Full Press Release Details
Mirna Therapeutics Reports First Quarter 2016 Financial Results and
AUSTIN, TX May 12, 2016 Mirna Therapeutics, Inc. (Nasdaq: MIRN), a clinical stage biopharmaceutical company developing a broad pipeline of microRNA-based oncology therapeutics, today reported financial results for the first quarter of 2016 and provided an update on recent developments.
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
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.
First Quarter 2016 Financial Results
About Mirna Therapeutics, Inc.
Mirna is a clinical stage biopharmaceutical company developing a broad pipeline of microRNA-based oncology therapeutics and is the first to establish clinical proof-of-concept for a microRNA replacement therapy for cancer. Mirna's lead product candidate, MRX34, a mimic of naturally occurring microRNA-34 (miR-34), is currently being studied in a Phase 1 clinical trial in patients with primary liver cancer, advanced solid tumors and hematological malignancies. miR-34 is one of the most widely published microRNAs and is considered a key regulator of multiple oncogenes across key oncogenic pathways, with the capacity to regulate more than 30 different oncogenes and repress the immune checkpoint signaling molecule PD-L1. The potential capacity to simultaneously affect multiple pathways and processes that are critical to cancer cell viability may make mimics of tumor suppressor microRNAs potent anti-cancer agents and less susceptible to drug resistance. Mirna plans to develop MRX34 as a monotherapy and in combination with other therapeutic modalities, such as targeted therapies and immuno-oncology agents. The Company was founded in 2007 and is located in Austin, Texas.
For more information, visit www.mirnarx.com.
Forward-Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Mirna, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding our pre-clinical and clinical activity, including regarding our current or potential Phase 1, 1b and 2 studies of MRX34, and the selection of a second product candidate; and our beliefs regarding the sufficiency of our current cash resources. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development program, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the outcomes of clinical trials, the regulatory approval process, our substantial dependence on MRX34, our commercialization plans and efforts and other matters that could affect the availability or commercial potential of our product candidates. We undertake no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to our business in general, see our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 30, 2016 and our Quarterly Report on Form 10-Q, expected to be filed with the SEC on or about May 12, 2016.
Mirna Therapeutics, Inc.
Condensed Balance Sheets
(in thousands, except per share data)
| March 31, | December 31, | ||||||
| 2016 | 2015 | ||||||
| (unaudited) | |||||||
| Assets | |||||||
| Current Assets: | |||||||
| Cash and cash equivalents | $ | 52,875 | $ | 89,713 | |||
| Marketable securities | 27,713 | ||||||
| Grant reimbursement and other receivables | 168 | 36 | |||||
| Prepaid expenses and other current assets | 853 | 793 | |||||
| Total current assets | 81,609 | 90,542 | |||||
| Property and equipment, net | 516 | 375 | |||||
| Total assets | $ | 82,125 | $ | 90,917 | |||
| Liabilities and Stockholders' Equity | |||||||
| Current Liabilities: | |||||||
| Accounts payable | $ | 1,239 | $ | 3,687 | |||
| Accrued expenses | 1,985 | 2,214 | |||||
| Total liabilities | 3,224 | 5,901 | |||||
| Commitments and contingencies | |||||||
| Stockholders' Equity (Deficit): | |||||||
| Preferred stock, $0.001 par value, 5,000,000 shares authorized at March 31, 2016 and December 31, 2015; 0 shares outstanding at March 31, 2016 and December 31, 2015 | |||||||
| Common stock, $0.001 par value; 250,000,000 shares authorized at March 31, 2016 and December 31, 2015; 20,830,555 shares issued and outstanding at March 31, 2016 and December 31, 2015 | 21 | 21 | |||||
| Additional paid in capital | 161,965 | 161,518 | |||||
| Accumulated other comprehensive income | 9 | ||||||
| Accumulated deficit | (83,094) | (76,523) | |||||
| Total stockholders' equity | 78,901 | 85,016 | |||||
| Total liabilities and stockholders' equity | $ | 82,125 | $ | 90,917 |
Mirna Therapeutics, Inc.
Condensed Statements of Operations and Comprehensive Loss (unaudited)
(in thousands, except per share data)
| Three Months Ended | |||||||
| March 31, | |||||||
| 2016 | 2015 | ||||||
| Operating expenses: | |||||||
| Research and development | $ | 4,523 | $ | 3,402 | |||
| General and administrative | 2,130 | 877 | |||||
| Total operating expenses | 6,653 | 4,279 | |||||
| Other income: | |||||||
| Interest income | 82 | ||||||
| Total other income | 82 | ||||||
| Net loss | $ | (6,571) | $ | (4,279) | |||
| Less: Accretion and dividends on convertible preferred stock | (1,118) | ||||||
| Net loss attributable to common stockholders | $ | (6,571) | $ | (5,397) |
Peter Rahmer, 646-378-2973
Amy Bonanno, 646-513-3117
Source: Mirna Therapeutics, Inc.