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].

Drug Development and Designation - Kintara Therapeutics received Orphan Drug Designation from the FDA for VAL-083 for the treatment of DIPG, a rare childhood brain cancer [82]. - VAL-083 has been designated as an orphan drug by both the FDA and EMA for the treatment of gliomas, including GBM [87]. - Kintara is evaluating the potential combination of VAL-083 with PARP inhibitors for ovarian cancer, for which it has also received orphan drug designation [86]. - VAL-083 has demonstrated activity against various tumor types in prior Phase 1 and Phase 2 clinical studies sponsored by the NCI, leveraging data from over 40 studies [83]. - The GBM AGILE Study employs a cost-efficient, adaptive study design, allowing multiple therapies to be evaluated simultaneously [91]. - Kintara anticipates topline results from the GBM AGILE Study for VAL-083 around the end of Q4 2023 [83]. - The GBM AGILE Study has screened over 1,300 patients, with enrollment rates 3 to 4 times greater than traditional GBM studies [90]. - VAL-083 has shown activity against MGMT-unmethylated GBM cells resistant to TMZ and nitrosoureas, and retains high activity in p53 mutated NSCLC, ovarian cancer, and medulloblastoma [99]. - In clinical studies, REM-001 Therapy achieved a complete response in approximately 80% of evaluable tumor sites in CMBC patients [101]. - VAL-083 and REM-001 have received Fast Track Designations from the FDA for their respective indications [106]. Financial Performance and Strategy - As of December 31, 2022, cash and cash equivalents were $4.874 million, down from $11.780 million on June 30, 2022 [113]. - For the three months ended December 31, 2022, the net loss was $3.454 million, compared to a net loss of $5.893 million for the same period in 2021 [115]. - Research and development expenses for the six months ended December 31, 2022, were $5.230 million, down from $7.695 million in 2021 [116]. - Total assets decreased from $15.948 million on June 30, 2022, to $9.917 million on December 31, 2022 [113]. - Research and development expenses decreased to $2,059 for the three months ended December 31, 2022, from $3,902 for the same period in 2021, a reduction of 47% [121]. - General and administrative expenses were $1,440 for the three months ended December 31, 2022, compared to $1,993 for the same period in 2021, a decrease of 28% [121]. - Net loss for the three months ended December 31, 2022, was $3,454, an improvement of 41% compared to a net loss of $5,893 for the same period in 2021 [121]. - For the six months ended December 31, 2022, research and development expenses decreased to $5,230 from $7,695 in the same period in 2021, a decline of 32% [126]. - General and administrative expenses for the six months ended December 31, 2022, were $2,915, down from $4,171 in the same period in 2021, a decrease of 30% [130]. - Net cash used in operating activities decreased to $8,530 for the six months ended December 31, 2022, from $10,177 for the same period in 2021, a reduction of 16% [132]. - The company reported an accumulated deficit of $144,772 and cash and cash equivalents of $4,874 as of December 31, 2022 [136]. - The company paused the REM-001 program to conserve cash for the development of VAL-083, indicating a strategic shift in resource allocation [124]. - Management is pursuing various financing alternatives to fund operations, including issuing new equity and entering strategic partnerships [137]. - The company has not generated any revenues to date and does not expect to achieve revenues until product candidates are commercialized or partnered [136]. - The company expects to finance future cash needs primarily through public or private equity and debt offerings, and/or strategic collaborations [139]. - If additional funding is not secured, the company may have to delay, reduce, or eliminate clinical trials or research and development programs [139]. Clinical Program Updates - The company paused the REM-001 program to conserve cash, expecting to save approximately $3.0 million through calendar 2023 [82]. - Avastin received full approval in the US, Canada, Australia, and Japan for recurrent GBM, but has a "black-box warning" for severe side effects [97]. - The median survival for GBM patients whose tumors progress after Avastin treatment is less than five months [98]. Accounting and Expense Recognition - The company recognizes compensation costs from stock-based awards over the service period based on fair value measurements [142]. - For the six months ended December 31, 2022, the company utilized the Black-Scholes model to estimate grant-date fair value for stock option awards [142]. - The company estimates expenses for clinical trials based on contracts with vendors and adjusts clinical expense recognition if actual results differ from estimates [143]. - There were no material adjustments to prior period estimates of accrued expenses for clinical trials for the six months ended December 31, 2022, and 2021 [143]. - The company does not have any off-balance sheet arrangements [144].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to (Registrant's telephone number, including area code) Commission file number: 001-37823 Kintara Therapeutics, Inc. (Exact name of registrant as specified in i ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D. C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from Commission file number 001-37823 Kintara Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) ...

(Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q For the transition period from to Commission file number: 001-37823 Kintara Therapeutics, Inc. (Exact name of registrant as specified in its charter) | Nevada | 99-0360497 | | --- | --- | | (Stat ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2021 or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37823 Kintara Therapeutics, Inc. (Exact name of registrant as specified in its charter) | Nevada | 99-0360497 | | --- | --- | | (S ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37823 Kintara Therapeutics, Inc. (Exact name of registrant as specified in its charter) | Nevada | 99-0360497 | | --- | --- | | ( ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D. C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from Commission file number 001-37823 Kintara Therapeutics, Inc. (Exact name of registrant as specified in its charter) | Nevada | 99-0360497 | | --- | --- | | (State or other jurisdi ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37823 Kintara Therapeutics, Inc. (Exact name of registrant as specified in its charter) | Nevada | 99-0360497 | | --- | --- | | (Stat ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2020 or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Kintara Therapeutics, Inc. (Exact name of registrant as specified in its charter) | Nevada | 99-0360497 | | --- | --- | | (State or other jurisdiction of | (I.R.S. Employer | | incorporation o ...