Catalyst Biosciences, Inc.(US:CBIO)2025-11-07 21:16Product Development and Commercialization - Gyre Pharmaceuticals successfully advanced pirfenidone to commercialization in the PRC for the treatment of idiopathic pulmonary fibrosis (IPF) and is conducting an additional Phase 3 trial for pneumoconiosis, with patient enrollment completed in Q3 2025 [125]. - The company received approval for a clinical trial application for pirfenidone to treat radiation-induced lung injury, with an adaptive Phase 2/3 trial expected to initiate in Q4 2025 [125]. - Gyre Pharmaceuticals launched Etorel® in the PRC in Q2 2025, targeting systemic sclerosis-associated interstitial lung disease and progressive fibrosing interstitial lung disease, aiming to enhance market penetration and brand recognition [126]. - Contiva® was commercialized in the PRC in March 2025 for treating thrombocytopenia in adults with chronic liver disease and immune thrombocytopenic purpura, expanding the company's product offerings [127]. - Hydronidone, a lead candidate for liver fibrosis, completed a pivotal Phase 3 trial with 248 patients, achieving a statistically significant ≥1-stage regression in liver fibrosis compared to placebo (P=0.0002) [129]. - The company plans to file a New Drug Application with the NMPA for Hydronidone and is preparing to submit a U.S. IND for a Phase 2 trial in 2026 for metabolic dysfunction-associated steatohepatitis-related liver fibrosis [130]. - Gyre Pharmaceuticals is currently enrolling patients in a Phase 2 trial for F573, a caspase inhibitor for acute liver failure, and has initiated a Phase 1 trial for F230, a selective endothelin receptor agonist for pulmonary arterial hypertension [131]. Financial Performance - For the three months ended September 30, 2025, the company reported revenues of $30.6 million, a 20% increase from $25.5 million in the same period of 2024, driven by sales growth in ETUARY®, Contiva®, and Etorel® [160]. - The net income for the three months ended September 30, 2025, was $5.9 million, representing a 108% increase compared to $2.9 million in the same period of 2024 [159]. - The cost of revenues increased by 70% to $1.6 million for the three months ended September 30, 2025, up from $1.0 million in 2024, primarily due to higher production costs and increased sales [161]. - Selling and marketing expenses rose by 12% to $15.3 million for the three months ended September 30, 2025, compared to $13.7 million in 2024, attributed to higher payroll and promotional costs [162]. - Research and development expenses decreased by 15% to $2.4 million for the three months ended September 30, 2025, down from $2.8 million in 2024, mainly due to reduced clinical trial costs [164]. - The company had an accumulated deficit of $66.7 million as of September 30, 2025, compared to $73.5 million as of December 31, 2024 [144]. - Revenues for the nine months ended September 30, 2025, were $79.4 million, a 2% increase from $77.9 million in 2024, driven by new product sales of Contiva® and Etorel® [171]. - Cost of revenues increased by $1.0 million, or 36%, to $3.7 million for the nine months ended September 30, 2025, primarily due to higher costs associated with Etorel® and Contiva® [173]. - Research and development expenses rose by $0.6 million, or 7%, to $8.9 million, mainly due to a $1.0 million increase in clinical trial costs [175]. - General and administrative expenses increased by $3.5 million, or 32%, to $14.1 million, driven by higher personnel and stock compensation costs [176]. - Net income attributable to common stockholders decreased by $5.4 million, or 45%, to $6.8 million for the nine months ended September 30, 2025 [170]. - Cash provided by operating activities was $6.6 million for the nine months ended September 30, 2025, compared to cash used of $0.9 million in 2024 [186]. - Cash provided by financing activities was $24.1 million, primarily from the issuance of common stock, for the nine months ended September 30, 2025 [191]. - The company expects continued revenue growth driven by the commercialization of Etorel® and Contiva® in 2025, alongside the growth of ETUARY® sales [160]. - The provision for income taxes increased to $1.7 million for the three months ended September 30, 2025, from $1.1 million in 2024, reflecting higher profits from operations [168]. - Other income for the three months ended September 30, 2025, was $0.7 million, compared to an expense of $0.1 million in 2024, primarily due to increased government grants [167]. Investments and Financing - On October 30, 2023, Catalyst Biosciences acquired an indirect controlling interest in Gyre Pharmaceuticals, increasing Gyre's indirect interest from 56.0% to 65.2% [133]. - BJC increased its capital contribution in Gyre Pharmaceuticals by $1.28 million in Q3 2025, raising Gyre's indirect interest to 69.7% [142]. - Gyre Pharmaceuticals entered into a private placement agreement with GNI USA for $5.0 million, involving the purchase of Series X Convertible Preferred Stock and warrants [140]. Future Commitments and Plans - The company expects revenue growth driven by the continued expansion of new product franchises [172]. - As of September 30, 2025, the company had cash and cash equivalents of $40.4 million, with an accumulated deficit of $66.7 million [181]. - The company anticipates initiating a Phase 2 trial for Hydronidone in 2026, pending approval of an IND submission [182]. - The company has committed to allocate $37.6 million toward future research and development activities, including the Hydronidone program [196]. - Commitments related to the purchase of property and equipment were $4.6 million as of September 30, 2025, expected to be incurred within one year [197]. - The company is committed to annual payments for the Etorel® IP Rights transferor over eight years following the commencement of commercial sales [198]. Regulatory and Reporting Status - There have been no significant changes to critical accounting policies and estimates compared to the previous Annual Report [199]. - The company qualifies as a "smaller reporting company" and can take advantage of scaled disclosures as long as certain market value and revenue thresholds are met [200]. - As of June 30, 2025, the company remains a smaller reporting company and continues to qualify as an "accelerated filer" under the Sarbanes-Oxley Act [201]. - The company is not required to provide quantitative and qualitative disclosures about market risk due to its status as a smaller reporting company [203].