Novus Therapeutics Reports Third Quarter 2018 Financial Results
“This is an exciting time for the company as we transition into the
clinic with a potential first-in-class treatment option for otitis
media. We continued to advance the OP-02 program during the quarter and
are now positioned to achieve several milestones over the next few
quarters,” said
“We recently received IRB approval to initiate additional phase 1 safety and exploration of efficacy studies; a study in adults with acute otitis media and a pharmacodynamic study in healthy adults. We expect to begin enrolling these studies in 2019,” concluded Mr. Flesher.
Anticipated Milestones in Q4 2018 and 1H 2019
- Q4 2018 – Initiate phase 1 study in healthy adults (safety/tolerability)
- Q4 2018 – Initiate phase 1 study in patients with acute otitis media (explore efficacy)
- Q1 2019 – Initiate phase 1 study in healthy adults (pharmacodynamic effects)
- 1H 2019 – Initiate phase 1 study in patients with otitis media with effusion (explore efficacy)
- 1H 2019 – Topline data from phase 1 studies
Financial Results for Third Quarter 2018
For the three-months ended
For the nine-months ended
The company had
Research and Development (R&D)
R&D expenses were
For the nine-months ended
The company expects R&D expenses to increase in subsequent periods as we advance our OP-02 program.
General and administrative (G&A)
G&A expenses were
For the nine-months ended
About OP-02
OP-02 is being developed as a potential first-in-class treatment option for otitis media (“OM”), which is often caused by Eustachian tube dysfunction (“ETD”). OP-02 is a drug-device combination product comprised of a proprietary formulation surfactant (dipalmitoylphosphatidylcholine or “DPPC”) and a spreading agent (cholesteryl palmitate or “CP”) suspended in propellant. The product is administered intranasally via a pressurized metered- dose inhaler (“pMDI”) and is intended to be used to restore the normal physiologic activity of the Eustachian tube (“ET”), which is the small tube that connects the middle ear to the back of the nasopharynx. Together DPPC and CP are designed to 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 is intended to promote ‘de-sticking’ of the ET so that ventilation and drainage of the middle ear may occur.
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,” “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: expectations
regarding the timing for the commencement and completion of product
development or 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. | |||||||||
CONSOLIDATED BALANCE SHEETS | |||||||||
(In thousands, except share data) | |||||||||
September 30, | December 31, | ||||||||
2018 | 2017 | ||||||||
(Unaudited) | |||||||||
ASSETS | |||||||||
Current assets: | |||||||||
Cash | $ | 16,324 | $ | 17,233 | |||||
Restricted cash | — | 70 | |||||||
Prepaid expenses and other current assets |
786 | 1,697 | |||||||
Total current assets | 17,110 | 19,000 | |||||||
Property and equipment, net | 17 | 25 | |||||||
Goodwill | 1,867 | 1,867 | |||||||
Other assets | 934 | — | |||||||
Total assets | $ | 19,928 | $ | 20,892 | |||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||
Current liabilities: | |||||||||
Accounts payable | $ | 751 | $ | 418 | |||||
Accrued severance | 90 | 668 | |||||||
Accrued expenses and other liabilities | 762 | 354 | |||||||
Total liabilities | 1,603 | 1,440 | |||||||
Commitments and contingencies | |||||||||
Stockholders’ equity: | |||||||||
Preferred stock, $0.001 par value, 5,000,000 shares authorized and none issued and outstanding at September 30, 2018 and December 31, 2017 |
— | — | |||||||
Common stock, $0.001 par value, 200,000,000 shares authorized at September 30, 2018 and December 31, 2017; 9,422,143 and 7,110,414 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively |
9 | 7 | |||||||
Additional paid-in capital | 55,313 | 46,951 | |||||||
Accumulated deficit | (36,997 | ) | (27,506 | ) | |||||
Total stockholders’ equity | 18,325 | 19,452 | |||||||
Total liabilities and stockholders’ equity | $ | 19,928 | $ | 20,892 | |||||
NOVUS THERAPEUTICS, INC. | ||||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS AND OTHER COMPREHENSIVE LOSS | ||||||||||||||||||
(In thousands, except share and per share data) | ||||||||||||||||||
For the Three Months | For the Nine Months | |||||||||||||||||
Ended September 30, | Ended September 30, | |||||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||||
Operating expenses | ||||||||||||||||||
Research and development | $ | 1,651 | $ | 517 | $ | 4,077 | $ | 1,529 | ||||||||||
General and administrative | 1,848 | 2,448 | 5,406 | 9,487 | ||||||||||||||
Total operating expenses | 3,499 | 2,965 | 9,483 | 11,016 | ||||||||||||||
Loss from operations | (3,499 | ) | (2,965 | ) | (9,483 | ) | (11,016 | ) | ||||||||||
Other income (expense), net | 3 | (5 | ) | (8 | ) | 10 | ||||||||||||
Net loss and comprehensive loss | $ | (3,496 | ) | $ | (2,970 | ) | $ | (9,491 | ) | $ | (11,006 | ) | ||||||
Net loss per share, basic and diluted | $ | (0.37 | ) | $ | (0.43 | ) | $ | (1.07 | ) | $ | (2.25 | ) | ||||||
Weighted-average common shares outstanding, basic and diluted
|
9,420,039 | 6,943,058 | 8,864,895 | 3,845,258 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20181113005196/en/
Source:
LifeSci Advisors, LLC
Timothy McCarthy, 212-915-2564
tim@lifesciadvisors.com