On May 5, 2025 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported its financial results for the first quarter ended March 31, 2025 (Press release, Castle Biosciences, MAY 5, 2025, View Source [SID1234652503]).

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"We are pleased with the exceptional start to the year, marked by continued growth in test report volume and revenue in the first quarter," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We believe our ongoing success reflects both the high clinical value that our clinicians receive from our tests coupled with consistent execution and teamwork across our therapeutic areas.

"We saw strong overall growth in our core revenue drivers. And in this month of May, Skin Cancer Awareness Month, I’m especially pleased DecisionDx-Melanoma recently achieved a significant milestone, surpassing 200,000 test orders since the launch of the test. This milestone is certainly expected, given the highly compelling data demonstrating DecisionDx-Melanoma is shown to be associated with improved patient survival, and I am extremely proud of the entire Castle team. We are grateful to the clinicians and patients who achieved this milestone with us.

"We believe our first-quarter results demonstrate our leadership across our proprietary, first-to-market test portfolio and unwavering commitment to impacting patient outcomes. Looking ahead, as we continue to drive forward our growth initiatives, we are raising our 2025 total revenue guidance to $287-297 million, compared to the previous guidance of $280-295 million."

First Quarter Ended March 31, 2025, Financial and Operational Highlights
•Revenues were $88.0 million, a 21% increase compared to $73.0 million in the first quarter of 2024.
•Adjusted Revenues, which exclude the effects of revenue adjustments related to tests delivered in prior periods, were $87.2 million, a 22% increase compared to $71.3 million for the same period in 2024.
•Delivered 24,402 total test reports in the first quarter of 2025, an increase of 17% compared to 20,888 in the same period of 2024:
◦DecisionDx-Melanoma test reports delivered in the quarter were 8,621, compared to 8,384 in the first quarter of 2024.
◦DecisionDx-SCC test reports delivered in the quarter were 4,375, compared to 3,577 in the first quarter of 2024.
◦MyPath Melanoma test reports delivered in the quarter were 926, compared to 998 in the first quarter of 2024.
◦TissueCypher Barrett’s Esophagus test reports delivered in the quarter were 7,432, compared to 3,429 in the first quarter of 2024.

◦IDgenetix test reports delivered in the quarter were 2,578, compared to 4,078 in the first quarter of 2024.
◦DecisionDx-UM test reports delivered in the quarter were 470, compared to 422 in the first quarter of 2024.
•Gross margin was 49%, and Adjusted Gross Margin was 81%, compared to 78% and 81%, respectively, for the same periods in 2024. Gross margin for the first quarter 2025 was impacted in large part due to the one-time adjustment of an acceleration of amortization expense of approximately $20.1 million during the three months ended March 31, 2025. During the first quarter of 2025, we made the decision to discontinue the IDgenetix test offering, effective May 2025. This change resulted in a change in estimated remaining useful life of IDgenetix.
•Net cash used in operations was $6.0 million, compared to net cash used in operations of $6.8 million for the same period in 2024.
•Net loss, which includes non-cash stock-based compensation expense of $11.2 million, was $25.8 million, compared to a net loss of $2.5 million for the same period in 2024.
•Net loss per share, basic and diluted, was $(0.90) and Adjusted Net Loss per Share, Basic and Diluted, was $(0.20) compared, in each case, to $(0.09), for the same periods in 2024.
•Adjusted EBITDA was $13.0 million, compared to $10.5 million for the same period in 2024.

Cash, Cash Equivalents and Marketable Investment Securities
As of March 31, 2025, the Company’s cash, cash equivalents and marketable investment securities totaled $275.2 million.

2025 Outlook

Castle Biosciences is raising its guidance for anticipated total revenue in 2025. The Company now anticipates generating between $287-297 million in total revenue in 2025, compared to the previously provided guidance of between $280-295 million.

First Quarter and Recent Accomplishments and Highlights

Dermatology
•DecisionDx-Melanoma: The Company announced its achievement of surpassing a significant milestone of 200,000 DecisionDx-Melanoma test orders. See the Company’s news release from April 28, 2025, for more information.
•DecisionDx-Melanoma: The Company announced the publication of a new study in Cancer Diagnosis & Prognosis demonstrating that DecisionDx-Melanoma outperforms both American Joint Committee on Cancer (AJCC) staging and the clinicopathologic and gene expression (CP-GEP) test in identifying patients at low risk of sentinel lymph node (SLN) positivity who may consider forgoing sentinel lymph node biopsy (SLNB) surgery. The new study provides an analysis of the accuracy of CP-GEP and DecisionDx-Melanoma in identifying patients with less than a 5% risk of SLN positivity, in T1-T2 tumors specifically, across five CP-GEP and four DecisionDx-Melanoma validation studies. Using a weighted average across all studies, patients classified as low risk by CP-GEP had an SLN positivity rate of 6.2%, exceeding the 5% NCCN threshold for ruling out SLNB. In contrast, patients identified as low risk by DecisionDx-Melanoma had a 2.8% SLN positivity rate, a significant improvement over AJCC staging. Overall, CP-GEP did not perform as well as staging alone, while DecisionDx-Melanoma outperformed staging, further demonstrating its ability to improve clinical decision-making and, ultimately, outcomes. See our press release from April 30, 2025, for more information.

•DecisionDx-Melanoma: The Company announced the recent publication of two papers in the World Journal of Surgical Oncology and Cancer Medicine sharing reports from the prospective, multicenter DECIDE study demonstrating the significant impact of the Company’s DecisionDx-Melanoma test on SLNB decision-making for patients with melanoma. Consistent with prior studies, published results from Castle’s DECIDE study support that DecisionDx-Melanoma can accurately identify patients with less than 5% risk of sentinel lymph node (SLN) positivity, who can safely consider forgoing the SLNB surgical procedure, and who are also unlikely to experience disease progression. See the Company’s news release from April 3, 2025, for more information.

•DecisionDx-Melanoma: The Company presented new data supporting the clinical value of the DecisionDx-Melanoma test in guiding risk-aligned management of patients with melanoma at the 11th World Congress of Melanoma and 21st European Association of Dermato-Oncology (EADO) Congress, which was held April 3-5, 2025, in Athens, Greece. The new study data demonstrated the significant risk stratification provided by DecisionDx-Melanoma in a real-world cohort of patients with stage IIB-IIC cutaneous melanoma (CM) to help guide adjuvant therapy, and the role of the test in prompting use of imaging surveillance in early-stage patients at high risk of metastasis to the central nervous system (CNS). See the Company’s news release from April 1, 2025, for more information.

•DecisionDx-Melanoma: The Company also presented new data on its DecisionDx-Melanoma test at the National Comprehensive Cancer Network (NCCN) 2025 Annual Conference, which was held March 28-30 in Orlando, Florida. Specifically, as part of Castle’s ongoing collaboration with the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) Program Registries, new data presented new validation of the DecisionDx-Melanoma test’s risk-stratification performance in patients with thin/early-stage CM tumors (stage I-IIA). In a large, unselected real-world cohort of 6,892 patients classified as low risk by the American Joint Committee on Cancer Eighth Edition (AJCC8) staging system, the test identified individuals at higher risk of death. In multivariable analysis that included key AJCC8 staging criteria such as tumor thickness and ulceration as well as age and mitotic rate, the data demonstrated that the DecisionDx-Melanoma test is a significant predictor of both melanoma-specific and overall mortality. These findings highlight the test’s significant, independent risk-stratification capabilities, designed to help identify patients at greater predicted risk than indicated by AJCC8 staging alone who may benefit from enhanced surveillance and management to potentially improve outcomes. See the Company’s news release from March 28, 2025, for more information.

•DecisionDx-Melanoma: Additionally, the Company presented new data on its DecisionDx-Melanoma test for patients with skin cancers at the 2025 AAD Annual Meeting, which took place from March 7-11 in Orlando, Florida. A poster from Castle’s ongoing collaboration with the National Cancer Institute’s SEER Program Registries provided an updated validation of the risk-stratification performance of the DecisionDx-Melanoma test. The study encompassed an additional year’s worth of data and approximately 4,800 more patients than the initial study by Bailey et al. In a large, unselected real-world cohort of nearly 10,000 patients who received the DecisionDx-Melanoma test as part of their clinical care, this study demonstrated the significant independent risk stratification provided by the test, beyond AJCC8 stage, and its association with improved survival relative to matched patients who did not receive testing. See the Company’s news release from March 7, 2025, for more information.

•DecisionDx-SCC: The Company also presented new data on its DecisionDx-SCC test at the NCCN 2025 Annual Conference in Orlando with an abstract that was selected as a Top Five Abstract at the meeting. Specifically, a study assessed how integrating the DecisionDx-SCC test with Brigham & Women’s Hospital (BWH) staging within NCCN guidelines can improve prognostic accuracy. An analysis of a new, combined multi-center cohort of 1,412 high-risk SCC patients, with one or more NCCN High-Risk or Very-High-Risk factors, showed that DecisionDx-SCC significantly enhanced metastatic risk stratification in NCCN High- and Very-High-Risk patient populations (p < 0.001). The test significantly improved BWH staging’s risk prediction accuracy (p < 0.001). Compared to the broader NCCN risk stratification, when DecisionDx-SCC was combined with BWH staging, Class 1 (low risk) test results showed a nearly two-fold decrease in metastatic risk and Class 2B (highest risk) results showed more than a five-fold increase in risk in lower-stage (BWH T1/T2a) NCCN High-Risk patients. These findings show that DecisionDx-SCC can significantly refine risk assessment when used with established staging methods, enabling more accurate, personalized treatment decisions based on a patient’s predicted metastatic risk. See the Company’s news release from March 28, 2025, for more information.
•DecisionDx-SCC: Additionally, the Company presented new data on its DecisionDx-SCC test for patients with skin cancer at the 2025 AAD Annual Meeting in Orlando. The study presented provided a validation of the ability of the DecisionDx-SCC test to predict metastatic risk in a novel, independent cohort of patients with high-risk SCC tumors (n=515). In the study, DecisionDx-SCC and BWH staging were both significant predictors of metastasis (p < 0.05). Overall, the study data provided further evidence that DecisionDx-SCC provides significant risk stratification (p < 0.001) of patients at higher risk of SCC metastasis to guide personalized, risk-aligned treatment decisions. See the Company’s news release from March 7, 2025, for more information.
Gastroenterology
•The Company announced it signed a definitive agreement to acquire Previse. Previse is a gastrointestinal health company with a primary focus on chronic acid reflux related diseases, including esophageal cancer. See the Company’s news release from May 5, 2025, for more information.

•The Company announced supporting key educational programs and initiatives throughout the month of April in recognition of Esophageal Cancer Awareness Month. Castle collaborated with the Esophageal Cancer Action Network (ECAN), the American Foregut Society (AFS) and The Gut Doctor Podcast LLC to promote esophageal cancer prevention, education and advocacy. See the Company’s news release from April 8, 2025, for more information.
Mental Health
•During the first quarter of 2025, the Company made the decision to discontinue its IDgenetix test offering, effective May 2025.
Corporate
•The Company earned a Top Workplace USA award for the fourth year in a row, underscoring Castle’s position as a leader in creating an exemplary workforce culture. See the Company’s news release from April 7, 2025, for more information.

Conference Call and Webcast Details
Castle Biosciences will hold a conference call on Monday, May 5, 2025, at 4:30 p.m. Eastern time to discuss its first quarter 2025 results and provide a corporate update.

A live webcast of the conference call can be accessed here:View Source or via the webcast link on the Investor Relations page of the Company’s website,
View Source Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until May 26, 2025.

To access the live conference call via phone, please dial 833 470 1428 from the United States, or +1 404 975 4839 internationally, at least 10 minutes prior to the start of the call, using the conference ID 040892.

There will be a brief Question & Answer session following management commentary.

On May 5, 2025 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small-molecule drugs for oncological and inflammatory diseases, reported that, it has raised $175 million in funding to date (Press release, Can-Fite BioPharma, MAY 5, 2025, View Source [SID1234652502]). These funds have enabled the advancement of its lead drug candidates, Namodenoson and Piclidenoson, into pivotal Phase III studies for liver cancer and psoriasis, respectively.

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Can-Fite is a recognized leader in the development of small-molecule therapeutics targeting the A3 adenosine receptor (A3AR), which is highly expressed in both inflammatory and cancer cells. Namodenoson, an orally bioavailable A3AR agonist, is currently enrolling patients in a pivotal Phase III study for advanced liver cancer. It has demonstrated selective targeting of liver and pancreatic tumor cells while sparing healthy tissue. Piclidenoson, also an orally administered A3AR agonist, is in a pivotal Phase III trial for patients with moderate-to-severe psoriasis.

Both candidates have shown favorable safety profiles, anti-cancer and anti-inflammatory properties, and promising efficacy in previous Phase II trials. Cumulative funding has also supported drug manufacturing, regulatory activities with the FDA and EMA, and the development of a broad patent portfolio providing extensive intellectual property protection.

In addition to its lead programs, Can-Fite is conducting a Phase IIa study of Namodenoson in pancreatic cancer, following successful preclinical studies demonstrating its ability to inhibit tumor growth by modulating the Wnt/β-catenin, NF-κB, and RAS signaling pathways. A Phase IIb trial in metabolic dysfunction-associated steatohepatitis (MASH) is also underway under an open IND with the FDA, leveraging Namodenoson’s hepatoprotective effects.

To date, Can-Fite has signed seven commercialization agreements with strategic partners for the future marketing of its drug candidates upon regulatory approval. Can-Fite continues to engage with potential partners and seeks to sign additional commercialization agreements in the future.

Motti Farbstein, CEO of Can-Fite, commented: "This funding milestone reflects the strong confidence our investors and partners have in Can-Fite’s scientific platform and clinical strategy. Progressing into pivotal Phase III trials marks a significant step toward bringing innovative, oral therapies to patients with serious unmet needs in liver cancer and psoriasis."

On May 5, 2025 bluebird bio, Inc. (NASDAQ: BLUE) ("bluebird" or "the Company"), Carlyle (NASDAQ: CG) ("Carlyle"), SK Capital Partners, LP ("SK Capital") and Beacon Parent Holdings, L.P. ("Parent") reported that all required regulatory approvals to complete the previously announced acquisition of the Company by Carlyle and SK Capital have been received (Press release, bluebird bio, MAY 5, 2025, View Source [SID1234652501]).

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No further regulatory approvals are required to complete the transaction. The parties expect to complete the merger promptly following the successful completion of the ongoing tender offer, which is scheduled to expire one minute after 11:59 p.m. New York City time on May 12, 2025, unless the tender offer is further extended or earlier terminated.

Under the terms of the merger agreement, stockholders will receive an upfront payment of $3.00 per share in cash and a contingent value right (CVR) of $6.84 per share in cash payable upon achievement of a net sales milestone, for a total potential value of $9.84 per share. The bluebird board of directors (the "Board") unanimously recommends that stockholders tender into the offer.

"The bluebird Board unanimously recommends that stockholders tender into the offer, which expires May 12, 2025. Absent a majority of stockholders tendering, bluebird is at significant risk of defaulting on its loan agreements with Hercules Capital and it is extremely unlikely that stockholders would receive any consideration for their shares in a bankruptcy or liquidation," said Mark Vachon, chairman of the bluebird bio Board of Directors. "The bluebird Board considered all reasonable alternatives during its review of strategic alternatives and concluded that the proposed transaction with Carlyle and SK Capital is the only viable solution to generate value for bluebird stockholders. We strongly urge stockholders to tender their shares before the expiration date to ensure the best possible outcome for all bluebird stakeholders and the patients that depend on its treatments."

"The receipt of all required regulatory approvals is excellent news for stockholders as well as for patients and families seeking to be treated with bluebird gene therapies," said Andrew Obenshain, chief executive officer, bluebird bio. "With this update, we have a clear path forward to close the transaction and officially begin the next chapter of bluebird’s journey to deliver potentially curative gene therapies in the commercial setting."

Stockholders who need assistance with tendering their shares of common stock of bluebird may contact the Information Agent, Innisfree M&A Incorporated, by calling toll-free at (877) 825-8793.

On May 5, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported financial results for the three months ended March 31, 2025 and provided an update on its corporate progress (Press release, BioNTech, MAY 5, 2025, View Source [SID1234652500]).

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"In the first quarter of 2025, we demonstrated continued execution against our strategic focus areas, highlighted by data updates for our PD-L1xVEGF-A bispecific antibody candidate BNT327 and the progress in clinical evaluation of our focus programs and combination treatment approaches," said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. "We will continue to focus on our key strategic programs as we remain steadfast in our vision to translate our science into survival for patients in need."

Financial Review for First Quarter 2025

in millions €, except per share data First Quarter 2025 First Quarter 2024
Revenues 182.8 187.6
Net loss (415.8) (315.1)
Basic and diluted loss per share (1.73) (1.31)
Revenues reported were €182.8 million for the three months ended March 31, 2025, compared to €187.6 million for the comparative prior year period. Revenues during the first quarter of 2025 were mainly driven by revenues derived from BioNTech’s COVID-19 vaccine collaboration.

Cost of sales were €83.8 million for the three months ended March 31, 2025, compared to €59.1 million for the comparative prior year period. The change was mainly due to a positive impact of an inventory revaluation in the first quarter of 2024.

Research and development ("R&D") expenses were €525.6 million for the three months ended March 31, 2025, compared to €507.5 million for the comparative prior year period. The increase was mainly driven by progressing late-stage clinical studies for candidates in BioNTech’s ADC and antibody portfolio.

Sales, general and administrative ("SG&A") expenses5, in total, amounted to €120.6 million for the three months ended March 31, 2025, compared to €132.6 million for the comparative prior year period. The decrease was primarily driven by a reduction in external services.

Income taxes were realized with an amount of €29.6 million in tax income for the three months ended March 31, 2025, compared to €16.7 million in realized tax income for the comparative prior year period.

Net loss was €415.8 million for the three months ended March 31, 2025, compared to a net loss of €315.1 million for the comparative prior year period.

Cash and cash equivalents plus security investments as of March 31, 2025, reached €15,854.4 million, comprising €10,184.9 million in cash and cash equivalents, €3,542.0 million in current security investments and €2,127.5 million in non-current security investments.

Basic and diluted loss per share was €1.73 for the three months ended March 31, 2025, compared to a basic and diluted loss per share of €1.31 for the comparative prior year period.

Shares outstanding as of March 31, 2025, were 240,392,622, excluding 8,159,578 shares held in treasury.

"Our revenues for the first quarter reflect the seasonal demand for COVID-19 vaccines and are in line with our expectations," said Jens Holstein, CFO of BioNTech. "BioNTech’s robust financial position empowers us to pursue our strategic goal of evolving into a leading biotech company with multiple oncology products by 2030."

2025 Financial Year Guidance Confirmed6

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. Potential changes to the law or governmental policy, including tariffs and public health policy, and evolving public sentiment worldwide, could further negatively impact our anticipated revenues and expenses.

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 continuously focus investments on R&D and scaling the business for late-stage development and commercial readiness in oncology, while remaining cost-disciplined. Strategic capital allocation will continue to be 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 interim unaudited condensed consolidated financial statements can be found in BioNTech’s Report on Form 6-K for the period ended March 31, 2025, filed today with the United States Securities and Exchange Commission ("SEC") and available at www.sec.gov.

Endnotes
1 All abbreviations are compiled in an abbreviation directory at the end of this press release.
2 All numbers in this press release have been rounded.
3 Calculated applying the average foreign exchange rate for the three months ended March 31, 2025, as published by the German Central Bank (Deutsche Bundesbank).
4 A settlement payment of $400 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 this and another settlement with the National Institutes of Health ("NIH"), BioNTech expects to be reimbursed approximately $535 million by its collaboration partner during 2025 and 2026. Reimbursement payments have begun with the first payment received by BioNTech in the first quarter of 2025.
5 Sales, general and administrative expenses ("SG&A") include sales and marketing expenses as well as general and administrative expenses.
6 Financial guidance 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. 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 First Quarter 2025, Key Post Period-End Events and 2025 Outlook

Selected Oncology Pipeline Updates

Next-Generation Immunomodulators

BNT327, formerly also known as PM8002, is a bispecific antibody candidate combining PD-L1 checkpoint inhibition with VEGF-A neutralization.

In March 2025, at the European Lung Cancer Congress ("ELCC"), preliminary data from two Phase 2 clinical trials conducted in China in first-line extensive-stage small cell lung cancer ("ES-SCLC") and second-line small cell lung cancer ("SCLC") were presented.
Preliminary data from the ongoing single-arm, open-label Phase 2 clinical trial (NCT05844150) evaluating BNT327 in combination with chemotherapy as a first-line treatment in patients with ES-SCLC showed anti-tumor activity and an acceptable safety profile with no new safety signals beyond those typically described for chemotherapy agents and anti-PD-(L)1 and anti-VEGF monotherapies. These data were the first presented for BNT327 as a potential first-line treatment in ES-SCLC supporting the ongoing global randomized Phase 3 clinical trial ROSETTA Lung-01 (NCT06712355).
Preliminary data from the ongoing Phase 2 clinical trial (NCT05879068) evaluating BNT327 in combination with chemotherapy as a second-line treatment in patients with SCLC showed anti-tumor activity, which was observed regardless of prior immuno-oncology treatment, and an acceptable safety profile.
In April 2025, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting 2025, first data were presented for the novel combination of the PD-L1xVEGF-A bispecific antibody candidate BNT327 with various ADC candidates.
Interim data from the ongoing Phase 1/2 clinical trial (NCT05438329) evaluating BNT327 with BNT325/DB-1305, a TROP2-targeting ADC candidate being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. ("DualityBio"), in patients with advanced/metastatic solid tumors showed a manageable safety profile and early signs of anti-tumor activity in a cohort with patients with platinum-resistant ovarian cancer ("PROC"). Across the 13 efficacy evaluable patients with PROC, seven patients achieved partial response and three stable disease. Responses were also observed in patients with non-small cell lung cancer ("NSCLC") or triple-negative breast cancer ("TNBC").
First data from an ongoing Phase 2 clinical trial (NCT05918107) in first-line mesothelioma and two trial-in-progress posters for the ongoing global Phase 3 and Phase 2/3 clinical trials, ROSETTA Lung-01 (NCT06712355) and ROSETTA Lung-02 (NCT06712316) respectively, will be presented at the American Society for Clinical Oncology ("ASCO") Annual Meeting taking place from May 30 to June 3, 2025 in Chicago, Illinois.
Abstract title: First report of efficacy and safety results from a Phase 2 trial evaluating BNT327/PM8002 plus chemotherapy (chemo) as first-line treatment (1L) in unresectable malignant mesothelioma
Abstract title: A global Phase III, double-blind, randomized trial of BNT327/PM8002 plus chemotherapy (chemo) compared to atezolizumab plus chemo in patients (pts) with first-line (1L) extensive-stage small cell lung cancer (ES-SCLC)
Abstract title: A global Phase 2/3, randomized, open-label trial of BNT327/PM8002 in combination with chemotherapy (chemo) in first-line (1L) non-small cell lung cancer (NSCLC)
mRNA Cancer Immunotherapies

BNT116 is based on BioNTech’s fully owned, off-the-shelf FixVac platform, and is designed to elicit an immune response to six tumor-associated antigens that were identified to be frequently expressed in NSCLC.

In April 2025, at the AACR (Free AACR Whitepaper) Annual Meeting 2025, preliminary data from a cohort with frail patients were presented from the ongoing Phase 1 clinical trial LuCa-MERIT-1 (NCT05142189) evaluating BNT116 in combination with cemiplimab in patients with PD-L1 positive (TPS≥1%) unresectable Stage III or metastatic Stage IV NSCLC who are not eligible for chemotherapy as first-line treatment. The preliminary data showed anti-tumor activity, consistent immune response induction and a manageable safety profile.
Antibody-Drug Conjugates

BNT324/DB-1311 is an B7H3-targeted ADC candidate that is being developed in collaboration with DualityBio. The program has received Fast Track designation from the U.S. Food and Drug Administration ("FDA") for the treatment of patients with advanced castration-resistant prostate cancer ("CRPC") whose disease has progressed while undergoing or after undergoing standard systemic regimens. In addition, the program has received Orphan Drug designation from the FDA for the treatment of patients with advanced esophageal squamous cell carcinoma.

Preliminary data from the ongoing Phase 1/2 clinical trial (NCT05914116) evaluating BNT324/DB-1311 in patients with advanced solid tumors, including patients with previously treated castration-resistant prostate cancer ("CRPC"), will be presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting.
Abstract title: DB‑1311/BNT324 (a novel B7H3 ADC) in patients with heavily pretreated castrate-resistant prostate cancer (CRPC)
BNT325/DB-1305 is a TROP2-targeted ADC candidate that is being developed in collaboration with DualityBio. BNT325/DB-1305 received Fast Track designation from the FDA for the treatment of patients with platinum-resistant ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.

In March 2025, at the Society of Gynecologic Oncology ("SGO") Annual Meeting, preliminary data were presented from an ongoing Phase 1/2 clinical trial (NCT05438329) evaluating BNT325/DB-1305 in signal-seeking cohorts across various cancer indications, including PROC. The data from a cohort of patients with PROC showed a manageable safety profile and early signs of anti-tumor activity.
Corporate and Commercial Update for the First Quarter 2025

Earlier today, BioNTech announced that the Supervisory Board has appointed Ramón Zapata-Gomez to the Management Board as Chief Financial Officer ("CFO") effective July 1, 2025. He will join BioNTech from Novartis AG’s global biomedical research organization where he has been serving as CFO since 2022. Ramón Zapata will succeed Jens Holstein, who, as previously planned and announced, will retire at the end of his term on June 30, 2025.
In February 2025, BioNTech completed the acquisition of Biotheus, obtaining 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.
BioNTech and Pfizer developed, manufactured and delivered their JN.1 and KP.2-adapted COVID-19 vaccines, which have received multiple regulatory approvals, including full approvals, authorizations for emergency or temporary use, or marketing authorizations, in more than 40 countries and regions. BioNTech is now focused on preparing for variant strain vaccine adaptation to be ready for commercial launch ahead of the upcoming 2025/2026 vaccination season, pending approvals.
Upcoming Investor and Analyst Events

Annual General Meeting: May 16, 2025
Innovation Series R&D Day: November 11, 2025
Conference Call and Webcast Information

BioNTech invites investors and the general public to join a conference call and webcast with investment analysts today, May 5, 2025, at 8:00 a.m. EDT (2:00 p.m. CEST) to report its financial results and provide a corporate update for the first quarter of 2025.

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.

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On May 5, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported that the Supervisory Board has appointed Ramón Zapata-Gomez to the Management Board as Chief Financial Officer ("CFO") effective July 1, 2025 (Press release, BioNTech, MAY 5, 2025, View Source [SID1234652499]). He will join BioNTech from Novartis AG’s global biomedical research organization where he has been serving as CFO since 2022. Ramón Zapata will succeed Jens Holstein, who, as previously planned and announced, will retire at the end of his term on June 30, 2025.

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In his new role as CFO at BioNTech, Ramón Zapata will ensure the Company’s financial direction continues to align with BioNTech’s strategy to become a multi-product company in the oncology field. In preparation for BioNTech’s oncology product launches, he will be responsible for fostering and further optimizing a strong financial infrastructure and performance in key markets. He will continue to drive sustainable organizational excellence and global execution in financial reporting, accounting, tax and treasury, and purchasing with the aim of furthering cost-effective value generation.

"Ramón Zapata is an accomplished leader with deep finance expertise who will be taking over from Jens Holstein at an exciting phase. He has gained extensive experience within the international pharmaceutical industry with a focus on North America, Europe, and Latin America, and has a deep understanding of market and business dynamics, resource optimization, and high-performing teams," said Helmut Jeggle, Chairman of the Supervisory Board. "We, the Supervisory and the Management Board, thank Jens Holstein for his financial leadership and contributions to BioNTech’s successful trajectory. He strengthened BioNTech’s global finance organization and processes and contributed to the Company’s financial stability while increasing operational efficiency. Today, the Company is uniquely positioned to continue its success story and transformation into a multi-product company."

"It has been a privilege to be part of the development of BioNTech into one of the largest global biotechnology companies," said Jens Holstein, CFO at BioNTech. "I would like to thank my colleagues on the Boards as well as my teams for their dedication and collaboration during this remarkable growth journey. For me personally, it is the right time to retire as CFO and focus on non-executive Board roles in the future."

"I am looking forward to joining BioNTech and am eager to contribute to its ambitious vision of improving patients’ lives," said Ramón Zapata, designated CFO at BioNTech. "Throughout my career, I have been driven by the goal of developing and providing access to innovative medicines for patients. As BioNTech focuses on its first oncology launches, while advancing its unique clinical pipeline with disruptive and synergistic potential, I look forward to working with the talented team at BioNTech and accelerating financial strategies that support the Company’s vision."

Ramón Zapata is a seasoned global finance executive with more than 25 years of experience in the pharmaceutical and consumer goods industries. He has held leadership roles at leading global companies including Novartis AG, Sandoz AG, and Mondelēz International. Throughout his career, Ramón Zapata has led finance functions enabling seamless execution from drug discovery through commercialization, including overseeing M&A transactions and successful integrations as well as driving digital finance transformations. Prior to joining BioNTech, Ramón Zapata served as CFO of BioMedical Research at Novartis, where he was responsible for the overall leadership of the division’s finance strategy and operations.

Ramón Zapata holds dual citizenship of the United States and Mexico. He is a Certified Public Accountant (CPA) from Universidad Panamericana in Mexico City and holds an MBA degree from IPADE Business School in Mexico City and from IESE Business School in Barcelona, Spain.