Barinthus Biotherapeutics (NASDAQ: BRNS) posts 2025 loss, pushes ahead with Clywedog all-stock merger
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Barinthus Biotherapeutics reported a 2025 net loss attributable to shareholders of
Research and development expenses declined to
Barinthus recorded a
The company is pursuing an all-stock combination with Clywedog Therapeutics, targeting a closing in the second quarter of 2026 and a new NASDAQ listing as “CLYD.” The combined company is expected to have a cash runway through 2027 and a diversified pipeline in metabolic and autoimmune diseases, including Barinthus’ VTP-1000 celiac program and Clywedog’s diabetes candidates.
Positive
- None.
Negative
- None.
Insights
Deal with Clywedog reshapes Barinthus into a broader metabolic and autoimmune platform while 2025 results show disciplined R&D spend but ongoing losses.
Barinthus Bio exited 2025 as a pre-revenue company, pivoting from infectious disease and oncology toward immunology and inflammation. R&D dropped from
General and administrative costs increased to
The planned all-stock combination, expected to close in
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 13, 2026
(Exact name of registrant as specified in its charter)
| Not Applicable | ||||||||
| (State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) | ||||||
(Address of principal executive offices, including zip code)
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trade Symbol(s) | Name of each exchange on which registered | ||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
*American Depositary Shares may be evidenced by American Depositary Receipts. Each American Depositary Share represents one (1) ordinary share. Not for trading, but only in connection with the listing of the American Depositary Shares on The Nasdaq Global Market. The American Depositary Shares represent the right to receive ordinary shares and are being registered under the Securities Act of 1933, as amended, pursuant to a separate Registration Statement on Form F-6. Accordingly, the American Depositary Shares are exempt from the operation of Section 12(a) of the Securities Exchange Act of 1934, as amended, pursuant to Rule 12a-8.
Item 2.02. Results of Operations and Financial Condition.
On March 13, 2026, Barinthus Biotherapeutics plc (the “Company”) provided an overview of the Company’s progress and announced its financial results for the year ended December 31, 2025. The full text of the press release issued in connection with the update is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in Item 2.02 of this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the "Securities Act"), or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 7.01 Regulation FD Disclosure.
On March 13, 2026, the Company updated its corporate presentation for use in meetings with investors, analysts and others. A copy of this presentation is furnished as Exhibit 99.2 to this Current Report on Form 8-K. The Company undertakes no obligation to update, supplement or amend the presentation.
The information in Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.2) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing by the Company under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such filing.
Additional Information and Where to Find It
In connection with the proposed transaction, the combined company plans to file with the Securities and Exchange Commission (the “SEC”) and mail or otherwise provide to Company’s investors and security holders a registration statement on Form S-4 that will contain a joint proxy statement/prospectus (the “Registration Statement”). THE COMPANY’S INVESTORS AND SECURITY HOLDERS ARE URGED TO CAREFULLY READ THE REGISTRATION STATEMENT IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS FILED BY THE COMPANY WITH THE SEC IN CONNECTION WITH THE PROPOSED TRANSACTION OR INCORPORATED BY REFERENCE THEREIN BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES TO THE PROPOSED TRANSACTION.
Investors and security holders may obtain a free copy of the Registration Statement and other documents that the combined company files with the SEC (when available) from the SEC’s website at www.sec.gov or at investors.barinthusbio.com.
Participants in the Solicitation
Clywedog Therapeutics Inc. (“Clywedog”), the Company and their respective directors, executive officers, other members of management, certain employees and other persons may be deemed to be participants in the solicitation of proxies from the security holders of the Company in connection with the proposed transaction. Security holders may obtain information
regarding the names, affiliations and interests of the Company’s directors and executive officers in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, which was filed with the SEC on March 13, 2026. To the extent holdings of the Company’s securities by the Company’s directors and executive officers have changed since the amounts set forth in such Annual Report on Form 10-K, such changes have been or will be reflected on subsequent Statements of Changes in Beneficial Ownership on Form 4 filed with the SEC. Additional information regarding the interests of such individuals in the proposed transaction will be included in the Registration Statement relating to the proposed transaction when it is filed with the SEC. These documents (when available) may be obtained free of charge from the SEC’s website at www.sec.gov and the Company’s website at investors.barinthusbio.com.
No Offer or Solicitation
This press release is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, and otherwise in accordance with applicable law.
Item 9.01. Financial Statements and Exhibits.
(d)Exhibits
99.1 | Press Release dated March 13, 2026. | ||||
99.2 | Corporate Deck dated March 2026. | ||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | ||||
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Barinthus Biotherapeutics plc | ||||||||
Date: March 13, 2026 | By: | /s/ William Enright | ||||||
| William Enright | ||||||||
| Chief Executive Officer | ||||||||
Barinthus Bio Reports Full Year 2025 Financial Results and Updates on Corporate Developments
•Proposed combination with Clywedog Therapeutics Inc. (“Clywedog”) to create a differentiated company focusing on clinical metabolic and autoimmune pipeline assets and to build on the Company’s base of high caliber institutional investors, expected to complete in the second quarter of 2026
•Multiple ascending dose part of the Phase 1 AVALON trial of VTP-1000 in celiac disease patients is progressing; data expected in the second half of 2026
GERMANTOWN, Maryland, March 13, 2026 (GLOBE NEWSWIRE) – Barinthus Biotherapeutics plc (NASDAQ: BRNS) (“Barinthus Bio,” or the “Company”), today announced its financial results for the year ended December 31, 2025, 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.
“As we move into 2026, we are excited by the proposed combination of Barinthus Bio and Clywedog, which positions us for multiple near-term catalysts emerging from our differentiated and complimentary clinical portfolio.” said Bill Enright, Chief Executive Officer of Barinthus Bio. “We finished 2025 reporting encouraging results from the single ascending dose portion of the Phase 1 AVALON clinical trial of VTP-1000 in celiac disease, and expect multiple ascending dose data in the second half of 2026. These upcoming results will help us confirm whether VTP-1000 has the potential to be disease-modifying by restoring balance to the immune system.”
Corporate Milestones
•In January 2025, Barinthus Bio announced a strategic business refocus and restructuring to prioritize immunology and inflammation indications, including antigen-specific immune tolerance and the development of VTP-1000 in celiac disease. Infectious disease and oncology assets, collectively referred to as "Barinthus legacy assets," which include VTP-300 in chronic hepatitis B ("CHB") and VTP-850 in prostate cancer, were deprioritized for direction operations, and will only be progressed with a partner.
•In May 2025, Barinthus Bio presented data from two Phase 2 clinical trials of VTP-300 in CHB at the European Association for the Study of the Liver (“EASL”) Congress 2025 showing VTP-300 induced meaningful and sustained reductions in hepatitis B surface antigen levels.
•In September 2025, Barinthus Bio announced it had entered into a definitive merger agreement to combine in an all-stock transaction with Clywedog, a private company advancing breakthrough medicines in diabetes. The newly combined company will advance a differentiated portfolio of clinical-stage candidates targeting metabolic and autoimmune diseases, with four clinical data milestones expected within 18 months of the closing of the transaction.
•In December 2025, Barinthus Bio announced that the single ascending dose portion of the Phase 1 AVALON trial (NCT06310291) of VTP-1000 for the treatment of celiac disease had been completed. A total of 18 patients were enrolled in three placebo-controlled cohorts of ascending doses. VTP-1000 was well tolerated at all dose levels with no treatment-related serious adverse events. Pharmacodynamic analyses, including IL-2 response, confirmed T cell recognition of VTP-1000 in celiac patients across cohorts.
•In February 2026, Barinthus Bio announced it had entered into an amendment to the definitive merger agreement with Clywedog to update the exchange ratio framework to provide additional flexibility in finalizing the transaction terms and to revise certain minimum cash requirements to reflect anticipated transaction timing. All other material terms remain unchanged.
Upcoming Milestones
Celiac Disease (VTP-1000):
•Data from the multiple ascending dose portion of the Phase 1 AVALON clinical trial, which includes a gluten challenge following three doses of test medication, is expected in the second half of 2026.
Corporate:
•Barinthus Bio expects to complete the merger with Clywedog in the second quarter of 2026. Upon the closing of the transaction, 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 TPAV, LLC, both existing shareholders in Clywedog, and new investors.
2025 Financial Highlights
•Cash: As of December 31, 2025, cash, cash equivalents and restricted cash were $71.9 million, compared to $112.4 million as of December 31, 2024. The $40.5 million decrease was a result of the net cash used in operating activities of which $48.0 million was used for the development of the Company's pipeline and general corporate expenses, offset by a $7.0 million translational gain from the conversion of balances in pound sterling denominated entities to the United States dollar reporting currency and $0.5 million in proceeds from the sale of equipment in the U.K. following the closure of the site. 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 $25.6 million in 2025 compared to $42.2 million in 2024. The decrease was primarily attributable to reduced activity in the Barinthus legacy asset clinical programs and the reduction in workforce. The year-on-year 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 autoimmune program will continue at current levels or increase, as the clinical development continues.
| Twelve months ended December 31, 2025 | Twelve months ended December 31, 2024 | Change | ||||||||||||||||||
$000 | $000 | $000 | ||||||||||||||||||
| Direct research and development expenses by program: | ||||||||||||||||||||
| VTP-1000 Celiac | $ | 6,063 | $ | 5,486 | $ | 577 | ||||||||||||||
Barinthus legacy assets1 | 8,531 | 18,223 | (9,692) | |||||||||||||||||
| Total direct research and development expenses | 14,594 | 23,709 | (9,115) | |||||||||||||||||
| Indirect research and development expenses: | ||||||||||||||||||||
| Personnel-related (including share-based compensation) | 8,413 | 15,867 | (7,454) | |||||||||||||||||
| Facility related | 1,370 | 1,249 | 121 | |||||||||||||||||
| Other indirect costs | 1,187 | 1,411 | (224) | |||||||||||||||||
| Total indirect research and development expenses | 10,970 | 18,527 | (7,557) | |||||||||||||||||
| Total research and development expense | $ | 25,564 | $ | 42,236 | $ | (16,672) | ||||||||||||||
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 $40.8 million in 2025, compared to $29.7 million in 2024. The increase of $11.1 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 attributable to strategic activity, partially offset by decreases in personnel-related expenses and other costs following the strategic prioritization in the year.
•Impairment of Intangible Assets: Impairment of intangible assets expense was $4.7 million in 2025, compared to nil in 2024. The anticipated valuation of the company, as implied by the definitive merger agreement with Clywedog entered into in the year, was less than the carrying value of the net assets and therefore resulted in an impairment of the intangible assets in the third quarter of 2025.
•Net Loss: For the financial year 2025, the Company generated a net loss attributable to its shareholders of $66.5 million, or $(1.64) per share on both basic and fully diluted bases, compared to a net loss attributable to its shareholders of $61.1 million, or $(1.55) per share on both basic and fully diluted bases for the financial year 2024.
About Barinthus Bio
Barinthus Biotherapeutics (NASDAQ: BRNS) is a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates designed to guide the immune system to overcome autoimmunity and chronic infectious diseases. Helping people and their families living with serious diseases is the guiding principle at the heart of Barinthus Bio. With a focused pipeline built around its proprietary platform technologies, Barinthus Bio is advancing immunotherapeutic product candidates in autoimmunity including: VTP-1000, which utilizes the Company's SNAP-Tolerance Immunotherapy (SNAP-TI) platform and is designed to treat people with celiac disease. Barinthus Bio’s differentiated technology platform and therapeutic approach, coupled with deep scientific expertise and focus on clinical development, positions the Company to navigate towards delivering treatments that improve the lives of people with autoimmunity. For more information, visit www.barinthusbio.com.
Forward Looking Statements
This press release contains forward-looking statements regarding Barinthus Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which can generally be identified as such by use of the words “may,” “will,” “plan,” “forward,” “encouraging,” “believe,” “potential,” “expect,” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements include, without limitation, express or implied statements regarding future expectations, plans and prospects, including product development activities and clinical trials, including timing for readouts of any preliminary, interim or final data for any of our programs, the timing for initiation of any clinical trials, anticipated regulatory filings and approvals, the Company’s cash runway and cash burn, the Company’s ability to develop and advance current and future product candidates and programs,the Company’s ability to establish and maintain collaborations or strategic relationships, the proposed transaction with Clywedog, the exchange of equity interests contemplated by the merger agreement, the issuance of shares of common stock of the newly formed combined company contemplated by the merger agreement, including the final exchange ratios, the anticipated percentage of the combined company securities to be received by Clywedog and Barinthus Bio shareholders in connection with the proposed transaction, the expected timing of the closing of the proposed transaction, the ability of the parties to complete the proposed transaction considering the various closing conditions, the expected benefits of the proposed transaction, the competitive ability and position of the combined company after completion of the proposed transaction, the anticipated impact of the proposed transaction on the combined company’s business and future financial and operating results, including without limitation the expected cash runway of the combined company, and the expected or estimated amount, achievability, sources, impact and timing of cost synergies and revenue, growth, operational enhancement, expansion and other value creation opportunities from the proposed transaction. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to numerous risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to the success, cost and timing of the Company’s pipeline development activities and planned and ongoing clinical trials, including the risk that the timing for preliminary, interim or final data or initiation of clinical trials may be delayed, the risk that interim or topline data may not reflect final data or results, the Company’s ability to execute on strategy, regulatory developments, the risk that the Company may not achieve the anticipated benefits of our pipeline prioritization and corporate restructuring, the Company’s ability to fund its operations and access capital, the Company’s cash runway, including the risk that the estimate of the cash runway may be incorrect, the risk that the proposed transaction may not be completed in a timely manner or at all, which may adversely affect our business and the price of our securities, the risk that that the proposed transaction may involve unexpected costs, liabilities or delays, or divert management’s attention from our ongoing business operations, the risk of any legal proceedings related to the proposed transaction or otherwise, or the impact of the proposed transaction thereupon, the risk that the anticipated benefits of the proposed transaction may otherwise not be fully realized or may take longer to realize than expected, risks relating to the value of the combined company securities to be issued in the proposed transaction, the risks associated with global economic uncertainty, including disruptions in the banking industry, the conflicts in Ukraine, Iran, Israel and Gaza, the disruptions in U.S. federal government operations, tariffs imposed by the U.S. and other countries, and the other risks identified in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including the Company’s most recent annual report on Form 10-K and subsequent filings the Company may make with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company expressly disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Additional Information and Where to Find It
In connection with the proposed transaction, the combined company plans to file with the SEC and mail or otherwise provide to Barinthus Bio's investors and security holders a registration statement on Form S-4 that will contain a joint proxy statement/prospectus (the “Registration Statement”). BARINTHUS BIO’S INVESTORS AND SECURITY HOLDERS ARE URGED TO CAREFULLY READ THE REGISTRATION STATEMENT IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS FILED BY BARINTHUS BIO WITH THE SEC IN CONNECTION WITH THE PROPOSED TRANSACTION OR INCORPORATED BY REFERENCE THEREIN BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES TO THE PROPOSED TRANSACTION.
Investors and security holders may obtain a free copy of the Registration Statement and other documents that the combined company files with the SEC (when available) from the SEC’s website at www.sec.gov or at investors.barinthusbio.com.
No Offer or Solicitation
This press release is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, and otherwise in accordance with applicable law.
Participants in the Solicitation
Clywedog, Barinthus Bio and their respective directors, executive officers, other members of management, certain employees and other persons may be deemed to be participants in the solicitation of proxies from the security holders of Barinthus Bio in connection with the proposed transaction. Security holders may obtain information regarding the names, affiliations and interests of Barinthus Bio’s directors and executive officers in Barinthus Bio’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, which was filed with the SEC on March 13, 2026. To the extent holdings of Barinthus Bio’s securities by Barinthus Bio’s directors and executive officers have changed since the amounts set forth in such Annual Report on Form 10-K, such changes have been or will be reflected on subsequent Statements of Changes in Beneficial Ownership on Form 4 filed with the SEC. Additional information regarding the interests of such individuals in the proposed transaction will be included in the Registration Statement relating to the proposed transaction when it is filed with the SEC. These documents (when available) may be obtained free of charge from the SEC’s website at www.sec.gov and Barinthus Bio’s website at investors.barinthusbio.com.
BARINTHUS BIOTHERAPEUTICS PLC
CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)
(UNAUDITED)
| As of December 31, 2025 | As of December 31, 2024 | |||||||||||||
| ASSETS | ||||||||||||||
| Cash and cash equivalents | $ | 70,456 | $ | 110,662 | ||||||||||
| Restricted cash | 1,396 | 1,738 | ||||||||||||
| Research and development incentives receivable | 1,108 | 7,139 | ||||||||||||
| Prepaid expenses and other current assets | 4,830 | 6,203 | ||||||||||||
| Total current assets | 77,790 | 125,742 | ||||||||||||
| Property and equipment, net | 3,523 | 7,373 | ||||||||||||
| Intangible assets, net | 14,288 | 21,947 | ||||||||||||
| Right of use assets, net | 1,638 | 4,384 | ||||||||||||
| Other assets | 930 | 881 | ||||||||||||
| Total assets | $ | 98,169 | $ | 160,327 | ||||||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||||||||
| Current liabilities: | ||||||||||||||
| Accounts payable | 350 | 2,474 | ||||||||||||
| Accrued expenses and other current liabilities | 6,249 | 9,525 | ||||||||||||
| Deferred income | 1,396 | 1,738 | ||||||||||||
| Operating lease liability - current | 2,023 | 1,920 | ||||||||||||
| Total current liabilities | 10,018 | 15,657 | ||||||||||||
| Non-current liabilities: | ||||||||||||||
| Operating lease liability - non-current | 9,258 | 10,087 | ||||||||||||
| Contingent consideration | 2,871 | 2,650 | ||||||||||||
| Other non-current liabilities | 1,476 | 1,360 | ||||||||||||
| Deferred tax liability, net | 254 | 438 | ||||||||||||
| Total liabilities | $ | 23,877 | $ | 30,192 | ||||||||||
| Commitments and contingencies (Note 16) | ||||||||||||||
| Stockholders’ equity: | ||||||||||||||
Ordinary shares, £0.000025 nominal value; 40,848,893 shares authorized, issued and outstanding (December 31, 2024: authorized, issued and outstanding: 40,234,663) | 1 | 1 | ||||||||||||
Deferred A shares, £1 nominal value; 63,443 shares authorized, issued and outstanding (December 31, 2024: authorized, issued and outstanding: 63,443) | 86 | 86 | ||||||||||||
| Additional paid-in capital | 393,944 | 393,474 | ||||||||||||
| Accumulated deficit | (304,092) | (237,664) | ||||||||||||
| Accumulated other comprehensive loss – foreign currency translation adjustments | (15,731) | (25,868) | ||||||||||||
| Total stockholders’ equity attributable to Barinthus Biotherapeutics plc shareholders | 74,208 | 130,029 | ||||||||||||
| Noncontrolling interest | 84 | 106 | ||||||||||||
| Total stockholders’ equity | $ | 74,292 | $ | 130,135 | ||||||||||
| Total liabilities and stockholders’ equity | $ | 98,169 | $ | 160,327 | ||||||||||
BARINTHUS BIOTHERAPEUTICS PLC
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)
(UNAUDITED)
| Twelve months ended | ||||||||||||||
| December 31, 2025 | December 31, 2024 | |||||||||||||
License revenue 1 | $ | — | $ | 14,969 | ||||||||||
| Total revenue | — | 14,969 | ||||||||||||
| Operating expenses | ||||||||||||||
| Research and development | $ | 25,564 | $ | 42,236 | ||||||||||
| General and administrative | 40,830 | 29,670 | ||||||||||||
| Impairment of intangible assets | 4,667 | — | ||||||||||||
| Goodwill impairment | — | 12,209 | ||||||||||||
| Total operating expenses | 71,061 | 84,115 | ||||||||||||
| Other operating income | 506 | 1,176 | ||||||||||||
| Loss from operations | (70,555) | (67,970) | ||||||||||||
| Other income/(expense): | ||||||||||||||
| Interest income | 1,957 | 2,678 | ||||||||||||
| Interest expense | (51) | (53) | ||||||||||||
| Research and development incentives | 2,000 | 3,983 | ||||||||||||
| Other income | 16 | 135 | ||||||||||||
| Total other income, net | 3,922 | 6,743 | ||||||||||||
| Loss before income tax | (66,633) | (61,227) | ||||||||||||
| Tax benefit | 175 | 44 | ||||||||||||
| Net loss | (66,458) | (61,183) | ||||||||||||
| Net loss attributable to noncontrolling interest | 30 | 109 | ||||||||||||
| Net loss attributable to Barinthus Biotherapeutics plc shareholders | (66,428) | (61,074) | ||||||||||||
| Weighted-average ordinary shares outstanding, basic | 40,527,218 | 39,348,240 | ||||||||||||
| Weighted-average ordinary shares outstanding, diluted | 40,527,218 | 39,348,240 | ||||||||||||
| Net loss per share attributable to ordinary shareholders, basic | $ | (1.64) | $ | (1.55) | ||||||||||
| Net loss per share attributable to ordinary shareholders, diluted | $ | (1.64) | $ | (1.55) | ||||||||||
| Net loss | $ | (66,458) | $ | (61,183) | ||||||||||
| Other comprehensive gain/(loss) – foreign currency translation adjustments | 10,145 | (2,549) | ||||||||||||
| Comprehensive loss | (56,313) | (63,732) | ||||||||||||
| Comprehensive loss/(gain) attributable to noncontrolling interest | 22 | 105 | ||||||||||||
| Comprehensive loss attributable to Barinthus Biotherapeutics plc shareholders | $ | (56,291) | $ | (63,627) | ||||||||||
1 Includes license revenue from related parties for the year ended December 31, 2025 of nil (year ended December 31, 2024: $15.0 million).
Company contact:
ir@barinthusbio.com
Barinthus Biotherapeutics Corporate Presentation Guiding the Immune System to Cure Disease March 2026 Nasdaq: BRNS
Disclosure 2 Cautionary Statement Regarding Forward-Looking Statements This presentation contains forward-looking statements within the meaning of federal securities laws, including the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based upon current plans, estimates and expectations of management of Clywedog and Barinthus Bio, in light of historical results and trends, current conditions and potential future developments, and are subject to various risks and uncertainties that could cause actual results to differ materially from such statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “possible,” “potential,” “project,” “pursue,” “should,” “target,” “will,” “would” and words and terms of similar substance used in connection with any discussion of future plans, actions or events identify forward-looking statements. All statements, other than historical facts, including express or implied statements regarding the proposed transaction; the conversion of equity interests contemplated by the Merger Agreement; the issuance of shares of common stock of newly formed combined company contemplated by the Merger Agreement; implementation of the proposed transaction through a UK scheme of arrangement and the merger of Clywedog into a wholly owned subsidiary of the combined company; the anticipated percentage of the combined company securities to be received by Clywedog and Barinthus Bio shareholders in connection with the proposed transaction; the expected timing of the closing of the proposed transaction; the ability of the parties to complete the proposed transaction considering the various closing conditions; the expected benefits of the proposed transaction; the competitive ability and position of the combined company after completion of the proposed transaction; future events and anticipated results of operations; business strategies; the anticipated impact of the proposed transaction on the combined company’s business and future financial and operating results; the expected or estimated amount, achievability, sources, impact and timing of cost synergies and revenue, growth, operational enhancement, expansion and other value creation opportunities from the proposed transaction; and any assumptions underlying any of the foregoing, are forward-looking statements. Important factors that could cause actual results to differ materially from Clywedog’s and Barinthus Bio’s plans, estimates or expectations described in such forward-looking statements could include, but are not limited to: (i) the risk that the proposed transaction may not be completed in a timely manner or at all, which may adversely affect Clywedog’s and Barinthus Bio’s businesses and the price of their respective securities; (ii) uncertainties as to the timing of the consummation of the proposed transaction; (iii) the potential failure to receive, on a timely basis or otherwise, the required approvals of the proposed transaction, including stockholder approvals by both Clywedog’s shareholders and Barinthus Bio’s shareholders and the sanction of the High Court of Justice of England and Wales to the Scheme of Arrangement, and the potential failure to satisfy the other conditions to the consummation of the transaction, including the consummation of a self-tender offer as previously disclosed; (iv) that the proposed transaction may involve unexpected costs, liabilities or delays; (v) the effect of the announcement, pendency or completion of the proposed transaction on each of Clywedog’s or Barinthus Bio’s ability to attract, motivate, retain and hire key personnel and maintain relationships with customers, distributors, suppliers and others with whom Clywedog or Barinthus Bio does business, or on Clywedog’s or Barinthus Bio’s operating results and business generally; (vi) that the proposed transaction may divert management’s attention from each of Clywedog’s and Barinthus Bio’s ongoing business operations; (vii) the risk of any legal proceedings related to the proposed transaction or otherwise, or the impact of the proposed transaction thereupon, including resulting expense or delay; (viii) that Clywedog or Barinthus Bio may be adversely affected by other economic, business and/or competitive factors; (ix) the occurrence of any event, change or other circumstance that could give rise to the termination of the Merger Agreement relating to the proposed transaction; (x) the risk that restrictions during the pendency of the proposed transaction may impact Clywedog’s or Barinthus Bio’s ability to pursue certain business opportunities or strategic transactions; (xi) the risk that Clywedog or Barinthus Bio may be unable to obtain governmental and regulatory approvals required for the proposed transaction, or that required governmental and regulatory approvals may delay the consummation of the proposed transaction or result in the imposition of conditions that could reduce the anticipated benefits of the proposed transaction or cause the parties to abandon the proposed transaction; (xii) the risk that the anticipated benefits of the proposed transaction may otherwise not be fully realized or may take longer to realize than expected; (xiii) the impact of legislative, regulatory, economic, competitive and technological changes; (xiv) risks relating to the value of the combined company securities to be issued in the proposed transaction; (xv) the risk that integration of the proposed transaction post-closing may not occur as anticipated or the combined company may not be able to achieve the growth prospects expected from the transaction; (xvi) the effect of the announcement, pendency or completion of the proposed transaction on the market price of the ADSs of Barinthus Bio; (xvii) the implementation of each of Clywedog’s and Barinthus Bio’s business model and strategic plans for product candidates and pipeline, and challenges inherent in developing, commercializing, manufacturing, launching, marketing and selling potential existing and new products; (xviii) the scope, progress, results and costs of developing Clywedog’s and Barinthus Bio’s product candidates and any future product candidates, including conducting preclinical studies and clinical trials, and otherwise related to the research and development of Clywedog’s and Barinthus Bio’s pipeline; (xix) the timing and costs involved in obtaining and maintaining regulatory approval for Clywedog’s and Barinthus Bio’s current or future product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product; (xx) the market for, adoption (including rate and degree of market acceptance) and pricing and reimbursement of Clywedog’s and Barinthus Bio’s product candidates and their respective abilities to compete with therapies and procedures that are rapidly growing and evolving; (xxi) uncertainties in contractual relationships, including collaborations, partnerships, licensing or other arrangements and the performance of third-party suppliers and manufacturers; (xxii) the ability of each of Clywedog and Barinthus Bio to establish and maintain intellectual property protection for their respective product candidates and products or avoid or defend claims of infringement; (xxiii) exposure to inflation, currency rate and interest rate fluctuations and risks associated with doing business locally and internationally, as well as fluctuations in the market price of the ADSs of Barinthus Bio; (xxiv) risks relating to competition within the industry in which each of Clywedog and Barinthus Bio operates; (xxv) the unpredictability and severity of catastrophic events, including, but not limited to, acts of terrorism or outbreak of war or hostilities; (xxvi) whether the termination of any of Clywedog’s or Barinthus Bio’s license agreements and/or collaboration agreements may impact the combined company’s ability to license in additional programs in the future and the risk of delays or unforeseen costs in terminating such arrangements; and (xxvii) Clywedog’s and Barinthus Bio’s response to any of the aforementioned factors. Additional factors that may affect the future results of Barinthus Bio are set forth in Barinthus Bio’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including Barinthus Bio’s most recently filed registration statement to register the common stock, $0.0001 par value per share, of the combined company (“Topco Common Stock”) to be issued in connection with the proposed transaction (the “Registration Statement”), Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, which are available on the SEC’s website at www.sec.gov. See in particular Item 1A of each of Barinthus Bio’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 under the headings “Risk Factors.” The risks and uncertainties described above and in the SEC filings cited above are not exclusive and further information concerning Clywedog and Barinthus Bio and their respective businesses, including factors that potentially could materially affect their respective businesses, financial conditions or operating results, may emerge from time to time. While the list of factors presented here is, and the list of factors presented in the Registration Statement are, considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Readers are urged to consider these factors carefully in evaluating these forward-looking statements, and not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. Except as required by law, each of Clywedog and Barinthus Bio assumes no obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.
Disclosure Additional Information and Where to Find It In connection with the proposed transaction, the combined company filed the Registration Statement with the SEC. The Registration Statement includes a proxy statement/prospectus which will be mailed or otherwise provided to Barinthus Bio’s investors and security holders of Topco Common Stock. BARINTHUS BIO’S INVESTORS AND SECURITY HOLDERS ARE URGED TO CAREFULLY READ THE REGISTRATION STATEMENT AND THE RELATED PROXY STATEMENT/PROSPECTUS, AS WELL AS ANY AMENDMENT OR SUPPLEMENTS TO THOSE DOCUMENTS IN THEIR ENTIRETY AND ANY OTHER DOCUMENTS FILED BY BARINTHUS BIO WITH THE SEC IN CONNECTION WITH THE PROPOSED TRANSACTION OR INCORPORATED BY REFERENCE THEREIN BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES TO THE PROPOSED TRANSACTION. Investors and security holders may obtain a free copy of the Registration Statement and other documents that the combined company files with the SEC (when available) from the SEC’s website at www.sec.gov or at investors.barinthusbio.com. No Offer or Solicitation This presentation is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, and otherwise in accordance with applicable law. Participants in the Solicitation Clywedog, Barinthus Bio and their respective directors, executive officers, other members of management, certain employees and other persons may be deemed to be participants in the solicitation of proxies from the security holders of Barinthus Bio in connection with the proposed transaction. Security holders may obtain information regarding the names, affiliations and interests of Barinthus Bio’s directors and executive officers in Barinthus Bio’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, which was filed with the SEC on March 13, 2026. To the extent holdings of Barinthus Bio’s securities by Barinthus Bio’s directors and executive officers have changed since the amounts set forth in such Annual Report on Form 10-K, such changes have been or will be reflected on subsequent Statements of Changes in Beneficial Ownership on Form 4 filed with the SEC. Additional information regarding the interests of such individuals in the proposed transaction will be included in the Registration Statement relating to the proposed transaction when it is filed with the SEC. These documents (when available) may be obtained free of charge from the SEC’s website at www.sec.gov and Barinthus Bio’s website at investors.barinthusbio.com. 3
Our Mission To advance the next generation of immunotherapies for autoimmunity and inflammatory diseases.
Company Overview 5 About us • Barinthus Bio is developing immunotherapies for autoimmunity and other inflammatory diseases (“I&I”) • Focusing on leveraging proprietary SNAP-TI platform to restore immune tolerance SNAP-TI Platform • Differentiated platform for antigen-specific immune tolerance, potentially more effective & patient friendly • Aims to reduce inflammation & restore the natural state of immune non-responsiveness to healthy tissue • Lead candidate, VTP-1000, is a celiac disease immunotherapy in ongoing Phase 1 trial in celiac patients • Phase 1 SAD portion showed VTP-1000 was well-tolerated and stimulated a targeted immune response Strong balance sheet: • Cash of $71.8 million1 • Outstanding ordinary shares: 40.8 million2 Financials 1 Including cash, cash equivalents and restricted cash as of December 31, 2025, as reported on Form 10-K on March 13, 2026. 2 The number of shares outstanding of the registrant’s ordinary shares as of March 6, 2026, as reported on Form 10-K on March 13, 2026 Transaction Summary • Announced combination with Clywedog Therapeutics pending with anticipated closing in 2Q 2026 • Diversifies pipeline with additional focus on Type 1 and Type 2 diabetes • Multiple value driving milestones • Proposed combination with Clywedog will enhance shareholder base • No debt or outstanding warrants
Antigen-Specific Immune Tolerance (ASIT) is a Targeted, Disease-Modifying Approach to I&I Diseases 6 I&I Diseases Indication Areas: • Autoimmune diseases • Allergy • Transplant rejection • Other inflammatory diseases I&I Therapeutics are Evolving ASIT, a promising targeted approach Current challenges • Limited antigen coverage • Often requires IV administration • Tolerability and ADAs • Adequacy of Treg response Treg cell therapies and promoters Broad T cell and B cell depletion Anti-cytokine antibodies SNAP-TI designed to address each Teff cell activation Autoantibody production Cytokine imbalance Result of an imbalance of the immune system, wrongly attacking our own tissues Novel broad-acting therapeutics showing potential in certain I&I diseases Addressing underlying disease by increasing Treg/Teff ratio Teff: T effector cell Treg: T regulatory cell ADA: Anti-drug antibodies Effector T cells (Teff)Regulatory T cells (Treg)
Teff 7 SOURCE: Based on unpublished preclinical data, Barinthus Bio, Data on File. APC: Antigen presenting cell; Treg: Regulatory T cell; Teff: Effector T cell. (II) Anergy or clonal deletion (I) Induction or transdifferentiation SNAP-TI targets lymph node APCs, critical for T cell immunity Treg SNAP-TI polarizes to Treg phenotype, restoring immune homeostasis Cytokines (e.g. IL-10) APC Target tissue cells Characteristics and Mechanism of Action SNAP-TI Designed to Promote Antigen-Specific Tolerance Enables • Broad antigen coverage • Patient friendly intramuscular/subcutaneous routes • Based on preclinical data, potentially improved tolerability and increased Treg/Teff ratio Self-Assembling Nanoparticle • Co-delivery of multiple disease- associated antigens and an immunomodulator • Nanoparticles of precise composition for ease of manufacturing SNAP-TI
8 SNAP-TI Ameliorates Disease by Increasing Treg:Teff Ratio 1 Unpublished preclinical data, Barinthus Bio, Data on File. EAE: Experimental autoimmune encephalomyelitis MOG: myelin oligodendrocyte glycoprotein Preclinical Results in EAE, a mouse model of Multiple Sclerosis (MS) Efficacy is antigen-specific (T cell mediated) Protection against re- challenge suggests immune memory mTOR inhibitor rapamycin: • improves Treg:Teff ratio • prevents toxicity associated with exposure to disease antigen • prevents Anti-drug Abs MoA and disease amelioration observed in multiple CD4- (e.g., MS) and CD8- (e.g., T1D) driven mouse disease models mTORi: mechanist target of rapamycin T1D: Type 1 diabetes Protection against disease onset1 Reverses established disease1 Treatment days 0 20 40 0 1 2 3 4 Days after disease induction D is e a s e s c o re Treatment days [1] Vehicle [6] SNAPvax TV MOG; Rapamycin; 40 nmol Vehicle control SNAP-TI (MOG + mTORi) 0 5 10 15 20 0 1 2 3 4 Days after disease induction D is e a s e s c o re Increased Treg:Teff ratio1 Vehicle control SNAP-TI (MOG + mTORi) SNAP-TI (MOG) SNAP-TI (irrelevant Ag + mTORi) 0 5 10 15 20 0 1 2 3 4 Day D is e a s e s c o re Legend Legend Legend Legend 0 5 10 15 20 0 1 2 3 4 Day D is e a s e s c o re Legend Legend Legend Legend 0 5 10 15 20 0 1 2 3 4 Day D is e a s e s c o re Legend Legend Legend Legend 0.0 0.6 1.2 1.8 2.4 T re g /T e ff r a ti o
VTP-1000 Celiac Disease Immunotherapeutic Guiding the immune system to cure disease
10 VTP-1000 • In celiac disease, effector T cells attack the lining of the small intestine, overwhelming the regulatory T cells that usually prevent autoimmunity and unwanted inflammation. • VTP-1000 aims to induce tolerance to gluten by reducing effector T cells and increasing regulatory T cells in a disease-specific manner to guide the immune system to tolerate gluten. Celiac disease Treatment goal Regulatory T cells Effector T cells VTP-1000 Regulatory T cells Effector T cells of people have Celiac Disease worldwide1~1% of patients are not able to adhere to a strict Gluten-Free Diet 2 ~60% of patients are Non-Responsive 3 ~20% current FDA/EMA approved treatments0 1Celiac Disease Foundation. 2024. 2Rubin, G., et al. (2009) Aliment Pharmacol Ther. 30(4), 315-330. 3Leffler, DA., et al (2007) Clin Gastroenterol Hepatol. 5(4),445-450. Celiac Disease: A Loss of Immune Tolerance to Gluten Celiac disease damages the small intestine and can cause long-lasting health problems
VTP-1000: Clinical Stage Celiac Disease Immunotherapy 11 • Celiac disease has well-defined gluten-derived antigens • Clinical POC in field that ASIT can mediate efficacy in Celiac • VTP-1000 comprises key antigens from gluten proteins and the mTOR immunomodulator rapamycin • VTP-1000 is administered by the IM route o Patient friendly compared to other ASIT approaches (IV) o SC route shown to be effective in preclinical models o SC route planned to be explored in clinic to enable autoinjector • Preclinical data suggest nanoparticle and immunomodulator provide potential key advantages of o Improved Treg skewing o Reduced risk of antigen-associated inflammation • Status: SAD portion of Phase 1 trial complete; MAD ongoing 20 nm Gluten derived peptide antigens Immunomodulator (mTOR inhibitor) .. . Self-assembling nanoparticle VTP-1000
12 VTP-1000 antigens recognized by Celiac disease subjects (n=6) VTP-1000 observed to reduce IL-2 and other inflammatory cytokines* *IL-1, IL-6, IL-8, TNF, IFNg, etc. VTP-1000 1Unpublished preclinical data, Barinthus Bio, Data on File. Irrelevant antigens or VTP-1000 incubated with subject whole blood and assessed for recognition by T cells Other tissues ✓ Liver ✓ Spleen 0.0 0.1 0.2 5 10 15 1 10 100 Time (days) F lu o re s c e n c e in te n s it y (F o ld c h a n g e ) Intestines VTP-1000 Free peptide TP-1000 Gluten peptides Gluten peptides or VTP-1000 incubated with subject (n=6) blood VTP-1000 traffics to draining lymph nodes and remains detectable in APCs past day 15 – key for strong immune response 0.0 0.2 5 10 15 0 50 100 Time (days) F re q u e n c y ( % ) a n ti g e n p o s it iv e 0.01 0.1 1 10 M a g n it u d e 0 10 20 30 IL -2 ( p g /m L ) ✱ ✓ Intestines VTP-1000 accesses majority of APCs in lymphoid and disease tissue VTP-1000 Preclinical Data Showed Potential for Differentiation
13 Key Inclusion Criteria Part A – Single Ascending Dose (n=18) Part B – Multiple Ascending Dose (n=24) Key Primary Endpoints VTP-1000 Dose Levels VTP-1000 Placebo Part A Part B 1 n=4 n=6 n=2 2 n=4 n=6 n=2 3 n=4 n=6 n=2 • Safety: incidence of AEs and SAEs. • Changes from baseline in anti-tissue transglutaminase immunoglobulin A antibodies. Other Outcome Measures • Serum cytokine (IL-2) concentrations. • Diagnosis of celiac disease as confirmed by positive serology and intestinal histology. • Well-controlled, gluten restricted diet ≥12 months. Study Reference: NCT06310291. Dosing End of Follow up Day 1 Day 22 Day 1 Day 57Day 15 Day 29 Day 43 Dosing Dosing Dosing End of Follow up Gluten Challenge Sequential dosing levels: 7-day gap from first 2 participants at each level and safety review before escalation to next dosing level. Single ascending dose completed: Q4 2025 Multiple ascending dose part ongoing: H2 2026 AVALON: Phase 1 – MAD Portion Ongoing Objective: Evaluating safety and tolerability of single and multiple doses of VTP-1000 in participants with Celiac disease
AVALON SAD Showed VTP-1000 was Well-Tolerated and Induced an Immunological Response 14 VTP-1000 0 10 20 30 0.01 0.1 1 10 100 1000 Sera IL-2 all cohorts QC Time (hours) IL -2 ( p g /m l) Placebo 1 - Low 2 - Medium 3 - High VTP-1000 IL-2 response shows pharmacodynamic effectVTP-1000 was Well-Tolerated ✓ No Treatment Emergent Adverse Events (TEAE) Above Grade 2 ✓ 83% of patients receiving active (n=12) and 83% of patients receiving placebo (n=5) had TEAE ✓ Clinical labs generally unchanged 1 Unpublished clinical data, Barinthus Bio, Data on File.
15 Key Design Features Optimal Design • Self assembling 20 nm nanoparticle. • Large loading capacity of a broad range of targetable antigens. Lymph Node Targeting • Optimally accesses lymph node APCs. • Key for T cell immunity. Co-delivered Immunomodulator • Efficacy: Enhanced Treg/Teff ratio. • Safety: Prevents antigen associated toxicity. Ease of Route of Administration • Intramuscular/subcutaneous injection. • Key for patient compliance. SNAP-TI Supporting Package VTP-1000 Diverse targetable indications e.g., Celiac, Type 1 diabetes, Rheumatoid arthritis, Vitiligo, Primary biliary cholangitis and more… Broad Applicability: • Range of disease-associated antigens • Various disease mechanisms • Different tissues The First Step Towards a Growing SNAP-TI Pipeline Preclinical proof-of-concept in a variety of disease models: AVALON SAD complete • Well-tolerated • Antigens recognized • Dose-dependent response AVALON MAD underway
Company Highlights Guiding the immune system to cure disease
Barinthus Bio and Clywedog Combination Creates Company Focused on Metabolic and Autoimmune Diseases 17 Transaction Summary • The transaction is structured as an all-stock transaction; combined company will operate under newly formed parent entity • Prior to the closing of the transaction, the combined company may commence a partial tender offer to acquire shares of the newly issued shares of the combined company held by Barinthus Bio shareholders for an aggregate offer price of up to $27 million • The transaction is expected to close in Q2 of 2026 with the combined company supported by existing cash and additional investments by OrbiMed and Torrey Pines Investment, both existing shareholders in Clywedog, and new investors Company Overview • Combined company will assume the name “Clywedog Therapeutics, Inc.” and trade on the NASDAQ under the new ticker symbol “CLYD” • Management team will be composed of members from both companies with Bill Enright serving as CEO • The combined company’s Board of Directors will be led by Executive Chairman Iain Dukes, MA, D.Phil (CEO of Clywedog and a venture partner at OrbiMed) and include Bill Enright and additional designees of each of Barinthus Bio and Clywedog • Estimated cash runway for combined company extends through 2027 Catalyst Rich Pipeline • Diversified pipeline will include three assets with broad potential for treating metabolic and autoimmune diseases, with an initial focus on Type 1 diabetes (T1D) and Type 2 diabetes (T2D) and celiac disease • Four key value-driving milestones including clinical POC in multiple indications
18 1Based on Barinthus managements’ current estimates on expected clinical data milestones. Product Candidate Description Preclinical Phase 1 Phase 2 Phase 3 Status CLY-101 (Balomenib) Menin PPI Inhibitor for Type 1/2 Diabetes Ph 1b ongoing CLY-201 TYK2 Inhibitor for Type 1 Diabetes Ph 1a complete VTP-1000 Tolerance Immunotherapy for Celiac disease Ph 1 MAD Ongoing; Data anticipated H2 ‘261 Clywedog Candidates Bartinthus Bio Candidate Combined Portfolio Rich with Near-Term Clinical Milestones
19 CLY-201CLY-101 (Balomenib) Description Reversible menin inhibitor, designed to avoid 1st gen liabilities Disease Area T2D & T1D Potential MOA Increased insulin production & glycemic control through proliferation of beta cells and increased GLP-1R expression Unmet Need Addressed Potentially disease modifying with durable benefit ROA Oral Status Ph 1b in T2D patients ongoing TYK2 JH2 inhibitor T1D Halt or delay disease progression by inflammatory cytokines implicated in disease progression Delay or prevent Type 1 diabetes in patients with recent onset Oral Ph 1 healthy volunteer complete VTP-1000 Immunotherapy comprising celiac antigens and immunomodulator Celiac Disease Induce tolerance to gluten by reducing effector T cells and increasing regulatory T cells Prevent or reduce symptoms associated with gluten exposure Intramuscular/Subcutaneous Ph 1 MAD in celiac patients ongoing Portfolio of Disease-Modifying Clinical Candidates
Financial Overview and Catalysts 20 Guiding the immune system to cure disease Cash $ 71.8 million1 as of December 31, 2025 No debt or outstanding warrants Expected near-term catalyst2 2H 2026 VTP-1000 (Celiac): Phase 1 multiple ascending dose data 1 Including cash, cash equivalents and restricted cash as of December 31, 2025, as reported on Form 10-K on March 13, 2026. 2Q 2026 Closing combination with Clywedog
Guiding the Immune System to Cure Disease Thank You
FAQ
How did Barinthus Biotherapeutics (BRNS) perform financially in 2025?
Barinthus Biotherapeutics reported a 2025 net loss of $66.5 million, or $(1.64) per share, compared with a $61.1 million loss in 2024. Total revenue dropped to zero from $15.0 million of license revenue, reflecting the absence of prior-year licensing income.
What is the status of Barinthus Biotherapeutics’ merger with Clywedog Therapeutics?
Barinthus Bio has a definitive all-stock merger agreement with Clywedog, aiming to close in the second quarter of 2026. The combined company will be renamed Clywedog Therapeutics, Inc., trade on NASDAQ as “CLYD,” and is expected to have cash runway through 2027.
What were Barinthus Biotherapeutics’ cash levels and runway at year-end 2025?
As of December 31, 2025, Barinthus held $71.9 million in cash, cash equivalents and restricted cash. Management expects these standalone resources to fund operating and capital needs for at least the next 12 months from the financial statement issuance date.
How did Barinthus Biotherapeutics’ R&D and G&A expenses change in 2025?
Research and development expenses fell to $25.6 million from $42.2 million, mainly due to reduced legacy infectious disease and oncology work. General and administrative expenses increased to $40.8 million from $29.7 million, driven by higher foreign exchange losses and strategic professional fees.
Why did Barinthus Biotherapeutics record a $4.7 million impairment of intangible assets?
Barinthus recorded a $4.7 million intangible asset impairment in 2025 because the anticipated valuation implied by its definitive merger agreement with Clywedog was below the carrying value of net assets, requiring a write-down under accounting rules in the third quarter of 2025.
What is the progress of Barinthus Biotherapeutics’ VTP-1000 celiac disease program?
VTP-1000, Barinthus’ lead celiac disease immunotherapy, completed the single ascending dose Phase 1 portion with favorable tolerability and immune responses. The multiple ascending dose part of the AVALON Phase 1 trial is ongoing, with data expected in the second half of 2026.
How will the Barinthus and Clywedog combination affect the pipeline focus?
The combined company will center on metabolic and autoimmune diseases, including celiac disease and Type 1/2 diabetes. It will house three clinical-stage candidates—VTP-1000, CLY-101 and CLY-201—with four clinical data milestones expected within 18 months after the transaction closes.
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Barinthus Biotherapeutics plc
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BRNS Latest News
Mar 13, 2026
Barinthus Bio Reports Full Year 2025 Financial Results and Updates on Corporate Developments
Dec 10, 2025
Barinthus Bio Announces Update on Phase 1 AVALON Clinical Trial of VTP-1000 for the Treatment of Celiac Disease
Nov 7, 2025
Barinthus Bio Reports Third Quarter 2025 Financial Results and Updates on Corporate Developments