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Share Name | Share Symbol | Market | Type |
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Synlogic Com USD0.001 | NASDAQ:MIRN | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.00 | 0.00% | 1.71 | 1.20 | 1.72 | 0 | 01:00:00 |
Mirna Therapeutics, Inc. (Nasdaq:MIRN), a clinical stage biopharmaceutical company developing a pipeline of microRNA-based oncology therapeutics, today reported financial results for the second quarter of 2016 and provided an update on recent developments.
MRX34 CLINICAL PROGRAM AND SECOND QUARTER UPDATE
Data highlights included four confirmed partial responses for up to 50+ weeks in duration in patients with late-stage, metastatic hepatocellular carcinoma cancer or HCC (liver cancer), renal cell carcinoma or RCC (kidney cancer) and acral melanoma (a rare and difficult-to-treat form of skin cancer). Stable disease was also observed in an additional 15 patients for more than four cycles (approximately three months) of therapy, including a small cell lung cancer (SCLC) patient who showed stable disease for more than one year on MRX34 as fourth line therapy.
As of the ASCO presentation, three patients had experienced possible immune-mediated serious adverse events (SAEs) after receiving MRX34. These previously reported events included enterocolitis, systemic inflammatory response syndrome, and pneumonitis/colitis. The first two patients recovered; the patient experiencing pneumonitis/colitis subsequently died.
The timing and pattern of response to treatment with MRX34 and the associated safety profile suggest a potential immune component to MRX34 activity.
CORPORATE UPDATES
SECOND QUARTER 2016 FINANCIAL RESULTS
The increase for the six months ended June 30, 2016 is primarily attributable to higher compensation, benefits and stock compensation expense due to a higher headcount. The increase was largely offset by higher costs associated with our Phase 1 trial in the prior year.
About Mirna Therapeutics, Inc.
Mirna is a clinical stage biopharmaceutical company developing a pipeline of microRNA-based oncology therapeutics and is the first to bring a synthetic microRNA mimic into clinical development for the treatment of cancer. Mirna's lead product candidate, MRX34, a mimic of naturally occurring microRNA-34 (miR-34), is being studied in a Phase 1 clinical trial which has included 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 immune checkpoint signaling molecules, including 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 an important new class of anti-cancer agents. Mirna plans to develop MRX34 as a monotherapy and in combination with other therapies. 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 plans for MRX34 development; our plans to let the results from the Phase 1 expansion cohorts and the translational medicine study guide the next steps in development of MRX34; our plans to continue the expansion phase of the ongoing Phase 1 study; our plans to launch a translational medicine trial in late 2016; and our expectation that current cash resources will be sufficient to meet operating requirements into 2018. 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 and the risk that our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval. 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 August 15, 2016.
Mirna Therapeutics, Inc.
Condensed Balance Sheets
(in thousands, except share data)
June 30, December 31, 2016 2015 (unaudited) Assets Current Assets: Cash and cash equivalents $ 30,796 $ 89,713 Marketable securities 41,756 — Grant reimbursement and other receivables — — Prepaid expenses and other current assets 947 829 Total current assets 73,499 90,542 Property and equipment, net 1,237 375 Restricted cash 2,430 — Total assets $ 77,166 $ 90,917 Liabilities and Stockholders’ Equity (Deficit) Current Liabilities: Accounts payable $ 1,462 $ 3,687 Accrued expenses 2,193 2,214 Total liabilities 3,655 5,901 Commitments and contingencies Stockholders’ Equity (Deficit): Preferred stock, $0.001 par value, 5,000,000 shares authorized at June 30, 2016 and December 31, 2015; 0 shares outstanding at June 30, 2016 and December 31, 2015 — — Common stock, $0.001 par value; 250,000,000 shares authorized at June 30, 2016 and December 31, 2015; 20,835,868 and 20,830,555 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively 21 21 Additional paid in capital 162,216 161,518 Accumulated other comprehensive income 6 — Accumulated deficit (88,732) (76,523) Total stockholders’ equity 73,511 85,016 Total liabilities and stockholders’ equity $ 77,166 $ 90,917Mirna Therapeutics, Inc.
Condensed Statements of Operations and Comprehensive Loss (unaudited)
(in thousands)
Three Months Ended Six Months Ended June 30, June 30, 2016 2015 2016 2015 Operating expenses: Research and development $ 3,682 $ 4,499 $ 8,205 $ 7,901 General and administrative 2,049 1,185 4,179 2,062 Total operating expenses 5,731 5,684 12,384 9,963 Other income: Interest income 93 — 175 — Total other income 93 — 175 — Net loss $ (5,638) $ (5,684) $ (12,209) $ (9,963) Less: Accretion and dividends on convertible preferred stock — (1,544) — (2,662) Net loss attributable to common stockholders $ (5,638) $ (7,228) $ (12,209) $ (12,625)
View source version on businesswire.com: http://www.businesswire.com/news/home/20160815005291/en/
InvestorsThe Trout GroupPete Rahmer, 646-378-2973prahmer@troutgroup.comorMediaBMC CommunicationsAmy Bonanno, 646-513-3117abonanno@bmccommunications.com
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