Third Harmonic Bio Announces Third Quarter 2022 Financial Results

Launched a successful expanded initial public offering offering funding through 2025

Ongoing patient dosing in Phase 1b clinical trial in chronic inducible urticaria

CAMBRIDGE, Mass., Nov. 09, 2022 (GLOBE NEWSWIRE) — Third Harmonic Bio, Inc. (Nasdaq: THRD), a clinical-stage biopharmaceutical company focused on advancing the next wave of drugs for allergy and inflammation, today announced results for the quarter ended September 30, 2022 and provided a business update.

“With the recent closing of our successful initial public offering, we believe we have the capital resources and an experienced team to advance the continued development of THB001 for the treatment of urticaria, or chronic urticaria, and asthma. – two inflammatory diseases where, despite current treatment options, a significant unmet medical need remains,” said Natalie Holles, CEO of Third Harmonic Bio. “We expect to initiate a Phase 1b clinical trial in asthma in the first half of 2023 and report results from our Phase 1b clinical trial in chronic inducible urticaria in the second half of 2023.”

Recent Business Highlights

Completion of a $213.1 million initial public offering
Third Harmonic Bio firm its initial public offering of 12,535,000 common shares, including the full exercise of the underwriters’ option to purchase up to an additional 1,635,000 common shares. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering costs payable by Third Harmonic Bio, were approximately $213.1 million.

Ongoing Patient Dosing in the Phase 1b Trial in Chronic Inducible Urticaria
Third Harmonic Bio has completed its Phase 1a clinical trial of THB001 and expects to present full trial results at an upcoming medical meeting in the first half of 2023. Third Harmonic has also begun dosing patients in its trial Phase 1b clinical trial in chronic inducible urticaria. The trial is evaluating three dose levels of THB001 over 12 weeks of treatment. The objectives of the clinical trial are to assess safety and tolerability, efficacy and pharmacokinetics. Additional study details can be found under clinicaltrials.gov identifier NCT05510843.

Recent Management Updates
Third Harmonic Bio continued to strengthen its management team and board of directors by appointing Adrian S. Ray, Ph.D.as Scientific Director, Edward R. Conner, MDas chief medical officer and Julie Personas CEO, and Thomas M. Soloway to its board of directors.

Upcoming milestones
Third Harmonic Bio expects to achieve the following goals:

  • Submit a Clinical Trial Application (CTA) in Canada for THB001 to support initiation of a Phase 1b trial in asthma in the first half of 2023.
  • To present initial clinical data from its Phase 1b proof-of-concept clinical trial in chronic inducible urticaria in the second half of 2023.
  • Submit both a CTA in Europe and an Investigational New Drug Application in the United States to support the initiation of a Phase 2 trial in chronic spontaneous urticaria in the first half of 2024.
  • Report initial data from the Phase 1b asthma trial in the second half of 2024.

Summary of financial results
Treasury : Cash and cash equivalents totaled $299.5 million as of September 30, 2022. Based on current internal infrastructure and pipeline initiatives, Third Harmonic Bio believes it has sufficient cash to fund operations through 2025.

R&D expenses: Research and development (R&D) expenses decreased to $4.8 million for the three months ended September 30, 2022 from $4.9 million for the same period in 2021 due to the timing of non-clinical and clinical activities . R&D expenses for the nine months ended September 30, 2022 increased to $15.2 million from $11.5 million for the same period in 2021, primarily due to higher related clinical trial expenses at THB001.

General and administrative costs: General and administrative (G&A) expenses increased to $3.8 million for the quarter ended September 30, 2022 from $0.8 million for the same period in 2021. G&A expenses for the nine months ended September 30 September 2022 increased to $9.0 million from $1.8 million for the same period in 2021. The increases were primarily due to increased costs associated with personnel related expenses and the IPO .

Net loss: Net loss for the three months ended September 30, 2022 was $8.2 million, compared to a net loss of $7.4 million for the same period in 2021. Net loss for the nine months ended September 30 2022 was $23.7 million, compared to a net loss of $13.8. million for the same period in 2021.

About Third Harmonic Bio, Inc.
Third Harmonic Bio is a clinical-stage biopharmaceutical company focused on advancing the next wave of allergy and inflammation medicines. Third Harmonic’s lead product candidate, THB001, is a highly selective oral small molecule inhibitor of KIT, a cell surface receptor that serves as a master regulator of mast cell function and survival. THB001 is currently being evaluated in a phase 1b proof-of-concept study in chronic inducible urticaria. With promising drug-like properties and an encouraging early clinical profile, THB001 has the potential to revolutionize the treatment of a wide range of mast cell-mediated allergic and inflammatory dermatological, respiratory and gastrointestinal diseases. 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 United States Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the results and timing of clinical trials. and regulatory submissions for THB001. , expectations regarding cash flow forecasts, planned clinical and development activities and timelines. Forward-looking statements can be identified by words such as: “anticipate”, “intend”, “plan”, “objective”, “seek”, “believe”, “project”, “estimate”, “will 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 relating to Third Harmonic’s cash flow forecasts, the ability to advance its product candidates, the receipt and timing of potential regulatory submissions, the designations, approvals and commercialization of product candidates, our ability to protect our intellectual property , the timing and results of preclinical and clinical trials, changes in laws or regulations, market conditions, geopolitical events and other impacts of the ongoing COVID-19 pandemic, which could cause e that actual results differ materially from what Third Harmonic Bio expects. Further information on potential risk factors that could affect Third Harmonic Bio’s business and financial results is detailed under the heading “Risk Factors” included in Third Harmonic Bio’s prospectus dated September 14, 2022 filed with the United States Securities and Exchange Commission (SEC) in September. 15, 2022, and Third Harmonic Bio’s annual and quarterly reports and other SEC filings filed from time to time with the SEC. Third Harmonic Bio undertakes no obligation to publicly update any forward-looking statements, 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
[email protected]

Investor contacts:
Bob Ho
[email protected]

THIRD HARMONIC BIO, INC.
Condensed consolidated balance sheet data
(Unaudited)
(In thousands)
The 31st of December,
2021
September 30,
2022
Assets
Cash and cash equivalents $ 128,280 $ 299,516
Other current assets 884 4,053
Non-current assets 1,193
Total assets $ 129 164 $ 304,762
Passives
Current liabilities $ 5,686 $ 6,340
Non-current liabilities
Total responsibilities 5,686 6,340
Redeemable Convertible Preferred Shares 170 184
Equity (46,706 ) 298,422
Total Liabilities and Equity $ 129 164 $ 304,762
THIRD HARMONIC BIO, INC.
Condensed consolidated statements of results
(Unaudited)
(In thousands of, except per share and per share amounts)
Quarter ended September 30 Nine-month period ended September 30
2021 2022 2021 2022
Operating costs :
Research and development $ 4,917 $ 4,757 $ 11,463 $ 15,150
general and administrative 780 3,831 1,790 9,008
Total operating expenses 5,697 8,588 13,253 24,158
Operating loss 5,697 8,588 13,253 24,158
Other (income) expenses, net 1,684 (383 ) 574 (493 )
Net loss $ 7,381 $ 8,205 $ 13,827 $ 23,665
Net loss per common share, basic and diluted $ 0.90 $ 0.69 $ 3.46 $ 2.26
Weighted average common shares outstanding, basic and diluted 8,159,044 11,827,663 3,994,784 10,451,300