Overview
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- TickerANIX on Nasdaq1
- IndustryPharmaceutical Preparations1
- HeadquartersSan Jose, California1
- Incorporated inDE2
- Business address3150 Almaden Expressway, Suite 250, San Jose, Ca 951182
- Filer categoryNon-accelerated filer, Smaller reporting company2
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Biosciences, Inc. is a biotechnology company developing therapies and vaccines that are focused on critical unmet needs in oncology.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 2024
Where the money goes
Where each dollar of revenue went, fiscal 2024
- Research and development100¢$6.4M
Out of $210.0K in revenue.54 The company lost money this year.
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.4
| Period ending | 2025-10-31 | 2024-10-31 |
|---|---|---|
| Research and development expenses (including non-cash stock-based compensation expenses of $1,560 and $1,859, respectively) | $5.1M | $6.4M |
| General and administrative expenses (including non-cash stock-based compensation expenses of $2,250 and $2,923, respectively) | $6.6M | $7.4M |
| Total operating costs and expenses | $11.7M | $13.8M |
| Loss from operations | -$11.7M | -$13.8M |
| Interest income | $673.0K | $1.1M |
| Net loss | -$11.0M | -$12.7M |
| Less: Net loss attributable to noncontrolling interest | -$101.0K | -$144.0K |
| Net loss attributable to common shareholders | -$10.9M | -$12.6M |
| Basic | -$0.34 | -$0.39 |
| Diluted | -$0.34 | -$0.39 |
| Basic | 32.5K shares | 31.9K shares |
| Diluted | 32.5K shares | 31.9K shares |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 3 fiscal years (annual) or 3 quarters (quarterly), latest first.4
| Period ending | 2025-10-31 | 2024-10-31 | 2023-10-31 |
|---|---|---|---|
| Cash and cash equivalents | $1.2M | $1.3M | |
| Shortterm investments | $13.9M | $18.7M | |
| Receivables | $173.0K | ||
| Prepaid expenses and other current assets | $713.0K | $1.3M | |
| Total current assets | $15.9M | $21.4M | |
| Operating lease right-of-use asset | $193.0K | $229.0K | |
| Total assets | $16.1M | $21.6M | |
| Accounts payable | $165.0K | $525.0K | |
| Accrued expenses | $1.8M | $1.9M | |
| Operating lease liability | $41.0K | $29.0K | |
| Total current liabilities | $2.0M | $2.5M | |
| Operating lease liability, non-current | $163.0K | $203.0K | |
| Total liabilities | $2.1M | $2.7M | |
| Common stock, par value $.01 per share; 100,000,000 shares authorized; 33,013,829 and 32,196,862 shares issued and outstanding as of October 31, 2025 and 2024, respectively | $330.0K | $322.0K | |
| Additional paid-in capital | $266.5M | $260.4M | |
| Accumulated deficit | -$251.7M | -$240.8M | |
| Treasury stock, 2,000 shares at cost as of October 31, 2024 | -$6.0K | ||
| Total shareholders equity | $15.2M | $20.0M | |
| Noncontrolling interest (Note 2) | -$1.2M | -$1.1M | -$966.0K |
| Total equity | $13.9M | $18.9M | $23.4M |
| Total liabilities and equity | $16.1M | $21.6M | |
| Preferred stock, par value | $100.00 | $100.00 | |
| Preferred stock, shares authorized | 19.9K shares | 19.9K shares | |
| Preferred stock, shares issued | 0 shares | 0 shares | |
| Preferred stock, shares outstanding | 0 shares | 0 shares | |
| Common stock, par value | $0.01 | $0.01 | |
| Common stock, shares authorized | 100.0M shares | 100.0M shares | |
| Common stock, shares issued | 33.0M shares | 32.2M shares | |
| Common stock, shares outstanding | 33.0M shares | 32.2M shares | |
| Treasury stock, common shares | 2.0K shares | 2.0K shares |
| Period ending | 2025-10-31 | 2024-10-31 | 2023-10-31 |
|---|---|---|---|
| Cash and cash equivalents | $1.2M | $1.3M | |
| Shortterm investments | $13.9M | $18.7M | |
| Receivables | $173.0K | ||
| Prepaid expenses and other current assets | $713.0K | $1.3M | |
| Total current assets | $15.9M | $21.4M | |
| Operating lease right-of-use asset | $193.0K | $229.0K | |
| Total assets | $16.1M | $21.6M | |
| Accounts payable | $165.0K | $525.0K | |
| Accrued expenses | $1.8M | $1.9M | |
| Operating lease liability | $41.0K | $29.0K | |
| Total current liabilities | $2.0M | $2.5M | |
| Operating lease liability, non-current | $163.0K | $203.0K | |
| Total liabilities | $2.1M | $2.7M | |
| Common stock, par value $.01 per share; 100,000,000 shares authorized; 33,013,829 and 32,196,862 shares issued and outstanding as of October 31, 2025 and 2024, respectively | $330.0K | $322.0K | |
| Additional paid-in capital | $266.5M | $260.4M | |
| Accumulated deficit | -$251.7M | -$240.8M | |
| Treasury stock, 2,000 shares at cost as of October 31, 2024 | -$6.0K | ||
| Total shareholders equity | $15.2M | $20.0M | |
| Noncontrolling interest (Note 2) | -$1.2M | -$1.1M | -$966.0K |
| Total equity | $13.9M | $18.9M | $23.4M |
| Total liabilities and equity | $16.1M | $21.6M | |
| Preferred stock, par value | $100.00 | $100.00 | |
| Preferred stock, shares authorized | 19.9K shares | 19.9K shares | |
| Preferred stock, shares issued | 0 shares | 0 shares | |
| Preferred stock, shares outstanding | 0 shares | 0 shares | |
| Common stock, par value | $0.01 | $0.01 | |
| Common stock, shares authorized | 100.0M shares | 100.0M shares | |
| Common stock, shares issued | 33.0M shares | 32.2M shares | |
| Common stock, shares outstanding | 33.0M shares | 32.2M shares | |
| Treasury stock, common shares | 2.0K shares | 2.0K 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.4
| Period ending | 2025-10-31 | 2024-10-31 |
|---|---|---|
| Net loss | -$11.0M | -$12.7M |
| Stock option compensation to employees and directors | $3.7M | $4.4M |
| Stock options issued to consultants | $129.0K | $125.0K |
| Common stock issued to consultants | $255.0K | |
| Amortization of operating lease right-of-use asset | $36.0K | $37.0K |
| Amortization of discount on held-to-maturity securities | -$143.0K | |
| Receivables | $173.0K | $97.0K |
| Prepaid expenses and other current assets | $552.0K | -$23.0K |
| Accounts payable | -$360.0K | $319.0K |
| Accrued expenses | -$185.0K | $176.0K |
| Operating lease liability | -$28.0K | -$43.0K |
| Net cash used in operating activities | -$7.2M | -$7.3M |
| Disbursements to acquire short-term investments | -$44.4M | -$63.8M |
| Proceeds from maturities of short-term investments | $49.2M | $68.0M |
| Net cash provided by investing activities | $4.9M | $4.3M |
| Proceeds from sale of common stock in an at-the-market offering, net of offering expenses of $183 and $168, for the years ended October 31, 2025 and 2024, respectively | $2.4M | $3.0M |
| Proceeds from sale of common stock pursuant to employee stock purchase plan | $7.0K | $10.0K |
| Net (costs) proceeds from exercise of stock options | -$105.0K | $456.0K |
| Disbursements for purchases of treasury stock | -$6.0K | |
| Net cash provided by financing activities | $2.3M | $3.4M |
| Net (decrease) increase in cash and cash equivalents | -$27.0K | $356.0K |
| Cash proceeds from interest income | $686.0K | $1.2M |
| Modification to operating lease right-of-use asset | -$100.0K | |
| Modification to operating lease liability | $100.0K | |
| Offering expenses | $183.0K | $168.0K |
No quarter-by-quarter statement was filed.
Corporate structure
Anixa Biosciences 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 Anixa Biosciences Inc
- Michael Catelani Filed SCHEDULE 13D/A on Anixa Biosciences Inc, latest Jan 6, 2026 (2 filings since May 3, 2024)
- Amit Kumar Filed SCHEDULE 13D/A on Anixa Biosciences Inc, latest Jun 6, 2025 (3 filings since Jan 16, 2024)
- Anixa Biosciences Inc San Jose, California
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Anixa Biosciences 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 |
|---|---|---|---|
| Operating-lease assets (leased space) | $193.0K4 Oct 31, 2025 | $229.0K4 Oct 31, 2024 | −15.7% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $1.2M4 Oct 31, 2025 | $1.3M4 Oct 31, 2024 | −2.1% |
| Marketable securities, current | $13.9M4 Oct 31, 2025 | $18.7M4 Oct 31, 2024 | −25.3% |
Properties, in its own words
We lease approximately 2,000 square feet of office space at 3150 Almaden Expressway, San Jose, California 95118 (our principal executive offices) from an unrelated party pursuant to a lease that expires September 30, 2027, with an option to extend the lease an additional two years. Our base rent is approximately $5,000 per month and the lease provides for annual increases of approximately 3% and an escalation clause for increases in certain operating costs.
Item 2 of the 10-K filed Jan 12, 2026.3
Leadership
Who has led Anixa Biosciences Inc, and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
Chief operating officer
- Chief executive officerLewis H. Titterton Jr. Sep 14, 2012 to Sep 14, 201213
- Chief executive officerDenis A. Krusos Jun 5, 2006 to Jan 26, 201214
- PresidentMichael Catelani Apr 15, 2022 to now15
- PresidentFrank J. Disanto Oct 31, 2006 to Nov 14, 200716
- Chief financial officerMichael Catelani Nov 9, 2016 to now17
- Chief financial officerHenry P. Herms Jan 4, 2006 to Oct 24, 201618
- Chief operating officerMichael Catelani Jul 25, 2017 to now19
- Chief operating officerTisha Stender Jul 17, 2014 to Jul 17, 201420
Board members and other officers (13)
- Sr. Vice President-EngineeringJohn H. Roop Sep 28, 2012 to Feb 4, 201421
- Board memberMichael Catelani Sep 20, 2019 to Sep 20, 201922
- Board memberEmily Gottschalk Oct 24, 2019 to now23
- Board memberDavid Cavalier Oct 1, 2018 to Aug 17, 202024
- Board memberArnold M. Baskies Sep 1, 2016 to now25
- Board memberJohn J. Monahan Sep 1, 2016 to Aug 17, 202026
- Board memberDale Fox Sep 2, 2014 to Sep 8, 201727
- Board memberAndrea Belz Sep 5, 2014 to Feb 5, 201528
- Board memberLewis H. Titterton Jr. Aug 24, 2010 to now29
- Board memberHenry P. Herms Jan 4, 2006 to Apr 30, 201418
- Board memberDenis A. Krusos Jun 5, 2006 to Jan 26, 201214
- Board memberGeorge P. Larounis Jun 5, 2006 to Sep 10, 201230
- Board memberFrank J. Disanto Oct 31, 2006 to Nov 14, 200716
Former names
Timeline
- Mar 11, 20268-K Shareholder vote; Regulation FD disclosure31
- Feb 9, 20268-K Regulation FD disclosure32
- Dec 12, 20258-K Regulation FD disclosure33
- Mar 21, 20258-K Shareholder vote; Regulation FD disclosure34
- Nov 8, 20248-K Regulation FD disclosure35
- May 8, 20248-K Entered a material agreement; Regulation FD disclosure36
- Mar 22, 20248-K Shareholder vote; Regulation FD disclosure37
- Dec 7, 20238-K Regulation FD disclosure38
- Apr 17, 20238-K Regulation FD disclosure39
- Mar 10, 20238-K Shareholder vote; Regulation FD disclosure40
- Dec 8, 20228-K Regulation FD disclosure41
- Sep 29, 20228-K Regulation FD disclosure42
- Sep 14, 2012New chief executive Lewis H. Titterton Jr. becomes CEO13
- Jun 5, 2006New chief executive Denis A. Krusos becomes CEO14
Filings
159 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 18 major events, 97 insider forms, 5 large holders, 19 other. The latest 20:
- Sep 30, 20264 EDGAR
- Sep 28, 20264 EDGAR
- Sep 28, 20264 EDGAR
- Sep 25, 20264 EDGAR
- Sep 14, 20264 EDGAR
- Sep 14, 20264 EDGAR
- Sep 11, 20264 EDGAR
- Sep 9, 202610-Q EDGAR
- Aug 3, 20264 EDGAR
- Jul 29, 20264 EDGAR
- Jul 28, 20264 EDGAR
- Jul 27, 20264 EDGAR
- Jul 27, 20264 EDGAR
- Jul 21, 20264 EDGAR
- Jul 20, 20264 EDGAR
- Jul 16, 20264 EDGAR
- Jul 13, 20264 EDGAR
- Jun 17, 20264 EDGAR
- Jun 16, 20264 EDGAR
- Jun 10, 202610-Q EDGAR
The 159 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
59 open-market trades by officers, directors and large owners since October 2021: 58 buys and 1 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Sep 30, 2026 | Catelani MichaelPresident, COO, & CFO | Buy | 5,500 | $2.84 | $15.6K | Form 4 |
| Sep 24, 2026 | KUMAR AMITChief Executive Officer | Buy | 7,000 | $2.78 | $19.5K | Form 4 |
| Sep 24, 2026 | Baskies Arnold MDirector | Buy | 5,000 | $2.76 | $13.8K | Form 4 |
| Sep 23, 2026 | Titterton Lewis H jrDirector | Buy | 49,036 | $2.69 | $131.9K | Form 4 |
| Sep 10, 2026 | KUMAR AMITChief Executive Officer | Buy | 3,000 | $2.75 | $8.2K | Form 4 |
| Sep 10, 2026 | Titterton Lewis H jrDirector | Buy | 10,000 | $2.73 | $27.3K | Form 4 |
| Sep 10, 2026 | KUMAR AMITChief Executive Officer | Buy | 5,000 | $2.76 | $13.8K | Form 4 |
| Jul 31, 2026 | KUMAR AMITChief Executive Officer | Buy | 5,000 | $3.47 | $17.4K | Form 4 |
| Jul 27, 2026 | KUMAR AMITChief Executive Officer | Buy | 5,000 | $3.44 | $17.2K | Form 4 |
| Jul 27, 2026 | KUMAR AMITChief Executive Officer | Buy | 3,188 | $3.37 | $10.7K | Form 4 |
| Jul 24, 2026 | KUMAR AMITChief Executive Officer | Buy | 3,000 | $3.73 | $11.2K | Form 4 |
| Jul 20, 2026 | KUMAR AMITChief Executive Officer | Buy | 5,000 | $3.46 | $17.3K | Form 4 |
| Jul 20, 2026 | Titterton Lewis H jrDirector | Buy | 12,000 | $3.47 | $41.6K | Form 4 |
| Jul 15, 2026 | Titterton Lewis H jrDirector | Buy | 2,797 | $3.28 | $9.2K | Form 4 |
| Jul 10, 2026 | KUMAR AMITChief Executive Officer | Buy | 5,000 | $3.04 | $15.2K | Form 4 |
| Jun 16, 2026 | Titterton Lewis H jrDirector | Buy | 2,836 | $2.64 | $7.5K | Form 4 |
| Jun 12, 2026 | KUMAR AMITChief Executive Officer | Buy | 21,000 | $2.50 | $52.5K | Form 4 |
| Jan 28, 2026 | Baskies Arnold MDirector | Buy | 10,000 | $3.04 | $30.4K | Form 4 |
| Jul 31, 2025 | Titterton Lewis H jrDirector | Buy | 10,000 | $3.08 | $30.8K | Form 4 |
| Jul 30, 2025 | KUMAR AMITChief Executive Officer | Buy | 5,000 | $3.16 | $15.8K | Form 4 |
All 59 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.
- Michael CatelaniSCHEDULE 13D/A, 2 filings May 3, 2024 to Jan 6, 202643
- Amit KumarSCHEDULE 13D/A, 3 filings Jan 16, 2024 to Jun 6, 202544
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 | Dr. Amit Kumar | 61 | $815.2K | $2.5M45 |
| 2025 | Michael J. Catelani | 59 | $553.2K | $1.3M45 |
| 2024 | Chairman of the Board and Chief Executive Officer | $785.5K | $3.5M45 | |
| 2024 | PresidentChief Operating Officer and Chief Financial Officer | $533.0K | $1.8M45 |
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 61. Change is in shares since the quarter before.
| Fund | Shares | Value | Share of the fund | Change |
|---|---|---|---|---|
| Vanguard Capital Management LLC | 1,329,852 | $3.7M | 0.0% | +14,870 |
| UBS Group AG | 585,430 | $1.6M | 0.0% | +33,793 |
| Laird Norton Wetherby Trust Company, LLC | 578,727 | $1.6M | 0.0% | +12,400 |
| D.a. Davidson & Co. | 539,272 | $1.5M | 0.0% | No change |
| Geode Capital Management, LLC | 359,194 | $1.0M | 0.0% | −5,537 |
| Marshall Wace, Llp | 328,332 | $919.3K | 0.0% | +155,153 |
| BlackRock, Inc. | 199,755 | $559.3K | 0.0% | +29,652 |
| Vanguard Fiduciary Trust Co | 192,356 | $538.6K | 0.0% | +1,282 |
| State Street Corp | 159,040 | $445.3K | 0.0% | No change |
| LPL Financial LLC | 111,535 | $312.3K | 0.0% | +30,559 |
| Northern Trust Corp | 69,235 | $193.9K | 0.0% | +2,410 |
| Renaissance Technologies LLC | 59,373 | $166.2K | 0.0% | −1,800 |
| CoreCap Advisors, LLC | 52,020 | $145.7K | 0.0% | No change |
| Bank of New York Mellon Corp | 47,442 | $132.8K | 0.0% | No change |
| Westside Investment Management, Inc. | 43,000 | $120.4K | 0.0% | −4,000 |
| HighTower Advisors, LLC | 41,150 | $115.2K | 0.0% | −400 |
| Kestra Advisory Services, LLC | 38,000 | $106.4K | 0.0% | −13,000 |
| Corient Private Wealth LP | 37,400 | $104.7K | 0.0% | +17,400 |
| Gemmer Asset Management LLC | 35,000 | $98.0K | 0.0% | No change |
| Modern Wealth Management, LLC | 32,000 | $89.6K | 0.0% | New |
| Citadel Advisors LLC | 31,887 | $89.3K | 0.0% | New |
| Vontobel Holding Ltd. | 30,000 | $84.0K | 0.0% | No change |
| CIBC Bancorp USA Inc. | 26,600 | $74.5K | 0.0% | No change |
| Nations Financial Group Inc, /ia/ /adv | 22,500 | $63.0K | 0.0% | No change |
| Keybank National Association/oh | 15,810 | $44.3K | 0.0% | No change |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Anixa Biosciences Inc is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARAnixa Biosciences Inc1
- CIK0000715446
- Employer ID (EIN)11-26226303
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; a shell company3
- Incorporated inDelaware3
- Fiscal year endsOctober 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address3150 Almaden Expressway, Suite 250, San Jose, CA 951181
- Phone408-708-98081
- Shares outstanding34,763,802 as of Sep 9, 202612
- Public float$85.1M as of Apr 30, 20253
- AuditorHASKELL & WHITE LLP, Irvine, California PCAOB ID 200; no auditor attestation of internal control over financial reporting3
- On EDGAR sinceJun 9, 19951
- Filings980 in all: 4 (433), 8-K (114), 10-Q (95), DEF 14A (31), 10-K (27), CORRESP (25), UPLOAD (25), S-8 (22)1
All 49 form types
SC 13D/A (21), 3 (19), EFFECT (13), 10-K/A (12), 5 (11), DEFA14A (11), SC 13D (9), 424B3 (8), S-3 (8), 424B5 (7), PRE 14A (7), 10-Q/A (6), CT ORDER (6), NT 10-K (6), S-3/A (6), D (5), 10-K405 (4), NT 10-Q (4), POS AM (4), SC 13G (4), 4/A (3), 424B2 (3), S-1 (3), S-8 POS (3), SC 13G/A (3), SCHEDULE 13D/A (3), 3/A (2), AW (2), FWP (2), S-1/A (2), 10-C (1), 10-K405/A (1), 144 (1), 8-A12B (1), ARS (1), CERTNAS (1), DEL AM (1), DFAN14A (1), PREC14A (1), PRER14A (1), RW (1)
- Latest filingsAnnual report (10-K) Jan 12, 2026
Quarterly report (10-Q) Sep 9, 2026
Proxy statement (DEF 14A) Jan 28, 2026
Latest 8-K (8-K) Mar 11, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, $0.01 par value | ANIX | NASDAQ |
From the cover page of the 10-K filed Jan 12, 2026 (Section 12(b) of the Exchange Act).3
Risk factors and legal proceedings
The risks Anixa Biosciences Inc names in Item 1A of its 10-K filed Jan 12, 2026: 40 risks under these headings, as written.3
- Risks Related to Our Financial Condition and Operations
- We have a history of losses and may incur additional losses in the future.
- We will need additional funding in the future which may not be available on acceptable terms, or at all, and, if available, may result in dilution to our stockholders.
- We may have difficulty in raising capital and may consume resources faster than expected.
- Failure to effectively manage our potential growth could place strains on our managerial, operational and financial resources and could adversely affect our business and operating results.
- We may use our financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater likelihood of success.
- Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
- Risks Related to our Research & Development, Clinical and Commercialization Activities
- Our therapeutic and vaccine programs are pre-revenue, and subject to the risks of an early-stage biotechnology company.
- Our current business model relies on strategic collaborations with commercial partners to provide the resources and infrastructure to manufacture and ultimately market and/or sell our technologies. We may have difficulty in timing the establishment of these partnerships to achieve the greatest economic benefit for the Company, or in establishing these partnerships at all.
- 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 we cannot license rights to use technologies on reasonable terms, we may not be able to commercialize new products in the future.
The other 30 risks
- Biotechnology and pharmaceutical product development is a highly speculative undertaking and involves a substantial degree of uncertainty. We have never generated any revenue from biotechnology and pharmaceutical product sales and our biotechnology and pharmaceutical products may never be profitable.
- Cancer vaccines are novel and present significant challenges.
- CAR-T cell therapies are novel and present significant challenges.
- While CAR-T technology has shown positive results in B cell cancers by others, its safety and efficacy has not been seen in solid tumors and we cannot guarantee our CAR-T technology will be safe or effective in ovarian or other cancers.
- While pre-clinical testing and the limited human clinical testing of our product candidates has been positive, we may experience unfavorable results once we collect statistically significant data from human clinical trials.
- We are dependent on third parties to conduct our pre-clinical studies and clinical trials.
- If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
- Any adverse developments that occur during any clinical trials conducted by academic investigators, our collaborators or other entities conducting clinical trials under independent IND applications may negatively affect the conduct of our clinical trials or our ability to obtain regulatory approvals or commercialize our product candidates.
- Adverse side effects or other safety risks associated with our product candidates could cause us to suspend or discontinue clinical trials or delay or preclude approval.
- Vaccine hesitancy, misinformation about vaccine safety, and evolving positions of public health authorities on vaccines could adversely affect the development and commercial success of our cancer vaccine product candidates.
- Clinical trials are expensive, time consuming and difficult to design and implement.
- We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
- Cell-based therapies rely on the availability of specialty raw materials, which may not be available to us on acceptable terms or at all.
- We may form or seek strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.
- The FDA regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development and regulatory approval of our product candidates.
- Even if we obtain regulatory approval of our product candidates, the products may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers, third-party payors and others in the medical community.
- Risks Related to Our Intellectual Property
- If we are unable to obtain and maintain intellectual property protection, our competitive position will be harmed.
- Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
- We rely on licenses from Wistar for our CAR-T technology and Cleveland Clinic for our cancer vaccine technologies, and if we lose any of these licenses we may be subjected to future litigation.
- If our efforts to protect the proprietary nature of our technologies are not adequate, we may not be able to compete effectively in our market.
- Obtaining and maintaining our patents depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent position could be reduced or eliminated for non-compliance with these requirements.
- Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court or the USPTO.
- We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.
- Risks Related to Our Common Stock
- The issuance or sale of shares in the future to raise money or for strategic purposes could reduce the market price of our common stock.
- We may fail to meet market expectations because of fluctuations in quarterly operating results, which could cause the price of our common stock to decline.
- Biotechnology company stock prices are especially volatile, and this volatility may depress the price of our common stock.
- Our common stock is currently listed on NASDAQ Capital Market, however if our common stock is delisted for any reason, it will become subject to the SEC’s penny stock rules which may make our shares more difficult to sell.
- We have issued a significant number of securities pursuant to our incentive plans and may continue to do so in the future. The vesting and, if applicable, exercise of these securities and the sale of the shares of common stock issuable thereunder may dilute stockholders’ percentage ownership interest and may also result in downward pressure on the price of our common stock.
- We are a smaller reporting company and the reduced reporting requirements applicable to smaller reporting companies may make our common stock less attractive to investors.
- We do not anticipate declaring any cash dividends on our common stock which may adversely impact the market price of our stock.
Legal proceedings
Other than lawsuits we bring to enforce our patent rights, we are not a party to any material pending legal proceedings, nor are we aware of any pending litigation or legal proceeding against us that would have a material adverse effect on our financial position or results of operations.
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 EDGARMichael Catelani, President
- 16SEC EDGARFrank J. Disanto, President
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- 22SEC EDGARMichael Catelani, Board member
- 23SEC EDGAREmily Gottschalk, Board member
- 24SEC EDGARDavid Cavalier, Board member
- 25SEC EDGARArnold M. Baskies, Board member
- 26SEC EDGARJohn J. Monahan, Board member
- 27SEC EDGARDale Fox, Board member
- 28SEC EDGARAndrea Belz, Board member
- 29SEC EDGARLewis H. Titterton Jr., Board member
- 30SEC EDGARGeorge P. Larounis, Board member
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- 32SEC EDGARRegulation FD disclosure
- 33SEC EDGARRegulation FD disclosure
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- 35SEC EDGARRegulation FD disclosure
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- 38SEC EDGARRegulation FD disclosure
- 39SEC EDGARRegulation FD disclosure
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- 41SEC EDGARRegulation FD disclosure
- 42SEC EDGARRegulation FD disclosure
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