Gordon Stein, CFO of CleanTech Lithium, explains why CTL acquired the 23 Laguna Verde licenses. Watch the video here.
Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough neuro-immunomodulation therapies, today announced “first patient dosed” in its Phase 2a study comparing two doses of intranasal foralumab and placebo in patients with non-active secondary-progressive multiple sclerosis (na-SPMS). Six investigational centers have been recruited for this double-blind, placebo-controlled trial, with up to 18 patients per treatment arm. The primary endpoint of the trial will be the change in microglial activation based on PET scans. Clinical evaluations include the Expanded Disability Status Scale (EDSS), QoL assessments, and the Modified Fatigue Impact Scale (MFIS), which assess parameters that are essential to a patient’s everyday life. Novel immuno-biomarkers will be measured also and assessed for predictive relevance. Central review of PET scans and images is an integral component of this study.
"The successful consenting, screening, completion of the baseline PET scan, and dosing of our first patient in the intranasal foralumab Phase 2a trial has occurred seamlessly,” said Tanuja Chitnis, M.D., the Principal Investigator at Brigham and Women’s Hospital, a founding member-hospital of Mass General Brigham Healthcare System, and Professor of Neurology at Harvard Medical School. “My anticipation is this randomized placebo-controlled trial is the first step in bringing this potential treatment to patients that have na-SPMS, a disease with no approved therapy. Our experience in the Expanded Access Program provides sustainable hope for relief of symptoms in these patients with an unmet medical need.”
Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences said, “I believe that our dosing of the first patient confirms Tiziana’s ability to execute on its commitments and potential to advance our fully human intranasal anti-CD3 mAb, foralumab, using novel imaging methods and clinically relevant endpoints. We hope our efforts will give a new therapeutic option to patients afflicted with this devastating disease. Currently, there are no FDA approved treatments for na-SPMS.”
Matthew W. Davis, MD, RPh, Chief Operating Officer and Chief Medical Officer of Tiziana, added, “I am very pleased the first patient has been dosed and our team is committed to remaining on track with our milestones. We are poised to accelerate enrollment and anticipate data readout in Q4 2024. I believe the study results will reveal important aspects for optimizing clinical management of na-SPMS - particularly the potential for a reduction in MFIS scores.”
https://www.tizianalifesciences.com/news-item?s=2023-12-19-tiziana-life-sciences-doses-first-patient-in-phase-2a-trial-of-intranasal-foralumab-in-multiple-sclerosis
Hi Volmer - interested in the background to the analysis of the below that you posted:
Ondo broker's research note estimates pre-tax losses of £3.3m in 2023 followed by £3.4m, £3.1m and breakeven in 2026. Net cash/debt is estimated at -£6m, -£6.2m, -£7.5m and -£7.2m in 2026. This indicates a continuing drain on cash in line with the business model. Also, it does not reflect the loan and interest due to be repaid from 31.3.2025.
With ONDO being a fairly capital light company, I would have expected break even ahead of 2026 and less cash drain. This concerns me, so I'm wondering what the basis for these predications are and what assumptions were factored in - ie. expected level of business growth. Does this factor in the large US contract or other potential new contracts?
Very little to dislike about that RNS. Reassuring and positive, everything going according to plan and more. Exciting times ahead. Next steps are further commercial agreements being finalised, Mistral being actively deployed and funding arrangements. 2024 should be transformative
Thanks Jim, great overview.
I'm sure they're under strict NDAs with Tier 1 clients which limits what they can disclose. Also, reaching contractual agreement with large companies can take a very long time - 6 months+ often just to go through the legal counsels.
All sounds very positive though
Yeah they should have released a load of hot air RNS the past few months to allow the pump and dump crew to take part. No thanks. You cannot change the fundamentals and any serious investor will be able to decipher and see the wood from the trees. I doubt Hawthorne is furious, he's been averaging down and will have had inside track to the majority of goings on