Tiziana Life Sciences is following biotech’s third-quarter cull trend, though it’s attempting to do so more covertly, putting several of its pipeline programs on the shelf in a “near-term focus” strategic update.
The company is going to “prioritize the lowest hanging fruit” where it has collected the most advanced clinical data, Tiziana Chief Medical Officer and acting Chief Scientific Officer Matthew Davis, M.D., said during a Nov. 10 investor call.
For the time being, the biotech will focus only on developing intranasal foralumab, its anti-CD3 monoclonal antibody, for inflammatory diseases of the central nervous system.
The refocus pushes two other drugs—a preclinical pulmonary fibrosis candidate and a phase 1 pan-CDK inhibitor cancer candidate—to the wayside. The company is also putting other formulations of foralumab “on the back burner,” Gabriele Cerrone, executive chair and interim CEO of Tiziana, said on the call. Current assessments of foralumab in diabetes and Crohn’s disease will be deprioritized as the company zooms in on studies in non-active secondary-progressive multiple sclerosis (SPMS), Alzheimer’s disease and amyotrophic lateral sclerosis.
The aim is to focus on areas of greatest potential success and maximize shareholder value while still maintaining optionality for other research programs, Cerrone said in a Nov. 10 release, leaving the door slightly ajar for a return to the deprioritized programs.
Since closing yesterday at 62 cents per share, Tiziana’s stock had risen nearly 13% to 70 cents per share at 11 a.m. ET on Nov. 10.
The biotech’s management team has significant stake in the company and is aligned with shareholders’ interests, Cerrone said, adding that his family has a 38% stake in the company.
“Tiziana has successfully managed to avoid engaging itself in toxic financings with excessive warrant coverage, or a reverse stock split associated financing commonly seen in the marketplace for small biotech companies,” Cerrone said. “It is not my goal to dilute my own position via a series of structured financing, nor yours.”
In June, Tiziana received a warning from Nasdaq that its sub-dollar share price was out of compliance, and the company could face delisting if its price did not increase in 180 days. Cerrone said the biotech intends to ask for another 180-day extension by Dec. 12.
The acting CEO continued to explain Tiziana’s financial standing, saying that, unlike other biotechs pursuing highly diluted deals with large discounts, Tiziana will hold off and focus instead on gathering more MS data to enable a stronger financial position. The company anticipates launching a phase 2 trial next year. While Big Pharmas have been in touch with Tiziana, mostly regarding its MS data, according to Cerrone, the leader said the company will generate as many data as possible before formally pursuing anything.
Tiziana doesn’t intend to raise any additional capital before the first quarter of 2024, Cerrone said, adding that the biotech’s cash runway should suffice until then.
Cerrone touted Tiziana’s “transformation” since Davis came aboard in July as chief medical officer and acting chief scientific officer. Davis, who joined from Endo International, mapped out other clinical milestones for the next 14 months, including plans to ask the FDA for a Type C meeting to discuss a phase 2 foralumab program in non-active SPMS patients by the end of the year.
Fierce Biotech has reached out to Tiziana for comment and will update this article as new information becomes available.