Mirna Therapeutics
03-29-16

Mirna Therapeutics Provides Operational Update and Reports Financial Results for Fourth Quarter and Full Year Ended December 31, 2015

Management to host conference call and webcast today at 5 p.m. Eastern

AUSTIN, Texas--(BUSINESS WIRE)-- 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 fourth quarter and full year ended December 31, 2015, and provided an update on the Company's recent progress.

"Mirna had a highly productive 2015 as we continued to advance the first microRNA therapeutic in clinical development in cancer," commented Paul Lammers, M.D., M.Sc., Mirna's President and CEO. "Our lead microRNA product candidate, MRX34, has demonstrated clinically significant responses in multiple cancers, and we are preparing to advance it into two Phase 2 studies late this year. We also continued to broaden our understanding of its unique mechanism capable of inhibiting multiple oncogenic and immune-mediated pathways known to drive tumor growth."

Dr. Lammers continued, "On the corporate front, we raised a total of over $100 million from an IPO and two private placements during the year and strengthened our management team, leaving us well-positioned to advance our clinical development strategy and fully leverage our microRNA technologies for the treatment of cancers."

MRX34 Program Updates

2015 Highlights

Corporate Activities

Fourth Quarter and Full Year 2015 Financial Results

Conference Call and Webcast

Mirna management will host a webcast and conference call at 5:00 p.m. Eastern today to discuss the financial results. To access the call, participants should dial 877-407-9079 (US & Canada) or 201-493-6746 (international) at least 10 minutes prior to the start of the call. The call will be webcast live and may be accessed from the Events & Presentations section of the Company's website. An archived version of the webcast will be available for replay for up to 30 days following the event.

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 and results of our clinical development program, including the projected timing and nature of a potential Phase 1b translational medicine study and Phase 2 studies of MRX34, our pre-clinical combination therapy studies of MRX34 and pre-clinical studies and a potential filing of an IND for a potential second product candidate; our ability to understand the anti-cancer properties of MRX34; and our belief that we are well-positioned to advance our clinical development strategy. 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. Mirna undertakes 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 Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on November 13, 2015 and our Annual Report on Form 10-K that we expect to file with the SEC on or about March 29, 2016.

 

Mirna Therapeutics, Inc.
Condensed Balance Sheet

(in thousands, except per share data)

 
December 31, December 31,
2015 2014
 
Assets
Current Assets:
Cash and cash equivalents $ 89,713 $ 9,319
Grant reimbursement and other receivables 36 155
Prepaid expenses and other current assets   793   143

Total current assets

90,542 9,617
Property and equipment, net 375 116
Deferred offering costs     92
Total assets $ 90,917 $ 9,825
 
Liabilities, Convertible Preferred Stock and Stockholders' Equity (Deficit)
Current Liabilities:
Accounts payable $ 3,687 $ 871
Accrued expenses   2,214   1,628
Total liabilities 5,901 2,499
Commitments and contingencies
Convertible preferred stock, $0.001 par value; 0 shares and 84,000,783 shares authorized at December 31, 2015 and 2014, respectively;
Series A, Series B, Series B-1, Series C and Series D: 0 and 5,599,939 shares issued and outstanding at December 31, 2015 and 2014, respectively; aggregate liquidation preference of $0 and $55.3 million at December 31, 2015 and 2014, respectively 55,277
Stockholders' Equity (Deficit):
Preferred stock, $0.001 par value, 5,000,000 and 0 shares authorized at December 31, 2015 and 2014; 0 shares outstanding at December 31, 2015 and 2014
Common stock, $0.001 par value; 250,000,000 and 95,000,000 shares authorized at December 31, 2015 and 2014, respectively; 20,830,555 and 83,325 shares issued and outstanding at December 31, 2015 and 2014, respectively 21
Additional paid in capital 161,518
Accumulated deficit   (76,523)   (47,951)
Total stockholders' equity (deficit)   85,016   (47,951)
Total liabilities, convertible preferred stock and stockholders' equity (deficit) $ 90,917 $ 9,825
 
 
Mirna Therapeutics, Inc.
Condensed Statements of Operations
 

For the Three Months Ended

December 31,

For the Year Ended

December 31,

2015   2014 2015   2014
(unaudited) (unaudited)
Operating expenses:
Research and development $ 6,363 $ 3,501 $ 18,947 $ 10,545
General and administrative 2,462 877 6,080 3,369
Write-off of offering costs         1,920
Total operating expenses 8,825 4,378 25,027 15,834
Other (income):
Interest (income)   (36)     (44)  

Total other (income)

  (36)     (44)  
Net loss (8,789) (4,378) (24,983) (15,834)
Less: Accretion and dividends on convertible preferred stock   (101)   (712)   (4,320)   (2,824)
 
Net loss attributable to common stockholders $ (8,890) $ (5,090) $ (29,303) $ (18,658)
 

Investors
The Trout Group
Josh Barer, 646-378-2948
jbarer@troutgroup.com
or
Media
BMC Communications
Amy Bonanno, 646-513-3117
abonanno@bmccommunications.com

Source: Mirna Therapeutics, Inc.

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