KTRA Kintara Therapeutics Inc.

0.89
-0.04  -5%
Previous Close 0.94
Open 0.93
52 Week Low 0.74
52 Week High 3.35
Market Cap $38,529,360
Shares 43,174,989
Float 42,720,449
Enterprise Value $49,412,988
Volume 1,914,921
Av. Daily Volume 1,972,753
Stock charts supplied by TradingView

Drug Pipeline

Drug Stage Notes
VAL-083 (GBM AGILE)
Glioblastoma
Phase 2/3
Phase 2/3
Phase 2/3 initiation of recruitment announced January 13, 2021.
VAL-083
MGMT-unmethylated Recurrent Glioblastoma Multiforme (GBM)
Phase 2
Phase 2
Phase 2 top-line data released July 1, 2021. Median overall survival 8.0 months.
VAL-083
Glioblastoma Multiforme (GBM) - Adjuvant
Phase 2
Phase 2
Phase 2 top-line data showed progression free survival (PFS) is 10.0 months, historical data for this patient population is a PFS of 5.3-6.9 months. Median overall survival (mOS) is 16.5 months compared to historical mOS of 12.7-16.0 months. Myelosuppression was the most common adverse event. One patient experienced a serious adverse event (SAE) possibly related to VAL-083, noted September 22, 2021.

Latest News

  1. 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

    ir@coreir.com

    Media:

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    julesa@coreir.com

    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

    SOURCE Kintara Therapeutics

    View Full Article Hide Full Article
  2. 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 placements@hcwco.com.

    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

    ir@coreir.com

    Media

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    julesa@coreir.com

    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

    View Full Article Hide Full Article
  3. 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 placements@hcwco.com.

    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

    ir@coreir.com

    Media

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    julesa@coreir.com

    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

    View Full Article Hide Full Article
  4. 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

    ir@coreir.com

    Media

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    julesa@coreir.com

    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

    View Full Article Hide Full Article
  5. 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: trista.morrison@saniona.com

    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.

     

    Attachment



    Primary Logo

    View Full Article Hide Full Article
View All Kintara Therapeutics Inc. News