On August 20, 2026 Akiram Therapeutics, a Swedish clinical-stage biotech company specializing in molecular radiotherapy, and ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported a supply agreement for non-carrier-added (n.c.a.) Lutetium-177 (Lu-177 or 177Lu) to support the development of 177Lu-AKIR001 (AKIR001), a targeted antibody-radionuclide conjugate with first-in-class potential, currently in clinical testing for the treatment of CD44v6-expressing solid tumors.

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Under the terms of the agreement, ITM will provide its high-quality n.c.a. Lu-177 for use in Akiram’s ongoing clinical trial for AKIR001, the company’s lead radiopharmaceutical candidate. Lu-177 is one of the most widely used medical radioisotopes in targeted radionuclide therapy and serves as the active payload in AKIR001. Reliable access to this isotope is essential for clinical development, and ITM’s position as a leading global supplier will support the continued advancement of the program. Additional details of the agreement have not been disclosed.

"We are pleased to partner with ITM, a leading global producer and supplier of n.c.a. Lu-177, as we continue advancing AKIR001 through clinical development," said Marika Nestor, chief executive officer of Akiram Therapeutics. "This agreement helps secure an important component for the continued development of AKIR001 and marks a significant step in advancing the program designed to address a primary driver of aggressive cancers."

AKIR001 is a targeted radiopharmaceutical drug candidate that combines the therapeutic radioisotope n.c.a. Lu-177 with a proprietary antibody targeting CD44v6, a cancer marker associated with several aggressive tumor types. The approach is designed to deliver radiation selectively to tumor cells while limiting exposure to healthy tissue. The candidate is currently being evaluated in a Phase I clinical trial (NCT06639191) at Stockholm’s Karolinska University Hospital in patients with irresectable or metastatic CD44v6-positive solid tumors, including lung, head and neck, thyroid, and gynecological cancers.

"At ITM, we remain committed to advancing and enabling the development of innovative radiopharmaceuticals for hard-to-treat cancers. This agreement with Akiram allows us to provide a dependable, high-quality source of n.c.a. Lu-177 for their clinical trials and research that may, in time, prove genuinely transformative," added Dr. Andrew Cavey, chief executive officer at ITM. "We are pleased to support the continued clinical development of AKIR001 through our manufacturing expertise and consistency of supply, and we wish Akiram every success as they advance this promising therapy."

(Press release, Akiram Therapeutics, AUG 20, 2026, View Source [SID1234670247])

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.

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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:

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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.

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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.

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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])