Full Press Release Details
Bio Reports Second Quarter 2025 Financial Results and Updates on Corporate Developments
| The final cohort of the single ascending dose (SAD) part of the Phase 1 A VALON trial initiated, with the SAD data readout expected early in the fourth quarter of 2025; | ||
| The multiple ascending dose (MAD) part of the AVALON trial initiated; | ||
| Available resources and cash runway guidance into 2027 remains unchanged. |
GERMANTOWN, Maryland, August
7, 2025 (GLOBE NEWSWIRE) - Barinthus Biotherapeutics plc (NASDAQ: BRNS) ("Barinthus Bio," or the "Company"),
an immunology and inflammation ("I&I") company focused on developing therapies that promote immune tolerance with curative
potential, today announced its financial results for the quarter ended June 30, 2025, and provided an overview of the Company's
corporate developments.
"In the second quarter,
we remained laser-focused on advancing VTP-1000, our highly differentiated immunotherapy designed to prevent or reduce symptoms following
gluten exposure in patients with celiac disease," said Bill Enright, Chief Executive Officer of Barinthus Bio. "We are currently
screening patients for the last cohort of the SAD portion of the Phase 1 AVALON trial, and as planned, we initiated the MAD portion of
the trial, which includes a gluten challenge, enabling us to assess the potential efficacy of VTP-1000 at this early stage. We look forward
to reporting topline data from the SAD portion of the trial early in the fourth quarter of 2025."
Recent Corporate Developments
Clinical Developments and
Quarter 2025 Financial Highlights
| Three months ended June 30, 2025 | Three months ended March 31, 2025 | Change | ||||||||||
| $000 | $000 | $000 | ||||||||||
| Direct research and development expenses by program: | ||||||||||||
| VTP-1000 Celiac | $ | 1,782 | $ | 982 | $ | 800 | ||||||
| VTP-300 HBV | 1,837 | 1,350 | 487 | |||||||||
| Other clinical programs 1 | 642 | 741 | (99 | ) | ||||||||
| Other pre-clinical programs | 449 | 419 | 30 | |||||||||
| Total direct research and development expenses | 4,710 | 3,492 | 1,218 | |||||||||
| Indirect research and development expenses: | ||||||||||||
| Personnel-related (including share-based compensation)2 | 2,450 | 3,944 | (1,494 | ) | ||||||||
| Facility related | 350 | 335 | 15 | |||||||||
| Other indirect costs | 443 | 519 | (76 | ) | ||||||||
| Total indirect research and development expenses | 3,243 | 4,798 | (1,555 | ) | ||||||||
| Total research and development expense | $ | 7,953 | $ | 8,290 | $ | (337 | ) |
This includes expenses relating to the infectious disease and oncology programs; VTP-850 Prostate cancer, VTP-200
HPV, VTP-600 NSCLC (the Phase 1/2a trial is sponsored by Cancer Research UK) and VTP-500 MERS (funded pursuant to an agreement with the
Coalition for Epidemic Preparedness Innovations ("CEPI"). Expenses relating to these programs were previously presented separately,
but are now aggregated for the prior period comparative.
This includes $0.1 million and $0.2 million for the six months ended
June 30, 2025 and 2024, respectively, of personnel-related
indirect expenses relating to time spent progressing the VTP-500 MERS program, which is funded by CEPI.
Barinthus Biotherapeutics (NASDAQ: BRNS) is a clinical-stage biopharmaceutical
company focused on developing novel immunotherapeutic candidates for treating autoimmune and inflammatory diseases. Our guiding principle
at the heart of Barinthus Bio is to help patients and their families by developing truly transformational and highly disease-specific
immunotherapies that are potentially curative. Barinthus Bio's pipeline for I&I indications is enabled by our proprietary and highly
differentiated platform for promoting immune tolerance, SNAP-TI, that is designed to guide a patient's T cells to a specific location
to reduce inflammation and restore the natural state of immune non-responsiveness to healthy tissue. Our lead candidate, VTP-1000, is
designed to restore immune non-responsiveness to gluten in patients with celiac disease and is currently in a Phase 1 clinical trial.
Barinthus Bio's differentiated technology platform and therapeutic approach, coupled with deep scientific expertise and focus on
clinical development, uniquely positions the company to navigate towards delivering treatments that improve the lives of people with autoimmune
and inflammatory diseases. 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 our future expectations,
plans and prospects, including our 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, our anticipated regulatory filings and
approvals, our cash runway and cash burn, our ability to develop and advance our current and future product candidates and programs,
and our ability to establish and maintain collaborations or strategic relationships. Any forward-looking statements in this press release
are based on our 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 our pipeline
development activities and planned and ongoing clinical trials, including the risk that the timing for preliminary, interim or final
data or initiation of our clinical trials may be delayed, the risk that interim or topline data may not reflect final data or results,
our ability to execute on our strategy, regulatory developments, the risk that we may not achieve the anticipated benefits of our pipeline
prioritization and corporate restructuring, our ability to fund our operations and access capital, our cash runway, including the risk
that our estimate of our cash runway may be incorrect, global economic uncertainty, including disruptions in the banking industry, the
conflicts in Ukraine, Iran, Israel and Gaza, tariffs imposed by the U.S. and other countries and other risks identified in our filings
with the Securities and Exchange Commission (the "SEC"), including our most recent annual report on Form 10-K and subsequent
filings we may make with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of
the date they are made. We expressly disclaim 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.
BARINTHUS BIOTHERAPEUTICS PLC
CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER
| As of June 30, 2025 | As of December 31, 2024 | |||||||
| ASSETS | ||||||||
| Cash and cash equivalents | $ | 86,259 | $ | 110,662 | ||||
| Restricted cash | 1,525 | 1,738 | ||||||
| Research and development incentives receivable | 4,536 | 7,139 | ||||||
| Prepaid expenses and other current assets | 7,681 | 6,203 | ||||||
| Assets held for sale | 413 | - | ||||||
| Total current assets | 100,414 | 125,742 | ||||||
| Property and equipment, net | 4,514 | 7,373 | ||||||
| Intangible assets, net | 20,366 | 21,947 | ||||||
| Right of use assets, net | 3,323 | 4,384 | ||||||
| Other assets | 944 | 881 | ||||||
| Total assets | $ | 129,561 | $ | 160,327 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | 1,800 | 2,474 | ||||||
| Accrued expenses and other current liabilities | 7,364 | 9,525 | ||||||
| Deferred income | 1,525 | 1,738 | ||||||
| Operating lease liability - current | 2,036 | 1,920 | ||||||
| Total current liabilities | 12,725 | 15,657 | ||||||
| Non-current liabilities: | ||||||||
| Operating lease liability - non-current | 9,952 | 10,087 | ||||||
| Contingent consideration | 2,544 | 2,650 | ||||||
| Other non-current liabilities | 1,468 | 1,360 | ||||||
| Deferred tax liability, net | 391 | 438 | ||||||
| Total liabilities | $ | 27,080 | $ | 30,192 | ||||
| Commitments and contingencies (Note 15) | ||||||||
| Stockholders' equity: | ||||||||
| Ordinary shares, 0.000025 nominal value; 40,348,665 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 | 393,663 | 393,474 | ||||||
| Accumulated deficit | (278,436 | ) | (237,664 | ) | ||||
| Accumulated other comprehensive loss - foreign currency translation adjustments | (12,937 | ) | (25,868 | ) | ||||
| Total stockholders' equity attributable to Barinthus Biotherapeutics plc shareholders | 102,377 | 130,029 | ||||||
| Noncontrolling interest | 104 | 106 | ||||||
| Total stockholders' equity | $ | 102,481 | $ | 130,135 | ||||
| Total liabilities and stockholders' equity | $ | 129,561 | $ | 160,327 |
BARINTHUS BIOTHERAPEUTICS PLC
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER
| Three months ended | Six months ended | |||||||||||||||
| June 30, 2025 | June 30, 2024 | June 30, 2025 | June 30, 2024 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | 7,953 | 11,662 | $ | 16,243 | $ | 22,787 | ||||||||||
| General and administrative | 15,384 | 7,201 | 28,023 | 13,195 | ||||||||||||
| Total operating expenses | 23,337 | 18,863 | 44,266 | 35,982 | ||||||||||||
| Other operating income | 13 | 577 | 342 | 782 | ||||||||||||
| Loss from operations | (23,324 | ) | (18,286 | ) | (43,924 | ) | (35,200 | ) | ||||||||
| Other income/(expense): | ||||||||||||||||
| Interest income | 523 | 635 | 1,079 | 1,410 | ||||||||||||
| Interest expense | (12 | ) | (12 | ) | (25 | ) | (24 | ) | ||||||||
| Research and development incentives | 1,342 | 693 | 1,644 | 1,287 | ||||||||||||
| Other income | 320 | 20 | 395 | 20 | ||||||||||||
| Total other income, net | 2,173 | 1,336 | 3,093 | 2,693 | ||||||||||||
| Loss before income tax | (21,151 | ) | (16,950 | ) | (40,831 | ) | (32,507 | ) | ||||||||
| Tax benefit | 25 | 7 | 47 | 44 | ||||||||||||
| Net loss | (21,126 | ) | (16,943 | ) | (40,784 | ) | (32,463 | ) | ||||||||
| Net loss attributable to noncontrolling interest | 2 | 12 | 12 | 43 | ||||||||||||
| Net loss attributable to Barinthus Biotherapeutics plc shareholders | (21,124 | ) | (16,931 | ) | (40,772 | ) | (32,420 | ) | ||||||||
| Weighted-average ordinary shares outstanding, basic | 40,343,521 | 39,041,111 | 40,304,584 | 38,907,296 | ||||||||||||
| Weighted-average ordinary shares outstanding, diluted | 40,343,521 | 39,041,111 | 40,304,584 | 38,907,296 | ||||||||||||
| Net loss per share attributable to ordinary shareholders, basic | $ | (0.52 | ) | $ | (0.43 | ) | $ | (1.01 | ) | $ | (0.83 | ) | ||||
| Net loss per share attributable to ordinary shareholders, diluted | $ | (0.52 | ) | $ | (0.43 | ) | $ | (1.01 | ) | $ | (0.83 | ) | ||||
| Net loss | $ | (21,126 | ) | $ | (16,943 | ) | $ | (40,784 | ) | $ | (32,463 | ) | ||||
| Other comprehensive gain/(loss) - foreign currency translation adjustments | 8,295 | 164 | 12,941 | (1,413 | ) | |||||||||||
| Comprehensive loss | (12,831 | ) | (16,779 | ) | (27,843 | ) | (33,876 | ) | ||||||||
| Comprehensive loss/(gain) attributable to noncontrolling interest | (5 | ) | 11 | 2 | 39 | |||||||||||
| Comprehensive loss attributable to Barinthus Biotherapeutics plc shareholders | $ | (12,836 | ) | $ | (16,768 | ) | $ | (27,841 | ) | $ | (33,837 | ) |