On March 10, 2025 NiKang Therapeutics Inc. ("NiKang"), a clinical stage biotech company focused on developing innovative small molecule oncology medicines to bring transformative therapies to patients in need, reported the successful completion of dosing the first cohort of patients in its Phase 1 dose escalation study of NKT3964 as a single agent. NKT3964 is a first-in-class, orally bioavailable small molecule that selectively degrades CDK2 (Press release, NiKang Therapeutics, MAR 10, 2025, View Source [SID1234651049]). NKT3964, with high potency, selectivity and sustained inhibition of the CDK2 pathway without cyclin E accumulation, has the potential to provide therapeutic benefits for patients with aberrant CDK2/cyclin E pathway activation, such as ovarian, endometrial, gastric and HR+HER2- breast cancers.

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The Phase 1 trial (NCT06586957) is an open-label, dose escalation study designed to evaluate safety, tolerability, PK, PD and preliminary anti-tumor activity to determine the recommended dose(s) for expansion of NKT3964 monotherapy in adults with advanced or metastatic solid tumors.

"We are thrilled to reach this milestone in the clinical development of NKT3964," said Zhenhai Gao, Ph.D., co-founder, president, and CEO of NiKang. "Completing dosing in our first cohort brings us one step closer to understanding the potential of this groundbreaking CDK2 degrader, one of several molecules in our portfolio targeting the cell cycle. Initial PK data from the first cohort demonstrated good oral exposure that aligns with human PK projections. Additionally, NKT3964 has achieved CDK2 degradation levels in patients that are consistent with those observed in preclinical in vivo studies. These early observations are particularly encouraging as they address the considerable challenges of achieving oral bioavailability with a PROTAC degrader. These findings will help guide dose optimization as the trial advances. Our pipeline focused on cell cycle inhibition via CDK2 degradation or CDK2/CDK4 dual degradation enables us to have multiple opportunities for success. We are excited by this progress and remain committed to advancing transformative therapies to help patients fight cancer and live better lives."

About NKT3964

NKT3964 is a first-in-class, highly potent and selective, orally bioavailable CDK2 degrader, causing prolonged CDK2 pathway inhibition without cyclin E accumulation. It has the potential to maximally and selectively suppress the CDK2 pathway, thereby harnessing the full therapeutic benefits of CDK2 inhibition. NKT3964 is currently under evaluation in a Phase 1 clinical study in advanced or metastatic solid tumors as a single agent (NCT06586957).

On March 10, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, reported the enrollment of the first patients in the HEROES clinical trial. HEROES is a multi-center, phase II trial that explores the discontinuation or de-escalation of anti-HER2 targeted therapy among patients with metastatic HER2+ breast cancer (Press release, Natera, MAR 10, 2025, View Source [SID1234651050]). The trial is supported by funding from the French Ministry of Health through the Hospital Clinical Research Program (PHRC) and is being sponsored by Unicancer. It is being developed within Unicancer’s French Breast Cancer Intergroup (UCBG) network.

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Human epidermal growth factor receptor 2 (HER2) is a type of protein found in cancer cells that can cause rapid cancer growth when higher than normal levels are present. Between 15%-20% of breast tumors are HER2+.¹ Current standard-of-care (SOC) recommendations for maintenance treatment include the use of anti-HER2 therapies, which for many patients means remaining on the drug for life.

The HEROES (NCT06450314) trial will enroll approximately 170 metastatic HER2+ breast cancer patients who have discontinued anti-HER2 maintenance therapy. The primary endpoint of the study is 1-year progression-free survival in the Signatera-negative cohort. It will also assess ctDNA dynamics and quality-of-life measures to gain deeper insights into the potential for ctDNA-guided de-escalation of treatment in patients with no detectable molecular disease burden.

Highlights from the study protocol include:

At baseline, all patients are currently being treated with SOC anti-HER2 targeted therapies and have been on therapy for two or more years.
Signatera-negative patients at baseline will stop treatment and will be monitored with serial Signatera testing and diagnostic imaging. If at any point during the trial radiological progression is confirmed or a patient becomes Signatera-positive, prior drug therapy will resume or a new treatment will begin.
Signatera-positive patients at baseline will continue maintenance therapy and will not move forward in the trial.
"The HEROES study could significantly reshape the way oncologists treat patients with metastatic HER2+ breast cancer," said Thibault de la Motte Rouge, M.D., Ph.D., principal investigator of the trial and medical oncologist at the Comprehensive Cancer Centre Eugène Marquis (Rennes, France), where he currently holds the position of research director. "This could also pave the way for future research into ctDNA-guided treatment de-escalation in breast cancer."

"We are excited to see the first patients enrolled in the HEROES clinical trial," said Angel Rodriguez, M.D., senior medical director of oncology at Natera. "Safely discontinuing treatment has been a long-lasting dilemma in HER2 metastatic breast cancer. With Signatera monitoring, we hope oncologists can identify the patients without detectable disease who may be able to avoid additional therapy that can be costly and potentially harmful to their care."

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard-of-care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer, and muscle-invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in over 100 peer-reviewed papers.

On March 10, 2025 Alterome Therapeutics, Inc., a clinical-stage biopharmaceutical company pioneering the development of next-generation, small molecule targeted therapies for the treatment of cancer, reported that the first patient has been dosed in the Phase 1/1b trial of ALTA3263 in adults with KRAS mutant solid tumors (Press release, Alterome Therapeutics, MAR 10, 2025, View Source [SID1234651034]).

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ALTA3263 is an oral KRAS-selective inhibitor specifically designed to potently inhibit the KRAS "ON" (active) state of greater than 90% of all KRAS mutations and to provide complete target coverage in tumors. These properties have the potential to translate into best-in-class safety and efficacy. KRAS driver mutations are found in greater than 20% of all patients with metastatic cancer, with the majority in non-small cell lung cancer (NSCLC), pancreatic ductal carcinoma (PDAC), and colorectal cancer (CRC).

"With this trial, we hope to bring a breakthrough therapy to the many patients with KRAS-driven cancers who are still underserved," said Andrew Chi, M.D., Ph.D., Chief Medical Officer of Alterome. "We have shown in preclinical studies that ALTA3263 has the attributes to potentially address this significant unmet need and transform patient outcomes."

"While progress has been made in KRAS mutant cancers, we still regularly see patients who have exhausted all available effective treatment options and also suffer from toxic side effects of current therapies," said Anthony Tolcher, M.D., FRCPC, Founder of NEXT Oncology and primary investigator on the ALTA3263 Phase 1/1b trial. "We are excited to participate in this trial, and hope that ALTA3263 will usher in the next generation of KRAS targeted therapies that promise greater efficacy and improved tolerability and safety for patients."

The Phase 1/1b, open-label, dose-escalation and multiple cohort study is evaluating the safety, tolerability, pharmacokinetics, and preliminary clinical activity of ALTA3263 in adults with advanced unresectable or metastatic solid tumors with KRAS mutations (NCT06835569).

About ALTA3263

ALTA3263 is a non-covalent, orally bioavailable, highly potent KRAS isoform-selective dual ON/OFF state inhibitor designed to target >90% of all KRAS driver mutations in cancer. While mutation-specific KRAS inhibitors that target the KRAS OFF-state have demonstrated clinical benefit, highly prevalent KRAS mutations such as G12D and G12V exist predominantly in the ON-state and remain a substantial unmet medical need. ALTA3263 inhibits KRAS with picomolar to low single-digit nanomolar potency and targets both the ON and OFF states while exhibiting high selectivity for KRAS over HRAS and NRAS to allow for a favorable therapeutic index. These properties, together with excellent pharmacokinetic and tolerability profiles enable complete and continuous target coverage to inhibit KRAS-driven cancers. ALTA3263 led to deep regressions in multiple KRAS mutant preclinical models while being well-tolerated during prolonged oral dosing. These data were presented in an oral presentation at the 2024 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium. For more information on ALTA3263, visit View Source

On March 10, 2025 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported that the first patient has been dosed in the Phase 1, first-in-human trial of IM-1021, a ROR1-targeted ADC (Press release, Immunome, MAR 10, 2025, View Source [SID1234651051]).

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"Immunome is developing differentiated ADCs that we believe can greatly benefit cancer patients," said Bob Lechleider, M.D., Chief Medical Officer at Immunome. "The dosing of our first patient with IM-1021 advances that mission, as we work to establish safety and explore efficacy of IM-1021 in patients with high unmet need in B-cell lymphomas and solid tumors."

IM-1021 is an optimized, ROR1-targeted ADC that incorporates Immunome’s proprietary TOP1 inhibitor, HC74. The Phase 1 trial is an open-label, multicenter dose escalation and expansion study designed to determine the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of IM-1021. The study is expected to include participants with advanced B-cell lymphomas and advanced solid tumors.

On March 10, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported financial results for the three months and full year ended December 31, 2024, and provided an update on its corporate progress (Press release, BioNTech, MAR 10, 2025, View Source [SID1234651035]).

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"From the very beginning, BioNTech’s vision has been to translate our science into survival and become an immunotherapy powerhouse. In 2024, we made significant progress towards our vision through important oncology pipeline advancements, including the initiation of global Phase 3 clinical trials for our anti-PD-L1/VEGF-A bispecific antibody candidate BNT327 and key data updates from our mRNA cancer immunotherapy programs," said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. "We expect 2025 to be a data-rich year with multiple important updates from our priority programs, which we believe have disruptive potential and could improve the standard of care, if successfully developed and approved."

Financial Review for Fourth Quarter and Full Year 2024 Financial Results

in millions €,
except per share data Fourth Quarter 2024 Fourth Quarter 2023 Full Year
2024 Full Year
2023
Total revenues 1,190.0 1,479.0 2,751.1 3,819.0
Net profit / (loss) 259.5 457.9 (665.3) 930.3
Diluted earnings / (loss) per share 1.08 1.88 (2.77) 3.83
Total revenues reported were €1,190.0 million for the three months ended December 31, 2024, compared to €1,479.0 million for the comparative prior year period. For the year ended December 31, 2024, revenues were €2,751.1 million, compared to €3,819.0 million for the comparative prior year period. The decrease in revenues was primarily driven by lower sales of the Company’s COVID-19 vaccines due to reduced market demand. In addition, write-downs by BioNTech’s collaboration partner Pfizer Inc. ("Pfizer") significantly reduced the Company’s gross profit share which negatively influenced its revenues.

Cost of sales were €243.5 million for the three months ended December 31, 2024, compared to €179.1 million for the comparative prior year period. For the year ended December 31, 2024, cost of sales were €541.3 million, compared to €599.8 million for the comparative prior year period. Cost of sales were influenced by COVID-19 vaccine sales and inventory write-downs and scrapping.

Research and development ("R&D") expenses were €611.8 million for the three months ended December 31, 2024, compared to €577.8 million for the comparative prior year period. For the year ended December 31, 2024, R&D expenses were €2,254.2 million, compared to €1,783.1 million for the comparative prior year period. R&D expenses were mainly influenced by advancing clinical studies for the Company’s late-stage oncology product candidates. Further contributions to the increase came from higher personnel expenses resulting from an increase in headcount.

Sales, general and administrative ("SG&A")3 expenses, in total, amounted to €132.1 million for the three months ended December 31, 2024, compared to €142.3 million for the comparative prior year period. For the year ended December 31, 2024, SG&A expenses were €599.0 million, compared to €557.7 million for the comparative prior year period. SG&A expenses were mainly influenced by the setup and enhancement of commercial IT platforms and personnel expenses resulting from an increase in headcount.

Other operating results amounted to negative €54.0 million during the three months ended December 31, 2024, compared to negative €53.6 million for the comparative prior year period. For the year ended December 31, 2024, other operating result amounted to negative €670.9 million compared to negative €188.0 million for the prior year period. The decrease was mainly due to the settlement of contractual disputes and related expenses to such disputes and other litigations. The amounts for contractual disputes are net of the related reimbursements expected to be received.

Income taxes were accrued with an amount of €41.7 million in tax expenses for the three months ended December 31, 2024, compared to €205.3 million in accrued tax expenses for the comparative prior year period. For the year ended December 31, 2024, income taxes were realized with an amount of €12.4 million in tax income for the year ended December 31, 2024, compared to €255.8 million of accrued tax expenses for the comparative prior year period.

Net profit was €259.5 million for the three months ended December 31, 2024, compared to €457.9 million net profit for the comparative prior year period. For the year ended December 31, 2024, net loss was €665.3 million, compared to a net profit of €930.3 million for the comparative prior year period.

Cash and cash equivalents plus security investments2 as of December 31, 2024, reached €17,359.2 million, comprising of €9,761.9 million in cash and cash equivalents, €6,536.2 million in current security investments and €1,061.1 million in non-current security investments.

Diluted earnings per share was €1.08 for the three months ended December 31, 2024, compared to €1.88 for the comparative prior year period. For the year ended December 31, 2024, diluted loss per share was €2.77, compared to diluted earnings per share of €3.83 for the comparative prior year period.
Shares outstanding as of December 31, 2024, were 239,970,804, excluding 8,581,396 shares held in treasury.

"Through strategic investments in our priority programs like our next-generation immunomodulator candidate BNT327, we strive to meaningfully improve treatments for patients," said Jens Holstein, CFO of BioNTech. "Our strong financial position enables us to fuel our R&D activities and to prepare for multiple product launches in the coming years. With our targeted investments we aim to create long-term value for the benefit of BioNTech’s stakeholders."

2025 Financial Year Guidance4

Total revenues for the 2025 financial year €1,700 million – €2,200 million
BioNTech expects its revenues for the full 2025 financial year to be in the range of €1,700 – €2,200 million and revenue phasing similar to 2024, primarily concentrated in the last three to four months, driving the full year revenue figure. The revenue guidance assumes: relatively stable vaccination rates, pricing levels and market share compared to 2024; estimated inventory write-downs and other charges by BioNTech’s collaboration partner Pfizer that negatively influence BioNTech’s revenues; anticipated revenues from a pandemic preparedness contract with the German government; and anticipated revenues from the BioNTech Group service businesses.

Planned 2025 Financial Year Expenses and Capex

R&D expenses €2,600 million – €2,800 million
SG&A expenses €650 million – €750 million
Capital expenditures for operating activities €250 million – €350 million
BioNTech expects to continue to focus investments on R&D and scaling the business for late-stage development and commercial readiness in oncology, while continuing to be cost disciplined. Strategic capital allocation will remain a key driver of the Company’s trajectory. As part of BioNTech’s strategy, the Company may continue to evaluate appropriate corporate development opportunities with the aim of driving sustainable long-term growth and create future value.

The full audited consolidated financial statements as of and for the year ended December 31, 2024, can be found in BioNTech’s Annual Report on Form 20-F filed today with the United States Securities and Exchange Commission ("SEC") and available at www.sec.gov.

Endnotes
1 Calculated applying the average foreign exchange rate for the year ended December 31, 2024, as published by the German Central Bank (Deutsche Bundesbank).

2 Payments associated with the closing of the Biotheus acquisition and with the resolved settlement of a contractual dispute with the National Institutes of Health ("NIH") are expected to result in a cash outflow of approximately $1.6 billion to be reflected in cash & cash equivalents in the Company’s first quarter 2025 financial results. The settlement payment of $467 million related to a contractual dispute with the University of Pennsylvania is expected to be reflected in the Company’s second quarter 2025 financial results. In connection with these settlements, BioNTech expects to be reimbursed approximately $535 million by its partner during 2025 and 2026.

3 Sales, general and administrative expenses ("SG&A") include sales and marketing expenses as well as general and administrative expenses.

4 Excludes external risks that are not yet known and/or quantifiable, including, but not limited to the effects of ongoing and/or future legal disputes and related activities, certain potential one-time effects and charges related to portfolio prioritization, as well as potential changes to the law or governmental policy, including public health policy, at the state or national level, and evolving public sentiment around vaccines and mRNA technology, in the United States and/or elsewhere. It includes effects identified from licensing arrangements, collaborations or potential M&A transactions to the extent disclosed and may be subject to update. The Company does not expect to report a positive net income figure for the 2025 financial year.

Operational Review for the Fourth Quarter 2024, Key Post Period-End Events and 2025 Outlook

Selected Oncology Pipeline Updates
In 2024, the Company’s pipeline continued to mature towards later stages of clinical development with a focus on two priority programs: our investigational next-generation immunomodulator candidate BNT327 and mRNA cancer immunotherapies. BioNTech’s oncology pipeline currently contains over 20 ongoing Phase 2 and 3 clinical trials. In 2025, the Company plans to continue progressing its pipeline towards commercialization, with its first oncology launch expected in 2026.

Next-Generation Immunomodulators

BNT327 is a bispecific antibody candidate combining PD-L1 checkpoint inhibition with VEGF-A neutralization.

In December 2024, BioNTech initiated a global randomized Phase 3 clinical trial (NCT06712355) evaluating BNT327 plus chemotherapy compared to atezolizumab plus chemotherapy in first-line extensive-stage small cell lung cancer ("ES-SCLC").
In December 2024, BioNTech initiated a global randomized Phase 2/3 clinical trial (NCT06712316) evaluating BNT327 plus chemotherapy compared to pembrolizumab plus chemotherapy in first-line non-small cell lung cancer ("NSCLC").
In December 2024, at the San Antonio Breast Cancer Symposium ("SABCS"), interim data were presented from the Phase 1/2 clinical trial (NCT05918133) evaluating BNT327 in combination with chemotherapy in a cohort of patients with locally advanced, previously untreated triple-negative breast cancer ("TNBC"). In 42 patients, first-line treatment with BNT327 combined with nab-paclitaxel chemotherapy showed encouraging antitumor activity and survival outcomes regardless of PD-L1 status, together with a manageable safety profile.
A global randomized Phase 3 clinical trial evaluating BNT327 in first-line TNBC is on track to start in 2025.
Data from the ongoing global Phase 2 dose optimization clinical trials evaluating BNT327 in combination with chemotherapy in first-line small cell lung cancer ("SCLC") (BNT327-01, NCT06449209) and TNBC (BNT327-02, NCT06449222) are planned to be published in 2025.
Data from two Phase 2 clinical trials conducted in China in first- and second-line SCLC (NCT05844150, NCT05879068, respectively) are expected to be presented at the European Lung Cancer Congress ("ELCC") taking place March 26-29, 2025 in Paris, France.
Title: Phase 2 study of the efficacy and safety of BNT327 plus systemic chemotherapy as first-line therapy for ES-SCLC
Presentation Date: March 28, 2025
Poster Number: 302P
Author: Y. Cheng

Title: Updated Phase 2 efficacy and safety results of BNT327 combined with paclitaxel as second-line therapy in SCLC
Presentation Date: March 28, 2025
Poster Number: 332P
Author: Y. Cheng

First clinical data from the ongoing global Phase 1/2 expansion cohorts (NCT05438329) evaluating the combination of BNT327 and BNT325/DB-1305, a TROP2-targeted antibody-drug conjugate ("ADC") candidate, are planned to be published in 2025.
Additional clinical trials exploring novel combinations of BNT327 with the ADC candidates BNT323/DB-1303 (trastuzumab pamirtecan) targeting HER2, BNT324/DB-1311 targeting B7-H3 or BNT326/YL202 targeting HER3 are planned to start in 2025.
BNT316/ONC-392 (gotistobart) is an anti-CTLA-4 monoclonal antibody candidate being developed in collaboration with OncoC4, Inc. ("OncoC4").

In December 2024, the U.S. Food and Drug Administration ("FDA") lifted the partial clinical hold on the OncoC4-sponsored Phase 3 clinical trial (PRESERVE-003; NCT05671510) evaluating the efficacy and safety of BNT316/ONC-392 as monotherapy in patients with metastatic NSCLC that progressed under previous PD-(L)1-inhibitor treatment. Based on the available clinical trial data and upon alignment with the FDA, the companies will solely continue enrollment of patients with squamous NSCLC.
mRNA Cancer Immunotherapies

Autogene cevumeran (BNT122/RO7198457) and BNT111 are investigational immunotherapies for the treatment of cancer based on BioNTech’s systemically administered uridine mRNA-lipoplex technology.

Autogene cevumeran is an individualized neoantigen-specific mRNA cancer immunotherapy candidate being developed in collaboration with Genentech, Inc. ("Genentech"), a member of the Roche Group ("Roche").

In December 2024, the first patient was treated in a global randomized Phase 2 clinical trial (IMCODE004; NCT06534983) evaluating autogene cevumeran in combination with nivolumab compared to nivolumab alone as an adjuvant treatment in high-risk muscle-invasive urothelial carcinoma ("MIUC").
In January 2025, a manuscript summarizing the results of a Phase 1 clinical trial (NCT03289962) evaluating autogene cevumeran in combination with atezolizumab in patients with advanced solid tumors was published in Nature Medicine (Lopez et al., 2025). In February 2025, a manuscript denoting follow up data from an investigator-initiated Phase 1 clinical trial (NCT04161755, Rojas et al., 2023) evaluating autogene cevumeran in combination with atezolizumab in patients with pancreatic ductal adenocarcinoma ("PDAC") in an adjuvant treatment setting was published in Nature (Sethna et al., 2025).
First data from the ongoing global randomized Phase 2 clinical trial (NCT04486378) evaluating autogene cevumeran as an adjuvant treatment compared to watchful waiting after standard of care chemotherapy in resected circulating tumor DNA+ ("ctDNA") stage II (high-risk) and III colorectal cancer ("CRC") are anticipated in late 2025 or early 2026.
BNT111 is based on BioNTech’s fully owned, off-the-shelf FixVac platform, and encodes four melanoma-associated antigens.

BioNTech plans to present data from the ongoing Phase 2 clinical trial (BNT111-01; NCT04526899) at a medical conference in 2025. In 2024, an initial topline readout was provided noting that the clinical trial had met its primary efficacy outcome measure, demonstrating a statistically significant improvement in overall response rate ("ORR") in patients with anti-PD-(L)1 refractory/relapsed, unresectable stage III or IV melanoma treated with BNT111 in combination with cemiplimab as compared to historical control in this treatment setting.
Antibody-Drug Conjugates

BNT323/DB-1303 (trastuzumab pamirtecan) is an ADC candidate targeting HER2 that is being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. ("DualityBio").

BNT323/DB-1303 is being evaluated in a Phase 1/2 clinical trial (NCT05150691) in patients with advanced/unresectable, recurrent or metastatic HER2-expressing solid tumors. Data from patients with HER2-expressing (IHC3+, 2+, 1+ or ISH-positive) advanced endometrial carcinoma are expected in 2025. A confirmatory Phase 3 clinical trial (NCT06340568) is planned to start in 2025.
Preparation of a potential Biologics License Application ("BLA") submission for BNT323/DB-1303 as a second line or subsequent therapy in HER2-expressing advanced endometrial cancer in 2025.
BNT324/DB-1311 is an ADC candidate targeting B7-H3 that is being developed in collaboration with DualityBio. The program has received Fast Track designation from the FDA for the treatment of patients with advanced castration-resistant prostate cancer ("CRPC") who have progressed on or after standard systemic regimens and Orphan Drug designation for the treatment of patients with advanced esophageal squamous cell carcinoma.

In December 2024, preliminary data from the first-in-human, open-label Phase 1/2 clinical trial (NCT05914116) were presented at the 2024 European Society for Medical Oncology ("ESMO") Asia Congress, demonstrating encouraging efficacy and a manageable safety profile across a range of advanced solid tumors.
Cell Therapies

BNT211 consists of a CAR-T cell product candidate targeting CLDN6-positive solid tumors in combination with a CAR-T cell-amplifying RNA cancer immunotherapy encoding CLDN6.

In January 2025, the FDA granted Regenerative Medicine Advanced Therapy ("RMAT") designation for BNT211. The RMAT designation is designed to expedite the development and review process for promising pipeline products, including cell therapies.
A pivotal Phase 2 clinical trial in patients with testicular germ cell tumors is expected to start in 2025 based on encouraging clinical activity observed in this patient population in the ongoing Phase 1 clinical trial (NCT04503278). The Phase 1 clinical trial is ongoing to evaluate BNT211 in other CLDN6+ cancer types, including NSCLC and gynecologic cancers.
Selected Infectious Diseases Pipeline Updates

BioNTech and Pfizer developed, manufactured and delivered JN.1- and KP.2-adapted COVID-19 vaccines which received multiple regulatory approvals and marketing authorizations in more than 40 countries and regions. In 2024, BioNTech and Pfizer delivered approximately 180 million variant-adapted COVID-19 vaccine doses worldwide.

BioNTech and Pfizer continue to invest in the research and development of next-generation and combination COVID-19 vaccine candidates.

Corporate Update for the Fourth Quarter 2024 and Key Post Period-End Events

In November 2024, BioNTech signed an agreement to acquire Biotheus and obtain full global rights to BNT327 and to all other candidates from Biotheus’ pipeline, as well as to its in-house antibody generation platform and bispecific ADC capability. The transaction amounted to an upfront consideration of $800 million, plus additional performance-based payments of up to $150 million. The acquisition was completed in February 2025.
Upcoming Investor and Analyst Events

Sustainability Report 2024 Publication: March 24, 2025
Annual General Meeting: May 16, 2025
Innovation Series AI Day: October 1, 2025
Innovation Series R&D Day: November 18, 2025
Conference Call and Webcast Information
BioNTech invites investors and the general public to join a conference call and webcast with investment analysts today, March 10, 2025, at 8:00 a.m. EDT (1:00 p.m. CET) to report its financial results and provide a corporate update for the fourth quarter and full year 2024.

To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a PIN number will be provided.

The slide presentation and audio of the webcast will be available via this link.

Participants may also access the slides and the webcast of the conference call via the "Events & Presentations" page of the Investor section of the Company’s website at www.BioNTech.com. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.