On June 18, 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 the closing on June 17, 2026 of its previously announced underwritten public offering (the "Offering") of 26,066,667 of its ordinary shares at an offering price of $3.75 per share, which includes 3,400,000 ordinary shares issued pursuant to the exercise in full by the underwriters of their option to purchase additional ordinary shares in the Offering. All ordinary shares sold in the Offering were offered by Alvotech. Before deducting the underwriting discounts and commissions and offering expenses, the aggregate gross proceeds to the Company were approximately $98 million.

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Concurrent with the Offering, Alvotech entered into Subscription Agreements with certain investors that are professional clients or eligible counterparties in the European Economic Area falling within article 1(4) of Regulation (EU) 2017/1129, pursuant to which Alvotech will issue and sell 17,826,666 ordinary shares to such investors at a price of $3.75 per ordinary share, which represents the per share public offering price, in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended. The gross proceeds from the concurrent private placement, before deducting any transaction-related expenses, are expected to be approximately $67 million. The concurrent private placement is expected to close on or about June 25, 2026, subject to customary conditions. The consummation of the Offering was not contingent on the consummation of the concurrent private placement.

The board of directors of Alvotech has resolved to issue 43,893,333 ordinary shares to be delivered to investors participating in the Offering and the concurrent private placement and following closing of the concurrent private placement the issued share capital of Alvotech will amount to 390,431,480 ordinary shares in total.

The total gross proceeds from the Offering, including gross proceeds from the underwriters’ exercise in full of their option to purchase additional shares, and the concurrent private placement are expected to be approximately $165 million, before deducting underwriting discounts and commissions and estimated offering expenses payable.

Alvotech intends to use the net proceeds from this Offering and the concurrent private placement to fund the continued development of its biosimilar assets, as well as working capital and general corporate purposes, which may include, among others, intellectual property protection and enforcement, commercial expenditures, capital expenditures, acquisitions or collaborations, pre-clinical and clinical development of its product candidates, research and development and product development, pre-commercialization activities and repayment or refinancing of indebtedness or other corporate borrowings.

BofA Securities, Jefferies and Evercore ISI acted as joint book-running managers for the Offering.

The Offering was made pursuant to a registration statement on Form F-3, including a base prospectus, that was previously filed with the U.S. Securities and Exchange Commission ("SEC") on October 20, 2023, and declared effective on October 30, 2023. The ordinary shares referred to in this press release were offered in the United States only by means of a prospectus supplement and the accompanying prospectus that forms a part of the registration statement. Copies of the final prospectus supplement and the accompanying prospectus related to this Offering may be obtained from: BofA Securities, Attention: Prospectus Department, 201 North Tryon Street, Charlotte, NC 28255-0001, or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected]. Investors may also obtain these documents at no cost by visiting the SEC’s website at View Source

(Press release, Alvotech, JUN 18, 2026, View Source [SID1234668809])

On June 18, 2026 Gandeeva Therapeutics, Inc., a biotech at the forefront of cryo-electron microscopy (cryo-EM)–driven drug design, and Zymeworks Inc. (Nasdaq: ZYME), a global biotechnology company, reported to have partnered to visualize structures of antibody-antigen interfaces at high resolution.

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While cryo-EM is now used routinely to determine structures of antibody complexes formed with compact and well-folded antigens, mapping antibody epitope footprints on small and flexible antigens remains highly challenging. In a new advance, Gandeeva scientists have determined the structure of a small and flexible antigen (< 20 kDa) bound to the Fab fragment of an antibody developed at Zymeworks. Of note, the team was able to visualize the nine amino acids that form the antibody-binding epitope at 2.6 Å resolution. The rest of the antigen is highly flexible and was not resolved in the reconstruction.

"Knowledge of the precise interactions at the binding interface of these types of challenging targets is incredibly useful for us in selecting antibody leads and provides us with crucial insights for the optimization of biologics", said Dr. Paul Moore, Chief Scientific Officer of Zymeworks.

"Our ability to obtain near-atomic resolution cryo-EM structures of the antibody binding epitope within flexible and structurally intractable proteins is a game-changer, especially in the context of accelerating design of AI-driven antibodies", said Dr. Sriram Subramaniam, Founder and CEO of Gandeeva Therapeutics. "Experimental validation by high-resolution and high-throughput cryo-EM using Gandeeva’s platform provides exactly the kind of rapid feedback that is essential for testing and validating antibodies derived by immunization and by computational design."

(Press release, Gandeeva Therapeutics, JUN 18, 2026, View Source [SID1234668794])

On June 18, 2026 Roche (SIX: RO, ROP; OTCQX: RHHBY) reported that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Lunsumio VELO (mosunetuzumab), as a subcutaneous formulation, in combination with Polivy (polatuzumab vedotin) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), after at least one prior line of systemic therapy. The FDA is expected to make a decision on approval by 9 February 2027.

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The sBLA acceptance is based on results from the phase III SUNMO study. At a median follow-up of 23.2 months, the Lunsumio VELO and Polivy combination demonstrated a 59% reduction in risk of disease progression or death (progression-free survival [PFS]) compared to MabThera/Rituxan (rituximab), gemcitabine and oxaliplatin (R-GemOx) (hazard ratio [HR] 0.41, 95% confidence interval [CI]: 0.28–0.61; p<0.0001) and a three-times longer median PFS at 11.5 months (95% CI: 5.6-17.6), compared to 3.8 months for R-GemOx (95% CI: 2.9-4.1).1 The safety profile of the Lunsumio and Polivy combination was consistent with the known profiles of the individual study medicines.1 The incidence of cytokine release syndrome events (CRS) in the Lunsumio VELO plus Polivy arm was low, occurring in one in four patients, with less than 5% of patients experiencing Grade 2 or 3 CRS events.1

Updated data were presented recently at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the European Hematology Association (EHA) (Free EHA Whitepaper) Congress, which showed that with longer follow-up, this treatment combination continued to demonstrate clinical benefit in PFS, particularly in the second-line setting, with no new safety signals.2,3

"Relapsed or refractory large B-cell lymphoma is an aggressive disease thereby representing one of the highest unmet needs in lymphoma care," said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. "If approved, this Lunsumio/Polivy combination could provide an important chemotherapy-free, outpatient-ready option to help improve outcomes in this setting."

"When treating large B-cell lymphoma, the second-line setting represents a critical window where we must act quickly with effective therapies," said Tara M. Graff, DO, MS, Director of Clinical Research at Mission Cancer and Blood. "Current advanced therapies may present complex logistical and geographical barriers for many patients. Since most patients in the US are treated in the community setting, we need more chemotherapy-free, outpatient-ready treatments, like Lunsumio and Polivy."

LBCL, composed predominantly of DLBCL, is the most common type of non-Hodgkin lymphoma with more than 18,000 new diagnoses each year in the US.4 While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short.5,6 Because this stage of disease is time-sensitive, delays caused by referral requirements, inpatient coordination, or complex treatment logistics can have meaningful clinical consequences.7,8

"Navigating relapsed or refractory large B-cell lymphoma can be challenging, particularly for patients who do not live near a major academic centre," said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. "The potential new Lunsumio VELO and Polivy combination may address this critical access issue by offering treatment options closer to where a patient lives. It fills a gap in care for people who can’t afford to travel far distances or for long periods of time for treatment."

Lunsumio is part of Roche’s industry-leading CD20xCD3 bispecific antibody programme. It is designed with the unique needs and preferences of patients in mind, offering the possibility of outpatient treatment and flexibility between intravenous (IV) and subcutaneous administration routes. Lunsumio IV and Lunsumio VELO are approved for people with third-line or later follicular lymphoma (FL). Lunsumio holds the most extensive long-term data for any bispecific antibody in lymphoma. Ongoing development of Lunsumio in combination with other treatments includes the phase III CELESTIMO and MorningLyte studies in second-line or later and frontline FL, respectively.

About the SUNMO study
The SUNMO study [NCT05171647] is a phase III, randomised, open-label, multicentre trial evaluating the efficacy and safety of Lunsumio VELO (mosunetuzumab) in combination with intravenously administered Polivy (polatuzumab vedotin) versus MabThera/Rituxan (rituximab) plus gemcitabine and oxaliplatin in patients with relapsed or refractory large B-cell lymphoma who have received at least one prior systemic therapy and are ineligible for autologous stem cell transplant. Outcome measures include progression-free survival and objective response rate (dual primary endpoints), overall survival, duration of objective response, complete response rate, duration of complete response, safety and tolerability, and patient-reported outcomes.

About Large B-cell Lymphoma (LBCL)
Large B-cell lymphomas, composed predominantly of diffuse large B-cell lymphoma (DLBCL), are the most common type of non-Hodgkin lymphoma (NHL) that affect B-cell lymphocytes, a type of white blood cell.5 DLBCL is a highly aggressive and life-threatening disease.9 While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short.5,6 While existing intensive standard-of-care treatments exist, structural, geographical, and clinical access barriers mean that many patients — particularly those in rural communities or receiving care outside of specialised academic transplant centres — face significant burdens and inequities in obtaining timely treatment.10,11 Improving treatments earlier in the course of the disease and providing much needed alternative options could help to improve long-term outcomes.

About Lunsumio (mosunetuzumab)
Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects a patient’s existing T cells to engage and eliminate malignant B cells. Lunsumio is currently approved as a fixed-duration monotherapy for the treatment of adult patients with third-line or later relapsed or refractory follicular lymphoma (FL) in both intravenous and subcutaneous (Lunsumio VELO) formulations. A robust, global development programme is ongoing to explore the clinical utility of Lunsumio earlier in the disease course and in novel combinations, including the phase III CELESTIMO trial in second-line or later FL.

About Polivy (polatuzumab vedotin)
Polivy is a first-in-class antibody-drug conjugate (ADC) targeted against CD79b, a protein preferentially expressed on the surface of mature B cells. Polivy binds to CD79b on the lymphoma cells and delivers a cytotoxic chemotherapy agent directly into the cell, inducing cell death via apoptosis while minimising damage to healthy tissue. Polivy is widely approved globally in combination with MabThera/Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone for previously untreated (first-line) diffuse large B-cell lymphoma (DLBCL), as well as in combination with bendamustine and MabThera/Rituxan for relapsed or refractory DLBCL.

(Press release, Hoffmann-La Roche, JUN 18, 2026, View Source [SID1234668810])

On June 18, 2026 FivepHusion, an advanced clinical-stage biotechnology company, reported that an independent Human Research Ethics Committee (HREC) has approved progression to phase II of the Deflexifol at Relapse Trial (DART). The phase II trial is investigating Deflexifol monotherapy as a treatment for refractory or recurrent paediatric ependymoma. This HREC approval follows the successful completion of the phase I DART study in 2025 and incorporation of a recommended phase II dose and other updates into the phase II trial protocol.
Key design elements of the phase II DART study include:

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A multi-centre single-arm clinical trial involving all major paediatric oncology centres in Australia, with patients enrolled to determine the objective response rate to Deflexifol.
Recruitment of ten evaluable participants (aged 1-21 years) with refractory or recurrent paediatric ependymoma, including three participants currently evaluable from the phase I study.
Primary Objective: To evaluate the anti-tumour activity of Deflexifol as a single agent in patients with refractory or recurrent ependymoma.
Secondary Objectives: To assess overall survival and progression-free survival, and to further characterise the pharmacokinetics of Deflexifol monotherapy.
The phase II DART study is an Australian trial led by Principal Investigators Professor David Ziegler and Dr Marion Mateos and sponsored by the Australian and New Zealand Children’s Haematology / Oncology Group (ANZCHOG) in collaboration with FivepHusion. The phase II study follows the successful completion of the phase I DART study, the results of which were presented as a poster in November 2025 at the Society of Neuro-Oncology (SNO) Annual Meeting in Honolulu, Hawaii, USA. The phase II trial is designed to investigate Deflexifol monotherapy as a treatment for refractory or recurrent paediatric ependymoma. The trial is coordinated by the KOALA National Coordinating Centre at the Sydney Children’s Hospitals Network and all major Australian paediatric oncology centres are participating in the study. Significant trial funding has been provided by the Kids with Cancer Foundation and the Robert Connor Dawes Foundation.

Dr Christian Toouli, CEO and Managing Director of FivepHusion commented, "Paediatric ependymoma is the third most common brain cancer in children, and with no approved drugs to treat this condition, presents a significant unmet medical need for a safe and efficacious therapy. The ethics approval of the Phase II DART protocol is an exciting milestone towards our goal of evaluating Deflexifol as a promising therapy for these patients."

Deflexifol is an innovative next-generation novel co-formulation of 5-fluorouracil (5-FU) and leucovorin (LV), a drug that significantly enhances 5-FU anti-tumour activity. Deflexifol has previously been evaluated in the phase I DART study in paediatric brain cancer patients and two successfully completed clinical trials in adults with a variety of solid tumours. FivepHusion is harnessing the proven cytotoxic activity of 5-FU together with the unique, optimised attributes of the Deflexifol co-formulation to pursue Deflexifol development in a range of strategic solid tumour indications presenting with significant unmet medical needs, including paediatric ependymoma.

Ependymomas are rare central nervous system tumours (annual incidence of ~4 patients per million) that are more common in young children 0-4 years of age. The current standard treatment for ependymoma is surgery and radiotherapy, though relapse occurs in one third of all paediatric patients and is associated with a poor prognosis. Currently, there are no therapeutic drugs approved for the treatment of ependymoma, presenting a significant unmet medical need for the development of safe and efficacious new treatments for this disease.

Previously, 5-FU has been reported as a promising drug candidate for the treatment of paediatric ependymoma by independent research groups1,2, and in a clinical trial conducted at the St Jude Children’s Research Hospital (Memphis, Tennessee, USA)3. Recently, independent studies have gained further insights into understanding the susceptibility of paediatric ependymoma to 5-FU4. Research by FivepHusion collaborators indicates that Deflexifol, as a novel optimised co-formulation of 5-FU and LV, may be efficacious against paediatric ependymoma and other brain cancers. Due to its superior safety, tolerability and anti-tumour efficacy, Deflexifol offers the exciting opportunity to address the limitations of current 5-FU formulations to enable development as potentially the first approved drug for ependymoma and possibly other brain tumours.

(Press release, FivepHusion, JUN 18, 2026, View Source [SID1234668795])

On June 18, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that the final subject has received their first dose in the Phase 2 DURIPANC clinical trial evaluating Ampligen (rintatolimod) in combination with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) for the treatment of metastatic pancreatic cancer.

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With this final subject, Primary Endpoint analysis is anticipated to begin in December 2026 and topline results are anticipated in Q1 2027. DURIPANC’s primary endpoint is Clinical Benefit Rate ("CBR"), defined as the proportion of patients achieving stable disease, partial response or complete response at 24 weeks following initiation of combination therapy.

Analysis of Secondary Endpoints is expected to begin in June 2027, or 49 weeks after this final subject received their first dose. DURIPANC’s Secondary Endpoints include Overall Survival ("OS") – the gold standard in oncology trials – as well as progression-free survival and immune profiling analysis that could potentially help identify subsets of future pancreatic cancer patients likely to experience the best survival results, which could be critical to the design of a pivotal Phase 3 clinical trial.

AIM Chief Executive Officer Thomas K. Equels stated: "AIM hopes to utilize the exploratory biomarker data generated through DURIPANC to design a Phase 3 study involving Ampligen in the treatment of pancreatic cancer. We are particularly interested in evaluating whether specific biomarkers may help to identify ‘super-responder’ patient subsets most likely to benefit from Ampligen-based therapy, thus supporting a more targeted and personalized treatment approach."

DURIPANC is a follow-up to the AIM/Erasmus Medical Center Named Patient Program utilizing Ampligen as a monotherapy in late-stage pancreatic cancer, where data suggested impressive improvements in survival, particularly when broken down by biomarker stratifications:

Based upon stratification for immune marker Neutrophil/Lymphocyte ratios less than 4.5, Progression-Free Survival ("PFS") of 17.7 months compared to 8.6 months for historical controls, for an improvement of 9.1 months in PFS
Based upon stratification for immune marker Neutrophil/Lymphocyte ratios less than 4.5, OS of 34.8 months compared to 12.5 months for historical controls, for an improvement of 22.3 months in OS
Based upon stratification for immune marker CA 19-9 less than 1000, PFS of 13.1 months compared to 8.6 months for historical controls, for an improvement of 4.5 months in PFS
Based upon stratification for immune marker CA 19-9 less than 1000, OS of 24.1 months compared to 12.5 months for historical controls, for an improvement of 11.6 months in OS
These results were accompanied by consistent reports of improved quality of life.

About DURIPANC

DURIPANC is an investigator-initiated, exploratory, open-label, single-center Phase 2 study. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center in the Netherlands. In addition to the Primary Endpoint of clinical benefit rate, the secondary/exploratory objectives include assessing overall survival (OS) and progression-free survival (PFS); exploring immune-monitoring using available tissue biopsies and peripheral immune profiling; and assessing quality of life.

Read more about the DURIPANC study at ClinicalTrials.gov NCT05927142.

(Press release, AIM ImmunoTech, JUN 18, 2026, View Source [SID1234668796])