Kintara Therapeutics(KTRA)

Search documents
Kintara Therapeutics(KTRA) - 2023 Q3 - Quarterly Report
2023-05-11 12:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37823 Kintara Therapeutics, Inc. (Exact name of registrant as specified in its charter) | Nevada | 99-0360497 | | --- | --- | | (Stat ...
Kintara Therapeutics(KTRA) - 2023 Q2 - Quarterly Report
2023-02-14 22:02
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 ...
Kintara Therapeutics(KTRA) - 2023 Q1 - Quarterly Report
2022-11-09 22:16
☑ 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 ...
Kintara Therapeutics(KTRA) - 2022 Q4 - Annual Report
2022-09-27 12:01
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) ...
Kintara Therapeutics (KTRA) Investor Presentation - Slideshow
2022-06-15 19:25
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]
Kintara Therapeutics(KTRA) - 2022 Q3 - Quarterly Report
2022-05-13 12:31
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)
Kintara Therapeutics(KTRA) - 2022 Q2 - Quarterly Report
2022-02-11 13:01
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 ...
Kintara Therapeutics(KTRA) - 2022 Q1 - Quarterly Report
2021-11-15 11:21
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37823 Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the ...
Kintara Therapeutics(KTRA) - 2021 Q4 - Annual Report
2021-09-28 20:09
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 ...
Kintara Therapeutics (KTRA) Investor Presentation - Slideshow
2021-05-21 19:33
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]