Arbutus Reports Second Quarter 2024 Financial Results and Provides Corporate Update
Arbutus Biopharma (ABUS) reported Q2 2024 financial results and provided updates on its hepatitis B virus (HBV) clinical programs. Key highlights include:
1. Positive data from two Phase 2a trials of imdusiran, showing 33% of patients achieved undetectable HBsAg after 48 weeks of treatment.
2. Company is prioritizing imdusiran's Phase 2b development and discontinuing HBV discovery efforts, resulting in a 40% workforce reduction.
3. Cash runway extended into Q4 2026.
4. Q2 revenue was $1.7 million, down from $4.7 million in Q2 2023.
5. Net loss of $19.8 million ($0.11 per share) compared to $17.1 million ($0.10 per share) in Q2 2023.
6. Cash, cash equivalents, and investments totaled $148.5 million as of June 30, 2024.
Arbutus Biopharma (ABUS) ha riportato i risultati finanziari del secondo trimestre 2024 e fornito aggiornamenti sui suoi programmi clinici per il virus dell’epatite B (HBV). I punti salienti includono:
1. Dati positivi da due studi di fase 2a di imdusiran, che mostrano che il 33% dei pazienti ha raggiunto livelli indetectabili di HBsAg dopo 48 settimane di trattamento.
2. L’azienda sta dando priorità allo sviluppo di fase 2b di imdusiran e interrompendo gli sforzi di scoperta dell'HBV, con una riduzione del personale del 40%.
3. Le disponibilità finanziarie sono state estese fino al quarto trimestre del 2026.
4. Le entrate del secondo trimestre ammontano a 1,7 milioni di dollari, in calo rispetto ai 4,7 milioni di dollari del secondo trimestre 2023.
5. Perdita netta di 19,8 milioni di dollari (0,11 dollari per azione) rispetto ai 17,1 milioni di dollari (0,10 dollari per azione) del secondo trimestre 2023.
6. Liquidità, equivalenti di liquidità e investimenti ammontano a 148,5 milioni di dollari al 30 giugno 2024.
Arbutus Biopharma (ABUS) informó sobre los resultados financieros del segundo trimestre de 2024 y proporcionó actualizaciones sobre sus programas clínicos para el virus de la hepatitis B (HBV). Los puntos destacados incluyen:
1. Datos positivos de dos ensayos de fase 2a de imdusiran, que muestran que el 33% de los pacientes alcanzó niveles indetectables de HBsAg después de 48 semanas de tratamiento.
2. La empresa está priorizando el desarrollo de fase 2b de imdusiran y descontinuando los esfuerzos de descubrimiento de HBV, lo que resulta en una reducción del 40% de la plantilla.
3. La duración de efectivo se ha extendido hasta el cuarto trimestre de 2026.
4. Los ingresos del segundo trimestre fueron $1.7 millones, una disminución de $4.7 millones en el segundo trimestre de 2023.
5. Pérdida neta de $19.8 millones ($0.11 por acción) en comparación con $17.1 millones ($0.10 por acción) en el segundo trimestre de 2023.
6. El efectivo, equivalentes de efectivo e inversiones totalizaron $148.5 millones al 30 de junio de 2024.
아르부투스 바이오파마(ABUS)는 2024년 2분기 재무 결과를 발표하고 B형 간염 바이러스(HBV) 임상 프로그램에 대한 업데이트를 제공했습니다. 주요 내용은 다음과 같습니다:
1. 두 개의 2a상 임상시험에서 임두시란의 긍정적인 데이터가 발표되었으며, 48주 치료 후 환자의 33%가 HBsAg 비검출 상태에 도달했습니다.
2. 회사는 임두시란의 2b상 개발에 우선순위를 두고 HBV 발견 작업을 중단하여 40%의 인력 감축을 초래했습니다.
3. 현금 운영 자금이 2026년 4분기까지 연장되었습니다.
4. 2분기 수익은 170만 달러로, 2023년 2분기의 470만 달러에서 감소했습니다.
5. 2분기에는 1980만 달러의 순손실($0.11 주당)을 기록했으며, 이는 2023년 2분기의 1710만 달러($0.10 주당)보다 증가한 수치입니다.
6. 2024년 6월 30일 기준으로 현금, 현금성 자산 및 투자 총액은 1억4850만 달러입니다.
Arbutus Biopharma (ABUS) a présenté ses résultats financiers pour le deuxième trimestre 2024 et a donné des mises à jour concernant ses programmes cliniques sur le virus de l'hépatite B (HBV). Les points essentiels comprennent :
1. Des données positives provenant de deux essais de phase 2a de imdusiran, montrant que 33% des patients ont atteint un niveau indétectable de HBsAg après 48 semaines de traitement.
2. La société priorise le développement de phase 2b de imdusiran et discontinue les efforts de découverte de HBV, ce qui entraîne une réduction de 40% des effectifs.
3. La durée de la trésorerie a été prolongée jusqu'au quatrième trimestre 2026.
4. Le revenu du deuxième trimestre s'élevait à 1,7 million de dollars, en baisse par rapport à 4,7 millions de dollars au deuxième trimestre 2023.
5. Perte nette de 19,8 millions de dollars (0,11 dollar par action) par rapport à 17,1 millions de dollars (0,10 dollar par action) au deuxième trimestre 2023.
6. Les liquidités, équivalents de liquidités et investissements s'élevaient à 148,5 millions de dollars au 30 juin 2024.
Arbutus Biopharma (ABUS) hat die Finanzzahlen für das zweite Quartal 2024 veröffentlicht und Updates zu seinen klinischen Programmen für das Hepatitis-B-Virus (HBV) gegeben. Die wichtigsten Punkte sind:
1. Positive Daten aus zwei Phase-2a-Studien von Imdusiran, die zeigen, dass 33% der Patienten nach 48 Wochen Behandlung einen undetektiertem HBsAg erreicht haben.
2. Das Unternehmen priorisiert die Entwicklung von Imdusiran in Phase 2b und stellt die HBV-Forschungsanstrengungen ein, was zu einer 40%igen Reduzierung der Belegschaft führt.
3. Der Cash-Rückhalt wurde bis ins vierte Quartal 2026 verlängert.
4. Der Umsatz im zweiten Quartal betrug 1,7 Millionen Dollar, im Vergleich zu 4,7 Millionen Dollar im zweiten Quartal 2023.
5. Nettoverlust von 19,8 Millionen Dollar (0,11 Dollar pro Aktie) im Vergleich zu 17,1 Millionen Dollar (0,10 Dollar pro Aktie) im zweiten Quartal 2023.
6. Bargeld, Bargeldäquivalente und Investitionen beliefen sich zum 30. Juni 2024 auf insgesamt 148,5 Millionen Dollar.
- Positive Phase 2a data for imdusiran, with 33% of patients achieving undetectable HBsAg
- Cash runway extended into Q4 2026
- Streamlining operations to focus on advancing clinical development of imdusiran and AB-101
- Cash, cash equivalents, and investments increased to $148.5 million from $132.3 million at end of 2023
- 40% workforce reduction and discontinuation of HBV discovery efforts
- Revenue decreased to $1.7 million in Q2 2024 from $4.7 million in Q2 2023
- Net loss increased to $19.8 million in Q2 2024 from $17.1 million in Q2 2023
- Termination of IM-PROVE III clinical trial prior to dosing any participants
Insights
Arbutus Biopharma's Q2 2024 results reveal both promising developments and strategic shifts. The company reported
Revenue decreased to
Notably, Arbutus is implementing a significant restructuring, reducing its workforce by
The company's prioritization of imdusiran's Phase 2b development, based on promising clinical data, represents a calculated bet on this asset's potential. While this focus could accelerate the path to a potential functional HBV cure, it also increases the company's dependence on imdusiran's success.
Investors should closely monitor the upcoming imdusiran Phase 2b trial and AB-101 data expected in H2 2024, as these will be critical in assessing Arbutus's future prospects and the wisdom of their strategic shift.
The clinical data presented for imdusiran at the EASL Congress is particularly intriguing. In the IM-PROVE I trial,
The IM-PROVE II trial, combining imdusiran with VTP-300, also showed promise. Statistically significant differences in HBsAg levels between treatment and placebo arms were observed 24 weeks post-treatment. This hints at the potential of combination therapies in achieving more durable responses.
However, it's important to note that these are Phase 2a trials with relatively small patient numbers. The upcoming Phase 2b trial will be important in confirming these results in a larger population and determining the optimal treatment regimen.
The decision to terminate the IM-PROVE III trial (combining imdusiran with durvalumab) before dosing any participants is somewhat disappointing from a scientific perspective, as it could have provided valuable insights into the role of PD-L1 inhibition in HBV treatment. However, given resource constraints, focusing on the most promising avenues is understandable.
The preliminary data from the AB-101 trial, showing dose-dependent receptor occupancy, is encouraging but early. The multiple-ascending dose data expected later this year will be important in assessing this oral PD-L1 inhibitor's potential.
The ongoing litigation against Moderna and Pfizer/BioNTech regarding Arbutus's LNP technology patents is a significant aspect of the company's potential future value. The trial date set for April 21, 2025, in the Moderna case provides a concrete timeline for potential resolution. However, it's important to note that trial dates are subject to change and patent litigation can be protracted and unpredictable.
Arbutus's stance that it's seeking "fair compensation" for the use of its patented LNP technology in COVID-19 vaccines suggests the company believes it has a strong case. If successful, this could result in substantial royalties or a settlement, potentially transforming Arbutus's financial position.
However, the lack of a set date for a claim construction hearing in the Pfizer/BioNTech case indicates this litigation may be progressing more slowly. Investors should be aware that patent litigation outcomes are never guaranteed and even if Arbutus prevails, the appeals process could further delay any financial benefits.
The company's commitment to "protect and defend its intellectual property" is commendable from a shareholder perspective, but also carries risks. Patent litigation is expensive and time-consuming, potentially diverting resources from core R&D activities. The
While a favorable outcome could be transformative for Arbutus, investors should view this as a potential upside rather than a certainty and focus primarily on the company's clinical progress in evaluating its prospects.
End-of-treatment data presented at the EASL Congress from two Phase 2a clinical trials supports advancing imdusiran as a potential cornerstone in a HBV functional cure treatment regimen
IM-PROVE I clinical trial demonstrated undetectable HBsAg in
Prioritizing imdusiran Phase 2b clinical development; eliminating HBV discovery efforts resulting in a reduction in workforce by
Conference Call and Webcast Today at 8:45 AM ET
WARMINSTER, Pa., Aug. 01, 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 second quarter 2024 financial results and provides a corporate update.
“At the EASL Congress we reported impressive imdusiran data. I’m particularly excited that in the IM-PROVE I clinical trial we saw undetectable HBsAg in
Mr. McElhaugh continued, “We intend to focus our existing resources on conducting a Phase 2b clinical trial with imdusiran, assuming continued positive data. This has the potential to create a true inflection point for both Arbutus and HBV patients. To ensure we have the resources to conduct such a program, we have made the difficult decision to discontinue our HBV research efforts and reduce our headcount leading to a projected cash runway into the fourth quarter of 2026. I want to express my sincere gratitude to those impacted by the workforce reduction for their invaluable contributions to our mission and their dedication to helping HBV patients.”
Clinical Development Update
Imdusiran (AB-729, RNAi Therapeutic)
- At the EASL Congress in June, end-of-treatment data was presented from IM-PROVE I (AB-729-201), a Phase 2a clinical trial evaluating the safety, tolerability and antiviral activity of the combination of imdusiran, nucleos(t)ide analogue (NA) therapy and pegylated interferon alfa-2a (IFN) in patients with cHBV. The data showed that
33.3% (n=4/12) of patients in Cohort A1 receiving 48 weeks of imdusiran combined with a short course of IFN (24-weeks) and NA therapy, achieved undetectable HBsAg at the end-of-treatment that was maintained in100% of these patients 24 weeks after completing imdusiran and IFN treatment. Undetectable HBsAg was achieved in67% of those patients with HBsAg less than 1000 IU/mL at baseline. A total of six patients who received 24 weeks of IFN (n=4 Cohort A1; n=2 Cohort A2) seroconverted, with HBsAg loss accompanied by high titers of anti-HBsAg antibodies. All six of these patients have stopped NA therapy, with two of those patients reaching 12 weeks off all therapy with sustained undetectable levels of HBsAg and HBV DNA. The combination of imdusiran and IFN in this clinical trial was generally safe and well-tolerated. - Also at the EASL Congress in June, end-of treatment data was presented from the IM-PROVE II (AB-729-202) Phase 2a clinical trial evaluating the safety and immunogenicity of imdusiran, NA therapy and Barinthus Bio’s VTP-300, an HBV antigen-specific immunotherapy. The data showed that at 24-weeks post-end of treatment with imdusiran and VTP-300, statistical significance (p<0.05) was achieved in HBsAg levels between the treatment arm (n=5) and placebo (n=6). In addition, more patients maintained HBsAg thresholds of <100 IU/mL and <10 IU/mL when administered VTP-300 vs. placebo at 24-weeks post end-of-treatment. The combination of imdusiran and VTP-300 in this clinical trial was generally safe and well-tolerated.
- IM-PROVE II includes an additional cohort of patients who will receive 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. Arbutus is on-track to report preliminary end-of-treatment data from this additional cohort in the second half of 2024.
- Arbutus has terminated its Phase 2a clinical trial evaluating the safety, tolerability and antiviral activity of imdusiran and NA therapy in combination with intermittent low doses of durvalumab, an approved anti-PD-L1 monoclonal antibody (IM-PROVE III, AB-729-203) prior to dosing any participants. This decision was based on a prioritization of resources and the projected availability of clinical data from this trial.
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 for up to 28 days in healthy subjects and patients with cHBV. Part 1 of the clinical trial has enrolled four sequential cohorts of eight healthy subjects each (6 active:2 placebo) to date, each receiving a single dose of AB-101 at increasing dose levels up to 25 mg or placebo. Data from Part 1 of this trial showed that AB-101 was generally well-tolerated with evidence of dose-dependent receptor occupancy. In the 25 mg cohort, all five evaluable subjects showed evidence of receptor occupancy between 50
-100% . Arbutus has moved into Part 2 of this clinical trial which evaluates multiple-ascending doses of AB-101 in healthy subjects and expects to report preliminary data in the second half of this year.
Corporate Updates
- The Company has made the decision to streamline the organization to focus its efforts on advancing the clinical development of imdusiran and AB-101, and is therefore ceasing all discovery efforts and discontinuing its IM-PROVE III clinical trial. In taking these steps to streamline the organization, Arbutus is implementing a reduction in its workforce of
40% , primarily affecting the discovery and general and administrative functions. As a result, Arbutus will incur a one-time restructuring charge of approximately$3.0 -$4.0 million that will be recorded in the third quarter of 2024. With these organizational changes and its ongoing cost management efforts, the Company now expects its current cash, cash equivalents and investments in marketable securities will be sufficient to fund operations into the fourth quarter of 2026.
LNP Litigation Update
- Next steps in the lawsuit against Moderna include expert reports and expert depositions. A trial date has been set for April 21, 2025, and is subject to change.
- The lawsuit against Pfizer/BioNTech is ongoing and a date for a claim construction hearing has not been set.
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 June 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
For the three months ended June 30, 2024, the Company’s net loss was
Outstanding Shares
As of June 30, 2024, the Company had approximately 188.7 million common shares issued and outstanding. In addition, the Company had approximately 20.5 million stock options and unvested restricted stock units outstanding as of June 30, 2024. Roivant Sciences Ltd. owned approximately
| UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF LOSS (in thousands, except share and per share data) | |||||||||||||||
| Three Months Ended March 31, | Six Months Ended June 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Revenue | |||||||||||||||
| Collaborations and licenses | $ | 1,155 | $ | 3,885 | $ | 2,094 | $ | 9,394 | |||||||
| Non-cash royalty revenue | 571 | 766 | 1,164 | 1,944 | |||||||||||
| Total revenue | 1,726 | 4,651 | 3,258 | 11,338 | |||||||||||
| Operating expenses | |||||||||||||||
| Research and development | 15,551 | 17,692 | 30,954 | 35,967 | |||||||||||
| General and administrative | 7,547 | 5,980 | 12,859 | 11,532 | |||||||||||
| Change in fair value of contingent consideration | 211 | (636 | ) | 391 | (363 | ) | |||||||||
| Total operating expenses | 23,309 | 23,036 | 44,204 | 47,136 | |||||||||||
| Loss from operations | (21,583 | ) | (18,385 | ) | (40,946 | ) | (35,798 | ) | |||||||
| Other income | |||||||||||||||
| Interest income | 1,829 | 1,461 | 3,374 | 2,729 | |||||||||||
| Interest expense | (34 | ) | (171 | ) | (78 | ) | (369 | ) | |||||||
| Foreign exchange gain | (8 | ) | 1 | (21 | ) | 5 | |||||||||
| Total other income | 1,787 | 1,291 | 3,275 | 2,365 | |||||||||||
| Net loss | $ | (19,796 | ) | $ | (17,094 | ) | $ | (37,671 | ) | $ | (33,433 | ) | |||
| Loss per share | |||||||||||||||
| Basic and diluted | $ | (0.11 | ) | $ | (0.10 | ) | $ | (0.21 | ) | $ | (0.20 | ) | |||
| Weighted average number of common shares | |||||||||||||||
| Basic and diluted | 188,041,489 | 166,063,284 | 181,842,519 | 163,855,661 | |||||||||||
| Comprehensive loss | |||||||||||||||
| Unrealized gain on available-for-sale securities | 63 | 166 | 113 | 1,020 | |||||||||||
| Comprehensive loss | $ | (19,733 | ) | $ | (16,928 | ) | $ | (37,558 | ) | $ | (32,413 | ) | |||
| UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) | |||||||
| June 30, 2024 | December 31, 2023 | ||||||
| Cash, cash equivalents and marketable securities, current | $ | 141,986 | $ | 126,003 | |||
| Accounts receivable and other current assets | 6,234 | 6,024 | |||||
| Total current assets | 148,220 | 132,027 | |||||
| Property and equipment, net of accumulated depreciation | 4,059 | 4,674 | |||||
| Investments in marketable securities, non-current | 6,527 | 6,284 | |||||
| Right of use asset | 1,237 | 1,416 | |||||
| Total assets | $ | 160,043 | $ | 144,401 | |||
| Accounts payable and accrued liabilities | $ | 11,108 | $ | 10,271 | |||
| Deferred license revenue, current | 11,034 | 11,791 | |||||
| Lease liability, current | 453 | 425 | |||||
| Total current liabilities | 22,595 | 22,487 | |||||
| Liability related to sale of future royalties | 5,859 | 6,953 | |||||
| Contingent consideration | 7,991 | 7,600 | |||||
| Lease liability, non-current | 1,144 | 1,343 | |||||
| Total stockholders’ equity | 122,454 | 106,018 | |||||
| Total liabilities and stockholders’ equity | $ | 160,043 | $ | 144,401 | |||
| UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands) | |||||||
| Six Months Ended June 30, | |||||||
| 2024 | 2023 | ||||||
| Net loss | $ | (37,671 | ) | $ | (33,433 | ) | |
| Non-cash items | 3,973 | 2,911 | |||||
| Change in deferred license revenue | (757 | ) | (7,128 | ) | |||
| Other changes in working capital | 656 | (9,210 | ) | ||||
| Net cash used in operating activities | (33,799 | ) | (46,860 | ) | |||
| Net cash provided by investing activities | 21,523 | 18,119 | |||||
| Issuance of common shares pursuant to the Open Market Sale Agreement | 44,124 | 24,604 | |||||
| Cash provided by other financing activities | 4,676 | 555 | |||||
| Net cash provided by financing activities | 48,800 | 25,159 | |||||
| Effect of foreign exchange rate changes on cash and cash equivalents | (21 | ) | 3 | ||||
| Increase/(decrease) in cash and cash equivalents | 36,503 | (3,579 | ) | ||||
| Cash and cash equivalents, beginning of period | 26,285 | 30,776 | |||||
| Cash and cash equivalents, end of period | 62,788 | 27,197 | |||||
| Investments in marketable securities | 85,725 | 136,344 | |||||
| Cash, cash equivalents and marketable securities, end of period | $ | 148,513 | $ | 163,541 | |||
Conference Call and Webcast Today
Arbutus will hold a conference call and webcast today, Thursday, August 1, 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
FAQ
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