Novus Therapeutics Reports First Quarter 2018 Financial Results
“We are excited by the ongoing progress being made with OP-02, our novel
and potential first-in-class treatment option for otitis media,” said
First Quarter 2018 Financial Results
For the three-month period ended
Research and development (R&D) expenses were
General and administrative (G&A) expenses were
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 - Topline data from phase 1 studies
About OP-02
OP-02 is a drug-device combination product comprised of a novel formulation of the surfactant dipalmitoylphosphatidylcholine (DPPC) and the spreading agent 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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March 31, |
December 31, |
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2018 |
2017 |
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ASSETS |
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Current assets: | ||||||||
Cash |
$ | 22,523 | $ | 17,233 | ||||
Restricted cash | — | 70 | ||||||
Prepaid expenses and other current assets | 1,505 | 1,697 | ||||||
Total current assets | 24,028 | 19,000 | ||||||
Property and equipment, net | 22 | 25 | ||||||
Goodwill | 1,867 | 1,867 | ||||||
Total assets | $ | 25,917 | $ | 20,892 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: | ||||||||
Accounts payable | $ | 449 | $ | 418 | ||||
Accrued severance | 428 | 668 | ||||||
Accrued expenses and other liabilities | 742 | 354 | ||||||
Total liabilities | 1,619 | 1,440 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ equity | ||||||||
Common stock, $0.001 par value, 200,000,000 shares authorized at March 31, 2018 and December 31, 2017; and 9,407,024 and 7,110,414 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively |
9 | 7 | ||||||
Additional paid-in capital | 54,601 | 46,951 | ||||||
Accumulated deficit | (30,312 | ) | (27,506 | ) | ||||
Total stockholders’ equity |
24,298 | 19,452 | ||||||
Total liabilities and stockholders’ equity |
$ | 25,917 | $ | 20,892 | ||||
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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Three Months Ended |
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March 31, |
March 31, |
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2018 |
2017 |
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Operating expenses |
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Research and development | $ | 1,097 | $ | 479 | ||||||
General and administrative | 1,698 | 906 | ||||||||
Total operating expenses | 2,795 | 1,385 | ||||||||
Loss from operations | (2,795 | ) | (1,385 | ) | ||||||
Other income (expense), net | (11 | ) | 11 | |||||||
Net loss and other comprehensive loss |
$ | (2,806 | ) | $ | (1,374 | ) | ||||
Net loss per share, basic and diluted | $ | (0.36 | ) | $ | (0.59 | ) | ||||
Weighted-average common shares outstanding, basic and diluted |
7,749,263 | 413,635 | ||||||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20180511005086/en/
Source:
Investor Contacts
LifeSci Advisors, LLC
Timothy
McCarthy, 917-679-9282
tim@lifesciadvisors.com