1. SAN DIEGO, Nov. 18, 2021 /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 data from two scientific posters for its Phase 2 clinical studies of VAL-083, the Company's lead compound for the treatment of glioblastoma multiforme (GBM).  The data are being presented at the 26th Annual Scientific Meeting of the Society for Neuro-Oncology (SNO) being held in Boston on November 18-21, 2021.

    Kintara is presenting posters on two Phase 2 clinical studies evaluating VAL-083 in patients with MGMT-unmethylated GBM as follows:

    Poster CTNI-21: "Phase 2 clinical trial of dianhydrogalactitol (VAL-083) in patients with

    SAN DIEGO, Nov. 18, 2021 /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 data from two scientific posters for its Phase 2 clinical studies of VAL-083, the Company's lead compound for the treatment of glioblastoma multiforme (GBM).  The data are being presented at the 26th Annual Scientific Meeting of the Society for Neuro-Oncology (SNO) being held in Boston on November 18-21, 2021.

    Kintara is presenting posters on two Phase 2 clinical studies evaluating VAL-083 in patients with MGMT-unmethylated GBM as follows:

    Poster CTNI-21: "Phase 2 clinical trial of dianhydrogalactitol (VAL-083) in patients with newly diagnosed MGMT-unmethylated GBM"

    The first poster outlined the open-label, Phase 2 study of VAL-083 as a first-line treatment in newly-diagnosed, unmethylated GBM patients conducted at Sun Yat-sen University Cancer Center in China.

    For the 25 efficacy evaluable patients enrolled with a starting dose of 30 mg/m2/day x 3 days every 21 days, progression free survival (PFS) was 8.7 months (95% confidence interval: CI 6.4-12.5) and median overall survival (mOS) was 19.1 months (CI 12.0-22.3). While not a head-to-head study, this compares favorably to historical temozolomide (TMZ) control ranging from 5.0-6.9 months PFS and 12.7-16.0 months mOS*.

    The poster also highlights a case report from the study for a patient who remains progression free for more than 37 months after diagnosis. All patients have completed treatment. Adverse events have been consistent with prior studies with myelosuppression being the most common adverse event.

    Poster CTNI-26: "Phase 2 study of dianhydrogalactitol (VAL-083) in patients with MGMT unmethylated, bevacizumab naïve glioblastoma in the adjuvant or recurrent setting"

    The second poster outlined the two groups of patients receiving VAL-083 in the open-label, Phase 2 study in recurrent and adjuvant unmethylated GBM being conducted at the MD Anderson Cancer Center in Houston.

    In the recurrent group, for the 48 efficacy evaluable patients enrolled with a starting dose of 30 mg/m2/day x 3 days every 21 days, mOS was 8.0 months (CI 6.6-10.3). While not a head-to-head study, this compares favorably to historical lomustine control mOS of 7.2 months**.

    In the adjuvant group, for the 36 efficacy evaluable patients enrolled with a starting dose of 30 mg/m2/day x 3 days every 21 days, PFS was 9.5 months (CI 8.2-10.8) and mOS was 16.5 months (CI 13.6-19.3). While not a head-to-head study, this compares favorably to historical TMZ control ranging from 5.0-6.9 months PFS and 12.7-16.0 months mOS*.

    All patients have completed treatment. Consistent with prior studies, myelosuppression was the most common adverse event in both recurrent GBM and in the adjuvant setting.

    *Hegi et al N Eng J Med (2005); Tanguturi et al. NeuroOncol (2017); Alnahhas et al. Neurooncol Adv (2020)

    ** Wick et al N.Eng.J.Med (2017)

    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 two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs.  The two programs are VAL-083 for GBM and REM-001 for CMBC.

    VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting its GBM AGILE study to support the development and commercialization of VAL-083 in GBM.

    Kintara is also advancing its 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 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. With clinical efficacy to date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing.

    For more information, please visit www.kintara.com or follow us on Twitter at @Kintara_Thera, Facebook and Linkedin.

    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 and the GBM AGILE study.  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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies.  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, 2021, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS:

    Investors:

    CORE IR

    516-222-2560

    Media:

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

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  2. SAN DIEGO, Nov. 15, 2021 /PRNewswire/ -- https://www.kintara.com/ (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, 2021 and provided a corporate update.

    CORPORATE HIGHLIGHTS AND RECENT DEVELOPMENTS

    • Positioned our management team for our next stage of development by announcing that Robert E. Hoffman, our current Chairman, succeeded Saiid Zarrabian as our President and Chief Executive Officer. Mr. Hoffman will continue in his capacity as our Chairman and Mr. Zarrabian has transitioned to heading up our strategic partnerships initiative and will remain a member of our Board of…

    SAN DIEGO, Nov. 15, 2021 /PRNewswire/ -- https://www.kintara.com/ (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, 2021 and provided a corporate update.

    CORPORATE HIGHLIGHTS AND RECENT DEVELOPMENTS

    • Positioned our management team for our next stage of development by announcing that Robert E. Hoffman, our current Chairman, succeeded Saiid Zarrabian as our President and Chief Executive Officer. Mr. Hoffman will continue in his capacity as our Chairman and Mr. Zarrabian has transitioned to heading up our strategic partnerships initiative and will remain a member of our Board of Directors (November).
    • Activated additional clinical trial sites for glioblastoma (GBM) patients for the VAL-083 arm of the GBM AGILE registrational study sponsored by the Global Coalition for Adaptive Research (GCAR). There are over 26 activated clinical sites (August).
    • Reported topline results from the Phase 2 study conducted at the MD Anderson Cancer Center that affirm the safety and efficacy of VAL-083 in two different GBM patient subtypes and support continued evaluation of VAL-083 in the GBM AGILE registrational study.
      • Topline Phase 2 clinical study results for VAL-083 as adjuvant therapy for newly-diagnosed GBM patients were reported demonstrating progression free survival and overall survival of 10.0 months and 16.5 months, respectively, in efficacy evaluable patients (September).
      • Topline Phase 2 clinical study results for VAL-083 for recurrent GBM were reported demonstrating median overall survival of 8.0 months for the 48 efficacy evaluable patients initially receiving the GBM AGILE treatment dose of 30 mg/m2/day (July).
    • Entered into securities purchase agreements with healthcare-focused institutional investors to raise approximately $15.0 million in gross proceeds. Funding from this registered direct offering provides cash for ongoing clinical studies and corporate working capital needs (September).
    • Continued to advance development of REM-001 for the treatment of Cutaneous Metastatic Breast Cancer (CMBC), including taking critical steps toward manufacturing sufficient quantity of drug to allow for initiation and completion of the 15-patient confirmatory study. Enrollment of first patient is expected in the second quarter of calendar 2022.

    "Our focus this past quarter was purely on executing the clinical strategy for VAL-083, our first-in-class, potentially transformational therapy for multiple oncology indications, and REM-001, our late-stage photodynamic therapeutic platform," commented Robert E. Hoffman, Kintara's President and Chief Executive Officer. "I'm particularly pleased to report that we have exceeded our expectations regarding the pace of enrollment for the GBM AGILE study and as such, remain confident that we'll meet the goal of advancing to the final registration stage of the study in the third quarter of calendar 2022."

    SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR 2022 FIRST QUARTER ENDED SEPTEMBER 30, 2021

    At September 30, 2021, the Company had cash and cash equivalents of approximately $19.3 million. For the three months ended September 30, 2021, the Company reported a net loss of approximately $6.0 million, or $0.25 per share, compared to a net loss of approximately $19.5 million, or $1.33 per share, for the three months ended September 30, 2020. The decrease in the net loss for the three months ended September 30, 2021 compared to the three months ended September 30, 2020 was largely due to the recognition of $16.1 million of non-cash expenses related to the acquisition of in-process research and development costs associated with the merger with Adgero Biopharmaceuticals Holdings, Inc. in August 2020.

    Selected Balance Sheet Data (in thousands)















    September 30,

    2021

    June 30,

    2021





    $

    $

    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 (in thousands, except per share data) 











    For the three months ended 











    September 30,

    September 30,





    2021

    2020





    $

    $

    Research and development



    3,793

    1,357

    General and administrative



    2,178

    1,534

    Merger costs



    500

    In-process research and development



    16,094

    Other (income) loss



    (5)

    33

    Net loss for the period



    (5,966)

    (19,518)

    Deemed dividend recognized on beneficial conversion

      features of Series C Preferred stock issuance



    (3,181)

    Series A Preferred cash dividend



    (2)

    (2)

    Series B Preferred stock dividend



    (5)

    Series C Preferred stock dividend



    (2,462)

    Net loss attributable to common stockholders



    (8,430)

    (22,706)

    Basic and fully diluted weighted average number of shares



    34,281

    17,106

    Basic and fully diluted loss per share



    (0.25)

    (1.33)









    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 two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs.  The two programs are VAL-083 for GBM and REM-001 for CMBC.

    VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting its GBM AGILE study to support the development and commercialization of VAL-083 in GBM.

    Kintara is also advancing its 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 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. With clinical efficacy to date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing.

    For more information, please visit www.kintara.com or follow us on Twitter at @Kintara_Thera, Facebook and Linkedin.

    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 and the GBM AGILE study.  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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies.  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, 2021, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS:

    Investors:

    CORE IR

    516-222-2560

    Media:

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

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  3. SAN DIEGO, Nov. 11, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announces today that its Chief Executive Officer, Robert E. Hoffman, will present a corporate overview at the Q4 Investor Summit Conference, which is being held virtually on November 16 – 17, 2021.

    Mr. Hoffman will deliver his corporate presentation on November 17, 2021 at 1:15 p.m.ET.

    Mr. Hoffman will be available for one-on-one meetings throughout the conference.

    Register HERE to watch the presentation.

    About Kintara

    Located in San Diego, California, Kintara (NASDAQ:KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs…

    SAN DIEGO, Nov. 11, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announces today that its Chief Executive Officer, Robert E. Hoffman, will present a corporate overview at the Q4 Investor Summit Conference, which is being held virtually on November 16 – 17, 2021.

    Mr. Hoffman will deliver his corporate presentation on November 17, 2021 at 1:15 p.m.ET.

    Mr. Hoffman will be available for one-on-one meetings throughout the conference.

    Register HERE to watch the presentation.

    About Kintara

    Located in San Diego, California, Kintara (NASDAQ:KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs. Kintara is currently developing two Phase 3-ready therapeutics, VAL-083 for glioblastoma multiforme (GBM) and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class", small-molecule, bifunctional alkylating agent that crosses the blood-brain-barrier and has a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    REM-001 is 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 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. With clinical efficacy of 80% complete responses of CMBC evaluable lesions, and an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. 

    For more information, please visit www.kintara.com or follow us on Twitter at @Kintara_TheraFacebook and Linkedin.

    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 and the GBM AGILE study. 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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. 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, 2021, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS

    Investors

    CORE IR

    516-222-2560

    Media

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/kintara-therapeutics-to-present-at-the-q4-investor-summit-virtual-conference-on-november-17-2021-301422038.html

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  4. SAN DIEGO, Nov. 9, 2021 /PRNewswire/ -- https://www.kintara.com/ (NASDAQ:KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced that Robert E. Hoffman, the Company's Chairman, will succeed Saiid Zarrabian as President and Chief Executive Officer, effective November 8, 2021. Mr. Hoffman will continue in his capacity as the Company's Chairman, and Mr. Zarrabian will transition to heading up Kintara's strategic partnerships initiative and will remain a member of the Board of Directors.

    "On behalf of the Board and the entire Kintara team, I wish to extend gratitude to Saiid for the tremendous impact he has made on the Company since joining the Board in 2017, and ultimately, taking over the helm of CEO back in 2018," commented Robert E. Hoffman, Kintara's President, Chief Executive Officer and Chairman. "Over the past few years, it was Saiid who led the effort to streamline and strengthen Kintara's operational foundation and product pipeline with the addition of REM-001, while also advancing multiple clinical trials for our platform asset VAL-083 highlighted by its participation in GCAR's GBM AGILE study. This is a transformational opportunity for the Company as the GCAR study is an FDA-approved registrational trial which is cost-effective through its expense-sharing protocol that is designed to greatly accelerate VAL-083's timeline for regulatory submission perhaps by up to 18 months. This is only one of many important milestones accomplished during Saiid's tenure as CEO, and I look forward to working with him to explore all that is possible for VAL-083 to help patients and to generate shareholder value."

    "It has been a pleasure serving as CEO and I'm thrilled to transition the post to Robert, as he brings an ideal operational and commercial leadership profile to the role, which is now needed as Kintara prepares for its next phase of growth given VAL-083 is entering the final stages of clinical development for the GBM indication," commented Saiid Zarrabian, Kintara's Head of Strategic Partnerships and member of the Board of Directors. "I joined Kintara based on my belief in VAL-083's potential to be a game-changing therapeutic agent.  Now that the Company is well-positioned to execute on its near-term clinical plan, I'm excited to dedicate my energy to working with Robert, my fellow Board members, and the entire Kintara team to explore potential strategic partnerships for VAL-083 and REM-001 for multiple oncology indications."

    Robert E. Hoffman has served as a director of Kintara since April 2018 and Chairman since June 2018. He currently serves as a Board member of Aslan Pharmaceuticals, Inc., Antibe Therapeutics, Inc., and Saniona AB.  Mr. Hoffman's previous experience includes serving as Senior Vice President and Chief Financial Officer of Heron Therapeutics from April 2017 to October 2020. Mr. Hoffman was part of the founding management team of Arena Pharmaceuticals, Inc. in 1997, serving in various roles until 2015, including Senior Vice President, Finance and Chief Financial Officer. Mr. Hoffman served as a member of the Financial Accounting Standards Board's Small Business Advisory Committee. Mr. Hoffman holds a B.B.A. from St. Bonaventure University.

    About the GBM AGILE Study and The Global Coalition for Adaptive Research (GCAR)

    The GBM AGILE study is a revolutionary, patient-centered, adaptive platform trial for registration, evaluating multiple therapies for patients with newly-diagnosed and recurrent GBM. VAL-083 currently represents the only therapeutic agent being evaluated in all subgroups of GBM AGILE (newly-diagnosed methylated MGMT, newly-diagnosed unmethylated MGMT, and recurrent patients). The study will enroll up to 150 patients in the initial evaluation (labeled 'stage 1') for the VAL-083 arm of the study at over 40 sites in the U.S. and Canada, with potential to increase to 65 clinical trial centers worldwide. Kintara has sufficient funding through stage 1, which could result in graduation to the final confirmatory stage, the potential NDA-enabling portion of the study. A key benefit to participating in the GBM AGILE Study is that it may accelerate VAL-083's time to pivotal trial completion and potential regulatory submission by up to 18 months.  As of August, 2021, 26 U.S. clinical sites have been activated.

    GCAR is a 501(c)(3) nonprofit organization, comprised of some of the world's foremost physicians, clinical researchers and investigators united in expediting the discovery and development of cures for patients with rare and deadly diseases.  Key strategic partners for its GBM AGILE study effort include the National Brain Tumor Society, National Foundation for Cancer Research, and Asian Fund for Cancer Research. 

    About Kintara

    Located in San Diego, California, Kintara (NASDAQ:KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs. Kintara is currently developing two Phase 3-ready therapeutics, VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class," small molecule bifunctional alkylating agent that crosses the blood-brain barrier. VAL-083 is independent of the MGMT resistance mechanism and has been assessed in over 40 Phase 1 and Phase 2 clinical trials in multiple indications sponsored by the U.S. National Cancer Institute. Published pre-clinical and clinical data indicate that VAL-083 has activity against a range of tumor types, including lung, brain, cervical, ovarian tumors and hematologic (blood) cancers. VAL-083 has been granted Orphan Drug Designation for GBM by the FDA and EMA and has also been granted Orphan Drug Designations for medulloblastoma and ovarian cancer by the FDA. In addition, the FDA has granted Fast Track Designation for VAL-083 in recurrent GBM. VAL-083 is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia and lung cancer. VAL-083 has not been approved for any indications outside of China.

    Kintara is also advancing its 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 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. With clinical efficacy to date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. 

    For more information, please visit www.kintara.com or follow us on Twitter at @Kintara_TheraFacebook and Linkedin.

    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 and the GBM AGILE study.  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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies.  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, 2021, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS

    Investors

    CORE IR

    516-222-2560

    Media

    Jules Abraham

    EVP, Head of Communications

    CORE IR

    917-885-7378

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/kintara-announces-changes-to-executive-leadership-team-301419582.html

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  5. SAN DIEGO, Sept. 29, 2021 /PRNewswire/ -- https://www.kintara.com/ (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 year ended June 30, 2021 and provided a corporate update.

    CORPORATE HIGHLIGHTS AND RECENT DEVELOPMENTS

    • Entered into securities purchase agreements with healthcare-focused institutional investors to raise approximately $15 million in gross proceeds (September). Funding from this registered direct offering, which was priced at a premium to market, was consummated on September 28, 2021, and provides cash for ongoing clinical studies and corporate working capital needs.
    • Bolstered patient enrollment…

    SAN DIEGO, Sept. 29, 2021 /PRNewswire/ -- https://www.kintara.com/ (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 year ended June 30, 2021 and provided a corporate update.

    CORPORATE HIGHLIGHTS AND RECENT DEVELOPMENTS

    • Entered into securities purchase agreements with healthcare-focused institutional investors to raise approximately $15 million in gross proceeds (September). Funding from this registered direct offering, which was priced at a premium to market, was consummated on September 28, 2021, and provides cash for ongoing clinical studies and corporate working capital needs.
    • Bolstered patient enrollment opportunities in the U.S. by activating additional clinical trial sites for glioblastoma (GBM) patients for the VAL-083 arm of the GBM AGILE registrational study sponsored by the Global Coalition for Adaptive Research (GCAR).
      • Announced initiation of patient recruitment at first site (January)
      • Reported activation of 15 clinical sites for the GBM AGILE study (May)
      • Updated site activation to 26 clinical sites (August)

    The GBM AGILE study is a revolutionary, patient-centered, adaptive platform trial for registration evaluating multiple therapies for patients with newly-diagnosed and recurrent GBM. VAL-083 currently represents the only therapeutic agent being evaluated in all subgroups of GBM AGILE (newly-diagnosed methylated MGMT, newly-diagnosed unmethylated MGMT, and recurrent patients). The study will enroll up to 150 patients in the initial evaluation (labeled 'stage 1') for the VAL-083 arm of the study at over 40 sites in the U.S. and Canada, with potential to increase to 65 clinical trial centers worldwide. The Company is forecasting that the recent financing will provide sufficient funding through stage 1, which could result in graduation to the final confirmatory stage, the potentially NDA enabling portion of the GBM AGILE study.

    • Reported topline results from the Phase 2 study conducted at the MD Anderson Cancer Center that affirm the safety and efficacy of VAL-083 in two different GBM patient subtypes and support continued evaluation of VAL-083 in the GBM AGILE registrational study.
      • In September, topline Phase 2 clinical study results for VAL-083 as adjuvant therapy for newly-diagnosed GBM patients were reported demonstrating progression free survival (PFS) and overall survival (OS) of 10.0 months and 16.5 months, respectively, in efficacy evaluable patients
      • In July, topline Phase 2 clinical study results for VAL-083 for recurrent GBM were reported demonstrating median overall survival (mOS) for the 48 efficacy evaluable patients initially receiving the GBM AGILE treatment dose of 30 mg/m2/day of 8.0 months.
    • Continued to advance development of REM-001 for the treatment of Cutaneous Metastatic Breast Cancer (CMBC), including taking critical steps toward manufacturing sufficient quantity of drug to allow for initiation and completion of our 15-patient lead-in CMBC study.
    • Joined the Russel Microcap Index effective June 28, 2021. Russell Indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell's U.S. Indexes.
    • Enhanced leadership team by appointing Tamara A. Seymour to the Board of Directors (April). Ms. Seymour is a corporate finance veteran with three decades of experience in biotech and life sciences including roles as a Chief Financial Officer and Board member of publicly-listed companies.

    "As we embark on a new fiscal year with a strengthened cash position from our recent financing, I'm extremely pleased with where the Company is positioned on the clinical and corporate development fronts," commented Saiid Zarrabian, Kintara's President and Chief Executive Officer. "Moving forward, our diversified, late-stage pipeline has multiple, significant near-term milestones, highlighted by the GCAR GBM AGILE study. We believe this registration study represents an extraordinary opportunity for the Company as it provides an optimal clinical path given its highly accelerated program as evidenced by the initiation of patient enrollment at 26 sites in less than eight months, and from a cost savings standpoint through an FDA approved registrational trial which provides Kintara the unique opportunity to enroll three separate GBM patient subtypes. We are entering a pivotal juncture in the Company's development, and I wish to extend gratitude to our longstanding shareholders for their continued support."

    SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR ENDED JUNE 30, 2021

    At June 30, 2021, the Company had cash and cash equivalents of approximately $10.5 million.  For the year ended June 30, 2021, the Company reported a net loss of approximately $38.3 million, or $1.60 per share, compared to a net loss of approximately $9.1 million, or $0.87 per share, for the year ended June 30, 2020.  The increase in loss for the year ended June 30, 2021 compared to the year ended June 30, 2020 was largely due to the recognition of $16.1 million of non-cash expenses related to the acquisition of in-process research and development costs associated with the acquisition of Adgero Biopharmaceuticals Holdings, Inc. and an expanded rate of expenditures with the initiation of the GCAR study and REM-001 development.

    Selected Balance Sheet Data (in thousands)







    June 30,

    2021



    June 30,

    2020





    $



    $

    Cash and cash equivalents



    10,537



    2,392

    Working capital



    9,013



    176

    Total assets



    13,543



    2,938

    Total stockholders' equity



    10,581



    263

     

    Selected Statement of Operations Data (in thousands, except per share data)



    For the years ended 





    June 30,

    2021



    June 30,

    2020



    $



    $

    Research and development

    11,815



    3,630

    General and administrative

    9,757



    4,514

    Merger costs

    500



    1,054

    In-process research and development

    16,094



    -

    Other loss (income)

    132



    (72)

    Net loss for the period

    (38,298)



    (9,126)

    Deemed dividend recognized on beneficial conversion features of Series C

    Preferred stock issuance

    (3,181)



    -

    Series A Preferred cash dividend

    (8)



    (8)

    Series B Preferred stock dividend

    (17)



    (9)

    Net loss attributable to common stockholders

    (41,504)



    (9,143)

    Basic and fully diluted weighted average number of shares

    25,886



    10,444

    Basic and fully diluted loss per share

    (1.60)



    (0.87)





    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 two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs.  The two programs are VAL-083 for GBM and REM-001 for CMBC.

    VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    Kintara is also advancing its 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, 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. With clinical efficacy to date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing.

    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 and the GBM AGILE study.  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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies.  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, 2021, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS:

    Investors:

    CORE IR

    516-222-2560

    Media:

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/kintara-therapeutics-announces-fiscal-year-2021-financial-results-and-provides-corporate-update-301387543.html

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  6. SAN DIEGO, Sept. 28, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA) ("Kintara" or the "Company"), a biopharmaceutical company developing novel cancer therapies for patients who are failing, or are resistant to, current treatment regimens today announced the closing of its previously announced registered direct offering, priced at-the-market under Nasdaq rules, with several healthcare-focused institutional investors of 12,000,000 shares of its common stock (or common stock equivalents) and warrants to purchase up to an aggregate of 12,000,000 shares of common stock, at a combined offering price of $1.25 per share and associated warrant. The warrants have an exercise price of $1.25 per share and are exercisable for three and one…

    SAN DIEGO, Sept. 28, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA) ("Kintara" or the "Company"), a biopharmaceutical company developing novel cancer therapies for patients who are failing, or are resistant to, current treatment regimens today announced the closing of its previously announced registered direct offering, priced at-the-market under Nasdaq rules, with several healthcare-focused institutional investors of 12,000,000 shares of its common stock (or common stock equivalents) and warrants to purchase up to an aggregate of 12,000,000 shares of common stock, at a combined offering price of $1.25 per share and associated warrant. The warrants have an exercise price of $1.25 per share and are exercisable for three and one half years from the date of issuance. The gross proceeds to the Company totaled approximately $15 million, before deducting placement agent fees and offering expenses.

    H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

    The Company currently intends to use the net proceeds from the offering for funding its clinical studies, working capital and other general corporate purposes, including, but not limited to, funding acquisitions or investments in businesses, products or technologies that are complementary to the Company's businesses, products and technologies.

    The securities described above were offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-254662) filed with the Securities and Exchange Commission (SEC) on March 24, 2021 and declared effective on April 1, 2021. The offering of the securities described herein was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered was filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC's website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996, or email at .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About Kintara

    Located in San Diego, California, Kintara (NASDAQ:KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs. Kintara is currently developing two Phase 3-ready therapeutics, VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class", small-molecule, bifunctional alkylating agent that crosses the blood-brain-barrier and has a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    REM-001 is 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 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. With clinical efficacy of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. 

    For more information, please visit www.kintara.com or follow us on Twitter at @Kintara_Thera, Facebook and Linkedin.

    Forward-Looking 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. 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 intended use of proceeds from the offering, the impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. 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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS

    Investors

    CORE IR

    516-222-2560

    Media

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/kintara-announces-closing-of-15-0-million-offering-priced-at-a-premium-to-market-301387017.html

    SOURCE Kintara Therapeutics

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  7. SAN DIEGO, Sept. 24, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA) ("Kintara" or the "Company"), a biopharmaceutical company developing novel cancer therapies for patients who are failing, or are resistant to, current treatment regimens today announced that it has entered into securities purchase agreements with certain healthcare-focused institutional investors to raise approximately $15 million in gross proceeds, before placement agent fees and other offering expenses payable by Kintara, through the issuance of 12,000,000 shares of its common stock (or common stock equivalents) and investor warrants to purchase up to an aggregate of 12,000,000 shares of common stock in a registered direct offering priced at-the-market under…

    SAN DIEGO, Sept. 24, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA) ("Kintara" or the "Company"), a biopharmaceutical company developing novel cancer therapies for patients who are failing, or are resistant to, current treatment regimens today announced that it has entered into securities purchase agreements with certain healthcare-focused institutional investors to raise approximately $15 million in gross proceeds, before placement agent fees and other offering expenses payable by Kintara, through the issuance of 12,000,000 shares of its common stock (or common stock equivalents) and investor warrants to purchase up to an aggregate of 12,000,000 shares of common stock in a registered direct offering priced at-the-market under Nasdaq rules. Each share of common stock (or common stock equivalent) is being sold together with one investor warrant to purchase one share of common stock at a combined offering price of $1.25. The investor warrants have an exercise price of $1.25 per share and are exercisable for three and one half years from the date of issuance. The closing of the offering is expected to occur on or about September 28, 2021, subject to the satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

    The Company currently intends to use the net proceeds from the offering for funding its clinical studies, working capital and other general corporate purposes, including, but not limited to, funding acquisitions or investments in businesses, products or technologies that are complementary to the Company's businesses, products and technologies.

    The securities described above are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-254662) filed with the Securities and Exchange Commission (SEC) on March 24, 2021 and declared effective on April 1, 2021. The offering of the securities described herein will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC's website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996, or email at .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About Kintara

    Located in San Diego, California, Kintara (NASDAQ:KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs. Kintara is currently developing two Phase 3-ready therapeutics, VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class", small-molecule, bifunctional alkylating agent that crosses the blood-brain-barrier and has a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    REM-001 is 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 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. With clinical efficacy of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. 

    For more information, please visit www.kintara.com or follow us on Twitter at @Kintara_Thera, Facebook and Linkedin.

    Forward-Looking 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 completion of the offering. 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 satisfaction of customary closing conditions related to the offering, the intended use of proceeds from the offering, the impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. 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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS

    Investors

    CORE IR

    516-222-2560

    Media

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/kintara-announces-15-0-million-offering-of-common-stock-and-warrants-priced-at-a-premium-to-market-301384567.html

    SOURCE Kintara Therapeutics

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  8. SAN DIEGO, Sept. 22, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA) ("Kintara" or the "Company"), a biopharmaceutical company developing novel cancer therapies for patients who are failing, or are resistant to, current treatment regimens today announced topline data results from the newly-diagnosed adjuvant arm of its open-label, Phase 2 clinical study being conducted at the MD Anderson Cancer Center (MD Anderson) in Houston, Texas.

    The Phase 2 trial was a two-arm, biomarker-driven study testing VAL-083 in glioblastoma multiforme (GBM) patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. The Company previously announced (July 2021) topline data results from the recurrent GBM arm of…

    SAN DIEGO, Sept. 22, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA) ("Kintara" or the "Company"), a biopharmaceutical company developing novel cancer therapies for patients who are failing, or are resistant to, current treatment regimens today announced topline data results from the newly-diagnosed adjuvant arm of its open-label, Phase 2 clinical study being conducted at the MD Anderson Cancer Center (MD Anderson) in Houston, Texas.

    The Phase 2 trial was a two-arm, biomarker-driven study testing VAL-083 in glioblastoma multiforme (GBM) patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. The Company previously announced (July 2021) topline data results from the recurrent GBM arm of the study which provided important safety and efficacy data to support the continued evaluation of VAL-083 as a treatment option for GBM.

    The newly-diagnosed adjuvant arm of the study addressed GBM patients requiring adjuvant therapy after chemoradiation with temozolomide. The trial arm enrolled 39 patients (36 efficacy evaluable) initially receiving a dose of 30 mg/m2/day on days 1, 2 and 3 of a 21-day cycle.

    Summary of results:

    • Progression Free Survival (PFS) for the 36 efficacy evaluable patients is 10.0 months (95% Confidence Interval (CI) 8.2-10.8 months). While this is not a head-to-head trial, historical data for this patient population has demonstrated PFS of 5.3-6.9 months*.
    • Median overall survival (mOS) for the 36 efficacy evaluable patients is 16.5 months (CI 13.3-19.3 months). While this is not a head-to-head trial historical data for this patient subpopulation has demonstrated mOS of 12.7-16.0 months*.
    • Consistent with prior studies, myelosuppression was the most common adverse event. One patient experienced a serious adverse event (SAE) possibly related to VAL-083.

    The dosing regimen (30 mg/m2/day) of the MD Anderson study mirrors the trial design of the newly-diagnosed adjuvant study arm of the GBM AGILE study. GBM AGILE, which is sponsored by the Global Coalition for Adaptive Research (GCAR), is a revolutionary, patient-centered, registrational, seamless Phase 2/3 adaptive platform trial evaluating multiple therapies for patients with newly-diagnosed and recurrent GBM. VAL-083 currently represents the only therapeutic agent being evaluated in all three GBM patient subtypes: methylated MGMT, newly-diagnosed unmethylated MGMT, and recurrent.

    "On behalf of the entire Kintara team, I wish to extend gratitude to MD Anderson, and all of the patients who participated in both arms of the trial," said Saiid Zarrabian, Kintara's Chief Executive Officer. "The topline results from the newly-diagnosed adjuvant arm are a particularly important milestone for the company as it further affirms the efficacy and safety data reported this past July from the recurrent arm, thus providing additional support and momentum to continue the evaluation of VAL-083 for the treatment of GBM."

    Dr. Barbara O'Brien, the Principal Investigator for the Phase 2 study at MD Anderson added, "I continue to be impressed by the clinical data generated by both arms of the study and remain excited by VAL-083's potential to be a game-changing therapeutic agent to help patients suffering from this deadly disease."

    VAL-083 is independent of the MGMT resistance mechanism and has been assessed in over 40 Phase 1 and Phase 2 clinical trials in multiple indications sponsored by the U.S. National Cancer Institute (NCI). Published pre-clinical and clinical data indicate that VAL-083 has activity against a range of tumor types, including lung, brain, cervical, ovarian tumors and hematologic (blood) cancers. VAL-083 has been granted Orphan Drug Designation for GBM by the FDA and EMA and has also been granted Orphan Drug Designations for medulloblastoma and ovarian cancer by the FDA. In addition, the FDA has granted Fast Track Designation for VAL-083 in recurrent GBM. VAL-083 is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia and lung cancer. VAL-083 has not been approved for any indications outside of China.

    * Hegi et al N Eng J Med 352; 997-1003 (2005);

    Tanguturi et al. NeuroOncol. 19(7): 908-917 (2017)

    About Kintara

    Located in San Diego, California, Kintara (NASDAQ:KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs. Kintara is currently developing two Phase 3-ready therapeutics, VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class", small-molecule, bifunctional alkylating agent that crosses the blood-brain-barrier and has a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the NCI. Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    REM-001 is 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 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. With clinical efficacy of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. 

    For more information, please visit www.kintara.com or follow us on Twitter at @Kintara_TheraFacebook and Linkedin.

    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 and the GBM AGILE study. 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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. 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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS

    Investors

    CORE IR

    516-222-2560

    Media

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/kintara-reports-topline-results-from-phase-2-clinical-study-of-val-083-as-adjuvant-therapy-for-newly-diagnosed-gbm-patients-301382460.html

    SOURCE Kintara Therapeutics

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  9. PRESS RELEASE

    16 September 2021

    Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today announced the appointment of Robert E. Hoffman to its board of directors, as resolved at the extraordinary shareholders' meeting held on September 16, 2021. Hoffman is an experienced financial executive and board member with nearly 30 years of experience and achievements in accounting, finance, fund raising, strategic planning, corporate governance, investor relations, and leadership.

    "Robert's depth of experience leading and advising U.S.-listed companies on corporate finance, investor relations and related activities will be valuable as we continue to develop our board and evaluate a future U.S. listing…

    PRESS RELEASE

    16 September 2021

    Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today announced the appointment of Robert E. Hoffman to its board of directors, as resolved at the extraordinary shareholders' meeting held on September 16, 2021. Hoffman is an experienced financial executive and board member with nearly 30 years of experience and achievements in accounting, finance, fund raising, strategic planning, corporate governance, investor relations, and leadership.

    "Robert's depth of experience leading and advising U.S.-listed companies on corporate finance, investor relations and related activities will be valuable as we continue to develop our board and evaluate a future U.S. listing," said J. Donald deBethizy, Chairman of the Saniona Board of Directors. 

    "I see in Saniona a company with a considerable amount of untapped potential. There is incredible depth in the pipeline and the talent, and I look forward to supporting and advising the team on how to ensure Saniona's potential is appreciated and valued," said Hoffman.

    Hoffman currently sits on three publicly-traded company boards with market capitalizations ranging from $30 million to $300 million (NASDAQ:ASLN, NASDAQ:KTRA, TSX:ATE), serving as chairman on one of the boards and as financial expert on the other boards. Hoffman also serves as a board member of the Association of Bioscience Financial Officers and FibroBiologics, Inc., a private biotechnology company. In his most recent operating role, Hoffman was Chief Financial Officer (CFO) of San Diego-based Heron Pharmaceuticals, a Nasdaq-listed, commercial-stage drug developer with a pipeline of acute pain therapeutics. During his tenure at Heron, the company raised more than $650 million and launched its second commercial drug product. Hoffman's career in the biotechnology sector began in 1997 at Arena Pharmaceuticals, where he was a member of the founding management team and rose to become CFO, holding that position for ten years. While at Arena, he was involved in its Initial Public Offering (IPO) and financings, raising more than $1.5 billion. Hoffman was the financial lead in two Arena acquisitions, including a Swiss manufacturing facility, and he became managing director of the facility upon the closing of the transaction. Hoffman also was an advisor to the Financial Accounting Standard Board (FASB) for 10 years (2010 to 2020), advising the United States accounting rulemaking organizations on emerging issues and new financial guidance. As a founder of Day For Change, a not-for-profit that serves underprivileged and abused children in San Diego, Hoffman has served on its board of directors for 20 years. Hoffman received his BBA in accounting from St. Bonaventure University and is a licensed CPA (Inactive) in the State of California.

    Hoffman is considered independent in relation to the company, its senior management and major shareholders. Hoffman does not own shares in Saniona.

    For more information, please contact

    Trista Morrison, Chief Communications Officer, Saniona. Office: + 1 (781) 810-9227. Email:

    The information was submitted for publication, through the agency of the contact person set out above, at 17.50 CEST on 16 September 2021.

    About Saniona

    Saniona is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing innovative therapies for patients suffering from rare diseases for which there are a lack of available treatment options. The company's lead product candidate, Tesomet, is in mid-stage clinical trials for hypothalamic obesity and Prader-Willi syndrome, serious rare disorders characterized by severe weight gain, disturbances of metabolic functions and uncontrollable hunger. Saniona has developed a proprietary ion channel drug discovery engine anchored by IONBASE™, a database of more than 130,000 ion channel modulators, of which more than 20,000 are Saniona's proprietary compounds. Through its ion channel expertise, Saniona is advancing two wholly-owned ion channel modulators, SAN711 and SAN903. SAN711 is in a Phase 1 clinical trial and may be applicable in the treatment of rare neuropathic disorders, and SAN903 is in preclinical development for rare inflammatory, fibrotic and hematological disorders. Led by an experienced scientific and operational team, Saniona has an established research organization in the Copenhagen area, Denmark, and a corporate office in the Boston, Massachusetts area, U.S. The company's shares are listed on Nasdaq Stockholm Small Cap (OMX: SANION). Read more at http://www.saniona.com.

     

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  10. SAN DIEGO, Aug. 17, 2021 /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 that the VAL-083 treatment arm in the Global Coalition for Adaptive Research (GCAR) registrational Phase 2/3 clinical trial for glioblastoma multiforme (GBM) has been activated in 26 U.S. sites as of August 16, 2021.

    The trial, titled GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment), is a patient-centered, Phase 2/3 adaptive platform trial evaluating multiple therapies for patients with newly-diagnosed and recurrent GBM. Since January 2021, GCAR has accelerated the pace of clinical site activation with…

    SAN DIEGO, Aug. 17, 2021 /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 that the VAL-083 treatment arm in the Global Coalition for Adaptive Research (GCAR) registrational Phase 2/3 clinical trial for glioblastoma multiforme (GBM) has been activated in 26 U.S. sites as of August 16, 2021.

    The trial, titled GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment), is a patient-centered, Phase 2/3 adaptive platform trial evaluating multiple therapies for patients with newly-diagnosed and recurrent GBM. Since January 2021, GCAR has accelerated the pace of clinical site activation with increased awareness in the medical community of Kintara's arm of the study. GCAR plans to enroll 150-200 patients in the Kintara arm of the study at over 40 sites in the U.S. and Canada with potential to increase this total to 65 clinical trial centers worldwide.

    "The entire Kintara team remains enthused by the pace at which our treatment arm is being activated in the study," commented Saiid Zarrabian, Kintara's Chief Executive Officer. "With 26 sites already active, including the recent addition of prestigious centers such as the Dana Farber Cancer Institute and Massachusetts General Hospital, we are delighted to witness GCAR's exceptional clinical trial execution capabilities that drew us to participate in this exciting and highly efficient registrational study."

    Key GBM AGILE Highlights for VAL-083

    • Only therapeutic agent currently being evaluated in all three GBM patient subtypes: newly-diagnosed methylated MGMT; newly-diagnosed unmethylated MGMT; and recurrent
    • May accelerate VAL-083's time to pivotal trial completion and potential regulatory submission by up to 18 months
    • Cost-effective opportunity to advance VAL-083 due to the GBM AGILE study's expense sharing protocol

    GBM AGILE is an international, innovative platform trial designed to more rapidly identify and confirm effective therapies for patients with GBM through response adaptive randomization and a seamless Phase 2/3 design. The trial, conceived by over 130 key opinion leaders, is conducted under a master protocol allowing multiple therapies, or combinations of therapies,

    from different pharmaceutical partners to be evaluated simultaneously. With its innovative design and efficient operational infrastructure, data from GBM AGILE may be used as the foundation for a new drug application and biologics license application submissions and registrations to the FDA and other health authorities.

    Kintara's VAL-083 is a "first-in-class," small molecule bifunctional alkylating agent that crosses the blood-brain barrier. VAL-083 is independent of the MGMT resistance mechanism and has been assessed in over 40 Phase 1 and Phase 2 clinical trials in multiple indications sponsored by the U.S. National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    Published pre-clinical and clinical data indicate that VAL-083 has activity against a range of tumor types, including lung, brain, cervical, and ovarian tumors as well as hematologic (blood) cancers. VAL-083 has been granted Orphan Drug Designation for GBM by the FDA and EMA and has also been granted Orphan Drug Designations for medulloblastoma and ovarian cancer by the FDA. In addition, the FDA granted Fast Track Designation for VAL-083 in recurrent GBM. VAL-083 is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia and lung cancer. VAL-083 has not been approved for any indications outside of China.

    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 two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs. The two programs are VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).

    Kintara's REM-001 is 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, 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. With clinical efficacy to date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing.

    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 and the GBM AGILE study. 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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. 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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS:

    Investors:

    CORE IR

    516-222-2560

    Media:

    Jules Abraham

    Director of Public Relations CORE IR

    917-885-7378

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/kintara-therapeutics-provides-positive-site-activation-update-on-gcar-phase-23-clinical-trial-for-glioblastoma-301356438.html

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  11. SAN DIEGO, Aug. 12, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA), a biopharmaceutical company developing novel cancer therapies for patients who are failing or are resistant to current treatment regimens, announced today that its Chief Executive Officer, Saiid Zarrabian, will present at the Investor Summit Conference being held August 17 – 18, 2021.

    Mr. Zarrabian will deliver his corporate presentation on August 17, 2021 at 12:30 p.m.ET.

    Investors can also request a one-on-one meeting with Mr. Zarrabian to be arranged following the conclusion of the conference.

    Investors can register here: Q3 Investor Summit Investor Registration

    About Kintara

    Located in San Diego, California, Kintara (NASDAQ:KTRA) is dedicated to the development…

    SAN DIEGO, Aug. 12, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA), a biopharmaceutical company developing novel cancer therapies for patients who are failing or are resistant to current treatment regimens, announced today that its Chief Executive Officer, Saiid Zarrabian, will present at the Investor Summit Conference being held August 17 – 18, 2021.

    Mr. Zarrabian will deliver his corporate presentation on August 17, 2021 at 12:30 p.m.ET.

    Investors can also request a one-on-one meeting with Mr. Zarrabian to be arranged following the conclusion of the conference.

    Investors can register here: Q3 Investor Summit Investor Registration

    About Kintara

    Located in San Diego, California, Kintara (NASDAQ:KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs. Kintara is currently developing two Phase 3-ready therapeutics, VAL-083 for glioblastoma multiforme (GBM) and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class", small-molecule, bifunctional alkylating agent that crosses the blood-brain-barrier and has a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    REM-001 is 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 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. With clinical efficacy of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. 

    For more information, please visit www.kintara.com or follow us on Twitter at @Kintara_TheraFacebook and Linkedin.

    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 and the GBM AGILE study. 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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. 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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS

    Investors

    CORE IR

    516-222-2560

    Media

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/kintara-therapeutics-to-present-at-the-investor-summit-virtual-conference-on-august-17-2021-301354010.html

    SOURCE Kintara Therapeutics

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  12. SAN DIEGO, Aug. 4, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA), a biopharmaceutical company developing novel cancer therapies for patients who are failing or are resistant to current treatment regimens, announced today that Saiid Zarrabian, Chief Executive Officer, will participate at the BTIG Virtual Biotechnology Conference on August 9, 2021.

    Mr. Zarrabian will deliver his corporate presentation on Monday, August 9, 2021 at 2:00 p.m. ET / 11:00 a.m. PT.

    The live webcast will be available on the BTIG conference website at the time of the event, after which it will be available through BTIG research access.

    Investors can also request a one-on-one meeting with Mr. Zarrabian to be arranged following the conclusion of the conference. Please…

    SAN DIEGO, Aug. 4, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA), a biopharmaceutical company developing novel cancer therapies for patients who are failing or are resistant to current treatment regimens, announced today that Saiid Zarrabian, Chief Executive Officer, will participate at the BTIG Virtual Biotechnology Conference on August 9, 2021.

    Mr. Zarrabian will deliver his corporate presentation on Monday, August 9, 2021 at 2:00 p.m. ET / 11:00 a.m. PT.

    The live webcast will be available on the BTIG conference website at the time of the event, after which it will be available through BTIG research access.

    Investors can also request a one-on-one meeting with Mr. Zarrabian to be arranged following the conclusion of the conference. Please contact a BTIG conference representative.

    About Kintara

    Located in San Diego, California, Kintara (NASDAQ:KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs. Kintara is currently developing two Phase 3-ready therapeutics, VAL-083 for glioblastoma multiforme (GBM) and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class", small-molecule, bifunctional alkylating agent that crosses the blood-brain-barrier and has a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    REM-001 is 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 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. With clinical efficacy of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing.

    For more information, please visit www.kintara.com or follow us on Twitter at @Kintara_TheraFacebook and Linkedin.

    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 and the GBM AGILE study. 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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. 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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS

    Investors

    CORE IR

    516-222-2560

    Media

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/kintara-therapeutics-to-present-at-the-btig-virtual-biotechnology-conference-on-august-9-2021-301348033.html

    SOURCE Kintara Therapeutics

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  13. SAN DIEGO, July 1, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA) ("Kintara" or the "Company"), a biopharmaceutical company developing novel cancer therapies for patients who are failing or are resistant to current treatment regimens, today announced topline data results from the recurrent arm of its open-label, Phase 2 clinical study of its lead compound VAL-083 being conducted at the MD Anderson Cancer Center (MD Anderson) in Houston, Texas.

    The Phase 2 trial is a two-arm, biomarker-driven study testing VAL-083 in glioblastoma multiforme (GBM) patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. The recurrent arm of the study addressed patients who have been pre-treated with…

    SAN DIEGO, July 1, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA) ("Kintara" or the "Company"), a biopharmaceutical company developing novel cancer therapies for patients who are failing or are resistant to current treatment regimens, today announced topline data results from the recurrent arm of its open-label, Phase 2 clinical study of its lead compound VAL-083 being conducted at the MD Anderson Cancer Center (MD Anderson) in Houston, Texas.

    The Phase 2 trial is a two-arm, biomarker-driven study testing VAL-083 in glioblastoma multiforme (GBM) patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. The recurrent arm of the study addressed patients who have been pre-treated with temozolomide prior to disease recurrence.

    The recurrent arm of the trial enrolled 89 patients, with 35 patients (35 efficacy evaluable) initially receiving a dose of VAL-083 at 40 mg/m2/day, and 54 patients (48 efficacy evaluable) initially receiving the treatment dose of 30 mg/m2/day on days 1, 2 and 3 of a 21-day cycle. This 30 mg dose corresponds to the dose being studied in the recently initiated and currently enrolling VAL-083 study arm of the GBM AGILE study.

     Summary of results:

    -       Median overall survival (mOS) for the 48 efficacy evaluable patients initially receiving the treatment dose of 30 mg/m2/day is 8.0 months (95% confidence interval: CI 5.9-9.9 months). While this is not a head-to-head trial, historically, lomustine, which is the most commonly used chemotherapy for these patients, has demonstrated mOS of 7.2 months*

    -       Consistent with prior studies, myelosuppression was the most common adverse event. In the 30 mg/m2/day starting dose cohort, five patients experienced a serious adverse event (SAE) possibly related to VAL-083

    -       For the 83 efficacy evaluable patients who have completed at least one cycle of treatment mOS was 7.5 months (CI 6.1-9.0 months)

    "I'm extremely pleased with the outcome of the recurrent arm of the study as it provided important safety and efficacy data to support further evaluation of VAL-083 for the treatment of GBM," said Saiid Zarrabian, Kintara's Chief Executive Officer. "The study of VAL-083 continues in GBM AGILE, an adaptive registration study where it is currently the only therapeutic agent being evaluated for all three GBM patient subtypes: newly-diagnosed methylated MGMT, newly-diagnosed unmethylated MGMT, and recurrent."

    Dr. Barbara O'Brien, the Principal Investigator for the Phase 2 study at MD Anderson added, "These data continue to support VAL-083's compelling potential as a potent DNA targeting cytotoxic agent for the treatment of GBM, which remains a deadly disease with an urgent need for improved treatment options."

    VAL-083 is independent of the MGMT resistance mechanism and has been assessed in over 40 Phase 1 and Phase 2 clinical trials in multiple indications sponsored by the U.S. National Cancer Institute (NCI). Published pre-clinical and clinical data indicate that VAL-083 has activity against a range of tumor types, including lung, brain, cervical, and ovarian tumors and hematologic (blood) cancers. VAL-083 has been granted Orphan Drug Designation for GBM by the FDA and EMA and has also been granted Orphan Drug Designations for medulloblastoma and ovarian cancer by the FDA. In addition, the FDA has granted Fast Track Designation for VAL-083 in recurrent GBM. VAL-083 is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia and lung cancer. VAL-083 has not been approved for any indications outside of China.

    * Wick et al N.Eng.J.Med . 377:1954 1963 (2017)

    About Kintara



    Located in San Diego, California, Kintara (NASDAQ:KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs. Kintara is currently developing two Phase 3-ready therapeutics, VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class", small-molecule, bifunctional alkylating agent that crosses the blood-brain-barrier and has a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the NCI. Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    REM-001 is 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 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. With clinical efficacy of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. 

    For more information, please visit www.kintara.com or follow us on Twitter at @Kintara_TheraFacebook and Linkedin.

    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 and the GBM AGILE study.  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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies.  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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS

    Investors

    CORE IR

    516-222-2560

    Media

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/kintara-reports-topline-results-from-phase-2-clinical-trial-of-val-083-for-recurrent-gbm-301324046.html

    SOURCE Kintara Therapeutics

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  14.  

    SAN DIEGO, June 7, 2021 /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 Kintara's addition to the Russell MicrocapÒ Index. This milestone will take place at the conclusion of the 2021 Russell Indexes' annual reconstitution, effective after the U.S. market opens on June 28, 2021 according to a preliminary list of additions posted June 4, 2021.

    "We are delighted for Kintara to have been added to the FTSE Russell Microcap® Index, which will help increase investor exposure to our Company's mission of developing novel cancer therapies for patients with unmet medical needs," said Saiid Zarrabian

     

    SAN DIEGO, June 7, 2021 /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 Kintara's addition to the Russell MicrocapÒ Index. This milestone will take place at the conclusion of the 2021 Russell Indexes' annual reconstitution, effective after the U.S. market opens on June 28, 2021 according to a preliminary list of additions posted June 4, 2021.

    "We are delighted for Kintara to have been added to the FTSE Russell Microcap® Index, which will help increase investor exposure to our Company's mission of developing novel cancer therapies for patients with unmet medical needs," said Saiid Zarrabian, CEO of Kintara. "We look forward to the opportunity to expand awareness of our late-stage oncology pipeline of which our lead product, VAL-083, is currently being tested in GCAR's GBM AGILE registrational study for all three GBM patient subtypes of newly-diagnosed methylated MGMT, newly-diagnosed unmethylated MGMT, and recurrent GBM."

    Membership in the Russell Microcap® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell Indexes primarily by objective, market-capitalization rankings, and style attributes.

    Russell Indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell's U.S. Indexes. Russell Indexes are part of FTSE Russell, a leading global index provider.

    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 two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs.  The two programs are VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    Kintara is also advancing its 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, 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. With clinical efficacy to date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. 

    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 and the GBM AGILE study.  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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies.  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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS:

    Investors:

    CORE IR

    516-222-2560

    Media:

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

     

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/kintara-therapeutics-set-to-join-russell-microcap-index-301306592.html

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  15. SAN DIEGO, June 3, 2021 /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 it has enrolled the final patient in the adjuvant arm of its ongoing Phase 2 clinical study of VAL-083 being conducted at the MD Anderson Cancer Center (MD Anderson). The adjuvant arm of the study investigates newly-diagnosed patients suffering from glioblastoma multiforme (GBM) receiving VAL-083 in place of standard of care temozolomide (TMZ) as adjuvant therapy following surgery and chemoradiation TMZ. The trial was designed to enroll up to 36 patients to determine whether treatment with VAL-083 improves overall survival.

    The…

    SAN DIEGO, June 3, 2021 /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 it has enrolled the final patient in the adjuvant arm of its ongoing Phase 2 clinical study of VAL-083 being conducted at the MD Anderson Cancer Center (MD Anderson). The adjuvant arm of the study investigates newly-diagnosed patients suffering from glioblastoma multiforme (GBM) receiving VAL-083 in place of standard of care temozolomide (TMZ) as adjuvant therapy following surgery and chemoradiation TMZ. The trial was designed to enroll up to 36 patients to determine whether treatment with VAL-083 improves overall survival.

    The Phase 2 trial is an open-label, two-arm, biomarker-driven study testing VAL-083 in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. Efficacy is being measured based on overall survival and progression-free survival. In February 2021, the Company announced the trial's second arm (recurrent GBM) enrolled its final patient.

    "Enrolling the final patient in the adjuvant arm of the Phase 2 study at MD Anderson is yet another important milestone for the Company as we continue to advance VAL-083 in multiple settings including the GCAR sponsored GBM AGILE study where we have already initiated patient recruitment at 15 sites as the only therapeutic agent currently being evaluated in this adaptive design registration study for all three GBM patient subtypes; newly-diagnosed methylated MGMT, newly-diagnosed unmethylated MGMT, and recurrent," commented Saiid Zarrabian, Kintara's Chief Executive Officer.

    VAL-083 is a small molecule bifunctional alkylating agent that crosses the blood-brain barrier. VAL-083 is independent of the MGMT resistance mechanism and has been assessed in over 40 Phase 1 and Phase 2 clinical trials in multiple indications sponsored by the U.S. National Cancer Institute (NCI).  VAL-083 has been granted Orphan Drug Designation for GBM by the FDA and EMA and has also been granted Orphan Drug Designations for medulloblastoma and ovarian cancer by the FDA. In addition, the FDA has granted Fast Track Designation for VAL-083 in recurrent GBM. VAL-083 is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia and lung cancer. VAL-083 has not been approved for any indications outside of China.

    About Kintara

    Located in San Diego, California, Kintara (NASDAQ:KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs. Kintara is currently developing two Phase 3-ready therapeutics, VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the NCI. Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    REM-001 is 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 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. With clinical efficacy of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing.

    For more information, please visit www.kintara.com or follow us on Twitter at @Kintara_TheraFacebook and Linkedin.

    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 and the GBM AGILE study. 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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. 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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS

    Investors

    CORE IR

    516-222-2560

    Media

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

     

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/kintara-therapeutics-enrolls-final-patient-in-phase-2-clinical-trial-of-val-083-for-adjuvant-treatment-of-brain-tumors-301304998.html

    SOURCE Kintara Therapeutics

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  16. SAN DIEGO, May 26, 2021 /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 that the VAL-083 treatment arm in the Global Coalition for Adaptive Research (GCAR) registrational Phase 2/3 clinical trial for glioblastoma multiforme (GBM) has been activated in 15 U.S. sites as of May 14, 2021. 

    The trial, titled GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment), is a patient-centered, adaptive platform trial for registration evaluating multiple therapies for patients with newly-diagnosed and recurrent GBM. Since January 2021, GCAR has accelerated the pace of clinical site activation…

    SAN DIEGO, May 26, 2021 /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 that the VAL-083 treatment arm in the Global Coalition for Adaptive Research (GCAR) registrational Phase 2/3 clinical trial for glioblastoma multiforme (GBM) has been activated in 15 U.S. sites as of May 14, 2021. 

    The trial, titled GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment), is a patient-centered, adaptive platform trial for registration evaluating multiple therapies for patients with newly-diagnosed and recurrent GBM. Since January 2021, GCAR has accelerated the pace of clinical site activation with increased awareness in the medical community of Kintara's arm of the study. GCAR plans to enroll 150-200 patients in the Kintara arm of the study at 30 sites in the U.S. and Canada with potential to increase this total to 40 clinical trial centers.

    "The entire Kintara team is enthused by the pace at which our treatment arm is being activated in the study," commented Saiid Zarrabian, Kintara's Chief Executive Officer.  "With 15 sites already active, including prestigious centers such as Memorial Sloan Kettering, Henry Ford Cancer Institute, Columbia University Irving Cancer Research Center, Emory University Winship Cancer Institute, and the University of Florida, we are delighted to witness GCAR's exceptional clinical trial execution capabilities that drew us to participate in this exciting and highly efficient registrational study."

    Key GBM AGILE Highlights for VAL-083

    • Only therapeutic agent currently being evaluated in all three GBM patient subtypes: newly-diagnosed methylated MGMT; newly-diagnosed unmethylated MGMT; and recurrent



    • May accelerate VAL-083's time to pivotal trial completion and potential regulatory submission by up to 18 months



    • Cost-effective opportunity to advance VAL-083 due to the GBM AGILE study's expense sharing protocol

    GBM AGILE is an international, innovative platform trial designed to more rapidly identify and confirm effective therapies for patients with GBM through response adaptive randomization and a seamless Phase 2/3 design.  The trial, conceived by over 130 key opinion leaders, is conducted under a master protocol allowing multiple therapies, or combinations of therapies, from different pharmaceutical partners to be evaluated simultaneously.  With its innovative design and efficient operational infrastructure, data from GBM AGILE can be used as the foundation for a new drug application and biologics license application submissions and registrations to the FDA and other health authorities.

    Kintara's VAL-083 is a "first-in-class," small molecule bifunctional alkylating agent that crosses the blood-brain barrier. VAL-083 is independent of the MGMT resistance mechanism and has been assessed in over 40 Phase 1 and Phase 2 clinical trials in multiple indications sponsored by the U.S. National Cancer Institute (NCI). Published pre-clinical and clinical data indicate that VAL-083 has activity against a range of tumor types, including lung, brain, cervical, ovarian tumors and hematologic (blood) cancers. VAL-083 has been granted Orphan Drug Designation for GBM by the FDA and EMA and has also been granted Orphan Drug Designations for medulloblastoma and ovarian cancer by the FDA. In addition, the FDA granted Fast Track Designation for VAL-083 in recurrent GBM. VAL-083 is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia and lung cancer. VAL-083 has not been approved for any indications outside of China.

    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 two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs.  The two programs are VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the NCI. Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    Kintara is also advancing its 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, 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. With clinical efficacy to date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. 

    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 and the GBM AGILE study.  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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies.  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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS:

    Investors:

    CORE IR

    516-222-2560

    Media:

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/kintara-therapeutics-provides-positive-site-activation-update-on-gcar-phase-23-clinical-trial-for-glioblastoma-301299618.html

    SOURCE Kintara Therapeutics

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  17. SAN DIEGO, May 14, 2021 /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 third quarter ended March 31, 2021 and provided a corporate update.

    Fiscal Third Quarter Highlights and Recent Developments

    • Commenced patient recruitment of Kintara's VAL-083 arm of the glioblastoma multiforme (GBM) AGILE registrational study sponsored by the Global Coalition for Adaptive Research (GCAR). VAL-083 is currently the only therapeutic agent being evaluated in all three GBM patient subtypes: newly-diagnosed methylated MGMT, newly-diagnosed unmethylated MGMT, and recurrent.

    • Continued…

    SAN DIEGO, May 14, 2021 /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 third quarter ended March 31, 2021 and provided a corporate update.

    Fiscal Third Quarter Highlights and Recent Developments

    • Commenced patient recruitment of Kintara's VAL-083 arm of the glioblastoma multiforme (GBM) AGILE registrational study sponsored by the Global Coalition for Adaptive Research (GCAR). VAL-083 is currently the only therapeutic agent being evaluated in all three GBM patient subtypes: newly-diagnosed methylated MGMT, newly-diagnosed unmethylated MGMT, and recurrent.



    • Continued to advance development of REM-001 for the treatment of Cutaneous Metastatic Breast Cancer (CMBC), including taking critical steps toward manufacturing sufficient quantity of drug to allow for initiation and completion of our CMBC Phase 3 trial for CMBC patients.



    • Extended calendar year cash runway from previously announced Q4 2021 to Q2 2022 primarily due to the exercise of previously issued warrants as well as operational and resource synergies realized through the Adgero acquisition.



    • Enhanced corporate and scientific leadership teams with appointments of Tamara A. Seymour to the Board of Directors and Dr. Mario Lacouture to the Scientific Advisory Board with an initial focus on CMBC.



    • Completed patient enrollment of the recurrent arm of the Phase 2 clinical study of VAL-083 being conducted at the MD Anderson Cancer Center (MD Anderson) for GBM patients who have been pre-treated with temozolomide prior to disease recurrence.



    • Presented positive data updates at the American Association for Cancer Research Annual Meeting from the ongoing Phase 2 clinical studies in newly-diagnosed first-line, newly-diagnosed adjuvant, and recurrent GBM.

    "As we head into the final fiscal quarter of 2021, we continue to make steady progress on our late-stage clinical pipeline, as well as making valuable additions to our leadership and advisory teams, and continuing to secure our foothold as a leader in oncology indications with clear unmet medical needs," commented Saiid Zarrabian, Kintara's President and Chief Executive Officer. "Commencing VAL-083's enrollment in the GBM AGILE registrational study was a significant milestone during the period, along with continued progress with both of our ongoing Phase 2 clinical trials, of which the MD Anderson study is anticipated to report topline results in the second quarter of calendar 2021."

    SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR 2021 THIRD QUARTER ENDED MARCH 31, 2021

    At March 31, 2021, the Company had cash and cash equivalents of approximately $15.7 million.  The cash and cash equivalents at March 31, 2021 are expected to be sufficient to fund the Company's planned operations into the second quarter of calendar year 2022.

    For the three months ended March 31, 2021, the Company reported a net loss of approximately $6.6 million, or $0.23 per share, compared to a net loss of approximately $2.0 million, or $0.17 per share, for the three months ended March 31, 2020. For the nine months ended March 31, 2021, the Company reported a net loss of approximately $31.6 million, or $1.47 per share, compared to a net loss of approximately $5.3 million, or $0.52 per share, for the nine months ended March 31, 2020.  The increase in loss for the nine months ended March 31, 2021 compared to the nine months ended March 31, 2020 was largely due to the recognition of $16.1 million of non-cash expenses related to the acquisition of in-process research and development costs associated with the merger with Adgero Biopharmaceuticals Holdings, Inc. and an expanded rate of expenditures with the initiation of the GCAR study and REM-001 development.

     

    Selected Balance Sheet Data (in thousands)







    March 31,

    2021





    June 30,

    2020







    $





    $



    Cash and cash equivalents





    15,718







    2,392



    Working capital





    14,055







    176



    Total assets





    18,853







    2,938



    Total stockholders' equity





    16,118







    263



     

    Selected Statement of Operations Data (in thousands, except per share data)



    For the three months ended 







    March 31,





    March 31,







    2021





    2020







    $





    $



    Research and development





    3,843





    899



    General and administrative





    2,762





    1,077



    Other loss (income)





    30





    (19)



    Net loss for the period





    6,635





    1,957



    Series A Preferred cash dividend





    2





    2



    Series B Preferred stock dividend





    6





    1



    Net loss attributable to common stockholders





    6,643





    1,960



    Basic and fully diluted weighted average number of shares





    29,273





    11,417



    Basic and fully diluted loss per share





    0.23





    0.17





















    For the nine months ended







    March 31,





    March 31,







    2021





    2020







    $





    $



    Research and development





    7,784





    2,332



    General and administrative





    7,091





    3,045



    Merger costs





    500





    -



    In-process research & development





    16,094





    -



    Other loss (income)





    97





    (74)



    Net loss for the period





    31,566





    5,303



    Deemed dividend recognized on beneficial conversion features of Series C Preferred stock issuance





    3,181





    -



    Series A Preferred cash dividend





    6





    6



    Series B Preferred stock dividend





    15





    6



    Net loss attributable to common stockholders





    34,768





    5,315



    Basic and fully diluted weighted average number of shares





    23,701





    10,117



    Basic and fully diluted loss per share





    1.47





    0.52



     

    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 two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs.  The two programs are VAL-083 for GBM and REM-001 for CMBC.

    VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    Kintara is also advancing its 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, 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. With clinical efficacy to date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. 

    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 and the GBM AGILE study.  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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies.  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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS:

    Investors:

    CORE IR

    516-222-2560

    Media:

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

     

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/kintara-therapeutics-announces-fiscal-third-quarter-2021-financial-results-and-provides-corporate-update-301291479.html

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  18. San Diego, California--(Newsfile Corp. - May 11, 2021) - Kintara Therapeutics, Inc. (NASDAQ:KTRA) today announced that Saiid Zarrabian, President & CEO will be attending the Q2 Virtual Investor Summit.

     Event Q2 Investor Summit
     Date May 17-18th, 2021
     Presentation May 18th at 11:00am ET
     Location https://zoom.us/webinar/register/WN_CaBoy6ovRySXUDmri34bUA

     

    About Kintara Therapeutics, Inc.

    Kintara (NASDAQ:KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs. Kintara is currently developing two Phase 3-ready therapeutics, VAL-083 for glioblastoma multiforme (GBM) and REM-001 for cutaneous metastatic breast cancer (CMBC).

    For further information:

    Kintara Therapeutics, Inc.
    Jules Abraham
    917-885-7378

    San Diego, California--(Newsfile Corp. - May 11, 2021) - Kintara Therapeutics, Inc. (NASDAQ:KTRA) today announced that Saiid Zarrabian, President & CEO will be attending the Q2 Virtual Investor Summit.

     Event Q2 Investor Summit
     Date May 17-18th, 2021
     Presentation May 18th at 11:00am ET
     Location https://zoom.us/webinar/register/WN_CaBoy6ovRySXUDmri34bUA

     

    About Kintara Therapeutics, Inc.

    Kintara (NASDAQ:KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs. Kintara is currently developing two Phase 3-ready therapeutics, VAL-083 for glioblastoma multiforme (GBM) and REM-001 for cutaneous metastatic breast cancer (CMBC).

    For further information:

    Kintara Therapeutics, Inc.
    Jules Abraham
    917-885-7378

    About the Investor Summit

    The Investor Summit (formerly MicroCap Conference) is an exclusive, independent conference dedicated to connecting smallcap and microcap companies with qualified investors. The Q2 Investor Summit will take place virtually, featuring 80+ companies and over 300 institutional and retail investors.

    To request complimentary investor registration: please visit our website at www.investorsummitgroup.com

    Contact:

    Sasha Murray at

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  19. SAN DIEGO, May 5, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announced today that its Chief Executive Officer Saiid Zarrabian will participate at the Benzinga Global Small Cap Conference on May 14, 2021.

    Mr. Zarrabian will deliver his corporate presentation at 12:25 pm ET on May 14, 2021.

    Investors can also request a one-on-one meeting with Mr. Zarrabian to be arranged following the conclusion of the conference.

    Investors can register for the conference here:   
    https://www.benzinga.com/events/small-cap/global/

    About Kintara
    Located in San Diego, California, Kintara (NASDAQ:KTRA) is dedicated to the development of novel cancer therapies…

    SAN DIEGO, May 5, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announced today that its Chief Executive Officer Saiid Zarrabian will participate at the Benzinga Global Small Cap Conference on May 14, 2021.

    Mr. Zarrabian will deliver his corporate presentation at 12:25 pm ET on May 14, 2021.

    Investors can also request a one-on-one meeting with Mr. Zarrabian to be arranged following the conclusion of the conference.

    Investors can register for the conference here:   

    https://www.benzinga.com/events/small-cap/global/

    About Kintara

    Located in San Diego, California, Kintara (NASDAQ:KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs. Kintara is currently developing two Phase 3-ready therapeutics, VAL-083 for glioblastoma multiforme (GBM) and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    REM-001 is 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 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. With clinical efficacy of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. 

    For more information, please visit www.kintara.com or follow us on Twitter at @Kintara_TheraFacebook and Linkedin.

    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 and the GBM AGILE study. 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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. 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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS

    Investors

    CORE IR

    516-222-2560

    Media

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/kintara-therapeutics-to-participate-at-the-benzinga-global-small-cap-conference-301284174.html

    SOURCE Kintara Therapeutics

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  20. SAN DIEGO, May 4, 2021 /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 the appointment of Tamara A. Seymour to the Company's Board of Directors replacing John Liatos, who will continue in his role as Kintara's Senior Vice President of Business Development.

    "We are delighted to welcome Tamara to the Board of Directors as she brings exceptional healthcare sector experience as an accomplished financial and operational executive," commented Saiid Zarrabian, Kintara's President and Chief Executive Officer. "Tamara's insights and perspectives will be a valuable addition to the Board and the entire Company as we continue to advance our platform assets VAL-083 and REM-001. We wish to thank John for his service to the Board and are excited to continue working with him as the Company's Senior VP of Business Development."

    Ms. Seymour is a corporate finance veteran with three decades of experience in the biotech and life sciences industries including 20 years as a chief financial officer. Her experience includes leading finance, investor relations, managed care and reimbursement, human resources, administration, and information technology. She has raised over $250 million in multiple private and public equity and debt financings, including spearheading an IPO.  She is a member of the Board of Directors and Audit Committee of Artelo Biosciences, Inc. (NASDAQ:ARTL), a clinical stage biopharmaceutical company in La Jolla, California, and a former Chief Financial Officer (CFO) at multiple private and public companies where she played an integral role in merger and acquisition activities.  Her recent CFO posts included serving as Interim CFO of Immunic, Inc., a clinical-stage drug development company, where she was instrumental in its transition from being a venture-backed private entity to a publicly-traded, post-merger company with Vital Therapies, Inc. During her illustrious career, Ms. Seymour has also served as CFO of Signal Genetics, Inc., a publicly-traded molecular diagnostics company and CFO of Favrille, Inc., a publicly-traded clinical-stage drug development company.  Ms. Seymour is a certified public accountant (inactive). She received an MBA, with an emphasis in finance, from Georgia State University and earned her bachelor's degree in Business Administration, with an emphasis in accounting, from Valdosta State University.

    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 two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs. The two programs are VAL-083 for glioblastoma multiforme (GBM) and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    Kintara is also advancing its 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, 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. With clinical efficacy to date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing.

    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. 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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. 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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS:

    Investors:

    CORE IR

    516-222-2560

    Media:

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

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  21. VANCOUVER, BC, April 29, 2021 /CNW/ - Today, Rakovina Therapeutics announced the formation of its inaugural Scientific Advisory Board. Made up of experts in biology, medicinal chemistry and pharmacology, the Scientific Advisory Board will contribute to Rakovina Therapeutics' development of new cancer treatments informed by the latest scientific research, and practical and clinical perspectives.

    "We are thrilled to have such a talented and experienced scientific advisory board providing critical expertise to our team", said Jeffrey Bacha, Rakovina Therapeutics executive chairman.  "Rakovina Therapeutics will benefit from their invaluable input as we advance our pipeline of novel oncology assets."

    Rakovina Therapeutics is committed to advancing new cancer treatments based on novel DNA-damage response technologies.  Under the advisement of the Scientific Advisory Board, made up of world-class experts who have been directly involved in the successful development of multiple life-saving cancer treatments, Rakovina Therapeutics aims to develop innovative therapies for a range of cancer indications.

    "Rakovina Therapeutics aims to become a leader in the development of new medicines in the fast-moving DNA-damage response field," said Prof. Mads Daugaard, Rakovina Therapeutics' president and chief scientific officer.  "Working with our distinguished Scientific Advisory Board allows us to deepen our commitment to conducting leading edge scientific research and developing best-in-class cancer therapeutics, ultimately benefiting cancer patients and their families."

    The inaugural members of the Rakovina Therapeutics scientific advisory board include:

    Dennis Brown, PhD has been involved in cancer drug discovery and development for more than 35 years. Initially with the Stanford Research Institute at Stanford University where he was involved in drug-screening activities sponsored by the US National Cancer Institute. Dr. Brown has founded or co-founded multiple companies including Matrix Pharmaceutical, Inc. (acquired by Chiron Corp. in 2002), Mountain View Pharmaceuticals, ChemGenex Pharmaceuticals (acquired by Cephalon/Teva in 2011) and Kintara Therapeutics, Inc. (NASDAQ:KTRA, formerly DelMar Pharmaceuticals))). During his career, Dr. Brown has been involved in the discovery and development of multiple FDA-approved cancer therapies. He currently serves as a member of the National Brain Tumor Society Research Roundtable, as a consultant to DelMar Pharmaceuticals, as Chairman of Mountain View Pharmaceutical's Board of Directors and is the President of Valent Technologies LLC, which supported the discovery and development of Edison Oncology's drug candidates. Dr. Brown served as an Assistant Professor of Radiology at Harvard University Medical School and as a Research Associate in Radiology at Stanford University Medical School. He received his B.A. in Biology and Chemistry (1971), M.S. in Cell Biology (1975) and Ph.D. in Radiation and Cancer Biology (1979), all from New York University. Dr. Brown is an inventor of more than 40 issued U.S. patents and applications, many with foreign counterparts.

    Leonard Post, PhD brings more than 35 years of drug development and leadership experience in the pharmaceutical and biotechnology industry spanning companies of all sizes. He currently serves as member of the board of directors and chief scientific officer of Vivace Pharmaceuticals. Previously, he served as chief scientific officer of BioMarin, a publicly held biopharmaceutical firm with a focus on rare diseases. He joined BioMarin when the company acquired LEAD Therapeutics, where he was chief scientific officer and responsible for the development of the blockbuster PARP inhibitor talazoparib until it was sold to Medivation, Inc. and ultimately commercialized by Pfizer, Inc. following the $14 billion acquisition of Medivation, Inc. Positions prior to LEAD included senior vice president of research and development for Onyx Pharmaceuticals and vice president of discovery research for Parke-Davis Pharmaceuticals. Dr. Post holds a doctorate in biochemistry from the University of Wisconsin and a B.S. in Chemistry from the University of Michigan.

    Neil Sankar, MD received his training in clinical research and tumor biology from NCI Bethesda Maryland and since has held Clinical development positions within leading Biotech/Pharma including Genentech, Medimmune, Pharmacyclis, Fiveprime, Otsuka, Portola, CBT Pharmaceuticals, LSK biopharma and Rhizen Pharmaceuticals. As an expert in providing global clinical development and regulatory strategies for therapeutic drugs, Dr Sankar has acted as clinical lead in numerous phase I, II and III clinical trials. He is and was instrumental in filing the New Drug Applications for the antibody-drug conjugate Kadcyla and the B cell receptor signaling kinase inhibitor Ibrutinib. He has extensive experience in the application of US Food and Drug Administration regulations and the Good Clinical Practice guidelines set forth by the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Dr. Sankar is an active member of the American Society of Clinical Oncology (ASCO), the American Society of Hematology (ASH), the European Hematology Association (EHA), Drug information association (DIA), European society of clinical oncology (ESMO), American association for cancer research (AACR), Enterprising Pharmaceutical Professionals from the Indian Sub-Continent (EPPIC GLOBAL), Connective Tissue Oncology Society (CTOS), and TiE Silicon Valley. Neil Sankar received his MD degree from Bangalore university and internal medicine residency from Univ of West indies, Kingston, Jamaica and trained in UK and the Caribbean. He also holds a postgraduate degree in public health from Queensland University in Australia.

    Wang Shen, PhD is the inventor of the kt-2000, kt-3000 and kt-4000 families of drug candidates under development by Rakovina Therapeutics. Dr. Shen is founder and chief executive officer of Viva Vision Biotech, an ophthalmology company based in Shanghai, China. Dr. Shen has more than 20 years of drug discovery and project management experiences in large pharmaceutical companies such as Abbott, Amgen, Sunesis and Kanion USA. He is the principal inventor of Lifitegrast (SAR1118), a potent LFA-1 inhibitor, approved by FDA to treat dry eye disease. He also made an important contribution to Venetoclax (ABT-199/GDC-0199), a selective BCL-2 inhibitor, approved by FDA in 2016 to treat certain types of leukemia. He is the co-author of over 40 peer-reviewed publications and co-inventor of over 40 patents. Dr. Shen received his B.S. in chemistry from Fudan University and Ph.D. in Organic Chemistry from Pittsburgh University with Professor Dennis P. Curran. Dr. Shen completed his postdoctoral training in Memorial Sloan-Kettering Cancer Center with Prof. Samuel J. Danishefsky.

    About Rakovina Therapeutics Inc.

    Rakovina Therapeutics Inc. was established in 2020 to develop new cancer treatments based on novel DNA-damage response technologies.  The Company has established a pipeline of DNA-damage response inhibitors with the goal of advancing one or more drug candidates into human clinical trials and obtaining marketing approval for new cancer therapeutics from Health Canada, the United States Food and Drug Administration and similar international regulatory agencies.  Further information may be found at www.rakovinatherapeutics.com.

    Additional Information

    The TSXV has neither approved nor disapproved the content of this press release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

    Notice regarding forward-looking statements:

    This release includes forward-looking statements regarding the Company and its respective business, which may include, but is not limited to, statements with respect to the proposed business plan of the Company and other statements. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative variations) of such words and phrases, or state that certain actions, events, or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such statements are based on the current expectations of the management of the Company. The forward-looking events and circumstances discussed in this release may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the medical device industry, economic factors, regulatory factors, the equity markets generally and risks associated with growth and competition. Although the Company has attempted to identify important factors that could cause actual actions, events, or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events, or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.  The reader is referred to the Company's most recent filings on SEDAR for a more complete discussion of all applicable risk factors and their potential effects, copies of which may be accessed through the Company's profile page at www.sedar.com.

    SOURCE Rakovina Therapeutics Inc.

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  22. SAN DIEGO, April 12, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA) ("Kintara" or the "Company"), a biopharmaceutical company developing novel cancer therapies for patients who are failing, or resistant to, current treatment regimens, today announced interim data results from two Phase 2 clinical trials evaluating VAL-083, the Company's lead compound, for the treatment of glioblastoma multiforme (GBM).  The data were presented in two posters at the 2021 American Association for Cancer Research (AACR) Annual Meeting, which is taking place virtually from April 10-15, 2021.

    Poster CT238 provides an update from two patient groups receiving VAL-083 in an open-label, Phase 2 study in recurrent and adjuvant unmethylated GBM settings…

    SAN DIEGO, April 12, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA) ("Kintara" or the "Company"), a biopharmaceutical company developing novel cancer therapies for patients who are failing, or resistant to, current treatment regimens, today announced interim data results from two Phase 2 clinical trials evaluating VAL-083, the Company's lead compound, for the treatment of glioblastoma multiforme (GBM).  The data were presented in two posters at the 2021 American Association for Cancer Research (AACR) Annual Meeting, which is taking place virtually from April 10-15, 2021.

    Poster CT238 provides an update from two patient groups receiving VAL-083 in an open-label, Phase 2 study in recurrent and adjuvant unmethylated GBM settings being conducted at the MD Anderson Cancer Center in Houston, Texas.  The second poster, CT172, updates the open-label, Phase 2 study of VAL-083 as a first-line treatment in newly-diagnosed, unmethylated GBM patients being conducted at Sun Yat-sen University Cancer Center in China.

    "These interim data updates at the AACR Annual Meeting continue to demonstrate VAL-083's potential as a game-changing treatment option for GBM patients," commented Saiid Zarrabian, Kintara's Chief Executive Officer. "Furthermore, it's important to note that both trials have provided valuable insights as we prepared to initiate the VAL-083 arm of the Global Coalition for Adaptive Research GBM AGILE registrational study which commenced patient enrollment in February 2021."

    Poster CT238: "Phase 2 study of dianhydrogalactitol (VAL-083) in patients with MGMT-unmethylated, bevacizumab-naïve glioblastoma in the adjuvant or recurrent setting"

    In newly-diagnosed patients receiving VAL-083 as adjuvant therapy following treatment with radiation and temozolomide (TMZ), for the 33 efficacy evaluable patients (of a planned 36 patients) as of the data cut-off of March 12, 2021, median progression-free survival (PFS) is currently 10.0 months (95% confidence interval: CI 8.2-10.8). While not a head-to-head study, this PFS data compares favorably to historical TMZ control of 5.3 months* and 6.9 months**, respectively.

    For patients in the fully enrolled recurrent group receiving second-line therapy with VAL-083 following first-line TMZ failure, 89 patients have been enrolled as of the data cut-off of March 12, 2021 with 35 patients (35 efficacy evaluable) initially receiving a dose of 40 mg/m2/day and 54 (48 efficacy evaluable) initially receiving the treatment dose that is being carried forward in the GBM AGILE study of 30 mg/ m2/day on days 1, 2 and 3 of a 21-day cycle. Median overall survival (mOS) for the 83 efficacy evaluable patients who have completed at least once cycle of treatment was 7.5 months (CI 6.0-9.0 months). Additionally, for the 48 efficacy evaluable patients initially receiving a dose of 30 mg/ m2/day, mOS is currently 7.9 months (CI 5.9-9.9 months). While this is not a head-to-head trial, historically lomustine, which is the most commonly used chemotherapy for these patients, has demonstrated mOS of 7.2 months***.

    Consistent with prior studies, myelosuppression is the most common adverse event with VAL-083 in both the recurrent GBM and adjuvant treatment settings. In the 30 mg/m2/day starting dose cohort (the dose that is being carried forward in the GBM AGILE study) seven subjects have experienced a serious adverse event (SAE) possibly related to VAL-083 in the recurrent group and one patient has experienced a possibly drug-related SAE in the adjuvant group as of the relevant data cut-off dates.

    Poster CT172: "Phase 2 clinical trial of dianhydrogalactitol (VAL-083) in patients with newly-diagnosed MGMT-unmethylated GBM"

    In the open-label, Phase 2 study of VAL-083 as a first-line treatment in newly-diagnosed, unmethylated GBM patients, median PFS for the 29 patients, as of the March 11, 2021 cut-off date, is currently 9.3 months (CI 6.4-12.0 months). Additionally, for the 25 patients initially receiving the treatment dose that is being carried forward in the GBM AGILE study of 30 mg/m2/day on days 1, 2 and 3 of a 21-day cycle, median PFS was reported to be 8.7 months (CI 6.4-12.5 months). While not a head-to-head study, this PFS data compares favorably to historical TMZ control of 5.3 months* and 6.9 months**, respectively. Three subjects have experienced an SAE possibly related to VAL-083. Multiple treatment cycles of VAL-083 at the 30 mg/m2/day dose in combination with standard radiation treatment (2 Gy/day, 5 days/week) were shown to be generally safe and well-tolerated. This study has been fully enrolled, and all patients have completed treatment with VAL-083 and are currently in follow-up.

    *Hegi et al N Eng J Med 352; 997-1003 (2005)

    **Tanguturi et al. NeuroOncol. 19(7): 908-917 (2017)

    *** Wick et al N.Eng.J.Med . 377:1954 1963 (2017)

    About Kintara

    Located in San Diego, California, Kintara (NASDAQ:KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs. Kintara is currently developing two Phase 3-ready therapeutics, VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    REM-001 is 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 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. With clinical efficacy of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. 

    For more information, please visit www.kintara.com or follow us on Twitter at @Kintara_TheraFacebook and Linkedin.

    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 and the GBM AGILE study.  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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies.  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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS

    Investors

    CORE IR

    516-222-2560

    Media

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

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  23. SAN DIEGO, March 17, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announced today that its Chief Executive Officer Saiid Zarrabian will participate in the Benzinga Biotech Small Cap Conference to be held March 24-25, 2021.  Mr. Zarrabian will present on March 24, 2021 at 9:45 am ET.

    Investors can view Mr. Zarrabian's general corporate presentation once they register for the conference here and can also request a 1x1 meeting with Mr. Zarrabian.

    About Kintara
    Located in San Diego, California, Kintara (NASDAQ:KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical…

    SAN DIEGO, March 17, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announced today that its Chief Executive Officer Saiid Zarrabian will participate in the Benzinga Biotech Small Cap Conference to be held March 24-25, 2021.  Mr. Zarrabian will present on March 24, 2021 at 9:45 am ET.

    Investors can view Mr. Zarrabian's general corporate presentation once they register for the conference here and can also request a 1x1 meeting with Mr. Zarrabian.

    About Kintara

    Located in San Diego, California, Kintara (NASDAQ:KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs. Kintara is currently developing two Phase 3-ready therapeutics, VAL-083 for glioblastoma multiforme (GBM) and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    REM-001 is 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 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. With clinical efficacy of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing.

    For more information, please visit www.kintara.com or follow us on Twitter at @Kintara_Thera, Facebook and Linkedin.

    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 and the GBM AGILE study.  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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies.  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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS

    Investors

    CORE IR

    516-222-2560

    Media

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

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  24. SAN DIEGO, March 10, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announces that its Chief Executive Officer Saiid Zarrabian will participate in Maxim Group's 2021 Emerging Growth Virtual Conference taking place March 17-18, 2021.  Mr. Zarrabian will be a speaker on a panel discussing glioblastoma and, more specifically, chemo-based and/or DNA repair target solutions.

    Investors can view Mr. Zarrabian's panel participation at 9:30 am ET on March 17, 2021 once they register for the conference here, and an archived replay of the panel discussion will be available on the conference website.  Investors can also…

    SAN DIEGO, March 10, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announces that its Chief Executive Officer Saiid Zarrabian will participate in Maxim Group's 2021 Emerging Growth Virtual Conference taking place March 17-18, 2021.  Mr. Zarrabian will be a speaker on a panel discussing glioblastoma and, more specifically, chemo-based and/or DNA repair target solutions.

    Investors can view Mr. Zarrabian's panel participation at 9:30 am ET on March 17, 2021 once they register for the conference here, and an archived replay of the panel discussion will be available on the conference website.  Investors can also request a 1x1 meeting with Mr. Zarrabian to be arranged following the conclusion of the conference.

    About Kintara

    Located in San Diego, California, Kintara (NASDAQ:KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs. Kintara is currently developing two Phase 3-ready therapeutics, VAL-083 for glioblastoma multiforme (GBM) and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    REM-001 is 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 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. With clinical efficacy of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. 

    For more information, please visit www.kintara.com or follow us on Twitter at @Kintara_TheraFacebook and Linkedin.

    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 and the GBM AGILE study.  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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies.  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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS

    Investors

    CORE IR

    516-222-2560

    Media

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

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  25. New York, March 03, 2021 (GLOBE NEWSWIRE) -- - Medexus Pharmaceuticals Inc (CVE:MDP)  shares climb as Canaccord Genuity upgrades rating to Buy from Hold following fiscal 3Q results click here

    - BioPorto A/S  (CPH:BIOPOR) expects to complete its clinical study and submit a De Novo application to the US FDA for pediatric use of its NGAL kidney test this summer click here

     - EVmo  Inc (OTC:YAYO) closes its controlling interest sale to Acuitas Group Holdings click here

    - Mountain Valley MD Holdings Inc (CSE:MVMD) (OTCQB:MVMDF) brings on Camargo Pharmaceutical Services to boost US FDA approval for Ivectsol click here

    - Alpine 4 Technologies Ltd (OTCQB:ALPP) appoints four new independent board members click here

    New York, March 03, 2021 (GLOBE NEWSWIRE) -- - Medexus Pharmaceuticals Inc (CVE:MDP)  shares climb as Canaccord Genuity upgrades rating to Buy from Hold following fiscal 3Q results click here

    - BioPorto A/S  (CPH:BIOPOR) expects to complete its clinical study and submit a De Novo application to the US FDA for pediatric use of its NGAL kidney test this summer click here

     - EVmo  Inc (OTC:YAYO) closes its controlling interest sale to Acuitas Group Holdings click here

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  26. SAN DIEGO, March 3, 2021 /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 the appointment of Mario Lacouture, M.D. to the REM-001 Scientific Advisory Board with the initial focus in Cutaneous Metastatic Breast Cancer (CMBC).

    "We are pleased to welcome Dr. Lacouture to our CMBC focused Scientific Advisory Board as we prepare REM-001, our photodynamic therapy platform, for late-stage pivotal testing in this debilitating oncology indication," commented Saiid Zarrabian, Kintara's Chief Executive Officer. "We look forward to working closely with Dr. Lacouture, utilizing his experience as a leading expert…

    SAN DIEGO, March 3, 2021 /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 the appointment of Mario Lacouture, M.D. to the REM-001 Scientific Advisory Board with the initial focus in Cutaneous Metastatic Breast Cancer (CMBC).

    "We are pleased to welcome Dr. Lacouture to our CMBC focused Scientific Advisory Board as we prepare REM-001, our photodynamic therapy platform, for late-stage pivotal testing in this debilitating oncology indication," commented Saiid Zarrabian, Kintara's Chief Executive Officer. "We look forward to working closely with Dr. Lacouture, utilizing his experience as a leading expert in the treatment of CMBC to ensure REM-001's pivotal clinical trial is optimally designed and executed."

    Dr. Lacouture is the Director of the Oncodermatology Program at the Memorial Sloan Kettering Cancer Center and a Professor of Dermatology at Weill Cornell Medicine in New York City. He is a well-known lecturer in the U.S. and abroad on dermatologic conditions as a result of cancer therapies. He founded a clinical program that encompasses patient care, education, and research on dermatologic care to minimize the development of side effects in cancer patients and survivors.  In 2012, CancerCare named Dr. Lacouture Physician of the Year for his contributions to the education of people living with cancer and has been on Castle-Connolly and New York Magazine's list of Top Doctors (2014-2021). He has published over 260 articles in peer-reviewed journals and is the author of the patient-directed book "Dr. Lacouture's Skin Care Guide for People Living with Cancer" and the textbook for healthcare providers "Dermatologic Principles and Practice in Oncology." Dr. Lacouture received his medical degree from Javeriana University in Bogota, Colombia. He completed an internship in General Surgery at The Cleveland Clinic, residency in dermatology at The University of Chicago, and postdoctoral work at Brigham and Women's Hospital in Boston.

    About Kintara

    Located in San Diego, California, Kintara (NASDAQ:KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs. Kintara is currently developing two Phase 3-ready therapeutics, VAL-083 for glioblastoma multiforme (GBM) and REM-001 for CMBC.

    VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    REM-001 is 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 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. With clinical efficacy of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. 

    For more information, please visit www.kintara.com or follow us on Twitter at @Kintara_TheraFacebook and Linkedin.

    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 and the GBM AGILE study.  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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies.  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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS

    Investors

    CORE IR

    516-222-2560

    Media

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/kintara-therapeutics-appoints-dr-mario-lacouture-to-scientific-advisory-board-for-cutaneous-metastatic-breast-cancer-301239425.html

    SOURCE Kintara Therapeutics

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  27. SAN DIEGO, March 2, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announces that its President and CEO Saiid Zarrabian will present at the H.C. Wainwright Global Life Sciences Conference taking place March 9-10, 2021.

    The presentation will be available on-demand beginning at 7:00 A.M. ET on Tuesday, March 9, 2021 and will be available for 90 days. For those interested in viewing Mr. Zarrabian's presentation, conference registration can be accessed here. Mr. Zarrabian will also be available for virtual one-on-one meetings on March 9-10, 2021 and meeting requests can be made once registered.

    About Kintara
    Located…

    SAN DIEGO, March 2, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announces that its President and CEO Saiid Zarrabian will present at the H.C. Wainwright Global Life Sciences Conference taking place March 9-10, 2021.

    The presentation will be available on-demand beginning at 7:00 A.M. ET on Tuesday, March 9, 2021 and will be available for 90 days. For those interested in viewing Mr. Zarrabian's presentation, conference registration can be accessed here. Mr. Zarrabian will also be available for virtual one-on-one meetings on March 9-10, 2021 and meeting requests can be made once registered.

    About Kintara

    Located in San Diego, California, Kintara (NASDAQ:KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs. Kintara is currently developing two Phase 3-ready therapeutics, VAL-083 for glioblastoma multiforme (GBM) and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    REM-001 is 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 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. With clinical efficacy of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. 

    For more information, please visit www.kintara.com or follow us on Twitter at @Kintara_TheraFacebook and Linkedin.

    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 and the GBM AGILE study. 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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. 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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS

    Investors

    CORE IR

    516-222-2560

    Media

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/kintara-therapeutics-to-present-at-the-hc-wainwright-global-life-sciences-conference-301238360.html

    SOURCE Kintara Therapeutics

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  28. SAN DIEGO, Feb. 17, 2021 /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 it has enrolled the final patient in the recurrent arm of its ongoing Phase 2 clinical study of VAL-083 being conducted at the MD Anderson Cancer Center (MD Anderson). The recurrent arm of the study addresses patients suffering from glioblastoma multiforme (GBM) who have been pre-treated with temozolomide (TMZ) prior to disease recurrence. The trial was designed to enroll up to 83 patients (35 patients at 40 mg/m2/day and 48 patients at 30mg/m2/day) to determine whether treatment with VAL-083 improves overall survival.

    "Given…

    SAN DIEGO, Feb. 17, 2021 /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 it has enrolled the final patient in the recurrent arm of its ongoing Phase 2 clinical study of VAL-083 being conducted at the MD Anderson Cancer Center (MD Anderson). The recurrent arm of the study addresses patients suffering from glioblastoma multiforme (GBM) who have been pre-treated with temozolomide (TMZ) prior to disease recurrence. The trial was designed to enroll up to 83 patients (35 patients at 40 mg/m2/day and 48 patients at 30mg/m2/day) to determine whether treatment with VAL-083 improves overall survival.

    "Given the urgent need for improved treatment options for this deadly disease, we are pleased to have reached the very important milestone of full enrollment in the recurrent arm of this Phase 2 clinical study," commented Saiid Zarrabian, Kintara's Chief Executive Officer. "We would like to thank our patients, their families, and MD Anderson for their participation and continued support for this arm of the trial and of course, for our adjuvant study arm as well. Moving forward, we anticipate reporting topline results from the recurrent arm in the second quarter of calendar 2021."

    The Phase 2 trial is an open-label, two-arm, biomarker-driven study testing VAL-083 in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene. Efficacy is being measured based on overall survival and progression-free survival. In addition to the recurrent arm, there is a second trial arm that is enrolling up to 36 newly-diagnosed patients who have undergone surgery and chemoradiation with TMZ, and who are receiving VAL-083 in place of standard of care TMZ for adjuvant therapy. In November 2020, the Company provided a clinical update on both arms of the study. For the recurrent arm, median overall survival (mOS) for the 77 efficacy evaluable patients who completed at least one cycle of treatment was 7.6 months (confidence interval: CI 6.4-10.6 months). Additionally, for the 43 efficacy evaluable patients initially receiving the 30 mg/m2/day dose that is being evaluated in the Global Coalition for Adaptive Research (GCAR) GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) registrational study, mOS was 8.5 months (CI 6.8-13.7 months). In the adjuvant therapy arm of the study, median progression-free survival (PFS) was 10.0 months (CI 7.6-10.8). Consistent with prior studies, myelosuppression was the most common adverse event with VAL-083 in both the recurrent GBM and adjuvant treatment setting. In the 30 mg/m2/day starting dose cohort (the planned dose for the GBM AGILE pivotal study) three subjects experienced a serious adverse event (SAE) possibly related to VAL-083 in the recurrent group and one patient experienced a possibly drug-related SAE in the adjuvant group.

    VAL-083 is a "first-in-class," small molecule bifunctional alkylating agent that crosses the blood-brain barrier. VAL-083 is independent of the MGMT resistance mechanism and has been assessed in over 40 Phase 1 and Phase 2 clinical trials in multiple indications sponsored by the U.S. National Cancer Institute (NCI). Published pre-clinical and clinical data indicate that VAL-083 has activity against a range of tumor types, including lung, brain, cervical, ovarian tumors and hematologic (blood) cancers. VAL-083 has been granted Orphan Drug Designation for GBM by the FDA and EMA and has also been granted Orphan Drug Designations for medulloblastoma and ovarian cancer by the FDA. In addition, the FDA has granted Fast Track Designation for VAL-083 in recurrent GBM. VAL-083 is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia and lung cancer. VAL-083 has not been approved for any indications outside of China.

    About Kintara

    Located in San Diego, California, Kintara (NASDAQ:KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs. Kintara is currently developing two Phase 3-ready therapeutics, VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class," small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the NCI. Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    REM-001 is 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 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. With clinical efficacy of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. 

    For more information, please visit www.kintara.com or follow us on Twitter at @Kintara_TheraFacebook and Linkedin.

    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 and the GBM AGILE study.  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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies.  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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS

    Investors

    CORE IR

    516-222-2560

    Media

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/kintara-therapeutics-enrolls-final-patient-in-phase-2-clinical-trial-of-val-083-for-recurrent-gbm-301229753.html

    SOURCE Kintara Therapeutics

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  29. SAN DIEGO, Feb. 12, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announces its financial results for its fiscal second quarter ended December 31, 2020 and provides a corporate update.

    Second Quarter Highlights and Recent Developments

    • Executed a definitive agreement with the Global Coalition for Adaptive Research (GCAR) to include VAL-083 in its Glioblastoma Adaptive Global Innovative Learning Environment Study (GBM AGILE), a registrational Phase 2/3 clinical trial for glioblastoma multiforme (GBM). GBM AGILE is a patient-centered, adaptive platform trial evaluating multiple therapies for patients with…

    SAN DIEGO, Feb. 12, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announces its financial results for its fiscal second quarter ended December 31, 2020 and provides a corporate update.

    Second Quarter Highlights and Recent Developments

    • Executed a definitive agreement with the Global Coalition for Adaptive Research (GCAR) to include VAL-083 in its Glioblastoma Adaptive Global Innovative Learning Environment Study (GBM AGILE), a registrational Phase 2/3 clinical trial for glioblastoma multiforme (GBM). GBM AGILE is a patient-centered, adaptive platform trial evaluating multiple therapies for patients with newly-diagnosed and recurrent GBM. Kintara will supply GCAR with the VAL-083 drug along with the funding to support the VAL-083 arm of the study. In turn, GCAR will manage all operational aspects of the study, including site activation and patient enrollment.



    • Initiated patient recruitment for the VAL-083 study arm of GBM AGILE.



    • Announced that VAL-083 is the only therapeutic agent currently being evaluated in all three GBM patient subtypes in GBM AGILE: newly-diagnosed methylated MGMT, newly-diagnosed unmethylated MGMT, and recurrent.



    • Announced positive data updates at the Society of Neuro-Oncology Annual Meeting from ongoing Phase 2 clinical studies in newly-diagnosed first-line, newly-diagnosed adjuvant, and recurrent GBM.

     "The second quarter of fiscal year 2021 proved to be an important period of progress as we continued to advance to the latter stages of clinical development for VAL-083, our first-in-class small-molecule chemotherapeutic, and REM-001, our photodynamic therapy platform that is maintaining development pace in its confirmatory cutaneous metastatic breast cancer study," commented Saiid Zarrabian, Kintara's President and Chief Executive Officer. "Certainly, receiving approval from the FDA and GCAR to participate in the GBM AGILE study was a major milestone for the Company as this is a registrational trial whereby VAL-083 is being evaluated in all three GBM patient subtypes."

    SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR 2021 SECOND QUARTER ENDED DECEMBER 31, 2020

    At December 31, 2020, the Company had cash and cash equivalents of approximately $17.2 million.  The cash and cash equivalents at December 31, 2020, along with the proceeds from warrant exercises received subsequent to December 31, 2020, are expected to be sufficient to fund the Company's planned operations into the fourth quarter of calendar year 2021.

    For the three months ended December 31, 2020, the Company reported a net loss of approximately $5.4 million, or $0.22 per share, compared to a net loss of approximately $1.7 million, or $0.15 per share, for the three months ended December 31, 2019. For the six months ended December 31, 2020, the Company reported a net loss of approximately $24.9 million, or $1.34 per share, compared to a net loss of approximately $3.3 million, or $0.35 per share, for the six months ended December 31, 2019.  The increased loss for the six months ended December 31, 2020 compared to the six months ended December 31, 2019 was largely due to the recognition of $16.1 million of non-cash expenses related to the acquisition of in-process research and development costs associated with the Adgero transaction.

    Selected Balance Sheet Data (in thousands)







    December 31,

    2020





    June 30,

    2020







    $





    $



    Cash and cash equivalents





    17,158







    2,392



    Working capital





    14,990







    176



    Total assets





    20,489







    2,938



    Total stockholders' equity





    17,585







    263



     

    Selected Statement of Operations Data (in thousands, except per share data)



    For the three months ended 







    December

    31,





    December

    31,







    2020





    2019







    $





    $



    Research and development





    2,584







    712



    General and administrative





    2,794







    1,054



    Other loss (income)





    35







    (26)



    Net loss for the period





    5,413







    1,740



    Series A Preferred cash dividend





    2







    2



    Series B Preferred stock dividend





    4







    3



    Net loss attributable to common stockholders





    5,419







    1,745



    Basic and fully diluted weighted average number of shares





    24,845







    11,408



    Basic and fully diluted loss per share





    0.22







    0.15

























     

    For the six months ended 







    December

    31,





    December

    31,







    2020





    2019







    $





    $



    Research and development





    3,941







    1,434



    General and administrative





    4,329







    1,967



    Merger costs





    500







    -



    In-process research & development





    16,094







    -



    Other loss (income)





    67







    (55)



    Net loss for the period





    24,931







    3,346



    Deemed dividend recognized on beneficial conversion features of Series C Preferred stock issuance





    3,181







    -



    Series A Preferred cash dividend





    4







    4



    Series B Preferred stock dividend





    9







    5



    Net loss attributable to common stockholders





    28,125







    3,355



    Basic and fully diluted weighted average number of shares





    20,976







    9,473



    Basic and fully diluted loss per share





    1.34







    0.35

























    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 two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs.  The two programs are VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g. NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    Kintara is also advancing its 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, 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. With clinical efficacy to date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. 

    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 and the GBM AGILE study.  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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies.  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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS:

    Investors:

    CORE IR

    516-222-2560

    Media:

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

     

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/kintara-therapeutics-announces-fiscal-second-quarter-2021-financial-results-and-provides-corporate-update-301227432.html

    SOURCE Kintara Therapeutics

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  30. SAN DIEGO, Jan. 13, 2021 /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 that patient recruitment has commenced in the Global Coalition for Adaptive Research (GCAR) registrational Phase 2/3 clinical trial for glioblastoma (GBM).  The trial, titled GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment), is a revolutionary, patient-centered, adaptive platform trial for registration evaluating multiple therapies for patients with newly-diagnosed and recurrent GBM. 

    Key GBM AGILE Highlights for VAL-083

    • Only therapeutic agent currently being evaluated in all three GBM patient subtypes…

    SAN DIEGO, Jan. 13, 2021 /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 that patient recruitment has commenced in the Global Coalition for Adaptive Research (GCAR) registrational Phase 2/3 clinical trial for glioblastoma (GBM).  The trial, titled GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment), is a revolutionary, patient-centered, adaptive platform trial for registration evaluating multiple therapies for patients with newly-diagnosed and recurrent GBM. 

    Key GBM AGILE Highlights for VAL-083

    • Only therapeutic agent currently being evaluated in all three GBM patient subtypes: newly-diagnosed methylated MGMT; newly-diagnosed unmethylated MGMT; and recurrent
    • May accelerate VAL-083's time to pivotal trial completion and potential regulatory submission by up to 18 months
    • Cost-effective opportunity to advance VAL-083 due to the GBM AGILE study's expense sharing protocol
    • Anticipating rapid enrollment, targeting 150-200 patients with 34 active and recruiting U.S. sites with plans to increase to 40 sites during Q1, 2021, including Canada and other international locations to follow

    "The entire Kintara team is grateful and excited to participate in GCAR's groundbreaking GBM AGILE study as it offers an extraordinary opportunity to facilitate the advancement of VAL-083's clinical development in a premier GBM study," commented Saiid Zarrabian, Kintara's Chief Executive Officer.  "This is truly an important milestone for Kintara as we believe the study will generate important insights into the breadth of VAL-083's potential to address this deadliest form of brain cancer in all patient subtypes, while potentially bringing the program to the doorstep of commercialization."

    GBM AGILE is an international, innovative platform trial designed to more rapidly identify and confirm effective therapies for patients with glioblastoma through response adaptive randomization and a seamless Phase 2/3 design.  The trial, conceived by over 130 key opinion leaders, is conducted under a master protocol allowing multiple therapies or combinations of therapies from different pharmaceutical partners to be evaluated simultaneously.  With its innovative design and efficient operational infrastructure, data from GBM AGILE can be used as the foundation for a new drug application and biologics license application submissions and registrations to the FDA and other health authorities.

    Kintara's VAL-083 is a "first-in-class," small molecule bifunctional alkylating agent that crosses the blood-brain barrier. VAL-083 is independent of the MGMT resistance mechanism and has been assessed in over 40 Phase 1 and Phase 2 clinical trials in multiple indications sponsored by the U.S. National Cancer Institute (NCI). Published pre-clinical and clinical data indicate that VAL-083 has activity against a range of tumor types, including lung, brain, cervical, ovarian tumors and hematologic (blood) cancers. VAL-083 has been granted Orphan Drug Designation for GBM by the FDA and EMA and has also been granted Orphan Drug Designations for medulloblastoma and ovarian cancer by the FDA. In addition, the FDA granted Fast Track Designation for VAL-083 in recurrent GBM. VAL-083 is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia and lung cancer. VAL-083 has not been approved for any indications outside of China.

    About Kintara

    Located in San Diego, California, Kintara (NASDAQ:KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs. Kintara is currently developing two Phase 3-ready therapeutics, VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class," small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the NCI. Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    REM-001 is 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 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. With clinical efficacy of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. 

    For more information, please visit www.kintara.com or follow us on Twitter at @Kintara_Thera, Facebook and Linkedin.

    About Global Coalition for Adaptive Research (GCAR)

    The Global Coalition for Adaptive Research (GCAR) is a 501(c)(3) nonprofit organization uniting physicians, clinical researchers, advocacy and philanthropic organizations, biopharma, health authorities, and other key stakeholders in healthcare to expedite the discovery and development of treatments for patients with rare and deadly diseases by serving as sponsor of innovative and complex trials including master protocols and platform trials. GCAR is the sponsor of GBM AGILE, an adaptive platform trial for patients with GBM – the most common and deadliest of malignant primary brain tumors. Key strategic partners for the GBM AGILE trial effort include the National Brain Tumor SocietyNational Foundation for Cancer Research, and Asian Fund for Cancer Research, three nonprofit organizations that are working together to provide philanthropic support as well as assistance in communicating with patients and families and inviting all others to join in supporting this innovating approach to brain tumor treatment development.

    To learn more about GCAR, visit www.gcaresearch.org.

    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 and the GBM AGILE study.  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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies.  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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS

    Investors

    CORE IR

    516-222-2560

    Media

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/kintara-announces-initiation-of-patient-recruitment-for-val-083s-study-arm-in-the-gbm-agile-trial-301207295.html

    SOURCE Kintara Therapeutics

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  31. Kazia and Kintara Now Enrolling in GBM AGILE, Registrational Phase 2-3 Adaptive Platform Trial to Evaluate Interventions for Patients With Glioblastoma

    Kazia's Paxalisib and Kintara's VAL-083 to Be Evaluated Across Multiple International Trial Sites

    Kintara's VAL-083 Will Be the First Investigational Drug to Also Be Tested in GBM AGILE For MGMT Methylated Tumors

    Global Coalition for Adaptive Research (LOS ANGELES, CA), Kazia Therapeutics Limited ((ASX: KZA, NASDAQ:KZIA, SYDNEY, Australia)), and Kintara Therapeutics, Inc. (NASDAQ:KTRA, SAN DIEGO, CA))) -- The Global Coalition for Adaptive Research (GCAR) in collaboration with Kazia and Kintara, today announced the activation of Kazia's paxalisib and Kintara's VAL-083 in GBM AGILE (Glioblastoma…

    Kazia and Kintara Now Enrolling in GBM AGILE, Registrational Phase 2-3 Adaptive Platform Trial to Evaluate Interventions for Patients With Glioblastoma

    Kazia's Paxalisib and Kintara's VAL-083 to Be Evaluated Across Multiple International Trial Sites

    Kintara's VAL-083 Will Be the First Investigational Drug to Also Be Tested in GBM AGILE For MGMT Methylated Tumors

    Global Coalition for Adaptive Research (LOS ANGELES, CA), Kazia Therapeutics Limited ((ASX: KZA, NASDAQ:KZIA, SYDNEY, Australia)), and Kintara Therapeutics, Inc. (NASDAQ:KTRA, SAN DIEGO, CA))) -- The Global Coalition for Adaptive Research (GCAR) in collaboration with Kazia and Kintara, today announced the activation of Kazia's paxalisib and Kintara's VAL-083 in GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment). GBM AGILE is a revolutionary patient-centered, adaptive platform trial for registration that tests multiple therapies for patients with newly-diagnosed and recurrent glioblastoma (GBM) – the deadliest form of brain cancer.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210106005257/en/

    Kazia's paxalisib and Kintara's VAL-083 are entering the GBM AGILE trial, which initially opened in July 2019 and has screened over 370 patients to date.

    Kazia's paxalisib will be enrolling in newly diagnosed unmethylated (NDUM) and recurrent GBM, and Dr. Ingo Mellinghoff, Chair of the Department of Neurology at Memorial Sloan Kettering Cancer Center and Dr. Eudocia Q Lee, Director of Clinical Research at the Center for Neuro-Oncology at Dana-Farber and an Assistant Professor of neurology at Harvard Medical School are serving as arm Principal Investigators for the paxalisib arm.

    Kintara's VAL-083 will be enrolling in NDUM and recurrent GBM, as well as be the first compound being evaluated for patients with newly diagnosed methylated MGMT. VAL-083 will be led by arm Principal Investigators, Dr. John de Groot, Professor, Department of Neuro-Oncology, MD Anderson Cancer Center, and Dr. James Perry, Professor of Neurology at the University of Toronto and Sunnybrook Research Institute.

    "GBM AGILE is an innovative clinical trial approach that enables us to simultaneously and dynamically study the effects of multiple new drug candidates. With the inclusion of paxalisib and VAL-083 for NDUM and recurrent GBM patients, as well as VAL-083 for the additional methylated GBM patient group, we are excited to offer all GBM patients access to these latest therapies," says Dr. James Perry. "Both investigational drugs have the potential to support improved outcomes for GBM patients, who need new treatment options."

    Dr. Ingo Mellinghoff, who also serves as co-Chair of the GBM AGILE Arm Identification and Selection Committee, adds, "GBM AGILE is a transformative effort in our field, designed to provide glioblastoma patients in many different countries access to the latest, most personalized therapies and, at the same time, rigorously evaluate the activity of these therapies in an optimized learning environment. Paxalisib and VAL-083 are two important steps in this direction and offer potentially beneficial treatments to our patients, who deserve new and better options for their care."

    GBM AGILE is an international, innovative platform trial designed to more rapidly identify and confirm effective therapies for patients with glioblastoma through response adaptive randomization and a seamless phase 2/3 design. The trial, conceived by over 130 key opinion leaders, is conducted under a master protocol, allowing multiple therapies or combinations of therapies from different pharmaceutical partners to be evaluated simultaneously. With its innovative design and efficient operational infrastructure, data from GBM AGILE can be used as the foundation for a new drug application (NDA) and biologics license application (BLA) submissions and registrations to the FDA and other health authorities.

    The new interventions are opening first at Henry Ford Cancer Institute in Detroit under Henry Ford site Principal Investigator, Dr. Tom Mikkelsen, Medical Director, Henry Ford Precision Medicine Program & Clinical Trials, and will subsequently open at over 30 trial sites across the United States, with additional global sites in Canada, Europe, and China to follow.

    "We were first in the world to enroll a patient in the GBM AGILE study, which is designed to help us quickly identify the most effective therapies for patients with glioblastoma," notes Dr. Tom Mikkelsen. "We are excited about the potentially improved treatments afforded to our patients in this study with the additional options of paxalisib and VAL-083."

    Kazia's paxalisib (formerly GDC-0084) is a small molecule inhibitor of the PI3K / AKT / mTOR pathway. The PI3K pathway appears to be disordered in more than 85% of cases of glioblastoma, making this pathway a high-potential target for new glioblastoma therapies. Paxalisib is a potent inhibitor of the PI3K pathway, and has been shown to have an anti-tumor effect in animal models of glioblastoma. Licensed from Genentech in late 2016, paxalisib is distinguished by its ability to cross the so-called blood-brain barrier, which prevents many drugs from fully affecting brain tissue. Seven additional studies are active in other forms of brain cancer. Paxalisib was granted Orphan Drug Designation for glioblastoma by the U.S. FDA in February 2018, and Fast Track Designation for glioblastoma by the U.S. FDA in August 2020. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Designation by the U.S. FDA for DIPG in August 2020.

    "We are proud to be joining GBM AGILE. This is an important and innovative effort, utilizing a platform approach and cutting-edge adaptive design to rapidly identify whether drugs such as paxalisib can bring benefit to patients with glioblastoma," said Dr. James Garner, Chief Executive Officer, Kazia. "There is a profound need for new therapeutic options in this disease, and GBM AGILE has been designed to accelerate the process of making new drugs available to patients and clinicians. We have seen encouraging data with paxalisib in earlier clinical studies, so we hope that success in GBM AGILE may pave the way to providing a new treatment in this disease."

    Kintara's VAL-083 is a "first-in-class," small molecule bifunctional alkylating agent that crosses the blood-brain barrier. VAL-083 is independent of the MGMT resistance mechanism, and has been assessed in over 40 Phase 1 and Phase 2 clinical trials in multiple indications sponsored by the U.S. National Cancer Institute (NCI). Published pre-clinical and clinical data indicate that VAL-083 has activity against a range of tumor types, including lung, brain, cervical, ovarian tumors and hematologic (blood) cancers. VAL-083 has been granted Orphan Drug Designation for GBM by the FDA and EMA, and has also been granted Orphan Drug Designations for medulloblastoma and ovarian cancer from the FDA. In addition, the FDA granted Fast Track Designation for VAL-083 in recurrent GBM. VAL-083 is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia and lung cancer. VAL-083 has not been approved for any indications outside of China.

    "Kintara is pleased to participate in the groundbreaking GBM AGILE trial, and is excited to be the first investigational drug selected for newly diagnosed methylated GBM in the study. With VAL-083 being evaluated in all subtypes, we expect that this study will generate important insights into VAL-083's potential to improve health outcomes for all GBM patients," said Saiid Zarrabian, Kintara's Chief Executive Officer.

    About Global Coalition for Adaptive Research (GCAR)

    The Global Coalition for Adaptive Research (GCAR) is a 501(c)(3) nonprofit organization uniting physicians, clinical researchers, advocacy and philanthropic organizations, biopharma, health authorities, and other key stakeholders in healthcare to expedite the discovery and development of treatments for patients with rare and deadly diseases by serving as sponsor of innovative and complex trials including master protocols and platform trials. GCAR is the sponsor of GBM AGILE, an adaptive platform trial for patients with GBM – the most common and deadliest of malignant primary brain tumors. Key strategic partners for the GBM AGILE trial effort include the National Brain Tumor Society, National Foundation for Cancer Research, and Asian Fund for Cancer Research, three nonprofit organizations that are working together to provide philanthropic support as well as assistance in communicating with patients and families and inviting all others to join in supporting this innovating approach to brain tumor treatment development.

    To learn more about GCAR, visit www.gcaresearch.org and follow us: @GCAResearch and www.facebook.com/GCAResearch.

    About Kazia Therapeutics Limited

    Kazia Therapeutics Limited ((ASX: KZA, NASDAQ:KZIA) is an innovative oncology-focused biotechnology company, based in Sydney, Australia. Our pipeline includes two clinical-stage drug development candidates, and we are working to develop therapies across a range of oncology indications.

    Our lead program is paxalisib (formerly GDC-0084), a small molecule inhibitor of the PI3K / AKT / mTOR pathway, which is being developed to treat glioblastoma, the most common and most aggressive form of primary brain cancer in adults. Licensed from Genentech in late 2016, paxalisib entered GBM AGILE, a pivotal study in glioblastoma, in October 2020. Seven additional studies are active in various forms of brain cancer. Paxalisib was granted Orphan Drug Designation for glioblastoma by the U.S. FDA in February 2018, and Fast Track Designation for glioblastoma by the U.S. FDA in August 2020. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Designation by the U.S. FDA for DIPG in August 2020.

    For more information, please visit www.kaziatherapeutics.com.

    About Kintara

    Located in San Diego, California, Kintara (NASDAQ:KTRA) is dedicated to the development of novel cancer therapies for patients with rare unmet medical needs. Kintara is currently developing two Phase 3-ready therapeutics, VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class," small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g. NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the NCI. Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    REM-001 is 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, 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. With clinical efficacy of 80% complete responses of evaluable CMBC lesions and an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing.

    For more information, please visit www.kintara.com.

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  32. SAN DIEGO, Jan. 5, 2021 /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 its President and CEO Saiid Zarrabian will present at the H.C. Wainwright Bioconnect 2021 Virtual Conference taking place January 11-14, 2021.

    The presentation will be available for on-demand listening beginning at 6:00 A.M. Eastern Time on Monday, January 11, 2021, through the close of business January 14, 2021.  For those interested in viewing Mr. Zarrabian's presentation, registration can be accessed here.

    ABOUT KINTARA

    Located in San Diego, California, Kintara is dedicated to the development of novel cancer therapies for patients…

    SAN DIEGO, Jan. 5, 2021 /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 its President and CEO Saiid Zarrabian will present at the H.C. Wainwright Bioconnect 2021 Virtual Conference taking place January 11-14, 2021.

    The presentation will be available for on-demand listening beginning at 6:00 A.M. Eastern Time on Monday, January 11, 2021, through the close of business January 14, 2021.  For those interested in viewing Mr. Zarrabian's presentation, registration can be accessed here.

    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 two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs.  The two programs are VAL-083 for glioblastoma multiforme (GBM) and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian, and other solid tumors (e.g. NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI).  Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    Kintara is also advancing its 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 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.  With clinical efficacy to-date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. 

    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 and the GBM AGILE study.  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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies.  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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS:

    Investors:

    CORE IR

    516-222-2560

    Media:

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/kintara-therapeutics-to-present-at-the-hc-wainwright-bioconnect-2021-virtual-conference-301200805.html

    SOURCE Kintara Therapeutics

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  33. SAN DIEGO, Dec. 3, 2020 /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 it will be presenting at the 2nd Annual Glioblastoma Drug Development Virtual Summit on Thursday, December 10, 2020 at 11:45 A.M. EST.

    Dr. John de Groot, Professor, Department of Neuro-Oncology, MD Anderson Cancer Center, and Dr. James Perry, Professor of Neurology, at the University of Toronto Temerty Sunnybrook Research Institute will present a talk titled "Kintara's VAL-083: A First-in-Class Bifunctional Alkylating Agent with Promising Activity in MGMT Promoter- Unmethylated & Methylated Glioblastoma." 

    Drs. de Groot and…

    SAN DIEGO, Dec. 3, 2020 /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 it will be presenting at the 2nd Annual Glioblastoma Drug Development Virtual Summit on Thursday, December 10, 2020 at 11:45 A.M. EST.

    Dr. John de Groot, Professor, Department of Neuro-Oncology, MD Anderson Cancer Center, and Dr. James Perry, Professor of Neurology, at the University of Toronto Temerty Sunnybrook Research Institute will present a talk titled "Kintara's VAL-083: A First-in-Class Bifunctional Alkylating Agent with Promising Activity in MGMT Promoter- Unmethylated & Methylated Glioblastoma." 

    Drs. de Groot and Perry are the Principal Investigators of Kintara's arm of the Global Coalition for Adaptive Research (GCAR) Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) study.

    ABOUT GLOBAL COALITION FOR ADAPTIVE RESEARCH

    GCAR is a 501(c)(3) nonprofit organization uniting physicians, clinical researchers, advocacy and philanthropic organizations, biopharma, health authorities, and other key stakeholders in healthcare to expedite the discovery and development of treatments for patients with rare and deadly diseases by serving as sponsor of innovative and complex trials including master protocols and platform trials. GCAR is the sponsor of GBM AGILE, an adaptive platform trial for patients with GBM – the most common and deadliest of malignant primary brain tumors.

    To learn more about GCAR, visit www.gcaresearch.org and follow us: @GCAResearch and www.facebook.com/GCAResearch.

    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 two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs.  The two programs are VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian, and other solid tumors (e.g. NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    Kintara is also advancing its 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 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. With clinical efficacy to date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. 

    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 and the GBM AGILE study.  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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies.  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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS:

    Investors:

    CORE IR

    516-222-2560

    Media:

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/kintara-therapeutics-to-present-at-the-2nd-annual-glioblastoma-drug-development-summit-301185678.html

    SOURCE Kintara Therapeutics

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  34. SAN DIEGO, Nov. 19, 2020 /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 interim data on its two Phase 2 trials of VAL-083, the Company's lead compound for the treatment of glioblastoma multiforme (GBM).  The data are to be presented in two posters at the 25th Annual Scientific Meeting of the Society for Neuro-Oncology (SNO) which will be held virtually due to the Covid-19 pandemic on November 19-21, 2020.

    "I'm extremely pleased with the continual progress being achieved by both of these ongoing Phase 2 clinical studies evaluating VAL-083, as the results garnered thus far are an indicator of the…

    SAN DIEGO, Nov. 19, 2020 /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 interim data on its two Phase 2 trials of VAL-083, the Company's lead compound for the treatment of glioblastoma multiforme (GBM).  The data are to be presented in two posters at the 25th Annual Scientific Meeting of the Society for Neuro-Oncology (SNO) which will be held virtually due to the Covid-19 pandemic on November 19-21, 2020.

    "I'm extremely pleased with the continual progress being achieved by both of these ongoing Phase 2 clinical studies evaluating VAL-083, as the results garnered thus far are an indicator of the compound's potential to be an important therapeutic option for GBM patients in the recurrent, newly-diagnosed first-line, and newly-diagnosed adjuvant treatment settings," commented Saiid Zarrabian, Kintara's Chief Executive Officer. "It is a pleasure to present the data updates at the Society for Neuro-Oncology's Annual Meeting, as these studies have provided valuable insight in initiating the VAL-083 arm of the Global Coalition for Adaptive Research GBM AGILE registrational study which is expected to occur later this year."

    Dr. John de Groot, professor, Department of Neuro-Oncology at The University of Texas MD Andersen Cancer Center and also a founding member of Kintara's Scientific Advisory Board stated, "These data continue to confirm VAL-083's compelling potential as a potent DNA targeting cytotoxic agent for the treatment of GBM.  I'm particularly encouraged by VAL-083's continued ability to demonstrate a favorable progression-free survival trend as compared to TMZ historical data in newly-diagnosed GBM, and improvement in overall survival compared to lomustine historical data in the recurrent setting."

    At the SNO Annual Meeting, Kintara is to present posters updating two Phase 2 clinical trials evaluating VAL-083 in patients with MGMT-unmethylated GBM as follows:

    Newly-Diagnosed and Recurrent GBM

    The first poster outlined interim data from two groups of patients receiving VAL-083 in the open-label, Phase 2 study in recurrent and adjuvant unmethylated GBM settings being conducted at the MD Anderson Cancer Center in Houston. 

    In newly-diagnosed patients receiving VAL-083 as adjuvant therapy following treatment with radiation and TMZ, for the 27 efficacy evaluable patients (of a planned up to 36 patients) as of the data cut-off of October 23, 2020, median progression-free survival (PFS) is currently 10.0 months (confidence interval: CI 7.6-10.8). While not a head-to-head study, this PFS data compares favorably to historical TMZ control of 5.3 months* and 6.9 months**, respectively.

    For patients in the recurrent group receiving second-line therapy with VAL-083 following first-line TMZ failure, 84 patients have been enrolled as of the data cut-off of October 23, 2020 with 35 patients (34 efficacy evaluable) having received an initial dose of 40 mg/m2/day and 49 (43 efficacy evaluable) having received the planned Phase 3 initial dose of 30 mg/m2/day (on days 1, 2 and 3 of a 21-day cycle). Median overall survival (mOS) for the 77 efficacy evaluable patients who have completed at least once cycle of treatment was 7.6 months (CI 6.4-10.6 months). Additionally, for the 43 efficacy evaluable patients initially receiving the planned Phase 3 initial dose of 30 mg/m2/day, mOS is currently 8.5 months (CI 6.8-13.7 months). While this is not a head-to-head trial, historically, lomustine, which is the most commonly used chemotherapy for these patients, has demonstrated mOS of 7.2 months***.

    Consistent with prior studies, myelosuppression is the most common adverse event with VAL-083 in both the recurrent GBM and adjuvant treatment setting. In the 30 mg/m2/day starting dose cohort (the planned dose for the GBM AGILE pivotal study) three subjects have experienced a serious adverse event (SAE) possibly related to VAL-083 in the recurrent group and one patient has experienced a possibly drug-related SAE in the adjuvant group as of the relevant data cut-off dates.

    First-Line GBM

    The second poster outlined the open-label, Phase 2 study of VAL-083 as a first-line treatment in newly-diagnosed, unmethylated GBM patients being conducted at Sun Yat-sen University Cancer Center in China. For the 29 patients who had completed at least their first efficacy assessment as of the October 21, 2020 cut-off date, median PFS with VAL-083 is currently 9.3 months (95% CI 6.4-12.0 months). Additionally, for the 25 patients initially receiving the treatment dose that will be carried forward in the GBM AGILE pivotal Phase 3 study of 30 mg/m2/day on days 1, 2 and 3 of a 21-day cycle, median PFS was reported to be 8.7 months (CI 6.4-12.5 months). While not a head-to-head study, this PFS data compares favorably to historical TMZ control of 5.3 months* and 6.9 months**, respectively.  Multiple treatment cycles of VAL-083 at the 30 mg/m2/day dose in combination with standard radiation treatment (2 Gy/day, 5 days/week) was shown to be generally safe and well-tolerated.

    *Hegi et al N Eng J Med 352; 997-1003 (2005)

    **Tanguturi et al. NeuroOncol. 19(7): 908-917 (2017)

    *** Wick et al N.Eng.J.Med . 377:1954 1963 (2017)

    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 two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs.  The two programs are VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g. NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    Kintara is also advancing its 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, 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. With clinical efficacy to date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. 

    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 and the GBM AGILE study.  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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies.  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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS:

    Investors:

    CORE IR

    516-222-2560

    Media:

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

     

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/kintara-therapeutics-reports-10-months-progression-free-survival-in-newly-diagnosed-mgmt-unmethylated-gbm-from-ongoing-md-anderson-cancer-center-phase-2-study-301176868.html

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  35. SAN DIEGO, Nov. 13, 2020 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announced its financial results for the first quarter ended September 30, 2020 and provided a corporate update.

    "The first quarter of our fiscal year marked the beginning of a new era for the company as we completed the acquisition of Adgero," commented Saiid Zarrabian, Kintara's President and Chief Executive Officer. "In conjunction with this transformational milestone, we strengthened our balance sheet with a $25 million private placement to enable us to execute a timely advance of our key programs including the clinical stage of the GCAR…

    SAN DIEGO, Nov. 13, 2020 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announced its financial results for the first quarter ended September 30, 2020 and provided a corporate update.

    "The first quarter of our fiscal year marked the beginning of a new era for the company as we completed the acquisition of Adgero," commented Saiid Zarrabian, Kintara's President and Chief Executive Officer. "In conjunction with this transformational milestone, we strengthened our balance sheet with a $25 million private placement to enable us to execute a timely advance of our key programs including the clinical stage of the GCAR GBM AGILE registrational study for VAL-083 and the confirmatory cutaneous metastatic breast cancer study for REM-001."

    First Quarter Highlights and Recent Developments

    • Consummated the acquisition of Adgero, a privately held biopharmaceutical company focused on the development of its late stage photodynamic therapy platform for the treatment of serious cutaneous oncology indications, which created a diversified biopharmaceutical company with a robust product pipeline targeting rare, unmet medical needs in oncology (August 2020).



    • Completed a private placement of Series C Convertible Preferred Stock for aggregate gross proceeds of approximately $25 million, or net proceeds of approximately $21.6 million (August 2020).



    • Executed a definitive agreement with the Global Coalition for Adaptive Research (GCAR) to include VAL-083 in GCAR's Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) study, an adaptive clinical trial platform in glioblastoma multiforme (GBM). Kintara will supply GCAR with the VAL-083 drug along with the funding to support the VAL-083 arm of the GBM AGILE registrational study. In turn, GCAR will manage all operational aspects of the study, including site activation and patient enrollment (October 2020).



    • Received award notification of a Small Business Technology Transfer grant to study the use of REM-001 in the prevention of arteriovenous fistula maturation failure (AFMF), a cardiovascular-related condition that occurs in hemodialysis patients. This grant will allow Kintara to further study the use of REM-001 in the prevention of AFMF in preclinical models (July 2020).

    SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR 2021 FIRST QUARTER ENDED SEPTEMBER 30, 2020

    At September 30, 2020, the Company had cash and cash equivalents of approximately $22.6 million.  In August 2020, the Company completed the private placement of Series C Convertible Preferred Stock for gross proceeds of approximately $25 million, or net proceeds of approximately $21.6 million. The cash and cash equivalents at September 30, 2020, along with the proceeds from warrant exercises received subsequent to September 30, 2020, are expected to be sufficient to fund the Company's planned operations into the fourth quarter of calendar year 2021.

    For the quarter ended September 30, 2020, the Company reported a net loss of approximately $19.5 million, or $1.33 per share, compared to a net loss of approximately $1.6 million, or $0.21 per share, for the quarter ended September 30, 2019. The increase in the current quarter was largely due to the recognition of $16.0 million of non-cash expenses related to the acquisition of in-process research and development costs associated with the Adgero transaction.

     

    Selected Balance Sheet Data (in thousands)







    September 30,

    2020





    June 30,

    2020







    $





    $



    Cash and cash equivalents





    22,602







    2,392



    Working capital





    20,566







    176



    Total assets





    23,131







    2,938



    Total stockholders' equity





    20,554







    263



     

    Selected Statement of Operations Data (in thousands, except per share data)



    For the quarters ended 







    September 30,



    September 30,









    2020



    2019









    $



    $





    Research and development





    1,357





    721





    General and administrative





    1,534





    914





    Merger costs





    500





    -





    In-process research & development





    16,094





    -





    Other loss (income)





    33





    (29)





    Net loss for the period





    19,518





    1,606





    Deemed dividend recognized on beneficial conversion features of Series C Preferred stock issuance





    3,181





    -





    Series A Preferred cash dividend





    2





    2





    Series B Preferred stock dividend





    5





    2





    Net loss attributable to common stockholders





    22,706





    1,610





    Basic and fully diluted weighted average number of shares





    17,106





    7,539





    Basic and fully diluted loss per share





    1.33





    0.21























     

    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 two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs.  The two programs are VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g. NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    Kintara is also advancing its 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, 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. With clinical efficacy to date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. 

    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 and the GBM AGILE study.  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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies.  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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS:

    Investors:

    CORE IR

    516-222-2560

    Media:

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

     

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/kintara-therapeutics-announces-first-fiscal-quarter-2021-financial-results-and-recent-corporate-updates-301172629.html

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  36. SAN DIEGO, Oct. 21, 2020 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announced today the execution of an agreement with the Global Coalition for Adaptive Research (GCAR) for VAL-083's participation in GCAR's Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) Study.

    This study was conceived by an international consortium of major thought leaders in the glioblastoma (GBM) space and is designed to more efficiently identify effective therapies for GBM patients. Since the launch of the study in 2019, GBM AGILE continues to gain momentum among the GBM medical community and has recently expanded…

    SAN DIEGO, Oct. 21, 2020 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announced today the execution of an agreement with the Global Coalition for Adaptive Research (GCAR) for VAL-083's participation in GCAR's Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) Study.

    This study was conceived by an international consortium of major thought leaders in the glioblastoma (GBM) space and is designed to more efficiently identify effective therapies for GBM patients. Since the launch of the study in 2019, GBM AGILE continues to gain momentum among the GBM medical community and has recently expanded the number of participating trial sites in the U.S. from 24 to 31 centers. Kintara is currently advancing two ongoing Phase 2 clinical trials in GBM with VAL-083 in adjuvant and recurrent MGMT unmethylated GBM, and in combination with radiotherapy in newly-diagnosed MGMT unmethylated GBM.  Kintara expects to provide an update on these Phase 2 studies at the Society of Neuro-Oncology SNO 2020 Virtual Conference, November 19-21, 2020.

    "The consummation of a definitive agreement with GCAR for VAL-083's participation in GBM AGILE is a significant corporate and clinical milestone for the Company as it is expected to enable us to accelerate the facilitation of the final clinical stages and the regulatory process for our novel therapeutic candidate while enabling us to maximize financial and operational resources," commented Saiid Zarrabian, Kintara's Chief Executive Officer. "The GCAR opportunity is a more robust, efficient, and cost-effective clinical trial solution than had we embarked on this effort independently and it provides multiple shots on goal via enrollment of three separate GBM patient subtypes enabled by GCAR's FDA-approved adaptive design protocol."

    Under the terms of the agreement, Kintara will supply GCAR with VAL-083 drug along with funding to support the VAL-083 arm of the GBM AGILE registrational study. In turn, GCAR will manage all operational aspects of the study, including site activation and patient enrollment.

    "We are pleased to have reached this major milestone with Kintara and look forward to including VAL-083 into GBM AGILE in the very near future. We are delighted to have a total of 31 U.S. sites already enrolling in GBM AGILE, and expect up to 40 total sites by the end of 2020 in the U.S. and Canada. We have plans to expand to Europe in 2021," commented Meredith Buxton, GCAR's Chief Executive Officer. "Having such a high number of sites simultaneously enrolling upon initiation of the Kintara trial arm should expedite the rate of patient enrollment."

    The GBM AGILE Study is an international effort in newly-diagnosed and recurrent GBM, utilizing an FDA-approved master protocol with multiple drugs to be tested simultaneously and over time against a common control arm. As an approved registrational study, results from the VAL-083 arm of GBM AGILE Study are intended to be utilized to file for FDA approval. This study employs a cost-efficient, adaptive trial design with a Stage 1 (Phase 2) learning and adapting phase and a Stage 2 (Phase 3) expansion and confirmation phase. The totality of the data from the Stage 1 and Stage 2 expansion would be used for the regulatory filing of an NDA. The effort is led by top-tier key opinion leaders in the GBM field and has the collective support of an international group of more than 130 clinicians, researchers, biostatisticians, imagers, pathologists, leaders from government and industry, and patient advocates. GCAR functions as the GBM AGILE Study sponsor, and provides financial support for the program infrastructure, as well as general trial oversight. Comprising some of the world's foremost clinical, translational, and basic science investigators, GCAR strives to support the development of novel treatments to fight against rare and deadly diseases like GBM where patient prognosis is poor and treatment options are limited.

    ABOUT GLOBAL COALITION FOR ADAPTIVE RESEARCH

    GCAR is a 501(c)(3) nonprofit organization, comprised of some of the world's foremost physicians, clinical researchers and investigators united in expediting the discovery and development of cures for patients with rare and deadly diseases. As its first priority, GCAR is sponsoring GBM AGILE, an adaptive platform trial for patients with GBM – the most common and deadliest of malignant primary brain tumors. Key strategic partners for the GBM AGILE study effort include the National Brain Tumor Society, National Foundation for Cancer Research, and Asian Fund for Cancer Research. These three nonprofit organizations are working together to provide philanthropic support as well as assistance in communicating with patients and families and inviting all others to join in supporting this innovative approach to brain tumor treatment development.

    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 two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs. The two programs are VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g. NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    Kintara is also advancing its 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, 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. With clinical efficacy to date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing.

    Forward-Looking Statements

    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 and the GBM AGILE Study.  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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies.  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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS:

    Investors:

    CORE IR

    516-222-2560

    Media:

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

     

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

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  37. SAN DIEGO, Sept. 21, 2020 /PRNewswire/ -- Kintara Therapeutics, Inc. (NASDAQ:KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announced its financial results for the year ended June 30, 2020 and provided a corporate update.

    "The past fiscal year was one of the most important periods in the Company's history, as it set the stage for the recently consummated acquisition of Adgero which was truly a transformational milestone," commented Saiid Zarrabian, President and Chief Executive Officer of Kintara. "Moving forward, we believe we are now well positioned to execute our growth strategy as we approach the important final stage of both of our clinical development programs with the initiation of the GCAR GBM AGILE registrational study for VAL-083 and the confirmatory cutaneous metastatic breast cancer study for REM-001."

    Recent Corporate Highlights

    • Completed a private placement of Series C Convertible Preferred Stock for aggregate gross proceeds of approximately $25 million, or net proceeds of approximately $21.7 million (August 2020).
    • Consummated the acquisition of Adgero Biopharmaceuticals Holdings, Inc. (Adgero), a privately held biopharmaceutical company focused on the development of its late stage photodynamic therapy platform for the treatment of serious cutaneous oncology indications, which created a diversified biopharmaceutical company with a robust product pipeline targeting rare, unmet medical needs in oncology (August 2020).
    • Received a notification of award of a Small Business Technology Transfer grant to study the use of REM-001 in the prevention of arteriovenous fistula maturation failure (AFMF), a cardiovascular-related condition that occurs in hemodialysis patients. This grant will allow Kintara to study the use of REM-001 in the prevention of AFMF further in preclinical models (July 2020).
    • Accepted invitation from the Global Coalition for Adaptive Research (GCAR) to include VAL-083 in GCAR's Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) study, an adaptive clinical trial platform in glioblastoma multiforme (GBM). The Company expects to utilize the GBM AGILE study to serve as the basis for VAL-083's new drug application submission and registration (June 2020).
    • Entered into a $500,000 loan agreement with the National Brain Tumor Society and the National Foundation for Cancer Research to support VAL-083's preparation for participation in the GBM AGILE study (June 2020).

    SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR ENDED JUNE 30, 2020

    At June 30, 2020, the Company had cash and cash equivalents of approximately $2.4 million.  In August 2020, the Company completed the private placement of Series C Convertible Preferred Stock for gross proceeds of approximately $25 million, or net proceeds of approximately $21.7 million. The cash and cash equivalents at June 30, 2020 plus the private placement proceeds are expected to be sufficient to fund the Company's planned operations into the fourth quarter of calendar year 2021.

    For the year ended June 30, 2020, the Company reported a net loss of approximately $9.1 million, or $0.87 per share, compared to a net loss of approximately $8.0 million, or $3.16 per share, for the year ended June 30, 2019.

     

    Selected Balance Sheet Data 







    June 30,

    2020





    June 30,

    2019







    $





    $



    Cash and cash equivalents





    2,392,402







    3,718,758



    Working capital





    176,161







    1,955,468



    Total assets





    2,938,137







    4,037,255



    Total stockholders' equity





    263,214







    1,967,530



     

    Selected Statement of Operations Data



    For the years ended 







    June 30,





    June 30,









    2020





    2019









    $





    $





    Research and development





    3,630,024







    3,662,056



    General and administrative





    4,514,520







    4,736,440



    Merger costs





    1,053,697







    -



    Other income





    (72,325)







    (350,275)



    Net loss for the period





    9,125,916







    8,048,221



    Series B Preferred stock dividend





    8,616







    80,431



    Net loss attributable to common stockholders





    9,134,532







    8,128,652



    Basic and fully diluted weighted average number of shares





    10,444,045







    2,574,692



    Basic and fully diluted loss per share





    0.87







    3.16

























    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 two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs.  The two programs are VAL-083 for GBM and REM-001 for cutaneous metastatic breast cancer (CMBC).

    VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g. NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    Kintara is also advancing its 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, 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. With clinical efficacy to date of 80% complete responses of CMBC evaluable lesions, and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. 

    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 and the GBM AGILE study.  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 impact of the COVID-19 pandemic on the Company's operations and clinical trials; the Company's ability to develop, market and sell products based on its technology; 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; and, the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies.  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, 2020, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS:

    Investors:

    CORE IR

    516-222-2560

    Media:

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/kintara-therapeutics-announces-fiscal-year-2020-financial-results-and-recent-corporate-updates-301134396.html

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  38. SAN DIEGO, Sept. 1, 2020 /PRNewswire/ -- Kintara Therapeutics, Inc. ("Kintara" or the "Company") (NASDAQ:KTRA) announced today the final closing of its previously announced private placement of Series C Convertible Preferred Stock (the "Preferred Stock") to accredited investors. Including the previously announced closings, Kintara received aggregate gross proceeds of approximately $25 million before deducting placement agent fees and other offering expenses payable by the Company.

    The capital raised from existing and new investors is expected to facilitate Kintara's strategic initiative to become a recognized leader in developing therapies for rare and difficult to treat oncology indications. The Company intends to use the net proceeds from…

    SAN DIEGO, Sept. 1, 2020 /PRNewswire/ -- Kintara Therapeutics, Inc. ("Kintara" or the "Company") (NASDAQ:KTRA) announced today the final closing of its previously announced private placement of Series C Convertible Preferred Stock (the "Preferred Stock") to accredited investors. Including the previously announced closings, Kintara received aggregate gross proceeds of approximately $25 million before deducting placement agent fees and other offering expenses payable by the Company.

    The capital raised from existing and new investors is expected to facilitate Kintara's strategic initiative to become a recognized leader in developing therapies for rare and difficult to treat oncology indications. The Company intends to use the net proceeds from the offering primarily to fund the previously announced registration study for VAL-083 in newly-diagnosed and recurrent glioblastoma multiforme (GBM) and the 15-patient REM-001 confirmatory lead-in study that is designed to seamlessly transition into a Phase 3 pivotal study for cutaneous metastatic breast cancer (CMBC) as well as for working capital. As previously disclosed, the VAL-083 GBM registration study will be executed through the Company's partnership with Global Coalition for Adaptive Research (GCAR) through the Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) Study, the world's first global adaptive clinical trial platform for GBM with regulatory support as a registrational study.

    "This is a transformational event for the Company as we believe it validates the combined portfolio of assets from the recently completed acquisition of Adgero," commented Saiid Zarrabian, President and Chief Executive Officer of Kintara. "Furthermore, and perhaps most importantly, we believe this financing provides sufficient capital to achieve meaningful value generating milestones for multiple clinical stage programs over the next 12-24 months. We look forward to enrolling the first patient into the VAL-083 arm of the GBM AGILE study in the fourth quarter of 2020 and plan to initiate the 15-patient REM-001 confirmatory study in the second quarter of 2021, with planned data results from this study as early as the fourth quarter of 2021."

    The private placement offering consisted of the issuance of an aggregate of 25,028 shares of the Company's Series C Convertible Preferred Stock (the "Preferred Stock") at a purchase price of $1,000 per share priced at-the-market under the rules of the Nasdaq Stock Market.  The Preferred Stock was issued in three separate series,  19,587 shares of Series C-1 Preferred Stock, which are convertible into 16,885,345 shares of the Company's common stock at a conversion price of $1.16 per share, 2,185 shares of Series C-2 Preferred Stock, which are convertible into 1,799,835 shares of the Company's common stock at a conversion price of $1.214 per share and 3,256 shares of Series C-3 Preferred Stock, which are convertible into 2,831,304 shares of the Company's common stock at a conversion price of $1.15 per share.  The Preferred Stock also accrues dividends as previously disclosed.

    "The strong investor response to this private placement is confirmation of the attractiveness of Kintara's unique corporate profile and diversified late-stage oncology product pipeline targeting rare, unmet medical needs," commented Adam Stern, Chief Executive Officer of SternAegis Ventures. "With the addition of new capital, the Company is now in a strong position to expedite the advancement of two potentially game-changing therapeutic candidates into late-stage clinical trials."

    SternAegis Ventures acted as the exclusive placement agent for the private placement.

    The shares of Preferred Stock described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "Act"), and, along with the common shares issuable upon their conversion or payable as dividends pursuant to the Preferred Stock, have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. 

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

    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 two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs.  The two programs are VAL-083 for GBM and REM-001 for CMBC.

    VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g. NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    Kintara is also advancing its proprietary late stage photodynamic therapy (PDT) platform that holds promise as a localized cutaneous or visceral tumor treatment as well as in other potential indications. REM-001 therapy, 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. With clinical efficacy to date of 80% complete responses of CMBC evaluable lesions and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late stage pivotal testing. 

    About SternAegis Ventures

    SternAegis Ventures is the management team within Aegis Capital Corp. that is responsible for venture capital and private equity financing. www.sternaegis.com

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 based upon Kintara's current expectations. Forward-looking statements are identified by terminology such as "may," "should," "expects," "plans," "anticipates," "could," "intends," "target," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar words. These statements are only predictions. Kintara has based these forward-looking statements largely on its then-current expectations and projections about future events, as well as the beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Kintara's control, and actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to: (i) risks associated with the impact of the COVID-19 pandemic, (ii) risks and uncertainties relating to Kintara's ability to develop, market and sell products based on its technology; the expected benefits and efficacy of Kintara's products and technology; the availability of substantial additional funding for Kintara to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, Kintara's business, research, product development, regulatory approval, marketing and distribution plans and strategies, (iii) whether the recently closed acquisition of Adgero Biopharmaceuticals Holdings, Inc. will be successful, and (iv) those risks detailed in Kintara's most recent Annual Report on Form 10-K and subsequent reports filed with the SEC, as well as other documents that may be filed by Kintara from time to time with the SEC. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Kintara cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. The forward-looking statements made in this communication relate only to events as of the date on which the statements are made. Except as required by applicable law or regulation, Kintara undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events. Investors should not assume that any lack of update to a previously issued "forward-looking statement" constitutes a reaffirmation of that statement.

    Contact Information

    Investors:

    CORE IR

    516-222-2560

    Media:

    Jules Abraham

    Head of Public Relations

    CORE IR

    917-885-7378

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/kintara-therapeutics-completes-final-closing-of-previously-announced-private-placement-for-an-aggregate-of-25-million-301121610.html

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  39. SAN DIEGO, Aug. 25, 2020 /PRNewswire/ -- Kintara Therapeutics, Inc. ("Kintara" or the "Company") (NASDAQ:KTRA) announced today that it has closed its previously announced private placement with investors providing for the sale and issuance of 2,185 shares of its Series C Convertible Preferred Stock (the "Preferred Stock") at a purchase price of $1,000 per share priced at-the-market under the rules of the Nasdaq Stock Market. The Preferred Stock is convertible into shares of the Company's common stock at a conversion price of $1.214 per share. The closing resulted in gross proceeds to the Company of approximately $2.2 million, which is in addition to the $19.6 million of gross proceeds previously announced in connection with the initial closing…

    SAN DIEGO, Aug. 25, 2020 /PRNewswire/ -- Kintara Therapeutics, Inc. ("Kintara" or the "Company") (NASDAQ:KTRA) announced today that it has closed its previously announced private placement with investors providing for the sale and issuance of 2,185 shares of its Series C Convertible Preferred Stock (the "Preferred Stock") at a purchase price of $1,000 per share priced at-the-market under the rules of the Nasdaq Stock Market. The Preferred Stock is convertible into shares of the Company's common stock at a conversion price of $1.214 per share. The closing resulted in gross proceeds to the Company of approximately $2.2 million, which is in addition to the $19.6 million of gross proceeds previously announced in connection with the initial closing of the private placement. The Preferred Stock accrues dividends as previously announced.

    The Company intends to use the net proceeds from the offering to fund the previously announced registration study for VAL-083 in newly diagnosed and recurrent GBM, the 15-patient REM-001 confirmatory lead-in study intended to continue seamlessly into a full Phase 3 pivotal study for CMBC, and for working capital. Also, as previously disclosed, the GBM trial will be executed through the Company's partnership with Global Coalition for Adaptive Research (GCAR) through the Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) Study, an adaptive clinical trial platform in GBM.

    The shares of Preferred Stock described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "Act"), and, along with the common shares issuable upon their exercise or payable as dividends pursuant to the Preferred Stock, have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. 

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

    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 two late-stage, Phase 3-ready therapeutics for clear unmet medical needs with reduced risk development programs. The two programs are VAL-083 for GBM and REM-001 for CMBC.

    VAL-083 is a "first-in-class", small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g. NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara's internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM.

    Kintara is also advancing its proprietary late stage photodynamic therapy (PDT) platform that holds promise as a localized cutaneous or visceral tumor treatment as well as in other potential indications. REM-001 therapy, 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. With clinical efficacy to date of 80% complete responses of CMBC evaluable lesions and with an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late stage pivotal testing. 

    Forward-Looking Statements

    This press release contains forward-looking statements based upon Kintara's current expectations. This communication contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are identified by terminology such as "may," "should," "expects," "plans," "anticipates," "could," "intends," "target," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar words. These statements are only predictions. Kintara has based these forward-looking statements largely on its then-current expectations and projections about future events, as well as the beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Kintara's control, and actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to: (i) risks associated with the impact of the COVID-19 pandemic; (ii) risks and uncertainties relating to Kintara's ability to develop, market and sell products based on its technology; the expected benefits and efficacy of Kintara's products and technology; the availability of substantial additional funding for Kintara to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, Kintara's business, research, product development, regulatory approval, marketing and distribution plans and strategies (ii) whether the recently closed merger with Adgero Biopharmaceuticals will be successful, and (iii) those risks detailed in Kintara's most recent Annual Report on Form 10-K and subsequent reports filed with the SEC, as well as other documents that may be filed by Kintara from time to time with the SEC. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Kintara cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. The forward-looking statements made in this communication relate only to events as of the date on which the statements are made. Except as required by applicable law or regulation, Kintara undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events. Investors should not assume that any lack of update to a previously issued "forward-looking statement" constitutes a reaffirmation of that statement.

    Contact Information

    Investors:

    CORE IR

    516-222-2560

    Media:

    Jules Abraham

    Head of Public Relations

    CORE IR

    917-885-7378

    Kintara Therapeutics logo (PRNewsfoto/Kintara Therapeutics)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/kintara-therapeutics-announces-closing-of-additional-2-2-million-private-placement-priced-at-the-market-301117630.html

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