quarter before.
| Fund | Shares | Value | Share of the fund | Change |
|---|---|---|---|---|
| Ikarian Capital, LLC | 135,830 | $649.3K | 0.1% | +90,000 |
| ADAR1 Capital Management, LLC | 70,000 | $334.6K | 0.0% | New |
| Stonepine Capital Management, LLC | 41,573 | $198.7K | 0.2% | −19,427 |
| Boothbay Fund Management, LLC | 13,524 | $64.6K | 0.0% | No change |
| Vanguard Fiduciary Trust Co | 10,226 | $48.9K | 0.0% | New |
| Vanguard Capital Management LLC | 6,993 | $33.4K | 0.0% | New |
| UBS Group AG | 1,461 | $7.0K | 0.0% | +732 |
| Tower Research Capital LLC (TRC) | 799 | $3.8K | 0.0% | −511 |
| Barclays PLC | 19 | $91 | 0.0% | New |
| Barrett & Company, Inc. | 8 | $38 | 0.0% | No change |
| Danske Bank A/s | 1 | $5 | 0.0% | No change |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How CNS 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 EDGARCNS Pharmaceuticals, Inc.1
- CIK0001729427
- Employer ID (EIN)82-23185454
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; a shell company4
- Incorporated inNevada4
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address2100 West Loop South, Suite 900, Houston, TX 770271
- Phone1-800-946-91851
- Shares outstanding1,461,449 as of Aug 11, 202612
- Public float$5.0M as of Jun 30, 20254
- AuditorMaloneBailey, LLP, Houston, Texas PCAOB ID 206; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceMar 13, 20181
- Filings390 in all: 8-K (100), 4 (68), CORRESP (43), 10-Q (21), 3 (15), EFFECT (12), UPLOAD (12), S-1/A (10)1
All 43 form types
424B5 (8), DEF 14A (8), S-1 (8), 10-K (7), 4/A (7), 10-K/A (6), 424B3 (5), 424B4 (5), PRE 14A (5), S-3 (5), SC 13G (4), SCHEDULE 13G/A (4), 1-A/A (3), 8-K/A (3), DRS (3), FWP (3), S-8 (3), SCHEDULE 13G (3), DEFA14A (2), SC 13G/A (2), 1-A (1), 1-A-W (1), 8-A12B (1), ARS (1), C (1), C-AR (1), C-TR (1), C-U (1), CERT (1), D (1), DEFR14A (1), DOS (1), DRSLTR (1), RW (1), SC 13D (1)
- Latest filingsAnnual report (10-K) Mar 31, 2026
Quarterly report (10-Q) Aug 12, 2026
Proxy statement (DEF 14A) Aug 21, 2026
Latest 8-K (8-K) Oct 2, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock | CNSP | NASDAQ |
From the cover page of the 10-K filed Mar 31, 2026 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks CNS Pharmaceuticals, Inc. names in Item 1A of its 10-K filed Mar 31, 2026: 36 risks under these headings, as written.4
- Risks Related to the Company’s Business and Industry
- Our future success depends on our ability to identify, acquire or license new drug candidates, and we may not be successful in doing so.
- Any drug candidates we acquire or license may require significant additional development, and there can be no assurance that such candidates will prove to be safe, effective or commercially viable.
- We may not have access to sufficient capital to pursue acquisition or licensing opportunities, which could limit our ability to expand our pipeline.
- We will require substantial funding to execute our new corporate strategy, which may not be available to us on acceptable terms, or at all, and, if not so available, may require us to delay, limit, reduce or cease our operations.
- The report of our independent registered public accounting firm expresses substantial doubt about our ability to continue as a going concern. Such “going concern” opinion could impair our ability to obtain financing.
- We have never been profitable, we have no products approved for commercial sale, and we have not generated any revenue from product sales. As a result, our ability to reduce our losses and reach profitability is unproven, and we may never achieve or sustain profitability. Therefore, we may not be able to continue as a going concern.
- We have a limited operating history and we expect a number of factors to cause our operating results to fluctuate on an annual basis, which may make it difficult to predict our future performance.
- We cannot be certain that any of our future product candidates will receive regulatory approval, and without regulatory approval we will not be able to market or commercialize them.
- Delays in the commencement, enrollment and completion of clinical trials could result in increased costs to us and delay or limit our ability to obtain regulatory approval for our product candidates.
- We have never completed a clinical trial or submitted an NDA before, and any product candidate we advance through clinical trials may not have favorable results in later clinical trials or receive regulatory approval.
- If a future product candidate is found to be unsafe or ineffective, we will not be able to obtain regulatory approval for it and our business would be materially and possibly irreparably harmed.
The other 25 risks
- Interim or 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.
- Our product candidates may have undesirable side effects that may delay or prevent marketing approval, or, if approval is received, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales.
- If the FDA does not find the manufacturing facilities of our future contract manufacturers acceptable for commercial production, we may not be able to commercialize any of our product candidates, or such commercialization efforts may be delayed until we can contract with manufacturers with facilities acceptable to the FDA or other regulatory authorities.
- We have no sales, marketing or distribution experience and we will have to invest significant resources to develop those capabilities or enter into third-party sales and marketing arrangements, the problems with which could materially harm our business at any time.
- We may not be successful in establishing and maintaining development and commercialization collaborations, which could adversely affect our ability to develop certain of our product candidates and our financial condition and operating results.
- We face competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively.
- Our licensed U.S. patents for Berubicin have expired and our licensed U.S. patents for TPI 287 will expire before commercialization is reasonably possible, and the expiration of our patents may subject us to increased competition, and the Orphan Drug Designations for TPI 287 and Berubicin will not bar approval of other similar products under certain circumstances.
- We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights.
- We may be subject to claims that our employees and contractors have wrongfully used or disclosed alleged trade secrets of their former employers.
- If we are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of our technology and products could be significantly diminished.
- We will need to expand our operations and increase the size of our Company, and we may experience difficulties in managing growth.
- We may not be able to manage our business effectively if we are unable to attract and retain key personnel and consultants.
- We do not expect that our insurance policies will cover all of our business exposures thus leaving us exposed to significant uninsured liabilities.
- Although dependent on certain key personnel, we do not have any key man life insurance policies on any such people.
- There may be limited suppliers for active pharmaceutical ingredients (“API”) used in our drug candidates. Problems with the third parties that manufacture the API used in our drug candidates, or in the supply chain between the manufacturer and CNS, may delay our clinical trials or subject us to liability.
- We may not be able to recover from any catastrophic event affecting our suppliers.
- We may be materially adversely affected in the event of cyber-based attacks, network security breaches, service interruptions, or data corruption.
- Our cash and cash equivalents could be adversely affected if the financial institutions in which we hold our cash and cash equivalents fail.
- Risks Related to Our Common Stock
- Failure to maintain effective internal control over our financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act has caused and may cause in the future our financial reports to be inaccurate.
- Failure to continue improving our accounting systems and controls could impair our ability to comply with the financial reporting and internal controls requirements for publicly traded companies.
- Our current stockholders’ ownership may be diluted if additional capital stock is issued to raise capital, to finance acquisitions or in connection with strategic transactions.
- We have in the past been unable to maintain compliance with the listing requirements of The Nasdaq Capital Market, and any future failure to maintain compliance could subject our common stock to be delisted from The Nasdaq Capital Market, which could have a material adverse effect on our financial condition and could make it more difficult for you to sell your shares.
- We may be required to repurchase certain of our warrants upon a fundamental transaction, which may prevent or deter a third party from acquiring us.
- General Risk Factors
- As a biotechnology company, we may be at an increased risk of securities class action litigation.
- If securities or industry analysts do not publish research or reports about us, or if they adversely change their recommendations regarding our common stock, then our stock price and trading volume could decline.
Legal proceedings
From time to time in the ordinary course of our business, we may be involved in legal proceedings, the outcomes of which may not be determinable. The results of litigation are inherently unpredictable. Any claims against us, whether meritorious or not, could be time consuming, result in costly litigation, require significant amounts of management time and result in diversion of significant resources. However, we are currently not a party to any pending legal actions. We have insurance policies covering any potential losses where such coverage is cost effective.
We are not at this time involved in any additional legal proceedings that we believe could have a material effect on our business, financial condition, results of operations or cash flows.
The opening of Item 3, Legal Proceedings.4
Sources
The numbers on this page point here. Each one links to the record it came from.
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- 13SEC EDGARRami Levin, Chief executive officer
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- 17SEC EDGARMichal Fisher, Board member
- 18SEC EDGARAmy Mahery, Board member
- 19SEC EDGARFaith L. Charles, Board member
- 20SEC EDGARBettina M. Cockroft, Board member
- 21SEC EDGARAndrzej Andraczke, Board member
- 22SEC EDGARCarl Anthony Evans, Board member
- 23SEC EDGARJeffry R. Keyes, Board member
- 24SEC EDGARJerzy Gumulka, Board member
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- 26SEC EDGARRegulation FD disclosure
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- 28SEC EDGARRegulation FD disclosure
- 29SEC EDGARExecutive or director change
- 30SEC EDGARExecutive or director change
- 31SEC EDGARExecutive or director change
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- 34SEC EDGARRegulation FD disclosure
- 35SEC EDGAREntered a material agreement
- 36SEC EDGARRegulation FD disclosure
- 37NasdaqNasdaq calendar
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