Arbutus Reports Third Quarter 2024 Financial Results and Provides Corporate Update
Arbutus Biopharma (ABUS) reported Q3 2024 financial results with a net loss of $19.7 million ($0.10 per share). Revenue decreased to $1.3 million from $4.7 million in Q3 2023. The company maintains a strong cash position of $130.8 million, expected to fund operations into Q4 2026.
Clinical progress includes promising data from the IM-PROVE I Phase 2a trial, where 33.3% of patients achieved HBsAg loss. The company's oral PD-L1 inhibitor, AB-101, showed positive safety data and dose-dependent receptor occupancy in healthy subjects, now advancing to cHBV patient dosing.
Arbutus Biopharma (ABUS) ha riportato i risultati finanziari del terzo trimestre 2024 con una perdita netta di 19,7 milioni di dollari (0,10 dollari per azione). Le entrate sono diminuite a 1,3 milioni di dollari rispetto ai 4,7 milioni di dollari del terzo trimestre 2023. L'azienda mantiene una solida posizione di liquidità di 130,8 milioni di dollari, che si prevede sosterrà le operazioni fino al quarto trimestre 2026.
I progressi clinici includono dati promettenti dalla trial IM-PROVE I di fase 2a, dove il 33,3% dei pazienti ha ottenuto la perdita di HBsAg. L'inibitore orale di PD-L1 dell'azienda, AB-101, ha mostrato dati di sicurezza positivi e occupazione del recettore dipendente dalla dose negli individui sani, progredendo ora verso la somministrazione ai pazienti cHBV.
Arbutus Biopharma (ABUS) informó sobre los resultados financieros del tercer trimestre de 2024 con una pérdida neta de 19,7 millones de dólares (0,10 dólares por acción). Los ingresos disminuyeron a 1,3 millones de dólares desde 4,7 millones de dólares en el tercer trimestre de 2023. La compañía mantiene una sólida posición de efectivo de 130,8 millones de dólares, que se espera financie las operaciones hasta el cuarto trimestre de 2026.
El progreso clínico incluye datos prometedores del ensayo IM-PROVE I de fase 2a, donde el 33,3% de los pacientes logró la pérdida de HBsAg. El inhibidor oral de PD-L1 de la compañía, AB-101, mostró datos de seguridad positivos y ocupación del receptor dependiente de la dosis en sujetos sanos, avanzando ahora hacia la dosificación en pacientes cHBV.
Arbutus Biopharma (ABUS)는 2024년 3분기 재무 결과를 발표하며 1,970만 달러(주당 0.10달러)의 순손실을 기록했습니다. 수익은 2023년 3분기의 470만 달러에서 130만 달러로 감소했습니다. 이 회사는 1억 3,080만 달러의 강력한 현금 보유액을 유지하고 있으며, 이는 2026년 4분기까지 운영 자금을 지원할 것으로 예상됩니다.
임상 진전으로는 IM-PROVE I 2a상 시험에서 유망한 데이터가 포함되어 있으며, 이 시험에서 33.3%의 환자가 HBsAg 손실을 달성했습니다. 회사의 경구 PD-L1 억제제 AB-101은 건강한 피험자에서 긍정적인 안전성 데이터를 보여주었으며, 용량 의존적 수용체 점유율을 보였고, 현재 cHBV 환자에 대한 투여로 진행되고 있습니다.
Arbutus Biopharma (ABUS) a annoncé les résultats financiers du troisième trimestre 2024 avec une perte nette de 19,7 millions de dollars (0,10 dollar par action). Les revenus ont diminué à 1,3 million de dollars contre 4,7 millions de dollars au troisième trimestre 2023. L'entreprise maintient une solide position de trésorerie de 130,8 millions de dollars, qui devrait financer ses opérations jusqu'au quatrième trimestre 2026.
Les progrès cliniques incluent des données prometteuses de l'
Arbutus Biopharma (ABUS) berichtete über die Finanzergebnisse des dritten Quartals 2024 mit einem Nettverlust von 19,7 Millionen Dollar (0,10 Dollar pro Aktie). Der Umsatz sank von 4,7 Millionen Dollar im dritten Quartal 2023 auf 1,3 Millionen Dollar. Das Unternehmen weist eine starke Liquiditätsposition von 130,8 Millionen Dollar auf, die voraussichtlich die Aktivitäten bis ins vierte Quartal 2026 finanzieren wird.
Der klinische Fortschritt umfasst vielversprechende Daten aus der IM-PROVE I Phase 2a-Studie, in der 33,3% der Patienten den Verlust von HBsAg erzielten. Der orale PD-L1-Inhibitor des Unternehmens, AB-101, zeigte positive Sicherheitsdaten und eine dosisabhängige Rezeptorbelegung bei gesunden Probanden und schreitet nun zur Dosierung bei cHBV-Patienten voran.
- Strong cash position of $130.8M with runway into Q4 2026
- 33.3% of patients in IM-PROVE I trial achieved HBsAg loss
- Operating expenses decreased by $5.9M YoY due to program discontinuation
- AB-101 showed positive safety data with >70% receptor occupancy in 25mg cohort
- Revenue declined 71.7% to $1.3M from $4.7M YoY
- Net loss of $19.7M in Q3 2024
- $3.6M one-time restructuring charge in Q3
- Decreased license royalty revenue from Alnylam due to lower ONPATTRO sales
Insights
The Q3 2024 results reveal a mixed financial picture. While
Operating expenses decreased significantly, with R&D costs down
The clinical development pipeline shows promising advancement. The IM-PROVE I trial data indicates
AB-101's Phase 1a/1b trial demonstrates encouraging receptor occupancy data, with
Imdusiran data from IM-PROVE I and IM-PROVE II Phase 2a clinical trials to be presented at upcoming AASLD - The Liver Meeting 2024
Multiple-ascending doses of AB-101 in healthy subjects in the Phase 1a/1b clinical trial were generally safe and well-tolerated with evidence of receptor occupancy
Now dosing cHBV patients with AB-101 in Part 3 of the Phase 1a/1b clinical trial
Cash runway into the fourth quarter of 2026
Conference Call and Webcast Today at 8:45 AM ET
WARMINSTER, Pa., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop a functional cure for people with chronic hepatitis B virus (cHBV) infection, today reports third quarter 2024 financial results and provides a corporate update.
“We are making significant progress in advancing the development of imdusiran to bring hope to millions of cHBV patients globally,” said Michael J. McElhaugh, Interim President and Chief Executive Officer of Arbutus Biopharma. “In June, we shared promising data from our IM-PROVE I Phase 2a clinical trial, showing that some patients treated with imdusiran and interferon were trending towards a functional cure. We look forward to presenting follow-up data from this trial, as well as end-of-treatment data from patients that received nivolumab in addition to imdusiran and VTP-300 in our IM-PROVE II Phase 2a trial, at the upcoming AASLD meeting. Assuming continued positive data, and with a projected cash runway extending into the fourth quarter of 2026, we are well-positioned to advance imdusiran into a Phase 2b clinical trial as a cornerstone in a treatment regimen aimed at functionally curing cHBV.”
Mr. McElhaugh continued, “Our proprietary oral PD-L1 checkpoint inhibitor, AB-101, is progressing well, as we continue to see dose-dependent receptor occupancy and have now advanced into dosing cHBV patients in our Phase 1a/1b clinical trial. We look forward to providing updates as this trial progresses.”
Clinical Development Update
Imdusiran (AB-729, RNAi Therapeutic)
- End-of-treatment data from the IM-PROVE I Phase 2a clinical trial evaluating the safety, tolerability and antiviral activity of the combination of imdusiran (4 or 6 doses over 24 or 48 weeks, respectively), nucleos(t)ide analogue (NA) therapy and a short course of pegylated interferon alfa-2a (IFN, 12 or 24 weeks) in patients with cHBV was presented at the EASL Congress in June. The data showed that
33.3% (n=4/12) of patients in Cohort A1 receiving 48 weeks (6 doses) of imdusiran combined with 24 weeks of IFN and NA therapy achieved HBsAg loss at the end-of-treatment that was maintained in100% of these patients 24 weeks after completing imdusiran and IFN treatment. HBsAg loss was achieved and maintained in67% of those patients with HBsAg less than 1000 IU/mL at baseline. A total of six patients from Cohort A1 (n=4) and Cohort A2 (n=2) seroconverted with HBsAg loss. At the time the data was reported, all six of those patients had stopped all therapy, with two of those patients reaching 12 weeks off all therapy with sustained HBsAg and HBV DNA loss. The combination of imdusiran and IFN in this clinical trial was generally safe and well-tolerated. The Company will present a late-breaker poster with additional follow-up data at the upcoming AASLD-The Liver Meeting 2024 later this month.
- End-of treatment data from the IM-PROVE II Phase 2a clinical trial evaluating the safety and immunogenicity of imdusiran, NA therapy and Barinthus Bio’s VTP-300, an HBV antigen-specific immunotherapy was presented at the EASL Congress in June. The data showed that the combination of imdusiran and VTP-300 was generally safe and well-tolerated. At 24-weeks post-end of treatment, statistical significance (p<0.05) was achieved in HBsAg levels between the VTP-300 arm (n=5) and placebo (n=6). IM-PROVE II includes an additional cohort of patients who received 4 doses of imdusiran plus NA therapy for 24 weeks followed by VTP-300 plus up to two low doses of nivolumab, an approved anti-PD-1 monoclonal antibody. The Company will present a late-breaker poster with preliminary end-of-treatment data from this additional cohort at the upcoming AASLD - The Liver Meeting 2024 in November.
AB-101 (Oral PD-L1 Inhibitor)
- AB-101-001 is a Phase 1a/1b double-blind, randomized, placebo-controlled clinical trial designed to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single- and multiple-ascending oral doses of AB-101 in healthy subjects and patients with cHBV.
- Part 2 of this clinical trial has enrolled to date two sequential cohorts of ten healthy subjects each receiving 10 mg or 25 mg of AB-101 (n=8) or placebo (n=2) daily for 7 days. AB-101 was generally well-tolerated with evidence of dose-dependent receptor occupancy. In the 25 mg cohort, all subjects showed evidence of receptor occupancy, with seven of the eight subjects demonstrating receptor occupancy greater than
70% during the 7-day dosing period. - Arbutus has moved into Part 3 of this clinical trial which evaluates repeat dosing of AB-101 for 28 days in patients with cHBV and expects to report preliminary data in the first half of next year.
LNP Litigation Update
- Expert reports and expert depositions continue in the Moderna lawsuit. A trial date has been set for September 24, 2025, and is subject to the Court’s availability.
- The lawsuit against Pfizer/BioNTech is ongoing and a date for the claim construction hearing has been set for December 18, 2024.
Arbutus continues to protect and defend its intellectual property, which is the subject of the on-going lawsuits against Moderna and Pfizer/BioNTech. The Company is seeking fair compensation for Moderna’s and Pfizer/BioNTech’s use of its patented LNP technology that was developed with great effort and at a great expense, without which Moderna’s and Pfizer/BioNTech’s COVID-19 vaccines would not have been successful.
Financial Results
Cash, Cash Equivalents and Investments
As of September 30, 2024, the Company had cash, cash equivalents and investments in marketable securities of
Revenue
Total revenue was
Operating Expenses
Research and development expenses were
Net Loss
The Company’s net loss was
Outstanding Shares
As of September 30, 2024, the Company had approximately 189.4 million common shares issued and outstanding. In addition, the Company had approximately 18.7 million stock options and unvested restricted stock units outstanding as of September 30, 2024. Roivant Sciences Ltd. owned approximately
| UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF LOSS | |||||||||||||||||||||||
| (in thousands, except share and per share data) | |||||||||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||||||||||
| Revenue | |||||||||||||||||||||||
| Collaborations and licenses | $ | 767 | $ | 3,935 | $ | 2,861 | $ | 13,329 | |||||||||||||||
| Non-cash royalty revenue | 572 | 723 | 1,736 | 2,667 | |||||||||||||||||||
| Total revenue | 1,339 | 4,658 | 4,597 | 15,996 | |||||||||||||||||||
| Operating expenses | |||||||||||||||||||||||
| Research and development | 14,273 | 20,169 | 45,227 | 56,136 | |||||||||||||||||||
| General and administrative | 4,537 | 5,842 | 17,396 | 17,374 | |||||||||||||||||||
| Change in fair value of contingent consideration | 344 | 205 | 735 | (158 | ) | ||||||||||||||||||
| Restructuring | 3,625 | - | 3,625 | - | |||||||||||||||||||
| Total operating expenses | 22,779 | 26,216 | 66,983 | 73,352 | |||||||||||||||||||
| Loss from operations | (21,440 | ) | (21,558 | ) | (62,386 | ) | (57,356 | ) | |||||||||||||||
| Other income | |||||||||||||||||||||||
| Interest income | 1,747 | 1,494 | 5,121 | 4,223 | |||||||||||||||||||
| Interest expense | (29 | ) | (46 | ) | (107 | ) | (415 | ) | |||||||||||||||
| Foreign exchange gain / (loss) | 5 | 6 | (16 | ) | 11 | ||||||||||||||||||
| Total other income | 1,723 | 1,454 | 4,998 | 3,819 | |||||||||||||||||||
| Net loss | $ | (19,717 | ) | $ | (20,104 | ) | $ | (57,388 | ) | $ | (53,537 | ) | |||||||||||
| Loss per share | |||||||||||||||||||||||
| Basic and diluted | $ | (0.10 | ) | $ | (0.12 | ) | $ | (0.31 | ) | $ | (0.32 | ) | |||||||||||
| Weighted average number of common shares | |||||||||||||||||||||||
| Basic and diluted | 188,997,194 | 167,512,708 | 184,244,819 | 165,085,243 | |||||||||||||||||||
| Comprehensive loss | |||||||||||||||||||||||
| Unrealized gain on available-for-sale securities | 218 | 584 | 331 | 1,604 | |||||||||||||||||||
| Comprehensive loss | $ | (19,499 | ) | $ | (19,520 | ) | $ | (57,057 | ) | $ | (51,933 | ) | |||||||||||
| UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
| (in thousands) | |||||||
| September 30, 2024 | December 31, 2023 | ||||||
| Cash, cash equivalents and marketable securities, current | $ | 127,794 | $ | 126,003 | |||
| Accounts receivable and other current assets | 4,983 | 6,024 | |||||
| Total current assets | 132,777 | 132,027 | |||||
| Property and equipment, net of accumulated depreciation | 3,556 | 4,674 | |||||
| Investments in marketable securities, non-current | 2,964 | 6,284 | |||||
| Right of use asset | 1,144 | 1,416 | |||||
| Total assets | $ | 140,441 | $ | 144,401 | |||
| Accounts payable and accrued liabilities | $ | 7,544 | $ | 10,271 | |||
| Deferred license revenue, current | 10,911 | 11,791 | |||||
| Lease liability, current | 468 | 425 | |||||
| Total current liabilities | 18,923 | 22,487 | |||||
| Liability related to sale of future royalties | 5,315 | 6,953 | |||||
| Contingent consideration | 8,335 | 7,600 | |||||
| Lease liability, non-current | 978 | 1,343 | |||||
| Total stockholders’ equity | 106,890 | 106,018 | |||||
| Total liabilities and stockholders’ equity | $ | 140,441 | $ | 144,401 | |||
| UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||
| (in thousands) | |||||||
| Nine Months Ended September 30, | |||||||
| 2024 | 2023 | ||||||
| Net loss | $ | (57,388 | ) | $ | (53,537 | ) | |
| Non-cash items | 5,453 | 4,613 | |||||
| Change in deferred license revenue | (880 | ) | (10,349 | ) | |||
| Other changes in working capital | (1,720 | ) | (9,371 | ) | |||
| Net cash used in operating activities | (54,535 | ) | (68,644 | ) | |||
| Net cash provided by investing activities | 9,537 | 28,548 | |||||
| Issuance of common shares pursuant to the Open Market Sale Agreement | 44,124 | 26,000 | |||||
| Cash provided by other financing activities | 6,451 | 840 | |||||
| Net cash provided by financing activities | 50,575 | 26,840 | |||||
| Effect of foreign exchange rate changes on cash and cash equivalents | (16 | ) | 11 | ||||
| Increase/(decrease) in cash and cash equivalents | 5,561 | (13,245 | ) | ||||
| Cash and cash equivalents, beginning of period | 26,285 | 30,776 | |||||
| Cash and cash equivalents, end of period | 31,846 | 17,531 | |||||
| Investments in marketable securities | 98,912 | 127,145 | |||||
| Cash, cash equivalents and marketable securities, end of period | $ | 130,758 | $ | 144,676 | |||
Conference Call and Webcast Today
Arbutus will hold a conference call and webcast today, Wednesday, November 6, 2024, 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 www.arbutusbio.com.
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 multiple 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 oral PD-L1 inhibitor candidate that we believe will allow for controlled checkpoint blockade 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 re-activation of exhausted 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 patients chronically infected with HBV. AB-101 is currently being evaluated in a Phase 1a/1b clinical trial.
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 250 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 Arbutus
Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics with distinct mechanisms of action, which can potentially be combined to provide a functional cure for patients with chronic hepatitis B virus (cHBV). We believe the key to success in developing a functional cure involves suppressing HBV DNA, reducing surface antigen, and boosting HBV-specific immune responses. Our pipeline of internally developed, proprietary compounds includes an RNAi therapeutic, imdusiran (AB-729), and an oral PD-L1 inhibitor, AB-101. Imdusiran has generated meaningful clinical data demonstrating an impact on both surface antigen reduction and reawakening of the HBV-specific immune response. Imdusiran is currently in two Phase 2a combination clinical trials. AB-101 is currently being evaluated in a Phase 1a/1b clinical trial. For more information, visit www.arbutusbio.com.
Forward-Looking Statements and Information
This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, forward-looking statements). Forward-looking statements in this press release include statements about our future development plans for our product candidates; 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; our expectations regarding our organizational changes; the potential for our product candidates to achieve success in clinical trials; our expectations regarding our pending litigation matters; 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 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; Arbutus may not realize the anticipated benefits from the organizational changes; Arbutus may incur additional unexpected expenses in connection with the organizational changes; Arbutus may experience additional employee turnover as a result of the organizational changes; uncertainties associated with litigation generally and patent litigation specifically; and Arbutus and its collaborators may never realize the expected benefits of the collaborations; 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 www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.
Contact Information
Investors and Media
Lisa M. Caperelli
Vice President, Investor Relations
Phone: 215-206-1822
Email: lcaperelli@arbutusbio.com
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