Alaunos Therapeutics Inc
For the period ended Sep 30, 2024. Filed Nov 14, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 14, 2024
TCRT$1.74-5.4%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-14.
0000950170-24-097142
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-14.
0000950170-24-126793
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 68 previous paragraphs and 71 current paragraphs.
39 unchanged; 28 reworded; 3 added; 0 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (3)
Current report
On October 10, 2024, we announced our continued progress and evaluation of our internally developed small molecule oral obesity program. The aim of this program is to develop a drug for obesity with a differentiated profile relative to currently marketed and in development oral and injectable products.
Current report
Obesity Program
Current report
On October 10, 2024, we announced our continued progress and evaluation of our internally developed small molecule oral obesity program. The aim of this program is to develop a drug for obesity with a differentiated profile relative to currently marketed and in development oral and injectable products. We believe our small molecule product candidates are distinct in that they do not rely on hormonal manipulation, which is common with many obesity treatments. We have engaged a contract development and manufacturing organization (CMDO) to manufacture active pharmaceutical ingredients for our small molecule product candidates. We believe reductions in overhead expenditures have extended the Company’s cash runway into the first quarter of 2025. We anticipate initiatingin vitro testing of our candidates in the fourth quarter 2024. If successful, we plan to conduct an in vivo efficacy study in the first half of 2025, followed by the initiation of nonclinical and IND-enabling activities in 2025. Our ability to execute on this plan is dependent on study results and our ability to raise additional capital or obtain a development partner in connection with the development of these assets.
Reworded paragraphs (28)
Previous wording
Except for the historical financial information contained herein, the matters discussed in this Quarterly Report on Form 10-Q may be deemed to contain forward-looking statements that reflect our plans, estimates and beliefs. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. In this Quarterly Report on Form 10-Q, words such as “may,” “expect,” “anticipate,” “estimate,” “intend,” “plan” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements.
Current wording
Except for the historical financial information contained herein, the matters discussed in this Quarterly Report on Form 10-Q may be deemed to contain forward-looking statements that reflect our plans, estimates and beliefs. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. In this Quarterly Report on Form 10-Q, words such as "aim", “may,” “expect,” “anticipate,” “estimate,” “intend,” “plan” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements.
Previous wording
On August 14, 2023, we announced a strategic reprioritization of our business and wind down of our TCR-T Library Phase 1/2 Trial. In connection with the reprioritization, we have significantly reduced our workforce, and we continue working to reduce costs in order to extend our cash runway. We continue to explore strategic alternatives, including, but not limited to, an acquisition, merger, reverse merger, sale of assets, strategic partnerships, capital raises or other transactions. We have engaged Cantor Fitzgerald & Co., or Cantor, to act as strategic advisor for this process. In addition, on August 14, 2023, we announced that we had provided the requisite notice to the NCI to terminate the Cooperative Research and Development Agreement, dated January 9, 2017, by and among us, the National Cancer Institute, or the NCI, and Intrexon Corporation, or Intrexon, as amended (such agreement referred to herein as the CRADA), pursuant to its terms, effective October 13, 2023. In addition, on October 27, 2023, we provided notice of termination of the Patent License with the NCI, effective December 26, 2023.
Current wording
On August 14, 2023, we announced a strategic reprioritization of our business and wind down of our TCR-T Library Phase 1/2 Trial. In connection with the reprioritization, we have significantly reduced our workforce, and we continue working to reduce costs in order to extend our cash runway. We continue to explore strategic alternatives, including, but not limited to, an acquisition, merger, reverse merger, sale of assets, strategic partnerships, capital raises or other transactions. We have engaged Cantor Fitzgerald & Co., or Cantor, to act as strategic advisor for this process. In addition, on August 14, 2023, we announced that we had provided the requisite notice to the NCI to terminate the Cooperative Research and Development Agreement, dated January 9, 2017, by and among us, the National Cancer Institute, or the NCI, and Intrexon Corporation, or Intrexon, as amended (such agreement referred to herein as the CRADA), pursuant to its terms, effective October 13, 2023. In addition, on October 27, 2023, we provided notice of termination of the Patent License with the NCI, effective December 26, 2023. Further, on October 4, 2024, we terminated the A&R License Agreement with Precigen.
Previous wording
We have not generated any product revenue and have incurred significant net losses in each year since our inception. For the six months ended June 30, 2024, we had a net loss of $3.2 million, and as of June 30, 2024, we have incurred approximately $918.9 million of accumulated deficit since our inception in 2003. We expect to continue to incur significant operating expenditures and net losses for the foreseeable future.
Current wording
We have not generated any product revenue and have incurred significant net losses in each year since our inception. For the nine months ended September 30, 2024, we had a net loss of $3.9 million, and as of September 30, 2024, we have incurred approximately $919.7 million of accumulated deficit since our inception in 2003. We expect to continue to incur significant operating expenditures and net losses for the foreseeable future.
Previous wording
Three and Six Months Ended June 30, 2024 Compared to Three and Six Months Ended June 30, 2023
Current wording
Three and Nine Months Ended September 30, 2024 Compared to Three and Nine Months Ended September 30, 2023
Previous wording
Revenue during the three and six months ended June 30, 2024 and 2023 was as follows:
Current wording
Revenue during the three and nine months ended September 30, 2024 and 2023 was as follows:
Previous wording
Revenue during the three months ended June 30, 2024 was $4 and was $4 for the three months ended June 30, 2023. Revenue during the six months ended June 30, 2024 was $6 thousand and was $4 thousand for the six months ended June 30, 2023.
Current wording
The company did not earn revenue during the three months ended September 30, 2024 and 2023. Revenue during the nine months ended September 30, 2024 was $6 thousand and was $4 thousand for the nine months ended September 30, 2023.
Previous wording
Research and development expenses during the three and six months ended June 30, 2024 and 2023 were as follows:
Current wording
Research and development expenses during the three and nine months ended September 30, 2024 and 2023 were as follows:
Previous wording
Research and development expenses for the three months ended June 30, 2024 decreased by $5.0 million when compared to the three months ended June 30, 2023, primarily due to lower program expenses of $2.5 million as a result of the wind-down of our clinical activities, a $1.6 million decrease in consulting and employee-related expenses due to our reduced headcount and a $0.9 million decrease in facility related cost due to the wind-down.
Current wording
Research and development expenses for the three months ended September 30, 2024 decreased by $3.5 million when compared to the three months ended September 30, 2023, primarily due to lower program expenses of $1.7 million as a result of the wind-down of our clinical activities, a $1.1 million decrease in consulting and employee-related expenses due to our reduced headcount and a $0.7 million decrease in facility related cost due to the wind-down.
Previous wording
Research and development expenses for the six months ended June 30, 2024 decreased by $11.3 million when compared to the six months ended June 30, 2023, primarily due to lower program expenses of $6.6 million as a result of the wind-down of our clinical activities, a $3.0 million decrease in consulting and employee-related expenses due to our reduced headcount and a $1.7 million decrease in facility related cost due to the wind-down.
Current wording
Research and development expenses for the nine months ended September 30, 2024 decreased by $14.8 million when compared to the nine months ended September 30, 2023, primarily due to lower program expenses of $7.9 million as a result of the wind-down of our clinical activities, a $4.6 million decrease in consulting and employee-related expenses due to our reduced headcount and a $2.4 million decrease in facility related cost due to the wind-down.
Previous wording
For the three and six months ended June 31, 2024, our clinical stage projects included our TCR-T Library Phase 1/2 Trial evaluating TCRs from our library for the investigational treatment of non-small cell lung, colorectal, endometrial, pancreatic, ovarian and bile duct cancers, which we are currently in the process of winding down.
Current wording
For the three and nine months ended September 30, 2024, our clinical stage projects included our TCR-T Library Phase 1/2 Trial evaluating TCRs from our library for the investigational treatment of non-small cell lung, colorectal, endometrial, pancreatic, ovarian and bile duct cancers, which we are currently in the process of winding down.
Previous wording
General and administrative expenses during the three and six months ended June 30, 2024 and 2023 were as follows:
Current wording
General and administrative expenses during the three and nine months ended September 30, 2024 and 2023 were as follows:
Previous wording
General and administrative expenses for the three months ended June 30, 2024 decreased by $2.0 million as compared to the three months ended June 30, 2023, primarily due to a $1.8 million decrease in consulting and employee-related expenses due our reduced headcount, and a $0.01 million decrease in facility cost due to the reduction indepreciation expenses and rent as a direct result of the lease termination in the prior period.
Current wording
General and administrative expenses for the three months ended September 30, 2024 decreased by $2.6 million as compared to the three months ended September 30, 2023, primarily due to a $2.4 million decrease in consulting and employee-related expenses due our reduced headcount, and a $0.1 million decrease in facility cost due to the reduction indepreciation expenses and rent as a direct result of the lease termination in the prior period.
Previous wording
General and administrative expenses for the six months ended June 30, 2024 decreased by $3.6 million as compared to the six months ended June 30, 2023, primarily due to a $2.6 million decrease in employee-related expenses due our reduced headcount, a $0.8 million decrease in consulting expenses and a $0.3 million decrease in facility cost due to the reduction in deprecation expenses and rent as a direct result of the lease termination in the prior period.
Current wording
General and administrative expenses for the nine months ended September 30, 2024 decreased by $6.2 million as compared to the nine months ended September 30, 2023, primarily due to a $3.2 million decrease in employee-related expenses due our reduced headcount, a $2.5 million decrease in consulting expenses and a $0.4 million decrease in facility cost due to the reduction in deprecation expenses and rent as a direct result of the lease termination in the prior period.
Previous wording
Other income (expense) during the three and six months ended June 30, 2024 and 2023 was as follows:
Current wording
Other income (expense) during the three and nine months ended September 30, 2024 and 2023 was as follows:
Previous wording
Other income (expense), net, for the three months ended June 30, 2024 increased be $0.8 million as compared to the three months ended June 30, 2023, primarily due to no interest expense associated with our former amended Loan and Security Agreement (as defined below).
Current wording
Other income (expense), net, for the nine months ended September 30, 2024 increased by $1.1 million as compared to the nine months ended September 30, 2023, primarily due to no interest expense associated with our former amended Loan and Security Agreement (as defined below).
Previous wording
To date, we have financed our operations primarily through public offerings of our common stock, private placements of our equity securities, term debt and collaborations. Through December 31, 2023, we have received an aggregate of $729.2 million from issuances of equity. We have had no financing activity for the six months ended June 30, 2024.
Current wording
To date, we have financed our operations primarily through public offerings of our common stock, private placements of our equity securities, term debt and collaborations. Through December 31, 2023, we have received an aggregate of $729.2 million from issuances of equity. We have had no financing activity for the nine months ended September 30, 2024.
Previous wording
The following table summarizes our net decrease in cash and cash equivalents for the six months ended June 30, 2024 and 2023:
Current wording
The following table summarizes our net decrease in cash and cash equivalents for the nine months ended September 30, 2024 and 2023:
Previous wording
Net cash used in operating activities for the six months ended June 30, 2024 was $3.6 million, as compared to net cash used in operating activities of $16.4 million for the six months ended June 30, 2023. The decrease in net cash used in operation activities was primarily related to changes in our net loss.
Current wording
Net cash used in operating activities for the nine months ended September 30, 2024 was $4.4 million, as compared to net cash used in operating activities of $22.8 million for the nine months ended September 30, 2023. The decrease in net cash used in operation activities was primarily related to changes in our net loss.
Previous wording
The net cash used in operating activities for the six months ended June 30, 2024 was primarily due to our net loss of $3.2 million, adjusted for $0.3 million of non-cash items such as depreciation and stock-based compensation and a $0.4 million decrease in accrued expenses, a decrease in accounts payable of $0.3 million, a decrease to prepaid expenses and other current assets and accounts receivables of $16 thousand.
Current wording
The net cash used in operating activities for the nine months ended September 30, 2024 was primarily due to our net loss of $3.9 million, adjusted for $0.4 million of non-cash items such as depreciation and stock-based compensation and a $0.9 million decrease in accrued expenses, a decrease in accounts payable of $0.2 million, a decrease to prepaid expenses and other current assets and accounts receivables of $0.3 million.
Previous wording
Net cash used in investing activities was $0 for the six months ended June 30, 2024, compared to $0.2 million for the six months ended June 30, 2023. The decrease is related to no investing activities during the current period as compared to the prior period.
Current wording
Net cash used in investing activities was $0 for the nine months ended September 30, 2024, compared to $0.2 million for the nine months ended September 30, 2023. The decrease is related to no investing activities during the current period as compared to the prior period.
Previous wording
Net cash used in financing activities for the six months ended June 30, 2024 was $0, compared to $18.1 million for the six months ended June 30, 2023. The decrease was primarily related to the repayment of long-term debt in 2023 that did not recur in 2024.
Current wording
Net cash used in financing activities for the nine months ended September 30, 2024 was $0, compared to $18.1 million for the nine months ended September 30, 2023. The decrease was primarily related to the repayment of long-term debt in 2023 that did not recur in 2024.
Previous wording
We anticipate that losses will continue for the foreseeable future. As of June 30, 2024, our accumulated deficit was approximately $918.9 million. Our actual cash requirements may vary materially from those planned because of a number of factors, including changes in the focus, direction and pace of our development programs.
Current wording
We anticipate that losses will continue for the foreseeable future. As of September 30, 2024, our accumulated deficit was approximately $919.7 million. Our actual cash requirements may vary materially from those planned because of a number of factors, including changes in the focus, direction and pace of our development programs.
Previous wording
As of June 30, 2024, we had approximately $2.5 million of cash and cash equivalents. In light of our announced strategic reprioritization and concurrent exploration of strategic alternatives, including our decision to halt work on our TCR-T Library Phase 1/2 Trial, our development programs and reducing our workforce, we anticipate our cash resources will be sufficient to fund our operations into the third quarter of 2024. In order to continue our operations beyond our forecasted runway, including if necessary to continue to explore strategic alternatives, we will need to raise additional capital, and we have no committed sources of additional capital at this time. The forecast of cash resources is forward-looking information that involves risks and uncertainties, and the actual amount of our expenses could vary materially and adversely as a result of a number of factors. We have based our estimates on assumptions that may prove to be wrong, and our expenses could prove to be significantly higher than we currently anticipate. Management does not know whether additional financing will be on terms favorable or acceptable to us when needed, if at all. If adequate additional funds are not available when required, we may be unable to persist as a going concern for sufficient time to identify or execute on any strategic alternatives.
Current wording
As of September 30, 2024, we had approximately $1.7 million of cash and cash equivalents. In light of our announced strategic reprioritization and concurrent exploration of strategic alternatives, including our decision to halt work on our TCR-T Library Phase 1/2 Trial, our development programs and reducing our workforce, we anticipate our cash resources will be sufficient to fund our operations into the third quarter of 2024. In order to continue our operations beyond our forecasted runway, including if necessary to continue to explore strategic alternatives, we will need to raise additional capital, and we have no committed sources of additional capital at this time. The forecast of cash resources is forward-looking information that involves risks and uncertainties, and the actual amount of our expenses could vary materially and adversely as a result of a number of factors. We have based our estimates on assumptions that may prove to be wrong, and our expenses could prove to be significantly higher than we currently anticipate. Management does not know whether additional financing will be on terms favorable or acceptable to us when needed, if at all. If adequate additional funds are not available when required, we may be unable to persist as a going concern for sufficient time to identify or execute on any strategic alternatives.
Previous wording
Working capital as of June 30, 2024 was $3.4 million, consisting of $4.7 million in current assets and $1.3 million in current liabilities. Working capital as of December 31, 2023 was $6.3 million, consisting of $8.3 million in current assets and $2.0 million in current liabilities.
Current wording
Working capital as of September 30, 2024 was $2.8 million, consisting of $3.6 million in current assets and $0.8 million in current liabilities. Working capital as of December 31, 2023 was $6.3 million, consisting of $8.3 million in current assets and $2.0 million in current liabilities.
Previous wording
On May 28, 2019, we entered into a patent license agreement, or the Patent License, with the NCI. The terms of the Patent License required us to pay the NCI minimum annual royalties in the amount of $0.3 million, which would be reduced to $0.1 million once the aggregate minimum annual royalties paid by us equaled $1.5 million. For the three and six months ended June 30, 2024, we did not recognize royalty payments under the Patent License, and for the three and six months ended June 30, 2023, we recognized $0.0 and $0.3 million related to royalty payments under the Patent License. As of June 30, 2024, we paid a total of $0.8 million in minimum annual royalty payments under the Patent License. On October 27, 2023, we provided notice of termination of the Patent License with the NCI, effective December 26, 2023.
Current wording
On May 28, 2019, we entered into a patent license agreement, or the Patent License, with the NCI. The terms of the Patent License required us to pay the NCI minimum annual royalties in the amount of $0.3 million, which would be reduced to $0.1 million once the aggregate minimum annual royalties paid by us equaled $1.5 million. For the three and nine months ended September 30, 2024, we did not recognize royalty payments under the Patent License, and for the three and nine months ended September 30, 2023, we recognized $0.0 and $0.3 million related to royalty payments under the Patent License. As of September 30, 2024, we paid a total of $0.8 million in minimum annual royalty payments under the Patent License. On October 27, 2023, we provided notice of termination of the Patent License with the NCI, effective December 26, 2023.
Previous wording
On October 5, 2018, we entered into the License Agreement with PGEN Therapeutics, Inc., or PGEN, a wholly owned subsidiary of Precigen. Except where the context otherwise requires, we refer to PGEN and Precigen together as Precigen. Under the License Agreement, we were obligated to pay Precigen an annual licensing fee of $0.1 million expected to be paid through the term of the License Agreement and we had also agreed to reimburse certain historical costs of Precigen up to $1.0 million.
Current wording
On October 5, 2018, we entered into the License Agreement with PGEN Therapeutics, Inc., or PGEN, a wholly owned subsidiary of Precigen. Except where the context otherwise requires, we refer to PGEN and Precigen together as Precigen.
Previous wording
Pursuant to the A&R License Agreement, annual license payments due to Precigen are $75 thousand. Payment of the licensing fee is scheduled annually, in the second quarter after the first payment in October 2023; therefore, in accordance with the terms of the agreement, no amounts were paid during the three and six months ended June 30, 2024 or 2023.
Current wording
Pursuant to the A&R License Agreement, annual license payments due to Precigen are $75 thousand. Payment of the licensing fee is scheduled annually, in the second quarter after the first payment in October 2023; therefore, in accordance with the terms of the agreement, no amounts were paid during the three and nine months ended September 30, 2024 or 2023. On October 4, 2024, the Company provided written notice to Precigen to terminate the A&R License Agreement.
Previous wording
In June 2022, Solasia Pharma K. K., or Solasia, announced that darinaparsin had been approved for relapsed or refractory Peripheral T-Cell Lymphoma by the Ministry of Health, Labor and Welfare in Japan. During the three months ended June 30, 2024 and 2023, we recorded revenue of $5 thousand and $4 thousand under the License and Collaboration Agreement, respectively. During the six months ended June 30, 2024 and 2023, we recorded revenue of $6 thousand and $4 thousand under the License and Collaboration Agreement,respectively.
Current wording
In June 2022, Solasia Pharma K. K., or Solasia, announced that darinaparsin had been approved for relapsed or refractory Peripheral T-Cell Lymphoma by the Ministry of Health, Labor and Welfare in Japan. During the three months ended September 30, 2024 and 2023, the Company did not earn collaboration revenue and did not earn royalty revenues on net sales under the Solasia License and Collaboration Agreement. During the nine months ended September 30, 2024 and 2023, we recorded revenue of $6 thousand and $4 thousand under the License and Collaboration Agreement, respectively.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Other income (expense), net, for the three months ended September 30, 2024 decreased by $0.2 million as compared to the three months ended September 30, 2023.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Other income (expense), net, for the six months ended June 30, 2024 increased be $1.3 million as compared to the six months ended June 30, 2023, primarily due to no interest expense associated with our former amended Loan and Security Agreement (as defined below).