Alaunos Therapeutics(TCRT) - 2023 Q3 - Quarterly Report

Form 10-Q Filing Information This section provides basic identification details for Alaunos Therapeutics, Inc., including its filing type, incorporation state, and stock exchange listing Registrant Information This section provides the basic identification details for Alaunos Therapeutics, Inc., including its filing type (Quarterly Report on Form 10-Q for the period ended September 30, 2023), incorporation state, principal executive offices, and stock exchange listing - The registrant is Alaunos Therapeutics, Inc., a Delaware corporation, filing a Quarterly Report on Form 10-Q for the period ended September 30, 2023[2] Common Stock Listing | Title of each class | Symbol(s) | Name of each exchange on which registered | | :------------------ | :-------- | :---------------------------------------- | | Common Stock | TCRT | The Nasdaq Stock Market LLC | - The company is classified as a Non-Accelerated Filer and a Smaller Reporting Company[4] Outstanding Shares As of November 9, 2023, the company reported 240,627,055 shares of common stock outstanding - As of November 9, 2023, the number of outstanding shares of the registrant's common stock, $0.001 par value, was 240,627,055 shares[4] Special Note Regarding Forward-Looking Statements This section highlights that the report contains forward-looking statements, which are based on management's current beliefs and assumptions but involve risks and uncertainties that could cause actual results to differ materially - Forward-looking statements are identified by terms such as 'anticipate,' 'believe,' 'estimate,' 'expect,' 'forecast,' 'intend,' 'may,' 'plan,' 'project,' 'target,' 'will' and other similar words[6] - These statements are subject to risks, uncertainties, and other factors that may cause actual results to be materially different from those expressed or implied[7] - Key forward-looking statements include the ability to implement strategic reprioritization, raise additional capital, consummate strategic transactions, and maintain Nasdaq listing[10] Summary of Selected Risks Associated with Our Business This section provides a high-level overview of significant risks facing the company, including the potential failure of its strategic reprioritization, the need for substantial additional financing, the impact of litigation, the halt in product development, intellectual property concerns, stock price volatility, and Nasdaq delisting - The strategic reprioritization may not be successful, and the company may fail to identify or implement any strategic transaction[12] - Substantial additional financial resources are required to continue as a going concern, and raising funds may dilute existing investments[12] - The company has halted development of its product candidates, which were in early-stage clinical trials, and faces uncertainty regarding future BLA submissions[12] - The company received a Delisting Determination from Nasdaq, which could negatively impact stock trading and strategic transactions[12] PART I. FINANCIAL INFORMATION This section presents the unaudited condensed financial statements and management's discussion and analysis of the company's financial condition and results of operations Item 1. Condensed Financial Statements (unaudited) This section presents the unaudited condensed financial statements for Alaunos Therapeutics, Inc., including the balance sheets, statements of operations, statements of changes in stockholders' equity, and statements of cash flows, along with comprehensive notes explaining the company's financial position, performance, and significant accounting policies Condensed Balance Sheets The condensed balance sheets show a significant decrease in total assets and stockholders' equity from December 31, 2022, to September 30, 2023, primarily driven by a reduction in cash and cash equivalents and the accumulated deficit Condensed Balance Sheet Data | Metric (in thousands) | September 30, 2023 | December 31, 2022 | | :-------------------- | :----------------- | :---------------- | | Cash and cash equivalents | $11,944 | $39,058 | | Restricted cash | — | $13,938 | | Total current assets | $12,869 | $53,799 | | Total assets | $19,440 | $64,937 | | Total current liabilities | $4,676 | $24,166 | | Total liabilities | $5,540 | $26,382 | | Total stockholders' equity | $13,900 | $38,555 | | Accumulated deficit | $(907,924) | $(880,627) | - Cash and cash equivalents decreased by approximately $27.1 million, and restricted cash was fully utilized, contributing to a $40.9 million decrease in total current assets[17] - Total stockholders' equity decreased by $24.6 million, largely due to the accumulated deficit increasing by $27.3 million[17] Condensed Statements of Operations The condensed statements of operations show a significant decline in collaboration revenue and continued net losses for both the three and nine months ended September 30, 2023, compared to the same periods in 2022, reflecting the company's strategic reprioritization and wind-down of clinical activities Condensed Statements of Operations Data | Metric (in thousands) | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :-------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Collaboration Revenue | $— | $2,911 | $4 | $2,911 | | Research and development | $3,656 | $7,893 | $15,346 | $19,411 | | General and administrative | $3,578 | $3,282 | $9,791 | $10,217 | | Total operating expenses | $8,664 | $11,175 | $26,322 | $29,495 | | Net loss | $(8,476) | $(8,851) | $(27,297) | $(28,571) | | Basic and diluted net loss per share | $(0.04) | $(0.04) | $(0.11) | $(0.13) | - Collaboration revenue decreased to $0 for the three months and $4 thousand for the nine months ended September 30, 2023, from $2.9 million in the prior year periods, primarily due to non-recurrence of revenue from the Solasia License and Collaboration Agreement[20][156] - Research and development expenses decreased by 54% for the three months and 21% for the nine months ended September 30, 2023, mainly due to the wind-down of clinical activities and reduced headcount[20][157][158] Condensed Statements of Changes in Stockholders' Equity The condensed statements of changes in stockholders' equity reflect a decrease in total equity, primarily driven by net losses, partially offset by stock-based compensation and minor common stock issuances Condensed Statements of Changes in Stockholders' Equity Data | Metric (in thousands) | Balance at Dec 31, 2022 | Stock-based compensation | Issuance of common stock, net | Net loss | Balance at Sep 30, 2023 | | :-------------------- | :---------------------- | :----------------------- | :---------------------------- | :------- | :---------------------- | | Common Stock Amount | $240 | — | $1 | — | $241 | | Additional Paid-in Capital | $918,942 | $2,550 | $91 | — | $921,583 | | Accumulated Deficit | $(880,627) | — | — | $(27,297) | $(907,924) | | Total Stockholders' Equity | $38,555 | $2,550 | $92 | $(27,297) | $13,900 | - For the nine months ended September 30, 2023, total stockholders' equity decreased from $38.6 million to $13.9 million, primarily due to a net loss of $27.3 million[25] Condensed Statements of Cash Flows The condensed statements of cash flows indicate a significant net decrease in cash, cash equivalents, and restricted cash for the nine months ended September 30, 2023, primarily due to cash used in operating activities and a substantial repayment of long-term debt Condensed Statements of Cash Flows Data | Cash Flow Activity (in thousands) | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :-------------------------------- | :-------------------------- | :-------------------------- | | Net cash used in operating activities | $(22,757) | $(22,102) | | Net cash used in investing activities | $(157) | $(100) | | Net cash used in financing activities | $(18,138) | $(2,107) |\ | Net decrease in cash, cash equivalents and restricted cash | $(41,052) | $(24,309) | | Cash and cash equivalents, end of period | $11,944 | $51,745 | - Net cash used in operating activities increased slightly to $22.8 million in 2023, mainly due to changes in working capital[30][182] - Net cash used in financing activities significantly increased to $18.1 million in 2023, primarily due to the full repayment of long-term debt[30][185] Notes to Condensed Financial Statements (unaudited) These notes provide detailed explanations and disclosures for the condensed financial statements, covering organization, financing, debt, fair value, net loss per share, related party transactions, leases, commitments, stock-based compensation, warrants, restructuring, joint venture dissolution, and subsequent events Note 1. Organization Alaunos Therapeutics, Inc. is a clinical-stage oncology cell therapy company that announced a strategic reprioritization in August 2023, winding down its clinical trial and reducing its workforce, which, combined with an accumulated deficit and limited cash runway, raises substantial doubt about its going concern ability - Alaunos Therapeutics, Inc. is a clinical-stage oncology-focused cell therapy company, leveraging its proprietary non-viral Sleeping Beauty gene transfer platform and cancer mutation hotspot TCR library[32] - On August 14, 2023, the company announced a strategic reprioritization, winding down its TCR-T Library Phase 1/2 Trial and reducing its workforce by approximately 80% to cut costs and extend its cash runway[34] - As of September 30, 2023, the company had $11.9 million in cash and cash equivalents and an accumulated deficit of $907.9 million, with cash resources projected to fund operations only into the second quarter of 2024, raising substantial doubt about its going concern ability[37][38] Note 2. Financings This note details the company's financing activities, including the repayment of the 2021 Loan and Security Agreement with Silicon Valley Bank, the 2022 Equity Distribution Agreement for an 'at the market offering' (with no sales in 2023), and the 2022 Public Offering which generated $14.7 million in net proceeds - The company repaid its outstanding debt obligations under the Loan and Security Agreement with Silicon Valley Bank in their entirety on May 1, 2023[47] - Under the 2022 Equity Distribution Agreement, the company can sell up to $50.0 million in common stock through an 'at the market offering,' but no sales occurred during the three and nine months ended September 30, 2023[49][52] - A 2022 Public Offering of common stock generated net proceeds of $14.7 million, with Cantor Fitzgerald & Co. acting as the sole underwriter[53][54] Note 3. Summary of Significant Accounting Policies This note states that there have been no material changes to the company's significant accounting policies since the filing of its Annual Report on Form 10-K for the year ended December 31, 2022 - No material changes have occurred in the company's significant accounting policies since the filing of its Annual Report[56] Note 4. Debt The company fully repaid its Loan and Security Agreement with Silicon Valley Bank on May 1, 2023, including principal, accrued interest, a final payment, and a prepayment premium, resulting in the debt balance being reduced to zero as of September 30, 2023 Debt Balances | Debt (in thousands) | September 30, 2023 | December 31, 2022 | | :------------------ | :----------------- | :---------------- | | Loan and Security Agreement | $— | $17,395 | | Unamortized discount | $— | $(630) | | Total debt | $— | $16,765 | - On May 1, 2023, the company fully repaid its outstanding obligations under the SVB Facility, including principal, accrued interest, a $0.5 million Final Payment, and a $0.1 million prepayment premium[60] - Interest expense, including amortization of issuance costs, was $0 for the three months ended September 30, 2023, and $1.9 million for the nine months ended September 30, 2023, a decrease from $0.8 million and $2.3 million respectively in 2022[64] Note 5. Fair Value Measurements The company's financial assets measured at fair value primarily consist of cash equivalents classified as Level 1. Following its strategic reprioritization in August 2023, the company recognized a $1.0 million impairment charge on property and equipment and a $0.1 million impairment charge on prepaid expenses due to changes in their intended use Fair Value Measurements | Description (in thousands) | Balance as of Sep 30, 2023 | Quoted Prices in Active Markets (Level 1) | | :------------------------- | :------------------------- | :---------------------------------------- | | Cash equivalents | $11,681 | $11,681 | - Following the strategic reprioritization on August 14, 2023, the company recorded a $1.0 million impairment charge on property and equipment (primarily lab equipment and leasehold improvements)[70] - An additional $0.1 million impairment charge was recorded for prepaid expenses and other current assets, recognized in research and development expenses[71] Note 6. Net loss per share Basic and diluted net loss per share calculations are presented, with potentially dilutive shares (options, restricted stock, warrants) excluded as their effect was antidilutive due to the net loss Potentially Dilutive Shares | Metric | September 30, 2023 | September 30, 2022 | | :----- | :----------------- | :----------------- | | Common stock options | 12,417,029 | 10,623,215 | | Unvested restricted stock | 437,500 | 940,000 | | Warrants | 22,922,342 | 22,922,342 | | Total Potentially Dilutive Shares | 35,776,871 | 34,485,557 | - The effect of computing diluted net loss per common share was antidilutive for all potentially issuable shares, leading to their exclusion from the calculation[73] Note 7. Related Party Transactions This note discusses the dissolution of Eden BioCell, a joint venture with TriArm Therapeutics, which was established to commercialize CAR-T therapies in Greater China and Korea, with the entity formally dissolved as of July 2023 - The Eden BioCell joint venture, formed with TriArm Therapeutics to commercialize CAR-T therapies in Greater China and Korea, was mutually agreed to be dissolved in September 2021[75] - The Eden BioCell entity was formally dissolved as of July 2023[75] Note 8. Leases The company has undertaken several lease modifications and terminations, including reducing its Houston office space in April 2022, terminating its Boston office lease in April 2023, and further terminating Houston office and laboratory leases effective November 2023, resulting in gains on lease modifications and reduced lease liabilities - In April 2022, the company modified its Houston lease, reducing space and remeasuring lease liability and right-of-use asset to $0.4 million, resulting in a $0.1 million gain[76] - On April 19, 2023, the Boston office lease was terminated, incurring $0.2 million in termination costs but resulting in a $0.2 million gain on lease termination[77] - Further Houston office and laboratory leases were mutually terminated with MD Anderson, effective November 15, 2023, with a final payment of $0.1 million[80] Note 9. Commitments and Contingencies This note details the company's various license agreements with Precigen, MD Anderson, and the NCI, outlining changes in obligations, royalties, and milestones, and covers the collaboration agreement with Solasia Pharma K.K. and the settlement of the KBI Biopharma litigation for $1.0 million - The Amended and Restated Exclusive License Agreement with Precigen (April 3, 2023) eliminated royalty and milestone obligations, reducing the annual license fee to $75 thousand[85][86] - The company provided notice on October 27, 2023, to terminate the Patent License with the NCI, effective 60 days from notice, due to its own proprietary TCR discovery platform[103] - The Cooperative Research and Development Agreement (CRADA) with the NCI was terminated by the company, effective October 13, 2023, as part of strategic alternatives exploration[110] - The company accrued $1.0 million as of September 30, 2023, to settle all claims in the KBI Biopharma litigation[117] Note 10. Stock-Based Compensation Stock-based compensation expense decreased for both the three and nine months ended September 30, 2023, compared to 2022, with fewer stock options granted in 2023 and unrecognized compensation costs for unvested options and restricted stock expected to be recognized over weighted-average periods of 1.70 and 1.48 years, respectively Stock-Based Compensation Expense | Stock-Based Compensation (in thousands) | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | | :-------------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Research and development | $90 | $145 | $446 | $673 | | General and administrative | $636 | $663 | $2,104 | $1,978 | | Total Stock-based compensation expense | $726 | $808 | $2,550 | $2,651 | - The company granted 10,000 stock options (weighted-average fair value $0.39/share) in Q3 2023 and 3,695,167 options (weighted-average fair value $0.39/share) for the nine months, significantly less than in 2022[119] - Total unrecognized compensation costs for unvested stock options were $4.2 million (expected recognition over 1.70 years) and for unvested restricted stock were $0.7 million (expected recognition over 1.48 years) as of September 30, 2023[121][122] Note 11. Warrants This note details the company's outstanding warrants, including the 2019 Warrants issued to investors (exercise price $7.00), the MD Anderson Warrant (exercise price $0.001, vesting upon clinical milestones not yet met), and the SVB Warrants (exercise price $1.16, fully vested upon issuance) - The company issued 2019 Warrants to purchase up to 17,803,031 shares of common stock with an exercise price of $7.00, expiring on the fifth anniversary of the initial exercise date[125] - The MD Anderson Warrant, issued in connection with the 2019 R&D Agreement, allows for the purchase of 3,333,333 shares at $0.001 per share, vesting upon certain clinical milestones which have not yet been met[126][128] - SVB Warrants for up to 649,615 shares of common stock, with an exercise price of $1.16 per share, were fully vested upon issuance and expire on August 6, 2031; none have been exercised as of September 30, 2023[129] Note 12. Restructuring Following its strategic reprioritization announcement on August 14, 2023, the company reduced its workforce by approximately 60% in Q3 2023 and recorded $0.4 million in termination benefits as restructuring costs, which were fully paid by September 30, 2023 - On August 14, 2023, the company announced a strategic reprioritization and wind-down of its TCR-T Library Phase 1/2 Trial, leading to a workforce reduction of approximately 60% in Q3 2023[130] - The company recorded $0.4 million in termination benefits as restructuring costs during the three and nine months ended September 30, 2023, which were fully paid by the end of the period[130] Note 13. Joint Venture This note confirms the dissolution of Eden BioCell, a joint venture with TriArm, as of July 2023, where the company had accounted for its 50% equity interest under the equity method, as it did not have primary beneficiary control over the variable interest entity - The Eden BioCell joint venture, formed with TriArm Therapeutics, was mutually agreed to be dissolved in September 2021 and formally dissolved as of July 2023[135] - The company held a 50% equity interest in Eden BioCell and accounted for it under the equity method, as it was deemed a variable interest entity where the company was not the primary beneficiary[133][134] Note 14. Subsequent Events The company has evaluated subsequent events through the issuance date of the financial statements and reported no material subsequent events other than those already described in other notes - No material subsequent events were identified that impacted the condensed financial statements or disclosures, beyond those already detailed in other notes[136] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial condition and results of operations, highlighting the strategic reprioritization, wind-down of clinical trials, workforce reduction, and ongoing exploration of strategic alternatives Overview Alaunos Therapeutics, Inc. is a clinical-stage oncology cell therapy company that has historically focused on developing adoptive TCR-T cell therapies. The company has incurred significant net losses since its inception, with an accumulated deficit of $907.9 million as of September 30, 2023. In August 2023, it announced a strategic reprioritization, winding down its TCR-T Library Phase 1/2 Trial, reducing its workforce by 80%, and exploring strategic alternatives - Alaunos Therapeutics is a clinical-stage oncology-focused cell therapy company developing adoptive TCR-T cell therapy for solid tumors, leveraging its Sleeping Beauty gene transfer platform[140] - The company has incurred significant net losses since inception, with a net loss of $27.3 million for the nine months ended September 30, 2023, and an accumulated deficit of $907.9 million[141] - On August 14, 2023, the company announced a strategic reprioritization, winding down its TCR-T Library Phase 1/2 Trial, reducing its workforce by approximately 80%, and exploring strategic alternatives[142] Recent Developments Recent developments include the wind-down of the TCR-T Library Phase 1/2 Trial despite encouraging data (13% objective response rate, 87% disease control rate), the discovery of proprietary TCRs through the hunTR® Platform, ongoing exploration of strategic alternatives, and a Nasdaq Delisting Determination due to the stock price falling below $0.10 - The TCR-T Library Phase 1/2 Trial treated eight patients, showing T-cells were generally well-tolerated with no DLTs or ICANS, and one patient achieved an objective partial response (13% overall response rate, 87% disease control rate)[143][144] - Despite positive trial data, the company will not pursue further clinical program development due to substantial costs and the current financing environment[146] - The hunTR® Platform has discovered multiple proprietary TCRs targeting driver mutations, including KRAS and TP53, with potential for a large patient population[147] - The company received a Nasdaq Delisting Determination on November 8, 2023, due to its common stock trading below $0.10 for 10 consecutive days, but intends to appeal to remain listed while exploring strategic transactions[149][150] Financial Overview This section outlines the components of the company's financial statements, including collaboration revenue, research and development expenses, general and administrative expenses, restructuring costs, and other income/expense - Collaboration revenue is recognized over the estimated period of performance, with no product revenue generated to date[151] - Research and development expenses primarily include salaries, contract manufacturing, clinical trial fees, and license payments[152] - Restructuring costs consist of severance provided to terminated employees as part of the strategic reprioritization[154] Results of Operations For the three and nine months ended September 30, 2023, collaboration revenue significantly decreased to near zero. Research and development expenses decreased due to clinical wind-down and reduced headcount, while general and administrative expenses saw a slight increase in Q3 2023 due to legal costs. The company recorded gains on lease modifications and incurred new restructuring costs and asset impairment charges related to its strategic reprioritization Results of Operations Summary | Metric (in thousands) | 3 Months Ended Sep 30, 2023 | 3 Months Ended Sep 30, 2022 | Change (3M) | 9 Months Ended Sep 30, 2023 | 9 Months Ended Sep 30, 2022 | Change (9M) | | :-------------------- | :-------------------------- | :-------------------------- | :---------- | :-------------------------- | :-------------------------- | :---------- | | Collaboration Revenue | $— | $2,911 | $(2,911) | $4 | $2,911 | $(2,907) | | Research and Development Expenses | $3,656 | $7,893 | $(4,237) | $15,346 | $19,411 | $(4,065) | | General and Administrative Expenses | $3,578 | $3,282 | $296 | $9,791 | $10,217 | $(426) | | Gain on Lease Modification | $— | $— | $— | $(245) | $(133) | $(112) | | Restructuring Costs | $419 | $— | $419 | $419 | $— | $419 | | Property and Equipment and Right-of-Use Asset Impairment | $1,011 | $— | $1,011 | $1,011 | $— | $1,011 | | Other Income (Expense), Net | $188 | $(587) | $775 | $(979) | $(1,987) | $1,008 | - Research and development expenses decreased by $4.2 million (54%) for the three months and $4.1 million (21%) for the nine months ended September 30, 2023, primarily due to the wind-down of clinical activities and reduced headcount[157][158] - General and administrative expenses increased by $0.3 million for the three months ended September 30, 2023, due to higher legal costs, but decreased by $0.4 million for the nine months due to lower employee-related expenses and insurance fees[160][161] - A $1.0 million impairment charge on property and equipment and right-of-use assets was recorded in Q3 2023 following the strategic reprioritization[164] Liquidity and Capital Resources The company, which has not generated product revenue and incurs net losses, anticipates cash resources will fund operations only into the second quarter of 2024, raising substantial doubt about its going concern ability, while actively exploring strategic alternatives - The company has not generated product revenue and has incurred net losses and negative cash flows since inception, financing operations primarily through equity issuances and debt[167] - As of September 30, 2023, the company had $11.9 million in cash and cash equivalents, with resources anticipated to fund operations only into the second quarter of 2024, leading to substantial doubt about its going concern ability[169][170] - Net cash used in operating activities for the nine months ended September 30, 2023, was $22.8 million, and net cash used in financing activities was $18.1 million, primarily due to the full repayment of long-term debt[182][185] - The company is actively exploring strategic alternatives, including acquisitions, mergers, or strategic partnerships, and has engaged Cantor Fitzgerald & Co. as a strategic advisor[168] Critical Accounting Policies and Estimates The company's critical accounting policies and estimates, identified in its 2022 Annual Report on Form 10-K, remain unchanged and relate to clinical trial and R&D expenses, collaboration agreements, fair value measurements for stock-based compensation, and income taxes - The most critical accounting policies and estimates include those related to clinical trial and other research and development expenses, collaboration agreements, fair value measurements for stock-based compensation, and income taxes[201] - There have been no changes to these critical accounting policies and estimates for the three and nine months ended September 30, 2023[201] Item 3. Quantitative and Qualitative Disclosures about Market Risk As a smaller reporting company, Alaunos Therapeutics, Inc. is not required to provide quantitative and qualitative disclosures about market risk - The company is exempt from providing quantitative and qualitative disclosures about market risk due to its status as a smaller reporting company[202] Item 4. Controls and Procedures Management, with the participation of its principal executive and accounting officers, concluded that the company's disclosure controls and procedures were effective as of September 30, 2023, with no material changes in internal control over financial reporting during the quarter - As of September 30, 2023, the company's disclosure controls and procedures were evaluated and deemed effective by management[203] - No material changes in internal control over financial reporting occurred during the quarter ended September 30, 2023[204] PART II. OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, defaults, mine safety, other information, and exhibits Item 1. Legal Proceedings This section discloses that the company is generally subject to legal proceedings in the ordinary course of business, specifically detailing the KBI Biopharma litigation, which was settled for $1.0 million as of October 20, 2023, with the amount accrued as of September 30, 2023 - The company settled the KBI Biopharma litigation for $1.0 million on October 20, 2023, and accrued this amount as of September 30, 2023[209] - KBI had initially sought unspecified monetary damages exceeding $3.2 million for alleged breach of a Master Services Agreement[209] Item 1A. Risk Factors This section outlines various significant risks that could materially and adversely affect the company's business, financial condition, and results of operations, categorized into those related to the strategic reprioritization, general business operations, clinical testing and government regulation, commercialization capabilities, intellectual property, and other company-specific factors - Risks related to the strategic reprioritization include the potential for the strategy to fail, the inability to realize anticipated benefits from transactions, and the need for substantial additional financial resources[211][219][220] - Business risks include the Nasdaq delisting determination, potential reverse stock split, and the challenges of developing non-viral adoptive TCR-T cell therapies[234][240][247] - Risks related to clinical testing and regulation involve difficulties in patient enrollment, extensive regulatory compliance, potential undesirable side effects of product candidates, and reliance on sole source vendors for manufacturing materials[274][278][288][292] - Intellectual property risks include the failure to adequately protect or enforce IP rights, potential claims of infringement by third parties, and the challenges of maintaining licenses with key partners like MD Anderson and NCI[341][351][359] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section states that there were no unregistered sales of equity securities or use of proceeds to report during the period - No unregistered sales of equity securities or use of proceeds occurred during the reporting period[388] Item 3. Defaults Upon Senior Securities This section indicates that there are no defaults upon senior securities to report - Not applicable; there are no defaults upon senior securities to report[389] Item 4. Mine Safety Disclosures This section states that mine safety disclosures are not applicable to the company - Not applicable; mine safety disclosures are not relevant to the company's operations[390] Item 5. Other Information This section reports that no directors or executive officers adopted or terminated Rule 10b5-1 trading plans during the quarter, details retention agreements for Melinda Lackey and Drew Deniger, and notes their subsequent termination effective November 15, 2023 - No directors or executive officers adopted or terminated Rule 10b5-1 trading plans during the three months ended September 30, 2023[391] - Retention agreements were entered into with Melinda Lackey (SVP, Legal and Administration) and Drew Deniger (VP, Research and Development) on August 14, 2023, providing bonuses for continued service through the strategic alternatives exploration[392][394] - Both Ms. Lackey and Dr. Deniger's employment was terminated 'Without Cause' effective November 15, 2023, with expected severance and consulting agreements[397] Item 6. Exhibits This section lists all exhibits filed with the Form 10-Q, including corporate governance documents, retention agreements, certifications, and Inline XBRL documents - Exhibits include the Amended and Restated Certificate of Incorporation, Amended and Restated Bylaws, Retention Agreements for Melinda Lackey and Drew Deniger, and various certifications (e.g., Section 302, Section 906)[399] - Inline XBRL documents are provided for financial data tagging[399] SIGNATURES This section contains the signatures of the company's authorized officers, including the Chief Executive Officer (also serving as Principal Executive Officer and Principal Financial Officer) and the Vice President, Finance (Principal Accounting Officer), certifying the report's submission - The report is signed by Kevin S. Boyle, Sr., Chief Executive Officer (also Principal Executive Officer and Principal Financial Officer), and Michael Wong, Vice President, Finance (Principal Accounting Officer)[402] - The report was dated November 14, 2023[402]