Artelo Biosciences(US:ARTL)2025-11-12 13:01Clinical Development - The company is developing a dual cannabinoid agonist, ART27.13, for cancer-related anorexia, currently in Phase 1b/2a trials, with 32 participants enrolled as of June 30, 2025[104][110]. - Interim results from the Phase 2a CAReS trial showed a mean body weight increase of 6.38% in the ART27.13 group compared to a -5.42% decrease in the placebo group after 12 weeks[110]. - The company received FDA clearance for ART26.12, targeting chemotherapy-induced peripheral neuropathy, with first-in-human studies completed in April 2025[105][113]. - ART26.12 demonstrated a favorable safety profile in a Phase 1 study with no drug-related serious adverse events reported among 49 subjects[105][111]. - The company has a pipeline that includes ART12.11, a patented CBD cocrystal, which may be considered a fixed drug combination by regulatory authorities[106]. - The company has licensed rights to FABP5 inhibitors from Stony Brook University, with preclinical evidence supporting their use in multiple pain models[112][113]. - The company aims to address significant unmet needs in treating chemotherapy-induced peripheral neuropathy, as there are currently no approved treatments in the U.S., UK, or EU[113]. - The company’s clinical programs leverage lipid-signaling modulation pathways, targeting unmet healthcare needs in oncology and pain management[103][104]. - The company plans to develop its synthetic CBD cocrystal for multiple indications, including anxiety disorders, PTSD, and depression[115]. Financial Performance - The company has not generated any revenue to date and may not do so in the near future[127]. - Operating expenses for the three months ended September 30, 2025, were $3.1 million, an increase of $1.9 million compared to $1.2 million for the same period in 2024[131]. - For the nine months ended September 30, 2025, total operating expenses were $8.6 million, up $2.3 million from $6.3 million in the same period in 2024[133]. - The net loss for the nine months ended September 30, 2025, was $8.7 million, compared to a net loss of $6.0 million for the same period in 2024[135]. - The company has not generated any revenue to date and anticipates substantial increases in expenses and capital requirements due to ongoing research and development activities[145]. - The company faces significant uncertainty regarding its ability to continue as a going concern without raising additional funds[144]. - Working capital as of September 30, 2025, was $(3.0) million, a decrease of $3.8 million from the previous year[149]. - Cash used in operating activities was $5.6 million for the nine months ended September 30, 2025, compared to $5.8 million for the same period in 2024, with a net loss of $8.7 million[152]. - Cash flows provided by financing activities were $5.3 million for the nine months ended September 30, 2025, compared to $0.1 million in 2024, driven by proceeds from common shares and convertible notes[155]. Funding and Capital Structure - The company closed an underwritten offering on October 1, 2025, raising approximately $2 million through the sale of 441,210 shares of common stock at $4.40 per share[117]. - The company issued convertible notes with gross proceeds of $0.9 million on May 1, 2025, bearing interest at 12%[138]. - The company has committed to using $250,000 to acquire Solana's native token, SOL, as part of its digital asset treasury strategy[119]. - The company entered into an At-The-Market Offering Agreement to sell up to $6.5 million of common stock, with 50,858 shares sold for net proceeds of $0.4 million during the quarter ended September 30, 2025[141]. - A securities purchase agreement for an at-the-market PIPE was initiated for the purchase of 906,687 shares at $10.45, expected to raise approximately $9.5 million, but was terminated on August 19, 2025[142]. - An Underwriting Agreement was executed for an offering of 640,924 shares at $4.40 per share, resulting in gross proceeds of approximately $3.0 million and net proceeds of $2.9 million after expenses[143]. Assets and Liabilities - As of September 30, 2025, the company had cash and cash equivalents of $1.7 million[135]. - Current assets decreased from $2.6 million as of December 31, 2024, to $1.8 million as of September 30, 2025, primarily due to funding operating activities[149]. - Current liabilities increased significantly from $1.8 million to $4.9 million during the same period, attributed to a cash preservation strategy[150]. - The company has two U.S. patents and six foreign patents related to its proprietary cocrystal composition of CBD, which is expected to provide long-lasting market exclusivity[115]. Accounting and Compliance - Stock-based compensation expense is recognized over the requisite service period, estimated using the Black-Scholes option pricing model[166]. - The fair value of equity awards is influenced by variables such as risk-free interest rate and expected stock price volatility[166]. - No new accounting standards were adopted during the nine months ended September 30, 2025[168].