Novus Therapeutics Reports Second Quarter 2019 Financial Results
Operational Highlights
- Announced results from three OP0201 phase 1 safety clinical trials
- Presented OP0201 data at the 20th International Symposium on Recent Advances in Otitis Media
-
Raised gross proceeds of
$10.7 million in a registered direct offering
“During the quarter, we completed the OP0201 phase 1 program which included a single-dose safety trial in healthy adults (study C-001), a single-dose safety trial in adults with acute otitis media (study C-004), and a 14-day safety trial in healthy adults (study C-002),” said
“The phase 1 program has shown OP0201 to be safe and tolerable, and we are now focusing our R&D activities towards the ongoing exploratory phase 2a trial in children with acute otitis media (study C-006). To date, we have enrolled more than 30% of the planned 140 patients into study C-006 and we look forward to sharing the results of this study in the first half of 2020. Finally, we are continuing to advance our plans for the phase 2 trial in children with chronic otitis media with effusion (study C-009) and plan to meet with the
Financial Results for Second Quarter 2019
For the three-months ended
Research and development (R&D) expenses were
General and administrative (G&A) expenses were
Upcoming Milestones
September 2019 –FDA meeting to discuss OP0201 phase 2 study in children with chronic otitis media with effusion (study C-009)- 1H 2020 – Results of OP0201 phase 2a study in children with acute otitis media (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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June 30,
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December 31,
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(Unaudited) |
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ASSETS |
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Current assets: |
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Cash |
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$ |
13,703 |
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$ |
12,972 |
|
Prepaid expenses and other current assets |
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1,478 |
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1,304 |
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Total current assets |
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15,181 |
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14,276 |
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Property and equipment, net |
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10 |
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14 |
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Operating lease asset, net |
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403 |
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— |
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Goodwill |
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1,867 |
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1,867 |
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Other assets |
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755 |
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|
869 |
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Total assets |
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$ |
18,216 |
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$ |
17,026 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
753 |
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$ |
689 |
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Current operating lease liability |
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173 |
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— |
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Accrued expenses and other liabilities |
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1,022 |
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|
1,845 |
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Total current liabilities |
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1,948 |
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2,534 |
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Non-current operating lease liability |
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236 |
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— |
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Total liabilities |
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2,184 |
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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, $0.001 par value, 5,000,000 shares authorized and none issued and outstanding at June 30, 2019 and December 31, 2018 |
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— |
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— |
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Common stock, $0.001 par value, 200,000,000 shares authorized at June 30, 2019 and December 31, 2018; 12,974,923 and 9,422,143 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively |
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13 |
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9 |
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Additional paid-in capital |
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66,564 |
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56,054 |
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Accumulated deficit |
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(50,545 |
) |
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(41,571 |
) |
Total stockholders’ equity |
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16,032 |
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14,492 |
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Total liabilities and stockholders’ equity |
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$ |
18,216 |
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$ |
17,026 |
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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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For the Six Months
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2019 |
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2018 |
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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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$ |
2,297 |
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$ |
1,329 |
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$ |
5,286 |
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$ |
2,426 |
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General and administrative |
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1,792 |
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1,860 |
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3,678 |
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3,558 |
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Total operating expenses |
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4,089 |
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3,189 |
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8,964 |
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5,984 |
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Loss from operations |
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(4,089 |
) |
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(3,189 |
) |
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(8,964 |
) |
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(5,984 |
) |
Other income (expense), net |
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(4 |
) |
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— |
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(10 |
) |
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(11 |
) |
Net loss and comprehensive loss |
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$ |
(4,093 |
) |
|
$ |
(3,189 |
) |
|
$ |
(8,974 |
) |
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$ |
(5,995 |
) |
Net loss per share, basic and diluted |
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$ |
(0.35 |
) |
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$ |
(0.34 |
) |
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$ |
(0.85 |
) |
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$ |
(0.70 |
) |
Weighted-average common shares outstanding, basic and diluted |
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11,751,110 |
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9,407,024 |
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10,595,511 |
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8,582,723 |
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View source version on businesswire.com: https://www.businesswire.com/news/home/20190813005646/en/
Source:
Investor Contacts
Timothy McCarthy
LifeSci Advisors, LLC
Tel: 212-915-2564
tim@lifesciadvisors.com