[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20-%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements.) The company's interim statements show a significant net loss and negative cash flow, raising substantial doubt about its going concern status Condensed Consolidated Interim Balance Sheet Highlights (in thousands) | Account | March 31, 2023 | June 30, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $3,045 | $11,780 | | Total current assets | $6,016 | $13,258 | | Total assets | $6,740 | $15,948 | | **Liabilities & Equity** | | | | Total current liabilities | $2,790 | $3,990 | | Total liabilities | $2,954 | $4,153 | | Total stockholders' equity | $3,786 | $11,795 | Condensed Consolidated Interim Statements of Operations Highlights (in thousands) | Metric | Three months ended Mar 31, 2023 | Nine months ended Mar 31, 2023 | | :--- | :--- | :--- | | Research and development | $2,005 | $7,235 | | General and administrative | $1,297 | $4,212 | | Net loss for the period | $(3,264) | $(11,314) | | Net loss attributable to common stockholders | $(3,266) | $(11,682) | | Basic and fully diluted loss per share | $(1.94) | $(7.32) | - The company's financial condition indicates **substantial doubt about its ability to continue as a going concern**, with a **loss of $11.3 million** and **negative cash flow from operations of $10.4 million**[27](index=27&type=chunk) - On November 10, 2022, the company executed a **1-for-50 reverse stock split** of its common stock, and all per-share data has been retrospectively restated[30](index=30&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Management discusses its focus on cancer therapies, decreased operating expenses, and critically low liquidity reinforcing the going concern risk [Product Pipeline and Corporate Strategy](index=19&type=section&id=Product%20Pipeline%20and%20Corporate%20Strategy) The strategy centers on advancing the lead GBM drug VAL-083 while pausing the REM-001 program to conserve cash and exploring strategic options - The company's two lead candidates are **VAL-083 for glioblastoma (GBM)** and **REM-001 for cutaneous metastatic breast cancer (CMBC)**[92](index=92&type=chunk) - The REM-001 program was paused to conserve cash resources, with an expected savings of approximately **$3.0 million through calendar 2023**[132](index=132&type=chunk) - Topline results for the **VAL-083 GBM AGILE Study** are expected around the end of the fourth quarter of calendar 2023[94](index=94&type=chunk)[105](index=105&type=chunk) - The company is evaluating strategic options which may include raising additional capital, acquiring another company or assets, a sale, or other strategic partnerships[103](index=103&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) Operating expenses decreased significantly year-over-year due to lower clinical development costs and reduced personnel expenses Comparison of Expenses for the Three Months Ended March 31 (in thousands) | Expense Category | 2023 | 2022 | Change $ | Change % | | :--- | :--- | :--- | :--- | :--- | | Research and development | $2,005 | $3,474 | $(1,469) | (42%) | | General and administrative | $1,297 | $1,884 | $(587) | (31%) | Comparison of Expenses for the Nine Months Ended March 31 (in thousands) | Expense Category | 2023 | 2022 | Change $ | Change % | | :--- | :--- | :--- | :--- | :--- | | Research and development | $7,235 | $11,169 | $(3,934) | (35%) | | General and administrative | $4,212 | $6,055 | $(1,843) | (30%) | - The decrease in R&D expenses was largely due to **lower clinical development costs** for the GBM AGILE Study and the pausing of the REM-001 program[148](index=148&type=chunk)[149](index=149&type=chunk)[154](index=154&type=chunk) - The decrease in G&A expenses was mainly a result of **lower non-cash, share-based compensation** and a reduction in personnel costs[150](index=150&type=chunk)[155](index=155&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) The company's precarious financial position, with only $3.0 million in cash, creates substantial doubt about its ability to continue as a going concern Cash Flow Summary for the Nine Months Ended March 31 (in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(10,357) | $(15,400) | | Net cash used in investing activities | $(232) | $0 | | Net cash provided by financing activities | $1,854 | $13,702 | - As of March 31, 2023, the company had **cash and cash equivalents of $3.0 million** and an **accumulated deficit of $148.0 million**[164](index=164&type=chunk) - The company received approximately **$1.86 million in net proceeds** from a stock purchase agreement, which is the maximum amount currently available under the agreement due to Nasdaq ownership limitations[161](index=161&type=chunk)[164](index=164&type=chunk) - The company's financial state indicates **substantial doubt about its ability to continue as a going concern**, and it will require additional funding to maintain operations[164](index=164&type=chunk)[165](index=165&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) This section is not applicable as the company qualifies as a smaller reporting company - Disclosure is not required for a smaller reporting company[175](index=175&type=chunk) [Item 4. Controls and Procedures](index=32&type=section&id=Item%204%20Controls%20and%20Procedures.) Disclosure controls and procedures were deemed effective, with no material changes to internal controls over financial reporting during the quarter - The company's disclosure controls and procedures were evaluated and **found to be effective** as of the end of the period covered by the report[176](index=176&type=chunk) - **No material changes** to the company's internal control over financial reporting were identified during the quarter ended March 31, 2023[178](index=178&type=chunk) [PART II - OTHER INFORMATION](index=33&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings.) The company reports that it is not a party to any legal proceedings, nor is any of its property subject to such proceedings - The company is **not party to any legal proceedings**[181](index=181&type=chunk) [Item 1A. Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors.) No material changes to the risk factors previously disclosed in the company's Annual Report have been reported - **No material changes** to risk factors were reported since the last Annual Report on Form 10-K[182](index=182&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=33&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) The company reported no unregistered sales of equity securities during the period - None reported[183](index=183&type=chunk) [Item 3. Defaults Upon Senior Securities](index=33&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities.) The company reported no defaults upon senior securities - None reported[184](index=184&type=chunk) [Item 4. Mine Safety Disclosures](index=33&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This item is not applicable to the company - Not applicable[185](index=185&type=chunk) [Item 5. Other Information](index=33&type=section&id=Item%205.%20Other%20Information.) The company reported no other information - None reported[186](index=186&type=chunk) [Item 6. Exhibits](index=34&type=section&id=Item%206.%20Exhibits.) This section lists filed exhibits, including officer certifications and Inline XBRL financial data files - The report includes certifications from the CEO and CFO pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[187](index=187&type=chunk) - Inline XBRL Instance Documents and related taxonomy files are also included as exhibits[187](index=187&type=chunk)

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, 2022 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. | Nevada | 99-0360497 | | --- | --- | | (State or other jurisdiction of | (I.R.S. Employer | | in ...

☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) San Diego, CA 92121 (Address of principal executive offices) (zip code) (858) 350-4364 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 na ...

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) ...

VAL-083 for Glioblastoma Multiforme (GBM) - VAL-083 targets Glioblastoma Multiforme (GBM), representing a significant market opportunity estimated at approximately $1 billion[3, 37] - The company is enrolling in all three GBM AGILE patient subtypes: Newly-Diagnosed Unmethylated (over 60% of GBM patients), Newly-Diagnosed Methylated (under 40% of GBM patients), and Recurrent[8, 24] - Kintara initiated the GBM AGILE International Registrational Study in January 2021, with 44 sites actively enrolling in the Kintara arm[3, 15, 16, 17, 20, 37] - Top-line results from the GCAR GBM AGILE International Registrational Study are expected around the end of 2023, 12 months after the last patient is randomized[5, 33, 37] REM-001 for Cutaneous Metastatic Breast Cancer (CMBC) - REM-001 targets Cutaneous Metastatic Breast Cancer (CMBC), with a market opportunity of approximately $500 million, representing up to 40,000 patients in the US[3, 25, 37] - Prior Phase 2/Phase 3 clinical trials of REM-001 demonstrated an 80% complete response rate across 674 evaluable lesions[3, 27, 37] - A 15-patient confirmatory study initiation is planned for Mid-2022, prior to a Phase 3 trial, with top-line results projected for Mid-2023[3, 28, 29, 37] Additional Opportunities - The company has orphan drug designation for VAL-083 in the US and EU, providing seven years and ten years of market exclusivity, respectively, after approval[31]

PART I - FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Kintara's Q3 2022 financials show significant losses and negative cash flow, raising substantial doubt about its going concern ability Condensed Consolidated Interim Balance Sheet Data (in thousands) | Account | March 31, 2022 (unaudited) | June 30, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $8,839 | $10,537 | | Total current assets | $10,093 | $11,793 | | Total assets | $12,798 | $13,543 | | Total current liabilities | $3,240 | $2,780 | | Total liabilities | $3,412 | $2,962 | | Total stockholders' equity | $9,386 | $10,581 | Condensed Consolidated Interim Statements of Operations (in thousands, except per share amounts) | Metric | Three Months Ended Mar 31, 2022 | Three Months Ended Mar 31, 2021 | Nine Months Ended Mar 31, 2022 | Nine Months Ended Mar 31, 2021 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $3,474 | $3,843 | $11,169 | $7,784 | | General and administrative | $1,884 | $2,762 | $6,055 | $7,091 | | In-process research and development | — | — | — | $16,094 | | Net loss | $(5,356) | $(6,635) | $(17,215) | $(31,566) | | Net loss attributable to common stockholders | $(5,358) | $(6,643) | $(19,683) | $(34,768) | | Basic and fully diluted loss per share | $(0.11) | $(0.23) | $(0.45) | $(1.47) | Condensed Consolidated Interim Statements of Cash Flows (in thousands) | Cash Flow Activity | Nine months ended March 31, 2022 | Nine months ended March 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(15,400) | $(14,171) | | Net cash provided by investing activities | — | $964 | | Net cash provided by financing activities | $13,702 | $26,533 | | (Decrease) increase in cash | $(1,698) | $13,326 | - The company's financial condition, including a net loss of $17.2 million and negative operating cash flow of $15.4 million for the nine months ended March 31, 2022, indicates substantial doubt about its ability to continue as a going concern. Management plans to seek additional funding, but success is not assured. A subsequent registered direct financing in April 2022 provided net proceeds of approximately $7.9 million[32](index=32&type=chunk)[91](index=91&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Kintara, a clinical-stage biopharmaceutical company, is advancing two lead candidates while managing increased R&D costs and persistent going concern uncertainties [Product Pipeline](index=21&type=section&id=Product%20Pipeline) The company's pipeline is led by VAL-083 for GBM, currently in a registrational study, and REM-001 for CMBC, with a confirmatory study planned - The company's two lead candidates are VAL-083 for glioblastoma multiforme (GBM) and REM-001, a photodynamic therapy (PDT) for cutaneous metastatic breast cancer (CMBC)[107](index=107&type=chunk) - VAL-083 is being evaluated in the GBM AGILE registrational Phase 2/3 study across all three GBM patient subtypes. Topline data is expected around the end of calendar year 2023[110](index=110&type=chunk)[113](index=113&type=chunk)[116](index=116&type=chunk) - In a Phase 2 study for newly-diagnosed MGMT-unmethylated GBM, VAL-083 demonstrated a median Overall Survival (mOS) of **19.1 months**, comparing favorably to historical temozolomide (TMZ) control data of **12.7-16.0 months**[128](index=128&type=chunk) - REM-001 therapy showed a complete response in approximately **80%** of evaluable tumor sites in previous Phase 2/3 studies for CMBC. A **15-patient** confirmatory study is planned to begin enrollment in mid-2022[111](index=111&type=chunk)[158](index=158&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) Net loss decreased for both three and nine-month periods ended March 31, 2022, primarily due to reduced non-cash charges and lower G&A, despite increased R&D Comparison of Operations for the Three Months Ended March 31 (in thousands) | Expense Category | 2022 | 2021 | Change $ | Change % | | :--- | :--- | :--- | :--- | :--- | | Research and development | $3,474 | $3,843 | $(369) | (10%) | | General and administrative | $1,884 | $2,762 | $(878) | (32%) | | **Net loss** | **$(5,356)** | **$(6,635)** | **$1,279** | **(19%)** | - The decrease in R&D and G&A expenses for the three-month period was largely due to lower non-cash, share-based compensation compared to the prior year, which had higher expenses related to stock options granted in September 2020[188](index=188&type=chunk)[191](index=191&type=chunk) Comparison of Operations for the Nine Months Ended March 31 (in thousands) | Expense Category | 2022 | 2021 | Change $ | Change % | | :--- | :--- | :--- | :--- | :--- | | Research and development | $11,169 | $7,784 | $3,385 | 43% | | General and administrative | $6,055 | $7,091 | $(1,036) | (15%) | | In-process research and development | — | $16,094 | $(16,094) | (100%) | | **Net loss** | **$(17,215)** | **$(31,566)** | **$14,351** | **(45%)** | - The increase in R&D expenses for the nine-month period was driven by costs for the GCAR GBM AGILE Study, which commenced patient recruitment in January 2021. The significant decrease in net loss was due to a one-time, non-cash $16.1 million charge for acquired in-process R&D in the prior year[194](index=194&type=chunk)[195](index=195&type=chunk)[201](index=201&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity declined for the nine months ended March 31, 2022, with increased operating cash burn and reduced financing, raising substantial doubt about its going concern Cash Flow Summary for the Nine Months Ended March 31 (in thousands) | Cash Flow Activity | 2022 | 2021 | | :--- | :--- | :--- | | Cash flows from operating activities | $(15,400) | $(14,171) | | Cash flows from investing activities | — | $964 | | Cash flows from financing activities | $13,702 | $26,533 | - Financing activities in the nine months to March 31, 2022, included **$13.6 million** in net proceeds from a registered direct financing in September 2021. This compares to **$21.6 million** from a Series C Preferred stock placement in the prior-year period[203](index=203&type=chunk)[204](index=204&type=chunk) - The company had **$8.8 million** in cash as of March 31, 2022. Despite raising an additional **$7.9 million** in April 2022, management has concluded there is substantial doubt about the company's ability to continue as a going concern for more than one year without securing additional funding[206](index=206&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable as the company qualifies as a smaller reporting company - Disclosure is not required as the company qualifies as a smaller reporting company[214](index=214&type=chunk) [Controls and Procedures](index=36&type=section&id=Item%204%20Controls%20and%20Procedures) The company's disclosure controls and procedures were effective as of March 31, 2022, with no material changes in internal control over financial reporting - Management concluded that as of the end of the period covered by this report, the company's disclosure controls and procedures were effective[215](index=215&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended March 31, 2022, that have materially affected, or are reasonably likely to materially affect, internal controls[217](index=217&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings - There are no legal proceedings the Company is party to or any of its property is subject to[220](index=220&type=chunk) [Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) No material changes to previously disclosed risk factors were reported since the last Form 10-K and Form 10-Q filings - No material changes to risk factors were reported since the last Form 10-K and Form 10-Q filings[221](index=221&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds - The company reported no unregistered sales of equity securities[222](index=222&type=chunk) [Defaults Upon Senior Securities](index=37&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - The company reported no defaults upon senior securities[223](index=223&type=chunk) [Mine Safety Disclosures](index=37&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - This item is not applicable to the company[224](index=224&type=chunk) [Other Information](index=37&type=section&id=Item%205.%20Other%20Information) The company reported no other material information - The company reported no other information[225](index=225&type=chunk) [Exhibits](index=38&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including financing agreements and officer certifications - Exhibits filed include forms of securities purchase agreements and warrant certificates related to the April 2022 financing, as well as required CEO and CFO certifications[227](index=227&type=chunk)

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 ...

[PART I. - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20-%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements.](index=3&type=section&id=Item%201.%20Financial%20Statements.) This section presents Kintara Therapeutics, Inc.'s unaudited condensed consolidated interim financial statements for the three months ended September 30, 2021, including balance sheets, statements of operations, statements of stockholders' equity, and statements of cash flows, along with detailed notes explaining the company's operations, significant accounting policies, and specific financial transactions [Condensed Consolidated Interim Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Interim%20Balance%20Sheets) Condensed Consolidated Interim Balance Sheets (September 30, 2021 vs. June 30, 2021) | Item | September 30, 2021 ($ thousands) | June 30, 2021 ($ thousands) | Change ($ thousands) | Change (%) | | :-------------------------------- | :------------------------------- | :-------------------------- | :------------------- | :--------- | | Cash and cash equivalents | 19,339 | 10,537 | 8,802 | 83.5% | | Total assets | 22,343 | 13,543 | 8,800 | 65.0% | | Total liabilities | 3,180 | 2,962 | 218 | 7.4% | | Total stockholders' equity | 19,163 | 10,581 | 8,582 | 81.1% | | Accumulated deficit | (119,655) | (111,225) | (8,430) | 7.6% | [Condensed Consolidated Interim Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Operations) Condensed Consolidated Interim Statements of Operations (Three months ended September 30, 2021 vs. 2020) | Item | September 30, 2021 ($ thousands) | September 30, 2020 ($ thousands) | Change ($ thousands) | Change (%) | | :---------------------------------------------- | :------------------------------- | :------------------------------- | :------------------- | :--------- | | Research and development | 3,793 | 1,357 | 2,436 | 179.5% | | General and administrative | 2,178 | 1,534 | 644 | 42.0% | | Merger costs | — | 500 | (500) | -100.0% | | In-process research and development | — | 16,094 | (16,094) | -100.0% | | Net loss for the period | (5,966) | (19,518) | 13,552 | -69.4% | | Net loss attributable to common stockholders | (8,430) | (22,706) | 14,276 | -62.9% | | Basic and fully diluted loss per share | (0.25) | (1.33) | 1.08 | -81.2% | | Basic and fully diluted weighted average shares | 34,281 | 17,106 | 17,175 | 100.4% | [Condensed Consolidated Interim Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Stockholders'%20Equity) Changes in Stockholders' Equity (Three months ended September 30, 2021) | Item | Amount ($ thousands) | | :---------------------------------------- | :------------------- | | Balance - June 30, 2021 | 10,581 | | Issuance of shares and warrants - net | 13,634 | | Conversion of Series C Preferred stock | — | | Exercise of 2020 Investor Warrants | 69 | | Exercise of pre-funded warrants | 5 | | Warrants issued for services | 31 | | Stock option expense | 811 | | Series A Preferred cash dividend | (2) | | Series C Preferred stock dividend | — | | Loss for the period | (5,966) | | Balance - September 30, 2021 | 19,163 | Changes in Stockholders' Equity (Three months ended September 30, 2020) | Item | Amount ($ thousands) | | :---------------------------------------------- | :------------------- | | Balance - June 30, 2020 | 263 | | Adgero merger | 16,725 | | Issuance of Series C Preferred stock | 25,028 | | Series C placement agent warrants | — | | Series C Preferred stock share issuance costs | (3,386) | | Deemed dividend on beneficial conversion features | — | | Exercise of warrants | 994 | | Warrants issued for services | 45 | | Stock option expense | 405 | | Series A Preferred cash dividend | (2) | | Series B Preferred stock dividend | — | | Loss for the period | (19,518) | | Balance - September 30, 2020 | 20,554 | [Condensed Consolidated Interim Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Cash%20Flows) Condensed Consolidated Interim Statements of Cash Flows (Three months ended September 30, 2021 vs. 2020) | Cash Flow Activity | September 30, 2021 ($ thousands) | September 30, 2020 ($ thousands) | Change ($ thousands) | Change (%) | | :------------------------ | :------------------------------- | :------------------------------- | :------------------- | :--------- | | Operating activities | (5,073) | (4,110) | (963) | 23.4% | | Investing activities | — | 969 | (969) | -100.0% | | Financing activities | 13,875 | 23,351 | (9,476) | -40.6% | | Increase in cash | 8,802 | 20,210 | (11,408) | -56.4% | | Cash, end of period | 19,339 | 22,602 | (3,263) | -14.4% | [Notes to Condensed Consolidated Interim Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Interim%20Financial%20Statements) [1. Nature of Operations, Corporate History, and Going Concern and Management Plans](index=9&type=section&id=1%20Nature%20of%20operations,%20corporate%20history,%20and%20going%20concern%20and%20management%20plans) - Kintara Therapeutics, Inc. is a clinical-stage drug development company focused on novel cancer therapies, specifically VAL-083 for glioblastoma multiforme (GBM) and REM-001 for cutaneous metastatic breast cancer (CMBC)[22](index=22&type=chunk) - The company completed a merger with Adgero Biopharmaceuticals Holdings, Inc. on August 19, 2020, and subsequently changed its name from DelMar Pharmaceuticals, Inc. to Kintara Therapeutics, Inc., trading under 'KTRA' on Nasdaq[23](index=23&type=chunk)[24](index=24&type=chunk) - The company reported a net loss of **$5,966 thousand** and negative cash flow from operations of **$5,073 thousand** for the three months ended September 30, 2021, with an accumulated deficit of **$119,655 thousand**, raising substantial doubt about its ability to continue as a going concern within one year[29](index=29&type=chunk) - Management is pursuing various financing alternatives, including new equity issuance and strategic partnerships, to fund operations, acknowledging the economic uncertainty and volatility caused by the COVID-19 pandemic[30](index=30&type=chunk) [2. Significant Accounting Policies](index=10&type=section&id=2%20Significant%20accounting%20policies) - The financial statements are prepared in accordance with U.S. GAAP and presented in United States dollars, consolidating all wholly-owned subsidiaries[32](index=32&type=chunk)[33](index=33&type=chunk) - Unaudited interim financial statements include all necessary normal and recurring adjustments, but do not contain all information required for complete annual financial statements[34](index=34&type=chunk) - Loss per share calculations exclude warrants, stock options, and convertible preferred shares as their effect was anti-dilutive for the periods ended September 30, 2021 and 2020[36](index=36&type=chunk) - Acquired in-process research and development assets from the Adgero Merger were expensed as they had no current or alternative future use, resulting in a **$16,094 thousand** expense for the three months ended September 30, 2020[37](index=37&type=chunk) [3. Merger](index=11&type=section&id=3%20Merger) - The merger with Adgero on August 19, 2020, was treated as an acquisition of Adgero assets and liabilities, with substantially all fair value concentrated in in-process research and development (IPR&D)[40](index=40&type=chunk) - The company issued **11,439 shares** of common stock and **2,315 stock purchase warrants** to Adgero security holders, with an aggregate fair value of consideration transferred of **$16,725 thousand**[41](index=41&type=chunk) - Merger-related legal, consulting, and professional fees totaled approximately **$1,554 thousand**, with **$500 thousand** incurred during the three months ended September 30, 2020[42](index=42&type=chunk) - A milestone payment liability of **$179 thousand** as of September 30, 2021, relates to the acquisition of REM-001, with future contingent payments tied to clinical study completion and regulatory approval[43](index=43&type=chunk)[45](index=45&type=chunk)[46](index=46&type=chunk) [4. Clinical Trial Deposit](index=12&type=section&id=4%20Clinical%20trial%20deposit) - Kintara entered a final agreement with a CRO for its glioblastoma multiforme registration study, recognizing **$1,952 thousand** in expenses for clinical site initiation and patient enrollment for the three months ended September 30, 2021[47](index=47&type=chunk) - A deposit payment of **$2,100 thousand** has been made to the CRO, anticipated to be applied to future invoices or refunded beyond twelve months from September 30, 2021[48](index=48&type=chunk) [5. Property, Equipment, and Intangibles](index=12&type=section&id=5%20Property,%20equipment%20and%20intangibles) Property, Equipment, and Intangibles (September 30, 2021 vs. June 30, 2021) | Item | September 30, 2021 ($ thousands) | June 30, 2021 ($ thousands) | | :--------------------------------- | :------------------------------- | :-------------------------- | | Property, equipment and intangibles | 150 | 180 | | Less accumulated depreciation | (15) | (30) | | Balance | 135 | 150 | [6. Related Party Transactions](index=12&type=section&id=6%20Related%20party%20transactions) - Kintara has a Patent Assignment Agreement with Valent Technologies, LLC, a related party, for VAL-083, entitling Valent to future royalties on revenues[50](index=50&type=chunk)[51](index=51&type=chunk) - The company recorded a **$2 thousand** dividend payment to Valent for Series A Preferred Stock for both the three months ended September 30, 2021, and 2020[52](index=52&type=chunk)[53](index=53&type=chunk) - Related party payables to officers and directors for fees, expenses, and accrued bonuses decreased from **$561 thousand** at June 30, 2021, to **$491 thousand** at September 30, 2021[54](index=54&type=chunk) [7. Stockholders' Equity](index=13&type=section&id=7%20Stockholders'%20equity) [Preferred Stock](index=13&type=section&id=Preferred%20stock) - The company issued **25,028 shares** of Series C Convertible Preferred Stock in August 2020 through a private placement, with conversion prices ranging from **$1.15 to $1.214 per share**[55](index=55&type=chunk) - Series C Preferred Stock holders are entitled to common stock dividends at increasing rates (**10%, 15%, 20%, 25%**) on the anniversary of the private placement, with a **$2,462 thousand** dividend paid on August 19, 2021[56](index=56&type=chunk) - A non-cash deemed dividend of **$3,181 thousand** was recognized for the beneficial conversion feature of Series C Preferred Stock issuance for the three months ended September 30, 2020[59](index=59&type=chunk) - Series B Preferred Stock was fully converted to common stock by April 29, 2021, and Series A Preferred Stock, held by Valent, is not convertible and has a stated value of **$1.00 per share** with a **3% annual dividend**[61](index=61&type=chunk)[63](index=63&type=chunk) [Common Stock](index=15&type=section&id=Common%20stock) - On September 28, 2021, Kintara closed a registered direct offering, selling **7,200 thousand shares** of common stock, **4,800 thousand pre-funded warrants (PFW)**, and **12,000 thousand common warrants (2022 Investor Warrants)** for approximately **$13,634 thousand** in net proceeds[66](index=66&type=chunk)[67](index=67&type=chunk) - All **4,800 thousand PFW** were exercised during the three months ended September 30, 2021, generating **$4.8 thousand** in proceeds[69](index=69&type=chunk) [Stock Options](index=15&type=section&id=Stock%20options) - The number of common shares available under the 2017 Omnibus Incentive Plan was increased to **13,000 thousand shares** as of June 25, 2021[70](index=70&type=chunk) Stock Options Outstanding (September 30, 2021) | Item | Number of stock options outstanding (in thousands) | Weighted average exercise price ($) | | :------------------------ | :----------------------------------------------- | :---------------------------------- | | Balance – June 30, 2021 | 6,392 | 2.26 | | Granted | 435 | 1.24 | | Expired | (18) | 13.11 | | Balance – September 30, 2021 | 6,809 | 2.16 | Stock Option Expense (Three months ended September 30, 2021 vs. 2020) | Expense Category | September 30, 2021 ($ thousands) | September 30, 2020 ($ thousands) | | :-------------------------- | :------------------------------- | :------------------------------- | | Research and development | 244 | 91 | | General and administrative | 567 | 314 | | Total Stock Option Expense | 811 | 405 | - As of September 30, 2021, there was **$2,597 thousand** in unrecognized compensation expense to be recognized over the next **2.58 years**[75](index=75&type=chunk) [Common Stock Warrants](index=17&type=section&id=Common%20stock%20warrants) Changes in Outstanding Common Stock Warrants (Three months ended September 30, 2021) | Item | Number of Warrants (in thousands) | Weighted average exercise price ($) | | :---------------------------------- | :-------------------------------- | :---------------------------------- | | Balance – June 30, 2021 | 6,974 | 3.34 | | Issuance of 2022 Investor Warrants | 12,000 | 1.25 | | Issuance of PFW | 4,800 | 0.001 | | Issuance of 2022 Agent Warrants | 600 | 1.5625 | | Exercise of PFW | (4,800) | 0.001 | | Exercise of 2020 Investor Warrants | (69) | 1.00 | | Expiry of Adgero replacement warrants | (353) | 3.18 | | Balance – September 30, 2021 | 19,152 | 1.99 | [Series C Preferred Stock Warrants](index=18&type=section&id=Series%20C%20Preferred%20Stock%20warrants) - In connection with the Series C Preferred Stock private placement, Kintara issued **2,504 Series C Agent Warrants**, exercisable at **$1,000 per share** with a cashless exercise feature and a four-year term from August 19, 2020[79](index=79&type=chunk) - The Series C Agent Warrants were valued at **$3,287 thousand** using a binomial pricing model[80](index=80&type=chunk) [8. Supplementary Statement of Cash Flows Information](index=19&type=section&id=8%20Supplementary%20statement%20of%20cash%20flows%20information) Non-Cash Investing and Financing Transactions (Three months ended September 30, 2021 vs. 2020) | Non-Cash Transaction | September 30, 2021 ($ thousands) | September 30, 2020 ($ thousands) | | :------------------------------------------------------ | :------------------------------- | :------------------------------- | | Series C Preferred Stock common stock dividend | 2,462 | — | | Series B Preferred Stock common stock dividend | — | 5 | | Deemed dividend on beneficial conversion features | — | 3,181 | | Non-cash issue costs | 333 | 3,287 | | Issue costs in accounts payable and accrued liabilities | 169 | 193 | [9. Financial Instruments](index=19&type=section&id=9%20Financial%20instruments) - Kintara's financial instruments are measured at fair value using a hierarchy of inputs (Level 1, 2, or 3), with the milestone payment liability classified as Level 3 inputs as of September 30, 2021[84](index=84&type=chunk)[85](index=85&type=chunk) - The carrying values of cash and cash equivalents, other receivables, accounts payable, and related party payables approximate their fair values due to their immediate or short-term maturity[86](index=86&type=chunk) [10. Subsequent Events](index=20&type=section&id=10%20Subsequent%20events) - Subsequent to September 30, 2021, **0.65 shares** of Series C-1 Preferred Stock were converted into **560 shares** of common stock[87](index=87&type=chunk) - On November 8, 2021, the company issued **3,519 stock options** to an officer and modified **2,715 previously issued stock options** to vest contingently upon strategic partnership initiatives[88](index=88&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) This section provides management's perspective on Kintara's financial condition and operational results for the three months ended September 30, 2021, compared to the prior year, discussing the impact of COVID-19, recent corporate highlights, clinical milestones, product pipeline, liquidity, and critical accounting policies [Impact of Coronavirus ("COVID-19") on our Operations, Financial Condition, Liquidity and Results of Operations](index=21&type=section&id=Impact%20of%20Coronavirus%20(%22COVID-19%22)%20on%20our%20Operations,%20Financial%20Condition,%20Liquidity%20and%20Results%20of%20Operations) - The COVID-19 pandemic did not significantly disrupt Phase 2 clinical studies, but current delays in contract manufacturing schedules and supplies for REM-001 are attributed to COVID-19, potentially impacting its program timeline[94](index=94&type=chunk)[95](index=95&type=chunk) - Despite a recent **$13.6 million** financing, the company estimates cash to fund operations for less than one year, with the ultimate impact of COVID-19 on its ability to raise additional capital remaining uncertain[96](index=96&type=chunk) [Background](index=21&type=section&id=Background) - Kintara Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel cancer therapies for patients with unmet medical needs, particularly orphan cancer indications[97](index=97&type=chunk)[102](index=102&type=chunk) - The company's lead candidates are VAL-083 for drug-resistant solid tumors like glioblastoma multiforme (GBM) and REM-001, a photodynamic therapy (PDT) for cutaneous metastatic breast cancer (CMBC)[103](index=103&type=chunk) [Recent Highlights](index=22&type=section&id=Recent%20Highlights) - Robert E. Hoffman was appointed President and CEO, succeeding Saiid Zarrabian, who will lead strategic partnerships[105](index=105&type=chunk) - A registered direct financing on September 28, 2021, raised approximately **$15 million** in gross proceeds, expected to fund the GBM AGILE study through Stage 1[105](index=105&type=chunk) - Positive topline data for the adjuvant arm of the VAL-083 Phase 2 clinical study in newly-diagnosed MGMT-unmethylated GBM patients was reported on September 22, 2021[105](index=105&type=chunk) - **26 clinical sites** in the United States were activated for the GBM AGILE registrational Phase 2/3 clinical study for GBM by August 17, 2021[105](index=105&type=chunk) [Targeted Clinical Milestones](index=23&type=section&id=Targeted%20Clinical%20Milestones) - **Q1 2022**: REM-001 Investigational New Drug (IND) application reactivation[106](index=106&type=chunk) - **Q2 2022**: Enroll first patient in REM-001 CMBC fifteen-patient confirmatory study[107](index=107&type=chunk) - **Q3 2022**: VAL-083 GCAR GBM AGILE registration study graduation from Stage 1 to Stage 2[108](index=108&type=chunk) [Product Pipeline](index=23&type=section&id=Product%20Pipeline) [VAL-083](index=23&type=section&id=VAL-083) - VAL-083 is a first-in-class, small-molecule, DNA-targeting chemotherapeutic with activity against various tumor types, leveraging over **40 prior NCI Phase 1 and Phase 2 clinical studies**[110](index=110&type=chunk) - It is currently the only therapeutic agent evaluated in all three GBM patient subtypes (newly-diagnosed methylated MGMT, newly-diagnosed unmethylated MGMT, and recurrent) in the GBM AGILE Study[111](index=111&type=chunk) - VAL-083 has received FDA Orphan Drug designation for gliomas (including GBM), medulloblastoma, and ovarian cancer, and Fast Track designation for recurrent GBM[114](index=114&type=chunk)[136](index=136&type=chunk) - Clinical studies show VAL-083's anti-tumor activity is independent of MGMT expression, addressing a significant unmet need in MGMT-unmethylated GBM patients resistant to standard temozolomide (TMZ) treatment[112](index=112&type=chunk)[141](index=141&type=chunk) - Topline data from the Phase 2 study in newly-diagnosed MGMT-unmethylated GBM showed median PFS of **9.3 months** and mOS of **19.6 months**, comparing favorably to historical TMZ control data[124](index=124&type=chunk) - The primary dose-limiting toxicity of VAL-083 is myelosuppression, particularly thrombocytopenia, which is a common chemotherapy side effect and is believed to be manageable[151](index=151&type=chunk) [REM-001](index=29&type=section&id=REM-001) - REM-001 is a photodynamic therapy (PDT) consisting of a laser light source, light delivery device, and the drug product (SnET2 photosensitizer), developed for rare, unmet medical needs like cutaneous metastatic breast cancer (CMBC)[152](index=152&type=chunk)[160](index=160&type=chunk) - Analysis of prior Phase 2/3 CMBC studies indicates REM-001 Therapy achieved a complete response in approximately **80% of evaluable tumor sites**[153](index=153&type=chunk)[166](index=166&type=chunk) - REM-001 has received FDA Orphan Drug designation for the treatment of Basal Cell Carcinoma Nevus Syndrome (BCCNS) and for the prevention of access graft failure in hemodialysis patients[158](index=158&type=chunk)[159](index=159&type=chunk) - The company plans an initial open-label, **15-patient study** in CMBC to confirm dose and optimize study design, followed by a Phase 3 clinical study for marketing approval, incorporating FDA feedback[167](index=167&type=chunk)[168](index=168&type=chunk) - REM-001 has been safely administered to over **1,100 patients** in prior clinical studies, demonstrating an inherent safety advantage due to its light-activated mechanism[164](index=164&type=chunk) [Corporate History](index=31&type=section&id=Corporate%20History) - Kintara Therapeutics, Inc. was formed on June 24, 2009, as Berry Only Inc., and became the parent company of Del Mar Pharmaceuticals (BC) Ltd. through a reverse acquisition on January 25, 2013[170](index=170&type=chunk) - The company acquired Adgero Biopharmaceuticals Holdings Inc. on August 19, 2020, and subsequently changed its name from DelMar Pharmaceuticals, Inc. to Kintara Therapeutics, Inc[171](index=171&type=chunk) [Outstanding Securities](index=32&type=section&id=Outstanding%20Securities) Outstanding Securities as of November 11, 2021 | Security Type | Number of Shares/Warrants (in thousands) | | :-------------------------------- | :--------------------------------------- | | Common stock | 48,535 | | Common stock warrants | 19,152 | | Series C Preferred Stock warrants | 2,444 (convertible into 2,100 common) | | Stock options | 10,328 | | Series C Preferred Stock | 17,747 (convertible into 15,267 common) | [Selected Quarterly Information](index=32&type=section&id=Selected%20Quarterly%20Information) Selected Balance Sheet Data (September 30, 2021 vs. June 30, 2021) | Item | September 30, 2021 ($ thousands) | June 30, 2021 ($ thousands) | | :------------------------ | :------------------------------- | :-------------------------- | | Cash and cash equivalents | 19,339 | 10,537 | | Working capital | 17,107 | 9,013 | | Total assets | 22,343 | 13,543 | | Total stockholders' equity | 19,163 | 10,581 | Selected Statement of Operations Data (Three months ended September 30, 2021 vs. 2020) | Item | September 30, 2021 ($ thousands) | September 30, 2020 ($ thousands) | | :---------------------------------------------- | :------------------------------- | :------------------------------- | | Research and development | 3,793 | 1,357 | | General and administrative | 2,178 | 1,534 | | Merger costs | — | 500 | | In-process research and development | — | 16,094 | | Net loss for the period | (5,966) | (19,518) | | Net loss attributable to common stockholders | (8,430) | (22,706) | | Basic and fully diluted loss per share | (0.25) | (1.33) | | Basic and fully diluted weighted average shares | 34,281 | 17,106 | [Expenses, net of non-cash, share-based compensation expense – non-GAAP](index=33&type=section&id=Expenses,%20net%20of%20non-cash,%20share-based%20compensation%20expense%20%E2%80%93%20non-GAAP) Non-GAAP Operational Expenses (Three months ended September 30, 2021 vs. 2020) | Expense Category | September 30, 2021 ($ thousands) | September 30, 2020 ($ thousands) | | :---------------------------------------------------------------------------- | :------------------------------- | :------------------------------- | | Research and development - GAAP | 3,793 | 1,357 | | Less: non-cash, share-based compensation expense | (244) | (91) | | Research and development net of non-cash, share-based, compensation expense – Non-GAAP | 3,549 | 1,266 | | General and administrative - GAAP | 2,178 | 1,534 | | Less: non-cash, share-based compensation expense | (598) | (359) | | General and administrative net of non-cash, share-based, compensation expense – Non-GAAP | 1,580 | 1,175 | [Results of Operations](index=34&type=section&id=Results%20of%20Operations) Comparison of Expenses (Three months ended September 30, 2021 vs. 2020) | Expense Category | September 30, 2021 ($ thousands) | September 30, 2020 ($ thousands) | Change ($ thousands) | Change (%) | | :---------------------------------- | :------------------------------- | :------------------------------- | :------------------- | :--------- | | Research and development | 3,793 | 1,357 | 2,436 | 180% | | General and administrative | 2,178 | 1,534 | 644 | 42% | | Merger costs | — | 500 | (500) | (100%) | | In-process research and development | — | 16,094 | (16,094) | (100%) | | Net loss | (5,966) | (19,518) | 13,552 | | - Research and development expenses increased by **$2,436 thousand (180%)** due to higher clinical development costs for the GCAR GBM AGILE Study, drug manufacturing for REM-001, and increased non-cash, share-based compensation and personnel costs[179](index=179&type=chunk)[180](index=180&type=chunk)[181](index=181&type=chunk) - General and administrative expenses increased by **$644 thousand (42%)** primarily due to higher non-cash, share-based compensation expenses, professional fees (legal and accounting), and personnel costs[182](index=182&type=chunk)[183](index=183&type=chunk) - The company recognized a **$2,462 thousand** stock dividend on Series C Preferred Stock for the three months ended September 30, 2021, and **$2 thousand** cash dividend on Series A Preferred Stock for both periods[184](index=184&type=chunk)[185](index=185&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) Cash Flows (Three months ended September 30, 2021 vs. 2020) | Cash Flow Activity | September 30, 2021 ($ thousands) | September 30, 2020 ($ thousands) | Change ($ thousands) | Change (%) | | :------------------------ | :------------------------------- | :------------------------------- | :------------------- | :--------- | | Operating activities | (5,073) | (4,110) | (963) | 23% | | Investing activities | — | 969 | (969) | (100%) | | Financing activities | 13,875 | 23,351 | (9,476) | (41%) | - Net cash used in operating activities increased by **$963 thousand**, primarily due to a larger net loss in the prior period offset by a non-cash IPR&D expense of **$16,094 thousand** in 2020[187](index=187&type=chunk) - Financing activities provided **$13,875 thousand** in 2021, mainly from a registered direct financing, compared to **$23,351 thousand** in 2020 from a Series C Preferred stock private placement and a loan[189](index=189&type=chunk)[190](index=190&type=chunk) - The company's accumulated deficit of **$119,655 thousand** and negative cash flow from operations indicate substantial doubt about its ability to continue as a going concern, necessitating additional funding through equity offerings or strategic collaborations[192](index=192&type=chunk)[195](index=195&type=chunk) [Critical Accounting Policies](index=36&type=section&id=Critical%20Accounting%20Policies) - Critical accounting policies include the fair value of financial instruments (stock-based awards, warrants) and accruals for research and development expenses and clinical trials[197](index=197&type=chunk)[198](index=198&type=chunk) - Stock-based awards and warrants are valued using the Black-Scholes model, with variables like expected volatility, exercise behavior, interest rates, and dividend yields requiring management estimates[199](index=199&type=chunk)[200](index=200&type=chunk) - Accruals for R&D and clinical trials are estimated based on discussions with personnel and service providers regarding study progress, with no material adjustments to prior period estimates for the reported periods[201](index=201&type=chunk) [Off-Balance Sheet Arrangements](index=37&type=section&id=Off-Balance%20Sheet%20Arrangements) - The company does not have any off-balance sheet arrangements[202](index=202&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk.](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) This section states that quantitative and qualitative disclosures about market risk are not required for Kintara Therapeutics, Inc. as it is a smaller reporting company - Quantitative and Qualitative Disclosures About Market Risk are not required for Kintara Therapeutics, Inc. as it is a smaller reporting company[203](index=203&type=chunk) [Item 4. Controls and Procedures.](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures.) This section details the evaluation of the company's disclosure controls and procedures, confirming their effectiveness as of September 30, 2021, and reporting no material changes in internal control over financial reporting during the quarter - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective as of September 30, 2021, ensuring timely and accurate reporting of information[204](index=204&type=chunk) - No changes in internal control over financial reporting materially affected, or are reasonably likely to materially affect, the company's internal control during the quarter ended September 30, 2021[206](index=206&type=chunk) [PART II - OTHER INFORMATION](index=39&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Item 1. Legal Proceedings.](index=39&type=section&id=Item%201.%20Legal%20Proceedings.) This section states that Kintara Therapeutics, Inc. is not a party to any legal proceedings, nor is any of its property subject to such proceedings - There are no legal proceedings the Company is party to or any of its property is subject to[208](index=208&type=chunk) [Item 1A. Risk Factors.](index=39&type=section&id=Item%201A.%20Risk%20Factors.) This section indicates that there are no new risk factors to report for the current period - No new risk factors are reported for the period[209](index=209&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.](index=39&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) This section states that there were no unregistered sales of equity securities or use of proceeds to report for the period - No unregistered sales of equity securities or use of proceeds to report[210](index=210&type=chunk) [Item 3. Defaults Upon Senior Securities.](index=39&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities.) This section confirms that there were no defaults upon senior securities during the reporting period - No defaults upon senior securities are reported[211](index=211&type=chunk) [Item 4. Mine Safety Disclosures.](index=39&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This section indicates that mine safety disclosures are not applicable to Kintara Therapeutics, Inc - Mine safety disclosures are not applicable[212](index=212&type=chunk) [Item 5. Other Information.](index=39&type=section&id=Item%205.%20Other%20Information.) This section states that there is no other information to report for the period - No other information to report[213](index=213&type=chunk) [Item 6. Exhibits.](index=40&type=section&id=Item%206.%20Exhibits.) This section lists the exhibits filed with the Form 10-Q, including certifications from the principal executive and financial officers, and Inline XBRL documents - The report includes certifications from the principal executive officer and principal financial officer pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002[215](index=215&type=chunk) - Inline XBRL documents (Instance, Schema, Calculation, Definition, Label, Presentation Linkbase Documents) and the Cover Page Interactive Data File are filed as exhibits[215](index=215&type=chunk)

Mergers and Acquisitions - The company completed a merger with Adgero Biopharmaceuticals Holdings, resulting in the conversion of each share of Adgero common stock into 1.5740 shares of the company's common stock[13]. Fundraising and Financials - The company raised approximately $15 million in gross proceeds by issuing 7,200,000 shares of common stock and warrants, which will fund the Phase 2/3 clinical study for GBM[19]. - The company plans to evaluate options for strategic direction, including raising additional capital and potential acquisitions[35]. - The company is obligated to pay milestone payments of $300,000 and $700,000 upon certain conditions, with potential payments in common stock based on recent financing[156]. - A royalty fee of 6% on net sales is owed to St. Cloud and Steven Rychnovsky, PhD, with specific distributions of 4.8% and 1.2% respectively[157]. Clinical Trials and Studies - Positive topline data was reported for the adjuvant arm of the Phase 2 clinical study of VAL-083, showing its potential as a treatment for GBM patients[19]. - The company activated 26 clinical sites in the U.S. for the GBM AGILE registration study, which evaluates multiple therapies for newly-diagnosed and recurrent GBM[19]. - VAL-083 is currently the only therapeutic agent being evaluated in all three GBM patient subtypes in the GBM AGILE study[29]. - The GBM AGILE Study plans to enroll 150-200 patients in the Kintara arm across over 40 sites in the U.S. and Canada, with potential expansion to 65 clinical study centers worldwide[42]. - In a Phase 2 study, VAL-083 demonstrated a median progression-free survival (PFS) of 9.3 months for 29 patients, compared to historical PFS of 5.3 months and 6.9 months for standard treatments[49]. - The study at MD Anderson for recurrent GBM patients enrolled 89 patients, with 35 patients receiving 40 mg/m²/day and 54 patients receiving 30 mg/m²/day[51]. - The GBM AGILE Study employs a cost-efficient, adaptive design, allowing for simultaneous evaluation of multiple therapies under a master protocol[43]. - VAL-083 is being studied as a potential replacement for standard-of-care chemoradiation with temozolomide in newly-diagnosed MGMT-unmethylated GBM patients[46]. - Clinical studies indicate that VAL-083 has no evidence of lung, liver, or kidney toxicity, supporting its safety profile over 15 years in the Chinese market[80]. - The planned Phase 3 study aims to enroll approximately 100-150 CMBC patients who have received prior radiation therapy and chemotherapy[141]. - A preliminary open-label study with 15 patients is planned to confirm the dose and study design before the Phase 3 clinical study[140]. Drug Efficacy and Safety - VAL-083 has shown increased median overall survival benefits compared to radiation alone, targeting MGMT-unmethylated GBM patients[28]. - The median overall survival (mOS) for efficacy evaluable patients receiving 30 mg/m²/day of VAL-083 was reported as 8.0 months, with a PFS of 10.0 months for 36 efficacy evaluable patients[60][61]. - Myelosuppression was the most common adverse event associated with VAL-083, occurring in both recurrent and newly-diagnosed treatment settings[59]. - The overall median survival for newly diagnosed GBM patients with best available treatments is less than 15 months, highlighting the urgent need for effective therapies[65]. - VAL-083 has demonstrated activity against MGMT-unmethylated GBM cells resistant to temozolomide, with high efficacy in p53 mutated NSCLC, ovarian cancer, and medulloblastoma cell lines[77]. - VAL-083 has shown superior efficacy compared to standard platinum-based therapies in both TKI-sensitive and TKI-resistant NSCLC models[85]. - REM-001 Therapy has shown a complete response in approximately 80% of evaluable tumor sites in CMBC patients, indicating promising efficacy[99]. - REM-001 Therapy demonstrated a 66% complete response rate and a 90% overall response rate in a Phase 1 study involving 27 cutaneous tumor lesions[128]. - In a Phase 1/2 clinical study for BCCNS, REM-001 Therapy showed a 91% overall response rate, with a 68% complete response rate and a 23% partial response rate[123]. Regulatory Approvals and Designations - The FDA granted orphan drug designation for VAL-083 for the treatment of both ovarian cancer and gliomas, including GBM[33]. - The FDA has granted Fast Track designation for VAL-083 in recurrent GBM, which may expedite the review process and increase communication frequency with the FDA[62][63]. - The FDA granted orphan drug designation for REM-001's active ingredient, tin ethyl etiopurpurin, for the treatment of Basal Cell Carcinoma Nevus Syndrome (BCCNS) on January 16, 2018[108]. - The FDA grants five years of data exclusivity for a new chemical entity, which REM-001 is expected to qualify for if approved[142]. - Orphan drug designation can provide exclusivity for 7 years in the U.S. and 10 years in the E.U. for drugs treating rare diseases, but does not shorten the review process[196]. Market Potential and Competition - VAL-083 is projected to generate over $1.0 billion in sales for glioblastoma multiforme by 2027, over $6.0 billion for ovarian cancer by 2028, and over $22.0 billion for non-small cell lung cancer by 2027[91]. - The estimated market opportunity for the treatment of CMBC is approximately $500 million[121]. - The oncology market is highly competitive, with major pharmaceutical and biotechnology companies actively developing products for cancer treatment, including VAL-083 and REM-001[205]. - The company faces competition from numerous firms in oncology, including those with approved products like Merck's Temodar and Genentech's Avastin[208]. Intellectual Property and Manufacturing - The company has filed patent applications related to VAL-083, including improvements to manufacturing processes and treatment regimens[160]. - The company has acquired intellectual property for REM-001, including scientific and regulatory data, through an asset purchase agreement[181]. - The company has pending national phase applications for various patents in multiple countries, indicating ongoing efforts to expand its market presence[167][170][171][172][173]. - The protection of intellectual property rights in China is relatively weak, which may impact revenue generation from VAL-083 in that market[179]. - The current manufacturing process for VAL-083 involves fewer than five synthetic steps, with improvements made to the original process established by the NCI[143]. - The manufacturing process for REM-001 has been established for commercial scale production, with stability testing currently underway for two API lots[148]. - A strategic collaboration with Guangxi Wuzhou Pharmaceutical Company has been established, which is the only manufacturer licensed by the CFDA to produce VAL-083 for the China market[149]. - The company has engaged third-party contract manufacturers to meet FDA standards, with drug supply now manufactured under full cGMP conditions for future clinical studies[146]. Regulatory Compliance and Challenges - Regulatory approval is required for all major markets, necessitating substantial resources for compliance with testing, manufacturing, and marketing regulations[183][185]. - The approval process for drug manufacturing facilities is stringent, requiring inspections and compliance with good manufacturing practices[192]. - Regulatory compliance requires significant financial resources and time, with ongoing inspections and potential penalties for non-compliance[197]. - The company must navigate complex healthcare regulations, including the Anti-Kickback Statute and false claims laws, which could impose civil and criminal penalties[201]. - The company is aware of the potential for policy changes that could impact study sizes, timelines, and expenditures for drug approvals[195].

VAL-083 (GBM) - VAL-083 targets Glioblastoma Multiforme (GBM), a market with >$800 million growing to $14 billion in 2027[5] - Kintara's VAL-083 is the only drug currently participating in all three GBM patient subtypes in the GBM AGILE trial[14] - In newly-diagnosed patients, VAL-083 showed a median Progression Free Survival of 87 months (SYSUCC) and 100 months (MDACC), compared to a TMZ historical comparator of 53-69 months[7] - In recurrent patients, VAL-083 showed a median Overall Survival of 79 months, compared to a Lomustine historical comparator of 72 months[8] - Kintara initiated patient randomization in the GBM AGILE trial for VAL-083 as of January 6, 2021[14] REM-001 (CMBC) - REM-001 targets Cutaneous Metastatic Breast Cancer (CMBC), representing a ~$500 million market opportunity[3, 16] - Prior clinical trials of REM-001 showed an 80% complete response rate in 674 evaluable lesions[17] - The company anticipates starting a lead-in study for CMBC in Q4 2021 / Q1 2022[18] General - The company estimates a combined investment of $240 million in R&D to date supporting its products[3] - Kintara has multiple US/EU Orphan Drug and Fast Track Designations for its products[27]