AB Science reports fourth consecutive case of response from Phase 1 data for the combination of AB8939 with venetoclax for the treatment of refractory or relapsed acute myeloid leukemia

AB Science reports fourth consecutive case of response from Phase 1 data for the combination of AB8939 with venetoclax for the treatment of refractory or relapsed acute myeloid leukemia




AB Science reports fourth consecutive case of response from Phase 1 data for the combination of AB8939 with venetoclax for the treatment of refractory or relapsed acute myeloid leukemia

PRESS RELEASE

AB SCIENCE REPORTS FOURTH CONSECUTIVE CASE OF RESPONSE FROM PHASE 1 DATA FOR THE COMBINATION OF AB8939 WITH VENETOCLAX FOR THE TREATMENT OF REFRACTORY OR RELAPSED ACUTE MYELOID LEUKEMIA

  • The combination treatment was well-tolerated, with no hematological toxicity and no dose limiting toxicity
  • The fourth patient had a complex karyotype including a monosomy of chromosome 5 and TP53 mutation, and was in the third-line of treatment. He had a near complete response after 14 days of treatment with AB8939 at 21 mg/m2 plus venetoclax
  • This is the fourth patient responding to the combination from a total of 4 patients treated
  • The partial response rate is 100% (4/4), including one patient in complete remission, one near complete response and 2 partial responses
  • The results were obtained after the first cycle of treatment (14 days) in patients receiving third- or fourth-line treatment, two of whom had previously progressed on venetoclax in combination with other chemotherapies
  • These four patients all have very difficult to treat cytogenetic profiles, including complex karyotype, TP53 mutation, NRAS mutation, monosomy 5 and MECOM-rearrangement, that typically have a poor prognosis due to their aggressive disease course and treatment resistance
  • This diversity of responsive patients appears to corroborate the mechanism of action of AB8939, which is capable of destabilizing microtubules while evading multi-drug resistance and also targeting cancer stem cells without eliminating non tumoral stem cells
  • These results corroborate the positioning of AB8939 in patients with adverse genetics, complex karyotypes, TP53 mutations, NRAS and KRAS mutations, monosomy 5 and 7, and MECOM-rearrangement, which represents the highest unmet medical need.

Paris, 07 January 2026, 6pm CET

AB Science SA (Euronext – FR0010557264 – AB) today provides an update on the Phase 1 study of the molecule AB8939 and the fourth consecutive response with the combination of AB8939 + venetoclax in patients with acute myeloid leukemia (AML) associated with a very unfavorable genetic profile.

The fourth patient received AB8939 (21.3 mg/m²) plus venetoclax for 14 days.

The patient had AML with a very negative risk profile,

  • complex karyotype including a monosomy of chromosome 5 and also an identified TP53 mutation
  • in third-line of treatment, having progressed after CPX-351 treatment and Citarine + Idarrubincine + Fludarabine (3+7) regimen.

Under the AB8939 + venetoclax combination, the patient achieved a partial response.

This fourth result is consistent with the responses previously reported on October 14, 2025, in the first three patients who received AB8939 + venetoclax.

Nicholas J. Short, MD, Associate Professor and Co-Lead of the Section of Developmental Therapeutics, Department of Leukemia, MD Anderson Cancer Center, said, “This new data is very encouraging, particularly considering the very adverse risk profile of this patient’s leukemia. These early efficacy and safety data suggest that AB8939 can be combined with venetoclax and could have significant activity in the highest-risk subtypes of AML. There is a strong interest in continuing the development of this combination in patients whose AML has high-risk features that are expected to lead to resistance to venetoclax + azacitidine.

Professor Olivier Hermine, MD, President of the Scientific Committee of AB Science and member of the Académie des Sciences in France, said, “There is a strong rationale to combine AB8939 and venetoclax as both molecules have low hematologic toxicity and complementary mode of actions. These first results are supportive of this rationale.”

About AB8939

AB8939 is a drug candidate that targets (i) cancer cells by destabilizing microtubules (essential for cell division) and (ii) cancer stem cells by inhibiting ALDH1A1 and ALDH2 (enzymes essential for maintaining their physiological state and survival).

  • AB8939 has shown in vitro activity in Ara-C (cytarabine, which is one of the standards of care) resistant patient cell lines, including adverse genetic MECOM and TP53 mutations.
  • Analysis of cell lines responsive to AB8939 showed that AB8939 is effective in cell lines with TP53 mutations, MECOM, and complex karyotypes, whereas ARAC and azacitidine are not effective.
  • AB8939 increased survival and had an additive effect in combination with venetoclax (another standard of care) in vivo in a MECOM-grafted PDX mouse model.
  • AB8939 increased survival and had an additive effect in combination with Vidaza (azacitidine, another standard of care) in vivo in the MECOM PDX#C1005 mouse model of leukemia.
  • AB8939 eradicated Leukemia Cancer Stem Cells in vivo in a human PDX AML mouse model, which is compatible with targeting stem cells via ALDH.

AB8939 is currently being evaluated in a Phase 1 clinical trial (study AB18001, NCT05211570) in patients with refractory and relapsed AML.

The Phase 1 clinical trial of AB8939 has completed its first two stages, which consisted of determining the maximum tolerated dose (MTD) after 3 and 14 consecutive days of monotherapy. In both cases, the MTD was 21.3 mg/m².

The third stage, currently underway, involves evaluating the combination of AB8939 and venetoclax. Three patients were evaluated at the first dose level (AB8939 14 days at a dose of 16 mg/m² + venetoclax 14 days). The current dose level evaluates (AB8939 14 days at a dose of 21.3 mg/m² + venetoclax 14 days)

Medical need in AML and AB8939 mechanism of action

Although several drugs have been registered for AML, 70% of patients still relapse and die, creating a persistent unmet medical need for effective treatments. Acute myeloid leukemia remains the most lethal form of leukemia in humans.

AML is a heterogeneous disease, and its outcome is highly dependent on genetic factors. TP53 mutation has a very poor prognosis, with a median overall survival (OS) of 5.5 months. NRAS and KRAS mutants have a poor prognosis, with a median OS of 12.1 months. MECOM also has a very poor prognosis in AML, with a median OS of 5.5 months in relapsed or refractory settings.

The challenge in AML is the recurrence of tumors due to a combination of two factors: the resistance of cancer cells to chemotherapy and relapse due to the persistence of cancer stem cells. This challenge may be overcome by AB8939’s dual mechanism of action.

  • First, AB8939 blocks the proliferation of leukemia cells through microtubule disruption. It is not subject to multi-drug resistance as it does not bind to PgP, which is responsible for efflux outside the cells, and is not degraded by myeloperoxidase.
    • Second, AB8939 targets leukemia cancer stem cells by inhibiting ALDH and promotes bone marrow repopulation of normal progenitors.

AB8939 + venetoclax combination

There is a strong rationale to combine AB8939 with venetoclax

  • Both molecules exhibit low hematologic toxicity. This combination is expected to be less toxic than azacitidine + venetoclax as first-line treatment for AML
  • These molecules have different and complementary targets in cancer cells. There is an additive, even synergistic, efficacy potential for the combination, with three mechanisms of action in a single treatment.
    • Venetoclax’s mechanism of action inhibits the BCL2 pathway, a protein that prevents apoptosis (programmed cell death) in cancer cells. BCL2 is a key factor in AML resistance, as it allows cancer cells to survive despite treatment
    • AB8939 is pro-apoptotic, destabilizing microtubules, and would benefit from BCL2 inhibition to optimize apoptosis
    • In addition, AB8939 specifically targets cancer stem cells by inhibiting ALDH, reducing resistance to treatment and limiting the risk of relapse

Next steps

The next step is to complete phase 1 in combination and launch an expansion study in approximately 15 AML patients eligible for AB8939 + venetoclax at the appropriate dose. The expansion phase is expected to generate robust preliminary evidence of efficacy in the AML label, sufficient to support the clinical development plan and a beneficial partnership agreement.

AB Science has started to discuss three possibilities for registration studies, which are not mutually exclusive, with the European Medicines Agency (EMA) and US Food and Drug Administration (FDA):

  • AB8939 + venetoclax as first-line treatment, with aged patients and/or patients with adverse genetics (complex karyotypes, TP53 mutations, NRAS and KRAS mutations, monosomy 5 and 7, and MECOM-rearrangement)
  • AB8939 + venetoclax as a second- or third-line treatment, in all patients or patients with adverse genetics
  • AB8939 as a single agent in MECOM as a second or third-line treatment.

Addressable market with AB8939 in relapsed/refractory AML

Treatments for relapsed or refractory AML represent an estimated market size potential of greater than EUR 2 billion per annum.

Region Incidence Case
(1)
% Relapse or Refractory (2,3) % Insured Patients (4) Drug Price (€) Market Size
(per in Mio EUR)
USA / CANADA 23,700 50%

 

 

 

 

 

90% 100,000(5) 1 000 000
EUROPE 27,600 90% 60,000 770 000
APAC 27,800 30% 60,000 250 000
INDIA 11,000 30% 60,000 100,000
LATAM 7,200 30% 60,000 65 000
MENA 3,900 30% 60,000 35 000
TOTAL 90,200       2 200 000

EUROPE = EU27 + Norway + United Kingdom + Switzerland ; APAC = Australia, People’s Republic of China , Japan, New Zealand, Singapore, Taiwan ; LATAM = Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico ; MENA = Algeria, Bahrain, Egypt, Israel, Kuwait, Morocco, Oman, Qatar, Saudi Arabia, Tunisia, United Arab Emirates
(1)    Zhou, Y et al. Global, regional, and national burden of acute myeloid leukemia, 1990–2021: a systematic analysis for the global burden of disease study 2021. Biomark Res 12, 101 (2024).
(2)    Ravandi F. Relapsed acute myeloid leukemia: Why is there no standard of care Best Pract Res Clin Haematol. 2013;26(3):253-9
(3)    Walter RB et al. Resistance prediction in AML: analysis of 4601 patients from MRC/NCRI, HOVON/SAKK, SWOG and MD Anderson Cancer Center. Leukemia (2015) 29:312–20. .
(4)    Estimated
(5)    Choi M. et al. Costs per patient achieving remission with venetoclax-based combinations in newly diagnosed patients with acute myeloid leukemia ineligible for intensive induction chemotherapy. Journal of Managed Care & Specialty Pharmacy Volume 28, Number 9. https://doi.org/10.18553/jmcp.2022.22021

Intellectual property

AB8939 intellectual property rights in AML are secured until 2036 through a ‘composition of matter’ patent and potentially until 2041 with a 5 years extension. Two additional ‘second medical use’ patent applications have been filed to protect the use of AB8939 in the treatment of AML with specific chromosomal abnormalities. If these applications are accepted, the protection for AB8939 will be extended until 2044 and 2046 for these AML subpopulations.

AB8939 has also received orphan drug designation for AML by both the EMA and FDA. This orphan drug designation confers 10 and 7 years of marketing exclusivity in Europe and the US, respectively, from the date of product registration.

AB Science is the sole proprietary holder of AB8939 and its family of compounds.

About AB Science
Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins whose action are key in signaling pathways within cells. Our programs target only diseases with high unmet medical needs, often lethal with short term survival or rare or refractory to previous line of treatment.
AB Science has developed a proprietary portfolio of molecules and the Company’s lead compound, masitinib, has already been registered for veterinary medicine and is developed in human medicine in oncology, neurological diseases, inflammatory diseases and viral diseases. The company is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB).

Further information is available on AB Science’s website:
www.ab-science.com.

Forward-looking Statements – AB Science
This press release contains forward-looking statements. These statements are not historical facts. These statements include projections and estimates as well as the assumptions on which they are based, statements based on projects, objectives, intentions and expectations regarding financial results, events, operations, future services, product development and their potential or future performance.

These forward-looking statements can often be identified by the words “expect”, “anticipate”, “believe”, “intend”, “estimate” or “plan” as well as other similar terms. While AB Science believes these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties that are difficult to predict and generally beyond the control of AB Science and which may imply that results and actual events significantly differ from those expressed, induced or anticipated in the forward-looking information and statements. These risks and uncertainties include the uncertainties related to product development of the Company which may not be successful or to the marketing authorizations granted by competent authorities or, more generally, any factors that may affect marketing capacity of the products developed by AB Science, as well as those developed or identified in the public documents published by AB Science. AB Science disclaims any obligation or undertaking to update the forward-looking information and statements, subject to the applicable regulations, in particular articles 223-1 et seq. of the AMF General Regulations.

For additional information, please contact:

AB Science
Financial Communication & Media Relations
investors@ab-science.com

Attachment

AB Science reports fourth consecutive case of response from Phase 1 data for the combination of AB8939 with venetoclax for the treatment of refractory or relapsed acute myeloid leukemia

AB Science reports fourth consecutive case of response from Phase 1 data for the combination of AB8939 with venetoclax for the treatment of refractory or relapsed acute myeloid leukemia




AB Science reports fourth consecutive case of response from Phase 1 data for the combination of AB8939 with venetoclax for the treatment of refractory or relapsed acute myeloid leukemia

PRESS RELEASE

AB SCIENCE REPORTS FOURTH CONSECUTIVE CASE OF RESPONSE FROM PHASE 1 DATA FOR THE COMBINATION OF AB8939 WITH VENETOCLAX FOR THE TREATMENT OF REFRACTORY OR RELAPSED ACUTE MYELOID LEUKEMIA

  • The combination treatment was well-tolerated, with no hematological toxicity and no dose limiting toxicity
  • The fourth patient had a complex karyotype including a monosomy of chromosome 5 and TP53 mutation, and was in the third-line of treatment. He had a near complete response after 14 days of treatment with AB8939 at 21 mg/m2 plus venetoclax
  • This is the fourth patient responding to the combination from a total of 4 patients treated
  • The partial response rate is 100% (4/4), including one patient in complete remission, one near complete response and 2 partial responses
  • The results were obtained after the first cycle of treatment (14 days) in patients receiving third- or fourth-line treatment, two of whom had previously progressed on venetoclax in combination with other chemotherapies
  • These four patients all have very difficult to treat cytogenetic profiles, including complex karyotype, TP53 mutation, NRAS mutation, monosomy 5 and MECOM-rearrangement, that typically have a poor prognosis due to their aggressive disease course and treatment resistance
  • This diversity of responsive patients appears to corroborate the mechanism of action of AB8939, which is capable of destabilizing microtubules while evading multi-drug resistance and also targeting cancer stem cells without eliminating non tumoral stem cells
  • These results corroborate the positioning of AB8939 in patients with adverse genetics, complex karyotypes, TP53 mutations, NRAS and KRAS mutations, monosomy 5 and 7, and MECOM-rearrangement, which represents the highest unmet medical need.

Paris, 07 January 2026, 6pm CET

AB Science SA (Euronext – FR0010557264 – AB) today provides an update on the Phase 1 study of the molecule AB8939 and the fourth consecutive response with the combination of AB8939 + venetoclax in patients with acute myeloid leukemia (AML) associated with a very unfavorable genetic profile.

The fourth patient received AB8939 (21.3 mg/m²) plus venetoclax for 14 days.

The patient had AML with a very negative risk profile,

  • complex karyotype including a monosomy of chromosome 5 and also an identified TP53 mutation
  • in third-line of treatment, having progressed after CPX-351 treatment and Citarine + Idarrubincine + Fludarabine (3+7) regimen.

Under the AB8939 + venetoclax combination, the patient achieved a partial response.

This fourth result is consistent with the responses previously reported on October 14, 2025, in the first three patients who received AB8939 + venetoclax.

Nicholas J. Short, MD, Associate Professor and Co-Lead of the Section of Developmental Therapeutics, Department of Leukemia, MD Anderson Cancer Center, said, “This new data is very encouraging, particularly considering the very adverse risk profile of this patient’s leukemia. These early efficacy and safety data suggest that AB8939 can be combined with venetoclax and could have significant activity in the highest-risk subtypes of AML. There is a strong interest in continuing the development of this combination in patients whose AML has high-risk features that are expected to lead to resistance to venetoclax + azacitidine.

Professor Olivier Hermine, MD, President of the Scientific Committee of AB Science and member of the Académie des Sciences in France, said, “There is a strong rationale to combine AB8939 and venetoclax as both molecules have low hematologic toxicity and complementary mode of actions. These first results are supportive of this rationale.”

About AB8939

AB8939 is a drug candidate that targets (i) cancer cells by destabilizing microtubules (essential for cell division) and (ii) cancer stem cells by inhibiting ALDH1A1 and ALDH2 (enzymes essential for maintaining their physiological state and survival).

  • AB8939 has shown in vitro activity in Ara-C (cytarabine, which is one of the standards of care) resistant patient cell lines, including adverse genetic MECOM and TP53 mutations.
  • Analysis of cell lines responsive to AB8939 showed that AB8939 is effective in cell lines with TP53 mutations, MECOM, and complex karyotypes, whereas ARAC and azacitidine are not effective.
  • AB8939 increased survival and had an additive effect in combination with venetoclax (another standard of care) in vivo in a MECOM-grafted PDX mouse model.
  • AB8939 increased survival and had an additive effect in combination with Vidaza (azacitidine, another standard of care) in vivo in the MECOM PDX#C1005 mouse model of leukemia.
  • AB8939 eradicated Leukemia Cancer Stem Cells in vivo in a human PDX AML mouse model, which is compatible with targeting stem cells via ALDH.

AB8939 is currently being evaluated in a Phase 1 clinical trial (study AB18001, NCT05211570) in patients with refractory and relapsed AML.

The Phase 1 clinical trial of AB8939 has completed its first two stages, which consisted of determining the maximum tolerated dose (MTD) after 3 and 14 consecutive days of monotherapy. In both cases, the MTD was 21.3 mg/m².

The third stage, currently underway, involves evaluating the combination of AB8939 and venetoclax. Three patients were evaluated at the first dose level (AB8939 14 days at a dose of 16 mg/m² + venetoclax 14 days). The current dose level evaluates (AB8939 14 days at a dose of 21.3 mg/m² + venetoclax 14 days)

Medical need in AML and AB8939 mechanism of action

Although several drugs have been registered for AML, 70% of patients still relapse and die, creating a persistent unmet medical need for effective treatments. Acute myeloid leukemia remains the most lethal form of leukemia in humans.

AML is a heterogeneous disease, and its outcome is highly dependent on genetic factors. TP53 mutation has a very poor prognosis, with a median overall survival (OS) of 5.5 months. NRAS and KRAS mutants have a poor prognosis, with a median OS of 12.1 months. MECOM also has a very poor prognosis in AML, with a median OS of 5.5 months in relapsed or refractory settings.

The challenge in AML is the recurrence of tumors due to a combination of two factors: the resistance of cancer cells to chemotherapy and relapse due to the persistence of cancer stem cells. This challenge may be overcome by AB8939’s dual mechanism of action.

  • First, AB8939 blocks the proliferation of leukemia cells through microtubule disruption. It is not subject to multi-drug resistance as it does not bind to PgP, which is responsible for efflux outside the cells, and is not degraded by myeloperoxidase.
    • Second, AB8939 targets leukemia cancer stem cells by inhibiting ALDH and promotes bone marrow repopulation of normal progenitors.

AB8939 + venetoclax combination

There is a strong rationale to combine AB8939 with venetoclax

  • Both molecules exhibit low hematologic toxicity. This combination is expected to be less toxic than azacitidine + venetoclax as first-line treatment for AML
  • These molecules have different and complementary targets in cancer cells. There is an additive, even synergistic, efficacy potential for the combination, with three mechanisms of action in a single treatment.
    • Venetoclax’s mechanism of action inhibits the BCL2 pathway, a protein that prevents apoptosis (programmed cell death) in cancer cells. BCL2 is a key factor in AML resistance, as it allows cancer cells to survive despite treatment
    • AB8939 is pro-apoptotic, destabilizing microtubules, and would benefit from BCL2 inhibition to optimize apoptosis
    • In addition, AB8939 specifically targets cancer stem cells by inhibiting ALDH, reducing resistance to treatment and limiting the risk of relapse

Next steps

The next step is to complete phase 1 in combination and launch an expansion study in approximately 15 AML patients eligible for AB8939 + venetoclax at the appropriate dose. The expansion phase is expected to generate robust preliminary evidence of efficacy in the AML label, sufficient to support the clinical development plan and a beneficial partnership agreement.

AB Science has started to discuss three possibilities for registration studies, which are not mutually exclusive, with the European Medicines Agency (EMA) and US Food and Drug Administration (FDA):

  • AB8939 + venetoclax as first-line treatment, with aged patients and/or patients with adverse genetics (complex karyotypes, TP53 mutations, NRAS and KRAS mutations, monosomy 5 and 7, and MECOM-rearrangement)
  • AB8939 + venetoclax as a second- or third-line treatment, in all patients or patients with adverse genetics
  • AB8939 as a single agent in MECOM as a second or third-line treatment.

Addressable market with AB8939 in relapsed/refractory AML

Treatments for relapsed or refractory AML represent an estimated market size potential of greater than EUR 2 billion per annum.

Region Incidence Case
(1)
% Relapse or Refractory (2,3) % Insured Patients (4) Drug Price (€) Market Size
(per in Mio EUR)
USA / CANADA 23,700 50%

 

 

 

 

 

90% 100,000(5) 1 000 000
EUROPE 27,600 90% 60,000 770 000
APAC 27,800 30% 60,000 250 000
INDIA 11,000 30% 60,000 100,000
LATAM 7,200 30% 60,000 65 000
MENA 3,900 30% 60,000 35 000
TOTAL 90,200       2 200 000

EUROPE = EU27 + Norway + United Kingdom + Switzerland ; APAC = Australia, People’s Republic of China , Japan, New Zealand, Singapore, Taiwan ; LATAM = Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico ; MENA = Algeria, Bahrain, Egypt, Israel, Kuwait, Morocco, Oman, Qatar, Saudi Arabia, Tunisia, United Arab Emirates
(1)    Zhou, Y et al. Global, regional, and national burden of acute myeloid leukemia, 1990–2021: a systematic analysis for the global burden of disease study 2021. Biomark Res 12, 101 (2024).
(2)    Ravandi F. Relapsed acute myeloid leukemia: Why is there no standard of care Best Pract Res Clin Haematol. 2013;26(3):253-9
(3)    Walter RB et al. Resistance prediction in AML: analysis of 4601 patients from MRC/NCRI, HOVON/SAKK, SWOG and MD Anderson Cancer Center. Leukemia (2015) 29:312–20. .
(4)    Estimated
(5)    Choi M. et al. Costs per patient achieving remission with venetoclax-based combinations in newly diagnosed patients with acute myeloid leukemia ineligible for intensive induction chemotherapy. Journal of Managed Care & Specialty Pharmacy Volume 28, Number 9. https://doi.org/10.18553/jmcp.2022.22021

Intellectual property

AB8939 intellectual property rights in AML are secured until 2036 through a ‘composition of matter’ patent and potentially until 2041 with a 5 years extension. Two additional ‘second medical use’ patent applications have been filed to protect the use of AB8939 in the treatment of AML with specific chromosomal abnormalities. If these applications are accepted, the protection for AB8939 will be extended until 2044 and 2046 for these AML subpopulations.

AB8939 has also received orphan drug designation for AML by both the EMA and FDA. This orphan drug designation confers 10 and 7 years of marketing exclusivity in Europe and the US, respectively, from the date of product registration.

AB Science is the sole proprietary holder of AB8939 and its family of compounds.

About AB Science
Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins whose action are key in signaling pathways within cells. Our programs target only diseases with high unmet medical needs, often lethal with short term survival or rare or refractory to previous line of treatment.
AB Science has developed a proprietary portfolio of molecules and the Company’s lead compound, masitinib, has already been registered for veterinary medicine and is developed in human medicine in oncology, neurological diseases, inflammatory diseases and viral diseases. The company is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB).

Further information is available on AB Science’s website:
www.ab-science.com.

Forward-looking Statements – AB Science
This press release contains forward-looking statements. These statements are not historical facts. These statements include projections and estimates as well as the assumptions on which they are based, statements based on projects, objectives, intentions and expectations regarding financial results, events, operations, future services, product development and their potential or future performance.

These forward-looking statements can often be identified by the words “expect”, “anticipate”, “believe”, “intend”, “estimate” or “plan” as well as other similar terms. While AB Science believes these forward-looking statements are reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties that are difficult to predict and generally beyond the control of AB Science and which may imply that results and actual events significantly differ from those expressed, induced or anticipated in the forward-looking information and statements. These risks and uncertainties include the uncertainties related to product development of the Company which may not be successful or to the marketing authorizations granted by competent authorities or, more generally, any factors that may affect marketing capacity of the products developed by AB Science, as well as those developed or identified in the public documents published by AB Science. AB Science disclaims any obligation or undertaking to update the forward-looking information and statements, subject to the applicable regulations, in particular articles 223-1 et seq. of the AMF General Regulations.

For additional information, please contact:

AB Science
Financial Communication & Media Relations
investors@ab-science.com

Attachment

Comprehensive Healthcare Welcomes Community Behavioral Health Veteran as Chief Medical Officer

Comprehensive Healthcare Welcomes Community Behavioral Health Veteran as Chief Medical Officer




Comprehensive Healthcare Welcomes Community Behavioral Health Veteran as Chief Medical Officer

YAKIMA, Wash., Jan. 07, 2026 (GLOBE NEWSWIRE) — Comprehensive Healthcare, the leading community behavioral health provider in Central and Southwest Washington, is proud to welcome Mark Bradshaw, M.D., as its new chief medical officer (CMO). In this role, Dr. Bradshaw will oversee Comprehensive Healthcare’s continuum of clinical programs and services and a growing team of dedicated professionals working to expand access to high-quality, integrated care.

“Comprehensive Healthcare is at a pivotal moment in its growth. We’re introducing new programs, expanding our facilities and making meaningful progress toward realizing the full promise of an innovative approach to care that’s responsive to local needs, and we’re excited to have Dr. Bradshaw at the helm,” said Jodi Daly, Ph.D., CEO of Comprehensive Healthcare. “Dr. Bradshaw brings the expertise and passion we need to guide this next chapter, keeping our focus on the people and communities we’re here to serve.”

A key priority for Dr. Bradshaw will be advancing implementation of the Certified Community Behavioral Health Clinic (CCBHC) model as part of Washington’s first CCBHC Pre-Certification Cohort. He will partner with clinical and operational teams to strengthen care coordination, enhance access to services and refine systems that support whole-person health.

In addition, Dr. Bradshaw will focus on expanding the organization’s continuum of mental health and substance use services, building on the success of recent initiatives that streamline care and improve client engagement, such as the opening of the Wellness Now Clinic in Yakima and the introduction of same-day substance use disorder (SUD) assessments.

“Comprehensive Healthcare immediately stood out to me for its commitment to the community and the wide range of services it offers,” said Dr. Bradshaw. “It’s clear that the team at Comprehensive Healthcare approaches their work with genuine care and energy. I’m honored to join an organization so deeply invested in improving the lives of those it serves.”

Dr. Bradshaw joins Comprehensive Healthcare after serving as the chief medical officer at Elevance Health and Georgia Collaborative ASO, a community behavioral health provider that delivers care to underserved individuals through grant-funded programs. His decades-long career also includes serving as CMO for a Coordinated Care Organization in Southern Oregon, in addition to leadership and psychiatric positions across a range of mental health agencies.

Throughout his career, Dr. Bradshaw has been recognized for his excellent clinical service and has shared his expertise with the next generation of providers through teaching. He has taught as an adjunct faculty member at Wright State University and the University of Cincinnati College of Medicine and has served on numerous healthcare boards and advisory committees. Dr. Bradshaw earned his Doctor of Medicine degree from the University of Mississippi School of Medicine.

For more information about Comprehensive Healthcare, visit https://comphc.org/.

About Comprehensive Healthcare: 
As one of largest behavioral health organizations in the state of Washington, Comprehensive Healthcare serves clients in the Greater Columbia Region. Comprehensive Healthcare is a Joint Commission accredited organization, providing compassionate, individualized behavioral healthcare since 1972. As a non-profit organization, Comprehensive Healthcare is dedicated to delivering high quality, evidence-based services to individuals, families and organizations. To learn more, visit Comprehensive Healthcare’s website at comphc.org.

Media Contacts: 
Cassidy Brown 
Comprehensive Healthcare 
(509) 317-2876 
cassidy.brown@comphc.org 

Kate Hughes 
Firmani + Associates
kate@firmani.com

GENFIT Announces 2026 Financial Calendar

GENFIT Announces 2026 Financial Calendar




GENFIT Announces 2026 Financial Calendar

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), January 7, 2026GENFIT (Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced its provisional financial calendar for 2026.

2026 Financial Calendar

February 26, 2026 Publication of revenue and cash position at December 31, 2025

April 2, 2026

Publication of Full Year 2025 financial statements

 

The 2025 Universal Registration Document and Annual Financial Report (included in the Universal Registration Document) will be made public by the end of April 2026.

May 21, 2026 Publication of revenue and cash position at March 31, 2026
June 15, 2026 Annual Shareholders Meeting
September 29, 2026 Publication of the half-year 2026 financial statements
November 5, 2026 Publication of revenue and cash position at September 30, 2026

This calendar is subject to change.

ABOUT GENFIT

GENFIT is a biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades.  

Today, GENFIT focuses on Acute on-chronic Liver Failure (ACLF) and associated conditions such as acute decompensation (AD) and hepatic encephalopathy (HE). It develops therapeutic assets which have complementary mechanisms of action, selected to address key pathophysiological pathways. GENFIT also targets other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorders (UCD) and organic acidemia (OA). Its R&D portfolio, covering several stages of development, ensures a constant news flow.

GENFIT’s expertise in developing high-potential molecules – from early to advanced pre-commercialization stages – culminated in 2024 with the accelerated approval of Iqirvo® (elafibranor) by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for the treatment of Primary Biliary Cholangitis (PBC). Iqirvo® is now marketed in several countries.1   

Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® for the detection of Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis).

GENFIT, a BCorp™ certified company since 2025, is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Euronext regulated market in Paris, Compartment B (Euronext: GNFT). In 2021, Ipsen became one of GENFIT’s largest shareholders, acquiring an 8% stake in the Company’s capital. www.genfit.com

FORWARD LOOKING STATEMENTS

This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to statements about GENFIT’s expected progress of its research and development programs and planned release of financial information. The use of certain words, such as “believe”, “potential”, “expect”, “target”, “may”, “will”, “should”, “could”, “if” and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in research and development, including in relation to non-clinical and pre-clinical programs, reproducibility of preclinical results, the translation of animal model data to human biology, in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, patient recruitment, review and approvals by regulatory authorities in the United States, Europe and worldwide, of our drug and diagnostic candidates, pricing, approval and commercial success of elafibranor in the relevant jurisdictions, exchange rate fluctuations, and our continued ability to raise capital to fund our development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 “Risk Factors and Internal Control” of the Company’s 2024 Universal Registration Document filed on April 29, 2025 (no. 25-0331) with the Autorité des marchés financiers (“AMF”), which is available on GENFIT’s website (www.genfit.com) and the AMF’s website (bdif.amf-france.org), and those discussed in the public documents and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s 2024 Annual Report on Form 20-F filed with the SEC on April 29, 2025 and subsequent filings and reports filed with the AMF or SEC or otherwise made public, by the Company. In addition, even if the results, performance, financial position and liquidity of the Company and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this press release. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.

CONTACTS

GENFIT | Investors

Tel: +33 3 2016 4000 | investors@genfit.com

GENFIT | Media

Stephanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com

GENFIT | 885 Avenue Eugène Avinée, 59120 Loos – FRANCE | +333 2016 4000 | www.genfit.com       


1 Elafibranor is marketed and commercialized, notably in the U.S and Europe, by Ipsen under the trademark Iqirvo® .

Attachment

National Institutes of Health Awards $1.54M Grant To Scottish Rite for Children for Rare Diseases Research

National Institutes of Health Awards $1.54M Grant To Scottish Rite for Children for Rare Diseases Research




National Institutes of Health Awards $1.54M Grant To Scottish Rite for Children for Rare Diseases Research

Promising Hydrogel Could Help Kids Walk Again and Adults Avoid Invasive Surgery

Dallas, Jan. 07, 2026 (GLOBE NEWSWIRE) — Every year, thousands of children and adults face the crippling effects of osteonecrosis. Now, thanks to a $1.54 million NIH grant, researchers at Scottish Rite for Children and UT Southwestern Medical Center are studying a promising new treatment using hydrogel. Osteonecrosis is a painful condition where reduced blood flow causes bone tissue to die, which leads to the bone collapsing. For children, the condition often appears as Legg-Calvé-Perthes disease, a hip disorder that can leave young patients limping or even unable to walk.

The study’s goal is to evaluate the treatment effectiveness of a pro-angiogenic bone coating (ABC) hydrogel, which is injected into the bone experiencing osteonecrosis. The gel is made mostly from natural ingredients, like gelatin and hyaluronic acid, and is designed to promote the growth of new blood vessels and support the healing and regeneration of damaged bone.

“The hydrogel works like a ‘smart glue.’ When it is injected into the injured bone, it quickly breaks down and clings to the bone where it is needed most,” says Chi Ma, Ph.D., senior research scientist at Scottish Rite for Children and assistant professor of orthopedic surgery at UT Southwestern. “This helps restore blood flow, stops the bone from breaking down further, and encourages the bone to heal, leading to a less invasive method for treating the progressive condition.”

According to the National Organization for Rare Diseases, osteonecrosis affects an estimated 20,000 people in the U.S. each year, including children, young adults and individuals undergoing treatments such as chemotherapy. In serious cases, the affected bone, often in the hip or knee, may collapse, making walking intolerable. Current treatments are limited and often involve invasive surgery or joint replacement, especially in advanced stages of the disease.

The hydrogel is designed to have unique features that make it a candidate for better treatment for osteonecrosis.

“Conducting groundbreaking research is a pillar of our institution,” says Scottish Rite for Children Chief of Staff Daniel J. Sucato, M.D., M.S. “We’ve had a relationship with UT Southwestern since 1948, and we’re grateful for this ongoing collaboration that allows us to focus on discovering new treatments, educating the next generation in pediatric orthopedics and providing the highest quality patient care.”

The ABC hydrogel as a treatment for osteonecrosis may offer hope not only for adults affected by the condition but also for children with Perthes disease. Perthes disease is a childhood hip disorder in which the blood supply to the ball of the hip’s ball-and-socket joint is temporarily cut off. This disruption causes all or part of the bone to die. As the condition progresses, the ball begins to collapse. A child with Perthes may begin limping and eventually, may be unable to walk. This treatment aims to preserve the rounded shape that fits into the socket of the hip joint and reverse the progression of the disease for full recovery.

“At Scottish Rite for Children, we are dedicated to transforming the lives of children and their families by turning our research discoveries into meaningful treatments and life-changing outcomes,” says Robert L. Walker, president/CEO of Scottish Rite.

About Scottish Rite for Children 
Scottish Rite for Children has been dedicated to giving children back their childhood for more than a century. The institution is a world-renowned leader in the treatment of pediatric orthopedic conditions, such as scoliosis, clubfoot, hand differences, hip disorders, limb lengthening and reconstruction, sports injuries and fractures, as well as certain related arthritic and neurological disorders and learning disorders, such as dyslexia. The organization conducts innovative research and provides high-level education opportunities for medical professionals around the world. Scottish Rite operates two campuses, including a hospital in Dallas, Texas, and an ambulatory surgery center in Frisco, Texas, and is known for being a bright, child-friendly place that does not look or feel like a health care institution. Patients receive treatment regardless of their family’s ability to pay. For more information about services available at the Dallas or Frisco campuses, volunteering or donating, visit scottishriteforchildren.org.

Contact Info

Liandra Larsen
Liandra.Larsen@tsrh.org
+1 469-929-4891

Attachment

Neocis Surpasses 100,000 Robotic Osteotomies with the Yomi Platform

Neocis Surpasses 100,000 Robotic Osteotomies with the Yomi Platform




Neocis Surpasses 100,000 Robotic Osteotomies with the Yomi Platform

Landmark milestone demonstrates proven robotic adoption as the next generation Yomi S completes the first real world cases

MIAMI, Jan. 07, 2026 (GLOBE NEWSWIRE) — Neocis, the market leader behind the Yomi® robotic dental implant system, today announced that clinicians have completed more than 100,000 osteotomies using the Yomi platform, marking a significant milestone in the real-world adoption of robotic assistance in implant dentistry.

Neocis also confirmed that the first clinical cases using Yomi S, its second-generation robotic system, have now been successfully completed by Dr. Jay Neugarten, DDS, MD, FACS. The initial procedures signal the new platform’s transition to clinical reality, reinforcing Neocis’ ability to translate innovation into deployable technology while building on the proven foundation established by more than 100,000 Yomi-guided osteotomies.

The achievement reflects sustained clinical use of Yomi across a broad range of implant indications and practice settings, underscoring the platform’s role in supporting precision, consistency, and confidence during dental implant surgeries.

“Reaching 100,000 osteotomies is more than just a statistical achievement — it represents clinicians across the country choosing to integrate robotics into their daily surgical workflow,” said Alon Mozes, Chief Executive Officer and co-founder of Neocis. “This level of usage demonstrates trust in the technology and reinforces our belief that robotics has set a new standard of care.”

Yomi is the first and only FDA-cleared robotic system for dental implant surgery, and Yomi S was recently announced in 2025 as the second generation system. The platform combines real-time haptic guidance, pre-operative digital planning, and intra-operative adaptability to assist clinicians during implant cases. Since its introduction, Yomi has been used in a wide variety of cases, from single-tooth to full-arch implant procedures.

“Clinicians are increasingly seeking technologies that integrate seamlessly into existing workflows while delivering tangible procedural value,” said Dennis Moses, Chief Technology Officer of Neocis. “The scale reflected in 100,000 osteotomies validates both the robustness of the platform and its proven ability to perform consistently across real-world clinical environments.”

Neocis continues to invest in expanding Yomi’s capabilities through software enhancements, workflow optimization, and advanced planning tools designed to support efficient case execution and broaden clinical applications.

The 100,000-osteotomy milestone represents another step forward in Neocis’ mission to advance robotic innovation in dentistry and support clinicians everywhere in delivering high-quality implant care.

About Neocis
Neocis is transforming dental surgery with robotics. The company collaborates closely with leading clinicians to develop innovative technologies that help advance patient care and improve quality of life. Based in Miami, Neocis is venture-backed with funding from Mirae Asset Financial Group, NVentures, Intuitive Ventures, DFJ Growth, Mithril Capital Management, Norwest Venture Partners, Vivo Capital, Section 32, and surgical robotics pioneer Fred Moll. For more information, visit neocis.com.

Contact
For more information, please contact the Neocis media relations team at info@neocis.com.

Viromed AG: Strategic Update on Operational Focus and Value Creation

Viromed Medical AG

/ Key word(s): Miscellaneous

Viromed AG: Strategic Update on Operational Focus and Value Creation

07.01.2026 / 14:15 CET/CEST

The issuer is solely responsible for the content of this announcement.


PRESS RELEASE

Viromed AG: Strategic Update on Operational Focus and Value Creation

Rellingen, January 7, 2026 – Viromed Medical AG (“Viromed”; ISIN: DE000A3MQR65), a medical technology company and pioneer in cold plasma technology, today provides a strategic update on its operational orientation. The focus of the Company’s entrepreneurial activities remains unchanged and is centered on sustainable, technology-driven growth in the international MedTech market. In this context, Viromed concentrates on the development of innovative medical devices as well as on translational research in the field of severe respiratory diseases — in particular ventilator-associated pneumonia (VAP).

Over the past two years, Viromed has developed two novel cold plasma medical devices:

  • ViroCAP® — an innovative cold plasma device for medical wound healing
  • PulmoPlas® — a globally unique cold plasma system for applications in pneumology and respiratory tract infections

Particular importance is attributed to the next-generation technological platform — PulmoPlas®. This unique cold plasma system forms the basis for future scaling potential across multiple medical indication areas.

In the research domain, Viromed has established a high-performance scientific consortium consisting of Hannover Medical School (MHH), the Helmholtz Centre for Infection Research (HZI) in Braunschweig, and the Leibniz Institute in Jena. This network brings together international top-level expertise in infectiology, pneumology, and translational research and enables the development of novel therapeutic approaches for diseases of the upper and lower respiratory tract.

The comprehensive publication of the results by MHH and HZI is expected at the end of January 2026.

For further technological development, Viromed works closely with Relyon Plasma, a subsidiary of TDK. In addition, international partnerships in Europe, Korea, and Turkey have been established, supporting future market entry and underscoring the global relevance of the technology.

As a result of the strategic focus on research, development, and the establishment of international market structures, longer innovation cycles naturally arise. Viromed therefore deliberately refrains from communicating short-term operational interim updates. Communication with various stakeholders follows the principle of reporting substantial and relevant milestones — in the interest of long-term, sustainable corporate development.

Viromed Medical AG’s corporate strategy is geared toward long-term value generation. Against this backdrop, the Company’s research and development programs are consistently aligned with medical benefit, clinical relevance, and sustainable market potential.

Viromed is recognized as a pioneer in pneumological research and plasma technology. The innovation work of the Company’s scientific network has the potential to significantly shape future therapeutic approaches for severe respiratory infections. According to its own assessment, Viromed will play a significant role in the global fight against pathogenic germs in the coming years — particularly with PulmoPlas®.

In addition, Viromed has successfully overcome the new, stringent regulatory hurdles for the approval of ViroCAP® over the past 18 months. Market acceptance and demand for ViroCAP® are already very high.

About Viromed Medical AG

Viromed Medical AG specializes in the development, manufacture and distribution of medical products. The operating business of the company, which has been listed on the stock exchange since October 2022, focuses on the distribution of innovative cold plasma technology for medical applications via its wholly owned subsidiary Viromed Medical GmbH. Viromed can draw on a broad customer base in the DACH region and beyond. Viromed is pursuing the goal of further advancing the use of cold plasma technology in medicine in the coming years and realizing the corresponding growth potential.

www.viromed-medical-ag.de

Contact Viromed

E-Mail: kontakt@viromed-medical.de
 

Press contact

E-mail: viromed@kirchhoff.de


07.01.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.


Language: English
Company: Viromed Medical AG
Hauptstraße 105
25462 Rellingen
Germany
E-mail: kontakt@viromed-medical.de
Internet: https://www.viromed-medical-ag.de/
ISIN: DE000A3MQR65
WKN: A3MQR6
Listed: Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt, Hamburg, Tradegate Exchange
EQS News ID: 2256300

 
End of News EQS News Service

2256300  07.01.2026 CET/CEST

Immunic Highlights 2025 Accomplishments and Upcoming Milestones

Issuer: Immunic AG

/ Key word(s): Miscellaneous/Conference

Immunic Highlights 2025 Accomplishments and Upcoming Milestones

07.01.2026 / 12:30 CET/CEST

The issuer is solely responsible for the content of this announcement.


Immunic Highlights 2025 Accomplishments and Upcoming Milestones

– Completed Enrollment for Both Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis; Top-Line Data Expected by End of 2026 –

– Phase 2 CALLIPER Data Showed Vidofludimus Calcium Reduced 24-Week Confirmed Disability Worsening and Increased 24-Week Confirmed Disability Improvement Across Progressive Multiple Sclerosis and Its Subtypes, Reinforcing the Drug’s Direct Neuroprotective Mechanism of Action –

 – Long-Term Open-Label Data from Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis Showed Low Rates of Confirmed Disability Worsening Events and Favorable Long-Term Safety and Tolerability –

 – U.S. Patent Allowed for Dose Strengths of Vidofludimus Calcium in Progressive Multiple Sclerosis, Strengthening Intellectual Property Protection Into 2041 –

NEW YORK, January 7, 2026 – Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases, today highlighted its 2025 accomplishments and upcoming milestones.

“The past year has been transformational for our lead asset vidofludimus calcium (IMU-838),” stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “We are pleased to have completed enrollment in our twin phase 3 ENSURE-1 and ENSURE-2 trials of vidofludimus calcium in relapsing multiple sclerosis (RMS) and are deeply grateful to the Immunic team, our clinical investigators, site teams, and especially the participants for making this milestone possible. We now eagerly anticipate the synchronized top-line data readout by the end of 2026. The scale, quality, and geographic breadth of the ENSURE trials give us exceptional confidence that the results will provide a clear and comprehensive picture of vidofludimus calcium’s potential to reshape the RMS treatment paradigm. Additionally, long-term open-label extension (OLE) data from the phase 2 EMPhASIS trial in relapsing-remitting multiple sclerosis (RRMS) showed that a substantial majority of patients remained free of confirmed disability worsening (CDW) over extended follow-ups, underscoring vidofludimus calcium’s potential to meaningfully slow disease progression, giving patients greater independence and a lower burden in managing symptoms over the long term.”

Jason Tardio, President and Chief Operating Officer of Immunic, added, “The ENSURE program represents more than a pivotal clinical milestone—it reflects an opportunity to advance how disease modification in RMS is approached. Today’s oral RMS treatment landscape is largely defined by therapies with complex risk-benefit profiles that primarily target inflammation and relapses, while often falling short of adequately addressing the neurodegeneration that drives long-term disability. With a dual mechanism of action, vidofludimus calcium is designed to provide direct neuroprotection by enhancing neuronal survival and function through Nurr1 activation, as well as limiting new inflammatory injury through selective DHODH inhibition. Together with its favorable safety and tolerability profile to date, we believe vidofludimus calcium has the potential to offer the most compelling benefit-risk profile among oral disease-modifying therapies for RMS.”

“Equally important are the strong signals we continue to see in progressive multiple sclerosis (PMS) from our phase 2 CALLIPER trial,” continued Dr. Vitt. “In particular, the data has demonstrated clinically meaningful reductions in 24-week CDW (24wCDW) across the overall PMS population, supported by consistent trends across PMS subtypes and subpopulations. Notably, there was no dependency of the 24wCDW effect size on the presence of markers of inflammatory disease at baseline, such as gadolinium-enhancing lesions, supporting our hypothesis of clinical neuroprotective effects independent of anti-inflammatory effects. The positive 24-week confirmed disability improvement (24wCDI) results were statistically significant in the overall PMS population, with consistent trends across subtypes. The findings from our CALLIPER trial reinforce vidofludimus calcium’s unique mechanism of action targeting neurodegeneration and help de-risk potential late-stage development in PMS.”

Dr. Vitt concluded, “As we execute our MS strategy with vidofludimus calcium, we also remain committed to advancing IMU-856, our orally available and systemically acting small molecule modulator that targets Sirtuin 6 (SIRT6), as our next pipeline innovation. IMU-856’s potential ability to restore intestinal barrier function and regenerate bowel epithelium has generated compelling early clinical signals in celiac disease patients, supporting potential development in various gastrointestinal disorders. Additionally, we have seen encouraging preclinical and early clinical effects that may indicate the potential for IMU-856 as an oral treatment option for weight management.”

Vidofludimus Calcium 2025 Highlights and Upcoming Milestones

  • Completed enrollment for both phase 3 ENSURE trials of vidofludimus calcium in patients with RMS. In total, 1,121 patients in ENSURE-1 and 1,100 patients in ENSURE-2 were randomized at more than 100 sites in 15 countries. Top-line data is expected by the end of 2026.
  • Announced positive phase 2 CALLIPER data in PMS, highlighting vidofludimus calcium’s neuroprotective potential across PMS as well as PMS subpopulations and subtypes. The data, showing consistent 24wCDW results across patient groups, including those without evidence of baseline inflammatory gadolinium-enhancing (Gd+) lesions, were seen in the overall population and in the key primary progressive multiple sclerosis (PPMS) and non-active secondary progressive multiple sclerosis (naSPMS) subgroups. 24wCDI data demonstrated more than a two-fold probability of clinical improvement versus placebo, achieving statistical significance in the overall PMS population with consistent trends across subtypes. Vidofludimus calcium also lowered thalamic atrophy and new or enlarging T2 lesion volume versus placebo. No new safety signals were observed and vidofludimus calcium continued to show a favorable safety and tolerability profile. Given that 24wCDW is an accepted regulatory endpoint in PMS, these results strengthen the evidence of clinical activity and should help to de-risk a potential phase 3 program.
  • Reported new, positive long-term OLE data from the phase 2 EMPhASIS trial of vidofludimus calcium in patients with RRMS. At week 144, 92.3% of patients remained free of 12wCDW with 92.7% remaining free of 24wCDW. Vidofludimus calcium continued to demonstrate a favorable safety and tolerability profile with long-term data available up to 5.5 years.
  • Received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a patent covering dose strengths of vidofludimus calcium for the treatment of PMS, including PPMS and SPMS. The company’s multilayered intellectual property strategy now provides protection into 2041 in the United States, unless extended further.
  • Presented key data highlighting vidofludimus calcium’s therapeutic potential in MS at various scientific and medical conferences, including the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), the 17th International Congress of the International Society of Neuroimmunology (ISNI), the 11th Congress of the European Academy of Neurology (EAN) – Helsinki 2025, the Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting 2025, the American Academy of Neurology (AAN) 2025 Annual Meeting and the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2025. The results from the phase 2 CALLIPER trial in PMS were also selected for the Best of ECTRIMS 2025 slide deck.

IMU-856 2025 Highlights and Upcoming Milestones

  • Announced that IMU-856 demonstrated a dose-dependent increase of endogenous glucagon-like peptide-1 (GLP-1) levels in a post hoc analysis of patients from the phase 1b clinical trial in celiac disease. IMU-856 also showed a dose-dependent reduction of body weight gain and food consumption in preclinical in vivo testing. These effects may indicate the potential for IMU-856 as an oral treatment option for weight management.
  • Presented further analyses from the phase 1/1b clinical trial of IMU-856 in healthy subjects and celiac disease patients at several key gastroenterology conferences, including at UEGW 2025 – United European Gastroenterology Week, Digestive Disease Week (DDW) and the 19th Congress of ECCO (European Crohn’s and Colitis Organisation).
  • The company continues preparing for further clinical testing of IMU-856, contingent on financing, licensing or partnering.

2025 Corporate Highlights

  • Closed a $5.1 million registered direct offering led by Aberdeen Investments.
  • Closed an oversubscribed $65 million underwritten public offering, co-led by BVF Partners and Coastlands Capital, and including participation from Aberdeen Investments, Adage Capital Partners LP, Janus Henderson Investors, and other institutional investors.

Immunic’s management, business development and investor relations teams will be hosting one-on-one meetings in connection with the 44th Annual J.P. Morgan Healthcare Conference taking place January 12-15, 2026, in San Francisco. To schedule a meeting, please contact Jessica Breu at: jessica.breu@imux.com.

About Immunic, Inc.

Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases. The company’s lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis and progressive multiple sclerosis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease as well as inflammatory bowel disease, Graft-versus-Host-Disease and weight management. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: www.imux.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic’s development programs and the targeted diseases; the potential for Immunic’s development programs to safely and effectively target diseases; preclinical and clinical data for Immunic’s development programs; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; expectations regarding the capitalization, resources and ownership structure of the company; the executive and board structure of the company; and the company’s expected cash runway. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, and the ability to raise sufficient capital to continue as a going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company’s products or product candidates, the protection and market exclusivity provided by Immunic’s intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned “Risk Factors,” in the company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 31, 2025, and in the company’s subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.

Contact Information 

Immunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com

US IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.com 

US Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com


Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.


Vaxxas Appoints Former Merck Global Vaccines President David Peacock as CEO

Vaxxas Appoints Former Merck Global Vaccines President David Peacock as CEO




Vaxxas Appoints Former Merck Global Vaccines President David Peacock as CEO

BRISBANE, Australia and CAMBRIDGE, Mass., Jan. 07, 2026 (GLOBE NEWSWIRE) — Vaxxas Pty Ltd today announced the appointment of global biopharmaceutical executive Mr David Peacock as Chief Executive Officer to lead the commercialisation of the Company’s proprietary high‑density microarray patch (HD‑MAP) vaccination technology.

Mr Peacock brings more than 25 years of global vaccine and pharmaceutical leadership, most recently in roles as President of Merck Global Vaccines, and President of MSD Asia Pacific.

His career spans senior commercial, operational, and financial positions across Japan, the United States, Europe, and Asia, and includes service on boards and industry bodies such as the US‑ASEAN Business Council, the Association of the British Pharmaceutical Industry, and Gavi, the Vaccine Alliance.

Throughout his career Mr Peacock has demonstrated strong entrepreneurial and innovation success through start-ups, digital commercial innovation and funding access initiatives.

Vaxxas Chair, Ms Sarah Meibusch said Mr Peacock’s appointment aligns with the company’s near‑term pathway to market and growth strategy.

“David’s appointment marks a clear inflection point for Vaxxas as we move from clinical validation towards commercial execution. He brings unmatched global vaccine commercialisation experience at precisely the moment the HD-MAP technology is transitioning from proof-of-concept to a scalable delivery platform with the potential to materially improve how vaccines are manufactured, distributed and administered worldwide.

“For global pharmaceutical partners, the HD-MAP offers a differentiated self-delivery administration option to enhance existing vaccine franchises, extend lifecycle value and address persistent challenges around cold-chain, dose efficiency and access. David’s leadership positions Vaxxas to engage at scale with governments and multinational vaccine companies as a long-term strategic partner,” said Ms Meibusch.

Mr Peacock said he is energised by the potential of Vaxxas’ HD‑MAP technology to reshape vaccine delivery and access.

“Over the course of my career, I have seen first-hand the limitations of conventional vaccine delivery technologies in both developed, and developing, healthcare systems. I believe Vaxxas’ HD-MAP technology has the potential to fundamentally reshape vaccine access, distribution, and administration.

“Vaxxas is now at a pivotal stage, with clinical validation, licensed manufacturing capability and a platform that can integrate with existing and future vaccine programs. I am excited to lead the company as we partner with pharmaceutical companies, research organisations and governments to translate this technology for global public-health and commercial impact,” said Mr Peacock.

Mr Peacock will also be appointed as Executive Director to the Vaxxas board.

Building Momentum Toward Market

Vaxxas recently secured a manufacturing licence from the Therapeutic Goods Administration (TGA), for HD‑MAP vaccine products at the company’s Brisbane biomedical facility, a significant regulatory milestone that materially de-risks the path to commercial supply. The licence follows the installation of Vaxxas’ first robotic lines for aseptic (sterile) manufacture, enabling scalable, GMP-compliant production to support clinical and future commercial programs.

Mr Peacock’s appointment also follows recent board and leadership additions, most notably global vaccine industry veteran Brent MacGregor, CEO of Medical Developments International (ASX: MVP), who has more than 30 years of senior commercial leadership across the global vaccines sector. Mr MacGregor has held leadership roles at CSL Seqirus, Novartis Vaccines and Sanofi Pasteur across North America, Europe and Asia, and brings deep experience in vaccine commercialisation and scale. He is complemented by Michael Shleifer, Co-Founder and Managing Partner of SPRIM Global Investments, which anchored Vaxxas’ approximately $90 million financing this year, joining as Board Observer.

“Together, these appointments provide Vaxxas significant depth in global vaccine commercialisation, manufacturing and partnership expertise. This strengthens Vaxxas’ ability to work credibly with multinational pharmaceutical companies and governments as the HD-MAP technology advances toward scaled manufacture and broader deployment,” Ms Meibusch added.

About Vaxxas
Vaxxas is a biotechnology company pioneering HD-MAP technology for future self-administered vaccine delivery. The HD-MAP has been administered to more than 750 participants across clinical trials, demonstrating strong safety, tolerability, and robust immune responses. Preclinical and clinical data indicate the technology has the potential to deliver all major vaccine types positioning HD-MAP as a universal delivery solution. By targeting immune cells just beneath the skin, the HD-MAP has the potential to achieve stronger protection with smaller doses, while reducing cold-chain requirements and enabling self-administration.

Vaxxas’ programs are advancing toward commercialisation with support from global partners including SK bioscience, the US Government, the Wellcome Trust, and the Gates Foundation, assessing the potential of HD‑MAP to vaccinate against COVID‑19, seasonal and pre‑pandemic influenza, and measles and rubella. The company recently installed robotic lines for aseptic (sterile) manufacture at its state‑of‑the‑art Brisbane biomedical facility supporting scalable, GMP-compliant production for clinical and future commercial supply.

Investigational Use Notice
HD‑MAP‑delivered vaccines are under investigation and are not approved for sale or purchase anywhere in the world. Vaxxas makes no claims regarding reliability, durability, dependability, safety, efficacy, or superiority to any other vaccine or vaccine delivery technology.

A photo accompanying this announcement is available at
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CONTACT: Media Contact
Helen Wallace
We. Communications
+61 310 710 305
hwallace@wecommunications.com

Verrica Pharmaceuticals Announces First Patient Dosed in Phase 3 Program Evaluating YCANTH® (VP-102) for the Treatment of Common Warts

Verrica Pharmaceuticals Announces First Patient Dosed in Phase 3 Program Evaluating YCANTH® (VP-102) for the Treatment of Common Warts




Verrica Pharmaceuticals Announces First Patient Dosed in Phase 3 Program Evaluating YCANTH® (VP-102) for the Treatment of Common Warts

– Common warts affects approximately 22 million patients in the United States alone, and there are no FDA approved prescription therapies for what is believed to be a multibillion-dollar market opportunity–

– Verrica has global rights to YCANTH for all indications in all territories outside of Japan –

WEST CHESTER, Pa., Jan. 07, 2026 (GLOBE NEWSWIRE) — Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing and selling medications for skin diseases requiring medical interventions, today announced that the first patient was dosed in December 2025 in the global Phase 3 program evaluating YCANTH (VP-102) for the treatment of common warts.

“The dosing of the first patient in the global Phase 3 program in common warts represents an important clinical milestone for our label expansion strategy of YCANTH,” said Jayson Rieger, PhD, MBA, President and Chief Executive Officer of Verrica. “The clinically meaningful activity observed for the primary endpoint of complete clearance in the Phase 2 COVE-1 study provides strong evidence that YCANTH has the potential to become the first therapy ever approved in both the United States and Japan for the treatment of common warts – a condition that impacts over 22 million people in the U.S. alone. Having retained full commercial rights for all potential YCANTH indications outside of Japan, common warts represents a substantial commercial and licensing opportunity for our company. Coupled with our recently completed $50 million financing and repayment of our debt facility with OrbiMed, this significant clinical milestone is another key step towards the expansion of the YCANTH franchise and the future growth of Verrica.”

COVE-1 Phase 2 Data and Phase 3 Program in Common Warts

The initiation of the global Phase 3 program in common warts is based upon positive results from the Phase 2 COVE-1 clinical trial that evaluated YCANTH (VP-102) for the treatment of common warts. COVE-1 was an open label clinical trial that evaluated the safety and efficacy of VP-102 in two cohorts of subjects with up to six warts. The primary efficacy analysis was conducted at Day 84 with an additional period of follow-up through Day 147. Topline analysis included data from the assessment of warts at study visits over 12 weeks. Results showed that 51% of subjects (18 of 35) treated with VP-102 in Cohort 2 achieved complete clearance of all treatable warts at Day 84. Adverse events were primarily expected local cutaneous reactions with no SAEs observed. Torii will split the costs of the global Phase 3 program with Verrica on a 50/50 basis and will fund the first $40 million of trial costs, representing approximately 90% of the current trial budget, with Verrica’s portion expected to be paid out of future milestones/royalties for YCANTH in Japan.

Market Opportunity in Common Warts

With a prevalence of approximately 22 million patients in the U.S. alone and no FDA approved therapies, common warts represent one of the largest unmet needs in all of dermatology, which Verrica believes could represent a multibillion-dollar commercial opportunity. In the United States, approximately 50% of the patients who seek treatment for common warts are children. If YCANTH is successfully developed, approved and commercialized for the treatment of common warts, Verrica anticipates a high degree of call point overlap and marketing synergies with its promotion of YCANTH for the treatment of molluscum. Verrica further believes that the common wart patient opportunity in the European Union is comparable to that in the United States.

About YCANTH® (VP-102)
YCANTH® is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin delivered via a single-use applicator that allows for precise topical dosing and targeted administration for the treatment of molluscum. YCANTH is the first and only healthcare professional-administered product approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. Approval of YCANTH was based upon the positive results from two Phase 3 clinical trials in approximately 500 patients which demonstrated that YCANTH was a safe and effective therapeutic for the treatment of molluscum. Approximately 250 million lives are eligible to receive YCANTH covered by insurance. Commercially insured patients pay just $25 per YCANTH treatment visit, for up to two applicators. Other uninsured patients may be eligible to receive YCANTH at a reduced cost if certain eligibility requirements are met for patient assistance. Please visit YCANTHPro.com for additional information.

About Verrica Pharmaceuticals Inc.
Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. Verrica’s product YCANTH® (VP-102) (cantharidin), is the first and only healthcare professional-administered treatment approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. YCANTH® (VP-102) is also in development to treat common warts, the largest remaining unmet need in medical dermatology. Verrica has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize VP-315 (ruxotemitide, formerly known as LTX-315 and VP-LTX-315) for non-melanoma skin cancers including basal cell carcinoma and squamous cell carcinoma.

Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Verrica’s current beliefs and expectations. These forward-looking statements include statements about the commercialization of YCANTH, clinical development, clinical timelines and potential benefits of YCANTH for the treatment of common warts, These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include risks and uncertainties related to market conditions, satisfaction of customary closing conditions related to the proposed public offering and other risks and uncertainties that are described in Verrica’s Annual Report on Form 10-K for the year ended December 31, 2024, Verrica’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 and other filings Verrica makes with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Verrica as of the date of this release, and Verrica assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

FOR MORE INFORMATION, PLEASE CONTACT:

Investors:

John Kirby
Interim Chief Financial Officer
jkirby@verrica.com

Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com