0001498382false00014983822023-11-132023-11-13
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 13, 2023
KINTARA THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
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Nevada |
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001-37823 |
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99-0360497 |
(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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9920 Pacific Heights Blvd, Suite 150 San Diego, CA |
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92121 |
(Address of principal executive office) |
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(Zip Code) |
Registrant’s telephone number, including area code: (858) 350-4364
N/A
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common Stock |
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KTRA |
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The Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
Kintara Therapeutics, Inc. (the “Company”) issued a press release on November 13, 2023, disclosing financial information and operating metrics for the first fiscal quarter ended September 30, 2023, and providing a corporate update. A copy of the Company’s press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 7.01. Regulation FD Disclosure.
See “Item 2.02 Results of Operation and Financial Condition” above.
The information in this Current Report on Form 8-K under Items 2.02 and 7.01, including the information contained in Exhibit 99.1, is being furnished to the Securities and Exchange Commission, and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by a specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits:
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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KINTARA THERAPEUTICS, INC. |
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Date: November 13, 2023 |
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By: |
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/s/ Robert E. Hoffman |
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Name: Robert E. Hoffman |
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Title: Chief Executive Officer |
Exhibit 99.1
Kintara Therapeutics Announces Fiscal 2024 First Quarter Financial Results and Provides Corporate Update
SAN DIEGO, November 13, 2023/PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) (“Kintara” or the “Company”), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced financial results for its fiscal first quarter ended September 30, 2023 and provided a corporate update.
RECENT CORPORATE DEVELOPMENTS
•Announced that preliminary topline results from the Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) study showed that VAL-083 did not perform better than the current standards of care in glioblastoma. These topline results included preliminary safety data for VAL-083 that was similar to that of the current standards of care used to treat glioblastoma. With this study outcome, Kintara is suspending the development of VAL-083 and turning its focus to its second program, REM-001. In addition to focusing on its REM-001 program, Kintara will evaluate a wide range of strategic options aimed at potentially maximizing shareholder value. (October 2023)
•Awarded a $2.0 million Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to support the clinical development of REM-001, a second-generation photodynamic therapy (PDT) photosensitizer agent for the treatment of cutaneous metastatic breast cancer (CMBC). (June 2023)
“We are looking forward to enrolling the first patient in our 15 patient REM-001 study for cutaneous metastatic breast cancer, a disease with little or no current treatment options” commented Robert E. Hoffman, Kintara’s President and Chief Executive Officer. “The majority of study expenses will be covered by the $2 million National Institutes of Health grant we were awarded to support the further development of REM-001. We have undertaken efforts to significantly cut costs and are continuing to evaluate strategic options with the goal of maximizing shareholder value.”
SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR 2023 FIRST QUARTER ENDED SEPTEMBER 30, 2023
As of September 30, 2023, Kintara had cash and cash equivalents of approximately $0.2 million. In November 2023, the Company has received net proceeds of approximately 1.0 million from the sale of common stock, primarily from its at-the-market (ATM) facility.
For the three months ended September 30, 2023, Kintara reported a net loss of approximately $3.0 million, or $1.83 per share, compared to a net loss of approximately $4.6 million, or $3.39 per share, for the three months ended September 30, 2022. The decreased net losses for the three months ended September 30, 2023 compared to the three months ended September 30, 2022 was largely due to lower research and development expenses, primarily lower clinical development costs. General and administrative costs were also lower during the same period primarily due to reduced level of staffing.
Selected Balance Sheet Data (in thousands)
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September 30, 2023 |
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June 30, 2023 |
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$ |
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$ |
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Cash and cash equivalents |
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216 |
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1,535 |
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Working capital (deficiency) |
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(2,553) |
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188 |
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Total assets |
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1,477 |
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3,979 |
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Total stockholders’ equity (deficiency) |
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(2,026) |
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731 |
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Selected Statement of Operations Data (in thousands, except per share data)
For the three months ended
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September 30, |
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June 30, |
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2023 |
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2023 |
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$ |
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$ |
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Research and development |
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1,859 |
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3,171 |
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General and administrative |
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1,103 |
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1,475 |
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Other income |
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- |
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(50) |
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Net loss for the period |
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(2,962) |
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(4,596) |
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Series A Preferred cash dividend |
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(2) |
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(2) |
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Series C Preferred stock dividend |
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(173) |
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(362) |
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Net loss for the period attributable to common stockholders |
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(3,137) |
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(4,960) |
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Basic and fully diluted weighted average number of shares |
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1,718 |
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1,464 |
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Basic and fully diluted loss per share |
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(1.83) |
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(3.39) |
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Kintara’s financial statements as filed with the U.S. Securities Exchange Commission can be viewed on the Company’s website at: http://ir.kintara.com/sec-filings.
ABOUT KINTARA
Located in San Diego, California, Kintara is dedicated to the development of novel cancer therapies for patients with unmet medical needs. Kintara is developing therapeutics for clear unmet medical needs with reduced risk development programs. The Company's lead program is REM-001 Therapy for cutaneous metastatic breast cancer (CMBC).
Kintara has a proprietary, late-stage photodynamic therapy platform that holds promise as a localized cutaneous, or visceral, tumor treatment as well as in other potential indications. REM-001 Therapy, which consists of the laser light source, the light delivery device, and the REM-001 drug product, has been previously studied in four Phase 2/3 clinical trials in patients with CMBC who had previously received chemotherapy and/or failed radiation therapy. In CMBC, REM-001 has a clinical efficacy to date of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications.
For more information, please visit www.kintara.com or follow us on X at @Kintara_Thera, Facebook and Linkedin.
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SAFE HARBOR STATEMENT
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including statements regarding the status of the Company's clinical trials; the topline results of the GBM AGILE Study; and the Company's review of strategic alternatives. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability to develop, market and sell products based on its technology; the status of the Company’s clinical trials; the topline results of the GBM AGILE Study; the expected benefits and efficacy of the Company's products and technology; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies; and global unrest. These and other factors are identified and described in more detail in the Company's filings with the SEC, including the Company's Annual Report on Form 10-K for the year ended June 30, 2023, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.
CONTACTS
Investors
Robert E. Hoffman
Kintara Therapeutics
rhoffman@kintara.com
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