Arbutus Biopharma Corporation (NASDAQ:ABUS) Q1 2023 Results Conference Call May 4, 2023 8:45 AM ET Company Participants Lisa Caperelli - VP of IR Bill Collier - President, CEO and Director David Hastings - CFO and CAO Karen Sims - VP of Clinical Development Michael Sofia - Chief Scientific Officer Conference Call Participants Thomas Yip - H.C. Wainwright Roy Buchanan - JMP Dennis Ding - Jefferies Operator Good day, and thank you for standing by. Welcome to the Arbutus Biopharma 2023 First Quarter Financial ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from to Commission File Number: 001-34949 ARBUTUS BIOPHARMA CORPORATION (Exact Name of Registrant as Specified in Its Charter) British Columbia, Canada 98-0597776 (State or O ...

Corporate Presentation NASDAQ: ABUS www.arbutusbio.com March 2, 2023 © 2023 Arbutus Biopharma, Inc. Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to: the potential market opportunity for HBV; Arbutus' abili ...

Arbutus Biopharma Corporation (NASDAQ:ABUS) Q4 2022 Earnings Conference Call March 2, 2023 8:45 AM ET Company Participants Lisa Caperelli - VP of IR William Collier - President and CEI Michael Sofia - Chief Scientific Officer David Hastings - CFO Michael McElhaugh - COO Conference Call Participants Dennis Ding - Jefferies Charles Moore - Baird Thomas Yip - H.C. Wainwright Keay Nakae - Chardan Roy Buchanan - JMP Securities Operator Good day, and thank you for standing by. Welcome to the Arbutus Biopharma Co ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from to Commission File Number: 001-34949 Arbutus Biopharma Corporation (Exact Name of Registrant as Specified in Its Charter) British Columbia, Canada 98-0597776 (State or Other ...

Arbutus Biopharma Corporation (NASDAQ:ABUS) Q3 2022 Earnings Conference Call January 1, 2022 8:45 AM ET Company Participants Lisa Caperelli - Vice President of Investor Relations Bill Collier - President and Chief Executive Officer David Hastings - Chief Financial Officer Gaston Picchio - Chief Development Officer Mike Sofia - Chief Scientific Officer Conference Call Participants Dennis Ding - Jefferies Roy Buchanan - JMP Keay Nakae - Chardan Operator Good day. And thank you for standing by, and welcome to ...

Arbutus Biopharma Corporation (NASDAQ:ABUS) Q2 2022 Earnings Conference Call August 4, 2022 8:45 AM ET Company Participants Lisa Caperelli - Vice President of Investor Relations Bill Collier - President & Chief Executive Officer David Hastings - Chief Financial Officer Gaston Picchio - Chief Development Officer Mike Sofia - Chief Scientific Officer Conference Call Participants Roy Buchanan - JMP Securities Dennis Ding - Jefferies Brian Skorney - Baird Keay Nakae - Chardan Thomas Yip - H.C. Wainwright Operat ...

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents Arbutus Biopharma Corporation's unaudited condensed consolidated financial statements and management's discussion and analysis of its financial condition and results of operations [ITEM 1. FINANCIAL STATEMENTS (UNAUDITED)](index=3&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS%20%28UNAUDITED%29) This section presents Arbutus Biopharma Corporation's unaudited condensed consolidated financial statements, including balance sheets, statements of operations, stockholders' equity, and cash flows, along with detailed explanatory notes [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of Arbutus Biopharma Corporation's financial position, detailing assets, liabilities, and stockholders' equity at specific reporting dates Table: Condensed Consolidated Balance Sheets | Assets/Liabilities | June 30, 2022 (in thousands) | December 31, 2021 (in thousands) | | :----------------- | :--------------------------- | :------------------------------- | | **Total Assets** | $215,836 | $204,485 | | **Total Liabilities** | $62,694 | $35,046 | | **Total Stockholders' Equity** | $153,142 | $169,439 | - Total assets increased by **$11.35 million (5.5%)** from December 31, 2021, to June 30, 2022, primarily driven by an increase in investments in marketable securities[6](index=6&type=chunk) - Total liabilities significantly increased by **$27.65 million (78.9%)** due to the recognition of deferred license revenue, current and non-current, related to the Qilu agreement[6](index=6&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details Arbutus Biopharma Corporation's financial performance over specific periods, including revenue, operating expenses, and net loss Table: Condensed Consolidated Statements of Operations and Comprehensive Loss | Metric (in thousands) | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | **Total Revenue** | $14,241 | $2,329 | $26,822 | $4,442 | | **Total Operating Expenses** | $28,350 | $20,971 | $51,905 | $38,760 | | **Loss from Operations** | $(14,109) | $(18,642) | $(25,083) | $(34,318) | | **Net Loss** | $(14,192) | $(19,387) | $(29,957) | $(35,768) | | **Basic and Diluted Loss per Share** | $(0.10) | $(0.23) | $(0.20) | $(0.44) | - Total revenue for the three months ended June 30, 2022, increased significantly by **$11.9 million (511%)** compared to the same period in 2021, primarily due to collaboration and license revenue[9](index=9&type=chunk) - Net loss decreased for both the three-month and six-month periods ended June 30, 2022, compared to 2021, indicating improved financial performance despite increased operating expenses[9](index=9&type=chunk) [Condensed Consolidated Statement of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statement%20of%20Stockholders'%20Equity) This section outlines changes in Arbutus Biopharma Corporation's stockholders' equity, reflecting net losses, share issuances, and other comprehensive income Table: Condensed Consolidated Statement of Stockholders' Equity | Equity Item (in thousands) | Balance Dec 31, 2021 | Balance June 30, 2022 | | :------------------------- | :------------------- | :-------------------- | | **Total Stockholders' Equity** | $169,439 | $153,142 | | **Common Shares Issued & Outstanding** | 144,987,736 | 148,794,262 | | **Net Loss** | $(15,765) (Q1 2022) | $(14,192) (Q2 2022) | - Total stockholders' equity decreased by **$16.297 million** from December 31, 2021, to June 30, 2022, primarily due to net losses and unrealized losses on available-for-sale securities, partially offset by common share issuances[12](index=12&type=chunk) - The number of common shares outstanding increased by **3,806,526 shares** during the six months ended June 30, 2022, through various issuances including a Share Purchase Agreement and exercise of options[12](index=12&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section details Arbutus Biopharma Corporation's cash inflows and outflows from operating, investing, and financing activities over specific periods Table: Condensed Consolidated Statements of Cash Flows | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------------------- | :----------------------------- | :----------------------------- | | **Net cash provided by (used in) operating activities** | $326 | $(31,890) | | **Net cash used in investing activities** | $(73,886) | $(20,526) | | **Net cash provided by financing activities** | $11,598 | $31,163 | | **Decrease in cash and cash equivalents** | $(61,962) | $(21,297) | | **Cash and cash equivalents, end of period** | $47,320 | $30,954 | - Operating activities generated **$0.326 million** in cash for the six months ended June 30, 2022, a significant improvement from the **$31.89 million** cash used in the prior year, primarily due to a **$40.0 million** upfront payment from Qilu[16](index=16&type=chunk)[172](index=172&type=chunk) - Net cash used in investing activities increased to **$73.886 million**, mainly due to higher purchases of marketable securities[16](index=16&type=chunk)[173](index=173&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanatory notes supporting the condensed consolidated financial statements, covering accounting policies, fair value measurements, and collaborations [1. Nature of business and future operations](index=8&type=section&id=1.%20Nature%20of%20business%20and%20future%20operations) This section describes Arbutus Biopharma Corporation's core business as a clinical-stage biopharmaceutical company and its strategic focus on developing therapeutics for viral diseases - Arbutus Biopharma Corporation is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for viral diseases, primarily Hepatitis B virus (HBV), SARS-CoV-2, and other coronaviruses[18](index=18&type=chunk) - The company's lead compound, AB-729, an RNAi therapeutic, is in Phase 2 clinical trials for chronic HBV infection and shows evidence of immune re-awakening[18](index=18&type=chunk) Table: Financial Position Highlights | Metric | June 30, 2022 (in millions) | | :----- | :-------------------------- | | **Cash, cash equivalents and marketable securities** | $200.6 | | **Outstanding Debt** | $0 | [2. Significant accounting policies](index=9&type=section&id=2.%20Significant%20accounting%20policies) This section outlines the key accounting principles and methods used in preparing Arbutus Biopharma Corporation's financial statements, including revenue recognition and fair value measurements - The unaudited condensed consolidated financial statements are prepared in accordance with GAAP for interim financial statements and include Arbutus Biopharma Corporation and its wholly-owned subsidiary[22](index=22&type=chunk) - Net loss attributable to common shareholders per share is calculated based on weighted average common shares, with potential common shares excluded if anti-dilutive[24](index=24&type=chunk) - Revenue from collaborations and licenses is recognized using a five-step model (ASC 606), identifying distinct performance obligations and allocating transaction price based on stand-alone selling prices[26](index=26&type=chunk)[27](index=27&type=chunk) [3. Fair value measurements](index=10&type=section&id=3.%20Fair%20value%20measurements) This section details Arbutus Biopharma Corporation's methodology for measuring financial instruments at fair value, utilizing a three-level hierarchy based on input observability - The company measures certain financial instruments at fair value using a three-level hierarchy based on observability of inputs[32](index=32&type=chunk) Table: Fair Value Measurements by Level | Item (in thousands) | Level 1 (June 30, 2022) | Level 2 (June 30, 2022) | Level 3 (June 30, 2022) | Total (June 30, 2022) | | :------------------ | :---------------------- | :---------------------- | :---------------------- | :-------------------- | | **Assets** | | | | | | Cash and cash equivalents | $47,320 | — | — | $47,320 | | Investments in marketable securities, current | — | $102,879 | — | $102,879 | | Investments in marketable securities, non-current | — | $50,450 | — | $50,450 | | **Total Assets** | $47,320 | $153,329 | — | $200,649 | | **Liabilities** | | | | | | Liability-classified stock options | — | — | $2 | $2 | | Contingent consideration | — | — | $5,707 | $5,707 | | **Total Liabilities** | — | — | $5,709 | $5,709 | - The fair value of contingent consideration increased by **$0.4 million** from December 31, 2021, to June 30, 2022, reflecting the progression of development programs[34](index=34&type=chunk)[41](index=41&type=chunk) [4. Investments in marketable securities](index=13&type=section&id=4.%20Investments%20in%20marketable%20securities) This section provides details on Arbutus Biopharma Corporation's investments in marketable securities, including their amortized cost and fair value Table: Investments in Marketable Securities | Investment Type (in thousands) | Amortized Cost (June 30, 2022) | Fair Value (June 30, 2022) | | :----------------------------- | :----------------------------- | :------------------------- | | **Cash equivalents** | $23,984 | $23,984 | | **Investments in marketable short-term securities** | $103,925 | $102,879 | | **Investments in marketable long-term securities** | $51,317 | $50,450 | - As of June 30, 2022, the company held **$102.9 million** in short-term marketable securities (maturing in less than one year) and **$50.5 million** in long-term marketable securities (maturing between one and five years)[44](index=44&type=chunk) - There were no realized gains or losses on marketable securities for the three and six months ended June 30, 2022 or 2021[44](index=44&type=chunk) [5. Investment in Genevant](index=14&type=section&id=5.%20Investment%20in%20Genevant) This section describes Arbutus Biopharma Corporation's equity investment in Genevant Sciences Ltd. and the associated licensing agreements for RNA-based applications - Arbutus accounts for its **16% interest** in Genevant Sciences Ltd. as equity securities without readily determinable fair values, with a carrying value of zero as of June 30, 2022[49](index=49&type=chunk) - The company licensed exclusive rights to its LNP and ligand conjugate delivery platforms to Genevant for RNA-based applications outside of HBV, retaining all rights for HBV[46](index=46&type=chunk) - Arbutus is entitled to a specified percentage (**14-20%**) of certain revenue Genevant receives from sublicenses or infringement actions related to the licensed intellectual property[47](index=47&type=chunk)[48](index=48&type=chunk) [6. Accounts payable and accrued liabilities](index=14&type=section&id=6.%20Accounts%20payable%20and%20accrued%20liabilities) This section details the composition and changes in Arbutus Biopharma Corporation's accounts payable and accrued liabilities over specific periods Table: Accounts Payable and Accrued Liabilities | Item (in thousands) | June 30, 2022 | December 31, 2021 | | :------------------ | :------------ | :---------------- | | **Trade accounts payable** | $0 | $3,174 | | **Research and development accruals** | $9,455 | $2,371 | | **Professional fee accruals** | $415 | $983 | | **Payroll accruals** | $2,632 | $4,279 | | **Other accrued liabilities** | $(28) | $31 | | **Total accounts payable and accrued liabilities** | $12,474 | $10,838 | - Total accounts payable and accrued liabilities increased by **$1.636 million (15.1%)** from December 31, 2021, to June 30, 2022, primarily due to a significant increase in research and development accruals[51](index=51&type=chunk) [7. Sale of future royalties](index=14&type=section&id=7.%20Sale%20of%20future%20royalties) This section describes Arbutus Biopharma Corporation's agreement for the sale of future ONPATTRO royalties and the associated financial impact - Arbutus sold a portion of its ONPATTRO royalty interest to OMERS for **$20 million** in 2019, with OMERS retaining entitlement until **$30 million** in royalties are received, after which rights revert to Arbutus[52](index=52&type=chunk) Table: Sale of Future Royalties Impact | Item (in thousands) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :------------------ | :----------------------------- | :----------------------------- | | **Non-cash royalty revenue** | $(3,048) | $(2,103) | | **Non-cash interest expense** | $985 | $1,531 | | **Net liability related to sale of future royalties - ending balance** | $14,233 | $18,982 | - The net liability related to the sale of future royalties decreased to **$14.233 million** as of June 30, 2022, from **$16.296 million** at the beginning of the period, reflecting the ongoing repayment through royalties[56](index=56&type=chunk) [8. Contingencies and commitments](index=15&type=section&id=8.%20Contingencies%20and%20commitments) This section addresses Arbutus Biopharma Corporation's potential financial obligations and legal claims, including arbitration and contingent consideration - An arbitration claim by the University of British Columbia (UBC) for **$2.0 million** in royalties from the ONPATTRO royalty sale was fully dismissed on July 11, 2022, with Arbutus intending to seek reimbursement for costs[58](index=58&type=chunk) - Contingent consideration related to the 2014 acquisition of Enantigen Therapeutics, Inc. was valued at **$5.7 million** as of June 30, 2022, tied to sales performance milestones for the first commercialized HBV product[60](index=60&type=chunk)[61](index=61&type=chunk) [9. Collaborations, contracts and licensing agreements](index=16&type=section&id=9.%20Collaborations,%20contracts%20and%20licensing%20agreements) This section details Arbutus Biopharma Corporation's strategic collaborations, licensing agreements, and their financial implications, including upfront payments and milestone opportunities - In December 2021, Arbutus entered a licensing agreement with Qilu Pharmaceutical Co., Ltd. for AB-729 in China, Hong Kong, Macau, and Taiwan, receiving a **$40.0 million** upfront payment and potential milestone payments up to **$245.0 million**, plus double-digit royalties[62](index=62&type=chunk)[63](index=63&type=chunk) Table: Qilu Licensing Agreement Financials | Item (in thousands) | Transaction Price | Collaboration Revenue Recognized (Six Months Ended June 30, 2022) | Deferred License Revenue (June 30, 2022) | | :------------------ | :---------------- | :-------------------------------------------------------------- | :--------------------------------------- | | **Combined performance obligation** | $49,270 | $20,655 | $28,615 | | **Net deferred license revenue liability** | | | $27,815 | - Arbutus has ongoing clinical collaborations for AB-729 with Vaccitech plc (Phase 2a, VTP-300 vaccine) and Assembly Biosciences, Inc. (Phase 2a, VBR capsid inhibitor), sharing costs for these trials[71](index=71&type=chunk)[72](index=72&type=chunk) - The collaboration with Antios for AB-729 was terminated due to patient loss to follow-up in Ukraine, and Assembly Biosciences announced plans to discontinue development of VBR, though Arbutus plans to continue dosing in their joint trial[72](index=72&type=chunk)[118](index=118&type=chunk) - A discovery research and license agreement with X-Chem and Proteros focuses on novel inhibitors for SARS-CoV-2 nsp5 main protease, with a candidate expected to be nominated in H2 2022[73](index=73&type=chunk) [10. Shareholders' equity](index=19&type=section&id=10.%20Shareholders%27%20equity) This section provides information on Arbutus Biopharma Corporation's share capital, stock-based compensation, and changes in common shares outstanding - The company's authorized share capital includes an unlimited number of common and preferred shares, and **1,164,000 Series A** participating convertible preferred shares[79](index=79&type=chunk) Table: Stock-based Compensation Expense | Stock-based Compensation (in thousands) | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | **Research and development** | $696 | $578 | $1,454 | $1,418 | | **General and administrative** | $1,369 | $1,165 | $2,346 | $1,960 | | **Total stock compensation expense** | $2,065 | $1,743 | $3,800 | $3,378 | - During the six months ended June 30, 2022, Arbutus issued **69,048 common shares** through its Open Market Sale Agreement, generating approximately **$0.3 million** in net proceeds[83](index=83&type=chunk) - Roivant Sciences Ltd. converted its Series A Preferred Shares into **22,833,922 common shares** on October 18, 2021, and now owns approximately **26%** of Arbutus's outstanding common shares[85](index=85&type=chunk) [11. Related party transactions](index=20&type=section&id=11.%20Related%20party%20transactions) This section discloses transactions between Arbutus Biopharma Corporation and related parties, specifically administrative services provided to Genevant - Genevant purchased administrative services from Arbutus, with income from these services being less than **$0.1 million** for both the three and six months ended June 30, 2022 and 2021, and netted against R&D expenses[87](index=87&type=chunk) [ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=21&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) This section provides management's analysis of Arbutus Biopharma Corporation's financial condition and operational results, covering strategic initiatives, product candidate progress, and liquidity [OVERVIEW](index=23&type=section&id=OVERVIEW) This section provides a high-level summary of Arbutus Biopharma Corporation's focus as a clinical-stage biopharmaceutical company and its pipeline for viral diseases - Arbutus is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for Hepatitis B virus (HBV), SARS-CoV-2, and other coronaviruses[97](index=97&type=chunk) - The company's HBV pipeline includes an RNAi therapeutic (AB-729), an oral capsid inhibitor, an oral PD-L1 inhibitor, and an oral RNA destabilizer, aiming for a functional cure for chronic HBV[97](index=97&type=chunk) - AB-729 is the lead RNAi therapeutic, currently in multiple Phase 2 clinical trials, with evidence of immune re-awakening[97](index=97&type=chunk) [Strategy](index=23&type=section&id=Strategy) This section outlines Arbutus Biopharma Corporation's strategic approach to developing a comprehensive portfolio of compounds for chronic HBV and advancing antiviral candidates for coronaviruses - Arbutus's strategy involves developing a broad portfolio of compounds targeting cHBV, including AB-729 (RNAi therapeutic), AB-836 (oral capsid inhibitor), AB-101 (oral PD-L1 inhibitor), and AB-161 (oral HBV RNA destabilizer), to achieve a functional cure[98](index=98&type=chunk)[99](index=99&type=chunk) - AB-729 is being evaluated in three Phase 2a proof-of-concept clinical trials in combination with other agents, positioning it as a cornerstone therapeutic[98](index=98&type=chunk)[100](index=100&type=chunk) - The company is also advancing small molecule antiviral candidates for COVID-19 and future coronavirus outbreaks, with a focus on Mpro and nsp12 viral polymerase inhibitors[104](index=104&type=chunk) [Our Product Candidates](index=24&type=section&id=Our%20Product%20Candidates) This section provides updates on the clinical and preclinical progress of Arbutus Biopharma Corporation's key product candidates for HBV and COVID-19 - AB-729 (GalNAc RNAi) continues to show robust HBsAg declines and immune restoration in Phase 1a/1b trials, with **76%** of patients achieving HBsAg <100 IU/mL and **50%** maintaining it 24 weeks post-last dose[109](index=109&type=chunk)[111](index=111&type=chunk) - AB-836 (Oral Capsid Inhibitor) demonstrated potent HBV replication inhibition in Phase 1a/1b, but transient Grade 3/4 ALT elevations were observed in some patients, prompting an additional Phase 1 trial in healthy volunteers[122](index=122&type=chunk) - AB-101 (Oral PD-L1 Inhibitor) showed preclinical activity in activating HBV-specific T-cells and profound tumor reduction in mouse models, with IND-enabling studies anticipated to complete in H2 2022[125](index=125&type=chunk) - AB-161 (Oral HBV RNA Destabilizer), a next-generation compound, is advancing through IND-enabling studies expected to complete in H2 2022, designed to avoid peripheral neuropathy seen in a prior generation[128](index=128&type=chunk) - The COVID-19 research program, in collaboration with X-Chem and Proteros, has identified several Mpro inhibitors, with a candidate expected to be nominated for IND-enabling studies in H2 2022[130](index=130&type=chunk) [COVID-19 Impact](index=29&type=section&id=COVID-19%20Impact) This section discusses the ongoing and potential disruptions caused by the COVID-19 pandemic on Arbutus Biopharma Corporation's clinical development and operational timelines - The COVID-19 pandemic has caused and may continue to cause significant disruptions to clinical development, including supply chain delays and patient enrollment challenges[131](index=131&type=chunk) - While clinical and pre-clinical activities have progressed, the future impact of the pandemic on plans and timelines remains unpredictable[131](index=131&type=chunk) [Other Collaborations and Royalty Entitlements](index=29&type=section&id=Other%20Collaborations%20and%20Royalty%20Entitlements) This section details Arbutus Biopharma Corporation's additional collaborations, royalty interests, and ongoing intellectual property litigation related to its LNP technology - Arbutus has a technology transfer and license agreement with Qilu Pharmaceutical Co., Ltd. for AB-729 in specific Asian territories, including an upfront payment and potential milestones and royalties[132](index=132&type=chunk) - The company holds two royalty entitlements on Alnylam's ONPATTRO sales: one partially sold to OMERS (with **$14.2 million** collected by OMERS as of June 30, 2022) and another retained from Acuitas Therapeutics[134](index=134&type=chunk)[135](index=135&type=chunk) - Arbutus and Genevant filed a patent infringement lawsuit against Moderna for the use of patented LNP technology in MRNA-1273, seeking damages but not an injunction[147](index=147&type=chunk) - Acuitas Therapeutics filed a declaratory judgment lawsuit against Arbutus and Genevant regarding patent infringement and validity concerning Pfizer and BioNTech's COMIRNATY vaccine[148](index=148&type=chunk) - The Federal Circuit upheld the validity of all claims in Arbutus's '069 patent and certain claims in the '435 patent against Moderna's Inter Partes Review petitions[143](index=143&type=chunk)[144](index=144&type=chunk) [CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGEMENTS AND ESTIMATES](index=32&type=section&id=CRITICAL%20ACCOUNTING%20POLICIES%20AND%20SIGNIFICANT%20JUDGEMENTS%20AND%20ESTIMATES) This section discusses the critical accounting policies and significant management judgments and estimates used in preparing Arbutus Biopharma Corporation's financial statements - The preparation of financial statements requires management to make estimates and assumptions that affect reported asset, liability, revenue, and expense amounts[149](index=149&type=chunk) - No significant changes in critical accounting policies and estimates were reported compared to the Annual Report on Form 10-K for the year ended December 31, 2021[149](index=149&type=chunk) [RECENT ACCOUNTING PRONOUNCEMENTS](index=32&type=section&id=RECENT%20ACCOUNTING%20PRONOUNCEMENTS) This section addresses the impact of recently issued accounting standards on Arbutus Biopharma Corporation's financial statements - The company has reviewed recently issued accounting standards and determined that they will not have a material impact on its financial statements upon adoption[150](index=150&type=chunk) [RESULTS OF OPERATIONS](index=32&type=section&id=RESULTS%20OF%20OPERATIONS) This section analyzes Arbutus Biopharma Corporation's financial performance, detailing fluctuations in revenue, operating expenses, and net loss over specific periods Table: Results of Operations Summary | Metric (in thousands) | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | **Total Revenue** | $14,241 | $2,329 | $26,822 | $4,442 | | **Total Operating Expenses** | $28,350 | $20,971 | $51,905 | $38,760 | | **Loss from Operations** | $(14,109) | $(18,642) | $(25,083) | $(34,318) | | **Net Loss attributable to common shares** | $(14,192) | $(22,653) | $(29,957) | $(42,246) | - Total revenue increased by **$11.9 million (511%)** for the three months and **$22.4 million (504%)** for the six months ended June 30, 2022, primarily due to the Qilu licensing agreement and increased royalty revenue from Alnylam and Acuitas[155](index=155&type=chunk) - Research and development expenses increased by **$7.1 million (45%)** for the three months and **$11.8 million (40%)** for the six months ended June 30, 2022, driven by AB-729 Phase 2a trials and early-stage programs (AB-101, AB-161)[159](index=159&type=chunk) - Income tax expense of **$4.4 million** was recognized for the six months ended June 30, 2022, related to withholding taxes paid by Qilu on the upfront license fee[168](index=168&type=chunk) [LIQUIDITY AND CAPITAL RESOURCES](index=36&type=section&id=LIQUIDITY%20AND%20CAPITAL%20RESOURCES) This section assesses Arbutus Biopharma Corporation's ability to meet its financial obligations, detailing cash flows, available capital, and future funding expectations Table: Cash Flow Summary | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------------------- | :----------------------------- | :----------------------------- | | **Net cash provided by (used in) operating activities** | $326 | $(31,890) | | **Net cash used in investing activities** | $(73,886) | $(20,526) | | **Net cash provided by financing activities** | $11,598 | $31,163 | | **Decrease in cash and cash equivalents** | $(61,962) | $(21,297) | | **Cash and cash equivalents, end of period** | $47,320 | $30,954 | - As of June 30, 2022, Arbutus had **$200.6 million** in cash, cash equivalents, and marketable securities, with no outstanding debt[175](index=175&type=chunk) - The company expects its current cash resources to fund operations into the second quarter of 2024, with an anticipated net cash burn between **$90 million** and **$95 million** in 2022[184](index=184&type=chunk) - Future funding needs will depend on factors like the COVID-19 pandemic's impact, revenue from collaborations, milestone payments, development progress, and intellectual property litigation costs[184](index=184&type=chunk) [OFF-BALANCE SHEET ARRANGEMENTS](index=38&type=section&id=OFF-BALANCE%20SHEET%20ARRANGEMENTS) This section confirms that Arbutus Biopharma Corporation has no material off-balance sheet arrangements impacting its financial condition or results of operations - Arbutus has no off-balance sheet arrangements that are material to its financial condition, revenues, expenses, results of operations, liquidity, capital expenditures, or capital resources[185](index=185&type=chunk) [ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=38&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) As a smaller reporting company, Arbutus Biopharma Corporation is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Arbutus Biopharma Corporation is not required to provide quantitative and qualitative disclosures about market risk[186](index=186&type=chunk) [ITEM 4. CONTROLS AND PROCEDURES](index=39&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) This section confirms the effectiveness of Arbutus Biopharma Corporation's disclosure controls and procedures and reports no material changes in internal control over financial reporting - Management, including the principal executive and financial officers, concluded that disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2022[187](index=187&type=chunk) - There were no material changes in internal control over financial reporting during the three months ended June 30, 2022[188](index=188&type=chunk) [PART II. OTHER INFORMATION](index=40&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides additional information beyond the financial statements, including legal proceedings, risk factors, and other required disclosures [ITEM 1. LEGAL PROCEEDINGS](index=40&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) This section details Arbutus Biopharma Corporation's ongoing legal proceedings, including patent infringement lawsuits against Moderna and Acuitas, and the dismissal of an arbitration claim by UBC - Arbutus and Genevant filed a lawsuit against Moderna for infringement of multiple U.S. patents related to nucleic acid-lipid particles in Moderna's COVID-19 vaccine (MRNA-1273), seeking damages[190](index=190&type=chunk) - Acuitas Therapeutics filed a declaratory judgment lawsuit against Arbutus and Genevant, seeking a declaration that Arbutus's patents are not infringed by Pfizer and BioNTech's COMIRNATY vaccine and that the patents are invalid[191](index=191&type=chunk) - An arbitration claim by the University of British Columbia (UBC) for **$2.0 million** in royalties was fully dismissed on July 11, 2022, with Arbutus planning to seek reimbursement for costs and attorneys' fees[192](index=192&type=chunk) [ITEM 1A. RISK FACTORS](index=40&type=section&id=ITEM%201A.%20RISK%20FACTORS) This section highlights the significant risk factor concerning the impact of military action in Ukraine on Arbutus Biopharma Corporation's clinical trials, causing potential delays and increased costs - Several clinical trials, including those for AB-836 and AB-729, have been impacted or could be further delayed/suspended due to military action in Ukraine, leading to patient loss to follow-up and increased costs[193](index=193&type=chunk)[195](index=195&type=chunk) - The company intends to utilize alternative clinical trial sites for affected trials, but the availability and timeliness of such sites are uncertain, potentially causing significant delays in product candidate development[193](index=193&type=chunk)[196](index=196&type=chunk) - No other material changes in risk factors were disclosed compared to the Annual Report on Form 10-K for the fiscal year ended December 31, 2021[197](index=197&type=chunk) [ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS](index=41&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) This section confirms no unregistered sales of equity securities or use of proceeds were reported for the period - No unregistered sales of equity securities or use of proceeds were reported for the period[197](index=197&type=chunk) [ITEM 3. DEFAULTS UPON SENIOR SECURITIES](index=41&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) This section confirms no defaults upon senior securities were reported for the period - No defaults upon senior securities were reported for the period[197](index=197&type=chunk) [ITEM 4. MINE SAFETY DISCLOSURES](index=41&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) This section states that mine safety disclosures are not applicable to Arbutus Biopharma Corporation - Mine safety disclosures are not applicable to Arbutus Biopharma Corporation[197](index=197&type=chunk) [ITEM 5. OTHER INFORMATION](index=41&type=section&id=ITEM%205.%20OTHER%20INFORMATION) This section confirms no other information was reported for the period - No other information was reported for the period[197](index=197&type=chunk) [EXHIBIT INDEX](index=42&type=section&id=EXHIBIT%20INDEX) This section provides a comprehensive list of all exhibits filed with the report [SIGNATURES](index=43&type=section&id=SIGNATURES) This section contains the required signatures of the company's authorized officers, certifying the accuracy of the report