Novus Therapeutics Reports Fourth Quarter and Full-Year 2017 Financial Results and Provides Corporate Update
“The past year was a productive year for us,” said
Fourth Quarter and Full-Year 2017 Financial Results
For the three-month period ended
Research and development (R&D) expenses were
General and administrative (G&A) expenses were
Recent Events
In
Anticipated Milestones
- Mid-2018 - Manufacture OP-02 drug product (cGMP)
- 2H 2018 - Initiate OP-02 phase 1 study in healthy adults (safety/tolerability)
- 1H 2019 - Initiate OP-02 phase 1 study in children with otitis media with effusion (explore efficacy)
- 1H 2019 - Initiate OP-02 phase 1 study in adults with acute otitis media (explore efficacy)
- 1H 2019 - Data from phase 1 studies
About OP-02
OP-02 is a drug-device combination product comprised of a novel formulation of dipalmitoylphosphatidylcholine (DPPC) and cholesteryl palmitate (CP) suspended in a propellant. The product is administered intranasally via a metered dose inhaler and is intended to be used to restore the normal physiologic activity of the Eustachian tube (ET). Together DPPC and CP effectively absorb to the air-liquid interface of the mucosa and reduce the interfacial surface tension of the ET, which reduces passive pressure required for the ET to open. In other words, OP-02 promotes ‘de-sticking’ of the ET so that ventilation and drainage of the middle ear may occur.
About
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
NOVUS THERAPEUTICS, INC. |
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CONSOLIDATED BALANCE SHEETS |
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(In thousands, except share data) |
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December 31, | |||||||||||||
2017 | 2016 | ||||||||||||
ASSETS |
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Current assets: | |||||||||||||
Cash and cash equivalents | $ | 17,233 | $ | 1,103 | |||||||||
Restricted cash | 70 | 14 | |||||||||||
Prepaid expenses and other current assets | 1,697 | 33 | |||||||||||
Total current assets | 19,000 | 1,150 | |||||||||||
Property and equipment, net | 25 | 31 | |||||||||||
Goodwill | 1,867 | — | |||||||||||
Other assets | — | 15 | |||||||||||
Total assets | $ | 20,892 | $ | 1,196 | |||||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | |||||||||||||
Accounts payable | $ | 418 | $ | 338 | |||||||||
Accrued severance | 668 | — | |||||||||||
Accrued expenses and other liabilities | 354 | 113 | |||||||||||
Convertible notes | — | 3,447 | |||||||||||
Total liabilities | 1,440 | 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 December 31, 2017; $0.001 par value, 44,140,630 shares authorized and 19,533,331 shares issued and outstanding at December 31, 2016 (1) |
— | 19 | |||||||||||
Common stock, $0.001 par value, 200,000,000 shares authorized and 7,110,414 shares issued and outstanding at December 31, 2017; $0.001 par value, 31,476,614 shares authorized and 394,306 shares issued and outstanding at December 31, 2016 (2) |
7 | — | |||||||||||
Additional paid-in capital | 46,951 | 11,378 | |||||||||||
Receipts on account of preferred stock | — | 291 | |||||||||||
Accumulated deficit | (27,506 | ) | (14,390 | ) | |||||||||
Total stockholders’ equity (deficit) | 19,452 | (2,702 | ) | ||||||||||
Total liabilities and stockholders’ equity (deficit) | $ | 20,892 | $ | 1,196 | |||||||||
(1) | Number of shares as of December 31, 2016, has been retroactively adjusted to reflect the effect of the conversion ratio of the Reverse Merger consummated on May 9, 2017. | |
(2) | Number of shares has been retroactively adjusted to reflect the effect of the conversion ratio of the Reverse Merger consummated on May 9, 2017, and the reverse stock-split effected on May 11, 2017. | |
NOVUS THERAPEUTICS, INC. |
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CONSOLIDATED STATEMENTS OF OPERATIONS AND OTHER COMPREHENSIVE LOSS |
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(In thousands, except share and per share data) |
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Year Ended |
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2017 | 2016 | ||||||||||||
Operating expenses | |||||||||||||
Research and development | $ | 2,022 | $ | 3,191 | |||||||||
General and administrative | 11,099 | 1,937 | |||||||||||
Total operating expenses | 13,121 | 5,128 | |||||||||||
Loss from operations | (13,121 | ) | (5,128 | ) | |||||||||
Other income (expense), net | 5 | (527 | ) | ||||||||||
Net loss and other comprehensive loss | $ | (13,116 | ) | $ | (5,655 | ) | |||||||
Net loss per share, basic and diluted | $ | (2.30 | ) | $ | (2.46 | ) | |||||||
Weighted-average common shares outstanding, |
4,677,610 | 382,747 | |||||||||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20180402005265/en/
Source:
Novus Therapeutics, Inc.
Gregory J. Flesher, CEO
(949) 238-8090
investors@novustherapeutics.com