Tempest Therapeutics, Inc.

There have been no material changes with respect to the risk factors disclosed in Part I, Item 1A. of our Annual Report on Form 10-K filed with the SEC on March 30, 2026.

There is substantial doubt regarding our ability to continue as a going concern. We will require significant additional funding to finance our operations, which may not be available on acceptable terms or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or our operations.

Our existing cash and cash equivalents of $0.8 million as of June 30, 2026 is expected to fund our operations through less than 12 months from the date our consolidated financial statements are available to be issued.

We have finite cash resources available to fund our operations. On February 3, 2026, we closed the Asset Acquisition. For more information regarding the Asset Acquisition see “—Recent Events—Asset Acquisition.” Pursuant to the Asset Purchase Agreement, we entered into an FCL with Factor, which provides us with financial support until the earlier to occur of 18 months following the closing of the Asset Acquisition andthe receipt by the Company of at least $20.0 million in gross proceeds from the sale of its equity or debt securities, up to a maximum amount of $20.0 million that is inclusive of any amounts raised and received by us after the date of the Asset Purchase Agreement, on the terms and subject to the conditions and other provisions set forth in the FCL. As of the date of this report, we have $11.8 million available under the FCL. There is significant uncertainty as to whether we will be able to satisfy the terms and conditions and other provisions set forth in the FCL, and, if we are unable to do so, we may be limited in the amount of funding that we are able to access under the FCL or we may not be able to access any funds under the FCL. The timing of any additional funding from Factor is uncertain.

To date, we have not generated product revenues from our activities and have incurred substantial operating losses. We expect that we will continue to generate substantial operating losses for the foreseeable future until we complete development and approval of one of our product candidates. As such, we will need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all. Our ability to raise additional capital has been adversely impacted by potential worsening global economic conditions, inflation expectations, and the recent disruptions to and volatility in the credit and financial markets in the United States and worldwide resulting from geopolitical tensions.

These conditions raise substantial doubt about our ability to continue as a going concern. We have evaluated the significance of the uncertainty regarding our financial condition in relation to our ability to meet our obligations, which has raised substantial doubt about our ability to continue as a going concern. There can be no assurances that we will be able to secure additional financing. If we are unable to access funding under the FCL or secure additional financing, we may be required to wind down our operations due to insufficient cash resources, and our stockholders will lose their investment.

In the event that we fail to regain compliance with the listing requirements of The Nasdaq Capital Market or satisfy any of the listing requirements of Nasdaq, our common stock may be delisted, which could affect our market price and liquidity.

Our common stock is listed on Nasdaq. For continued listing on Nasdaq, we will be required to comply with the continued listing requirements, including the minimum stockholders’ equity requirement, the board independence requirements, the audit committee composition requirements, the corporate governance requirements and the minimum closing bid price requirement, among other requirements.

On May 19, 2026, the Company received a letter from the Listing Qualifications Department of Nasdaq stating that the Company no longer meets the minimum stockholders’ equity requirement for continued listing on the Nasdaq Capital Market because the Company reported stockholders’ equity was below the required minimum of $2.5 million, and the Company did not meet the alternatives of market value of listed securities or net income from continuing operations. The Company received a period of 45 calendar days to submit a plan to regain compliance with the minimum stockholders’ equity requirement. The Company submitted a compliance plan to Nasdaq and, as of the date of this report, has not received Nasdaq’s determination with respect thereto.

On May 22, 2026, the Company received a letter from the Listing Qualifications Department of Nasdaq stating that, following the resignation of two independent directors, the Company no longer complied with Nasdaq’s board independence, audit committee, compensation committee and nominating committee composition requirements. The Company received a period of 45 calendar days to submit a plan to regain compliance with such requirements. The Company subsequently appointed two independent directors and regained compliance with the board independence, compensation committee and nominating committee composition requirements. The Company submitted a compliance plan with respect to the remaining audit committee composition deficiency and, as of the date of this report, has not received Nasdaq’s determination with respect thereto.

In the event that we fail to receive a compliance period, or to otherwise regain compliance with the Minimum Bid Price Requirement or satisfy any of the listing requirements of Nasdaq, our common stock may be delisted. We will have an opportunity to appeal the determination to a Hearings Panel, but we cannot guarantee that such appeal will be successful. If we are unable to list on Nasdaq, we would likely be more difficult to trade in or obtain accurate quotations as to the market price of our common stock. If our common stock is delisted from trading on Nasdaq, and we are not able to list our common stock on another exchange or to have it quoted on Nasdaq, our securities could be quoted on the OTC Bulletin Board or on the “pink sheets.” As a result, we could face significant adverse consequences including, without limitation:

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We experienced significant board and management turnover, and instability in governance and leadership could adversely affect our business.

We recently underwent significant governance and leadership changes. As disclosed in our Current Reports on Form 8-K, we had several directors resign from our Board of Directors, and, separately, our Chief Financial Officer resigned from that position and from all other positions he held with us. Although we have since appointed two new independent directors to fill board vacancies, this transition may cause temporary uncertainty and disruption.

Departures of members of our senior management team and our Board have created, and will create if they continue, significant continuity risks and challenges to our ability to operate our business, execute our clinical and business strategy, assess and manage risks and comply with applicable laws. These events could adversely affect us by:

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disrupting strategic execution;

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weakening our internal controls or disclosure controls;

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diverting management attention;

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increasing legal, accounting and administrative burden;

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impairing our ability to recruit, retain and motivate qualified personnel; and

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damaging confidence among investors, business partners, regulators, auditors and other stakeholders.

Management and board turnover may cause loss of institutional knowledge, which can negatively affect strategy and execution. It is important that we attract and retain qualified directors promptly and develop and implement an effective succession plan. We expect to face significant competition in attracting experienced executives, directors and other key personnel, and there can be no assurance that we will be able to do so. In addition, there are significant uncertainties as to how our transitional state of operations, financial condition and related matters will impact our ability to attract the necessary personnel and manage these succession risks. If we are unable to maintain stable and effective leadership, our business, reporting quality, prospects and financial condition would be adversely impacted.