Zacks Small Cap Analysis – CRVO: Enrollment Set to Full in Part 2b RewinD-LB Trial in 2Q24; Topline Information in 4Q24… – Cyber Tech

By David Bautz, PhD

NASDAQ:CRVO

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Enrollment of Part 2b RewinD-LB Trial to Full in 2Q24; Topline Information in 4Q24

CervoMed Inc. (NASDAQ:CRVO) is at the moment conducting the Part 2b RewinD-LB trial of neflamapimod in sufferers with dementia with Lewy our bodies (DLB). Trial members will obtain both 40 mg neflamapimod administered TID or matching placebo. Roughly 80 topics shall be enrolled into every group. These with elevated ptau181 ranges shall be excluded. Dosing will proceed for 16 weeks in the principle, placebo managed portion of the trial with a 36-week open label remedy extension for these finishing the preliminary 16 weeks of the trial.

The first consequence of the trial is enchancment in dementia severity as assessed by change from baseline to week 16 in CDR-SB rating. Secondary outcomes embody results on cognition (as assessed by DBL-specific cognitive check battery), motor perform (as assessed by TUG check), and world ranking of remedy impact (as assessed by the ADCS-Clinician World Impression of Change). Tertiary outcomes embody neuropsychiatric outcomes (as assessed by the NPI-12), impact on fluctuations in cognition (as assessed by the Dementia Cognitive Fluctuations Scale), affect on resting-state EEG, and (in a subset of sufferers) basal forebrain atrophy as assessed by structural MRI.

In January 2023, CervoMed was awarded a $21.0 million grant from the Nationwide Institutes on Growing old (NIA) to help the RewinD-LB trial. Funds from the grant are disbursed as prices are incurred. As of March 31, 2024, $10.1 million has been obtained from the NIA grant, with roughly $10.9 million in funding remaining.

We anticipate enrollment within the trial being accomplished within the second quarter of 2024 and topline outcomes being introduced within the fourth quarter of 2024.

Built-in Abstract of Part 2a Scientific Outcomes Printed in JPAD

In February 2024, CervoMed introduced that knowledge from the Part 2a AscenD-LB trial evaluating neflamapimod in sufferers with DLB have been revealed within the Journal of Prevention of Alzheimer’s Illness (JPAD) (Prins et al., 2024). Outcomes revealed 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 comprises sufferers with DLB with proof of AD and sufferers with pure DLB; and B) the pure DLB affected person inhabitants. As the next desk reveals, the magnitude of the neflamapimod remedy impact in comparison with placebo is considerably larger within the pure DLB affected person inhabitants. The pure DLB affected person inhabitants additionally confirmed vital enchancment in working reminiscence (assessed by the Worldwide Buying Listing Take a look at [ISLT] recognition) that’s not evident within the total 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 because 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 useful connectivity. Deficits in beta band useful connectivity could also be a key differentiator between DLB and AD.

MRI research weren’t carried out within the AscenD-LB trial, nevertheless MRI photos pre-treatment and after 12 weeks of remedy 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 main cholinergic neuronal cluster within the basal forebrain. Outcomes confirmed that after 12 weeks of remedy, NbM quantity was 3.1% larger vs. baseline (P=0.03). Therapy with neflamapimod was additionally related to larger useful dynamic connectivity between the NbM and deep gray matter on the finish of remedy (imply 11% larger; 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 useful MRI shall be evaluated in a 40-patient subgroup to evaluate remedy results on atrophy of the basal forebrain together with useful connectivity.

Monetary Replace

On Could 15, 2024, CervoMed introduced monetary outcomes for the primary quarter of 2024. Grant income within the first quarter of 2024 was $2.3 million in comparison with $1.4 million for the primary quarter of 2023. The income in each quarters was derived from the $21.0 million grant awarded to the corporate from the NIA to help the RewinD-LB trial. R&D bills for the primary quarter of 2024 have been $2.8 million in comparison with $1.8 million for the primary quarter of 2023. The rise was primarily as a result of improve in outsourced CRO and associated website bills associated to the RewinD-LB trial. G&A bills for the primary quarter of 2024 have been $2.1 million in comparison with $1.0 million for the primary quarter of 2023. The rise was primarily because of public firm associated prices, together with insurance coverage, elevated headcount, and stock-based compensation.

As of March 31, 2024, CervoMed had roughly $6.4 million in money and money equivalents. On April 1, 2024, CervoMed closed a non-public 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 personal 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 at the moment has enough capital to finance operations by means of the tip of 2025. Following the financing, we estimate the corporate at the moment has roughly 8.3 million shares excellent and, when factoring in inventory choices and warrants, a totally diluted share rely of roughly 11.4 million.

Conclusion

We look ahead to the completion of enrollment within the RewinD-LB trial within the second quarter of 2024 and launch of topline leads to the fourth quarter of 2024. The corporate has additionally alluded to exploring alternatives to broaden the therapeutic potential of neflamapimod as a remedy in extra cholinergic dysfunction pushed neurological circumstances, thus we shall be very to listen to extra particulars concerning these plans. With no adjustments to our mannequin our valuation stays at $30 per share.

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