Third Harmonic Bio Announces Third Quarter 2024 Financial Results

Rhea-AI Summary

Third Harmonic Bio (Nasdaq: THRD) reported Q3 2024 financial results, highlighting its Phase 1 SAD/MAD clinical trial of THB335 progressing towards data readout in Q1 2025. The company maintains a strong financial position with $296.1 million in cash and equivalents. Q3 2024 saw increased R&D expenses of $11.3 million, up from $6.0 million in Q3 2023, while net loss widened to $13.8 million from $7.3 million year-over-year. The company expects current cash reserves to fund operations through at least 2026.

Positive

• Strong cash position of $296.1 million sufficient to fund operations through 2026
• Phase 1 clinical trial progressing on schedule with results expected Q1 2025

Negative

• Net loss increased to $13.8 million in Q3 2024 from $7.3 million in Q3 2023
• R&D expenses nearly doubled to $11.3 million from $6.0 million year-over-year
• G&A expenses increased to $5.7 million from $4.9 million year-over-year

Insights

Financial Analyst

Third Harmonic Bio presents a mixed financial picture with some concerning trends but maintains a strong cash position. The $296.1 million cash reserve provides substantial runway through 2026, but increasing losses are noteworthy. Q3 net loss widened to $13.8 million from $7.3 million year-over-year, while R&D expenses nearly doubled to $11.3 million.

The increased R&D spending, while elevating losses, reflects investment in the promising THB335 program. The termination of THB001 program suggests strategic portfolio optimization. The 16.3% increase in G&A expenses to $5.7 million warrants monitoring, though partially justified by executive recruitment costs. Interest income provides some offset to operational losses, indicating effective cash management.

Medical Research Analyst

The THB335 clinical development program shows strategic focus on mast cell-mediated inflammatory diseases, with chronic spontaneous urticaria as the lead indication. The Phase 1 SAD/MAD trial's use of serum tryptase as a biomarker is particularly significant, as it provides an objective measure of drug activity that correlates with clinical outcomes in urticaria.

The planned transition to Phase 2 trials indicates confidence in the preliminary safety profile. The oral small molecule approach targeting KIT could offer competitive advantages over existing injectable treatments in the urticaria market, potentially improving patient compliance and accessibility. The Q1 2025 data readout will be important for validating this therapeutic strategy.

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, 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 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 $18.1 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.

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 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

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

FAQ

What is Third Harmonic Bio's (THRD) cash position as of Q3 2024?

Third Harmonic Bio reported cash and cash equivalents of $296.1 million as of September 30, 2024, sufficient to fund operations through at least 2026.

When will THRD report results from the THB335 Phase 1 clinical trial?

Third Harmonic Bio expects to report results from the THB335 Phase 1 SAD/MAD clinical trial in the first quarter of 2025.

What was Third Harmonic Bio's (THRD) net loss in Q3 2024?

Third Harmonic Bio reported a net loss of $13.8 million for the third quarter of 2024, compared to a net loss of $7.3 million in the same period of 2023.