Prioritizing strategic partnership to advance neflamapimod into Phase 3 for the treatment of dementia with Lewy bodies $(DLB)$
Neflamapimod awarded Innovation Passport Designation under the United Kingdom's Innovative Licensing and Access Pathway (ILAP) for development in DLB
New analyses presented at the Alzheimer's Association International Conference $(AAIC)$ 2026 reinforce neflamapimod's treatment effect in pure DLB and support 50 mg TID dose for planned Phase 3 trial
Initial, 12-week biomarker data from Phase 2a clinical trial in nonfluent variant primary progressive aphasia (nfvPPA) to be presented at the 15(th) International Conference on Frontotemporal Dementia (ISFTD) in October 2026; full 12-week and initial, 24-week biomarker data to be presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference in November 2026
Completed two equity financings in June 2026 for aggregate gross proceeds of approximately $20.5 million, extending cash runway through the third quarter of 2027
BOSTON, Aug. 10, 2026 (GLOBE NEWSWIRE) -- CervoMed Inc. $(CRVO)$, a clinical-stage biotechnology company developing treatments for age-related brain disorders (CervoMed or the Company), today reported financial results for the second quarter ended June 30, 2026, and provided corporate updates.
"The second quarter was marked by meaningful progress across both our business and pipeline. The additional analyses presented at AAIC 2026 further strengthen our conviction in neflamapimod's potential as a meaningful, disease-modifying treatment for DLB. These findings provide important insight into the RewinD-LB results, reinforce the treatment effect observed in patients with pure DLB, and support selection of the 50 mg three-times-daily (TID) dose for our planned Phase 3 trial. Looking ahead, our primary strategic objective is securing a partner to support the advancement of neflamapimod into Phase 3 and realize its potential for patients living with DLB," said John Alam, MD, Chief Executive Officer of CervoMed.
Dr. Alam continued, "We are also excited by the continued progress in our nfvPPA program. The trends observed in the 12-week biomarker data from the initial eight participants in our ongoing Phase 2a clinical trial are highly encouraging and we're honored to have the opportunity to share those results with the frontotemporal dementia (FTD) community at ISFTD in October. We also look forward to reporting additional biomarker data from the trial at CTAD in November. We believe nfvPPA represents a significant and underappreciated opportunity for neflamapimod."
Second Quarter 2026 and Recent Program Highlights
Dementia with Lewy Bodies
-- In June 2026, CervoMed announced its intent to establish a strategic
partnership to advance its neflamapimod program into a Phase 3 clinical
trial in patients with DLB.
-- CervoMed received a notice of allowance from the U.S. Patent and
Trademark Office in June 2026 for a new patent covering the use of
neflamapimod into 2042 in the treatment of DLB in patients without
substantial Alzheimer's disease-like tau pathology, or "pure" DLB.
-- In August 2026, neflamapimod was awarded an Innovation Passport
designation to enter the United Kingdom's ILAP for development in DLB.
This designation recognizes neflamapimod as an innovative therapy that
addresses a condition of high unmet need with the demonstrated potential
to offer a major therapeutic advantage in DLB treatment.
-- At AAIC 2026, there were five data presentations from CervoMed, including
four presentations focused on neflamapimod as a treatment for DLB,
spanning clinical, plasma biomarker, imaging, and dosing data:
-- Exploratory analyses of the Phase 2b RewinD-LB trial indicate that
the study's primary endpoint result was affected by a
higher-than-targeted proportion of patients with Alzheimer's
disease $(AD)$ co-pathology and by a drug product batch that
underachieved target plasma concentrations, rather than a lack of
treatment effect. Specifically, neflamapimod-treated patients with
low plasma pTau181 levels showed improvement relative to placebo
in change from baseline to week 16 during the randomized phase of
the trial (improvement vs. placebo was 0.70 points on CDR-SB,
p=0.054, MMRM analysis). In addition, greater improvement in
change in CDR-SB was seen in participants with trough plasma drug
concentration above the median for the study, compared to either
placebo or neflamapimod-recipients with trough plasma drug
concentration below the median (p=0.036, Jonckeere-Terpstra trend
test).
-- A within-participant analysis of participants who received a
higher-exposure drug batch during the trial's open-label extension
demonstrated a significant improvement in CDR-SB relative to
placebo (0.17 increase with neflamapimod treatment compared to
0.95 with placebo, p=0.005), while no such improvement was
observed with the lower-exposure drug batch used during the
placebo-controlled period.
-- In the MRI sub-study in RewinD-LB, data showed that neflamapimod
produced a durable slowing of basal forebrain atrophy relative to
placebo [for right basal forebrain volume, at week 16, +3.5%
neflamapimod (n=8), -4.2% placebo (n=10), p=0.0282 for the
difference; in patients (n=7) receiving 48 weeks of neflamapimod
treatment, change from baseline=+3.1% +/-1.9%], reinforcing the
RewinD-LB clinical trial results by providing evidence that
neflamapimod may act on the underlying disease process in DLB.
-- A pharmacokinetic-pharmacodynamic analysis identified a trough
plasma drug concentration threshold (4 ng/mL) associated with
clinical and biomarker improvement, supporting the Company's
selection of 50 mg TID as the dose for its planned Phase 3 trial,
which is expected to achieve this threshold in approximately 90%
of patients.
-- A separate, open-label, Phase 2 study of an 80 mg twice-daily dose
of neflamapimod in 26 DLB patients met its primary objectives for
safety, tolerability, and pharmacokinetics, with encouraging
secondary findings on clinical activity, including on CDR-SB
outcomes.
Frontotemporal Dementia
-- In July 2026, CervoMed announced the completion of enrollment in its
Phase 2a clinical trial evaluating neflamapimod for the treatment of
nfvPPA, a type of FTD, with 25 participants enrolled in total.
Recovery After Stroke (RAS)
-- In June 2026, CervoMed ended enrollment in its Phase 2a RESTORE trial evaluating neflamapimod in patients recovering from acute ischemic stroke.
Corporate Updates
-- In June 2026, CervoMed completed two equity financings resulting in
aggregate gross proceeds of approximately $20.5 million, before deducting
approximately $1.9 million of aggregate offering fees and expenses.
Anticipated Milestones
CervoMed's anticipated milestones for the remainder of 2026 and early 2027 include:
-- DLB: CervoMed will continue to advance its strategic objective to
establish a partnership to advance neflamapimod into a pivotal, Phase 3
clinical trial in patients with DLB.
-- FTD: CervoMed will present 12-week biomarker data from the first eight
participants in its ongoing Phase 2a trial in patients with nfvPPA at
ISFTD, taking place October 8-11, 2026, in Philadelphia, Pennsylvania.
Full 12-week and initial, 24-week biomarker data from the trial will be
presented at the 19th CTAD conference, taking place November 16-19, 2026,
in Boston, Massachusetts. The Company also expects to report initial
topline clinical data, as well as additional biomarker data, in the first
quarter of 2027.
-- ALS: CervoMed expects to dose the first patient in its EXPERTS-ALS trial
evaluating neflamapimod for the treatment of amyotrophic lateral
sclerosis (ALS) by the end of 2026.
-- RAS: CervoMed expects to report topline data from its Phase 2a RESTORE
trial evaluating neflamapimod in patients recovering from acute ischemic
stroke in the second half of 2026.
Second Quarter 2026 Financial Results
Cash Position: As of June 30, 2026, CervoMed had approximately $24.9 million in cash, cash equivalents and marketable securities, as compared to $20.9 million as of December 31, 2025. Based on its current operating plan, CervoMed believes its cash, cash equivalents, and marketable securities on hand as of June 30, 2026, will enable the Company to fund its planned operating expenses and capital expenditure requirements through the third quarter of 2027.
Grant Revenue: There was no grant revenue recognized for the three months ended June 30, 2026, compared to approximately $1.8 million for the same period in 2025. The decrease was due to the completion of CervoMed's Phase 2b RewinD-LB trial in mid-2025 and, accordingly, there currently being no further funding available or expected under the $21.3 million grant previously awarded to CervoMed by the National Institute on Aging to support the trial.
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