Company Overview - Kintara Therapeutics, Inc. is focused on developing novel cancer therapies, particularly for drug-resistant solid tumors like glioblastoma and ovarian cancer[78]. - The company has two lead candidates: VAL-083, a DNA-targeting agent, and REM-001, a photodynamic therapy for cutaneous metastatic breast cancer, with the latter program paused to conserve cash[79]. Clinical Trials and Studies - The GBM AGILE Study, an international Phase 2/3 clinical study for VAL-083, is ongoing at 39 clinical sites in the U.S., four in Canada, and two in Europe, with over 1,300 patients screened[90]. - Topline results from the GBM AGILE Study are expected by the end of Q4 2023, following the last patient randomization[81]. - VAL-083 has shown anti-tumor activity independent of MGMT expression, which is significant as over 60% of GBM patients have MGMT-unmethylated tumors[84]. - The GBM AGILE Study employs a cost-efficient, adaptive design, with enrollment rates 3 to 4 times greater than traditional studies[90]. - VAL-083 demonstrated activity in cell lines resistant to other chemotherapy types, with no reported cross-resistance in clinical studies[99]. - In clinical studies, approximately 80% of evaluable tumor sites treated with REM-001 Therapy showed a complete response in CMBC patients[101]. Financial Performance - As of March 31, 2023, cash and cash equivalents were $3,045,000, down from $11,780,000 on June 30, 2022[112]. - For the three months ended March 31, 2023, the net loss attributable to common stockholders was $3,266,000, compared to $5,358,000 for the same period in 2022[114]. - Research and development expenses for the nine months ended March 31, 2023, were $7,235,000, a decrease from $11,169,000 in the same period in 2022[115]. - Total assets decreased from $15,948,000 on June 30, 2022, to $6,740,000 on March 31, 2023[112]. - The company has a basic and fully diluted loss per share of $(1.94) for the three months ended March 31, 2023, compared to $(5.45) for the same period in 2022[114]. - Net loss for the three months ended March 31, 2023, was $(3,264), an improvement of $2,092 compared to a net loss of $(5,356) for the same period in 2022[119]. - For the nine months ended March 31, 2023, the company reported a net loss of $(11,314) compared to $(17,215) for the same period in 2022, an improvement of $5,901[127]. Cost Management and Strategic Direction - The company expects to save approximately $3.0 million through calendar 2023 by pausing the REM-001 program to conserve cash[105]. - Kintara is evaluating options for strategic direction, including raising additional capital and potential acquisitions[89]. - The company is pursuing various financing alternatives to fund operations and has paused the REM-001 program to conserve cash for the VAL-083 clinical study[134]. - The company expects to finance future cash needs primarily through public or private equity and debt offerings, and/or strategic collaborations[136]. - If additional funding is not secured, the company may have to delay or reduce the scope of clinical trials or research and development programs[136]. Research and Development Expenses - Research and development expenses decreased to $2,005 for the three months ended March 31, 2023, from $3,474 for the same period in 2022, a reduction of 42%[119]. - General and administrative expenses were $1,297 for the three months ended March 31, 2023, compared to $1,884 for the same period in 2022, a decrease of 31%[119]. - General and administrative expenses for the nine months ended March 31, 2023, were $4,212, compared to $6,055 for the same period in 2022, a reduction of 30%[127]. - Net cash used in operating activities decreased to $(10,357) for the nine months ended March 31, 2023, from $(15,400) for the same period in 2022, a change of 33%[129]. Regulatory Designations - The FDA has granted orphan drug designation for VAL-083 in the treatment of gliomas, including GBM, medulloblastoma, and ovarian cancer[87]. - The FDA granted Fast Track Designation for both VAL-083 in recurrent and newly-diagnosed unmethylated GBM and for REM-001 in CMBC[106]. Compensation and Expense Recognition - The company recognizes compensation costs from stock-based awards over the service period based on fair value measurements[140]. - For the nine months ended March 31, 2023, the company utilized the Black-Scholes model to estimate grant-date fair value for stock option awards[140]. - The company estimates expenses related to clinical trials based on contracts with vendors and adjusts clinical expense recognition as actual results differ from estimates[141]. - There were no material adjustments to prior period estimates of accrued expenses for clinical trials for the nine months ended March 31, 2023, and 2022[141]. - The company does not have any off-balance sheet arrangements[142].
TuHURA Biosciences, Inc.(HURA) - 2023 Q3 - Quarterly Report