CNS Pharmaceuticals(US:CNSP)2025-11-14 22:10Financial Performance - General and administrative expenses decreased to approximately $1,057,000 for the three months ended September 30, 2025, down from approximately $1,384,000 in the same period in 2024, reflecting a reduction of about 23.5%[70] - Research and development expenses were approximately $2,197,000 for the three months ended September 30, 2025, compared to approximately $4,245,000 in the same period in 2024, indicating a decline of about 48.3%[71] - The net loss for the three months ended September 30, 2025, was approximately $3,218,000, a reduction from approximately $5,606,000 in the comparable period in 2024, representing a decrease of about 42.5%[72] - General and administrative expenses decreased to approximately $3,394,000 for the nine months ended September 30, 2025, down from approximately $3,910,000 in 2024, reflecting a reduction of about 13.2%[73] - Research and development expenses were approximately $6,607,000 for the nine months ended September 30, 2025, compared to approximately $7,792,000 in 2024, a decrease of about 15.2%[74] - The net loss for the nine months ended September 30, 2025, was approximately $9,895,000, an improvement from a net loss of approximately $11,681,000 in 2024, representing a reduction of about 15.3%[75] - Net cash used in operating activities was approximately $10,759,000 for the nine months ended September 30, 2025, compared to $11,642,000 in 2024, a decrease of about 7.6%[80] - Net cash provided by financing activities was approximately $14,162,000 for the nine months ended September 30, 2025, compared to $18,067,000 in 2024, a decrease of about 21.7%[81] Cash and Working Capital - As of September 30, 2025, the company had cash of approximately $9,864,000 and working capital of approximately $9,447,000[76] - The company estimates sufficient working capital to last into the second half of 2026, based on an annual core operations expense run rate of approximately $5.5 million[79] - The company has no commitments for additional financing and may need to raise funds through the sale of equity or debt securities to support operations[79] Research and Development - The decrease in research and development expenses was primarily due to a decline of approximately $1,628,000 in trial costs for the Berubicin trial[71] - The estimated cost for the TPI 287 trial is projected to be between $12 million and $15 million, subject to final trial design[79] Clinical Trials and Drug Development - TPI 287 has been granted Orphan Drug Designation by the FDA, potentially providing market exclusivity of 7 years upon approval of a New Drug Application[61] - Berubicin's clinical trial for Glioblastoma Multiforme involved 252 patients, with a 2 to 1 randomization to Berubicin or Lomustine, and the trial design included a pre-planned interim futility analysis[65] - The first patient in the Berubicin trial was treated during the third quarter of 2021, with overall survival as the primary endpoint recognized by the FDA for oncology drug approval[64] - The company is exploring additional intellectual property rights for compounds to develop drugs for brain and other cancers, contingent on securing further financing[68] Licensing and Manufacturing - The company entered into an Exclusive License Agreement with Cortice for TPI 287, covering the United States, Canada, Mexico, and Japan, with the license term expiring after ten years from the first commercial sale[69] - The company does not have manufacturing facilities and outsources all manufacturing activities to third parties[66]