UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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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.
Item 2.02 Results of Operations and Financial Condition.
On March 29, 2023, Third Harmonic Bio, Inc. (the “Company”) issued a press release reporting the Company’s financial results for the fourth quarter and full year ended December 31, 2022. 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 |
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Description |
99.1 |
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Press Release issued by Third Harmonic Bio, Inc. dated March 29, 2023 |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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.
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THIRD HARMONIC BIO, INC. |
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Date: |
March 29, 2023 |
By: |
/s/ Robert Ho |
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Robert Ho |
Exhibit 99.1
Third Harmonic Bio Announces Fourth Quarter and Year-End 2022 Financial Results
Company Progresses Preclinical Next-Generation oral KIT Inhibitor for Mast Cell-Mediated Inflammatory Diseases
SAN FRANCISCO, CA, March 29, 2023 (GLOBE NEWSWIRE) -- Third Harmonic Bio, Inc. (Nasdaq: THRD), a biopharmaceutical company focused on advancing the next wave of medicine for inflammatory diseases, today announced financial results for the fourth quarter and full year ended December 31, 2022.
“Given the promising preliminary clinical activity observed in our discontinued Phase 1b clinical trial of THB001, we believe 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, intracellular small molecule inhibitor may provide the optimal therapeutic profile against this target,” said Natalie Holles, Chief Executive Officer of Third Harmonic Bio. “We are making meaningful progress toward selecting a next-generation KIT inhibitor development candidate in 2023 and look forward to providing a more substantive update in the near term.”
Recent Business Highlights
In December 2022, the Company announced the discontinuation of its Phase 1b clinical trial of THB001 in chronic inducible urticaria following observation of asymptomatic liver transaminitis in two subjects enrolled in the first dose cohort of 200 mg BID. As a result, Third Harmonic Bio initiated nonclinical studies to elucidate the mechanism for the observed transaminitis, which was not predicted by extensive GLP toxicology studies of THB001 nor observed in the Phase 1a clinical trial. Preliminary analyses showed evidence of pharmacodynamic and clinical activity at the 200 mg BID dose. The Company plans to present the full data set from the five enrolled subjects at an upcoming scientific conference.
In parallel with the early clinical development of THB001, the company has conducted an extensive medicinal chemistry effort to identify chemically distinct next-generation oral wild-type KIT inhibitors and has advanced multiple candidate molecules into exploratory toxicology studies. Third Harmonic Bio intends to nominate a development candidate from this program in early 2023.
Summary of Financial Results
Cash Position: Cash and cash equivalents totaled $288.9 million as of December 31, 2022. 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 the next twelve months.
R&D Expenses: Research and development (R&D) expenses increased to $9.3 million for the three months ended December 31, 2022, from $4.3 million for the same period in 2021. R&D expenses for the year ended December 31, 2022, increased to $24.4 million from $15.7 million for the same period in 2021. The increases were primarily due to increases in discovery and development costs relating to the research and nonclinical development of next generation molecules and other discovery programs, as well as increases in personnel related costs.
G&A Expenses: General and administrative (G&A) expenses increased to $4.3 million for the three months ended December 31, 2022, from $1.5 million for the same period in 2021. G&A expenses for the year ended December 31, 2022, increased to $13.3 million from $3.3 million for the same period in 2021. The increases were primarily attributable to increases in costs associated with personnel-related expenses and the initial public offering.
Net Loss: Net loss for the three months ended December 31, 2022, decreased to $11.5 million from a net loss of $15.8 million for the same period in 2021, primarily due to the change in fair value of the preferred stock tranche liability partially offset by increases in loss from operations. Net loss for the year ended December 31, 2022 was $35.2 million compared to a net loss of $29.6 million for the same period in 2021.
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 a novel highly selective, oral small-molecule inhibitor 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, intracellular small molecule inhibitor may provide the optimal therapeutic profile against this target. For more information, please visit the Third Harmonic Bio website: www.thirdharmonicbio.com.
Forward-Looking Statements
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 timing of selecting a next-generation KIT inhibitor development candidate and additional corporate announcements and presentations, the results and timing of preclinical studies and clinical trials for future development candidates, expectations regarding cash forecasts, and planned clinical and development activities and timelines. 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 the ongoing COVID-19 pandemic, 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, 2022, filed with the U.S. Securities and Exchange Commission (SEC) on March 29, 2023, and in Third Harmonic Bio’s other filings with the SEC 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.
Media Contact:
Lori Murray
lori.murray@thirdharmonicbio.com
Investor Contact:
Bob Ho
rho@thirdharmonicbio.com
Exhibit 99.1
THIRD HARMONIC BIO, INC.
Condensed consolidated balance sheet data
(Unaudited)
(In thousands)
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December 31, |
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December 31, |
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Assets |
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Cash and cash equivalents |
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$ |
128,280 |
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$ |
288,877 |
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Other current assets |
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884 |
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3,958 |
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Non-current assets |
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— |
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5,840 |
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Total assets |
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$ |
129,164 |
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$ |
298,675 |
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Liabilities |
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Current liabilities |
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$ |
5,686 |
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$ |
5,653 |
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Non-current liabilities |
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— |
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3,954 |
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Total liabilities |
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5,686 |
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9,607 |
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Redeemable convertible preferred stock |
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170,184 |
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— |
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Stockholders' equity |
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(46,706 |
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289,068 |
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Total liabilities and stockholders' equity |
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$ |
129,164 |
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$ |
298,675 |
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THIRD HARMONIC BIO, INC.
Condensed consolidated statements of operations
(Unaudited)
(In thousands of, except per share and share amounts)
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Year Ended December 31, |
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2021 |
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2022 |
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Operating expenses: |
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Research and development |
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$ |
15,748 |
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$ |
24,407 |
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General and administrative |
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3,256 |
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13,301 |
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Total operating expenses |
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19,004 |
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37,708 |
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Loss from operations |
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19,004 |
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37,708 |
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Other (income) expense, net |
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10,605 |
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(2,553 |
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Net loss |
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$ |
29,609 |
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$ |
35,155 |
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Net loss per share of common stock, basic and diluted |
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$ |
7.32 |
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$ |
2.62 |
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Weighted-average common stock outstanding, basic and diluted |
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4,043,416 |
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13,426,066 |
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