On August 4, 2025 Bristol Myers Squibb (NYSE: BMY) reported that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Breyanzi (lisocabtagene maraleucel; liso-cel) as a potential treatment for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy (Press release, Bristol-Myers Squibb, AUG 4, 2025, View Source;Food-and-Drug-Administration-FDA-in-Fifth-Cancer-Type-for-Relapsed-or-Refractory-Marginal-Zone-Lymphoma-MZL/default.aspx [SID1234654724]). The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 5, 2025.

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"While initial therapy for MZL can be effective, multiple relapses over the course of several years are common, leaving patients in need of a new treatment option that can provide high, lasting response rates," said Rosanna Ricafort, vice president, Senior Global Program Lead for Hematology and Cell Therapy, Bristol Myers Squibb. "This FDA acceptance brings us one step closer to potentially standardizing CAR T cell therapy as a treatment option for MZL, while building on our commitment to bring this personalized therapy to as many eligible patients as possible."

The application is based on results from the primary analysis of the MZL cohort in TRANSCEND FL, an open-label, multicenter, Phase 2, single-arm study, which was shared in an oral presentation during the 2025 International Conference on Malignant Lymphoma (ICML) in June 2025.

The development progress of Breyanzi reflects BMS’ continued efforts to collaborate across the healthcare ecosystem, with the ultimate goal of reaching more patients and democratizing access to cell therapy. Recently, the FDA approved streamlined patient monitoring requirements and the removal of the REMS program for Breyanzi, easing known barriers to treatment and administration while maintaining patient safety.

About TRANSCEND FL
TRANSCEND FL (NCT04245839) is an open-label, global, multicenter, Phase 2, single-arm study to determine the efficacy and safety of Breyanzi in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including follicular lymphoma and marginal zone lymphoma. The primary outcome measure is overall response rate. Secondary outcome measures include complete response rate, duration of response, and progression-free survival.

About MZL
Marginal zone lymphoma (MZL) is the third most common lymphoma, accounting for about 7% of all non-Hodgkin lymphoma cases. Most patients with MZL are at a median age of 67 years when they are diagnosed. MZL develops when white blood cells cluster together to form lumps in a person’s lymph nodes or organs. Initial therapy often leads to remission, but relapse is common, sometimes occurring several times over many years. A small portion of MZL cases transform into diffuse large-B-cell lymphoma, a more aggressive lymphoma.

About Breyanzi
Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. Breyanzi is made from a patient’s own T cells, which are collected and genetically reengineered to become CAR T cells that are then delivered via infusion as a one-time treatment. The treatment process includes blood collection, CAR T-cell creation, potential bridging therapy, lymphodepletion, administration, and side-effect monitoring.

Breyanzi is approved in the U.S. for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior line of therapy, has received accelerated approval for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of therapy and relapsed or refractory follicular lymphoma (FL) in the third-line plus setting, and is approved for the treatment of relapsed or refractory mantle cell lymphoma (MCL) in the third-line plus setting. Breyanzi is also approved in Japan, the European Union (EU), Switzerland, the United Kingdom, and Canada for the treatment of relapsed or refractory LBCL after at least one prior line of therapy; in Japan for the treatment of patients with relapsed or refractory high-risk FL after one prior line of systemic therapy, and in patients with relapsed or refractory FL after two or more lines of systemic therapy; and in the EU for the treatment of relapsed or refractory FL after two or more lines of systemic therapy.

Bristol Myers Squibb’s clinical development program for Breyanzi includes clinical studies in several types of lymphoma. For more information, visit clinicaltrials.gov.

Breyanzi U.S. FDA-Approved Indications

BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:
refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or
refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or
relapsed or refractory disease after two or more lines of systemic therapy.
Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.

adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.
Breyanzi U.S. Important Safety Information

WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids.
Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed.
T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI.
Cytokine Release Syndrome

Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. In clinical trials of BREYANZI, which enrolled a total of 702 patients with non-Hodgkin lymphoma (NHL), CRS occurred in 54% of patients, including ≥ Grade 3 CRS in 3.2% of patients. The median time to onset was 5 days (range: 1 to 63 days). CRS resolved in 98% of patients with a median duration of 5 days (range: 1 to 37 days). One patient had fatal CRS and 5 patients had ongoing CRS at the time of death. The most common manifestations of CRS (≥10%) were fever, hypotension, tachycardia, chills, hypoxia, and headache.

Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, diffuse alveolar damage, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).

Ensure that 2 doses of tocilizumab are available prior to infusion of BREYANZI.

Neurologic Toxicities

Neurologic toxicities that were fatal or life-threatening, including immune effector cell-associated neurotoxicity syndrome (ICANS), occurred following treatment with BREYANZI. Serious events including cerebral edema and seizures occurred with BREYANZI. Fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, also occurred.

In clinical trials of BREYANZI, CAR T cell-associated neurologic toxicities occurred in 31% of patients, including ≥ Grade 3 cases in 10% of patients. The median time to onset of neurotoxicity was 8 days (range: 1 to 63 days). Neurologic toxicities resolved in 88% of patients with a median duration of 7 days (range: 1 to 119 days). Of patients developing neurotoxicity, 82% also developed CRS.

The most common neurologic toxicities (≥5%) included encephalopathy, tremor, aphasia, headache, dizziness, and delirium.

CRS and Neurologic Toxicities Monitoring

Monitor patients daily for at least 7 days following BREYANZI infusion for signs and symptoms of CRS and neurologic toxicities and assess for other causes of neurological symptoms. Continue to monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 2 weeks after infusion and treat promptly. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. Manage neurologic toxicity with supportive care and/or corticosteroid as needed. Advise patients to avoid driving for at least 2 weeks following infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time.

Hypersensitivity Reactions

Allergic reactions may occur with the infusion of BREYANZI. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO).

Serious Infections

Severe infections, including life-threatening or fatal infections, have occurred in patients after BREYANZI infusion. In clinical trials of BREYANZI, infections of any grade occurred in 34% of patients, with Grade 3 or higher infections occurring in 12% of all patients. Grade 3 or higher infections with an unspecified pathogen occurred in 7%, bacterial infections in 3.7%, viral infections in 2%, and fungal infections in 0.7% of patients. One patient who received 4 prior lines of therapy developed a fatal case of John Cunningham (JC) virus progressive multifocal leukoencephalopathy 4 months after treatment with BREYANZI. One patient who received 3 prior lines of therapy developed a fatal case of cryptococcal meningoencephalitis 35 days after treatment with BREYANZI.

Febrile neutropenia developed after BREYANZI infusion in 8% of patients. Febrile neutropenia may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad- spectrum antibiotics, fluids, and other supportive care as medically indicated.

Monitor patients for signs and symptoms of infection before and after BREYANZI administration and treat appropriately. Administer prophylactic antimicrobials according to standard institutional guidelines. Avoid administration of BREYANZI in patients with clinically significant, active systemic infections.

Viral reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. In clinical trials of BREYANZI, 35 of 38 patients with a prior history of HBV were treated with concurrent antiviral suppressive therapy. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines.

Prolonged Cytopenias

Patients may exhibit cytopenias not resolved for several weeks following lymphodepleting chemotherapy and BREYANZI infusion. In clinical trials of BREYANZI, Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in 35% of patients, and included thrombocytopenia in 25%, neutropenia in 22%, and anemia in 6% of patients. Monitor complete blood counts prior to and after BREYANZI administration.

Hypogammaglobulinemia

B-cell aplasia and hypogammaglobulinemia can occur in patients receiving BREYANZI. In clinical trials of BREYANZI, hypogammaglobulinemia was reported as an adverse reaction in 10% of patients. Hypogammaglobulinemia, either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion, was reported in 30% of patients. Monitor immunoglobulin levels after treatment with BREYANZI and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement as clinically indicated.

Live vaccines: The safety of immunization with live viral vaccines during or following BREYANZI treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during BREYANZI treatment, and until immune recovery following treatment with BREYANZI.

Secondary Malignancies

Patients treated with BREYANZI may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing.

Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS)

Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. Three of 89 (3%) safety evaluable patients with R/R CLL/SLL developed IEC-HS. Time to onset of IEC-HS ranged from 7 to 18 days. Two of the 3 patients developed IEC-HS in the setting of ongoing CRS and 1 in the setting of ongoing neurotoxicity. IEC-HS was fatal in 2 of 3 patients. One patient had fatal IEC-HS and one had ongoing IEC-HS at time of death. IEC-HS is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of IEC-HS should be administered per current practice guidelines.

Adverse Reactions

The most common adverse reaction(s) (incidence ≥30%) in:

LBCL are fever, cytokine release syndrome, fatigue, musculoskeletal pain, and nausea. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, platelet count decrease, and hemoglobin decrease.
CLL/SLL are cytokine release syndrome, encephalopathy, fatigue, musculoskeletal pain, nausea, edema, and diarrhea. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, hemoglobin decrease, platelet count decrease, and lymphocyte count decrease.
FL is cytokine release syndrome. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, and white blood cell decrease.
MCL are cytokine release syndrome, fatigue, musculoskeletal pain, and encephalopathy. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, and platelet count decrease.
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.

On August 4, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported financial results for the six months ended June 30, 2025 and provided an update on its corporate progress (Press release, BioNTech, AUG 4, 2025, View Source [SID1234654723]).

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"In the second quarter, we took significant steps to advance BioNTech into a multiproduct biotechnology company by strengthening the two pillars of our oncology strategy," said Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. "We entered into a collaboration with BMS to accelerate and expand the development of our PD-L1xVEGF-A bispecific antibody candidate BNT327 and announced a strategic transaction to acquire CureVac to complement our own capabilities and proprietary technologies in mRNA design, delivery formulations, and mRNA manufacturing. These transformative transactions contribute to our mission of delivering truly transformative options for patients in need."

Financial Review for Second Quarter and First Half of 2025

in millions €,
except per share data Second Quarter 2025 Second Quarter 2024 First Half
2025 First Half
2024
Revenues 260.8 128.7 443.6 316.3
Net loss (386.6) (807.8) (802.4) (1,122.9)
Basic and diluted loss per share (1.60) (3.36) (3.33) (4.67)
Revenues for the three months ended June 30, 2025, were €260.8 million, compared to €128.7 million for the comparative prior year period. For the six months ended June 30, 2025, revenues were €443.6 million, compared to €316.3 million for the comparative prior year period. The increases were mainly driven by higher revenues derived from BioNTech’s COVID-19 vaccine collaboration.

Research and development ("R&D") expenses were €509.1 million for the three months ended June 30, 2025, compared to €584.6 million for the comparative prior year period. For the six months ended June 30, 2025, R&D expenses were €1,034.7 million, compared to €1,092.1 million for the comparative prior year period. The decreases were mainly driven by the reprioritization of clinical trials towards focus programs.

Sales, general and administrative ("SG&A") expenses, in total, amounted to €137.4 million for the three months ended June 30, 2025, compared to €183.8 million for the comparative prior year period. For the six months ended June 30, 2025, SG&A expenses were €258.0 million, compared to €316.4 million for the comparative prior year period. The decreases were primarily driven by a reduction in external services.

Net loss was €386.6 million for the three months ended June 30, 2025, compared to a net loss of €807.8 million for the comparative prior year period. For the six months ended June 30, 2025, net loss was €802.4 million, compared to a net loss of €1,122.9 million for the comparative prior year period.
Basic and diluted loss per share was €1.60 for the three months ended June 30, 2025, compared to a basic and diluted loss per share of €3.36 for the comparative prior year period. For the six months ended June 30, 2025, basic and diluted loss per share was €3.33, compared to a basic and diluted loss per share of €4.67 for the comparative prior year period.

Cash and cash equivalents plus security investments as of June 30, 2025, reached €15,989.3 million, comprising €10,269.5 million in cash and cash equivalents, €3,363.8 million in current security investments and €2,356.0 million in non-current security investments.

Shares outstanding as of June 30, 2025, were 240,398,724, excluding 8,153,476 shares held in treasury.

"Joining BioNTech is a privilege, especially during this decisive phase in which we aim to capitalize on our innovative pipeline with clear strategic focus. While we continue to significantly invest into the execution of our strategy, our commitment to operational and financial discipline is starting to show tangible results," said Ramón Zapata, Chief Financial Officer at BioNTech. "With the strategic BMS collaboration we will further strengthen our topline and cash position. As such, we will receive an upfront cash-payment of $1.5 billion in Q3 that we anticipate to be recognized as revenue over the development phase of BNT327."

Anticipated Financial Effect4 of the BMS Partnership

As part of the agreement with BMS, BioNTech expects to receive $1.5 billion in an upfront cash payment this year, and for this payment to be reflected in the Company’s reported cash position as of the third quarter 2025. BioNTech also expects to receive $2.0 billion in total non-contingent anniversary cash payments from 2026 through 2028. The upfront and non-contingent cash payments, amounting to $3.5 billion, are expected to be recognized as revenues over the development phase of BNT327.

In addition, BioNTech will be eligible to receive up to $7.6 billion in development, regulatory and commercial milestones, with the majority of milestone payments expected to be triggered upon approvals and during commercialization. All milestones payments are anticipated to be reflected in the Company’s cash position and to be recognized as revenues following milestone achievement.

Under the agreement, BioNTech and BMS will share joint development and manufacturing costs of BNT327 on a 50:50 basis, subject to certain exceptions. Global profits and losses will be equally shared between BioNTech and BMS.

2025 Financial Year Guidance Reaffirmed5:

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 primarily concentrated in the last three to four months, driving the full year revenue figure. The revenue guidance assumes: relatively stable pricing and market share as compared to 2024; inventory write-downs and other charges estimated to be approximately 15% of BioNTech’s share of gross profit from COVID-19 vaccines sales in Pfizer Inc.’s ("Pfizer") territory; anticipated revenues from a pandemic preparedness contract with the German government, from collaborations and from the BioNTech Group service businesses. Current and potential further developments in law, public policy, international trade, and public sentiment as they continue to evolve could further negatively impact the anticipated COVID-19 vaccine 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 June 30, 2025, filed today with the United States Securities and Exchange Commission ("SEC") and is available at www.sec.gov.

Endnotes
1 An overview of target abbreviations is compiled in a 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 June 30, 2025, as published by the German Central Bank (Deutsche Bundesbank).
4 These statements, including the anticipated timing of certain events, are based on BioNTech’s current expectations regarding the BMS collaboration and are subject to the successful co-development, approval and co-commercialization of BNT327. These statements are also based in part on assumptions and judgments that the Company has made, which may be subject to significant uncertainties. Although the Company’s approach to revenue recognition is based on facts and circumstances known to the Company and various other assumptions that the Company believes to be reasonable under the circumstances, the revenue assessment is ongoing, and its actual results may deviate from its current expectations. Revenue of initially constrained milestone payments may be recognized at the point of satisfaction or over time, including catch-up effects for prior periods as applicable. More information can be found in BioNTech’s Report on Form 6-K for the three and six months ended June 30, 2025, filed today, and in BioNTech’s Report on Form 20-F for the year ended December 31, 2024 filed on March 10, 2025, both of which are available at www.sec.gov.
5 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 as well as certain potential one-time effects and charges related to portfolio prioritization. It includes effects identified from licensing arrangements, collaborations and M&A transactions to the extent disclosed and completed and may be subject to update. It excludes the effect of the announced transaction to acquire CureVac, which is ongoing. The Company does not expect to report a positive net income figure for the 2025 financial year. These statements are also based in part on assumptions and judgments that the Company has made, which may be subject to significant uncertainties. Although the Company’s approach to revenue recognition is based on facts and circumstances known to the Company and various other assumptions that the Company believes to be reasonable under the circumstances, the revenue assessment is ongoing and its actual results may deviate from its current expectations.

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

Variant-adapted COVID-19 Vaccine

BioNTech and Pfizer have submitted regulatory applications to the European Medicines Agency ("EMA") and to the United States Food and Drug Administration ("FDA") for approval of their LP.8.1-adapted monovalent COVID-19 vaccine for the 2025-2026 vaccination season.

In July, BioNTech and Pfizer’s LP.8.1-adapted monovalent COVID-19 vaccine was approved by the European Commission following recommendation for marketing authorization by the EMA’s Committee for Medicinal Products for Human Use ("CHMP"). The new variant-adapted COVID-19 vaccine will be ready to ship to applicable EU member states in August.

Selected Oncology Pipeline Updates

Next-Generation Immunomodulators and Combinations

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

A global Phase 3 clinical trial (ROSETTA Lung-01; NCT06712355) is being conducted to evaluate BNT327 as a first-line treatment in combination with chemotherapy compared to atezolizumab in combination with chemotherapy in patients with untreated extensive-stage small cell lung cancer ("ES-SCLC").

A global Phase 2 clinical trial (NCT06449209) to evaluate BNT327 in combination with chemotherapy in patients with untreated ES-SCLC and in patients with SCLC whose disease progressed after first- or second-line treatment is fully enrolled and treatment is ongoing. Data from this clinical trial is expected in 2025.

In June, BNT327 received Orphan Drug Designation from the FDA for the treatment of SCLC.

A global Phase 2/3 clinical trial (ROSETTA Lung-02; NCT06712316) is being conducted to evaluate BNT327 in combination with chemotherapy compared to pembrolizumab and chemotherapy in patients with first-line non-small cell lung cancer ("NSCLC").

A global Phase 2 clinical trial (NCT06449222) is being conducted to evaluate BNT327 in combination with chemotherapy as a first- and second-line treatment for patients with locally advanced or metastatic triple-negative breast cancer ("TNBC"). Data from this clinical trial is expected in 2025. A global Phase 3 clinical trial in patients with first-line TNBC (ROSETTA Breast-01) is planned to start in 2025.

In June, at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting, preliminary data were presented from an ongoing Phase 2 clinical trial (NCT05918107) evaluating BNT327 in combination with chemotherapy in first-line mesothelioma. The preliminary data indicated anti-tumor activity and a manageable safety profile. Two trial-in-progress posters were also presented for ROSETTA Lung-01 and ROSETTA Lung-02.

In the last quarter, BioNTech initiated several signal-seeking clinical trials to evaluate BNT327 with the Company’s proprietary novel assets:

In May, the first patient was dosed in a Phase 1/2 clinical trial (NCT06827236) evaluating BNT327 in combination with BioNTech and Duality Biologics (Suzhou) Co. Ltd.’s ("DualityBio") HER2 antibody-drug conjugate ("ADC") candidate BNT323/DB-1303 in patients with HR+ or HR-, HER2-low, ultra-low, or null advanced metastatic breast cancer or TNBC.

In May, the first patient was dosed in a Phase 1/2 clinical trial (NCT06892548) evaluating BNT327 in combination with BioNTech and DualityBio’s B7-H3 ADC candidate BNT324/DB-1311 in patients with advanced lung cancers.

In July, the first patient was dosed in a Phase 2 clinical trial (NCT06953089) evaluating BNT324/DB-1311 in combination with BNT327 or with BioNTech and DualityBio’s TROP2 ADC candidate BNT325/DB-1305 in patients with advanced solid tumors.

A Phase 1/2 clinical trial (NCT07070232) to evaluate BNT327 in combination with BioNTech and MediLink Therapeutics’s ("MediLink") HER3 ADC candidate BNT326/YL202 and BNT326/YL202 as monotherapy in advanced solid tumors is expected to start in 2025.

A Phase 1/2 clinical trial (NCT07079631) to evaluate BNT327 and/or chemotherapy in combination with BioNTech and Genmab AS’s ("Genmab") novel EpCAM x 4-1BB bispecific antibody BNT314/GEN1059 in patients with advanced colorectal cancer is expected to start in 2025.

Antibody-Drug Conjugates

BNT323/DB-1303 (trastuzumab pamirtecan) is an ADC candidate targeting HER2 that is being developed in collaboration with DualityBio.

A Phase 1/2 clinical trial (NCT05150691) is being conducted to evaluate BNT323/DB-1303 in patients with advanced HER2-expressing tumors. A potentially registrational cohort with HER2-expressing (IHC3+, 2+, 1+ or ISH-positive) patients with recurrent endometrial cancer is ongoing. Data are planned to be shared at a medical conference in 2026.

A global Phase 3 clinical trial (NCT06340568) to evaluate BNT323/DB-1303 in patients with advanced endometrial cancer is expected to start in 2025.

BNT324/DB-1311 is an B7-H3-targeted ADC candidate that is being developed in collaboration with DualityBio.

In June, preliminary data from the ongoing Phase 1/2 clinical trial (NCT05914116) evaluating BNT324/DB-1311 in patients with advanced solid tumors were presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting. In 73 patients with heavily pretreated castration-resistant prostate cancer ("CRPC"), BNT324/DB-1311 was observed to have a manageable safety profile and showed encouraging preliminary clinical activity.

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. A Phase 1 clinical trial (LuCa-MERIT-1; NCT05142189) is being conducted in collaboration with Regeneron Pharmaceuticals Inc. ("Regeneron") to evaluate BNT116 as monotherapy and in several combinations including with chemotherapy, cemiplimab, and some of BioNTech’s proprietary assets across various treatment lines and clinical settings in patients with NSCLC.

In May, the first patient was dosed in a new cohort in the LuCa-MERIT-1 clinical trial to evaluate BNT116 in combination with BNT324/DB-1311.
Data from a cohort from the LuCa-MERIT-1 clinical trial evaluating BNT116 in combination with cemiplimab in patients with NSCLC who have received chemoradiotherapy will be provided in a mini-oral session at the 2025 World Conference on Lung Cancer ("WCLC") in Barcelona, Spain, September 6-9, 2025.
Corporate Update for the Second Quarter 2025

In June, BioNTech and BMS entered into an agreement for the global co-development and co-commercialization of BNT327 across numerous solid tumor types. Under the agreement, BMS will pay BioNTech $1.5 billion in an upfront cash payment and $2 billion total in non-contingent anniversary payments from 2026 through 2028. In addition, BioNTech will be eligible to receive up to $7.6 billion in additional development, regulatory and commercial milestones.

In June, BioNTech entered into a definitive Purchase Agreement pursuant to which BioNTech intends to acquire all of the shares of CureVac, a clinical-stage biotech company developing a novel class of transformative medicines in oncology and infectious diseases based on mRNA. The transaction is expected to close in 2025.

In May, BioNTech signed a grant agreement with the United Kingdom ("UK") Government to broaden the Company’s R&D activities for innovative medicines in the UK. As part of the agreement, BioNTech is committed to investing up to £1 billion over the next 10 years. The Company’s efforts will be supported by a grant of up to £129 million for a period of 10 years by the UK Government, which marks one of the largest grants of its kind in UK history for a pharmaceutical company.

Upcoming Investor and Analyst Events

AI Day: October 1, 2025, in London, United Kingdom

Innovation Series R&D Day: November 11, 2025, in New York City, United States

Conference Call and Webcast Information

BioNTech invites investors and the general public to join a conference call and webcast with investment analysts today, August 4, 2025, at 8:00 a.m. EDT (2:00 p.m. CEST) to report its financial results and provide a corporate update for the second 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.

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 made available shortly after the closing of the call and archived on the Company’s website for 30 days following the call.

On August 4, 2025 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported financial results for the second quarter ended June 30, 2025, and provided a corporate update (Press release, BioCryst Pharmaceuticals, AUG 4, 2025, View Source [SID1234654722]).

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"The financial performance this quarter is the best in the company’s history resulting from better-than-expected revenue growth and very meaningful operating profit. In the fifth year since approval, ORLADEYO revenue and demand have never been stronger, and this is driven by outstanding execution and increasing confidence in the product. Our accelerating operating profit and the sale of our European ORLADEYO business strengthen our financial position to deliver even greater value, and our pipeline remains on track for initial data later this year in two clinical programs," said Jon Stonehouse, chief executive officer of BioCryst.

ORLADEYO (berotralstat): Oral, Once-daily Treatment for Prevention of Hereditary Angioedema (HAE) Attacks

ORLADEYO net revenue in the second quarter of 2025 was $156.8 million (+45 percent year-over-year (y-o-y)).

New patient prescriptions in the second quarter were the highest ever in a quarter, beating those in the first quarter of the launch by over 10 percent.

The number of new prescribers of ORLADEYO in the U.S. in the second quarter increased to 69, up from 59 in the first quarter.

Patient discontinuations in the U.S. were lower in the first half of 2025 than in the first half of 2024, despite the larger base of patients taking ORLADEYO.

New real-world data from over 350 patients with HAE with normal C1 inhibitor showed substantial reductions in attack rates with ORLADEYO, reinforcing its value for a historically underserved patient segment and providing strong evidence to close both treatment and reimbursement gaps.

Sales from the U.S. contributed 89.5 percent of global ORLADEYO net revenues in the second quarter.

"ORLADEYO continued its upward trajectory in the second quarter, delivering our strongest quarter yet for new patient prescriptions and revenue. Growth was fueled by increasing demand in the U.S. and internationally, improved efficiency in getting paid shipments, fewer discontinuations, gross-to-net improvements, and continued impact of our real-world evidence generation—especially for patients with HAE with normal C1 inhibitor. With this momentum, we are confident in meeting our prior full-year guidance, even when factoring in the expected removal of European ORLADEYO sales in the fourth quarter," said Charlie Gayer, president and chief commercial officer of BioCryst.

Rare Disease Pipeline

Our goal is to build on our success with ORLADEYO by bringing additional selected, highly differentiated products to patients with rare diseases.

The Prescription Drug User Fee Act goal date for the company’s new drug application for ORLADEYO granules in children with HAE aged 2 to 11 is December 12, 2025. ORLADEYO would be the first targeted oral prophylactic therapy for children with HAE.

BCX17725, an investigational KLK5 inhibitor for the treatment of Netherton syndrome, is enrolling a phase 1 trial in healthy volunteers and patients. The company expects initial data from this program by the end of the year.

Avoralstat, an investigational plasma kallikrein inhibitor for the treatment of diabetic macular edema (DME), is enrolling a phase 1 trial in patients. The company expects initial data from this program by the end of the year.

Second Quarter 2025 Financial Results

For the three months ended June 30, 2025, total revenues were $163.4 million, compared to $109.3 million in the second quarter of 2024 (+50 percent y-o-y). The increase was primarily due to $156.8 million in ORLADEYO net revenue in the second quarter of 2025, compared to $108.3 million in ORLADEYO net revenue in the second quarter of 2024 (+45 percent y-o-y).

Research and development expenses for the second quarter of 2025 increased to $43.4 million from $37.6 million in the second quarter of 2024 (+15 percent y-o-y), primarily due to an increase in preclinical and early clinical work for avoralstat and BCX17725, investigational new drug application-enabling activities for early phase pipeline programs, and stock-based compensation. These increases were partially offset by the discontinuation and close-out of the Factor D programs and ORLADEYO-related regulatory, safety, quality, and manufacturing expenses, previously recorded in research and development, that are now recorded in selling, general, and administrative to reflect the program’s commercial progression.

Selling, general and administrative expenses for the second quarter of 2025 increased to $87.4 million, compared to $61.2 million in the second quarter of 2024 (+43 percent y-o-y). Approximately $10.7 million of the increase was driven by deal-related costs and stock-based compensation. Approximately $6.5 million was driven by ORLADEYO-related regulatory, safety, quality, and manufacturing expenses, previously recorded in research and development, that are now recorded in selling, general, and administrative to reflect the program’s commercial progression. The remainder was driven by the growth of ORLADEYO and general and administrative expenses.

Operating income for the second quarter of 2025 was $29.8 million, compared to $8.8 million for the second quarter of 2024. Non-GAAP operating income, excluding stock-based compensation expense and deal-related costs, was $57.0 million for the second quarter of 2025, compared to $21.9 million for the second quarter of 2024.

Interest expense was $21.6 million in the second quarter of 2025, compared to $24.7 million in the second quarter of 2024 (-13 percent y-o-y). The decrease was primarily the result of the $75 million partial prepayment on the outstanding principal amount under the Pharmakon Term Loan in April 2025, and the decrease in the effective interest rate related to the Pharmakon Loan Agreement.

Net income for the second quarter of 2025 was $5.1 million, or $0.02 per share, compared to a net loss of $12.7 million, or $0.06 per share, for the second quarter of 2024. Non-GAAP net income, excluding stock-based compensation expense and deal-related costs, was $32.3 million, or $0.15 per share, for the second quarter of 2025, compared to $0.5 million, or $0.00 per share, for the second quarter of 2024.

Cash, cash equivalents, restricted cash and investments totaled $287.1 million at June 30, 2025, of which $15.1 million of cash and cash equivalents are held within the company’s European business and is reflected in current assets held for sale, compared to $338.1 million at June 30, 2024. Net cash utilization for the second quarter of 2025 was $30.4 million, which was driven by the $75 million Pharmakon prepayment made in April 2025. Excluding this prepayment, there was $44.6 million of cash generated during the quarter, primarily driven by ORLADEYO sales.

In July, the company paid down an additional $50 million on the outstanding principal amount under the Pharmakon term loan, leaving a remaining principal balance of $199 million. Upon the expected closing of the sale of its European business in early October, the company intends to retire all its remaining term debt.

Financial Outlook for 2025
The company is maintaining its outlook for full year 2025 global net ORLADEYO revenue to between $580 million and $600 million, even when excluding fourth quarter European revenue after the expected closing of the sale of its European business.

Excluding stock-based compensation expense and deal-related costs, and without removal of fourth quarter European operating expenses, the company expects 2025 non-GAAP operating expenses to be between $440 million and $450 million. The company plans to provide updated 2025 operating expense guidance on its 3Q 2025 earnings call, after the expected closing of the sale of its European business.

The company remains on track to deliver net income and positive cash flows for full year 2025. Positive cash flow refers to the improvement in cash, cash equivalents, restricted cash and investments from year end 2024 to year end 2025, not including the impact of $125 million in Pharmakon prepayments made in 2025.

Conference Call and Webcast
BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 1-844-481-2942 for domestic callers and 1-412-317-1866 for international callers. A live webcast and replay of the call will be available online in the investors section of the company website at www.biocryst.com.

On August 4, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that, in collaboration with Cleveland Clinic, it has initiated the transfer of the Investigational New Drug (IND) application that supported the Phase 1 clinical trial of its breast cancer vaccine (Press release, Anixa Biosciences, AUG 4, 2025, View Source [SID1234654721]).

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With enrollment completed and encouraging immune response data observed in the Phase 1 trial, Anixa plans to advance the vaccine into a Phase 2 clinical trial and will assume full sponsorship of the IND. The IND, currently held by Cleveland Clinic, is in the process of being transferred to Anixa. To oversee this process, Anixa has engaged Advyzom, a leading regulatory consulting firm specializing in strategic FDA interactions, to act as its U.S. regulatory agent regarding the assigned application.

Anixa’s breast cancer vaccine, developed in collaboration with Cleveland Clinic, targets α-lactalbumin—a lactation-associated protein that is typically expressed only in breast tissue during lactation, but which re-emerges in many forms of breast cancer. By establising an immune response against α-lactalbumin-expressing cells, the vaccine may offer both therapeutic and preventive benefits for patients with tumors expressing this protein.

"We are pleased with the progress and preliminary findings from our Phase 1 clinical trial, which show that the vaccine is well tolerated, with more than 70% of patients tested to date exhibiting protocol-defined immune responses," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "The IND transfer represents a major step in advancing to a Phase 2 trial under our sponsorship. We look forward to working closely with Cleveland Clinic, Advyzom, and the FDA as we continue to move this important program forward."

On August 4, 2025 AB Science S.A. (the "Company" or "AB Science", Euronext – FR0010557264 – AB) reported the successful completion of a capital increase of a total gross amount of EUR 2.55 million subscribed by a limited number of investors (the "Private Placement") (Press release, AB Science, AUG 4, 2025, View Source [SID1234654720]).

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The Private Placement is not subject to a prospectus requiring an approval from the French Financial Market Authority (Autorité des Marchés Financiers –the "AMF"). In accordance with Article 1.5.(ba) of the Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017, as amended (the "Prospectus Regulation"), the Company file with the AMF a document containing the information set out in Appendix IX of the Prospectus Regulation (the "Information document"), copies of which will be available free of charge on the Company’s website at www.ab-science.com and on the AMF’s website at www.amf-france.org.

Use of proceeds

The Company intends to use the net proceeds of the Private Placement to finance its ongoing activities, with a focus on the clinical development of the AB8939 program.

This transaction strengthens the Company’s cash position and enables it to cover its financing needs in 2025 and beyond the next 12 months, taking into account the explanations set out in section 5.2.1.5 (note 2) of the 2024 financial report.

Terms and conditions of the Private Placement

The Private Placement, for a total amount of EUR 2.55 million (including share issue premium), was carried out through the issuance, without preferential subscription rights and without a priority subscription period, of 2,276,787 new ordinary shares of the Company (the "New Shares"), each with one share warrant attached (a "BSA" and, together with the New Share to which it is attached, an "ABSA"), as part of a share capital increase with cancellation of shareholders’ preferential subscription rights for the benefit of investors within the category of persons defined by the 16th resolution of the Combined General Meeting of the Company’s shareholders of June 30, 2025 (the "General Meeting"), in accordance with Article L. 225-138 of the French commercial code (the "Private Placement").

The issue of the ABSAs, representing approximately 3.34% of the Company’s share capital, on a non-diluted basis, before completion of the Private Placement, and 3.23% of the Company’s share capital, on a non-diluted basis, after completion of the Private Placement, was decided on August 1st, 2025 by the Chief Executive Officer, pursuant to the delegation of competence granted to him by the board of directors dated July 24, 2025, pursuant to the delegation of competence granted to it under the 16thresolution of the General Meeting.

The issue price of one ABSA is EUR 1.12 (including share issue premium), representing a facial discount of 24.68% (i.e. EUR 0.3669) to the volume-weighted average price of the AB Science shares on the regulated market of Euronext Paris ("Euronext Paris") over the three trading days preceding the setting of such issue price, i.e. August 1st and July 31 and 30, 2025 (the "3-day VWAP").

The issue price of an ABSA, including the theoretical value of the BSA attached to it (as described below, together with the exercise price of such BSA) represents a total 17.87% discount per AB Science share to the 3-day VWAP, consistent with the maximum discount authorized by the General Meeting pursuant to its 16th resolution.

Terms and conditions of the BSA

One BSA is attached to each New Share.

One BSA entitles their holder to subscribe to one new ordinary share of the Company, at a price of EUR 1.71 per ordinary share.

The BSAs may be exercised at any time within 60 months of their issuance. In the event all BSAs are exercised, a total number of 2,276,787 additional ordinary shares of the Company will be issued, representing additional total proceeds of approximately EUR 3.89 million.

The theoretical value of each BSA, assuming a volatility of 34.355%1 and based on closing price as of August 1st, 2025, is equal to EUR 0.3877 using Black & Scholes model.

The BSAs will be immediately detached (détachés) from the New Shares upon issuance and are expected to be listed on Euronext Growth Paris ("Euronext Growth Paris") on or prior to August 11, 2025.

Impact of the Private Placement on the Company’s shareholding

Following the issuance of the ABSAs, the Company’s total share capital will be EUR 704,695.95 (or EUR 727,463.82 in the event of exercise of all BSAs). It will be comprised of 63,706,916 ordinary shares (or of 65,983,703 ordinary shares in the event of exercise of all BSAs) with a par value of EUR 0.01. There will be no change on the number of preferred shares.

On the basis of the share capital of the Company immediately after completion of the Private Placement, the interest of a shareholder who held 1.00% of the Company’s share capital prior to the above-mentioned capital increase and who did not subscribe to it now stands at 0.97% on a non-diluted basis and 0.77% on a diluted basis.

Admission to trading of the New Shares

The New Shares are expected to be admitted to trading on the regulated market of Euronext Paris on August 7, 2025.The New Shares will be subject to the provisions of the Company’s by-laws and will be assimilated to existing shares upon final completion of the Private Placement. They will bear current dividend rights and will be admitted to trading on the same listing line as the Company’s existing shares under the same ISIN code FR0010557264 – AB.

Lock-up commitments

– The Company has signed a lock-up commitment (to the benefit of the investors) pursuant to which it has agreed to a lock-up period of 45 calendar days from the date of the settlement and delivery of the Private Placement, subject to certain customary exceptions.

– The directors and officers of the Company have signed a lock-up commitment pursuant to which they have agreed to a lock-up period of 90 calendar days from the date of the settlement and delivery of the Private Placement, subject to certain customary exceptions.

Indicative timetable

July 24, 2025 Decisions of the Board of Directors deciding the principle of the Private Placement. August 1st, 2025 Decisions of the Chief Executive Officer setting the terms and conditions of the Private Placement (including the subscription price of the ABSAs and the gross amount of the Private Placement). August 4, 2025 Publication of this press release. Publication of the Information Document. August 7, 2025Publication of the Euronext notice of admission of the New Shares to trading on Euronext Paris. August 7, 2025Settlement-delivery of the ABSAs – Detachment of the BSA – Start of trading of the New Shares on Euronext Paris. August 11, 2025 Admission of the BSAs on Euronext Growth Paris.

Risk factors

AB Science draws the attention of the public to the risk factors relating to the Company and its business described in its annual management reports and press releases, which are available free of charge on the Company’s website (www.ab-science.com).

In addition, the main risks specific to securities are as follows:

The existing shareholders who do not participate in the Private Placement will see their shareholding in the share capital of AB Science diluted, and this shareholding may also be diluted in the event of exercise of the BSA, as well as in the event of new securities transactions.

-The volatility and liquidity of AB Science shares could fluctuate significantly. The market price of the Company’s shares may fluctuate and fall below the subscription price of the shares issued in the context of the Private Placement. The sale of Company shares may occur on the secondary market, after the Private Placement, and have a negative impact on the Company share price.

About masitinib

Masitinib is a novel oral tyrosine kinase inhibitor that is being developed to target mast cells and macrophages, key immune cells, through inhibition of a limited number of kinases. Due to its unique mode of action, the Company believed that masitinib can be developed in a wide range of diseases, including oncology, inflammatory diseases, and certain central nervous system diseases. In oncology, through its immunotherapy activity, masitinib may have an effect on survival, alone or in combination with chemotherapy. Through its activity on mast cells and microglial cells and therefore its inhibitory effect on the activation of the inflammatory process, masitinib may have an effect on the symptoms associated with certain inflammatory and central nervous system diseases.

About AB8939

AB8939 is a new synthetic microtubule-destabilizing drug candidate. Preclinical data suggests that AB8939 has broad anticancer activity, with a notable advantage over standard chemotherapies that target microtubules of being able to overcome P-glycoprotein (Pgp) and myeloperoxidase (MPO) mediated drug resistance. Development of drug resistance often restricts the clinical efficacy of microtubule-targeting chemotherapy drugs (for example, taxanes and vinca alkaloids); thus, AB8939 has the potential to be developed in numerous oncology indications.