CRVO
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Related articleQuarter not tagged2026-10-12CervoMed Presents Initial Results of Phase 2a Trial of Neflamapimod in Nonfluent Variant Primary Progressive Aphasia (nfvPPA) Showing Positive Effects on a Key Neurodegeneration Biomarker in Late-Breaking Oral Session at ISFTD 2026
GlobeNewswire
CervoMed Presents Initial Results of Phase 2a Trial of Neflamapimod in Nonfluent Variant Primary Progressive Aphasia (nfvPPA) Showing Positive Effects on a Key Neurodegeneration Biomarker in Late-Breaking Oral Session at ISFTD 2026
On average, reduction in plasma neurofilament light levels was observed during the first 12 weeks of treatment, with a greater decline in participants with baseline levels at or above the median 24-week biomarker data to be presented at the Clinical Trials on Alzheimer's Disease in November 2026; clinical data expected in the first quarter of 2027 nfvPPA, the form of frontotemporal dementia most commonly associated with tau pathology, has no approved treatments in the United States or European Union BOSTON, Oct. 12, 2026 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO) (CervoMed or the Company) announced initial data showing a reduction in mean plasma levels of neurofilament light chain (NfL), a key biomarker of neuronal damage and degeneration, over the first 12 weeks of treatment with neflamapimod in the open-label portion of the Company's Phase 2a clinical trial in nonfluent variant primary progressive aphasia (nfvPPA). The findings were presented in a late-breaking oral presentation at the 15th International Society of Frontotemporal Dementias (ISFTD) Annual Meeting in Philadelphia, Pennsylvania. "In nfvPPA, NfL levels are often elevated and correlate with disease progression," said John Alam, M.D., Chief Executive Officer of CervoMed. "The mean reduction in NfL observed over the first 12 weeks of the study contrasts with the increases typically reported in natural history studies and is particularly notable given NfL's long half-life. While these are early results, we believe they are highly encouraging and support continued evaluation of neflamapimod in nfvPPA. We look forward to presenting 24-week biomarker data at the Clinical Trials on Alzheimer's Disease conference in November, followed by topline clinical data in the first quarter of 2027." Initial Biomarker Data from the Phase 2a Study in nfvPPA The presentation included initial results for two plasma biomarkers, NfL and glial fibrillary acidic protein (GFAP), during the first 12 weeks of an open-label treatment period with neflamapimod, finding: - At baseline, relative to the general population, 18 of 25 participants (72%) had elevated NfL levels and four of 25 (16%) had elevated GFAP levels. Mean baseline NfL across all participants was 45.7 pg/mL (standard deviation [SD] 39.6 pg/mL), and mean baseline GFAP was 103.4 pg/mL (SD 43.2 pg/mL). - Over the first 12 weeks, mean change in plasma NfL le…Read full documentShow less
On average, reduction in plasma neurofilament light levels was observed during the first 12 weeks of treatment, with a greater decline in participants with baseline levels at or above the median 24-week biomarker data to be presented at the Clinical Trials on Alzheimer's Disease in November 2026; clinical data expected in the first quarter of 2027 nfvPPA, the form of frontotemporal dementia most commonly associated with tau pathology, has no approved treatments in the United States or European Union BOSTON, Oct. 12, 2026 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO) (CervoMed or the Company) announced initial data showing a reduction in mean plasma levels of neurofilament light chain (NfL), a key biomarker of neuronal damage and degeneration, over the first 12 weeks of treatment with neflamapimod in the open-label portion of the Company's Phase 2a clinical trial in nonfluent variant primary progressive aphasia (nfvPPA). The findings were presented in a late-breaking oral presentation at the 15th International Society of Frontotemporal Dementias (ISFTD) Annual Meeting in Philadelphia, Pennsylvania. "In nfvPPA, NfL levels are often elevated and correlate with disease progression," said John Alam, M.D., Chief Executive Officer of CervoMed. "The mean reduction in NfL observed over the first 12 weeks of the study contrasts with the increases typically reported in natural history studies and is particularly notable given NfL's long half-life. While these are early results, we believe they are highly encouraging and support continued evaluation of neflamapimod in nfvPPA. We look forward to presenting 24-week biomarker data at the Clinical Trials on Alzheimer's Disease conference in November, followed by topline clinical data in the first quarter of 2027." Initial Biomarker Data from the Phase 2a Study in nfvPPA The presentation included initial results for two plasma biomarkers, NfL and glial fibrillary acidic protein (GFAP), during the first 12 weeks of an open-label treatment period with neflamapimod, finding: - At baseline, relative to the general population, 18 of 25 participants (72%) had elevated NfL levels and four of 25 (16%) had elevated GFAP levels. Mean baseline NfL across all participants was 45.7 pg/mL (standard deviation [SD] 39.6 pg/mL), and mean baseline GFAP was 103.4 pg/mL (SD 43.2 pg/mL). - Over the first 12 weeks, mean change in plasma NfL levels was ~ 3.1 pg/mL, with most of the decline occurring between weeks six and 12. - In an exploratory analysis of participants with baseline NfL levels at or above the median (n=13), mean change in NfL levels was ~ 5.7 pg/mL over 12 weeks. - GFAP levels were stable over the first 12 weeks. Neflamapimod was generally well tolerated, and no new safety signals were identified. One patient with elevated liver enzyme levels met protocol-defined criteria for discontinuation. The patient was asymptomatic, with no associated bilirubin elevation, and the elevation resolved with treatment discontinuation. "nfvPPA is a rare, progressive form of dementia that takes away a person's ability to speak, and there are currently no approved pharmacological treatment options for patients," said Dr. Ian M. Grant, Assistant Professor, Neurology, Feinberg School of Medicine, Northwestern University. "Preclinical research links p38α to the nerve damage caused by tau, the protein most often associated with nfvPPA, which makes neflamapimod a logical drug to study. While these are early results, the reduction in NfL is intriguing, and I look forward to seeing further results from this study." The Phase 2a clinical trial of neflamapimod for the treatment of nfvPPA was designed to evaluate the safety, pharmacokinetics, and clinical effects of neflamapimod in participants with nfvPPA. The 36-week trial enrolled 25 participants and is being conducted at academic medical centers in the United States (U.S) and United Kingdom. The study includes 24 weeks of open-label treatment with neflamapimod 40 mg three times daily (n=19) or 80 mg twice daily (n=6), followed by a 12-week double-blind, placebo-controlled randomized withdrawal period in which participants are assigned 1:1 to continue neflamapimod or switch to placebo (ClinicalTrials.gov identifier: NCT07033481). CervoMed's oral presentation of the results described above is accessible in the Events and Presentations section of CervoMed's website, https://www.cervomed.com/. About nfvPPA nfvPPA, a type of FTD, gradually causes people with the condition to have trouble expressing themselves, although they still understand the meaning of words. Initially, they might use shorter phrases or pause while speaking and have difficulty pronouncing words. It can also be challenging for them to understand long or complex sentences. In advanced nfvPPA, people may stop speaking completely, and difficulty with planning and judgment, as well as moving, can also occur. There are an estimated 10,000-15,000 people living with nfvPPA in the U.S. and 15,000-20,000 in the European Union (E.U.). Currently, there are no approved treatments for nfvPPA in the U.S. or E.U. About Neflamapimod Neflamapimod is an investigational, orally administered small-molecule drug that readily crosses the blood-brain barrier and selectively inhibits the alpha isoform of p38 MAP kinase, a key driver of neuroinflammation and synaptic dysfunction. Preclinical research links p38α to tau-related neuronal deficits, supporting the study of neflamapimod in tau-driven forms of frontotemporal dementia such as nfvPPA. By targeting the critical disease processes underlying degenerative disorders of the brain, neflamapimod has the potential to reverse synaptic dysfunction, improve neuron health, and slow or prevent disease progression. Neflamapimod is currently in clinical development for the treatment of dementia with Lewy bodies (DLB), recovery after ischemic stroke, nfvPPA, and amyotrophic lateral sclerosis (ALS). Neflamapimod has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of DLB, and Orphan Drug Designation for the treatment of nfvPPA. About CervoMed CervoMed is a clinical-stage company developing treatments for age-related brain disorders. Its lead drug candidate, neflamapimod, is an oral small molecule targeting critical disease processes underlying degenerative disorders of the brain by inhibiting a key enzyme involved in neuroinflammation and neurodegeneration. CervoMed's recently completed Phase 2b RewinD-LB trial evaluated neflamapimod in patients with DLB, enriched for those without Alzheimer's disease (AD) co-pathology. In November 2025, CervoMed announced alignment with the FDA on a potential registration path for neflamapimod in DLB, and the Company is currently focused on identifying a strategic partner to advance neflamapimod into a Phase 3 trial in DLB. CervoMed reported initial 12-week biomarker data from its ongoing Phase 2a clinical trial in nfvPPA in October 2026 and expects to present 24-week biomarker data at CTAD in November 2026. The Company also expects to dose the first patient in the EXPERTS-ALS Phase 2a clinical trial in the fourth quarter of 2026. Forward-Looking Statements This press release includes express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, regarding the intentions, plans, beliefs, expectations or forecasts for the future of the Company, including, but not limited to: the Company's need to acquire sufficient funding, including funding (through a strategic partnership or otherwise) for any Phase 3 trial in patients with DLB; the sustainability and reproducibility of the effects observed in the first 12 weeks of the Company's Phase 2a clinical trial in nfvPPA; the Company's plan to focus on strategic partnering to advance neflamapimod into Phase 3 for DLB and the timing of entering into any such partnership, if at all; the therapeutic potential of neflamapimod in DLB, nfvPPA, ALS, or any other indication, including the degree of sustainability of any therapeutic effects, its potential impact on the rate of disease progression and/or clinical worsening, the optimal dosing regimen to achieve therapeutic effects, or any other treatment effects observed in any clinical trial on any clinical, biomarker, or other outcome measure; the extent to which changes in plasma NfL or other biomarkers may predict or correlate with clinical benefit in nfvPAA or any other indication; whether the observed biomarker changes are attributable to treatment with neflamapimod; the anticipated timing and achievement of clinical and development milestones, including the Company's initiation of any Phase 3 trial in patients with DLB; the additional anticipated data readouts from the Company's Phase 2a trial in nfvPPA and the anticipated dosing of the first patient with neflamapimod in the EXPERTS-ALS trial; any other expected or implied benefits, results, or expectations with respect to neflamapimod, including the extent (if any) to which neflamapimod may demonstrate efficacy or other clinical or biomarker improvements in patients or the timing of any regulatory submissions and potential approvals thereof, if any, in DLB, nfvPPA, or any other indication. Terms such as "believes," "estimates," "anticipates," "expects," "plans," "aims," "seeks," "intends," "may," "could," "might," "will," "should," "approximately," "potential," "target," "project," "contemplate," "predict," "forecast," "continue," "encouraging," "signal," or other words that convey uncertainty of future events or outcomes (including the negative of these terms) may identify these forward-looking statements. Although the Company believes it has a reasonable basis for each forward-looking statement contained herein, forward-looking statements by their nature involve risks and uncertainties, known and unknown, many of which are beyond the Company's control and, as a result, actual results could differ materially from those expressed or implied in any forward-looking statement. Particular risks and uncertainties include, among other things, those related to: the Company's available cash resources, the availability of additional funds on acceptable terms or at all, and the Company's ability to continue as a going concern; the results of the Company's clinical trials, including the open-label nature of the initial results from the Company's Phase 2a trial in nfvPPA; the small number of participants in the trial, the absence of placebo or other control group during the open-label treatment period, and the risk that later data from the trial may not be consistent with the initial results; the risk that plasma NfL or other biomarkers may not be accepted by the FDA or other regulators as a surrogate for, or predictor of, clinical benefit; the Company's ability to successfully enter into a partnership to advance neflamapimod into Phase 3 for DLB in a timely manner, on acceptable terms, or at all; the likelihood and timing of any regulatory approval of neflamapimod or the nature of any feedback the Company may receive from the FDA or other regulators; the Company's ability to maintain the intellectual property protection afforded by the Company's patent portfolio; the ability to implement business plans, forecasts, and other expectations in the future; general economic, political, business, industry, and market conditions, inflationary pressures, and geopolitical conflicts; and the other factors discussed under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 filed with the US Securities and Exchange Commission (SEC) on March 13, 2026, and other filings that the Company may file from time to time with the SEC. Any forward-looking statements in this press release speak only as of the date hereof (or such earlier date as may be identified). The Company does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except to the extent required by law. Contacts Media: Biongage Communications [email protected] 202-330-3431 Investor Relations: Argot Partners [email protected] 212-600-1902
Related articleQuarter not tagged2026-09-28CervoMed Announces Pharmacokinetic Results with New Neflamapimod Oral Tablet Formulation and Secures FDA Removal of Drug Exposure Limit
GlobeNewswire
CervoMed Announces Pharmacokinetic Results with New Neflamapimod Oral Tablet Formulation and Secures FDA Removal of Drug Exposure Limit
New 50 mg tablet formulation delivers an improved pharmacokinetic profile and enables greater exposure and patient convenience FDA removal of the prior drug exposure limit provides greater dosing flexibility in future clinical trials CervoMed plans to advance a 100 mg twice-daily regimen expected to achieve higher plasma trough drug concentrations than those associated with clinical activity in prior trials BOSTON, Sept. 28, 2026 (GLOBE NEWSWIRE) -- CervoMed Inc. ("CervoMed" or the "Company") (NASDAQ: CRVO), a clinical-stage biotechnology company developing treatments for age-related brain disorders, today announced pharmacokinetic (PK), regulatory, and manufacturing advances that enable a higher-dose, twice-daily (BID) oral regimen of neflamapimod in future clinical trials. The developments include a new neflamapimod 50 mg oral tablet formulation with a PK profile favorable for twice-daily dosing, the U.S. Food and Drug Administration's (FDA) removal of the previous plasma drug exposure limit, and the implementation of a controlled manufacturing process designed to support reproducible, large-scale tablet production. "The new 50 mg tablet addresses the formulation issue identified during the Phase 2b RewinD-LB study and we intend to move forward with it in future clinical development," said John J. Alam, M.D., Chief Executive Officer of CervoMed. "Combined with the FDA's removal of the prior exposure limit, the new pharmacokinetic profile enables us to advance a 100 mg twice-daily regimen that we expect will achieve substantially higher trough drug concentrations than those associated with clinical activity in previous trials, while reducing dosing frequency from three times to twice daily. These developments substantially reduce both clinical execution and manufacturing risk as we move the neflamapimod program forward." Supporting Data and Details Formulation and manufacturing: New 50 mg tablet The new 50 mg tablet contains the most stable crystalline form of neflamapimod, addressing the manufacturing variability seen with the 40 mg capsule used in the Phase 2b RewinD-LB study. This updated formulation is designed to provide a consistent drug product for future trials and, if approved, commercial supply. The new controlled manufacturing process enables reproducible, large-scale production of the tablet, thus reducing chemistry, manufacturing and controls…Read full documentShow less
New 50 mg tablet formulation delivers an improved pharmacokinetic profile and enables greater exposure and patient convenience FDA removal of the prior drug exposure limit provides greater dosing flexibility in future clinical trials CervoMed plans to advance a 100 mg twice-daily regimen expected to achieve higher plasma trough drug concentrations than those associated with clinical activity in prior trials BOSTON, Sept. 28, 2026 (GLOBE NEWSWIRE) -- CervoMed Inc. ("CervoMed" or the "Company") (NASDAQ: CRVO), a clinical-stage biotechnology company developing treatments for age-related brain disorders, today announced pharmacokinetic (PK), regulatory, and manufacturing advances that enable a higher-dose, twice-daily (BID) oral regimen of neflamapimod in future clinical trials. The developments include a new neflamapimod 50 mg oral tablet formulation with a PK profile favorable for twice-daily dosing, the U.S. Food and Drug Administration's (FDA) removal of the previous plasma drug exposure limit, and the implementation of a controlled manufacturing process designed to support reproducible, large-scale tablet production. "The new 50 mg tablet addresses the formulation issue identified during the Phase 2b RewinD-LB study and we intend to move forward with it in future clinical development," said John J. Alam, M.D., Chief Executive Officer of CervoMed. "Combined with the FDA's removal of the prior exposure limit, the new pharmacokinetic profile enables us to advance a 100 mg twice-daily regimen that we expect will achieve substantially higher trough drug concentrations than those associated with clinical activity in previous trials, while reducing dosing frequency from three times to twice daily. These developments substantially reduce both clinical execution and manufacturing risk as we move the neflamapimod program forward." Supporting Data and Details Formulation and manufacturing: New 50 mg tablet The new 50 mg tablet contains the most stable crystalline form of neflamapimod, addressing the manufacturing variability seen with the 40 mg capsule used in the Phase 2b RewinD-LB study. This updated formulation is designed to provide a consistent drug product for future trials and, if approved, commercial supply. The new controlled manufacturing process enables reproducible, large-scale production of the tablet, thus reducing chemistry, manufacturing and controls (CMC) risk. The new tablet was evaluated in a Phase 1 food-effect and drug-exposure study that met its primary objectives. After single-dose administration, the 50 mg tablet and the prior 40 mg capsule (previously referred to as "DP Batch B") produced similar overall plasma drug exposure. However, the new tablet demonstrated a PK profile better suited to BID administration, with approximately 20% lower peak plasma concentration (Cmax) and approximately 20% higher plasma concentration 12 hours post dose (Ctrough, with BID dosing). Regulatory: FDA removal of drug exposure limit A 39-week dog toxicology study completed in the first half of 2026 established a no-observed-adverse-effect level (NOAEL) based on plasma drug levels, that was three-fold higher than in prior dog toxicology studies, and more than 30-fold higher than the pharmacologically and clinically active exposure range observed in previously completed clinical trials of neflamapimod in central nervous system disorders. After reviewing these data, the FDA removed the plasma drug exposure limit that had constrained neflamapimod dosing, providing CervoMed greater dosing flexibility in future clinical trials. Dose selection: 100 mg twice daily Based on the observed PK profile and pharmacokinetic pharmacodynamic (PK-PD) relationships across the neflamapimod clinical trials, CervoMed plans to advance a 100 mg BID regimen in future clinical trials. PK modeling indicates that the higher daily dose is expected to increase trough plasma drug concentrations by approximately 33% relative to the 40 mg three times a day (TID) regimen used in the Phase 2a clinical trial and the extension phase of the Phase 2b clinical trial in dementia with Lewy bodies (DLB). The clinical safety and tolerability of the planned higher dose regimen are further supported by clinical data with neflamapimod administered at 80 mg BID (two 40 mg capsules), presented at the Alzheimer's Association International Conference (AAIC) in July 2026. Compared with 80 mg BID, the planned 100 mg BID tablet regimen is expected to provide similar overall plasma drug exposure, with a higher Ctrough and lower Cmax. These PK characteristics are particularly relevant to neflamapimod because previously reported PK-PD analyses indicate that clinical activity is associated with Ctrough, while safety and tolerability are more closely related to Cmax. The planned regimen is therefore designed to increase pharmacologically relevant trough concentrations without a commensurate increase in peak drug exposure. About CervoMed CervoMed is a clinical-stage company developing treatments for age-related brain disorders. Its lead drug candidate, neflamapimod, is an oral small molecule targeting critical disease processes underlying degenerative disorders of the brain by inhibiting a key enzyme involved in neuroinflammation and neurodegeneration. CervoMed's recently completed Phase 2b RewinD-LB trial evaluated neflamapimod in patients with DLB, enriched for those without AD co-pathology. In November 2025, CervoMed announced alignment with the FDA on a potential registration path for neflamapimod in DLB, and the Company is currently focused on identifying a strategic partner to advance neflamapimod into a Phase 3 trial in DLB. CervoMed also recently completed enrollment in its ongoing Phase 2a clinical trial evaluating neflamapimod in nfvPPA, a subtype of frontotemporal disorders, from which interim biomarker data is anticipated in the early fourth quarter of 2026, and expects the first patient to be dosed with neflamapimod in the EXPERTS-ALS Phase 2a clinical trial in the fourth quarter of 2026. Forward-Looking Statements This press release includes express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, regarding the intentions, plans, beliefs, expectations or forecasts for the future of the Company, including, but not limited to: the Company's need to acquire sufficient funding, including funding (through a strategic partnership or otherwise) for any Phase 3 trial in patients with DLB; the Company's plan to focus on strategic partnering to advance neflamapimod into Phase 3 for DLB and the timing of entering into any such partnership, if at all; the therapeutic potential of neflamapimod in DLB, nfvPPA, ALS, or any other indication, including the degree of sustainability of any therapeutic effects, its potential impact on the rate of disease progression and/or clinical worsening, the optimal dosing regimen to achieve therapeutic effects, or any other treatment effects observed in any clinical trial on any clinical, biomarker, or other outcome measure, the expected pharmacokinetic profile, drug exposure, or other characteristics of the new 50 mg tablet formulation or the planned 100 mg twice-daily dosing regimen, including initial biomarker data from the Company's Phase 2a trial in nfvPPA; the anticipated timing and achievement of clinical and development milestones, including the Company's initiation of any Phase 3 trial in patients with DLB or the impact, if any, of the Innovation Passport Designation on any future regulatory milestone or the timing thereof; the anticipated data readouts from the Company's Phase 2a trial in nfvPPA and the anticipated dosing of the first patient with neflamapimod in the EXPERTS-ALS trial; and any other expected or implied benefits, results, or expectations, including the extent (if any) to which neflamapimod may demonstrate efficacy or other clinical or biomarker improvements in patients with DLB or in any other indication. Terms such as "believes," "estimates," "anticipates," "expects," "plans," "aims," "seeks," "intends," "may," "could," "might," "will," "should," "approximately," "potential," "target," "project," "contemplate," "predict," "forecast," "continue," or other words that convey uncertainty of future events or outcomes (including the negative of these terms) may identify these forward-looking statements. Although there is believed to be a reasonable basis for each forward-looking statement contained herein, forward-looking statements by their nature involve risks and uncertainties, known and unknown, many of which are beyond the Company's control and, as a result, actual results could differ materially from those expressed or implied in any forward-looking statement. Particular risks and uncertainties include, among other things, those related to: the Company's available cash resources, the availability of additional funds on acceptable terms or at all, and the Company's ability to continue as a going concern; the results of the Company's clinical trials; the Company's ability to successfully enter into a partnership to advance neflamapimod into Phase 3 for DLB in a timely manner, on acceptable terms, or at all; the likelihood and timing of any regulatory approval of neflamapimod or the nature of any feedback the Company may receive from the FDA or other regulators; the Company's ability to maintain the intellectual property protection afforded by the Company's patent portfolio; the ability to implement business plans, forecasts, and other expectations in the future; general economic, political, business, industry, and market conditions, inflationary pressures, and geopolitical conflicts; and the other factors discussed under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 filed with the U.S. Securities and Exchange Commission (SEC) on March 13, 2026, and other filings that the Company may file from time to time with the SEC. Any forward-looking statements in this press release speak only as of the date hereof (or such earlier date as may be identified). The Company does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except to the extent required by law. Contacts Media: Lisa Guiterman Biongage Communications [email protected] 202-330-3431 Investor Relations: Argot Partners [email protected] 212-600-1902
Related articleQuarter not tagged2026-09-10CervoMed Announces Initial Results from the Phase 2a Clinical Trial of Neflamapimod in Nonfluent Variant Primary Progressive Aphasia (nfvPPA) Have Been Accepted as a Late-Breaking Oral Session at ISFTD 2026
GlobeNewswire
CervoMed Announces Initial Results from the Phase 2a Clinical Trial of Neflamapimod in Nonfluent Variant Primary Progressive Aphasia (nfvPPA) Have Been Accepted as a Late-Breaking Oral Session at ISFTD 2026
12-week biomarker data to be highlighted at the International Society of Frontotemporal Dementias (ISFTD) Annual Meeting nfvPPA, the type of frontotemporal dementia (FTD) most commonly associated with tau pathology, currently has no approved treatments in the United States or European Union BOSTON, Sept. 10, 2026 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical-stage biotechnology company developing treatments for age-related brain disorders, today announced that neflamapimod, an oral, small molecule, drug candidate targeting critical disease processes underlying degenerative disorders of the brain, will be featured in a late-breaking oral presentation at the International Society of Frontotemporal Dementias (ISFTD) Annual Meeting in Philadelphia, Pennsylvania, taking place October 8-11, 2026. CervoMed recently completed enrollment in the Phase 2a clinical trial of neflamapimod for the treatment of nonfluent variant primary progressive aphasia (nfvPPA). The presentation at the ISFTD conference, which was accepted based on an abstract describing 12-week biomarker data from the trial’s first eight participants, will highlight initial results for two plasma biomarkers, neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP), from at least 22 study participants. The trial was designed to evaluate the safety, pharmacokinetics, and clinical effects of neflamapimod in participants with nfvPPA. The trial enrolled 25 participants and is being conducted at leading academic medical centers in the United States (U.S.) and United Kingdom (U.K.). Neflamapimod Late-Breaking Oral Presentation Title: Initial Biomarker Results from a Phase 2a Clinical Trial of Neflamapimod in Patients with Nonfluent Variant Primary Progressive Aphasia (NCT07033481)Session: Plenary 6 (Hot Topics)Date/Time: Sunday, October 11, 2026; 8:30 a.m. - 10:30 a.m. ET About nfvPPAnfvPPA, a type of frontotemporal dementia (FTD), gradually causes people with the condition to have trouble expressing themselves, although they still understand the meaning of words. Initially, they might use shorter phrases or pause while speaking and have difficulty pronouncing words. It can also be challenging for them to understand long or complex sentences. In advanced nfvPPA, people may stop speaking completely, and difficulty with planning and judgment, as well as moving, can also occur. Th…Read full documentShow less
12-week biomarker data to be highlighted at the International Society of Frontotemporal Dementias (ISFTD) Annual Meeting nfvPPA, the type of frontotemporal dementia (FTD) most commonly associated with tau pathology, currently has no approved treatments in the United States or European Union BOSTON, Sept. 10, 2026 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical-stage biotechnology company developing treatments for age-related brain disorders, today announced that neflamapimod, an oral, small molecule, drug candidate targeting critical disease processes underlying degenerative disorders of the brain, will be featured in a late-breaking oral presentation at the International Society of Frontotemporal Dementias (ISFTD) Annual Meeting in Philadelphia, Pennsylvania, taking place October 8-11, 2026. CervoMed recently completed enrollment in the Phase 2a clinical trial of neflamapimod for the treatment of nonfluent variant primary progressive aphasia (nfvPPA). The presentation at the ISFTD conference, which was accepted based on an abstract describing 12-week biomarker data from the trial’s first eight participants, will highlight initial results for two plasma biomarkers, neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP), from at least 22 study participants. The trial was designed to evaluate the safety, pharmacokinetics, and clinical effects of neflamapimod in participants with nfvPPA. The trial enrolled 25 participants and is being conducted at leading academic medical centers in the United States (U.S.) and United Kingdom (U.K.). Neflamapimod Late-Breaking Oral Presentation Title: Initial Biomarker Results from a Phase 2a Clinical Trial of Neflamapimod in Patients with Nonfluent Variant Primary Progressive Aphasia (NCT07033481)Session: Plenary 6 (Hot Topics)Date/Time: Sunday, October 11, 2026; 8:30 a.m. - 10:30 a.m. ET About nfvPPAnfvPPA, a type of frontotemporal dementia (FTD), gradually causes people with the condition to have trouble expressing themselves, although they still understand the meaning of words. Initially, they might use shorter phrases or pause while speaking and have difficulty pronouncing words. It can also be challenging for them to understand long or complex sentences. In advanced nfvPPA, people may stop speaking completely, and difficulty with planning and judgment, as well as moving, can also occur. There are an estimated 10,000-15,000 people living with nfvPPA in the U.S. and 15,000-20,000 in the E.U. Currently there are no approved treatments for nfvPPA in the U.S. or E.U. About NeflamapimodNeflamapimod is an investigational, orally administered small-molecule drug that readily crosses the blood-brain barrier and selectively inhibits the alpha isoform of p38 MAP kinase, a key driver of neuroinflammation and synaptic dysfunction. Peer-reviewed data demonstrate relevance of p38α as a therapeutic target and support neflamapimod's potential to treat frontotemporal dementia driven by tau pathology. By targeting the critical disease processes underlying degenerative disorders of the brain, neflamapimod has the potential to reverse synaptic dysfunction, improve neuron health, and slow or prevent disease progression. Neflamapimod is currently in clinical development for the treatment of dementia with Lewy bodies (DLB), recovery after ischemic stroke, and nonfluent variant primary progressive aphasia. Neflamapimod was granted Orphan Drug Designation by the U.S. FDA for FTD in 2024. Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases that affect fewer than 200,000 people in the U.S. Orphan drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity. About CervoMedCervoMed is a clinical-stage company developing treatments for age-related brain disorders. Its lead drug candidate, neflamapimod, is an oral small molecule targeting critical disease processes underlying degenerative disorders of the brain by inhibiting a key enzyme involved in neuroinflammation and neurodegeneration. CervoMed’s recently completed Phase 2b RewinD-LB trial evaluated neflamapimod in patients with DLB, enriched for those without AD co-pathology. In November 2025, CervoMed announced alignment with the FDA on a potential registration path for neflamapimod in DLB and the Company is currently focused on identifying a strategic partner to advance neflamapimod into a Phase 3 trial in DLB. CervoMed also recently completed enrollment in its ongoing Phase 2a clinical trial evaluating neflamapimod in nfvPPA, a subtype of FTD, and expects the first patient to be dosed with neflamapimod in the EXPERTS-ALS Phase 2a clinical trial in the fourth quarter of 2026. Forward-Looking StatementsThis press release includes express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, regarding the intentions, plans, beliefs, expectations or forecasts for the future of the Company, including, but not limited to: the therapeutic potential of neflamapimod in DLB, nfvPPA, ALS, or any other indication, including the degree of sustainability of any therapeutic effects, its potential impact on the rate of disease progression and/or clinical worsening, the optimal dosing regimen to achieve therapeutic effects, or any other treatment effects observed in any clinical trial on any clinical, biomarker, or other outcome measure, including initial biomarker results from the Company’s Phase 2a clinical trial in nfvPPA; the nature of the results to be presented at ISFTD and the number of participants for which results will be available; the Company’s need to acquire sufficient funding, including funding (through a strategic partnership or otherwise) for any Phase 3 trial in patients with DLB; the Company’s plan to focus on strategic partnering to advance neflamapimod into Phase 3 for DLB and the timing of entering into any such partnership, if at all; the anticipated timing and achievement of clinical and development milestones, including the Company’s initiation of any Phase 3 trial in patients with DLB, the anticipated data readouts from the Company’s Phase 2a trial in nfvPPA and the anticipated dosing of the first patient with neflamapimod in the EXPERTS-ALS trial; and any other expected or implied benefits, results, or expectations, including the extent (if any) to which neflamapimod may demonstrate efficacy or other clinical or biomarker improvements in patients with nfvPPA, DLB, or in any other indication. Terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “aims,” “seeks,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately,” “potential,” “target,” “project,” “contemplate,” “predict,” “forecast,” “continue,” or other words that convey uncertainty of future events or outcomes (including the negative of these terms) may identify these forward-looking statements. Although there is believed to be reasonable basis for each forward-looking statement contained herein, forward-looking statements by their nature involve risks and uncertainties, known and unknown, many of which are beyond the Company’s control and, as a result, actual results could differ materially from those expressed or implied in any forward-looking statement. Particular risks and uncertainties include, among other things, those related to: the Company’s available cash resources, the availability of additional funds on acceptable terms or at all, and the Company’s ability to continue as a going concern; the results of the Company’s clinical trials; the Company’s ability to successfully enter into a partnership to advance neflamapimod into Phase 3 for DLB in a timely manner, on acceptable terms, or at all; the likelihood and timing of any regulatory approval of neflamapimod or the nature of any feedback the Company may receive from the FDA or other regulators; the Company’s ability to maintain the intellectual property protection afforded by the Company’s patent portfolio; the ability to implement business plans, forecasts, and other expectations in the future; general economic, political, business, industry, and market conditions, inflationary pressures, and geopolitical conflicts; and the other factors discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 filed with the US Securities and Exchange Commission (SEC) on March 13, 2026, and other filings that the Company may file from time to time with the SEC. Any forward-looking statements in this press release speak only as of the date hereof (or such earlier date as may be identified). The Company does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except to the extent required by law. Contacts Media:Biongage [email protected] Investor Relations:Argot [email protected]
Related articleQuarter not tagged2026-05-18CervoMed Reports First Quarter 2026 Financial Results and Provides Corporate Updates
GlobeNewswire
CervoMed Reports First Quarter 2026 Financial Results and Provides Corporate Updates
Continued progress towards initiating planned Phase 3 trial evaluating neflamapimod in patients with dementia with Lewy bodies in second half of 2026, subject to financing Presented new analyses at AAN 2026 highlighting first-ever MRI data demonstrating evidence of reversible disease progression in the basal forebrain with neflamapimod treatment Presented new analyses at AD/PD™ 2026 demonstrating that patients with lower plasma pTau181 levels, a biomarker indicating an earlier stage of disease and a low likelihood of having Alzheimer’s disease co-pathology, experienced greater clinical benefit from neflamapimod BOSTON, May 18, 2026 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical-stage biotechnology company developing treatments for age-related brain disorders (CervoMed or the Company), today reported financial results for the first quarter ended March 31, 2026, and provided corporate updates. John Alam, MD, Chief Executive Officer of CervoMed, stated: “CervoMed has built a robust and compelling neflamapimod dataset in patients with dementia with Lewy bodies (DLB) comprised of positive Phase 2b clinical data, including first-ever magnetic resonance imaging (MRI) data showing evidence of increase in size and enhancement of function in the basal forebrain, key accompanying biomarker and PK/PD data, and a new formulation and manufacturing process. Collectively, this work has led to alignment with the United States (US) Food and Drug Administration (FDA) and global regulatory authorities on a final design for our planned Phase 3 trial in patients with DLB. We are extremely proud of the recent progress we have made, and are encouraged by the positive feedback received from various stakeholders around the potential of neflamapimod as a disease-modifying treatment for DLB.” First Quarter 2026 and Recent Program Highlights Dementia with Lewy Bodies Aligned with global regulatory authorities and finalized design for the Company’s planned Phase 3 trial in patients with DLB, which is subject to available financing. CervoMed selected 50mg three times per day of a stable crystal form of neflamapimod produced using a new, controlled manufacturing process as the dose and dosing regimen that will be used for the Company’s planned Phase 3 trial in patients with DLB. At AAN 2026, CervoMed presented first-ever placebo-controlled MRI analyses which provided e…Read full documentShow less
Continued progress towards initiating planned Phase 3 trial evaluating neflamapimod in patients with dementia with Lewy bodies in second half of 2026, subject to financing Presented new analyses at AAN 2026 highlighting first-ever MRI data demonstrating evidence of reversible disease progression in the basal forebrain with neflamapimod treatment Presented new analyses at AD/PD™ 2026 demonstrating that patients with lower plasma pTau181 levels, a biomarker indicating an earlier stage of disease and a low likelihood of having Alzheimer’s disease co-pathology, experienced greater clinical benefit from neflamapimod BOSTON, May 18, 2026 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical-stage biotechnology company developing treatments for age-related brain disorders (CervoMed or the Company), today reported financial results for the first quarter ended March 31, 2026, and provided corporate updates. John Alam, MD, Chief Executive Officer of CervoMed, stated: “CervoMed has built a robust and compelling neflamapimod dataset in patients with dementia with Lewy bodies (DLB) comprised of positive Phase 2b clinical data, including first-ever magnetic resonance imaging (MRI) data showing evidence of increase in size and enhancement of function in the basal forebrain, key accompanying biomarker and PK/PD data, and a new formulation and manufacturing process. Collectively, this work has led to alignment with the United States (US) Food and Drug Administration (FDA) and global regulatory authorities on a final design for our planned Phase 3 trial in patients with DLB. We are extremely proud of the recent progress we have made, and are encouraged by the positive feedback received from various stakeholders around the potential of neflamapimod as a disease-modifying treatment for DLB.” First Quarter 2026 and Recent Program Highlights Dementia with Lewy Bodies Aligned with global regulatory authorities and finalized design for the Company’s planned Phase 3 trial in patients with DLB, which is subject to available financing. CervoMed selected 50mg three times per day of a stable crystal form of neflamapimod produced using a new, controlled manufacturing process as the dose and dosing regimen that will be used for the Company’s planned Phase 3 trial in patients with DLB. At AAN 2026, CervoMed presented first-ever placebo-controlled MRI analyses which provided evidence that neflamapimod may increase the size and enhance the function of the basal forebrain in patients with DLB. Basal forebrain atrophy is the primary pathogenic driver of disease expression and progression in DLB. The results are consistent with pre-clinical studies demonstrating that, in the early stages of the neurodegenerative process, disease progression in the basal forebrain is reversible. The findings also correlate with previously reported results on neflamapimod’s observed effects on a blood biomarker of neurodegenerative disease activity, providing additional evidence of neflamapimod’s potential to act on the underlying disease biology. At AD/PD™ 2026, CervoMed presented new analyses from DLB patients treated in the Phase 2b RewinD-LB trial evaluating neflamapimod. The analyses showed that patients with lower plasma pTau181 levels, a biomarker indicating an earlier stage of disease and a low likelihood of having Alzheimer’s disease co-pathology, experienced greater clinical benefit with neflamapimod. These results reinforce the thesis that neflamapimod targets disease processes that are specific to DLB Frontotemporal Disorders (FTD) Enrollment in CervoMed’s Phase 2a trial in patients with non-fluent variant primary progressive aphasia (nfvPPA) has been completed in the US, with 19 patients randomized and having initiated treatment. Enrollment has also been in initiated in the United Kingdom (UK), where up to an additional six patients are to be enrolled. To date, neflamapimod has been well tolerated in the trial, with no early treatment discontinuations. Amyotrophic Lateral Sclerosis (ALS) In February 2026, neflamapimod was selected for inclusion in the EXPERTS-ALS platform in the UK. EXPERTS-ALS facilitates rapid testing of potential treatments for ALS to identify promising drug candidates and potentially accelerate their path to regulatory approval. EXPERTS-ALS, funded by the UK government and UK-based charities, will conduct the clinical trial and CervoMed will provide drug product. Corporate Updates In March 2026, a European patent related to the use of p38α MAP kinase inhibitors for the treatment of DLB was issued to the Company. The patent is set to expire in 2040. Anticipated Milestones CervoMed’s anticipated milestones for the remainder of 2026, subject to available funding, include: DLB: CervoMed [has initiated clinical site startup activities in the U.S. utilizing internal resources and] plans to initiate a Phase 3 trial evaluating neflamapimod in patients with DLB in the second half of 2026. Recovery After Stroke (RAS): CervoMed expects to complete treatment in the Phase 2a RESTORE trial evaluating neflamapimod in patients recovering from acute ischemic stroke in mid-2026 and to report topline data from the trial in the second half of 2026. nfvPPA: CervoMed expects to complete enrollment in its ongoing Phase 2a trial evaluating neflamapimod in patients with nfvPPA in mid-2026. The Company also expects to report initial biomarker data from the trial in mid-2026 and initial topline 24-week biomarker and clinical and data from the trial in the second half of 2026. ALS: CervoMed expects EXPERTS-ALS to dose the first patient with ALS with neflamapimod by the end of 2026. First Quarter 2026 Financial Results Cash Position: As of March 31, 2026, CervoMed had approximately $12.9 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 March 31, 2025, will enable the Company to fund its planned operating expenses and capital expenditure requirements into the third quarter of 2026. Grant Revenue: There was no grant revenue recognized for the three months ended March 31, 2026, compared to approximately $1.9 million for the same period in 2025. The decrease was due to the completion of the 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 RewinD-LB trial. Research and Development (R&D) Expenses: R&D expenses for the three months ended March 31, 2026, were approximately $5.1 million, compared to approximately $4.8 million for the same period in 2025. The increase was primarily due to increases in R&D expenses, clinical costs, and nonclinical costs, driven by increased chemistry, manufacturing and controls activities to develop and evaluate a stable crystal form of neflamapimod and a new controlled manufacturing process, clinical costs related to the ongoing Phase 2a trial in nfvPPA, and certain personnel and consulting costs. These increases were largely offset by a decrease in costs related to the Company’s DLB program, including the recently completed Phase 2b RewinD-LB trial. General and Administrative (G&A) Expenses: G&A expenses were approximately $3.0 million during the three months ended March 31, 2026, compared to approximately $2.4 million for the same period in 2025. The increase was primarily due to increases in professional fees and personnel costs. Net Loss: Net loss was approximately $8.0 million for the three months ended March 31, 2026, compared to approximately $4.9 million for the same period in 2025. The aggregate increase of $3.1 million was primarily due to a $1.9 million decrease in grant revenue and a $0.9 million increase in total operating expenses. About NeflamapimodNeflamapimod is an investigational, orally administered small-molecule drug that readily crosses the blood-brain barrier and selectively inhibits the alpha isoform of p38 MAP kinase, a key driver of neuroinflammation and synaptic dysfunction. By targeting the critical disease processes underlying degenerative disorders of the brain, neflamapimod has the potential to reverse synaptic dysfunction, improve neuron health, and slow or prevent disease progression. Neflamapimod is currently in clinical development for the treatment of DLB, recovery after ischemic stroke, and primary progressive aphasia. In non-clinical studies, neflamapimod restored synaptic function within the basal forebrain cholinergic system, the brain region most affected in DLB. Across Phase 1 and 2 clinical trials involving more than 800 participants, the drug has been generally well tolerated and demonstrated consistent signals of efficacy. In the 91-patient Phase 2a AscenD-LB trial, neflamapimod significantly improved dementia severity and functional mobility in patients with DLB. Results from the 159-patient Phase 2b RewinD-LB trial, a 16-week randomized, double-blind, placebo-controlled trial followed by a 32-week open-label extension, further supported neflamapimod’s potential to deliver meaningful clinical benefit, improving both cognitive and functional outcomes and showing a positive effect on a key blood biomarker of neurodegeneration during the extension phase. Across both studies, the greatest benefits were observed in patients without Alzheimer’s disease (AD) co-pathology. Collectively, these findings underscore the therapeutic promise and scientific validity of neflamapimod as a potential treatment for DLB and other degenerative brain disorders. About CervoMedCervoMed is a clinical-stage company developing treatments for age-related brain disorders. Its lead drug candidate, neflamapimod, is an oral small molecule targeting critical disease processes underlying degenerative disorders of the brain by inhibiting a key enzyme involved in neuroinflammation and neurodegeneration. CervoMed’s recently completed Phase 2b RewinD-LB trial evaluated neflamapimod in patients with DLB, enriched for those without AD co-pathology. The Company plans to initiate a global, pivotal Phase 3 trial in patients with DLB in the second half of 2026, subject to available funding. Forward-Looking StatementsThis press release includes express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, regarding the intentions, plans, beliefs, expectations or forecasts for the future of the Company, including, but not limited to: the Company’s need to acquire sufficient funding, including funding for its planned Phase 3 trial in DLB; the Company’s anticipated cash runway; the therapeutic potential of neflamapimod in DLB or any other indication, including the degree of sustainability of any therapeutic effects; the anticipated timing and achievement of clinical and development milestones, including the Company’s initiation of the Company’s planned Phase 3 trial in DLB patients and the announcement of any data therefrom; the anticipated data readouts from the Phase 2a trials in RAS and nfvPPA and the anticipated dosing of the first patient with neflamapimod in the EXPERTS-ALS trial; any other expected or implied benefits or results, including the extent (if any) to which neflamapimod may demonstrate efficacy or other clinical or biomarker improvements in patients; and expectations with respect to neflamapimod, including the timing of any regulatory submissions and potential approvals thereof, if any, in DLB or any other indication. Terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “aims,” “seeks,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately,” “potential,” “target,” “project,” “contemplate,” “predict,” “forecast,” “continue,” or other words that convey uncertainty of future events or outcomes (including the negative of these terms) may identify these forward-looking statements. Although there is believed to be reasonable basis for each forward-looking statement contained herein, forward-looking statements by their nature involve risks and uncertainties, known and unknown, many of which are beyond the Company’s control and, as a result, actual results could differ materially from those expressed or implied in any forward-looking statement. Particular risks and uncertainties include, among other things, those related to: the Company’s available cash resources, the availability of additional funds on acceptable terms, and the Company’s ability to continue as a going concern; the results of the Company’s clinical trials; the likelihood and timing of any regulatory approval of neflamapimod or the nature of any feedback the Company may receive from the FDA or other regulators; the ability to implement business plans, forecasts, and other expectations in the future; general economic, political, business, industry, and market conditions, inflationary pressures, and geopolitical conflicts; and the other factors discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 filed with the U.S. Securities and Exchange Commission (SEC) on March 13, 2026, and other filings that the Company may file from time to time with the SEC. Any forward-looking statements in this press release speak only as of the date hereof (or such earlier date as may be identified). The Company does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except to the extent required by law. Contacts Media:Lisa GuitermanBiongage [email protected] Investor Relations:Argot [email protected]
Related articleQuarter not tagged2026-03-26CervoMed (CRVO)’s Q4 Results Feature Advancements in Its Neflamapimod Program for Dementia Lewy Bodies (DLB)
Insider Monkey
CervoMed (CRVO)’s Q4 Results Feature Advancements in Its Neflamapimod Program for Dementia Lewy Bodies (DLB)
CervoMed Inc. (NASDAQ:CRVO) earns a place on our top 10 stocks under $5 that could triple. On March 17, 2026, CervoMed Inc. (NASDAQ:CRVO) announced results for the fourth quarter and full year 2025. The company highlighted advancements in its neflamapimod program for dementia with Lewy bodies (DLB). CervoMed Inc. (NASDAQ:CRVO) further reported favorable Phase 2b RewinD-LB data at CTAD 2025 while achieving an agreement with the FDA and international authorities on the design of a Phase 3 trial. This trial is expected to commence in the latter part of 2026. With the start of the EXPERTS-ALS investigation and topline findings from Phase 2a trials in ischemic stroke recovery and primary progressive aphasia, the upcoming calendar remains catalyst-heavy. In terms of finances, CervoMed Inc. (NASDAQ:CRVO) reported $20.9 million in cash as of December 31, 2025, indicating a runway of roughly six months, with R&D expenses of $21.8 million and a net loss of $27.0 million for the year. A day later, Boobalan Pachaiyappan of Roth Capital reduced the price target on CervoMed Inc. (NASDAQ:CRVO) from $19 to $11 while keeping a “Buy” rating. The analyst noted that results were largely in line with expectations, but the company may need to raise capital on less favorable terms. CervoMed Inc. (NASDAQ:CRVO) is a clinical-stage biotechnology firm specializing in CNS-targeted therapeutics, namely, neflamapimod, aimed at neurodegenerative conditions such as dementia with Lewy bodies, stroke rehabilitation, and several other cerebral disorders. While we acknowledge the potential of CRVO as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and 15 Stocks That Will Make You Rich in 10 Years Disclosure: None. Follow Insider Monkey on Google News.
Related articleQuarter not tagged2026-03-17CervoMed Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Updates
GlobeNewswire
CervoMed Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Updates
Reported positive Phase 2b RewinD-LB clinical data at CTAD 2025; additional analyses to be presented at AD/PD 2026 Obtained alignment with FDA and global regulators for planned Phase 3 trial design in patients with DLB and selected Phase 3 formulation, dose and dosing regimen Multiple potential catalysts anticipated in the second half of 2026, including initiation of the planned Phase 3 trial, topline data from Phase 2a ischemic stroke recovery trial, initial topline data from Phase 2a primary progressive aphasia trial, and initiation of EXPERTS-ALS trial in Amyotrophic Lateral Sclerosis BOSTON, March 17, 2026 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical-stage biotechnology company developing treatments for age-related brain disorders (CervoMed or the Company), today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided corporate updates. “CervoMed made significant strides in 2025 and early 2026 with its lead neflamapimod program in dementia with Lewy bodies (DLB). We reported positive and supportive Phase 2b RewinD-LB data at the 18th Clinical Trials on Alzheimer's Disease (CTAD) Conference, obtained alignment with the U.S. Food and Drug Administration (FDA) and other global regulators on the design of our planned Phase 3 trial design in patients with DLB, and selected the neflamapimod formulation, dose and dosing regimen that will be used in the planned Phase 3 trial,” said John Alam, MD, Chief Executive Officer of CervoMed. “We are now looking ahead to a catalyst-driven 2026, including initiation of the planned Phase 3 trial evaluating neflamapimod in DLB in the second half of 2026, subject to available financing. In addition, we expect to report initial topline Phase 2a results from our other programs evaluating neflamapimod in both ischemic stroke recovery (RAS) and the non-fluent variant primary progressive aphasia (nfvPPA), along with initiation of the EXPERTS-ALS trial in amyotrophic lateral sclerosis (ALS), all during the second half of 2026 as well.” Fourth Quarter 2025 and Recent Program Highlights Dementia with Lewy Bodies CervoMed selected 50mg three times per day (TID) of a stable crystal form of neflamapimod produced using a new, controlled manufacturing process as the dose and dosing regimen that will be used for the Company’s planned Phase 3 trial in patients with DLB. CervoMed…Read full documentShow less
Reported positive Phase 2b RewinD-LB clinical data at CTAD 2025; additional analyses to be presented at AD/PD 2026 Obtained alignment with FDA and global regulators for planned Phase 3 trial design in patients with DLB and selected Phase 3 formulation, dose and dosing regimen Multiple potential catalysts anticipated in the second half of 2026, including initiation of the planned Phase 3 trial, topline data from Phase 2a ischemic stroke recovery trial, initial topline data from Phase 2a primary progressive aphasia trial, and initiation of EXPERTS-ALS trial in Amyotrophic Lateral Sclerosis BOSTON, March 17, 2026 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical-stage biotechnology company developing treatments for age-related brain disorders (CervoMed or the Company), today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided corporate updates. “CervoMed made significant strides in 2025 and early 2026 with its lead neflamapimod program in dementia with Lewy bodies (DLB). We reported positive and supportive Phase 2b RewinD-LB data at the 18th Clinical Trials on Alzheimer's Disease (CTAD) Conference, obtained alignment with the U.S. Food and Drug Administration (FDA) and other global regulators on the design of our planned Phase 3 trial design in patients with DLB, and selected the neflamapimod formulation, dose and dosing regimen that will be used in the planned Phase 3 trial,” said John Alam, MD, Chief Executive Officer of CervoMed. “We are now looking ahead to a catalyst-driven 2026, including initiation of the planned Phase 3 trial evaluating neflamapimod in DLB in the second half of 2026, subject to available financing. In addition, we expect to report initial topline Phase 2a results from our other programs evaluating neflamapimod in both ischemic stroke recovery (RAS) and the non-fluent variant primary progressive aphasia (nfvPPA), along with initiation of the EXPERTS-ALS trial in amyotrophic lateral sclerosis (ALS), all during the second half of 2026 as well.” Fourth Quarter 2025 and Recent Program Highlights Dementia with Lewy Bodies CervoMed selected 50mg three times per day (TID) of a stable crystal form of neflamapimod produced using a new, controlled manufacturing process as the dose and dosing regimen that will be used for the Company’s planned Phase 3 trial in patients with DLB. CervoMed obtained alignment with the FDA on a proposed Phase 3 trial design to support a potential New Drug Application for neflamapimod in DLB in November 2025 and with other global regulators during the first quarter of 2026. Based on FDA feedback, CervoMed plans to initiate a single, global, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of neflamapimod in approximately 300 patients with DLB, subject to available funding. The trial will exclude patients who have historical evidence of AD co-pathology by brain imaging scan or cerebrospinal fluid sampling and will be further enriched for participants who do not have AD co-pathology by excluding patients with plasma ptau181 ≥ 21.0 pg/mL at screening. Participants will be randomized 1:1 to receive either oral neflamapimod or placebo for 32 weeks, followed by a neflamapimod only extension for 48 weeks. The primary endpoint will be worsening of global cognition and function as measured by change in the Clinical Dementia Rating-Sum of Boxes (CDR-SB). Secondary endpoints include the percentage of participants who have a greater than 1.5-point increase in CDR-SB and other well-established measures of cognitive and motor function. Assessments of key biomarkers of the neurodegenerative process will also be included. In a late-breaking oral session at CTAD Conference, clinical investigators shared the full results of the Phase 2b RewinD-LB trial evaluating neflamapimod for the treatment of DLB. The results of the trial demonstrated a significant and clinically meaningful effect on multiple outcomes in DLB patients, including on the primary outcome measure, change in CDR-SB, in the participants who received neflamapimod drug product that achieved expected and targeted plasma drug concentrations. These positive clinical outcomes were correlated with observed reductions in established biomarkers of neurodegeneration, supporting neflamapimod’s mode of action targeting the underlying DLB mechanism. Amyotrophic Lateral Sclerosis (ALS) Neflamapimod was recently selected for inclusion in the EXPERTS-ALS platform in the United Kingdom (UK). EXPERTS-ALS facilitates rapid testing of potential treatments for ALS to identify promising drug candidates and potentially accelerate their path to regulatory approval. EXPERTS-ALS, funded by the UK government and UK-based charities, will conduct the clinical trial and CervoMed will provide drug product. Corporate Updates During the fourth quarter of 2025 and first quarter of 2026, multiple patents related to neflamapimod were issued in Europe, Japan, and China, strengthening CervoMed’s global intellectual property portfolio supporting the development of neflamapimod for neurodegenerative disorders. In October 2025, Matthew Winton, Ph.D., joined CervoMed as Chief Commercial and Business Officer and David Quigley joined the Company’s Board of Directors. Anticipated Milestones for 2026 DLB: CervoMed plans to initiate a Phase 3 trial evaluating neflamapimod in patients with DLB in the second half of 2026, subject to obtaining sufficient funding. The Company will present additional data supporting its choice of patient population and dosing regimen for the trial at the AD/PD 2026 Scientific Conference taking place March 17-21, 2026, in Copenhagen, Denmark. RAS: CervoMed expects to complete enrollment in its ongoing Phase 2a RESTORE trial evaluating neflamapimod in patients recovering from acute ischemic stroke in mid-2026 and to report topline data from the trial in the second half of 2026. nfvPPA: CervoMed expects to complete enrollment in its ongoing Phase 2a trial evaluating neflamapimod in patients with nfvPPA in mid-2026. The Company also expects to report initial biomarker data from the trial in mid-2026 and initial topline clinical data from the trial in the second half of 2026. ALS: CervoMed expects initiation of the EXPERTS-ALS trial evaluating neflamapimod in patients with ALS by the end of 2026. Full Year 2025 Financial Results Cash Position: As of December 31, 2025, CervoMed had approximately $20.9 million in cash, cash equivalents and marketable securities, as compared to $38.9 million as of December 31, 2024. Based on its current operating plan, CervoMed believes its cash, cash equivalents, and marketable securities on hand as of December 31, 2025, will enable the Company to fund its planned operating expenses and capital expenditure for approximately six months from the date of this release. Grant Revenue: Grant revenue was approximately $4.0 million for the twelve months ended December 31, 2025, compared to approximately $9.7 million for the same period in 2024. The decrease in grant revenue was due to the completion of the randomized phase of the RewinD-LB Trial in late 2024, followed by the subsequent completion of the extension phase in mid-2025. Research and Development (R&D) Expenses: R&D expenses for the twelve months ended December 31, 2025, were approximately $21.8 million, compared to approximately $18.8 million for the same period in 2024. The increase in R&D expenses was primarily due to increases in personnel and consulting costs, R&D- and CMC-related activities related to the batch issues identified during the RewinD-LB trial, implementation of the Company’s pre-Phase 3 manufacturing improvements, and non-DLB clinical work for neflamapimod, including costs related to the RAS and nfvPPA clinical trials, which were both initiated during 2025. General and Administrative (G&A) Expenses: G&A expenses were approximately $10.5 million during the twelve months ended December 31, 2025, compared to approximately $9.2 million for the same period in 2024. The increase in G&A expenses was primarily due to increases in personnel costs, insurance and taxes, and professional fees, partially offset by a decrease in stock-based compensation. Net Loss: Net loss was approximately $27.0 million for the twelve months ended December 31, 2025, compared to approximately $16.2 million for the same period in 2024. About Neflamapimod Neflamapimod is an investigational, orally administered small-molecule drug that readily crosses the blood–brain barrier and selectively inhibits the alpha isoform of p38 MAP kinase, a key driver of neuroinflammation and synaptic dysfunction. By targeting the critical disease processes underlying degenerative disorders of the brain, neflamapimod has the potential to reverse synaptic dysfunction, improve neuron health, and slow or prevent disease progression. Neflamapimod is currently in clinical development for the treatment of DLB, recovery after ischemic stroke, and primary progressive aphasia. In non-clinical studies, neflamapimod restored synaptic function within the basal forebrain cholinergic system, the brain region most affected in DLB. Across Phase 1 and 2 clinical trials involving more than 800 participants, the drug has been generally well tolerated and demonstrated consistent signals of efficacy. In the 91-patient Phase 2a AscenD-LB trial, neflamapimod significantly improved dementia severity and functional mobility in patients with DLB. Results from the 159-patient Phase 2b RewinD-LB trial, a 16-week randomized, double-blind, placebo-controlled trial followed by a 32-week open-label extension, further supported neflamapimod’s potential to deliver meaningful clinical benefit, improving both cognitive and functional outcomes and showing a positive effect on a key blood biomarker of neurodegeneration during the extension phase. Across both studies, the greatest benefits were observed in patients without AD co-pathology. Collectively, these findings underscore the therapeutic promise and scientific validity of neflamapimod as a potential treatment for DLB and other degenerative brain disorders. About CervoMed CervoMed is a clinical-stage company developing treatments for age-related brain disorders. Its lead drug candidate, neflamapimod, is an oral small molecule targeting critical disease processes underlying degenerative disorders of the brain by inhibiting a key enzyme involved in neuroinflammation and neurodegeneration. CervoMed’s recently completed Phase 2b RewinD-LB trial evaluated neflamapimod in patients with DLB, enriched for those without AD co-pathology. The Company plans to initiate a global, pivotal Phase 3 trial in patients with DLB, enriched for those without AD co-pathology, in the second half of 2026, subject to available funding. Forward-Looking Statements This press release includes express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, regarding the intentions, plans, beliefs, expectations or forecasts for the future of the Company, including, but not limited to: the Company’s need to acquire sufficient funding, including funding for its planned Phase 3 trial; our anticipated cash runway; the therapeutic potential of neflamapimod in DLB or any other indication, including the degree of sustainability of any therapeutic effects and the plasma drug concentrations that may be achieved with neflamapimod treatment in any of the Company’s future clinical trials; the anticipated timing and achievement of clinical and development milestones, including the Company’s initiation of the Company’s planned Phase 3 trial in DLB patients and the announcement of any data therefrom; the anticipated data readouts from the Phase 2a trials in RAS and nfvPPA and the anticipated dosing of the first patient with neflamapimod in the EXPERTS-ALS trial; any other expected or implied benefits or results, including the extent (if any) to which neflamapimod may demonstrate efficacy or other clinical or biomarker improvements in patients; and expectations with respect to neflamapimod, including the timing of any regulatory submissions and potential approvals thereof, if any, in DLB or any other indication. Terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “aims,” “seeks,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately,” “potential,” “target,” “project,” “contemplate,” “predict,” “forecast,” “continue,” or other words that convey uncertainty of future events or outcomes (including the negative of these terms) may identify these forward-looking statements. Although there is believed to be reasonable basis for each forward-looking statement contained herein, forward-looking statements by their nature involve risks and uncertainties, known and unknown, many of which are beyond the Company’s control and, as a result, actual results could differ materially from those expressed or implied in any forward-looking statement. Particular risks and uncertainties include, among other things, those related to: the Company’s available cash resources, the availability of additional funds on acceptable terms, and the Company’s ability to continue as a going concern; the results of the Company’s clinical trials; the likelihood and timing of any regulatory approval of neflamapimod or the nature of any feedback the Company may receive from the FDA or other regulators; the ability to implement business plans, forecasts, and other expectations in the future; general economic, political, business, industry, and market conditions, inflationary pressures, and geopolitical conflicts; and the other factors discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 filed with the U.S. Securities and Exchange Commission (SEC) on March 13, 2026, and other filings that the Company may file from time to time with the SEC. Any forward-looking statements in this press release speak only as of the date hereof (or such earlier date as may be identified). The Company does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except to the extent required by law. Contacts Media: Lisa Guiterman Biongage Communications [email protected] 202-330-3431 Investor Relations: Argot Partners [email protected] 212-600-1902
Related articleQuarter not tagged2026-03-03Pharming Group Gears Up to Report Q4 Earnings: What's in the Cards?
Zacks
Pharming Group Gears Up to Report Q4 Earnings: What's in the Cards?
Pharming Group PHAR is slated to report fourth-quarter 2025 results on March 12, 2026, before the opening bell. We expect investors to focus on the sales performances of PHAR’s marketed drugs and other pipeline updates when it reports fourth-quarter 2025 results. The Zacks Consensus Estimate for quarterly revenues in the to-be-reported quarter is pegged at $104.8 million. The consensus mark for Pharming Group’s earnings per share is pinned at 15 cents. Let us see how things are likely to have shaped up for PHAR in the soon-to-be-reported quarter. Pharming Group’s total revenues only comprise its product sales. It derives the bulk of its revenues from the sale of Ruconest (conestat alfa), its flagship therapy for treating hereditary angioedema (HAE), which is approved in the United States, the EU and the U.K. Since its launch, Ruconest has become the company’s primary growth engine, driven by a growing patient and prescriber base, which is expected to have boosted fourth-quarter sales as well. In the third-quarter earnings release, Pharming Group announced that it would withdraw Ruconest from all non-U.S. markets, which generated $1.1 million (1.3% of quarterly revenues) and were not financially sustainable. The company will focus on ensuring patient continuity of care while redirecting resources to higher-growth pipeline opportunities. Investors are likely to seek greater clarity on this matter during the fourth-quarter earnings call. Pharming Group’s second marketed product, Joenja (leniolisib), was in-licensed from Novartis and is approved for treating patients (aged 12 years and older), with activated phosphoinositide 3-kinase delta syndrome (APDS) in the United States, the EU and the U.K. Joenja sales are also expected to have grown year over year in the fourth quarter, primarily driven by an increase in U.S. and U.K. patients on paid therapy. Please note that both marketed drugs have also posted sequential growth in all three quarters of 2025. This trend is expected to have continued in the fourth quarter as well. Pharming Group shares have gained 11.5% in the past six months compared with the industry’s 22% growth. Image Source: Zacks Investment Research Investors will also likely be interested in updates regarding PHAR’s mid to late-stage pipeline candidates on the fourth-quarter earnings call. The FDA recently rejected the company’s regulatory appl…Read full documentShow less
Pharming Group PHAR is slated to report fourth-quarter 2025 results on March 12, 2026, before the opening bell. We expect investors to focus on the sales performances of PHAR’s marketed drugs and other pipeline updates when it reports fourth-quarter 2025 results. The Zacks Consensus Estimate for quarterly revenues in the to-be-reported quarter is pegged at $104.8 million. The consensus mark for Pharming Group’s earnings per share is pinned at 15 cents. Let us see how things are likely to have shaped up for PHAR in the soon-to-be-reported quarter. Pharming Group’s total revenues only comprise its product sales. It derives the bulk of its revenues from the sale of Ruconest (conestat alfa), its flagship therapy for treating hereditary angioedema (HAE), which is approved in the United States, the EU and the U.K. Since its launch, Ruconest has become the company’s primary growth engine, driven by a growing patient and prescriber base, which is expected to have boosted fourth-quarter sales as well. In the third-quarter earnings release, Pharming Group announced that it would withdraw Ruconest from all non-U.S. markets, which generated $1.1 million (1.3% of quarterly revenues) and were not financially sustainable. The company will focus on ensuring patient continuity of care while redirecting resources to higher-growth pipeline opportunities. Investors are likely to seek greater clarity on this matter during the fourth-quarter earnings call. Pharming Group’s second marketed product, Joenja (leniolisib), was in-licensed from Novartis and is approved for treating patients (aged 12 years and older), with activated phosphoinositide 3-kinase delta syndrome (APDS) in the United States, the EU and the U.K. Joenja sales are also expected to have grown year over year in the fourth quarter, primarily driven by an increase in U.S. and U.K. patients on paid therapy. Please note that both marketed drugs have also posted sequential growth in all three quarters of 2025. This trend is expected to have continued in the fourth quarter as well. Pharming Group shares have gained 11.5% in the past six months compared with the industry’s 22% growth. Image Source: Zacks Investment Research Investors will also likely be interested in updates regarding PHAR’s mid to late-stage pipeline candidates on the fourth-quarter earnings call. The FDA recently rejected the company’s regulatory application seeking the label expansion of Joenja to also treat pediatric patients aged four to 11 years with APDS. The company plans to work with the FDA, address the issues raised and request a Type A meeting to determine next steps for resubmission. Investors are likely to look for an update on this setback during the upcoming earnings call. Pharming Group has completed enrollment in a phase III study of a new pediatric leniolisib formulation for children aged one to six with APDS in 2025. Results are expected soon, and if positive, the company plans to pursue regulatory approval for this younger age group. It is also developing leniolisib in separate mid-stage studies for additional primary immunodeficiencies beyond APDS, including genetically defined primary immunodeficiencies and common variable immunodeficiency, which together affect far more patients. Top-line data from both studies are expected in the second half of 2026. Pharming Group’s clinical pipeline comprises another candidate, napazimone (KL1333), which is currently being evaluated in the pivotal phase III FALCON study for adult patients with primary mitochondrial disease caused by mitochondrial DNA mutations. Top-line data is expected in 2027. Total operating expenses of the company are likely to have increased year over year in the fourth quarter due to an increase in Research and Development expenses on account of higher clinical study costs. Pharming Group has a mixed earnings surprise history so far. Earnings surpassed estimates in three of the trailing four quarters, while missing the mark on the remaining occasion, delivering an average surprise of 60.86%. In the last reported quarter, the company delivered an earnings surprise of 100%. Pharming Group N.V. Sponsored ADR price-consensus-eps-surprise-chart | Pharming Group N.V. Sponsored ADR Quote Our proven model does not conclusively predict an earnings beat for Pharming Group this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. That is not the case here, as you will see below. You can uncover the best stocks to buy or sell before they are reported with our Earnings ESP Filter. Earnings ESP: Pharming Group has an Earnings ESP of 0.00% as the Most Accurate Estimate and the Zacks Consensus Estimate are both pegged at 15 cents per share. Zacks Rank: Pharming Group currently carries a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 Rank stocks here. Here are a few stocks worth considering from the medical sector, as our model shows that these have the right combination of elements to beat on earnings this reporting cycle. Abivax SA Sponsored ADR ABVX has an Earnings ESP of +31.77% and a Zacks Rank #2 at present. ABVX shares have rallied 35.2% in the past six months. The company’s earnings beat estimates in one of the past two reported quarters, while missing the same on the other occasion. Abivax delivered an average negative surprise of 5.02%. Cardiol Therapeutics CRDL has an Earnings ESP of +17.65% and a Zacks Rank #3 at present. CRDL shares have lost 6.4% in the past six months. The company’s earnings beat estimates in three of the trailing four quarters and matched once. Cardiol Therapeutics delivered an average surprise of 17.77%. CERVOMED INC CRVO has an Earnings ESP of +1.68% and a Zacks Rank #3 at present. CRVO shares of have plunged 63.6% in the past six months. The company’s earnings beat estimates in one of the trailing four quarters, while missing the mark on the remaining three occasions. CERVOMED delivered an average negative surprise of 14.77%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Pharming Group N.V. Sponsored ADR (PHAR) : Free Stock Analysis Report Cardiol Therapeutics Inc. (CRDL) : Free Stock Analysis Report CervoMed Inc. (CRVO) : Free Stock Analysis Report Abivax SA Sponsored ADR (ABVX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Related articleQuarter not tagged2025-11-10CervoMed Reports Third Quarter 2025 Financial Results and Provides Corporate Updates
GlobeNewswire
CervoMed Reports Third Quarter 2025 Financial Results and Provides Corporate Updates
Aligned with U.S Food and Drug Administration (FDA) on design of planned Phase 3 clinical trial of neflamapimod in patients with dementia with Lewy bodies (DLB) Reported 32-week data from Phase 2b RewinD-LB trial showing neflamapimod treatment in patients with DLB had a durable beneficial effect on clinical progression and resulted in substantial reductions in plasma levels of a well-established biomarker of neurodegeneration Meeting with global regulators in coming months and preparing for global pivotal trial initiation in second half of 2026 Initial biomarker data from Phase 2a trial in a sub-type of frontotemporal dementia (FTD) and topline results from Phase 2a trial in recovery after stroke expected in 2026 BOSTON, Nov. 10, 2025 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related brain disorders (CervoMed or the Company), today reported its financial results for the third quarter ended September 30, 2025, and provided corporate updates. “In the past nine months, CervoMed has made remarkable strides, culminating in our recent alignment with the FDA on key aspects of the design of our planned Phase 3 clinical trial in DLB” said John Alam, M.D., Chief Executive Officer of CervoMed. “Our 32-week treatment data from the RewinD‑LB trial announced during the third quarter and in early October demonstrated a sustained beneficial effect on clinical progression and a substantial effect on an established biomarker of neurodegenerative disease activity. The combination of the results observed in our Phase 2a and 2b trials and our recent alignment with the FDA fuels our optimism and reinforces our commitment to developing a much-needed therapy for patients, caregivers, and families facing DLB. We believe neflamapimod has the potential to transform the treatment landscape for DLB by treating the cognitive and functional decline that defines this devastating disease and that these recent milestones have brought us closer to delivering the first approved therapy for patients with DLB in the United States.” Recent Highlights and Anticipated Milestones In November 2025, CervoMed announced alignment with the FDA on a registration path for neflamapimod in DLB. The FDA’s feedback will enable CervoMed to proceed with the proposed endpoints, patient enrichment strategy, and other key aspects of the Compa…Read full documentShow less
Aligned with U.S Food and Drug Administration (FDA) on design of planned Phase 3 clinical trial of neflamapimod in patients with dementia with Lewy bodies (DLB) Reported 32-week data from Phase 2b RewinD-LB trial showing neflamapimod treatment in patients with DLB had a durable beneficial effect on clinical progression and resulted in substantial reductions in plasma levels of a well-established biomarker of neurodegeneration Meeting with global regulators in coming months and preparing for global pivotal trial initiation in second half of 2026 Initial biomarker data from Phase 2a trial in a sub-type of frontotemporal dementia (FTD) and topline results from Phase 2a trial in recovery after stroke expected in 2026 BOSTON, Nov. 10, 2025 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related brain disorders (CervoMed or the Company), today reported its financial results for the third quarter ended September 30, 2025, and provided corporate updates. “In the past nine months, CervoMed has made remarkable strides, culminating in our recent alignment with the FDA on key aspects of the design of our planned Phase 3 clinical trial in DLB” said John Alam, M.D., Chief Executive Officer of CervoMed. “Our 32-week treatment data from the RewinD‑LB trial announced during the third quarter and in early October demonstrated a sustained beneficial effect on clinical progression and a substantial effect on an established biomarker of neurodegenerative disease activity. The combination of the results observed in our Phase 2a and 2b trials and our recent alignment with the FDA fuels our optimism and reinforces our commitment to developing a much-needed therapy for patients, caregivers, and families facing DLB. We believe neflamapimod has the potential to transform the treatment landscape for DLB by treating the cognitive and functional decline that defines this devastating disease and that these recent milestones have brought us closer to delivering the first approved therapy for patients with DLB in the United States.” Recent Highlights and Anticipated Milestones In November 2025, CervoMed announced alignment with the FDA on a registration path for neflamapimod in DLB. The FDA’s feedback will enable CervoMed to proceed with the proposed endpoints, patient enrichment strategy, and other key aspects of the Company’s proposed Phase 3 trial design to support a potential New Drug Application. The full announcement is available here. In July 2025, the Company presented 32-week treatment results from the RewinD-LB trial at the Alzheimer’s Association International Conference in Toronto, Canada. These results further supported neflamapimod’s potential to deliver meaningful clinical benefit, improving both cognitive and functional outcomes - including a 64% risk reduction in clinically significant worsening (>= 1.5-point increase in Clinical Dementia Rating Sum of Boxes (CDR-SB)) compared to control over 32 weeks of neflamapimod treatment (p<0.001) in patients with low likelihood of Alzheimer’s disease (AD) co-pathology (plasma ptau181 =< 21.0 pg/mL at screening) – and showing a beneficial treatment effect on plasma glial fibrillary acidic protein (GFAP), a well-established biomarker of neurodegeneration. The full presentation of these results is available here. In September 2025, the potential benefits of neflamapimod for the treatment of DLB were highlighted in a presentation on advances in DLB drug development at the 150th Annual American Neurological Association conference by Dr. James E. Galvin, MD, MPH, Professor of Neurology at the Miller School of Medicine in Miami, Co-Principal Investigator of the RewinD-LB trial and member of the Board at the Lewy Body Dementia Association. A link to the neflamapimod section of the presentation is available here. In October 2025, the Company announced additional data from its Phase 2b RewinD-LB trial including results from a within-subject analysis demonstrating significant improvement relative to placebo on mean change in CDR-SB in participants with low likelihood of likelihood of having AD co-pathology (plasma ptau181 =< 21.0 pg/mL at screening), which will also be the primary endpoint and screening plasma ptau181 exclusion threshold in the Company’s planned Phase 3 trial in DLB. The within-subject analysis also demonstrated significant reduction in plasma GFAP levels, an effect that was correlated to treatment response assessed by CDR-SB. The full announcement is available here. In October 2025, CervoMed announced the appointment of Matthew Winton, Ph.D., as Chief Commercial and Business Officer and the appointment of David Quigley to its Board of Directors. Third Quarter 2025 Financial Results Cash Position: As of September 30, 2025, CervoMed had approximately $27.3 million in cash, cash equivalents, and marketable securities, as compared to $38.9 million as of December 31, 2024. Based on its current operating plan, CervoMed believes its cash, cash equivalents, and marketable securities on hand as of September 30, 2025, will enable the Company to fund its planned operating expenses and capital expenditure requirements into the third quarter of 2026. Grant Revenue: In January 2023, CervoMed was awarded a $21.0 million grant from the National Institute on Aging to support the RewinD-LB trial and, in August 2024, CervoMed was awarded an additional $0.3 million under the grant. Grant revenue was approximately $0.3 million for the three months ended September 30, 2025, compared to approximately $1.9 million for the same period in 2024. The decrease is due to the completion of the initial phase of the RewinD-LB trial and transition to the extension phase in late 2024, followed by the subsequent completion of the extension phase in mid-2025. Research and Development (R&D) Expenses: R&D expenses for the quarter ended September 30, 2025, were approximately $6.0 million, compared to approximately $5.1 million in the same period in 2024. The aggregate $0.9 million increase in R&D expenses was primarily due to an increase of $1.1 million in personnel costs, driven by higher headcount and outsourced consulting costs, an increase of $0.8 million in other R&D costs, driven by increased chemistry, manufacturing, and controls activities to evaluate, analyze and address the drug product issue identified in December 2024, and an aggregate increase of $0.6 million in costs related to our recovery after stroke and FTD programs. These increases were offset by a $1.6 million decrease in costs related to our neflamapimod DLB program, driven by our recent completion of the RewinD-LB trial. General and Administrative (G&A) Expenses: G&A expenses were approximately $2.3 million during the three months ended September 30, 2025, versus approximately $2.2 million in the same period in 2024. The increase was primarily due to a $0.1 million increase in stock-based compensation. Net Loss: Net loss was approximately $7.7 million for the three months ended September 30, 2025, compared to net loss of approximately $4.8 million for the same period in 2024. About CervoMed CervoMed is a clinical-stage company developing treatments for age-related brain disorders. Its lead drug candidate – neflamapimod – is an oral, small molecule targeting critical disease processes underlying degenerative disorders of the brain by inhibiting a key enzyme involved in neuroinflammation and neurodegeneration. CervoMed’s recently completed Phase 2b RewinD-LB trial evaluated neflamapimod in DLB patients who have a low likelihood of AD co-pathology, and the Company plans to initiate a global, pivotal Phase 3 trial in the same patient population in the second half of 2026. About Neflamapimod Neflamapimod is an investigational, orally administered small-molecule drug that readily crosses the blood–brain barrier and selectively inhibits the alpha isoform of p38 MAP kinase, a key driver of neuroinflammation and synaptic dysfunction. By targeting the critical disease processes underlying degenerative disorders of the brain, neflamapimod has the potential to reverse synaptic dysfunction, improve neuron health, and slow or prevent disease progression. Neflamapimod is currently in clinical development for the treatment of DLB, recovery after ischemic stroke, and frontotemporal dementia. In non-clinical studies, neflamapimod restored synaptic function within the basal forebrain cholinergic system, the brain region most affected in DLB. Across Phase 1 and 2 clinical trials involving more than 800 participants, the drug has been generally well tolerated and demonstrated consistent signals of efficacy. In the 91-patient Phase 2a AscenD-LB trial, neflamapimod significantly improved dementia severity and functional mobility in patients with DLB. Results from the 159-patient Phase 2b RewinD-LB trial, a 16-week randomized, double-blind, placebo-controlled trial followed by a 32-week open-label extension, further supported neflamapimod’s potential to deliver meaningful clinical benefit, improving both cognitive and functional outcomes and showing a positive effect on a key blood biomarker of neurodegeneration during the extension phase. Across both studies, the greatest benefits were observed in patients with “pure” DLB – those without AD co-pathology. Collectively, these findings underscore the therapeutic promise and scientific validity of neflamapimod as a potential treatment for DLB and other degenerative brain disorders. Forward-Looking Statements This press release includes express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, regarding the intentions, plans, beliefs, expectations or forecasts for the future of the Company, including, but not limited to: the therapeutic potential of neflamapimod, including the degree of sustainability of any therapeutic effects; the anticipated timing and achievement of clinical and development milestones, including the Company’s announcement of any meeting or correspondence between the Company and the FDA or other regulatory bodies; any other expected or implied benefits or results, including that any initial clinical results observed with respect to neflamapimod in the RewinD-LB trial will be replicated in later trials, including the Company’s planned Phase 3 clinical trial evaluating the efficacy and safety of neflamapimod in patients with DLB; the timing of the initiation of, and the design and endpoints of, any potential future trials, including the Company’s planned Phase 3 clinical trial evaluating the efficacy and safety of neflamapimod in patients with DLB; the Company’s need to acquire sufficient funding for any Phase 3 trial of neflamapimod in DLB; expectations with respect to neflamapimod, including the timing of any regulatory submissions and potential approvals thereof, if any; the timing of the Company’s potential submission of an NDA, if any; and the potential market for any DLB treatment that may be approved in the future. Terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “aims,” “seeks,” “intends,” “may,” “might,” “could,” “might,” “will,” “should,” “approximately,” “potential,” “target,” “project,” “contemplate,” “predict,” “forecast,” “continue,” or other words that convey uncertainty of future events or outcomes (including the negative of these terms) may identify these forward-looking statements. Although there is believed to be reasonable basis for each forward-looking statement contained herein, forward-looking statements by their nature involve risks and uncertainties, known and unknown, many of which are beyond the Company’s control and, as a result, actual results could differ materially from those expressed or implied in any forward-looking statement. Particular risks and uncertainties include, among other things, those related to: the Company’s available cash resources and the availability of additional funds on acceptable terms; the results of the Company’s clinical trials, including RewinD-LB; the likelihood and timing of any regulatory approval of neflamapimod or the nature of any feedback the Company may receive from the FDA; the ability to implement business plans, forecasts, and other expectations in the future; general economic, political, business, industry, and market conditions, inflationary pressures, and geopolitical conflicts; and the other factors discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the U.S. Securities and Exchange Commission (SEC) on March 17, 2025, and other filings that the Company may file from time to time with the SEC. Any forward-looking statements in this press release speak only as of the date hereof (or such earlier date as may be identified). The Company does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except to the extent required by law. Investor Contact: PJ Kelleher LifeSci Advisors [email protected] 617-430-7579
Related articleQuarter not tagged2025-08-11CervoMed Reports Second Quarter 2025 Financial Results and Provides Corporate Updates
GlobeNewswire
CervoMed Reports Second Quarter 2025 Financial Results and Provides Corporate Updates
Reported 32-week data from Phase 2b RewinD-LB Trial Extension phase showing neflamapimod treatment resulted in a substantial reduction in clinically significant worsening compared to control arm over 32 weeks, which improved further among patients who have minimal evidence of Alzheimer’s disease (AD) co-pathology (ptau181 < 2.2 pg/mL at screening) At week 32 of the Extension phase, patients treated with neflamapimod demonstrated a significant reduction from baseline in plasma levels of glial fibrillary acidic protein (GFAP) Plan to engage with U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025 to align on trial design for the Phase 3 program in Dementia with Lewy Bodies (DLB) BOSTON, Aug. 11, 2025 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders (CervoMed or the Company), today reported its financial results and corporate updates for the second quarter ended June 30, 2025. “With the reporting of both 16- and 32-week Extension phase data from the Phase 2b RewinD-LB trial, we have solidified the evidence for slowing clinical progression in DLB associated with neflamapimod treatment. This proof-of-concept, combined with the notable reductions seen in plasma levels of GFAP, an important blood-based biomarker of the underlying neurodegenerative process in DLB, provide us with valuable results and a deeper understanding that further increases our confidence in Phase 3 success and neflamapimod’s potential to make a meaningful difference for patients if approved. We are actively preparing for discussions with the FDA, which we expect to take place in the fourth quarter of 2025, to align on the design of our planned Phase 3 trial,” said John Alam, MD, Chief Executive Officer of CervoMed. Recent Highlights and Anticipated Milestones In July 2025, the Company presented 32-week results from the open-label Extension phase of the Phase 2b RewinD-LB trial at the Alzheimer’s Association International Conference in Toronto, Canada. Based on the primary endpoint of Clinical Dementia Rating Sum of Boxes (CDR-SB), patients treated with neflamapimod showed 54% risk reduction in clinically significant worsening compared to control at Week 32 of treatment (p=0.0037). This risk reduction improved to 64% (p=0.0001) among patients who have minimal evidence of AD co-patho…Read full documentShow less
Reported 32-week data from Phase 2b RewinD-LB Trial Extension phase showing neflamapimod treatment resulted in a substantial reduction in clinically significant worsening compared to control arm over 32 weeks, which improved further among patients who have minimal evidence of Alzheimer’s disease (AD) co-pathology (ptau181 < 2.2 pg/mL at screening) At week 32 of the Extension phase, patients treated with neflamapimod demonstrated a significant reduction from baseline in plasma levels of glial fibrillary acidic protein (GFAP) Plan to engage with U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025 to align on trial design for the Phase 3 program in Dementia with Lewy Bodies (DLB) BOSTON, Aug. 11, 2025 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders (CervoMed or the Company), today reported its financial results and corporate updates for the second quarter ended June 30, 2025. “With the reporting of both 16- and 32-week Extension phase data from the Phase 2b RewinD-LB trial, we have solidified the evidence for slowing clinical progression in DLB associated with neflamapimod treatment. This proof-of-concept, combined with the notable reductions seen in plasma levels of GFAP, an important blood-based biomarker of the underlying neurodegenerative process in DLB, provide us with valuable results and a deeper understanding that further increases our confidence in Phase 3 success and neflamapimod’s potential to make a meaningful difference for patients if approved. We are actively preparing for discussions with the FDA, which we expect to take place in the fourth quarter of 2025, to align on the design of our planned Phase 3 trial,” said John Alam, MD, Chief Executive Officer of CervoMed. Recent Highlights and Anticipated Milestones In July 2025, the Company presented 32-week results from the open-label Extension phase of the Phase 2b RewinD-LB trial at the Alzheimer’s Association International Conference in Toronto, Canada. Based on the primary endpoint of Clinical Dementia Rating Sum of Boxes (CDR-SB), patients treated with neflamapimod showed 54% risk reduction in clinically significant worsening compared to control at Week 32 of treatment (p=0.0037). This risk reduction improved to 64% (p=0.0001) among patients who have minimal evidence of AD co-pathology (ptau181 < 2.2 pg/mL at screening). In July 2025, the Company also announced that at Week 32 of the Phase 2b RewinD-LB Extension phase, there was a statistically significant reduction (p<0.0001) from baseline (i.e., start of Extension) in GFAP plasma levels in patients who received active neflamapimod for all 32 weeks, with a mean change of -18.4±4.0 pg/mL in all participants (N=107) and -21.2±4.4 pg/mL in participants with screening plasma ptau181 below 2.2 pg/mL (N=91). In contrast, placebo-recipients in the initial, double-blind phase of the trial had a mean increase from baseline to Week 16 of +1.1±3.0 pg/mL in all participants (N=74) and +1.1±3.3 pg/mL in the subset with screening plasma ptau181 below 2.2 pg/mL (N=65). The full details of these results can be found here. In June 2025, the Company announced that Marco Verwijs, PhD joined CervoMed as Executive Vice President, Technical Operations, a key senior leadership role to oversee the Company’s Chemistry, Manufacturing, and Controls (CMC) division and advance the development of neflamapimod through Phase 3 testing and preparation of commercial batches. In April 2025, the full 16-week results from the Extension phase of the Phase 2b RewinD-LB trial, demonstrating a meaningful beneficial impact on clinical progression in patients treated with neflamapimod compared to controls, were presented at the 19th International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurologic Disorders (AD/PD™) in Vienna, Austria. The full details of these results can be found here. The Company plans to meet with the FDA in the fourth quarter of 2025 to align on the design of the Company’s planned Phase 3 trial, which it plans to initiate in mid-2026 subject to available funding. Initial safety, biomarker and pharmacokinetic data from an ongoing trial in patients with mild-to-moderate DLB evaluating a twice daily regimen (80mg BID) of neflamapimod are expected to be available in the fourth quarter of 2025. In the second of quarter of 2025, CervoMed enrolled the first patients in a Phase 2a trial of neflamapimod in patients recovering from acute stroke and initiated a Phase 2a trial of neflamapimod in patients with the nonfluent/agrammatic variant of primary progressive aphasia (PPA) – a subtype of frontotemporal dementia (FTD) – in mid-2025. In November 2024, the FDA granted neflamapimod Orphan Drug designation for the treatment of FTD. Second Quarter 2025 Financial Results Cash Position: As of June 30, 2025, CervoMed had approximately $33.5 million in cash, cash equivalents and marketable securities, as compared to $38.9 million as of December 31, 2024. Based on its current operating plan, CervoMed believes its cash, cash equivalents and marketable securities on hand as of June 30, 2025, along with remaining funds to be received from the Company’s grant from the NIA, will enable the Company to fund its planned operating expenses and capital expenditure requirements into the third quarter of 2026. Grant Revenue: In January 2023, CervoMed was awarded a $21.0 million grant from the NIA to support the RewinD-LB trial and, in August 2024, CervoMed was awarded an additional $0.3 million under the grant. Grant revenue was approximately $1.8 million for the three months ended June 30, 2025, compared to approximately $3.3 million for the same period in 2024. The decrease is due to the completion of the initial, double-blind phase of the RewinD-LB Trial and transition to the Extension phase in December 2024. Research and Development (R&D) Expenses: R&D expenses for the quarter ended June 30, 2025, were approximately $5.1 million, compared to approximately $3.8 million in the same period in 2024. The increase of $1.3 million was primarily due to an increase in costs related to CMC activities, increased non-clinical studies, increased headcount costs, and outsourced CRO costs related to clinical work for neflamapimod, including costs related to our Phase 2a clinical trials of neflamapimod in recovery from acute stroke and with the nonfluent/agrammatic variant of PPA, both of which were initiated in the second quarter of 2025. General and Administrative (G&A) Expenses: G&A expenses were approximately $3.3 million during the three months ended June 30, 2025, versus approximately $2.5 million in the same period in 2024. The increase of $0.8 million was primarily due to headcount costs and outsourced services. Net Loss: Net loss was approximately $6.3 million for the three months ended June 30, 2025, compared to net loss of approximately $2.3 million for the same period in 2024. About the RewinD-LB Phase 2b Trial in Dementia with Lewy Bodies The initial phase of RewinD-LB was a randomized, 16-week, double-blind, placebo-controlled clinical trial evaluating oral neflamapimod (40mg TID) in 159 patients with DLB, followed by a 32-week neflamapimod-only treatment Extension phase. Patients with AD co-pathology, as assessed by plasma ptau181 levels, were excluded from the trial. Compared to patients with “pure” DLB – who may comprise up to 50% of the total diagnosed DLB patient population at any given time – DLB patients with AD co-pathology have significant, irreversible neuronal loss in the hippocampus that limits response to treatment. The primary endpoint in the trial is change in the CDR-SB, and secondary endpoints include the Alzheimer's Disease Cooperative Study — Clinical Global Impression of Change, the Timed Up and Go test, and a cognitive test battery. The RewinD-LB trial is funded primarily by a $21.3 million grant from the National Institutes of Health’s National Institute on Aging, which is expected to be disbursed over the course of the trial as costs are incurred. The trial includes 43 sites across in the United States, the United Kingdom, and the Netherlands. The initial phase of the study did not effectively evaluate the clinical activity of 40mg TID neflamapimod compared to placebo because the batch of neflamapimod capsules utilized during the placebo-controlled phase of the study did not lead to the plasma drug concentrations expected with such a dose. However, in the Extension phase, a portion of patients were administered a more recently manufactured batch of capsules that achieved targeted plasma drug concentrations, allowing the effects of 40 mg TID neflamapimod treatment to be effectively evaluated during the Extension phase, with patients receiving the newer capsules serving as an active drug arm. Outcomes in these patients were compared with those in the subset of patients who continued to receive the older batch of capsules during the Extension phase, which served as a control arm. About CervoMed CervoMed is a clinical-stage company focused on developing treatments for age-related neurologic disorders. The Company is currently developing neflamapimod, an investigational, orally administered small molecule brain penetrant that inhibits p38 mitogen-activated protein kinase alpha. Neflamapimod has the potential to treat synaptic dysfunction, the reversible aspect of the underlying neurodegenerative processes that cause disease in DLB and certain other major neurological disorders. Our recently completed Phase 2b trial evaluated neflamapimod in patients with DLB. Forward-Looking Statements This press release includes express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, regarding the intentions, plans, beliefs, expectations or forecasts for the future of the Company, including, but not limited to: the Company’s cash runway; the therapeutic potential of neflamapimod, including the degree of sustainability of any therapeutic effects; the anticipated timing and achievement of clinical and development milestones, including the Company’s announcement of additional data, if any, from the RewinD-LB Phase 2b clinical trial and any meeting or correspondence between the Company and the FDA; any other expected or implied benefits or results, including that any initial clinical results observed with respect to neflamapimod in the RewinD-LB trial will be replicated in later trials; and the timing of the initiation of any potential future trials or interactions with regulatory authorities, including the Company’s need to acquire sufficient funding for any Phase 3 trial of neflamapimod in DLB. Terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “aims,” “seeks,” “intends,” “may,” “might,” “could,” “might,” “will,” “should,” “approximately,” “potential,” “target,” “project,” “contemplate,” “predict,” “forecast,” “continue,” or other words that convey uncertainty of future events or outcomes (including the negative of these terms) may identify these forward-looking statements. Although there is believed to be reasonable basis for each forward-looking statement contained herein, forward-looking statements by their nature involve risks and uncertainties, known and unknown, many of which are beyond the Company’s control and, as a result, actual results could differ materially from those expressed or implied in any forward-looking statement. Particular risks and uncertainties include, among other things, those related to: the Company’s available cash resources and the availability of additional funds on acceptable terms; the results of the Company’s clinical trials, including RewinD-LB; the likelihood and timing of any regulatory approval of neflamapimod or the nature of any feedback the Company may receive from the FDA; the ability to implement business plans, forecasts, and other expectations in the future; general economic, political, business, industry, and market conditions, inflationary pressures, and geopolitical conflicts; and the other factors discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the U.S. Securities and Exchange Commission (SEC) on March 17, 2025, and other filings that the Company may file from time to time with the SEC. Any forward-looking statements in this press release speak only as of the date hereof (or such earlier date as may be identified). The Company does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except to the extent required by law. Investor Contact: PJ Kelleher LifeSci Advisors [email protected] 617-430-7579
Related articleQuarter not tagged2025-08-10CervoMed Second Quarter 2025 Earnings: Revenues Beat Expectations, EPS Lags
Simply Wall St.
CervoMed Second Quarter 2025 Earnings: Revenues Beat Expectations, EPS Lags
Explore CervoMed's Fair Values from the Community and select yours Revenue: US$1.76m (down 47% from 2Q 2024). Net loss: US$6.26m (loss widened by 170% from 2Q 2024). US$0.70 loss per share (further deteriorated from US$0.27 loss in 2Q 2024). This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue exceeded analyst estimates by 22%. Earnings per share (EPS) missed analyst estimates by 19%. Looking ahead, revenue is forecast to grow 11% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are up 12% from a week ago. You should always think about risks. Case in point, we've spotted 5 warning signs for CervoMed you should be aware of, and 2 of them don't sit too well with us. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Related articleQuarter not tagged2025-05-14CervoMed First Quarter 2025 Earnings: Beats Expectations
Simply Wall St.
CervoMed First Quarter 2025 Earnings: Beats Expectations
Revenue: US$1.92m (down 18% from 1Q 2024). Net loss: US$4.89m (loss widened by 95% from 1Q 2024). US$0.56 loss per share (further deteriorated from US$0.41 loss in 1Q 2024). Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue exceeded analyst estimates by 13%. Earnings per share (EPS) also surpassed analyst estimates by 9.0%. Looking ahead, revenue is forecast to grow 8.0% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are down 7.2% from a week ago. It's necessary to consider the ever-present spectre of investment risk. We've identified 4 warning signs with CervoMed (at least 2 which make us uncomfortable), and understanding these should be part of your investment process. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com.This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Related articleQuarter not tagged2025-05-12CervoMed Reports First Quarter 2025 Financial Results and Provides Corporate Updates
GlobeNewswire
CervoMed Reports First Quarter 2025 Financial Results and Provides Corporate Updates
Reported positive 16-week results from the extension phase of the Phase 2b RewinD-LB trial, demonstrating proof-of-concept for neflamapimod as a potential treatment for dementia with Lewy bodies (DLB) Plan to initiate Phase 3 trial of neflamapimod in DLB in mid-2026 following meeting with regulatory authorities Initiating separate Phase 2a trials to evaluate neflamapimod in patients with primary progressive aphasia and patients in the recovery phase after ischemic stroke BOSTON, May 12, 2025 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders (CervoMed or the Company), today reported its financial results for the first quarter ended March 31, 2025. “The first quarter of 2025 represented a tidal shift for CervoMed. We believe the evidence of slowed clinical progression demonstrated in the 16-week results from the extension phase of our RewinD-LB trial affirm our initial hypothesis of drug benefit, and explain the results from the initial phase of the trial reported in December 2024. More importantly, we believe the 16-week data demonstrate proof-of-concept for neflamapimod as a potential treatment for DLB, underscoring neflamapimod’s first-to-market potential for this devastating disease. We anticipate 32-week results from the extension phase in the second half of 2025 and are actively preparing for discussions with the U.S. Food and Drug Administration (FDA) regarding the design of our Phase 3 trial, which we plan to initiate in mid-2026,” said John Alam, MD, Chief Executive Officer of CervoMed. “In parallel, in the near future we will be initiating a Phase 2 trial evaluating neflamapimod in patients with primary progressive aphasia (PPA), and recently initiated a Phase 2 trial in patients recovering from ischemic stroke—important steps that we believe complement our lead DLB program, build on the compelling data seen so far, and expand our exploration of neflamapimod’s full therapeutic potential. I want to express my deep gratitude to our dedicated scientific team, as well as to the patients and caregivers participating in our clinical programs.” Recent Highlights and Anticipated Milestones In March 2025, CervoMed reported positive 16-week results from the extension phase of the RewinD-LB trial in which patients who were administered a more recently manufactured ba…Read full documentShow less
Reported positive 16-week results from the extension phase of the Phase 2b RewinD-LB trial, demonstrating proof-of-concept for neflamapimod as a potential treatment for dementia with Lewy bodies (DLB) Plan to initiate Phase 3 trial of neflamapimod in DLB in mid-2026 following meeting with regulatory authorities Initiating separate Phase 2a trials to evaluate neflamapimod in patients with primary progressive aphasia and patients in the recovery phase after ischemic stroke BOSTON, May 12, 2025 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders (CervoMed or the Company), today reported its financial results for the first quarter ended March 31, 2025. “The first quarter of 2025 represented a tidal shift for CervoMed. We believe the evidence of slowed clinical progression demonstrated in the 16-week results from the extension phase of our RewinD-LB trial affirm our initial hypothesis of drug benefit, and explain the results from the initial phase of the trial reported in December 2024. More importantly, we believe the 16-week data demonstrate proof-of-concept for neflamapimod as a potential treatment for DLB, underscoring neflamapimod’s first-to-market potential for this devastating disease. We anticipate 32-week results from the extension phase in the second half of 2025 and are actively preparing for discussions with the U.S. Food and Drug Administration (FDA) regarding the design of our Phase 3 trial, which we plan to initiate in mid-2026,” said John Alam, MD, Chief Executive Officer of CervoMed. “In parallel, in the near future we will be initiating a Phase 2 trial evaluating neflamapimod in patients with primary progressive aphasia (PPA), and recently initiated a Phase 2 trial in patients recovering from ischemic stroke—important steps that we believe complement our lead DLB program, build on the compelling data seen so far, and expand our exploration of neflamapimod’s full therapeutic potential. I want to express my deep gratitude to our dedicated scientific team, as well as to the patients and caregivers participating in our clinical programs.” Recent Highlights and Anticipated Milestones In March 2025, CervoMed reported positive 16-week results from the extension phase of the RewinD-LB trial in which patients who were administered a more recently manufactured batch of neflamapimod capsules had higher plasma drug concentration levels and demonstrated improvements on the primary outcome measure, Clinical Dementia Rating Sum of Boxes (CDR-SB) (p<0.001 v. old capsules; p=0.003 v. placebo), and a key secondary endpoint. The full details on these results can be found here. In April 2025, the full 16-week results from the extension phase of the Phase 2b RewinD-LB trial demonstrating a meaningful beneficial impact on clinical progression in patients treated with neflamapimod compared to controls were presented at the 19th International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurologic Disorders (AD/PD™) in Vienna, Austria. The full details of these results can be found here. The Company expects to report 32-week results from the extension phase of the RewinD-LB trial in the second half of 2025. Initial safety, biomarker and pharmacokinetic data from an ongoing trial in patients with mild-to-moderate DLB evaluating a twice daily regimen (80mg BID) of neflamapimod are expected to be available in the fourth quarter of 2025. The Company plans to initiate a Phase 3 trial in DLB in mid-2026, following a meeting with the FDA and subject to available funding. CervoMed recently initiated a Phase 2a trial evaluating neflamapimod in patients recovering from ischemic stroke and plans to initiate a Phase 2a trial in patients with the nonfluent/agrammatic variant of PPA – a subtype of frontotemporal dementia (FTD) – in mid-2025. In November 2024, the FDA granted neflamapimod Orphan Drug designation for the treatment of FTD. First Quarter 2025 Financial Results Cash Position: As of March 31, 2025, CervoMed had approximately $35.2 million in cash, cash equivalents and marketable securities, as compared to $38.9 million as of December 31, 2024. Based on its current operating plan, CervoMed believes its cash, cash equivalents and marketable securities on hand as of March 31, 2025, along with the remaining funds to be received from the Company’s grant from the National Institutes of Health’s National Institute on Aging (NIA), will enable the Company to fund its planned operating expenses and capital expenditure requirements into mid-2026. Grant Revenue: In January 2023, CervoMed was awarded a $21.0 million grant from the NIA to support the RewinD-LB trial and, in August 2024, CervoMed was awarded an additional $0.3 million under the grant. Grant revenue was approximately $1.9 million for the three months ended March 31, 2025, compared to approximately $2.3 million for the same period in 2024. This decrease was related to a decrease in services performed with respect to the RewinD-LB trial during the three months ended March 31, 2025, as a result of, among other things, the trial transitioning from the double-blind initial phase to the ongoing extension phase. Research and Development (R&D) Expenses: R&D expenses for the three months ended March 31, 2025, were approximately $4.8 million, compared to approximately $2.8 million in 2024. This increase was attributable to chemistry, manufacturing and controls activities, increased non-clinical studies, increased headcount costs, and outsourced contract research organization costs related to clinical work for neflamapimod, including start-up costs related to our recently initiated Phase 2a clinical trial in recovery after ischemic stroke and our planned Phase 2a clinical trial in PPA, which we intend to initiate in mid-2025. General and Administrative (G&A) Expenses: G&A expenses were approximately $2.4 million during the three months ended March 31, 2025, versus approximately $2.1 million in the same period in 2024. The increase was primarily due to increased headcount costs and outsourced services. Net Loss: Net loss was approximately $4.9 million for the three months ended March 31, 2025, compared to net loss of approximately $2.5 million for the same period in 2024. About the RewinD-LB Phase 2b Study in Dementia with Lewy BodiesThe initial phase of RewinD-LB is a randomized, 16-week, double-blind, placebo-controlled clinical trial evaluating oral neflamapimod (40mg TID), with a 32-week neflamapimod only treatment Extension phase in 159 patients with DLB. Patients with AD co-pathology, as assessed by plasma ptau181 levels, were excluded from the trial. Compared to patients with “pure” DLB – who may comprise up to 50% of the total diagnosed DLB patient population at any given time – DLB patients with Alzheimer’s disease co-pathology have significant, irreversible neuronal loss in the hippocampus that limits response to treatment. The primary outcome measure in the trial is change in CDR-SB, and secondary endpoints include Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change, the Timed Up and Go test, and a cognitive test battery. The RewinD-LB trial is funded primarily by a $21.3 million grant from the NIA, which is expected to be disbursed over the course of the trial as costs are incurred. The trial includes 43 sites across in the United States, the United Kingdom, and the Netherlands. Participants completing the 16-week initial phase of the trial were able to continue in the trial while receiving neflamapimod treatment for an additional 32-week extension phase, within which the same efficacy assessments were conducted during the first 16 weeks as were obtained during the Initial phase. About CervoMedCervoMed is a clinical-stage company focused on developing treatments for age-related neurologic disorders. The Company is currently developing neflamapimod, an investigational, orally administered small molecule brain penetrant that inhibits p38 mitogen-activated protein kinase alpha. Neflamapimod has the potential to treat synaptic dysfunction, the reversible aspect of the underlying neurodegenerative processes that cause disease in DLB and certain other major neurological disorders. Neflamapimod is currently being evaluated in a Phase 2b study in patients with DLB. Forward-Looking StatementsThis press release includes express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, regarding the intentions, plans, beliefs, expectations or forecasts for the future of the Company, including, but not limited to, the Company’s financial position and cash runway, the therapeutic potential of neflamapimod, the anticipated timing and achievement of clinical and development milestones, including the completion the RewinD-LB Phase 2b clinical trial and the Company’s announcement of additional data therefrom, any other expected or implied benefits or results, including that any initial clinical results observed with respect to neflamapimod in the AscenD-LB trial or RewinD-LB trial will be replicated in later trials, and the timing of the initiation of any potential future trials or interactions with regulatory authorities, including the Company’s need to acquire sufficient funding prior to initiating any Phase 3 trial of neflamapimod in DLB. Terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “aims,” “seeks,” “intends,” “may,” “might,” “could,” “might,” “will,” “should,” “approximately,” “potential,” “target,” “project,” “contemplate,” “predict,” “forecast,” “continue,” or other words that convey uncertainty of future events or outcomes (including the negative of these terms) may identify these forward-looking statements. Although there is believed to be reasonable basis for each forward-looking statement contained herein, forward-looking statements by their nature involve risks and uncertainties, known and unknown, many of which are beyond the Company’s control and, as a result, actual results could differ materially from those expressed or implied in any forward-looking statement. Particular risks and uncertainties include, among other things, those related to: the Company’s available cash resources and the availability of additional funds on acceptable terms; the results of the Company’s clinical trials, including RewinD-LB; the likelihood and timing of any regulatory approval of neflamapimod or the nature of any feedback the Company may receive from the FDA; the ability to implement business plans, forecasts, and other expectations in the future; general economic, political, business, industry, and market conditions, inflationary pressures, and geopolitical conflicts; and the other factors discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the U.S. Securities and Exchange Commission (SEC) on March 17, 2025, and other filings that the Company may file from time to time with the SEC. Any forward-looking statements in this press release speak only as of the date hereof (or such earlier date as may be identified). The Company does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except to the extent required by law. Investor Contact: PJ KelleherLifeSci [email protected]

