SEC Filing | Tempest Therapeutics

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10-Q

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, 2024


☐	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)


Delaware	45-1472564
(State or Other Jurisdiction of	(I.R.S. Employer
Incorporation or Organization)	Identification No.)
2000 Sierra Point Parkway, Suite 400
Brisbane, California	94005
(Address of Principal Executive Offices)	(Zip Code)

Registrant’s telephone number, including area code: (415) 798-8589

(Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading	Name of each exchange
Title of each class		Symbol(s)	on which registered
Common Stock, $0.001 par value	TPST	The Nasdaq Stock Market LLC
Series A Junior Participating Preferred Purchase Rights	N/A	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

The number of shares of Registrant’s Common Stock, $0.001 par value per share, outstanding as of August 5, 2024 was 25,207,792.

INDEX TO FORM 10-Q


		Page
Special Note Regarding Forward-Looking Statements		3
	PART I — FINANCIAL INFORMATION	5
Item 1.	Financial Statements (unaudited):	5
	Condensed Consolidated Balance Sheets as of June 30, 2024 and December 31, 2023	5
	Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2024 and 2023	6
	Condensed Consolidated Statements of Stockholders’ Equity for the Three and Six Months Ended June 30, 2024 and 2023	7
	Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2024 and 2023	8
	Notes to Condensed Consolidated Financial Statements	9
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	17
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	26
Item 4.	Controls and Procedures	26

	PART II — OTHER INFORMATION	28
Item 1.	Legal Proceedings	28
Item 1A.	Risk Factors	28
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	79
Item 3.	Defaults Upon Senior Securities	79
Item 4.	Mine Safety Disclosures	79
Item 5.	Other Information	79
Item 6.	Exhibits	80
Signatures

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q 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”)) about us and our industry that involve substantial risks and uncertainties. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of our management, as well as assumptions made by, and information currently available to, our management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “could,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “intend,” and other similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: our strategies, prospects, plans, expectations or objectives for future operations; the progress, scope or timing of the development of our product candidates; the benefits that may be derived from any future products or the commercial or market opportunity with respect to any of our future products; our ability to protect our intellectual property rights; our anticipated operations, financial position, ability to raise capital to fund operations, revenues, costs or expenses; statements regarding future economic conditions or performance; statements of belief and any statement of assumptions underlying any of the foregoing. These risks and uncertainties include, but are not limited to, the risks included in this Quarterly Report on Form 10-Q under Part II, Item 1A, “Risk Factors.” Other sections of this Quarterly Report on Form 10-Q, as well as our other disclosures and filings, include additional factors that could harm our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ from those contained in, or implied by, any forward-looking statements.

Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our estimates and assumptions only as of the date of this document. You should read this document with the understanding that our actual future results may be materially different from what we expect. Except as required by law, we do not undertake any obligation to update or revise any forward-looking statements contained in this report, whether as a result of new information, future events or otherwise.

Forward-looking statements contained in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:

•

our expected future growth and our ability to manage such growth;

•

our ability to develop, obtain regulatory approval for and commercialize amezalpat (previously known as TPST-1120), TPST-1495 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 our product candidates, and our ability to serve those markets;

•

the development, regulatory approval, efficacy and commercialization of competing products;

•

our ability to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product candidates;

•

our ability to retain regulatory approval for our product candidates or future product candidates in the United States and in any foreign countries in which we make seek to do business;

•

our ability to retain and hire our board of directors, senior management, or operational personnel;

•

our ability to develop and maintain our corporate infrastructure, including our ability to design and maintain an effective system of internal controls;

•

our ability to remain in compliance with our obligations under our term loan with Oxford Finance LLC, or to obtain a waiver from Oxford for any failure to comply with the covenants contained in such term loan agreement;

•

general economic, political, and market conditions and overall fluctuations in the financial markets in the United States and abroad, including as a result of bank failures, public health crises or geopolitical tensions;

•

our expectation regarding the period during which we will qualify as a smaller reporting company under the federal securities laws; and

•

our expectations regarding our ability to obtain, maintain and enforce intellectual property protection for our products and technology, as well as our ability to operate our business without infringing, misappropriating or otherwise violating the intellectual property rights of others.

You should read this Quarterly Report on Form 10-Q as well as the documents that we reference in, and have filed as exhibits to, this report with the understanding that our actual future results, levels of activity, performance and achievements may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

Unless the context suggests otherwise, references in this Quarterly Report on Form 10-Q to “Tempest,” “the Company,” “we,” “us,” and “our” refer to Tempest Therapeutics, Inc. and, where appropriate, its subsidiaries.

PART I – FINANCIAL INFORMATION

Item 1 – Financial Statements

TEMPEST THERAPEUTICS, INC.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share amounts)




	June 30, 2024 (Unaudited)			December 31, 2023
Assets
Current assets:
Cash and cash equivalents	$	31,124		$	39,230
Prepaid expenses and other current assets		424			1,133
Total current assets		31,548			40,363
Property and equipment — net		1,014			840
Operating lease right-of-use assets		9,159			9,952
Other noncurrent assets		448			448
Total assets	$	42,169		$	51,603
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	1,357		$	845
Accrued expenses		2,379			1,673
Current loan payable (net of discount and issuance costs of $150 and $112, respectively)		8,645			4,285
Current operating lease liabilities		939			952
Accrued compensation		1,133			1,543
Interest payable		106			113
Total current liabilities		14,559			9,411
Loan payable (net of discount and issuance costs of $22 and $164, respectively)		2,008			6,264
Operating lease liabilities, less current portion		8,663			9,160
Total liabilities		25,230			24,835
Commitments and contingencies (Note 5)
Stockholders’ equity:
Common stock, $0.001 par value; 100,000,000 shares authorized; 24,475,799 and 22,045,255 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively		24			22
Additional paid-in capital		199,652			192,009
Accumulated deficit		(182,737	)		(165,263	)
Total stockholders’ equity		16,939			26,768
Total liabilities and stockholders’ equity	$	42,169		$	51,603

See accompanying Notes to the Condensed Consolidated Financial Statements

TEMPEST THERAPEUTICS, INC.

Condensed Consolidated Statements of Operations

(Unaudited)

(in thousands, except share and per share amounts)


	Three Months Ended June 30,						Six Months Ended June 30,
	2024			2023			2024			2023
Operating expenses:
Research and development	$	5,837		$	4,416		$	10,177		$	9,094
General and administrative		3,745			3,054			7,379			5,957
Loss from operations		(9,582	)		(7,470	)		(17,556	)		(15,051	)
Other income (expense), net:
Interest expense		(372	)		(355	)		(740	)		(699	)
Interest income and other income (expense), net		384			244			822			533
Total other income (expense), net		12			(111	)		82			(166	)
Provision for income taxes		—			—			—			—
Net loss	$	(9,570	)	$	(7,581	)	$	(17,474	)	$	(15,217	)
Net loss per share of common stock, RSUs and pre-funded warrants, basic and diluted	$	(0.42	)	$	(0.54	)	$	(0.78	)	$	(1.09	)
Weighted-average shares of common stock, RSUs and pre-funded warrants outstanding, basic and diluted		22,546,370			14,102,211			22,390,298			13,933,629

See accompanying Notes to the Condensed Consolidated Financial Statements

TEMPEST THERAPEUTICS, INC.

Condensed Consolidated Statements of Stockholders’ Equity

(Unaudited)

(in thousands, except share amounts)

Six Months Ended June 30, 2024


	Common Stock				Additional Paid-In		Accumulated			Total Stockholders'
	Shares		Amount		Capital		Deficit			Equity
BALANCE — December 31, 2023		22,045,255	$	22	$	192,009	$	(165,263	)	$	26,768
Issuance of common stock in connection with at-the-market offering (net of issuance costs of $8)		56,288		—		253		—			253
Stock-based compensation		—		—		1,318		—			1,318
Issuance of common stock under equity plan awards		115,722		—		197		—			197
Net loss		—		—		—		(7,904	)		(7,904	)
BALANCE — March 31, 2024		22,217,265	$	22	$	193,777	$	(173,167	)	$	20,632
Issuance of common stock in connection with at-the-market offering (net of issuance costs of $261)		2,133,534		2		4,555		—			4,557
Stock-based compensation		—		—		1,320		—			1,320
Issuance of common stock under equity plan awards		125,000		—		—		—			—
Net loss		—		—		—		(9,570	)		(9,570	)
BALANCE — June 30, 2024		24,475,799	$	24	$	199,652	$	(182,737	)	$	16,939

Six Months Ended June 30, 2023


	Common Stock				Additional Paid-In		Accumulated			Total Stockholders'
	Shares		Amount		Capital		Deficit			Equity
BALANCE — December 31, 2022		10,518,539	$	11	$	153,872	$	(135,772	)	$	18,111
Issuance of common stock for cash		43,161		—		44		—			44
Stock-based compensation		—		—		446		—			446
Net loss		—		—		—		(7,636	)		(7,636	)
BALANCE — March 31, 2023		10,561,700	$	11	$	154,362	$	(143,408	)	$	10,965
Issuance of common stock for cash (net of issuance cost of $30)		537,546		1		1,185		—			1,186
Exercise of pre-funded warrants		1,484,174		1		—		—			1
Stock-based compensation		—		—		440		—			440
Exercise of stock options		413		—		1		—			1
Net loss		—		—		—		(7,581	)		(7,581	)
BALANCE — June 30, 2023		12,583,833	$	13	$	155,988	$	(150,989	)	$	5,012

See accompanying Notes to the Condensed Consolidated Financial Statements.

TEMPEST THERAPEUTICS, INC.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(in thousands)


	For the Six Months Ended June 30,
	2024			2023
Operating activities:
Net loss	$	(17,474	)	$	(15,217	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense		243			208
Stock-based compensation expense		2,638			886
Non-cash lease expense		793			846
Non-cash interest and other expense, net		104			96
Changes in operating assets and liabilities:
Prepaid expenses and other assets		709			370
Accounts payable		512			(240	)
Accrued expenses and other liabilities		296			(931	)
Interest payable		(7	)		8
Operating lease liabilities		(510	)		(721	)
Cash used in operating activities		(12,696	)		(14,695	)
Investing activities:
Purchase of property and equipment		(417	)		(163	)
Cash used in investing activities		(417	)		(163	)
Financing activities:
Proceeds from the issuance of common stock in connection with at-the-market offering, net of issuance costs		4,810			1,232
Proceeds from the issuance of common stock under equity plan awards		197			—
Cash provided by financing activities		5,007			1,232
Net decrease in cash, cash equivalents and restricted cash		(8,106	)		(13,626	)
Cash, cash equivalents and restricted cash at beginning of period		39,673			31,598
Cash, cash equivalents and restricted cash at end of period	$	31,567		$	17,972
Supplemental disclosure of cash flow information:
Cash paid for interest	$	651		$	604
Cash paid for business taxes	$	6		$	104

See accompanying Notes to the Condensed Consolidated Financial Statements

TEMPEST THERAPEUTICS, INC.

Notes to the Condensed Consolidated Financial Statements

(Unaudited)

(Amounts are in thousands, except share and per share data)

1. ORGANIZATION AND DESCRIPTION OF THE BUSINESS

Description of Business

Tempest Therapeutics, Inc. (“Tempest” or the “Company”) is a clinical-stage biotechnology company moving into late-stage development with a diverse portfolio of targeted and immune-mediated product candidates with the potential to be first-in-class treatments for a wide range of cancers. Tempest’s 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 liver cancer. Tempest is also developing other potential product candidates in its Discovery Research group. The Company is headquartered in Brisbane, California.

Liquidity and Management Plans

The accompanying financial statements have been prepared assuming the Company will continue as a going concern. The Company has incurred operating losses since inception. As of June 30, 2024, the Company had cash and cash equivalents of $31.1 million. The Company has not yet generated product sales and as a result has experienced operating losses since inception. The Company expects to incur additional losses in the future to conduct research and development and will need to raise additional capital to continue operations. The Company intends to raise such capital through the issuance of additional debt or equity including in connection with potential merger opportunities, or through business development activities. The Company’s ability to continue as a going concern is dependent upon its ability to control its variable spend over the next 12 months, while management plans to secure sources of financing and ultimately attain profitable operations. If the Company are unable to obtain adequate capital, it could be forced to cease operations. Management believes that its existing cash and cash equivalents will be sufficient to fund the Company’s cash requirements for at least 12 months following the issuance of these financial statements.

ATM Program

On July 23, 2021, the Company entered into a sales agreement with Jefferies LLC (“Jefferies”), pursuant to which the Company 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, the Company 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, the Company and Jefferies terminated the Prior ATM Program and entered a new Open Market Sale AgreementSM (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 the Company with the U.S. Securities and Exchange Commission (“SEC”), the Company will be able to offer and sell up to $205,000,000 of its shares of common stock pursuant to the Sales Agreement. The Company 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 June 30, 2024, the Company has sold an aggregate of 2,133,534 shares of its common stock for gross proceeds of approximately $4.8 million ($4.7 million net of commissions and estimated expenses), after deducting commissions and offering expenses pursuant to the ATM Program. As of June 30, 2024, approximately $200.2 million remained available for sale under the ATM Program. Between July 1, 2024 and July 18, 2024, the Company sold 672,539 shares of our common stock for gross proceeds of $1.5 million ($1.4 million net of commissions and estimated expenses) pursuant to the ATM program.

PIPE Financing

On April 29, 2022, the Company completed a private investment in public equity (“PIPE”) financing from the sale of 3,149,912 shares of its common stock at a price per share of $2.36 and, and in lieu of shares of common stock, pre-funded warrants to purchase up to 3,206,020 shares of its common stock at a price per pre-funded warrant of $2.359 to EcoR1 Capital, LLC and Versant Venture Capital (the “PIPE Investors”). Net proceeds from the PIPE financings totaled approximately $14.5 million, after deducting offering expenses. The Company entered into a registration rights agreement with the PIPE Investors pursuant to which the Company filed a registration statement with the SEC registering the resale of the 3,149,912 shares common stock and the 3,206,020 shares of common stock underlying the pre-funded warrants issued in the PIPE financing. As of June 30, 2024, all pre-funded warrants had been exercised.

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Significant Accounting Policies—The Company’s significant accounting policies are described in Note 2, “Summary of Significant Accounting Policies,” in the Company’s Annual Report on Form 10-K filed with the SEC on March 19, 2024. There have been no material changes to the significant accounting policies during the period ended June 30, 2024.

Basis of Presentation—The unaudited interim Condensed Consolidated Financial Statements have been prepared pursuant to the rules and regulations of the U.S. Securities and Exchange Commission. Accordingly, certain information and footnote disclosures normally included in annual financial statements prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) have been omitted. These unaudited interim Condensed Consolidated Financial Statements should be read in conjunction with the Company’s audited Consolidated Financial Statements and notes included in the company’s Annual Report on Form 10-K for the year ended December 31, 2023.

The Company has prepared the accompanying Condensed Consolidated Financial Statements on the same basis as the audited financial statements, and the unaudited interim financial statements include, in the Company’s opinion, all adjustments, consisting only of normal recurring adjustments that the Company considers necessary for a fair presentation of its financial position and results of operations for these periods.

Use of Estimates—The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. On an ongoing basis, the Company evaluates its estimates and assumptions, including those related to research and development accruals, recoverability of long-lived assets, right-of-use assets, lease obligations, stock-based compensation and income taxes uncertainties and valuation allowances. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from those estimates.

3. FAIR VALUE MEASUREMENTS

The following tables present the Company’s fair value hierarchy for assets measured at fair value on a recurring basis:


	As of June 30, 2024
	Level 1		Level 2		Level 3		Total
Cash and cash equivalents	$	31,124	$	—	$	—	$	31,124
Total	$	31,124	$	—	$	—	$	31,124

	As of December 31, 2023
	Level 1		Level 2		Level 3		Total
Cash and cash equivalents	$	39,230	$	—	$	—	$	39,230
Total	$	39,230	$	—	$	—	$	39,230

4. BALANCE SHEET COMPONENTS

Prepaid expenses and other current assets consist of the following:


	June 30, 2024		December 31, 2023
Prepaid expenses	$	272	$	700
Prepaid research and development costs		117		337
Other current assets		35		96
Total	$	424	$	1,133

Property and equipment, net, consists of the following:


	June 30, 2024			December 31, 2023
Computer equipment and software	$	205		$	169
Furniture and fixtures		328			328
Lab equipment		1,456			1,133
Leasehold improvements		293			235
Property and equipment		2,282			1,865
Less accumulated depreciation		(1,268	)		(1,025	)
Property and equipment—net	$	1,014		$	840

Depreciation expense for the three and six months ended June 30, 2024 was $155 and $243, respectively. Depreciation expense for the three and six months ended June 30, 2023 was $83 and $208, respectively.

Accrued liabilities consist of the following:


	June 30, 2024		December 31, 2023
Accrued other liabilities	$	2,031	$	626
Accrued clinical trial liability		348		1,047
Total	$	2,379	$	1,673

5. COMMITMENTS AND CONTINGENCIES

Facilities Lease Agreements

In January 2022, the Company entered into a new 8-year office lease agreement for a 20,116 square feet facility in Brisbane, California (“Brisbane Lease”). The lease commenced in December 2022.

As of June 30, 2024 and December 31, 2023, the balance of the operating lease right of use assets were $9,159 and $9,952, respectively, and the related operating lease liability were $9,602 and $10,112, respectively, as shown in the accompanying consolidated balance sheets.

Rent expense was $587 and $1,272 for the three and six months ended June 30, 2024, respectively. Rent expense was $659 and $1,369 for the three and six months ended June 30, 2023, respectively.

As of June 30, 2024, future minimum lease payments under the Company's operating lease liabilities were as follows:



Year Ending	Total Commitment
2024 (excluding six months ended June 30, 2024)	$	898
2025		1,861
2026		1,926
2027		1,994
2028 and beyond		6,410
Total minimum lease payments		13,089
Less: imputed interest		(3,487	)
Present value of operating lease obligations		9,602
Less: current portion		(939	)
Noncurrent operating lease obligations	$	8,663

Related to this Brisbane Lease agreement, the Company entered into a letter of credit with a bank to deposit $388 in a separate account that is classified as restricted cash to serve as security rent deposit. This amount is included in other noncurrent assets in the accompanying consolidated balance sheets as of June 30, 2024.

6. LOAN PAYABLE

On January 15, 2021, the Company entered into a loan agreement with Oxford Finance LLC (the “Lender”) to borrow a term loan amount of up to $35,000 to be funded in three tranches. The company has only drawn Tranche A in the amount of $15,000 which was wired to the Company on January 15, 2021. Tranche B of $10,000 expired on March 31, 2022. Tranche C of $10,000 is available at the Lender’s option.

On December 23, 2022, in connection with and following the Company’s merger with Millendo Therapeutics, Inc. (“Millendo”), the Company entered into a First Amendment to the loan agreement. The amendment modified the agreement as follows: (i) each of the Company and Millendo Therapeutics US, Inc., a Delaware corporation and wholly owned non-operating subsidiary of the Company created in connection with the merger (“Millendo US”), were joined as co-borrowers under the Loan Agreement; (ii) the interest-only repayment period was extended through December 31, 2023 (which interest-only period may be further extended through June 30, 2024 under certain circumstances); and (iii) a security interest in all of the assets of the Company and Millendo, in addition to the existing interest the Lender had in TempestTx, including any intellectual property, was granted to the Lender. In addition, the Lender permitted a one-time prepayment in the amount of $5.0 million, which the Company paid on December 23, 2022.

Following the amendment to the loan agreement, 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%. In the fourth quarter of 2023, the Company achieved the circumstances necessary to extend the interest-only repayment period through June 30, 2024. Monthly principal payments of $733 began on July 1, 2024 and the Company paid the first principal payment to Oxford in July 2024. Related to this borrowing, the Company recorded loan discounts totaling $898 and paid $95 of debt issuance costs. These amounts would be amortized as additional interest expense over the life of the loan. As of June 30, 2024, the balance of the loan payable (net of debt issuance costs) was $10.7 million. The carrying value of the loan approximates fair value (Level 2).

For the three and six months ended June 30, 2024, total interest expense was $372 and $740, respectively. For the three and six months ended June 30, 2023, total interest expense was $356 and $700, respectively.

7. STOCKHOLDERS' EQUITY

Common Stock

As of June 30, 2024 and December 31, 2023, the Company was authorized to issue 100,000,000 shares of common stock and 5,000,000 shares of preferred stock, each with a par value of $0.001 per share. Of the common stock shares authorized, 24,475,799 and 22,045,255 were issued and outstanding at June 30, 2024 and December 31, 2023, respectively. There were no shares subject to repurchase due to remaining vesting requirements. Common stockholders are entitled to dividends as declared by the Company’s board of directors (the “Board of Directors”), subject to rights of holders of all classes of stock outstanding having priority rights as to dividends. There was no preferred stock issued nor outstanding as of June 30, 2024 and December 31, 2023.

Common stockholders are entitled to dividends as declared by the Board of Directors, subject to rights of holders of all classes of stock outstanding having priority rights as to dividends. There have been no dividends declared to date. The holders of each share of common stock are entitled to one vote. Except for effecting or validating certain specific actions intended to protect the preferred stockholders, the holders of common stock vote together with preferred stockholders and have the right to elect one member of the Board of Directors.

Rights Plan

On October 10, 2023, the Board of Directors adopted a limited duration stockholder rights plan (the “Rights Plan”), effective immediately, and declared a dividend of one preferred share purchase right (a “Right”) for each outstanding share of the common stock, par value $0.001 per share (the “Common Shares”), of the Company. The dividend was effective as of October 23, 2023 (the “Record Date”) with respect to stockholders of record on that date. The Rights will also attach to new Common Shares issued after the Record Date. Each Right entitles the registered holder to purchase from the Company one one-thousandth of a share of Series A Junior Participating Preferred Stock, par value $0.001 per share, (the “Preferred Shares”), of the Company at a price of $25.00 per one one-thousandth of a Preferred Share, subject to adjustment. The descriptions and terms of the Rights are set forth in a Rights Agreement, dated as of October 10, 2023 (the “Rights Agreement”), between the Company and Computershare Trust Company, NA. The Rights will expire on October 10, 2024, or, if the Company’s stockholders approve the Rights Plan, on October 10, 2026, unless the Rights are earlier redeemed or exchanged by the Company.

8. STOCK-BASED COMPENSATION

Equity Plans

The Board of Directors adopted the Amended and Restated 2023 Equity Incentive Plan (the “2023 Plan”) on April 30, 2023, subject to approval by the Company’s stockholders. On June 15, 2023, the Company’s stockholders approved the 2023 Plan, which amended and restated the A&R 2019 Plan and will be a successor to, and replacement of, the A&R 2019 Plan. The number of shares of the Company's common stock reserved for issuance under the 2023 Plan will automatically increase on January 1st of each year, for a period of 10 years, from January 1, 2024 continuing through January 1, 2033, by 4% of the total number of shares of the Company's common stock outstanding on December 31st of the preceding calendar year, or a lesser number of shares as may be determined by the Board of Directors. Accordingly, on January 1, 2024, the common stock reserved for issuance was increased by 881,810 shares. As of June 30, 2024, there were 508,017 shares available for future grant under the 2023 Plan.

The 2023 Plan allows the Company to grant stock awards to employees, directors and consultants of the Company, including incentive stock options (“ISOs”), non-qualified stock options (“NSOs”), stock appreciation rights, restricted stock awards, restricted stock unit awards and other stock awards.

The Board of Directors adopted the 2023 Inducement Plan (“2023 Inducement Plan”) on June 21, 2023, pursuant to which the Company reserved 1,150,000 shares of its common stock to be used exclusively for grants of awards to individuals who were not previously employees or directors of the Company, as an inducement material to the individual’s entry into employment with the Company within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules. The 2023 Inducement Plan was approved by the Board of Directors without stockholder approval in accordance with such rule. As of June 30, 2024, there were 1,072,950 shares available for future grant under the 2023 Inducement Plan.

The Company measures employee and non-employee stock-based awards at grant date fair value and records compensation expense on a straight-line basis over the vesting period of the award.

Employee Stock Ownership Plan

The Millendo board of directors adopted the 2019 Employee Stock Purchase Plan on April 29, 2019, which became effective upon stockholder approval on June 11, 2019. On June 17, 2022, the Company’s stockholders approved the Amended and Restated 2019 Employee Stock Purchase Plan (the “2019 ESPP”). The 2019 ESPP enables employees to purchase shares of the Company's common stock through offerings of rights to purchase the Company's common stock to all eligible employees.

The 2019 ESPP provides that the number of shares of common stock reserved for issuance under the 2019 ESPP will automatically increase on January 1, 2023 and continuing through (and including) January 1, 2029, by the lesser of 1.5% of the total number of shares of Common Stock outstanding on December 31st of the preceding calendar year, (ii) 500,000 shares of Common Stock, or (iii) such lesser number of shares of Common Stock as determined by the Board of Directors (which may be zero). On January 1, 2024, the common stock reserved for issuance was increased by 330,678 shares.

As of June 30, 2024, 528,791 shares of common stock remained available for future issuance under the 2019 ESPP. During the three and six months ended June 30, 2024, 34,023 shares of common stock were issued under the 2019 ESPP.

Stock Options

Options to purchase the Company’s common stock may be granted at a price not less than the fair market value in the case of both NSOs and ISOs, except for an options holder who owns more than 10% of the voting power of all classes of stock of the Company, in which case the exercise price shall be no less than 110% of the fair market value per share on the grant date. Stock options granted under the Plans generally vest over four years and expire no later than ten (10) years from the date of grant. Vested options can be exercised at any time.

The following shows the stock option activities for the six months ended June 30, 2024 and 2023:


	Total Options Outstanding			Weighted-Average Exercise Price
Balance—December 31, 2023		3,554,112		$	7.28
Granted		748,175			4.45
Exercised		(81,699	)		1.91
Cancelled and forfeited		(208,376	)		8.23
Balance—June 30, 2024		4,012,212			6.81

Balance—December 31, 2022		1,553,041		$	6.66
Granted		679,150			1.29
Exercised		(413	)		1.23
Cancelled and forfeited		(44,075	)		4.58
Balance—June 30, 2023		2,187,703			5.04

The following table summarizes information about stock options outstanding at June 30, 2024:


	Shares		Weighted Average Remaining Contractual Life (In Years)		Weighted Average Exercise Price		Aggregate Intrinsic Value
Options outstanding		4,012,212		8.63	$	6.81	$	475,246
Vested and expected to vest		4,012,212		8.63	$	6.81	$	475,246
Exercisable		1,056,469		7.35	$	6.01	$	185,744

During the six months ended June 30, 2024 and 2023, the Company granted employees and non-employees stock options to purchase 748,175 and 679,150 shares of common stock, respectively, with a weighted-average grant date fair value of $3.74 and $1.08 per share, respectively. As of June 30, 2024 and 2023, total unrecognized compensation costs related to unvested employee stock options were $14,772 and $3,775, respectively. These costs are expected to be recognized over a weighted-average period of approximately 3.1 years and 2.4 years, respectively.

The Company estimated the fair value of stock options using the Black-Scholes option pricing valuation model. The fair value of employee and non-employee stock options is being amortized on the straight-line basis over the requisite service period of the awards. The fair value of employee and non-employee stock options was estimated using the following assumptions for the six months ended June 30, 2024 and 2023:


	2024			2023
Expected term (in years)	5.5 - 6.1			5.5 - 6.1
Expected volatility	109% - 113%			109% - 111%
Risk-free interest rate	3.8% - 4.7%			3.4% - 3.9%
Dividends		—	%		—	%

Expected Term—The expected term of options granted represents the period of time that the options are expected to be outstanding. Due to the lack of historical exercise history, the expected term of the Company’s employee stock options has been determined utilizing the simplified method for awards that qualify as plain-vanilla options.

Expected Volatility—The expected stock price volatility assumption was determined by examining the historical volatilities for industry peers, as the Company did not have any trading history for the Company’s common stock. The Company will continue to analyze the historical stock price volatility and expected term assumption as more historical data for the Company’s common stock becomes available.

Risk-Free Interest Rate—The risk-free interest rate assumption is based on the U.S. Treasury instruments whose term was consistent with the expected term of the Company’s stock options.

Dividends—The Company has not paid any cash dividends on common stock since inception and does not anticipate paying any dividends in the foreseeable future. Consequently, an expected dividend yield of zero was used.

Stock-Based Compensation Expense

The following table summarizes the components of stock-based compensation expense recognized in the Company’s condensed consolidated statement of operations for the three and six months ended June 30, 2024:


	Three Months Ended June 30,				Six Months Ended June 30,
	2024		2023		2024		2023
Research and development	$	559	$	147	$	1,105	$	292
General and administrative		761		293		1,533		594
Total	$	1,320	$	440	$	2,638	$	886

9. RETIREMENT PLAN

The Company participates in a qualified 401(k) Plan sponsored by its professional service organization. The retirement plan is a defined contribution plan covering eligible employees. Participants may contribute a portion of their annual compensation limited to a maximum annual amount set by the Internal Revenue Service. During the three and six months ended June 30, 2024, the Company contributed $43 and $94 to the 401(k) Plan, respectively. During the three and six months ended June 30, 2023, the Company contributed $35 and $92 to the 401(k) Plan, respectively.

10. NET LOSS PER SHARE

The following table sets forth the computation of the Company’s basis in diluted net loss per share for the three and six months ended June 30, 2024 and 2023 (in thousands, except share and per share amounts):


	Three Months Ended June 30,						Six Months Ended June 30,
	2024			2023			2024			2023
Numerator:
Net loss	$	(9,570	)	$	(7,581	)	$	(17,474	)	$	(15,217	)
Denominator:
Weighted-average common shares outstanding		22,546,370			14,102,211			22,390,298			13,933,629
Weighted-average shares used in computing basic and diluted net loss per share		22,546,370			14,102,211			22,390,298			13,933,629
Net loss per share attributable to common stockholders—basic and diluted	$	(0.42	)	$	(0.54	)	$	(0.78	)	$	(1.09	)

As of June 30, 2024 and 2023, the Company’s potentially dilutive securities included unvested stock warrants and stock options, which have been excluded from the computation of diluted net loss per share attributable to common stockholders as the effect would be anti-dilutive. The issuance of pre-funded warrants and vested RSUs have been included in the computation of basic and diluted net loss per share attributable to common stockholders. Based on the amounts outstanding as of June 30, 2024 and 2023, the Company excluded the following potential common shares from the computation of diluted net loss per share attributable to common stockholders because including them would have had an anti-dilutive effect:


	As of June 30,
	2024		2023
Options to purchase common stock		4,012,212		2,187,703
Common stock warrants		6,036		6,036
Total		4,018,248		2,193,739

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

You should read the following discussion of our financial condition and results of operations in conjunction with our unaudited condensed financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q, and our audited consolidated financial statements and related notes for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission ("SEC") on March 19, 2024. This discussion and other parts of this report contains forward-looking statements that involve risks and uncertainties, such as our plans, objectives, expectations, intentions, and beliefs, as well as assumptions made by, and information currently available to, our management. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section of this report entitled “Risk Factors,” under Part II, Item 1A of this report and those discussed in our other disclosures and filings with the SEC.

Overview

We are a clinical-stage biotechnology company moving into 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”). 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 therapeutics product candidates are amezalpat and TPST-1495, which we believe are the first clinical-stage molecules designed to inhibit their respective targets.

Amezalpat is a selective antagonist of peroxisome proliferator-activated receptor alpha (“PPARα”). On June 20, 2024, we announced new and updated positive data from the ongoing global randomized Phase 1b/2 trial of amezalpat combined with the standard-of-care first-line regimen of atezolizumab and bevacizumab 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. The data cutoff was February 14, 2024.

With 10 additional months of follow-up relative to the earlier primary analysis from April 20, 2023, a median overall survival (“OS”) was reached, showing a meaningful 6-month improvement over the standard of care with a median of 21 months in the amezalpat arm versus 15 months in the control arm. Importantly, the hazard ratio (“HR”), which expresses the relative hazard reduction achieved by the experimental arm compared to the control arm, remained stable with a positive value of 0.65, a slight shift from 0.59 observed ten months earlier in the primary analysis. Also notably, 50% (20/40) of patients in the amezalpat arm remained in survival follow-up versus 30% (9/30) in the control arm as of the cutoff date. OS is the primary endpoint used by regulatory agencies globally for first-line HCC.

The response rate, an earlier measure of patient status, showed a 30% confirmed objective response rate (“ORR”) in the amezalpat arm compared to 13.3% for atezolizumab and bevacizumab in the control arm in the earlier primary analysis. In June 2024, the ORR remained consistent with one important update: one patient in the amezalpat arm who had previously achieved at least a 30% reduction in measured tumor burden (a partial response, “PR”) as of April 2023, converted to a complete response (“CR”) and achieved at least an 80% reduction in their measured tumor burden as of February 2024. Notably, this patient’s tumor profile, a PD-L1 score <1%, an immune desert phenotype, and a wildtype b-catenin gene, does not typically respond to anti-PD(L)1 or anti-angiogenic therapies (the same drug classes as atezolizumab and bevacizumab, respectively) even in combination, yet achieved a CR when amezalpat was added to the regimen.

In addition to the overall data, the biomarker subpopulation findings are consistent with the mechanism of action of amezalpat: patients with b-catenin activating mutations (21% in this study (n=7)) showed a confirmed ORR of 43% and a disease control rate (“DCR”) of 100% in the amezalpat arm; and distinct from the control arm, the amezalpat arm was consistently active

across PD-L1 negative tumors with a confirmed ORR of 27% in the amezalpat arm, compared to a reduced ORR of 7% for the control arm.

These randomized data build upon clinical data from Phase 1 trials, both as a monotherapy and in combination with an anti-PD1 therapy, nivolumab, that were reported at a podium presentation at the American Society of Clinical Oncology (“ASCO”) annual meeting in June 2022. RECIST responses were also observed in this study at the two highest amezalpat doses in combination with nivolumab for an ORR of those cohorts of 30% (three of 10 patients), including in patients who previously progressed on anti-PD-1 (-L1) therapy.

We believe the next step in amezalpat’s development is a pivotal Phase 3 trial in first-line HCC and anticipate receiving feedback from the FDA during the third quarter of 2024 towards that goal, and given the totality of the data, also have interest in development in kidney cancer (“RCC”) and potentially other indications.

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.

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.

Potential Future Milestones

•

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, and we anticipate receiving feedback from the FDA during the third quarter of 2024. We are also evaluating further development in RCC and cholangiocarcinoma (“CCA”) based on the Phase 1 data presented at ASCO 2022.

•

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.

Going Concern

We have no products approved for commercial sale and have not generated any revenue from product sales. From inception to June 30, 2024, we have raised $207.5 million, through sales of our capital securities.

We have never been profitable and have incurred operating losses in each period since inception. Our net losses were $17.5 million and $15.2 million for the six months ended June 30, 2024 and 2023, respectively. As of June 30, 2024, we had an accumulated deficit of $182.7 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.

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.

Based on our business strategy, our existing cash and cash equivalents of $31.1 million as of June 30, 2024 and the $1.4 million of net proceeds raised between July 1, 2024 and July 18, 2024 through sales of common stock under our ATM Program, will be sufficient to fund the projected operating expenses and capital expenditure requirements, and to meet our obligations as they become due. 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.

Components of Results of Operations

Research and Development Expense

Research and development expenses represent costs incurred to conduct research and development, such as the development of our product candidates.

We recognize all research and development costs as they are incurred. Research and development expenses consist primarily of the following:

•

salaries, benefits and stock-based compensation;

•

licensing costs;

•

allocated occupancy;

•

materials and supplies;

•

contracted research and manufacturing;

•

consulting arrangements; and

•

other expenses incurred to advance our research and development activities.

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.

The process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in timely developing and achieving regulatory approval for our product candidates. The probability of success of our product candidates may be affected by numerous factors, including clinical data, competition, manufacturing capability and

commercial viability. As a result, we are unable to determine the duration and completion costs of our development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our product candidates.

General and Administrative Expenses

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

Other Income (Expense), Net

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

Results of Operations

Comparison of the three months ended June 30, 2024 and 2023

The following table summarizes our operating results for the three months ended June 30, 2024 and 2023:


	Three Months Ended						Increase/ (Decrease)		Percentage Increase/ (Decrease)
	June 30,
	2024			2023			2024 vs. 2023		2024 vs. 2023
	(in thousands, except percentages)
Operating expenses:
Research and development	$	5,837		$	4,416		$	1,421		32	%
General and administrative		3,745			3,054			691		23	%
Loss from operations		(9,582	)		(7,470	)		2,112		28	%
Other income (expense), net:
Interest expense		(372	)		(355	)		17		5	%
Interest income and other income (expense), net		384			244			140		57	%
Total other income (expense), net		12			(111	)		123		111	%
Provision for income taxes		—			—			—		0	%
Net loss	$	(9,570	)	$	(7,581	)	$	1,989		26	%

Research and development

Our research and development expenses for the three months ended June 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.

The following table shows our research and development expenses by program for the three months ended June 30, 2024 and 2023:


	Three Months Ended				Increase/ (Decrease)			Percentage Increase/ (Decrease)
	June 30,
	2024		2023		2024 vs. 2023			2024 vs. 2023
	(in thousands, except percentages)
Amezalpat	$	2,196	$	536	$	1,660			310	%
TPST-1495		678		936		(258	)		(28	)%
Preclinical and other		642		1,039		(397	)		(38	)%
Total candidate specific research costs		3,516		2,511		1,005			40	%
Personnel and other costs		1,627		1,758		(131	)		(7	)%
Stock-based compensation and depreciation		694		147		547			372	%
Total research and development expenses	$	5,837	$	4,416	$	1,421			32	%

Research and development expenses increased by $1.4 million to $5.8 million for the three months ended June 30, 2024, compared to three months ended June 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 three months ended June 30, 2024 and 2023:

     
    Three Months Ended

    Increase/ (Decrease)

    Percentage Increase/ (Decrease)

     
    June 30,

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