VTP-200

OXFORD, United Kingdom, Aug. 08, 2024 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates, provided an overview of the Company’s progress and announced its financial results for the second quarter of 2024. “Following the positive VTP-300 Phase 2 data in hepatitis B virus (HBV) in the second quarter, we made the strategic decision to prioritize our HBV and celiac disease programs. These two programs have the greatest probability for success and value creation, and represent significant opportunities in therapeutic areas with substantial unmet patient need,” said Bill Enright, Chief Executive Officer of Barinthus Bio. "We are very excited as we plan to initiate our first in human clinical trial of VTP-1000 in celiac disease in the third quarter, utilizing our novel SNAP-TI platform. Celiac disease is an increasingly common autoimmune disease with no FDA or EMA-approved treatments. Towards the end of the year we look forward to sharing updated data from our HBV program as our two Phase 2 trials utilizing VTP-300, which are evaluating a potential functional cure regimen, mature further." Second Quarter 2024 and Recent Corporate Developments Clinical developments: VTP-300 (HBV) In June 2024, we announced updated data from two ongoing Phase 2 clinical trials in people with chronic hepatitis B (CHB) at the European Association for the Study of the Liver (EASL) Congress 2024. The presentations included updated interim data from the Phase 2b clinical trial (HBV003), as well as updated interim data from the Phase 2a clinical trial (IM-PROVE II, AB-729-202) in partnership with Arbutus Biopharma, both in people with CHB receiving ongoing standard of care nucleos(t)ide analogue (NUC) therapy. Interim HBV003 data: VTP-300 and Low-dose Nivolumab Interim data from the HBV003 trial showed; Nearly 20% of participants across the groups had undetectable HBsAg and this was maintained for ≥16 weeks in the two cases who had reached that time point. 76% of participants were eligible for NUC discontinuation.71% of those who did discontinue remained off NUCs at time of data cutoff on April 15, 2024.67% of participants across all groups assessed for NUC discontinuation had HBsAg <10 IU/mL at Week 24 or later.Robust T cell responses were observed to all VTP-300 encoded antigens.There were no Serious Adverse Events (SAEs), Grade 3 or 4 Adverse Events (AEs) related to treatment. Interim IM-PROVE II data: imdusiran and VTP-300 Interim data from the IM-PROVE II clinical trial showed; 20% of participants had undetectable HBsAg at Week 72 in the VTP-300 treatment group, compared to none in the placebo group.84% of participants in the VTP-300 treatment group were eligible for NUC discontinuation, compared to 52% in the placebo group.88% of those who did discontinue remained off NUCs, compared to 80% in the placebo group remaining off NUCs at time of data cutoff on April 12, 2024.Robust reductions of HBsAg were observed during the imdusiran lead-in period with 95% of participants achieving HBsAg <100 IU/mL before undergoing dosing in the VTP-300 treatment or placebo groups at week 24. A statistically significant difference (p<0.05) in HBsAg levels between the VTP-300 treatment and placebo groups was recorded at Week 72.Treatment with imdusiran and VTP-300 was generally well-tolerated, with no SAEs or treatment discontinuations reported. Corporate Updates On June 3, 2024, Dr. Leon Hooftman joined the Company as Chief Medical Officer. He brings significant drug development expertise across a broad array of therapeutic areas including immunology, autoimmunity, hematology, oncology and infectious diseases. In June 2024, we announced a strategic pipeline prioritization following the positive interim data from VTP-300 in CHB presented at EASL. This announcement included the prioritization of the development of VTP-300 in CHB and VTP-1000 in celiac disease, and consequently a reduction in workforce. Upcoming Milestones In the third quarter of 2024, the Company expects to: VTP-1000 (Celiac Disease): Dose the first patient in GLU001, a randomized, placebo-controlled Phase 1 trial including a controlled gluten challenge to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VTP-1000 in adults with celiac disease. In the fourth quarter of 2024, the Company expects to: VTP-300 (HBV): Announce updated interim data from HBV003, our Phase 2b trial evaluating additional dosing of VTP-300 and timing of PD-1 inhibition, in people with CHB on NUC therapy.Announce updated interim data from the Phase 2a AB-729-202 clinical trial evaluating the combination of VTP-300 and Arbutus’ imdusiran, in people with CHB on NUC therapy. Pipeline These are estimated timelines only and our pipeline may be subject to change. Second Quarter 2024 Financial Highlights Cash position: As of June 30, 2024, cash, cash equivalents and restricted cash were $117.8 million, compared to $130.0 million as of March 31, 2024. The net cash used in operating activities was $12.0 million in the second quarter of 2024, primarily resulting from development of our pipeline and ongoing clinical trials offset by receipt of an R&D tax credit of $1.4 million. Based on current research and development plans, the Company expects its available resources to fund its operating expenses and capital expenditure requirements into the second quarter of 2026.Research and development expenses: Research and development expenses were $11.7 million in the second quarter of 2024 compared to $11.1 million in the first quarter of 2024, with the increase mainly attributable to the progression of VTP-300 (HBV) through the two ongoing Phase 2 trials, partially offset by a reduction in expense from VTP-200 (HPV) which completed in the first quarter of 2024 and for which data was presented in April 2024. The quarter-on-quarter R&D expense per program is outlined in the following table. Period ended Three monthsended June30, 2024 Three monthsended March31, 2024 Change $000 $000 $000 Direct research and development expenses by program: VTP-200 HPV $383 $1,253 $(870)VTP-300 HBV 3,034 1,913 1,121 VTP-500 MERS1 304 172 132 VTP-600 NSCLC2 24 164 (140)VTP-850 Prostate cancer 414 178 236 VTP-1000 Celiac 1,371 1,374 (3)Other and earlier stage programs 908 784 124 Total direct research and development expenses $6,438 $5,838 $600 Indirect research and development expenses: Personnel-related (including share-based compensation) 4,763 4,335 428 Facility related 342 390 (48)Other indirect costs 119 562 (443)Total indirect research and development expenses 5,224 5,287 (63)Total research and development expense $11,662 $11,125 $537 1 The development of VTP-500 is funded pursuant to an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI). 2 The VTP-600 NSCLC Phase 1/2a trial is sponsored by Cancer Research UK. General and administrative expenses: General and administrative expenses were $7.2 million in the second quarter of 2024, compared to $6.0 million in the first quarter of 2024. The increase of $1.2 million relates primarily to a loss of $0.1 million on foreign exchange in the second quarter of 2024, compared to a gain of $1.2 million in the first quarter of 2024.Net loss: For the second quarter of 2024, the Company generated a net loss attributable to its shareholders of $16.9 million, or $(0.43) per share on both basic and fully diluted bases, compared to a net loss attributable to its shareholders of $15.5 million, or $(0.40) per share on both basic and fully diluted bases in the first quarter of 2024. About Barinthus Bio Barinthus Bio is a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases and autoimmunity. Helping people living with serious diseases and their families is the guiding principle at the heart of Barinthus Bio. With a focused pipeline built around our proprietary platform technologies, Barinthus Bio is advancing product candidates in infectious disease and autoimmunity, including: VTP-300, an immunotherapeutic candidate utilizing our ChAdOx/MVA platform designed as a potential component of a functional cure for chronic HBV infection and VTP-1000, an autoimmune candidate designed to utilize the SNAP-Tolerance Immunotherapy (TI) platform to treat patients with celiac disease. Barinthus Bio also has a Phase 1 clinical trial for VTP-850, a second-generation immunotherapeutic candidate designed to treat recurrent prostate cancer. Barinthus Bio’s proven scientific expertise, diverse portfolio and focus on pipeline development uniquely positions the company to navigate towards delivering treatments for people with infectious diseases and autoimmunity that have a significant impact on their everyday lives. 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, including dosing of the first patient in GLU001 for VTP-1000, our anticipated regulatory filings and approvals, our cash runway, and our ability to develop and advance our current and future product candidates and programs. 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, including our Annual Report on Form 10-K for the year ended December 31, 2023, our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. 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) (UNAUDITED) June 30,2024 December 31,2023ASSETS Cash, cash equivalents and restricted cash$117,774 $142,090 Research and development incentives receivable 4,523 4,908 Prepaid expenses and other current assets 9,582 9,907 Total current assets 131,879 156,905 Goodwill 12,209 12,209 Property and equipment, net 10,962 11,821 Intangible assets, net 23,527 25,108 Right of use assets, net 7,286 7,581 Other assets 886 882 Total assets$186,749 $214,506 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable 2,556 1,601 Accrued expenses and other current liabilities 10,278 9,212 Deferred income 839 — Operating lease liability - current 1,916 1,785 Total current liabilities 15,589 12,598 Non-current liabilities: Operating lease liability - non-current 10,654 11,191 Contingent consideration 1,888 1,823 Other non-current liabilities 1,338 1,325 Deferred tax liability, net 490 574 Total liabilities$29,959 $27,511 Commitments and contingencies (Note 15) Stockholders’ equity: Ordinary shares, £0.000025 nominal value; 39,184,338 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 390,273 386,602 Accumulated deficit (209,010) (176,590)Accumulated other comprehensive loss – foreign currency translation adjustments (24,732) (23,315)Total stockholders’ equity attributable to Barinthus Biotherapeutics plc shareholders 156,618 186,784 Noncontrolling interest 172 211 Total stockholders’ equity$156,790 $186,995 Total liabilities and stockholders’ equity$186,749 $214,506 BARINTHUS BIOTHERAPEUTICS PLC CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS) (UNAUDITED) Three months ended Six months ended June 30, 2024 June 30, 2023 June 30, 2024 June 30, 2023License revenue 1$— $334 $— $802 Total revenue — 334 — 802 Operating expenses Research and development 11,662 13,543 22,787 23,357 General and administrative 7,201 13,128 13,195 25,266 Total operating expenses 18,863 26,671 35,982 48,623 Other operating income 577 — 782 — Loss from operations (18,286) (26,337) (35,200) (47,821)Other income/(expense): Interest income 635 522 1,410 2,110 Interest expense (12) (14) (24) (14)Research and development incentives 693 559 1,287 1,716 Other income 20 310 20 310 Total other income, net 1,336 1,377 2,693 4,122 Loss before income tax (16,950) (24,960) (32,507) (43,699)Tax benefit 7 1,136 44 1,652 Net loss (16,943) (23,824) (32,463) (42,047)Net loss attributable to noncontrolling interest 12 22 43 65 Net loss attributable to Barinthus Biotherapeutics plc shareholders (16,931) (23,802) (32,420) (41,982) Weighted-average ordinary shares outstanding, basic 39,041,111 38,407,672 38,907,296 38,211,625 Weighted-average ordinary shares outstanding, diluted 39,041,111 38,407,672 38,907,296 38,211,625 Net loss per share attributable to ordinary shareholders, basic$(0.43) $(0.62) $(0.83) $(1.10)Net loss per share attributable to ordinary shareholders, diluted$(0.43) $(0.62) $(0.83) $(1.10) Net loss$(16,943) $(23,824) $(32,463) $(42,047)Other comprehensive gain/(loss) – foreign currency translation adjustments 164 5,604 (1,413) 10,184 Comprehensive loss (16,779) (18,220) (33,876) (31,863)Comprehensive loss attributable to noncontrolling interest 11 15 39 52 Comprehensive loss attributable to Barinthus Biotherapeutics plc shareholders$(16,768) $(18,205) $(33,837) $(31,811) 1 Includes license revenue from related parties for the three and six months ended June 30, 2024 of nil (three and six months ended June 30, 2023: $0.3 million and $0.8 million, respectively). IR contacts:Christopher M. Calabrese Managing Director LifeSci Advisors+1 917-680-5608ccalabrese@lifesciadvisors.com Kevin GardnerManaging DirectorLifeSci Advisors+1 617-283-2856kgardner@lifesciadvisors.com Media contact:Audra FriisSam Brown, Inc.+1 917-519-9577audrafriis@sambrown.com Company contact:Jonothan BlackbournIR & PR ManagerBarinthus Bioir@barinthusbio.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c0677b65-29bb-4869-b045-22325fa94f17

Barinthus Biotherapeutics expects a restructuring to stretch the company's cash runway into 2026. Barinthus Biotherapeutics has used positive interim data from a pair of phase 2 trials for its hepatitis B therapy as justification for sidelining its prostate cancer candidate and jettisoning a quarter of the T-cell-focused biotech’s workforce. The U.K.-based company—formerly known as Vaccitech—said the interim readouts from the trials of VTP-300 it unveiled at the European Association for the Study of the Liver (EASL) Congress last week “demonstrated VTP-300’s potential to significantly reduce and maintain hepatitis B surface antigen (HBsAg) levels and achieve undetectable HBsAg levels in patients with” chronic hepatitis B (CHB). At the time, analysts at William Blair said the “results demonstrate VTP-300's ability to potentially induce a functional cure for CHB, pending the outcome of further development.” In Wednesday’s postmarket release, Barinthus also pointed to “encouraging” preclinical findings for its lead candidate, a celiac disease drug called VTP-1000, as reason for prioritizing that asset along with VTP-300. VTP-1000 is designed to balance the immune response by inducing gluten-specific T regulatory cells and reduce gluten-specific T effector cell responses. After preclinical research in disease models demonstrated “mode of action and disease amelioration,” Barinthus said it is gearing up to take VTP-1000 into the clinic in the third quarter. “The company expects to undergo a restructuring to align resources with the streamlined pipeline, which will include a workforce reduction of approximately 25% and an estimated extension of the cash runway into the second quarter of 2026,” the company said in the June 12 release. The biotech had previously expected the $130 million in cash and equivalents it had to hand as of the end of March to run out by the end of 2025. An ongoing phase 1 trial of VTP-850 in prostate cancer will be completed, the company confirmed in yesterday’s release. But the immunotherapeutic, which encodes for multiple prostate-associated antigens, didn’t appear to feature in the company’s future plans as set out in the announcement. There was also no mention in the release of VTP-200, an immunotherapeutic combo regimen for high-risk human papillomavirus that hit the primary safety endpoint of a phase 1b/2 trial in April. However, the data for the trial’s overall patient population didn’t demonstrate a significant improvement in hrHPV clearance or cervical lesion clearance. “With this pipeline prioritization, we put the company in a strong position to maximize the probability of success, particularly given the encouraging VTP-300 phase 2 interim data presented at EASL earlier this month and the compelling differentiation of our novel SNAP-TI platform to treat autoimmune diseases,” CEO Bill Enright said in the release. “In line with our pipeline prioritization, we have made the difficult decision to reduce our workforce,” Enright added. “I would like to thank our talented employees for their contributions to the company’s achievements.” In a note this morning, analysts at William Blair gave their blessing to Barinthus’ move. “We agree with management’s decision to streamline the company’s R&D pipeline, which in our view is evidence-based and driven by evolving data,” the analysts wrote. “We believe new data generated from the VTP-300 program could showcase the regimen’s role in helping patients living with CHB to achieve functional cures.”