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Third Harmonic Bio Announces Third Quarter 2024 Financial Results

THRD 11.07.2024

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Drug:THB335-001 THB335

Diseases:chronic spontaneous urticaria

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THB335Phase 1 SAD/MAD clinical trial on track to deliver clinical results in 1Q’25

Strong financial position with cash and cash equivalents totaling$296.1million as ofSeptember 30, 2024

SAN FRANCISCO,Nov. 07, 2024(GLOBE NEWSWIRE) --Third Harmonic Bio, Inc.(Nasdaq: THRD), a clinical-stage biopharmaceutical company focused on advancing the next wave of medicine for dermal, respiratory and gastrointestinal inflammatory diseases, today announced financial results for the third quarterSeptember 30, 2024.

“As the Phase 1 clinical trial of our development candidateTHB335continues toward an anticipated data readout in the first quarter of 2025, we are also making excellent progress in preparing to move efficiently into a Phase 2 clinical trial in chronic spontaneous urticaria,” saidNatalie Holles, Chief Executive Officer atThird Harmonic Bio. “We believe an oral small molecule has the potential to be the optimal approach to targeting KIT for the treatment of urticaria and other mast cell-mediated inflammatory diseases.”

The Phase 1 SAD/MAD clinical trial ofTHB335is being conducted in healthy volunteers to assess safety and tolerability, characterize pharmacokinetics, and to measure the pharmacodynamic effect by reductions in serum tryptase, a biomarker associated with mast cell activation and correlated with clinical response in urticaria studies. Results are expected in the first quarter of 2025.

Summary of Financial Results

Cash Position:Cash and cash equivalents totaled$296.1 millionas ofSeptember 30, 2024. Based on the Company’s current operating plan,Third Harmonic Biobelieves that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements through at least 2026.

R&D Expenses:Research and development (R&D) expenses increased to$11.3 millionfor the three months endedSeptember 30, 2024, from$6.0 millionfor the same period in 2023. R&D expenses for the nine months endedSeptember 30, 2024, increased to$26.0 million, from$18.1 millionfor the same period in 2023. The increases were primarily due to increased spend related to theTHB335program and increased personnel-related expenses, partially offset by decreases in development costs relating to the termination of theTHB001program.

G&A Expenses:General and administrative (G&A) expenses increased to$5.7 millionfor the three months endedSeptember 30, 2024, from$4.9 millionfor the same period in 2023. G&A expenses for the nine months endedSeptember 30, 2024, increased to$16.5 million, from$15.5 millionfor the same period in 2023. The increases were primarily attributable to increased personnel-related expenses, including executive recruiting during 2024.

Net Loss:Net loss for the three months endedSeptember 30, 2024, increased to$13.8 millionfrom a net loss of$7.3 millionfor the same period in 2023. Net loss for the nine months endedSeptember 30, 2024, increased to$32.4 millionfrom a net loss of$24.0 millionfor the same period in 2023, primarily due to increases in research and development expenses that were partially offset by increases in interest income.

AboutThird Harmonic Bio, Inc.

Third Harmonic Biois a clinical-stage biopharmaceutical company focused on advancing the next wave of medicine for dermal, respiratory, and gastrointestinal inflammatory diseases through the development of novel, highly selective, small-molecule inhibitors of KIT, a cell surface receptor that serves as the master regulator of mast cell function and survival. Early clinical studies demonstrate that KIT inhibition has the potential to revolutionize the treatment of a broad range of mast-cell-mediated inflammatory diseases and that a titratable, oral, small molecule inhibitor may provide the optimal therapeutic profile against this target. Third Harmonic Bio’s lead product candidate,THB335, is a titratable, oral, small molecule inhibitor that is currently in a Phase 1 clinical trial. For more information, please visit theThird Harmonic Biowebsite:www.thirdharmonicbio.com.

Forward-Looking Statement

This press release contains “forward-looking” statements within the meaning of the safe harbor provisions of theU.S.Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the expected timing for clinical trials, progress of the clinical trials and the availability of clinical data from such trials, and regulatory submissions forTHB335, planned clinical and development activities and timelines, and the sufficiency of Third Harmonic Bio’s cash and cash equivalents to fund its operating expenses and capital expenditure requirements through at least 2026. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods. These statements are subject to numerous risks and uncertainties, including risks and uncertainties related to Third Harmonic Bio’s cash forecasts, ability to advance its product candidates, the receipt and timing of potential regulatory submissions, designations, approvals and commercialization of product candidates, our ability to protect our intellectual property, the timing and results of preclinical and clinical trials, changes to laws or regulations, market conditions, geopolitical events, and further impacts of pandemics or health epidemics, that could cause actual results to differ materially from whatThird Harmonic Bioexpects. Further information on potential risk factors that could affect Third Harmonic Bio’s business and its financial results are detailed under the heading “Risk Factors” included in Third Harmonic Bio’s Quarterly Report on Form 10-Q for the nine months endedSeptember 30, 2024, filed with theU.S. Securities and Exchange Commission(SEC) onNovember 7, 2024, and in Third Harmonic Bio’s other filings filed from time to time with theSEC.Third Harmonic Bioundertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investor and Media Contact:

Lori Murraylori.murray@thirdharmonicbio.com

THIRD HARMONIC BIO, INC. Condensed consolidated balance sheet data(Unaudited)(In thousands)

	December 31 ,2023		September 30 ,2024
Assets
Cash and cash equivalents	$	269,070	$	296,093
Other current assets		3,376		4,139
Non-current assets		5,265		4,261
Total assets	$	277,711	$	304,493
Liabilities
Current liabilities	$	5,418	$	7,065
Non-current liabilities		3,208		2,574
Total liabilities		8,626		9,639
Stockholders' equity		269,085		294,854
Total liabilities and stockholders' equity	$	277,711	$	304,493

THIRD HARMONIC BIO, INC. Condensed consolidated statements of operations(Unaudited)(In thousands of, except per share and share amounts)

	Nine Months EndedSeptember 30,
	2023			2024
Operating expenses:
Research and development	$	18,046		$	25,963
General and administrative		15,503			16,470
Total operating expenses		33,549			42,433
Loss from operations		33,549			42,433
Other (income) expense, net		(9,561	)		(10,071	)
Net loss	$	23,988		$	32,362

Net loss per share of common stock, basic and diluted	$	0.61		$	0.80
Weighted-average common stock outstanding, basic and diluted		39,567,206			40,697,668

Third Harmonic Bio

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