Financial Performance - The company reported a net loss of $35,444,361 for the year ended December 31, 2025, compared to a net loss of $11,155,516 for the previous year, representing an increase of 217.5%[400] - Cash used in operating activities was $22,776,769 for the year ended December 31, 2025, compared to $10,247,231 for the previous year, indicating a significant increase in operational spending[425] - The company has an accumulated deficit of $64,348,118 as of December 31, 2025, compared to $28,903,903 at the end of 2024[411] - The company expects to continue incurring significant operating losses for the foreseeable future and may never become profitable[409] Operating Expenses - Total operating expenses for 2025 reached $34,359,302, a significant increase from $11,180,902 in 2024, representing a 208% rise[399] - Research and development (R&D) expenses increased by $4,193,650 or 118.9% for the year ended December 31, 2025, primarily due to increased clinical trial activity for SKNJCT-003, SKNJCT-004, and Teverelix[403] - General and administrative expenses rose by $10,267,275 or 134.2% for the year ended December 31, 2025, mainly due to increased salaries and wages from a higher headcount[401] Financing Activities - The Company raised $4.0 million from its initial public offering by selling 970,000 units at $4.125 per unit[388] - The Company completed a Regulation A Offering, raising $4.2 million from the sale of 1,490,000 units at $2.80 per unit[390] - Cash flows provided by financing activities were $31,939,785 for the year ended December 31, 2025, compared to $12,692,216 for the previous year, reflecting increased proceeds from equity offerings and other financing[426] - The company entered into a Standby Equity Purchase Agreement (SEPA) allowing it to sell up to $15,000,000 of common shares to Yorkville over 36 months, with conditions for execution[419] - The company has entered into an equity distribution agreement to sell up to $15.3 million of common shares as part of an at-the-market program[398] Clinical Studies - The SKNJCT-003 Phase 2 clinical study demonstrated more than 60% clinical clearance in an interim analysis after over 50% of the targeted 60 patients were randomized[376] - The Company has initiated a clinical study (SKNJCT-002) but ultimately closed it without further enrollment due to variability in array application, with no adverse events reported[374] - The Company received approval from the UAE Department of Health to commence clinical study SKNJCT-004, which will randomize 36 patients across four clinical sites[377] Acquisitions - The Company completed the acquisition of Antev for approximately $2.97 million in cash and 1,603,164 common shares, acquiring 98.6% of Antev's outstanding shares[378] - The company accounts for business combinations using the acquisition method, recording any excess purchase price over fair values of net assets as goodwill[434] - For asset acquisitions, costs are allocated to identifiable assets and liabilities based on relative fair values, with no goodwill recognized[435] Research and Development - Research and development costs are fully expensed as incurred, primarily consisting of salaries and clinical trial costs[437] - The company accrues estimated research and development costs based on services performed by third-party contractors and clinical trial sites[438] Stock and Shares - As of December 31, 2025, the company had 25,176,303 Common Shares outstanding, with an additional 2,505,000 shares issuable from stock options and 7,281,795 from warrants[444] - Stock-based compensation is expensed over the requisite service period based on estimated grant-date fair value, using the Black-Scholes model[442] Other - The Company incurred total issuance costs of $2.1 million related to its initial public offering, including underwriter fees and legal costs[389] - The company completed a Regulation A Offering of 1,490,000 units at $2.80 per unit, with 1,473,800 warrants exercised for proceeds of $4,126,639 during the year ended December 31, 2025[412] - Fair value measurements include cash and cash equivalents, with the fair value option elected for Initial Debentures, resulting in no gain or loss at issuance[440] - The Company entered into a non-binding memorandum of understanding with Helix Nanotechnologies to develop an advanced mRNA platform[380]
Medicus Pharma Ltd(MDCX) - 2025 Q4 - Annual Report