On August 20, 2026 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported it will present new clinical data from its diversified development program in lung cancer treatment at the IASLC 2026 World Conference on Lung Cancer ("WCLC") in Seoul, Republic of Korea, from September 12-15, 2026.

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The breadth of data highlights the latest progress across key strategic assets, pumitamig (BNT327/BMS986545) and gotistobart (BNT316/ONC-392), as well as BioNTech’s mRNA-based immunotherapy approaches, highlighting the strength of BioNTech’s lung cancer treatment pipeline. Additionally, a late breaking oral presentation will detail data from the novel-novel combination trial of pumitamig with the investigational B7H3-targeted antibody-drug conjugate ("ADC") elfetabart drozuntecan (elfe-D or BNT324/DB-1311), representing the first combination data for any PD-(L)1xVEGF bispecific immunomodulator and an ADC in lung cancer.

"Progress in lung cancer care means both improving treatment outcomes for patients and, importantly, finding better options for more patients who still do not sufficiently benefit from current standard therapies," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "The data we are presenting at this year’s WCLC provide further clinical evidence for our late-stage assets, gotistobart and pumitamig, and help to define the role of next-generation immunomodulators in addressing unmet medical needs in lung cancer. We are also presenting the first clinical evidence from a novel-novel treatment combination in lung cancer as part of our evaluation of pumitamig as a potential backbone for combination strategies of complementary mechanisms. Taken together, these data will inform the next steps in our clinical development programs and our broader efforts to expand treatment options for patients."

Highlights from BioNTech’s presentations at WCLC 2026:

Novel-novel combination trial of pumitamig, developed in collaboration with Bristol Myers Squibb Company ("BMS"), and elfetabart drozuntecan, developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. ("DualityBio"):
•Advanced/metastatic SCLC and NSCLC: First data from the global Phase 1/2 trial (NCT06892548) evaluating pumitamig in combination with the B7H3-targeting ADC elfetabart drozuntecan in patients with advanced or metastatic small cell lung cancer ("SCLC") and NSCLC will be presented for this novel-novel treatment combination approach, underlining BioNTech’s leadership in novel-novel combination treatment strategies.

Gotistobart – a tumor microenvironment-selective regulatory T cell depletion candidate targeting CTLA-4, developed in collaboration with OncoC4, Inc. ("OncoC4"):

•2L+ squamous NSCLC: Updated overall survival data from stage 1 of the PRESERVE-003 Phase 3 clinical trial (NCT05671510) of gotistobart in patients with squamous non-small cell lung cancer ("NSCLC") who progressed on prior PD-(L)1 inhibitor treatment will be presented. The results further contribute to the growing body of evidence for this chemotherapy-free treatment approach. The pivotal stage 2 part of the trial is ongoing.

All abstracts are available through the WCLC website. Further information on BioNTech’s lung cancer pipeline can be accessed here.

Full presentation details:

Candidate
Abstract Title
Abstract Number/Presentation Details
Pumitamig + elfetabart drozuntecan
Pumitamig (PD-L1 x VEGF-A bsAb) + Elfetabart Drozuntecan (Elfe-D, B7H3 ADC) in Patients with Advanced/Metastatic Lung Cancer (NSCLC or SCLC)
Abstract # OA14.01
Oral Presentation
The Breakthrough Immunotherapy for Advanced NSCLC
Sep 15, 2026: 12:30 – 01:45pm KST
Pumitamig
First-line Pumitamig (PD-L1 × VEGF-A bsAb) Plus Chemotherapy in Unresectable Malignant Mesothelioma: Long-term PFS and OS
Abstract #MO04.09
Mini Oral
Novel Therapeutics and Molecular Insights in Thymic Malignancies and Pleural Mesothelioma
Sep 13, 2026: 4:45 – 6:00pm KST
ROSETTA Lung‑201: A Phase 3 Trial of Pumitamig Monotherapy vs Durvalumab in Unresectable Stage III NSCLC Post-Chemoradiation
Abstract #P2.330
Poster
Clinical Trials in Progress
Sep 14, 2026: 10:30am – 12:00pm KST
ROSETTA Lung-202: A Phase 3 trial of first-line pumitamig monotherapy vs pembrolizumab in locally advanced/metastatic NSCLC
Abstract #P2.355
Poster
Clinical Trials in Progress
Sep 14, 2026: 10:30am – 12:00pm KST
Gotistobart
Gotistobart vs Docetaxel in Metastatic Squamous NSCLC After PD-(L)1 Progression: Updated Overall Survival of the stage 1 of PRESERVE-003
Abstract #MO07.04
Mini Oral
Novel Immunotherapeutic Strategies in mNSCLC
Sep 14, 2026: 5:00 – 6:15pm KST
BNT116
Neoadjuvant BNT116 + Cemiplimab + Carboplatin + Paclitaxel in Resectable NSCLC: Preliminary Results From a Phase I Trial
Abstract #MO06.03
Mini Oral
Emerging Precision Approaches in Perioperative Therapy for Resectable NSCLC Integrating Targeted Therapy, Immunotherapy, Biomarkers, and Multimodal Strategies
Sep 14, 2026: 3:30 – 4:45pm KST

About BioNTech in Lung Cancer Treatment
Lung cancer is one of BioNTech’s key focus areas. Through a diversified portfolio of investigational next-generation immunomodulators, ADCs and mRNA-based cancer immunotherapies, the Company is pursuing multiple approaches designed to address significant unmet needs for patients across lung cancer subtypes, histologies and treatment settings. BioNTech’s clinical pipeline encompasses both monotherapies and combinations with standard of care treatments, as well as novel-novel combination regimens aimed at delivering differentiated therapeutic profiles for the treatment of patients with lung cancer. With 16 ongoing lung cancer trials, including five pivotal Phase 3 and two novel-novel combination trials, BioNTech is advancing a comprehensive development strategy with the aim of improving outcomes for patients across the continuum of lung cancer.

(Press release, BioNTech, AUG 20, 2026, View Source [SID1234670248])

On August 20, 2026 Artelo Biosciences, Inc. (Nasdaq: ARTL) ("Artelo" or the "Company"), a clinical-stage pharmaceutical company focused on modulating lipid-signalling pathways to develop treatments for people living with cancer, pain, dermatologic, or neurological conditions, reported that the Japanese Patent Office has issued a notification of allowance with a Decision to Grant for the Company’s patent application covering the intended commercial formulation of ART27.13, Artelo’s peripherally selective dual cannabinoid agonist currently being evaluated in two Phase 2 clinical trials.

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The allowed claims in Japan protect compositions of ART27.13 dispersed in polyethylene glycol. These claims are consistent with those previously allowed in the United States and Europe, and all jurisdictions are expected to provide patent protection through 2041. This brings Artelo’s intellectual property estate for ART27.13 to issued or allowance status in three major pharmaceutical markets, the United States, Japan, and Europe, and further strengthens the program’s global IP position while supporting its long-term commercial potential.

"Receiving this allowance decision in Japan represents another important advancement in our global intellectual property and clinical development strategy for ART27.13," said Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences. "The innovator of our investigational drug, AstraZeneca, previously conducted a Phase 1 safety study with ART27.13 in Japan, with no major safety or tolerability concerns, and had concluded the plasma exposure and adverse event profiles were comparable between Japanese and Caucasian participants." ART27.13 was fully licensed to Artelo in 2019.

Currently being evaluated in the Phase 2 portion of CAReS targeting cancer-related anorexia, ART27.13 was well-tolerated in the Phase 1 stage and showed early signs of stabilizing or reversing weight loss in more than 60% of participants. Interim results from the CAReS Phase 2 demonstrated the ability of the drug to reverse cancer-related anorexia in all patients taking the highest dose of 1300 µg whereas the all the participants on placebo continued to lose weight throughout the study.

ART27.13 is also being evaluated in the DREAM study, a pilot Phase 2 in people with glaucoma or ocular hypertension. Funded by Glaucoma UK and the HSC R&D Division in the UK, the investigator-led study is evaluating ART27.13’s potential at a 600 µg orally administered daily dose to reduce intraocular pressure, alongside additional assessments of visual acuity, body weight, mood, safety and tolerability. Initial results are anticipated in the fourth quarter of this year.

"With allowances now secured in the United States, Europe and Japan for claims covering our intended commercial formulation, we believe we have established a strong foundation for ART27.13 across three of the world’s major pharmaceutical markets. This growing patent estate further enhances the strategic and commercial value of the program as ART27.13 advances in multiple potential indications," concluded Mr. Gorgas.

About ART27.13
ART27.13 is a dual cannabinoid agonist and novel benzimidazole derivative. Initially developed by AstraZeneca plc, ART27.13 has been in over seven clinical studies with nearly 300 participants. It is primarily being developed as a once-daily, orally administered agent selectively targeting peripheral CB1 and CB2 receptors, with the potential to reduce muscle degeneration while improving body weight, appetite, and quality of life in cancer patients. Importantly, the drug enables systemic metabolic effects while minimizing central nervous system-mediated toxicity. Artelo is conducting a Phase 2 named the Cancer Appetite Recovery Study (CAReS) evaluating ART27.13 as a supportive care therapy for cancer patients suffering from anorexia and weight loss. Interim Phase 2 data revealed patients who had lost at least 5% of body weight to be included in CAReS and titrated to the highest ART27.13 dose (1300 µg) achieved an average +6% weight gain over 12 weeks, while patients on placebo lost an additional ~5%. Currently, there is no FDA approved treatment for cancer anorexia cachexia syndrome. In addition to CAReS, ART27.13 is also being evaluated in a Phase 2 study in people with glaucoma, called the DREAM study. In DREAM, ART27.13 is administered orally at a daily dose of 600 µg.

(Press release, Artelo Biosciences, AUG 20, 2026, View Source [SID1234670265])

On August 20, 2026 BioOra Limited reported a commercial manufacturing supply agreement with Miltenyi Biotec, a global leader innovating technologies and services for patient-specific cell and gene therapies. Under the agreement, Miltenyi Biotec’s CDMO division, Miltenyi Bioindustry, will provide commercial manufacturing and supply of lentiviral vectors for atlacabtagene autoleucel (Atla-cel), BioOra’s lead CD19-directed CAR T cell therapy. The agreement builds on a long-standing relationship between the two companies and supports the therapy’s continued development and potential commercialization.

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Atla-cel, currently in Phase II clinical development, is a third-generation autologous CD19-targeted CAR T therapy being developed for patients with B-cell non-Hodgkin lymphoma and other B-cell malignancies. Originating from research at the Malaghan Institute of Medical Research, the therapy has generated encouraging early clinical results and is advancing into registration-directed clinical development. John Robson, our Managing Director at BioOra, said:"BioOra was established to expand patient access to CAR T therapies through a scalable manufacturing approach. Partnering with Miltenyi Biotec strengthens our ability to deliver novel therapies such as Atla-cel to patients while supporting our long-term vision of building a globally relevant cell therapy manufacturing ecosystem from New Zealand."

Miltenyi Biotec will produce the lentiviral vectors for Atla-cel at its FDA-approved facility in Gaithersburg, Maryland. Since receiving approval in 2024, the site has delivered more than 500 GMP batches at 50L and 200L scale, supporting more than 100 clinical trials across 28 countries. "As Atla-cel advances toward pivotal development, we are pleased to contribute the expertise, quality standards, and supply reliability needed to help bring innovative therapies to patients," said Boris Stoffel, Managing Director of Miltenyi Biotec.

About Atla-cel
Atla-cel is a third-generation autologous CD19-targeted CAR T cell therapy being developed for the treatment of B-cell malignancies, including B-cell non-Hodgkin lymphoma. Developed initially by the Malaghan Institute of Medical Research and commercialized through BioOra, Atla-cel is designed to combine potent anti-tumor activity with an improved tolerability profile while enabling more efficient manufacturing and delivery of therapy. The program has completed initial clinical evaluation and is advancing through registration-directed development.

(Press release, BioOra, AUG 20, 2026, https://bioora.com/our-stories/miltenyi-biotec-to-support-commercial-manufacturing-of-biooras-cd19-car-t-therapy-candidate-atla-celnbsp [SID1234670249])

On August 20, 2026 Adagene Inc. (Nasdaq: ADAG) a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, reported that senior management will participate in three upcoming investor conferences taking place in New York, New York.

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2026 Cantor Global Healthcare Conference; New York, NY – September 9-11, 2026

Format: 1×1 Meetings
Date/Time: September 11, 2026
Morgan Stanley 24th Annual Global Healthcare Conference; New York, NY – September 14-16, 2026

Format: Fireside Chat and 1×1 Meetings
Fireside Chat Date/Time: September 15, 2026, 10:45–11:20 AM (Eastern Time)
H.C. Wainwright 28th Annual Global Investment Conference; New York, NY – September 14-16, 2026

Format: Fireside Chat and 1×1 Meetings
Fireside Chat Date/Time: September 16, 2026, 9:00–9:30 AM (Eastern Time)
If you are interested in meeting with Adagene management during the conferences, please reach out to your representative for each respective conference.

Webcasts of the fireside chats will be accessible in the Investors section of the Company’s website at View Source for at least 30 days following each of the conferences.

(Press release, Adagene, AUG 20, 2026, View Source [SID1234670266])

On August 20, 2026 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology platform, reported business update and announces second quarter 2026 financial results.

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Business highlights (since last quarterly update)
Evaxion is making steady progress towards completing its strategic milestones for 2026. Highlights include:

Announcing the upcoming presentation of three-year clinical data for personalized cancer vaccine candidate EVX-01 at the ESMO (Free ESMO Whitepaper) Congress 2026
Presentation of new data for EVX-04, an off-the-shelf cancer vaccine for acute myeloid leukemia (AML)
Expansion and refocusing of our R&D pipeline with EVX-05, a novel off-the-shelf therapeutic cancer vaccine program for glioblastoma
Presentation of new data for cytomegalovirus (CMV) vaccine candidate EVX-V1
Winning the 2026 Prix Galien UK Award for Best digital health solution for AI-Immunology
Cash runway unchanged with cash at hand to fund operations into the second half of 2027
"Progress remains strong in recent months, particularly regarding the expansion and progression of our R&D pipeline. Both EVX-04 and EVX-05 represent completely new concepts in targeting hard-to-treat cancers and are great examples of what we can do with AI-Immunology to identify novel, conserved cancer targets for off-the-shelf vaccines. The same is true for EVX-V1 in the infectious disease space and we are excited by the successful progress of this next-generation, multi-component CMV-vaccine program. These programs and the combined R&D pipeline show how our AI-Immunology platform can truly deliver product candidates, which is crucial in validating our platform and for partnerships," says Helen Tayton-Martin, CEO of Evaxion.

Conference call and webcast
Evaxion’s executive management will host a conference call and webcast at 8.30 ET/14.30 CET today, presenting the business update and financial results as well as taking questions.

To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique PIN code. The call can be accessed 15 minutes prior to the start of the live event.

To join the webcast, please click on this link. The webcast recording will be available on our website shortly after the event.

Research & Development (R&D) update
Evaxion has a R&D pipeline of innovative vaccine candidates for both cancer and infectious diseases. In future, this is expected to be supplemented by programs for autoimmune diseases following application of AI-Immunology in this space in the second half of 2026.

We are looking forward to presenting three-year clinical efficacy data for personalized cancer vaccine EVX-01, our most advanced pipeline asset, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026 in October.

Developed with AI-Immunology, EVX-01 is designed to target multiple neoantigens; cancer unique proteins arising from mutations. We completed the initially planned two-year treatment in the phase 2 trial with EVX-01 in patients with advanced melanoma (skin cancer) last year with unprecedented results presented at ESMO (Free ESMO Whitepaper) in 2025.

Following on with a one-year extension of the phase 2 trial, the upcoming data will provide additional insights into potentially enhanced treatment effects and durability of the EVX-01-induced immune response. It will also offer insights into the vaccine’s effect also as stand-alone treatment of these patients with advanced melanoma, in comparison to the prior administration in combination with pembrolizumab in the first two years of the trial.

In addition to the personalized approach, we are leveraging AI-Immunology’s capabilities to develop novel off-the-shelf cancer vaccines, including EVX-04 targeting AML. Developed with AI-Immunology, EVX-04 targets multiple non-conventional endogenous retrovirus (ERV) tumor antigens from the dark genome.

ERV antigens are present in tumors but absent in normal tissue, making them highly attractive targets for cancer vaccines. AI-Immunology has unique capabilities in identifying ERVs and this opens a whole new source of antigens, which can potentially greatly improve patient outcomes.

We are progressing preclinical activities with EVX-04 as planned and presented new data at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress. The data demonstrates EVX-04’s complete expression in human cells, including correct transcription and translation. Further, EVX-04 is secreted in human cells, enabling immune recognition and activation.

The data also shows that all ERV antigens included in EVX-04 drive specific immune responses both in mice (in vivo) and human cells (in vitro) across different human immune profiles. These vaccine-induced immune cells mediate targeted cell-killing, highlighting EVX-04’s potential as a new effective therapeutic cancer vaccine.

In parallel with preclinical studies, we are preparing the regulatory filing for clinical testing of EVX-04, which is expected to be submitted before the end of the year.

We have also leveraged our capabilities to identify clinically relevant ERVs to expand our pipeline with EVX-05, a novel off-the-shelf cancer vaccine candidate for the deadly brain cancer glioblastoma.

Partly based on data analysis done in collaboration with leading experts from Duke University School of Medicine, EVX-05 targets endogenous retrovirus (ERV)-derived antigens shared between glioblastoma patients. The use of such antigens could potentially be highly effective for glioblastoma patients, who generally have few neoantigens to target due to low mutational burden.

We also carry out preclinical activities for infectious disease programs and presented new data for CMV vaccine program EVX-V1 at the International Herpesvirus Workshop 2026 in July. EVX-V1 is a next-generation, multi-component CMV vaccine program designed with AI-Immunology. It combines novel AI-Immunology identified protective B-cell antigens and T-cell epitopes complemented by known optimized structural B-cell antigens.

This broader multi-targeted strategy is expected to strengthen the protective potential of a future vaccine. The concept represents a scalable strategy for rational vaccine development across other herpesviruses. The new data demonstrates the potential to improve control of acute infection, latency, and viral reactivation, further supporting the concept behind EVX-V1.

Business development update
We remain active in several parallel partnership discussions based on external interest in both our AI-platform and R&D pipeline as we continue to pursue our strategy of strengthening our platform and building value through multiple partnerships.

We were honored to receive the Prix Galien UK Award for Best digital health solution for AI-Immunology in June. The award is another strong external validation and recognition of the AI-Immunology platform and as such supporting our partnering efforts, alongside the new data we continuously generate to further validate the fact that AI-Immunology is a platform that deliver product candidates. This is an important proposition to potential business partners.

Second quarter 2026 financial results
The financial results for the second quarter 2026 were in line with expectations with a net loss of $3.7 million, compared to $3.6 million in the first quarter 2026 and $4.8 million in the second quarter 2025. The reduced loss compared to same period last year primarily relates to lower capital market transaction costs and financial expenses from significantly reduced derivative liability.

Research and development (R&D) expenses were $2.3 million for the second quarter 2026, aligned with first quarter 2026, and a slight increase compared to second quarter last year, as we progress our pipeline according to plan.

General and administrative (G&A) expenses were $1.5 million for the quarter, which was at same level with first quarter 2026, and compared to $2.2 million in second quarter 2025. Compared to last year the reduced cost is primarily driven by lower capital market costs.

Net financial expense of $0.1 million for the second quarter 2026 compared to net financial expense of $0.7 million same quarter last year, a reduction of net expense mainly due to reduced derivative liability and the thereof related remeasurement.

Cash and cash equivalents as of June 30, 2026, were $14.0 million, compared to $18.4 million as of March 31, 2026, and confirm our current cash runway until second half of 2027.

Total equity amounts to $9.5 million as of June 30, 2026, reflecting the net loss of the first six months of 2026 when compared to $17.0 million as of December 31, 2025.

Evaxion A/S
(Unaudited) Consolidated statement of financial position data
(USD in thousands)

Jun 30,
2026 Dec 31,
2025
Cash and cash equivalents 14,000 23,234
Total assets 19,380 28,408
Total liabilities 9,849 11,369
Share capital 15,791 15,791
Other reserves 127,343 127,492
Accumulated deficit (133,603) (126,244)
Total equity 9,531 17,039
Total liabilities and equity 19,380 28,408

Evaxion A/S
(Unaudited) Consolidated statement of comprehensive loss data
(USD in thousands, except per share data)

Three Months Ended
June 30, Six Months Ended
June 30,
2026 2025 2026 2025
Revenue - 37 - 37
Research and development (2,334) (2,165) (4,631) (4,321)
General and administrative (1,512) (2,212) (3,034) (3,924)
Operating loss (3,846) (4,340) (7,665) (8,208)
Finance income 147 546 405 4,305
Finance expenses (234) (1,232) (519) (2,895)
Net loss before tax (3,933) (5,026) (7,779) (6,798)
Income tax benefit 204 195 420 387
Net loss for the period (3,729) (4,831) (7,359) 6,411
Net loss attributable to shareholders of Evaxion A/S (3,729) (4,831) (7,359) 6,411
Loss per share – basic and diluted (0.01) (0.02) (0.02) (0.02)
Number of shares used for calculation (basic and diluted) 417,010,756 315,828,608 417,010,756 275,434,522

(Press release, Evaxion, AUG 20, 2026, View Source [SID1234670250])