On May 6, 2021 Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplants to more patients, reported financial results for the first quarter ended March 31, 2021 and recent program highlights (Press release, Magenta Therapeutics, MAY 6, 2021, View Source [SID1234579383]).
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"Magenta continues to make progress across our program portfolio, building momentum towards several key anticipated clinical and data milestones throughout 2021, including the initial Phase 2 trial results evaluating MGTA-145 plus plerixafor in Multiple Myeloma patients in an autologous transplant setting and filing an IND for first-in-human Phase 1/2 clinical trial of MGTA-117, our first product candidate from our targeted conditioning platform," said Jason Gardner, D.Phil., President and Chief Executive Officer, Magenta Therapeutics. "We are optimistic about our programs’ ability to transform clinical practice of stem cell transplants and gene therapies with new first-line medicines, which we believe could increase access to curative transplants across multiple disease areas."
Program Highlights:
MGTA-145 Upcoming Scientific Conference Presentations:
Magenta will present preliminary MGTA-145 Phase 2 data in Multiple Myeloma patients at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held virtually June 4-8, 2021, and at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress, to be held virtually June 9-17, 2021.
MGTA-145 Stem Cell Mobilization and Collection
Recent and Planned Activity:
Phase 2 clinical trial in Multiple Myeloma is ongoing at Stanford University, evaluating the ability of MGTA-145, in combination with plerixafor, to mobilize stem cells for collection prior to autologous stem cell transplant. This 25-patient, investigator-initiated trial will also measure engraftment and disease outcome measures, with stem cell mobilization as the primary endpoint. Preliminary results will be presented at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) and final clinical data from this trial are expected in the second half of 2021.
Phase 2 clinical trial in collaboration with the National Marrow Donor Program/Be The Match, evaluating MGTA-145, in combination with plerixafor, in the mobilization and collection of stem cells from allogeneic donors for transplant in patients with Acute Myeloid Leukemia (AML), Acute Lymphocytic Leukemia (ALL) and Myelodysplastic Syndromes (MDS). Initial data from this trial are expected in the second half of 2021.
Initiate Phase 2 clinical trial in Sickle Cell Disease in collaboration with bluebird bio in the second half of 2021 to evaluate the utility of MGTA-145, in combination with plerixafor, for the mobilization and collection of stem cells in patients with Sickle Cell Disease where mobilization and collection is difficult and there is a clear unmet medical need.
MGTA-117 and CD45-ADC Targeted Conditioning Programs
Recent and Planned Activity:
MGTA-117 Investigational New Drug (IND) filing anticipated mid-2021. If the IND is accepted by the FDA, Magenta plans to initiate a Phase 1/2 clinical trial evaluating MGTA-117 in patients with AML and MDS. Magenta expects to assess initial safety and pharmacokinetic data internally in the fourth quarter of 2021, and also expects to be able to provide an update regarding the study’s progress within the dose escalation study design.
Magenta recently completed its GLP toxicology studies, its GMP manufacturing process and has finished its pre-IND communications with the FDA.
Financial Results:
Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2021, were $132.3 million, compared to $148.8 million as of December 31, 2020. Magenta anticipates that its cash, cash equivalents and marketable securities will be sufficient to fund operations and capital expenditures into the first quarter of 2023.
Research and Development Expenses: Research and development expenses were $11.7 million in the first quarter of 2021, compared to $14.0 million in the first quarter of 2020. The decrease was driven primarily by the completion of the GMP manufacturing campaign to support the upcoming IND for MGTA-117, and the discontinuation of the Phase 2 trial of MGTA-456 in inherited metabolic diseases in June 2020.
General and Administrative Expenses: General and administrative expenses were $7.0 million for the first quarter of 2021, compared to $7.3 million for the first quarter of 2020.
Net Loss: Net loss was $17.5 million for the first quarter of 2021, compared to net loss of $20.0 million for the first quarter of 2020.