On August 20, 2026 Zelluna (OSE: ZLNA), a clinical-stage company pioneering allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for the treatment of solid cancers, reported its results for the second quarter 2026.

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!

Webcast scheduled for 20 August 2026 at 09:00 (CEST). Link to webcast here.

Operational Highlights:

First patient dosed with ZI-MA4-1: On 13 July 2026, Zelluna announced the dosing of the first patient in the Phase 1 ZIMA-101 study, marking the first clinical evaluation of the Company’s proprietary TCR-NK platform. ZI-MA4-1 is the world’s first MAGE-A4-targeting TCR-NK therapy to enter clinical testing. Patient recruitment is ongoing at two clinical sites in the UK.
Favourable initial safety observations support continued enrolment: On 17 August 2026, the Independent Data Monitoring Committee (IDMC) completed its planned safety review of the first patient. ZI-MA4-1 was well tolerated during the protocol-defined safety observation period, with no dose-limiting toxicities observed. The IDMC recommended recruitment of the remaining two patients at Dose Level 1. These observations represent the first clinical data from ZIMA-101.
The Royal Marsden activated as second clinical site: On 29 June 2026, Zelluna announced that The Royal Marsden NHS Foundation Trust had been activated as the second clinical site in the ZIMA-101 Phase 1 clinical trial. Together with The Christie NHS Foundation Trust, the two sites provide a strong clinical foundation for patient recruitment and execution of the ZIMA-101 study.
Private placement and retail offering successfully completed: In June 2026, Zelluna successfully completed a private placement and retail offering, raising gross proceeds of approximately NOK 58.2 million through the issuance of 3,143,958 new shares at a subscription price of NOK 18.50 per share. The financing strengthens Zelluna’s position as the Company approaches initial clinical data, supports the continued execution of the ZIMA-101 clinical trial, and enhances financial flexibility to pursue future strategic opportunities.
NOK 16 million grant awarded by the Research Council of Norway: In June 2026, the Research Council of Norway approved a NOK 16 million grant to Zelluna under the Innovation Project for the Industrial Sector (IPN) scheme. The funding will support the ongoing Phase 1 ZIMA-101 clinical study.
ZIMA-101 to be presented at ESMO (Free ESMO Whitepaper) 2026: In July 2026, an abstract describing the ongoing ZIMA-101 Phase 1 study of ZI-MA4-1 was accepted for poster presentation at the ESMO (Free ESMO Whitepaper) Congress 2026 in Madrid on 23–27 October 2026. The poster will be presented by Professor Fiona Thistlethwaite, Chief Investigator of the study at The Christie NHS Foundation Trust.
Notice of EGM – election of new Board member: On 17 August 2026, the Board called for an Extraordinary General Meeting regarding election of a new member of the Board. The Nomination Committee has proposed Martin Welschof for election as a new member of the Board, whilst Hans Ivar Robinson, who has served on the Board since its foundation, has decided to step down from the Board in line with Birk Venture’s approach of transitioning out of board positions within a reasonable period following a listing.
Financial Highlights Q2 2026:

Total operating expenses: MNOK 19.9 in Q2 2026 and MNOK 40.2 YTD
Total loss: MNOK 19.7 in Q2 2026 and MNOK 40.1 YTD
Cash and cash equivalents: MNOK 86.2 as of 30 June 2026
Financial runway: Into Q3 2027
"The second quarter and the period immediately following it have been defining for Zelluna. We set out to establish the clinical infrastructure for ZIMA-101, bring ZI-MA4-1 into the clinic and begin generating the first clinical data from our TCR-NK platform, and we have delivered on those objectives.

The first patient has now been treated, and we have reported favourable initial safety observations, with the independent monitoring committee recommending continued enrolment. I am incredibly proud of what our team has achieved. Our focus now is on continuing to execute ZIMA-101, generating the clinical data that will begin to define the potential of our TCR-NK platform, and continuing to build the pipeline that can extend that potential beyond ZI-MA4-1," says CEO Namir Hassan.

Outlook

Zelluna enters the second half of 2026 with strong momentum following the initiation of the ZIMA-101 first-in-human Phase 1 study and the Independent Data Monitoring Committee’s recommendation to continue enrolment after its review of the first patient’s safety data. With both clinical sites now activated, patient recruitment is ongoing and ZIMA-101 is progressing as planned. In parallel, Zelluna continues to strengthen its manufacturing capabilities to support the future development of ZI-MA4-1 and the broader TCR-NK platform. The Company remains focused on disciplined execution and the generation of high-quality clinical data to advance ZI-MA4-1 and its broader TCR-NK platform. Zelluna’s cash position is expected to fund planned operations into the third quarter of 2027, providing a solid foundation to execute its strategy and pursue future value-creating opportunities.

The quarterly report and presentation materials will be made publicly available on the Zelluna website at 07:00 CEST on 20 August 2026. The Company will host a webcast on 20 August at 09:00 CEST, and questions can be submitted during the event. The webcast recording will remain available on the Company’s website after the event.

(Press release, Zelluna Immunotherapy, AUG 20, 2026, View Source [SID1234670229])

On August 19, 2026 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported it will webcast management participation as follows:

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!

2026 Wells Fargo Healthcare Conference at 8:45 a.m. ET on Wednesday, September 9, 2026
Morgan Stanley 24th Annual Global Healthcare Conference at 1:05 p.m. ET on Monday, September 14, 2026
Bernstein Insights: Healthcare Leaders and Disruptors – 3rd Annual Healthcare Forum at 10:30 a.m. ET on Wednesday, September 23, 2026

The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays and transcripts of the webcasts will be archived on the Company’s website for at least 30 days.

(Press release, Regeneron, AUG 19, 2026, View Source [SID1234670244])

On August 19, 2026 Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) ("Biodexa" or "the Company"), a clinical stage biopharmaceutical company developing innovative products focused on the treatment or prevention of gastrointestinal cancers reported that it has exceeded the half-way point in the recruitment of subjects in its registrational Phase 3 trial of eRapa in Familial Adenomatous Polyposis (FAP), NCT06950385. As of today, 87 of a planned 168 subjects have been recruited into the Serenta trial. The trial is recruiting at 29 clinical sites across the US and five countries in Europe with a further three sites in Canada expected to be initiated shortly.

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!

The Company is planning a futility analysis after 25 Progression Free Survival (PFS) events and database lock after 75 PFS events in the Serenta trial. The Serenta protocol includes a composite endpoint which defines the nature of the PFS events.

Commenting, Stephen Stamp, Chief Executive Officer of Biodexa said "I should like to thank our collaborators at the leading FAP treatment centers who have helped drive recruitment in Serenta and put us ahead of any competition."

About Familial Adenomatous Polyposis

FAP is characterized by the proliferation of polyps in the colon and/or rectum, usually occurring in mid-teens. There is no approved therapeutic option for treating FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. If untreated, FAP typically leads to cancer of the colon and/or rectum. There is a significant hereditary component to FAP with a reported incidence of one in 5,000 to 10,000 in the US and one in 11,300 to 37,600 in Europe. eRapa has received Orphan Drug Designation in the US and in Europe. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP.

About eRapa
eRapa is a proprietary oral capsule formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorigenesis. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP. Data from an open label Phase 2 trial were presented at Digestive Disease Week and InSIGHT 2024 in May and June 2024, respectively. Based on those data, Biodexa initiated a double-blind, placebo-controlled Phase 3 registrational trial which is planned to initiate 30 clinical sites across the US and Europe and to enrol 168 subjects randomized 2:1, drug: placebo. The Phase 3 program is supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas.

(Press release, Biodexa Pharmaceuticals, AUG 19, 2026, View Source [SID1234670243])

On August 19, 2026 Alvotech (NASDAQ: ALVO; ALVO-SDB) ("Alvotech" or the "Company"), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, reported financial results for the first half of 2026 and provided a business update.

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 supplemental long‑form earnings release and management presentation providing additional details and business update is available on our website: View Source1" target="_blank" title="View Source1" rel="nofollow">View Source

H1 2026 financial highlights

Adjusted total revenue2 was $211.9 million compared to $306.1 million in the same period last year.
Gross Margin of 54% was broadly level with the same period last year.
Adjusted EBITDA2 was $46.9 million compared to $53.7 million in the same period last year.
Cash-balance at the end of the period was $142.8 million compared to $172.4 million on December 31, 2025.

USD millions – adjusted financial measures2 H1 2026 H1 2025 Change %
Product and Service Revenue 105.9 204.7 -48.3%
License and Other Revenue 105.7 101.4 4.4%
Other Income 0.2 0.1 49.7%
Total revenue 211.9 306.1 -30.8%
Gross margin 54% 55%
EBITDA 46.9 53.7 -12.7%

Q2 2026 business highlights

Alvotech resubmitted US Biologics License Applications for AVT05, proposed biosimilar to Simponi and Simponi Aria and AVT06, proposed biosimilar to Eylea, following the comprehensive responses to the US Food and Drug Administration’s (FDA) Post-Application Action Letter (PAAL).
Alvotech’s partner, Dr. Reddy’s Laboratories, resubmitted the US Biologics License Application for AVT03, proposed biosimilar to Prolia/Xgeva.
FDA confirmed review completion goal dates in alignment with the standard 6-month process, with decisions anticipated in the fourth quarter of 2026.
FDA closed its inspection of the company’s manufacturing facility in Reykjavik, conducted in April-May 2026, and confirmed a VAI classification.
Alvotech closed an underwritten public offering and private placement, generating gross proceeds of approximately $165 million that will be used for continued pipeline development, working capital and general corporate purposes.
Liquidity was further strengthened by a new term loan facility of $75 million with funds managed by GoldenTree Asset Management LP.

Comments by Lisa Graver, CEO:

"During the first half, we continued to advance our strategic priorities, including significant improvements to our manufacturing facility and quality systems. This work enabled the resubmission in June of our U.S. applications for AVT05 and AVT06 alongside our partner’s resubmission of AVT03. This was an important inflection point as we work towards FDA approvals in the fourth quarter of 2026. The FDA also formally closed its recent routine cGMP surveillance inspection of our facility with a VAI classification.

"We have also continued to advance our pipeline, including the FDA acceptance of our BLA for AVT16, our proposed interchangeable biosimilar to Entyvio, and validation by the EMA of the European applications for AVT16 and AVT80. We believe we are well positioned for the next wave of product launches.

"The manufacturing improvement program affected output and product availability during the first half, which was reflected in our revenues and adjusted EBITDA. Manufacturing returned to planned operating levels at the end of the second quarter, and we are building supply to meet confirmed demand. We expect this to support strengthening financial performance as we move through the second half of the year. Importantly, underlying commercial demand for products remains strong, both in the U.S. and Europe.

"We enter the second half with five biosimilars now contributing to product revenue, and important regulatory catalysts ahead. The strong support received from existing and new investors in our recent equity financing, together with the new term loan facility, further strengthens our financial position as we execute on the significant opportunities that lie ahead."

Outlook for 2026 full year

Management anticipates total revenues to be in the range of $650-$700 million and adjusted EBITDA to be in the range of $180-220 million in 2026.

Invitation to management presentation

Join us to listen to the live audio webcast at 8:00 AM EST (12:00 GMT, 13:00 CET) on Thursday, August 20, 2026. All materials for the webcast are available at View Source

The audio webcast will be accessible via the following link:
View Source

To participate via telephone in the Q&A session, register using this link:
View Source

(Press release, Alvotech, AUG 19, 2026, View Source [SID1234670242])

On August 19, 2026 Ascentage Pharma Group International (Ascentage Pharma) (NASDAQ: AAPG; HKEX: 6855) (referred hereinto as "Ascentage Pharma," the "Company," "we," "us" or "our"), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, reported its unaudited financial results for the six months ended June 30, 2026, and provided updates on key ongoing clinical programs and commercial activities.

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!

Dr. Dajun Yang, Chairman and Chief Executive Officer of Ascentage Pharma, said, "During the first half of 2026, we continued to execute on our key strategic priorities while expanding our global footprint. The appointments of Dr. Faiçal Miyara as Chief Business Officer and Mr. Jim Ziegler as Chief Commercial Officer further strengthen our strategic capabilities and commercial leadership as we continue building a global commercial-stage oncology company."

Key Commercial Product and Pipeline Updates

Olverembatinib (HQP1351) is a novel, third-generation TKI and the first third-generation BCR-ABL1 TKI approved in China for treatment of patients with chronic myeloid leukemia (CML) in chronic-phase (-CP) or CML in accelerated phase (-AP) with T315I mutations, and in CML-CP that is resistant and/or intolerant to first and second-generation TKIs.

Commercial progress

The number of Direct-to-Patient (DTP) pharmacies and hospitals where Olverembatinib is on the formulary reached 879 as of June 30, 2026, a 12% increase compared to 782 as of June 30, 2025. In particular, the number of hospitals where Olverembatinib is on the formulary increased by 34% over the same period, to 394 hospitals as of June 30, 2026, from 295 hospitals as of June 30, 2025.

Clinical progress

Enrollment continues in an FDA and EMA-cleared global registrational Phase III clinical trial of Olverembatinib in combination with chemotherapy versus investigator-choice TKI in combination with chemotherapy in patients with newly diagnosed Philadelphia chromosome positive ALL (Ph+ ALL) (POLARIS-1).

Enrollment continues in an FDA and EMA-cleared global registrational Phase III clinical trial of Olverembatinib for previously treated CML-CP patients, both with and without the T315I mutation (POLARIS-2).

Enrollment continues in a multinational registrational Phase III clinical trial of Olverembatinib for the treatment of patients with succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) who have not responded to prior systemic treatment (POLARIS-3).

Continue to evaluate Olverembatinib in combination with the Bcl-2 inhibitor Lisaftoclax in early-phase clinical trials.

Upcoming milestones

Continue to advance enrollment in the POLARIS-1, POLARIS-2, and POLARIS-3 trials.

Lisaftoclax (APG-2575) is a novel, oral B-cell lymphoma 2 (Bcl-2) inhibitor developed to treat a variety of hematologic malignancies and solid tumors by selectively blocking Bcl-2 to restore the normal apoptosis process in cancer cells.

Commercial progress

As of June 30, 2026, the number of DTP pharmacies and hospitals where Lisaftoclax is on the formulary reached 415, including 60 hospitals where Lisaftoclax is on the formulary.

Clinical progress

Enrollment continues in an FDA and EMA-cleared global, registrational Phase III clinical trial of Lisaftoclax in combination with AZA for the treatment of patients with newly diagnosed HR-MDS (GLORA-4).

Enrollment continues in a multinational registrational Phase III clinical trial of Lisaftoclax in combination with AZA for the treatment of elderly or unfit patients with newly diagnosed AML (GLORA-3).

Enrollment continues in a registrational Phase III clinical trial to evaluate Lisaftoclax in combination with the BTK inhibitor acalabrutinib, versus immunochemotherapy in patients with previously untreated CLL/SLL, to investigate a fixed duration of combination regimen as a first-line treatment (GLORA-2).

Enrollment continues in an FDA and EMA-cleared global registrational Phase III clinical trial of Lisaftoclax in combination with BTK inhibitors in patients with CLL/SLL previously treated sub-optimally with BTK inhibitors (GLORA).

Enrollment continues in Phase Ib/II clinical trials of Lisaftoclax in combination with other therapies for the treatment of patients with multiple myeloma (MM) in the United States.

Enrollment continues in a Phase Ib/II study of Lisaftoclax as a single agent or in combination with other therapies for the treatment of patients with AML/MDS, including patients resistant to venetoclax, in China.

Enrollment continues in Phase Ib/II studies of Lisaftoclax in combination with other therapies for the treatment of patients with AML/MDS in the United States.

Upcoming milestones

Plan to initiate clinical studies to confirm Lisaftoclax’s potential to overcome venetoclax resistance in patients who have failed venetoclax treatment.

Continue to advance enrollment in the GLORA, GLORA-2, GLORA-3, and GLORA-4 trials.

Plan to actively advance the inclusion of Lisaftoclax in China’s NRDL in 2026.

APG-3288 is a novel, highly potent, and selective BTK degrader and first clinical candidate developed utilizing our proprietary proteolysis-targeting chimera (PROTAC) technology platform.

Clinical progress

Received IND clearance from the FDA in January 2026 and received IND application clearance from the China CDE in February 2026.

Continue to advance the global Phase I study evaluating APG-3288’s pharmacokinetics, safety, tolerability and efficacy data in patients with relapsed/refractory B-cell malignancies, including in the U.S. and China.

Business Updates

Appointment of Dr. Faiçal Miyara as Chief Business Officer and Jim Ziegler as Chief Commercial Officer

Removal of the "B" marker from the HKEX stock short name

Half Year 2026 Unaudited Financial Results

Revenue for the six months ended June 30, 2026 was US$44.5 million, compared to US$32.6 million for the six months ended June 30, 2025, which represented an increase of US$11.9 million, or 29.3% on a constant currency basis. The increase in revenue was primarily due to product sales, which increased by US$11.9 million, or 32.6% on a constant currency basis, to US$41.6 million for the first half of 2026 from US$29.7 million for the six months ended June 30, 2025.

Selling and distribution expenses for the six months ended June 30, 2026 were US$33.4 million, compared to US$19.2 million for the six months ended June 30, 2025, which represented an increase of US$14.2 million, or 64.3% on a constant currency basis. The increase was mainly attributable to increased marketing and promotion investment for Lisaftoclax.

Research and development expenses for the six months ended June 30, 2026 were US$102.8 million, compared to US$73.8 million for the six months ended June 30, 2025, which represented an increase of US$29.0 million, or 32.0% on a constant currency basis. The increase was attributable to increased internal research and development expenses related to our ongoing global clinical trials.

Administrative expenses for the six months ended June 30, 2026 were US$17.5 million, compared to US$13.9 million for the six months ended June 30, 2025, which represented an increase of US$3.6 million, or 19.3% on a constant currency basis. The increase was due to an increase in Share Option and RSU expenses.

Other expenses for the six months ended June 30, 2026 were US$10.2 million, compared to US$5.6 million for the six months ended June 30, 2025, which represented an increase of US$4.6 million, or 71.9% on a constant currency basis. The increase was primarily attributable to the increase in foreign exchange loss and donation expenditure.

Loss for the six months ended June 30, 2026 was US$120.4 million, compared to the loss of US$82.5 million for the six months ended June 30, 2025. The loss per share attributable to ordinary equity holders was US$0.32 per ordinary share for the six months ended June 30, 2026, compared to the loss per share of US$0.24 per ordinary share for the six months ended June 30, 2025.

Cash and bank balances as of June 30, 2026, were US$279.4 million, compared to US$353.2 million as of December 31, 2025, which represented a decrease of US$73.8 million, or 23.3% on a constant currency basis. The decrease was primarily due to the acceleration of global clinical progress, leading to a significant increase in research and development expenses.

Investor Conference Call and Webcast

Ascentage Pharma will be holding investor webcasts to discuss its six months 2026 unaudited interim results.

Ascentage Pharma will host the Chinese (Mandarin) investor webcast at 9:00 am HKT on August 20, 2026 / 9:00 pm EDT on August 19, 2026. To access the Chinese language investor event or conference call, please register in advance here.

The English language investor webcast will be held at 8:00 am EDT / 8:00 pm HKT on August 20, 2026. To access the English language webcast, please register in advance here. The webcast replay for English language conference call and presentation will also be available on the News & Events page of the Ascentage Pharma website.

Currency and Exchange Rate Information

Unless otherwise indicated, translations from RMB to U.S. dollars for the six months ended June 30, 2026 and 2025 and as at December 31, 2025 are made at RMB6.7851 to US$1.00, RMB7.1636 to US$1.00 and RMB6.9931 to US$1.00, respectively, representing the noon buying rate in the City of New York, as certified by the Federal Reserve Bank of New York, on June 30, 2026, June 30, 2025 and December 31, 2025. Ascentage Pharma makes no representation that the RMB or U.S. dollar amounts referred to in this press release could have been or could be converted into U.S. dollars or RMB, as the case may be, at any particular rate or at all.

(Press release, Ascentage Pharma, AUG 19, 2026, View Source [SID1234670241])