OXFORD, United Kingdom and GERMANTOWN, Md., March 20, 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 year ended December 31, 2024 and provided an overview of the Company's business updates.
"We've entered 2025 with a refreshed strategic focus on immunological and inflammatory diseases. Following our restructuring, we are strongly positioned to advance our highly differentiated lead asset,VTP-1000, (and the underlying SNAP-TI platform) in patients with celiac disease. Through design innovations enabling greater targeting of disease antigens, intramuscular administration and potentially improved tolerability, VTP-1000 has promise to be a leading therapy for the approximate 80 million people worldwide with celiac disease. We look forward to reporting single-ascending dose Phase 1 data for this program in the third quarter of this year." said Bill Enright, Chief Executive Officer of Barinthus Bio. "VTP-1000 is based on our innovative SNAP-TI platform, which is differentiated based on its capacity to promote antigen-specific immune tolerance that specifically guides a patient's T cells to suppress unwanted inflammation and restore the natural state of immune non-responsiveness to healthy tissue without affecting immunity against cancer or infections. Given this mild and potentially curative approach to restoring balance to the immune system, we believe SNAP-TI is poised to drive multiple future pipeline and partnership opportunities for the company particularly for autoimmune diseases where broadly immunosuppressive drugs are not optimal."
"Turning to our development candidates designated for partnering, we reported highly encouraging results from two Phase 2 trials in our chronic hepatitis B ("CHB") program demonstrating that VTP-300 contributed to the achievement of undetectable HBsAg levels in eight participants, with two participants meeting functional cure criteria. Further Phase 2 data are anticipated in the second quarter of 2025, which are expected to strengthen VTP-300's market positioning as a component of a functional cure for CHB."
2024 Corporate Milestones
Clinical developments
Celiac Disease (VTP-1000)
Chronic Hepatitis B (VTP-300)
Prostate Cancer (VTP-850)
High-Risk Human Papillomavirus (VTP-200)
Corporate Updates
Upcoming Milestones
Celiac Disease (VTP-1000):
Chronic Hepatitis B (VTP-300):
Prostate Cancer (VTP-850):
2024 Financial Highlights
| Period ended | Twelve months ended December 31, 2024 | Twelve months ended December 31, 2023 | Change | |||||||||
| $ | 000 | $ | 000 | $ | 000 | |||||||
| Direct research and development expenses by program: | ||||||||||||
| VTP-1000 Celiac1 | $ | 5,486 | $ | 8,420 | $ | (2,934 | ) | |||||
| VTP-300 HBV | 10,474 | 11,276 | (802 | ) | ||||||||
| VTP-850 Prostate cancer | 1,429 | 2,726 | (1,297 | ) | ||||||||
| VTP-200 HPV | 2,009 | 4,950 | (2,941 | ) | ||||||||
| VTP-600 NSCLC2 | 473 | 597 | (124 | ) | ||||||||
| VTP-500 MERS3 | 610 | — | 610 | |||||||||
| Other and earlier stage programs4 | 3,228 | 1,787 | 1,441 | |||||||||
| Total direct research and development expenses | $ | 23,709 | $ | 29,756 | $ | (6,047 | ) | |||||
| Indirect research and development expenses: | ||||||||||||
| Personnel-related (including share-based compensation) | 15,867 | 12,702 | 3,165 | |||||||||
| Facility related | 1,249 | 1,339 | (90 | ) | ||||||||
| Other indirect costs | 1,411 | 1,077 | 334 | |||||||||
| Total indirect research and development expenses | 18,527 | 15,118 | 3,409 | |||||||||
| Total research and development expense | $ | 42,236 | $ | 44,874 | $ | (2,638 | ) | |||||
1 Research and development expenses related to VTP-1100 HPV Cancer were presented together with VTP-1000 Celiac in the prior period comparative, because our SNAP product candidates were both preclinical. Expenses related to VTP-1100 HPV Cancer are now included in "Other and earlier stage programs," because we are deferring the planned IND application for VTP-1100 in HPV cancer and we have initiated the clinical trial for VTP-1000 Celiac.
2 The VTP-600 NSCLC Phase 1/2a trial is sponsored by Cancer Research UK.
3 The development of VTP-500 is funded pursuant to an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI).
4 This includes $0.9 million of personnel-related indirect expenses relating to time spent progressing the VTP-500 MERS program, which is funded by CEPI.
About Barinthus Bio
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, our ability to develop and advance our current and future product candidates and programs, and the terms and timing of the restructuring and related activities. 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, Israel and Gaza, 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 SHARE AMOUNTS) | |||||||
| December 31, 2024 | December 31, 2023 | ||||||
| ASSETS | |||||||
| Cash and cash equivalents | $ | 110,662 | $ | 142,090 | |||
| Restricted cash | 1,738 | — | |||||
| Research and development incentives receivable | 7,139 | 4,908 | |||||
| Prepaid expenses and other current assets | 6,203 | 9,907 | |||||
| Total current assets | 125,742 | 156,905 | |||||
| Goodwill | — | 12,209 | |||||
| Property and equipment, net | 7,373 | 11,821 | |||||
| Intangible assets, net | 21,947 | 25,108 | |||||
| Right of use assets, net | 4,384 | 7,581 | |||||
| Other assets | 881 | 882 | |||||
| Total assets | $ | 160,327 | $ | 214,506 | |||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
| Current liabilities: | |||||||
| Accounts payable | 2,474 | 1,601 | |||||
| Accrued expenses and other current liabilities | 9,525 | 9,212 | |||||
| Deferred income | 1,738 | — | |||||
| Operating lease liability - current | 1,920 | 1,785 | |||||
| Total current liabilities | 15,657 | 12,598 | |||||
| Non-current liabilities: | |||||||
| Operating lease liability - non-current | 10,087 | 11,191 | |||||
| Contingent consideration | 2,650 | 1,823 | |||||
| Other non-current liabilities | 1,360 | 1,325 | |||||
| Deferred tax liability, net | 438 | 574 | |||||
| Total liabilities | $ | 30,192 | $ | 27,511 | |||
| Commitments and contingencies (Note 17) | |||||||
| Stockholders' equity: | |||||||
| Ordinary shares, £0.000025 nominal value; 40,234,663 shares authorized, issued and outstanding (December 31, 2023: authorized, issued and outstanding: 38,643,540) | 1 | 1 | |||||
| Deferred A shares, £1 nominal value; 63,443 shares authorized, issued and outstanding (December 31, 2023: authorized, issued and outstanding: 63,443) | 86 | 86 | |||||
| Additional paid-in capital | 393,474 | 386,602 | |||||
| Accumulated deficit | (237,664 | ) | (176,590 | ) | |||
| Accumulated other comprehensive loss – foreign currency translation adjustments | (25,868 | ) | (23,315 | ) | |||
| Total stockholders' equity attributable to Barinthus Biotherapeutics plc shareholders | 130,029 | 186,784 | |||||
| Noncontrolling interest | 106 | 211 | |||||
| Total stockholders' equity | $ | 130,135 | $ | 186,995 | |||
| Total liabilities and stockholders' equity | $ | 160,327 | $ | 214,506 | |||
| BARINTHUS BIOTHERAPEUTICS PLC CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS) | ||||||||
| Twelve months ended | ||||||||
| December 31, 2024 | December 31, 2023 | |||||||
| License revenue 1 | $ | 14,969 | $ | 802 | ||||
| Total revenue | 14,969 | 802 | ||||||
| Operating expenses | ||||||||
| Research and development | 42,236 | 44,874 | ||||||
| General and administrative | 29,670 | 39,842 | ||||||
| Goodwill impairment | 12,209 | — | ||||||
| Total operating expenses | 84,115 | 84,716 | ||||||
| Other operating income | 1,176 | — | ||||||
| Loss from operations | (67,970 | ) | (83,914 | ) | ||||
| Other income/(expense): | ||||||||
| Interest income | 2,678 | 2,877 | ||||||
| Interest expense | (53 | ) | (28 | ) | ||||
| Research and development incentives | 3,983 | 3,461 | ||||||
| Other income | 135 | 1,082 | ||||||
| Total other income, net | 6,743 | 7,392 | ||||||
| Loss before income tax | (61,227 | ) | (76,522 | ) | ||||
| Tax benefit | 44 | 3,075 | ||||||
| Net loss | (61,183 | ) | (73,447 | ) | ||||
| Net loss attributable to noncontrolling interest | 109 | 100 | ||||||
| Net loss attributable to Barinthus Biotherapeutics plc shareholders | (61,074 | ) | (73,347 | ) | ||||
| Weighted-average ordinary shares outstanding, basic | 39,348,240 | 38,386,491 | ||||||
| Weighted-average ordinary shares outstanding, diluted | 39,348,240 | 38,386,491 | ||||||
| Net loss per share attributable to ordinary shareholders, basic | $ | (1.55 | ) | $ | (1.91 | ) | ||
| Net loss per share attributable to ordinary shareholders, diluted | $ | (1.55 | ) | $ | (1.91 | ) | ||
| Net loss | $ | (61,183 | ) | $ | (73,447 | ) | ||
| Other comprehensive (loss)/gain – foreign currency translation adjustments | (2,549 | ) | 10,151 | |||||
| Comprehensive loss | (63,732 | ) | (63,296 | ) | ||||
| Comprehensive loss attributable to noncontrolling interest | 105 | 94 | ||||||
| Comprehensive loss attributable to Barinthus Biotherapeutics plc shareholders | $ | (63,627 | ) | $ | (63,202 | ) | ||
1 All license revenue is from related parties and is generated in the United Kingdom for the years ended December 31, 2024 and 2023.
IR contact:
Kevin Gardner
Managing Director
LifeSci Advisors
+1 617-283-2856
kgardner@lifesciadvisors.com
Media contacts:
Alexis Feinberg
Vice President
ICR Healthcare
Alexis.feinberg@icrhealthcare.com
Jonathan Edwards
Associate Partner
ICR Healthcare
Barinthus@icrinc.com
Company contact:
ir@barinthusbio.com
