Research and Development - The company reported a total research and development expense of $7.9 million for the three months ended June 30, 2024, compared to $9.5 million for the same period in 2023, reflecting a decrease of approximately 16.5%[96] - PIPE-791, the lead asset, is in development for idiopathic pulmonary fibrosis (IPF) and progressive multiple sclerosis (Progressive MS), with plans to submit a clinical trial application for a Phase 1b trial in 2024[82] - PIPE-307, the second drug candidate, has completed two Phase 1 trials and has initiated a Phase 2 trial for relapse-remitting multiple sclerosis (RRMS), making it the most clinically advanced selective M1R antagonist[83] - The company anticipates that its research and development expenses will increase substantially in connection with planned preclinical and clinical development activities[98] - The company has incurred direct external development program expenses of $2.3 million for PIPE-307 in the first half of 2024, compared to $1.3 million in the same period of 2023, indicating an increase of approximately 75%[96] - The company is leveraging its drug discovery capabilities and has commenced preclinical studies for CTX-343, a peripherally-restricted LPA1R antagonist targeting other NI&I indications[84] - Research and development expenses decreased to $7.9 million for the three months ended June 30, 2024, from $9.5 million in 2023, a reduction of $1.6 million[104] - Research and development expenses for the six months ended June 30, 2024, were $15.7 million, up from $13.1 million in 2023, an increase of $2.6 million[111] Financial Performance - License revenue for the three months ended June 30, 2024, was $0, compared to $50.0 million for the same period in 2023, resulting in a decrease of $50.0 million[103] - The net loss for the three months ended June 30, 2024, was $9.0 million, compared to a net income of $41.6 million for the same period in 2023, a decrease of $50.6 million[103] - For the six months ended June 30, 2024, license revenue was $0, down from $50.0 million in 2023, a decrease of $50.0 million[110] - Interest income rose to $2.0 million for the three months ended June 30, 2024, compared to $0.7 million in 2023, an increase of $1.3 million[106] - General and administrative expenses increased to $3.0 million for the three months ended June 30, 2024, from $1.6 million in 2023, an increase of $1.4 million[105] Cash Flow and Financing - As of June 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $218.7 million[116] - The company raised approximately $107.9 million in net proceeds from its IPO in April 2024[115] - Net cash used in operating activities was $16.5 million for the six months ended June 30, 2024, compared to $35.4 million provided in the same period of 2023[120] - Net cash used in investing activities was $30.2 million for the six months ended June 30, 2024, primarily due to $99.6 million in purchases of marketable securities[121] - Net cash provided by financing activities was $108.3 million for the six months ended June 30, 2024, mainly from $108.2 million in net proceeds from the issuance of common stock in the IPO[122] - The company expects to finance operations through public and private sales of equity, debt financings, or other commercial arrangements, but there is no assurance that additional financing will be available on acceptable terms[86] - The company may finance cash needs through public or private equity or debt financings, which could dilute existing stockholders' ownership[126] Future Outlook - Total operating expenses are expected to significantly increase as the company continues to develop its drug candidates and expand operations[85] - The company expects to incur substantial expenditures as it advances its drug candidates through clinical development and regulatory approval processes[114] - The company anticipates that existing cash, cash equivalents, and marketable securities will be sufficient to support operations for at least 12 months from the date of the report[123] - Future capital requirements will depend on the progress and costs of clinical trials and regulatory reviews[124] Licensing and Agreements - The company received an upfront payment of $50 million from Johnson & Johnson (J&J) in May 2023 as part of the licensing agreement for PIPE-307, with potential milestone payments totaling approximately $1 billion[91] - The J&J License Agreement allows for tiered royalties in the low-double digit to high-teen percent range on net sales of products containing PIPE-307[91] Company Classification - The company is classified as an "emerging growth company" and a "smaller reporting company," allowing it to take advantage of scaled disclosures[131][132] - There were no off-balance sheet arrangements during the periods presented[128]
Contineum Therapeutics, Inc.(CTNM) - 2024 Q2 - Quarterly Report