Alaunos Therapeutics Inc
For the period ended Mar 31, 2025. Filed May 15, 2025.
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.
Mar 31, 2025 · Filed May 15, 2025
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 2024-09-30; filed 2024-11-14.
0000950170-24-126793
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-15.
0000950170-25-072709
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 71 previous paragraphs and 61 current paragraphs.
19 unchanged; 20 reworded; 22 added; 29 removed; 3 previous and 0 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 (22)
Current report
2024 Developments
Current report
The ongoingin vitro study aims to evaluate the impact of ALN1001 and its derivatives on lipid deposition and gene expression. This study evaluates if genes related to thermogenic activity, lipid metabolism, and energy regulation are activated or deactivated by treatment, to determine if these compounds positively affect fat and energy metabolism. The results of this study, which are expected second quarter of 2025, will provide critical insights into the development strategy for ALN1001 and its derivatives for obesity, metabolic disorders, and inflammation. Drug development candidates most effective in increasing metabolic activity and reducing fat accumulation may be advanced to evaluation of the compounds in rodent models of obesity.
Current report
As is standard in the industry, if the aforementionedin vitro study is successful, we plan to conduct a proof-of-concept diet-induced obesity or DIO mouse study to validate our mechanism of action by the third quarter of 2025 before proceeding to Investigational New Drug or IND Application enabling studies. Our ability to execute on this plan is dependent on study results and our ability to raise additional capital or partner these assets with other companies or research institutions.
Current report
Nasdaq Shareholders Equity Deficiency Notice
Current report
On April 7, 2025, the Company received a notice (the “Notice”) from the Listing Qualifications staff of Nasdaq notifying the Company that the Company’s stockholders equity as reported in its Annual Report on Form 10-K for the period ended December 31, 2024 (the “2024 10-K”), did not satisfy the continued listing requirements under Nasdaq Listing Rule 5550(b)(1) for the Nasdaq Capital Market, which requires that a listed company’s stockholder equity be at least $2.5 million. In its 2024 10-K, the Company reported stockholders’ equity of $2.1 million, and, as a result, does not currently satisfy Nasdaq Listing Rule 5550(b)(1).
Current report
The Notice has no immediate effect on the Company’s listing on the Nasdaq Capital Market. In accordance with Nasdaq rules, the Company has 45 calendar days from the date of the notification to submit a plan to regain compliance with Nasdaq Listing Rule 5550(b)(1) to Nasdaq. The Company intends to submit a compliance plan within 45 days of the date of the notification and will evaluate available options to resolve the deficiency and regain compliance. If the Company’s compliance plan is accepted, the Company may be granted up to 180 calendar days from April 7, 2025 to evidence compliance.
Current report
Royalty Revenue
Current report
Collaboration revenue during the three months ended March 31, 2025 was $2 thousand and was $1 for the three months ended March 31, 2024.
Current report
Research and development expenses for the three months ended March 31, 2025 increased by $0.2 million when compared to the three months ended March 31, 2024, primarily due to an increase of $0.2 million in regulatory writing as part of our wind-down clinical activities and consulting fees incurred in pursuit of our obesity program.
Current report
Other Income
Current report
Other income during the three months ended March 31, 2025 and 2024 was as follows:
Current report
Other income, net, for the three months ended March 31, 2025 decreased be $0.04 million as compared to the three months ended March 31, 2024, primarily due to reduced interest income from our cash reserves, as our cash balances were lower in the current quarter as compared to prior quarters.
Current report
Liquidity
Current report
Sales of Series A-1 Preferred Stock
Current report
On April 11, 2025, the Company entered into a Subscription Agreement (the “Agreement”), by and between the Company and Watermill Asset Management, pursuant to which the Company agreed to issue and sell, in a private offering to the Purchaser shares of Series A-1 Convertible Preferred Stock of the Company, par value of $0.001 per share (the “Series A-1 Preferred Stock”), at a price per share of $1,000 (the “Preferred Offering”) for an aggregate purchase price of $500,000. The Preferred Offering also relates to the offering of the shares of the Company's common stock (the "Common Stock") issuable upon the conversion of or otherwise pursuant to the terms of the Series A-1 Preferred Stock). The Preferred Offering closed on April 11, 2025.
Current report
Cash flows from operating activities represent the cash receipts and disbursements related to all of our activities other than investing and financing activities. Cash flows from operating activities are derived by adjusting our net loss for:
Current report
Non-cash operating items such as depreciation, amortization, impairment charges, stock-based compensation and reduction in right-of-use assets; and
Current report
Changes in operating assets and liabilities which reflect timing differences between the receipt and payment of cash associated with transactions and when they are recognized in results of operations.
Current report
Capital Resources
Current report
Operating Leases
Current report
As of March 31, 2025, we have no lease commitments, other than a short-term lease.
Current report
On May 28, 2019, the Company entered into a Patent License with the NCI for exclusive worldwide rights to develop and commercialize certain engineered T-cell therapies targeting mutated KRAS, TP53, and EGFR neoantigens, as well as related manufacturing technologies. The agreement included minimum annual royalties, milestone payments upon achieving clinical, regulatory, and sales benchmarks, and royalties on product sales. The Company terminated the agreement effective December 26, 2023, after developing proprietary alternatives internally.
Removed paragraphs (29)
Previous report
We have operated as a clinical-stage oncology-focused cell therapy company developing adoptive TCR-T cell therapy, designed to treat multiple solid tumor types in large cancer patient populations with unmet clinical needs. We were working to leverage our cancer hotspot mutation TCR library and our proprietary, non-viral Sleeping Beauty gene transfer platform to design and manufacture patient-specific cell therapies that target neoantigens arising from shared tumor-specific mutations in key oncogenic genes, including KRAS, TP53 and EGFR. In collaboration with the MD Anderson Cancer Center, or MD Anderson, we were enrolling and treating patients for a Phase 1/2 clinical trial which was evaluating 12 TCRs reactive to mutated KRAS, TP53 and EGFR from our TCR library for the investigational treatment of non-small cell lung, colorectal, endometrial, pancreatic, ovarian and bile duct cancers, which we refer to as our TCR-T Library Phase 1/2 Trial.
Previous report
Recent Developments
Previous report
One patient with non-small cell lung cancer (NSCLC) achieved an objective partial response with six months progression-free survival. Six other patients achieved a best overall response of stable disease. The total overall response rate was 13% and disease control rate was 87% in evaluable patients with advanced, metastatic, refractory solid tumors. Disease control was measured by objective responses and stable disease. Increased secretion of interferon-gamma relative to baseline was detected in all patients' serum post-cell transfer suggesting recognition of the tumor by the infused TCR-T cells. Persistence of TCR-T cells in peripheral blood was detected in all evaluable patients at their last follow-up, including up to six months in one patient. Infiltration of TCR-T cells into the tumor was also detected in three samples where a fresh biopsy was collected suggesting homing to the tumor microenvironment. All patients have progressed or withdrawn from the trial and long-term follow-up is ongoing for a subset of patients with no further intervention per the treatment protocol. This trial established proof-of-concept that Sleeping Beauty TCR-T cells can result in objective clinical responses and recognize established tumors in vivo.
Previous report
Nasdaq Delisting Determination
Previous report
As previously disclosed on January 4, 2023, we were notified by the Listing Qualifications Department, or the Staff, of The Nasdaq Stock Market LLC, or Nasdaq, that we were in breach of Listing Rule 5450(a)(1), or the Minimum Bid Price Rule, for continued listing on the Nasdaq Global Select Market because the minimum bid price of our listed securities for 30 consecutive business days had been less than $1 per share. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), or the Compliance Period Rule, we were provided a period of 180 calendar days, or until July 3, 2023, or the Compliance Date, to regain compliance with the Bid Price Requirement. On June 22, 2023, we applied to transfer our listing from the Nasdaq Global Select Market to the Nasdaq Capital Market, or the Transfer. On July 5, 2023, Nasdaq notified us that the Transfer was approved, and that, in connection with the Transfer, we were eligible for an additional 180 calendar day period, or until January 2, 2024, or the Extended Compliance Date, to regain compliance with the Minimum Bid Price Rule. On November 8, 2023, we received a Staff Delisting Determination letter, or the Delisting Determination, from the Staff notifying us that, because the closing bid price for our common stock was below $0.10 per share for 10 consecutive trading days during the Extended Compliance Period, the Staff has determined to suspend trading of our common stock on Nasdaq pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(iii), effective November 17, 2023, and file a Form 25-NSE with the SEC to remove our common stock from listing and registration under the Securities Exchange Act of 1934, as amended, unless we timely request an appeal of the Delisting Determination to a Nasdaq Hearings Panel, or the Panel. We timely requested a hearing before the Panel to appeal the Delisting Determination and were granted a hearing before the Panel on January 25, 2024. This timely request for a hearing stayed the suspension or delisting of our common stock so our common stock continued to trade on the Nasdaq Capital Market under the symbol “TCRT” while the appeal process was pending. By letter dated February 16, 2024, we were notified by the Nasdaq Stock Market LLC that we regained compliance with the minimum $1.00 bid price requirement, and otherwise satisfied all applicable criteria for continued listing on the Nasdaq Capital Market. As such, the listing matter was closed. Pursuant to Nasdaq Listing Rule 5815(d)(4)(B), we will be subject to a mandatory panel monitor for the one-year period through February 16, 2025.
Previous report
Financial Overview
Previous report
Revenue
Previous report
We recognize royalties, research and development funding revenue over the estimated period of performance. To date we have not generated product revenue. Unless and until we receive approval from the U.S. Food and Drug Administration, or the FDA, and/or other regulatory authorities for our product candidates, we cannot sell our products and will not have product revenue.
Previous report
Our research and development expenses have historically consisted primarily of salaries and related expenses for personnel, costs of contract manufacturing services, costs of facilities, reagents, and equipment, fees paid to professional service providers in conjunction with our clinical trials, fees paid to contract research organizations, or CROs, in conjunction with clinical trials, fees paid to CROs in conjunction with costs of materials used in research and development, consulting, license and milestone payments and sponsored research fees paid to third parties.
Previous report
General and administrative expenses consist primarily of salaries, benefits and stock-based compensation, consulting and professional fees, including patent related costs, general corporate costs and facility costs not otherwise included in research and development expenses.
Previous report
Other Income (Expense)
Previous report
Other income (expense) consists primarily of interest expense associated with our amended Loan and Security Agreement (as defined below), interest income on our cash balances and sublease income.
Previous report
Revenue
Previous report
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 report
Research and Development Expenses
Previous report
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 report
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 report
General and Administrative Expenses
Previous report
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 report
Other Income (Expense)
Previous report
Other income (expense) during the three and nine months ended September 30, 2024 and 2023 was as follows:
Previous report
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.
Previous report
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 report
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 report
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 report
Operating Capital and Capital Expenditure Requirements
Previous report
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 report
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 report
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.
Reworded paragraphs (20)
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 "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.
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 “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. Further, on October 4, 2024, we terminated the A&R License Agreement with Precigen.
Current wording
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 have also operated as a clinical-stage oncology-focused cell therapy company developing adoptive TCR-T cell therapy, designed to treat multiple solid tumor types in large cancer patient populations with unmet clinical needs. 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 reduced our workforce during the third and fourth quarters of 2023, 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 engaged Cantor Fitzgerald & Co., or Cantor, to act as strategic advisor for this process.
Previous 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.
Current wording
We have not generated any product revenue and have incurred significant net losses in each year since our inception. For the three months ended March 31, 2025, we had a net loss of $1.6 million, and as of March 31, 2025, we have incurred approximately $921.5 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
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.
Current wording
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 an oral drug for obesity and other metabolic disorders 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 aim to develop an oral obesity compound that addresses many of the shortcomings of injectable GLP-1 receptor agonists including preserving lean muscle mass. We engaged a contract development and manufacturing organization or CMDO to manufacture active pharmaceutical ingredients for our small molecule product candidates and initiatedin vitro testing of our candidates in the fourth quarter 2024.
Previous wording
Eight patients were treated and evaluated in our TCR-T Library Phase 1/2 Trial. Patients with pancreatic (3), colorectal (4) and non-small cell lung cancer (1) were treated, with certain pancreatic and colorectal patients also having lung metastases. Overall, the trial showed our T-cells were generally well-tolerated in all evaluable participants with no dose-limiting toxicities (DLTs) and no immune effector cell-associated neurotoxicity syndrome (ICANS) were observed. All cytokine release syndrome (CRS) events were within grades 1-3 and were self-limiting or resolved with standard clinical management and, in some cases, a single dose of tocilizumab.
Current wording
Eight patients were treated and evaluated in our TCR-T Library Phase 1/2 Trial from 2022-2023. Patients with pancreatic (3), colorectal (4) and non-small cell lung cancer (1) were treated, with certain pancreatic and colorectal patients also having lung metastases. Overall, the trial showed our T-cells were generally well-tolerated in all evaluable participants with no dose-limiting toxicities (DLTs) and no immune effector cell-associated neurotoxicity syndrome (ICANS) were observed. All cytokine release syndrome (CRS) events were within grades 1-3 and were self-limiting or resolved with standard clinical management and, in some cases, a single dose of tocilizumab. One patient with non-small cell lung cancer (NSCLC) achieved an objective partial response with six months progression-free survival. Six other patients achieved a best overall response of stable disease. The total overall response rate was 13% and disease control rate was 87% in evaluable patients with advanced, metastatic, refractory solid tumors (see Figure A). This trial established proof-of-concept that Sleeping Beauty TCR-T cells can result in objective clinical responses and recognize established tumors in vivo. Despite the encouraging TCR-T Library Phase 1/2 Trial data, based on the substantial cost to continue development and the current financing environment, we announced in August 2023 that we would not pursue any further development of our clinical programs.
Previous wording
We continue to explore strategic alternatives, which may include but are not limited to, an acquisition, merger, reverse merger, sale of assets, strategic partnerships, capital raises or other transactions. In connection with the strategic reprioritization, we have reduced our workforce by approximately 95% to date in order to streamline the organization and to maximize our cash runway.
Current wording
We continue to explore strategic alternatives, which may include but are not limited to, an acquisition, merger, reverse merger, sale of assets, strategic partnerships, capital raises or other transactions.
Previous wording
Three and Nine Months Ended September 30, 2024 Compared to Three and Nine Months Ended September 30, 2023
Current wording
Three Months Ended March 31, 2025 Compared to Three Months Ended March 31, 2024
Previous wording
Revenue during the three and nine months ended September 30, 2024 and 2023 was as follows:
Current wording
Collaboration revenue during the three months ended March 31, 2025 and 2024 was as follows:
Previous wording
Research and development expenses during the three and nine months ended September 30, 2024 and 2023 were as follows:
Current wording
Research and development expenses during the three months ended March 31, 2025 and 2024 was as follows:
Previous 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.
Current wording
For the three months ended March 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. For the three months ended March 31, 2025, our clinical stage projects mainly consisted of developing and manufacturing of our active pharmaceutical ingredients. We continue to incur costs associated with the process of winding down the TCR studies.
Previous wording
General and administrative expenses during the three and nine months ended September 30, 2024 and 2023 were as follows:
Current wording
General and administrative expenses during the three months ended March 31, 2025 and 2024 was as follows:
Previous 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.
Current wording
General and administrative expenses for the three months ended March 31, 2025 decreased by $0.9 million as compared to three months ended March 31, 2024, primarily due to a $0.1 million decrease in employee-related expenses due to lower salaries and employee related costs, a $0.4 decrease in consulting expenses and a $0.4 decrease in insurance cost, filing fees and a combination of reduced travel costs and bank fees due to our downsized operations.
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 nine months ended September 30, 2024.
Current wording
To date, we have financed our operations primarily through public offerings of our common stock, private placements of our convertible and preferred equity securities, term debt and collaborations.
Previous wording
We follow the guidance of Accounting Standards Codification, or ASC, Topic 205-40, Presentation of Financial Statements - Going Concern, in order to determine whether there is substantial doubt about our ability to continue as a going concern for one year after the date our condensed financial statements are issued. Given our current development plans and cash management efforts, we anticipate that our cash resources will be sufficient to fund operations into the third quarter of 2024. Our ability to continue operations after our current cash resources are exhausted depends on our ability to obtain additional financing, as to which no assurances can be given. Cash requirements may vary materially from those now planned because of changes in our focus and direction of our research and development programs, competitive and technical advances, patent developments, regulatory changes or other developments. If adequate additional funds are not available when required, management may need to curtail its development efforts and planned operations to conserve cash.
Current wording
Given our current development plans and cash management efforts, we anticipate that our cash resources will be sufficient to fund operations into the second quarter of 2025. Our ability to continue operations after our current cash resources are exhausted depends on our ability to obtain additional financing, as to which no assurances can be given. Cash requirements may vary materially from those now planned because of changes in our focus and direction of our research and development programs, competitive and technical advances, patent developments, regulatory changes or other developments. If adequate additional funds are not available when required, management may need to curtail its development efforts and planned operations to conserve cash.
Previous 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.
Current wording
We anticipate that losses will continue for the foreseeable future. As of March 31, 2025, our accumulated deficit was approximately $921.5 million. Our working capital as of March 31, 2024 was $0.1 million, consisting of $1.1 million in current assets and $1.0 million in current liabilities. 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 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.
Current wording
As of March 31, 2025, we had approximately $0.3 million of cash and cash equivalents. Our streamlined and cost efficiency efforts, in light of our 2023 announced strategic reprioritization , we anticipate our cash resources will be sufficient to fund our operations into the second quarter of 2025. 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
The following table summarizes our net decrease in cash and cash equivalents for the nine months ended September 30, 2024 and 2023:
Current wording
The following table summarizes our net decrease in cash and cash equivalents for the three months ended March 31, 2025 and 2024:
Previous 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.
Current wording
Net cash flows from operating activities for the three months ended March 31, 2025 was $0.8 million, as compared to net cash used in operating activities of $1.9 million for the three months ended March 31, 2024. The decrease in net cash used in operating activities was primarily related to changes in our net loss.
Previous 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.
Current wording
The net cash flows from operating activities for the three months ended March 31, 2025 was primarily due to our net loss of $1.01 million, adjusted for $0.01 million of non-cash items such as depreciation and stock-based compensation and a $0.01 million increase in accrued expenses, an increase in accounts payable of $0.3 million, a decrease to prepaid expenses and other current assets of $0.01 million.
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 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.
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 year ended December 31, 2024, the Company did not earn collaboration revenue and earned $10 thousand in royalty revenues on net sales under the Solasia License and Collaboration Agreement. During the three months ended March 31, 2025 and 2024, the Company did not earn collaboration revenue and earned $2 thousand and $1 thousand, respectively, in royalty revenues on net sales under the Solasia License and Collaboration Agreement.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
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.
Previous report — wording carried elsewhere
Despite the encouraging TCR-T Library Phase 1/2 Trial data, based on the substantial cost to continue development and the current financing environment, we announced in August 2023 that we would not pursue any further development of our clinical programs.
Previous report — wording carried elsewhere
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.