Novus Therapeutics Explodes 166% On Anelixis Deal, Capital Raise


Novus Therapeutics (NVUS) has announced it has completed the acquisition of Anelixis Therapeutics, a privately held clinical stage biotech developing a next generation anti-CD40 Ligand (CD40L) antibody as a potential treatment for organ and cellular transplantation, autoimmune diseases, and neurodegenerative diseases.

At the same time, Novus entered into a definitive agreement to sell $108M of non-voting convertible preferred stock in a private placement to a group of institutional accredited investors.

The company says it will use these proceeds to fund its operations, including to advance Phase 2 clinical trials of AT-1501, a humanized IgG1 anti-CD40L antibody with high affinity for CD40L, in renal transplantation, islet cell transplantation, autoimmune nephritis, and amyotrophic lateral sclerosis (ALS).

“We are excited about AT-1501 and the potential to develop and commercialize the next generation anti-CD40L antibody, a well-validated target with broad therapeutic possibilities,” said Keith A. Katkin, Chairman of Novus.

“After exploring a range of strategic options to maximize shareholder value, we believe this acquisition represents the greatest value creation opportunity for Novus stockholders, and we are confident that we have the management and scientific leadership team to fully realize this opportunity for patients in need of new treatment options” he concluded.

Shares in Novus spiked 166% after-hours on the news to $1.01, with shares currently down 35% year-to-date. The stock has received two recent ratings from the Street, with the analysts split between hold and buy. Their average price target of $1.23 indicates significant further upside potential lies ahead.

Novus reported in June results from its first exploratory trial with OP0201 from 110 6-to-24-month-old children with confirmed acute otitis media (AOM).

While the trial met the safety endpoint, OP0201 just missed on one of two possible efficacy endpoints (p=0.07), resulting in the company seeking strategic options.

“As this is a near-miss in a Phase 2, we suspect Novus will continue to seek further development of OP0201, but expect the company will need to secure a partner and/or non-dilutive funding to continue its development with another Phase 2” wrote Ladenburg’s Michael Higgins in August as he explained his hold rating on the stock.

However HC Wainwright’s Vernon Bernadino noted that although the study did not achieve statistical significance for the primary efficacy endpoints, he was encouraged by the statistical trend in resolution of MEE that favored OP0201 treatment. According to the analyst the effects of small numbers from this study negatively affected statistical analyses.

“Importantly, 47% more children achieve resolution of MEE with OP0201 than with placebo. We reiterate our Buy rating and $2 PT” he wrote on August 27. (See NVUS stock analysis on TipRanks)

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