Third Harmonic Bio Announces Fourth Quarter and Full Year 2023 Financial Results
- Third Harmonic Bio filed for U.S. IND for THB335 with clinical trials set to begin in 2Q’24.
- The company has a robust financial position with $269.1 million in cash and cash equivalents as of December 31, 2023.
- R&D expenses decreased to $5.9 million for the three months ended December 31, 2023, from $9.3 million in the same period in 2022.
- G&A expenses increased to $4.5 million for the three months ended December 31, 2023, from $4.3 million in the same period in 2022.
- Net loss for the three months ended December 31, 2023, decreased to $6.8 million from $11.5 million in the same period in 2022.
- None.
Insights
The report from Third Harmonic Bio, Inc. highlights a strategic milestone with the filing of a U.S. IND for THB335, indicating progress in their drug development pipeline. From a financial perspective, the company's robust cash position of $269.1 million provides substantial runway, with projected funding sufficiency through at least 2026. This reflects a prudent capital management strategy that investors often favor, as it suggests a lower risk of near-term dilutive financing events.
In analyzing R&D expenditures, a decrease to $24.0 million for the year, compared to $24.4 million in the previous year, indicates a focus on cost efficiency, especially following the termination of the THB001 program. The shift in resource allocation towards THB335 and other discovery efforts may signal strategic prioritization, which is important for biotech firms where investment in research is a significant driver of future value.
However, the increase in G&A expenses to $20.0 million from $13.3 million year-on-year reflects the administrative costs of scaling operations as a public entity. While this is expected, it is essential to monitor these expenses to ensure they do not disproportionately erode the company's financial resources. The reduction in net loss is a positive indicator of financial health, but it is also attributable to increased interest income, a variable that can fluctuate with market conditions.
The IND filing for THB335 marks a significant advancement in Third Harmonic Bio's pipeline, focusing on chronic spontaneous urticaria and other mast cell-mediated inflammatory diseases. The designation of THB335 as a potentially first-in-class oral wild-type KIT inhibitor underscores its novelty and the unmet need it addresses. The planned Phase 1 SAD/14-day MAD study will be critical in establishing the drug's safety and pharmacokinetics/dynamics profile, which are fundamental to its subsequent development phases.
For stakeholders, the progress into clinical trials is a pivotal stage that can significantly influence the company's valuation. Positive data from these trials could catalyze investor interest and partnership opportunities, while any setbacks could pose risks to the company's projected timelines and financial expenditure. The balance between advancing the clinical program and maintaining financial health is a delicate one in the biopharmaceutical industry, where research progress and capital burn rates are closely scrutinized.
Chronic spontaneous urticaria is a condition with a considerable patient population and a demand for more effective treatments, which suggests a substantial market opportunity for THB335 if it proves to be safe and effective. The company's strategic positioning within the inflammatory disease space, coupled with a strong cash reserve, provides it with a competitive edge to potentially capture market share upon successful drug development and approval.
Investors should consider the long-term potential of THB335, given the market dynamics of the inflammatory disease sector and the current treatment landscape. The successful progression through clinical trials could enhance Third Harmonic Bio's market position and investor sentiment. However, it is imperative to remain cognizant of the inherent risks associated with drug development, including regulatory hurdles and the possibility of unsuccessful trial outcomes, which could impact the company's financial standing and stock performance.
U.S. IND filed for THB335 with anticipated clinical trial start during 2Q’24
Strong financial position with cash and cash equivalents totaling
as of December 31, 2023
SAN FRANCISCO, March 26, 2024 (GLOBE NEWSWIRE) -- Third Harmonic Bio, Inc. (Nasdaq: THRD), a biopharmaceutical company focused on advancing the next wave of medicine for inflammatory diseases, today reported financial results for the fourth quarter and full year ended December 31, 2023.
“Our team’s execution continues to be outstanding, with the filing of our U.S. IND for THB335 ahead of our internal timelines for submission,” said Natalie Holles, Chief Executive Officer of Third Harmonic Bio. “We look forward to the agency’s feedback and the opportunity to initiate clinical studies during the second quarter for this potentially first-in-class oral wild-type KIT inhibitor for the treatment of chronic spontaneous urticaria and other mast cell-mediated inflammatory diseases.”
The Phase 1 SAD/14-day MAD study is designed to evaluate safety, pharmacokinetics and pharmacodynamics of THB335 in healthy volunteers, followed by planned Phase 2 expansion initially focusing on chronic spontaneous urticaria.
Third Harmonic Bio has a strong financial position with cash and cash equivalents totaling
Summary of Financial Results
Cash Position: Cash and cash equivalents totaled
R&D Expenses: Research and development (R&D) expenses decreased to
G&A Expenses: General and administrative (G&A) expenses increased to
Net Loss: Net loss for the three months ended December 31, 2023 decreased to
About Third Harmonic Bio, Inc.
Third Harmonic Bio is a biopharmaceutical company focused on advancing the next wave of medicine for 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 expected to enter clinical trials during the second quarter of 2024. 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, the expected timing for clinical activities for THB335, 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 Annual Report on Form 10-K for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission (SEC) on March 26, 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, 2022 | December 31, 2023 | |||||
| Assets | ||||||
| Cash and cash equivalents | $ | 288,877 | $ | 269,070 | ||
| Other current assets | 3,958 | 3,376 | ||||
| Non-current assets | 5,840 | 5,265 | ||||
| Total assets | $ | 298,675 | $ | 277,711 | ||
| Liabilities | ||||||
| Current liabilities | $ | 5,653 | $ | 5,418 | ||
| Non-current liabilities | 3,954 | 3,208 | ||||
| Total liabilities | 9,607 | 8,626 | ||||
| Stockholders' equity | 289,068 | 269,085 | ||||
| Total liabilities and stockholders' equity | $ | 298,675 | $ | 277,711 | ||
| THIRD HARMONIC BIO, INC. Condensed consolidated statements of operations (Unaudited) | ||||||||
| (In thousands of, except per share and share amounts) | ||||||||
| Year Ended December 31, | ||||||||
| 2022 | 2023 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 24,407 | $ | 23,964 | ||||
| General and administrative | 13,301 | 19,990 | ||||||
| Total operating expenses | 37,708 | 43,954 | ||||||
| Loss from operations | 37,708 | 43,954 | ||||||
| Other (income) expense, net | (2,553 | ) | (13,130 | ) | ||||
| Net loss | $ | 35,155 | $ | 30,824 | ||||
| Net loss per share of common stock, basic and diluted | $ | 2.45 | $ | 0.78 | ||||
| Weighted-average common stock outstanding, basic and diluted | 14,353,102 | 39,645,392 | ||||||
FAQ
What did Third Harmonic Bio file for with the U.S. FDA?
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