Novus Therapeutics Reports Third Quarter 2019

IRVINE, Calif. Novus Therapeutics, Inc. a specialty pharmaceutical company focused on developing products for patients with disorders of the ear, nose, and throat (ENT), today announced financial results for the quarter ended September 30, 2019.

“We continue to make progress with the OP0201 otitis media program,” said Gregory J. Flesher, CEO of Novus Therapeutics, Inc. “To date we have enrolled more than 40% of the planned patients into study C-006, our ongoing phase 2a clinical trial in infants and children with acute otitis media. Study C-006 is designed to explore the effect of OP0201 in resolving a bulging tympanic membrane and/or resolving middle ear effusion, both of which are hallmark symptoms of acute otitis media. We expect results from this study to be available in the first half of 2020.”

“In addition, we recently had a meeting with the FDA in which we gained alignment on the overall design and efficacy endpoints for study C-009, our planned phase 2a clinical trial in infants and children with chronic otitis media with effusion. This non-infectious form of otitis media affects millions of people every year and is characterized by middle ear effusion and hearing loss that persists for many months. Study C-009 is designed to explore the effect of OP0201 in restoring hearing and/or resolving middle ear effusion in patients with bilateral chronic otitis media with effusion. We look forward to initiating this study in the future,” concluded Mr. Flesher.

Upcoming Milestones

• Results of OP0201 phase 2a study in acute otitis media (study C-006) in the first half of 2020

Upcoming Investor Conferences

• Piper Jaffray Healthcare Conference, Lotte Palace Hotel, New York, December 3-5, 2019
• LD Micro Conference, Luxe Sunset Hotel, Los Angeles, CA December 10-12, 2019

Financial Results for the Three Months Ended September 30, 2019

The company reported a net loss of $2.9 million, or $0.22 per share, for the three months ended September 30, 2019, compared to a net loss of $3.5 million, or $0.37 per share, for the same period in 2018.

Research and development (R&D) expenses were $1.5 million for the three months ended September 30, 2019, compared to $1.7 million for the same period in 2018. The decrease in R&D expenses of $142,000 is primarily due to lower clinical and formulation development costs, as well as a decrease in travel and meetings expense. The decreases were offset by an increase in consulting services, personnel costs, and stock-based compensation costs.

General and administrative (G&A) expenses were $1.4 million for the three months ended September 30, 2019, compared to $1.8 million for the same period in 2018. The decrease in G&A expenses of $437,000 is primarily attributable to a decrease in litigation costs, costs associated with operating a publicly traded company, stock-based compensation costs, and general operating costs. The decreases were offset by increases in personnel costs and travel and meetings expense.

Financial Results for the Nine Months Ended September 30, 2019

Novus reported a net loss of $11.9 million, or $1.04 per share, for the nine months ended September 30, 2019, compared to a net loss of $9.5 million, or $1.07 per share, for the same period in 2018.

R&D expenses were $6.8 million for the nine months ended September 30, 2019, compared to $4.1 million for the same period in 2018. The increase in R&D expenses of $2.7 million is primarily attributable to an increase in clinical development costs for OP0201, personnel costs, stock-based compensation, and an increase in other development costs. The increases were offset by decreases in formulation development costs and travel and meetings expense.

G&A expenses were $5.1 million for the nine months ended September 30, 2019, compared to $5.4 million for the same period in 2018. The decrease in G&A expenses of $317,000 was primarily due to decreases in costs associated with operating a publicly traded company, litigation costs, general operating costs, as well as a decrease in travel and meetings expense. The decreases were offset by increases in personnel and stock-based compensation costs.

The company had approximately $10.8 million in cash and cash equivalents as of September 30, 2019, compared to approximately $13.7 million in cash and cash equivalents as of June 30, 2019. The company’s cash and cash equivalents is expected to fund operations through study C-006 data in 2020.-Business Wire