By David Bautz, PhD
READ THE FULL CRVO RESEARCH REPORT
Enterprise Replace
Biomarker Knowledge Introduced at AD/PD 2024
On March 5, 2024, CervoMed Inc. (NASDAQ:CRVO) introduced the presentation of biomarker knowledge from the AscenD-LB Part 2a trial of neflamapimod in sufferers with dementia with Lewy our bodies (DLB) was featured in a poster presentation on the 18th Worldwide Convention on Alzheimer’s and Parkinson’s Illness (AD/PD) 2024. One other summary offered by scientific collaborators from College School London (UCL) demonstrated p38 MAPK inhibition, together with with neflamapimod, improved tau-induced axonal transport defects each in vitro and in a tauopathy mouse mannequin.
EFFECT OF NEFLAMAPIMOD TREATMENT ON PLASMA GLIAL FIBRIALLARY ACIDIC PROTEIN (GFAP) LEVELS IN PATIENTS WITH DEMENTIA WITH LEWY BODIES (DLB). This evaluation examined the impact of neflamapimod on plasma GFAP within the general and pure DLB populations. The information confirmed that within the general inhabitants there was a imply 3.7 pg/mL improve in GFAP ranges in placebo-treated sufferers in comparison with a imply 12.3 pg/mL discount within the neflamapimod-treated sufferers (P=0.13). The next determine exhibits that within the pure DLB affected person inhabitants (i.e., sufferers with pre-treatment plasma ptau118 under the cutoff for Alzheimer’s illness (AD)-related co-pathology), there was a imply 14.1 pg/mL improve in placebo-treated sufferers in comparison with a imply 10.6 pg/mL discount in neflamapimod-treated sufferers (P=0.04).
For the pure DLB affected person inhabitants, the next graph exhibits that therapy with neflamapimod resulted in a major correlation (r=0.542, P=0.036) between the results of GFAP and scientific outcomes assessed by change from baseline to week 16 in CDR-SB (Scientific Dementia Ranking – Sum of Packing containers; used to watch dementia signs), with elevated GFAP being related to worsening CDR-SB and a discount in GFAP being related to improved CDR-SB. There was no correlation noticed in placebo-treated sufferers.
IN VIVO IMAGING OF AXONAL TRANSPORT REVEALS EARLY PATHOLOGICAL CHANGES INDUCED BY TAU MUTATIONS AND THEIR REVERSIBILITY. Researchers from College School London evaluated the impact of p38 MAPK inhibition on frontotemporal dementia (FTD) linked tau mutation each in vivo and in vitro. FTD-linked mutations induced aberrant tau envelopes (clusters) alongside axons, an impact that was reversed by inhibition of p38 MAPK. Neflamapimod was administered twice each day for 5 days at a dose of three mg/kg and was demonstrated to reinforce axonal transport within the rTg450 transgenic mouse mannequin of FTD that accommodates the P301L mutation within the tau gene. The authors concluded that inhibition of p38 MAPK potentiated axonal transport reduces tau phosphorylation and helps the inhibition of p38 MAPK as a promising therapeutic technique in tauopathies.
Built-in Abstract of Part 2a Scientific Outcomes Printed in JPAD
In February 2024, CervoMed introduced that knowledge from the Part 2a AscenD-LB Part 2a trial evaluating neflamapimod in sufferers with DLB have been printed within the Journal of Prevention of Alzheimer’s Illness (JPAD) (Prins et al., 2024). Outcomes printed for the primary time embody an built-in abstract of the results of neflamapimod 40 mg three-times-a-day (TID) in comparison with placebo in A) the general affected person inhabitants that accommodates sufferers with DLB with proof of AD and sufferers with pure DLB; and B) the pure DLB affected person inhabitants. As the next desk exhibits, the magnitude of the neflamapimod therapy impact in comparison with placebo is considerably increased within the pure DLB affected person inhabitants. The pure DLB affected person inhabitants additionally confirmed important enchancment in working reminiscence (assessed by the Worldwide Procuring Listing Check [ISLT] recognition) that isn’t evident within the general affected person inhabitants.
Electroencephalography (EEG) was the one biomarker evaluated within the AscenD-LB research. A complete of 29 of 91 sufferers obtained EEG recordings at baseline and Week 16 (the remaining sufferers didn’t obtain a Week 16 EEG primarily as a result of limitations imposed by the COVID-19 pandemic restrictions). The outcomes confirmed that neflamapimod 40 mg TID led to enchancment (P=0.01 vs. placebo TID) in beta purposeful connectivity. Deficits in beta band purposeful connectivity could also be a key differentiator between DLB and AD.
MRI research weren’t carried out within the AscenD-LB trial, nonetheless MRI photos pre-treatment and after 12 weeks of therapy with neflamapimod from a beforehand accomplished Part 2a research in sufferers with early AD have been examined to evaluate the impact of neflamapimod on the quantity of the nucleus basalis of Meynert (NbM), the key cholinergic neuronal cluster within the basal forebrain. Outcomes confirmed that after 12 weeks of therapy, NbM quantity was 3.1% increased vs. baseline (P=0.03). Remedy with neflamapimod was additionally related to increased purposeful dynamic connectivity between the NbM and deep gray matter on the finish of therapy (imply 11% increased; P=0.04).
The outcomes from AscenD-LB helped information the design of the RewinD-LB Part 2b trial, together with the usage of a single 40 mg TID dose routine, enrolling sufferers with pure DLB, and using CDR-SB as the first endpoint. As well as, structural and purposeful MRI will likely be evaluated in a 40-patient subgroup to evaluate therapy results on atrophy of the basal forebrain together with purposeful connectivity.
Joshua Boger Appointed as Chair of the Board
In February 2024, CervoMed introduced the appointment of Joshua Boger, PhD to its Board of Administrators and as Chair of the Board. Dr. Boger is an trade veteran with 40+ years of expertise. He’s presently Government Chairman of Alkeus Prescription drugs. He based Vertex Prescription drugs in 1989 and was Chief Government Officer from 1992 till 2009. He continued to serve on the Vertex Board and Chair Vertex’s Science & Expertise Committee till 2017. Dr. Boger’s huge expertise will likely be invaluable to CervoMed because it progresses towards topline outcomes from the RewinD-LB trial later this 12 months and its potential development within the clinic.
Monetary Replace
On April 1, 2024, CervoMed introduced monetary outcomes for full 12 months 2023. The corporate reported grant income of $7.1 million for 2023 in comparison with no income for a similar interval in 2022. The income in 2023 was associated to the $21.0 million grant awarded to the corporate by the Nationwide Institute on Getting old (NIA) in January 2023 to help the Part 2b trial of neflamapimod in DLB. R&D bills in 2023 have been $8.4 million in comparison with $1.3 million for 2022. The rise was primarily because of the Part 2b trial starting within the first quarter of 2023. G&A bills in 2023 have been $6.5 million in comparison with $2.1 million for the 12 months ending December 31, 2022. The rise was primarily because of the reverse merger and public firm associated prices. Different earnings in 2023 was $5.4 million in comparison with $(2.4) million in 2022. The quantity in 2022 was pushed by a rise within the estimated truthful worth of the convertible notes whereas the rise in 2023 was pushed by the inventory worth on the date of conversion because of the reverse merger.
As of December 31, 2023, CervoMed had roughly $7.8 million in money and money equivalents. In March 2023, the corporate introduced a personal placement of as much as $149.4 million with main institutional buyers. The financing consisted of two,532,285 items, with every unit comprised of (i) A) one share of widespread inventory or B) one pre-funded warrant to buy shares of widespread inventory and (ii) one Sequence A warrant to buy shares of widespread inventory. Every unit had a purchase order worth of $19.745 (or $19.744 if it included pre-funded warrants). The Sequence A warrants have an train worth of $39.24 and can expire on the sooner of 1) April 1, 2027 or 2) 180 days after the date that the corporate makes a public announcement of optimistic topline knowledge from the Part 2b RewinD-LB trial. Gross proceeds from the non-public placement have been $50.0 million, with as much as an extra $99.4 million tied to the train of the Sequence A warrants. We estimate the corporate presently has adequate capital to finance operations by means of the top of 2025. Following the financing, we estimate the corporate presently has roughly 8.3 million shares excellent and, when factoring in inventory choices and warrants, a totally diluted share rely of roughly 12.2 million.
Conclusion
The latest financing demonstrates the strong degree of curiosity within the firm from a number of high-tier institutional buyers and helps to strengthen the steadiness sheet as the corporate will get nearer to finishing enrollment within the RewinD-LB trial, anticipated within the second quarter of 2024, and the discharge of topline knowledge, which we anticipate within the fourth quarter of 2024. We now have adjusted our mannequin following the latest financing and have superior it ahead a 12 months. Our valuation now stands at $30 per share.
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