On May 12, 2016 Mirna Therapeutics, Inc. (Nasdaq:MIRN), a clinical stage biopharmaceutical company developing a broad pipeline of microRNA-based oncology therapeutics, reported financial results for the first quarter of 2016 and provided an update on recent developments (Press release, Mirna Therapeutics, MAY 12, 2016, View Source [SID:1234512339]).
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"During the first quarter we continued to make progress advancing our lead product candidate MRX34, the first microRNA therapeutic in clinical development in cancer," commented Paul Lammers, M.D., M.Sc., Mirna’s President and CEO. "To date, MRX34 has produced clinically significant responses in patients with various types of late-stage cancers, demonstrating its ability to affect multiple pathways involved in cancer growth and immune evasion. We are continuing to advance MRX34 toward Phase 2 in late 2016 and also pushing ahead with our preclinical program to study its potential in combination with other cancer drugs."
Dr. Lammers continued, "On the corporate front, we were pleased to welcome Peter Greenleaf, Chief Executive Officer of Sucampo Pharmaceuticals, to our Board of Directors, and Dr. Vincent J. O’Neill as our new Chief Medical Officer. We look forward to their unique contributions as we advance our clinical development strategy in the promising new field of microRNA therapeutics."
FIRST QUARTER AND MRX34 PROGRAM UPDATES
Update from MRX34 Phase 1 trial planned at ASCO (Free ASCO Whitepaper). The Company expects to present additional clinical data from the ongoing Phase 1 trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in early June. To date, MRX34 has demonstrated compelling clinical results as a single agent therapy, including confirmed partial responses in patients with renal cell carcinoma, acral melanoma, and hepatocellular carcinoma. Additionally, several patients with solid tumors have achieved long-term stable disease during treatment with MRX34. These responses were observed in cancer patients with advanced Stage 4 metastatic disease, whose cancer had progressed after previously receiving multiple rounds of therapy. Top-line data from this study are expected in 2017.
Phase 1b translational medicine trial on track to begin in late 2016. This study will include serial tumor biopsies and is intended to develop deeper insights into the mechanism of action of MRX34 in melanoma patients and identify potential biomarkers of drug activity and treatment response.
MRX34 expected to begin Phase 2 by end of 2016. Studies in renal cell carcinoma and melanoma patients are being planned based on the responses observed to date in the ongoing Phase 1 trial, and on the high unmet medical need despite the availability of new therapies.
Preclinical studies ongoing of combination regimens with potential to enhance effectiveness of standard cancer therapies. At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April, Mirna researchers presented in vitro findings that demonstrated the synergistic anticancer effects between MRX34 and platinum and other commonly used cytotoxic chemotherapy drugs across a range of non-small cell lung cancer (NSCLC) cell lines. Synergistic anticancer effects were also shown between MRX34 and tyrosine kinase inhibitors. These results suggest a broad potential for combination of MRX34 with other standard of care drug classes.
Preclinical studies are also ongoing to support selection of a second microRNA product candidate from the Company’s pipeline, with an Investigational New Drug (IND) application planned in late 2017.
CORPORATE UPDATES
Further strengthened management with the appointments of Peter Greenleaf to the Company’s Board of Directors and Dr. Vincent J. O’Neill to the role of Chief Medical Officer. Mr. Greenleaf, an industry veteran with over 20 years of experience in drug development and commercialization, including three years as President of Medimmune, currently serves as the Chief Executive Officer of Sucampo Pharmaceuticals. Dr. O’Neill is a medical oncologist with 15 years of therapeutic and diagnostic product development experience, and has held senior leadership roles at several global pharmaceutical companies, including Sanofi, Genentech and GlaxoSmithKline.
FIRST QUARTER 2016 FINANCIAL RESULTS
Cash Position and Guidance: Cash, cash equivalents, and marketable securities totaled $80.6 million as of March 31, 2016, compared to $89.7 million as of December 31, 2015. The Company has no debt. Based on the current operating plan, the Company expects that current cash resources will be sufficient to meet operating requirements into 2018.
Research and Development Expenses: Research and development expenses were approximately $4.5 million for the three months ended March 31, 2016 as compared to $3.4 million for the same period in 2015. The increase was primarily attributable to increased employee compensation expense due to a higher headcount to support the advancement of the Company’s clinical and preclinical development programs, as well as increases in manufacturing, clinical, and intellectual property costs.
General and Administrative Expenses: General and administrative expenses were approximately $2.1 million for the three months ended March 31, 2016 as compared to approximately $0.9 million for the same period in 2015. The increase in general and administrative expenses was primarily attributable to increased employee compensation expense due to a higher headcount and higher outside professional and consulting costs, the majority of which were costs to comply with public company operating and reporting requirements.
Net Loss: Net loss was approximately $6.6 million for the first quarter of 2016 compared to $4.3 million in the comparable period in 2015. The results included non-cash, stock-based compensation charges of approximately $447,000 in the three months ended March 31, 2016 and approximately $134,000 in the same period in 2015.