Tempest Therapeutics Files 2023 Annual Report on Form 10-K

TL;DR

<b>Tempest Therapeutics filed its 2023 10-K, detailing financial performance, equity events, and operational data.</b>

AI Summary

Tempest Therapeutics, Inc. (TPST) filed a Annual Report (10-K) with the SEC on March 19, 2024. Tempest Therapeutics, Inc. filed its annual report for the fiscal year ended December 31, 2023. The company was formerly known as Millendo Therapeutics, Inc. and OvaScience, Inc. The filing includes details on share-based payment arrangements for employees, including stock options and restricted stock units. Key dates mentioned include financing events in 2021 and 2022, and a rights issuance in October 2023. The report covers financial data and operational details for the fiscal year 2023.

Why It Matters

For investors and stakeholders tracking Tempest Therapeutics, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Tempest Therapeutics' financial health and strategic activities throughout 2023, crucial for investors assessing the company's current standing and future prospects. The inclusion of historical company names and specific financing dates offers context for the company's evolution and capital-raising efforts, important for understanding its growth trajectory.

Risk Assessment

Risk Level: medium — Tempest Therapeutics, Inc. shows moderate risk based on this filing. The company is in the pharmaceutical preparations industry, which is subject to significant regulatory oversight, lengthy development cycles, and high R&D costs, as indicated by the 'ResearchAndDevelopmentExpenseMember' data.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand the company's financial position and the inherent risks in drug development.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-03-19 — Filing Date (Date of submission)
• 2021-01-15 — Tranche A Term Loan Date (Financing event)
• 2022-04-29 — P குறிப்பிடத்தக்க Investment Date (Financing event)
• 2023-10-10 — Series A Rights Issuance Date (Event date)

Key Players & Entities

• Tempest Therapeutics, Inc. (company) — Filer name
• Millendo Therapeutics, Inc. (company) — Former company name
• OvaScience, Inc. (company) — Former company name
• Ecor1 Capital, LLC (company) — Financing participant
• Versant Venture Capital (company) — Financing participant
• 2000 Sierra Point Parkway, Suite 400, Brisbane, CA 94005 (location) — Business address

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The pharmaceutical industry is subject to extensive regulation by governmental authorities, which can impact product development, manufacturing, and marketing.
• Need for Additional Financing [high — financial]: The company has a history of net losses and may require substantial additional capital to fund its ongoing operations and drug development programs.
• Research and Development Risks [high — operational]: Drug development is a lengthy, expensive, and uncertain process with a high risk of failure, impacting the company's ability to bring products to market.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-03-19: Filing Date — Date the 10-K was officially submitted to the SEC.
• 2022-04-29: Private Investment in Public Equity Financing — Significant financing event involving Ecor1 Capital and Versant Venture Capital.

Key Financial Figures

• $0.001 — nge on which Registered Common Stock, $0.001 par value TPST The Nasdaq Stock Mar
• $1.27 — l quarter), based on a closing price of $1.27 per share of the registrant's common st

Filing Documents

• tpst-20231231.htm (10-K) — 1994KB
• tpst-ex4_1.htm (EX-4.1) — 76KB
• tpst-ex10_26.htm (EX-10.26) — 79KB
• tpst-ex23_1.htm (EX-23.1) — 10KB
• tpst-ex31_1.htm (EX-31.1) — 17KB
• tpst-ex31_2.htm (EX-31.2) — 17KB
• tpst-ex32_1.htm (EX-32.1) — 9KB
• tpst-ex97_1.htm (EX-97.1) — 45KB
• img41960366_0.jpg (GRAPHIC) — 136KB
• img41960366_1.jpg (GRAPHIC) — 43KB
• img41960366_2.jpg (GRAPHIC) — 376KB
• img41960366_3.jpg (GRAPHIC) — 102KB
• img41960366_4.jpg (GRAPHIC) — 66KB
• img41960366_5.jpg (GRAPHIC) — 101KB
• img41960366_6.jpg (GRAPHIC) — 155KB
• img41960366_7.jpg (GRAPHIC) — 189KB
• img41960366_8.jpg (GRAPHIC) — 150KB
• 0000950170-24-033555.txt (&nbsp;) — 10621KB
• tpst-20231231.xsd (EX-101.SCH) — 994KB
• tpst-20231231_htm.xml (XML) — 974KB

Business

Business 3 Item 1A.

Risk Factors

Risk Factors 28 Item 1B. Unresolved Staff Comments 76 Item 1C. Cybersecurity 76 Item 2.

Properties

Properties 78 Item 3.

Legal Proceedings

Legal Proceedings 78 Item 4. Mine Safety Disclosures 78 PART II 79 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 79 Item 6. [Reserved] 79 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 80 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 88 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 89 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 110 Item 9A.

Controls and Procedures

Controls and Procedures 110 Item 9B. Other Information 110 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 111 PART III 112 Item 10. Directors, Executive Officers and Corporate Governance 112 Item 11.

Executive Compensation

Executive Compensation 112 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 113 Item 13. Certain Relationships and Related Transactions, and Director Independence 113 Item 14. Principal Accountant Fees and Services 113 PART IV 114 Item 15. Exhibit and Financial Statement Schedules 114 Item 16 Form 10-K Summary 116

Signatures

Signatures SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K (this "Annual Report"), contains 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, (the "Exchange Act"), that involve substantial risks and uncertainties. The forward-looking statements are contained principally in Part I, Item 1. "Business," Part I, Item 1A. "Risk Factors," and Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations," but are also contained elsewhere in this Annual Report. In some cases, you can identify forward-looking statements by the words "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "objective," "anticipate," "believe," "estimate," "predict," "project," "potential," "continue" and "ongoing," or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Annual Report, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. Forward-looking statements include statements about: our expected future growth and our ability to manage such growth; our ability to develop, obtain regulatory approval for and commercialize TPST-1495 and TPST-1120 and any future product candidates; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the size and growth potential of the markets for

BUSINESS

ITEM 1. BUSINESS Overview We are a clinical-stage biotechnology company moving into late-stage development with a diverse portfolio of novel targeted and immune-mediated product candidates with the potential to be first-in-class treatments for a wide range of cancers. The company's programs range from early research to the lead program, TPST-1120, that is poised to begin a pivotal study in first-line liver cancer. 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. Our two clinical-stage therapeutic product candidates are TPST-1120 and TPST-1495, which we believe are the first clinical-stage molecules designed to inhibit their respective targets. TPST-1120 is a selective antagonist of peroxisome proliferator-activated receptor alpha ("PPAR"). On October 11, 2023, we announced new and updated positive results from the planned data analysis of the ongoing global randomized Phase 1b/2 trial of TPST-1120 combined with the standard-of-care first-line regimen of atezolizumab and bevacizumab in patients with advanced or metastatic hepatocellular carcinoma ("HCC"). The study is comparing the TPST-1120 arm to standard of care alone and enrolled 40 patients randomized to the TPST-1120 arm and 30 patients randomized to the control arm. With a median follow-up of 9.2 and 9.9 months for the TPST-1120 arm and standard-of-care arm, respectively, the data showed a 30% confirmed objective response rate ("ORR") achieved in the TPST-1120 arm compared to 13.3% in the control arm, a substantial increase as compared to the previous data cut of 17.5% in the TPST-1120 arm and 10.3% in the control arm. In the TPST-1120 arm, 40% of patients remained on treatment versus 16.7% in the control arm

View Full Filing

View this 10-K filing on SEC EDGAR