COVID-19 Vaccine (ChAdOx1-S [recombinant])(AstraZeneca Plc)

OXFORD, United Kingdom, May 13, 2024 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity, and cancer, announced its financial results for the first quarter of 2024 and provided an overview of the Company’s progress. “So far in 2024 we have continued to make strides across our programs. Notably, we received clearance from the FDA on an IND to progress VTP-1000 in a first in human clinical trial in celiac disease, as well as clearance from the Australian Ethics Committee on this trial. We expect to begin our Phase 1 trial of VTP-1000 in participants with celiac disease in the coming months. Additionally, we reported topline final data from the Phase 1b/2 trial of VTP-200 in participants with persistent high-risk (hr) human papillomavirus (HPV) infections,” said Bill Enright, Chief Executive Officer of Barinthus Bio. "Looking ahead to Q2, we will present additional interim data from our VTP-300 hepatitis B trials at the European Association for the Study of the Liver (EASL) Congress in June. This follows the encouraging data presented at The American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® in November last year. We will also welcome Dr. Leon Hooftman as our new Chief Medical Officer in June and look forward to him supporting the growth of our robust pipeline and programs.” Recent Corporate Developments Clinical developments VTP-1000 (Celiac Disease): In April 2024, we received clearance from the U.S. FDA on an Investigational New Drug (IND) application, as well as from the Australian regulatory authorities, to progress VTP-1000 in a first in human clinical trial in celiac disease. GLU001 is a randomized, placebo-controlled Phase 1 trial with a controlled gluten challenge to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VTP-1000 in adults with celiac disease. The study is designed in two parts; a single ascending dose part followed by a multiple ascending dose part, each randomized and placebo-controlled with three dose levels. The primary endpoint is assessment of the safety and tolerability of single and multiple dosing, and determination of a dose and schedule for further investigation. The trial also aims to demonstrate proof-of-principle of induction of immune tolerance and early proof-of-concept for VTP-1000, as a potential treatment for celiac disease, based on assessment of pharmacodynamics and preliminary efficacy determined by means of a controlled gluten challenge.VTP-200 (HPV): In April 2024, we announced topline final data from the APOLLO trial, (also known as HPV001) a Phase 1b/2 dose-ranging study of VTP-200 in women with low-grade cervical lesions associated with persistent hrHPV infection. The APOLLO study met its primary safety endpoint, demonstrating that VTP-200 was generally well-tolerated and was administered with no treatment-related grade 3 or higher unsolicited adverse events (AEs) and no treatment-related serious AEs. Positive trends in clearance rate for both hrHPV (60%, Group 2) and cervical lesions (67%, Groups 2 and 5), were observed in the groups receiving the highest ChAdOx dose. Pooled data from the five different active dose groups demonstrated no statistically significant improvement in either hrHPV or cervical lesion clearance in comparison to the placebo group.VTP-300 (HBV): In April 2024, abstracts on interim data from HBV003 and AB-729-202 were accepted for presentation at the upcoming EASL Congress in Milan, Italy, June 5-8, 2024. Management Team On May 1, 2024, we announced the appointment of Dr. Leon Hooftman as Chief Medical Officer. Dr. Hooftman will join the company on June 3, 2024, and brings significant drug development expertise across a broad array of therapeutic areas including immunology, autoimmunity, hematology, oncology and infectious diseases. Upcoming Milestones In the second quarter of 2024, the Company expects to: VTP-300 (HBV): Present interim data from HBV003, our Phase 2b trial evaluating additional dosing of VTP-300 and timing of PD-1 inhibition, in participants with chronic hepatitis B (CHB) on nucleos(t)ide analogue (NUC) therapy at the EASL Congress in June.VTP-300 (HBV): Announce interim data from the Phase 2a AB-729-202 clinical trial evaluating the combination of VTP-300 and Arbutus’ imdusiran, in participants with CHB on NUC therapy following presentation at the EASL Congress in June. 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 with a controlled gluten challenge to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VTP-1000 in adults with celiac disease. This timing update is based on the latest feasibility and expected site set-up timelines. First Quarter 2024 Financial Highlights Cash position: As of March 31, 2024, cash, cash equivalents and restricted cash was $130.0 million, compared to $142.1 million as of December 31, 2023. The cash used in operating activities was $11.8 million in the first quarter of 2024, primarily resulting from development of our pipeline and ongoing clinical trials. Based on current research and development plans, the Company expects its cash runway to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2025.Revenue: Revenue was nil in the first quarter of 2024 compared to $0.5 million in the first quarter of 2023 and was due to no commercial sales of Vaxzevria® by AstraZeneca in 2024.Research and development expenses: Research and development expenses were $11.1 million in the first quarter of 2024 compared to $9.8 million in the first quarter of 2023, with the increase mainly attributable to hiring of personnel and increased costs related to the advancement of our programs. The quarter-on-quarter R&D expense per program is outlined in the following table. Year ended Three monthsended March31, 2024 Three monthsended March31, 2023 Change $000 $000 $000 Direct research and development expenses by program: VTP-200 HPV $1,253 $1,338 $(85)VTP-300 HBV 1,913 2,118 (205)VTP-500 MERS1 172 — 172 VTP-600 NSCLC2 164 275 (111)VTP-850 Prostate cancer 178 215 (37)VTP-1000 Celiac 1,374 1,572 (198)Other and earlier stage programs3 784 280 504 Total direct research and development expenses $5,838 $5,798 $40 Indirect research and development expenses: Personnel-related (including share-based compensation) 4,335 3,601 734 Facility related 390 371 19 Other indirect costs 562 44 518 Total indirect research and development expenses 5,287 4,016 1,271 Total research and development expense $11,125 $9,814 $1,311 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. 3 Research and development expenses related to VTP-1100 HPV Cancer were previously included with VTP-1000 Celiac but are now included in 'Other and earlier stage programs' because we are focusing resources on other clinical programs and deferring the IND application for VTP-1100 in HPV cancer. General and administrative expenses: General and administrative expenses were $6.0 million in the first quarter of 2024, compared to $12.1 million in the first quarter of 2023. The decrease of $6.1 million relates primarily to a gain of $1.2 million on foreign exchange for the first quarter of 2024, compared to a loss of $3.5 million for the first quarter of 2023, a decrease in personnel expenses, including share-based payment charges of $0.8 million, primarily due to a reduction in non-cash share-based payment charges, and a decrease in insurance costs of $0.9 million due to a reduction in insurance premiums.Net loss: For the first quarter of 2024, the Company generated a net loss attributable to its shareholders of $15.5 million, or $(0.40) per share on both basic and fully diluted bases, compared to a net loss attributable to its shareholders of $18.2 million, or $(0.48) per share on both basic and fully diluted bases in the first quarter of 2023. 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, autoimmunity and cancer. Helping people living with serious diseases and their families is the guiding principle at the heart of Barinthus Bio. With a broad pipeline, built around three proprietary platform technologies: ChAdOx, MVA and SNAP, Barinthus Bio is advancing a pipeline of five product candidates across a diverse range of therapeutic areas, including: VTP-300, an immunotherapeutic candidate designed as a potential component of a functional cure for chronic HBV infection; VTP-200, a non-surgical product candidate for persistent high-risk human papillomavirus (HPV); VTP-1000, an autoimmune candidate designed to utilize the SNAP-Tolerance Immunotherapy (TI) platform to treat patients with celiac disease; and 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, autoimmunity and cancers 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 preliminary estimated cash and cash equivalents, 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 trails may be delayed, our ability to execute on our strategy, regulatory developments, 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 conflict in Ukraine, the conflict in Israel and Gaza, and other risks identified in our filings with the Securities and Exchange Commission (the “SEC”), 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) March 31,2024 December 31,2023ASSETS Cash, cash equivalents and restricted cash$129,971 $142,090 Research and development incentives receivable 5,196 4,908 Prepaid expenses and other current assets 7,964 9,907 Total current assets 143,131 156,905 Goodwill 12,209 12,209 Property and equipment, net 11,532 11,821 Intangible assets, net 24,317 25,108 Right of use assets, net 7,408 7,581 Other assets 885 882 Total assets$199,482 $214,506 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable 1,162 1,601 Accrued expenses and other current liabilities 8,330 9,212 Deferred income 1,434 — Operating lease liability - current 1,909 1,785 Total current liabilities 12,835 12,598 Non-Current liabilities: Operating lease liability - non-current 10,897 11,191 Contingent consideration 1,867 1,823 Other non-current liabilities 1,330 1,325 Deferred tax liability, net 537 574 Total liabilities$27,466 $27,511 Commitments and contingencies (Note 15) Stockholders’ equity: Ordinary shares, £0.000025 nominal value; 38,952,956 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 388,720 386,602 Accumulated deficit (192,079) (176,590)Accumulated other comprehensive loss – foreign currency translation adjustments (24,895) (23,315)Total stockholders’ equity attributable to Barinthus Biotherapeutics plc shareholders 171,833 186,784 Noncontrolling interest 183 211 Total stockholders’ equity$172,016 $186,995 Total liabilities and stockholders’ equity$199,482 $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 March 31, 2024 March 31, 2023License revenue 1 $— $468 Total revenue — 468 Operating expenses Research and development 11,125 9,814 General and administrative 5,994 12,138 Total operating expenses 17,119 21,952 Other operating income 205 — Loss from operations (16,914) (21,484)Other income/(expense): Interest income 775 1,588 Interest expense (12) — Research and development incentives 594 1,157 Total other income, net 1,357 2,745 Loss before income tax (15,557) (18,739)Tax benefit 37 516 Net loss (15,520) (18,223)Net loss attributable to noncontrolling interest 31 43 Net loss attributable to Barinthus Biotherapeutics plc shareholders (15,489) (18,180) Weighted-average ordinary shares outstanding, basic 38,773,482 38,013,399 Weighted-average ordinary shares outstanding, diluted 38,773,482 38,013,399 Net loss per share attributable to ordinary shareholders, basic $(0.40) $(0.48)Net loss per share attributable to ordinary shareholders, diluted $(0.40) $(0.48) Net loss $(15,520) $(18,223)Other comprehensive (loss)/gain – foreign currency translation adjustments (1,577) 4,580 Comprehensive loss (17,097) (13,643)Comprehensive loss attributable to noncontrolling interest 28 37 Comprehensive loss attributable to Barinthus Biotherapeutics plc shareholders $(17,069) $(13,606) 1 Includes license revenue from related parties for the three months ended March 31, 2024 of nil (March 31, 2023: $0.5 million). 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

On a day when struggling Novavax slashed its 2024 revenue projection from a range of $800 million to $1 million to a window of $400 million to $600 million, the company announced that it has partnered with vaccine powerhouse Sanofi in a $1.2 billion deal. After years of missteps in developing and commercializing its coronavirus shot, Novavax is turning to one of the biopharma industry’s most experienced vaccine companies to help salvage its COVID efforts: Sanofi. The French Big Pharma will partner with the struggling Maryland biotech to co-commercialize its COVID-19 jab Nuvaxovid and develop combination vaccines. In all, Novavax will receive $500 million up front, plus up to $700 million in potential development, regulatory and launch milestones plus tiered royalties. As part of the arrangement, Sanofi is taking a 4.9% equity position in Novavax. Sanofi will book sales for Nuvaxovid at the start of next year. The French company’s vaccine legacy includes developing, manufacturing and commercializing shots worldwide to protect against polio, rabies, meningitis and the flu. The partnership allows Novavax to lift its “going concern” notice from February when it warned investors that the plunging demand for COVID vaccines could send the company into bankruptcy. It also relieves Novavax from pressure from activist investor Shah Capital, which called the company “historically mismanaged,” in a public letter last month. With the announcement, Novavax’s share price increased by 121% to $9.89—still far from the $289 price Novavax’s shares attracted in February 2021 when the company was hailed as a rags-to-riches story after scoring a $1.6 billion government grant to develop its COVID shot. During a Friday conference call, Novavax CEO John Jacobs called the deal “the beginning of a new chapter for the future of our company.” “I’d rather not comment on what Sanofi may be thinking or why they came to the conclusion why this is such an exciting platform to partner with, but we’re not surprised because we know the value our technology can offer,” Jacobs added. The agreement gives more people around the world access to Nuvaxovid, a traditional, protein-based adjuvanted vaccine, which differs from the mRNA-type shots manufactured by Moderna and Pfizer and its German partner BioNTech. In exchange, Sanofi receives access to Novavax’s Matrix-M adjuvant technology. Novavax can receive up to $200 million plus tiered royalties for each Sanofi vaccine product developed using the platform. Novavax will retain the rights to a combination COVID/flu vaccine that's under development, while Sanofi gains the ability to use Nuvaxovid in developing non-influenza combination vaccines. “We have an opportunity to develop non-mRNA flu-COVID-19 combination vaccines, offering patients both enhanced convenience and protection against two serious respiratory viruses,” Jean-Francois Toussaint, Sanofi’s head of vaccines R&D, said in a release. “We're excited by the prospect of combining Novavax's adjuvanted COVID-19 vaccine that has shown high efficacy and favorable tolerability with our rich portfolio of differentiated flu vaccines.” Novavax’s urgency to make a deal was highlighted on Friday as the company presented its quarterly financial report, slashing its guidance for annual sales from a range of $800 million to $1 billion to a window of $400 million to $600 million. The company achieved revenue of $2 billion in 2022 and $984 million in 2023. This comes as AstraZeneca is pulling its non-mRNA COVID vaccine from markets around the world. This week the EMA said it had accepted a request from AZ and withdrawn the company’s European marketing authorization for its pandemic shot Vaxzevria. “As multiple, variant COVID-19 vaccines have since been developed there is a surplus of available updated vaccines,” the company said. “This has led to a decline in demand for Vaxzervria, which is no longer being manufactured or supplied.”