PROSPECTUS SUMMARY
This summary highlights certain information about us and this offering contained elsewhere in this prospectus. Because it is only a summary, it does not
contain all of the information that you should consider before investing in shares of our securities and it is qualified in its entirety by, and should be read in conjunction with, the more detailed information appearing elsewhere in this
prospectus. Before you decide to invest in our securities, you should read the entire prospectus carefully, including Risk Factors beginning on page 3, and the consolidated financial statements and related notes and information
incorporated by reference into this prospectus.
Company Overview
Novus Therapeutics, Inc. is a specialty pharmaceutical company focused on developing products for patients with disorders of the ear, nose, and
throat. The Company has two platform technologies, a surfactant and a foam, each with the potential to be developed for multiple indications. Novus lead program, OP0201, is a surfactant-based nasal aerosol drug-device combination product
candidate being developed as a potential first-in-class treatment option for patients at risk for, or with, otitis media (OM). Novus is also exploring a
second product candidate from the surfactant platform, NVUS01, a dry-powder drug-device combination product as a treatment option for OM. OM is defined as middle ear inflammation and effusion with or without
infection. Globally, OM affects more than 700 million adults and children every year, with over half of the cases occurring in children under five years of age. OM is one of the most common disorders seen in pediatric practice, and is a leading
cause of health care visits and the most frequent reason children are prescribed antibiotics or undergo surgery in the United States. Novus also has a foam-based drug delivery technology platform, which may be developed in the future to deliver
drugs into the ear, nasal, and sinus cavities.
Surfactant Platform
The first product candidate in the surfactant platform program, OP0201, is being developed as a potential first-in-class treatment option for OM. OM is often caused by Eustachian tube dysfunction. 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. OP0201is intended to be used
to restore the normal physiologic activity of the Eustachian tube (ET), which is a small tube that connects from the chamber of the middle ear 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 promotes de-sticking of the ET so that ventilation of the middle ear is restored.
Novus has
completed three phase 1 placebo-controlled clinical trials in adults that were designed to evaluate safety and tolerability of single and repeated intranasal doses of OP0201. Results of a single-dose phase 1 trial in healthy adults (study C-001), a single-dose phase 1 trial in adults with acute otitis media (study C-004), and a 14-day phase 1 trial in healthy adults
(study C-002) demonstrated the safety and tolerability of OP0201 nasal aerosol. Novus is currently conducting an exploratory phase 2a clinical trial of OP0201 nasal aerosol in infants and children with acute
otitis media (study C-006).
Novus is currently exploring a second product candidate in the
surfactant platform program, NVUS01, a dry-powder, drug-device combination product comprised of a novel formulation of a surfactant (DPPC) and a spreading agent (CP). NVUS01 is a
pre-clinical drug product candidate; no clinical trials are ongoing with NVUS01.
Novus
surfactant development program, if successful, will lead to registration of a surfactant-based product in North America and key European markets to treat and/or prevent OM in infants and children. Additional development activities to support
registration in other countries, or for other indications, or other patient populations, may occur in the future.
Foam Platform
Novus has two
product candidates developed, OP0101 and OP0102, which are foam-based product candidates intended to be used as a delivery vehicle for drugs to be administered into the ear canals, as well as the nasal and sinus cavities. OP0101 foam otic was the
initial product candidate utilizing the foam platform. It was developed as an improved treatment option for acute otitis externa (AOE), a common infectious medical condition of the outer ear canal that affects tens of millions of adults
and children each year (frequently called swimmers ear). Novus completed four clinical trials of OP0101 foam otic in 353 adult and pediatric subjects, including a successful phase 2b study with a steroid-free, antibiotic-only
formulation of OP0101 foam otic that was non-inferior to standard of care, but with a more favorable dosing regimen (once a day dosing instead of twice a day).
OP0102 foam otic is a second-generation formulation designed to rapidly relieve ear pain (an unmet need in AOE) and eradicate infection with
less than seven days of treatment. In May 2017, Novus suspended the foam otic platform development program.
Corporate Information
We were incorporated under the laws of the State of Delaware on March 26, 2004 under the name Tokai Pharmaceuticals, Inc. and we changed
our name to Novus Therapeutics on May 9, 2017. Our principal executive offices are located at 19900 MacArthur Boulevard, Suite 550, Irvine, California 92612, and our telephone number is (949) 238-8090.
Our website address is novustherapeutics.com. The information contained in, or accessible through, our website does not constitute part of this prospectus. We have included our website address in this prospectus solely as an inactive textual
reference.