UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Table of Contents Commission File Number 001-33038 Alaunos Therapeutics, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 84-1475642 (State or Other Jurisdiction of Incorporation or Organization) (IR ...

Financial Data and Key Metrics Changes - For Q3 2022, Alaunos reported a net loss of approximately $8.9 million or $0.04 net loss per share, compared to a net loss of approximately $22.7 million or $0.11 net loss per share for Q3 2021, indicating a significant reduction in losses [76]. - Collaboration revenue increased to approximately $2.9 million for Q3 2022, up from approximately $0.4 million in Q3 2021, primarily due to sales-based milestones achieved in Japan [77]. - Research and development expenses decreased by 46% to approximately $7.9 million in Q3 2022 from approximately $14.5 million in Q3 2021, attributed to lower program-related costs and reduced headcount [78]. - General and administrative expenses also saw a 60% decrease to approximately $3.3 million in Q3 2022 from approximately $8.2 million in the same period in 2021 [79]. - As of September 30, 2022, the company had approximately $37.8 million in cash and cash equivalents, with an operating cash burn of approximately $6.1 million for Q3 2022, down from approximately $9.6 million in Q3 2021 [80]. Business Line Data and Key Metrics Changes - The company is advancing its TCR-T Library Phase 1/2 trial, which targets hotspot mutations across six solid tumor indications, with ongoing patient enrollment at MD Anderson Cancer Center [18][45]. - The manufacturing suite has been updated to allow for simultaneous production of multiple products, increasing throughput capabilities [14][52]. Market Data and Key Metrics Changes - The company is focusing on solid tumors, specifically targeting KRAS, TP53, and EGFR mutations, which are prevalent in various cancers [73][74]. - The early clinical data presented at the CICON 2022 conference highlighted the first confirmed partial response using a non-viral TCR-T cell therapy in a solid tumor, generating increased interest from clinicians and patients [22][45]. Company Strategy and Development Direction - Alaunos aims to expand its TCR library by adding new TCRs targeting frequent mutations and HLAs, which will increase the addressable market for its therapy [85]. - The company plans to file an IND amendment to transition from fresh to cryopreserved TCR-T cell products, which is expected to enhance patient scheduling flexibility and reduce manufacturing time [86]. - The development of the membrane-bound IL-15 program is also underway, with an IND filing anticipated in the second half of 2023 [88]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the early clinical data and the potential of the TCR-T cell therapy to treat solid tumors effectively, with expectations for increased patient enrollment in 2023 [90][91]. - The company is exploring various financing options to extend its cash runway into the second quarter of 2023, with interest from both existing and new investors [100][101]. Other Important Information - The company has successfully produced high-quality TCR-T cells at clinical scale and has demonstrated the ability to manufacture products for both KRAS and TP53 mutations [44][48]. - The persistence of TCR-T cells was observed in patients, indicating the potential for durable responses in the clinical setting [43]. Q&A Session Summary Question: Why is there a delay in dosing the next patient? - Management noted that the excitement from early data has built momentum for enrollment, and the addition of new TCRs will expand the patient funnel [95]. Question: What is the cash runway and financing options? - The cash runway extends into the second quarter of 2023, with various financing options available, including an ATM and shelf registration [100][101]. Question: Will the next patient be dosed at the same level as the previous one? - The next patient will be treated at the second dose level, which ranges from approximately 10 billion to 70 billion TCR-T cells [118]. Question: What are the expected tumor types for the next patient? - The specific tumor types for the next patient have not been disclosed, but they will be within the existing focus on KRAS, TP53, and EGFR mutations [120].

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-33038 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) Alaunos Therapeutics, Inc. Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the S ...

Financial Data and Key Metrics Changes - For Q2 2022, Alaunos reported a net loss of approximately $9.9 million or $0.05 net loss per share, compared to a net loss of approximately $22.7 million or $0.11 net loss per share for Q2 2021, indicating a significant improvement in financial performance [22] - Research and Development expenses decreased to approximately $5.9 million in Q2 2022 from approximately $13.6 million in Q2 2021, a reduction of 56% [22] - General and Administrative expenses were approximately $3.4 million for Q2 2022, down from approximately $9.1 million in the same period in 2021, a decrease of 62% [24] - Operating cash burn for Q2 2022 was $8.2 million, compared to $21.5 million in Q2 2021, a decrease of $13.3 million or 62% [25] Business Line Data and Key Metrics Changes - The TCR-T Library Phase 1/2 trial is actively enrolling patients, with the company moving to the second dose level after safety reviews [10] - The TCR-T library consists of 10 TCRs targeting hotspot mutations across six solid tumor indications, including non-small cell lung, colorectal, endometrium, pancreas, ovary, and bile duct cancers [10][11] Market Data and Key Metrics Changes - Over 500 lung and colorectal patients have been screened, with a match rate of over 5% for the TCRs in the library [40] - The company anticipates that the addition of new TCRs will increase the addressable market for its library TCR-T program [21] Company Strategy and Development Direction - The company is focused on expanding manufacturing capacity to support future clinical expansion and has implemented new SOPs for simultaneous production of multiple products [13] - Alaunos has extended its collaboration agreement with the National Cancer Institute (NCI) to 2025, aiming to develop personalized cancer therapies using its TCR-T cell platform [10][18] - The company is also advancing its membrane-bound IL-15 program towards an IND filing in the second half of 2023 [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of the TCR-T Library trial and the potential of their proprietary Sleeping Beauty technology for commercial scalability [12][19] - The company remains focused on improving the lives of cancer patients with solid tumors and is optimistic about the upcoming data presentation at a scientific conference [31] Other Important Information - Alaunos had approximately $60 million in cash and cash equivalents as of June 30, 2022, with a cash runway anticipated to fund operations into Q2 2023 [25] - The company is not expecting significant capital from royalties on sales from its collaboration with Solasia Pharma, which has been approved for a product in Japan [15][62] Q&A Session Summary Question: Has the second patient been dosed or identified? - Management indicated that they are excited about the trial's progress and will provide updates on patient dosing in the upcoming weeks [34][35] Question: What is the total number of patients screened and the match rate? - Over 500 patients have been screened, with a match rate exceeding 5%, which is encouraging for ongoing enrollment [40] Question: What types of patients are being screened? - Patients of all stages are being screened, including those newly diagnosed and those who may have failed frontline therapies [42] Question: Is manufacturing capacity a limiting factor for patient treatment? - Currently, manufacturing is not a limiting factor, and the company is working on optimizing processes to increase throughput [46] Question: What are the anticipated total patients to be dosed for the Phase 1/2 study? - The company plans to let the science guide the number of patients treated, emphasizing a flexible trial design [53] Question: What is the expected timeline for commercialization with Solasia? - The company expects low single-digit royalties from Solasia, which will not significantly alleviate capital needs but will support R&D efforts [62]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-33038 Alaunos Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 84 ...

Financial Data and Key Metrics Changes - For Q1 2022, Alaunos reported a net loss of approximately $9.8 million or $0.05 net loss per share, compared to a net loss of approximately $21.6 million or $0.10 net loss per share for Q1 2021, indicating a significant improvement in financial performance [14] - Research and Development expenses decreased to approximately $5.6 million in Q1 2022 from approximately $13.3 million in Q1 2021, a reduction of 58% [14] - General and Administrative expenses also decreased to approximately $3.5 million in Q1 2022 from approximately $8.2 million in Q1 2021, a decrease of 57% [14] - Operating cash burn for Q1 2022 was $7.8 million, down from $15.3 million in Q1 2021, a decrease of 49% [14] - As of March 2022, the company had approximately $68.3 million in cash and cash equivalents, with an anticipated cash runway into Q2 2023 [14] Business Line Data and Key Metrics Changes - The company is advancing its TCR-T Library trial, which targets hotspot mutations across six solid tumor indications, including non-small cell lung cancer and colorectal cancer [6][7] - The first patient in the Phase 1/2 TCR-T Library trial was successfully dosed, and the patient has cleared the 28-day safety window [8][10] - Approximately 500 lung or colorectal patients have been screened, with over 5% matching one of the TCRs in the library [9] Market Data and Key Metrics Changes - The company is collaborating with MD Anderson Cancer Center for patient enrollment and treatment in the TCR-T Library trial [7] - The trial design allows for the potential dosing of multiple patients at different dose levels based on Bayesian design principles [17] Company Strategy and Development Direction - Alaunos is focused on expanding its manufacturing capabilities through a three-pronged strategy, including implementing SOPs for simultaneous production, hiring additional staff, and investigating physical expansion of its cGMP footprint [9] - The company aims to file an IND for its membrane bound IL-15 program in the second half of 2023, indicating a commitment to advancing its R&D pipeline [11] - The company has realigned its Scientific Advisory Board with key opinion leaders in TCR-T cell therapy to guide its strategic direction [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to manage capital effectively and maximize shareholder value despite challenging market conditions [15] - The company has reduced its expected operating cash flow for 2022 to between $40 million and $45 million, reflecting a strategic restructuring completed last year [15] - Management emphasized the importance of safety in the early stages of the TCR-T Library trial and the need for continuous learning as the trial progresses [20] Other Important Information - The company plans to present initial data from the TCR-T Library trial at a major medical meeting in the second half of 2022 [10] - Alaunos is actively working on expanding its TCR library and enhancing its research capabilities using its proprietary hunTR platform [11][30] Q&A Session Summary Question: How many patients need to be enrolled to complete the TCR-T Phase 1/2 study? - Management indicated that the number of patients would depend on the dose levels and the information gained from treating patients with different indications, estimating around 10 to 15 patients for early Phase 1a [17][18] Question: How does the logistics work for patient identification and dosing? - Management explained that they work closely with MD Anderson to identify patients at the appropriate time, considering that many patients are at different stages of their disease [21] Question: What needs to be done before filing the IND for the membrane bound IL-15 program? - Management noted that manufacturing runs and regulatory strategy need to be completed, with preclinical data being encouraging [22][23] Question: How many patients can be treated per month with the current GMP facility? - Management stated that they would provide updates on manufacturing capabilities as they execute their initiatives, emphasizing the learning curve associated with new hires [25][26] Question: What is the status of the patient pipeline? - Management expressed confidence in patient accrual from MD Anderson, highlighting the diversity of cancer types and potential patients for treatment [38]

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents the unaudited interim 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 detailed notes explaining the company's organization, significant accounting policies, debt, fair value measurements, related party transactions, commitments, and equity-related activities [Balance Sheets](index=6&type=section&id=Balance%20Sheets%20as%20of%20March%2031%2C%202022%20(unaudited)%20and%20December%2031%2C%202021) **Balance Sheet Highlights (in thousands):** | Item | March 31, 2022 | December 31, 2021 | | :--------------------------------- | :------------- | :---------------- | | Cash and cash equivalents | $68,255 | $76,054 | | Total current assets | $69,772 | $78,831 | | Total assets | $84,991 | $94,865 | | Current portion of long-term debt | $13,993 | $7,868 | | Total current liabilities | $21,234 | $16,041 | | Total liabilities | $35,869 | $36,809 | | Total stockholders' equity | $49,122 | $58,057 | [Statements of Operations](index=7&type=section&id=Statements%20of%20Operations%20for%20the%20Periods%20Ended%20March%2031%2C%202022%20and%202021%20(unaudited)) **Statements of Operations Highlights (Three Months Ended March 31, in thousands):** | Item | 2022 | 2021 | | :---------------------------------------------------------------- | :----- | :----- | | Research and development | $5,580 | $13,336 | | General and administrative | $3,505 | $8,227 | | Total operating expenses | $9,085 | $21,563 | | Loss from operations | $(9,085) | $(21,563) | | Net loss | $(9,788) | $(21,554) | | Basic and diluted net loss per share | $(0.05) | $(0.10) | | Weighted average common shares outstanding | 214,946,569 | 213,954,665 | [Statements of Changes in Stockholders' Equity](index=8&type=section&id=Statements%20of%20Changes%20in%20Stockholders'%20Equity%20for%20the%20Periods%20Ended%20March%2031%2C%202022%20and%202021%20(unaudited)) **Statements of Changes in Stockholders' Equity Highlights (in thousands):** | Item | Balance at Dec 31, 2021 | Stock-based compensation | Cancelled restricted common stock | Net loss | Balance at Mar 31, 2022 | | :------------------------ | :---------------------- | :----------------------- | :------------------------------ | :------- | :---------------------- | | Common Stock Amount | $216 | — | — | — | $216 | | Additional Paid-in Capital | $900,693 | $853 | — | — | $901,546 | | Accumulated Deficit | $(842,852) | — | — | $(9,788) | $(852,640) | | Total Stockholders' Equity | $58,057 | $853 | — | $(9,788) | $49,122 | [Statements of Cash Flows](index=9&type=section&id=Statements%20of%20Cash%20Flows%20for%20the%20Periods%20Ended%20March%2031%2C%202022%20and%202021%20(unaudited)) **Statements of Cash Flows Highlights (Three Months Ended March 31, in thousands):** | Activity | 2022 | 2021 | | :-------------------------------- | :------- | :------- | | Net cash used in operating activities | $(7,770) | $(15,313) | | Net cash used in investing activities | $(29) | $(717) | | Net cash provided by financing activities | $— | $1,017 | | Net decrease in cash and cash equivalents | $(7,799) | $(15,013) | | Cash and cash equivalents, end of period | $68,255 | $100,056 | [Notes to Unaudited Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Financial%20Statements%20(unaudited)) - The Company changed its corporate name from ZIOPHARM Oncology, Inc. to **Alaunos Therapeutics, Inc.** on January 25, 2022[29](index=29&type=chunk) - The Company is a clinical-stage oncology-focused cell therapy company developing adoptive TCR-T cell therapies, leveraging its proprietary non-viral Sleeping Beauty gene transfer platform and cancer hotspot mutation TCR library[29](index=29&type=chunk) - The Company has operated at a loss since its inception in 2003, with an accumulated deficit of approximately **$852.6 million** as of March 31, 2022[32](index=32&type=chunk) - Cash and cash equivalents were approximately **$68.3 million** as of March 31, 2022, anticipated to fund operations into the **second quarter of 2023**, raising substantial doubt about the Company's ability to continue as a going concern[32](index=32&type=chunk)[33](index=33&type=chunk) - The Loan and Security Agreement with Silicon Valley Bank (SVB Facility) was fully drawn at **$25.0 million** as of March 31, 2022, bearing interest at **8.00%**[48](index=48&type=chunk) - The SVB Facility maturity can extend from August 1, 2023, to August 1, 2024, if the Company achieves Amended Milestones by August 31, 2022, including receiving **$50.0 million** in net cash proceeds from equity sales and positive data in the first cohort of the Library TCR-T Trial[43](index=43&type=chunk)[48](index=48&type=chunk) - The Company is required to cash collateralize **half of the outstanding principal plus 5.75% of the original principal** if Amended Milestones are not met by August 31, 2022[50](index=50&type=chunk) - Cash equivalents of **$67.255 million** (March 31, 2022) and **$75.222 million** (December 31, 2021) are classified as Level 1 assets[56](index=56&type=chunk) **Potentially Dilutive Shares (as of March 31, in thousands):** | Item | 2022 | 2021 | | :---------------------- | :----------- | :----------- | | Common stock options | $10,969,654 | $10,738,378 | | Unvested restricted stock | $993,879 | $1,074,606 | | Warrants | $22,922,342 | $22,272,727 | | Total | $34,885,875 | $34,549,044 | - The joint venture Eden BioCell with TriArm Therapeutics was mutually agreed to be dissolved in **September 2021**[63](index=63&type=chunk)[117](index=117&type=chunk) - The Company has exclusive worldwide license agreements with PGEN Therapeutics, MD Anderson Cancer Center, and the National Cancer Institute (NCI) for various TCR, CAR, and Sleeping Beauty technologies, involving annual fees, milestone payments, and royalties[64](index=64&type=chunk)[71](index=71&type=chunk)[82](index=82&type=chunk) **Stock-Based Compensation Expense (Three Months Ended March 31, in thousands):** | Item | 2022 | 2021 | | :-------------------------- | :--- | :--- | | Research and development | $315 | $733 | | General and administrative | $538 | $1,464 | | Total | $853 | $2,197 | - Total unrecognized compensation costs related to unvested stock options amounted to **$7.5 million**, expected to be recognized over **2.08 years**[102](index=102&type=chunk) - Total unrecognized compensation costs related to unvested restricted stock amounted to **$1.5 million**, expected to be recognized over **2.15 years**[104](index=104&type=chunk) - Warrants outstanding include 2019 Warrants (**17,803,031 shares**, **$7.00 exercise price**), MD Anderson Warrant (**3,333,333 shares**, **$0.001 exercise price**, vests upon clinical milestones), and SVB Warrants (**649,615 shares**, **$1.16 exercise price**)[107](index=107&type=chunk)[108](index=108&type=chunk)[109](index=109&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition, results of operations, and liquidity for the three months ended March 31, 2022, compared to the same period in 2021, highlighting the company's focus on TCR-T cell therapy, recent developments, and the ongoing need for additional capital due to significant net losses and limited cash runway - The Company is a clinical-stage oncology-focused cell therapy company developing adoptive TCR-T cell therapy, leveraging its proprietary non-viral Sleeping Beauty gene transfer platform and cancer hotspot mutation TCR library[125](index=125&type=chunk) - The Company is currently enrolling patients for a Phase 1/2 clinical trial (TCR-T Library Phase 1/2 Trial) evaluating **ten TCRs** for various solid tumor types, with the first patient treated on **May 2, 2022**, and interim data anticipated in the **second half of 2022**[125](index=125&type=chunk)[131](index=131&type=chunk) - The Company incurred a net loss of **$9.8 million** for the three months ended March 31, 2022, and an accumulated deficit of approximately **$852.6 million** since inception[126](index=126&type=chunk) - A restructuring in **September 2021** eliminated approximately **60 positions**, extending the anticipated cash runway into the **second quarter of 2023**[129](index=129&type=chunk) - Management has determined that current capital resources are insufficient to fund planned operations for at least **one year**, raising substantial doubt about the Company's ability to continue as a going concern[146](index=146&type=chunk)[147](index=147&type=chunk) **Operating Expenses Comparison (Three Months Ended March 31, in thousands):** | Expense Category | 2022 | 2021 | Change ($) | Change (%) | | :-------------------------- | :----- | :----- | :--------- | :--------- | | Research and development | $5,580 | $13,336 | $(7,756) | (58)% | | General and administrative | $3,505 | $8,227 | $(4,722) | (57)% | | Other income (expense), net | $(703) | $9 | $(712) | (7911)% | - The decrease in R&D expenses was primarily due to winding down IL-12 and CAR-T programs and reduced headcount[140](index=140&type=chunk) - The increase in other expense, net, was primarily due to **$0.7 million** in interest expense associated with the Amended Loan and Security Agreement[143](index=143&type=chunk) **Cash Flow Summary (Three Months Ended March 31, in thousands):** | Activity | 2022 | 2021 | | :-------------------------------- | :------- | :------- | | Net cash used in operating activities | $(7,770) | $(15,313) | | Net cash used in investing activities | $(29) | $(717) | | Net cash provided by financing activities | $— | $1,017 | | Net decrease in cash and cash equivalents | $(7,799) | $(15,013) | - Working capital as of March 31, 2022, was **$48.6 million**, a decrease from **$62.8 million** as of December 31, 2021[161](index=161&type=chunk) - The Company recognized **$0.3 million** in license payments to the NCI for the three months ended March 31, 2022 and 2021[164](index=164&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Alaunos Therapeutics, Inc. is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, the registrant is not required to provide quantitative and qualitative disclosures about market risk[169](index=169&type=chunk) [Item 4. Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the principal executive and accounting officers, concluded that the company's disclosure controls and procedures were effective as of March 31, 2022, with no material changes in internal control over financial reporting during the quarter - Management concluded that disclosure controls and procedures were **effective** at the reasonable assurance level as of March 31, 2022[170](index=170&type=chunk) - There were no changes in internal control over financial reporting that materially affected, or are reasonably likely to materially affect, internal control over financial reporting during the three months ended March 31, 2022[171](index=171&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The Company is not currently subject to any material legal proceedings that are likely to have a material adverse effect on its financial position, results of operations, or cash flows - As of March 31, 2022, there are no material legal matters that are likely to result in a material adverse effect on the Company's financial position, results of operations, or cash flows[174](index=174&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks that could materially affect the company's business and financial results, including the need for substantial additional capital, challenges in developing novel cell therapies, regulatory hurdles, manufacturing complexities, commercialization difficulties, intellectual property disputes, and other company-specific risks such as stock price volatility and corporate governance issues - The Company requires substantial additional financial resources to continue as a going concern, with current cash resources anticipated to fund operations only into the **second quarter of 2023**, raising substantial doubt about its ability to continue[176](index=176&type=chunk)[177](index=177&type=chunk) - Developing and commercializing non-viral adoptive TCR-T cell therapies is a new approach to cancer treatment, subject to significant challenges including regulatory approval, clinical trial design, manufacturing, and market acceptance[189](index=189&type=chunk) - The Company's product candidates are based on novel technologies with limited clinical data, and there is no assurance that current and planned clinical trials will produce data supporting regulatory approval[191](index=191&type=chunk)[196](index=196&type=chunk) - The Company faces substantial competition from other biopharmaceutical companies in the TCR and CAR technology space, many of which have greater financial resources and experience[203](index=203&type=chunk)[208](index=208&type=chunk) - Any termination of licenses with PGEN, MD Anderson, or NCI, or research and development agreements, could result in the loss of significant rights and harm the ability to develop and commercialize product candidates[210](index=210&type=chunk) - The Company is partly reliant on the NCI for research and development and early clinical testing, with limited control over the timing and progress of NCI's clinical trials, which have experienced delays[218](index=218&type=chunk) - Manufacturing cell-based therapy product candidates is complex, relies on limited vendors for specialized materials, and the Company has limited experience in large-scale production, posing risks to supply and clinical trial timelines[253](index=253&type=chunk)[258](index=258&type=chunk)[261](index=261&type=chunk) - The gene transfer vectors used in the Sleeping Beauty system carry a theoretical risk of insertional oncogenesis, potentially triggering new cancers or other adverse events[268](index=268&type=chunk) - Commercialization success depends on obtaining U.S. and worldwide regulatory approvals, establishing sales and marketing capabilities, achieving physician and patient acceptance, and securing adequate reimbursement from payors[273](index=273&type=chunk)[276](index=276&type=chunk)[278](index=278&type=chunk)[280](index=280&type=chunk) - The market price for the Company's common stock is **volatile**, and failure to satisfy Nasdaq listing standards (e.g., minimum bid price) could lead to delisting, potentially requiring a reverse stock split[332](index=332&type=chunk)[335](index=335&type=chunk)[339](index=339&type=chunk) - The exercise of outstanding warrants (**22.9M shares**) and issuance of equity awards (**11.0M options**) may have a dilutive effect on the stock and negatively impact its price[353](index=353&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=58&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The Company did not report any unregistered sales of equity securities or use of proceeds during the period - No unregistered sales of equity securities or use of proceeds were reported[358](index=358&type=chunk) [Item 3. Defaults Upon Senior Securities](index=58&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the Company for the reporting period - This item is not applicable[359](index=359&type=chunk) [Item 4. Mine Safety Disclosures](index=58&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the Company for the reporting period - This item is not applicable[360](index=360&type=chunk) [Item 5. Other Information](index=58&type=section&id=Item%205.%20Other%20Information) The Company announced the resignation of Dr. Eleanor de Groot, Executive Vice President, Operations, effective May 13, 2022 - Dr. Eleanor de Groot resigned from her position as Executive Vice President, Operations, effective **May 13, 2022**[361](index=361&type=chunk) [Item 6. Exhibits](index=59&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Quarterly Report on Form 10-Q, including corporate governance documents, certifications, and XBRL data files - Exhibits include Amended and Restated Certificate of Incorporation, Certifications of Principal Executive Officer and Principal Accounting Officer, and Inline XBRL documents[363](index=363&type=chunk)

Financial Data and Key Metrics Changes - For Q4 2021, the company reported a net loss of approximately $11.8 million or $0.05 net loss per share, compared to a net loss of approximately $22.8 million or $0.11 net loss per share for Q4 2020, indicating a significant improvement in financial performance [19] - For the full year 2021, the net loss was approximately $78.8 million or $0.37 net loss per share, compared to a net loss of approximately $80 million or $0.38 net loss per share for 2020, showing a slight improvement [21] - Research and development expenses decreased by 41% to approximately $8.2 million in Q4 2021 from approximately $14 million in Q4 2020 [19] - General and administrative expenses decreased by 76% to approximately $2.1 million in Q4 2021 from approximately $8.8 million in the same period in 2020 [20] - As of December 31, 2021, the company had approximately $76.1 million in cash and cash equivalents, with a cash burn of $61.5 million for the full year 2021 [22] Business Line Data and Key Metrics Changes - The TCRT library study is a basket trial targeting hotspot mutations across six solid tumor indications, with the first patient consented and expected to be treated in Q2 2022 [10][13] - The TCRT library now includes a total of 10 TCRs, which increases the addressable market and pool of patients eligible for the trial [11] Market Data and Key Metrics Changes - The company is focused on executing its clinical programs and expanding its research and development efforts, particularly in collaboration with the National Cancer Institute [15] Company Strategy and Development Direction - The company aims to focus on execution and delivering clinical results, with plans to advance its membrane-bound IL-15 program towards an IND filing in 2023 [24] - The strategic restructuring has reduced headcount from 112 to approximately 40, emphasizing capital stewardship [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the TCRT platform and its potential to create shareholder value through clinical data generation [9] - The company anticipates sufficient cash runway to fund operations into Q2 2023, indicating a stable financial outlook [22] Other Important Information - The company has engaged a consultant with over 30 years of experience in clinical and drug development to support its efforts following the departure of the Chief Medical Officer [14] Q&A Session Summary Question: Clinical development plans under new leadership - Management indicated that there would not be wholesale changes to the clinical development plan despite the leadership change, maintaining focus on patient accrual and preclinical progress [31][32] Question: Expansion of TCRT library - The company confirmed that it is flexible in including additional mutations into the current trial without launching a new study [43] Question: Manufacturing capacity and patient enrollment - Management clarified that while the manufacturing capacity is one product per month, actual patient enrollment may vary due to various factors [50] Question: Efficacy signals from initial dosing - The primary focus of the Phase 1 trial is on safety, with any efficacy signals being a secondary consideration [61]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission File Number 001-33038 Alaunos Therapeutics, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 84-1475642 (State or Other ...

Financial Data and Key Metrics Changes - For Q3 2021, the company reported a net loss of approximately $22.7 million, or $0.11 net loss per share, compared to a net loss of approximately $20.3 million, or $0.10 net loss per share for Q3 2020, indicating a year-over-year increase in net loss [13] - Research and development expenses totaled approximately $14.5 million for Q3 2021, an increase of 4% from approximately $14 million for the same period in 2020 [13] - General and administrative expenses were approximately $8.2 million for Q3 2021, compared to approximately $6.4 million for Q3 2020 [13] - Total operating expenses for Q3 2021 were approximately $22.7 million, an increase of 12% compared to approximately $20.3 million for the same period in 2020 [14] - Cash and cash equivalents as of September 30, 2021, were approximately $91.7 million, with an anticipated cash runway extending into the second quarter of 2023 [14][15] Business Line Data and Key Metrics Changes - The company is focusing on advancing its differentiated TCR-T cell platform and has made significant progress in operationalizing its in-house CGMP clinical production unit [5][6] - The TCR-T library trial is set to evaluate patients across six solid tumor indications, including lung, colorectal, endometrial, pancreatic, ovarian, and bile duct cancers [10] Market Data and Key Metrics Changes - The company has opened its screening study at the MD Anderson Cancer Center and is actively screening patients for the Phase 1/2 treatment study [10] Company Strategy and Development Direction - The company has strategically restructured to focus on generating clinical data and advancing its TCR-T platform [4] - The TCR-T library platform is enabled by non-viral Sleeping Beauty technology, allowing the company to target multiple solid tumor indications within a single trial, which is critical for its go-forward strategy [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the internal capabilities to advance scientific research into clinical applications and emphasized the importance of generating clinical data [5][15] - The company aims to begin treating patients in the first half of 2022 and is focused on executing its strategic priorities to bring value to stakeholders [15] Other Important Information - The company has developed an innovative platform with internal resources, including genomics, bioinformatics, and cellular immunology, to generate and validate TCR-T targets exclusively owned by the company [12] Q&A Session Summary Question: What are the gating factors to starting the Phase 1/2 study? - Management indicated that the all-clear on the IND from the FDA is crucial, along with screening and enrolling patients [18] Question: What is the plan for operating expenses following the restructuring? - Management anticipates cash burn to be less than $15 million per quarter moving forward [18] Question: What needs to be completed before dosing the first patient in the TCR-T trial? - Management reiterated that they are waiting for FDA review and are actively screening patients [23] Question: What are the plans for commercial manufacturing? - Management stated that commercial manufacturing is several years away and no strategy has been communicated yet [25] Question: Have there been any retention strategies for staff after restructuring? - Management confirmed that incentive stock options were granted to retain staff, and there have been no unexpected resignations [31] Question: Will new TCRs be added to the IND prior to clearance? - Management indicated that adding new TCRs will be an ongoing process, not linked to the IND submission timeline [33]