Benzinga | Jan 24, 2022 07:33AM EST

Arbutus Announces 2022 Corporate Objectives And Provides Financial Update

Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, today announced its 2022 corporate objectives and provided a financial update.

William Collier, President and CEO, stated, "This year is an important one for Arbutus and the HBV patient community based on the many accomplishments we achieved in 2021. With five clinical trials on-going in HBV that include either AB-729 or AB-836, we are now poised for several key data readouts throughout this year that we anticipate will support Phase 2b clinical development. In addition, we intend to advance AB-101, our oral PD-L1 inhibitor compound for HBV which is designed to re-awaken the immune system, through IND-enabling studies this year. Similarly, this year we intend to complete IND-enabling studies for our RNA destabilizer, AB-161."

Mr. Collier continued, "As the COVID-19 pandemic lingers, we are expediting our efforts to advance novel oral pan-coronavirus compounds against viral protease and polymerase targets. We intend to advance an Mpro candidate into IND-enabling studies for the treatment of SARS-CoV-2 this year.

"Lastly, we are entering 2022 from a position of financial strength, with a cash runway expected to extend into the second quarter of 2024. I am thrilled with the company's accomplishments and execution in 2021 and look forward to providing further updates over the course of this coming year."

Summary of 2022 Anticipated Key Milestones

HBV Franchise:

* Announce preliminary AB-729 data in the second half of 2022 from the following three on-going Phase 2a proof-of-concept clinical trials in patients with chronic hepatitis B (HBV) infection: AB-729 in combination with ongoing standard-of-care nucleos(t)ide analogues ("NA") therapy and short courses of PEG-IFN?-2a. AB-729 plus vebicorvir ("VBR"), Assembly Bio's lead investigational HBV core inhibitor (capsid inhibitor) candidate, and a NA. AB-729 plus ATI-2173, Antios' proprietary Active Site Polymerase Inhibitor Nucleotide (ASPIN), and Viread(r) (tenofovir disoproxil fumarate).

* Initiate a triple combination Phase 2a proof-of-concept clinical trial in the first half of 2022 to evaluate AB-729, combined with VTP-300, Vaccitech's therapeutic vaccine, and a NA.

* Present at a medical conference the long-term on- and off-treatment follow-up data from our Phase 1a/1b clinical trial evaluating multiple doses and dosing schedules of AB-729.

* Announce data from our Phase 1a/1b clinical trial evaluating AB-836 in patients with chronic HBV in the first half of 2022.

* Complete IND-enabling studies with our oral PD-L1 inhibitor compound, AB-101, in the second half of 2022.

* Complete IND-enabling studies for AB-161, our next-generation oral HBV specific RNA destabilizer, in the second half of 2022. Arbutus has conducted extensive non-clinical safety evaluations with AB-161 that gives us confidence in this molecule's ability to circumvent the peripheral neuropathy findings seen in non-clinical safety studies with the Company's first-generation oral RNA destabilizer, AB-452.

COVID-19 & Pan-Coronavirus Franchise

* Nominate a candidate that inhibits the SARS-CoV-2 nsp5 main protease (Mpro) in the first half of 2022 and advance into IND-enabling studies.

* Continue lead optimization activities for an Nsp12 viral polymerase candidate.

Other Opportunities

* Explore potential oncology applications for internal PD-L1 portfolio.

Financial Update:

* We had cash, cash equivalents and investments in marketable securities totaling $191 million as of December 31, 2021. This amount does not include a $40 million upfront payment and $15 million of proceeds resulting from the sale of common stock to Qilu Pharmaceutical as part of the exclusive licensing agreement and strategic partnership to develop and commercialize AB-729 in mainland China, Hong Kong, Macau and Taiwan. These amounts were received in January 2022.

* For the full year of 2021 we received $135 million of net proceeds from the issuance of common shares under Arbutus's "at-the-market" offering program. As of December 31, 2021, we had approximately 145 million common shares issued and outstanding, and approximately 11.4 million stock options outstanding.

* We expect our net cash burn to range from $90 to $95 million in 2022. We believe our cash, cash equivalents and investments in marketable securities of $191 million as of December 31, 2021, plus the amounts received from Qilu Pharmaceutical in January 2022 are sufficient to fund the Company's operations into the second quarter of 2024.

* The preliminary cash, cash equivalents and investments, the amount received from the issuance of common shares under Arbutus's "at-the-market" offering program and the common shares and stock options outstanding as of December 31, 2021 were calculated prior to the completion of an audit by Arbutus' independent registered public accounting firm and are therefore subject to adjustment.