Novus Therapeutics Reports Fourth Quarter and Full-Year 2019 Financial Results
Data from the fully enrolled phase 2a efficacy study in infants and children with acute otitis media to be announced by early
“We made steady progress in the OP0201 development program during 2019. During the year, the company generated data from three phase 1 safety studies, which established safety and tolerability of single and multiple doses of OP0201 in both healthy adult volunteers and in adults with acute otitis media. We also initiated our first phase 2a efficacy study in patients with acute otitis media. Finally, we completed a successful meeting with the
“Looking ahead, we expect to announce data from the fully enrolled phase 2a efficacy study in infants and children with acute otitis media in the coming months,” concluded
Financial Results for the Three Months Ended
The company reported a net loss of
Research and development (R&D) expenses were
General and administrative (G&A) expenses were
Financial Results for the Year Ended
Novus reported a net loss of
R&D expenses were
G&A expenses were
The company had approximately
In
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 ongoing OP0201 clinical trial; 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
CONSOLIDATED BALANCE SHEETS (In thousands, except share data) |
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2019 |
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2018 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
8,791 |
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$ |
12,972 |
|
Prepaid expenses and other current assets |
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1,180 |
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|
|
1,304 |
|
Total current assets |
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9,971 |
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|
14,276 |
|
Property and equipment, net |
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5 |
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|
14 |
|
Operating lease asset, net |
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316 |
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|
— |
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— |
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1,867 |
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Other assets |
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|
639 |
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|
|
869 |
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Total assets |
|
$ |
10,931 |
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$ |
17,026 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Accounts payable |
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$ |
329 |
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$ |
689 |
|
Current operating lease liability |
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180 |
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— |
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Accrued expenses and other liabilities |
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|
813 |
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|
1,845 |
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Total current liabilities |
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1,322 |
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2,534 |
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Non-current operating lease liability |
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144 |
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— |
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Total liabilities |
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1,466 |
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2,534 |
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Commitments and contingencies |
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Stockholders’ equity: |
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Preferred stock, |
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— |
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— |
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Common stock, |
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13 |
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|
9 |
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Additional paid-in capital |
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67,034 |
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|
56,054 |
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Accumulated deficit |
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(57,582 |
) |
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(41,571 |
) |
Total stockholders’ equity |
|
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9,465 |
|
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|
14,492 |
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Total liabilities and stockholders’ equity |
|
$ |
10,931 |
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|
$ |
17,026 |
|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share data) |
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Year Ended
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2019 |
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2018 |
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Operating expenses |
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Research and development |
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$ |
8,128 |
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$ |
6,817 |
|
General and administrative |
|
|
6,056 |
|
|
|
7,243 |
|
|
|
|
1,867 |
|
|
|
— |
|
Total operating expenses |
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|
16,051 |
|
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|
14,060 |
|
Loss from operations |
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(16,051 |
) |
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|
(14,060 |
) |
Other income (expense), net |
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40 |
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(5 |
) |
Net loss and other comprehensive loss |
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$ |
(16,011 |
) |
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$ |
(14,065 |
) |
Net loss per share, basic and diluted |
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$ |
(1.36 |
) |
|
$ |
(1.56 |
) |
Weighted-average common shares outstanding, basic and diluted |
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11,793,125 |
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9,005,352 |
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View source version on businesswire.com: https://www.businesswire.com/news/home/20200317005025/en/
Investor Contacts
Tel: 212-915-2564
tim@lifesciadvisors.com
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