Carrick Therapeutics Announces Positive Results from Phase 2 Randomized Trial of Samuraciclib in Combination with Fulvestrant in Patients with Hormone Receptor Positive, HER2 Negative Advanced Breast Cancer




Carrick Therapeutics Announces Positive Results from Phase 2 Randomized Trial of Samuraciclib in Combination with Fulvestrant in Patients with Hormone Receptor Positive, HER2 Negative Advanced Breast Cancer

Overall response rate (ORR) of 55% and median progression-free survival of 14.5 months in patients without TP53 gene mutation

Phase 2 results presented at 2025 San Antonio Breast Cancer Symposium

BOSTON, Dec. 10, 2025 (GLOBE NEWSWIRE) — Carrick Therapeutics Inc., an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, today announced positive results from the Phase 2 SUMIT-BC clinical trial evaluating samuraciclib in combination with fulvestrant in patients with second-line advanced hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) breast cancer who were previously treated with a CDK4/6 inhibitor therapy. The clinical trial results were presented today in a late-breaking poster presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS). Samuraciclib is an oral first-in-class CDK7 inhibitor (CDK7i).

“These Phase 2 trial results show that samuraciclib in combination with fulvestrant provided a very notable and clinically meaningful benefit in a broad patient population with HR positive, HER2 negative metastatic breast cancer whose disease progressed following treatment with a CDK4/6 inhibitor. Carrick now has positive efficacy and safety data from three independent clinical trials of samuraciclib in advanced breast cancer,” said Tim Pearson, Chief Executive Officer of Carrick Therapeutics. “The best-in-class PFS and ORR of samuraciclib positions it to be a meaningful therapy that could transform how women with advanced breast cancer are treated following treatment with CDK4/6 inhibitors. We have achieved clinical proof of concept and look forward to advancing samuraciclib into a Phase 3 clinical trial in 2026 to build on these promising results.”

Results among study participants without a TP53 gene mutation per baseline circulating tumor DNA (ctDNA), a pre-specified stratification, indicated improved CBR, ORR and mPFS compared to those with the mutation. In the trial, the median PFS of samuraciclib combined with fulvestrant in this TP53wt population was 14.5 months versus 6.8 months with fulvestrant alone, an incremental improvement of 7.7 months.

“Identifying the optimal treatment strategy for patients with HR positive, HER2 negative breast cancer following progression on CDK4/6 inhibitor therapy remains a significant clinical challenge,” said Dr. Sonia Pernas, Breast Medical Oncologist at the Catalan Institute of Oncology, L’Hospitalet, Barcelona (Spain), and lead author of the SABCS poster. “The SUMIT-BC results indicate that the combination of samuraciclib and fulvestrant may offer a promising new therapeutic option, with the potential for particularly favorable outcomes in patients with TP53 wild-type tumors.”

“We are encouraged by the results of the SUMIT-BC trial of samuraciclib, which demonstrated strong efficacy and durable responses regardless of ESR1 or PI3K mutation status with a tolerable side effect profile,” said Dr. Stuart McIntosh, Chief Medical Officer of Carrick Therapeutics. “SUMIT-BC is now the third study to demonstrate enhanced efficacy in the TP53wt patient population, which makes up 70% of patients in second line setting. The use of baseline ctDNA means this selection biomarker should be straightforward to integrate into clinical practice.”

The late-breaking poster presentation at the 2025 San Antonio Breast Cancer Symposium is available on the Posters & Publications page of Carrick Therapeutics’ website.

About the Phase 2b SUMIT-BC Trial
SUMIT-BC is a randomized, multicenter Phase 2b clinical trial (NCT05963984) evaluating the efficacy and safety of oral samuraciclib (360mg or 240mg) in combination with fulvestrant, an intramuscularly injected selective estrogen receptor degrader (SERD), versus fulvestrant alone in 60 patients with HR+, HER2- locally advanced or metastatic breast cancer who were previously treated with a CDK4/6 inhibitor and aromatase therapy. The primary endpoint is clinical benefit rate, defined as the overall compete response (CR), partial response (PR) or stable disease (SD) ≥ 24-weeks according to RECIST version 1.1 from randomization until disease progression or death due to any cause. Secondary endpoints included objective response rate, duration of response, progression-free survival and safety.

About Samuraciclib (CT7001)
Samuraciclib is the most advanced cyclin dependent kinase 7 (CDK7) inhibitor in clinical development. Inhibiting CDK7 is a promising therapeutic strategy in cancer, as CDK7 regulates the transcription of cancer-causing genes, promotes uncontrolled cell cycle progression, and promotes resistance to anti-hormone therapy. Samuraciclib, an oral CDK7 inhibitor, has demonstrated a favorable safety profile and encouraging efficacy in early clinical studies in HR+ breast cancer. CDK7 activity mechanistically suppresses the TP53 gene so when CDK7 is inhibited, the activity of p53 is restored thereby further adding to the suppression of tumors by CDK7 inhibition (Reference below). TP53 status is available using commercially available ctDNA tests. Because of its ability to inhibit CDK7, samuraciclib has the potential to treat prostate, pancreatic, small cell lung cancer, triple negative breast (TNBC), ovarian and colorectal cancers. Samuraciclib was discovered by scientists at Imperial College London, in work funded by Cancer Research UK and has been granted Fast Track designation from the U.S. Food and Drug Administration (FDA) for use in combination with fulvestrant for the treatment of CDK4/6i resistant HR+, HER2- advanced breast cancer.

About Carrick Therapeutics
Carrick Therapeutics is an oncology-focused biopharmaceutical company developing highly differentiated novel therapies that address significant unmet needs. The Company’s lead program, samuraciclib, is a novel oral first-in-class inhibitor of CDK7 currently in multiple Phase 2 clinical trials for metastatic HR+ breast cancer. Additionally, Carrick is developing CT7439, a novel CDK12/13 inhibitor / Cyclin-K glue-degrader, which is currently in a Phase 1 clinical trial.

Reference: Wang, Y., Zhang, Z., Mi, X. et al. Elevation of effective p53 expression sensitizes wild-type p53 breast cancer cells to CDK7 inhibitor THZ1. Cell Commun Signal 20, 96 (2022). https://doi.org/10.1186/s12964-022-00837-z

For more information about Carrick Therapeutics, please visit www.carricktherapeutics.com

Carrick Contacts

Carrick Therapeutics
Jenny Horsfield, Chief Business Officer
jenny.horsfield@carricktherapeutics.com

Investors and Media
Luke Heagle, Real Chemistry
lheagle@realchemistry.com

Carrick Therapeutics Announces Positive Results from Phase 2 Randomized Trial of Samuraciclib in Combination with Fulvestrant in Patients with Hormone Receptor Positive, HER2 Negative Advanced Breast Cancer




Carrick Therapeutics Announces Positive Results from Phase 2 Randomized Trial of Samuraciclib in Combination with Fulvestrant in Patients with Hormone Receptor Positive, HER2 Negative Advanced Breast Cancer

Overall response rate (ORR) of 55% and median progression-free survival of 14.5 months in patients without TP53 gene mutation

Phase 2 results presented at 2025 San Antonio Breast Cancer Symposium

BOSTON, Dec. 10, 2025 (GLOBE NEWSWIRE) — Carrick Therapeutics Inc., an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, today announced positive results from the Phase 2 SUMIT-BC clinical trial evaluating samuraciclib in combination with fulvestrant in patients with second-line advanced hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) breast cancer who were previously treated with a CDK4/6 inhibitor therapy. The clinical trial results were presented today in a late-breaking poster presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS). Samuraciclib is an oral first-in-class CDK7 inhibitor (CDK7i).

“These Phase 2 trial results show that samuraciclib in combination with fulvestrant provided a very notable and clinically meaningful benefit in a broad patient population with HR positive, HER2 negative metastatic breast cancer whose disease progressed following treatment with a CDK4/6 inhibitor. Carrick now has positive efficacy and safety data from three independent clinical trials of samuraciclib in advanced breast cancer,” said Tim Pearson, Chief Executive Officer of Carrick Therapeutics. “The best-in-class PFS and ORR of samuraciclib positions it to be a meaningful therapy that could transform how women with advanced breast cancer are treated following treatment with CDK4/6 inhibitors. We have achieved clinical proof of concept and look forward to advancing samuraciclib into a Phase 3 clinical trial in 2026 to build on these promising results.”

Results among study participants without a TP53 gene mutation per baseline circulating tumor DNA (ctDNA), a pre-specified stratification, indicated improved CBR, ORR and mPFS compared to those with the mutation. In the trial, the median PFS of samuraciclib combined with fulvestrant in this TP53wt population was 14.5 months versus 6.8 months with fulvestrant alone, an incremental improvement of 7.7 months.

“Identifying the optimal treatment strategy for patients with HR positive, HER2 negative breast cancer following progression on CDK4/6 inhibitor therapy remains a significant clinical challenge,” said Dr. Sonia Pernas, Breast Medical Oncologist at the Catalan Institute of Oncology, L’Hospitalet, Barcelona (Spain), and lead author of the SABCS poster. “The SUMIT-BC results indicate that the combination of samuraciclib and fulvestrant may offer a promising new therapeutic option, with the potential for particularly favorable outcomes in patients with TP53 wild-type tumors.”

“We are encouraged by the results of the SUMIT-BC trial of samuraciclib, which demonstrated strong efficacy and durable responses regardless of ESR1 or PI3K mutation status with a tolerable side effect profile,” said Dr. Stuart McIntosh, Chief Medical Officer of Carrick Therapeutics. “SUMIT-BC is now the third study to demonstrate enhanced efficacy in the TP53wt patient population, which makes up 70% of patients in second line setting. The use of baseline ctDNA means this selection biomarker should be straightforward to integrate into clinical practice.”

The late-breaking poster presentation at the 2025 San Antonio Breast Cancer Symposium is available on the Posters & Publications page of Carrick Therapeutics’ website.

About the Phase 2b SUMIT-BC Trial
SUMIT-BC is a randomized, multicenter Phase 2b clinical trial (NCT05963984) evaluating the efficacy and safety of oral samuraciclib (360mg or 240mg) in combination with fulvestrant, an intramuscularly injected selective estrogen receptor degrader (SERD), versus fulvestrant alone in 60 patients with HR+, HER2- locally advanced or metastatic breast cancer who were previously treated with a CDK4/6 inhibitor and aromatase therapy. The primary endpoint is clinical benefit rate, defined as the overall compete response (CR), partial response (PR) or stable disease (SD) ≥ 24-weeks according to RECIST version 1.1 from randomization until disease progression or death due to any cause. Secondary endpoints included objective response rate, duration of response, progression-free survival and safety.

About Samuraciclib (CT7001)
Samuraciclib is the most advanced cyclin dependent kinase 7 (CDK7) inhibitor in clinical development. Inhibiting CDK7 is a promising therapeutic strategy in cancer, as CDK7 regulates the transcription of cancer-causing genes, promotes uncontrolled cell cycle progression, and promotes resistance to anti-hormone therapy. Samuraciclib, an oral CDK7 inhibitor, has demonstrated a favorable safety profile and encouraging efficacy in early clinical studies in HR+ breast cancer. CDK7 activity mechanistically suppresses the TP53 gene so when CDK7 is inhibited, the activity of p53 is restored thereby further adding to the suppression of tumors by CDK7 inhibition (Reference below). TP53 status is available using commercially available ctDNA tests. Because of its ability to inhibit CDK7, samuraciclib has the potential to treat prostate, pancreatic, small cell lung cancer, triple negative breast (TNBC), ovarian and colorectal cancers. Samuraciclib was discovered by scientists at Imperial College London, in work funded by Cancer Research UK and has been granted Fast Track designation from the U.S. Food and Drug Administration (FDA) for use in combination with fulvestrant for the treatment of CDK4/6i resistant HR+, HER2- advanced breast cancer.

About Carrick Therapeutics
Carrick Therapeutics is an oncology-focused biopharmaceutical company developing highly differentiated novel therapies that address significant unmet needs. The Company’s lead program, samuraciclib, is a novel oral first-in-class inhibitor of CDK7 currently in multiple Phase 2 clinical trials for metastatic HR+ breast cancer. Additionally, Carrick is developing CT7439, a novel CDK12/13 inhibitor / Cyclin-K glue-degrader, which is currently in a Phase 1 clinical trial.

Reference: Wang, Y., Zhang, Z., Mi, X. et al. Elevation of effective p53 expression sensitizes wild-type p53 breast cancer cells to CDK7 inhibitor THZ1. Cell Commun Signal 20, 96 (2022). https://doi.org/10.1186/s12964-022-00837-z

For more information about Carrick Therapeutics, please visit www.carricktherapeutics.com

Carrick Contacts

Carrick Therapeutics
Jenny Horsfield, Chief Business Officer
jenny.horsfield@carricktherapeutics.com

Investors and Media
Luke Heagle, Real Chemistry
lheagle@realchemistry.com

Tiny Health Celebrates 100,000 Tests Milestone, Expands from Baby Gut Health Pioneer to Longevity Innovator




Tiny Health Celebrates 100,000 Tests Milestone, Expands from Baby Gut Health Pioneer to Longevity Innovator

The microbiome startup powering preventive and personalized health launches new aging study and deepens partnerships with leading wellness and longevity programs

AUSTIN, Texas, Dec. 10, 2025 (GLOBE NEWSWIRE) — Tiny Health, the first precision microbiome wellness platform built for lifelong health, today announced it has surpassed 100,000 people and 3,000 health practitioners utilizing its microbiome tests.

Founded in 2020, Tiny Health began with a mission to help parents uncover and correct early gut imbalances in babies — a critical step in preventing chronic conditions like eczema, food allergies, and asthma. It is the only clinically-validated gut test for babies, with a published randomized controlled trial showing that Tiny Health personalized microbiome support reduced infants’ odds of eczema by 83%.

Today, its science and technology are helping people of all ages strengthen gut resilience, extend healthspan, and personalize care through a growing network of medical and wellness partnerships.

“This milestone is evidence that microbiome health is becoming mainstream,” said Cheryl Sew Hoy, Founder and CEO of Tiny Health. “We started by giving families the power to prevent and reverse chronic disease in their babies, and now we’ve expanded into longevity and healthy aging alongside major health systems, longevity clinics, and personalized medicine brands to help adults take control of their health with the same level of scientific rigor.”

From the First 1,000 Days to the Last 1,000 Days: Translating Microbiome Science Across the Lifespan

Tiny Health’s research has shown how the first 1,000 days of life — when the gut microbiome trains the developing immune system — set the foundation for lifelong health. By examining microbial patterns shared between well-trained infant immune systems and resilient aging microbiomes, the company aims to uncover how early-life microbial education influences vitality later in life. This new focus bridges decades of microbiome research, connecting the mechanisms that support thriving beginnings with those that sustain healthy longevity.

Tiny Health uses shotgun metagenomic sequencing to map gut health with strain-level precision and quantifies functional pathways of critical modulators in the gut. This year, the company has introduced new functional insights into the adult microbiome, including Gut Resilience, Urolithin-A potential, GLP-1 production, beta glucuronidase, and markers tied to conditions such as IBS and menopause.

“Our science gives people a real-time view of how their microbiome impacts aging, metabolism, hormone regulation, and disease risk,” said Sew Hoy. “It’s a personalized health dashboard for your gut, built on one of the most comprehensive microbiome datasets in the world.”

The Microbiome Age Study: Unlocking the Secrets of Healthy Aging

Tiny Health is also announcing its Microbiome Age Research Edition, a new study for adults aged 60+. The study aims to identify microbial patterns linked to healthy aging and resilience. Qualifying participants can purchase a discounted gut or vaginal health test and contribute to one of the world’s first datasets tracking how the microbiome changes with age.

Adults who are interested in the study are encouraged to learn more at www.tinyhealth.com/research/microbiomeage.

Powering the Longevity Movement

Through its Powered by Tiny B2B platform, Tiny Health partners with leading health and wellness organizations to integrate microbiome testing into preventive care models. Partners include:

• Leading longevity clinics including Mayo Clinic’s Executive and Longevity Health Programs and Pritikin Longevity Center — incorporating gut testing into clinical preventive, metabolic, and performance programs.
• Health assessment innovators including Superpower and Mito Health — integrating Tiny Health’s microbiome insights alongside their biomarker panels; and Tastermonial — helping users run real-world food response experiments with CGMs, using microbiome insights to personalize their food choices.
• AI-powered health solutions including ProteusDx, a diagnostics company using Tiny Health’s results to identify candidates for its ingestible capsule GI test.

Health and wellness companies, research institutions, and health practitioners interested in offering Tiny Health tests in their clinical practice can learn more at poweredbytiny.com.

About Tiny Health

Tiny Health is the first and only precision microbiome wellness platform designed for lifelong health — from the first 1,000 days to the last. Founded in 2020 and built by microbiome scientists and physicians, Tiny Health uses shotgun metagenomics to deliver strain-level and functional microbiome insights. Its research-backed gut and vaginal tests help families and practitioners address the root causes of many chronic conditions with evidence-based interventions. Trusted by over 100,000 people, Tiny Health is redefining the microbiome as a cornerstone of personalized wellness. Learn more at tinyhealth.com.

Media Contact:
Hannah Goering
press@tinyhealth.com 

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/562ae4a5-b672-40d6-93c0-3ad9bdb7c097

Tiny Health Celebrates 100,000 Tests Milestone, Expands from Baby Gut Health Pioneer to Longevity Innovator




Tiny Health Celebrates 100,000 Tests Milestone, Expands from Baby Gut Health Pioneer to Longevity Innovator

The microbiome startup powering preventive and personalized health launches new aging study and deepens partnerships with leading wellness and longevity programs

AUSTIN, Texas, Dec. 10, 2025 (GLOBE NEWSWIRE) — Tiny Health, the first precision microbiome wellness platform built for lifelong health, today announced it has surpassed 100,000 people and 3,000 health practitioners utilizing its microbiome tests.

Founded in 2020, Tiny Health began with a mission to help parents uncover and correct early gut imbalances in babies — a critical step in preventing chronic conditions like eczema, food allergies, and asthma. It is the only clinically-validated gut test for babies, with a published randomized controlled trial showing that Tiny Health personalized microbiome support reduced infants’ odds of eczema by 83%.

Today, its science and technology are helping people of all ages strengthen gut resilience, extend healthspan, and personalize care through a growing network of medical and wellness partnerships.

“This milestone is evidence that microbiome health is becoming mainstream,” said Cheryl Sew Hoy, Founder and CEO of Tiny Health. “We started by giving families the power to prevent and reverse chronic disease in their babies, and now we’ve expanded into longevity and healthy aging alongside major health systems, longevity clinics, and personalized medicine brands to help adults take control of their health with the same level of scientific rigor.”

From the First 1,000 Days to the Last 1,000 Days: Translating Microbiome Science Across the Lifespan

Tiny Health’s research has shown how the first 1,000 days of life — when the gut microbiome trains the developing immune system — set the foundation for lifelong health. By examining microbial patterns shared between well-trained infant immune systems and resilient aging microbiomes, the company aims to uncover how early-life microbial education influences vitality later in life. This new focus bridges decades of microbiome research, connecting the mechanisms that support thriving beginnings with those that sustain healthy longevity.

Tiny Health uses shotgun metagenomic sequencing to map gut health with strain-level precision and quantifies functional pathways of critical modulators in the gut. This year, the company has introduced new functional insights into the adult microbiome, including Gut Resilience, Urolithin-A potential, GLP-1 production, beta glucuronidase, and markers tied to conditions such as IBS and menopause.

“Our science gives people a real-time view of how their microbiome impacts aging, metabolism, hormone regulation, and disease risk,” said Sew Hoy. “It’s a personalized health dashboard for your gut, built on one of the most comprehensive microbiome datasets in the world.”

The Microbiome Age Study: Unlocking the Secrets of Healthy Aging

Tiny Health is also announcing its Microbiome Age Research Edition, a new study for adults aged 60+. The study aims to identify microbial patterns linked to healthy aging and resilience. Qualifying participants can purchase a discounted gut or vaginal health test and contribute to one of the world’s first datasets tracking how the microbiome changes with age.

Adults who are interested in the study are encouraged to learn more at www.tinyhealth.com/research/microbiomeage.

Powering the Longevity Movement

Through its Powered by Tiny B2B platform, Tiny Health partners with leading health and wellness organizations to integrate microbiome testing into preventive care models. Partners include:

• Leading longevity clinics including Mayo Clinic’s Executive and Longevity Health Programs and Pritikin Longevity Center — incorporating gut testing into clinical preventive, metabolic, and performance programs.
• Health assessment innovators including Superpower and Mito Health — integrating Tiny Health’s microbiome insights alongside their biomarker panels; and Tastermonial — helping users run real-world food response experiments with CGMs, using microbiome insights to personalize their food choices.
• AI-powered health solutions including ProteusDx, a diagnostics company using Tiny Health’s results to identify candidates for its ingestible capsule GI test.

Health and wellness companies, research institutions, and health practitioners interested in offering Tiny Health tests in their clinical practice can learn more at poweredbytiny.com.

About Tiny Health

Tiny Health is the first and only precision microbiome wellness platform designed for lifelong health — from the first 1,000 days to the last. Founded in 2020 and built by microbiome scientists and physicians, Tiny Health uses shotgun metagenomics to deliver strain-level and functional microbiome insights. Its research-backed gut and vaginal tests help families and practitioners address the root causes of many chronic conditions with evidence-based interventions. Trusted by over 100,000 people, Tiny Health is redefining the microbiome as a cornerstone of personalized wellness. Learn more at tinyhealth.com.

Media Contact:
Hannah Goering
press@tinyhealth.com 

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/562ae4a5-b672-40d6-93c0-3ad9bdb7c097

GENFIT: GNS561 Shows Promising Antitumor Activity in Combination Therapy  




GENFIT: GNS561 Shows Promising Antitumor Activity in Combination Therapy  

• Highly encouraging early data from the ongoing Phase 1b study evaluating investigational drug GNS561 with a MEK inhibitor (MEKi) in KRAS mutated cholangiocarcinoma (CCA), positioning this novel combination as a potential new therapeutic approach for difficult-to-treat cancers:
  • No dose limiting toxicity reached to date, enabling recruitment of a third patient cohort
  • GNS561 and MEKi combination demonstrated disease stabilization in all evaluable patients with evidence of tumor shrinkage in a subset of patients, warranting further investigation
  • Recommended Phase 2 doses expected for 1H26

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), December 10, 2025 – GENFIT (Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today reports encouraging preliminary Phase 1b data from its CCA clinical trial evaluating GNS561 in combination.

Clinical trial context and objective
CCA is a rare and aggressive cancer of the bile ducts, often diagnosed at an advanced stage. The unmet medical need is characterized by strong limitations in current treatments and poor prognosis. GNS561 is an investigational small molecule that targets PPT1, leading to autophagy inhibition and lysosomal dysfunction, which disrupt cancer cell survival mechanisms. By blocking autophagy, GNS561 aims to promote cancer cell death and may enhance sensitivity to other treatments. Combining GNS561 with a MEKi aims to unlock synergistic potential by simultaneously targeting autophagy and MAPK signaling pathways. In the on-going Phase 1b study, patients with advanced KRAS mutated CCA who have previously failed one or two lines of prior standard of care therapies are enrolled to evaluate the safety and tolerability of GNS561 when given in combination with trametinib, a MEKi, and to identify the recommended doses of the combination to be administered in Phase 2.

Preliminary results
The analysis evaluated 9 patients with measurable disease at baseline, 4 of them reaching tumor assessment at week 6. At this point, the combination therapy demonstrated:

• Disease stabilization observed in all 4 evaluated patients, who had all shown disease progression during previous treatment;
• Tumor shrinkage in a subgroup of patients with the best response showing a 20% reduction approaching the partial response (PR) threshold.

Achieving disease control and tumor reduction in such heavily pretreated patient population with advanced CCA is a significant signal of antitumor activity.

Clinical Impact

The results to date show a potential to address a critical unmet medical need in oncology. Patients with advanced solid tumors who have progressed on multiple prior therapies have limited treatment options and poor prognoses. The ability of the investigational drug GNS561 associated with a MEKi to achieve disease control in this challenging patient population would represent a significant advance. The consistent pattern of disease stabilization observed across all evaluated patients, combined with objective tumor shrinkage in a subgroup of heavily pretreated patients, suggests the combination has the potential to provide meaningful clinical benefit. Optimization of dosing and patient selection could lead to further improvement in response rates.

Dr. Mark Yarchoan, Associate Professor of Oncology at John Hopkins Medicine (Baltimore, MD, USA), principal investigator of the program, commented: “Advanced KRAS-mutated cholangiocarcinoma remains a formidable clinical challenge, and the emerging activity seen in this initial study is encouraging. Because MEK inhibition alone has historically shown limited efficacy in this setting, the early signs of benefit with dual targeting of autophagy and MAPK signaling provide meaningful rationale for continued evaluation of this combination strategy.”

Pascal Prigent, Chief Executive Officer of GENFIT, added: “These early results suggest a potential breakthrough for patients with limited options, and we are committed to advancing this program rapidly to individuals impacted by cholangiocarcinoma. We will also explore GNS561 potential in combination with other agents and in other tumors where autophagy inhibition plays a central role.”

Next development steps

Phase 1b dose escalation will continue as planned to confirm the activity signal, with new data for the next patient cohorts expected in 1Q26. These results will be used to establish the recommended Phase 2 combination doses, with completion expected in 1H26. Phase 2 initiation is targeted for 2H26.

END

ABOUT CCA
Biliary tract cancer (BTC) is the second most common primary liver malignancy diagnosed globally. Cholangiocarcinoma (CCA) is a type of BTC and represents approximately 15% of all primary liver tumors and 3% of gastrointestinal cancers. Based on its anatomical origin, CCA is best classified anatomically as intrahepatic (iCCA) or extrahepatic (eCCA), which is comprised of perihilar (pCCA) and distal (dCCA) CCA. Early diagnosis is a major challenge as most patients with early-stage disease do not have symptoms due to limited biliary obstruction. Rather, patients characteristically manifest symptoms related to their underlying cirrhosis, a condition present in some patients with CCA. Taken together, the majority of patients with CCA are diagnosed with advanced disease, often precluding potentially curative therapies. There are limited therapeutic options for this aggressive disease. The 5-year survival rates drop to 5-15% in the advanced and unresectable settings. The only potentially curative treatment remains surgical resection. Unfortunately, at time of first diagnosis, only about 25% of the patients are eligible for surgery. Moreover, even after curative intent surgery, the clinical outcomes are disappointing, with 5-year survival rates of 7% to 20%.

ABOUT GNS561
GNS561 is a first-in-class investigational lysosomotropic agent with a novel mechanism of action. When combined with MEK inhibitors, GNS561 targets complementary pathways critical for cancer cell survival and proliferation, resulting in potent antitumor activity. The combination is being developed as a potential breakthrough therapy for patients with advanced solid tumors. In December 2021, we licensed the exclusive rights from Genoscience Pharma to develop and commercialize the investigational treatment GNS561 in CCA in the United States, Canada and Europe, including the United Kingdom and Switzerland. In early 2025, GENFIT completed the acquisition of the full intellectual property rights for GNS561 from Genoscience Pharma, expanding upon the limited rights initially obtained through the 2021 license.

ABOUT THE GNS561-222-1 TRIAL
The GNS561-222-1 trial is an ongoing Phase I/II clinical study evaluating the safety, tolerability, and efficacy of GNS561 in combination with a MEK inhibitor in patients with advanced solid tumors. The trial uses RECIST 1.1 criteria to assess tumor response and includes comprehensive biomarker analyses to identify predictive markers of response.

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 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 with respect to GENFIT, including, but not limited to, statements about the anticipated completion of Phase 1b and initiation of Phase 2 clinical trials; the potential of GNS561 in combination with MEK inhibitors to provide meaningful clinical benefit and represent a breakthrough therapy for patients with advanced solid tumors; the possibility of improving response rates through optimization of dosing and patient selection; plans to potentially further investigate GNS561 in combination with other agents and in additional tumor types; and GENFIT’s commitment to advancing treatment options for CCA. 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.fr) and the AMF’s website (www.amf.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, including the Half-Year Business and Financial Report at June 30, 2025, 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

Jean-Christophe Marcoux – Chief Corporate Affairs Officer | Tel: +33 3 2016 4000 | jean-christophe.marcoux@genfit.com

GENFIT | Media

Bruno Arabian – Agence Maarc | Tel : 06 87 88 47 26 | bruno.arabian@maarc.fr

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

• GENFIT- GNS561 Shows Promising Antitumor Activity in Combination Therapy

Tristan Imbert co-opted as Independent Director




Tristan Imbert co-opted as Independent Director

Paris – December 10, 2025 – EUROAPI today announces that, following the resignation of Rodolfo Savitzky from his position as Independent Director (effective December 31, 2025)¹, and upon the recommendation of the Nominations and Compensation Committee, the Board of Directors has decided to co-opt Tristan Imbert as Independent Director, subject to the vote of EUROAPI Shareholders’ meeting on May 27, 2026. Tristan Imbert will be appointed Chair of the Audit Committee, effective January 01, 2026, succeeding Rodolfo Savitzky.

A French national, Tristan Imbert began his career in R&D at Sanofi Aventis in 1989. In 2000, he joined the Boston Consulting Group, advising pharmaceutical industry clients in New York and Paris, before moving to Novartis in 2005 as Head of Strategic Planning. At Novartis, he held several executive finance roles, before being appointed as Novartis Gene Therapies’ Chief Financial Officer. In 2021, he became CFO of the biotech company Cimeio Therapeutics, where he prepared the company for a potential IPO and new financing round. Tristan Imbert holds a master’s degree in applied mathematics from Université Paris-Sud and an MBA from Columbia University-Graduate School of Business in New York.

“I am delighted to welcome Tristan Imbert as an Independent Director and look forward to working with him. His deep knowledge of the pharmaceutical industry, combined with extensive and international experience in Finance, R&D, and Strategy, will be a valuable asset to EUROAPI’s Board of Directors,” said Emmanuel Blin, EUROAPI’s Chairman. “I would like to warmly thank Rodolfo Savitzky for his dedication as EUROAPI’s Board member, and Chair of the Audit Committee over the past 3 years.”

Financial agenda (all dates to be confirmed)

• 3 March 2026: FY 2025 results
• 27 May 2026: 2026 AGM
• 28 July 2026: H1 2026 results

About EUROAPI
EUROAPI is focused on reinventing active ingredient solutions to sustainably meet customers’ and patients’ needs around the world. We are a leading player in active pharmaceutical ingredients with approximately 200 products in our portfolio, offering a large span of technologies while developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO) activities.

Taking action for health by enabling access to essential therapies inspires our 3,270 people every day. With strong research and development capabilities and five manufacturing sites, all located in Europe, EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries. EUROAPI is listed on Euronext Paris; ISIN: FR0014008VX5; ticker: EAPI). Find out more at www.euroapi.com and follow us on Linkedin.

Forward-Looking Statements
Certain information contained in this press release is forward looking and not historical data. These forward-looking statements are based on opinions, projections and current assumptions including, but not limited to, assumptions concerning the Group’s current and future strategy, financial and non-financial future results and the environment in which the Group operates, as well as events, operations, future services or product development and potential. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Forward looking statements and information do not constitute guarantees of future performances, and are subject to known or unknown risks, uncertainties and other factors, a large number of which are difficult to predict and generally outside the control of the Group, which could cause actual results, performances or achievements, or the results of the sector or other events, to differ materially from those described or suggested by these forward-looking statements. These risks and uncertainties include those that are indicated and detailed in Chapter 3 “Risk factors” of the Universal Registration Document filed with the French Financial Markets Authority (Autorité des marchés financiers, AMF) on April 1, 2025. These forward-looking statements are given only as of the date of this press release and the Group expressly declines any obligation or commitment to publish updates or corrections of the forward-looking statements included in this press release in order to reflect any change affecting the forecasts or events, conditions or circumstances on which these forward-looking statements are based.

1 Please refer to September 30, 2025 press release

Attachment

• EUROAPI – Press release – December 10, 2025

Valneva Reports Positive Final Phase 2 Antibody Persistence and Safety Results in Children for its Chikungunya Vaccine IXCHIQ®




Valneva Reports Positive Final Phase 2 Antibody Persistence and Safety Results in Children for its Chikungunya Vaccine IXCHIQ®

• IXCHIQ^® was well tolerated by children aged one to eleven years regardless of the dose or previous chikungunya infection (CHIKV)
•  Antibody levels remained high after twelve months in both dose groups, although more robust with the full dose
•  Twelve-month data continues to support full dose selection for a future Phase 3 trial

Saint-Herblain (France), December 10, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced positive final antibody persistence and safety data for its Phase 2 clinical trial evaluating the safety and immunogenicity of two different dose levels of its single-shot chikungunya vaccine, IXCHIQ^®, in 304 children, twelve months after vaccination. Partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI), with support from the European Union, the trial results continue to support future Phase 3 development in children, which the Company plans to initiate after gathering additional real-world experience in the adolescent population.

Final VLA1553-221 results aligned with the initial data and six-month outcomes that the Company previously reported for this trial in January 2025¹ and June 2025² respectively. A full dose (licensed IXCHIQ^® formulation and presentation) elicited a higher immune response in children aged one to eleven years at Day 360 post vaccination compared to a half dose. Overall, the immunological response profile was in line with what was previously observed in adults and adolescents³⁴⁵⁶⁷⁸.

The strong immune response was confirmed in CHIKV-naïve children with a 94.7% seroresponse rate (full dose) at Day 360. The vaccine was well tolerated in children aged one to eleven years regardless of the dose or previous CHIKV infection. No safety concerns were identified.

The comparability of the vaccine doses tested in terms of safety and tolerability, along with the more pronounced immune response of the full dose observed for all age groups tested in children up to Day 360 post-vaccination, continues to support the selection of the full dose for use in this population.
Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “The twelve months persistence and safety data in children are consistent with the robust antibody response and favorable safety profile previously observed in adolescents following a single vaccination. As safety is of the utmost importance, particularly when advancing into a Phase 3 pediatric study, we have decided, in alignment with the regulatory authorities, to continue gathering additional real-world experience in the adolescent population before initiating our planned Phase 3 study in children. We remain convinced, considering the significant risk chikungunya poses to individuals living in or traveling to endemic areas, that it is crucial to ensure a vaccine capable of potentially offering long-term protection from a single shot is accessible to people of all ages. This is especially important in Low- and Middle-Income countries (LMICs) where access to vaccines is often limited.”

Brazil has reported the highest number of chikungunya cases worldwide, with over one million cases between January 2019 and July 2024⁹, followed by India with 370,000 cases during the same period. Reports of Chikungunya infection have expanded rapidly and globally in 2025, with six countries (Bangladesh, Cuba, China; Kenya, Madagascar, Somalia and Sri Lanka) currently experiencing CHIKV outbreaks¹⁰.

About Chikungunya
Chikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes which causes fever, severe joint and muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years¹¹.
In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, CHIKV has now been identified in over 110 countries in Asia, Africa, Europe and the Americas¹². Between 2013 and 2023, more than 3.7 million cases were reported in the Americas¹³ and the economic impact is considered to be significant. The medical and economic burden is expected to grow with climate change as the mosquito vectors that transmit the disease continue to spread geographically. As such, the World Health Organization (WHO) has highlighted chikungunya as a major public health problem.¹⁴

About Phase 2 Trial VLA1553-221
VLA1553-221 was a multi-center, randomized, observer-blinded, dose response Phase 2 clinical trial in 304 healthy children aged one to eleven years. The trial was performed at three trial sites in the Dominican Republic and Honduras. The primary and secondary objectives of the trial were to evaluate the safety and immunogenicity of two different dose levels of Valneva’s single-shot chikungunya vaccine. Participants were randomized 2:2:1 to receive either a full dose (licensed IXCHIQ^® formulation and presentation) or a half dose of the vaccine, or an active control (Nimenrix). Additional information, including a detailed description of the trial design, eligibility criteria and investigator sites, is available at ClinicalTrials.gov (Identifier: NCT06106581).

About Valneva SE
We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.
We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines.
Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world’s most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against other global public health threats. More information is available at www.valneva.com.

About CEPI
CEPI was launched in 2017 as an innovative partnership between public, private, philanthropic and civil organisations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic disease threats and enable equitable access to them. CEPI has supported the development of more than 70 vaccine candidates or platform technologies against multiple known high-risk pathogens and is advancing the development of rapid response platforms for vaccines against a future Disease X. Central to CEPI’s pandemic-beating five-year plan for 2022-2026 is the ‘100 Days Mission’ to compress the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days.

About Horizon Europe
Horizon Europe — #HorizonEU — is the European Union’s flagship Research and Innovation programme, part of the EU-long-term Multiannual Financial Framework (MFF) with a budget of €95,5 billion to spend over a seven-year period (2021-2027).  Under Horizon Europe, health research will be supported with the aim to find new ways to keep people healthy, prevent diseases, develop better diagnostics and more effective therapies, use personalised medicine approaches to improve healthcare and wellbeing, and take up innovative health technologies, such as digital ones.

Forward-Looking Statements
This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to use and regulatory review of existing products. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results or new adverse events, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

¹ Valneva Reports Positive Phase 2 Results in Children for its Chikungunya Vaccine and Announces Phase 3 Dose Decision – Valneva
² Valneva Reports Positive Six-Month Antibody Persistence and Safety Phase 2 Results in Children for its Single-Shot Chikungunya Vaccine IXCHIQ® – Valneva
³ Valneva Announces Positive Phase 3 Pivotal Results for its Single-Shot Chikungunya Vaccine Candidate – Valneva
⁴ Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate – Valneva
⁵ Lancet Paper: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00641-4/fulltext
⁶ Valneva Reports Positive Initial Phase 3 Safety Data in Adolescents for its Single-Shot Chikungunya Vaccine Candidate – Valneva

⁷ Valneva Reports Positive Pivotal Phase 3 Immunogenicity Data in Adolescents for its Single-Shot Chikungunya Vaccine Candidate – Valneva
⁸ Lancet Paper: https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(24)00458-4/abstract
⁹ https://bluedot.global/vaccines-on-the-table-as-chikungunya-outbreak-intensifies-in-india/

¹⁰ https://www.cdc.gov/chikungunya/data-maps/index.html

¹¹ https://jvi.asm.org/content/jvi/88/20/11644.full.pdf
¹² https://cmr.asm.org/content/31/1/e00104-16
¹³ PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017). https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html. Last accessed 01 Aug 2023.

¹⁴ Geographical expansion of cases of dengue and chikungunya beyond the historical areas of transmission in the Region of the Americas (who.int)

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• 2025_12_10_VLA1553-221_12M_Data_PR_EN_Final

EmblemHealth Announces New Agreement with the Hospital for Special Surgery




EmblemHealth Announces New Agreement with the Hospital for Special Surgery

City workers will retain access to the country’s highest-ranked orthopedic center

NEW YORK, Dec. 10, 2025 (GLOBE NEWSWIRE) — With the New York City Employees (NYCE) PPO health plan going live January 1, EmblemHealth issued the following statement regarding its new agreement with the Hospital for Special Surgery.

“Today, we announce that we have reached an agreement with the nation’s highest-ranked orthopedic center. This important step gives city workers peace of mind, knowing that this leading national Center of Excellence will continue to be available to them. It also demonstrates to the City and its unions that HSS is an important partner in helping the City achieve its goal of preserving and protecting health care coverage for City workers. Our collaboration with HSS is rooted in our mutual commitment to increasing access to affordable, high-quality care for the working families of New York who are vital to our city,” said Michael Costa, EmblemHealth’s SVP of Provider Network and Population Health.

“HSS has been honored to provide New Yorkers with specialized orthopedic care for more than 162 years,” said HSS President, CEO, and Surgeon-in-Chief Emeritus Bryan Kelly, MD, MBA. “We are delighted to continue collaborating with EmblemHealth to further increase access to the world’s highest quality care for the New York City employees who keep the world’s greatest city moving.”

The New York City Employees (NYCE) PPO Plan was negotiated by the City of New York and the Municipal Labor Committee. The plan offers city workers a modernized program, access to a much larger network of healthcare providers, care team support for people with chronic disease, and the continuity of customer service from a team well known to city workers.

About EmblemHealth 

EmblemHealth is one of the nation’s largest not-for-profit health insurers, serving members across New York’s diverse communities with a full range of commercial and government-sponsored health plans for employers, individuals, and families. With a commitment to value-based care, EmblemHealth partners with top hospitals and doctors, including its AdvantageCare Physicians, to deliver quality, affordable, convenient care. At over a dozen EmblemHealth Neighborhood Care locations, members and non-members can receive community-based health and wellness guidance and resources. For more information, visit emblemhealth.com. 

Contact:    
EmblemHealth Public Relations Office| Email: press@emblemhealth.com  

Priority Partners Opening Two More Free Mini-Pantries in Maryland




Priority Partners Opening Two More Free Mini-Pantries in Maryland

New Cupboards Target Food Insecurity In Time for Holidays

HANOVER, Md., Dec. 10, 2025 (GLOBE NEWSWIRE) — Priority Partners’ Cupboards Project is celebrating the season of giving with the launch of two new free self-serve mini-pantries in Anne Arundel and Prince George’s counties.

On Sunday, Dec. 14, the first of the two cupboards will be unveiled at noon at Living Word Seventh Day Adventist Church at 508 Aquahart Rd. in Glen Burnie, Maryland. Then at noon on Tuesday, Dec. 16, Priority Partners will unveil the second cupboard at CCI Health Services at 7615 Ora Glen Dr., Greenbelt, Maryland.

“We are so thankful for the opportunity to be a host site for this innovative way to increase access to food in our community,” said Jeff Kern, Senior Pastor of the Living Word Church. “We thank Priority Partners for their collaboration in installing this pantry, and look forward to the support it will provide to neighbors.”

Priority Partners, the Maryland managed care organization from Johns Hopkins Health Plans, is inviting the community to join these Cupboards Project grand opening events during a time when many Maryland families are experiencing deepening food insecurity. Guests can expect refreshments, music, local community leaders and a guest appearance by Cubby Bear, Priority Partners’ beloved mascot.

“We’re excited to host this cupboard at CCI Health Services and grateful to Priority Partners for bringing this resource to Greenbelt,” said Sonya Bruton, CCI Health Services CEO. “Without good health people can’t live full lives and without food they can’t be healthy. This partnership allows us to complement our WIC and HarvestRx Programs, bolstering our efforts to address food insecurity in a broadly accessible way that makes a difference.”

Priority Partners’ Cupboards Project was started in 2021 to address food insecurity in the communities it serves. Adding the Glen Burnie and Greenbelt locations brings the total number of free-standing mini-pantries in Maryland to nine, including three “Club on the Go” mobile pantries in operation through local Boys & Girls Club chapters.

Working under the motto “Take What You Need, Leave What You Can,” the custom-built mini-pantries provide free healthy food and nutrition resources to remote or underserved neighborhoods. The Cupboards Project is further supported by generous donations, which are always welcome.

Learn more about the Priority Partners Cupboards Project at prioritypartnerscupboards.org. 

About Priority Partners

Priority Partners is one of nine managed care organizations authorized by the state of Maryland to provide health care services for approximately 300,000 Medicaid, Maryland Children’s Health Program (MCHP) and Medical Assistance for Families recipients. Priority Partners is owned by Johns Hopkins Health Plans and the Maryland Community Health System. The mission is to provide high-value health care services that optimize individual wellness, improve community health and maintain the strength and viability of the plan. The vision is to be a national leader in Medicaid managed care, the plan of choice in Maryland, and a collaborative, innovative force for change.

Learn more at ppmco.org.  

24/7 Market News- Kraig Labs Breakthrough Science is Pivoting to Scalable Business




24/7 Market News- Kraig Labs Breakthrough Science is Pivoting to Scalable Business

How Decades of Innovation Are Converging for Commercial Spider Silk Success

DENVER, Dec. 10, 2025 (GLOBE NEWSWIRE) — 247marketnews.com, a pioneer in digital media dedicated to the swift distribution of financial market news and information, reports that Kraig Biocraft Laboratories (OTCQB: KBLB)(“the Company”, “Kraig”, “Kraig Labs”), the undisputed global leader in the development and commercialization of spider silk, is entering a defining phase in its corporate and scientific evolution.

What began as a bold idea by Kim Thompson, Kraig’s founder and CEO, more than a decade ago, is now maturing into a viable business model blending genetic engineering, biotechnology, and commercial textile manufacturing. Kraig Labs’ journey, from acquiring key patent rights abandoned by a failed predecessor to developing proprietary gene-insertion protocols and delivering advanced materials for the U.S. Army, highlights how persistence and innovation can transform a visionary concept into a tangible, scalable technology.

From Nexia’s Collapse to Kraig’s Breakthrough

In the early 2000s, Nexia Biotechnologies spent more than $110 million attempting to mass-produce spider silk proteins using goats and bacterial systems. The idea was compelling, but the results were not. When Nexia’s model collapsed, Thompson strategically acquired the license to key patents from the University of Wyoming after Nexia Biotechnologies, the Canadian firm burned through its funding without achieving commercial viability. This acquisition provided KBLB with foundational spider silk gene sequences, but the real breakthrough came through Thompson’s vision to combine them with cutting-edge genetic engineering, establishing the Company as the world’s first to viable solution to produce recombinant spider silk at industrial scale in a $200 billion technical textiles market (5.2% CAGR to 2030, Grand View Research).

Rather than using mammals or fermentation vats, Thompson envisioned leveraging one of nature’s most efficient silk producers: the silkworm. His insight was simple but revolutionary, insert spider silk DNA into silkworms so that they could spin the protein naturally, at industrial scale.

Collaboration with the University of Notre Dame: PiggyBac Technology and the Birth of a Platform

To execute that vision, Kraig Labs entered into a pivotal collaboration with the University of Notre Dame, where scientists utilized PiggyBac transposon gene-insertion technology, a tool that allows integration of foreign genes into host organisms. Using PiggyBac, Kraig and Notre Dame successfully created the world’s first transgenic silkworms capable of spinning recombinant spider silk in 2010.

That collaboration led to the creation of the Dragon Silk™ line, a hybrid fiber blending the elasticity and strength of spider silk with the processability of silkworm silk. Building on these early successes, Kraig Labs then developed its own proprietary genetic protocols, expanding beyond PiggyBac into advanced editing systems tailored specifically for its production needs.

Scientific Milestones and Military Collaboration

Kraig Labs’ spider silk has since evolved through multiple generations of material advancements, including:

• Monster Silk® – the company’s first commercially viable hybrid fiber.
• Dragon Silk™ – developed for enhanced toughness and durability.
• BAM-1 and Next-Generation Hybrids – the latest fibers optimized for strength, flexibility, and yield in production environments.

From Lab to Market: Building the Business Model

After years of R&D validation, Kraig Labs shifted its focus toward commercial scalability, establishing rearing and production operations in Asia to leverage existing sericulture infrastructure. The Company now operates multiple production centers, each capable of sustaining overlapping rearing cycles to ensure continuous fiber output.

With these facilities running concurrently, Kraig Labs has entered a new phase, moving from prototype to production.

A Long Road to a New Industry

Unlike the efforts that rode on its coattails, Kraig Labs’ efforts to bring spider silk to market was never about chasing hype, it was always about solving one of nature’s hardest engineering challenges and then about bringing the resulting technological breakthroughs to market.

So many competitors walked away, after burning through eight and nine-figure budgets and realizing creating usable spider silk is nearly impossible, as Kraig Labs developed new genetics and new production methods that turned decades of failed theory into a scalable reality.

Key Milestones in Kraig Labs’ Evolution

• 2006–2008: Kraig Biocraft Laboratories founded; acquisition of spider silk-related patents from Nexia Biotechnologies.
• 2009–2012: Collaboration with the University of Notre Dame yields first transgenic silkworms using PiggyBac technology.
• 2016: U.S. Army awards Kraig Labs a contract to develop ballistic “shoot packs” using Dragon Silk.
• 2018–2022: Monster Silk® and Dragon Silk™ commercial validation efforts expand; production trials begin in Vietnam.
• 2023–2025: Kraig Labs opens new hybrid breeding facilities; achieves largest production runs in company history; expands to dual-facility operations.

Looking Ahead: Commercialization and Global Opportunity

With advanced genetics, and a growing production base, Kraig Labs is positioning itself at the forefront of the bio-materials revolution. The Company’s recombinant spider silk platform is designed for applications across performance textiles, defense, luxury goods, and industrial composites; potential multi-billion-dollar market opportunities.

As 2025 draws to a close, Kraig Biocraft Laboratories stands as a rare biotech success story, a company that not only persisted through two decades of scientific and economic challenges but now appears poised to redefine the materials industry itself.

For more information about Kraig Labs’ spider silk technology and partnership opportunities, visit www.kraiglabs.com

Please click here to read the full Kraig Labs analyst report on 247marketnews.com.

About Kraig Biocraft Laboratories, Inc.

Kraig Biocraft Laboratories, Inc. (OTCQB: KBLB) is a biotechnology company focused on the development and commercialization of spider silk-based fiber technologies. Through its proprietary silkworm-based genetic engineering platform, Kraig Labs produces high-performance, cost-effective, and scalable spider silk materials for use in defense, performance apparel, technical textiles, and medical applications.

For more information, please visit: www.kraiglabs.com

Contact sales@247marketnews.com for Analyst Report coverage and other investor/public relations services.

About 24/7 Market News

24/7 Market News (247) is a leading market news platform for public companies. As a pioneer in digital media, 247 is dedicated to the swift distribution of financial market news and information. 247 takes great pride in creating innovative public relations campaigns that help clients reach the target audience.

PAID EDITORIAL DISCLOSURE: This is a paid editorial communication intended for informational purposes only. 247 is a third-party media provider and has been compensated for providing ongoing KBLB market outreach and other services. This press release may include technical analysis and should not be construed as financial or investment advice. Trading stocks involves risks, and readers should consult with their financial advisor before making investment decisions. Please review 247’s Full Disclaimer https://www.247marketnews.com/disclaimer/. Please go to https://247marketnews.com/kblb-disclosure/ for further KBLB and 247marketnews.com disclosure information.

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Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that are subject to various risks and uncertainties. Such statements include statements regarding the Company’s ability to grow its business and other statements that are not historical facts, including statements which may be accompanied by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Actual results could differ materially from those described in these forward-looking statements due to a number of factors, including without limitation, the Company’s ability to continue as a going concern, general economic conditions, and other risk factors detailed in the Company’s filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake any responsibility to update such forward-looking statements except in accordance with applicable law.