ESSA Pharma (US:EPIX)2022-05-10 11:00Financial Performance - Net loss for the period before taxes was $10,854,604 for the three months ended March 31, 2022, compared to a loss of $12,965,247 for the same period in 2021, indicating an improvement of about 16.3%[28] - Basic and diluted loss per common share improved from $(0.36) in Q1 2021 to $(0.25) in Q1 2022[28] - The company reported a comprehensive loss of $10,903,335 for the three months ended March 31, 2022, compared to a loss of $12,965,247 for the same period in 2021, indicating a reduction in losses[212] - ESSA's net losses for the six months ended March 31, 2022, were $20,001,254, compared to $19,493,951 for the same period in 2021, indicating ongoing financial challenges[195] Assets and Liabilities - Total assets decreased from $198,165,818 as of September 30, 2021, to $182,609,005 as of March 31, 2022, representing a decline of approximately 7.85%[22] - Total liabilities decreased from $4,160,266 as of September 30, 2021, to $3,894,071 as of March 31, 2022, a decrease of approximately 6.4%[22] - Shareholders' equity decreased from $194,005,552 as of September 30, 2021, to $178,714,934 as of March 31, 2022, a decline of approximately 7.8%[22] - Working capital as of March 31, 2022, was $178,353,354, down from $206,202,601 a year earlier[197] - Current liabilities stood at $3,748,803 as of March 31, 2022, a decrease from $3,929,663 on September 30, 2021[217] Cash Flow - Cash and cash equivalents decreased from $137,825,024 to $86,235,830, a reduction of about 37.4%[22] - Cash used in operating activities for the six months ended March 31, 2022, was $14,204,791, compared to $11,515,058 for the same period in 2021, an increase of about 23.3%[30] - Net cash used in investing activities for the six months ended March 31, 2022, was $37,625,805, compared to $35,003,478 for the same period in 2021, an increase of approximately 7.5%[30] - Available cash reserves and short-term investments were $181,018,439 as of March 31, 2022, compared to $194,927,183 on September 30, 2021[217] Research and Development - Research and development expenses for the three months ended March 31, 2022, were $7,649,459, compared to $7,268,257 for the same period in 2021, an increase of approximately 5.2%[28] - Research and development (R&D) expenses for the six months ended March 31, 2022, totaled $13,669,218, up from $11,754,029 in the same period of 2021, reflecting ongoing clinical trials[199] - The company recognized research and development expenses of $1,113,376 for the three months ended March 31, 2022, compared to $782,846 for the same period in 2021, reflecting a 42.3% increase[79] - The company has no products in commercial production or use as of March 31, 2022[35] Clinical Trials and Product Development - The company’s investigational compound EPI-7386 is designed to disrupt the androgen receptor signaling pathway, which is crucial for prostate cancer growth[94] - The company has completed a Phase I clinical trial of its first-generation agent, ralaniten acetate (EPI-506), which showed prostate-specific antigen declines, although not sufficient for clinical benefit[95] - The Phase I clinical trial of EPI-7386 began in June 2020, with the first patient dosed in July 2020, and is currently actively enrolling patients[114] - The Phase 1 part of the clinical trial evaluates safety and tolerability to establish recommended doses for EPI-7386 and enzalutamide[192] Intellectual Property and Collaborations - The Company has developed a strong intellectual property position with 48 issued patents, including 5 covering EPI-7386, expected to provide protection until 2036 to 2041[107] - The Company retains all commercial rights for its aniten series drug portfolio and is evaluating potential collaborations to enhance the value of its prostate cancer program[141] - The Company has initiated collaborations with Janssen, Astellas, and Bayer to evaluate EPI-7386 in combination with existing antiandrogens in clinical trials[116] Future Outlook and Financial Needs - The company believes it has sufficient capital to meet its obligations for more than twelve months[217] - Future cash requirements may vary due to costs associated with preclinical work and strategic opportunities[219] - The company may need to raise additional funds in the future through strategic collaborations or share issuances[219] - There is no assurance that the company will successfully raise funds to continue its operational activities[219]