DMPI DelMar Pharmaceuticals Inc.

0.63
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Previous Close 0.63
Open 0.62
52 Week Low 0.38
52 Week High 2.66
Market Cap $7,200,414
Shares 11,429,228
Float 11,309,625
Enterprise Value $7,007,604
Volume 70,876
Av. Daily Volume 749,384
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Upcoming Catalysts

Drug Stage Catalyst Date
VAL-083
MGMT-unmethylated newly diagnosed Glioblastoma Multiforme (GBM)
Phase 2
Phase 2
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VAL-083
MGMT-unmethylated Recurrent Glioblastoma Multiforme (GBM)
Phase 2
Phase 2
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Latest News

  1. SAN DIEGO, June 24, 2020 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (NASDAQ:DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies announced today it has received a $500,000 loan from the National Brain Tumor Society (NBTS) and the National Foundation for Cancer Research (NFCR) to support VAL-083's preparation for participation in the Global Coalition for Adaptive Research's (GCAR) sponsored trial, Glioblastoma (GBM) Adaptive Global Innovative Learning Environment (GBM AGILE) study. On June 4, 2020, the Company announced that VAL-083, its "first-in-class," small-molecule chemotherapeutic with a novel mechanism of action, was selected by GCAR as the third investigational…

    SAN DIEGO, June 24, 2020 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (NASDAQ:DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies announced today it has received a $500,000 loan from the National Brain Tumor Society (NBTS) and the National Foundation for Cancer Research (NFCR) to support VAL-083's preparation for participation in the Global Coalition for Adaptive Research's (GCAR) sponsored trial, Glioblastoma (GBM) Adaptive Global Innovative Learning Environment (GBM AGILE) study. On June 4, 2020, the Company announced that VAL-083, its "first-in-class," small-molecule chemotherapeutic with a novel mechanism of action, was selected by GCAR as the third investigational therapy to participate in GBM AGILE, in which the compounds will be simultaneously evaluated across multiple international trial sites of which 25 are currently activated. DelMar intends to utilize GBM AGILE, which is an adaptive registration clinical trial, to serve as the basis for VAL-083's new drug application submission and registration.

    "It means a great deal to all of us involved with VAL-083's development to receive support from the National Brain Tumor Society and the National Foundation for Cancer Research as these organizations are two of the leading advocacy and funding partners for GBM AGILE," commented Saiid Zarrabian, Chief Executive Officer of DelMar Pharmaceuticals. "This funding is an important milestone as it enables us to accelerate VAL-083's participation in GBM AGILE, which is expected to reduce VAL-083's pivotal trial completion and regulatory submission timeline by up to 18 months."

    GBM AGILE is an international effort in newly diagnosed and recurrent GBM, utilizing an FDA approved master protocol to evaluate multiple therapies against a common control arm. As an approved registrational study, positive results from the VAL-083 arm of GBM AGILE are expected to be utilized to file for FDA approval. This study employs a cost-efficient, seamless phase 2/3 adaptive trial design with a Stage 1 learning and adapting phase and a Stage 2 expansion and confirmation phase. 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, a 501(c)(3) organization, is the international trial sponsor, and provides financial support for the program infrastructure, as well as trial oversight and management. Comprised 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.

    "We are supporting the inclusion of VAL-083 in the GBM AGILE adaptive clinical trial platform as it is consistent with our mission to support research for, and ultimately enable delivery of, effective treatments to patients with brain tumors. We are particularly pleased to lend our support to VAL-083 given the significant unmet medical need that exists for patients with GBM," commented David Arons, Chief Executive Officer of the National Brain Tumor Society.

    Sujuan Ba, President & Chief Executive Officer of the National Foundation for Cancer Research added, "We are dedicated to facilitating the development of therapies for all cancers, and are pleased to lend our support to VAL-083's participation in GBM AGILE. We are very hopeful that the knowledge established from VAL-083 in GBM AGILE can be insightful for other cancers – giving patients hope for treatments that are best suited for their care."

    "We are delighted to help bring together our key strategic partners, NBTS, NFCR, and DelMar Pharmaceuticals," shared Faramarz Yousefzadeh, GCAR Board Chairman. "We believe this is a model for collaboration – aiding small pharma to test promising new drugs in GBM AGILE."   

    About VAL-083

    VAL-083 (dianhydrogalactitol) is a "first-in-class", bifunctional DNA-targeting agent that introduces inter-strand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute (NCI). DelMar has demonstrated that VAL-083's anti-tumor activity is unaffected by common mechanisms of chemoresistance, including MGMT, in cancer cell models and animal studies. Further details regarding these studies can be found at: 

    http://www.delmarpharma.com/scientific-publications.html.

    About the National Foundation for Cancer Research

    The NFCR is a 501(c)(3) nonprofit organization that provides scientists in the lab the funding they need to make game-changing discoveries in cancer treatments, detection, prevention and ultimately, a cure. NFCR has distinguished itself in the cancer research sector by emphasizing long-term, transformative research often overlooked by other major funding sources. With the help of more than 5.2 million individual donors over the last 47 years, NFCR has delivered more than $380 million in funding to public education and cancer research leading to several important, life-saving discoveries.

    About the National Brain Tumor Society

    The NBTS unrelentingly invests in, mobilizes, and unites the community to discover a cure, deliver effective treatments, and advocate for patients and care partners. It is in the unique position to affect change across the drug development, policy and legislative, research, and clinical trial systems at all levels. NBTS doesn't focus on a single method or approach to defeating brain tumors. It drives a multi-faceted and thoughtful approach to aggressively influence and fund strategic research and discovery, as well as advocate for public policy changes, in order to achieve the greatest impact, results, and progress for brain tumor patients.

    About DelMar Pharmaceuticals, Inc.

    Located in San Diego, California, DelMar is focused on the development and commercialization of new therapies for cancer patients who have limited or no treatment options. By focusing on understanding tumor biology and mechanisms of treatment resistance, the Company identifies biomarkers to personalize new therapies in indications where patients are failing, or are unable to tolerate, standard-of-care treatments.

    The Company's current pipeline is based around VAL-083, 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 DelMar's internal research programs and these prior NCI-sponsored clinical studies, the Company is conducting clinical trials to support the development and commercialization of VAL-083 to solve significant unmet medical needs.

    VAL-083 is being studied in two collaborator-supported, biomarker-driven Phase 2 clinical trials for MGMT-unmethylated GBM. Overcoming MGMT-mediated resistance represents a significant unmet medical need in the treatment of GBM. In addition, DelMar has announced the allowance of a separate IND for VAL-083 as a potential treatment for platinum-resistant ovarian cancer.

    Further information on DelMar's clinical trials can be found on clinicaltrials.gov:  https://www.clinicaltrials.gov/ct2/results?cond=&term=val-083&cntry1=&state1=&recrs.

    For additional information, please visit http://delmarpharma.com/; or contact DelMar Pharmaceuticals Investor Relations: / (604) 629-5989.

    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 GBM AGILE, the status of the Company's clinical trials, the reporting of the results and the impact of the COVID-19 pandemic. 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, 2019, 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

    DelMar Pharmaceuticals Logo

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/delmar-pharmaceuticals-receives-500-000-loan-from-the-national-brain-tumor-society-and-national-foundation-for-cancer-research-to-support-val-083s-participation-in-a-pivotal-study-for-glioblastoma-sponsored-by-the-global-coaliti-301082598.html

    SOURCE DelMar Pharmaceuticals, Inc.

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  2. SAN DIEGO, June 22, 2020 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (NASDAQ:DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced positive interim data from its two Phase 2 trials of VAL-083 for the treatment of glioblastoma multiforme (GBM) demonstrating improved outcomes over current standard of care as both a first-line treatment and for recurrent GBM. The data, presented in two posters at the 2020 American Association for Cancer Research Virtual Annual Meeting II, support the Company's planned participation in the Global Coalition for Adaptive Research's (GCAR) Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) clinical trial…

    SAN DIEGO, June 22, 2020 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (NASDAQ:DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced positive interim data from its two Phase 2 trials of VAL-083 for the treatment of glioblastoma multiforme (GBM) demonstrating improved outcomes over current standard of care as both a first-line treatment and for recurrent GBM. The data, presented in two posters at the 2020 American Association for Cancer Research Virtual Annual Meeting II, support the Company's planned participation in the Global Coalition for Adaptive Research's (GCAR) Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) clinical trial. DelMar previously announced its invitation from GCAR to participate in the selective GBM AGILE study. This pivotal study, with its robust trial design, industry leading partners, and strong regulatory endorsement, is intended to serve as the basis for VAL-083's new drug application (NDA) submission and registration.

    Dr. John de Groot, Chairman of the Department of Oncology at MD Anderson Cancer Center and planned Principal Investigator for the VAL-083 arm of the GCAR GBM AGILE registration study, noted, "These data continue to demonstrate an improvement over the historical outcomes of standard therapy and validate VAL-083's inclusion in a more robust setting as part of the GBM AGILE study. In MD Anderson's Glioblastoma Moon Shots Program, we are looking to create giant leaps to help patients with GBM where treatment options are limited. It is our hope that VAL-083 may serve as an important new therapy to help physicians and patients dramatically reduce mortality and suffering due to this deadly cancer. We continue to be encouraged by these results and are excited by the opportunity to collaborate with DelMar and GCAR to further explore the potential of VAL-083."

    Interim outcomes included:

    Poster #CT273 - "Phase 2 study of dianhydrogalactitol (VAL-083) in patients with newly diagnosed MGMT-unmethylated glioblastoma"

    Results:

    • For the 25 patients initially receiving the treatment dose that will be carried forward in the GBM AGILE pivotal study (30 mg/m2/day on days 1, 2 and 3 of a 21-day cycle) median progression-free survival (PFS) was reported to be 8.7 months (confidence interval, or CI 6.0-12.0 months) as of the May 15, 2020 cut-off date.
    • Overall PFS (n=29) with VAL-083 was 8.7 months (CI 6.4-11.2 months).
    • While not a head-to-head trial, historically temozolomide (TMZ), the standard of care, has been demonstrated to have 6.9 months PFS in newly_diagnosed unmethylated GBM patients.

    The open-label Phase 2 study in newly-diagnosed unmethylated GBM is being conducted at Sun Yat-sen University Cancer Center in China. The Company announced full enrollment of the study on February 19, 2020.

    Poster #CT272 - "Phase 2 study of dianhydrogalactitol (VAL-083) in patients with MGMT-unmethylated bevacizumab-naïve glioblastoma in the recurrent of adjuvant setting"

    Results:

    • In recurrent GBM, for the 37 patients initially receiving the intended treatment dose that will be carried forward in the GBM AGILE pivotal study (30 mg/m2/day on days 1, 2 and 3 of a 21-day cycle), median overall survival (mOS) is currently 8.5 months (CI 5.7-14.3 months) as of the May 28, 2020 cut-off date.
    • Overall mOS for the 72 patients who have completed at least one cycle of treatment was 7.1 months (CI 5.8-9.9 months).
    • While this is not a head-to-head trial, historically lomustine, which is the most commonly used chemotherapy for these patients, has demonstrated a mOS of 7.2 months in recurrent unmethylated GBM patients.
    • In the adjuvant setting, patients receive VAL-083 as adjuvant therapy following treatment with radiation and TMZ. As of the data cut-off date of May 28, 2020, 19 evaluable subjects have completed at least one 21-day cycle of treatment, with a total of 25 subjects enrolled. Enrollment for this arm was initiated in July 2019, and all 25 subjects enrolled to-date were alive at the data cut-off date.
    • Based on encouraging outcomes, the Company plans to increase the adjuvant arm from the originally planned 24 patients to include up to 12 additional patients.

    The open-label Phase 2 study in recurrent and adjuvant unmethylated GBM is being conducted at M.D. Anderson Cancer Center in Houston.

    Dr. Barbara O'Brien, Principal Investigator, commented, "These results continue to demonstrate the promise of VAL-083, along with a very favorable safety profile in both the adjuvant and recurrent settings. Further, we are excited to be able to add additional patients to the adjuvant arm of the study, which has received great interest from patients, and has enrolled faster than predicted. VAL-083 is well tolerated by these patients and extending the study provides an opportunity for patients to have access to this important trial for glioblastoma."

    Similar to prior experience with VAL-083, myelosuppression has been the most common adverse event observed. Three subjects experienced a serious adverse event (SAE), possibly related to VAL-083 in the newly-diagnosed group, while 10 subjects have experienced a possibly drug-related SAE 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.

    Saiid Zarrabian, CEO of DelMar Pharmaceuticals, added, "We continue to be encouraged with the interim outcomes for both of our ongoing Phase 2 trials of VAL-083 in GBM. With the support of these findings, we have commenced preparations for VAL-083's participation in the GCAR pivotal GBM AGILE study. We look forward to reporting top-line results for the newly diagnosed Phase 2 study in the third quarter of 2020 and providing additional updates on both studies at the Society for Neuro-Oncology Annual Scientific Meeting in November 2020."

    ABOUT DELMAR PHARMACEUTICALS

    Located in San Diego, California, DelMar is focused on the development and commercialization of new therapies for cancer patients who have limited or no treatment options. By focusing on understanding tumor biology and mechanisms of treatment resistance, DelMar identifies biomarkers to personalize new therapies in indications where patients are failing, or are unable to tolerate, standard-of-care treatments.

    DelMar's current pipeline is based around VAL-083, 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 DelMar's internal research programs and these prior NCI-sponsored clinical studies, DelMar is conducting clinical trials to support the development and commercialization of VAL-083 to solve significant unmet medical needs.

    VAL-083 is being studied in two collaborator-supported, biomarker-driven Phase 2 clinical trials for MGMT-unmethylated GBM. Overcoming MGMT-mediated resistance represents a significant unmet medical need in the treatment of GBM. In addition, DelMar has announced the allowance of a separate IND for VAL-083 as a potential treatment for platinum-resistant ovarian cancer.

    Further information on DelMar's clinical trials can be found on clinicaltrials.gov: https://www.clinicaltrials.gov/ct2/results?cond=&term=val-083&cntry1=&state1=&recrs

    For additional information, please visit http://delmarpharma.com/; or contact DelMar Pharmaceuticals Investor Relations:  / (604) 629-5989.

    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 GBM AGILE study, the status of the Company's clinical trials, the reporting of the results and the impact of the COVID-19 pandemic. 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, 2019, the Company's Quarterly Reports on Form 10-Q, and the Company's Current Reports on Form 8-K.

    CONTACTS:

    Investors:

    John Marco Managing Director CORE IR

    516-222-2560

    Media:

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    DelMar Pharmaceuticals Logo

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/delmar-pharmaceuticals-presents-positive-interim-data-on-val-083-demonstrating-favorable-outcomes-in-both-newly--diagnosed-and-recurrent-gbm-at-the-aacr-virtual-annual-meeting-ii-301080704.html

    SOURCE DelMar Pharmaceuticals, Inc.

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  3. SAN DIEGO & PRINCETON, N.J., June 10, 2020 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (NASDAQ:DMPI) ("DelMar") and Adgero Biopharmaceuticals Holdings, Inc. ("Adgero") today announced the companies have entered into a definitive merger agreement pursuant to which DelMar, a biopharmaceutical company focused on the development of new solid tumor cancer therapies, will acquire 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. In an all-equity transaction, Adgero stockholders will receive shares of DelMar common stock for shares of Adgero common stock.

    Upon completion of the merger, current DelMar and Adgero stockholders…

    SAN DIEGO & PRINCETON, N.J., June 10, 2020 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (NASDAQ:DMPI) ("DelMar") and Adgero Biopharmaceuticals Holdings, Inc. ("Adgero") today announced the companies have entered into a definitive merger agreement pursuant to which DelMar, a biopharmaceutical company focused on the development of new solid tumor cancer therapies, will acquire 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. In an all-equity transaction, Adgero stockholders will receive shares of DelMar common stock for shares of Adgero common stock.

    Upon completion of the merger, current DelMar and Adgero stockholders will own 50.5% and 49.5% of the total voting power of the combined company, respectively, exclusive of securities to be issued in a financing to occur prior to the merger closing, as well as compensation payable in connection with the merger and the financing. Subject to stockholder approval of both companies and other closing conditions, the transaction is expected to close in the third quarter of 2020, at which time DelMar is expected to change its name to Kintara Therapeutics, Inc. and trade on Nasdaq under the new ticker symbol "KTRA."

    This combination brings together DelMar's first-in-class, DNA-targeting chemotherapeutic with proven anti-cancer activities with Adgero's photodynamic therapy platform.  The combined company expects to benefit from complementary capabilities along with greater financial resources and flexibility to engage in a wide range of research and development activities that the companies believe will ultimately result in the creation of sustainable long-term growth.

    "The acquisition of Adgero by DelMar positions the combined company for long-term corporate growth and increased shareholder value by bringing together DelMar's oncology therapeutic candidate, VAL-083, and Adgero's REM-001 photodynamic therapy with a lead indication in CMBC," commented Saiid Zarrabian, President and Chief Executive Officer of DelMar. "This acquisition is the result of an extensive search for a suitable oncology therapy and provides the combined company with a diversified, late-stage oncology pipeline. During the next 12-18 months, we expect to achieve significant clinical milestones, driven by a seasoned leadership team that will bolster our oncology drug development expertise."

    Mr. Zarrabian continued, "The clinical data from Adgero's REM-001 has demonstrated significant anti-tumor efficacy to date, with 80% complete responses reported across four studies in CMBC, and we believe it will be a valuable late-stage pipeline complement to DelMar's VAL-083 as we prepare for the GBM AGILE registration study."

    John Liatos, interim Chief Executive Officer and Chief Financial Officer of Adgero, added, "This combination provides us with the opportunity to not only deepen our pipeline but also strengthen our oncology drug development expertise and capabilities. Furthermore, our enthusiasm to merge with DelMar was reinforced by the Global Coalition for Adaptive Research's (GCAR) invitation to include VAL-083 in its GBM AGILE pivotal study for the treatment of newly-diagnosed and recurrent GBM.  This is an important milestone with the potential to greatly reduce VAL-083's development timeline and speaks to the potential of VAL-083 given that only a limited number of drug candidates will be invited to participate in the study. On our end, we are tremendously proud of the progress we have accomplished to date, and through this combination we look forward to creating a highly focused oncology company that can develop new therapies to help physicians and patients combat cancers where current treatment options are limited."

    Strategic Rationale for the Merger:

    • Creates a diversified, late-stage oncology company with two Phase 3-ready products that target rare, unmet medical needs in oncology;
    • Combined robust development efforts to date with an estimated $300 million invested in the development of DelMar's VAL-083 and Adgero's REM-001, both of which have demonstrated anti-tumor activity in clinical trials and possess a large patient safety database;
    • Potential future pipeline expansion opportunities with an existing Orphan designation and an approved IND in ovarian cancer, and existing Orphan designations in basal cell carcinoma nevus syndrome and hemodialysis grafts; and
    • Bolstered oncology drug development expertise by the combination of DelMar and Adgero leadership is instrumental for the further clinical development of VAL-083 and REM-001.

    Anticipated Late-stage Clinical Milestones Over the Next 12-18 Months*:

    • Report at various oncology meetings, including the American Association for Cancer Research Virtual Annual Meeting II being held June 22-24, 2020;
    • Top-line results from VAL-083's Phase 2 study in newly-diagnosed GBM;
    • Top-line results from VAL-083's Phase 2 study conducted at the MD Andersen Cancer Center in recurrent GBM;
    • Top-line results from VAL-083's Phase 2 study conducted at the MD Andersen Cancer Center in adjuvant GBM;
    • Initiation of patient enrollment into the VAL-083 arm of the Global Coalition for Adaptive Research's GBM AGILE registrational study in newly-diagnosed and recurrent GBM patients; and
    • REM-001 confirmatory trial results in CMBC

    *(subject to financing proceeds available to the combined company)

    Organizational Structure

    Following the close of the transaction, Saiid Zarrabian, DelMar's President and Chief Executive Officer, will continue to serve as President and Chief Executive Officer, John Liatos, Adgero's interim Chief Executive Officer and Chief Financial Officer, will serve as Senior Vice President, Business Development, Scott Praill, DelMar's Chief Financial Officer, and Dennis Brown, DelMar's Chief Scientific Officer, will each continue to serve in their respective capacities, and Steve Rychnovsky, Adgero's Vice President, Operations and Product Development will serve as Vice President, Research and Development.

    The combined Company's Board of Directors will consist of seven directors, four of which will be designated by DelMar, two of which will be nominated by Adgero and approved by DelMar, and the remaining Director will be mutually agreed upon by DelMar and Adgero.

    Merger Process Overview and Financial Rationale

    Each outstanding share of Adgero common stock will be converted into shares of DelMar common stock at an exchange ratio such that current DelMar and Adgero stockholders will own 50.5% and 49.5% of the total voting power of the combined company, respectively (the "Exchange Ratio"), upon completion of the merger and exclusive of (i) securities to be issued in a financing to occur prior to the merger closing and (ii) compensation payable in connection with the merger and the financing. Each of the 1,470,092 outstanding warrants to purchase Adgero's common stock will be exchanged for a warrant to purchase DelMar common stock as calculated based on the Exchange Ratio, resulting in a total of 2,299,036 additional DelMar warrants outstanding. Each outstanding Adgero stock option, whether vested or unvested, that has not been exercised will be cancelled for no consideration as it is anticipated that none of the options will be in-the money at the time of the merger.

    The transaction has been unanimously approved by the Boards of Directors of DelMar and Adgero. The transaction is subject to customary closing conditions, including, among others, approval by the stockholders of each company, the closing on a minimum $10 million financing, and DelMar's continued listing on the Nasdaq Capital Market, and is expected to close in third quarter of 2020. Additionally, the transaction has the support from each of the directors and executive officers of DelMar and Adgero. 

    Lowenstein Sandler LLP acted as external legal counsel to DelMar and Ladenburg Thalmann & Co. Inc. provided a fairness opinion to DelMar. Gracin & Marlow, LLP acted as external legal counsel to Adgero.

    About DelMar

    Located in San Diego, California, DelMar is focused on the development and commercialization of new therapies for cancer patients who have limited or no treatment options. By focusing on understanding tumor biology and mechanisms of treatment resistance, DelMar identifies biomarkers to personalize new therapies in indications where patients are failing, or are unable to tolerate, standard-of-care treatments.

    DelMar's current pipeline is based around VAL-083, 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 DelMar's internal research programs and these prior NCI-sponsored clinical studies, DelMar is conducting clinical trials to support the development and commercialization of VAL-083 to solve significant unmet medical needs.

    VAL-083 is being studied in two collaborator-supported, biomarker-driven Phase 2 clinical trials for MGMT-unmethylated GBM. Overcoming MGMT-mediated resistance represents a significant unmet medical need in the treatment of GBM. In addition, DelMar has announced the allowance of a separate IND for VAL-083 as a potential treatment for platinum-resistant ovarian cancer.

    About Adgero

    Adgero Biopharmaceuticals Holdings, Inc. is a biopharmaceutical company focused on building a pipeline by advancing its proprietary late stage photodynamic therapy ("PDT") platform that holds promise as a localized cutaneous or visceral tumor treatment. Additionally, PDT has immune activating properties and has potential therapeutic utility in oncology as a combination therapy in conjunction with immunotherapies.  It is also being investigated in the cardiovascular setting as treatment for hemodialysis access failure. Adgero's lead product candidate, REM-001 therapy, has been previously studied in four Phase 2/3 clinical trials in patients with cutaneous metastatic breast cancer (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, Adgero is currently focused on advancing the REM-001 program to late stage pivotal testing.

    Forward-Looking Statements

    This press release contains forward-looking statements based upon DelMar's and Adgero'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. DelMar and Adgero have based these forward-looking statements largely on their 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 each of DelMar's and Adgero'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 DelMar's and Adgero's ability to obtain the stockholder approval required to consummate the proposed merger transaction and the timing of the closing of the proposed merger transaction, including the risks that a condition to closing would not be satisfied within the expected timeframe or at all or that the closing of the proposed merger transaction will not occur; (ii) the outcome of any legal proceedings that may be instituted against the parties and others related to the merger agreement; (iii) the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the merger agreement, (iv) unanticipated difficulties or expenditures relating to the proposed merger transaction, the response of business partners and competitors to the announcement of the proposed merger transaction, and/or potential difficulties in employee retention as a result of the announcement and pendency of the proposed merger transaction; (v) whether the combined business of Adgero and DelMar will be successful, and (vi) those risks detailed in DelMar'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 DelMar from time to time with the SEC. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Neither DelMar nor Adgero can 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, DelMar and Adgero undertake 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.

    Additional Information and Where to Find It

    This press release is for informational purposes only and does not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities or a solicitation of any vote or approval. This press release relates to the proposed merger of DelMar and Adgero. In connection with the proposed merger, DelMar will file a registration statement on Form S-4, which will include a document that serves as a prospectus and proxy statement of DelMar (the "proxy statement/prospectus"), and DelMar will file other documents regarding the proposed merger transaction with the U.S. Securities and Exchange Commission (the "SEC"). No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY, WHEN THEY BECOME AVAILABLE, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT STOCKHOLDERS SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING THE PROPOSED MERGER. A definitive proxy statement/prospectus will be sent to DelMar's stockholders. Investors and security holders will be able to obtain these documents (when available) free of charge from the SEC's website at www.sec.gov. The documents filed by DelMar with the SEC may also be obtained free of charge from DelMar by requesting them by mail at DelMar Pharmaceuticals, Inc., 12707 High Bluff Drive, Suite 200, San Diego, CA 92130.

    Participants in the Solicitation

    DelMar and its respective directors and executive officers and other members of management and employees and certain of their respective significant stockholders may be deemed to be participants in the solicitation of proxies from DelMar stockholders in respect of the proposed merger transaction. Information about DelMar's directors and executive officers is available in DelMar's proxy statement, filed June 2, 2020 for the 2020 Annual Meeting of Stockholders, DelMar's Annual Report on Form 10-K for the fiscal year ended June 30, 2019, which was filed with the SEC on September 9, 2019 and DelMar's Current Report on Form 8-K filed on September 9, 2019.  Information regarding the persons who may, under the rules of the SEC, be deemed participants in the proxy solicitation and a description of their direct and indirect interests, by security holding or otherwise, will be contained in the proxy statement/prospectus and other relevant materials to be filed with the SEC regarding the proposed merger transaction when they become available. Investors should read the proxy statement/prospectus carefully when it becomes available before making any voting or investment decisions. You may obtain free copies of these documents from the SEC and DelMar as indicated above. 

    No Offer or Solicitation

    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.

    Contact Information

    DelMar:

    Investors:

    CORE IR

    516-222-2560

    Media:

    Jules Abraham

    Director of Public Relations

    CORE IR

    917-885-7378

    Adgero:

    Jenene Thomas Communications

    DelMar Pharmaceuticals Logo

     

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  4. SAN DIEGO, June 4, 2020 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (NASDAQ:DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announced today the acceptance of an 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). DelMar will utilize the GBM AGILE study to serve as the basis for VAL-083's new drug application (NDA) submission and registration.

    "We wish to convey our gratitude to GCAR for extending an invitation to DelMar to participate in the GBM AGILE study. We believe that…

    SAN DIEGO, June 4, 2020 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (NASDAQ:DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announced today the acceptance of an 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). DelMar will utilize the GBM AGILE study to serve as the basis for VAL-083's new drug application (NDA) submission and registration.

    "We wish to convey our gratitude to GCAR for extending an invitation to DelMar to participate in the GBM AGILE study. We believe that GCAR's already-approved robust adaptive trial design, industry leading partners and clinical support vendors, as well as strong regulatory endorsement can measurably accelerate our efforts to bring VAL-083 to market for GBM patients who have significant unmet medical needs," commented Saiid Zarrabian, Chief Executive Officer of DelMar Pharmaceuticals. "With 24 clinical sites currently enrolling patients and with additional sites in the US, Canada, Europe and China expected to come online in the next 12 months, our participation in GBM AGILE is expected to provide a significant time and cost savings advantage related to clinical trial initiation. We look forward to enrolling the first patient into the VAL-083 arm of the study which is planned for the fourth quarter of this year."

    GBM AGILE 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 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 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 is a 501(c)(3) organization that functions as GBM AGILE study sponsor, and provides financial support for the program infrastructure, as well as general trial oversight. Comprising 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.

    "We look forward to advancing DelMar's promising compound, VAL-083, in GBM AGILE. This registrational study is designed to accelerate the identification and approval of new drugs for patients with glioblastoma, a challenging disease with limited treatment options.  We are very pleased to collaborate with DelMar Pharmaceuticals to initiate planning for the inclusion of VAL-083 in the trial for recurrent and newly-diagnosed GBM patients," commented Meredith Buxton, PhD, MPH, Chief Executive Officer of GCAR.

    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 DELMAR PHARMACEUTICALS, INC.

    Located in San Diego, California, DelMar is focused on the development and commercialization of new therapies for cancer patients who have limited or no treatment options.  By focusing on understanding tumor biology and mechanisms of treatment resistance, the Company identifies biomarkers to personalize new therapies in indications where patients are failing, or are unable to tolerate, standard-of-care treatments.

    The Company's current pipeline is based around VAL-083, 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 & neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on DelMar's internal research programs and these prior NCI-sponsored clinical studies, the Company is conducting clinical trials to support the development and commercialization of VAL-083 to solve significant unmet medical needs.

    VAL-083 is being studied in two collaborator-supported, biomarker-driven Phase 2 clinical trials for MGMT-unmethylated GBM. Overcoming MGMT-mediated resistance represents a significant unmet medical need in the treatment of GBM. In addition, DelMar has announced the allowance of a separate IND for VAL-083 as a potential treatment for platinum-resistant ovarian cancer.

    Further information on DelMar's clinical trials can be found on clinicaltrials.gov: https://www.clinicaltrials.gov/ct2/results?cond=&term=val-083&cntry1=&state1=&recrs.
    For additional information, please visit http://delmarpharma.com/; or contact DelMar Pharmaceuticals Investor Relations:  / (604) 629-5989.

    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 AGILE study, the status of the Company's clinical trials, the reporting of the results and the impact of the COVID-19 pandemic. 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, 2019, 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

     

    DelMar Pharmaceuticals Logo

     

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  5. SAN DIEGO, June 1, 2020 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (NASDAQ:DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced that two posters updating results from the company's two Phase 2 clinical trials of VAL-083 will be presented at the 2020 American Association for Cancer Research Virtual Annual Meeting II to be held June 22-24, 2020.

    Details regarding the posters to be presented in the Phase 2 Trials in Progress session are as follows:

    Title: "Phase 2 trial of dianhydrogalactitol (VAL-083) in patients with newly diagnosed MGMT-unmethylated glioblastoma"
    Lead Author: Dr. Zhong-Ping Chen, Sun Yat-sen University Cancer Center
    Poster Number: CT273…

    SAN DIEGO, June 1, 2020 /PRNewswire/ -- DelMar Pharmaceuticals, Inc. (NASDAQ:DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced that two posters updating results from the company's two Phase 2 clinical trials of VAL-083 will be presented at the 2020 American Association for Cancer Research Virtual Annual Meeting II to be held June 22-24, 2020.

    Details regarding the posters to be presented in the Phase 2 Trials in Progress session are as follows:

    Title: "Phase 2 trial of dianhydrogalactitol (VAL-083) in patients with newly diagnosed MGMT-unmethylated glioblastoma"
    Lead Author: Dr. Zhong-Ping Chen, Sun Yat-sen University Cancer Center
    Poster Number: CT273
    Summary: This poster will include data from the company's ongoing Phase 2 trial of VAL-083 being conducted at Sun Yat-sen University Cancer Center as a first line therapy, and includes updates on enrollment, safety and efficacy.

    Title: "Phase 2 study of dianhydrogalactitol (VAL-083) in patients with MGMT-unmethylated, bevacizumab-naïve glioblastoma in the recurrent or adjuvant setting"
    Lead Author: Dr. Barbara O'Brien, M.D. Anderson Cancer Center
    Poster Number: CT272
    Summary: This poster will include data from the company's ongoing Phase 2 trial of VAL-083 being conducted at M.D. Anderson Cancer Center as a treatment in the recurrent and adjuvant settings, and includes updates on enrollment, safety and efficacy.

    Additional posters relevant to VAL-083 to be available from the conference include:

    Session: Mechanisms of DNA Damaging Therapeutics 
    Title: "Dianhydrogalactitol (VAL-083) synergizes with topoisomerase inhibitors to overcome homologous recombination repair activity in glioblastoma and prostate cancer cells"
    Poster Number: 1369

    Session: DNA-reactive Agents and Other
    Title: "Dianhydrogalactitol (VAL-083) exhibits strong efficacy in GBM tumors with different (epi)genetic background and treatment history"
    Poster Number: 5231

    All abstracts can be accessed via https://www.abstractsonline.com/pp8/#!/9045.

    About VAL-083
    VAL-083 (dianhydrogalactitol) is a "first-in-class", bifunctional DNA-targeting agent that introduces inter-strand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute (NCI). DelMar has demonstrated that VAL-083's anti-tumor activity is unaffected by common mechanisms of chemoresistance, including MGMT, in cancer cell models and animal studies. Further details regarding these studies can be found at: 

    http://www.delmarpharma.com/scientific-publications.html.

    About DelMar Pharmaceuticals, Inc.

    Located in San Diego, California, DelMar is focused on the development and commercialization of new therapies for cancer patients who have limited or no treatment options. By focusing on understanding tumor biology and mechanisms of treatment resistance, the Company identifies biomarkers to personalize new therapies in indications where patients are failing, or are unable to tolerate, standard-of-care treatments.

    The Company's current pipeline is based around VAL-083, 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 DelMar's internal research programs and these prior NCI-sponsored clinical studies, the Company is conducting clinical trials to support the development and commercialization of VAL-083 to solve significant unmet medical needs.

    VAL-083 is being studied in two collaborator-supported, biomarker-driven Phase 2 clinical trials for MGMT-unmethylated GBM. Overcoming MGMT-mediated resistance represents a significant unmet medical need in the treatment of GBM. In addition, DelMar has announced the allowance of a separate IND for VAL-083 as a potential treatment for platinum-resistant ovarian cancer.

    Further information on DelMar's clinical trials can be found on clinicaltrials.gov:  https://www.clinicaltrials.gov/ct2/results?cond=&term=val-083&cntry1=&state1=&recrs.
    For additional information, please visit http://delmarpharma.com/; or contact DelMar Pharmaceuticals Investor Relations: / (604) 629-5989.

    Safe Harbor Statement

    Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including statements regarding the status of the Company's clinical trials, the reporting of the results, and the impact of the COVID-19 pandemic. . 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, 2019, 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

     

    DelMar Pharmaceuticals Logo

     

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