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Alaunos Therapeutics(TCRT) - 2025 Q1 - Quarterly Report
2025-05-15 20:27
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 March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Address, including zip code, and telephone number, including area code, of registrant's principal executive offices) Securities registered pursuant to Section 12(b) of the Act: Commission ...
Alaunos Therapeutics(TCRT) - 2024 Q4 - Annual Report
2025-03-31 20:18
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, 2024 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 Jurisdiction of In ...
Alaunos Therapeutics(TCRT) - 2024 Q3 - Quarterly Report
2024-11-14 14:30
Financial Performance - The company reported a net loss of $3.9 million for the nine months ended September 30, 2024, with an accumulated deficit of approximately $919.7 million since inception in 2003[55]. - Revenue for the nine months ended September 30, 2024, was $6 thousand, compared to $4 thousand for the same period in 2023, reflecting a 50% increase[67]. - Other income, net, for the three months ended September 30, 2024 was $23, a decrease of $0.2 million (88%) compared to $188 in the same period in 2023[72]. - For the nine months ended September 30, 2024, other income, net, increased by $1.1 million compared to the same period in 2023, primarily due to no interest expense associated with the former amended Loan and Security Agreement[73]. - Net cash used in operating activities for the nine months ended September 30, 2024 was $4.4 million, a decrease from $22.8 million in the same period in 2023[76]. - Working capital as of September 30, 2024 was $2.8 million, a decrease from $6.3 million as of December 31, 2023[77]. Research and Development - Research and development expenses for the three months ended September 30, 2024, decreased by $3.5 million (96%) compared to the same period in 2023, primarily due to the wind-down of clinical activities[68]. - Research and development expenses for the nine months ended September 30, 2024, decreased by $14.8 million (97%) compared to the same period in 2023, driven by reduced program expenses and headcount[69]. - The TCR-T Library Phase 1/2 Trial treated eight patients, achieving a total overall response rate of 13% and a disease control rate of 87% in evaluable patients[56][58]. - The company aims to develop a small molecule oral obesity drug with a differentiated profile, anticipating in vitro testing to begin in Q4 2024[62]. Administrative Expenses - General and administrative expenses for the three months ended September 30, 2024 decreased by $2.6 million (72%) compared to the same period in 2023, primarily due to a $2.4 million decrease in consulting and employee-related expenses[70]. - For the nine months ended September 30, 2024, general and administrative expenses decreased by $6.2 million (63%) compared to the same period in 2023, mainly due to a $3.2 million decrease in employee-related expenses and a $2.5 million decrease in consulting expenses[71]. Strategic Actions - The company has engaged Cantor Fitzgerald & Co. as a strategic advisor to explore alternatives including acquisitions, mergers, and capital raises[55][60]. - The company has reduced its workforce by approximately 95% to extend its cash runway amid strategic reprioritization efforts[60]. - The company announced the termination of its Cooperative Research and Development Agreement with the NCI effective October 13, 2023, and the termination of the Patent License with the NCI effective December 26, 2023[55]. Compliance and Financing - The company received a delisting determination from Nasdaq due to a closing bid price below $0.10 per share, but successfully appealed and regained compliance with the minimum bid price requirement by February 16, 2024[61]. - The company anticipates that its cash resources will be sufficient to fund operations into the third quarter of 2024, but additional financing will be necessary to continue operations beyond that[77]. - The company did not recognize any royalty payments under the Patent License for the three and nine months ended September 30, 2024, and had paid a total of $0.8 million in minimum annual royalty payments under the Patent License as of September 30, 2024[78]. - The company recorded revenue of $6 thousand under the License and Collaboration Agreement for the nine months ended September 30, 2024, compared to $4 thousand in the same period in 2023[79].
Alaunos Therapeutics(TCRT) - 2024 Q3 - Quarterly Results
2024-10-10 12:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 4, 2024 Alaunos Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 001-33038 (State or other jurisdiction of incorporation) (Commission File Number) | --- | --- | |------------|-------| | | | | | | | | | | | | | | | | | | | 84-1475642 | | | | | | | | | (I ...
Alaunos Therapeutics(TCRT) - 2024 Q2 - Quarterly Report
2024-08-14 20:54
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock TCRT The Nasdaq Capital Stock Market 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, 2024 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. ...
Alaunos Therapeutics(TCRT) - 2024 Q1 - Quarterly Report
2024-05-15 12:57
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 March 31, 2024 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 8 ...
Alaunos Therapeutics(TCRT) - 2023 Q4 - Annual Report
2024-04-01 11:30
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, 2023 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 Jurisdiction of In ...
Alaunos Therapeutics(TCRT) - 2023 Q3 - Quarterly Report
2023-11-14 12:35
Form 10-Q (Mark One) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 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) Delawa ...
Alaunos Therapeutics(TCRT) - 2023 Q2 - Quarterly Report
2023-08-14 20:37
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, 2023 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 ...
Alaunos Therapeutics(TCRT) - 2023 Q1 - Earnings Call Transcript
2023-05-10 19:40
Financial Data and Key Metrics Changes - For Q1 2023, the company reported a net loss of approximately $10 million, or a $0.04 net loss per share, compared to a net loss of approximately $9.8 million, or a $0.05 net loss per share for the same period in 2022, indicating a slight increase in losses [22] - Research and development expenses increased by 17% to approximately $6.5 million in Q1 2023 from approximately $5.6 million in Q1 2022, primarily due to increased manufacturing and TCR discovery activities [23] - General and administrative expenses decreased by 10% to approximately $3.2 million in Q1 2023 from approximately $3.5 million in Q1 2022, attributed to lower professional fees [24] - As of March 31, 2023, total cash balances were approximately $37.4 million, with an operating cash burn of approximately $9.4 million for Q1 2023, up from approximately $7.8 million in Q1 2022 [25][27] Business Line Data and Key Metrics Changes - The company is focused on advancing its TCR platform targeting solid tumors, with significant enhancements made to screening enrollment and manufacturing processes, facilitating faster patient accrual [3][4] - The TCR library Phase 1/2 trial is actively enrolling patients across six solid tumor indications, with expectations to treat between nine and twelve patients by the end of the year [5][6] Market Data and Key Metrics Changes - The company noted that investor engagement remains encouraging, with evidence pointing to supportive capital markets for companies with differentiated science [28] - The follow-on market has raised $7.3 billion by 60 follow-ons year-to-date, compared to $4.6 billion raised in 44 follow-ons at the same point in 2022, indicating a positive trend for biotech [36] Company Strategy and Development Direction - The company aims to become a Phase 2-ready company by the end of 2023, with recent corporate and capital changes supporting the belief in the upside potential of its TCR platform [1][6] - The amendment of the license agreement with Precigen eliminates all commercial sales-based royalties and milestone obligations, representing potential savings of over $160 million [7][9] - The company is expanding its TCR library through the Hunter platform, targeting more HLAs and new mutations to bolster its IP portfolio and pipeline [12][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of their TCR-T platform to transform cancer treatment, highlighting early clinical responses and accelerated patient enrollment [33][35] - The management team is optimistic about the upcoming interim results in Q3, which are expected to provide a more comprehensive readout of clinical data [5][39] Other Important Information - The company fully prepaid its term loan with Silicon Valley Bank, allowing for complete operational control over cash and eliminating additional interest expenses [9][27] - The company has implemented cryopreservation in its manufacturing process, increasing flexibility for patient scheduling and treatment [3][4] Q&A Session Summary Question: Update on ASCO data presentation - Management confirmed that the poster will include data on the first three patients treated, but further details cannot be disclosed until the embargo lifts on May 25 [50] Question: Change in target enrollment for Phase 1 - Management clarified that the guidance remains unchanged, with the nine to twelve patients expected to complete Phase 1 including those treated in 2022 [55] Question: Confidence in interim update financing - Management expressed confidence that the cash runway will extend to the next data readout, while remaining opportunistic regarding fundraising options [56][57] Question: Interim readout patient dosing levels - Management indicated that multiple patients will be included in the clinical update in Q3, with flexibility in trial design regarding dosing levels [60] Question: Manufacturing capacity for Phase 2 - Management discussed a multipronged manufacturing strategy to increase capacity for Phase 2, utilizing both in-house and external resources [62][64] Question: Cash balance clarification - Management confirmed that the $13.9 million of restricted cash is included in the total cash balance of $37.4 million as of March 31, 2023 [80]