Tempest Therapeutics, Inc.

Previous wording

We are a clinical-stage biotechnology company with a diverse portfolio of targeted and immune-mediated product candidates with the potential to be first-in-class to treat a wide range of cancers. Our novel programs range from early research to the lead program, amezalpat (previously known as TPST-1120), that, subject to the need for additional resources, is ready to begin a pivotal study in first-line hepatocellular carcinoma (“HCC”). In addition to amezalpat, our second clinical-stage therapeutic product candidate is TPST-1495, which we expect to start a Phase 2 study in Familial Adenomatous Polyposis (“FAP”) this year. We believe both amezalpat and TPST-1495 are the first clinical-stage molecules designed to inhibit their respective targets.

Current wording

We are a clinical-stage biotechnology company with a diverse portfolio of targeted and immune-mediated product candidates with the potential to be first-in-class to treat a wide range of cancers. Our novel programs range from early research to the lead program, amezalpat (previously known as TPST-1120), that, subject to the need for additional resources, is ready to begin a pivotal Phase 3 study in first-line hepatocellular carcinoma (“HCC”). In addition to amezalpat, our second clinical-stage therapeutic product candidate is TPST-1495, which we expect to start a Phase 2 study in Familial Adenomatous Polyposis (“FAP”) late this year, subject to potential delays resulting from the ongoing U.S. government shutdown. We believe both amezalpat and TPST-1495 are the first clinical-stage molecules designed to inhibit their respective targets.

Previous wording

Our philosophy is to build a company based upon not only good ideas and creative science, but also upon the efficient translation of those ideas into therapies that will improve patients’ lives. Each of our programs are designed to provide different and independent approaches to fighting cancer, providing a portfolio of truly diversified assets. Given market conditions, in April 2025, we announced plans to explore a full range of strategic alternatives to advance our promising programs.

Current wording

Given market conditions, in April 2025, we announced plans to explore a full range of strategic alternatives to advance our promising programs. If a strategic alternative is not available to us, we will be required to take additional actions to fund the Company’s operations or we may be forced to wind down our operations.

Previous wording

In November 2024, we received a “Study May Proceed” letter from the FDA, authorizing the initiation of our pivotal Phase 3 trial, and in June 2025, we received the equivalent “Clearance to Proceed” letter from the National Medical Products Administration (“NMPA”) in China. In January 2025, the FDA granted Orphan Drug Designation (“ODD”) for amezalpat for the treatment of patients with HCC. In February 2025, the FDA granted Fast Track Designation (“FTD”), underscoring the agency’s recognition of the urgent need for new treatment options for HCC. In addition to receiving ODD from the FDA, in

Current wording

In November 2024, we received a “Study May Proceed” letter from the FDA, authorizing the initiation of our pivotal Phase 3 trial, and in June 2025, we received the equivalent “Clearance to Proceed” letter from the National Medical Products Administration (“NMPA”) in China. In January 2025, the FDA granted Orphan Drug Designation (“ODD”) for amezalpat for the treatment of patients with HCC. In February 2025, the FDA granted Fast Track Designation (“FTD”), underscoring the agency’s recognition of the urgent need for new treatment options for HCC. In addition to receiving ODD from the FDA, in June 2025, the European Medical Agency (“EMA”) also granted ODD for the treatment of patients with HCC. These designations provide potential regulatory benefits, including increased engagement with the FDA, eligibility for accelerated approval and priority review, and, for ODD, potential market exclusivity upon approval.

Previous wording

In March 2025, the Cancer Prevention Clinical Trials Network (“CP-CTNet”) received a “Study May Proceed” letter from the FDA, authorizing the initiation of a National Cancer Institute (“NCI”)-funded Phase 2 clinical trial evaluating TPST-1495 in patients with FAP. This trial, run by CP-CTNet and financially supported by the NCI’s Division of Cancer Prevention, underscores the urgent need for innovative cancer prevention strategies in high-risk patient populations. In April 2025, the FDA granted ODD for TPST-1495 for the treatment of patients with FAP. The Phase 2 study is expected to begin in 2025.

Current wording

In March 2025, the Cancer Prevention Clinical Trials Network (“CP-CTNet”) received a “Study May Proceed” letter from the FDA, authorizing the initiation of a National Cancer Institute (“NCI”)-funded Phase 2 clinical trial evaluating TPST-1495 in patients with FAP. This trial, run by CP-CTNet and financially supported by the NCI’s Division of Cancer Prevention, underscores the urgent need for innovative cancer prevention strategies in high-risk patient populations. In April 2025, the FDA granted ODD for TPST-1495 for the treatment of patients with FAP. The Phase 2 study is expected to begin in late 2025, subject to potential delays resulting from the ongoing U.S. government shutdown.

Previous wording

Explore strategic and business development opportunities to maximize the potential of our pipeline and extend financial resources. We believe that our pipeline has broad potential reach and partnerships that bring in additional expertise and/or geographic presence could be important to increase the likelihood of success. We currently own all rights to our programs.

Current wording

Explore strategic and business development opportunities to maximize the potential of our pipeline and extend financial resources.

Previous wording

Subject to the need for additional resources, advance amezalpat into a pivotal Phase 3 study in first-line HCC patients where amezalpat will be studied in a combination treatment and compared to a standard-of-care therapy. We believe the continued positive results from the ongoing randomized Phase 1b/2 study provides strategic opportunities for us, and we received positive feedback from the FDA and European Medicines Agency (“EMA”) on the pivotal Phase 3 clinical trial design. The program may also may warrant further development in RCC and CCA based on the Phase 1 data presented at ASCO 2022.

Current wording

Subject to the need for additional financial resources, advance amezalpat into a pivotal Phase 3 study in first-line HCC patients where amezalpat will be studied in a combination treatment and compared to a standard-of-care therapy. We believe the continued positive results from the ongoing randomized Phase 1b/2 study provides strategic opportunities for us, and we received positive feedback from the FDA and European Medicines Agency (“EMA”) on the pivotal Phase 3 clinical trial design. The program may also warrant further development in RCC and CCA based on the Phase 1 data presented at ASCO 2022.

Previous wording

Explore TPST-1495 in a Phase 2 study in patients with FAP with the CP-CTNet in 2025.

Current wording

Explore TPST-1495 in a Phase 2 study in patients with FAP with the CP-CTNet, which is expected to begin in late 2025, subject to potential delays resulting from the ongoing U.S. government shutdown.

Previous wording

As of June 30, 2025, we had cash and cash equivalents totaling $14.3 million compared to $30.3 million as of December 31, 2024. We have incurred operating losses since inception and our accumulated deficit as of June 30, 2025 is $225.8 million. We expect that our existing cash and cash equivalents will fund our projected operating expense requirements through less than 12 months from the date our consolidated financial statements were available to be issued.

Current wording

As of September 30, 2025, we had cash and cash equivalents totaling $7.5 million compared to $30.3 million as of December 31, 2024. We have incurred operating losses since inception and our accumulated deficit as of September 30, 2025 is $229.3 million. We expect that our existing cash and cash equivalents will fund our projected operating expense requirements through less than 12 months from the date our consolidated financial statements were available to be issued. Accordingly, there is substantial doubt regarding our ability to continue as a going concern for a period of 12 months from the date of the issuance of the unaudited condensed financial statements included elsewhere in this Quarterly Report on Form 10-Q.

Previous wording

In April 2025, we announced plans to explore a full range of strategic alternatives to advance its promising clinical stage programs and maximize stockholder value. Strategic alternatives under consideration may include, but are not limited to, mergers, acquisitions, partnerships, joint ventures, licensing arrangements or other strategic transactions. We have retained MTS Health Partners, L.P., an internationally recognized financial advisor with substantial experience in the biotechnology industry, to support us with the strategic evaluation process. We have not set a timetable for completion of the process for evaluating strategic alternatives and do not intend to disclose further developments or guidance on the status of our programs or the process for evaluating strategic alternatives unless and until it is determined that further disclosure is appropriate or necessary.

Current wording

In April 2025, we announced plans to explore a full range of strategic alternatives to advance its promising clinical stage programs and maximize stockholder value. Strategic alternatives under consideration may include, but are not limited to, mergers, acquisitions, partnerships, joint ventures, licensing arrangements or other strategic transactions. We have retained MTS Health Partners, L.P., an internationally recognized financial advisor with substantial experience in the biotechnology industry, to support us with the strategic evaluation process. We have not set a timetable for completion of the process for evaluating strategic alternatives and do not intend to disclose further developments or guidance on the status of our programs or the process for evaluating strategic alternatives unless and until it is determined that further disclosure is appropriate or necessary. If a strategic alternative is not available to us, we will be required to take additional actions to fund the Company’s operations or we may be forced to wind down our operations.

Previous wording

The above conditions raise substantial doubt regarding our ability to continue as a going concern for a period of 12 months from the date of the issuance of the unaudited condensed financial statements included elsewhere in this Quarterly Report on Form 10-Q. If a strategic alternative is not available to us, we will be required to take additional actions to fund the Company’s operations or we may be forced to wind down our operations.

Current wording

The above conditions raise substantial doubt regarding our ability to continue as a going concern for a period of 12 months from the date of the issuance of the unaudited condensed financial statements included elsewhere in this Quarterly Report on Form 10-Q.

Previous wording

The largest component of our operating expenses has historically been the investment in research and development activities. Historically, our research and development expenses were primarily driven by our amezalpat program, which has been paused while we complete our ongoing strategic review. As a result of the ongoing strategic review and the RIF, we expect research and development expenses will decrease period over period. If we resume the advancement of our product candidates into and through clinical trials and pursues regulatory approvals, we expect research and development expenses will increase in the future, which will require a significant investment in costs of clinical trials, regulatory support and contract manufacturing and inventory build-up.

Current wording

The largest component of our operating expenses has historically been the investment in research and development activities. Historically, our research and development expenses were primarily driven by our amezalpat program, which has been paused while we complete our ongoing strategic review. As a result of the ongoing strategic review and the RIF, we expect research and development expenses will decrease period over period. If we resume our research and development efforts, we expect research and development expenses will increase in the future, which will require a significant investment in costs of clinical trials, regulatory support and contract manufacturing and inventory build-up.

Previous wording

Research and development expenses decreased by $1.9 million to $3.9 million for the three months ended June 30, 2025, compared to three months ended June 30, 2024, which was primarily due to a decrease in costs incurred as a result of re-prioritizing efforts towards exploring strategic alternatives.

Current wording

Research and development expenses decreased by $7.0 million to $0.6 million for the three months ended September 30, 2025, compared to three months ended September 30, 2024, which was primarily attributable to a decrease in costs incurred as a result of re-prioritizing efforts towards exploring strategic alternatives initiated in April 2025.

Previous wording

The following table summarizes our operating results for the six months ended June 30, 2025 and 2024:

Current wording

The following table summarizes our operating results for the nine months ended September 30, 2025 and 2024:

Previous wording

Our research and development expenses for the six months ended June 30, 2025 and 2024 were primarily incurred in connection with our most advanced product candidate, amezalpat.

Current wording

Our research and development expenses for the nine months ended September 30, 2025 and 2024 were primarily incurred in connection with our most advanced product candidate, amezalpat.

Previous wording

Research and development expenses increased by $1.3 million to $11.5 million for the six months ended June 30, 2025, compared to the six months ended June 30, 2024. The increase was primarily attributable to an increase in costs incurred from engaging contract research and manufacturing organizations in preparation for our pivotal Phase 3 trial of amezalpat for the treatment of first-line HCC.

Current wording

Research and development expenses decreased by $5.6 million to $12.1 million for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024, which was primarily attributable to a decrease in costs incurred as a result of re-prioritizing efforts towards exploring strategic alternatives initiated in April 2025. Expenses in the nine months ended September 30, 2025 included $4.5 million related to contract research and manufacturing organizations in preparation for our pivotal Phase 3 trial of amezalpat for the treatment of first-line HCC.

Previous wording

General and administrative expenses remained relatively flat at $7.4 million for the six months ended June 30, 2025, compared to the six months ended June 30, 2024, and were primarily related to employee compensation costs, inclusive of one-time separation costs for employees terminated during the six months ended June 30, 2025, as well as consulting and professional services.

Current wording

General and administrative expenses increased by $0.1 million to $10.4 million for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024. The increase was primarily related to employee compensation costs, inclusive of one-time separation costs for employees terminated during the nine months ended September 30, 2025, as well as consulting and professional services.

Previous wording

For the three months ended June 30, 2025 and 2024, other income (expense), net, consisted of total interest expense of $46 thousand and $372 thousand, respectively, related to the loan with Oxford Finance LLC (“Oxford” and such loan the “Oxford Loan”), and interest income of $142 thousand and $384 thousand, respectively.

Current wording

For the nine months ended September 30, 2025 and 2024, other income (expense), net consisted of total interest expense of $207 thousand and $1.1 million, respectively, related to the Oxford Loan, and interest income of $464 thousand and $1.1 million, respectively. The Oxford Loan was repaid in full and terminated in accordance with its terms in April 2025.

Previous wording

our common stock, convertible preferred stock and issuance of debt. As of June 30, 2025, we had $14.3 million in cash and

Current wording

our common stock, convertible preferred stock and issuance of debt. In April 2025, we announced plans to explore a full range of strategic alternatives to advance our promising programs. If a strategic alternative is not available to us, we will be required to take additional actions to fund the Company’s operations or we may be forced to wind down our operations. As of September 30, 2025, we had $7.5 million in cash and cash equivalents and an accumulated deficit of $229.3 million.

Previous wording

We have entered into a sales agreement (the “Sales Agreement”) with Jefferies LLC (“Jefferies”), pursuant to which we may sell, from time to time at our sole discretion through Jefferies, as our sales agent, shares of our common stock (the “ATM Program”). Any shares of our common stock sold will be issued pursuant to our shelf registration statement on Form S-3 (File No. 333-280918). On June 11, 2025, in connection with the RDO (as defined below) we delivered written notice to Jefferies that we were suspending and terminating the prospectus supplement, dated February 6, 2025, related to the ATM Program (the “ATM Prospectus”). We will not make any sales of our securities pursuant to the Sales Agreement, unless and until a new prospectus, prospectus supplement or a new registration statement is filed. Other than the termination of the ATM Prospectus, the Sales Agreement remains in full force and effect. As of the six months ended June 30, 2025, we have sold an aggregate of 312,830 shares of our common stock for proceeds of $2.8 million pursuant to the ATM Program. As of June 30, 2025, $11.6 million remained available for sale under the ATM Program.

Current wording

We have entered into a sales agreement (the “Sales Agreement”) with Jefferies LLC (“Jefferies”), pursuant to which we may sell, from time to time at our sole discretion through Jefferies, as our sales agent, shares of our common stock (the “ATM Program”). Any shares of our common stock sold will be issued pursuant to our shelf registration statement on Form S-3 (File No. 333-280918). On June 11, 2025, in connection with the RDO (as defined below) we delivered written notice to Jefferies that we were suspending and terminating the prospectus supplement, dated February 6, 2025, related to the ATM Program (the “ATM Prospectus”). We will not make any sales of our securities pursuant to the Sales Agreement, unless and until a new prospectus, prospectus supplement or a new registration statement is filed. Other than the termination of the ATM Prospectus, the Sales Agreement remains in full force and effect. As of the nine months ended September 30, 2025, we have sold an aggregate of 312,830 shares of our common stock for proceeds of $2.8 million pursuant to the ATM Program. As of September 30, 2025, $11.6 million remained available for sale under the ATM Program.

Previous wording

On June 11, 2025, we sold an aggregate of 405,000 shares of our common stock and pre-funded warrants to purchase 334,000 shares of our common stock in a registered direct offering (the “RDO”). The offering price was $6.25 per share of common stock and $6.249 per pre-funded warrant, which is the price of each share of common stock sold in the offering, minus the $0.001 exercise price per pre-funded warrant. The net proceeds from the offering were approximately $4.1 million, after deducting placement agent fees and estimated offering expenses payable by us. As of June 30, 2025, all pre-funded warrants had been exercised.

Current wording

On June 11, 2025, we sold an aggregate of 405,000 shares of our common stock and pre-funded warrants to purchase 334,000 shares of our common stock in a registered direct offering (the “RDO”). The offering price was $6.25 per share of common stock and $6.249 per pre-funded warrant, which is the price of each share of common stock sold in the offering, minus the $0.001 exercise price per pre-funded warrant. The net proceeds from the RDO were approximately $4.1 million, after deducting placement agent fees and estimated offering expenses payable by us. As of September 30, 2025, all pre-funded warrants had been exercised.

Previous wording

The following table summarizes our cash flows for the six months ended June 30, 2025 and 2024:

Current wording

The following table summarizes our cash flows for the nine months ended September 30, 2025 and 2024:

Previous wording

Cash used in operating activities for the six months ended June 30, 2025 was $16.5 million, consisting of a net loss of $18.7 million, add back of non-cash adjustments for depreciation, stock-based compensation, non-cash operating lease expense and other non-cash items totaling $3.2 million, less changes in operating assets and liabilities of $1.0 million.

Current wording

Cash used in operating activities for the nine months ended September 30, 2025 was $23.2 million, consisting of a net loss of $22.2 million, add back of non-cash adjustments for depreciation, stock-based compensation, non-cash operating lease expense and other non-cash items totaling $3.6 million, less changes in operating assets and liabilities of $4.6 million.

Previous wording

Cash used in operating activities for the six months ended June 30, 2024 was $12.7 million, consisting of a net loss of $17.5 million, add back of non-cash adjustments for depreciation, stock-based compensation, non-cash operating lease expense and other non-cash items totaling $3.8 million, plus changes in operating assets and liabilities of $1.0 million.

Current wording

Cash used in operating activities for the nine months ended September 30, 2024 was $22.9 million, consisting of a net loss of $28.0 million, add back of non-cash adjustments for depreciation, stock-based compensation, non-cash operating lease expense and other non-cash items totaling $3.2 million, plus changes in operating assets and liabilities of $2.4 million.

Previous wording

No cash was used in investing activities for the six months ended June 30, 2025.

Current wording

No cash was used in investing activities for the nine months ended September 30, 2025.

Previous wording

Cash used in investing activities for the six months ended June 30, 2024 was related to purchases of property and equipment, primarily related to laboratory and computer equipment.

Current wording

Cash used in investing activities for the nine months ended September 30, 2024 was related to purchases of property and equipment, primarily related to laboratory and computer equipment.

Previous wording

Cash provided by financing activities for the six months ended June 30, 2025 was related to net proceeds from the June 2025 registered direct offering of $4.1 million as well as the issuance of common stock of $2.8 million under the ATM Program, offset by $6.4 million in outflows related to the repayment of the Oxford Loan.

Current wording

Cash provided by financing activities for the nine months ended September 30, 2025 was related to net proceeds from the June 2025 registered direct offering of $4.1 million as well as the issuance of common stock of $2.8 million under the ATM Program, offset by $6.4 million in outflows related to the repayment of the Oxford Loan.

Previous wording

Cash provided by financing activities for the six months ended June 30, 2024 was related to proceeds from the issuance of common stock of $5.0 million.

Current wording

Cash provided by financing activities for the nine months ended September 30, 2024 was related to proceeds from the issuance of common stock of $8.8 million, offset by $2.2 million in outflows related to the repayment of the Oxford Loan.

Previous wording

Our primary use of cash is to fund operating expenses, which has historically consisted primarily of research and development expenditures related to our therapeutic discovery and preclinical development efforts and clinical activities, and to a lesser extent, general and administrative expenditures. Currently, our primary use of cash is headcount cost and lease and overhead expenses as we explore strategic alternatives. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.

Current wording

Our primary use of cash is to fund operating expenses, which has historically consisted primarily of research and development expenditures related to our therapeutic discovery and preclinical development efforts and clinical activities, and to a lesser extent, general and administrative expenditures. Currently, our primary use of cash is headcount cost and lease and overhead expenses as we explore strategic alternatives. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses. If a strategic alternative is not available to us, we will be required to take additional actions to fund the Company’s operations or we may be forced to wind down our operations.

Previous wording

Our material cash requirements primarily relate to the maturities of the principal obligations under our long-term debt, operating leases for office space, trade payables, and accrued expenses. As of June 30, 2025, we had $7.1 million payable within 12 months, including $1.1 million related to the Brisbane Lease. Refer to Note 5 to our Condensed Consolidated Financial Statements for additional information.

Current wording

Our material cash requirements primarily relate to our operating lease for office space, trade payables, and accrued expenses. As of September 30, 2025, we had $3.5 million payable within 12 months, including $1.1 million related to the Brisbane Lease. Refer to Note 5 to our Condensed Consolidated Financial Statements for additional information.

Previous wording

We are a “smaller reporting company,” as defined in Rule 12b-2 of the Securities Exchange Act of 1934, or the Exchange Act, meaning that the market value of our shares held by non-affiliates is less than $700 million and our annual revenue was less than $100 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our shares held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year for which audited financial statements are available as of the determination date and the market value of our shares held by non-affiliates is less than $700 million. As a smaller reporting company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company, we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation. If investors consider our common stock less attractive as a result of our election to use the scaled-back disclosure permitted for smaller reporting companies, there may be a less active trading market for our common stock and our share price may be more volatile.

Current wording

(i) the market value of our shares held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed fiscal year for which audited financial statements are available as of the determination date and the market value of our shares held by non-affiliates is less than $700 million. As a smaller reporting company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company, we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation. If investors consider our common stock less attractive as a result of our election to use the scaled-back disclosure permitted for smaller reporting companies, there may be a less active trading market for our common stock and our share price may be more volatile.