Core Viewpoint - Third Harmonic Bio, Inc. has announced positive Phase 1 clinical trial results for THB335, supporting its advancement into Phase 2 trials for chronic spontaneous urticaria (CSU) while also initiating a strategic review to maximize shareholder value [1][2] Clinical Results - The Phase 1 clinical trial included single ascending dose (SAD) with 48 participants and multiple ascending dose (MAD) with 32 participants, evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics of THB335 [3] - THB335 demonstrated a half-life of approximately 40 hours, allowing for once daily dosing, with dose-dependent increases in exposure observed across all cohorts [4] - Significant reductions in serum tryptase, a biomarker for mast cell activation, were noted in MAD cohorts, with reductions ranging from 13% to 84% at Day 15 [5] Safety Profile - THB335 was generally safe and well tolerated, with isolated, transient asymptomatic transaminase elevations observed in three subjects, which management does not believe to be drug-related [6] - Adverse events included hair color changes and reductions in hemoglobin and neutrophil counts, which were dose-dependent and resolved during follow-up [7] Next Steps for THB335 - The company plans to continue development activities for THB335 through the first half of 2025, preparing for a 12-week, placebo-controlled Phase 2 study in CSU by mid-2025 [9] - Ongoing activities include completing subchronic toxicology studies and submitting regulatory filings for Phase 2 initiation [9] Corporate Strategy - In parallel with THB335 Phase 2 readiness, the company is exploring strategic transactions and business combinations to enhance shareholder value, engaging TD Cowen for advisory support [10] - The company is halting all non-THB335 related research and reducing its workforce by approximately 50% [10] Financial Position - As of December 31, 2024, the company reported approximately $285 million in cash and cash equivalents, with an estimated range of $262 million to $267 million expected by June 30, 2025, after accounting for various expenses [11]

Core Viewpoint - Third Harmonic Bio, Inc. (THRD) shows potential for further upside, with a mean price target of $19 indicating a 26.7% upside from the current price of $15 [1] Price Targets - The average price targets range from a low of $15 to a high of $23, with a standard deviation of $3.37, indicating variability among analysts [2] - The most optimistic estimate suggests a potential upside of 53.3%, while the lowest estimate indicates no increase from the current price [2] Analyst Sentiment - Analysts are optimistic about THRD's earnings prospects, as indicated by a positive trend in earnings estimate revisions, which historically correlates with stock price movements [4][9] - Over the last 30 days, the Zacks Consensus Estimate for the current year has increased by 2.9%, with one estimate moving higher and no negative revisions [10] Zacks Rank - THRD holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, suggesting strong potential for upside [11]

Financial Performance - Cash and cash equivalents totaled $296.1 million as of September 30, 2024, an increase from $269.1 million as of December 31, 2023[10] - Net loss for Q3 2024 increased to $13.8 million from $7.3 million in Q3 2023, a rise of 89.0%[6] - Net loss for the nine months ended September 30, 2024, was $32.4 million, compared to $24.0 million for the same period in 2023, an increase of 35.0%[6] - Total assets increased to $304.5 million as of September 30, 2024, from $277.7 million as of December 31, 2023[10] Research and Development - Research and development (R&D) expenses increased to $11.3 million for Q3 2024, up from $6.0 million in Q3 2023, representing an increase of 88.3%[4] - R&D expenses for the nine months ended September 30, 2024, rose to $26.0 million, compared to $18.0 million for the same period in 2023, reflecting a 44.4% increase[4] - The lead product candidate, THB335, is a small-molecule inhibitor currently in Phase 1 clinical trials targeting mast cell-mediated inflammatory diseases[7] - The Phase 1 SAD/MAD clinical trial of THB335 is on track to deliver results in Q1 2025[1] General and Administrative Expenses - General and administrative (G&A) expenses for Q3 2024 were $5.7 million, up from $4.9 million in Q3 2023, a 16.3% increase[5] Cash Flow and Funding - The company expects its existing cash and cash equivalents to fund operations through at least 2026[3]

Financial Performance - The company reported a net loss of $30.8 million for the year ended December 31, 2023, and $32.4 million for the nine months ended September 30, 2024, with an accumulated deficit of approximately $146.6 million as of September 30, 2024[87]. - Total operating expenses increased by 57% to $17.1 million for the three months ended September 30, 2024, compared to $10.8 million for the same period in 2023[96]. - The company expects to continue incurring net operating losses for several years as it advances its product candidates through clinical development[87]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $23.3 million, primarily due to a net loss of $32.4 million[106]. - The company expects to incur significant expenses and operating losses for the foreseeable future, primarily for research and development services and general overhead costs[109]. Research and Development - Research and development expenses rose by 90% to $11.3 million for the three months ended September 30, 2024, from $6.0 million in the prior year[96]. - Total research and development expenses for the nine months ended September 30, 2024, were $26.0 million, an increase of $8.0 million from $18.0 million for the same period in 2023[98]. - The company initiated a Phase 1 clinical trial for THB335, a potent oral small molecule KIT inhibitor, with results expected in Q1 2025[82]. - THB335 demonstrated nanomolar potency against KIT and improved pharmacokinetic profiles compared to the first-generation product candidate THB001[84]. - The company has not generated any revenue from product sales since its inception in 2019 and relies on financing from equity offerings and capital sources[86]. Cash and Funding - The company has $296.1 million in cash and cash equivalents as of September 30, 2024, which is expected to fund operations through at least 2026[94]. - The company sold 3,900,000 shares of common stock through its ATM Facility, generating net proceeds of approximately $48.7 million[103]. - The company filed a shelf registration statement allowing for the offering of up to $400.0 million in various securities, including common stock and debt securities[102]. - The company is obligated to pay Novartis up to $31.7 million upon achieving certain development milestones and $200 million upon achieving specified sales milestones for licensed products[95]. Internal Controls and Compliance - The company identified a material weakness in internal control over financial reporting, which has not been fully remediated since it was first noted in 2021[120]. - The material weakness is attributed to a lack of segregation of duties, system limitations in accounting software, and insufficient internal resources with appropriate accounting and finance expertise[120]. - The company has implemented measures to improve internal controls, including engaging financial consultants and enhancing supervisory reviews by financial management[121]. - The company qualifies as an "emerging growth company" and has elected to delay the adoption of new accounting standards until they apply to private companies[123]. - The company is classified as a "smaller reporting company," with a market value of stock held by non-affiliates less than $700 million and annual revenue below $100 million[124]. Market and Economic Conditions - Interest income is sensitive to changes in U.S. interest rates, and cash equivalents are subject to interest rate risk, which could lead to a decrease in value if market rates increase[128]. - The company is currently not exposed to significant foreign currency exchange risk as all operations and expenses are denominated in U.S. dollars[129]. - Inflation has not materially impacted the company's financial position to date, but rising inflation rates may affect labor and clinical trial costs in the near future[130]. - The company has not had a formal hedging program for foreign currency, and foreign currency transaction gains and losses have not been material to its financial statements[129].

Financial Performance - Net loss for Q2 2024 was $10.7 million, compared to a net loss of $7.6 million in Q2 2023, representing a 40.9% increase[4] - General and administrative (G&A) expenses rose to $5.7 million for Q2 2024, slightly up from $5.4 million in Q2 2023[4] - Total operating expenses for the six months ended June 30, 2024, were $25.4 million, compared to $22.7 million for the same period in 2023[8] Cash Position - Cash and cash equivalents totaled $255.3 million as of June 30, 2024, sufficient to fund operations through at least 2026[3] - Total liabilities increased to $9.1 million as of June 30, 2024, from $8.6 million as of December 31, 2023[7] Research and Development - Research and development (R&D) expenses increased to $8.4 million for Q2 2024, up from $5.3 million in Q2 2023, reflecting a 58.5% increase[3] - R&D expenses for the six months ended June 30, 2024, increased to $14.6 million from $12.1 million for the same period in 2023, a 20.7% increase[3] - The Phase 1 SAD/MAD clinical trial of THB335 is on track to report results in Q1 2025[2] - The company is preparing to move THB335 into a Phase 2 clinical trial for chronic spontaneous urticaria[2] Shareholder Information - The weighted-average common stock outstanding for the six months ended June 30, 2024, was 40,384,338 shares[8]

Financial Performance - The company reported a net loss of $30.8 million for the year ended December 31, 2023, and $18.6 million for the six months ended June 30, 2024, with an accumulated deficit of approximately $132.8 million as of June 30, 2024[71]. - The company has not generated any revenue from product sales and will need substantial additional funding to support ongoing operations and growth strategy[73]. - Net loss for the three months ended June 30, 2024 was $10.7 million, an increase of $3.1 million or 42% compared to the net loss of $7.6 million for the same period in 2023[78]. - The company expects to continue incurring significant expenses and operating losses for the foreseeable future, with existing cash expected to fund operations through at least 2026[89]. - Net cash used in operating activities for the six months ended June 30, 2024 was $15.1 million, primarily due to a net loss of $18.6 million[86]. Cash and Funding - The company has $255.3 million in cash and cash equivalents as of June 30, 2024, which is expected to fund operations through at least 2026[75]. - The company filed a shelf registration statement allowing for the offering of up to $400.0 million in various securities, including $150.0 million in common stock through an Open Market Sales Agreement[84]. - Net cash provided by financing activities increased from $0.1 million in 2023 to $1.4 million in 2024, related to proceeds from the exercise of stock options[88]. - The company has cash and cash equivalents of $255.3 million as of June 30, 2024, primarily in money market funds and U.S. Treasury-backed securities[104]. Research and Development - The FDA has cleared the company's IND application to initiate a first-in-human clinical trial of THB335, with clinical results expected to be reported in Q1 2025[67]. - THB335 is designed to be a potent, highly selective oral small molecule KIT inhibitor, demonstrating nanomolar potency against KIT and improved pharmacokinetic profiles compared to the first-generation product THB001[69]. - The company plans to conduct a Phase 2 trial for THB335 in chronic spontaneous urticaria (CSU) following the Phase 1 trial[67]. - Research and development expenses increased by $3.1 million, from $5.3 million for the three months ended June 30, 2023 to $8.4 million for the three months ended June 30, 2024, representing a 57% increase[80]. Operating Expenses - General and administrative expenses rose by $0.3 million, from $5.4 million for the three months ended June 30, 2023 to $5.7 million for the three months ended June 30, 2024, a 6% increase[81]. - The company has incurred significant operating losses since inception and expects to continue incurring net operating losses for several years[71]. Contracts and Obligations - The company is required to pay Novartis up to $31.7 million upon achieving certain development milestones and $200 million upon achieving specified sales milestones for licensed products[76]. - The company has not paid any royalties to Novartis to date, as there are no commercially approved products for sale, with royalty percentages expected to be in the mid-single digits of sales[92]. Internal Controls and Compliance - The company identified a material weakness in internal control over financial reporting, related to lack of segregation of duties and insufficient internal resources, which has not yet been fully remediated[97]. - The company has implemented measures to improve internal controls, including strengthening supervisory reviews and engaging financial consultants[98]. Market and Economic Conditions - The company is classified as an "emerging growth company" and a "smaller reporting company," with annual revenue less than $100 million and market value of stock held by non-affiliates less than $700 million[101]. - The company does not currently face significant foreign currency exchange risk, as all operations and expenses are denominated in U.S. dollars[105]. - Inflation has not materially impacted the company's financial position to date, but rising inflation rates may affect labor and clinical trial costs in the near future[106]. Manufacturing and Supply Chain - The manufacturing process for THB335 is supported by readily-sourced raw materials and scalability, with current manufacturers expected to supply upcoming clinical trials[74]. - The company has entered into contracts with third-party vendors for research and manufacturing services, most of which do not contain minimum purchase commitments[94]. - The company has not experienced material foreign currency transaction gains or losses and does not have a formal hedging program[105].

Financial Performance - Cash and cash equivalents totaled $262.8 million as of March 31, 2024, sufficient to fund operating expenses through at least 2026[10] - Net loss for Q1 2024 decreased to $7.9 million from $9.1 million in Q1 2023, attributed to increased interest income and decreased operating expenses[13] - The total operating expenses for Q1 2024 were $11.3 million, compared to $12.0 million in Q1 2023[20] Research and Development - Research and development (R&D) expenses decreased to $6.2 million for Q1 2024, down from $6.7 million in Q1 2023, primarily due to the termination of the THB001 program[11] - The U.S. FDA cleared the Investigational New Drug application for THB335, with a Phase 1 clinical trial initiated and results expected in the first half of 2025[2] - The Phase 1 trial of THB335 aims to evaluate safety and pharmacokinetics in healthy volunteers, with a focus on chronic spontaneous urticaria[4] - The company plans to rapidly expand THB335's development into additional mast cell-mediated disorders following the Phase 1 trial[2] Administrative Expenses - General and administrative (G&A) expenses decreased to $5.1 million for Q1 2024, down from $5.3 million in Q1 2023, mainly due to reductions in non-cash stock-based compensation[12] Leadership Changes - The leadership team was strengthened with the appointment of Christopher J. Dinsmore as Chief Scientific Officer and Dennis Dean as Chief Non-Clinical Development Officer[5] Stock Information - The weighted-average common stock outstanding increased to 40,213,158 in Q1 2024 from 39,438,572 in Q1 2023[20]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission File Number: 001-41498 THIRD HARMONIC BIO, INC. (Exact Name of Registrant as Specified in its Charter) Delaw ...

Exhibit 99.1 Third Harmonic Bio Announces Fourth Quarter and Full Year 2023 Financial Results U.S. IND filed for THB335 with anticipated clinical trial start during 2Q'24 Strong financial position with cash and cash equivalents totaling $269.1 million as of December 31, 2023 SAN FRANCISCO, CA, 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 th ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ____________________ TO ____________________ Commission File Number 001-41498 THIRD HARMONIC BIO, INC. (Exact name of Registrant as specified in its Charter) Washington, D.C. 20549 | Del ...