Stockholders overwhelmingly approved liquidation and dissolution of the Company at the June 5, 2025 Annual Meeting Initial distribution currently expected in the range between approximately $5.30 and $5.35 per share of common stock, expected in the third quarter of 2025 THB335 demonstrated 85% serum tryptase reduction with an encouraging safety profile in an additional Phase 1 cohort evaluating 100mg dose with new drug product capsule formulation Company initiating a sale process of THB335 SAN FRANCISCO, J ...

Financial Performance - The company reported a net loss of $15.8 million for the three months ended March 31, 2025, representing a 102% increase compared to a net loss of $7.9 million for the same period in 2024[110]. - Total operating expenses increased by 66% to $18.7 million in Q1 2025, up from $11.3 million in Q1 2024, driven by a 71% increase in research and development expenses[110]. - The company has an accumulated deficit of approximately $175.5 million as of March 31, 2025[99]. - Net cash used in operating activities increased from $6.3 million in Q1 2024 to $13.5 million in Q1 2025, primarily due to a net loss of $15.8 million in 2025[120]. Cash and Liquidity - As of March 31, 2025, the company had $271.6 million in cash and cash equivalents, expected to fund operations through at least 2026[106]. - The company expects existing cash and cash equivalents to fund operations through at least 2026, although this estimate is based on assumptions that may prove incorrect[124]. - As of March 31, 2025, the company had cash and cash equivalents totaling $271.6 million, primarily in money market funds and U.S. Treasury-backed securities[138]. Research and Development - The company plans to complete Phase 2 readiness activities for THB335 by mid-2025 to maximize the value of the program for potential sale[93]. - Research and development expenses increased by $4.4 million, from $6.2 million for the three months ended March 31, 2024, to $10.6 million for the same period in 2025, representing a 71% increase[112]. - The increase in research and development expenses was primarily due to higher direct costs related to the THB335 program and increased indirect employee-related costs[112]. - The company has halted all non-THB335-related research and reduced its workforce by approximately 50% as part of a restructuring effort[92]. Strategic Initiatives - The company intends to seek stockholder approval for a Plan of Liquidation and Dissolution at the annual meeting on June 5, 2025[94]. - The company has entered into a license agreement with Novartis, which includes potential milestone payments totaling up to $231.7 million and tiered royalties on net sales of licensed products[108]. Market and Economic Conditions - The company qualifies 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[135]. - The company is exposed to interest rate risk, as cash equivalents are sensitive to changes in U.S. interest rates, which could affect interest income[139]. - The company currently does not face significant foreign currency exchange risk, as all operations and expenses are in U.S. dollars, but future contracts with non-U.S. vendors may introduce some risk[140]. - Inflation has not materially impacted the company's financial position to date, but rising inflation rates could increase labor and clinical trial costs in the near future[141]. Other Financial Metrics - Total other income, net decreased by $0.6 million, from $3.4 million in Q1 2024 to $2.9 million in Q1 2025, mainly due to fluctuations in interest rates affecting interest income[114]. - General and administrative expenses rose by $3.0 million, from $5.1 million in Q1 2024 to $8.1 million in Q1 2025, driven by personnel-related expenses and stock-based compensation[113]. - 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[116]. - During the year ended December 31, 2024, the company sold 3,900,000 shares through its ATM Facility, generating gross proceeds of approximately $49.9 million[117]. - The company may incur contingent royalty payments under the Novartis Agreement, with royalty percentages in the mid-single digits of sales, but has not paid any royalties to date[128].

Financial Position - As of March 31, 2025, the company's preliminary unaudited cash, cash equivalents, and restricted cash amount to approximately $272 million[5]. Liquidation and Dissolution - The board of directors unanimously approved the liquidation and dissolution of the company on April 10, 2025[7]. - The company plans to hold its annual meeting on June 5, 2025, to seek stockholder approval for the liquidation and dissolution[8]. - The board reserves the right to abandon the proposed liquidation and dissolution if deemed not in the best interests of the company and its stockholders[8]. - The company intends to file a proxy statement and other relevant materials with the SEC regarding the planned dissolution[10]. Strategic Alternatives - The company is evaluating strategic alternatives to maximize stockholder value, including potential acquisitions or mergers[7]. Risks and Uncertainties - Forward-looking statements regarding the dissolution process involve substantial risks and uncertainties[12]. - The company may face potential tax claims and litigation matters that could impact the dissolution process[13]. - The adequacy of reserves to satisfy obligations during the dissolution is uncertain and subject to change[13]. - The company has not conducted an exhaustive inquiry into all relevant information regarding the dissolution[13].

Core Viewpoint - Third Harmonic Bio, Inc. has approved a Plan of Liquidation and Dissolution, aiming to maximize stockholder value through asset sales and cash distributions to shareholders [1][2][3] Group 1: Plan of Liquidation and Dissolution - The Board of Directors unanimously approved the dissolution and liquidation of the Company, pending stockholder approval, with a meeting scheduled for June 5, 2025 [3] - The initial distribution to stockholders is expected to be between approximately $246.6 million and $255.4 million, translating to about $5.13 to $5.33 per share, anticipated in the third quarter of 2025 [1][3] - The Company plans to sell its assets, including the THB335 program, to maximize value for stockholders during the liquidation process [1][2] Group 2: Financial Estimates and Provisions - The total estimated distribution to stockholders could range from approximately $246.6 million to $259.8 million, or about $5.13 to $5.42 per share, depending on the outcomes of asset sales [3] - The Company will establish a reserve to cover expenses and liabilities during the dissolution process, ensuring sufficient funds are available to meet obligations [3] Group 3: Management Statements - The CEO emphasized the management team's commitment to maximizing asset value and acting in the best interest of patients and shareholders [2] - The Board retains the right to abandon the Plan of Dissolution at any time before it becomes effective if deemed in the best interest of the Company and its stockholders [4]

Financial Performance - As of December 31, 2024, Third Harmonic Bio reported cash and cash equivalents of $285.1 million, an increase from $269.1 million in 2023[6][15]. - The net loss for Q4 2024 was $13.1 million, compared to a net loss of $6.8 million in Q4 2023, with the annual net loss increasing to $45.5 million from $30.8 million in 2023[10][17]. - Total operating expenses for the year ended December 31, 2024, were $58.9 million, up from $44.0 million in 2023[17]. - The weighted-average common stock outstanding increased from 39.6 million in 2023 to 41.7 million in 2024[17]. Research and Development - Research and development (R&D) expenses for Q4 2024 were $10.5 million, up from $5.9 million in Q4 2023, and total R&D expenses for the year increased to $36.5 million from $24.0 million in 2023[8][17]. - Third Harmonic Bio plans to initiate a 12-week, placebo-controlled Phase 2 study for THB335 in chronic spontaneous urticaria by mid-2025[3]. - The company has halted all non-THB335 related research and reduced its workforce by approximately 50%[5]. Strategic Initiatives - Third Harmonic Bio is exploring strategic alternatives to maximize shareholder value through potential transactions or business combinations[4]. - The company estimates cash and cash equivalents will range from approximately $262 million to $267 million by June 30, 2025[7][6]. General and Administrative Expenses - General and administrative (G&A) expenses for Q4 2024 rose to $5.9 million from $4.5 million in Q4 2023, with total G&A expenses for the year increasing to $22.4 million from $20.0 million in 2023[9][17].

Recently presented THB335 Phase 1 data support advancement into Phase 2 clinical trial in chronic spontaneous urticaria (CSU) Strategic alternatives process underway to maximize value creation across all assets in the company Strong financial position with cash and cash equivalents totaling $285.1 million as of December 31, 2024 SAN FRANCISCO, March 27, 2025 (GLOBE NEWSWIRE) -- Third Harmonic Bio, Inc. (Nasdaq: THRD), a biopharmaceutical company focused on advancing the next wave of medicine for inflammator ...

Financial Performance - The company has incurred significant net losses of $30.8 million and $45.5 million for the years ended December 31, 2023 and 2024, respectively, with an accumulated deficit of $159.7 million as of December 31, 2024[159]. - The company has not generated any revenue to date and does not expect to do so until regulatory approval and successful commercialization of THB335 or any future product candidates[162]. - The company anticipates substantial increases in expenses as it advances THB335 through clinical development and seeks regulatory approvals[160]. - The company expects to continue incurring significant losses for the foreseeable future as it develops THB335 and other product candidates[161]. - The company may not generate sufficient revenue from THB335 if it does not achieve adequate market acceptance among physicians and third-party payors[205]. Cash and Funding - As of December 31, 2024, the company had $285.1 million in cash and cash equivalents, which is expected to fund operations through at least 2026[165]. - The company plans to seek additional funding through public or private equity offerings or debt financings to support its business objectives[168]. Clinical Development and Regulatory Approval - The company has a limited operating history since its inception in 2019 and has not completed any clinical trials beyond Phase 1[157]. - The company's future performance is heavily dependent on the success of THB335 and the ability to develop future product candidates, with ongoing clinical trials planned[179]. - The company currently has no products approved for sale and cannot assure that THB335 or future candidates will achieve success in clinical trials or obtain regulatory approval[180]. - Regulatory approval for THB335 and future candidates will require compliance with varying requirements across jurisdictions, including the U.S., EU, UK, and Japan[181]. - Clinical trial delays could significantly impact the company's ability to commercialize THB335, potentially harming business and financial results[190]. Risks in Clinical Trials - The company faces numerous risks in clinical trials, including patient enrollment challenges and potential regulatory hold or termination of trials[187]. - The outcome of clinical testing is uncertain, and previous product candidates have failed to obtain marketing approval despite promising early results[186]. - The company has limited experience in designing clinical trials, which may hinder the ability to support marketing approval for THB335 or any future oral KIT inhibitor product candidates[191]. - Significant variability in safety or efficacy results can occur between different clinical trials, impacting the development timeline and regulatory approval prospects for THB335[192]. - Adverse events not seen in nonclinical studies may emerge during clinical trials, which could inhibit regulatory approval or market acceptance of THB335[194]. Competition and Market Acceptance - The company faces substantial competition from larger pharmaceutical and biotechnology companies, which may affect the ability to develop and commercialize THB335 successfully[200]. - Market acceptance of THB335 will depend on factors such as safety, efficacy, and the willingness of healthcare providers to prescribe the treatment[204]. - The success of THB335 will be influenced by the effectiveness of sales and marketing efforts, pricing, and the availability of reimbursement from payors[206]. Internal Controls and Compliance - The company has experienced material weaknesses in internal control over financial reporting, which could impact the accuracy of financial results[174]. - The company identified a material weakness in internal control over financial reporting for the years ended December 31, 2021, 2022, and 2023, related to insufficient internal resources and system limitations[175]. - Measures implemented to improve internal controls included hiring additional qualified accounting staff and engaging consultants, which were effective in remediating the material weakness by December 31, 2024[177]. Employee and Operational Risks - As of December 31, 2024, the company had 53 full-time employees, but a reduction in force impacting approximately 50% of the workforce was announced in February 2025[213]. - Retaining key employees is critical, as the loss of management or technical staff could delay research and development programs[217]. - Competition for skilled employees in the biotechnology sector is intense, which may limit the company's ability to attract and retain qualified personnel[218]. Intellectual Property and Patent Risks - The company’s ability to maintain patent protection for its technologies is critical for the development and commercialization of THB335 and future products[250]. - The company may face challenges in controlling the prosecution and enforcement of licensed patents, which could adversely affect its competitive position[251]. - Future patents may not be broad enough to prevent competitors from developing similar products, impacting the company's market position[252]. - The patent application process is complex and uncertain, with potential delays in enforcement against third parties until patents are granted[254]. - The company may face third-party claims for patent infringement, which could require costly litigation or licensing agreements that may not be available on commercially reasonable terms[278]. Regulatory Environment and Compliance - The regulatory approval process for product candidates like THB335 is highly uncertain, and delays in obtaining U.S. or foreign regulatory approvals could hinder commercialization efforts[290]. - The company is subject to various healthcare laws and regulations, including the federal Anti-Kickback Statute, which prohibits remuneration to induce referrals for services covered by federal healthcare programs[305]. - Compliance with healthcare laws may involve substantial costs, and violations could lead to significant penalties, including civil and criminal penalties, loss of FDA approvals, and reputational harm[307]. Market Conditions and Stock Performance - The lack of an active trading market for the company's common stock may impair the ability to raise capital and affect stock value[330]. - Quarterly and annual operating results may fluctuate significantly, impacting stock price and investor expectations[331]. - The company is classified as an "emerging growth company" and a "smaller reporting company," with a market value of common stock held by non-affiliates less than $700 million and annual revenue below $100 million[343][346].

Group 1 - The stock of Third Harmonic Bio, Inc. (THRD) has experienced a significant decline of 31.6% over the past four weeks due to excessive selling pressure, but it is now in oversold territory, indicating a potential for a turnaround [1] - The Relative Strength Index (RSI) is a key technical indicator used to determine if a stock is oversold, with a reading below 30 typically indicating this condition [2] - THRD's current RSI reading is 26.95, suggesting that the heavy selling may be exhausting itself and a trend reversal could be imminent [5] Group 2 - There is a strong consensus among sell-side analysts regarding THRD's ability to report better earnings than previously predicted, with a 25.2% increase in the consensus EPS estimate over the last 30 days [6] - The upward trend in earnings estimate revisions is generally associated with price appreciation in the near term, indicating a positive outlook for THRD [6] - THRD holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate trends and EPS surprises, further supporting the potential for a turnaround [7]

Core Viewpoint - Third Harmonic Bio, Inc. (THRD) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Performance - The Zacks rating system emphasizes the correlation between changes in earnings estimates and stock price movements, suggesting that revisions in earnings estimates are a powerful indicator of future stock performance [4][6]. - For Third Harmonic Bio, the Zacks Consensus Estimate has increased by 25.2% over the past three months, reflecting a positive trend in earnings outlook [8]. Company Financials - The company is projected to earn -$1.08 per share for the fiscal year ending December 2024, which represents a year-over-year decline of 38.5% [8]. Investment Implications - The upgrade to Zacks Rank 2 positions Third Harmonic Bio in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [10].

Core Viewpoint - Third Harmonic Bio, Inc. (THRD) has experienced a significant decline of 39.6% in its stock price over the past four weeks, but it is now in oversold territory, suggesting a potential turnaround due to improved earnings expectations from analysts [1]. Group 1: Stock Performance and Technical Indicators - The stock is currently in oversold territory with a Relative Strength Index (RSI) reading of 15.51, indicating that the heavy selling pressure may be exhausting itself [5]. - A stock is generally considered oversold when its RSI falls below 30, which helps investors identify potential entry points for a rebound [2][3]. Group 2: Earnings Estimates and Analyst Consensus - There has been a strong consensus among sell-side analysts to raise earnings estimates for THRD, resulting in a 25.2% increase in the consensus EPS estimate over the last 30 days [5]. - An upward trend in earnings estimate revisions typically correlates with price appreciation in the near term, indicating a potential recovery for THRD [5]. Group 3: Zacks Rank and Investment Potential - THRD currently holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the potential for a turnaround [6].