Novus Therapeutics Reports First Quarter 2019 Financial Results
Operational Highlights
- Announced results of two single-dose OP0201 phase 1 clinical trials, demonstrating safety and tolerability in healthy adults (study C-001) and in adults with acute otitis media (study C-004)
- Completed enrollment of multi-dose OP0201 phase 1 clinical trial in healthy adults (study C-002, three doses daily for 14-days), with results expected next month
- Initiated enrollment of multi-dose OP0201 exploratory phase 2a clinical trial in infants and children with acute otitis media (study C-006, two doses daily for 10-days)
“We had a very productive first quarter with the completion of two
single-dose safety and tolerability OP0201 clinical trials,” said
“In February we announced the initiation of our first phase 2 study, an
exploratory phase 2a clinical trial designed to explore the effects of a
10-day course of OP0201 treatment in combination with oral antibiotics
in infants and children with acute otitis media. With the recently
completed
Financial Results for First Quarter 2019
For the three-months ended
R&D expenses were
G&A expenses were
Upcoming Milestones
June 2019 – Results of OP0201 phase 1 study C-002June 2019 – Poster presentation of OP0201 phase 1 study C-001 data at the 20th International Symposium on Recent Advances in Otitis Media (June 9-13 ,Los Angeles, CA )- 1H 2020 – Results of OP0201 phase 2a study C-006
About
Forward-Looking Statements
This press release contains forward‐looking statements that involves
substantial risks and uncertainties. Any statements about the company’s
future expectations, plans and prospects, including statements about its
strategy, future operations, development of its product candidates, and
other statements containing the words “believes,” “anticipates,”
“plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,”
“targets,” “looks forward,” “could,” “may,” and similar expressions,
constitute forward‐looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, although not all
forward‐looking statements include such identifying words.
Forward‐looking statements include, but are not limited to statements
regarding: risks related to market conditions, the completion of the
common stock and warrant financing, including the satisfaction of the
closing conditions, and the use of anticipated proceeds; expectations
regarding the timing for the commencement and completion of product
development or clinical trials, including the four ongoing OP0201
clinical trials; expectations regarding the success of clinical trials;
the rate and degree of market acceptance and clinical utility of the
company’s products; the company’s commercialization, marketing and
manufacturing capabilities and strategy; the company’s intellectual
property position and strategy; the company’s ability to identify
additional products or product candidates with significant commercial
potential; the company’s estimates regarding expenses, future revenue,
capital requirements and needs for additional financing; developments
relating to the company’s competitors and industry; and the impact of
government laws and regulations. Actual results may differ materially
from those indicated by such forward‐looking statements as a result of
various important factors, including: the ability to develop
commercially viable product formulations; the sufficiency of the
company’s cash resources; the ability to obtain necessary regulatory and
ethics 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; whether any such submission will receive
approval from the
NOVUS THERAPEUTICS, INC. |
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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(In thousands, except share data) |
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March 31, |
December 31, |
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(Unaudited) | ||||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash | $ | 9,056 | $ | 12,972 | ||||
Prepaid expenses and other current assets | 1,265 | 1,304 | ||||||
Total current assets | 10,321 | 14,276 | ||||||
Property and equipment, net | 12 | 14 | ||||||
Operating lease asset, net | 446 | — | ||||||
Goodwill | 1,867 | 1,867 | ||||||
Other assets | 805 | 869 | ||||||
Total assets | $ | 13,451 | $ | 17,026 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 480 | $ | 689 | ||||
Current operating lease liability | 170 | — | ||||||
Accrued expenses and other liabilities | 2,591 | 1,845 | ||||||
Total current liabilities | 3,241 | 2,534 | ||||||
Non-current operating lease liability | 281 | — | ||||||
Total liabilities | 3,522 | 2,534 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ equity: | ||||||||
Preferred stock, $0.001 par value, 5,000,000 shares authorized and none issued and outstanding at March 31, 2019 and December 31, 2018 | — | — | ||||||
Common stock, $0.001 par value, 200,000,000 shares authorized at
March 31, 2019 and December 31, 2018; 9,447,361 and 9,422,143 shares
issued and
outstanding at March 31, 2019 and December 31, 2018, respectively |
9 | 9 | ||||||
Additional paid-in capital | 56,372 | 56,054 | ||||||
Accumulated deficit | (46,452 | ) | (41,571 | ) | ||||
Total stockholders’ equity | 9,929 | 14,492 | ||||||
Total liabilities and stockholders’ equity | $ | 13,451 | $ | 17,026 | ||||
NOVUS THERAPEUTICS, INC. |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
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(In thousands, except share and per share data) |
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For the Three Months |
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2019 | 2018 | |||||||
Operating expenses | ||||||||
Research and development | $ | 2,989 | $ | 1,097 | ||||
General and administrative | 1,886 | 1,698 | ||||||
Total operating expenses | 4,875 | 2,795 | ||||||
Loss from operations | (4,875 | ) | (2,795 | ) | ||||
Other income (expense), net | (6 | ) | (11 | ) | ||||
Net loss and comprehensive loss | $ | (4,881 | ) | $ | (2,806 | ) | ||
Net loss per share, basic and diluted | $ | (0.52 | ) | $ | (0.36 | ) | ||
Weighted-average common shares outstanding, basic and
diluted |
9,427,073 | 7,749,263 | ||||||
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Source:
Investor Contacts
Timothy McCarthy
LifeSci Advisors, LLC
Tel:
212-915-2564
tim@lifesciadvisors.com