On August 6, 2026 Barinthus Biotherapeutics plc (NASDAQ: BRNS) ("Barinthus Bio," or the "Company"), reported its financial results for the quarter ended June 30, 2026, and provided an overview of the Company’s corporate developments. Barinthus Bio is an immunology and inflammation ("I&I") company focused on developing therapies that promote immune tolerance with curative potential.

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"During the second quarter, our primary focus remained advancing the proposed combination with Clywedog and progressing the clinical development of VTP-1000, our lead asset for celiac disease," said Bill Enright, Chief Executive Officer of Barinthus Bio. "We are pleased to announce the completion of enrollment in the multiple ascending dose portion of the Phase 1 AVALON trial and remain on track to report topline data in the fourth quarter of 2026. We believe VTP-1000 has the potential to address a significant unmet need in celiac disease and to be an important driver of long-term value for shareholders of the combined company."

Recent Corporate Developments

•During the third quarter of 2026, Barinthus Bio completed enrollment in all cohorts in the MAD portion of the Phase 1 AVALON clinical trial.
•On June 30, 2026, Barinthus Bio received a notice (the "Extension Notice") from the Nasdaq Stock Market ("Nasdaq") informing the Company that Nasdaq had granted the Company an additional 180 calendar days, or until December 28, 2026, to regain compliance with the Bid Price Requirement for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). In connection with the Extension Notice, the listing of the Company’s American Depositary Shares (the "ADSs") was transferred from the Nasdaq Global Market to the Nasdaq Capital Market, effective as of July 2, 2026. The Extension Notice has no other immediate effect on the listing of the ADSs.

Upcoming Milestones

Celiac Disease (VTP-1000):
•Data from the MAD portion of the Phase 1 AVALON clinical trial, which includes a gluten challenge following three doses of test medication, is expected in the fourth quarter of 2026.
•An abstract outlining Phase 1 Single Ascending Dose data for VTP-1000 has been selected for poster presentation at the American College of Gastroenterology ("ACG") Annual Scientific Meeting, to be held October 9–14, 2026 in Nashville, Tennessee. The poster will be presented by Dr. Adam Bledsoe, from the Division of Gastroenterology and Hepatology at Mayo Clinic.

Corporate:
•Barinthus Bio expects to complete the merger with Clywedog in the second half of 2026 which will result in a differentiated biopharmaceutical company focusing on metabolic and autoimmune diseases with three potentially disease-modifying clinical stage therapies.
•At closing, the combined company will be renamed "Clywedog Therapeutics Holdings, Inc." and is expected to trade on the NASDAQ under the new ticker symbol "CLYD." The combined company’s estimated cash runway is expected to extend through 2027, supported by existing cash and additional investments by OrbiMed and Torrey Pines Investments, LLC, both existing shareholders in Clywedog, and new investors.

Second Quarter 2026 Financial Highlights

•Cash: As at June 30, 2026, cash, cash equivalents and restricted cash were $59.6 million, compared to $67.2 million as of March 31, 2026. The $7.6 million decrease was a result of the net cash used in operating activities of which $8.1 million was used for the development of the Company’s pipeline and general corporate expenses, and a $0.5 million translational gain from the conversion of balances in pound sterling denominated entities to the United States dollar reporting currency. Based on standalone research and development plans, the Company expects its available resources to fund its operating expenses and capital expenditure requirements for at least the next 12 months from the date of issuance of the financial statements.
•Research and Development Expenses: Research and development expenses were $3.9 million in the second quarter of 2026 compared to $3.6 million for the first quarter of 2026. The increase was primarily attributable to an increase in VTP-1000 Celiac program cost in second quarter of 2026 offset by reduced activity in the Barinthus legacy asset clinical programs and the reduction in workforce. The quarter-on-quarter research and development expenses are outlined in the following table, with the expense primarily attributable to the continued progression of the Phase 1 AVALON clinical trial of VTP-1000 in celiac disease, and the reduced activity on legacy assets in infectious disease and oncology. It is anticipated that research and development expenses related to the Barinthus legacy assets in infectious disease and oncology will continue to decrease going forward as the clinical trials complete, and that research and development expenses related to the autoimmune program will continue at current levels or increase, as the clinical development continues.
Three months ended June 30, 2026 Three months ended March 31, 2026 Change
$000
$000
$000
Direct research and development expenses by program:
VTP-1000 Celiac $ 2,936 $ 1,422 $ 1,514
Barinthus legacy assets1
506 1,480 (974)
Total direct research and development expenses 3,442 2,902 540
Indirect research and development expenses:
Personnel-related (including share-based compensation) 440 503 (63)
Facility related 15 87 (72)
Other indirect costs 26 101 (75)
Total indirect research and development expenses 481 691 (210)
Total research and development expense $ 3,923 $ 3,593 $ 330

1 In January 2025, we announced a strategic focus on developing a pipeline in I&I, and the deprioritization of our programs in infectious disease and oncology. The following programs were previously presented separately and have been grouped collectively as "Barinthus Legacy Assets" for both years presented: VTP-300 HBV, VTP-850 Prostate Cancer, VTP-200 HPV, VTP-600 NSCLC, VTP-500 MERS and other and earlier stage programs.
•General and Administrative Expenses: General and administrative expenses were $7.1 million in the second quarter of 2026, compared to $2.5 million for the first quarter of 2026. The increase of $4.6 million related primarily to an increase in unrealized losses on foreign exchange driven mainly by translation of United States dollar balances in pound sterling denominated entities and an increase in professional fees.
•Net Loss: For the second quarter of 2026, the Company generated a net loss attributable to its shareholders of $10.6 million or $(0.26) per share on both basic and fully diluted bases, compared to a net loss attributable to its shareholders of $5.5 million, or $(0.14) per share on both basic and fully diluted bases for the first quarter of 2026.

(Press release, Barinthus Biotherapeutics, AUG 6, 2026, View Source [SID1234669787])

On August 6, 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, reported financial results for the second quarter ended June 30, 2026, and provided an update on its financing-supported strategy to advance botensilimab (BOT), a multifunctional, Fc-enhanced anti-CTLA-4 antibody, plus balstilimab (BAL), an anti-PD-1 antibody, in a curative-intent treatment setting before surgery in high-risk, resectable microsatellite-stable (MSS) colon cancer.

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As previously announced, Agenus completed an oversubscribed private placement in July 2026 structured to support ROBBIN, its planned global registrational Phase 3 trial of neoadjuvant (before surgery) BOT+BAL in patients with high-risk Stage II and Stage III microsatellite-stable (MSS) colon cancer. MSS disease accounts for approximately 85% of early-stage colorectal cancers. In the population targeted by ROBBIN, treatment remains centered on surgery followed by chemotherapy or observation, with no new curative-intent therapies approved in more than 20 years.,

The decision to accelerate ROBBIN is grounded in previously reported findings from the independent NEST and UNICORN studies evaluating neoadjuvant BOT+BAL treatment in patients with Stage II/III MSS colorectal cancer. Treatment before surgery produced deep pathologic responses, while recent advanced-disease updates provide complementary evidence of durable BOT+BAL immune activity.

ROBBIN addresses an estimated 38,000 newly diagnosed patients annually in the United States and more than 200,000 worldwide. Agenus estimates that this population represents an annual addressable sales opportunity of more than $7 billion.

"The financing completed in July gives us a clear path to act on the clinical evidence supporting BOT+BAL in a large, underserved patient population," said Garo H. Armen, Ph.D., Chairman and Chief Executive Officer of Agenus. "The previously reported neoadjuvant findings support testing whether BOT+BAL before surgery can reduce recurrence and improve the potential for cure. With capital aligned to ROBBIN’s development milestones, we are positioned to pursue that opportunity with focus and urgency."

Previously Announced Financing Supports ROBBIN Execution
The private placement, announced and completed in July, provided approximately $85 million in upfront gross proceeds and included milestone-aligned warrants that could provide up to approximately $255 million in additional gross proceeds if fully exercised. The warrant structure aligns potential additional capital with planned ROBBIN milestones.

Based on the company’s current operating plan, the upfront proceeds are expected to support ROBBIN initiation, regulatory alignment and company operations through Q3 2027. Assuming full exercise of the warrants, the financing is expected to support the planned ROBBIN program and company operations through year-end 2031.

Agenus continues to implement disciplined cost-management measures and is directing internal resources toward ROBBIN execution, clinical and access-program supply, regulatory activities and supporting data generation.

Clinical Evidence Reinforces BOT+BAL’s Differentiated Profile
Previously reported findings from the independent NEST and UNICORN studies provide the direct neoadjuvant clinical rationale for ROBBIN in Stage II and Stage III MSS colon cancer.

Among 38 BOT+BAL-treated patients, approximately 30% achieved a pathologic complete response (pCR; no viable tumor found at surgery), and approximately 40% achieved a major pathologic response (MPR; 10% or less viable tumor remaining). At the applicable data cutoffs, no disease recurrences had been reported. Manuscripts with longer-term follow-up from both studies are anticipated in the second half of 2026.

Recent advanced-disease updates further reinforced the durability of BOT+BAL activity. At ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2026, follow-up from the fully enrolled 123-patient Phase 1b cohort in refractory MSS metastatic colorectal cancer without active liver metastases showed median overall survival of 21.2 months and three-year overall survival of 33%. At last follow-up, 17% of patients were alive and off all systemic cancer therapy. No new safety signals or treatment-related deaths were reported.

During the quarter, durable BOT+BAL activity was also reported in checkpoint-refractory melanoma and post-immunotherapy hepatocellular carcinoma, further supporting the combination’s activity across tumors that had resisted prior immunotherapy or multiple lines of treatment.

Expanding Patient Access and Supporting Treatment Continuity
Agenus broadened authorized access to BOT+BAL during the second quarter through France’s national Autorisation d’Accès Compassionnel (AAC) program and physician-led paid named-patient programs in additional countries.

The programs now span a broader network of countries, treating institutions and healthcare professionals. Agenus recognized $6.4 million in pre-commercial product revenue from authorized access programs during the second quarter, compared with $4.6 million in the first quarter of 2026.

As Agenus concentrates its development resources on ROBBIN, the access programs enable the company to continue supporting eligible patients with advanced disease, sustain engagement with experienced treating physicians and advance its neoadjuvant registrational strategy.

As part of prioritizing resources toward the ROBBIN trial, Agenus discontinued its planned future funding commitment to BATTMAN, the Phase 3 study sponsored by the Canadian Cancer Trials Group (CCTG) evaluating BOT+BAL in refractory MSS metastatic colorectal cancer. Agenus was one of the study’s funding sources and supplied BOT+BAL, while CCTG sponsored and conducted the trial. Following Agenus’s funding decision, CCTG formally terminated the study. The decision reflected financing and development priorities and was not driven by enrollment performance, efficacy or safety findings.

Agenus remains committed to supporting continued BOT+BAL treatment for patients already enrolled in BATTMAN when medically appropriate and permitted under applicable requirements. In France, eligible patients may continue to access BOT+BAL through the established national AAC program. Agenus has also established physician-led compassionate-access pathways in Canada, Australia and New Zealand, the other countries in which BATTMAN had been planned to enroll patients. The pathways in Canada, Australia and New Zealand will remain open to new physician requests through December 31, 2026.

Second Quarter 2026 Financial Results
Revenue

Total revenue for the second quarter of 2026 was $34.5 million, compared with $25.7 million a year earlier. This included $6.4 million in pre-commercial BOT+BAL product revenue from authorized patient-access programs and $28.1 million in non-cash royalty revenue, up from $24.8 million. Non-cash royalty revenue relates to royalty interests Agenus previously monetized and does not provide cash to the company.

Total revenue for the first six months of 2026 was $68.3 million, compared with $49.8 million a year earlier, including $11.0 million in pre-commercial product revenue and $57.3 million in non-cash royalty revenue.

Near-Term Milestones

•
Manuscripts with longer-term follow-up from NEST and UNICORN anticipated in the second half of 2026
•
Investigator-sponsored BOT+BAL presentations at ESMO (Free ESMO Whitepaper) 2026
•
ROBBIN initiation and first patient dosing anticipated in the first quarter of 2027
Corporate Webcast Information

Agenus will host a corporate strategy webcast, including a live question-and-answer session, on Thursday, September 10, 2026, at 4:30 p.m. ET. Following the company’s recent financing webcast, the September event will provide a more comprehensive discussion of Agenus’s corporate priorities, including the acceleration of BOT+BAL in neoadjuvant colon cancer through ROBBIN, upcoming clinical and data milestones, and ongoing patient-access efforts. The webcast was previously anticipated for late August; the revised timing allows for broader speaker participation and a more substantive strategic discussion. Additional details, including the agenda and access information, will be announced prior to the event.

(Press release, Agenus, AUG 6, 2026, View Source [SID1234669786])

On August 6, 2026 Circio Holding ASA (OSE: CRNA), a biotechnology company developing novel circular RNA expression technology for gene and cell therapy, reported that it has been selected for an oral presentation at the European Society of Gene and Cell Therapy annual meeting in Hamburg, Germany, 27-30 October 2026.

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The ESGCT Annual Meeting is the leading gene and cell therapy conference in Europe and the second largest globally, recognized as one of the most prestigious scientific meetings in the field. The meeting is widely attended by pharma industry professionals, academics, patient advocacy organizations and life science media. Only a small number of submitted abstracts are selected for oral presentation, underscoring the scientific quality and relevance of the work presented.

"ESGCT is one of the most important international meetings in the gene and cell therapy field, and it is very important for Circio that the organizing committee has selected one of Circio´s abstracts for an oral presentation," said Dr. Thomas B Hansen, CTO of Circio. "Presenting our circVec platform at ESGCT provides an excellent opportunity to showcase how our proprietary DNA vector technology has the potential to significantly enhance next-generation gene and cell therapies to a highly relevant audience of life science and industry leaders. This meeting also provides an important forum to engage with existing and prospective collaborators and partners as we continue to advance our R&D programs and expand commercial opportunities."

Circio has submitted three abstracts for ESGCT 2026, of which one has been selected for oral presentation and two for poster presentation. Further information about the Circio presentations and the full abstract texts will be released on the general abstract publication date, 27 October 2026.

Presentation title: circVec: A DNA Vector Platform Harnessing Intracellular Circular RNA Biogenesis for Next-Generation T Cell Therapies

Session: Non-viral vectors/nanotechnology and RNA therapeutics I

Time & location: Wednesday 28 October at 10:00am – Hamburg, Germany

(Press release, Circio, AUG 6, 2026, View Source [SID1234669740])

On August 5, 2026 Synthekine, Inc., a clinical-stage biotechnology company developing precision cytokine therapeutics, reported the appointment of Susan M. Molineaux, Ph.D., as Chief Executive Officer. Dr. Molineaux brings more than 20 years of C-level biotechnology leadership experience to Synthekine as the company continues to advance STK-012, an engineered α/β-biased IL-2 partial agonist, into late-stage clinical development in non-small cell lung cancer (NSCLC). Dr. Molineaux succeeds Debanjan Ray, who has served as CEO since the company’s founding and will continue to serve as an advisor to Synthekine.

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"On behalf of the board, I am delighted to welcome Susan as CEO," said John Orwin, Chairman of Synthekine. "Her experience and leadership in late-stage oncology drug development will be critical in guiding Synthekine through its next stage of growth."

"I’m honored to join Synthekine at a pivotal moment for the company," said Dr. Molineaux. "Debanjan and the team have built something remarkable – a deep scientific platform and a clear path forward with STK-012. I’m excited to help guide Synthekine through late-stage clinical development and bring a new option to a population of NSCLC patients who face limited treatment choices today."

Dr. Molineaux brings broad leadership experience in the biopharmaceutical industry and has extensive experience guiding companies through clinical development. Previously, she served as CEO and co-founder of Para Therapeutics, Inc., from April 2023 to July 2025. Before this, Dr. Molineaux was CEO and President of Calithera Biosciences, Inc., which she co-founded in June 2010, took public in 2014, and led until March 2023. Prior to this, she co-founded Proteolix in December 2003 and served first as its Chief Scientific Officer and then as CEO. Proteolix was acquired by Onyx Pharmaceuticals, Inc., in November 2009.

Previously, Dr. Molineaux held multiple senior management positions in biopharmaceutical companies, including Vice President of Biology at Rigel Pharmaceuticals, Inc., Vice President of Biology at Praelux, Inc., and Vice President of Drug Development at Praecis Pharmaceuticals, Inc. She currently serves as a Scientific Advisor to Lightstone Ventures, a private life sciences investment company. Dr. Molineaux also brings considerable board experience to Synthekine. She is currently the Executive Chair of Seranova Bio, Inc. and a member of the board at Geron Corporation. She has also served on the boards of Repare Therapeutics, Inc., Cyteir Therapeutics, Inc., and Theravance Biopharma, Inc. Dr. Molineaux holds a B.S. in biology from Smith College, a Ph.D. in molecular biology from Johns Hopkins University, and completed a postdoctoral fellowship at Columbia University.

"The board and I would also like to thank Debanjan for his many accomplishments from founding Synthekine and leading the company over the past seven years," continued Mr. Orwin. "Starting from Synthekine’s formation, he has built the company from its earliest stages of research and has continued its momentum through the advancement of STK-012 into a global, randomized Phase 2 study. His leadership and vision have been instrumental in Synthekine’s success, and we wish him the very best."

"It has been a privilege to lead Synthekine and help turn an ambitious scientific vision into real medicines for patients," said Mr. Ray. "Together, we pioneered new approaches to cytokine engineering, forged partnerships with leading pharmaceutical companies, and advanced STK-012 into a randomized Phase 2 study. I look forward to supporting a smooth transition and watching this team continue to redefine what cytokine therapeutics can do."

(Press release, Synthekine, AUG 5, 2026, View Source [SID1234670271])

On August 5, 2026 CellFiber Co., Ltd. ("CellFiber"), a Tokyo-based biotechnology company built on its proprietary CellFiber cell encapsulation platform, and Tidewave Bio ("Tidewave"), a Los Angeles-based biotechnology company developing a universal, off-the-shelf immunotherapy platform for solid tumors, reported a collaboration to evaluate CellFiber’s closed, automated 3D cell culture platform in support of the scalable manufacturing of Tidewave’s next-generation cell immunotherapy.

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Under the collaboration, the parties have agreed to undertake a joint proof-of-concept evaluation comparing conventional planar (2D) cell culture against CellFiber’s encapsulation (3D) approach for the expansion and differentiation of immune cells relevant to Tidewave’s allogeneic platform. The work, to be conducted at CellFiber’s facility in Tokyo, is designed to generate process performance data that will drive Tidewave’s manufacturing strategy as the program advances, while demonstrating the applicability of the CellFiber platform to off-the-shelf solid tumor immunotherapy manufacturing. Any further activities beyond the proof-of-concept evaluation will be subject to separate written agreement between the parties.

"Tidewave Bio’s mission is to make next-generation cancer immunotherapy accessible to every solid tumor patient, regardless of tumor type, treatment setting, or geography," said Francois Binette, Chief Executive Officer of Tidewave Bio. "Delivering on that mission requires manufacturing approaches that can scale efficiently, reliably, and cost-effectively. We are pleased to partner with CellFiber to evaluate how their innovative encapsulation platform can support our process development strategy as we advance toward the clinic."

"Tidewave Bio is pursuing a genuinely differentiated approach to solid tumor immunotherapy, and we are excited to support their program," said Dr. Kazuchika Furuishi, Representative Director and Chief Executive Officer of CellFiber. "Our CellFiber platform was designed to remove the manufacturing bottlenecks that have historically constrained cell therapy scale-up. This collaboration is an opportunity to demonstrate the value our closed, automated 3D culture system can bring to the next generation of off-the-shelf cell therapies, and to advance our shared vision of making these therapies more widely accessible to patients."

(Press release, Tidewave Bio, AUG 5, 2026, View Source [SID1234669762])