Tempest Therapeutics, Inc.
For the period ended Mar 31, 2025. Filed May 13, 2025.
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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 13, 2025
TPST$0.38+1.4%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 2024-11-12.
0000950170-24-125499
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-13.
0000950170-25-070441
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 109 previous paragraphs and 92 current paragraphs.
42 unchanged; 23 reworded; 24 added; 40 removed; 4 previous and 3 current paragraphs rearranged.
Tables are not compared: 7 previous and 4 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 (24)
Current report
In June 2024, we unveiled positive survival data from the ongoing global randomized Phase 1b/2 clinical study demonstrating that amezalpat delivered a six-month improvement in median overall survival (“OS”) with a hazard ratio (“HR”) of 0.65 when combined with atezolizumab and bevacizumab in comparison to atezolizumab and bevacizumab alone, the standard of care, in the first-line treatment of patients with unresectable or metastatic HCC. Additionally, the survival benefit was preserved across key subpopulations, including patients with PD-L1 negative disease and β-catenin mutated disease, consistent with amezalpat’s proposed mechanism of action targeting both tumor cells directly and the patient’s immune system.
Current report
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 report
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 report
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 report
On April 8, 2025, we effected a one-for-thirteen (1:13) reverse stock split (the “Reverse Stock Split”). Pursuant to their terms, a proportionate adjustment was made to the per share exercise price and number of shares issuable under all of the Company’s outstanding options and warrants, and the number of shares authorized for issuance pursuant to the Company’s equity incentive plans have been reduced proportionately. The Reverse Stock Split did not reduce the number of authorized shares of common stock and did not alter the par value.
Current report
All share and per share amounts of common stock presented in this Quarterly Report on Form 10-Q have been retroactively adjusted to reflect the Reverse Stock Split. Refer to Note 12 of our unaudited condensed financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q for further information.
Current report
Strategic Review
Current report
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 report
Reduction in Force
Current report
In April 2025, we adopted a plan to extend our capital resources. As part of the plan, we reduced our workforce by 21 of 26 full-time employees, which became effective April 30, 2025. We anticipate that key employees within this group will transition to consulting agreements and continue to be available to us. 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.
Current report
Nasdaq Compliance
Current report
On December 27, 2024, we received a letter from the Listing Qualifications Staff of The Nasdaq Stock Market LLC (“Nasdaq”) notifying us that for the last 30 consecutive business days, the bid price of our common stock had closed below $1.00 per share, the minimum closing bid price required by the continued listing requirements of Nasdaq Listing Rule 5550(a)(2). Following the Reverse Stock Split described above, on April 24, 2025, we received a formal notification from Nasdaq confirming that we have regained compliance with Nasdaq Listing Rule 5550(a)(2).
Current report
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 report
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 report
Other (Expense) Income , Net
Current report
Our lack of operating revenue or cash inflows and our cash resources at March 31, 2025 raise substantial doubt as to our
Current report
ability to continue as a going concern. See “—Funding Requirements” below for additional information on our future capital needs.
Current report
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 report
As of the date of this Form 10-Q, our public float was less than $75.0 million. As a result, we are subject to the limitations of General Instruction I.B.6 to Form S-3 until such time as our public float exceeds $75 million, which means we only have the capacity to sell shares up to one-third of our public float under the S-3 Registration Statement, including the ATM program, in any twelve-month period. On February 6, 2025, we filed a prospectus supplement with the SEC limiting the availability under the ATM Program to $14.5 million.
Current report
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 report
Except as disclosed above, we have no long-term debt and no material non-cancelable purchase commitments with service providers, as we have generally contracted on a cancelable, purchase-order basis. We enter into contracts in the normal course of business with equipment and reagent vendors, CROs, CMOs and other third parties for clinical trials, preclinical research studies and testing and manufacturing services. These contracts are cancelable by us upon prior notice. Payments due upon cancellation consist only of payments for services provided or expenses incurred, including noncancelable obligations of our service providers, up to the date of cancellation.
Current report
Smaller Reporting Company Status and a Non-Accelerated Filer
Current report
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 report
Additionally, as a non-accelerated filer, we may continue to take advantage of the exception from compliance with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended.
Removed paragraphs (40)
Previous report
Randomized Phase 2 Trial Results
Previous report
As of an updated February 14, 2024 data cut, the ongoing global randomized Phase 1b/2 trial of amezalpat combined with the standard-of-care first-line regimen of atezolizumab and bevacizumab continued to show positive outcomes in patients with advanced or metastatic HCC. This study compares the amezalpat arm to the standard-of-care control and enrolled 40 patients randomized to the amezalpat arm and 30 patients randomized to the control arm. With 10 additional months of follow-up since the April 2023 primary analysis, the median OS in the amezalpat arm reached 21 months, representing a 6-month improvement over the 15-month OS in the control arm. Importantly, the hazard ratio (“HR”) remained stable at 0.65 from 0.59 observed earlier, demonstrating a sustained reduction in the relative risk of death compared to the control arm.
Previous report
At the cutoff date, 50% (20/40) of patients in the amezalpat arm remained in survival follow-up versus 30% (9/30) in the control arm. We believe this reinforces the meaningful clinical benefit observed in this population, with OS serving as the primary endpoint for regulatory approval globally for first-line HCC.
Previous report
The confirmed objective response rate (“ORR”) for the amezalpat arm remained consistent at 30%, compared to 13.3% in the control arm. Notably, one patient in the amezalpat arm who had previously achieved a partial response (“PR”) as of April 2023 converted to a complete response (“CR”) by February 2024, with at least an 80% reduction in tumor burden. This patient, despite having a PD-L1 score <1% and an immune desert phenotype, achieved a CR with the addition of amezalpat, highlighting its potential efficacy in hard-to-treat tumors.
Previous report
Additionally, in biomarker subpopulation analyses, patients with b-catenin activating mutations (21% of the study population) showed an increased confirmed ORR of 43% and a disease control rate (“DCR”) of 100% in the amezalpat arm. The triplet regimen with amezalpat remained active across PD-L1 negative tumors, with a confirmed ORR of 27% compared to a reduced ORR of 7% for the control arm.
Previous report
These randomized data, combined with clinical data from the earlier Phase 1 trials that were reported at a podium presentation at the American Society of Clinical Oncology (“ASCO”) annual meeting in June 2022, we believe support the advancement of amezalpat to a pivotal Phase 3 trial in first-line HCC, with further potential indications in kidney cancer (“RCC”) under consideration.
Previous report
Leadership Team Expansion and Update
Previous report
In preparation for the pivotal Phase 3 of amezalpat, we continued to strengthen our leadership team. In September 2024, we announced the appointment of Sheldon Mullins as Vice President of Regulatory Affairs, following the addition of Troy Wagner as Vice President of Quality Assurance. In addition, Darrin Bomba and Henry Johnson are now serving as Vice President, Development Operations and Vice President, CMC & Medicinal Chemistry, respectively, reflecting their roles in supporting the company’s late-stage clinical development.
Previous report
Beyond these clinical programs, we plan to continue to leverage our drug development and company-building experience along with academic relationships to identify promising new targets that may feed new programs into our pipeline. Our Discovery Research team employs a multidisciplinary approach to identify and validate therapeutic targets in oncology, and preclinical validation studies are then conducted to further understand the mechanism of action and potential therapeutic benefit to patients.
Previous report
Roche Master Clinical Supply Agreement
Previous report
In October 2024, we entered into a master clinical supply agreement (“Roche Supply Agreement”) with F. Hoffmann-La Roche Ltd. (“Roche”), pursuant to which Roche will supply Roche’s atezolizumab (TECENTRIQ) for use in one or more clinical studies conducted by us involving amezalpat in combination with atezolizumab, in each case, in accordance with the applicable study protocol prepared by us and reviewed by Roche. Under the Roche Supply Agreement, the parties may execute one or more clinical supply agreement supplements (each, a “CSA Supplement”) that will set forth the study to be conducted by us, the quantities of atezolizumab to be supplied by Roche for such study, and the delivery timeline for such quantities of atezolizumab.
Previous report
In October 2024, we entered into a CSA Supplement for Roche to supply atezolizumab to us, free of charge, for use in our planned phase 3 trial.
Previous report
Stockholder Rights Plan
Previous report
We amended our stockholder rights plan on October 9, 2024 to extend the final expiration date until immediately following our 2025 Annual Meeting of Stockholders or, if our stockholders approve the rights plan at or prior to such meeting, to October 10, 2026, unless the rights are earlier redeemed or exchanged by the Company. We do not have any obligation under the rights plan to seek stockholder approval. The rights plan otherwise remains unmodified and in full force and effect in accordance with its original terms. The rights plan is intended to reduce the likelihood that any person or group gains control of Tempest through open market accumulation without paying stockholders an appropriate control premium or without providing the Board sufficient time to make informed judgments and take actions that are in the best interests of all stockholders.
Previous report
We have no products approved for commercial sale and have not generated any revenue from product sales. From inception through September 30, 2024, we have raised $211.3 million, through sales of our capital securities.
Previous report
We have never been profitable and have incurred operating losses in each period since inception. Our net losses were $28.0 million and $22.0 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, we had an accumulated deficit of $193.3 million. Substantially all of the operating losses resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations.
Previous report
We expect to incur significant expenses and increasing operating losses for at least the next several years as we initiate and continue the clinical development of, and seek regulatory approval for, our product candidates and add personnel necessary to advance our pipeline of clinical-stage product candidates. In addition, operating as a publicly traded company involves the hiring of additional financial and other personnel, upgrading our financial information and other systems, and incurring substantial costs associated with operating as a public company. We expect our operating losses will fluctuate significantly from quarter to quarter and year to year due to timing of clinical development programs and efforts to achieve regulatory approval.
Previous report
Based on our business strategy, our existing cash and cash equivalents of $22.1 million as of September 30, 2024 and the $19.9 million of net proceeds raised between October 1, 2024 and November 8, 2024 through sales of common stock under our ATM Program, will be sufficient to fund our cash requirements for at least 12 months from the date our consolidated financial statements were available to be issued. Our ability to fund continued development will require additional capital, and we intend to raise such capital through the issuance of additional debt or equity including in connection with potential merger opportunities, or through business development activities. Our ability to continue as a going concern is dependent upon our ability to successfully accomplish these plans and secure sources of financing and ultimately attain profitable operations. If we are unable to obtain adequate capital, we could be forced to cease operations.
Previous report
Other income (expense), net
Previous report
Comparison of the nine months ended September 30, 2024 and 2023
Previous report
Research and development
Previous report
General and administrative
Previous report
General and administrative expenses increased by $2.0 million to $10.4 million for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023. The increase was primarily due to an increase in stock-based compensation expense due to increased headcount as well as an increase in expenses related to legal and consulting services.
Previous report
Other income (expense), net
Previous report
We believe our cash and cash equivalents as of September 30, 2024 and the $19.9 million of net proceeds raised between October 1, 2024 and November 8, 2024 through sales of common stock under our ATM Program will fund our ongoing working capital, investing, and financing requirements into the fourth quarter of 2025.
Previous report
In January 2021, we entered into a Loan Agreement with Oxford that provided us with up to $35.0 million of borrowing capacity across three potential tranches, which was subsequently amended in December 2022. The initial tranche of $15.0 million was funded at the closing of the Loan Agreement, of which $5.0 million was repaid in December 2022. As of September 30, 2024, the balance of the loan payable (net of debt issuance costs) was $8.5 million and a total of $10.0 million in borrowing capacity remained available at the option of Oxford. Monthly principal payments of $733 thousand began on July 1, 2024 and the Company paid the first principal payment to Oxford in July 2024. The term loan matures on August 1, 2025 and has an annual floating interest rate of 7.15% which is an Index Rate plus 7.10%. Index Rate is the greater of (i) 1-Month CME Term SOFR or (ii) 0.05%. Refer to Note 6 to our consolidated financial statements for additional information on our Loan Agreement with Oxford.
Previous report
We believe that our available cash and cash equivalents are sufficient to fund existing and planned cash requirements for the next 12 months from the date our consolidated financial statements were available to be issued. Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, third-party clinical research and development services, clinical costs, legal and other regulatory expenses and general overhead costs. We have based our estimates on assumptions that may prove to be incorrect, and we could use our capital resources sooner than we currently expect.
Previous report
Our future funding requirements will depend on many factors, including the following:
Previous report
the costs associated with a pivotal study for amezalpat in first-line HCC patients, as well as other costs associated with the scope, progress and results of discovery, preclinical development, laboratory testing and clinical trials for our product candidates;
Previous report
the costs associated with the manufacturing of our product candidates;
Previous report
the costs related to the extent to which we enter into partnerships or other arrangements with third parties to further develop our product candidates;
Previous report
the costs and fees associated with the discovery, acquisition or in-license of product candidates or technologies;
Previous report
our ability to establish collaborations on favorable terms, if at all;
Previous report
the costs of future commercialization activities, if any, including product sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval;
Previous report
revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval; and
Previous report
the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims.
Previous report
Further, our operating plan may change, and we may need additional funds to meet operational needs and capital requirements for clinical trials and other research and development expenditures. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated clinical studies.
Previous report
Until we can generate a sufficient amount of product revenue to finance our cash requirements, we expect to finance our future cash needs, including those set forth above, primarily through the issuance of additional equity, borrowings and strategic alliances with partner companies. To the extent that we raise additional capital through the issuance of additional equity or convertible debt securities, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of existing stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or commercialization efforts or grant rights to develop and market product candidates to third parties that we would otherwise prefer to develop and market ourselves.
Previous report
Smaller Reporting Company Status
Previous report
We are a smaller reporting company as defined in the Securities Exchange Act of 1934, as amended. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as (i) our voting and non-voting common stock held by nonaffiliates is less than $250.0 million measured on the last business day of our second fiscal quarter or (ii) our annual revenue is less than $100.0 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.
Reworded paragraphs (23)
Previous wording
We are a clinical-stage biotechnology company moving towards late-stage development 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 is poised 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; we believe both 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 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.
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.
Current 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.
Previous wording
Amezalpat is a selective antagonist of peroxisome proliferator-activated receptor alpha (“PPARα”). On August 15, 2024, we announced the successful completion of our end-of-Phase 2 meeting with the U.S. Food and Drug Administration (“FDA”) regarding the development of amezalpat for the treatment first-line unresectable or metastatic HCC. The FDA provided positive feedback on the pivotal Phase 3 clinical trial design, which closely mirrors the positive randomized Phase 2 study.
Current wording
Amezalpat is an oral, small molecule, selective antagonist of peroxisome proliferator-activated receptor alpha (“PPARα”) being developed for the treatment of first-line unresectable or metastatic HCC.
Previous wording
The planned Phase 3 trial is designed to use the current amezalpat dose and schedule in combination with atezolizumab and bevacizumab and will be compared to atezolizumab and bevacizumab alone, the standard of care. The primary endpoint of the trial will be Overall Survival (“OS”). The FDA also agreed on a pre-specified early efficacy analysis, that if met would potentially reduce the time to primary read-out by up to 8 months.
Current wording
In August 2024, we announced the successful completion of our end-of-Phase 2 meeting with the U.S. Food and Drug Administration (“FDA”) regarding the development of amezalpat for the treatment of first-line unresectable or metastatic HCC. The FDA provided positive feedback on the pivotal Phase 3 clinical trial design, which closely mirrors the positive randomized Phase 2 study. The planned Phase 3 trial is designed to use the current, Phase 2 amezalpat dose and schedule in combination with atezolizumab and bevacizumab and will be compared to atezolizumab and bevacizumab alone, the standard of care. The primary endpoint of the trial will be OS. Additionally, the FDA agreed to a pre-specified early efficacy analysis, which, if met, would potentially reduce the time to primary read-out by up to eight months.
Previous wording
Our second clinical program, TPST-1495, is a dual antagonist of the EP2 and EP4 receptors of prostaglandin E2. Data from the TPST-1495 Phase 1 trial was presented at the ASCO annual meeting in June 2023, and we are planning to advance TPST-1495 in a new indication, Familial Adenomatous Polyposis (“FAP”), for which there are no approved systemic therapies. Given that prostaglandin signaling is implicated in FAP and based on positive preclinical data in a relevant mouse model, we believe there is strong mechanistic support for this approach. We are working with the Cancer Prevention Clinical Trials Network on a National Cancer Institute (“NCI”)-funded Phase 2 study and subject to final approval, plan to start the study in the second half of 2024.
Current wording
Our second clinical program, TPST-1495, is a novel, small-molecule dual antagonist of the EP2 and EP4 receptors of prostaglandin E2 (“PGE2”), a pathway implicated in multiple cancers. Our development strategy for TPST-1495 includes evaluation in FAP, a rare genetic disorder that significantly increases the risk of gastrointestinal cancers and for which there are no approved systemic therapies. Given that prostaglandin signaling is also implicated in FAP and based on positive preclinical data in a relevant mouse model, we believe there is strong mechanistic support for this approach.
Previous wording
Advance amezalpat into a pivotal study in first-line HCC patients where amezalpat will be studied in a combination treatment and compared to a standard-of-care therapy, subject to obtaining feedback from the FDA. We believe positive results from the ongoing randomized Phase 1b/2 study provide strategic opportunities for us. We are also evaluating further development in RCC and cholangiocarcinoma (“CCA”) based on the Phase 1 data presented at ASCO 2022.
Current 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.
Previous wording
Explore TPST-1495 beyond original tumor types of interest. We plan to complete the ongoing combination arm in patients with advanced endometrial cancer, where prostaglandin signaling is implicated, and report the data in 2024. Additionally, subject to final approval from the NCI, we are planning to advance TPST-1495 with the Cancer Prevention Clinical Trials Network into a Phase 2 study in patients with FAP in the second half of 2024.
Current wording
Explore TPST-1495 in a Phase 2 study in patients with FAP with the CP-CTNet in 2025.
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. In addition, we continue to evaluate opportunities to acquire or in-license other product candidates and technologies, which may result in higher research and development expenses due to license fee and/or milestone payments, as well as added clinical development costs.
Current 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.
Previous wording
Other income (expense), net consists primarily of interest expense, interest income, and various other income or expense items of a non-recurring nature.
Current wording
Other (expense) income, net consists primarily of interest expense, interest income, and various income or expense items of a non-recurring nature.
Previous wording
Our research and development expenses for the three months ended September 30, 2024 and 2023 were primarily incurred in connection with our most advanced product candidates, amezalpat and TPST-1495. We typically have various early-stage research and drug discovery projects, as well as various potential product candidates undergoing clinical trials. Our internal resources, employees and infrastructure are not directly tied to any one research and drug discovery project and our resources are typically deployed across multiple projects.
Current 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.
Previous wording
Research and development expenses increased by $3.3 million to $7.6 million for the three months ended September 30, 2024, compared to three months ended September 30, 2023, 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. The following table summarizes our research and development expenses for the three months ended September 30, 2024 and 2023:
Current 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.
Previous wording
General and administrative expenses increased by $0.6 million to $3.0 million for the three months ended September 30, 2024, compared to the three months ended September 30, 2023. The increase was primarily due to an increase in stock-based compensation expense due to increased headcount as well as an increase in expenses related to legal and consulting services.
Current 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.
Previous wording
For the three months ended September 30, 2024 and 2023, other income (expense), net consisted of total interest expense of $329 thousand and $373 thousand, respectively, related to the loan with Oxford Finance, LLC (“Oxford” and such loan the “Oxford Loan”), and interest income of $324 thousand and $179 thousand, respectively.
Current 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.
Previous wording
Since inception through September 30, 2024, our operations have been financed primarily by net cash proceeds from the sale of our common stock, convertible preferred stock and issuance of debt. As of September 30, 2024, we had $22.1 million in cash and cash equivalents and an accumulated deficit of $193.3 million. We expect that our research and development and general and administrative expenses will increase, and, as a result, we anticipate that we will continue to incur increasing losses in the foreseeable future.
Current wording
Since inception through March 31, 2025, our operations have been financed primarily by proceeds from the sale of
Previous wording
Loan Agreement with Oxford Finance LLC
Current wording
Loan Agreement with Oxford Finance
Previous wording
On July 23, 2021, we entered into a sales agreement with Jefferies LLC (“Jefferies”), pursuant to which we may sell, from time to time at its sole discretion through Jefferies, as its sales agent, shares of its common stock having, up to an aggregate sales price of $100.0 million of its common stock through Jefferies (the “Prior ATM Program”). As of June 20, 2024, we had sold an aggregate 9,017,110 shares of its common stock for gross proceeds of approximately $42.7 million ($41.5 million net of commissions and estimated expenses) under the Prior ATM Program. On June 20, 2024, we and Jefferies terminated the Prior ATM Program and entered a new Open Market Sale Agreement SM (the “Sales Agreement”) to sell shares of common stock from time to time through Jefferies acting as sales agent (the “ATM Program”). Pursuant to the prospectus supplement dated June 20, 2024 (the “Prospectus Supplement”) filed by us with the U.S. Securities and Exchange Commission (“SEC”), we will be able to offer and sell up to $205,000,000 of its shares of common stock pursuant to the Sales Agreement. We will pay Jefferies a commission up to 3.0% of the gross sales proceeds of any shares of its common stock sold through Jefferies under the ATM Program and also has provided Jefferies with indemnification and contribution rights. As of September 30, 2024, we have sold an aggregate of 4,164,167 shares of its common stock for gross proceeds of approximately $8.6 million, or $8.3 million after deducting commissions and offering expenses, pursuant to the ATM Program. As of September 30, 2024, approximately $196.4 million remained available for sale under the ATM Program. Between October 1, 2024 and November 8, 2024 the Company sold 17,076,186 shares of our common stock for gross proceeds of $20.5 million or $19.9 million after deducting commissions and estimated offering expenses, pursuant to the ATM Program.
Current 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.
Previous wording
The following table summarizes our cash flows for the nine months ended September 30, 2024 and 2023:
Current wording
The following table summarizes our cash flows for the three months ended March 31, 2025 and 2024:
Previous wording
Cash used in operating activities for the nine months ended September 30, 2023 was $21.2 million, consisting of a net loss of $22.0 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.
Current 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.
Previous 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 $5.5 million, less changes in operating assets and liabilities of $0.4 million.
Current 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.
Previous wording
Cash used in investing activities for the nine months ended September 30, 2024 and 2023 was related to purchases of property and equipment, primarily related to laboratory and computer equipment.
Current 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.
Previous wording
Cash provided by financing activities for the nine months ended September 30, 2023 was related to proceeds from the issuance of common stock of $1.3 million.
Current 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.
Previous 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 $6.5 million.
Current 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.
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 September 30, 2024, we have $14.0 million payable within 12 months, including the current loan payable (net of discount and issuance costs) of $8.5 million due to Oxford and $0.8 million related to the Brisbane Lease. Refer to Notes 5 and 6 to our consolidated financial statements for additional information. We also expect our operating expenses to continue to increase in connection with our ongoing development activities, particularly as we continue the research, development and clinical trials of, and seek regulatory approval for, our product candidates. Accordingly, we will need substantial additional funding in connection with our continuing operations.
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 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.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
The following table summarizes our research and development expenses for the three months ended March 31, 2025 and 2024:
Current report — wording carried from elsewhere
our common stock, convertible preferred stock and issuance of debt. As of March 31, 2025, we had $21.5 million in cash and
Current report — wording carried from elsewhere
cash equivalents and an accumulated deficit of $218.0 million.
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
The following table summarizes our operating results for the nine months ended September 30, 2024 and 2023:
Previous report — wording carried elsewhere
Our research and development expenses for the nine months ended September 30, 2024 and 2023 were primarily incurred in connection with our most advanced product candidates, amezalpat and TPST-1495. We typically have various early-stage research and drug discovery projects, as well as various potential product candidates undergoing clinical trials. Our internal resources, employees and infrastructure are not directly tied to any one research or drug discovery project and our resources are typically deployed across multiple projects.
Previous report — wording carried elsewhere
Research and development expenses increased by $4.4 million to $17.7 million for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023, 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, as well as an increase in stock-based compensation due to increased headcount. The following table summarizes our research and development expenses for the nine months ended September 30, 2024 and 2023:
Previous report — wording carried elsewhere
For the nine months ended September 30, 2024 and 2023, other income (expense), net consisted of total interest expense of $1.1 million in each period, related to the Oxford Loan, and interest income of $1.1 million and $0.7 million, respectively.