Mirna Therapeutics, Inc. (Nasdaq: MIRN), a biopharmaceutical
company, today reported financial results for the fourth quarter
and year ended December 31, 2016 and provided a corporate
update.
Following its November 2016 decision to discontinue all research
and development activities including the development of MRX34,
Mirna began implementing operating cost reductions and
organizational restructuring to reduce overall cash burn, including
a reduction in its workforce. The Company engaged a financial
advisor and has been pursuing activities to identify and evaluate
strategic alternatives, including a possible merger or sale of the
Company.
“Our strategic process is active and ongoing and we are pursuing
discussions with third parties on a range of potential
transactions,” said President and CEO Paul Lammers, M.D., M.Sc. “We
are committed to serving our shareholders’ best interests through
our efforts to identify, evaluate and potentially consummate a
transaction that may result from these activities.”
2016 FINANCIAL RESULTS
- Cash Position and Guidance:
Cash, cash equivalents, and marketable securities totaled $60.5
million as of December 31, 2016, compared to $89.7 million as of
December 31, 2015. The Company has no debt.The Company expects its
quarterly cash burn rate to remain within the range of $2.1 million
and $2.3 million. This quarterly guidance includes contractual
commitments and obligations for future minimum lease payments, but
excludes any one-time charges related to any strategic transaction
should such be consummated and contractual payments for executive
severance or change-in-control provisions.
- Research and development
expenses: Research and development expenses were approximately
$2.3 million and $13.9 million for the quarter and year
ended December 31, 2016 compared to research and
development expenses of $6.4 million and $18.9 million during
the comparable periods in 2015. The decrease was primarily due
to the closing of the Company’s Phase 1 clinical trial of MRX34 in
September 2016 and discontinuing all research and development
activities.
- General and administrative
expenses: General and administrative expenses were
approximately $2.0 million and $8.1 million for the quarter
and year ended December 31, 2016, compared to general and
administrative expenses of $2.5 million and $6.1 million during the
comparable periods in 2015. The increase for the year
ended December 31, 2016 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 incurred to comply with public company operating and
reporting requirements in the Company’s first full year operating
as a public company.
- Restructuring charges:
Restructuring charges were approximately $4.4 million for the
quarter and year ended December 31, 2016 and $0 for the year
ended December 31, 2015. In September 2016, Mirna announced its
decision to close the ongoing Phase 1 study of MRX34 and
voluntarily halted the enrollment and dosing of patients in the
study prior to receiving notice from the U.S. Food and Drug
Administration ("FDA”) that its Investigational New Drug
Application for MRX34 had been placed on full clinical hold.
Following the Company's announcement and notification from the FDA,
Mirna's Board of Directors approved a reduction of the total number
of full-time employees from 36 to 12. The restructuring charges
recognized during the year ended December 31, 2016 included
approximately $1.5 million for employee severance and benefits, an
accounting charge under U.S. Generally Accepted Accounting
Principles (“U.S. GAAP”) of $1.5 million for lease facility
termination costs, and $1.4 million for non-cash impairment charges
of property and equipment. The majority of these employee severance
and related benefits are expected to be settled in the first
quarter of 2017. The Company expects to incur additional
restructuring charges under U.S. GAAP of approximately $0.3 million
through the six months ended June 30, 2017.
- Net Loss: Net loss was
approximately $8.7 million and $26.3 million for the quarter and
year ended December 31, 2016, compared to a net loss of $8.8
million and $25.0 million for the comparable periods in 2015. The
results included non-cash, stock-based related compensation charges
of $1.6 million and $1.0 million for the years ended December 31,
2016 and December 31, 2015, respectively.
About Mirna Therapeutics, Inc.
Mirna is a biopharmaceutical company that has been focused on
the development of microRNA-based oncology therapeutics. Mirna's
first product candidate, MRX34, the first microRNA mimic to enter
clinical development in oncology, was studied as a single agent in
a multicenter Phase 1 clinical trial. In September 2016, Mirna
voluntarily halted enrollment and dosing in the clinical study
following multiple immune-related serious adverse events (SAEs)
observed in patients dosed with MRX34 over the course of the trial.
Subsequently, the U.S. Food and Drug Administration (FDA) notified
the Company that the Investigational New Drug (IND) Application for
MRX34 was placed on full clinical hold. The Company is currently
evaluating opportunities to enhance stockholder value.
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 the evaluation of strategic
alternatives with the goal of enhancing stockholder value, our
expectations regarding projected restructuring charges, our
expectations regarding the timing of settlement of employee
severance and related benefits and our expectations regarding our
quarterly cash burn rate. Such forward-looking statements involve
substantial risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from
those expressed or implied by the forward-looking statements. 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 14, 2017.
Mirna Therapeutics, Inc. Condensed Balance
Sheets (in thousands, except per share data)
December 31, December 31, 2016 2015
Assets Current Assets: Cash and cash equivalents $ 16,432 $
89,713 Short-term marketable securities 44,066 — Prepaid expenses
and other current assets 882 829 Total current assets
61,380 90,542 Property and equipment, net 354 375 Restricted cash
2,432 — Total assets $ 64,166 $ 90,917
Liabilities and Stockholders’ Equity (Deficit) Current
Liabilities: Accounts payable $ 361 $ 3,687 Accrued expenses 2,400
2,214 Total current liabilities 2,761 5,901 Lease
obligations, long-term 1,053 — Total liabilities
3,814 5,901 Stockholders’ Equity (Deficit):
Common stock, $0.001 par value;
250,000,000 shares authorizedat December 31, 2016 and December 31,
2015; 20,841,393 and20,830,555 shares issued and outstanding at
December 31, 2016and December 31, 2015, respectively
21 21 Additional paid in capital 163,126 161,518 Accumulated
deficit (102,791 ) (76,523 ) Accumulated other comprehensive loss
(4 ) — Total stockholders’ equity 60,352 85,016
Total liabilities and stockholders’ equity $ 64,166 $
90,917
Mirna
Therapeutics, Inc. Condensed Statement of Operations and
Comprehensive Loss (in thousands)
For the Quarter Ended December
31,
For the Year EndedDecember
31,
2016 2015 2016
2015 (unaudited) (unaudited) Operating expenses: Research
and development $ 2,341 $ 6,363 $ 13,930 $ 18,947 General and
administrative 1,999 2,462 8,118 6,080 Restructuring charges 4,442
— 4,442 — Loss on disposal of assets — — 128 —
Total operating expenses 8,782 8,825 26,618 25,027 Other
income: Interest income 88 36 350 44
Net loss $ (8,694 ) $ (8,789 ) $ (26,268 ) $ (24,983 ) Less:
Accretion and dividends on convertible preferred stock —
(101 ) — (4,320 ) Net loss attributable to common
stockholders $ (8,694 ) $ (8,890 ) $ (26,268 ) $ (29,303 )
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version on businesswire.com: http://www.businesswire.com/news/home/20170314006493/en/
InvestorsMirna Therapeutics, Inc.Alan Fuhrman,
512-901-0950afuhrman@mirnarx.comorMediaBMC
CommunicationsBrad Miles,
646-513-3125bmiles@bmccommunications.com
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