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])