Vaccitech (UK) Ltd.

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.”

Barinthus Biotherapeutics is evaluating “future development options for the VTP-200 program.” Barinthus Biotherapeutics has hit the primary endpoint of a phase 1b/2 trial by showing its treatment for high-risk human papillomavirus (hrHPV) is safe. But the failure to prove the therapy actually works has left the biotech mulling how to take the candidate further. The trial involved 108 women across the U.K. and the EU aged 25 to 55 with persistent hrHPV infection and low-grade cervical lesions who received either the therapy, dubbed VTP-200, or placebo. VTP-200 is an immunotherapeutic combo regimen that involves patients receiving an initial dose using the ChAdOx vector and a second dose using the MVA vector. Both doses encode the same HPV antigens, with the aim of producing an antigen-specific T-cell immune response to HPV. The U.K.-based company—formerly known as Vaccitech—said the trial hit its primary endpoint of demonstrating VTP-200 was generally safe and well tolerated. No treatment-related adverse events of grade 3 or above were recorded. However, when it came to whether the immunotherapeutic actually works, things weren’t as straightforward. Barinthus was keen to zoom down into the five groups who had received different variations of the VTP-200 combo regimen to try to salvage some success. For example, in group 2—which included the highest dose of ChAdOx—there was a hrPV clearance rate of 60% at 12 months, compared to 33% for the placebo cohort. But the other four groups received either little additional benefit or actually fared worse, with clearance rates ranging from just 11% to 36%. It was a similar story when it came to clearing cervical lesions. The highest clearance rate of 67% was observed in two of the groups—both of which received the highest dose of ChAdOx—compared to 39% in the placebo cohort. But the other three groups saw rates of just 20%, 33% and 40%. Ultimately, when the data from all five groups were pooled, they didn’t demonstrate a significant improvement in hrHPV clearance or cervical lesion clearance, the biotech acknowledged. For now, the company is evaluating “future development options for the VTP-200 program.” “We were pleased to see that VTP-200 was generally well-tolerated, meeting the primary safety endpoint in this study,” Barinthus Chief Scientific Officer Nadege Pelletier, Ph.D., said in the release. “The most promising hrHPV and cervical lesion clearance data were observed in the highest ChAdOx-HPV dosing groups which is informative for future development,” Pelletier added. “However, these differences compared to placebo were not statistically significant given that the trial was not powered for individual dose group comparisons.” “Further analyses are ongoing, mostly focusing on immunological responses and we plan to share the detailed results in due course,” she said.

OXFORD, United Kingdom, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), formerly Vaccitech plc, today announced its financial results for the third quarter of 2023 and provided an overview of its progress. The Company is a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious disease, autoimmunity and cancer. “The third quarter of 2023 was a period of solid progress for the Company. We have since revealed the evolution of the company identity from Vaccitech to Barinthus Bio. This change reflects the evolution of our pipeline beyond vaccines, towards T cell immunotherapeutic candidates designed to guide the capabilities of T cells, to stimulate their disease-fighting capacity or to restore immune balance,” said Bill Enright, Chief Executive Officer of Barinthus Bio. “We remain focused on progressing our pipeline, particularly in HBV, for which upcoming preliminary data from both of our Phase 2 trials will be presented at The American Association for the Study of Liver Diseases – The Liver Meeting® 2023 this month.” Recent Corporate Developments In November 2023, the Company announced it changed its name to Barinthus Biotherapeutics plc to represent the evolution and expansion of its focus beyond vaccines. The Company’s new name takes inspiration from “Barinthus,” the mythological navigator who guided King Arthur of Britain by ship to the island of Avalon to be healed when he was wounded. The story of the legendary king being guided to a place of healing is reflective of the way the Company’s proprietary platforms and technology are designed to guide the immune system to treat infectious diseases, autoimmunity and cancer.On November 6, 2023, the Company held a general meeting where its shareholders approved resolutions granting the Company’s board of directors or any duly authorized committee of the board of directors an increase in the authority to allot shares in the Company or grant rights to subscribe for or to convert any security into shares in the Company free from pre-emption rights. Pursuant to such approval, our board of directors was authorized to allot shares up to an aggregate nominal amount of £1,928, free from statutory pre-emption rights. Upcoming Milestones In the fourth quarter of 2023, the Company expects to: Announce interim efficacy data from HBV003 (NCT05343481), a Phase 2b clinical trial of VTP-300, that further evaluates its potential as a component of a functional cure for chronic Hepatitis B.Announce interim efficacy data from the Phase 2a clinical trial (ACTRN12622000317796) collaboration with Arbutus of VTP-300 in combination with Arbutus’ siRNA therapeutic candidate, AB-729 for chronic hepatitis B.Submit a regulatory submission application in Australia for VTP-1000, the Company’s lead SNAP-TI candidate, for the treatment of celiac disease. Third Quarter 2023 Financial Highlights Cash position: As of September 30, 2023, the Company had cash and cash equivalents of $160.3 million, compared to $173.0 million as of June 30, 2023. The net cash used in operating activities was $11.2 million, primarily resulting from its net loss of $14.1 million adjusted by unrealised foreign exchange gains of $6.2 million, depreciation and amortization of $1.5 million, and changes in its operating assets and liabilities. Based on current research and development plans, the Company expects its cash runway to fund its operating expenses and capital expenditure requirements into the second quarter of 2025.Research and development expenses: Research and development expenses were $15.1 million in the third quarter of 2023 compared to $13.5 million in the second quarter of 2023, showing increased spend due to the phasing of ongoing clinical trials. VTP-300 HBV research and development expenses increased as a result of the increased trial cost and manufacturing development costs, VTP-850 Prostate cancer has also increased as a result of the increased trial costs as the trial progresses. The quarter-on-quarter R&D expense per program is outlined in the following table. Three months endedSeptember 30, 2023June 30, 2023Change $000$000$000 Direct research and development expenses by program: VTP-200 HPV 1,288 1,837 (549)VTP-300 HBV 4,877 3,757 1,120 VTP-600 NSCLC1 155 79 76 VTP-850 Prostate cancer 1,724 242 1,482 VTP-1000/VTP-1100 Celiac/HPV Cancer 2,507 3,018 (511)Other and earlier stage programs 1,069 701 368 Total direct research and development expenses 11,620 9,634 1,986 Indirect research and development expenses: Personnel-related (including share-based compensation) 2,711 3,388 (677)Facility-related 368 202 166 Other internal costs 445 319 126 Total indirect research and development expenses 3,524 3,909 (385)Total research and development expense 15,144 13,543 1,601 1 The VTP-600 NSCLC Phase 1/2a trial is sponsored by Cancer Research UK. General and administrative expenses: General and administrative expenses were $1.0 million in the third quarter of 2023, compared to $13.1 million in the second quarter of 2023. The decrease was mainly attributable to the unrealized foreign exchange gain of $6.6 million in the third quarter of 2023, compared to an unrealized foreign exchange loss of $4.2 million in the second quarter of 2023. The remainder of the decrease was primarily attributable to a decrease in legal and professional fees of $0.5 million and decrease in share-based compensation expense.Net loss: For the third quarter of 2023, the Company generated a net loss attributable to its shareholders of $14.1 million, or $0.37 per share on both basic and fully diluted bases, compared to a net loss attributable to shareholders of $23.8 million, or $0.62 per share on both basic and fully diluted bases in the second quarter of 2023. About Barinthus Bio We are 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 patients and their families is the guiding principle at the heart of Barinthus Bio. The company stands apart through its broad pipeline, built around four proprietary platform technologies; ChAdOx, MVA, SNAP-TI and SNAP-CI. 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 hepatitis B viral (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-TI platform to treat patients with celiac disease; VTP-850, a second-generation immunotherapeutic candidate designed to treat recurrent prostate cancer; and VTP-1100, a preclinical cancer candidate designed to utilize the SNAP-CI platform to treat patients with HPV-related cancer. Barinthus Bio’s proven scientific expertise, high-value portfolio and focus on product development uniquely positions the company to navigate towards delivering treatments for patients with infectious diseases, autoimmunity and cancers that have a significant impact on their lives every day. For more information, visit www.barinthusbio.com. Forward Looking Statements This press release contains forward-looking statements, 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 “would,” “aim,” “forward,” “expect,” “plan,” “intend,” “believe,” “potential,” “continue,” and similar expressions, although not all forward-looking statements contain these identifying words. These forward looking statements include express or implied statements regarding the Company’s future expectations, plans and prospects, and include, without limitation, statements regarding the timing and advancement of the Company’s programs, including the clinical trials of VTP-200, VTP-300, and VTP-850, statements regarding the timing for the potential IND application for VTP-1000, statements regarding the presentation of interim data, including with respect to VTP-300, and statements regarding the Company’s capital, including its cash runway. 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 product development activities and planned and ongoing clinical trials, the Company’s ability to execute on its strategy, regulatory developments, approval of the Company’s product candidates, the Company’s ability to fund its operations and access capital, and global economic uncertainty, including disruptions in the banking industry, the conflict in Ukraine, and the conflict in Israel and Gaza, and other risks identified in the Company’s filings with the Securities and Exchange Commission (the SEC), including its Annual Report on Form 10-K for the year ended December 31, 2022, its Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. 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. BARINTHUS BIOTHERAPEUTICS PLC CONDENSED CONSOLIDATED BALANCE SHEETS (IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS) (UNAUDITED) September 30, December 31, 2023 2022 ASSETS Current assets: Cash and cash equivalents$160,309 $194,385 Accounts receivable — 323 Accounts receivable - related parties — 5,524 Research and development incentives receivable 4,172 4,541 Prepaid expenses and other current assets 6,584 8,268 Total current assets 171,065 213,041 Goodwill 12,209 12,209 Property and equipment, net 12,269 7,957 Intangible assets, net 25,898 28,269 Right of use assets, net 7,474 7,753 Other assets 1,055 976 Total assets$229,970 $270,205 LIABILITIES AND SHAREHOLDERS’ EQUITY Current liabilities: Accounts payable$5,145 $3,748 Accrued expenses and other current liabilities 11,923 8,061 Operating lease liability - current 1,501 433 Total current liabilities 18,569 12,242 Non-Current liabilities: Operating lease liability 11,202 8,340 Contingent consideration 1,797 1,711 Deferred tax liability, net 1,521 3,746 Other non-current liabilities 1,278 965 Total liabilities$34,367 $27,004 Commitments and contingencies (Note 14) Shareholders’ equity: Ordinary shares, £0.000025 nominal value; 38,546,594 shares authorized, issued and outstanding (December 31, 2022: authorized, issued and outstanding: 37,683,531) 1 1 Deferred A shares, £1 nominal value; 63,443 shares authorized, issued and outstanding (December 31, 2022: authorized, issued and outstanding: 63,443) 86 86 Deferred B shares, £0.01 nominal value; nil shares authorized, issued and outstanding (December 31, 2022:authorized, issued and outstanding: 570,987) — 8 Deferred C shares, £0.000007 nominal value, nil shares authorized, issued and outstanding (December 31, 2022: authorized, issued and outstanding: 27,828,231) — 0 Additional paid-in capital 385,707 379,504 Accumulated deficit (159,297) (103,243) Accumulated other comprehensive loss – foreign currency translation adjustments (31,099) (33,460) Total shareholders’ equity attributable to Barinthus Biotherapeutics plc shareholders 195,398 242,896 Noncontrolling interest 205 305 Total shareholders’ equity$195,603 $243,201 Total liabilities and shareholders’ equity$229,970 $270,205 1 indicates amount less than thousand. BARINTHUS BIOTHERAPEUTICS PLC CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS) (UNAUDITED) Three months ended Nine months ended September 30, 2023 September 30, 2022 September 30, 2023 September 30, 2022License revenue (1) $— $6,165 $802 $38,237 Research grants and contracts — — — 9 Total revenue — 6,165 802 38,246 Operating expenses Research and development 15,144 9,744 38,501 30,165 General and administrative 961 (10,815) 26,227 (12,971)Total operating expenses 16,105 (1,071) 64,728 17,194 (Loss)/income from operations (16,105) 7,236 (63,926) 21,052 Other income (expense): Interest income 196 1,024 2,306 1,776 Interest expense (7) 11 (21) 3 Research and development incentives 1,205 (724) 2,921 1,150 Other income (2) — 308 51 Total other income (expense) 1,392 311 5,514 2,980 (Loss)/profit before income tax (14,713) 7,547 (58,412) 24,032 Tax benefit 603 674 2,255 2,452 Net (loss)/income (14110) 8,221 (56,157) 26,484 Net loss attributable to noncontrolling interest 38 21 103 47 Net (loss)/income attributable to Barinthus Biotherapeutics plc shareholders (14,072) 8,242 (56,054) 26,531 Weighted-average ordinary shares outstanding, basic 38,533,833 37,247,123 38,320,208 37,213,787 Weighted-average ordinary shares outstanding, diluted 38,533,833 38,156,564 38,320,208 38,226,092 Net (loss)/income per share attributable to ordinary shareholders, basic $(0.37) $0.22 $(1.46) $0.71 Net (loss)/income per share attributable to ordinary shareholders, diluted $(0.37) $0.22 $(1.46) $0.69 Net (loss)/income $(14,110) $8,221 $(56,157) $26,484 Other comprehensive gain/(loss) – foreign currency translation adjustments (7,820) (19,940) 2,364 (42,730)Comprehensive loss (21,930) (11,719) (53,793) (16,246)Comprehensive loss attributable to noncontrolling interest 48 51 100 122 Comprehensive loss attributable to Barinthus Biotherapeutics plc shareholders $(21,882) $(11,668) $(53,693) $(16,124) 1 Includes license revenue from related parties for the three and nine month periods ended September 30, 2023 of $Nil million and $0.8 million, respectively and for the three and nine month periods ended September 30, 2022 of $6.2 million and $38.2 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