Tillkännagivande • Sep 27

Vaccinex Reports Groundbreaking Findings At Medical Conferences Supporting Development of Pepinemab for the Treatment of Neurodegenerative Diseases and Cancer

Vaccinex, Inc. will report on novel findings for its lead product, pepinemab, with implications for treatment of Alzheimer's and other slowly progressive neurodegenerative diseases and for cancer immunotherapy at two upcoming Medical Conferences. Results from phase 2 SIGNAL trial suggest pepinemab is the first therapeutic agent that appears to have the potential to prevent decline in brain metabolic activity and to slow or halt cognitive decline in Huntington’s disease (HD) [1], a slowly progressive, orphan neurodegenerative disease with many pathological similarities to the much more prevalent Alzheimer’s disease (AD). Encouraged by these findings, a separate, randomized, phase 1/2a study in AD is ongoing in which the last patient is anticipated to complete the planned 12-months of treatment in early June 2024. Pepinemab in combination with a checkpoint inhibitor is, to knowledge, the firsttreatment that has shown the potential to induce formation of lymphoid structures in tumors that promote efficient immune responses and are known to be associated with improved outcomes in head and neck cancer. Clinical results indicate an approximate doubling of objective responses (ORR) and progression free survival (PFS) relative to historical results with checkpoint monotherapy in patients with hard-to-treat tumors that express low levels of PD-L1 (CPS<20). Vaccinex completed enrollment in the randomized, double-blind SIGNAL-AD phase 1/2a study for early AD in May 2023. The last patient is anticipated to complete the planned 12 months of treatment by early June 2024 at which time the database will be locked and results analyzed. Key endpoints include brain metabolic activity along with measures of cognition specific to AD (CDR-SB, ADAS-Cog13) that have been recognized as clinically meaningful by the U.S. Food and Drug Administration (FDA). Investors will be aware of recent excitement surrounding full FDA approval of Eisai and Biogen’s drug Leqembi (lecanemab), the first anti-Aß amyloid antibody for treatment of AD. A second such drug from Eli Lilly, donanemab, has reported equivalent data and may be FDA approved before year end. Clinical consensus is that Leqembi and donanemab provide a modest but real benefit to patients at a very early stage of disease. Common side effects associated with these drugs, however, include an inflammatory and hemorrhagic response in brain denoted as ARIA. Although ARIA often resolves itself, it has proven to be life-threatening in a small percentage of patients. As a result, all patients treated with these drugs must be followed carefully with significant effort and expense to avoid complications. It is important to appreciate that pepinemab has a very different mechanism of action than Leqembi or donanemab and, in clinical studies conducted to date, has not been found to be associated with inflammatory responses in the brain. Believe that use of pepinemab to treat slowly progressive neurodegenerative diseases like AD has been substantially de-risked by results from completed phase 2 study in HD. Have had the opportunity to meet with several major pharmaceutical companies. Believe from their responses that they have prioritized improving treatments for AD. Believe that the prevalence of AD (6 million people diagnosed with AD in the US alone) and current concerns about the limitations of anti-Aß amyloid antibodies would make pepinemab attractive as a potential alternative to anti-Aß antibodies or possibly for use in combination with an anti-Aß for greater efficacy. The potential impact of the AD program on Vaccinex valuation and financial resources, therefore, make this Vaccinex’s most important near term catalyst. Highest priority in the coming months will be to complete the SIGNAL-AD trial, which believe may make substantial resources available for initiatives in cancer and other neurodegenerative diseases such as HD. The Phase 2 KEYNOTE-B84 study (NCT04815720) evaluated Vaccinex’s pepinemab antibody in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® for immunotherapy of recurrent or metastatic head and neck squamous cell carcinoma. Results of a preplanned interim analysis of the first 36 patients treated in this study indicated that the Objective Response (ORR) for the PD-L1 low population, CPS <20 (N=19), was 21.1% (2 CR and 2 PR) and median progression free survival (PFS) was 5.79 months, which are approximately twice that of historical ORR and PFS for checkpoint monotherapy in this population [2]. In contrast, in the CPS =20 (N=17) subgroup, the ORR and PFS for combination therapy was similar to historical checkpoint monotherapy. The improvement in response to treatment is important for the 55% of HNSCC patients whose tumors are characterized as CPS <20. These data are also consistent with a prior study in which observed that the combination of pepinemab with PD-L1 inhibitor BAVENCIO® (avelumab) appeared to approximately double ORR in patients with PD-L1-low non-small cell lung cancer (NCT03268057). In view of these clinical findings, investigated the changes in the tumor immune environment that might correlate with response to pepinemab treatment by analyzing pre-treatment and on-treatment tumor biopsies collected during the KEYNOTE-B84 study. The results indicate that treatment with pepinemab in combination with KEYTRUDA appears to induce formation of highly organized lymphoid aggregates in the tumor of patients who demonstrate disease control (complete response plus partial response plus stable disease). Such aggregates are characterized by a high density of B cells, antigen-presenting dendritic cells and activated T cells; further, treatment-induced increase in the number of aggregates correlates with Disease Control and with Progression Free Survival. Representative images of 5-week on-treatment biopsies. Left: from a patient with stable disease, tumor biopsy contains highly organized immune aggregates consisting of high density antigen presenting cells as well as T lymphocytes. Right: from a patient with progressive disease, immune cells in the tumor biopsy are disorganized and include relatively high levels of inhibitory T regulatory (Treg) cells, but relatively few antigen presenting cells (B cells, DC). Patients who experience clinical benefit (Disease Control) during treatment with pepinemab and KEYTRUDA have a higher frequency of mature immune aggregates with a high density of B cells in their on-treatment biopsy compared to their pre-treatment biopsies, p<0.0001. This difference is not observed in on- and pre-treatment biopsies from patients whose cancer progresses rapidly. One-way ANOVA, <0.0001; ns = not significant, p=0.05. Immune Aggregates correlate with PFS. On-treatment patient biopsies with B cell aggregates positively correlate with longer progression-free survival. Log Rank survival analysis, p= 0.0056.

Biotechs Tillväxt i branschen	17.04%
Intäkternas tillväxttakt	5.44%
Avkastning på eget kapital	n/a
Nettomarginal	-3,100.50%
Senaste uppdateringen av resultatet	31 Dec 2024

Datum	Intäkter	Intäkter	G+A Kostnader	FoU-kostnader
31 Dec 24	1	-19	7	0
30 Sep 24	0	-19	7	-3
30 Jun 24	0	-18	7	0
31 Mar 24	0	-19	7	0
31 Dec 23	1	-20	7	0
30 Sep 23	1	-22	7	3
30 Jun 23	1	-22	7	0
31 Mar 23	1	-20	6	0
31 Dec 22	0	-20	6	0
30 Sep 22	0	-19	6	10
30 Jun 22	0	-20	6	0
31 Mar 22	0	-20	6	0
31 Dec 21	1	-22	6	0
30 Sep 21	1	-24	7	-17
30 Jun 21	1	-28	7	0
31 Mar 21	1	-28	7	0
31 Dec 20	1	-29	7	0
30 Sep 20	1	-29	7	17
30 Jun 20	0	-28	7	0
31 Mar 20	0	-30	7	-7
31 Dec 19	1	-32	7	0
30 Sep 19	1	-34	6	7
30 Jun 19	1	-33	6	12
31 Mar 19	1	-31	5	25
31 Dec 18	1	-30	5	22
30 Sep 18	1	-24	4	20
30 Jun 18	0	-24	4	19
31 Mar 18	0	-23	5	17
31 Dec 17	0	-22	4	17
31 Dec 16	0	-26	4	16

Uppgifter	Senast uppdaterad (UTC-tid)
Analys av företag	2026/05/25 22:41
Aktiekurs vid dagens slut	2026/05/21 00:00
Intäkter	2024/12/31
Årlig intjäning	2024/12/31

Paket	Uppgifter	Tidsram	Exempel US-källa
Företagets finansiella ställning	10 år	Resultaträkning Kassaflödesanalys Balansräkning	SEC Form 10-K SEC Form 10-Q
Analytikernas konsensusuppskattningar	+3 år	Prognos för finansiella poster Analytikernas prismål	Rapporter från analytiker Blue Matrix
Marknadspriser	30 år	Aktiekurser Utdelningar, splittar och åtgärder	ICE Marknadsdata SEC Form S-1
Ägarskap	10 år	Största aktieägare Insiderhandel	SEC Formulär 4 SEC Formulär 13D
Förvaltning	10 år	Ledningsgrupp Styrelse och verkställande direktörer	SEC Form 10-K SEC Form DEF 14A
Viktiga utvecklingstendenser	10 år	Företagsmeddelanden	SEC Formulär 8-K

Analytiker	Institution
Thomas Shrader	BTIG
Matthew Kaplan	Ladenburg Thalmann & Company
Leland Gershell	Oppenheimer & Co. Inc.

Vaccinex Tidigare resultatutveckling

Tidigare kriterier kontrolleras 0/6

Viktig information

Senaste uppdateringar av tidigare prestationer

Full year 2023 earnings released: US$43.68 loss per share (vs US$98.05 loss in FY 2022)

First half 2022 earnings released: US$0.24 loss per share (vs US$0.47 loss in 1H 2021)

Recent updates

Vaccinex to Report Promising New Clinical Results of Neoadjuvant Treatment with Pepinemab to Enhance Immunotherapy in Patients with Head and Neck Cancer At Asco Annual Meeting

Vaccinex to Report Promising New Clinical Data Revealing Pepinemab's Unique Mechanism to Enhance Immunotherapy at Annual Meeting of American Association for Cancer Research (AACR)

Vaccinex, Inc. announced delayed annual 10-K filing

Vaccinex, Inc. Files Form 15

Vaccinex, Inc. Intends to Delist Common Stock from Nasdaq

Vaccinex, Inc.(OTCPK:VCNX) dropped from S&P TMI Index

Vaccinex, Inc.(OTCPK:VCNX) dropped from NASDAQ Composite Index

Vaccinex, Inc. announced that it has received $2.149995 million in funding from Vaccinex (Rochester), L.L.C, FCMI Parent Co.

Vaccinex, Inc. Reports New Findings for Signal-AD Phase 1b/2 Trial of Pepinemab at Clinical Trials on Alzheimer's Disease Conference in Madrid, Spain

Vaccinex Receives Non-Compliance Letter Regarding Nasdaq Listing Rule 5550(b)(1)

New major risk - Financial position

Vaccinex Provides Update on New Findings for SIGNAL-AD Phase 1b/2 Trial of Pepinemab in Alzheimer’s Disease and Plans to Pursue a Development Partnership

Vaccinex, Inc. Reports Positive Data for Signal-Ad Phase 1B/2 Trial of Pepinemab in Alzheimer’S Disease

Insufficient new directors

Vaccinex Reports Completion of Last Patient Visit in Randomized, SIGNAL-AD Phase 1b/2 Study of Pepinemab Treatment for Alzheimer’s Disease

Vaccinex, Inc. announced that it has received $1.75 million in funding

Vaccinex, Inc. announced delayed annual 10-K filing

Full year 2023 earnings released: US$43.68 loss per share (vs US$98.05 loss in FY 2022)

Vaccinex, Inc. announced that it expects to receive $1.49961 million in funding

Vaccinex, Inc. has filed a Follow-on Equity Offering.

Vaccinex Announces 1-for-14 Reverse Stock Split to Regain Compliance with the Minimum Bid Price Requirement of The Nasdaq Capital Market

Vaccinex, Inc. announced that it expects to receive $3.700126 million in funding

New major risk - Market cap size

New major risk - Financial position

Vaccinex, Inc. Reports Clinical Benefit in Interim Analyses from Two Phase 2 Studies of Pepinemab Combination Treatment At Society for Immunotherapy of Cancer's Annual Meeting

Vaccinex Reports Positive Effect of Pepinemab Treatment on New Biomarker of Brain Inflammation in Neurodegenerative Diseases

Vaccinex Receives Non-Compliance Notice From Nasdaq

Vaccinex's Next Generation ActivMAb®? Technology Published in mAbs

Vaccinex, Inc. to Present Update on PDAC/Pepinemab Study

Vaccinex Reports Groundbreaking Findings At Medical Conferences Supporting Development of Pepinemab for the Treatment of Neurodegenerative Diseases and Cancer

Vaccinex, Inc. Provides Nasdaq Compliance Update

Vaccinex, Inc. announced that it has received $0.65 million in funding

New major risk - Financial position

New minor risk - Share price stability

Vaccinex Receives Letter from the Listing Qualifications Staff of the Nasdaq Notifying the Company No Longer Complies with the Requirement Under Nasdaq Listing Rule 5550(b)(1)

Vaccinex, Inc. announced that it has received $2.959999 million in funding from FCMI Parent Co.

Vaccinex, Inc. Announces First Patient Dosed with Anti-Ccr8 Antibody Licensed to Surface Oncology

Insufficient new directors

Vaccinex, Inc. and its Collaborators Present Two Abstracts Related to Pepinemab Combination Immunotherapy Trials at 37Th Annual Meeting of Society for Immunotherapy of Cancer

Vaccinex Receives a Letter from the Listing Qualifications Staff of the Nasdaq Stock Market Regarding Minimum Bid Requirement

First half 2022 earnings released: US$0.24 loss per share (vs US$0.47 loss in 1H 2021)

Insufficient new directors

Vaccinex, Inc., Annual General Meeting, May 12, 2022

Vaccinex, Inc. announced that it expects to receive $6.599997 million in funding

Vaccinex Reports Two Complete Responses in First Three Patients Enrolled in the Phase 1B/2 KEYNOTE-B84 Study of Pepinemab in Combination with KEYTRUDA (Pembrolizumab) in Patients with Recurrent or Metastatic Head and Neck Cancer

Vaccinex, Inc. Reports Phase Ib KEYNOTE B84 Combination Study of Keytruda® and Pepinemab in Patients with Advanced, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Passes Planned Interim Safety Analysis

Vaccinex to Present at the Oppenheimer & Co. Inc. Fall Healthcare Life Sciences and MedTech Summit

Rock star Growth Puts Vaccinex (NASDAQ:VCNX) In A Position To Use Debt

Price target decreased to US$7.00

Vaccinex, Inc.(NasdaqCM:VCNX) dropped from Russell Microcap Value Index

Vaccinex, Inc. Announces Activation of Clinical Sites to Enroll Patients in Studies of Pepinemab as Single Agent in Alzheimer’s Disease

Vaccinex, Inc. Announces Initiation of Phase 2 Clinical Trial with Merck’s anti-PD-1 therapy KEYTRUDA

Fördelning av intäkter och kostnader

Resultat- och intäktshistorik

Fritt kassaflöde vs resultatanalys

Analys av tidigare vinsttillväxt

Avkastning på eget kapital

Avkastning på tillgångar

Avkastning på sysselsatt kapital

Upptäck starka bolag som tidigare presterat bra

Företagsanalys och finansiella data Status

Datakällor

Analysmodell och snöflinga

Industri- och sektormått

Källor för analytiker