UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 3, 2019 (September 30, 2019)
Arbutus Biopharma Corporation
(Exact name of registrant as specified in charter)
British Columbia, Canada | 001-34949 | 98-0597776 | ||
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||
701 Veterans Circle Warminster, Pennsylvania | 18974 | |
(Address of principal executive offices) | (Zip Code) | |
(267) 469-0914
Registrant’s telephone number, including area code
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o | Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
o | Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
o | Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
Common Shares, without par value | ABUS | The Nasdaq Stock Market LLC | ||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 8.01. Other Events.
In July 2019, Arbutus Biopharma Corporation (“Arbutus” or “Company”) announced preliminary results from a Phase 1a/1b clinical trial of AB-506, the Company’s second generation capsid inhibitor, in healthy subjects and two cohorts of chronic hepatitis B (“CHB”) infected subjects. As Arbutus has also previously reported, no serious adverse events (“SAEs”) or clinically significant safety findings were observed in healthy subjects (N=33), with alanine aminotransferase (“ALT”) levels and other liver function tests remaining normal throughout the 10 days of dosing in healthy subjects.
Arbutus further reported, however, that in two cohorts of CHB subjects, four CHB subjects (two in each of the cohorts) experienced Grade 4 ALT flares, which returned to baseline levels upon AB-506 discontinuation or completion of the 28-day treatment period. Aspartate aminotransferase values were also elevated to a lesser degree, however, none of the subjects met the criteria for drug induced liver injury as bilirubin values and liver synthetic function remained normal. All four ALT flares occurred after the subjects experienced a >2 log decline in hepatitis B virus DNA from baseline.
To further investigate the nature of the ALT flares, the Company initiated a healthy subjects study testing 28 days of dosing. Before completing the study, the Company observed two cases of acute hepatitis. Consequently, the Company immediately stopped the clinical trial and decided to discontinue all further development of AB-506.
As a result of its decision to discontinue further development of AB-506, Arbutus no longer expects to initiate a combination study of AB-506 and AB-729 in the second half of 2020.
On October 3, 2019, Arbutus posted an updated corporate presentation on its website at www.arbutusbio.com. A copy of the presentation is filed herewith as Exhibit 99.1 and is incorporated by reference herein.
Forward-Looking Statements and Information
This Current Report on Form 8-K 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 report include statements about the Company’s expectations regarding the timing and clinical development of its product candidates.
There are known and unknown risks and uncertainties which could cause the Company’s 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 risks and uncertainties include, among others: changes in the Company’s strategy regarding its product candidates and clinical development activities; anticipated pre-clinical studies and clinical trials may be more costly or take longer to complete than anticipated; economic and market conditions may worsen; and market shifts may require a change in strategic focus.
A more complete discussion of the risks and uncertainties facing the Company appears in the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s 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 the Company 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.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number | Description | |
99.1 | ||
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Arbutus Biopharma Corporation | ||
Date: October 3, 2019 | By: | /s/ David C. Hastings |
Name: | David C. Hastings | |
Title: | Chief Financial Officer | |
Singularly Focused on HBV October 2019 NASDAQ: ABUS www.arbutusbio.com
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 for HBV to have a larger market opportunity than HCV; our ability to meet a significant unmet medical need; the sufficiency of our cash and cash equivalents to extend into the second half of 2020; our ability to develop a curative regimen for HBV and unlock significant market growth opportunities; our expectations regarding the timing and clinical development of our product candidates; our expectation for AB-729 for preliminary results from our Phase I trial to be available in the first quarter of 2020; the timeline to a combination cure for HBV; and other statements relating to our future operations, future financial performance, future financial condition, prospects or other future events. With respect to the forward-looking statements contained in this presentation, Arbutus has made numerous assumptions regarding, among other things: the timely receipt of expected payments; 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. Forward-looking statements herein involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, among others: anticipated pre-clinical 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 drug candidate; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus' products; economic and market conditions may worsen; 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 and Arbutus' periodic disclosure filings which are available at www.sec.gov and at www.sedar.com. The forward-looking statements made in connection with this presentation represent our views only as of the date of this presentation (or any earlier date indicated in such statement). While we may update certain forward-looking statements from time to time, we specifically disclaim any obligation to do so, even if new information becomes available in the future. NASDAQ: ABUS www.arbutusbio.com 2
Investment Highlights Singular therapeutic focus - curing chronic Hepatitis B Virus (HBV) Team with Significant antiviral Broad Financial Goal unmet medical expertise & HBV Position Functional need in HBV proven track Portfolio Cure record Global HBV Applying HBV assets $95M cash at 6/30/19 Goal of functional cure prevalence knowledge gained generating excludes $20M gross through finite duration double that from HIV and HCV pre clinical and proceeds received treatment with a of HCV, success to find clinical data from Onpattro combination of drugs potential for HBV cure through royalty monetization with different modes larger market proprietary drug in July 2019 of action opportunity combinations and $5.9M arbitration payment to UBC in Sept 2019 Cash runway NASDAQ: ABUS into 2H 2020 www.arbutusbio.com HCV: Hepatitis C Virus | NA: Nucleoside Analogue 3
Proven Leadership Team William H. Collier Michael J. Sofia, PhD Gaston Picchio, PhD Successful track records President and CEO Chief Scientific Officer Chief Development Officer in both the discovery, development, and commercialization of multiple antivirals: sofosbuvir, etravirine, rilpivirine, telaprevir and simeprevir David C. Hastings Elizabeth Howard, PhD, JD Michael J. McElhaugh Chief Financial Officer EVP, General Counsel and Chief Business Officer Chief Compliance Officer NASDAQ: ABUS www.arbutusbio.com 4
HBV Lifecycle Illustrates Key Points for Intervention A combination of agents with complementary MOA is needed to cure HBV 1 –Nucleoside Analogue 2 –Capsid Inhibitor 3 –AB-729 3 –RNA Destabilizer 2 3 1 2 NASDAQ: ABUS www.arbutusbio.com
1 Reduce/Suppress Keys to Viral DNA & Antigens Therapeutic Block Replication . NA . Capsid Inhibitor . RNAi Success . RNA Destabilizer Block HBsAg . RNAi . RNA Destabilizer Suppress HBV DNA Address cccDNA and viral antigens . Capsid Inhibitor . cccDNA inhibitor Leading to an Reawaken host HBV CURE immune response Reactivate by HBsAg Reduction Therapeutic success will . RNAi require a combination . RNA Destabilizer of agents with Activate . PD-L1 antagonist complementary MOAs. . PegIFN Reawaken/Boost Host 2 Immune Response NASDAQ: ABUS www.arbutusbio.com MOA: Mechanism Of Action | NA: Nucleoside Analogue | PegIFN: Pegylated Interferon | HBsAg: HBV Surface Antigen 6
Arbutus HBV Pipeline Phase I Lead Op Development IND Enabling Healthy Subjects HBV Subjects Phase II HBV DNA Suppression AB-506 Development discontinued Capsid Inhibitors 3rd gen HBsAg Reduction RNAi AB-729 AB-452 HBV RNA Destabilizers 2nd Gen Immune Reawakening PD-L1 1st gen cccDNA 1st gen NASDAQ: ABUS 7 www.arbutusbio.com
Reduce Capsid Viral DNA & Antigens Inhibitor: Blocking HBV HBV Replication Replication cccDNA Formation Driving HBV DNA to undetectable, in the serum and Reduced HBsAg in the liver is a key to therapeutic Immuno-modulation success in HBV Reawaken Immune Response NASDAQ: ABUS www.arbutusbio.com 8
AB-506 Arbutus Announces Decision to Discontinue Development of Capsid AB-506, an Oral Capsid Inhibitor for the Treatment of Chronic Hepatitis B Inhibitor William H. Collier, President and Chief Executive Officer of Arbutus, stated, “We have observed two cases of acute hepatitis in our Phase 1a 28-day clinical trial in healthy volunteers. Consequently, the clinical trial and further development of AB-506 have been stopped.” “The two subjects are experiencing resolution of their acute hepatitis. We will continue to follow them and the other study participants, as safety is our highest priority at Arbutus,” said Gaston Picchio, Ph.D. Chief Development Officer of Arbutus. “We intend to present results from the AB-506 Phase 1a/1b clinical trial along with further details Press Release regarding the two cases of acute hepatitis at an appropriate scientific meeting later in 2019.” Michael J. Sofia, Ph.D., Chief Scientific Officer of Arbutus, added, “While we are disappointed in these recent clinical findings, we have a number of oral follow-on capsid inhibitor compounds with distinct chemical scaffolds that we believe have the potential to contribute to the inhibition of HBV replication as part of a combination regimen. Our objective is to select one of several lead compounds for IND-enabling studies by December of this year.” NASDAQ: ABUS www.arbutusbio.com 9
Reduce/Suppress Driving Viral DNA & Antigens Down HBsAg Is A Key to HBV Replication HBsAg Therapeutic cccDNA Formation Success in HBV HBsAg is responsible for immune exhaustion Reduced HBsAg Replication inhibitors do not block HBsAg production Immunotherapy Reawaken/Boost Immune Response NASDAQ: ABUS www.arbutusbio.com 10
AB-729 RNAi Single trigger RNAi agent targeting all HBV transcripts Therapeutic Inhibits HBV replication and lowers all HBV antigens . Potent HBsAg reduction in preclinical models Pan-genotypic activity across HBV genotypes Proprietary GalNAc-conjugate delivery technology provides Duration of HBsAg reduction supports once per month dosing liver targeting and enables subcutaneous dosing Demonstrated complementarity with capsid inhibitors Phase I initiated in July 2019; preliminary results expected Q1 2020 HBx sAg sAg Polymerase, Core Ag, e Ag, pgRNA NASDAQ: ABUS 11 www.arbutusbio.com
AB-729 In Vivo Single 4 Dose Response 3 Saline & Duration 1 mg/kg 2 3 mg/kg 9 mg/kg Clear dose response Mean (n=5) ± SD 1 in AAV mouse model (Log IU/mL) Serum HBsAg Serum Achieves maximum HBsAg reduction possible 0 in this model LLOQ -1 Duration supports 0 2 4 6 8 10 a clinical dosing frequency 1 dose Weeks After One SC Dose of once per month siRNA AB-729 also reduces HBV RNA, HBV DNA and e-antigen NASDAQ: ABUS 12 www.arbutusbio.com Lee, A., Et al, EASL 2019, Abstract FRI-184
Small Molecule HBV RNA Destabilizers HBV RNA reduction leads to interference in viral gene AAV mouse model expression, DNA replication, and virion assembly PO dosing Dose-dependent reduction in HBsAg HBsAg reduction correlates with reductions in liver HBV RNAs NASDAQ: ABUS Gotchev, D., et al., AASLD, 2017, Abstract 923 13 www.arbutusbio.com Liu, F., et al., Int HBV Meeting 2018, Sicily
AB-452 and RNA Destabilizer Program Multiple evaluations underway to support AB-452 and RNA destabilizer program next steps Completed Ongoing IND enabling studies and . In vitro target engagement 28 day toxicology and target-based cell viability evaluations Multiple AB-452 mechanism of action studies small molecule demonstrating AB-452 causes . Additional, specialized HBV mRNA poly A tail shortening in vitro and in vivo non- chemotypes under Host protein knock out causes clinical safety assessments investigation to no cellular tox . In depth DMPK evaluations maximize program Host gene expression studies . 90 day toxicology studies, opportunity indicating that AB-452 has no two species detectable effect on host cell mRNAs NASDAQ: ABUS www.arbutusbio.com 14
Arbutus HBV Pipeline Phase I Lead Op Development IND Enabling Healthy Subjects HBV Subjects Phase II HBV DNA Suppression AB-506 Development discontinued Capsid Inhibitors 3rd gen HBsAg Reduction RNAi AB-729 AB-452 HBV RNA Destabilizers 2nd Gen Immune Reawakening PD-L1 1st gen cccDNA 1st gen NASDAQ: ABUS 15 www.arbutusbio.com