For the third quarter of 2017, Novus reported a net loss of $3.0 million, or $0.43 loss per share, compared to a net loss of $2.0 million, or $4.35 loss per share, for the same period in 2016.
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IRVINE, Calif., Nov. 8, 2017 /PRNewswire/ -- Novus Therapeutics (NASDAQ: NVUS), a development stage specialty pharmaceutical company focused on the development of products for disorders of the ear, nose, and throat (ENT), announced financial results for the quarter ended September 30, 2017. For the third quarter of 2017, Novus reported a net loss of $3.0 million, or $0.43 loss per share, compared to a net loss of $2.0 million, or $4.35 loss per share, for the same period in 2016. For the nine months ended September 30, 2017, Novus reported a net loss of $11.0 million, or $2.25 loss per share, as compared to a net loss of $4.1 million, or $9.09 loss per share, for the first nine months of 2016. Novus ended the third quarter 2017 with $19.1 million in cash and cash equivalents. Research and development (R&D) expenses were $517,000 during the third quarter of 2017 compared to $1.1 million for the same period in 2016. For the nine months ended September 30, 2017, R&D expenses were $1.5 million, compared to $2.3 million for the same period in 2016. The decrease in R&D expense for both periods is primarily due to decreased spending towards the OP-01 program, offset by wind-down costs incurred for legacy Tokai programs. We expect R&D expenses to increase in subsequent periods as we advance our OP-02 program. General and administrative (G&A) expenses were $2.5 million for the third quarter of 2017 compared to $0.6 million for the third quarter of 2016. For the nine months ended September 30, 2017, G&A expenses were $9.5 million, compared to $1.3 million for the first nine months of 2016. The increase in G&A expense for both periods is primarily due to merger related expenses of $7.2M, plus legal costs associated with the legacy Tokai litigation and administrative costs associated with operating as a publicly traded company. "We are continuing formulation development and clinical planning activities for our OP-02 program and we are expecting to begin our clinical trials in 2018," said Gregory J. Flesher, Chief Executive Officer of Novus Therapeutics. "As a potential first-in-class treatment option to both treat and prevent otitis media, OP-02 has the ability to dramatically improve the lives of millions of patients around the world." About Novus Therapeutics Novus Therapeutics is a development stage specialty pharmaceutical company focused on the development of products for disorders of the ear, nose, and throat (ENT). Novus has two technologies, each of which has the potential to be developed for multiple ENT indications. The company's lead product (OP-02) is a surfactant-based, combination drug product being developed as a potential first-in-class treatment option for patients at risk for or with otitis media ("OM") (middle ear inflammation and effusion with or without infection). Globally, OM affects more than 700 million adults and children every year. OM is a common disorder seen in pediatric practice, and in the United States is the most frequent reason children are prescribed antibiotics and undergo surgery. Novus also has a foam-based drug delivery technology (OP-01), which may be developed in the future to deliver drugs into the ear, nasal, and sinus cavities. For more information please visit novustherapeutics.com. Forward-looking Statements Any statements in this press release about the company's future expectations, plans and prospects, including statements about its strategy, future operations, development of its product candidates, the review of strategic alternatives and the outcome of such review and other statements containing the words "believes," "anticipates," "plans," "expects," "may," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, expectations regarding the timing for the commencement and completion of our clinical trials and our ability to accelerate the development of our drug candidates. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the sufficiency of the company's cash resources; the ability to timely develop and manufacture clinical batches of our study drugs; the ability to obtain necessary approvals to commence additional clinical trials; whether data from early clinical trials will be indicative of the data that will be obtained from future clinical trials; whether the results of clinical trials will warrant submission for regulatory approval of any investigational product, any such submission will receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies and, if we are able to obtain such approval for an investigational product, it will be successfully distributed and marketed. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Contacts The Trout Group Novus Therapeutics, Inc.
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NOVUS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
September 30, December 31,
2017 2016
(Unaudited)
----------
ASSETS
Current assets:
Cash and cash equivalents $19,094 $1,103
Restricted cash - 14
Prepaid expenses and other current
assets 1,941 33
----- ---
Total current assets 21,035 1,150
Property and equipment, net 47 31
Restricted cash 70 -
Goodwill 1,867 -
Other assets - 15
--- ---
Total assets $23,019 $1,196
======= ======
LIABILITIES AND STOCKHOLDERS' EQUITY
(DEFICIT)
Current liabilities:
Accounts payable $189 $338
Accrued severance 963 -
Accrued expenses and other liabilities 1,154 113
Convertible notes - 3,447
--- -----
Total current liabilities 2,306 3,898
Long-term liabilities 94 -
--- ---
Total liabilities 2,400 3,898
Commitments and contingencies
Stockholders' equity (deficit):
Preferred stock, $0.001 par value,
5,000,000 shares authorized and none
issued and outstanding at September
30, 2017; preferred stock, $0.0026 par
value, 6,565,540 shares authorized and
452,706 shares issued and outstanding
at December 31, 2016 - 11
Common stock, $0.001 par value,
200,000,000 shares authorized and
6,943,058 shares issued and
outstanding at September 30, 2017;
common stock, $0.0026 par value,
9,207,060 shares authorized and 82,246
shares issued and outstanding at
December 31, 2016 7 1
Additional paid-in capital 46,008 11,385
Receipts on account of Preferred A
stock - 291
Accumulated deficit (25,396) (14,390)
------- -------
Total stockholders' equity (deficit) 20,619 (2,702)
------ ------
Total liabilities and stockholders'
equity (deficit) $23,019 $1,196
======= ======
NOVUS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(In thousands, except share and per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
------------- -------------
2017 2016 2017 2016
---- ---- ---- ----
Operating expenses
Research and development $517 $1,053 $1,529 $2,335
General and administrative 2,448 564 9,487 1,326
----- --- ----- -----
Total operating expenses 2,965 1,617 11,016 3,661
----- ----- ------ -----
Loss from operations (2,965) (1,617) (11,016) (3,661)
Other income (expense), net (5) (418) 10 (479)
--- ---- --- ----
Net loss and comprehensive
loss $(2,970) $(2,035) $(11,006) $(4,140)
======= ======= ======== =======
Net loss per share, basic and
diluted $(0.43) $(4.35) $(2.25) $(9.09)
====== ====== ====== ======
Weighted-average common
shares outstanding, basic and
diluted 6,943,058 81,339 3,845,258 79,026
========= ====== ========= ======
NOVUS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
Nine Months Ended
September 30,
-------------
2017 2016
---- ----
Operating activities
Net loss $(11,006) $(4,140)
Adjustments to reconcile net loss
to net cash used in operating
activities:
Depreciation and amortization 18 16
Stock-based compensation 386 142
Loss on disposal of fixed assets 31 -
Fair value of debt in excess of
proceeds - 517
Changes in operating assets and
liabilities:
Prepaid expenses and other assets (761) 42
Accounts payable and accrued
expenses (998) (218)
---- ----
Net cash used in operating
activities (12,330) (3,641)
Investing activities
Cash received from merger
transaction 23,250 -
Proceeds from sale of equipment 8 -
Purchase of property and
equipment - (12)
--- ---
Net cash provided by (used in)
investing activities 23,258 (12)
Financing activities
Proceeds from issuance of common
stock, net 4,000 -
Proceeds from exercise of
warrants 3,119 -
Proceeds from convertible loan - 2,930
--- -----
Net cash provided by financing
activities 7,119 2,930
----- -----
Net increase (decrease) in cash,
cash equivalents and restricted
cash 18,047 (723)
Cash, cash equivalents and
restricted cash at beginning of
period 1,117 3,095
----- -----
Cash, cash equivalents and
restricted cash at end of period $19,164 $2,372
======= ======
Supplemental disclosure of cash
flow information
Noncash activities:
Conversion of promissory notes
and interest to common stock $3,447 $ -
====== === ===
Conversion of contingently
issuable shares to common stock $291 $ -
==== === ===
Fair value of assets acquired and
liabilities assumed in the
merger:
Fair value of assets acquired,
excluding cash and restricted
cash $3,072
Fair value of liabilities assumed (2,947)
------
Fair value of net assets acquired
in the merger $125
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Company Codes: NASDAQ-SMALL:NVUS |