Mergers and Acquisitions - The company completed a merger with Adgero Biopharmaceuticals Holdings, resulting in the conversion of Adgero common stock into 1.5740 shares of the company's common stock[120]. - The company incurred merger costs of $500,000 during the nine months ended March 31, 2021[228]. - The company recognized an expense of $16,094,000 for acquired in-process research and development assets in connection with the Adgero merger[247]. Financial Performance - The net loss for the period attributable to common stockholders for the nine months ended March 31, 2021 was $34,768,000, compared to $5,315,000 for the same period in 2020[228]. - The net loss for the three months ended March 31, 2021, was $6,635,000, up from $1,957,000 for the same period in 2020, reflecting an increase of 239%[232]. - The net loss for the nine months ended March 31, 2021, was $31,566,000, compared to $5,303,000 for the same period in 2020, an increase of 496%[250]. - Total cash and cash equivalents increased from $2,392,000 in June 30, 2020 to $15,718,000 in March 31, 2021[226]. - Cash flows from operating activities decreased to $(14,171,000) for the nine months ended March 31, 2021, from $(5,350,000) for the same period in 2020, a 165% increase in cash used[249]. - Total stockholders' equity increased from $263,000 in June 30, 2020 to $16,118,000 in March 31, 2021[226]. Research and Development - The company has two ongoing Phase 2 studies for VAL-083 targeting MGMT-unmethylated GBM, with a focus on patients resistant to standard treatments[137]. - VAL-083 is being evaluated in the GBM AGILE Study, which is an adaptive clinical trial for glioblastoma, and is the only therapeutic agent assessed in all three GBM patient subtypes[139]. - The company announced positive data updates from ongoing Phase 2 clinical studies for GBM at the AACR Annual Meeting[125]. - VAL-083 has received orphan drug designation from the FDA for the treatment of ovarian cancer, gliomas, and medulloblastoma[144]. - The company is focused on developing anti-cancer therapies for patients with solid tumors that are resistant to current treatments, particularly in orphan cancer indications[122]. - The company plans to conduct a Phase 3 clinical study for REM-001 Therapy following initial open-label studies to confirm dosing[193]. Clinical Trials and Results - The Phase 2 study of VAL-083 in newly-diagnosed MGMT-unmethylated GBM patients reported a median progression-free survival (PFS) of 9.3 months[156]. - The median overall survival (mOS) for 83 efficacy evaluable patients in the recurrent GBM study was reported at 7.5 months[166]. - For the 48 efficacy evaluable patients receiving the intended treatment dose of 30 mg/m2/day, the mOS was 7.9 months[166]. - The Phase 2 studies showed a tumor response rate of 33% ± 37% for study CA008 and 39% ± 47% for study CA009, both achieving statistical significance (p < 0.001)[213]. - Clinical Success rates for studies CA008 and CA009 were 60% and 50% respectively, with confidence intervals of 39%-81% and 28%-72%[215]. - In studies CA013 and CA019, Clinical Success rates were 88% and 83% respectively, with confidence intervals of 71%-97% and 45%-86%[216]. Regulatory Designations - The FDA has granted Fast Track designation for VAL-083 in recurrent GBM, which may expedite the review process and increase access for patients[167][168]. - The FDA granted orphan drug designation for tin ethyl etiopurpurin (REM-001's active ingredient) for treatment of Basal Cell Carcinoma Nevus Syndrome (BCCNS)[194]. Financial Management and Expenses - Research and development expenses for the three months ended March 31, 2021 were $3,843,000, compared to $899,000 for the same period in 2020[227]. - General and administrative expenses rose to $2,762,000 for the three months ended March 31, 2021, compared to $1,077,000 for the same period in 2020, marking a 156% increase[236]. - For the nine months ended March 31, 2021, research and development expenses totaled $7,784,000, compared to $2,332,000 for the same period in 2020, a 234% increase[240]. - General and administrative expenses for the nine months ended March 31, 2021, were $7,091,000, up from $3,045,000 for the same period in 2020, indicating a 133% increase[243]. Strategic Direction - The company is evaluating options for strategic direction, including potential acquisitions and raising additional capital[146]. - The company has established a strategic partnership with GCAR for the GBM AGILE trial, which aims to expedite the discovery of effective therapies for glioblastoma[141]. Safety and Efficacy - REM-001 has been safely administered to over 1,100 patients in prior clinical studies, indicating a strong safety profile[204]. - Myelosuppression, particularly thrombocytopenia, is the main dose-limiting toxicity associated with VAL-083, but modern medicine allows for better management of these side effects[184]. - VAL-083's anti-tumor mechanism is active independent of MGMT status, suggesting its potential as a new standard-of-care treatment for GBM[150]. - VAL-083 demonstrated activity against MGMT-unmethylated GBM cells resistant to temozolomide, indicating potential for treating resistant tumors[182].
Kintara Therapeutics(KTRA) - 2021 Q3 - Quarterly Report