trml-20240930

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

_____________________________

FORM 10-Q

_____________________________

(Mark One)


x			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2024


o			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number: 001-40384

__________________________________________________________

TOURMALINE BIO, INC.

(Exact name of Registrant as specified in its Charter)

___________________________________________________________


Delaware			83-2377352
(State or other jurisdiction of incorporation or organization)			(I.R.S. Employer Identification No.)
27 West 24th Street, Suite 702 New York, NY			10010
(Address of principal executive offices)			(Zip Code)

Registrant’s telephone number, including area code: (646) 481-9832

Not Applicable

(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 Symbol

Name of each exchange on which registered

Common Stock, $0.0001 par value per share

TRML

The Nasdaq Global Select Market

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 x No o

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 x No o

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. (Check one):

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. o

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x

The registrant had outstanding 25,642,610 shares of common stock, $0.0001 par value per share, as of November 1, 2024.

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TABLE OF CONTENTS


PART I. FINANCIAL INFORMATION
Item 1. Financial Statements			3
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations			19
Item 3. Quantitative and Qualitative Disclosures About Market Risk			31
Item 4. Controls and Procedures			31

PART II. OTHER INFORMATION
Item 1. Legal Proceedings			33
Item 1A. Risk Factors			33
Item 2. Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Securities			80
Item 3. Defaults Upon Senior Securities			80
Item 4. Mine Safety Disclosures			80
Item 5. Other Information			80
Item 6. Exhibits			81

SIGNATURES			82

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials and results thereof, research and development costs, planned regulatory submissions, regulatory approvals, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that are in some cases beyond our control and may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “continue” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these terms or other similar expressions. Forward-looking statements contained in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:

•the success, cost and timing of our development activities, non-clinical studies and clinical trials;

•the timing and outcome of our current and future clinical trials, and the reporting of data from those trials;

•the therapeutic potential of pacibekitug (also referred to as TOUR006) and future product candidates;

•the ability to obtain funding for our operations, including funding necessary to develop and commercialize our current and future product candidates, subject to regulatory approvals;

•our ability to extend our operating capital;

•the potential of our technologies and our ability to execute on our corporate strategy;

•our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;

•our reliance on third parties to manufacture and conduct preclinical studies and clinical trials of our current and future product candidates;

•the success of competing therapies that are or may become available;

•our ability to obtain regulatory approval for our product candidates and any related restrictions, limitations and/or warnings in the label of any approved product candidate;

•existing regulations and regulatory developments in the United States (the “U.S.”) and other jurisdictions;

•the strength and breadth of our patent portfolio;

•our ability to obtain and adequately protect intellectual property rights for our product candidates;

•potential claims relating to our intellectual property;

•our financial performance;

•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 remediate the existing material weaknesses in our internal control over financial reporting;

•our ability to attract and retain key scientific, medical, commercial and management personnel;

•our ability to continue to satisfy the listing requirements of The Nasdaq Stock Market and have our stock continue to trade thereon; and

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•the effects of macroeconomic and geopolitical conditions and unforeseeable events, such as the war in Ukraine and hostilities in the Middle East, potential bank failures and global health crises like the COVID-19 pandemic.

We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of risks, uncertainties and assumptions described in the section titled “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in such statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein after we distribute this Quarterly Report on Form 10-Q, whether as a result of any new information, future events or otherwise.

In addition, “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely upon them.

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PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

Tourmaline Bio, Inc.

Condensed Consolidated Balance Sheets (unaudited)

(amounts in thousands, except share and par value mounts)


	September 30,		December 31,
	2024		2023
Assets
Current assets
Cash and cash equivalents	$	35,008	$	140,726
Short-term investments	246,916		62,225
Prepaid expenses and other current assets	11,861		5,923
Total current assets	293,785		208,874
Property and equipment, net	55		85
Long-term investments	32,467		—
Restricted cash	227		227
Operating lease right-of-use asset	252		362
Other non-current assets	1,661		747
Total assets	$	328,447	$	210,295
Liabilities and stockholders’ equity
Current liabilities
Accounts payable	$	2,054	$	1,071
Accrued expenses and other current liabilities	5,004		3,710
Operating lease liability, current portion	226		221
Total current liabilities	7,284		5,002
Operating lease liability, net of current portion	64		194
Other liabilities	31		57
Total liabilities	7,379		5,253
Commitments and Contingencies (Note 11)
Stockholders’ equity
Undesignated preferred stock, $0.0001 par value – 10,000,000 shares authorized as of September 30, 2024 and December 31, 2023, no shares issued or outstanding as of September 30, 2024 or December 31, 2023	—		—
Common stock, $0.0001 par value – 140,000,000 voting shares authorized as of September 30, 2024 and December 31, 2023, 25,649,002 voting shares issued and 25,642,610 voting shares outstanding as of September 30, 2024; 20,337,571 voting shares issued and outstanding as of December 31, 2023; 10,000,000 non-voting shares authorized as of September 30, 2024 and December 31, 2023, no non-voting shares issued or outstanding as of September 30, 2024 or December 31, 2023	3		2
Additional paid-in capital	433,270		267,024
Accumulated other comprehensive income	821		67
Accumulated deficit	(113,026)		(62,051)
Total stockholders’ equity	321,068		205,042
Total liabilities and stockholders’ equity	$	328,447	$	210,295

The accompanying notes are an integral part of these condensed consolidated financial statements.

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Tourmaline Bio, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)

(amounts in thousands, except per share amounts)


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Operating expenses:
Research and development	$	19,330	$	3,762	$	46,440	$	24,353
General and administrative	5,108		2,881		17,486		6,166
Total operating expenses	24,438		6,643		63,926		30,519
Loss from operations	(24,438)		(6,643)		(63,926)		(30,519)
Other income, net	4,261		1,052		12,951		1,297
Net loss	$	(20,177)	$	(5,591)	$	(50,975)	$	(29,222)
Net loss per share, basic and diluted	$	(0.78)	$	(5.16)	$	(2.02)	$	(29.40)
Weighted-average common shares outstanding, basic and diluted	25,767		1,084		25,197		994
Comprehensive loss:
Net loss	$	(20,177)	$	(5,591)	$	(50,975)	$	(29,222)
Other comprehensive income:
Unrealized gain on investments	1,273		—		754

SEC Form 10-Q filed by Tourmaline Bio Inc.