Novus Therapeutics Reports Fourth Quarter and Full-Year 2018 Financial Results and Provides Clinical Updates
“We made significant progress on the OP0201 program in 2018,” said
OP0201 Development Updates
- Study C-001 is a phase 1 clinical trial designed to evaluate safety, tolerability, and Eustachian tube (“ET”) function following a single intranasal dose of OP0201 in 16 healthy adults. The randomized, double-blind, placebo-controlled, cross-over trial explores the effects of a 20 mg dose of OP0201 on ET function. Assessment of ET function is captured using continuous tympanic impedance while subjects are exposed to changes in atmospheric pressure produced within a hyperbaric/hypobaric chamber. Data from this study is expected to be available in Q2 2019.
- Study C-002 is a phase 1 clinical trial designed to evaluate safety and tolerability of daily intranasal administration of OP0201 over 14 consecutive days in 30 healthy adults. The randomized, double-blind, placebo-controlled, parallel-group, dose-escalation trial includes a 30 mg per day dose (Cohort A) and 60 mg per day dose (Cohort B) of OP0201. Data from this study is expected to be available in Q2 2019.
-
Study C-004 is a phase 1 clinical trial designed to evaluate safety,
tolerability, and relief of ear pain over a 60-minute observation
period following a single intranasal dose of OP0201 in 24 adults with
acute otitis media. The randomized, double-blind, placebo-controlled,
parallel-group trial explores the effects of a 20 mg intranasal dose
of OP0201. Assessment of pain relief is captured utilizing a Visual
Analog Scale (VAS), Numeric Rating Scale (NRS-11), Patient Global
Impression of Change (PGIC), and Clinical Global Impressions Scale:
Global Improvement (CGI-I). Data from this study is expected to be
available in
April 2019 . - Study C-006 is an exploratory phase 2a clinical trial designed to evaluate safety, tolerability, and efficacy of daily intranasal administration of OP0201 over 10 consecutive days in up to 50 pediatric patients, 6 to 24 months of age, with acute otitis media. The randomized, double-blind, placebo-controlled, parallel-group trial explores the effects of a 20 mg per day dose of OP0201 as an adjunct to oral antibiotics. Patients will receive 10 days of treatment and will be followed for up to 30 days, during which multiple endpoints will be explored. Enrollment is currently ongoing with data expected in 2H 2019.
Fourth Quarter and Full-Year 2018 Financial Results
For the three-month period ended
Research and development (R&D) expenses were
General and administrative (G&A) expenses were
About OP0201
OP0201 is being developed as a potential first-in-class treatment option for OM. OM is often caused by Eustachian tube dysfunction (ETD). OP0201 is a nasal aerosol, drug-device combination product comprised of a novel formulation of a surfactant (dipalmitoylphosphatidylcholine [DPPC]) and a spreading agent (cholesteryl palmitate [CP]) suspended in propellant. The product is administered intranasally via a pressurized metered-dose inhaler (pMDI). OP0201 is intended to be used to restore the normal physiologic activity of the ET, which is a small tube that connects the middle ear cavity to the back of the nasopharynx. Together, the active ingredients in OP0201 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, OP0201 is intended to promote ‘de-sticking’ of the ET so that ventilation 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,” “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: 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. | ||||||||||
CONSOLIDATED BALANCE SHEETS | ||||||||||
(In thousands, except share data) | ||||||||||
December 31, | ||||||||||
2018 | 2017 | |||||||||
ASSETS | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ | 12,972 | $ | 17,233 | ||||||
Restricted cash | — | 70 | ||||||||
Prepaid expenses and other current assets | 1,304 | 1,697 | ||||||||
Total current assets | 14,276 | 19,000 | ||||||||
Property and equipment, net | 14 | 25 | ||||||||
Goodwill | 1,867 | 1,867 | ||||||||
Other assets | 869 | — | ||||||||
Total assets | $ | 17,026 | $ | 20,892 | ||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||||
Accounts payable | $ | 689 | $ | 418 | ||||||
Accrued severance | — | 668 | ||||||||
Accrued expenses and other liabilities | 1,845 | 354 | ||||||||
Total liabilities | 2,534 | 1,440 | ||||||||
Commitments and contingencies | ||||||||||
Stockholders’ equity: | ||||||||||
Preferred stock, $0.001 par value, 5,000,000 shares authorized and
none
issued and outstanding at December 31, 2018 and 2017 |
— | — | ||||||||
Common stock, $0.001 par value, 200,000,000 shares authorized at
December 31, 2018 and 2017; 9,422,143 and 7,110,414 shares issued and
outstanding at December 31, 2018 and 2017, respectively |
9 | 7 | ||||||||
Additional paid-in capital | 56,054 | 46,951 | ||||||||
Accumulated deficit | (41,571 | ) | (27,506 | ) | ||||||
Total stockholders’ equity | 14,492 | 19,452 | ||||||||
Total liabilities and stockholders’ equity | $ | 17,026 | $ | 20,892 |
NOVUS THERAPEUTICS, INC. | ||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||||
(In thousands, except share and per share data) | ||||||||||
Year Ended | ||||||||||
December 31, | ||||||||||
2018 | 2017 | |||||||||
Operating expenses | ||||||||||
Research and development | $ | 6,817 | $ | 2,022 | ||||||
General and administrative | 7,243 | 11,099 | ||||||||
Total operating expenses | 14,060 | 13,121 | ||||||||
Loss from operations | (14,060 | ) | (13,121 | ) | ||||||
Other income (expense), net | (5 | ) | 5 | |||||||
Net loss and other comprehensive loss | $ | (14,065 | ) | $ | (13,116 | ) | ||||
Net loss per share, basic and diluted | $ | (1.56 | ) | $ | (2.30 | ) | ||||
Weighted-average common shares outstanding, basic and
diluted |
9,005,352 | 4,677,610 |
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Source:
Investor Contacts
Timothy McCarthy
LifeSci Advisors, LLC
tim@lifesciadvisors.com
Tel:
(212) 915-2564