Tempest Therapeutics, Inc.

Previous wording

In November 2024, we received a “Study May Proceed” letter from the FDA, authorizing the initiation of our pivotal Phase 3 trial. 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. 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.

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

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. 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 2025.

Previous wording

As of March 31, 2025, we had cash and cash equivalents totaling $21.5 million compared to $30.3 million as of December 31, 2024. We have incurred operating losses since inception and our accumulated deficit as of March 31, 2025 is $218.0 million. We expect that our existing cash and cash equivalents plus the proceeds of $1.2 million from our ATM Program (as described below) will fund our projected operating expense requirements through less than 12 months from the date our consolidated financial statements were available to be issued. These conditions and the events described above under “—Recent Events” 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. We plan to address our operating cash flow requirements through the recently announced strategic review and implementation of cash preservation activities, including the recent reduction in force, to reduce discretionary spending.

Current 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.

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, acquisition, 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 its 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.

Previous wording

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. 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 largest component of our operating expenses has historically been the investment in research and development activities. We expect research and development expenses will increase in the future as we advance our product candidates into and through clinical trials and pursues regulatory approvals, 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 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.

Previous wording

The process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in timely developing and achieving regulatory approval for our product candidates. The probability of success of our product candidates may be affected by numerous factors, including clinical data, competition, manufacturing capability and commercial viability. As a result, we are unable to determine the duration and completion costs of our development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our product candidates.

Current wording

The process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in timely developing and achieving regulatory approval for our product candidates. The probability of success of our product candidates may be affected by numerous factors, including availability of capital, clinical data, competition, manufacturing capability and commercial viability. As a result, we are unable to determine the duration and completion costs of our development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our product candidates.

Previous wording

General and administrative expenses consist of employee-related expenses, including salaries, benefits, travel and non-cash stock-based compensation, for our personnel in executive, finance and accounting, and other administrative functions, as well as fees paid for legal, accounting and tax services, consulting fees and facilities costs not otherwise included in research and development expenses. Legal costs include general corporate legal fees and patent costs. We expect to continue to incur expenses as a result of being a public company, including expenses related to compliance with the rules and regulations of the SEC and Nasdaq, additional insurance, investor relations and other administrative expenses and professional services.

Current wording

General and administrative expenses consist of employee-related expenses, including salaries, benefits, travel and non-cash stock-based compensation, for our personnel in executive, finance and accounting, and other administrative functions, as well as fees paid for legal, accounting and tax services, consulting fees and facilities costs not otherwise included in research and development expenses. Legal costs include general corporate legal fees and patent costs. We expect to continue to incur expenses as a result of being a public company, including expenses related to compliance with the rules and regulations of the SEC and Nasdaq, additional insurance, investor relations and other administrative expenses and professional services. As a result of the ongoing strategic review and the RIF, we expect general and administrative expenses will decrease period over period.

Previous wording

Other (expense) income, net consists primarily of interest expense, interest income, and various income or expense items of a non-recurring nature.

Current wording

Other income (expense), net consists primarily of interest expense, interest income, and various other income or expense items of a non-recurring nature.

Previous wording

Our research and development expenses for the three months ended March 31, 2025 and 2024 were primarily incurred in connection with our most advanced product candidate, amezalpat. Our internal resources, employees and infrastructure are not directly tied to any one research and drug discovery project and our resources have been typically deployed across multiple projects.

Current wording

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

Previous wording

General and administrative expenses decreased by $0.3 million to $3.3 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. The decrease was primarily due to a decrease in consulting services.

Current 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.

Previous wording

For the three months ended March 31, 2025 and 2024, other income (expense), net consisted of total interest expense of $161 thousand and $368 thousand, respectively, related to the loan with Oxford Finance, LLC (“Oxford”, and such loan the “Oxford Loan”), and interest income of $237 thousand and $438 thousand, respectively.

Current 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.

Previous wording

Research and development expenses increased by $3.3 million to $7.6 million for the three months ended March 31, 2025, compared to three months ended March 31, 2024, which 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 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.

Previous wording

our common stock, convertible preferred stock and issuance of debt. As of March 31, 2025, we had $21.5 million in cash and

Current wording

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

Previous wording

cash equivalents and an accumulated deficit of $218.0 million.

Current wording

cash equivalents and an accumulated deficit of $225.8 million.

Previous wording

On January 15, 2021, we entered into a loan and security agreement, as amended from time to time, with Oxford to borrow a term loan amount of $35.0 million to be funded in three tranches (the “Loan Agreement”). On April 8, 2025, we repaid $3.5 million in full satisfaction of the aggregate outstanding amount, including accrued interest and exit fees as of such date. As a result of the repayment, all liens and security interests were terminated.

Current wording

On January 15, 2021, we entered into a loan and security agreement, as amended from time to time, with Oxford to borrow a term loan amount of $35.0 million to be funded in three tranches. On April 8, 2025, we repaid $3.5 million in full satisfaction of the aggregate outstanding amount, including accrued interest and exit fees as of such date. As a result of the repayment, all liens and security interests were terminated.

Previous wording

We have entered into a sales agreement with Jefferies LLC, 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). As of March 31, 2025, we have sold an aggregate of 133,521 shares of our common stock for proceeds of $1.5 million pursuant to the ATM Program. As of March 31, 2025, $13.0 million remained available for sale under the ATM Program. Between March 31, 2025 and April 30, 2025, we sold 156,028 shares of our common stock for proceeds of $1.2 million pursuant to the ATM Program. As of April 30, 2025, we had $11.8 million 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 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.

Previous wording

The following table summarizes our cash flows for the three months ended March 31, 2025 and 2024:

Current wording

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

Previous wording

Cash used in operating activities for the three months ended March 31, 2024 was $7.2 million, consisting of a net loss of $7.9 million, add back of non-cash adjustments for depreciation, stock-based compensation, non-cash operating lease expense and other non-cash items totaling $1.9 million, plus changes in operating assets and liabilities of $1.2 million.

Current 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.

Previous wording

Cash used in operating activities for the three months ended March 31, 2025 was $8.0 million, consisting of a net loss of $10.9 million, add back of non-cash adjustments for depreciation, stock-based compensation, non-cash operating lease expense and other non-cash items totaling $1.8 million, plus changes in operating assets and liabilities of $1.1 million.

Current 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.

Previous wording

Cash used in investing activities for the three months ended March 31, 2025 and 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 six months ended June 30, 2024 was related to purchases of property and equipment, primarily related to laboratory and computer equipment.

Previous wording

Cash used in financing activities for the three months ended March 31, 2025 was related to Oxford loan principle payments of $2.2 million, offset by proceeds from the issuance of common stock of $1.4 million.

Current 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.

Previous wording

Cash provided by financing activities for the three months ended March 31, 2024 was related to proceeds from the issuance of common stock of $450 thousand.

Current 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.

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 March 31, 2025, we had $13.2 million payable within 12 months, including the current loan payable (net of discount and issuance costs) of $4.2 million due to Oxford under the Loan Agreement and $1.1 million related to the Brisbane Lease. On April 8, 2025, we made a repayment of $3.5 million in full satisfaction of the aggregate outstanding amount, including accrued interest and exit fees as of such date, under the Loan Agreement. Additionally, related to the reduction in force executed in April 2025, we estimate that we will incur $1.5 million of cash expenditures, consisting primarily of one-time severance payments, benefits and other related costs (excluding non-cash charges associated with equity-based compensation), with the majority of such costs to be incurred in the second quarter of 2025. Refer to Notes 5, 6 and 12 to our Condensed Consolidated Financial Statements for additional information.

Current 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.