TEMPEST THERAPEUTICS Company Overview April 2022 Information Regarding Disclosures Forward-Looking Statements This presentation contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (the "Securities Act")) concerning Tempest Therapeutics, Inc. ("Tempest Therapeutics"). These statements may discuss goals, intentions and expectations as to future plans, trends, events, resul ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 _______________________________________________________________________________________________________________________________ FORM 10-K _______________________________________________________________________________________________________________________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXC For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXC For the transition period from to . Commission File No. 001-35890 Tempest Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 45-1472564 (State or Other Jurisdiction of (I.R.S. Employer Incorporation ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-35890 Tempest Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) (Former Name, Former Address and Form ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________________________________________________________ FORM 10-Q _____________________________________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ ...

Corporate Restructuring and Workforce Reduction - The company discontinued the development of livoletide, nevanimibe, and MLE-301 due to insufficient trial results and strategic reevaluation, with a significant workforce reduction of approximately 85% planned by April 15, 2021[21]. - The company expects to incur costs of approximately $5.5 million for termination benefits and retention arrangements related to the corporate restructuring plan[21]. - The company plans to reduce its workforce by up to 85%, with the majority of reductions expected to be completed by April 15, 2021[113]. - The company has discontinued further investment in MLE-301, resulting in a reduced workforce of 12 employees as of the date of the filing[128]. - The company may face significant risks related to employment litigation due to workforce reductions and the need to retain key employees for the merger[128]. - The company may need to reassess its workforce requirements and raise funds to support continued operations if the merger does not close[124]. - The company implemented a reduction in force, reducing employee count by up to 85%, which may disrupt operations and lead to loss of institutional knowledge[184]. Merger and Strategic Transactions - A merger agreement was entered into with Tempest Therapeutics, Inc. on March 29, 2021, which, if completed, will allow Tempest's business to continue as part of the combined organization[22]. - If the merger is not completed, the company may consider dissolving and liquidating its assets or pursuing another strategic transaction[24]. - The merger with Tempest Therapeutics, Inc. is expected to result in pre-Merger Millendo shareholders owning approximately 18.5% and pre-Merger Tempest stockholders owning approximately 81.5% of the combined company, assuming gross proceeds of approximately $30 million[119]. - If the merger is not consummated, the company may incur a termination fee of $1.4 million or reimburse Tempest's expenses up to a maximum of $1.0 million[120]. - The announcement and pendency of the merger may adversely affect the trading price of the company's common stock and its business prospects[121]. - The company is devoting substantially all resources to consummating the merger transaction, but there is no assurance that it will deliver the anticipated benefits[119]. Financial Performance and Projections - The company incurred a net loss of $36.4 million and $44.6 million for the years ended December 31, 2020 and 2019, respectively, with an accumulated deficit of $245.1 million as of December 31, 2020[129]. - The company expects to continue incurring significant operating losses and increasing expenses for the foreseeable future, particularly if drug development activities resume[130]. - As of December 31, 2020, the company had cash, cash equivalents, and restricted cash of $38.7 million, which is expected to fund operations for at least the next 12 months[135]. - The company has never generated revenue from product sales and has a limited operating history, making it difficult to assess future viability[131]. - If the merger is not completed, the company may need to raise substantial additional funding, which may not be available on acceptable terms[132]. - The company has never obtained marketing approval for any product candidate, which could delay or prevent commercialization and revenue generation[139]. - The company anticipates that any delay in obtaining marketing approvals could significantly harm its business and financial condition[140]. Regulatory Compliance and Risks - The company is subject to various federal and state laws that impose significant penalties for violations, which could adversely affect its operations and financial condition[110]. - The FDA requires a 30-day waiting period after the submission of an IND application before clinical testing can begin in the U.S.[49]. - The FDA has a goal of responding to standard review NDAs within ten months after the 60-day filing review period, with priority review drugs typically reviewed within six to eight months[59]. - The FDA may require a risk evaluation and mitigation strategy (REMS) as a condition of NDA approval, which can affect the market and profitability of the drug[62]. - Post-approval, the FDA regulates drugs with specific requirements for recordkeeping, periodic reporting, and changes to approved drugs[65]. - The FDA requires drug manufacturers to comply with cGMP regulations, necessitating significant investment in production and quality control to maintain compliance[66]. - Non-compliance with FDA regulations can lead to severe consequences, including withdrawal of drug approval, fines, and potential criminal penalties[67][70]. - The FDA grants a five-year marketing exclusivity period for new chemical entities (NCEs), preventing the approval of generic versions during this time[69]. - The Patient Protection and Affordable Care Act (PPACA) has increased Medicaid rebates to 23.1% for branded drugs and 13% for generics, impacting manufacturers' financial obligations[76]. - Legislative changes have led to a 70% point-of-sale discount requirement for Medicare Part D beneficiaries during coverage gaps, affecting drug pricing strategies[76]. - The FDA's regulations on drug marketing prohibit off-label promotion, with significant liability risks for violations[68]. - The European Union requires extensive regulatory compliance for drug marketing, including a centralized procedure for certain drug categories[85]. - The new EU clinical trials regulation aims to streamline the authorization process and improve transparency, although full implementation is pending[82]. - Ongoing legislative interest in drug pricing practices may lead to increased transparency and potential reforms in reimbursement methodologies[79]. - The European Union grants eight years of data exclusivity for new active substances, followed by two years of market exclusivity, which can be extended to three years if a new therapeutic indication is approved during the initial exclusivity period[94]. - Orphan drugs receive a 10-year exclusivity period post-marketing authorization, which can be reduced to six years if criteria for orphan designation are no longer met[89]. - Companies must establish a pharmacovigilance system and appoint a qualified person for pharmacovigilance to oversee safety reporting obligations after obtaining marketing authorization[92]. - New marketing authorizations must include a risk management plan detailing the safety profile and risk-minimization measures for the product[93]. - The approval process for generic drugs in the EU allows for abridged applications referencing innovator data once data exclusivity has expired[94]. - Third-party payors increasingly challenge drug pricing and may require pharmacoeconomic studies to demonstrate cost-effectiveness for coverage and reimbursement[97]. - Governments in the EU influence drug pricing through reimbursement rules, which can create barriers to market entry for new drugs[99]. - The FDA regulates all advertising and promotion activities for drugs, and only approved claims regarding safety and efficacy may be used in labeling[102]. - Companies face potential civil, criminal, or administrative sanctions if they fail to comply with manufacturing regulations and standards[91]. - The marketability of drugs may suffer if adequate coverage and reimbursement are not provided by government and third-party payors[100]. Intellectual Property and Legal Risks - The company relies on a combination of patents, trade secrets, and confidentiality agreements to protect its intellectual property, which is critical for competitive positioning[154]. - The patent prosecution process is expensive and time-consuming, and the company may not be able to secure necessary patent protections in a timely manner[155]. - Changes in patent laws or interpretations could diminish the value of the company's patents, affecting its ability to compete effectively[156]. - The company may face challenges from third-party submissions or litigation that could invalidate or limit its patent rights, allowing competitors to enter the market[158]. - Patent terms may not provide adequate protection for the company's product candidates, as patents could expire before commercialization[164]. - The biotechnology and pharmaceutical industries are characterized by extensive litigation regarding intellectual property rights, which could adversely impact the company's business[165]. - The company may face litigation regarding intellectual property rights, which could adversely affect its ability to commercialize future product candidates[166]. - Legal claims to protect or enforce patents could be expensive and time-consuming, potentially leading to unsuccessful outcomes[167]. - Changes in U.S. patent law could diminish the value of patents, impairing the company's ability to protect its product candidates[170]. - The company may not be able to protect its intellectual property rights globally, which could allow competitors to develop similar drugs[171]. Operational Challenges and External Factors - The ongoing COVID-19 pandemic has resulted in operational disruptions, potentially delaying clinical programs and impacting financial condition[176]. - The pandemic may also affect the company's ability to access capital, which could negatively impact liquidity[178]. - The company is highly dependent on key executives, and their loss could impede the achievement of corporate objectives[181]. - Attracting and retaining qualified personnel is critical, as competition for talent in the biotechnology sector is intense[183]. - The company may face challenges in securing successful collaborations with third parties for product development, which could harm its business[175]. - Patent litigation can lead to substantial costs and distract management, impacting overall business operations[168]. - The company is exposed to foreign exchange risk, particularly with expenses and potential revenues in euros, which could negatively impact financial results[189]. - The company may face significant unexpected costs and liabilities related to the historic OvaScience business, which could adversely affect liquidity and operations[190]. - The market price of the company's common stock has been volatile, influenced by various factors including the ongoing COVID-19 pandemic and program discontinuations[191]. Tax and Compliance Issues - The company had federal net operating loss carryforwards (NOLs) of $330.8 million and state NOLs of $280.9 million as of December 31, 2020[207]. - The company does not anticipate paying any cash dividends on its common stock in the foreseeable future, intending to retain future earnings for business development[210]. - The company expects to incur increased costs due to compliance with public company responsibilities and corporate governance practices, which were not present as a private company[203]. - The effective tax rate may fluctuate due to various factors, including changes in tax laws and the mix of profitability across jurisdictions[206]. - The company may face limitations on using NOLs and other tax attributes to offset future taxable income due to ownership changes[208]. - The company is subject to various legal proceedings, which could have a material effect on its financial position and results of operations[215]. - The company has not declared or paid cash dividends to date, and capital appreciation will be the sole source of gain for investors in the foreseeable future[211]. - The company is required to maintain effective internal controls over financial reporting, and failure to do so could impair the accuracy of financial statements[202]. - The company may experience increased legal and financial compliance costs due to the Sarbanes-Oxley Act and other regulations[203]. - Changes in tax laws or regulations could materially adversely affect the company's business and financial condition[205].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________________________________________________________ FORM 10-Q _____________________________________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ ...

Corporate Presentation August 2020 Cautionary Statement Regarding Forward-Looking Statements Certain statements contained in this presentation regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by the words "may," "might," "will," "could," "would," "should," "expect," "intend," " ...

PART I – FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Unaudited interim financials for H1 2020 report a **$22.7 million net loss**, reduced cash, and a strategic pivot to MLE-301 development [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) Total assets decreased to **$57.1 million** by June 30, 2020, primarily due to a reduction in cash and cash equivalents Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | $50,312 | $62,478 | | Total current assets | $54,072 | $71,132 | | Total assets | $57,132 | $74,970 | | Total current liabilities | $10,086 | $12,520 | | Total liabilities | $12,188 | $15,099 | | Total stockholders' equity | $44,944 | $59,871 | [Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss for Q2 2020 was **$10.7 million**, and **$22.7 million** for H1 2020, primarily due to increased R&D expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended June 30, 2020 | Three Months Ended June 30, 2019 | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $6,466 | $5,981 | $14,006 | $12,185 | | General and administrative | $4,138 | $4,179 | $8,733 | $8,632 | | Loss from operations | $10,604 | $10,160 | $22,739 | $20,817 | | Net loss | $(10,672) | $(9,871) | $(22,670) | $(20,237) | | Net loss per share | $(0.56) | $(0.74) | $(1.21) | $(1.51) | [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations for H1 2020 was **$18.0 million**, with a **$12.5 million** decrease in total cash Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2020 | 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(18,030) | $(21,174) | | Net cash (used in) provided by investing activities | $(26) | $4,108 | | Net cash provided by (used in) financing activities | $5,513 | $(38) | | Net decrease in cash, cash equivalents and restricted cash | $(12,495) | $(17,139) | | Cash, cash equivalents and restricted cash at end of period | $51,017 | $56,631 | [Notes to Unaudited Interim Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Interim%20Consolidated%20Financial%20Statements) Notes detail program discontinuations, associated **$3.1 million** closeout costs and **$1.1 million** termination benefits, and a **$51.0 million** cash position - The company discontinued the development of livoletide for PWS in April 2020, recording **$3.1 million** in associated costs in Q2 2020[22](index=22&type=chunk) - Following the PWS program discontinuation, the company eliminated approximately **30% of its workforce**, resulting in **$1.1 million** in one-time termination benefits in Q2 2020[23](index=23&type=chunk) - In June 2020, the company ceased investing in the development of nevanimibe for CAH based on an interim data review[24](index=24&type=chunk) - As of June 30, 2020, the company had **$51.0 million** in cash, cash equivalents, and restricted cash, which management believes is sufficient to fund operations for at least 12 months[27](index=27&type=chunk)[31](index=31&type=chunk) - In March 2020, the company sold 719,400 shares of common stock under its "at-the-market" (ATM) equity distribution agreement for net proceeds of approximately **$5.7 million**[30](index=30&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the strategic shift to MLE-301, increased R&D expenses, and a **$51.0 million** cash position projected to fund operations into 2022 [Overview and COVID-19 Update](index=22&type=section&id=Overview%20and%20COVID-19%20Update) The company refocused on MLE-301 development with a Phase 1 trial planned for Q3 2020, initiated a strategic review, and monitors COVID-19 impacts - The company's primary focus is now on developing MLE-301 for vasomotor symptoms (VMS) in menopausal women, with a Phase 1 trial expected to start in Q3 2020[78](index=78&type=chunk)[79](index=79&type=chunk) - Development of livoletide for PWS was discontinued in April 2020, and investment in nevanimibe for CAH ceased in June 2020[80](index=80&type=chunk)[82](index=82&type=chunk) - The company has engaged SVB Leerink to support a strategic review process to maximize stockholder value[84](index=84&type=chunk) - The COVID-19 pandemic is being closely monitored, but the company expects to have an adequate supply of MLE-301 for its planned Phase 1 trial[86](index=86&type=chunk)[87](index=87&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) R&D expenses increased to **$6.5 million** in Q2 2020 and **$14.0 million** in H1 2020, driven by MLE-301 and closeout costs Comparison of Operating Results (in thousands) | Metric | Three Months Ended June 30, 2020 | Three Months Ended June 30, 2019 | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $6,466 | $5,981 | $14,006 | $12,185 | | General and administrative | $4,138 | $4,179 | $8,733 | $8,632 | | Net loss | $(10,672) | $(9,871) | $(22,670) | $(20,237) | - The increase in Q2 2020 R&D expense was driven by a **$0.5 million** increase in preclinical/clinical costs (mainly for MLE-301) and a **$0.3 million** increase in compensation due to severance, partially offset by a **$0.2 million** decrease in stock-based compensation[100](index=100&type=chunk)[101](index=101&type=chunk)[102](index=102&type=chunk) - The increase in H1 2020 R&D expense was primarily due to a **$1.9 million** rise in preclinical/clinical development costs related to MLE-301 and livoletide program closeout activities[107](index=107&type=chunk)[110](index=110&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds **$51.0 million** in cash, projected to fund operations into 2022, after using **$18.0 million** in H1 2020 operations - The company had cash, cash equivalents, and restricted cash of **$51.0 million** as of June 30, 2020[119](index=119&type=chunk) - Management projects the current cash position is sufficient to fund operations into 2022, based on current plans[90](index=90&type=chunk)[119](index=119&type=chunk) - In March 2020, the company sold 719,400 shares under its ATM agreement for net proceeds of approximately **$5.7 million**[118](index=118&type=chunk) - Net cash used in operating activities for the first six months of 2020 was **$18.0 million**, compared to **$21.2 million** for the same period in 2019[111](index=111&type=chunk)[112](index=112&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exempt from market risk disclosures as it qualifies as a smaller reporting company - The company is not required to provide disclosures about market risk as it qualifies as a smaller reporting company[127](index=127&type=chunk) [Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2020, with no material changes in internal controls - Management concluded that disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2020[128](index=128&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[129](index=129&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) The company is defending against shareholder derivative and class action lawsuits inherited from OvaScience, unable to estimate potential losses - The company is defending against a purported shareholder derivative action (Cima v. Dipp) and a shareholder class action lawsuit (Dahhan v. OvaScience, Inc.) related to the former operations of OvaScience[132](index=132&type=chunk)[133](index=133&type=chunk) - A third shareholder derivative complaint (Chiu v. Dipp) is currently stayed pending the resolution of the Dahhan Action[134](index=134&type=chunk) - The company believes the complaints are without merit but cannot estimate potential losses at this time[132](index=132&type=chunk)[133](index=133&type=chunk)[134](index=134&type=chunk) [Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) Significant risks include operating losses, capital needs, dependence on MLE-301, COVID-19 impacts, intense competition, and reliance on third parties - The company has a history of significant operating losses (**$231.3 million** accumulated deficit as of June 30, 2020) and expects to incur substantial losses for the foreseeable future[137](index=137&type=chunk) - Future success is highly dependent on the successful clinical development, regulatory approval, and commercialization of MLE-301, as previous lead candidates have been discontinued[155](index=155&type=chunk)[156](index=156&type=chunk) - The COVID-19 pandemic poses a material risk to business operations, clinical trial timelines, and the ability to access capital[305](index=305&type=chunk)[308](index=308&type=chunk) - The company relies on third-party CMOs for manufacturing and CROs for clinical trials, making it dependent on their performance and compliance with regulations like cGMP and GCP[291](index=291&type=chunk)[300](index=300&type=chunk) - The company faces substantial competition from major pharmaceutical and biotech companies with greater resources, such as Astellas and KaNDy Therapeutics in the VMS space[177](index=177&type=chunk)[179](index=179&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=90&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered equity securities were sold, nor were any issuer purchases made during Q2 2020 - There were no sales of unregistered securities during the three months ended June 30, 2020[346](index=346&type=chunk) [Defaults Upon Senior Securities](index=90&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable as the company has no defaults upon senior securities to report - Not applicable[348](index=348&type=chunk) [Mine Safety Disclosures](index=90&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not applicable[349](index=349&type=chunk) [Other Information](index=90&type=section&id=Item%205.%20Other%20Information) No other information is reported for this period - Not applicable[350](index=350&type=chunk) [Exhibits](index=91&type=section&id=Item%206.%20Exhibits) Exhibits include amendments to equity incentive plans and CEO/CFO certifications required by Sarbanes-Oxley - The report includes amendments to the 2012 and 2019 Equity Incentive Plans[352](index=352&type=chunk) - Certifications by the CEO and CFO pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act are filed as exhibits[352](index=352&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________________________________________________________ FORM 10-Q _____________________________________________________________________ x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ ...