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)

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 ...

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]

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].