Imdusiran

WARMINSTER, Pa., April 04, 2024 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop a functional cure for people with chronic hepatitis B virus (cHBV) infection, today issued the following statement regarding the claim construction ruling of the U.S. District Court for the District of Delaware in the lawsuit brought by Arbutus and its licensee Genevant Sciences (Plaintiffs) against Moderna, Inc. and a Moderna affiliate seeking damages for infringement of U.S. Patent Nos. 8,058,069, 8,492,359, 8,822,668, 9,364,435, 9,504,651, and 11,141,378 in the manufacture and sale of MRNA-1273, Moderna’s vaccine for COVID-19. The following summarizes the Court’s Opinion: Composition of Total Lipid (‘069) The Court agreed with Plaintiffs’ position that the claimed molar percentage (mol. %) ranges can be met by any particle and is not limited to “finished” particles that are not subjected to further process steps.The Court agreed with Plaintiffs’ position that the claimed mol. % ranges include standard variation based on the number of significant figures recited in the claim. Cationic Lipid with Protonatable Tertiary Amine (‘378) The Court agreed with Plaintiffs’ position that there is no limitation as to the mol. % of the claimed cationic lipid. Encapsulation of mRNA (‘651) The Court held that “wherein at least 70% / at least 80% / about 90% of the mRNA in the formulation is fully encapsulated in the lipid vesicles” means “wherein at least 70% / at least 80% / about 90% of the mRNA is fully, as distinct from partially, contained inside the lipid vesicles”. “We are pleased with how the Court construed the disputed claim terms,” said Michael J. McElhaugh, Interim President and Chief Executive Officer of Arbutus Biopharma. “We remain committed to protecting and defending our intellectual property and look forward to the next steps in the litigation.” Arbutus and Genevant Sciences are seeking fair compensation for Moderna’s use of its patented LNP technology that was developed with great effort and at great expense, and without which Moderna’s COVID-19 vaccine would not have been successful. The Court’s claim construction ruling has been posted on the Arbutus website. About Arbutus Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to identify and develop novel therapeutics with distinct mechanisms of action, which can be combined to provide a functional cure for patients with chronic hepatitis B virus (cHBV). We believe the key to success in developing a functional cure involves suppressing HBV DNA, reducing surface antigen, and boosting HBV-specific immune responses. Our pipeline of internally developed, proprietary compounds includes an RNAi therapeutic, imdusiran (AB-729) and an oral PD-L1 inhibitor, AB-101. Imdusiran has generated meaningful clinical data demonstrating an impact on both surface antigen reduction and reawakening of the HBV-specific immune response. Imdusiran is currently in two Phase 2a combination clinical trials. AB-101 is currently being evaluated in a Phase 1a/1b clinical trial. For more information, visit www.arbutusbio.com. Forward-Looking Statements and Information This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, forward-looking statements). Forward-looking statements in this press release include statements about our future development plans for our product candidates; our program updates; our belief that checkpoint inhibitors may play a key role in antiviral immune tolerance in cHBV; the potential for our product candidates to achieve success in clinical trials and; our plans and expectations with respect to the ongoing patent litigation matters.   With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of preclinical studies and clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued demand for Arbutus’ assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies, including uncertainties and contingencies related to the ongoing patent litigation matters.   Additionally, there are known and unknown risk factors which could cause Arbutus’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: anticipated pre-clinical studies and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested product candidate; Arbutus may elect to change its strategy regarding its product candidates and clinical development activities; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus’ products; economic and market conditions may worsen; uncertainties associated with litigation generally and patent litigation specifically; it may take considerable time and expense to resolve the clinical hold that has been placed on AB-101 by the FDA, and no assurance can be given that the FDA will remove the clinical hold; Arbutus and its collaborators may never realize the expected benefits of the collaborations; and market shifts may require a change in strategic focus; and risks related to the sufficiency of Arbutus’ cash resources and its ability to obtain adequate financing in the future for its foreseeable and unforeseeable operating expenses and capital expenditures.   A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus’ Annual Report on Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and Arbutus’ continuous and periodic disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.   Contact Information Investors and MediaLisa M. CaperelliVice President, Investor RelationsPhone: 215-206-1822Email: lcaperelli@arbutusbio.com

OXFORD, United Kingdom, March 20, 2024 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), formerly Vaccitech plc, announced its financial results for the year ended December 31, 2023, and an overview of the Company’s progress. 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. “2023 was a productive year for Barinthus Bio, with data presented in our HBV and HPV programs, the first patient visit in our next generation prostate cancer program and up to $35 million of future funding committed from the Coalition for Epidemic Preparedness Innovations (CEPI) secured for our MERS program,” said Bill Enright, Chief Executive Officer of Barinthus Bio. “We expect another data rich year in 2024, with anticipated final results from our Phase 1b/2 HPV APOLLO trial of VTP-200, and additional data from our two ongoing Phase 2 trials of VTP-300 in chronic HBV infection. In addition, our SNAP-TI platform is heading into the clinic for the first time as we expect to initiate a Phase 1 clinical trial of VTP-1000 in celiac disease, our lead program in autoimmunity.” 2023 Corporate Milestones Clinical Developments HBV (VTP-300): In March 2023, we announced positive topline final data from the HBV002 Phase 2 clinical trial for VTP-300 in Chronic Hepatitis B (CHB). The data showed meaningful, durable reductions of Hepatitis B Surface Antigen (HBsAg) in all participants with a >0.5 log10 reduction in HBsAg who received VTP-300 alone or in combination with a single administration of low-dose PD-1 inhibitor, nivolumab. Two of five patients with baseline HBsAg below 100 IU/mL in Group 3, developed a non-detectable HBsAg level, which continued eight months after last dose. We presented the final data in June 2023 at the European Association for the Study of the Liver Congress 2023 – The International Liver CongressTM. In November 2023, we presented interim data from the HBV003 Phase 2b clinical trial for VTP-300 in CHB showing that VTP-300 in combination with nivolumab continued to show sustained HBsAg reductions, particularly in patients with HBsAg levels below or equal to 200IU/mL at screening. We presented this data during an oral presentation at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2023. Also in November 2023, interim data from the Phase 2a AB-729-202 clinical trial in collaboration with Arbutus Biopharma Corporation (Arbutus) in CHB patients were presented at AASLD, showing that imdusiran in combination with VTP-300 demonstrated meaningful and sustained declines in HBsAg levels. HPV (VTP-200): In March 2023, we announced favorable topline interim data from the HPV001 Phase 1b/2 clinical trial of VTP-200 in high-risk HPV (hrHPV) infection. In April, we presented interim data from the VTP-200 APOLLO (HPV001) Phase 1b/2 clinical trial in hrHPV infection at the 35th Annual International Papillomavirus Conference. Immunological results showed VTP-200 induced high T cell responses to HPV antigens, and was generally well-tolerated with no product-related grade 3 unsolicited events and no product-related SAEs. Celiac Disease (VTP-1000): In December 2023, we submitted an Australian ethics submission and regulatory notification to the Alfred Research Review Committee for the Phase 1 GLU001 study in Celiac disease. Prostate Cancer (VTP-850): In June 2023, we announced the dosing of the first patient in the PCA001 Phase 1/2 clinical trial for VTP-850 in prostate cancer. MERS (VTP-500): In December 2023, we announced an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Oxford, aiming to fast-track the development of our vaccine candidate, VTP-500, for the prevention of Middle East Respiratory Syndrome. This agreement includes CEPI investing funding of up to $35 million to Barinthus Bio in addition to funds previously committed to the University of Oxford to develop and stockpile a ready reserve of VTP-500. Key Operational Updates In January 2023, we announced the appointment of Nadège Pelletier, Ph.D., as Chief Scientific Officer. In June 2023, we completed the move of our U.S. facility to Germantown, Maryland, which houses a state-of-the art wet laboratory and office space. In November 2023, we announced the company’s renaming as Barinthus Biotherapeutics plc to represent the evolution and expansion of its focus beyond vaccines. As part of the renaming, the Company changed its Nasdaq ticker to "BRNS", which became effective on Nasdaq on November 7, 2023. Upcoming Milestones In 2024, the Company expects to: Q2 2024: HBV: Announce 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 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. HPV: Announce final results from participants receiving VTP-200 in the Phase 1b/2 APOLLO (HPV001) trial evaluating the safety, immunogenicity and efficacy of VTP-200 in persistent HPV infection and low-grade cervical lesions. Celiac disease: Initiate a Phase 1 clinical trial of VTP-1000. Q4 2024: HBV: Announce more mature 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 more mature 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. 2023 Financial Highlights Cash position: As of December 31, 2023, cash was $142.1 million, compared to $194.4 million as of December 31, 2022. The cash used in operating activities was $50.9 million, primarily resulting from our net loss of $73.4 million, adjusted by foreign exchange loss on translation of $7.5 million, share-based compensation of $5.1 million, depreciation and amortization of $5.4 million, deferred tax movements of $3.1 million and changes in our operating assets and liabilities, net of $6.2 million primarily related to a $5.8 million decrease in accounts receivable, a $2.2 million decrease in prepaid expenses and other current assets, $3.4 million decrease in accounts payable and $2.0 million increase in accrued expenses. Revenue: Revenue was $0.8 million in 2023 compared to $44.7 million in 2022 and was comprised of the Company’s share of royalties received by Oxford University Innovation as a result of commercial sales of Vaxzevria® by AstraZeneca, sales of which reduced significantly in 2023 when compared to 2022. Research and development expenses: Research and development expenses were $44.9 million in 2023 compared to $42.4 million in 2022, demonstrating the progression of our pipeline through the clinic. Direct research and development expenses reduced $0.6 million, comprising of a $3.3 million increase in expense on the SNAP platform candidates, namely VTP-1000, offset by a reduction in expense of $2.4 million due to the phasing of VTP-300 in two ongoing Phase 2 clinical trials, and a $2.3 million reduction as a result of VTP-850 getting into the clinic in a Phase 1/2 clinical trial in prostate cancer. Indirect research and development expenses increased $3.1 million as a result of an increase in headcount attributing to an increase in personnel costs of $2.3 million and an increase in facility costs due to moving the U.S. office to a 19,700 square foot, state-of-the-art wet laboratory and office facility in Germantown, Maryland, in June 2023. The year-on-year R&D expense per program is outlined in the following table. Year ended December 31, 2023 December 31, 2022 Change $ 000 $ 000 $ 000 Direct research and development expenses by program: VTP-200 HPV $ 4,950 $ 4,050 $ 900 VTP-300 HBV 11,276 13,700 (2,424 ) VTP-600 NSCLC1 597 532 65 VTP-850 Prostate cancer 2,726 5,011 (2,285 ) VTP-1000/VTP-1100 Celiac/HPV Cancer 8,420 5,118 3,302 Other and earlier stage programs 1,787 1,916 (129 ) Total direct research and development expenses $ 29,756 $ 30,327 $ (571 ) Indirect research and development expenses: Personnel-related (including share-based compensation) 12,702 10,424 2,278 Facility-related 1,339 1,308 31 Other internal costs 1,077 291 786 Total indirect research and development expenses 15,118 12,023 3,095 Total research and development expense $ 44,874 $ 42,350 $ 2,524 1 The VTP-600 NSCLC Phase 1/2a trial is sponsored by Cancer Research UK. General and administrative expenses: General and administrative expenses were $39.8 million in 2023, compared to $6.4 million in 2022. The increase is primarily attributable to a $7.6 million loss on foreign exchange in 2023 compared to a $26.4 million gain on foreign exchange in 2022 as a result of movements in the USD:GBP exchange rate during the respective periods. Net loss: For the financial year 2023, the Company generated a net loss attributable to its shareholders of $73.3 million, or $1.91 per fully diluted share and per basic share, compared to a net income attributable to shareholders of $5.3 million, or $0.14 per fully diluted share and per basic share, for 2022. 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 four 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 HPV infection; 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 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,” 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 interim data for any of our programs, 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, our ability to execute on our strategy, regulatory developments, the risk that we may not realize the benefits related to our rebranding and name change, our ability to fund our operations and access capital, our preliminary estimates of our cash and cash equivalents and cash runway, including the risk that final financial results may differ materially from our preliminary estimates, 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) December 31, 2023 December 31, 2022 ASSETS Cash and cash equivalents $ 142,090 $ 194,385 Accounts receivable — 323 Accounts receivable – related parties — 5,524 Research and development incentives receivable 4,908 4,541 Prepaid expenses and other current assets 9,907 8,268 Total current assets 156,905 213,041 Goodwill 12,209 12,209 Property and equipment, net 11,821 7,957 Intangible assets, net 25,108 28,269 Right of use assets, net 7,581 7,753 Other assets 882 976 Total assets $ 214,506 $ 270,205 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable 1,601 3,748 Accrued expenses and other current liabilities 9,212 8,061 Deferred revenue — — Operating lease liability - current $ 1,785 $ 433 Total current liabilities 12,598 12,242 Non-Current liabilities: Operating lease liability - non-current 11,191 8,340 Contingent consideration 1,823 1,711 Other non-current liabilities 1,325 965 Deferred tax liability, net 574 3,746 Total liabilities $ 27,511 $ 27,004 Commitments and contingencies (Note 16) Stockholders’ equity: Ordinary shares, £0.000025 nominal value; 38,643,540 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 386,602 379,504 Accumulated deficit (176,590 ) (103,243 ) Accumulated other comprehensive loss – foreign currency translation adjustments (23,315 ) (33,460 ) Total stockholders’ equity attributable to Barinthus Biotherapeutics plc shareholders 186,784 242,896 Noncontrolling interest 211 305 Total stockholders’ equity $ 186,995 $ 243,201 Total liabilities and stockholders’ equity $ 214,506 $ 270,205 1 indicates amount less than thousand. BARINTHUS BIOTHERAPEUTICS PLC CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS) December 31, 2023 December 31, 2022 License revenue 1 $ 802 $ 44,694 Research grants and contracts — 9 Total revenue 802 44,703 Operating expenses Research and development 44,874 42,350 General and administrative 39,842 6,394 Total operating expenses 84,716 48,744 Loss from operations (83,914 ) (4,041 ) Other income /(expense): Interest income 2,877 3,103 Interest expense (28 ) (19 ) Research and development incentives 3,461 1,240 Other income, net 1,082 567 Total other income, net 7,392 4,891 (Loss)/profit before income tax (76,522 ) 850 Tax benefit 3,075 4,471 Net (loss)/income (73,447 ) 5,321 Net loss attributable to noncontrolling interest 100 21 Net (loss)/income attributable to Barinthus Biotherapeutics plc shareholders (73,347 ) 5,342 Weighted-average ordinary shares outstanding, basic 38,386,491 37,248,126 Weighted-average ordinary shares outstanding, diluted 38,386,491 38,169,307 Net (loss)/income per share attributable to ordinary shareholders, basic $ (1.91 ) $ 0.14 Net (loss)/income per share attributable to ordinary shareholders, diluted $ (1.91 ) $ 0.14 Net (loss)/income $ (73,447 ) $ 5,321 Other comprehensive gain/(loss) – foreign currency translation adjustments 10,151 (25,083 ) Comprehensive loss (63,296 ) (19,762 ) Comprehensive loss attributable to noncontrolling interest 94 132 Comprehensive loss attributable to Barinthus Biotherapeutics plc shareholders $ (63,202 ) $ (19,630 ) 1 Includes license revenue from related parties for the year ended December 31, 2023 of $0.8 million (December 31, 2022: $44.7 million). IR contacts: Christopher M. Calabrese  Managing Director  LifeSci Advisors +1 917-680-5608 ccalabrese@lifesciadvisors.com Kevin Gardner Managing Director LifeSci Advisors +1 617-283-2856 kgardner@lifesciadvisors.com Media contact: Audra Friis Sam Brown, Inc. +1 917-519-9577 audrafriis@sambrown.com Company contact: Jonothan Blackbourn IR & PR Manager Barinthus Bio ir@barinthusbio.com