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SHY Therapeutics Announces the First Patient Has Been Dosed in Phase 1 Clinical Trial Evaluating SHY-ONC6, a Novel, Oral Proteasome Inhibitor for the Treatment of Solid Tumors

On August 4, 2026 SHY Therapeutics ("SHY" or "the Company"), a clinical-stage biotechnology company developing small molecules that non-covalently target ATPases and GTPases and modulate their activity, reported that the first patient has been dosed in Luca-1, the Company’s first-in-human Phase 1 clinical trial evaluating SHY-ONC6, an investigational, novel and potentially first-in-class oral proteasome inhibitor for patients with advanced solid tumors. The Company expects initial Phase 1 data in 2027.

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"SHY-ONC6 targets the ubiquitin-proteasome system, which governs the degradation of damaged or unneeded proteins. Unlike current FDA-approved proteasome inhibitors that target the 20S Core Particle, SHY-ONC6 inhibits the ATPases within the 19S Regulatory Particle of the proteasome, introducing a novel and differentiated mechanism of proteasome inhibition," said Yaron Hadari, Ph.D., SHY’s Chief Executive Officer and Co-Founder.

While treatment with the current FDA approved proteasome inhibitors is limited to hematologic malignancies, SHY-ONC6 is being developed to expand this clinically validated therapeutic approach to solid tumors. Preclinical studies of SHY-ONC6 have demonstrated robust anti-tumor activity and favorable tolerability in multiple in vivo models of solid tumors, with similarly strong activity observed in hematologic malignancy models, supporting potential future development in additional cancer types.

"Dosing the first patient represents an important milestone as SHY advances its first clinical program and validates our strategy of developing differentiated small molecules against high-value ATPase and GTPase targets," said Michael Schmertzler, Executive Chairman and Co-Founder of SHY Therapeutics. "We believe SHY-ONC6 has the potential to expand the clinical utility of proteasome inhibition beyond hematologic cancers, addressing a much broader population of patients with solid tumors, and look forward to generating the first clinical data from the program next year," added Mr. Schmertzler.

The Luca-1 trial is a first-in-human, open-label, multicenter Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of SHY-ONC6 in patients with advanced solid tumors. Additional information about the trial is available at ClinicalTrials.gov.

(Press release, SHY Therapeutics, AUG 4, 2026, View Source [SID1234669688])

Nurix Announces $10 Million Milestone Payment Associated with Initiation of a Phase 1 Clinical Trial of a STAT6 Degrader

On August 4, 2026 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, reported that it has earned a $10 million milestone payment following the initiation by its collaborator, Sanofi, of the Phase 1 first-in-human clinical trial of SAR448272/NX-3911, an oral STAT6 degrader.

STAT6 is a key transcription factor within the interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling pathways that drive type 2 inflammation and play a central role in diseases including atopic dermatitis and asthma. With the receipt of the $10 million development milestone payment from Sanofi, Nurix will have received approximately $139 million under the companies’ 2019 collaboration agreement. Sanofi is solely responsible for the ongoing clinical development of SAR448272.

"Advancing SAR448272 into the clinic marks an important milestone for the STAT6 program and further validates the productivity of our DEL-AI drug discovery platform in generating differentiated degrader medicines for immunology," said Gwenn M. Hansen, Ph.D., chief scientific officer of Nurix. "We look forward to seeing the program advance through clinical evaluation by our partner Sanofi."

"Today’s announcement represents another important advancement in our long-standing collaboration with Sanofi and further demonstrates our ability to discover innovative targeted protein degraders for major inflammatory diseases," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "The advancement of SAR448272 into Phase 1 builds on the strong momentum across our partnered immunology portfolio and reflects the continued execution of our strategy to create significant value through both our wholly owned and partnered degrader programs."

About the Nurix/Sanofi Collaboration
Under the 2019 collaboration agreement, Nurix deployed its proprietary DEL-AI drug discovery platform to identify novel agents that utilize E3 ligases to induce the degradation of specified proteins. In 2025, Sanofi exercised its license extension option for two programs targeting transcription factors for the treatment of autoimmune/inflammatory diseases including an undisclosed target and STAT6. For both programs, Nurix retains the option to co-develop and co-promote in the United States following demonstration of clinical proof of concept. Upon execution of the collaboration agreement in December 2019, Sanofi made an upfront payment to Nurix of $55 million and subsequently paid an additional $22 million to expand the scope of the collaboration. In June 2025, Sanofi exercised its exclusive license extension option for an undisclosed target and for the STAT6 program, triggering two $15 million license extension payments. Following the receipt of the $10 million milestone associated with initiation of the Phase 1 study, Nurix will have received a total of approximately $139 million under the Sanofi collaboration. Nurix remains eligible to receive approximately $453 million in future development, regulatory and commercial milestone payments associated with the STAT6 program, in addition to potential royalties on future product sales. Nurix also retains an option to co-develop, co-promote, and share profits and losses for the program equally in the United States.

(Press release, Nurix Therapeutics, AUG 4, 2026, View Source [SID1234669687])

Lisata Therapeutics Provides Update Following Termination of Merger Agreement

On August 4, 2026 Lisata Therapeutics, Inc. (Nasdaq: LSTA) ("Lisata"), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, reported an update following the termination of its merger agreement with Kuva Labs Inc. and its subsidiary Kuva Acquisition Corp. (collectively, "Kuva").

Lisata has filed suit in the Delaware Court of Chancery against Kuva over Kuva’s breach of the previously-disclosed Agreement and Plan of Merger dated March 6, 2026 (as amended, the "Merger Agreement"), seeking, among other things, damages for the benefit of its stockholders and the $2,000,000 termination fee Lisata is owed under the Merger Agreement.

Lisata’s Board of Directors continues to evaluate strategic alternatives to enhance stockholder value, which will include, but are not limited to, an acquisition, merger, reverse merger, other business combination, sales of assets, liquidation and dissolution, among other strategic transactions. The Company has not set a timetable for completion of this strategic review and does not intend to comment further on the status of this process unless or until its Board of Directors has approved a definitive course of action, or it is determined that another disclosure is warranted.

In order to reduce operating expenses and preserve cash to pursue strategic alternatives, Lisata has implemented a reduction in force, eliminating approximately 72% of its full-time employees, including its Executive Vice President of R&D and Chief Medical Officer position. Certain members of the separated staff may be engaged as external consultants for a period of time, as necessary.

(Press release, Lisata Therapeutics, AUG 4, 2026, View Source [SID1234669686])

OnKure Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Highlights

On August 4, 2026 OnKure Therapeutics, Inc. (Nasdaq: OKUR), a clinical-stage biopharmaceutical company focused on developing novel precision medicines, reported financial results for the second quarter ended June 30, 2026, and provided recent business highlights.

"Following our strategic transformation earlier this year, we continue to advance our next-generation PI3Kα pan-mutant selective inhibitor pipeline, which we believe represents the most compelling opportunity to deliver differentiated therapies across PI3Kα-driven diseases," said Nicholas Saccomano, Ph.D., President and Chief Executive Officer of OnKure. "Both OKI-355 and OKI-345 continue to advance through IND-enabling activities and remain on track for planned IND submissions in the first half of 2027. We believe the combination of our chemistry platform and deep understanding of PI3Kα biology positions us to develop differentiated therapies with the potential to meaningfully improve outcomes for patients. Our recent Key Opinion Leader event reinforced the scientific rationale underpinning our strategy and highlighted the significant opportunity for next-generation PI3Kα pan-mutant selective inhibitors to overcome the limitations of current therapies across multiple disease settings."

Vascular Anomalies

OnKure continues to advance OKI-355, a next-generation PI3Kα pan-mutant-selective inhibitor candidate announced in March 2026 to lead its development pipeline in vascular anomalies. OKI-355 has been designed to selectively inhibit mutant PI3Kα while sparing wildtype PI3Kα, potentially enabling a wider therapeutic index and avoidance of class-limiting toxicities. High and sustained target coverage across all hotspot PI3Kα mutations can support the potential for deep and durable responses in vascular anomalies. OnKure plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for OKI-355 in the first half of 2027.

Additionally, earlier this year, OnKure initiated a discovery research program to expand its vascular anomalies pipeline beyond targeting PI3Kα.

Breast Cancer

In breast cancer, OnKure continues to advance OKI-345, a next-generation PI3Kα pan-mutant-selective inhibitor candidate selected in March 2026. OKI-345 has been designed to selectively inhibit mutant PI3Kα while sparing wildtype PI3Kα, potentially enabling a wider therapeutic index and avoidance of class-limiting toxicities. High and sustained target coverage across all hotspot PI3Kα mutations can support the potential for deep and durable responses in breast cancer, both as monotherapy and in combination. OnKure plans to submit an IND application to the FDA for OKI-345 in the first half of 2027.

Scientific Engagement

OnKure recently hosted a virtual Key Opinion Leader event titled "Selectivity Matters and Pan-Mutant Allosteric Inhibition Delivers," featuring Benjamin F. Cravatt, Ph.D., of Scripps Research, and Robert Abraham, Ph.D., Chief Scientific Officer of Engine Biosciences. The discussion explored the scientific rationale supporting next-generation PI3Kα pan-mutant selective inhibitors, including the importance of PI3Kα selectivity, the potential to overcome limitations of current therapies, and the Company’s structure-based drug design approach.

OnKure also participated as an exhibitor and sponsor at the International Society for the Study of Vascular Anomalies (ISSVA) World Congress 2026 in Philadelphia, held in May.

Financial Results

Cash position: As of June 30, 2026, the Company reported cash, cash equivalents, and marketable securities of $176.4 million, which is expected to provide cash runway into 2029.

Research and development (R&D) expenses: R&D expenses were $12.6 million for both the second quarter of 2026 and the second quarter of 2025. During the second quarter of 2026, an increase in clinical trial and outsourced manufacturing expenses was offset by a decrease in outsourced preclinical R&D expenses.

General and Administrative (G&A) expenses: G&A expenses were $4.3 million for the second quarter of 2026, compared to $3.7 million for the second quarter of 2025. The increase of $0.6 million was primarily driven by increases in personnel-related and consulting costs.

Net loss and net loss per share were $15.3 million, or $0.31 per share, for the second quarter of 2026, compared to $15.4 million, or $1.14 per share, for the second quarter of 2025.

(Press release, OnKure Therapeutics, AUG 4, 2026, View Source [SID1234669685])

BioNTech Announces Second Quarter 2026 Financial Results and Corporate Update

On August 4, 2026 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported financial results for the three and six months ended June 30, 2026 and provided an update on its corporate progress.

"In the first half of 2026, we made important progress in turning our mission into reality. We significantly advanced our late-stage oncology pipeline, with six pivotal trials initiated; we pioneered the generation of first-in-class global Phase 2 data for an investigational PD-L1xVEGF bispecific antibody in first-line non-small cell lung cancer across PD-L1 expression levels and histologies; and we demonstrated at medical congresses that our novel-novel combination therapy strategy is gaining momentum," said Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. "We look forward to welcoming BioNTech’s next CEO. Guido Oelkers will take office by February 1, 2027, at the latest, and, together with the Management Board and teams across the company, is expected to continue to write the BioNTech success story."

Financial Review for Second Quarter and First Half of 2026

in millions €,
except per share data Second Quarter 2026 Second Quarter 2025
IFRS Results Adjusted Results2 IFRS Results Adjusted Results2
Revenues 105.6 105.6 260.8 260.8
Net loss (820.8) (562.3) (386.6) (348.8)
Diluted loss per share (3.24) (2.22) (1.60) (1.45)

in millions €,
except per share data Year-to-date 2026 Year-to-date 2025
IFRS Results Adjusted Results2 IFRS Results Adjusted Results2
Revenues 223.7 223.7 443.6 443.6
Net loss (1,352.7) (1,056.9) (802.4) (779.6)
Diluted loss per share (5.34) (4.17) (3.33) (3.23)
Below figures compare the second quarter of 2026 and the year-to-date period ended June 30, 2026, to the corresponding prior year periods, except as noted.

Revenues were €105.6 million for the second quarter of 2026, compared to €260.8 million. Year-to-date revenues were €223.7 million, compared to €443.6 million. The decreases in both quarterly and year-to-date revenues compared to the prior year were primarily driven by lower demand from BioNTech’s COVID-19 vaccines.

Research and development ("R&D") expenses were €551.0 million for the second quarter of 2026, compared to €509.1 million. Year-to-date R&D expenses were €1,108.0 million, compared to €1,034.7 million. 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, impairment losses of intangible assets, and the inclusion of operations from CureVac, which was acquired in late 2025. The quarterly and year-to-date increases were partially offset by lower costs from non-focus programs and positive effects from cost shares with BioNTech’s collaboration partners.

Adjusted R&D expenses were €477.1 million for the second quarter of 2026, compared to €509.1 million. Year-to-date adjusted R&D expenses were €1,004.2 million, compared to €1,034.7 million. Adjusted R&D expenses for both the second quarter and year-to-date period in 2026 exclude impairment losses of intangible assets.

Sales, general and administrative ("SG&A") expenses were €197.8 million for the second quarter of 2026, compared to €137.4 million. Year-to-date SG&A expenses were €348.6 million, compared to €258.0 million. The increases in both quarterly and year-to-date were mainly driven by the ongoing pre‑launch activities and commercial build-up, the inclusion of operations from CureVac, and expenses associated with BioNTech’s global initiative on scaling processes and ERP infrastructure to strengthen operational execution. This was partly offset by cost reductions resulting from the execution of initiatives related to BioNTech’s pipeline prioritization and increased cost discipline.

Other operating result was negative €207.9 million for the second quarter of 2026, compared to negative €39.0 million. Year-to-date other operating result was negative €224.3 million, compared to negative €25.9 million. Both quarterly and year-to-date decreases were primarily driven by higher expenses in connection with BioNTech’s pipeline prioritization.

Adjusted other operating result was negative €23.3 million for the second quarter of 2026, compared to negative €1.2 million. Year-to-date adjusted other operating result was negative €32.3 million, compared to negative €3.1 million. Adjusted other operating results for both the second quarter and year-to-date periods in 2026 and 2025 exclude employee-related costs and impairment losses, both related to BioNTech’s pipeline prioritization.

Net loss was €820.8 million for the second quarter of 2026, compared to a net loss of €386.6 million. Year-to-date net loss was €1,352.7 million, compared to a net loss of €802.4 million.

Adjusted net loss was €562.3 million for the second quarter of 2026, compared to an adjusted net loss of €348.8 million. Year-to-date adjusted net loss was €1,056.9 million, compared to an adjusted net loss of €779.6 million.

Diluted loss per share was €3.24 for the second quarter of 2026, compared to a diluted loss per share of €1.60. Year-to-date diluted loss per share was €5.34, compared to a diluted loss per share of €3.33.

Adjusted diluted loss per share was €2.22 for the second quarter of 2026, compared to an adjusted diluted loss per share of €1.45. Year-to-date adjusted diluted loss per share was €4.17, compared to adjusted diluted loss per share of €3.23.

Cash, cash equivalents and security investments as of June 30, 2026 were €16,634.2 million, comprising €9,741.0 million in cash and cash equivalents, €5,035.1 million in current security investments disclosed as financial assets and €1,858.1 million in non-current security investments disclosed as financial assets.

Shares outstanding as of June 30, 2026 were 251,204,366, excluding 7,823,121 shares held in treasury.

In May 2026, BioNTech entered into a share repurchase program, pursuant to which the Company may purchase American Depositary Shares ("ADSs"), each representing one ordinary share of the Company, in the amount of up to $1.0 billion until and including May 6, 2027. During the second quarter of 2026, 1,693,056 ADSs were repurchased at an average price of $89.50 (€77.85), for total consideration of $151.6 million (€131.8 million).

"We are revising our full-year 2026 financial guidance in light of recently emerged external developments," said Ramón Zapata, Chief Financial Officer at BioNTech. "Our capital allocation strategy is delivering results: our financial position is strong, our share repurchase program is well underway, and we continue to make meaningful progress across our pipeline. Moving forward, we continue to execute on our strategy to turn BioNTech into a multi-product biopharmaceutical company by 2030."

Revised 2026 Financial Year Guidance5:

2026 FY Guidance (March 2026) 2026 FY Guidance (August 2026)
Revenues €2,000 – €2,300 million €1,600 – €1,900 million
BioNTech is revising its full-year 2026 financial guidance revenue range due to:

COVID-19 vaccine market
Softer than anticipated global COVID-19 vaccine demand
In Germany existing vaccine inventory will be used in the 2026 vaccination season
The timing of milestone-related revenues resulting from an out-licensed R&D program, which are no longer expected in 2026.
BioNTech continues to expect the majority of 2026 revenues to be realized in the second half of the year, specifically in the third quarter, when it also expects to recognize the €613 million Bristol Myers Squibb Company ("BMS") collaboration revenue.

Planned 2026 Financial Year Adjusted Expenses5:

2026 FY Guidance (March 2026) 2026 FY Guidance (August 2026)
Adjusted R&D expenses €2,200 – €2,500 million €2,000 – €2,300 million
Adjusted SG&A expenses3 €700 – €800 million €700 – €800 million
BioNTech now expects adjusted R&D expenses in the range of €2.0 billion to €2.3 billion. Adjusted SG&A expenses remain unchanged in the range of €700 million to €800 million.

This reflects BioNTech’s focus on optimizing its R&D resources and continued cost discipline as it prioritizes the development of its late-stage clinical pipeline. The Company expects these cost savings based on prioritization and optimization to continue into future years.

BioNTech’s strong balance sheet and continued cost discipline support the Company’s ability to invest strategically.

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

Corporate and Commercial Update for the Second Quarter 2026 and Post Period Events

On August 3, 2026, BioNTech announced that the Supervisory Board has appointed Guido Oelkers, Ph.D., to the Management Board as Chief Executive Officer ("CEO"), who will take office by February 1, 2027, at the latest, succeeding Prof. Ugur Sahin, M.D. Guido Oelkers is a seasoned CEO and strategic leader with over 30 years of experience in the biotechnology and pharmaceutical industries. He has a strong track record of transforming and scaling global organizations, driving sustainable growth through disciplined execution, focused capital allocation, and operational excellence. Throughout his career, Guido Oelkers has successfully built, prioritized and strengthened complex and innovative product portfolios across multiple areas, including oncology and immunology, while driving global business operations in key markets, notably in the United States. He will join BioNTech from the global Nasdaq Stockholm-listed biopharmaceutical company Swedish Orphan Biovitrum AB ("Sobi"), where he has served as CEO since 2017.
In May 2026, the Company held its Annual General Meeting ("AGM"). Shareholders approved expanding the Supervisory Board from six to eight members and adding additional expertise: Prof. Iris Löw-Friedrich, M.D., Ph.D., and Susanne Schaffert, Ph.D., were elected as new members of the Supervisory Board.
Variant-adapted COVID-19 Vaccine

BioNTech and Pfizer Inc. ("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 XFG variant-adapted monovalent COVID-19 vaccine for the 2026-2027 vaccination season.
In July 2026, BioNTech and Pfizer’s XFG variant-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").
Select Oncology Pipeline Updates

Next-Generation Immunomodulators and Combinations

Pumitamig (BNT327/BMS986545) is an investigational bispecific immunomodulator combining PD-L16 checkpoint inhibition with VEGF-A neutralization that is being developed in collaboration with BMS.

Pumitamig is currently being evaluated in seven pivotal trials across the ROSETTA clinical development program, with five new global clinical trials initiated in the first half of 2026 spanning triple-negative breast cancer, colorectal cancer, gastric cancer, and non-small cell lung cancer, including two NSCLC clinical trials in patients with unresectable stage III disease and advanced PD-L1 ≥ 50% disease, respectively.
A global Phase 2/3 clinical trial (ROSETTA Lung-02; NCT06712316) is ongoing to evaluate pumitamig in combination with chemotherapy compared to pembrolizumab and chemotherapy in patients with first-line NSCLC. The Phase 3 part of the trial is currently recruiting. In May 2026, data from the Phase 2 part of the trial was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting 2026. The data showed encouraging anti-tumor activity, with high response rates observed in both non-squamous and squamous NSCLC and across PD-L1 expression levels.
Pumitamig is also being evaluated in additional solid tumor indications, including first-line hepatocellular carcinoma ("HCC"), second-line glioblastoma ("GBM"), first-line pancreatic ductal adenocarcinoma ("PDAC") and first-line renal cell carcinoma ("RCC") in various Phase 1/2 and Phase 2 trials, both as monotherapy and in combination with standard of care.
BioNTech has several signal-seeking clinical trials ongoing evaluating pumitamig in novel/novel combinations with the Company’s proprietary assets. These trials will inform the dose selection for pumitamig and explore anti-tumor activity in multiple tumors for later-stage development. Multiple data readouts from these combinations are expected in 2026.
Gotistobart (BNT316/ONC-392) is a tumor microenvironment-selective regulatory T cell depletion candidate that targets CTLA-4 and is being developed in collaboration with OncoC4, Inc. ("OncoC4").

A global Phase 3 clinical trial (PRESERVE-003; NCT05671510) is ongoing to evaluate the efficacy and safety of gotistobart as monotherapy in patients with metastatic squamous NSCLC that progressed on previous platinum-based chemotherapy and PD-(L)1-inhibitor treatment.
In March 2026, updated data from the non-pivotal dose-confirmation stage, the first of two stages of the global Phase 3 clinical trial, were presented at the European Lung Cancer Congress ("ELCC"). Gotistobart demonstrated a clinically meaningful overall survival benefit (hazard ratio: 0.46) compared to standard of care chemotherapy and a manageable safety profile in patients with squamous NSCLC whose disease had progressed following anti-PD-(L)1 therapy and platinum-based chemotherapy.
Updated data from the Stage 1 of this trial are expected to be presented at the International Association for the Study of Lung Cancer ("IASLC") 2026 World Conference on Lung Cancer ("WCLC").
Based on current event accrual projections, the first interim analysis from Stage 2 of the two-stage Phase 3 clinical trial is expected in 2026.
A Phase 2 clinical trial (PRESERVE-004; NCT05446298) is being conducted to evaluate gotistobart in combination with pembrolizumab in patients with platinum-resistant ovarian cancer ("PROC").
In May 2026, data from the trial were presented at the ASCO (Free ASCO Whitepaper) Annual Meeting 2026. Gotistobart in combination with pembrolizumab demonstrated encouraging and durable antitumor activity in heavily pretreated patients with PROC.
Antibody-Drug Conjugates

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

A Phase 1/2 clinical trial (NCT05150691) is being conducted to evaluate trastuzumab pamirtecan 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 ("EC") is fully recruited.
In June 2026, additional data were presented from the Phase 2 portion of the trial at the ESMO (Free ESMO Whitepaper) Gynaecological Cancers Congress 2026 in Copenhagen, Denmark. Trastuzumab pamirtecan showed encouraging and durable anti-tumor activity and meaningful survival in patients with advanced HER2-expressing endometrial cancer. The safety profile was manageable and consistent with the known class effects of anti-HER2 ADCs.
A Phase 3 clinical trial (FERN-EC-01, NCT06340568) is being conducted to evaluate trastuzumab pamirtecan compared to investigator’s choice of chemotherapy in patients with advanced and HER2-expressing recurrent EC.
A Phase 3 clinical trial (DYNASTY-Breast02, NCT06018337) to evaluate trastuzumab pamirtecan in patients with HR-positive, HER2-low metastatic breast cancer is ongoing. Based on current event accrual projections, the primary analysis is expected in the fourth quarter 2026.
While BioNTech and DualityBio plan to file a biologics license application ("BLA") in 2026, the companies will determine the optimal regulatory path for trastuzumab pamirtecan based on the totality of clinical data in endometrial cancer and breast cancer. This approach is in line with the companies’ value-optimization strategy for the asset in an evolving treatment landscape and focuses on prioritizing opportunities where they can deliver significant benefit for patients.
Elfetabart drozuntecan (BNT324/DB-1311) is an ADC candidate targeting B7-H3 that is being developed in collaboration with DualityBio. More than one thousand patients have now been treated with elfetabart drozuntecan in clinical trials across more than ten tumor types, including 400 patients treated with elfetabart drozuntecan in combination with pumitamig.

In May 2026, a Phase 3 clinical trial (NCT07365995) to evaluate elfetabart drozuntecan compared to docetaxel in patients with metastatic castration-resistant prostate cancer ("mCRPC") was initiated.
Upcoming Investor and Analyst Events

BioNTech Third Quarter 2026 Financial Results and Corporate Update: November 3, 2026
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, 2026, 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 2026.

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.

(Press release, BioNTech, AUG 4, 2026, View Source [SID1234669684])