On May 6, 2026 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported its participation in the Bank of America Securities 2026 Health Care Conference being held at the Encore Hotel in Las Vegas, Nevada. Management will participate in a fireside chat on Wednesday, May 13, 2026, at 3:00 pm Pacific Time and will also participate in one-on-one investor meetings.

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

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

                  Schedule Your 30 min Free Demo!

A live audio webcast of the event will be available online at Erasca.com/events. An archived replay of the event will be available for 30 days following the webcast at Erasca.com/events.

(Press release, Erasca, MAY 6, 2026, View Source [SID1234665231])

On May 6, 2026 Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that The New England Journal of Medicine (NEJM) has published a report describing data from the Phase 1/2 clinical trial evaluating daraxonrasib, a RAS(ON) multi-selective inhibitor, in patients with previously treated metastatic RAS mutant pancreatic ductal adenocarcinoma (PDAC). The promising Phase 1/2 findings provided important insights supporting initiation of the company’s global, randomized Phase 3 registrational trial, RASolute 302. Revolution Medicines recently announced positive topline results from the RASolute 302 clinical trial showing an unprecedented overall survival benefit with daraxonrasib compared to standard of care cytotoxic chemotherapy, consistent with the Phase 1/2 single-arm observations.

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

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

                  Schedule Your 30 min Free Demo!

"RAS mutations are a central driver of disease across multiple solid tumors, including particularly pancreatic ductal adenocarcinoma. There is significant room for improvement in outcomes over current standard of care — cytotoxic chemotherapies that are not targeted to these underlying RAS cancer drivers," said Alan Sandler, M.D., chief development officer of Revolution Medicines. "Data from the Phase 1/2 trial show that daraxonrasib demonstrated promising clinical antitumor activity and durable responses, with an acceptable safety and tolerability profile, in patients with previously treated metastatic RAS mutant PDAC. These results, along with those from our Phase 3 trial, RASolute 302, strengthen our confidence in daraxonrasib’s potential to establish an important new treatment option for patients with pancreatic cancer and other RAS-addicted cancers."

The data published in NEJM reflect outcomes in the PDAC cohort from the RMC-6236-001 trial (NCT05379985), an open-label, multicenter Phase 1/2 trial evaluating daraxonrasib monotherapy in patients previously treated for metastatic solid tumors harboring RAS mutations.

In addition to RASolute 302, daraxonrasib is being evaluated in three other global Phase 3 registrational trials, including in patients with PDAC in earlier treatment lines and those with metastatic RAS mutant non-small cell lung cancer.

About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma
Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that annually approximately 60,000 people are diagnosed with pancreatic cancer, and about 50,000 people will die from this aggressive disease.1

Due to the lack of early symptoms and detection methods, approximately 80% of patients are diagnosed with PDAC at an advanced or metastatic stage. It is the most common RAS-addicted malignancy of all major cancers, and more than 90% of patients have tumors that harbor RAS mutations.2 Metastatic PDAC remains one of the most common causes of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3%.3,4

About Daraxonrasib
Daraxonrasib is an investigational, oral RAS(ON) multi-selective, non-covalent inhibitor that is not approved by any regulatory authority, including in the United States or Europe. The U.S. Food and Drug Administration (FDA) granted daraxonrasib Breakthrough Therapy Designation and Orphan Drug Designation for the treatment of patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) harboring G12 mutations. In addition, daraxonrasib was selected for the FDA Commissioner’s National Priority Voucher pilot program, which is intended to accelerate the development and review of therapies aligned with U.S. national health priorities.

Daraxonrasib is designed to target cancers driven by a broad range of common RAS mutations, including PDAC, non-small cell lung cancer (NSCLC), and colorectal cancer. In addition to the RASolute 302 trial, daraxonrasib is being evaluated in three other global Phase 3 registrational trials, including in patients with PDAC and metastatic RAS mutant NSCLC.

Daraxonrasib works by suppressing RAS signaling through inhibition of the interaction between both wild-type and mutant RAS(ON) proteins and their downstream effectors.

(Press release, Revolution Medicines, MAY 6, 2026, View Source [SID1234665197])

On May 6, 2026 BioOra Limited, a New Zealand-based company pioneering automated, cost-effective CAR T-cell manufacturing, reported the signing of a binding Heads of Terms agreement with Wellington Zhaotai Therapies Limited (Wellington Zhaotai) under which BioOra secures global rights to develop and commercialise Wellington Zhaotai’s novel third-generation anti-CD19 CAR T-cell therapy for the treatment of multiple conditions (WZTL-002), including haematological malignancies and auto-immune diseases.

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

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

                  Schedule Your 30 min Free Demo!

BioOra’s automated manufacturing process, utilising the Cocoon platform developed by the Octane Medical Group, is a core competitive advantage, enabling more consistent, scalable, and lower-cost production of CAR T-cells compared to manual methods. This technology supports the transition from clinical development to commercial supply, addressing key barriers in CAR-T accessibility, such as high costs and manufacturing complexity.
BioOra’s automated manufacturing process, utilising the Cocoon platform developed by the Octane Medical Group, is a core competitive advantage, enabling more consistent, scalable, and lower-cost production of CAR T-cells compared to manual methods. This technology supports the transition from clinical development to commercial supply, addressing key barriers in CAR-T accessibility, such as high costs and manufacturing complexity.
This milestone agreement builds on BioOra’s existing partnership with the Malaghan Institute of Medical Research through which BioOra already holds exclusive rights for commercialisation of WZTL-002 in New Zealand and Australia. The agreement with Wellington Zhaotai will provide BioOra the exclusive rights to commercialise the therapy in all markets outside of China and India, including USA, Europe and the UK.

BioOra have combined the unique CAR-T asset developed by Wellington Zhaotai, with BioOra’s manufacturing and commercialisation expertise to deliver Atla-cel, an autologous CAR T-cell product incorporating patented co-stimulatory domains designed to deliver robust efficacy with a favourable safety profile, including low rates of neurotoxicity. The clinical value of the third-generation design has been demonstrated through New Zealand’s first CAR T-cell clinical trial, sponsored by Malaghan Institute and conducted in collaboration with Wellington Zhaotai (ENABLE-1, NCT04049513). This study also confirmed BioOra’s capabilities in automated manufacturing in a clinical setting. Results from 30 patients showed a complete response rate and fewer serious toxicities than those observed in similar clinical trials of first- and second-generation CAR T-cell therapies1.

Through their partnership, BioOra and the Malaghan Institute are now confirming the safety and efficacy of Atla-cel in patients with relapsed/refractory large B-cell lymphoma in a pivotal Phase 2 study designed to enable registration in New Zealand and Australia (ENABLE-2, NCT06486051)

BioOra’s automated manufacturing process, utilising the Cocoon platform developed by the Octane Medical Group, is a core competitive advantage, enabling more consistent, scalable, and lower-cost production of CAR T-cells compared to manual methods. This technology supports the transition from clinical development to commercial supply, addressing key barriers in CAR-T accessibility, such as high costs and manufacturing complexity.

John Robson, CEO of BioOra Limited said, "This agreement positions BioOra to expand Atla-cel into high-value global markets and marks an important commercial milestone for the company. At its heart is the opportunity to bring CAR-T to more patients in more markets. Too many people around the world still have limited access to these personalised cell therapies, largely because of cost. Combining Wellington Zhaotai’s innovative science with BioOra’s automated manufacturing expertise creates the pathway to change that. To date, Atla-cel has demonstrated remarkable safety outcomes, which are central to its clinical and commercial potential."

Dr Peter Crabree, Chairman of BioOra Limited said, "CAR T-cell therapy represents one of the most consequential advances in oncology of the past decade, yet access remains profoundly unequal. This agreement with Wellington Zhaotai is a concrete step toward changing that, bringing technology developed through world-class international collaboration, and further advanced here in New Zealand, to patients across the globe. For BioOra, this is about more than commercial expansion; it is about ensuring that patients with blood cancers and B-cell mediated diseases have access to therapies that can genuinely alter the course of their disease".

(Press release, BioOra, MAY 6, 2026, View Source [SID1234665216])

On May 6, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported it has received FDA clearance to initiate clinical evaluation of Bria-BRES+, its next generation, personalized, off-the-shelf, cell-based immunotherapy for metastatic breast cancer.

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

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

                  Schedule Your 30 min Free Demo!

"We are honored to announce FDA clearance of the first IND for our next generation personalized immunotherapy, Bria-BRES+," stated Dr. William V. Williams, BriaCell’s President & CEO. "The unique design of Bria-BRES+ offers the potential for a favorable safety profile and meaningful therapeutic benefit in metastatic breast cancer. We look forward to advancing Bria-BRES+ into the clinic as we seek to bring new hope to these patients who have few to no effective treatment options."

As reported in BriaCell’s recent AACR (Free AACR Whitepaper) preclinical poster presentation, Bria-BRES+ demonstrated activation of both adaptive and innate immunity including activation of naïve (resting) T-cells, dendritic cells and natural killer (NK) cells. BriaCell believes this multipronged immune activation may enhance clinical efficacy and help prevent immune escape in patients with metastatic breast cancer.

BriaCell’s Bria-BRES+ builds on its Bria-OTS breast cancer clinical program, where the first patient dosed experienced the sustained complete resolution of a lung metastasis. This 78-year-old woman with advanced metastatic breast cancer and multiple prior treatment failures achieved complete (100%) resolution of a lung metastasis following four doses of Bria-OTS single agent therapy. The complete response of the lesion, initially observed at 2 months, was subsequently confirmed at 4 months, 6 months, and at 11 months. The patient received 17 cycles of Bria-OTS, completed 12 months of the study, and remains in survival follow-up.

(Press release, BriaCell Therapeutics, MAY 6, 2026, View Source [SID1234665232])

On May 5, 2026 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported financial results for the three months ended March 31, 2026 and provided an update on its corporate progress.

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

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

                  Schedule Your 30 min Free Demo!

"In the first quarter, we made substantial progress in executing towards our oncology strategy, highlighted by data presentations from our priority pan-tumor program pumitamig as well as our versatile antibody-drug conjugate portfolio. Simultaneously, we continue to broaden our clinical programs to include novel-novel combinations in order to inform the optimal set-up for registrational combination trials and maximize the potential of our pipeline," said Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. "We will continue to focus on accelerating our key strategic programs as we remain steadfast in our vision to translate our science into survival for patients living with cancer."

Financial Review for First Quarter 2026

in millions €,
except per share data First Quarter 2026 First Quarter 2025
IFRS Results Adjusted Results2 IFRS Results Adjusted Results2
Revenues 118.1 118.1 182.8 182.8
Net loss (531.9) (494.6) (415.8) (430.8)
Diluted loss per share (2.10) (1.95) (1.73) (1.79)

Revenues for the first quarter of 2026 were €118.1 million, compared to €182.8 million for the comparative prior year period. The decrease was primarily driven by lower revenues of BioNTech’s COVID-19 vaccines.

Research and development ("R&D") expenses were €557.0 million for the first quarter of 2026, compared to €525.6 million for the comparative prior year period. R&D expenses were mainly driven by higher expenses for the development of immuno-oncology ("IO") and antibody-drug conjugate ("ADC") programs, in particular pumitamig and gotistobart, as well as costs from operations of entities acquired during 2025, BioNTech China (previously Biotheus) and CureVac, and an impairment of an intangible asset. These effects were partly offset by lower R&D expenses related to the Company’s COVID‑19 vaccine collaboration with Pfizer Inc. ("Pfizer").

Adjusted R&D expenses were €527.1 million for the first quarter of 2026, compared to €525.6 million for the comparative prior year period. For the first quarter of 2026, adjusted R&D expenses exclude the impairment of an intangible asset.

Sales, general and administrative ("SG&A") expenses5 were €150.8 million for the first quarter of 2026, compared to €120.6 million for the comparative prior year period. The increase was mainly driven by the ongoing commercial build-up and the inclusion of operations of entities acquired in 2025, BioNTech China (previously Biotheus) and CureVac. These costs were partly offset by a reduction in external services.

Net loss was €531.9 million for the first quarter of 2026, compared to a net loss of €415.8 million for the comparative prior year period.

Adjusted net loss was €494.6 million for the first quarter of 2026, compared to an adjusted net loss of €430.8 million for the comparative prior year period.

Diluted loss per share was €2.10 for the first quarter of 2026, compared to a diluted loss per share of €1.73 for the comparative prior year period.

Adjusted diluted loss per share was €1.95 for the first quarter of 2026, compared to adjusted diluted loss per share of €1.79 for the comparative prior year period.

Cash, cash equivalents and security investments as of March 31, 2026, were €16,763.3 million, comprising €9,939.4 million in cash and cash equivalents, €4,696.9 million in current security investments disclosed as financial assets and €2,127.0 million in non-current security investments disclosed as financial assets.

Shares outstanding as of March 31, 2026, were 252,884,261, excluding 6,143,226 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 Ramón Zapata, Chief Financial Officer at BioNTech. "We are committed to a diligent capital allocation strategy that empowers us to pursue our goal of evolving into a leading biopharmaceutical company with multiple oncology products by 2030."

Reaffirmed 2026 Financial Year Guidance6:

Revenues for the 2026 financial year €2,000 – €2,300 m

In 2026, BioNTech anticipates lower COVID-19 vaccine revenues compared to 2025, driven by declines in both the European and United States markets. The United States continues to be a competitive and dynamic market, where, as a result, lower revenues are expected. In Europe, the Company expects lower revenues as it defends its market share and begins managing the transition away from multi-year contracts. In Germany specifically, BioNTech recognizes direct sales of its COVID-19 vaccines as revenue. Hence, the anticipated declines in sales of COVID-19 vaccines in Germany will have a direct impact on the Company’s topline, whereas revenues outside of Germany only affect the Company’s topline as part of the 50% gross profit split with its partner Pfizer. Per the outlined partnership terms, revenues from the collaboration with Bristol Myers Squibb Company ("BMS") in 2026 are expected to be broadly in line with 2025. Revenues from the pandemic preparedness contract with the German government and service businesses are expected to remain stable.

Planned 2026 Financial Year Adjusted Expenses6:

Adjusted R&D expenses €2,200 – €2,500 m
Adjusted SG&A expenses5 €700 – €800 m

BioNTech will continue to 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 foster innovation and 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 creating future value.

Planned Capital Return to Shareholders
The Management Board and Supervisory Board expect to authorize a share repurchase program of BioNTech’s American Depositary Shares ("ADSs"), pursuant to which the Company may repurchase ADSs in the amount of up to $1.0 billion over the next twelve months. BioNTech expects to use the repurchased ADSs to satisfy obligations in the ordinary course of business. The program is designed to enhance capital efficiency and support long-term value creation to execute BioNTech’s objective to become a multi-product company by 2030.

Manufacturing Footprint Consolidation
BioNTech continues to allocate capital strategically while optimizing capacities broadly to drive operational efficiency and sustainable value creation. To this end, BioNTech plans to align and consolidate its manufacturing network further where excess capacity is expected, due to evolving supply needs, mergers and acquisitions, BioNTech’s partners’ manufacturing capacities and completion of contracts.

BioNTech plans to exit operations at the manufacturing sites in Idar-Oberstein, Marburg, and Singapore as well as CureVac’s sites, affecting up to approximately 1,860 positions in total. The exit from the sites in Idar-Oberstein, Marburg, and Tübingen is planned by the end of 2027, while operations in Singapore are expected to conclude in Q1 2027. For each of these manufacturing sites, BioNTech is exploring divestment options, including a partial or total sale.

BioNTech expects cost savings to ramp up over time, potentially reaching approximately €500 million in recurring annual savings upon full implementation of the measures in 2029.7 These savings are intended to support the Company’s capital allocation to further advance its growing oncology pipeline toward commercialization.

BioNTech continues to ensure a robust drug supply via its established manufacturing network. No impact on commercial or clinical supply nor contractual obligations is expected as the affected sites will become underutilized or idle in the next 24 months.

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, 2026, filed today with the United States Securities and Exchange Commission ("SEC") and available at www.sec.gov.

(Press release, BioNTech, MAY 5, 2026, View Source [SID1234665106])