Core Insights - Cycle Group Holdings Limited has successfully acquired Applied Therapeutics, Inc., a clinical-stage biopharmaceutical company listed on NASDAQ [1] - The acquisition aims to enhance Cycle's portfolio in the rare metabolic disease sector, particularly focusing on treatments for conditions with no FDA-approved options [2][3] Company Overview - Cycle Pharmaceuticals was founded in 2012 with a mission to provide drug treatments and support for the underserved rare disease community, focusing on rare genetic conditions across various fields including metabolic, immunology, urology, and oncology [5] - The company is headquartered in Cambridge, UK, with additional offices in Detroit, Boston, and High Point [5] Drug Candidate Information - Applied Therapeutics' lead drug candidate, govorestat, is an Aldose Reductase Inhibitor designed to treat central nervous system rare metabolic diseases, including Classic Galactosemia, Charcot-Marie-Tooth Sorbitol Dehydrogenase Deficiency, and PMM2-CDG [2] - These conditions currently lack FDA-approved treatment options, highlighting the potential market opportunity for Cycle following the acquisition [2] Transaction Details - The acquisition will be funded using cash on hand, indicating Cycle's financial readiness to expand its operations [3] - Legal counsel for Cycle during the transaction was provided by Goodwin Procter LLP, while Applied Therapeutics engaged Aquilo Partners, L.P. for a fairness opinion and Ropes & Gray LLP for legal counsel [4]

Core Viewpoint - Applied Therapeutics, Inc. is undergoing a tender offer from AT2B, Inc., a subsidiary of Cycle Group Holdings Limited, to acquire the company, which is focused on developing treatments for rare diseases [1][2]. Company Overview - Applied Therapeutics is a clinical-stage biopharmaceutical company dedicated to creating transformative treatments for rare diseases, with its lead drug candidate, govorestat, targeting Classic Galactosemia, CMT-SORD, and PMM2-CDG, all of which currently lack FDA-approved treatments [3][14]. Tender Offer Details - The tender offer price is set at $0.088 per share in cash, plus one non-tradeable contingent value right per share, with the expiration date extended to January 29, 2026 [2]. - The Board of Directors recommends that stockholders tender their shares, believing the merger with Cycle represents the best path forward for maximizing stockholder value [3][5]. Financial Implications - If the tender offer does not succeed, the company may face significant risks, including potential liquidation, as the Board has determined that the offer price is more favorable than other alternatives [4]. - Cycle has issued a promissory note to Applied Therapeutics, advancing $8.5 million, which will become due if the merger agreement is terminated [4]. Strategic Alternatives - The company has explored various strategic alternatives and concluded that the merger with Cycle is the best option available, as no alternative proposals have been received since the merger agreement was signed [4][5]. Shareholder Actions - Stockholders who have already tendered their shares do not need to take further action due to the extension of the offer [6]. - Instructions for tendering shares are provided, emphasizing the importance of acting promptly to meet broker processing deadlines [8][10].

Core Viewpoint - Shares of Applied Therapeutics Inc. (APLT) have experienced a significant decline of 46.8% over the past week, but the formation of a hammer chart pattern suggests potential support and a possible trend reversal in the future [1] Technical Analysis - The hammer chart pattern indicates a minor difference between opening and closing prices, with a long lower wick, suggesting that the stock may have found support after a downtrend [4] - This pattern signals that bears might be losing control, and the emergence of buying interest could indicate a potential trend reversal [5] Fundamental Analysis - Rising optimism among Wall Street analysts regarding APLT's future earnings enhances the prospects for a trend reversal [2] - Over the last 30 days, the consensus EPS estimate for APLT has increased by 1.9%, indicating that analysts expect better earnings than previously predicted [8] - APLT currently holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [9][10]

Core Viewpoint - Halper Sadeh LLC is investigating the fairness of the sale of Applied Therapeutics, Inc. to Cycle Group Holdings Limited for $0.088 per share in cash plus a contingent value right for potential additional payments [1] Company Summary - The sale price of Applied Therapeutics is set at $0.088 per share in cash [1] - Shareholders are encouraged to explore their legal rights and options regarding the sale [1]

Core Insights - Applied Therapeutics has entered into a definitive agreement for Cycle Group Holdings Limited to acquire the company, focusing on advancing its lead drug candidate, govorestat, for rare CNS metabolic diseases [1][3][6] Company Overview - Applied Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing novel drug candidates targeting rare diseases, with its lead candidate being govorestat, an Aldose Reductase Inhibitor for CNS rare metabolic diseases [2][10] Acquisition Details - Cycle will initiate a tender offer to acquire all outstanding shares of Applied common stock at a price of $0.088 per share in cash, along with a non-transferrable contingent value right (CVR) for potential additional payments [3][4] - The CVR includes payments based on FDA approvals and sales milestones, with potential cash payments of up to $0.10 for FDA approval of new drug applications for specific indications and up to $0.20 for achieving worldwide net sales of $200 million [8] Financial Support - Applied has issued a Promissory Note to Cycle, allowing for loans up to $8.5 million to support its working capital needs, with repayment obligations triggered if the transaction is terminated [5] Board Approval - The merger agreement was unanimously approved by the Applied Board of Directors after evaluating strategic alternatives, determining it to be in the best interest of the company and its stockholders [6]

Core Insights - Applied Therapeutics Inc. (APLT) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates [1][4][11] Earnings Estimates and Stock Price Impact - The Zacks rating system is primarily driven by changes in a company's earnings estimates, which are crucial for stock price movements [2][5] - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, influencing their buying or selling decisions [5][6] Recent Performance and Projections - The Zacks Consensus Estimate for Applied Therapeutics has increased by 11.9% over the past three months, with expectations of -$0.52 earnings per share for the fiscal year ending December 2025, showing no year-over-year change [9] - The upgrade to Zacks Rank 2 places Applied Therapeutics in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10][11] Zacks Rating System Overview - The Zacks Rank system categorizes stocks into five groups based on earnings estimates, with a strong historical performance of Zacks Rank 1 stocks averaging a +25% annual return since 1988 [8] - The system maintains a balanced distribution of ratings, ensuring that only the top 5% of stocks receive a "Strong Buy" rating, while the next 15% are rated as "Buy" [10]

Core Viewpoint - Applied Therapeutics has initiated a process to explore strategic alternatives to maximize shareholder value, which may include mergers, acquisitions, partnerships, and other strategic transactions [1][2][3] Strategic Alternatives - The Board is evaluating a broad range of opportunities to enhance shareholder value, including potential mergers, acquisitions, partnerships, joint ventures, and licensing arrangements [2] - There is no set timetable for the completion of this strategic review process, and the company will not provide further public comments unless necessary [3] Workforce Reduction - The company is reducing its workforce by approximately 46% as part of cost-containment and cash conservation measures [4] Commitment to Patients - The interim CEO emphasized the company's commitment to advancing govorestat for patients with rare diseases while maximizing shareholder value [5] Regulatory Updates - The company completed a Type C meeting with the FDA regarding govorestat for the treatment of Charcot-Marie-Tooth Sorbitol Dehydrogenase Deficiency (CMT-SORD) and plans to submit a request for an additional Type C meeting to discuss a potential Phase 3 trial design [6] - Feedback from the FDA regarding govorestat for Classic Galactosemia is being evaluated, with potential discussions for a Phase 3 trial design to follow [7] Company Overview - Applied Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel drug candidates for rare diseases, with its lead candidate being govorestat, aimed at treating CNS rare metabolic diseases [8]

Core Viewpoint - Applied Therapeutics, Inc. is experiencing a significant decline in stock price while providing updates on its regulatory strategy for Govorestat related to Charcot-Marie-Tooth Sorbitol Dehydrogenase Deficiency (CMT-SORD) following a Type C meeting with the FDA [1][4]. Regulatory Strategy - The company received official meeting minutes from the FDA regarding Govorestat for CMT-SORD, which is a genetic defect that leads to toxic sorbitol buildup in cells, damaging peripheral nerves [2]. - Key open issues discussed in the meeting included the need for conclusive evidence on the pathophysiology of CMT-SORD, the use of sorbitol levels as a surrogate endpoint, selection of a primary endpoint for a potential Phase 3 trial, and carcinogenicity testing [3]. - The company plans to request an additional Type C meeting with the FDA to further discuss the design of a potential Phase 3 trial [3]. Financial Position - As of September 30, 2025, the company reported cash and cash equivalents totaling $11.9 million [4]. - The stock price of APLT has decreased by 58.8%, trading at $0.37 during the latest check [4].

Financial Performance - Total revenue for the three months ended September 30, 2025, was $1,000,000, compared to $122,000 for the same period in 2024, representing a significant increase[20]. - The net loss for the three months ended September 30, 2025, was $18,990,000, compared to a net loss of $68,591,000 for the same period in 2024, reflecting an improvement of approximately 72%[20]. - For the nine months ended September 30, 2025, the company reported a net loss of $62.1 million, compared to a net loss of $149.6 million for the same period in 2024, indicating a 58.5% improvement year-over-year[27]. - The company reported a net cash used in operating activities of $67.4 million for the nine months ended September 30, 2025, compared to $64.8 million for the same period in 2024[27]. - The company reported a net loss of $62.1 million for the nine months ended September 30, 2025, with an accumulated deficit of $636.4 million[153]. Cash and Liquidity - Cash and cash equivalents decreased to $11,945,000 as of September 30, 2025, from $79,398,000 as of December 31, 2024, a decline of approximately 85%[18]. - The company had cash and cash equivalents of $11.9 million as of September 30, 2025, down from $98.9 million at the beginning of the period, reflecting a net decrease of $67.5 million in cash[27]. - As of September 30, 2025, cash and cash equivalents were $11.9 million, indicating a need for substantial additional funding for ongoing operations[188]. - The company has not generated any product revenue since inception and is dependent on debt and equity financing[188]. Expenses - Research and development expenses for the nine months ended September 30, 2025, were $27,361,000, down from $37,049,000 in the same period in 2024, indicating a reduction of approximately 26%[20]. - Total research and development expenses for the three months ended September 30, 2025 were $9.6 million, a decrease of $5.2 million (35%) from $14.8 million in 2024[174]. - General and administrative expenses for the three months ended September 30, 2025 were $8.2 million, down $6.9 million (46%) from $15.0 million in 2024[174]. - General and administrative expenses increased to $39.0 million for the nine months ended September 30, 2025, from $34.7 million in 2024, representing a $4.3 million increase[184]. - Legal and professional fees rose by $15.7 million, primarily due to securities class action and shareholder derivative litigation[184]. Assets and Liabilities - The total assets decreased to $34,374,000 as of September 30, 2025, from $86,691,000 as of December 31, 2024, a decline of approximately 60%[18]. - Total current liabilities increased to $32,902,000 as of September 30, 2025, from $27,296,000 as of December 31, 2024, representing an increase of about 21%[18]. - The total stockholders' equity showed a deficit of $(561,000) as of September 30, 2025, compared to a positive equity of $57,006,000 as of December 31, 2024[18]. - The accumulated deficit increased to $(636,355,000) as of September 30, 2025, from $(574,210,000) as of December 31, 2024, indicating a worsening of approximately 11%[18]. Financing and Capital Raising - The company is actively pursuing long-term financing options, including equity capital and debt, to support its operations and has engaged in discussions with potential partners for business development opportunities[33]. - The Company entered into a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald, allowing for the sale of up to $75.0 million in common stock[97]. - The March 2024 Private Placement raised approximately $92.3 million from the sale of 12,285,714 shares at $7.00 each and 2,000,000 Pre-Funded Warrants[99]. - The Company sold an aggregate of 20,615,976 shares of common stock under the Leerink ATM Agreement, resulting in net proceeds of $49.3 million[96]. Research and Development - The company operates in a single segment focused on research and development activities related to rare diseases[37]. - The FDA accepted the New Drug Application (NDA) for AT-007 for Classic Galactosemia in February 2024, but issued a Complete Response Letter on November 27, 2024, citing deficiencies in the clinical application[146]. - The company initiated a clinical development program for AT-007 in PMM2-CDG, a rare pediatric disease affecting an estimated 14,000 patients in North America and Europe[149]. - AT-007 reduced blood sorbitol levels by approximately 66% from baseline in a pilot study involving eight CMT-SORD patients[148]. Legal and Regulatory Matters - A settlement loss of $15.4 million was recognized within General and Administrative Expense due to a securities class action lawsuit, which includes a $15.0 million cash settlement and $0.4 million for warrant liability[137]. - The Company expects to recover $16.7 million from insurance related to the settlement loss, which includes $15.0 million for the cash settlement and $1.7 million for legal expenses[137]. - The Company is involved in multiple derivative actions seeking corporate governance reforms and recovery for alleged misconduct by current and former officers and directors[138]. - As of September 30, 2025, the Company assessed the probability of loss from the derivative lawsuits as reasonably possible, but does not believe any potential exposure will be material to its operations[142]. Internal Controls and Compliance - Management has identified a material weakness in internal control over financial reporting related to communication deficiencies, which has been addressed through enhanced controls and resources[215][216]. - The company has implemented a rigorous disclosure review process involving the executive team and legal counsel to improve communication and compliance[216]. - Management believes that enhanced resources and control activities will support the functioning of information and communication processes[216]. - The company has evaluated its disclosure controls and procedures, concluding they were effective at a reasonable assurance level as of September 30, 2025[214].

Financial Performance - Cash and cash equivalents totaled $11.9 million as of September 30, 2025, down from $79.4 million at December 31, 2024, representing a decrease of approximately 85%[12] - Net loss for Q3 2025 was $19.0 million, or $0.13 per share, compared to a net loss of $68.6 million, or $0.48 per share, for Q3 2024, indicating a significant reduction in losses[13] - Total revenue for the three months ended September 30, 2025, was $1,000, compared to $122 for the same period in 2024, representing a significant increase[23] - The net loss for the three months ended September 30, 2025, was $18,990, compared to a net loss of $68,591 for the same period in 2024[23] - Net loss per share attributable to common stockholders for the three months ended September 30, 2025, was $(0.13), compared to $(0.48) for the same period in 2024[23] - Total costs and expenses for the three months ended September 30, 2025, were $17,758, a decrease from $29,865 in the same period in 2024[23] - Interest income for the three months ended September 30, 2025, was $144, compared to $1,357 for the same period in 2024[23] - The change in fair value of warrant liabilities resulted in a loss of $(2,369) for the three months ended September 30, 2025, compared to a loss of $(40,184) for the same period in 2024[23] - The total other income (expense), net for the three months ended September 30, 2025, was $(2,232), compared to $(38,848) for the same period in 2024[23] Expenses - Research and development expenses for Q3 2025 were $9.6 million, a decrease of approximately 35% compared to $14.8 million in Q3 2024[12] - General and administrative expenses were $8.2 million for Q3 2025, down approximately 46% from $15.0 million in Q3 2024[12] - Research and development expenses for the three months ended September 30, 2025, were $9,601, a decrease from $14,828 in the same period in 2024[23] - General and administrative expenses for the three months ended September 30, 2025, were $8,157, down from $15,037 in the same period in 2024[23] Regulatory and Development Updates - The company received constructive feedback from the FDA regarding the regulatory strategy for govorestat for CMT-SORD, with plans to submit another meeting request to discuss a potential Phase 3 trial design[7] - A meeting is scheduled with the FDA in Q4 2025 to review govorestat for the treatment of Classic Galactosemia, following a Complete Response Letter received in November 2024[9] - Results from a single-patient trial of govorestat for PMM2-CDG showed a 46% improvement in the Nijmegen Pediatric CDG Rating Scale, with no adverse effects reported[10] - The company has received Orphan Drug Designation and Rare Pediatric Disease designation from the FDA for govorestat for PMM2-CDG[10] Liabilities and Deficits - Total current liabilities increased to $32.9 million as of September 30, 2025, compared to $27.3 million at December 31, 2024[21] - The company’s accumulated deficit increased to $636.4 million as of September 30, 2025, compared to $574.2 million at December 31, 2024[21]