CERO on OTC
CERO THERAPEUTICS HOLDINGS, INC.
CERO THERAPEUTICS HOLDINGS, INC. is an American biological products company based in South San Francisco.1
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Last updated Oct 21, 2026.
Overview
- TickerCERO on OTC1
- IndustryBiological Products, (No Diagnostic Substances)1
- HeadquartersSouth San Francisco, California1
- Incorporated inDE2
- Business address201 Haskins Way, Suite 230, South San Francisco, Ca 940802
- Filer category, Emerging growth company2
- Legal formCorporation
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Drug Designation for the treatment of acute myeloid leukemia. In September 2025, CER-1236 received FDA Fast Track Designation.3 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 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|
| Research and development | $5.3M5 | |||||
| Operating expenses | $2.9M9 | $7.7M5 | ||||
| Operating income | -$2.9M4 | -$7.7M5 | ||||
| Income before tax | -$68.6K4 | -$2.4M4 | -$19.9M6 | |||
| Income tax | $599.2K4 | $94.8K4 | ||||
| Net income | -$667.7K4 | -$7.3M5 | -$19.9M6 | |||
| Earnings per share | -$1,248.645 | |||||
| Earnings per share (diluted) | -$1,248.645 | |||||
| Shares (weighted, basic) | 5.8K shares5 | |||||
| Shares (weighted, diluted) | 5.8K shares5 |
| Fiscal year | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|
| Cash | $1.1M9 | $475.9K4 | $96.9K4 | $3.3M6 | $1.7M6 | |
| Current assets | $1.4M9 | $42.4M9 | $2.0M5 | $3.7M6 | $2.7M6 | |
| Property, plant and equipment | $966.7K5 | $528.5K6 | $246.1K6 | |||
| Total assets | $180.1M9 | $42.4M4 | $5.1M5 | $6.2M6 | $3.6M6 | |
| Accounts payable | $1.7M5 | $4.5M6 | $7.6M6 | |||
| Current liabilities | $98.1K9 | $30.7M4 | $3.5M5 | $7.4M6 | $9.1M6 | |
| Total liabilities | $9.2M9 | $39.9M4 | $5.1M5 | $8.1M6 | $9.1M6 | |
| Retained earnings | -$11.0M4 | -$43.1M5 | -$70.9M6 | -$90.8M6 | ||
| Shareholders’ equity | -$7.7M4 | -$11.0M4 | -$42.1M5 | -$1.9M6 | -$5.4M6 | |
| Shares outstanding | 5.8K shares5 | 14.7M shares4 | 5.6M shares10 | 36.8M shares11 |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
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Corporate structure
CERO THERAPEUTICS HOLDINGS, 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 CERO THERAPEUTICS HOLDINGS, INC.
- Isaiah Tibbs Filed SCHEDULE 13G/A on CERO THERAPEUTICS HOLDINGS, INC., latest Aug 14, 2026 (2 filings since Mar 12, 2026)
- ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G/A on CERO THERAPEUTICS HOLDINGS, INC., latest Aug 14, 2025 (2 filings since May 15, 2025)
- Brian G. Atwood Filed SCHEDULE 13D/A on CERO THERAPEUTICS HOLDINGS, INC., latest Apr 4, 2025 (3 filings since Oct 30, 2024)
- YK Bioventures Opportunities GP I, LLC Filed SCHEDULE 13G/A on CERO THERAPEUTICS HOLDINGS, INC., latest Dec 17, 2024 (2 filings since Nov 14, 2024)
- Lawrence Corey Filed SC 13G on CERO THERAPEUTICS HOLDINGS, INC., latest Dec 13, 2024
- Stuart M. Sloan Filed SC 13G/A on CERO THERAPEUTICS HOLDINGS, INC., latest Nov 20, 2024 (2 filings since Nov 20, 2024)
- Shaolin Capital Management LLC Filed SC 13G/A on CERO THERAPEUTICS HOLDINGS, INC., latest Feb 22, 2024 (2 filings since Feb 14, 2023)
- PHOENIX BIOTECH SPONSOR, LLC Filed SC 13D/A on CERO THERAPEUTICS HOLDINGS, INC., latest Feb 20, 2024 (3 filings since Feb 8, 2022)
- Saba Capital Management, L.P. Filed SC 13G/A on CERO THERAPEUTICS HOLDINGS, INC., latest Feb 8, 2024 (3 filings since May 6, 2022)
- Beryl Capital Management LLC Filed SC 13G/A on CERO THERAPEUTICS HOLDINGS, INC., latest Feb 14, 2023 (3 filings since Oct 18, 2021)
- Goldman Sachs Filed SC 13G/A on CERO THERAPEUTICS HOLDINGS, INC., latest Feb 14, 2023 (2 filings since Feb 13, 2023)
- HIGHBRIDGE CAPITAL MANAGEMENT LLC Filed SC 13G/A on CERO THERAPEUTICS HOLDINGS, INC., latest Jan 25, 2023 (3 filings since Oct 22, 2021)
- CERO THERAPEUTICS HOLDINGS, INC. South San Francisco, California
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What CERO THERAPEUTICS HOLDINGS, 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 | $246.1K6 Dec 31, 2025 | $528.5K6 Dec 31, 2024 | −53.4% |
| Operating-lease assets (leased space) | $660.7K6 Dec 31, 2025 | $1.5M6 Dec 31, 2024 | −54.9% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Deposits held (banks) | $1.3M6 Dec 31, 2025 |
Properties, in its own words
We do not own any real estate or other physical properties. We currently maintain our executive office in approximately 12,000 square feet of office and laboratory space in a multi-tenant building at 201 Haskins Way in South San Francisco, California. The lease for our headquarters expires on September 30, 2026. We believe that our existing facilities are adequate for our near-term needs. We believe that suitable additional or alternative space would be available if required in the future on commercially reasonable terms.
Item 2 of the 10-K filed Apr 15, 2026.3
Leadership
Who has led CERO THERAPEUTICS HOLDINGS, INC., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
- Chief executive officerBrian G. Atwood Feb 16, 2024 to Mar 27, 202412
- Chief executive officerChristopher B. Ehrlich Oct 5, 2021 to Feb 16, 202413
- ChairChristopher B. Ehrlich Oct 2, 2024 to now14
- Chief financial officerCharles Ross Carter Feb 16, 2024 to Jul 1, 202415
- Chief financial officerAndrew Albert Kucharchuk Oct 2, 2024 to now16
- Chief financial officerDaniel E. Geffken Oct 5, 2021 to Feb 16, 202417
Board members and other officers (12)
- Chief Technical OfficerDaniel Corey Feb 16, 2024 to Mar 27, 202418
- Chief Development OfficerKristen Pierce Oct 2, 2024 to now19
- Board memberEric Francois Apr 21, 2026 to now20
- Board memberDaniel Corey Feb 16, 2024 to Mar 27, 202418
- Board memberLindsey Rolfe Feb 16, 2024 to now21
- Board memberRobyn Rapaport Feb 16, 2024 to Mar 27, 202422
- Board memberShami Patel Oct 11, 2024 to now23
- Board memberBarbara Kosacz Oct 5, 2021 to Feb 16, 202424
- Board memberBrian G. Atwood Oct 5, 2021 to now25
- Board memberCaroline M. Loewy Oct 5, 2021 to Feb 16, 202426
- Board memberChristopher B. Ehrlich Oct 5, 2021 to Mar 27, 202413
- Board memberKathleen Laporte Oct 5, 2021 to now27
Named in SEC Form D filings
People the company listed in its private-offering notices.
Former names
- PHOENIX BIOTECH ACQUISITION CORP.Jul 8, 2021 to Feb 14, 20242
Timeline
- Oct 7, 20268-K Entered a material agreement30
- Aug 31, 20268-K Entered a material agreement; Ended a material agreement; New debt or obligation31
- Jul 17, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares32
- Jun 26, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares33
- May 29, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares34
- May 1, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares35
- Apr 14, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares36
- Mar 11, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares37
- Feb 13, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares38
- Feb 4, 20268-K Other events39
- Feb 3, 20268-K Listing notice or transfer40
- Jan 7, 20268-K Regulation FD disclosure; Other events41
- Feb 16, 2024New chief executive Brian G. Atwood becomes CEO12
- Oct 5, 2021New chief executive Christopher B. Ehrlich becomes CEO13
Calendar
When it reported results
- Oct 11, 2024Reported quarterly or annual results42
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
440 filings to the SEC since October 2021: 7 annual reports, 16 quarterly reports, 80 major events, 95 insider forms, 30 large holders, 3 private raises, 209 other. The latest 20:
- Oct 7, 20268-K CURRENT REPORT EDGAR
- Aug 31, 20268-K CURRENT REPORT EDGAR
- Aug 14, 2026SCHEDULE 13G/A EDGAR
- Aug 14, 2026424B3 PROSPECTUS SUPPLEMENT EDGAR
- Aug 14, 202610-Q QUARTERLY REPORT EDGAR
- Jul 17, 2026424B3 PROSPECTUS SUPPLEMENT EDGAR
- Jul 17, 20268-K CURRENT REPORT EDGAR
- Jul 13, 202625-NSE EDGAR
- Jun 26, 2026424B3 PROSPECTUS SUPPLEMENT EDGAR
- Jun 26, 20268-K CURRENT REPORT EDGAR
- May 29, 2026424B3 PROSPECTUS SUPPLEMENT EDGAR
- May 29, 20268-K CURRENT REPORT EDGAR
- May 15, 2026424B3 PROSPECTUS SUPPLEMENT EDGAR
- May 15, 202610-Q QUARTERLY REPORT EDGAR
- May 1, 2026424B3 PROSPECTUS SUPPLEMENT EDGAR
- May 1, 20268-K CURRENT REPORT EDGAR
- May 1, 2026424B3 PROSPECTUS SUPPLEMENT EDGAR
- Apr 30, 202610-K/A AMENDMENT NO. 1 TO FORM 10-K EDGAR
- Apr 21, 20264 EDGAR
- Apr 21, 20263 EDGAR
The 440 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
8 open-market trades by officers, directors and large owners since October 2021: 0 buys and 8 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Dec 13, 2024 | YK Bioventures Opportunities GP I, LLC10% owner | Sale | 2,998,908 | $0.06 | $179.9K | Form 4 |
| Dec 12, 2024 | YK Bioventures Opportunities GP I, LLC10% owner | Sale | 1,614,541 | $0.07 | $113.0K | Form 4 |
| Dec 11, 2024 | YK Bioventures Opportunities GP I, LLC10% owner | Sale | 1,343,801 | $0.08 | $107.5K | Form 4 |
| Dec 10, 2024 | Kossar Mitchell William10% owner | Sale | 1,570,947 | $0.09 | $141.4K | Form 4 |
| Dec 9, 2024 | Kossar Mitchell William10% owner | Sale | 850,543 | $0.11 | $93.6K | Form 4 |
| Dec 6, 2024 | Kossar Mitchell William10% owner | Sale | 1,236,874 | $0.12 | $148.4K | Form 4 |
| Oct 10, 2024 | Kossar Mitchell William10% owner | Sale | 3,250,000 | $0.10 | $325.0K | Form 4 |
| Sep 25, 2024 | SLOAN STUART M10% owner | Sale | 532,486 | $0.10 | $53.2K | 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.
- Isaiah TibbsSCHEDULE 13G/A, 2 filings Mar 12, 2026 to Aug 14, 202643
- ARMISTICE CAPITAL, LLCSCHEDULE 13G/A, 2 filings May 15, 2025 to Aug 14, 202544
- Brian G. AtwoodSCHEDULE 13D/A, 3 filings Oct 30, 2024 to Apr 4, 202545
- YK Bioventures Opportunities GP I, LLCSCHEDULE 13G/A, 2 filings Nov 14, 2024 to Dec 17, 202446
- Lawrence CoreySC 13G, 1 filing Dec 13, 202447
- Stuart M. SloanSC 13G/A, 2 filings Nov 20, 202448
- Shaolin Capital Management LLCSC 13G/A, 2 filings Feb 14, 2023 to Feb 22, 202449
- PHOENIX BIOTECH SPONSOR, LLCSC 13D/A, 3 filings Feb 8, 2022 to Feb 20, 202450
- Saba Capital Management, L.P.SC 13G/A, 3 filings May 6, 2022 to Feb 8, 202451
- Beryl Capital Management LLCSC 13G/A, 3 filings Oct 18, 2021 to Feb 14, 202352
- Goldman SachsSC 13G/A, 2 filings Feb 13, 2023 to Feb 14, 202353
- HIGHBRIDGE CAPITAL MANAGEMENT LLCSC 13G/A, 3 filings Oct 22, 2021 to Jan 25, 202354
- CANTOR FITZGERALD SECURITIESSC 13G/A, 2 filings Oct 18, 2021 to Feb 14, 202255
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) $16.4M
Figures by year
| Year | Private raises (Form D) | Total |
|---|---|---|
| 2025 | $5.0M | $5.0M |
| 2024 | $11.4M | $11.4M |
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 22, 2025Raised $5 million in a private offering of equity28 Form D: $8 million offered in all Form D
- Sep 26, 2024Raised $1.2 million in a private offering of equity29 Form D: 13 investors so far Form D
- Feb 14, 2024Raised $10.2 million in a private offering of equity56 Form D: 46 investors so far Form D
SEC filer profile
How CERO THERAPEUTICS HOLDINGS, INC. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARCERO THERAPEUTICS HOLDINGS, INC.1
- CIK0001870404
- Employer ID (EIN)81-41821293
- Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company3
- Incorporated inDelaware3
- Fiscal year endsDecember 311
- Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address201 Haskins Way, Suite 230, South San Francisco, CA 940801
- Phone650-407-23761
- Shares outstanding71,630,992 as of Aug 13, 20268
- Public float$11.2M as of Jun 30, 20253
- AuditorSalberg & Company, P.A., Boca Raton, Florida PCAOB ID 106; no auditor attestation of internal control over financial reporting3
- On EDGAR sinceJul 8, 20211
- Filings445 in all: 424B3 (79), 8-K (77), 4 (71), CORRESP (27), 3 (19), UPLOAD (16), 10-Q (15), 425 (14)1
All 45 form types
EFFECT (11), SC 13G/A (11), S-1/A (9), SC 13G (9), DEF 14A (8), PRE 14A (8), S-1 (8), 10-K (5), DEFA14A (5), S-4/A (5), NT 10-Q (4), 4/A (3), 8-K/A (3), D (3), NT 10-K (3), SCHEDULE 13G/A (3), 10-K/A (2), 25-NSE (2), 3/A (2), PRER14A (2), S-8 (2), SC 13D (2), SCHEDULE 13D/A (2), SCHEDULE 13G (2), 10-Q/A (1), 424B4 (1), 424B5 (1), 8-A12B (1), ARS (1), CERT (1), DEFM14A (1), DEFR14A (1), DRS (1), POS AM (1), S-3 (1), S-4 (1), SC 13D/A (1)
- Latest filingsAnnual report (10-K) Apr 15, 2026
Quarterly report (10-Q) Aug 14, 2026
Proxy statement (DEF 14A) Nov 28, 2025
Latest 8-K (8-K) Oct 7, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.0001 per share | CERO | NONE |
| Warrants to purchase one share of Common Stock | CEROW | NONE |
From the cover page of the 10-K filed Apr 15, 2026 (Section 12(b) of the Exchange Act).3
Risk factors and legal proceedings
The risks CERO THERAPEUTICS HOLDINGS, INC. names in Item 1A of its 10-K filed Apr 15, 2026: 76 risks under these headings, as written.3
- Risks Related to our Business and Industry
- We have incurred significant losses in every year since our inception. We expect to continue to incur losses over the next several years and may never achieve or maintain profitability.
- Nasdaq has delisted our securities from trading on Nasdaq, which could limit investors’ ability to make transactions in our securities and subject us to additional trading restrictions.
- There is substantial doubt as to our ability to continue as a going concern.
- Our limited operating history makes it difficult to evaluate our business and assess our future viability and prospects.
- Our business is highly dependent on the success of our lead product candidate. If we are unable to advance clinical development, obtain approval of and successfully commercialize our lead product candidate for the treatment of patients in approved indications, our business would be significantly harmed.
- Our engineered CER-T cells represent a novel approach to cancer treatment that creates significant challenges for us.
- Our current product candidates are in early clinical or preclinical development and have never been tested in humans. One or all of our current product candidates may fail in clinical development or suffer delays that materially and adversely affect their commercial viability.
- Success in preclinical studies or clinical trials may not be indicative of results in future clinical trials.
- Manufacturing genetically engineered products is complex and we, or our third-party manufacturers, may encounter difficulties in production. If we or any of our third-party manufacturers encounter such difficulties, our ability to provide supply of our product candidates for clinical trials or our products for patients, if approved, could be delayed or prevented.
- Genetic engineering of T cells to create CER-T cells is a relatively new technology, and if we are unable to use this technology in our intended product candidates, our revenue opportunities will be materially limited.
- We may not be successful in our efforts to identify or discover additional product candidates.
The other 65 risks
- Even if we obtain regulatory approval of a product candidate, the product may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers and others in the medical community.
- Data from our preclinical studies and clinical trials is limited and may change as additional patient data become available or may not be validated in any future or advanced clinical trial.
- We may not be able to file INDs or IND amendments to commence clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed.
- Clinical trials are difficult to design and implement, involve uncertain outcomes and may not be successful.
- We will depend on enrollment of patients in our clinical trials for our product candidates. If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
- If the market opportunities for any of our product candidates are smaller than we believe they are, our revenue may be adversely affected, and our business may suffer.
- We currently have no marketing and sales organization and have no experience in marketing products. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, if licensed, we may not be able to generate product revenue.
- We face competition from companies that have developed or may develop product candidates for the treatment of the diseases that we may target, including companies developing novel therapies and platform technologies. If these companies develop platform technologies or product candidates more rapidly than we do, if their platform technologies or product candidates are more effective or have fewer side effects, our ability to develop and successfully commercialize product candidates may be adversely affected.
- We are highly dependent on our key personnel, including individuals with expertise in cell therapy development and manufacturing, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
- We will need to continue to grow the size of our organization, and we may experience difficulties in managing this growth.
- We may form or seek strategic alliances or enter into licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.
- We will need substantial additional financing to develop our product candidates and implement our operating plans, which financing we may be unable to obtain, or unable to obtain on acceptable terms. If we fail to obtain additional financing, we may be unable to complete the development and commercialization of our product candidates.
- Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates.
- The issuance of shares of our Common Stock upon conversion or exercise of our outstanding Preferred Shares and Common Warrants and other securities that we may issue in future financing transactions may result in substantial dilution to our stockholders.
- If our security measures, or those of our CROs, CDMOs, collaborators, contractors, consultants or other third parties upon whom we rely, are compromised or the security, confidentiality, integrity or availability of our information technology, software, services, networks, communications or data is compromised, limited or fails, we could experience a material adverse impact.
- Disruptions at the FDA, the SEC and other government agencies caused by reduction in staffing, funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
- Business disruptions, including financial institution distress, could seriously harm our future revenue and financial condition and increase our costs and expenses.
- Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
- Our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.
- Our product candidates may target healthy cells expressing target antigens, leading to potentially fatal adverse effects.
- Our product candidates may have serious and potentially fatal cross-reactivity to lipids, peptides or protein sequences within the body.
- If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.
- Public opinion and scrutiny of cell-based immune-oncology therapies for treating cancer, or negative clinical trial results from our cell-based therapy competitors, or auto-immune cell therapy candidates, may impact public perception of our company and product candidates, or impair our ability to conduct our business.
- Our product candidates for which we intend to seek approval as biological products may face competition sooner than anticipated, including from other therapeutic modalities.
- The insurance coverage and reimbursement status of newly-approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for new products could limit our product revenues.
- Even if we obtain regulatory and marketing approval for a product candidate, our product candidates will remain subject to regulatory oversight.
- Prior treatments can alter the cancer or target of CER-T cell therapy and negatively impact chances for achieving clinical activity with our programmed T cells.
- Risks Related to Reliance on Third-Parties
- We will rely on third parties to conduct our clinical trials. If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our product candidates.
- We rely on third parties to manufacture and store our clinical product supplies, and we may have to rely on third parties to produce and process our product candidates, if approved. There can be no assurance that we will be able to establish or maintain relationships with such third parties. We may in the future establish our own manufacturing facility and infrastructure in addition to or in lieu of relying on third parties for the manufacture of our product candidates, which would be costly, time-consuming and which may not be successful.
- We maintain single supply relationships for certain key components, and our business and operating results could be harmed if supply is restricted or ends or the price of raw materials used in our suppliers’ manufacturing process increases.
- Our product candidates rely on the availability of specialty raw materials, which may not be available to us on acceptable terms or at all.
- If we or our third-party suppliers use hazardous, non-hazardous, biological or other materials in a manner that causes injury or violates applicable law, we may be liable for damages.
- Risks Related to Government and Regulation
- Clinical development and the regulatory approval process involve a lengthy and expensive process with an uncertain outcome and results of earlier studies and preclinical data, and trials may not be predictive of future clinical trial results. If our preclinical studies and clinical trials are not sufficient to support regulatory approval of any of our product candidates, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of such product candidate.
- Our manufacturing process needs to comply with FDA regulations relating to the quality and reliability of such processes. Any failure to comply with relevant regulations could result in delays in or termination of our clinical programs and suspension or withdrawal of any regulatory approvals.
- Even if we receive regulatory approval for any of our product candidates, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. Additionally, our product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products.
- Regulatory requirements in the United States and abroad governing cell therapy products have changed frequently and may continue to change in the future, which could negatively impact our ability to complete clinical trials and commercialize our product candidates in a timely manner, if at all.
- We may seek approval of our product candidates, where applicable, under the FDA’s accelerated approval pathway. This pathway may not lead to a faster development, regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approval.
- We may not be able to obtain orphan drug designation or orphan drug exclusivity for one or more of our product candidates, and even if we do, that exclusivity may not prevent the FDA from approving other competing products.
- We are subject to stringent and changing privacy laws, regulations and standards as well as policies, contracts and other obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to enforcement or litigation (that could result in fines or penalties), a disruption of clinical trials or commercialization of products, reputational harm, or other adverse business effects.
- Like many companies, we may use artificial intelligence and machine learning (AI) technologies, including generative AI, to efficiently grow and manage our business. These technologies have increasingly been the focus of attention for lawmakers and regulators around the globe.
- The impact of recent healthcare reform legislation and other changes in the healthcare industry and in healthcare spending on us is currently unknown, and may adversely affect our business model.
- Our business could be negatively impacted by environmental, social and corporate governance matters or our reporting of such matters.
- Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
- Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations.
- Even if we obtain FDA approval of any of our product candidates, we may never obtain approval or commercialize such products outside of the United States, which would limit our ability to realize their full market potential.
- Our business operations and current and future relationships with healthcare professionals, principal investigators, consultants, customers and third-party payors in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, physician payment transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to substantial penalties.
- 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 have a material adverse effect on the success of our business.
- We may be affected by regulatory responses to climate-related issues.
- Risks Related to Intellectual Property
- Our intellectual property rights are valuable, and any inability to protect them could reduce the value of our products, services and brand.
- It is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection. We cannot assure investors that any of the currently pending or future patent applications will result in granted patents, nor can we predict how long it will take for such patents to be granted.
- If we are unable to obtain and maintain patent protection for any products we develop and for our technology, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to commercialize any product candidates we may develop and our technology may be adversely affected.
- Third-party claims of intellectual property infringement may prevent or delay our product discovery and development efforts, and could increase our costs.
- We may not be successful in obtaining or maintaining necessary rights to product components and processes for our manufacturing and development pipeline through acquisitions and in-licenses.
- We may be involved in lawsuits to protect or enforce our patents which could be expensive, time-consuming and unsuccessful.
- Obtaining and maintaining our 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.
- We may be subject to claims challenging the inventorship of our patents and other intellectual property.
- We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
- Issued patents covering our product candidates could be found unpatentable, invalid or unenforceable if challenged in court or the USPTO.
- Changes to patent law in the United States and in foreign jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
- We may not be able to protect our intellectual property rights throughout the world.
- We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
- We may not have sufficient patent lifespan to effectively protect our products and business.
- The life of patent protection is limited, and third parties could develop and commercialize products and technologies similar or identical to ours and compete directly with us after a patent licensed to us expires, which could materially and adversely affect our ability to commercialize our products and technologies.
Legal proceedings
From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. To the knowledge of our management, there is no material litigation, arbitration or governmental proceeding currently pending against us or any members of our management team in their capacity as such.
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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- 14SEC EDGARChristopher B. Ehrlich, Chair
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- 20SEC EDGAREric Francois, Board member
- 21SEC EDGARLindsey Rolfe, Board member
- 22SEC EDGARRobyn Rapaport, Board member
- 23SEC EDGARShami Patel, Board member
- 24SEC EDGARBarbara Kosacz, Board member
- 25SEC EDGARBrian G. Atwood, Board member
- 26SEC EDGARCaroline M. Loewy, Board member
- 27SEC EDGARKathleen Laporte, Board member
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- 30SEC EDGAREntered a material agreement
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- 39SEC EDGAROther events
- 40SEC EDGARListing notice or transfer
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