On August 19, 2026 Chemomab Therapeutics Ltd. (Nasdaq: CMMB) ("Chemomab"), a clinical stage biotechnology company developing innovative therapeutics for immune-fibrotic diseases with high unmet need, reported financial and operating results for the second quarter ended June 30, 2026, and provided a corporate update.

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Adi Mor, PhD, co-founder and Chief Executive Officer of Chemomab, said, "The planned merger with Scipher Medicine continues to advance. As we have reported, Scipher’s validated AI network medicine platform, SPECTRA, identified nebokitug as the leading candidate to address a major unmet need in rheumatoid arthritis (RA), a $24 billion market. We believe this merger provides our shareholders a compelling opportunity to potentially realize value through the clinical advancement of nebokitug in a large indication, as well as through Scipher’s revenue-generating precision medicine business and its biopharma partnerships. The opportunity also remains to secure a potential partner for a nebokitug Phase 3 trial in primary sclerosing cholangitis (PSC), an indication with no FDA-approved therapies. We look forward to working with our colleagues at Scipher to complete the proposed transaction and expedite the initiation of the Phase 2 trial in RA, marking an important new phase in the development of nebokitug and our anti-CCL24 platform."

Reg Seeto, MBBS, Chief Executive Officer of Scipher Medicine, said, "We believe the announced strategic merger with Chemomab is a unique opportunity to transform the treatment of immunology-based diseases with precision medicine. We plan to start with nebokitug in patients with rheumatoid arthritis, which like other immunology-based diseases is complex in origin. This complexity results in a heterogeneous patient population with unmet medical needs, since one-size-fits-all therapies do not work well for many patients. In RA, this approach has resulted in the majority of moderate-to-severe patients not achieving an enduring response, despite multiple available treatment options."

Dr. Seeto continued, "We reached out to Chemomab because SPECTRATM, our validated AI-enabled network medicine platform, had identified nebokitug’s novel mechanism as the highest ranked clinical program for potentially achieving efficacy in RA compared to both current and pipeline drugs in development. We intend to develop a nebokitug-specific molecular treatment-response signature (MTRS) using the technology that built the only MTRS approved by CMS in immunology. We believe this technology could increase the probability of clinical success, as we preferentially target the population that may benefit from nebokitug. Oncology has already demonstrated patient benefit with precision medicine by improving outcomes in a targeted population and has expanded the overall market with this approach of the right drug for the right patient. We see the field of immunology as the next frontier for precision medicine and we are already leading the way.

Second Quarter 2026 and Recent Highlights:

Entered into Definitive Merger Agreement with Scipher Medicine. On July 8, 2026, Chemomab announced that it had entered into a definitive merger agreement (the "Merger Agreement") with Scipher Medicine Corporation pursuant to which the companies will combine in an all-stock transaction (the "Merger"). Under the terms of the Merger Agreement, Chemomab equity holders are expected to own approximately 32% of the combined company, with Scipher equity holders owning approximately 68%, subject to customary adjustments. The combined company is valued at $150 million prior to a concurrent $30 million private placement financing and is expected to have sufficient cash to fund operations through the readout of the nebokitug Phase 2 RA trial. The private placement is being led by a syndicate of current Scipher investors, including Northpond Ventures, with participation from Khosla Ventures, Blue Owl Healthcare Opportunities, funds managed by Neuberger, and other leading investors, and includes 100% warrant coverage, with the warrants having an exercise price based on a $75 million valuation. In addition, immediately following the closing, Chemomab shareholders will receive contingent value rights (CVRs), providing the opportunity to receive future cash payments of $10 million upon U.S. Food and Drug Administration approval of nebokitug for any indication and $40 million if Chemomab’s PSC program advances to a Phase 3 clinical trial or is partnered, in each case subject to the terms and conditions of the CVR agreement. Upon completion of the Merger, the combined company is expected to operate as Scipher Medicine Corporation and trade on the Nasdaq Capital Market under the ticker symbol "SCIP." The combined company plans to initially focus on advancing nebokitug, a first-in-class clinical stage anti-CCL24 antibody, into a Phase 2 clinical trial for the treatment of rheumatoid arthritis, with topline results expected in the first half of 2028. Following the closing, Dr. Reginald Seeto will serve as Chief Executive Officer of the combined company, and Chemomab co-founder and Chief Executive Officer Dr. Adi Mor will join the combined company’s Board of Directors.
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Presented three abstracts on May 30, 2026 at EASL 2026, the Annual Congress of the European Association for the Study of the Liver in Barcelona, Spain.

In one EASL 2026 study1, Olink-generated analyses of circulating proteins in patient samples from the nebokitug PSC Phase 2 SPRING trial were used to generate an AI/machine learning model to identify patients who showed a combined improvement in three key fibrosis-related measures. The model showed strong performance and reliability, accurately distinguishing patients who met the combined improvement definition from those who did not.

A second EASL 2026 study2 examined the impact of nebokitug treatment on four PSC-specific gene expression programs (GEPs). Treatment with nebokitug was associated with statistically significant and dose-dependent reductions in the signatures linked to the PSC-related fibrotic and immune proteins. These findings provide further support for nebokitug’s CCL24 blocking activity as a mechanism-based approach targeting core molecular drivers of PSC pathogenesis.

A third EASL 2026 study3 examined nebokitug and its CCL24 target in patients with both PSC and inflammatory bowel disease (IBD). This study evaluated whether CCL24 inhibition modulates inflammatory and tissue-remodeling signatures relevant to PSC-IBD pathogenesis. The authors conclude that treatment with nebokitug resulted in improvements across inflammatory and tissue-remodeling proteins relevant to PSC with coexisting intestinal inflammation from ulcerative colitis and Crohn’s disease. These findings suggest that CCL24 inhibition may beneficially impact shared gut–liver inflammatory circuits in patients with co-existing PSC and IBD.

Presented new data from the company’s Phase 2 SPRING trial of nebokitug in PSC in an oral presentation at Digestive Disease Week (DDW 2026)4. On May 4, 2026, a new proteomic study showed that treatment with nebokitug resulted in dose-dependent reductions in multiple inflammatory and tissue-remodeling signatures relevant to both PSC and IBD. The authors conclude that inhibition of nebokitug’s CCL24 target may provide meaningful benefit in PSC patients with concomitant IBD.
1 – AI-driven proteomic profiling differentiates composite improvement following treatment with nebokitug in PSC; T. Snir, R. Aricha, J. Lawler, C Cirillo, D. Weiner, and A. Mor; EASL 2026 Abstract No. 1839; Immune-mediated and cholestatic disease: Clinical aspects; May 30, 2026, 8:30 – 16:00 CEDT

2 – Nebokitug down-regulates core fibrotic and immune pathways defined by single-cell liver profiling; R Aricha, T Snir, J Lawler, C Cirillo, D Weiner, A Mor; EASL 2026 Abstract No. 1852; Immune-mediated and cholestatic disease: Clinical aspects; May 30, 2026, 8:30 – 16:00 CEDT

3 – Nebokitug modulates gut-liver inflammatory and tissue remodeling signatures in PSC patients with coexisting IBD; R Aricha, T Snir, J Lawler, C Cirillo, D Weiner, and A Mor; EASL 2026 Abstract No. 1859; Immune-mediated and cholestatic disease: Clinical aspects; May 30, 2026, 8:30 – 16:00 CEDT

4 – Nebokitug modulates inflammatory and tissue-remodeling signatures in patients with PSC and coexisting IBD: Biomarker findings from SPRING Phase 2 trial; P. Mantry, T Snir, R Aricha, J Lawler, C Cirillo, D Weiner, A Mor; DDW 2026 Abstract No. 4484827, Advances in the Management of Primary Sclerosing Cholangitis; May 4, 2026, 2:00 – 3:30 PM CDT

Second Quarter 2026 Financial Highlights:

Cash Position: Cash, cash equivalents and short-term bank deposits were $6.7 million as of June 30, 2026, compared to $8.0 million as of March 31, 2026.

Research and Development (R&D) Expenses: R&D expenses were $1.1 million for the second quarter of 2026, compared to $1.3 million for the second quarter of 2025.

General and Administrative (G&A) Expenses: G&A expenses were $1.1 million for the second quarter of 2026, compared to $1.0 million for the second quarter of 2025.

Net Loss: Net loss was $2.2 million, or a net loss of less than $0.01 per basic and diluted ordinary share, for the second quarter of 2026, compared to $2.1 million, or a net loss of less than $0.01 per basic and diluted ordinary share, for the second quarter of 2025. The weighted average number of ordinary shares outstanding, basic and diluted, was 640,243,933 (equal to approximately 8,003,049 ADSs) for the second quarter of 2026.

Liquidity and Capital Resources: Chemomab believes its existing liquidity resources as of June 30, 2026 will enable it to fund its operations through the first quarter of 2027.

Number of Issued and Outstanding Shares: As of June 30, 2026, the company had 579,648,600 issued and outstanding shares compared to 575,381,320 as of December 31, 2025.
Merger Update
Chemomab has confidentially submitted a draft registration statement on Form S-4 to the U.S. Securities and Exchange Commission (SEC) in connection with its proposed Merger with Scipher Medicine. The confidential submission enables the SEC review process to begin while certain required financial information is being finalized, helping to support the transaction timeline. The registration statement is expected to be publicly filed following the SEC’s initial review process, in accordance with applicable SEC rules. The companies expect the Merger to close before the end of 2026, subject to SEC review, shareholder approvals and other customary closing conditions. For additional information, please refer to the company’s Form 6-K filed with the SEC today.

(Press release, Chemomab, AUG 19, 2026, View Source [SID1234670225])

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.

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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])

On August 19, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Moderna, Inc. (NASDAQ: MRNA) reported positive topline results from the Phase 3 INTerpath-001 trial evaluating adjuvant treatment with intismeran autogene (intismeran; V940 or mRNA-4157), a novel investigational mRNA-based individualized neoantigen therapy (INT) being jointly developed by Merck and Moderna, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with completely resected stage IIB-IV melanoma. The trial met its primary endpoint of recurrence-free survival (RFS) and a key secondary endpoint of distant metastasis-free survival (DMFS). This represents the first positive Phase 3 readout for an individualized neoantigen therapy (INT) and for an mRNA-based cancer therapy, as well as the first Phase 3 study to demonstrate a clinically meaningful improvement over KEYTRUDA alone, a standard-of-care immunotherapy, in the adjuvant setting for patients with resected melanoma.

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At a pre-specified interim analysis, intismeran in combination with KEYTRUDA as adjuvant therapy demonstrated statistically significant and clinically meaningful improvements in RFS and DMFS compared to KEYTRUDA alone for patients with completely resected stage IIB, IIC, III or IV cutaneous melanoma who had not undergone prior treatment with systemic therapy. In accordance with the trial protocol, the study will continue in order to evaluate other key secondary endpoints, including overall survival (OS).

The safety profiles of intismeran and KEYTRUDA in this trial were consistent with those observed in previously reported studies for the combination, with no new safety signals observed.

These data will be presented at an upcoming international medical meeting and shared with regulatory authorities.

"Today’s results represent a landmark moment for adjuvant melanoma treatment. This is the first Phase 3 study to show that intismeran, a treatment designed based on the unique mutational ‘fingerprint’ of a patient’s own tumor, given in combination with pembrolizumab can reduce the risk of recurrence or death in patients with completely resected stage IIB-IV melanoma compared to KEYTRUDA alone," said Professor Georgina Long, the study’s principal investigator and medical director of Melanoma Institute Australia, Chair of Melanoma Medical Oncology and Translational Research at the University of Sydney. "Intismeran in combination with pembrolizumab has the potential to establish a new treatment paradigm in the adjuvant melanoma setting, helping patients remain cancer-free for longer."

"By intervening earlier in the course of disease, when many cancers are considered most treatable, the goal of adjuvant therapy given after surgery is to increase the possibility of cure for more patients," said Dr. Dean Y. Li, president, Merck Research Laboratories. "These first Phase 3 findings for intismeran in combination with KEYTRUDA as adjuvant therapy reinforce the promise of a more personalized approach to cancer treatment. We believe individualized neoantigen therapies have the potential to redefine how patients with completely resected stage IIB-IV melanoma are treated. Together with Moderna, we look forward to presenting data from INTerpath-001 at an international medical meeting and sharing with regulatory authorities."

"These Phase 3 findings represent a pivotal moment for the field of cancer research. For many years, the idea of creating an mRNA treatment designed specifically for an individual patient’s cancer was aspirational. We are now helping turn that vision into a reality," said Stéphane Bancel, CEO of Moderna. "Together with Merck, we have started to demonstrate the transformative potential of this technology to address critical unmet needs in the adjuvant melanoma setting. We are deeply grateful to the patients, investigators and study teams whose contributions make this progress possible."

Merck and Moderna are advancing the robust INTerpath clinical development program evaluating the safety and efficacy of intismeran in combination with KEYTRUDA and other anti-cancer therapies, and as a monotherapy. The INTerpath program currently consists of nine total Phase 2 and Phase 3 clinical trials across multiple tumor types and stages of disease, including melanoma, non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma. Additional clinical studies include the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial in adjuvant melanoma and a Phase 1 study exploring adjuvant pancreatic ductal adenocarcinoma, perioperative gastric carcinoma and perioperative NSCLC.

Today’s Phase 3 readout builds on previously reported Phase 2b results for intismeran in combination with KEYTRUDA from the KEYNOTE-942/mRNA-4157-P201 trial, including the five-year follow-up data presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting, in which the combination demonstrated a 49% reduction in the risk of recurrence or death (HR=0.51; [95% CI, 0.294-0.887]) and a 59% reduction in the risk of distant metastasis or death (HR=0.411; [95% CI, 0.200-0.843]) compared to KEYTRUDA alone.

About INTerpath-001
INTerpath-001 is a randomized, double-blind, placebo- and active-comparator-controlled global Phase 3 trial (ClinicalTrials.gov, NCT05933577) evaluating the safety and efficacy of intismeran in combination with KEYTRUDA compared to KEYTRUDA alone in patients with high-risk (stage IIB-IV) resected cutaneous melanoma. The trial enrolled 1,137 patients who, following complete surgical resection, were randomized 2:1 to receive intismeran (1 mg every three weeks for up to nine doses) and KEYTRUDA (400 mg every six weeks up to nine cycles [for approximately one year]) versus KEYTRUDA alone for approximately one year until disease recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever was sooner.

The primary endpoint is RFS, defined as the time from randomization to any disease recurrence (local, locoregional, regional or distant) as assessed by the investigator, or death due to any cause. Key secondary endpoints include DMFS, OS, safety, tolerability and quality of life.

About intismeran autogene
Intismeran autogene (intismeran; V940 or mRNA-4157) is a novel, potential first-in-class investigational messenger RNA (mRNA)-based individualized neoantigen therapy (INT) jointly developed by Merck and Moderna. Intismeran is designed and produced using a patient’s tumor sample to identify the unique mutational signature, or "fingerprint," of their cancer and generate an anti-tumor immune response. Each therapy consists of a synthetic mRNA coding for up to 34 neoantigens and is tailored to the unique biology of an individual patient’s tumor. Upon administration, the RNA-encoded neoantigen sequences are translated in the body and presented to the immune system, a key step in generating specific T-cell responses against cancer cells. Individualized neoantigen therapies are designed to train and activate an anti-tumor immune response based on the unique mutational signature of a patient’s tumor.

About melanoma
Melanoma, one of the deadliest forms of skin cancer, is characterized by the uncontrolled growth of pigment-producing cells. The rates of melanoma have been rising over the past few decades, with more than 330,000 new cases diagnosed worldwide in 2022. In the U.S., skin cancer is one of the most common types of cancer diagnosed, and melanoma accounts for a large majority of skin cancer deaths. It is estimated there will be about 112,000 new cases of melanoma diagnosed and over 8,500 deaths resulting from the disease in the U.S. in 2026 alone. Despite advances in treatment, patients with resected melanoma remain at risk of disease recurrence, which most often occurs within the first two years. The majority of recurrences are metastatic rather than localized, highlighting the ongoing need for treatment approaches that may help reduce the risk of recurrence and improve long-term outcomes.

(Press release, Merck & Co, AUG 19, 2026, View Source [SID1234670226])

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

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

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])