THRD Third Harmonic Bio Inc

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 07, 2024

 

 

THIRD HARMONIC BIO, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-41498	83-4553503
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
1700 Montgomery Street, Suite 210
San Francisco, California				94111
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (209) 727-2457

 

N/A

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

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

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.0001 per share		THRD		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

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. ☐

 

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Item 2.02 Results of Operations and Financial Condition.

On November 7, 2024, Third Harmonic Bio, Inc. (the “Company”) issued a press release reporting the Company’s financial results for the third quarter ended September 30, 2024. A copy of the Company’s press release is attached as Exhibit 99.1 to this report.
 

The information in this Item 2.02, including Exhibit 99.1 attached to this report, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information contained in this Item 2.02 and in the accompanying Exhibit 99.1 shall not be incorporated by reference into any other filing under the Exchange Act or under the Securities Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit Number		Description
99.1		Press Release issued by Third Harmonic Bio, Inc. dated November 7, 2024
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

			THIRD HARMONIC BIO, INC.
Date:	November 7, 2024	By:	/s/ Christopher Murphy
			Christopher Murphy Chief Financial and Business Officer

 

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Third Harmonic Bio Announces Third Quarter 2024 Financial Results
 

THB335 Phase 1 SAD/MAD clinical trial on track to deliver clinical results in 1Q’25

Strong financial position with cash and cash equivalents totaling $296.1 million

as of September 30, 2024

 

SAN FRANCISCO, CA, November 7, 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 quarter September 30, 2024.

 

“As the Phase 1 clinical trial of our development candidate THB335 continues 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,” said Natalie Holles, Chief Executive Officer at Third 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 of THB335 is 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 million as of September 30, 2024. Based on the Company’s current operating plan, Third Harmonic Bio believes 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 million for the three months ended September 30, 2024, from $6.0 million for the same period in 2023. R&D expenses for the nine months ended September 30, 2024, increased to $26.0 million, from $18.0 million for the same period in 2023. The increases were primarily due to increased spend related to the THB335 program and increased personnel-related expenses, partially offset by decreases in development costs relating to the termination of the THB001 program.

 

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G&A Expenses: General and administrative (G&A) expenses increased to $5.7 million for the three months ended September 30, 2024, from $4.9 million for the same period in 2023. G&A expenses for the nine months ended September 30, 2024, increased to $16.5 million, from $15.5 million for 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 ended September 30, 2024, increased to $13.8 million from a net loss of $7.3 million for the same period in 2023. Net loss for the nine months ended September 30, 2024, increased to $32.4 million from a net loss of $24.0 million for the same period in 2023, primarily due to increases in research and development expenses that were partially offset by increases in interest income.

 

About Third Harmonic Bio, Inc.

Third Harmonic Bio is 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 the Third Harmonic Bio website: www.thirdharmonicbio.com.

 

Forward-Looking Statement

This press release contains “forward-looking” statements within the meaning of the safe harbor provisions of the U.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 for THB335, 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

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conditions, geopolitical events, and further impacts of pandemics or health epidemics, that could cause actual results to differ materially from what Third Harmonic Bio expects. 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 ended September 30, 2024, filed with the U.S. Securities and Exchange Commission (SEC) on November 7, 2024, and in Third Harmonic Bio’s other filings filed from time to time with the SEC. Third Harmonic Bio undertakes 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 Murray
lori.murray@thirdharmonicbio.com

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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 Ended September 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

 

 

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Document And Entity Information	Nov. 07, 2024
Cover [Abstract]
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Document Period End Date	Nov. 07, 2024
Entity Registrant Name	THIRD HARMONIC BIO, INC.
Entity Central Index Key	0001923840
Entity Emerging Growth Company	true
Entity File Number	001-41498
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	83-4553503
Entity Address, Address Line One	1700 Montgomery Street, Suite 210
Entity Address, City or Town	San Francisco
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94111
City Area Code	(209)
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Pre-commencement Tender Offer	false
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Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	THRD
Security Exchange Name	NASDAQ

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