PAPD5

SAN MATEO, Calif., Sept. 21, 2023 (GLOBE NEWSWIRE) -- Bluejay Therapeutics, Inc. a private clinical stage biopharmaceutical company focused on viral and liver diseases, today announced the appointment of Christopher Holterhoff as Senior Vice President, Head of Business Development. Mr. Holterhoff will lead Bluejay’s business and corporate development function and will play a significant role in Bluejay’s corporate strategy and strategic planning activities. He will be a member of Bluejay’s Executive team, reporting to Keting Chu, Founder and CEO of Bluejay Therapeutics. “I am delighted to welcome Chris to the senior leadership team at Bluejay”, stated Mrs. Chu. “Chris has an outstanding track record in business & corporate development with both public and private biotech and pharma companies. His business development experience, as well as his strategic aptitude will play a critical role as we execute on our vision of building a leading biotechnology company focused on curative treatments for serious viral and liver diseases.” “Bluejay is extremely well-positioned with a pipeline of first-in-class or best-in-class treatment options addressing serious and highly prevalent viral and liver diseases where there exists substantial unmet medical need. I am thrilled to join the organization at such a pivotal time in its development, and I look forward to working with Bluejay’s exceptional team and leveraging my experience in business development to advance the company’s promising pipeline toward approval for patients who are in dire need of new treatment options.” Mr. Holterhoff has nearly two decades of diverse experience encompassing business & corporate development, corporate finance & strategy, and capital markets. Before joining Bluejay, he served as VP, Business & Corporate development at LEXEO Therapeutics, where he led all business development, strategic transactions and played a significant role in the company’s capital raising activities. Prior to LEXEO, Mr. Holterhoff served as executive director of business development at Amicus Therapeutics where he executed on new strategic business opportunities for Amicus’ gene therapy pipeline, including license agreements, M&A transactions, and R&D collaborations, and led the alliance management function. Earlier in his career, he worked in healthcare investment banking at MTS Health Partners, where he advised public and private biotechnology and pharmaceutical companies on strategic buy and sell side transactions and financings and served as a senior publishing equity research analyst at Oppenheimer & Co. Inc., providing coverage of biotechnology and pharmaceutical companies. Mr. Holterhoff holds an MBA from Columbia University, MS in Biotechnology from Georgetown University, and BS from Providence College. Mr. Holterhoff joins a seasoned executive leadership team, including: Keting Chu, M.D., Ph.D., founder and chief executive officer, was previously a partner at LYFE Capital and venture partner at Apple Tree Partners, and was responsible for venture philanthropy at The Leukemia and Lymphoma Society. Dr. Chu was also the CEO of several companies, including Mission Therapeutics, DigitAB, and BioCubed Corporation. Earlier in her career, she held R&D leadership roles at Five Prime Therapeutics and Chiron Corporation. Hassan Javanbakht, Ph.D., chief scientific officer, was previously at Hoffman La-Roche, Gilead sciences and SQZ biotechnologies where he worked on developing novel antivirals and immunomodulators to treat HIV, HBV, influenza and other infectious diseases. He was part of the team that advanced Elipida® (RO4970335), a potent and highly selective NNRTI, into clinical development . He led the teams that developed a first-in-class small-molecule viral expression inhibitor (RG7834) and a liver-targeted anti-HBV locked nucleic acid (RG6004). His work also led to discovery of PAPD5/7 as host factors for HBV expression. He has authored more than 45 peer-reviewed scientific publications in high-impact journals and holds more than 11 issued patents and applications. Nancy Shulman, M.D., CMO, has over 20 years of clinical development experience including at Roche, Genentech, AbbVie, and most recently at Ambys Medicines, where she was the vice president of translational medicine. She brings broad clinical development experience ranging from first-in-human and translational studies through Phase 4 studies, including extensive experience in the virology/hepatology disease area, but also in immunology and oncology. She has been a part of multiple INDs and was a key leader on the NDA approvals of the HCV antivirals Viekira Pak®, Viekirax®, and Mavyret®. Kevin Lin, M.D., vice president of development, has over 30 years of experience in the biotechnology industry in the areas of process development, technology transfer, scale up, troubleshooting, GMP manufacturing, and CMC regulatory submission. He has worked at several biotech companies, such as Bayer Healthcare, Catalant, Avid Bioservices, ImmunityBio, and Kindred Biosciences. Jeff Zablocki, Ph.D., vice president of chemistry, has led chemistry teams at AbbVie, Gilead, CV Therapeutics, Amgen, and Searle. Dr. Zablocki has discovered 15 development compounds including 3 approved agents: Lexiscan™ – an adenosine A2A agonist used in over 60 million patients as a pharmacological stress agent capturing a large market share; Ranexa™ for stable angina; and Voxilaprevir™ for Hepatitis C where he helped address pre-clinical metabolism challenges by applying novel medicinal chemistry approaches. About Bluejay Therapeutics Bluejay Therapeutics is a clinical stage private biopharmaceutical company committed to developing effective treatments and cures for viral and liver diseases ( ). Its initial target indications are CHB and CHD, diseases that have a global prevalence and an urgent need for improved medical solutions. Bluejay is advancing two potential therapeutic approaches: best-in-class fully human IgG1 anti-HBs monoclonal antibodies and orally liver-targeted HBV transcript inhibitors. The company has developed a platform for liver-directed drug targeting, with potential applications to multiple therapeutic agents. For more information on potential collaborations with Bluejay Therapeutics regarding partnering opportunities or preclinical or clinical research programs, please contact us at info@bluejaytx.com.

Regulatory approval received in New Zealand to advance AB-101, our oral PD-L1 inhibitor, into a Phase 1 clinical trial with dosing to begin this quarter AB-729 (imdusiran), in combination with pegylated interferon alfa-2a, in a Phase 2a clinical trial, was generally well tolerated and appears to result in continued HBsAg declines in some patients First patient dosed in additional arm of Phase 2a clinical trial combining imdusiran, VTP-300, NA therapy and nivolumab – advancing towards goal of further stimulating host HBV-associated immunity Cash runway into the first quarter of 2025 Conference Call and Webcast Today at 8:45 AM ET WARMINSTER, Pa., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, today reported second quarter 2023 financial results and provided a corporate update. “In the second quarter of 2023, we achieved two important milestones in our Phase 2a clinical trials that support our efforts in developing AB-729 (imdusiran), our lead RNAi therapeutic, as a cornerstone therapy in a functional cure treatment regimen for HBV,” said William Collier, Arbutus President and Chief Executive Officer. “First, we reported data from our Phase 2a clinical trial showing that imdusiran in combination with interferon, is well tolerated and appears to result in continued HBsAg declines in some patients. Second, we made solid progress towards our goal of further stimulating host HBV-associated immunity, as we dosed the first patient in the additional treatment arm of the ongoing Phase 2a trial assessing the addition of low-dose nivolumab, a PD-1 monoclonal antibody, to VTP-300 and imdusiran.” Mr. Collier continued, “Regarding our early-stage HBV assets, we are now prepared to move AB-101 forward into a Phase 1 clinical trial in New Zealand, which we expect to initiate this quarter, and AB-161, our oral RNA destabilizer, is in an on-going Phase 1 clinical trial. Additionally, we are on-track to complete IND-enabling studies with our coronavirus Mpro inhibitor candidate, AB-343, as well as initiate IND-enabling studies for a coronavirus nsp12 inhibitor candidate in the second half of this year.” Pipeline Updates and Key Milestones Imdusiran (AB-729, RNAi Therapeutic)   At the European Association for the Study of the Liver (EASL) Congress, we presented data from our on-going Phase 2a clinical trial (AB-729-201), evaluating the safety, tolerability and antiviral activity of the combination of imdusiran and pegylated interferon alfa-2a (IFN) in patients with chronic hepatitis B virus (cHBV). Preliminary data suggests that the addition of IFN to imdusiran was generally well tolerated and appears to result in continued HBsAg declines in some patients. The mean HBsAg decline from baseline during the imdusiran lead-in phase was 1.6 log10 at week 24 of treatment which is comparable to what was previously seen in other imdusiran clinical trials.  Four patients reached HBsAg below the lower limit of quantitation (LLOQ) at some point during IFN treatment. We plan to provide a further update on this clinical trial when we have additional meaningful patient data. We have completed enrollment in the first group of our Phase 2a clinical trial (AB-729-202) that is evaluating imdusiran, nucleos(t)ide analogue (NA) therapy and Vaccitech’s HBV antigen-specific immunotherapeutic, VTP-300. Preliminary data from patients in the clinical trial are expected in the second half of 2023. We recently expanded the AB-729-202 clinical trial to enroll 20 patients who will receive imdusiran (60mg every 8 weeks) plus NA therapy for 24 weeks followed by VTP-300 plus up to two doses of low-dose nivolumab (Opdivo®). In June 2023, we announced that the first patient received the first dose of imdusiran in this additional arm. Preliminary data from this additional treatment arm are expected in 2024. AB-161 (Oral RNA destabilizer) The Phase 1 clinical trial with AB-161 is on-going with single-ascending dose data expected in the second half of 2023. AB-161 is our next-generation oral HBV-specific RNA destabilizer, which is being developed as part of a potential all-oral treatment regimen to functionally cure HBV. Recently reported preclinical data showed that AB-161 provides robust anti-HBV activity including suppression of HBV RNA and HBsAg production in vitro and in vivo. AB-101 (Oral PD-L1 Inhibitor)  In April 2023, AB-101 was placed on clinical hold by the U.S. Food and Drug Administration (FDA) during the Investigational New Drug (IND) application review process prior to dosing subjects. In July 2023, the New Zealand Medicine and Medical Device Safety Authority (Medsafe) approved our CTA application for a Phase 1 clinical trial in New Zealand for AB-101, and we believe the protocol approved by Medsafe adequately addresses the clinical trial design and safety monitoring issues raised by the FDA. We are planning to initiate the Phase 1 clinical trial this quarter. We are developing AB-101 to reawaken and boost the immune system of patients with cHBV. Preclinical data generated thus far indicates that AB-101 is highly potent and mediates activation and reinvigoration of HBV-specific T-cells from cHBV patients. COVID-19 and Pan-Coronavirus Programs We are continuing to conduct IND-enabling studies with AB-343 and are on track to complete those studies in the second half of 2023. We are continuing to direct our research efforts to identifying an nsp12 viral polymerase inhibitor clinical candidate. Such a candidate could potentially be combined with AB-343 to achieve better patient treatment outcomes and for use in prophylactic settings.  We expect to nominate an nsp12 inhibitor clinical candidate and initiate IND-enabling studies in the second half of 2023. Corporate Updates In July 2023, we announced that Melissa V. Rewolinski, PhD was appointed to the Board of Directors. Melissa brings to the Board more than 20 years of strategic, operational and drug development experience within the pharmaceutical industry. In July 2023, we announced the promotion of Karen Sims, MD, PhD to Chief Medical Officer. Karen is a board-certified infectious disease physician with more than 12 years of industry experience in conducting and overseeing early stage through global Phase 2 clinical trials. She joined Arbutus in April 2017 and has held positions of increasing seniority, including most recently as Vice President, Clinical Development, before being promoted to Chief Medical Officer. In July 2023, we also announced the appointment of Christopher Naftzger as General Counsel and Chief Compliance Officer. Chris succeeds Dr. Elizabeth Howard who will continue in an advisory role with respect to the on-going patent infringement litigations. Chris brings more than 25 years of legal experience, including over a decade of experience serving in senior in-house counsel positions with life science companies. Financial Results Cash, Cash Equivalents and Investments As of June 30, 2023, we had cash, cash equivalents and investments in marketable securities of $163.5 million compared to $184.3 million as of December 31, 2022. During the six months ended June 30, 2023, we used $46.9 million in operating activities, which was partially offset by $24.6 million of net proceeds from the issuance of common shares under our “at-the-market” offering program. We expect our 2023 net cash burn to range from between $90 to $95 million, excluding any proceeds received from our “at the market program”. We believe our cash runway will be sufficient to fund our operations into the first quarter of 2025. Revenue Total revenue was $4.7 million for the three months ended June 30, 2023 compared to $14.2 million for the same period in 2022. The decrease of $9.5 million for the 2023 period was due primarily to lower revenue recognition from our license agreement with Qilu compared to the 2022 period based on lower employee labor hours expended by us in the 2023 period compared to the 2022 period to perform our manufacturing obligations under the license agreement. Operating Expenses Research and development expenses were $17.7 million for the three months ended June 30, 2023 compared to $22.9 million for the same period in 2022. The decrease of $5.2 million was due primarily to a decrease in expenses for drug supply manufacturing for our imdusiran, AB-101 and AB-161 clinical trials, as well as a decrease in expenses related to our AB-836 Phase 1a/1b clinical trial, which was discontinued in the fourth quarter of 2022. These were partially offset by an increase in expenses for our coronavirus program, including drug supply manufacturing. General and administrative expenses were $6.0 million for the three months ended June 30, 2023, compared to $5.2 million for the same period in 2022. This increase was due primarily to increases in non-cash stock-based compensation expense and professional fees. Net Loss For the three months ended June 30, 2023, our net loss was $17.1 million, or a loss of $0.10 per basic and diluted common share, as compared to a net loss of $14.2 million, or a loss of $0.10 per basic and diluted common share, for the three months ended June 30, 2022. Outstanding Shares As of June 30, 2023, we had approximately 166.9 million common shares issued and outstanding, as well as approximately 20.2 million stock options and unvested restricted stock units outstanding. Roivant Sciences Ltd. owned approximately 23% of our outstanding common shares as of June 30, 2023. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF LOSS (in thousands, except share and per share data) Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Revenue Collaborations and licenses $ 3,885 $ 12,556 $ 9,394 $ 23,774 Non-cash royalty revenue 766 1,685 1,944 3,048 Total revenue 4,651 14,241 11,338 26,822 Operating expenses Research and development 17,692 22,942 35,967 41,404 General and administrative 5,980 5,200 11,532 10,092 Change in fair value of contingent consideration (636 ) 208 (363 ) 409 Total operating expenses 23,036 28,350 47,136 51,905 Loss from operations (18,385 ) (14,109 ) (35,798 ) (25,083 ) Other income (loss) Interest income 1,461 396 2,729 555 Interest expense (171 ) (482 ) (369 ) (988 ) Foreign exchange gain 1 3 5 3 Total other income (loss) 1,291 (83 ) 2,365 (430 ) Loss before income taxes (17,094 ) (14,192 ) (33,433 ) (25,513 ) Income tax expense — — — (4,444 ) Net loss $ (17,094 ) $ (14,192 ) $ (33,433 ) $ (29,957 ) Net loss per common share Basic and diluted $ (0.10 ) $ (0.10 ) $ (0.20 ) $ (0.20 ) Weighted average number of common shares Basic and diluted 166,063,284 148,750,048 163,855,661 148,589,711 UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) June 30, 2023 December 31, 2022 Cash, cash equivalents and marketable securities, current $ 152,484 $ 146,913 Accounts receivable and other current assets 6,316 4,226 Total current assets 158,800 151,139 Property and equipment, net of accumulated depreciation 5,370 5,070 Investments in marketable securities, non-current 11,057 37,363 Right of use asset 1,585 1,744 Other non-current assets 11 103 Total assets $ 176,823 $ 195,419 Accounts payable and accrued liabilities $ 8,805 $ 16,029 Deferred license revenue, current 15,327 16,456 Lease liability, current 397 372 Total current liabilities 24,529 32,857 Liability related to sale of future royalties 8,787 10,365 Deferred license revenue, non-current — 5,999 Contingent consideration 7,168 7,531 Lease liability, non-current 1,646 1,815 Total stockholders’ equity 134,693 136,852 Total liabilities and stockholders’ equity $ 176,823 $ 195,419 UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands) Six Months Ended June 30, 2023 2022 Net loss $ (33,433 ) $ (29,957 ) Non-cash items 2,911 3,154 Change in deferred license revenue (7,128 ) 27,815 Other changes in working capital (9,210 ) (686 ) Net cash (used in) provided by operating activities (46,860 ) 326 Net cash provided by (used in) investing activities 18,119 (73,886 ) Issuance of common shares pursuant to Share Purchase Agreement — 10,973 Issuance of common shares pursuant to the Open Market Sale Agreement 24,604 268 Cash provided by other financing activities 555 357 Net cash provided by financing activities 25,159 11,598 Effect of foreign exchange rate changes on cash and cash equivalents 3 — Decrease in cash and cash equivalents (3,579 ) (61,962 ) Cash and cash equivalents, beginning of period 30,776 109,282 Cash and cash equivalents, end of period 27,197 47,320 Investments in marketable securities 136,344 153,329 Cash, cash equivalents and marketable securities, end of period $ 163,541 $ 200,649 Conference Call and Webcast Today Arbutus will hold a conference call and webcast today, Thursday, August 3, 2023, at 8:45 AM Eastern Time to provide a corporate update. To dial-in for the conference call by phone, please register using the following link: Registration Link. A live webcast of the conference call can be accessed through the Investors section of Arbutus' website at . An archived webcast will be available on the Arbutus website after the event. About imdusiran (AB-729) Imdusiran is an RNA interference (RNAi) therapeutic specifically designed to reduce all HBV viral proteins and antigens including hepatitis B surface antigen which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine (GalNAc) delivery technology enabling subcutaneous delivery. Clinical data generated thus far has shown single- and multi-doses of imdusiran to be generally safe and well-tolerated, while also providing meaningful reductions in hepatitis B surface antigen and hepatitis B DNA. Imdusiran is currently in multiple Phase 2a clinical trials. About AB-101 AB-101 is our lead oral PD-L1 inhibitor candidate that we believe will allow for controlled checkpoint blockade and enable oral dosing, while minimizing the systemic safety issues typically seen with checkpoint antibody therapies. Immune checkpoints such as PD-1/PD-L1 play an important role in the induction and maintenance of immune tolerance and in T-cell activation. Preclinical data generated thus far indicates that AB-101 mediates activation and reinvigoration of HBV-specific T-cells from cHBV patients. We believe AB-101, when used in combination with other approved and investigational agents, could potentially lead to a functional cure in HBV chronically infected patients. We are also exploring oncology applications for our internal PD-L1 portfolio.  About AB-161 AB-161 is our next generation oral small molecule RNA destabilizer, specifically designed to target the liver. Mechanistically, RNA destabilizers target the host proteins PAPD5/7, which are involved in regulating the stability of HBV RNA transcripts. In doing so, RNA destabilizers lead to the selective degradation of HBV RNAs, thus reducing HBsAg levels and inhibiting viral replication. To provide a proprietary all-oral treatment regimen for patients with cHBV, we believe inclusion of a small molecule RNA destabilizer is key. About AB-343 AB-343 is our lead coronavirus drug candidate that inhibits the SARS-CoV-2 main protease (Mpro), a validated target for the treatment of COVID-19 and potential future coronavirus outbreaks. In our pre-clinical research conducted to date, AB-343 has shown pan-coronavirus antiviral activity, no reduction in potency against known SARS-CoV-2 variants, robust activity against SARS-CoV-2 Mpro resistant strains, and a favorable drug-drug interaction pro no need for ritonavir boosting. We see an opportunity to pursue a potential combination therapeutic strategy focusing on Mpro and nsp12 viral polymerase targets to reduce hospitalizations, achieve better patient treatment outcomes and provide pre-exposure prophylactic therapy. About HBV Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. Chronic HBV infection represents a significant unmet medical need. The World Health Organization estimates that over 290 million people worldwide suffer from chronic HBV infection, while other estimates indicate that approximately 2.4 million people in the United States suffer from chronic HBV infection. Approximately 820,000 people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options.  About Coronaviruses Coronaviruses are a large family of viruses that range from the common cold to more severe diseases such as severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), and COVID-19. COVID-19 has caused approximately 7.2 million deaths globally according to an analysis by the Institute for Health Metrics and Evaluation (IHME). As we strive to identify and develop new antiviral small molecules to treat COVID-19 and future coronavirus outbreaks, we have focused our research efforts on two essential targets critical for replication across all coronaviruses – nsp5 protease and nsp12 polymerase.  About Arbutus Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases. Our current focus areas include Hepatitis B virus (HBV), SARS-CoV-2, and other coronaviruses. To address HBV, we are developing a RNAi therapeutic, an oral PD-L1 inhibitor, and an oral RNA destabilizer to potentially identify a combination regimen with the aim of providing a functional cure for patients with chronic HBV by suppressing viral replication, reducing surface antigen and reawakening the immune system. We believe our lead compound, imdusiran (AB-729), is the only RNAi therapeutic with evidence of immune re-awakening. Imdusiran is currently being evaluated in multiple phase 2 clinical trials. We also have an ongoing drug discovery and development program directed to identifying novel, orally active agents for treating coronaviruses, (including SARS-CoV-2), for which we have nominated a compound and have begun IND-enabling pre-clinical studies. In addition, we are also exploring oncology applications for our internal PD-L1 portfolio. For more information, visit . 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; the expected cost, timing and results of our clinical development plans and clinical trials with respect to our product candidates; our expectations with respect to the release of data from our clinical trials and the expected timing thereof; our expectations and goals for our collaborations with third parties and any potential benefits related thereto; statements regarding our plans for AB-101 in light of the FDA’s clinical hold; the potential for our product candidates to achieve success in clinical trials; and our expected financial condition, including our anticipated net cash burn, the anticipated duration of cash runways and timing regarding needs for additional capital. 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. 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 and at . 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 Media Lisa M. Caperelli Vice President, Investor Relations Phone: 215-206-1822 Email: lcaperelli@arbutusbio.com

Additional AB-729 off-treatment data highlighted in an oral presentation at the Global Hepatitis Summit 2023 Dosed first subject in Phase 1 clinical trial with oral RNA Destabilizer, AB-161 Filed patent infringement lawsuit against Pfizer and BioNTech seeking compensation for use of unlicensed patented technologies in COVID-19 mRNA-LNP vaccines Strong financial position – cash runway extends into the first quarter of 2025 Conference Call and Webcast Today at 8:45 AM ET WARMINSTER, Pa., May 04, 2023 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, today reported first quarter 2023 financial results and provided a corporate update. “In the first quarter of 2023, we made meaningful progress advancing our pipeline of HBV and coronavirus assets to address large global market opportunities,” said William Collier, Arbutus’ President and Chief Executive Officer. “We reported data from our lead HBV-focused RNAi therapeutic, AB-729, showing low levels of HBsAg and HBV DNA in most patients persisting for at least a year and a half after their last dose of AB-729. In addition, we dosed the first healthy subject in our Phase 1 clinical trial with AB-161, our oral RNA destabilizer, for which we expect data in the second half of this year. We continue to advance our coronavirus programs and expect to initiate a Phase 1 clinical trial with our Mpro inhibitor candidate, AB-343, as well as IND-enabling studies for an nsp12 inhibitor candidate in the second half of this year.” Pipeline Updates and Key Milestones AB-729 (RNAi Therapeutic) At the Global Hepatitis Summit in April, we reported in an oral presentation additional off-treatment data from the patients in our Phase 1b clinical trial (AB-729-001) who have discontinued both AB-729 and nucleos(t)ide analogue (NA) therapy. These seven remaining patients continue to maintain low HBV DNA levels off all therapy, and HBsAg levels remain below baseline (-0.8 to -1.6 log10) up to one and a half years after the last dose of AB-729. We are continuing to evaluate the safety and tolerability of AB-729 in combination with ongoing NA therapy and short courses of PEG-IFNα-2a (IFN) in 43 patients with chronic hepatitis B virus (cHBV) infection in a Phase 2a clinical trial (AB-729-201). Preliminary data from the lead-in phase of the trial further validated AB-729’s capacity to reduce HBsAg. We expect to announce preliminary data from patients receiving the combination of AB-729, NA therapy and IFN in the second quarter of 2023. We are continuing to evaluate AB-729, NA therapy and Vaccitech’s HBV antigen-specific immunotherapeutic, VTP-300, in a Phase 2a clinical trial (AB-729-202). Once enrollment is complete in the initial portion of this trial, we will begin enrolling 20 patients in an additional arm of the trial. These patients will receive AB-729 (60mg every 8 weeks) plus NA therapy for 24 weeks, followed by VTP-300 plus one to two low doses of nivolumab (Opdivo®). We expect preliminary data from patients who receive AB-729, NA therapy and VTP-300 in the second half of 2023, and we expect to dose the first patient in the additional arm receiving AB-729, NA therapy, VTP-300 and nivolumab in the second quarter of 2023. AB-161 (Oral RNA destabilizer) In March, we dosed the first healthy subject in our Phase 1 clinical trial with AB-161. The single-ascending dose data is expected in the second half of 2023. AB-161 is our next-generation oral HBV-specific RNA destabilizer, which is being developed as part of a potential all-oral treatment regimen to functionally cure HBV. At the Global Hepatitis Summit in April, we presented preclinical data showing that AB-161 provides robust anti-HBV activity including suppression of HBV RNA and HBsAg production in vitro and in vivo. The differentiated anti-HBV mode of action of AB-161 compared to other classes of HBV inhibitors, suggest that AB-161 may be an important component in combination to provide a functional cure for cHBV. AB-101 (Oral PD-L1 Inhibitor) In April, we received verbal communication from the U.S. Food and Drug Administration (FDA) that the AB-101 Investigational New Drug (IND) application has been placed on clinical hold. For purposes of clarity, the Phase 1 clinical trial had not been initiated and we had not dosed any patients with AB-101. The FDA indicated they will provide an official clinical hold letter to Arbutus within 30 days of the verbal communication. Based on this communication, we no longer intend to report initial data from the single-ascending dose portion of a Phase 1 clinical trial in the second half of 2023. We are developing AB-101, our oral PD-L1 inhibitor, to reawaken and boost the immune system of patients with cHBV. Preclinical data generated thus far indicates that AB-101 is highly potent and mediates activation and reinvigoration of HBV-specific T-cells from cHBV patients. COVID-19 and Pan-Coronavirus Programs At the 36th International Conference on Antiviral Research in March, we presented pre-clinical data for AB-343, our lead coronavirus drug candidate that inhibits the main protease (Mpro). The antiviral potency, selectivity and favorable pharmacokinetic data support the further development of AB-343 as a potential ritonavir-free oral treatment for COVID-19 and other human coronaviruses. We are currently conducting IND-enabling studies with AB-343, and on completion, we expect to initiate a Phase 1 clinical trial in the second half of 2023. We are continuing to direct our research efforts to identifying an nsp12 viral polymerase clinical candidate. Such a candidate could potentially be combined with AB-343 to achieve better patient treatment outcomes and for use in prophylactic settings. We expect to nominate an nsp12 clinical candidate and initiate IND-enabling studies in the second half of 2023. Financial Results Cash, Cash Equivalents and Investments As of March 31, 2023, we had cash, cash equivalents and investments in marketable securities of $178.5 million compared to $184.3 million as of December 31, 2022. During the three months ended March 31, 2023, we used $27.3 million in operating activities, which was partially offset by $19.9 million of net proceeds from the issuance of common shares under our “at-the-market” offering program. Based on AB-101's IND being placed on clinical hold by the FDA and a resulting shift in the timing of our AB-101 Phase 1 clinical trial, we are reducing our 2023 cash burn guidance from between $95 to $100 million to between $90 to $95 million. We believe our cash runway will be sufficient to fund our operations into the first quarter of 2025. Revenue Total revenue was $6.7 million for the three months ended March 31, 2023 compared to $12.6 million for the same period in 2022. The decrease of $5.9 million was due primarily to less revenue recognition from our license agreement with Qilu compared to last year based on employee labor hours expended by us to perform our manufacturing obligations under the license agreement. Operating Expenses Research and development expenses were $18.3 million for the three months ended March 31, 2023 compared to $18.5 million for the same period in 2022. The decrease of $0.2 million was due primarily to a decrease in expenses for our AB-836 Phase 1a/1b clinical trial, which was discontinued in the fourth quarter of 2022, partially offset by an increase in expenses for our coronavirus program and other early-stage development programs. Net Loss For the three months ended March 31, 2023, our net loss was $16.3 million, or a loss of $0.10 per basic and diluted common share, as compared to a net loss of $15.8 million, or a loss of $0.11 per basic and diluted common share, for the three months ended March 31, 2022. Net loss for the three months ended March 31, 2022 included $4.4 million of income tax expense for withholding taxes paid to the Chinese taxing authority by Qilu on our behalf in connection with the upfront license fee Qilu paid us. Outstanding Shares As of March 31, 2023, we had approximately 165.1 million common shares issued and outstanding, as well as approximately 19.7 million stock options and unvested restricted stock units outstanding. Roivant Sciences Ltd. owned approximately 23% of our outstanding common shares as of March 31, 2023. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF LOSS (in thousands, except share and per share data) Three Months Ended March 31, 2023 2022 Revenue Collaborations and licenses $ 5,509 $ 11,218 Non-cash royalty revenue 1,178 1,363 Total revenue 6,687 12,581 Operating expenses Research and development 18,275 18,462 General and administrative 5,552 4,892 Change in fair value of contingent consideration 273 201 Total operating expenses 24,100 23,555 Loss from operations (17,413 ) (10,974 ) Other income (loss) Interest income 1,268 159 Interest expense (198 ) (506 ) Foreign exchange gain 4 — Total other income (loss) 1,074 (347 ) Loss before income taxes (16,339 ) (11,321 ) Income tax expense — (4,444 ) Net loss $ (16,339 ) $ (15,765 ) Net loss per common share Basic and diluted $ (0.10 ) $ (0.11 ) Weighted average number of common shares Basic and diluted 161,643,404 148,428,326 UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) March 31, 2023 December 31, 2022 Cash, cash equivalents and marketable securities, current $ 146,728 $ 146,913 Accounts receivable and other current assets 6,126 4,226 Total current assets 152,854 151,139 Property and equipment, net of accumulated depreciation 4,853 5,070 Investments in marketable securities, non-current 31,790 37,363 Right of use asset 1,665 1,744 Other non-current assets 62 103 Total assets $ 191,224 $ 195,419 Accounts payable and accrued liabilities $ 9,653 $ 16,029 Deferred license revenue, current 15,055 16,456 Lease liability, current 446 372 Total current liabilities 25,154 32,857 Liability related to sale of future royalties 9,384 10,365 Deferred license revenue, non-current 3,296 5,999 Contingent consideration 7,804 7,531 Lease liability, non-current 1,671 1,815 Total stockholders’ equity 143,915 136,852 Total liabilities and stockholders’ equity $ 191,224 $ 195,419 UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands) Three Months Ended March 31, 2023 2022 Net loss $ (16,339 ) $ (15,765 ) Non-cash items 1,372 1,642 Change in deferred license revenue (4,104 ) 38,840 Other changes in working capital (8,230 ) (4,098 ) Net cash (used in) provided by operating activities (27,301 ) 20,619 Net cash provided by (used in) investing activities 16,678 (60,056 ) Issuance of common shares pursuant to Share Purchase Agreement — 10,973 Issuance of common shares pursuant to the Open Market Sale Agreement 19,862 268 Cash provided by other financing activities 555 244 Net cash provided by financing activities 20,417 11,485 Effect of foreign exchange rate changes on cash and cash equivalents 4 - Increase (decrease) in cash and cash equivalents 9,798 (27,952 ) Cash and cash equivalents, beginning of period 30,776 109,282 Cash and cash equivalents, end of period 40,574 81,330 Investments in marketable securities 137,944 153,500 Cash, cash equivalents and marketable securities, end of period $ 178,518 $ 234,830 Conference Call and Webcast Today Arbutus will hold a conference call and webcast today, Thursday, May 4, 2023, at 8:45 AM Eastern Time to provide a corporate update. To dial-in for the conference call by phone, please register using the following link: Registration Link. A live webcast of the conference call can be accessed through the Investors section of Arbutus' website at . An archived webcast will be available on the Arbutus website after the event. About AB-729 AB-729 is an RNA interference (RNAi) therapeutic specifically designed to reduce all HBV viral proteins and antigens including hepatitis B surface antigen which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. AB-729 targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine (GalNAc) delivery technology enabling subcutaneous delivery. Clinical data generated thus far has shown single- and multi-doses of AB-729 to be generally safe and well-tolerated, while also providing meaningful reductions in hepatitis B surface antigen and hepatitis B DNA. AB-729 is currently in multiple Phase 2a clinical trials. About AB-101 AB-101 is our lead oral PD-L1 inhibitor candidate that we believe will allow for controlled checkpoint blockade and enable oral dosing, while minimizing the systemic safety issues typically seen with checkpoint antibody therapies. Immune checkpoints such as PD-1/PD-L1 play an important role in the induction and maintenance of immune tolerance and in T-cell activation. Preclinical data generated thus far indicates that AB-101 mediates activation and reinvigoration of HBV-specific T-cells from cHBV patients. We believe AB-101, when used in combination with other approved and investigational agents, could potentially lead to a functional cure in HBV chronically infected patients. We are also exploring oncology applications for our internal PD-L1 portfolio. About AB-161 AB-161 is our next generation oral small molecule RNA destabilizer, specifically designed to target the liver. Mechanistically, RNA destabilizers target the host proteins PAPD5/7, which are involved in regulating the stability of HBV RNA transcripts. In doing so, RNA destabilizers lead to the selective degradation of HBV RNAs, thus reducing HBsAg levels and inhibiting viral replication. To provide a proprietary all-oral treatment regimen for patients with cHBV, we believe inclusion of a small molecule RNA destabilizer is key. About AB-343 AB-343 is our lead coronavirus drug candidate that inhibits the SARS-CoV-2 main protease (Mpro), a validated target for the treatment of COVID-19 and potential future coronavirus outbreaks. In our pre-clinical research conducted to date, AB-343 has shown pan-coronavirus antiviral activity, no reduction in potency against known SARS-CoV-2 variants, robust activity against SARS-CoV-2 Mpro resistant strains, and a favorable drug-drug interaction pro no need for ritonavir boosting. We see an opportunity to pursue a potential combination therapeutic strategy focusing on Mpro and nsp12 viral polymerase targets to reduce hospitalizations, achieve better patient treatment outcomes and provide pre-exposure prophylactic therapy. About HBV Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. Chronic HBV infection represents a significant unmet medical need. The World Health Organization estimates that over 290 million people worldwide suffer from chronic HBV infection, while other estimates indicate that approximately 2.4 million people in the United States suffer from chronic HBV infection. Approximately 820,000 people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options.  About Coronaviruses Coronaviruses are a large family of viruses that range from the common cold to more severe diseases such as severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), and COVID-19. COVID-19 has caused approximately 7.2 million deaths globally according to an analysis by the Institute for Health Metrics and Evaluation (IHME). As we strive to identify and develop new antiviral small molecules to treat COVID-19 and future coronavirus outbreaks, we have focused our research efforts on two essential targets critical for replication across all coronaviruses – nsp5 protease and nsp12 polymerase.  About Arbutus Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases. Our current focus areas include Hepatitis B virus (HBV), SARS-CoV-2, and other coronaviruses. To address HBV, we are developing a RNAi therapeutic, an oral PD-L1 inhibitor, and an oral RNA destabilizer to potentially identify a combination regimen with the aim of providing a functional cure for patients with chronic HBV by suppressing viral replication, reducing surface antigen and reawakening the immune system. We believe our lead compound, AB-729, is the only RNAi therapeutic with evidence of immune re-awakening. AB-729 is currently being evaluated in multiple phase 2 clinical trials. We also have an ongoing drug discovery and development program directed to identifying novel, orally active agents for treating coronaviruses, (including SARS-CoV-2), for which we have nominated a compound and have begun IND-enabling pre-clinical studies. In addition, we are also exploring oncology applications for our internal PD-L1 portfolio. For more information, visit . 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; the expected cost, timing and results of our clinical development plans and clinical trials with respect to our product candidates; our expectations with respect to the release of data from our clinical trials and the expected timing thereof; our expectations and goals for our collaborations with third parties and any potential benefits related thereto; the potential for our product candidates to achieve success in clinical trials; and our expected financial condition, including our anticipated net cash burn, the anticipated duration of cash runways and timing regarding needs for additional capital. 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 COVID-19 pandemic and 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; Arbutus and its collaborators may never realize the expected benefits of the collaborations; market shifts may require a change in strategic focus; and the ongoing COVID-19 pandemic could significantly disrupt Arbutus’ clinical development programs. 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 and at . 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 Media Lisa M. Caperelli Vice President, Investor Relations Phone: 215-206-1822 Email: lcaperelli@arbutusbio.com