Overview
- TickerMBIO on Nasdaq2
- IndustryPharmaceutical Preparations2
- HeadquartersNew York, United States2
- Incorporated inDE4
- Business address95 Sawyer Rd, Suite 110, Waltham, Ma 024534
- Filer categoryNon-accelerated filer, Smaller reporting company4
- Legal formCorporation2
- LEI5493004W0VC1DPECQ7792
- StatusActive2
- LEI statusLapsed (not renewed)2
- Registered addressC/O INCORPORATING SERVICES, LTD., 19901 Dover, United States2
- Registered withDivision of Corporations, Department of State, 57094162
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Mustang Bio, Inc. (“Mustang,” “we,” “us,” “our” or the “Company”) is a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs into potential cures for difficult-to-treat cancers. We aim to acquire rights to these technologies by licensing or otherwise acquiring an ownership interest in the technologies, funding their research and development and eventually either out-licensing or bringing the technologies to market.5 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 2025
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.3
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Research and development | -$1.5M | $8.4M |
| Asset impairment | $0 | $3.7M |
| General and administrative | $3.9M | $4.1M |
| Total operating expenses | $2.4M | $16.2M |
| Loss from operations | -$2.4M | -$16.2M |
| Other income | $0 | $314.0K |
| Interest income, net | $511.0K | $179.0K |
| Total other income | $511.0K | $493.0K |
| Net Loss | -$1.9M | -$15.8M |
| Net loss per Class A common and common shares outstanding, basic | -$0.39 | -$38.57 |
| Net loss per Class A common and common shares outstanding, diluted | -$0.39 | -$38.57 |
| Weighted average number of Class A common and common shares outstanding, basic | 4.9M shares | 609.7K shares |
| Weighted average number of Class A common and common shares outstanding, diluted | 4.9M shares | 609.7K 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.3
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $17.3M | $6.8M | |
| Other receivables | $217.0K | $402.0K | |
| Prepaid expenses and other current assets | $110.0K | $200.0K | |
| Property, plant and equipment, held for sale | $0 | $1.2M | |
| Total current assets | $17.6M | $8.6M | |
| Property, plant and equipment, net | $0 | $371.0K | |
| Other assets | $0 | $250.0K | |
| Operating lease right-of-use asset, net | $0 | $81.0K | |
| Total Assets | $17.6M | $9.3M | |
| Accounts payable and accrued expenses | $5.4M | $9.5M | |
| Payables and accrued expenses - related party | $2.5M | $2.7M | |
| Operating lease liabilities - short-term | $0 | $456.0K | |
| Total current liabilities | $7.9M | $12.6M | |
| Deferred income | $150.0K | $150.0K | |
| Operating lease liabilities - long-term | $0 | $422.0K | |
| Total Liabilities | $8.1M | $13.2M | |
| Preferred stock ($0.0001 par value), 2,000,000 shares authorized, 250,000 shares of Class A preferred stock issued and outstanding as of December 31, 2025 and December 31, 2024, respectively | $0 | $0 | |
| Common stock issuable, 278,385 and 69,046 shares as of December 31, 2025 and December 31, 2024, respectively | $273.0K | $611.0K | |
| Additional paid-in capital | $407.9M | $392.2M | |
| Accumulated deficit | -$398.6M | -$396.7M | |
| Total Stockholders' Equity (Deficit) | $9.5M | -$3.9M | $123.0K |
| Total Liabilities and Stockholders' Equity (Deficit) | $17.6M | $9.3M | |
| Preferred stock par value (in dollars per share) | $0.00 | $0.00 | |
| Preferred stock, shares authorized | 2.0M shares | 2.0M shares | |
| Preferred stock, shares issued | 250.0K shares | 250.0K shares | |
| Preferred stock, shares outstanding | 250.0K shares | 250.0K shares | |
| Common stock par value (in dollars per share) | $0.00 | $0.00 | |
| Common stock, shares authorized | 200.0M shares | 200.0M shares | |
| Common stock, shares issuable | 278.4K shares | 69.0K shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $17.3M | $6.8M | |
| Other receivables | $217.0K | $402.0K | |
| Prepaid expenses and other current assets | $110.0K | $200.0K | |
| Property, plant and equipment, held for sale | $0 | $1.2M | |
| Total current assets | $17.6M | $8.6M | |
| Property, plant and equipment, net | $0 | $371.0K | |
| Other assets | $0 | $250.0K | |
| Operating lease right-of-use asset, net | $0 | $81.0K | |
| Total Assets | $17.6M | $9.3M | |
| Accounts payable and accrued expenses | $5.4M | $9.5M | |
| Payables and accrued expenses - related party | $2.5M | $2.7M | |
| Operating lease liabilities - short-term | $0 | $456.0K | |
| Total current liabilities | $7.9M | $12.6M | |
| Deferred income | $150.0K | $150.0K | |
| Operating lease liabilities - long-term | $0 | $422.0K | |
| Total Liabilities | $8.1M | $13.2M | |
| Preferred stock ($0.0001 par value), 2,000,000 shares authorized, 250,000 shares of Class A preferred stock issued and outstanding as of December 31, 2025 and December 31, 2024, respectively | $0 | $0 | |
| Common stock issuable, 278,385 and 69,046 shares as of December 31, 2025 and December 31, 2024, respectively | $273.0K | $611.0K | |
| Additional paid-in capital | $407.9M | $392.2M | |
| Accumulated deficit | -$398.6M | -$396.7M | |
| Total Stockholders' Equity (Deficit) | $9.5M | -$3.9M | $123.0K |
| Total Liabilities and Stockholders' Equity (Deficit) | $17.6M | $9.3M | |
| Preferred stock par value (in dollars per share) | $0.00 | $0.00 | |
| Preferred stock, shares authorized | 2.0M shares | 2.0M shares | |
| Preferred stock, shares issued | 250.0K shares | 250.0K shares | |
| Preferred stock, shares outstanding | 250.0K shares | 250.0K shares | |
| Common stock par value (in dollars per share) | $0.00 | $0.00 | |
| Common stock, shares authorized | 200.0M shares | 200.0M shares | |
| Common stock, shares issuable | 278.4K shares | 69.0K 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.3
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$1.9M | -$15.8M |
| Issuance of common shares - equity fee on equity offerings to Fortress Biotech | $395.0K | $329.0K |
| Common shares issuable - Annual Stock Dividend to Fortress Biotech | $273.0K | $611.0K |
| Research and development - licenses acquired | $0 | $250.0K |
| Stock-based compensation expenses | $129.0K | -$450.0K |
| Depreciation expense | $34.0K | $671.0K |
| Amortization of operating lease right-of-use assets | $7.0K | $152.0K |
| Settlement of payables | -$2.1M | -$2.4M |
| Loss on disposal of property and equipment | $0 | $29.0K |
| Asset impairment | $0 | $3.7M |
| Gain on lease termination | -$394.0K | -$314.0K |
| Prepaid expenses and other assets | $90.0K | $586.0K |
| Other receivables | $435.0K | $494.0K |
| Accounts payable and accrued expenses | -$2.0M | -$591.0K |
| Payable and accrued expenses - related party | -$164.0K | $1.8M |
| Deferred income | $0 | -$120.0K |
| Lease liabilities | -$73.0K | -$447.0K |
| Net cash used in operating activities | -$5.3M | -$11.4M |
| Proceeds from the sale of property and equipment | $1.2M | $0 |
| Net cash from investing activities | $1.2M | $0 |
| Proceeds from issuance of common shares, net of offering costs - equity offering | $6.8M | $5.2M |
| Proceeds from issuance of common shares, net of offering costs - At-the-Market offering | $599.0K | $2.5M |
| Proceeds from warrant exercises | $7.1M | $3.5M |
| Proceeds from issuance of common shares under ESPP | $0 | $48.0K |
| Net cash provided by financing activities | $14.5M | $11.3M |
| Net change in cash and cash equivalents | $10.4M | -$145.0K |
| Issuance of common shares - Founders Agreement and equity fee to Fortress | $611.0K | $591.0K |
| Fair value of assets received | $0 | $2.2M |
| Fair value of supplies received expensed to research and development | $0 | $2.5M |
| Accounts receivable written off | $0 | -$7.0M |
| Accounts payable written off | $0 | $3.6M |
| Deferred purchase consideration | $0 | -$1.3M |
No quarter-by-quarter statement was filed.
Corporate structure
MUSTANG BIO, 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 MUSTANG BIO, INC.
- INTRACOASTAL CAPITAL, LLC Filed SCHEDULE 13G/A on MUSTANG BIO, INC., latest Aug 12, 2025 (3 filings since Feb 11, 2025)
- ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G/A on MUSTANG BIO, INC., latest May 15, 2025 (4 filings since Feb 14, 2024)
- MUSTANG BIO, INC. New York, New York, 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 MUSTANG BIO, 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 |
|---|---|---|---|
| Accumulated depreciation | $5.1M11 Dec 31, 2024 | $4.5M11 Dec 31, 2023 | +15.0% |
| Property and equipment, net | $03 Dec 31, 2025 | $371.0K3 Dec 31, 2024 | −100.0% |
| Operating-lease assets (leased space) | $03 Dec 31, 2025 | $81.0K3 Dec 31, 2024 | −100.0% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $17.3M3 Dec 31, 2025 | $6.8M3 Dec 31, 2024 | +152.5% |
Properties, in its own words
Our corporate and executive office is located at 95 Sawyer Road, Waltham, MA 02453.
Item 2 of the 10-K filed Mar 19, 2026.5
Leadership
Who has led MUSTANG BIO, INC., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chair
President
Chief financial officer
- Chief executive officerManuel Litchman Md. Jun 30, 2017 to now16
- ChairMichael S. Weiss Jun 30, 2017 to Jul 20, 201717
- PresidentManuel Litchman Md. Jun 30, 2017 to now16
- Chief financial officerManuel Litchman Md. Apr 28, 2025 to now18
- Chief financial officerJames B. Murphy Feb 12, 2024 to Feb 12, 202419
- Chief financial officerEliot M. Lurier Jun 7, 2022 to Jun 7, 202220
- Chief financial officerDavid J. Horin Jun 30, 2017 to Jun 30, 201721
Board members and other officers (8)
- OfficerPeter Carney Dec 19, 2023 to Dec 19, 202322
- VP, Fin. & Corp. ControllerBrian Achenbach Nov 27, 2018 to Dec 16, 202123
- Board memberMichael S. Weiss Jan 17, 2020 to Jul 7, 202324
- Board memberMichael J. Zelefsky Apr 29, 2020 to Jul 7, 202325
- Board memberAdam J. Chill Jun 30, 2017 to now26
- Board memberManuel Litchman Md. Jun 30, 2017 to now16
- Board memberNeil Herskowitz Jun 30, 2017 to now27
- Board memberLindsay A. Rosenwald Md. Jul 20, 2017 to Jul 7, 202328
Timeline
- Oct 15, 20268-K Other events29
- Apr 17, 20268-K Listing notice or transfer30
- Dec 23, 20258-K Shareholder vote; Other events31
- Jul 9, 20258-K Other events32
- Mar 5, 20258-K Other events33
- Feb 27, 20258-K Completed an acquisition or sale; Other events34
- Feb 21, 20258-K Shareholder vote35
- Feb 13, 20258-K Entered a material agreement; Ended a material agreement36
- Feb 11, 20258-K Entered a material agreement; Other events37
- Jan 17, 20258-K Change to shareholders' rights; Bylaws or fiscal year changed; Other events38
- Jan 10, 20258-K Shareholder vote39
- Jan 2, 20258-K Shareholder vote40
- Jun 30, 2017New chief executive Manuel Litchman Md. becomes CEO16
- Mar 13, 2015Founded MUSTANG BIO, INC. is founded2
Calendar
Coming up
- Nov 6, 2026Reports results for the quarter ending Sep/202641
When it reported results
- Apr 29, 2024Reported quarterly or annual results42
- Mar 11, 2024Reported quarterly or annual results43
- Nov 14, 2023Reported quarterly or annual results44
- Aug 14, 2023Reported quarterly or annual results45
- May 12, 2023Reported quarterly or annual results46
- Mar 29, 2023Reported quarterly or annual results47
- Nov 14, 2022Reported quarterly or annual results48
- Aug 11, 2022Reported quarterly or annual results49
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
202 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 63 major events, 35 insider forms, 15 large holders, 2 private raises, 67 other. The latest 20:
- Oct 15, 20268-K EDGAR
- Aug 5, 202610-Q EDGAR
- May 5, 202610-Q EDGAR
- Apr 27, 20264 OWNERSHIP DOCUMENT EDGAR
- Apr 17, 20268-K EDGAR
- Mar 19, 202610-K EDGAR
- Jan 5, 20264 EDGAR
- Jan 5, 2026SCHEDULE 13D/A EDGAR
- Dec 30, 20254 OWNERSHIP DOCUMENT EDGAR
- Dec 30, 20254 OWNERSHIP DOCUMENT EDGAR
- Dec 30, 20254 OWNERSHIP DOCUMENT EDGAR
- Dec 23, 20258-K EDGAR
- Dec 3, 2025DEF 14A EDGAR
- Nov 7, 202510-Q EDGAR
- Oct 1, 20254 EDGAR
- Oct 1, 2025SCHEDULE 13D/A EDGAR
- Sep 5, 2025424B5 EDGAR
- Aug 12, 2025SCHEDULE 13G/A EDGAR
- Aug 8, 202510-Q EDGAR
- Jul 9, 20258-K EDGAR
The 202 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
10 open-market trades by officers, directors and large owners since October 2021: 6 buys and 4 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Dec 30, 2025 | Herskowitz NeilDirector | Sale | 247 | $0.96 | $237 | Form 4 |
| Dec 30, 2025 | Chill Adam J.Director | Sale | 4 | $0.95 | $4 | Form 4 |
| Dec 30, 2025 | Jin DavidDirector | Buy | 247 | $0.96 | $237 | Form 4 |
| Sep 13, 2022 | Litchman Manuel MDPresident, CEO and Interim CFO | Buy | 5,000 | $0.52 | $2.6K | Form 4 |
| Sep 13, 2022 | ROSENWALD LINDSAY A MDDirector | Buy | 5,000 | $0.52 | $2.6K | Form 4 |
| Mar 18, 2022 | Litchman Manuel MDPresident, CEO and Interim CFO | Buy | 5,000 | $0.74 | $3.7K | Form 4 |
| Mar 18, 2022 | ROSENWALD LINDSAY A MDDirector | Buy | 4,094 | $0.74 | $3.0K | Form 4 |
| Dec 14, 2021 | Achenbach BrianSVP, Fin. & Corp. Controller | Sale | 4,374 | $1.83 | $8.0K | Form 4 |
| Oct 27, 2021 | Litchman Manuel MDPresident, CEO and Interim CFO | Buy | 65,000 | $2.24 | $145.6K | Form 4 |
| Oct 12, 2021 | Achenbach BrianSVP, Fin. & Corp. Controller | Sale | 4,450 | $2.28 | $10.1K | 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.
- INTRACOASTAL CAPITAL, LLCSCHEDULE 13G/A, 3 filings Feb 11, 2025 to Aug 12, 202550
- ARMISTICE CAPITAL, LLCSCHEDULE 13G/A, 4 filings Feb 14, 2024 to May 15, 202551
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 |
|---|---|---|---|---|
| 2024 | Manuel LitchmanM.D. | 71 | $485.5K | $498.0K52 |
| 2024 | James Murphy | $199.5K | $199.5K52 | |
| 2023 | PresidentChief Executive Officer and Interim Chief Financial Officer | $481.1K | $514.5K52 |
Money raised
Private offerings the company reported to the SEC on 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 |
|---|---|---|---|---|
| Kestra Advisory Services, LLC | 196,991 | $138.3K | 0.0% | +20,949 |
| BlackRock, Inc. | 84,745 | $59.5K | 0.0% | No change |
| Citadel Advisors LLC | 59,459 | $41.7K | 0.0% | +6,259 |
| Geode Capital Management, LLC | 42,240 | $29.7K | 0.0% | −50,550 |
| CFO4Life Group, LLC | 33,510 | $23.5K | 0.0% | +13,049 |
| Vanguard Fiduciary Trust Co | 32,120 | $22.5K | 0.0% | No change |
| Vanguard Capital Management LLC | 25,704 | $18.0K | 0.0% | No change |
| XTX Topco Ltd | 14,648 | $10.3K | 0.0% | New |
| Two Sigma Securities, LLC | 13,742 | $9.6K | 0.0% | New |
| Susquehanna International Group, Llp | 13,664 | $9.6K | 0.0% | New |
| UBS Group AG | 4,155 | $2.9K | 0.0% | +496 |
| Tower Research Capital LLC (TRC) | 1,895 | $1.3K | 0.0% | No change |
| Barclays PLC | 1,121 | $787 | 0.0% | New |
| SBI Securities Co., Ltd. | 509 | $357 | 0.0% | No change |
| Morgan Stanley | 118 | $83 | 0.0% | No change |
| Virtu Financial LLC | 14,356 | $10 | 0.0% | New |
| Cullen/Frost Bankers, Inc. | 13 | $9 | 0.0% | No change |
| Bnp Paribas Financial Markets | 6 | $4 | 0.0% | No change |
| Lanark Financial, Inc. | 3 | $2 | 0.0% | No change |
| Jpmorgan Chase & Co | 2 | $1 | 0.0% | No change |
| Danske Bank A/s | 2 | $1 | 0.0% | No change |
| Group One Trading LLC | 1 | $1 | 0.0% | No change |
| Osaic Holdings, Inc. | 2 | $1 | 0.0% | No change |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How MUSTANG BIO, INC. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARMUSTANG BIO, INC.1
- CIK0001680048
- Employer ID (EIN)47-38287605
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company5
- Incorporated inDelaware5
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address95 Sawyer Rd, Suite 110, Waltham, MA 024531
- Phone78165245001
- Shares outstanding845,385 Common Class A shares; 6,732,092 Common Unspecified Class shares as of Mar 17, 20265
- Public float$3.2M as of Jun 30, 20255
- AuditorKPMG LLP, New York, NY PCAOB ID 185; no auditor attestation of internal control over financial reporting5
- On EDGAR sinceJul 28, 20161
- Filings403 in all: 8-K (112), 4 (64), 10-Q (30), UPLOAD (18), CORRESP (17), 424B5 (15), 3 (14), EFFECT (11)1
All 42 form types
10-K (10), DEF 14A (9), DEFA14A (7), DEF 14C (6), PRE 14C (6), S-3 (6), S-8 (6), 424B3 (5), D/A (5), S-1/A (5), SC 13G (5), 3/A (4), D (4), S-1 (4), SCHEDULE 13D/A (4), 10-12G/A (3), 4/A (3), CT ORDER (3), PRE 14A (3), SC 13D/A (3), SCHEDULE 13G/A (3), 424B4 (2), PX14A6G (2), S-3/A (2), SC 13G/A (2), SCHEDULE 13G (2), 10-12G (1), 10-Q/A (1), 8-A12B (1), CERTNAS (1), POS AM (1), POS EX (1), PRER14C (1), SC 13D (1)
- Latest filingsAnnual report (10-K) Mar 19, 2026
Quarterly report (10-Q) Aug 5, 2026
Proxy statement (DEF 14A) Dec 3, 2025
Latest 8-K (8-K) Oct 15, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.0001 per share | MBIO | Nasdaq |
From the cover page of the 10-K filed Mar 19, 2026 (Section 12(b) of the Exchange Act).5
Risk factors and legal proceedings
The risks MUSTANG BIO, INC. names in Item 1A of its 10-K filed Mar 19, 2026: 67 risks under these headings, as written.5
- Risks Related to Our Finances and Capital Requirements
- We have incurred significant losses since our inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability. We do not have any products that are approved for commercial sale and therefore do not expect to generate any revenues from product sales in the foreseeable future, if ever.
- We may in the future need to raise substantial additional funding, which may not be available on acceptable terms to us, or at all. If we are unable to raise capital, we could be required to delay, limit or terminate our product development efforts or other operations, or seek bankruptcy protection or other alternatives that would likely result in our securityholders losing some or all of their investment in us.
- Our limited operating history makes it difficult to evaluate our business and prospects.
- SEC regulations limit the amount of funds we can raise during any 12-month period pursuant to our shelf registration statement on Form S-3.
- Raising additional capital, including through lending arrangements, may cause dilution to our existing stockholders, restrict our operations or require us to relinquish proprietary rights.
- We will continue to incur significant increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.
- We are a "smaller reporting company," and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.
- Our ability to use our pre-change net operating loss carryforwards and other pre-change tax attributes to offset post-change taxable income or taxes may be subject to limitation.
- Risks Related to Our Business Strategy, Structure, and Organization
- We currently have no products for sale. We are heavily dependent on the success of our product candidates, and we cannot give any assurances that any of our product candidates will receive regulatory approval or be successfully commercialized.
- Our approach to the development of our product candidates is unproven, and we do not know whether we will be able to develop any products of commercial value.
The other 57 risks
- CAR T is a relatively new approach to cancer treatment that presents significant challenges.
- We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
- Risks Inherent in Drug Development and Commercialization
- Delays in the commencement or conduct of our clinical trials could result in increased costs and delay our ability to pursue regulatory approval.
- Suspensions or delays in the completion of clinical testing could result in increased costs, and delay or prevent our ability to complete development of that product candidate or generate product revenues, if approved.
- Product candidates that we advance into clinical trials may not receive regulatory approval.
- Any product candidates we advance into clinical development are subject to extensive regulation, which can be costly and time consuming, cause unanticipated delays or prevent the receipt of the required approvals to commercialize product candidates.
- Regulatory approval for our product candidates by the FDA, or any similar regulatory authorities outside the United States, is limited to those specific indications and conditions for which clinical safety and efficacy have been demonstrated.
- If any of our product candidates are approved and we, or our contract manufacturer(s), fail to produce the product, or components of the product, in the volumes that we require on a timely basis, or fail to comply with stringent regulations applicable to pharmaceutical drug manufacturers, we may face delays in the commercialization of our product candidates, if approved, or be unable to meet market demand, and may lose potential revenues.
- If serious adverse events are identified during the development of one or more of our product candidates or any future product candidate, we may need to abandon or limit the development of some of our product candidates.
- Even if one or more of our product candidates receives regulatory approval, it and any other products we may market will remain subject to substantial regulatory scrutiny.
- We will need to obtain FDA approval of any proposed product brand names, and any failure or delay associated with such approval may adversely impact our business.
- Public concern regarding the safety of drug products could delay or limit our ability to obtain regulatory approval, result in the inclusion of unfavorable information in our labeling, or require us to undertake other activities that may entail additional costs.
- If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
- If our competitors develop treatments for any of our product candidates’ target indications and those competitor products are approved more quickly, marketed more successfully or demonstrated to be more effective, the commercial opportunity for our product candidate will be reduced or eliminated.
- If any of our product candidates are successfully developed but, if approved, do not achieve broad market acceptance among physicians, patients, healthcare payors and the medical community, the revenues that any such product candidates generate from sales will be limited.
- Reimbursement may be limited or unavailable in certain market segments for our product candidates, which could make it difficult for us to sell our products profitably.
- If we are unable to establish sales, marketing and distribution capabilities or to enter into agreements with third parties to market and sell our product candidates, we may be unsuccessful in commercializing our product candidates, if they are approved.
- We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability for one or more of our product candidates or a future product candidate, if approved, we may license or acquire and may have to limit their commercialization.
- Product candidates, even if successfully developed and commercialized, may be effective only in combating certain specific types of cancer, and the market for drugs designed to combat such cancer type(s) may be small and unprofitable.
- Negative public opinion and increased regulatory scrutiny of the therapies that underpin many of our product candidates may damage public perception of our product candidates or adversely affect our ability to conduct our business or obtain regulatory approvals for our product candidates.
- Changes in U.S. government policy, regulation, enforcement priorities, and funding decisions could adversely affect our business, financial condition and results of operations.
- Risks Related to Reliance on Third Parties
- We rely, and expect to continue to rely, on third parties to conduct our preclinical studies and clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials or complying with applicable regulatory requirements.
- We are currently reliant on COH, Nationwide and UAB for all of our research and development efforts and the early clinical testing of our product candidates.
- We contract with third parties for the manufacture of our product candidates for preclinical and clinical testing and may also do so for commercialization, if and when our product candidates are approved. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or any future product candidate or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
- We rely on third parties to conduct all aspects of our LV vector production and these third parties may not perform satisfactorily.
- We rely on clinical data and results obtained by third parties that could ultimately prove to be inaccurate or unreliable.
- 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.
- Collaborative relationships with third parties could cause us to expend significant resources and incur substantial business risk with no assurance of financial return.
- The contractual provisions we may be forced to agree upon in services, manufacturing, supply and other agreements may be inordinately one-sided, vis-à-vis current or historical standard market terms (especially as it pertains to contractual liability and indemnification paradigms), and as a result we may be subject to liabilities that are not attributable to our own actions or the actions of our personnel.
- Risks Relating to Legislation and Regulation Affecting the Biopharmaceutical and Other Industries
- We are subject to new legislation, regulatory proposals and managed care initiatives that may increase our costs of compliance and adversely affect our ability to market our products, obtain collaborators and raise capital.
- Changes in funding for the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new products and services from being developed or commercialized in a timely manner, which could negatively impact our business or the business of our partners.
- Our current and future relationships with 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, transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
- 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.
- Risks Related to Intellectual Property and Potential Disputes Thereof
- If we are unable to obtain and maintain sufficient patent protection for our technology and products, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and products may be impaired.
- We depend on our licensors to maintain and enforce the intellectual property covering certain of our product candidates. We have limited, if any, control over the resources that our licensors can or will devote to securing, maintaining, and enforcing patents protecting our product candidates.
- Protecting our proprietary rights is difficult and costly, and we may be unable to ensure their protection.
- We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful, and an unfavorable outcome in any litigation would harm our business.
- If we or our licensors are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business.
- Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
- If we fail to comply with our obligations under our intellectual property licenses and third-party funding arrangements, we could lose rights that are important to our business.
- We may be subject to claims that our employees and/or consultants have wrongfully used or disclosed to us alleged trade secrets of their former employers or other clients.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- We in-license intellectual property pertaining to certain product candidates from third parties. As such, any dispute with the licensors or the non-performance of such license agreements may adversely affect our ability to develop and commercialize the applicable product candidates.
- Risks Relating to Our Control by Fortress
- Fortress controls a voting majority of our common stock.
- Fortress has the right to receive a significant grant of shares of our common stock annually which will result in the dilution of your holdings of common stock upon each grant, which could reduce their value.
- We might have received better terms from unaffiliated third parties than the terms we receive in our agreements with Fortress.
- The dual roles of our directors who also serve in similar roles with Fortress could create a conflict of interest and will require careful monitoring by our independent directors.
- General Risks and Risks Associated with Ownership of our Common Stock
- We rely on information technology, and our business, reputation and operations would suffer in the event of any internet or internal computer system failures, inadequacies, interruptions, compromises, deficiencies, cyber-attacks, or other cybersecurity incidents affecting our systems or those of our third-party providers, or by any compromise of confidential information.
- Our growth is subject to economic and geopolitical conditions.
- We may not be able to manage our business effectively if we are unable to attract and retain key personnel.
- Our employees, consultants, or third-party partners may engage in misconduct or other improper activities, including but not necessarily limited to noncompliance with regulatory standards and requirements or internal procedures, policies or agreements to which such employees, consultants and partners are subject, any of which could have a material adverse effect on our business.
- The occurrence of a catastrophic disaster could damage our facilities beyond insurance limits, or we could lose key data which could cause us to curtail or cease operations.
- The market price for our common stock has been volatile and may continue to fluctuate or may decline significantly in the future.
- We may become involved in securities class action litigation that could divert management’s attention and harm our business.
- If we are unable to maintain compliance with all applicable continued listing requirements and standards of Nasdaq, our common stock may be delisted from Nasdaq.
Legal proceedings
We are not involved in any legal proceedings that we believe could have a material adverse effect on our financial position or results of operations. There is no action, suit, proceeding, inquiry or investigation before or by any court, public board, government agency, self-regulatory organization or body pending or, to the knowledge of our executive officers, threatened against or affecting our company or our officers or directors in their capacities as such.
The opening of Item 3, Legal Proceedings.5
Sources
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- 17SEC EDGARMichael S. Weiss, Chair
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- 24SEC EDGARMichael S. Weiss, Board member
- 25SEC EDGARMichael J. Zelefsky, Board member
- 26SEC EDGARAdam J. Chill, Board member
- 27SEC EDGARNeil Herskowitz, Board member
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