On December 15, 2025 PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported key accomplishments from 2025 and provided an overview of strategic priorities and anticipated milestones for 2026. The Company also announced its attendance at the 44th Annual J.P. Morgan Healthcare Conference, with a presentation scheduled for Thursday, January 15 at 10:30 a.m. PT (1:30 p.m. ET).

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"PharmaEssentia delivered a year of substantial progress in 2025, driven by the strong performance of BESREMi and preparation for continued growth supported by exceptional commercial execution and important pending product milestones," said Ko-Chung Lin, Ph.D., Founder and CEO of PharmaEssentia. "BESREMi has become a key growth engine for our company with the potential to transform treatment across multiple patient populations living with serious myeloproliferative neoplasms (MPNs). In 2025, we saw strong performance in polycythemia vera (PV) and are well positioned for further acceleration. With our injection pen submitted to the FDA and a supplemental BLA under review for the essential thrombocythemia (ET) indication, we are preparing for meaningful opportunities to expand adoption and patient reach. Alongside these anticipated 2026 catalysts, we continue to advance our pipeline, including the ongoing Phase 3 study evaluating BESREMi in pre-fibrotic/early primary myelofibrosis (Early PMF), and preparing to move additional earlier-stage programs into the clinic."

2025 Major Accomplishments

Commercial Performance of BESREMi

Delivered strong commercial growth of BESREMi in PV, with substantial year-over-year revenue growth (Q3 2025 revenue of $127.8 million, representing 44% YoY growth)
Strengthened commercial and medical affairs readiness for anticipated 2026 product launches
Regulatory & Clinical Progress

Submitted the BESREMi injection pen presentation to the FDA for review
Submitted supplemental BLA seeking BESREMi label expansion for ET based on positive head-to-head Phase 3 results
Continued global enrollment in the Phase 3 trial in Early PMF
Earlier Stage Program Progress

Advanced six high value programs to the IND-enabling stage:
PEG-IL-2 and P11838 for immunology and inflammation indications
PD-1–IL-2 immunocytokine for solid tumors
Dual-targeting LILRB1/2 monoclonal antibody for solid tumors
Novel ADC candidate for solid tumors
KRAS and NY-ESO TCR-T cell therapies for solid tumors
2026 Anticipated Milestones

BESREMi

U.S. launch of BESREMi Pen expected (H1 2026)
Potential FDA approval and commercial launch of ET indication (H2 2026)
Completion of enrollment in the global Early PMF Phase 3 clinical trial (H1 2026)
Pipeline & Portfolio Growth

File IND submissions for multiple earlier-stage pipeline programs
Share initial clinical results from multiple earlier-stage programs

(Press release, PharmaEssentia, DEC 15, 2025, View Source [SID1234661449])

On December 15, 2025 Strand Therapeutics, a leader in next-generation mRNA-based therapeutics, reported that Jake Becraft, PhD, Co-founder and Chief Executive Officer, will present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, at 10:30 AM PT.

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"2025 was a transformative year as we moved programmable mRNA from promise to proof, delivering clinical results that have the potential to redefine what’s possible in oncology," said Dr. Becraft. "Strand is programming conditional therapeutic protein expression into the mRNA itself, enabling it to sense its environment and activate selectively within the target. We’re entering 2026 with clinical momentum and a platform that positions us at the forefront of the next generation of genetic medicine."

In 2025, Strand achieved multiple expansive milestones and validation with significant progress across clinical development, pipeline expansion, and corporate growth:

Clinical validation: Presented first-in-human Phase 1 data for STX-001 at the ASCO (Free ASCO Whitepaper) Annual Meeting, demonstrating response rates in late-stage cancer patients who had exhausted other treatment options
Capital to scale: Closed a $153 million Series B financing led by Kinnevik with participation from Regeneron Ventures, ICONIQ, Amgen Ventures, Eli Lilly, and other leading pharma investors
Pipeline acceleration: Unveiled preclinical data for STX-003 at the AACR (Free AACR Whitepaper) Annual Meeting, advanced ongoing solid tumor trials, progressed multiple programs to support 2026 clinical entry for STX-003, and expanded into in vivo CAR-T therapy
Board and leadership expansion: Appointed Jeb Keiper to Strand’s Board of Directors; Jason J. Luke, MD, FACP, as Chief Medical Officer; Prashant Nambiar, DVM, PhD, MBA, as Chief Scientific Officer; and Ethan Cash as Senior Vice President of Portfolio Management and Program Development

(Press release, Strand Therapeutics, DEC 15, 2025, View Source [SID1234661448])

On December 15, 2025 Dren Bio, a privately held, clinical-stage biotechnology company developing first-in-class myeloid cell engager therapeutics, reported that it has entered into a strategic collaboration with Sanofi (NASDAQ: SNY) for the discovery and development of a next-generation B-cell depleting therapy for the treatment of various autoimmune diseases.

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The new agreement builds on the existing relationship between the two companies, following Sanofi’s acquisition earlier this year of Dren Bio’s DR-0201 program for deep B-cell depletion. DR-0201, now known as SAR448501, is currently being evaluated in two ongoing phase 1 studies and has shown robust B-cell depletion, with the potential to induce sustained treatment-free remission in patients with autoimmune diseases.

"Our newly expanded strategic alliance with Dren Bio reflects Sanofi’s deep commitment to developing best-in-class therapies with the potential to achieve remission in patients with immune-mediated diseases," said Alyssa Johnsen, Global Therapeutic Head, Immunology and Oncology Development at Sanofi. "By combining Dren Bio’s unique scientific approach with Sanofi’s development expertise, we aim to accelerate the development of innovative therapies for patients in need."

Amit Mehta, Ph.D., Chief Operating Officer and Chief Business Officer of Dren Bio, added, "Sanofi has been a valued partner in unlocking the full potential of deep B-cell depletion through the acquisition of DR-0201, and we’re thrilled to expand our collaboration by further leveraging the capabilities of our Targeted Myeloid Engager and Phagocytosis platform. The U.S. profit/loss share option allows us to partner with a global commercial leader and represents an important milestone in our growth into a fully integrated biopharmaceutical company."

Under the terms of the agreement, Dren Bio will receive an upfront payment of $100 million and is eligible to receive up to $1.7 billion in development, regulatory, and commercial milestone payments. The companies will collaborate on discovery and preclinical development activities leveraging Dren Bio’s proprietary platform. Following development candidate selection, Sanofi will assume subsequent responsibility for development, manufacturing, regulatory, and commercialization efforts. Dren Bio has the option to enter into a U.S. profit/loss sharing arrangement with Sanofi. If exercised, Dren Bio will co-fund 40% of ongoing global development costs in exchange for U.S. co-promotion rights and a 50/50 share of U.S. profits and losses. Dren Bio will also remain eligible to receive milestones and tiered royalties on net sales outside the United States.

(Press release, Dren Bio, DEC 15, 2025, View Source [SID1234661447])

On December 15, 2025 Pilatus Biosciences Inc., a biopharmaceutical company developing novel metabolic checkpoint immunotherapies for liver and gastrointestinal cancers, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for PLT012, a first-in-class anti-CD36 monoclonal antibody, to enter clinical development for the treatment of solid tumors. Pilatus plans to initiate this Phase 1 clinical trial in the first quarter of 2026.

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PLT012 is a first-in-class metabolic checkpoint antibody designed to block CD36-mediated lipid uptake and immune suppression within the tumor microenvironment. CD36 is an immunometabolic regulator highly expressed on exhausted T cells, regulatory T cells, and tumor-associated macrophages, but is far less prevalent in healthy tissues.

By targeting CD36, PLT012 is engineered to restore metabolic fitness in cytotoxic T cells, reduce immunosuppressive cell populations, and promote stronger anti-tumor immune responses. In preclinical models, PLT012 demonstrated monotherapy activity across immune-hot and immune-cold tumors and showed potential synergy with PD-1/PD-L1 inhibitors, supporting its development as both a single agent and a combination therapy.

"PLT012 represents a fundamentally new approach to treating solid tumors by addressing the metabolic dysfunction that underlies immune exhaustion," said Raven Lin, Ph.D., Co-Founder and CEO, Pilatus Biosciences. "Leveraging our deep expertise in metabolic immunology, PLT012 was developed to simultaneously enhance effector T cell function and suppress tumor-promoting immune populations, while maintaining a favorable safety profile. We believe this dual-action metabolic checkpoint mechanism has the potential to deliver meaningful benefits for patients whose tumors do not respond to existing immunotherapies. We look forward to initiating our Phase 1 clinical trial of PLT012 early next year."

"Targeting CD36 represents a promising new way to reshape the tumor microenvironment," said the trial lead principal investigator, Anthony El-Khoueiry, M.D., Verna R. Richter Chair in Cancer Research, Associate Director for Clinical Research and Chief of Section of Developmental Therapeutics/Phase I Program at USC Norris Comprehensive Cancer Center, part of Keck Medicine of USC, and Associate Professor of Clinical Medicine at Keck School of Medicine of USC. "PLT012’s ability to modulate metabolic dysfunction and reinvigorate exhausted T cells positions it as a potentially important therapeutic option for tumors that do not respond to current immunotherapies."

The upcoming Phase 1, first-in-human clinical trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary signs of clinical activity, with expansion cohorts planned for tumor types strongly influenced by CD36-mediated metabolic dysregulation. Pilatus has also received FDA Orphan Drug Status for PLT012 for the treatment of liver and intrahepatic bile duct cancers.

"The hepatic microenvironment is tolerogenic and macrophage-rich which can dampen effector T-cell activity, contributing to weaker responses to immunotherapy treatments for HCC and liver metastases," said Anthony W Tolcher, M.D., FRCPC, FACP of New Experimental Therapeutics (NEXT), San Antonio, Texas. "Preclinical data has shown that PLT012 can overcome this immunogenically cold environment and elicit strong anticancer effects, which we hope will be translated into improved patient outcomes in the planned Phase 1 clinical trial."

About PLT012

PLT012 is a humanized monoclonal antibody designed to selectively block CD36-mediated lipid uptake, a key mechanism driving immunosuppression and immune exclusion within the tumor microenvironment. By targeting lipid metabolism, PLT012 exerts a unique mechanism of action: it reduces immunosuppressive cell populations, including Tregs and pro-tumor macrophages, while simultaneously enhancing anti-tumor activities of intratumoral NK cell and cytotoxic CD8+ T cell that are otherwise susceptible to lipid-induced exhaustion. In preclinical studies, PLT012 has demonstrated potent monotherapy efficacy in models of liver malignancies, with a favorable safety profile across species. Leveraging its distinct mechanism of action, PLT012 further acts as a potent sensitizer in combination with anti–PD-L1 therapies, effectively overcoming drug resistance in immune "cold" tumors and liver metastases.

(Press release, Pilatus Biosciences, DEC 15, 2025, View Source [SID1234661446])

On December 15, 2025 AstraZeneca and Daiichi Sankyo reported that Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been approved in the US for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer, as determined by a Food and Drug Administration (FDA)-approved test.

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The approval follows Priority Review and Breakthrough Therapy Designation by the FDA and is based on the results of the DESTINY-Breast09 Phase III trial. The data were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and published in The New England Journal of Medicine.1

Sara Tolaney, MD, MPH, Chief of the Division of Breast Oncology, Dana-Farber Cancer Institute and principal investigator for the trial, said: "Trastuzumab deruxtecan plus pertuzumab is the only 1st-line treatment approved in more than a decade to demonstrate a statistically significant improvement in progression-free survival over the current standard regimen for patients with HER2-positive metastatic breast cancer. With a median progression-free survival exceeding three years, versus approximately two years with THP, trastuzumab deruxtecan combined with pertuzumab should become a new 1st-line standard of care in this setting."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "With this approval, we are bringing Enhertu to the earliest setting for HER2-positive metastatic breast cancer, where optimising efficacy has an important impact on long‑term outcomes. The treatment approach with Enhertu plus pertuzumab in DESTINY-Breast09 sets a new benchmark of more than three years without disease progression or death for patients in this setting."

Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, said: "Since its initial approval six years ago, Enhertu has transformed the treatment of HER2-positive metastatic breast cancer. With this approval of Enhertu in the 1st-line HER2-positive metastatic setting, Enhertu once again offers significant improvements in progression-free survival and has practice-changing potential when used in combination with pertuzumab."

In the trial, Enhertu in combination with pertuzumab reduced the risk of disease progression or death by 44% versus a taxane, trastuzumab and pertuzumab (THP) (based on a hazard ratio of 0.56; 95% confidence interval [CI] 0.44-0.71; p<0.0001) as a 1st-line treatment for patients with HER2-positive metastatic breast cancer. Median progression-free survival (PFS) was 40.7 months with Enhertu plus pertuzumab compared to 26.9 months for THP. The PFS benefit for Enhertu plus pertuzumab versus THP was consistent across subgroups.1

The safety profile of Enhertu plus pertuzumab in DESTINY-Breast09 was consistent with the known profiles of each individual therapy with no new safety concerns identified.

Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

This application was approved under the FDA’s Real-Time Oncology Review (RTOR), an initiative by the FDA to ensure safe and effective treatments are available to patients as early as possible.

This US regulatory submission was also reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. As part of Project Orbis, the Enhertu plus pertuzumab 1st-line regimen is under review by Switzerland’s Swissmedic (SMC) and Singapore’s Health Sciences Authority (HSA). Separate regulatory applications are also under review in other countries.

Financial considerations
Following this approval in the US, an amount of $150m is due from AstraZeneca to Daiichi Sankyo as a milestone payment for the 1st-line unresectable or metastatic HER2-positive breast cancer indication. Sales of Enhertu in the US are recognised by Daiichi Sankyo. For further details on the financial arrangements, please consult the collaboration agreement from March 2019.

Notes

HER2-positive metastatic breast cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.2 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.2 In the US, more than 300,000 cases of breast cancer are diagnosed annually with more than 42,000 deaths.3 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis.4

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast cancer.5 HER2 protein overexpression may occur as a result of HER2 gene amplification.6 Approximately one in five cases of breast cancer are considered HER2-positive.7

HER2-positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2.8 Approximately 10,000 patients are treated each year in the 1st-line HER2-positive metastatic setting in the US.9 While HER2-targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of 1st-line treatment with THP, which has been the standard of care for more than a decade.6,10-12 Approximately 25% to 30% of patients do not receive any treatment following 1st-line therapy due to discontinuation or death.13-15

DESTINY-Breast09
DESTINY-Breast09 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg) either alone or in combination with pertuzumab versus standard of care THP as a 1st-line treatment in patients with HER2-positive metastatic breast cancer.

Patients were randomised 1:1:1 to receive either Enhertu monotherapy with a pertuzumab matching placebo; Enhertu in combination with pertuzumab; or THP. Randomisation was stratified by prior treatment (de novo metastatic disease versus progression from early-stage disease), hormone receptor (HR) status and PIK3CA mutation status.

The primary endpoint of DESTINY-Breast09 is PFS as assessed by blinded-independent central review in the Enhertu monotherapy and Enhertu combination arms. Secondary endpoints include investigator-assessed PFS, overall survival, objective response rate, duration of response, pharmacokinetics and safety. The investigational arm assessing Enhertu monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis.

DESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Enhertu (5.4mg/kg) in combination with pertuzumab is approved in the US as a 1st-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-approved test based on the results from the DESTINY-Breast09 trial.

Enhertu (5.4mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4mg/kg) is approved in more than 85 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu (5.4mg/kg) is approved in more than 55 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

Enhertu (5.4mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (5.4mg/kg) is approved in more than 10 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu development programme
A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu as a monotherapy, in combination or sequentially with other cancer medicines across multiple HER2-targetable cancers.

(Press release, AstraZeneca, DEC 15, 2025, View Source [SID1234661445])