On February 27, 2026 Daiichi Sankyo (TSE: 4568) reported that it has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for ENHERTU (trastuzumab deruxtecan) as an adjuvant therapy for patients with HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization (ISH)+) breast cancer with residual invasive disease after neoadjuvant therapy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being developed and commercialized by Daiichi Sankyo in Japan.

The sNDA is based on data from the DESTINY‑Breast05 phase 3 trial presented at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) (#ESMO25) Congress and subsequently published in The New England Journal of Medicine. In the trial, ENHERTU demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (IDFS) compared to trastuzumab emtansine (T-DM1) in patients with HER2 positive breast cancer with residual invasive disease following neoadjuvant therapy.

Press Release
ENHERTU Supplemental New Drug Application Submitted in Japan as Adjuvant Therapy for Patients with HER2 Positive Early Breast Cancer
Published : February 27, 2026
Ref: Daiichi Sankyo
Submission based on DESTINY-Breast05 phase 3 trial results, which showed ENHERTU reduced the risk of invasive disease recurrence or death by 53% compared to T-DM1
If approved, ENHERTU has the potential to become a new standard of care in this early breast cancer setting
Tokyo – (February 27, 2026) – Daiichi Sankyo (TSE: 4568) has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for ENHERTU (trastuzumab deruxtecan) as an adjuvant therapy for patients with HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization (ISH)+) breast cancer with residual invasive disease after neoadjuvant therapy.

ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being developed and commercialized by Daiichi Sankyo in Japan.

The sNDA is based on data from the DESTINY‑Breast05 phase 3 trial presented at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) (#ESMO25) Congress and subsequently published in The New England Journal of Medicine. In the trial, ENHERTU demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (IDFS) compared to trastuzumab emtansine (T-DM1) in patients with HER2 positive breast cancer with residual invasive disease following neoadjuvant therapy.

Integrated CRDMO Services That Unlock Your Molecule’s True Potential
Explore Quotient Sciences’ core services, including drug product development & manufacturing, Translational Pharmaceutics, and clinical pharmacology.

Sponsored by Quotient
"New adjuvant treatment options for breast cancer are needed to help reduce the likelihood of disease recurrence and improve long-term outcomes for more patients," said Yuki Abe, PhD, Head of R&D Division in Japan and Head of Research, Daiichi Sankyo. "This submission demonstrates our commitment to bring ENHERTU to patients in this curative-intent breast cancer setting."

ENHERTU received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) based on DESTINY-Breast05, and a regulatory submission is also under review in the European Union. Two additional submissions are under review in Japan, including ENHERTU in combination with pertuzumab for the first-line treatment of patients with HER2 positive unresectable or recurrent breast cancer based on data from DESTINY-Breast09 and ENHERTU for the treatment of patients with HER2 positive advanced or recurrent solid tumors refractory or intolerant to standard treatments based on HERALD, an investigatorinitiated trial conducted in Japan, DESTINY-PanTumor02, DESTINY-CRC02 and DESTINY-Lung01.

About DESTINY-Breast05

DESTINY-Breast05 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) versus T-DM1 in patients with HER2 positive early breast cancer with residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy and a high risk of recurrence. High risk of recurrence was defined as presentation with inoperable cancer (prior to neoadjuvant therapy) or pathologically positive axillary lymph nodes following neoadjuvant therapy.

The primary endpoint of DESTINY-Breast05 is investigator-assessed IDFS, which is defined as the time from randomization until first invasive local, axillary or distant recurrence or death from any cause. The key secondary endpoint is investigator-assessed disease-free survival. Other secondary endpoints include overall survival, distant recurrence-free interval, brain metastases-free interval and safety.

DESTINY-Breast05 enrolled 1,635 patients in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov.
About ENHERTU

ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) 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 program 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 (5.4 mg/kg) in combination with pertuzumab is approved in the U.S. as a first-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 (5.4 mg/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 (5.4 mg/kg) is approved in more than 90 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 (5.4 mg/kg) is approved in more than 60 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 (5.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors 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 U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (6.4 mg/kg) is approved in more than 80 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-Gastric04 trials.

ENHERTU (5.4 mg/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 tumors 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 in the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the ENHERTU Clinical Development Program

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

About the Daiichi Sankyo and AstraZeneca Collaboration

Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and DATROWAY in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY.

About the ADC Portfolio of Daiichi Sankyo

The Daiichi Sankyo ADC portfolio consists of eight ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo.

The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include ENHERTU and DATROWAY, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo.

An additional ADC being developed by Daiichi Sankyo is DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING.

Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610 and DS3790 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.
About HER2 Positive Early Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.1 In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases diagnosed and 17,600 deaths in 2022.2

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer.3 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer.3 Approximately one in five cases of breast cancer is considered HER2 positive.4

For patients with HER2 positive early breast cancer, achieving pathologic complete response (pCR) with neoadjuvant treatment is the earliest indicator of improved long-term survival.5 However, approximately half of patients who receive neoadjuvant treatment do not experience pCR, putting them at increased risk of disease recurrence.6,7,8,9,10

Despite receiving additional treatment for residual disease in the post-neoadjuvant setting, some patients still experience invasive disease or death and current treatment options have shown limited impact on central nervous system recurrence. 11 Once patients are diagnosed with metastatic disease, the five-year survival rate drops from nearly 90% to approximately 30%.12

Post-neoadjuvant therapy represents a key opportunity to minimize the risk of recurrence and prevent progression to metastatic disease for patients with residual disease. New treatment options are needed in the early breast cancer setting to help reduce the likelihood of disease progression and improve long-term outcomes for more patients.

(Press release, Daiichi Sankyo, FEB 27, 2026, View Source [SID1234663091])

On February 27, 2026 WuXi XDC Cayman Inc. ("WuXi XDC", stock code: 2268.HK), a leading global CRDMO (Contract Research, Development, and Manufacturing Organization) specializing in antibody-drug conjugates (ADCs) and other bioconjugates, reported a strategic collaboration with Earendil Labs on WuXi XDC’s proprietary WuXiTecan-2 payload-linker technology platform. Earendil Labs is an AI-powered biotech company focused on researching and developing next-generation innovative biologics for the treatment of autoimmune diseases, cancer, and other conditions with unmet medical needs. This collaboration marks the establishment of a robust strategic partnership aimed at accelerating the development of next-generation ADCs by synergistically combining WuXi XDC’s globally leading ADC technology platform with Earendil Labs’ cutting-edge AI-driven antibody discovery and development capabilities to address significant unmet medical needs.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the agreement, WuXi XDC will grant Earendil Labs an exclusive global license to its proprietary WuXiTecan-2 payload-linker technology for use against multiple specific targets. Earendil Labs will utilize this technology to conjugate antibodies and bispecific antibodies discovered through its AI platform and to advance the development of the ADC candidates against these specific targets. The total potential deal value could reach up to approximately $885 million, comprising an upfront payment, and certain development, regulatory, and sales milestone payments. Additionally, WuXi XDC will be eligible to receive tiered royalties on net sales upon commercialization of any resulting ADC products.

Leveraging its world-leading integrated CRDMO platform, WuXi XDC will also fully support the Chemical, Manufacturing, and Controls (CMC) development and manufacturing of the ADC components within the collaboration. Earendil Labs will focus on subsequent product development, global regulatory submissions, and commercialization. This complementary partnership ensures maximized resource utilization and efficient project progression.

Jimmy Li, PhD, CEO of WuXi XDC, stated, "We are very pleased to establish this strategic partnership with Earendil Labs. This collaboration not only fully demonstrates the value of our WuXiTecan-2 payload-linker technology platform but also marks another significant milestone for WuXi XDC in empowering cutting-edge innovation alongside our partners. Earendil Labs has generated bispecific antibodies with differentiated advantages using its unique AI platform. Combining these with our WuXiTecan-2 technology helps develop more effective and safer next-generation ADCs. We look forward to supporting Earendil Labs in accelerating the R&D and commercialization of their ADCs through our integrated, end-to-end CRDMO service platform, ultimately benefiting patients worldwide."

Jian Peng, PhD, CEO of Earendil Labs, said, "Partnering with WuXi XDC represents a critical step in our mission to transform biopharmaceutical R&D through AI. WuXi XDC possesses a globally recognized and validated ADC technology platform and end-to-end manufacturing capabilities. This collaboration is a powerful alliance between frontier AI exploration and WuXi XDC’s integrated CRDMO services. We eagerly anticipate working closely with WuXi XDC to drive innovative breakthroughs through technological integration, empowering high-quality development in the global biopharma industry and contributing to the health of patients globally."

Zhenping Zhu, MD, PhD, President & co-CEO of Earendil Labs, added, "ADCs are emerging as a promising class of therapeutics in the treatment of cancer and many other human diseases. At Earendil Labs, we are developing a rich pipeline of bispecific / multi-specific ADCs utilizing our cutting-edge AI and high-throughput biology plaforms. We believe WuXiTecan-2 payload-linker technology will significantly enhance the success rate and speed of our novel ADC development, ultimately bringing these potentially life-transforming treatments to patients worldwide as soon as possible."

(Press release, Earendil Labs, FEB 27, 2026, View Source [SID1234663135])

On February 27, 2026 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, reported that its partner IDEAYA Biosciences, Inc. ("IDEAYA"; Nasdaq: IDYA) has dosed the first patient in IDEAYA’s Phase 1 dose-escalation/expansion clinical trial of IDE034, an investiagational B7H3/PTK7 bispecific TOP1 ADC. Pursuant to the companies’ option and license agreement, first patient dosing triggers a $5 million milestone payment to Biocytogen.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

According to IDEAYA, the Phase 1 study is designed to characterize IDE034’s safety profile, tolerability, and PK as a monotherapy, and IDEAYA also intends to evaluate combination regimens with DNA damage response (DDR) -targeting agents such as its oral PARG inhibitor IDE161 as the program advances.

IDE034 is a potential first-in-class bispecific B7H3/PTK7 TOP1 ADC, independently developed by Biocytogen and licensed to IDEAYA in July 2024. IDEAYA has stated that IDE034 is designed to preferentially internalize in tumor cells co-expressing B7H3 and PTK7, supporting selectivity and tolerability, and estimates 30–40% co-expression across several major solid tumors with limited dual expression in normal tissues.

"Reaching first dosing in the IDE034 Phase 1 trial marks an important step in translating this bispecific TOP1 ADC concept into clinical evaluation," said Dr. Yuelei Shen, President and CEO of Biocytogen. "We appreciate IDEAYA’s strong execution in advancing IDE034 into the clinic and look forward to the readout of initial safety and PK data from the ongoing Phase 1 study."

(Press release, Biocytogen, FEB 27, 2026, View Source [SID1234663136])

On February 27, 2026 ALX Oncology Holdings Inc. ("ALX Oncology"; Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported financial results for the fourth quarter and full year 2025, and provided a corporate update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Through strong execution of our targeted clinical development strategy in 2025, we have positioned ourselves to achieve multiple significant catalysts in the clinical programs for evorpacept and ALX2004, two potentially best- and first-in-class agents, in the coming 12 to 18 months," said Jason Lettmann, Chief Executive Officer at ALX Oncology. "We are particularly pleased that recent topline biomarker data from the Phase 1b/2 trial evaluating evorpacept with zanidatamab in advanced HER2-positive breast cancer reinforce findings from the ASPEN-06 HER2-positive gastric cancer trial, suggesting that CD47 is a predictive biomarker for evorpacept response. These findings strengthen our confidence in the ongoing Phase 2 ASPEN-09-Breast trial, where we will evaluate patient responses by CD47 level to further define the predictive potential of this biomarker among patients with HER2-positive disease that has progressed following ENHERTU.

"Additionally, we are pleased with the clinical progress of ALX2004, which has successfully cleared the first two dose cohorts in the ongoing Phase 1 trial. The potential of these two novel therapies, coupled with our substantial progress on their respective clinical programs, contributed to the successful completion of our recent financing. With our newly strengthened balance sheet, we now have the opportunity to deliver more robust and meaningful data readouts in both of our ongoing clinical programs, as reflected in our milestone updates," said Lettmann.

ALX Oncology Q4 and Full Year 2025 Highlights and Recent Developments

Evorpacept

Data from a pre-planned exploratory analysis of the Phase 2 ASPEN-06 clinical trial in gastric cancer showed that CD47 overexpression is a key predictive biomarker for evorpacept response and durable benefit in patients whose tumors have retained HER2 expression. Retained HER2 expression is defined as tumors that are HER2-positive following HER2-targeted treatment, as assessed by either a repeat tumor biopsy or HER2 gene amplification in circulating tumor DNA (ctDNA). These data were highlighted as part of a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November 2025.
In patients with retained HER2-positive and CD47-high gastric cancer (n=43), evorpacept + HERCEPTIN (trastuzumab), CYRAMZA (ramucirumab) and paclitaxel (TRP) generated a 65.0% objective response rate (ORR) versus 26.1% ORR for TRP alone.
The duration of response (DOR) was three times longer in the evorpacept + TRP arm relative to TRP alone in these patients. Evorpacept + TRP generated a median DOR (mDOR) of 25.5 months versus 8.4 months mDOR for TRP alone. Progression-free survival (PFS) and overall survival (OS) data were also evaluated in these patients. Treatment with evorpacept + TRP resulted in a median PFS (mPFS) of 18.4 months versus 7.0 months for TRP alone, with a hazard ratio (HR) of 0.39. Treatment with evorpacept + TRP resulted in a median OS of 17 months versus 9.9 months for TRP alone, with an HR of 0.70.
Consistent with the results from the ASPEN-06 trial, topline data from an exploratory analysis in the Phase 1b/2 trial of evorpacept with investigational zanidatamab in advanced HER2-positive breast cancer suggest that CD47 expression level helps predict therapeutic response.
Researchers had previously reported primary trial results showing a 56% (5/9) confirmed objective response rate (cORR) and an mPFS of 7.4 months in the nine patients with centrally confirmed HER2-positive breast cancer who received the investigational combination (2024 San Antonio Breast Cancer Symposium).
In January 2026, ALX Oncology announced topline data from the exploratory analysis conducted to identify biomarkers of response to the evorpacept/zanidatamab combination. These findings show that among patients with centrally confirmed HER2-positive breast cancer, responses were largely restricted to patients with higher CD47 expression.
The full Phase 1b/2 trial biomarker analysis has been accepted for poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer 2026 Annual Congress on May 7, 2026, in Berlin.
The Phase 2 ASPEN-09-Breast trial evaluating evorpacept plus trastuzumab and physician’s choice of chemotherapy in patients with HER2-positive breast cancer previously treated with ENHERTU (fam-trastuzumab deruxtecan-nxki) began enrollment in January 2026, and site activation remains on track globally. ALX Oncology has updated the primary objective of this trial to assess the overall response rate in patients whose tumors overexpress CD47. The company now plans to expand the number of patients enrolled in ASPEN-09-Breast – from 80 to up to 120 — to increase the number of patients whose cancer overexpresses this biomarker. The company expects to provide topline data for 80 patients in mid-2027.
The Sanofi-partnered, randomized Phase 1/2 UMBRELLA study evaluating evorpacept with SARCLISA (isatuximab-irfc) and dexamethasone in patients with previously treated multiple myeloma continues to enroll patients in the dose-optimization portion of the trial.
Data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2025 from a Phase 2 investigator-sponsored trial (IST) of evorpacept in combination with standard-of-care rituximab and lenalidomide for patients with previously untreated, indolent B-cell non-Hodgkin lymphoma (iNHL) demonstrated a 100% ORR and 92% complete response (CR) rate (with historical control around 50%), and a one-year PFS rate of 91%. While longer follow-up matures, minimal residual disease (MRD) eradication rate with this novel regimen will be evaluated.
ALX2004

The Phase 1 trial of ALX2004, a novel antibody-drug conjugate (ADC) for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors, began enrolling patients in the third dose cohort at 4mg/kg in January 2026, after no dose-limiting toxicities were observed in the prior two dose cohorts. ALX Oncology plans to share safety data from the dose-escalation phase of this trial in 2H 2026.
The ongoing ALX2004 Phase 1 dose-escalation portion of the trial is enrolling patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC), and colorectal cancer (CRC).
ALX2004 preclinical data presented at the World ADC 2026 Conference and at the 2025 AACR (Free AACR Whitepaper)-NCI-EORTC International Conference on Molecular Targets and Cancer demonstrated potent preclinical anti-tumor activity in EGFR-expressing in vivo tumor models across multiple tumor types with differing levels of EGFR expression and varied mutational status across the EGFR signaling pathway. A favorable preclinical safety profile, including no skin toxicity or interstitial lung disease, was observed in pre-clinical toxicology studies at clinically relevant doses of ALX2004.
Corporate Update

In February 2026, the company completed a registered equity offering, selling 76,979,112 shares of common stock at $1.57 per share and pre-funded warrants to purchase 18,574,120 shares of common stock at $1.569 per underlying share. Gross proceeds from the offering were $150 million. Net proceeds of the offering were $140.4 million, after deducting the underwriting discount and other offering expenses.
After serving as Chief Medical Officer in an interim capacity since September 2025, Barbara Klencke, M.D., has been appointed to the position permanently. Dr. Klencke was instrumental in ALX Oncology’s clinical development progress over the past five months.
Upcoming Clinical Milestones

Phase 1b/2 trial evaluating evorpacept in combination with investigational zanidatamab in advanced HER2-positive breast cancer: Full biomarker analysis to be presented in a poster session on May 7, 2026, at the ESMO (Free ESMO Whitepaper) Breast Cancer 2026 Annual Congress.
Phase 2 ASPEN-09 breast cancer trial: Topline data readout for 80 patients anticipated in mid-2027.
Phase 1 ALX2004 trial: Safety data from the dose-escalation phase of trial anticipated in 2H 2026.
Fourth Quarter and Full Year 2025 Webcast Information

To access the conference call, please dial +1-877-407-0752 or +1-201-389-0912 and ask to be joined into the ALX Oncology Fourth Quarter and Full Year 2025 Financial Results Conference Call.

Another option for instant telephone access to the event is to use the Call me link below:

View Source;passcode=13755276&h=true&info=company&r=true&B=6

A live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the company’s website, www.alxoncology.com. An archived webcast will be available on the company’s website after the event.

Date & Time: Friday, February 27, 2026, 5:30 a.m. PT / 8:30 a.m. ET

Webcast Access: View Source;tp_key=d6cfaba210

Fourth Quarter and Full Year 2025 Financial Results

Cash, Cash Equivalents and Investments: ALX held $48.3 million in cash, cash equivalents and investments as of December 31, 2025. Along with the $140.4 million in net proceeds from the February 2026 financing, the cash, cash equivalents and investments on hand are expected to be sufficient to fund ALX’s operating expenses through the first half of 2028.
Research and Development ("R&D") Expenses: R&D expenses consist primarily of preclinical, clinical and development costs related to the development of the company’s current product candidates, evorpacept and ALX2004, and R&D personnel-related expenses, including stock-based compensation. R&D expenses for the three months ended December 31, 2025 were $17.6 million compared to $23.5 million for the prior-year period, or a decrease of $5.9 million. This decrease was primarily attributable to a decrease of $2.7 million in stock-based compensation expense, a decrease of $2.5 million in personnel and related costs, and a decrease of $1.5 million in preclinical costs due to pipeline prioritization strategy. These decreases were partially offset by an increase of $0.6 million in clinical and development costs to support active clinical trials for ALX product candidates, evorpacept and ALX2004. R&D expenses for the year ended December 31, 2025, were $77.0 million compared to $116.4 million for the prior-year period.
General and Administrative ("G&A") Expenses: G&A expenses consist primarily of administrative personnel-related expenses, including stock-based compensation and other costs such as legal and other professional fees, patent filing and maintenance fees, and insurance. G&A expenses for the three months ended December 31, 2025 were $5.4 million compared to $7.1 million for the prior year period, or a decrease of $1.7 million. This decrease was primarily attributable to a decrease in stock-based compensation expense and decreases in legal and corporate costs. G&A expenses for the year ended December 31, 2025 were $23.9 million compared to $26.1 million for the prior-year period.
Net loss: GAAP net loss was ($22.8) million for the three months ended December 31, 2025, or ($0.42) per basic and diluted share, as compared to a GAAP net loss of ($29.2) million for the three months ended December 31, 2024, or ($0.55) per basic and diluted share. The lower net loss is primarily attributed to lower R&D expenses. GAAP net loss was ($101.7) million for the year ended December 31, 2025, or ($1.90) per basic and diluted share, as compared to a GAAP net loss of ($134.9) million for the year ended December 31, 2024, or ($2.58) per basic and diluted share. Non-GAAP net loss was ($20.1) million for the three months ended December 31, 2025, as compared to a non-GAAP net loss of ($23.2) million for the three months ended December 31, 2024. Non-GAAP net loss was ($88.8) million for the year ended December 31, 2025, as compared to a non-GAAP net loss of ($107.5) million for the year ended December 31, 2024. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.

(Press release, ALX Oncology, FEB 27, 2026, View Source [SID1234663120])

On February 27, 2026 Novocure (NASDAQ: NVCR) reported that management will participate in the Leerink Global Healthcare Conference on Tuesday, March 10, 2026. Frank Leonard, Chief Executive Officer, and Christoph Brackmann, Chief Financial Officer, will take part in a fireside chat at 11:20 a.m. EST, as well as one-on-one meetings with investors throughout the event.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live audio webcast of this presentation can be accessed from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for replay for at least 14 days following the event.

(Press release, NovoCure, FEB 27, 2026, View Source [SID1234663137])