Edesa Biotech(EDSA) - 2023 Q3 - Quarterly Report

Financial Performance - Total operating expenses decreased by $3.74 million to $2.06 million for the three months ended June 30, 2023, compared to $5.80 million for the same period last year[87] - Net loss for the three months ended June 30, 2023, was $1.98 million, or $0.10 per common share, compared to a net loss of $5.79 million, or $0.37 per common share, for the same period last year[88] - Total operating expenses decreased by $8.68 million to $6.85 million for the nine months ended June 30, 2023, compared to $15.53 million for the same period last year[89] - Net loss for the nine months ended June 30, 2023, was $6.65 million, or $0.34 per common share, compared to a net loss of $14.74 million, or $1.04 per common share, for the same period last year[90] - As of June 30, 2023, the company had cash and cash equivalents of $6.46 million, working capital of $5.39 million, and shareholders' equity of $7.85 million, with an accumulated deficit of $50.70 million[98] Research and Development - Research and development expenses decreased by $3.52 million to $1.03 million for the three months ended June 30, 2023, compared to $4.55 million for the same period last year[87] - Research and development expenses for the nine months ended June 30, 2023, were $3.84 million, a decrease from $11.54 million in the same period of 2022, primarily due to reduced external research expenses[100] - Research and development activities focus on innovative therapeutics for inflammatory and immune-related diseases, with costs incurred as activities progress[99] - The fluctuation in research and development costs is influenced by study initiation expenses and patient recruitment rates, expected to continue varying significantly[100] Clinical Trials and Regulatory Affairs - The company plans to increase the number of investigational centers from 23 to up to 60 hospitals in the U.S. and Canada for clinical trials[83] - The FDA granted Fast Track designation for the drug candidate EB05 based on significant mortality reductions observed in a Phase 2 study[78] - The company is preparing for an End of Phase 2 meeting with the FDA for the drug candidate EB01 following positive preliminary results[79] Financing and Funding - The company has entered into an equity distribution agreement for up to $20 million in gross cash proceeds, with $0.69 million net proceeds from sales in the three months ended June 30, 2023[93] - Under a contribution agreement with the Canadian government's Strategic Innovation Fund, the company was eligible to receive cash reimbursements up to approximately $11 million USD for certain R&D expenses[97] - The company plans to finance operations over the next twelve months through cash on hand and equity sales, with potential additional financing from government grants, debt, or strategic transactions[98] - Market volatility, inflation, interest rates, and geopolitical concerns may significantly impact the availability and terms of funding sources[98] Miscellaneous - The company does not have any off-balance sheet arrangements that could materially affect its financial condition or operations[101] - As a smaller reporting company, the company is not required to provide disclosures regarding market risk[102]