On August 6, 2025 Royalty Pharma plc (Nasdaq: RPRX) reported financial results for the second quarter of 2025 and raised full year 2025 guidance for Portfolio Receipts (Press release, Royalty Pharma , AUG 6, 2025, View Source [SID1234654871]).

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"We delivered excellent second quarter 2025 results, as the strength of our diversified portfolio drove 20% growth in Portfolio Receipts, and raised our full year guidance," said Pablo Legorreta, Royalty Pharma’s founder and Chief Executive Officer. "Additionally, we closed the acquisition of our external manager, enabling Royalty Pharma to become an integrated company, which is an important milestone in our evolution. Furthermore, we announced a groundbreaking funding agreement with Revolution Medicines, which enables our partner to retain operational control over their pipeline development and global commercialization, and exemplifies a new funding paradigm for innovative biotech companies. Guided by our dynamic capital allocation framework, we repurchased $1 billion of our Class A ordinary shares in the first half of this year, highlighting our attractive fundamental outlook. The prospects for the royalty market and our business have never been stronger and we look forward to sharing more details at our upcoming Investor Day on September 11th."

Strong double-digit growth in Royalty Receipts and Portfolio Receipts

•
Royalty Receipts grew 11% to $672 million, primarily driven by Voranigo, Trelegy, Evrysdi, and Tremfya.

•
Portfolio Receipts increased by 20% to $727 million.

Flexible and scaled synthetic royalty deal underpins Capital Deployment in the second quarter of 2025

•
Capital Deployment of $595 million; announced innovative partnership with Revolution Medicines of up to $2 billion including a synthetic royalty of up to $1.25 billion on daraxonrasib (in Phase 3 for RAS-addicted cancers).

•
Repurchased eight million Class A ordinary shares for $277 million in the second quarter, with total repurchases of $1 billion in the first half 2025.

Positive clinical updates across royalty portfolio

•
Positive Phase 3 results for Gilead’s Trodelvy in first-line metastatic triple-negative breast cancer.

Completed acquisition of external manager, RP Management, LLC, to become an integrated public company

•
Acquisition closed in May 2025 and combines Royalty Pharma’s portfolio with the intellectual capital of the manager; transaction received overwhelming support from shareholders with 99.9% of votes cast in favor.

Raising financial guidance for full year 2025 (excludes contribution from future transactions)

•
Royalty Pharma expects 2025 Portfolio Receipts to be between $3,050 million and $3,150 million (previously $2,975 to $3,125), representing expected growth of 9% to 12% (previously 6% to 12%).

Financial & Liquidity Summary

Three Months Ended June 30,
(unaudited)
($ and shares in millions) 2025 2024 Change
Portfolio Receipts

727 608 20%
Net cash provided by operating activities

364 658 (45)%
Adjusted EBITDA (non-GAAP)*

633 560 13%
Portfolio Cash Flow (non-GAAP)*

641 574 12%
Weighted average Class A ordinary shares outstanding – diluted

562 597 (6)%

Portfolio Receipts Highlights

Three Months Ended June 30,
(unaudited)
($ in millions) 2025 2024 Change
Products:

Marketers: Therapeutic Area:
Cystic fibrosis franchise

Vertex Rare disease 194 195 0%
Trelegy

GSK Respiratory 57 48 17%
Tysabri

Biogen Neuroscience 56 64 (13)%
Imbruvica

AbbVie, J&J Cancer 44 49 (11)%
Xtandi

Pfizer, Astellas Cancer 42 39 8%
Tremfya

Johnson & Johnson Immunology 37 30 24%
Evrysdi

Roche Rare disease 33 25 32%
Promacta

Novartis Hematology 33 30 7%
Voranigo

Servier Cancer 26 — n/a
Cabometyx/Cometriq

Exelixis, Ipsen, Takeda Cancer 20 17 22%
Spinraza

Biogen Rare disease 12 10 25%
Erleada

Johnson & Johnson Cancer 10 9 10%
Trodelvy

Gilead Cancer 10 10 (4)%
Other products(5)

98 79 25%

Royalty Receipts

672 605 11%
Milestones and other contractual receipts

56 3 n/a

Portfolio Receipts

727 608 20%
Amounts shown in the table may not add due to rounding.

Royalty Receipts was $672 million in the second quarter of 2025, an increase of 11% compared to $605 million in the second quarter of 2024. The increase was primarily driven by Voranigo, Trelegy, Evrysdi, and Tremfya.

Portfolio Receipts was $727 million in the second quarter of 2025, an increase of 20% compared to $608 million in the second quarter of 2024, primarily driven by the same Royalty Receipts increases noted above and a one-time payment included in Milestones and other contractual receipts.

Liquidity and Capital Resources

Royalty Pharma’s liquidity and capital resources are summarized below:

As of June 30, 2025, Royalty Pharma had cash and cash equivalents of $632 million and total debt with principal value of $8.2 billion.

In January 2025, Royalty Pharma announced a new share repurchase program under which it may repurchase up to $3.0 billion of its Class A ordinary shares. During the second quarter of 2025, Royalty Pharma repurchased approximately eight million Class A ordinary shares for $277 million. During the first half of 2025, Royalty Pharma repurchased approximately 31 million Class A ordinary shares for $1 billion. During the second quarter and first half of 2024, Royalty Pharma repurchased approximately three million Class A ordinary shares for $84 million. The weighted-average number of diluted Class A ordinary shares outstanding for the second quarter of 2025 was 562 million as compared to 597 million for the second quarter of 2024.Liquidity Summary

Three Months Ended June 30,
(unaudited)
($ in millions) 2025 2024
Portfolio Receipts

727 608
Payments for operating and professional costs

(94) (48)

Adjusted EBITDA (non-GAAP)

633 560
Interest received, net

8 14

Portfolio Cash Flow (non-GAAP)

641 574
  Amounts may not add due to rounding.

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Adjusted EBITDA (non-GAAP) was $633 million in the second quarter of 2025. Adjusted EBITDA is calculated as Portfolio Receipts minus payments for operating and professional costs.

•
Portfolio Cash Flow (non-GAAP) was $641 million in the second quarter of 2025. Portfolio Cash Flow is calculated as Adjusted EBITDA minus interest paid or received, net. This measure reflects the cash generated by Royalty Pharma’s business that can be redeployed into value-enhancing royalty acquisitions, used to repay debt, returned to shareholders through dividends or share purchases, or utilized for other discretionary investments.

Refer to Table 4 for Royalty Pharma’s reconciliation of each non-GAAP measure to the most directly comparable GAAP financial measure, net cash provided by operating activities.

Capital Deployment reflects cash payments during the period for new and previously announced transactions. Capital Deployment was $595 million in the second quarter of 2025, consisting primarily of funding for daraxonrasib, a milestone payment related to Adstiladrin and research and development funding for litifilimab.

In April 2025, Ferring Pharmaceuticals announced U.S. Food and Drug Administration (FDA) approval of a new manufacturing hub in Parsippany, NJ for Adstiladrin, its novel gene therapy for bladder cancer. The approval triggered a $200 million milestone payment that was paid in the second quarter of 2025.

The table below details Capital Deployment by category:

Capital Deployment

Three Months Ended June 30, Six Months Ended June 30,
(unaudited) (unaudited)
($ in millions) 2025 2024 2025 2024
Purchases of available for sale debt securities

(75) (150) (75) (150)
Acquisitions of financial royalty assets

(1) (729) (2) (815)
Acquisitions of other financial assets

— (18) — (18)
Development-stage funding payments

(301) (1) (351) (1)
Milestone payments

(219) (50) (269) (50)
Investments in equity method investees

— (4) — (11)
Contributions from legacy non-controlling interests – R&D

0 0 0 0

Capital Deployment

(595) (951) (696) (1,044)

Royalty Transactions

During 2025, Royalty Pharma has announced new transactions of up to $2.25 billion. The announced transactions amount reflects the entire amount of capital committed for new transactions year to date, including potential future milestones.

Recent transactions include:

•
In June 2025, Royalty Pharma entered into a two part $2 billion funding arrangement with Revolution Medicines. The funding arrangement includes up to $1.25 billion ($250 million upfront) to purchase a synthetic royalty on daraxonrasib and a senior secured term loan of up to $750 million. The first tranche of the senior secured term loan must be drawn following FDA approval of daraxonrasib. Daraxonrasib is in Phase 3 development for the treatment of RAS mutant pancreatic cancer and non-small cell lung cancer.

The information in this section should be read together with Royalty Pharma’s reports and documents filed with the SEC at www.sec.gov and the reader is also encouraged to review all other press releases and information available in the Investors section of Royalty Pharma’s website at www.royaltypharma.com.

Internalization Transaction

In January 2025, Royalty Pharma agreed to acquire its external manager, RP Management, LLC ("RPM"). In May 2025, Royalty Pharma completed the internalization transaction and became an integrated company as employees of RPM became employees of Royalty Pharma. The acquisition received overwhelming support from Royalty Pharma’s shareholders, with 99.9% of votes cast in favor of the transaction.

Key Developments Relating to the Portfolio

The key developments related to Royalty Pharma’s royalty interests are discussed below based on disclosures from the marketers of the products.

CF Franchise
In the second quarter of 2025, Royalty Pharma did not receive from Vertex the full amount of Royalty Receipts on Alyftrek net sales to which it is contractually entitled. Accordingly, Royalty Pharma has commenced the dispute resolution procedures contemplated by the agreements relating to our royalties on Vertex’s cystic fibrosis products.

In July 2025, Vertex announced that the European Commission (EC) approved Alyftrek for people with cystic fibrosis (CF) ages 6 years and older who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

In April 2025, Vertex announced EC approval for the label expansion of Kaftrio in combination with ivacaftor for CF patients ages 2 years and older who have at least one non-class I mutation in the CFTR gene.

Cabometyx In July 2025, Ipsen announced that the EC has approved Cabometyx for previously treated advanced neuroendocrine tumors.
Skytrofa In July 2025, Ascendis announced that the U.S. FDA approved Skytrofa for the replacement of endogenous growth hormone in adults with growth hormone deficiency.
deucrictibant In July 2025, Pharvaris announced that it anticipates topline data for the Phase 3 study (RAPIDe-3) evaluating deucrictibant for the on-demand treatment of hereditary angioedema attacks in the fourth quarter of 2025 and, pending positive data, expects to submit an New Drug Application (NDA) with the FDA in the first half of 2026.
Xtandi In July 2025, Pfizer and Astellas Pharma announced topline results from the overall survival (OS) analysis from the Phase 3 EMBARK study evaluating Xtandi, in combination with leuprolide and as a monotherapy, in men with non-metastatic hormone-sensitive prostate cancer. For patients treated with Xtandi plus leuprolide versus placebo plus leuprolide, EMBARK met the key secondary endpoint with a statistically significant and clinically meaningful improvement in OS. Results also showed a favorable trend towards improved OS for patients treated with Xtandi monotherapy versus placebo plus leuprolide, however the difference did not reach statistical significance.

Trodelvy
In May 2025, Gilead Sciences announced positive topline results from the Phase 3 ASCENT-03 study. The study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy in patients with first-line metastatic triple-negative breast cancer (mTNBC) who are ineligible to receive immunotherapy. Overall survival, was not mature at the time of PFS primary analysis. Gilead will continue to monitor OS outcomes, with ongoing patient follow-up and further analysis planned.

In April 2025, Gilead announced positive topline results from the Phase 3 Ascent-04/Keynote-D19 study, demonstrating that Trodelvy plus Keytruda significantly improved PFS compared to Keytruda and chemotherapy in patients with previously untreated PD-L1+ mTNBC. Overall survival, a key secondary endpoint, was not mature at the time of the PFS primary analysis. However, there was an early trend in improvement for OS with Trodelvy plus Keytruda and Gilead will continue to monitor OS outcomes.

Promacta In May 2025, Camber Pharmaceuticals announced the U.S. launch of eltrombopag, the AB-rated generic for Promacta.
Tremfya
In May 2025, Johnson & Johnson announced that the EC approved Tremfya for the treatment of adult patients with moderately to severely active Crohn’s disease.

In April 2025, Johnson & Johnson announced that the EC approved Tremfya for the treatment of adult patients with moderately to severely active ulcerative colitis.

In April 2025, Johnson & Johnson announced that the Phase 3b APEX study achieved both its primary endpoint of reducing signs and symptoms and its major secondary endpoint of reducing progression of structural damage as measured by radiographic progression at 24 weeks, in adults living with active psoriatic arthritis, compared to placebo.

Airsupra In May 2025, AstraZeneca announced positive BATURA Phase 3b results that showed Airsupra demonstrated statistically significant and clinically meaningful improvements in all primary and secondary endpoints compared to albuterol in patients with mild asthma.
aficamten
In May 2025, Cytokinetics announced positive topline results from MAPLE-HCM, a Phase 3 trial comparing aficamten to metoprolol in patients with symptomatic obstructive hypertrophic cardiomyopathy. The study met its primary endpoint, demonstrating a statistically significant improvement in peak oxygen uptake from baseline to Week 24 for aficamten with a favorable safety profile.

In May 2025, Cytokinetics announced that the FDA extended the Prescription Drug User Fee Act action date for the NDA for aficamten to December 26, 2025. The FDA required additional time to conduct a full review of the company’s proposed Risk Evaluation and Mitigation Strategy. No additional clinical data or studies have been requested by the FDA.

olpasiran In May 2025, Amgen announced that a Phase 3 cardiovascular (CV) outcomes study in patients with elevated Lp(a) and at a high risk for a first CV event is expected to be initiated in the second half of 2025 or first half of 2026.
Cobenfy In April 2025, Bristol Myers Squibb announced that topline results from the Phase 3 ARISE trial evaluating Cobenfy as an adjunctive treatment to atypical antipsychotics in adults with schizophrenia did not reach the threshold for a statistically significant difference compared to placebo with an atypical antipsychotic for the primary endpoint of the change from baseline to Week 6 in the Positive and Negative Syndrome Scale total score.
trontinemab In April 2025, Roche announced that new trontinemab data continue to support rapid and deep, dose-dependent reduction of amyloid plaques in Phase 1b/2a Brainshuttle AD study. Roche expects to initiate a Phase 3 program for trontinemab at the end of 2025.

2025 Financial Outlook

Royalty Pharma has provided guidance for full year 2025, excluding new transactions and borrowings announced after the date of this release, as follows:

Provided August 6, 2025

Previous

Portfolio Receipts

$3,050 million to $3,150 million

(Growth of ~+9% to 12% year/year)

$2,975 million to $3,125 million

(Growth of ~+6% to 12% year/year)

Payments for operating and professional costs ~9% to 9.5% of Portfolio Receipts Approximately 10% of Portfolio Receipts
Interest paid

$275 million $260 million
The above Portfolio Receipts guidance represents expected growth of 9% to 12% in 2025. Royalty Pharma’s full year 2025 guidance reflects a negligible estimated foreign exchange impact to Portfolio Receipts, assuming current foreign exchange rates prevail for the rest of 2025.

Payments for operating and professional costs in the second half of 2025 are expected to decrease due to extinguishment of the management fee following the completion of the internalization transaction on May 16, 2025. Payments for operating and professional costs include one-time payments amounting to approximately $70 million (>2% of 2025 Portfolio Receipts), comprised of transaction costs for the Internalization and the sale of the MorphoSys Development Funding Bonds.

Total interest paid is based on the semi-annual interest payment schedule of Royalty Pharma’s existing notes and the quarterly interest payment schedule for the term loan assumed as part of the internalization transaction. In 2025, total interest paid(7) is anticipated to be approximately $275 million, including $126 million in the third quarter of 2025 and $8 million in the fourth quarter of 2025. These projections assume no additional debt financing in 2025, including no drawdown on the revolving credit facility. In the second quarter of 2025, Royalty Pharma collected interest of $9 million on its cash and cash equivalents, which partially offset interest paid.

Royalty Pharma today provides this guidance based on its most up-to-date view of its prospects. This guidance assumes no major unforeseen adverse events or changes in foreign exchange rates and excludes the contributions from transactions announced subsequent to the date of this press release.

Financial Results Call

Royalty Pharma will host a conference call and simultaneous webcast to discuss its second quarter 2025 results today at 8:00 a.m., Eastern Time. Please visit the "Investors" page of the company’s website at View Source to obtain conference call information and to view the live webcast. A replay of the conference call and webcast will be archived on the company’s website for at least 30 days.

On August 6, 2025 Arbutus Biopharma Corporation (Nasdaq: ABUS) ("Arbutus" or the "Company"), a clinical-stage biopharmaceutical company focused on infectious disease, reported second quarter 2025 financial results and provided a corporate update (Press release, Arbutus Biopharma, AUG 6, 2025, View Source [SID1234654856]).

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"We delivered a strong quarter, marked by positive quarterly earnings resulting from the conclusion of our Greater China partnership with Qilu," said Lindsay Androski, President and CEO of Arbutus. "Once again holding global rights for imdusiran, and launching a late-stage clinically focused Scientific Advisory Board, were two important steps taken this quarter in our quest to drive long-term value through our chronic hepatitis B virus (cHBV) programs."

"I am excited to announce that Dr. Harry Janssen of Erasmus MC in Rotterdam has joined our Scientific Advisory Board, bringing his unparalleled knowledge and experience in late-stage clinical trials in cHBV," Ms. Androski continued. "Today, the Company also congratulates Anuj Hasija on his appointment as Vice President, Global Commercial Strategy for Type 1 Diabetes at Vertex. Anuj has stepped down from the Arbutus Board in order to focus exclusively on this new role, and on behalf of the Company and the entire Board, I thank Anuj for his service. We are also excited to welcome Dr. Roger Sawhney as the newest member of our Board. Dr. Sawhney has enjoyed a distinguished career spanning senior executive roles in biotech, pharma and investing, and also brings extensive public company board experience."

LNP Litigation

Arbutus continues to consult closely with and support our exclusive licensee, Genevant Sciences, to protect and defend Arbutus’s intellectual property, which is the subject of on-going lawsuits against Moderna and Pfizer/BioNTech. The Company, together with Genevant, is seeking fair compensation for Moderna’s and Pfizer/BioNTech’s use of Arbutus’s patented LNP technology that was developed with great effort and at a great expense, and without which Moderna’s and Pfizer/BioNTech’s COVID-19 vaccines would not have been successful.
In the Moderna U.S. litigation, fact discovery has been completed, and expert discovery is concluding. The summary judgment phase of the case began in July 2025 and a jury trial is scheduled to be held in March 2026. Additionally, in July 2025, the case was reassigned to a different judge in the same court. In March 2025, the Company, alongside Genevant Sciences, filed five international lawsuits against Moderna and its affiliates seeking to enforce patents protecting the Company’s patented LNP technology across 30 countries. The first major hearings in the international lawsuits are expected in the first half of calendar year 2026.
The claim construction hearing for the lawsuit against Pfizer/BioNTech occurred in December 2024. The court has not provided guidance for the timing of its ruling in the claim construction hearing, which could potentially come in 2025.

Corporate Updates

In June 2025, the Company and Qilu Pharmaceutical mutually agreed to conclude the strategic partnership for the development, manufacturing, and commercialization of imdusiran in Greater China. The Company now once again holds global rights for its lead compound, imdusiran.
Dr. Harry L.A. Janssen, MD, PhD, joined the Company’s Scientific Advisory Board effective August 1, 2025, increasing the membership to six global experts in cHBV treatment. Dr. Janssen is a Professor of Hepatology and the Chair of the Department of Gastroenterology and Hepatology at Erasmus MC, Rotterdam, The Netherlands.
Effective August 4, 2025, Anuj Hasija resigned from the Company’s Board of Directors due to his transition to a full-time executive role that precludes his participation on the Arbutus and other boards of directors.
Filling the vacancy on our Board of Directors, Dr. Roger Sawhney, MD, joined the Board effective August 4, 2025. Dr. Sawhney is a seasoned executive and board member with extensive experience across biotechnology, pharmaceuticals, healthcare technology, and investment sectors. He holds an MD from Harvard Medical School and a BA in Economics from Stanford University.

Financial Results

Cash, Cash Equivalents and Investments

As of June 30, 2025, the Company had cash, cash equivalents and investments in marketable securities of $98.1 million compared to $122.6 million as of December 31, 2024. During the six months ended June 30, 2025, the Company used $29.1 million in operating activities, which included one-time payments related to our restructuring efforts. This was partially offset by $3.1 million of proceeds from the exercise of employee stock options.

Revenue

Total revenue was $10.7 million for the quarter ended June 30, 2025, compared to $1.7 million for the same period in 2024. The increase of $9.0 million was primarily due to the recognition of all previously-deferred revenue as a result of the conclusion of the Company’s strategic partnership with Qilu Pharmaceutical, partially offset by a decrease in license royalty revenues due to a decline in Alnylam’s sales of ONPATTRO.

Operating Expenses

Research and development expenses were $5.5 million for the quarter ended June 30, 2025 compared to $15.6 million for the same period in 2024. The decrease of $10.1 million was due primarily to cost savings from the Company’s decision in August 2024 to streamline the organization to focus its efforts on advancing the clinical development of imdusiran and AB-101, which included ceasing all discovery efforts, discontinuing its IM-PROVE III clinical trial and reducing the Company’s workforce.

General and administrative expenses were $3.3 million for the quarter ended June 30, 2025, compared to $7.5 million for the same period in 2024. This decrease was due primarily to cost cutting efforts by the Company, which drove reductions in litigation-related legal fees and employee compensation-related expenses.

Restructuring costs in the quarter ended June 30, 2025 were $0.2 million, and all remaining restructuring-related payments are expected to be made in the second half of 2025.

Net Income/Loss

For the quarter ended June 30, 2025, the Company’s net income was $2.5 million, or income of $0.01 per basic and diluted common share, as compared to a net loss of $19.8 million, or a loss of $0.11 per basic and diluted common share, for the quarter ended June 30, 2024.

Outstanding Shares

As of June 30, 2025, the Company had 191.6 million common shares issued and outstanding, as well as 15.2 million stock options and unvested restricted stock units outstanding.

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF INCOME AND LOSS
(in thousands, except share and per share data)

Three Months Ended June 30, Six Months Ended June 30,
2025 2024 2025 2024
Revenue
Collaborations and licenses $ 10,213 $ 1,155 $ 11,529 $ 2,094
Non-cash royalty revenue 526 571 974 1,164
Total Revenue 10,739 1,726 12,503 3,258
Operating expenses
Research and development 5,498 15,551 14,457 30,954
General and administrative 3,328 7,547 9,160 12,859
Change in fair value of contingent consideration 260 211 559 391
Restructuring costs 165 — 12,538 —
Total operating expenses 9,251 23,309 36,714 44,204
Gain (loss) from operations 1,488 (21,583 ) (24,211 ) (40,946 )
Other income
Interest income 1,042 1,829 2,239 3,374
Interest expense (28 ) (34 ) (56 ) (78 )
Foreign exchange gain (loss) 21 (8 ) 25 (21 )
Total other income 1,035 1,787 2,208 3,275
Income tax expense — — — —
Net income (loss) $ 2,523 $ (19,796 ) $ (22,003 ) $ (37,671 )
Net income (loss) per common share
Basic $ 0.01 $ (0.11 ) $ (0.12 ) $ (0.21 )
Diluted $ 0.01 $ (0.11 ) $ (0.12 ) $ (0.21 )
Weighted average number of common shares
Basic 191,551,282 188,041,489 191,130,631 181,842,519
Diluted 192,399,733 188,041,489 191,130,631 181,842,519

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)

June 30, 2025 December 31, 2024
Cash, cash equivalents and marketable securities, current $ 98,088 $ 122,623
Accounts receivable and other current assets 5,031 4,693
Total current assets 103,119 127,316
Property and equipment, net of accumulated depreciation and impairment 148 3,309
Right of use asset — 1,048
Other non-current assets — 34
Total assets $ 103,267 $ 131,707

Accounts payable and accrued liabilities $ 4,508 $ 7,564
Deferred license revenue, current — 7,571
Lease liability, current 514 483
Total current liabilities 5,022 15,618
Liability related to sale of future royalties 3,910 4,829
Deferred license revenue, non-current — 2,863
Contingent consideration 10,784 10,225
Lease liability, non-current 575 806
Total stockholders’ equity 82,976 97,366
Total liabilities and stockholders’ equity $ 103,267 $ 131,707

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)

Six Months Ended June 30,
2025 2024
Net loss $ (22,003 ) $ (37,671 )
Non-cash items 5,834 3,973
Change in deferred license revenue (10,434 ) (757 )
Other changes in working capital (2,537 ) 656
Net cash used in operating activities (29,140 ) (33,799 )
Net cash provided by investing activities 26,960 21,523
Issuance of common shares pursuant to the Open Market Sale Agreement — 44,124
Cash provided by other financing activities 3,237 4,676
Net cash provided by financing activities 3,237 48,800
Effect of foreign exchange rate changes on cash and cash equivalents 25 (21 )
Increase in cash and cash equivalents 1,082 36,503
Cash and cash equivalents, beginning of period 36,330 26,285
Cash and cash equivalents, end of period 37,412 62,788
Investments in marketable securities 60,676 85,725
Cash, cash equivalents and marketable securities, end of period $ 98,088 $ 148,513

About Imdusiran (AB-729)  

Imdusiran is an RNAi therapeutic specifically designed to reduce all hepatitis B viral proteins and antigens including HBsAg, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to control the virus. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine (GalNAc) delivery technology enabling subcutaneous delivery. To date, Arbutus has reported a total of eight patients with cHBV who have achieved a functional cure following treatment with imdusiran and NA therapy in combination with either IFN or low dose nivolumab plus an immunotherapeutic. Clinical data generated thus far has shown imdusiran to be generally safe and well-tolerated, while also providing meaningful reductions in HBsAg and hepatitis B virus DNA.

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. cHBV infection represents a significant unmet medical need. The World Health Organization estimates that over 250 million people worldwide suffer from cHBV infection, while other estimates indicate that approximately 2 million people in the United States suffer from cHBV infection. Approximately 1.1 million people die every year from complications related to cHBV infection despite the availability of effective vaccines and current treatment options.

On August 6, 2025 Sana Biotechnology, Inc. (Nasdaq: SANA) ("Sana"), a company focused on changing the possible for patients through engineered cells, reported that it has commenced an underwritten public offering of $75.0 million of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock (Press release, Sana Biotechnology, AUG 6, 2025, View Source [SID1234654872]). In addition, Sana intends to grant the underwriters a 30-day option to purchase up to an additional $11.25 million of shares of its common stock. All of the shares of common stock and pre-funded warrants to be sold in the proposed offering will be sold by Sana. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the proposed offering.

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Morgan Stanley, Goldman Sachs & Co. LLC, BofA Securities, and TD Cowen are acting as joint book-running managers for the proposed offering.

The proposed offering is being made pursuant to a Registration Statement on Form S-3, including a base prospectus, previously filed with and declared effective by the SEC, and Sana will file a preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the proposed offering, copies of which can be accessed for free through the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the proposed offering may also be obtained from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014 or by email at [email protected]; Goldman Sachs & Co. LLC, Attn: Prospectus Department, at 200 West Street, New York, NY 10282, by telephone at (866) 471-2526 or by email at [email protected]; BofA Securities, Attn: Prospectus Department, NC1-022-02-25, 201 North Tryon Street, Charlotte, NC 28255-0001 or by email at [email protected]; or TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, New York 10017, by telephone at (855) 495-9846 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of any such state or jurisdiction.

On August 6, 2025 Vir Biotechnology, Inc. (Nasdaq: VIR), reported a corporate update and provided financial results for the second quarter ended June 30, 2025 (Press release, Vir Biotechnology, AUG 6, 2025, View Source [SID1234654891]).

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"We achieved several important milestones across our pipeline, reflecting our commitment to our mission of powering the immune system to transform lives," said Marianne De Backer, Chief Executive Officer, Vir Biotechnology. "The initiation of our Phase 1 study of PRO-XTEN dual-masked VIR-5525 positions us to potentially address the shortcomings of available treatment options across multiple EGFR-expressing solid tumors. The universal PRO-XTEN masking technology represents a next-generation approach to cancer treatment, designed to expand the therapeutic index of T-cell engagers. We now have three clinical trials of PRO-XTEN masked T-cell engagers ongoing, supported by promising early clinical data for VIR-5818 and VIR-5500, and we are leveraging insights from our ongoing programs to efficiently execute clinical trials and expand our oncology portfolio. Additionally, our ECLIPSE registrational program is now fully underway, and we are advancing toward a potentially highly effective, well-tolerated and convenient treatment option for patients with chronic hepatitis delta."

Pipeline Programs

Chronic Hepatitis Delta (CHD)

ECLIPSE registrational program is fully underway following enrollment of the first patients in ECLIPSE 2 and ECLIPSE 3.
ECLIPSE 2 will compare the combination of tobevibart and elebsiran to continued bulevirtide monotherapy in participants with CHD who have not achieved undetectable hepatitis delta virus RNA despite bulevirtide treatment.
ECLIPSE 3 will compare the combination of tobevibart and elebsiran to bulevirtide monotherapy in participants with CHD who have not received bulevirtide before.
ECLIPSE 1 and 2 are designed to provide the registrational efficacy and safety data needed for potential submission to global regulatory agencies, including agencies in the U.S. and Europe. ECLIPSE 3 is expected to provide important supportive data to help establish access and reimbursement in key markets.
Solid Tumors

First patient dosed in the Phase 1 clinical study of VIR-5525, the Company’s investigational PRO-XTEN dual-masked T-cell engager (TCE) targeting EGFR.
VIR-5525 will be evaluated for the treatment of a variety of EGFR-expressing solid tumors in areas of high unmet need such as non-small cell lung cancer, colorectal cancer, head and neck squamous cell carcinoma and cutaneous squamous cell carcinoma.
The Company’s Phase 1 clinical trial of PRO-XTEN masked VIR-5818 evaluates the TCE in multiple tumor types, including metastatic breast cancer and metastatic colorectal cancer.
VIR-5818 is the only dual-masked HER2-targeting TCE in clinical development.
The Company has completed monotherapy dose escalation and is analyzing the data while continuing to dose escalate VIR-5818 in combination with pembrolizumab.
VIR-5500, the only dual-masked PSMA-targeting TCE in clinical trials, continues to advance through dose escalation.
The Company received Investigational New Drug clearance from the U.S. Food and Drug Administration to evaluate VIR-5500 in combination with androgen receptor pathway inhibitors for earlier lines of metastatic castration-resistant prostate cancer treatment, unlocking new opportunities to transform patient lives.
Early Phase 1 data for VIR-5818 and VIR-5500 reported in January 2025 showed promising safety profiles for both clinical candidates, with maximum tolerated dose not yet reached, no dose-limiting cytokine release syndrome (CRS) observed and no CRS greater than grade 2 reported.
Initial clinical data demonstrate the PRO-XTEN masking technology’s potential to minimize systemic toxicity while enabling selective killing of cancer cells in the tumor microenvironment, minimizing CRS and expanding the therapeutic index compared to traditional therapeutic approaches.
Preclinical Pipeline Candidates

Leveraging its immune system expertise and platform strengths, the Company continues to progress multiple undisclosed PRO-XTEN dual-masked TCEs against clinically validated targets with potential applications across a number of solid tumors. These preclinical candidates integrate the PRO-XTEN masking technology with novel TCEs discovered and engineered using the Company’s antibody discovery platform and proprietary dAIsY (data AI structure and antibody) AI engine.
The Company is advancing its broadly neutralizing antibody development candidate for the treatment of HIV in collaboration with the Gates Foundation.
Second Quarter 2025 Financial Results

Cash, Cash Equivalents and Investments: As of June 30, 2025, the Company had $892.1 million in cash, cash equivalents and investments, representing a decrease of approximately $127.7 million during the second quarter of 2025. The current quarter decrease includes $50.5 million in milestone payments related to the initiation of the ECLIPSE Phase 3 registrational program, which were previously expensed in prior quarters.

In addition to the $892.1 million in cash, cash equivalents and investments, the Company had $95.2 million in restricted cash and cash equivalents as of June 30, 2025. This included a $75.0 million milestone payment due to the former shareholders of Amunix Pharmaceuticals, Inc., upon VIR-5525 achieving "first in human dosing," which occurred in July 2025.

Revenues: Total revenues for the second quarter of 2025 were $1.2 million compared to $3.1 million for the same period in 2024.

Cost of Revenue: The change in cost of revenue for the second quarter of 2025 compared to the same period in 2024 was nominal.

Research and Development Expenses (R&D): R&D expenses for the second quarter of 2025 were $97.5 million, which included $6.9 million of non-cash stock-based compensation expense, compared to $105.1 million for the same period in 2024, which included $13.1 million of non-cash stock-based compensation expense. The decrease was primarily driven by cost savings from previously announced restructuring initiatives, partially offset by higher clinical expenses from the initiation of our ECLIPSE registrational program for CHD, progression of our oncology programs and an increase in the fair value of contingent payment obligations for our CHD program.

Selling, General and Administrative Expenses (SG&A): SG&A expenses for the second quarter of 2025 were $22.3 million, which included $5.5 million of non-cash stock-based compensation expense, compared to $30.3 million for the same period in 2024, which included $9.1 million of non-cash stock-based compensation expense. The decrease was largely due to efficiencies and cost savings from previously announced restructuring initiatives.

Restructuring, Long-Lived Assets Impairment and Related Charges, Net: Restructuring, long-lived assets impairment and related charges, net for the second quarter of 2025 was $(0.2) million compared to $26.3 million for the same period in 2024. The decrease was due to the fact that our restructuring initiatives implemented in prior years were substantially completed by the end of 2024.

Other Income: Other income for the second quarter of 2025 was $7.6 million compared to $18.7 million for the same period in 2024. The decrease was primarily driven by lower interest income.

(Provision for) Benefit from Income Taxes: The provision for income taxes for the second quarter of 2025 was nominal.

Net Loss: Net loss for the second quarter of 2025 was $111.0 million, or $0.80 per share, basic and diluted, compared to a net loss of $138.4 million, or $1.02 per share, basic and diluted for the same period in 2024.

2025 Financial Guidance

Based on current operating plans, the Company expects its cash, cash equivalents and investments to fund operations into mid-2027.

Conference Call

Vir Biotechnology will host a conference call to discuss the second quarter results at 1:30 p.m. PT / 4:30 p.m. ET today. A live webcast will be available on View Source and will be archived for 30 days.

About VIR-5818, VIR-5500, VIR-5525

VIR-5818, VIR-5500 and VIR-5525 are investigational, clinical candidates currently being evaluated for the treatment of solid tumors. These assets leverage the PRO-XTEN masking technology with three different T-cell engagers (TCEs) targeting HER2, PSMA and EGFR, respectively.

TCEs are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. The PRO-XTEN masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells. By driving the activity exclusively to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with TCEs and increase their efficacy and tolerability. Additionally, the mask is designed to help drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing less frequent dosing regimens for patients and clinicians.

About Tobevibart and Elebsiran

Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen (HBsAg). It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir Biotechnology’s proprietary monoclonal antibody discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor’s Xtend technology to extend half-life. Tobevibart is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta.

Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) discovered by Alnylam Pharmaceuticals, Inc. It is designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Current data indicate that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta.

On August 6, 2025 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, reported financial results for the second quarter ended June 30, 2025, and provided a pipeline update on its clinical-stage investigational molecules across multiple common cancers (Press release, Arcus Biosciences, AUG 6, 2025, View Source [SID1234654857]).

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"We have now presented data from over 125 patients treated with casdatifan monotherapy or casdatifan plus cabozantinib, which we believe demonstrate the potential for casdatifan to be the best-in-class HIF-2a inhibitor for clear cell RCC," said Terry Rosen, Ph.D., chief executive officer of Arcus. "We are forging ahead with speed and efficiency in our development of casdatifan across multiple ccRCC settings, including our global Phase 3 PEAK-1 trial in the IO-experienced setting and Phase 1b/3 eVOLVE-RCC02 trial in the first-line metastatic setting, the latter in collaboration with AstraZeneca. With a strong balance sheet and focused investment, we are well equipped to fund casdatifan through data for PEAK-1, which has been designed to enroll rapidly and to achieve a readout as quickly as possible."

Pipeline Highlights:

Casdatifan (HIF-2a inhibitor)
Phase 3 Program:
•PEAK-1, a Phase 3 study evaluating casdatifan + cabozantinib versus cabozantinib in IO-experienced metastatic ccRCC, has been initiated.
•eVOLVE-RCC02, a Phase 1b/3 study sponsored and operationalized by AstraZeneca, evaluating casdatifan + volrustomig, an investigational anti-PD-1/CTLA-4 bispecific antibody, in first-line (1L), metastatic ccRCC, has also been initiated. The study was designed to support initiation of the Phase 3 portion as efficiently as possible.
Recent Data Presentations:
•Initial data from the ARC-20 study of casdatifan + cabozantinib in IO-experienced patients with metastatic ccRCC were presented in an oral session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

◦At the time of the data cutoff (DCO, March 14, 2025), treatment with casdatifan+cabozantinib showed a confirmed overall response rate (ORR) of 46% in patients who reached a minimum of 12 weeks (two scans) of follow-up, and almost all patients achieved tumor reduction.
◦At the time of DCO, the vast majority of patients remained on therapy.
◦There was no meaningful overlapping toxicity for the two drugs, and the combination had a well-tolerated safety profile with no patients discontinuing both therapies due to adverse events.
◦This cohort is evaluating the same regimen, in the same setting, as the PEAK-1 Phase 3 study.
Planned Data Readouts:
◦Fall 2025: More mature data from the ARC-20 cohorts evaluating casdatifan monotherapy in patients who had progressed on both an anti-PD-1 and a TKI.
◦2026: More mature data from the casdatifan plus cabozantinib cohort and initial data from the new ARC-20 cohorts evaluating casdatifan in the 1L and IO-experienced settings.
Domvanalimab (Fc-silent anti-TIGIT antibody) plus Zimberelimab (anti-PD-1 antibody)

Planned Data Readouts:

•An abstract describing OS data from the Phase 2 EDGE-Gastric study, evaluating domvanalimab plus zimberelimab and chemotherapy in upper GI adenocarcinomas, has been accepted for presentation at the 2025 ESMO (Free ESMO Whitepaper) Congress in October.
•The first Phase 3 OS data readout for domvanalimab plus zimberelimab will be from the ongoing Phase 3 study STAR-221, evaluating domvanalimab plus zimberelimab plus chemotherapy in PD-L1 all-comer 1L unresectable or metastatic upper GI adenocarcinomas. Results for this trial are event-driven, and OS data are expected in 2026.
Quemliclustat (small-molecule CD73 inhibitor)
•Orphan Drug Designation was granted by the U.S. Food and Drug Administration (FDA) to quemliclustat for the treatment of pancreatic cancer.
•PRISM-1, a Phase 3 trial of quemliclustat combined with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in first-line metastatic pancreatic ductal adenocarcinoma, is enrolling rapidly, with enrollment completion expected in the third quarter of 2025, well within 12 months of study initiation.
Etrumadenant (adenosine A2a/A2b receptor antagonist)
•In March 2025, we engaged with the FDA regarding promising results from the ARC-9 study evaluating etrumadenant in third-line metastatic colorectal cancer (mCRC); although the FDA’s feedback confirmed the potential for a registrational path for this program in third-line mCRC, based on our strategic priorities, Arcus and Gilead agreed to not pursue a Phase 3 study at this time and, in June 2025, Gilead returned its license to etrumadenant to Arcus.
Early Discovery
•Arcus has several research and preclinical programs ongoing that are addressing validated oncology and inflammation targets. Arcus expects that the next development candidate to enter the clinic will be a small molecule directed against an inflammation target.

Financial Results for Second Quarter 2025:
•Cash, Cash Equivalents and Marketable Securities were $927 million as of June 30, 2025, compared to $992 million as of December 31, 2024. The decrease during the period is primarily due to the use of cash in our research and development activities partially offset by the net proceeds from our underwritten offering in February 2025 and the additional $50 million draw down under our term loan facility in June 2025. We believe our cash, cash equivalents and marketable securities, together with available facilities, will be sufficient to fund operations through the initial pivotal readouts for domvanalimab, quemliclustat and casdatifan, which include PEAK-1.

•Revenues were $160 million for the second quarter 2025, compared to $39 million for the same period in 2024. The increase in revenue was driven by a cumulative catch-up to revenue of $143 million relating to pausing future development of etrumadenant and Gilead’s related return of its license to the program. Arcus expects to recognize GAAP revenue of between $225 million and $235 million for the full year 2025, which includes the cumulative catch-up.
•Research and Development (R&D) Expenses were $139 million for the second quarter 2025, compared to $115 million for the same period in 2024. The net increase of $24 million was primarily due to increased CMC costs. We expect to incur elevated CMC costs through the third quarter of 2025. Otherwise, clinical costs for our late-stage programs were flat, as increased enrollment and start-up activities for PRISM-1 and PEAK-1 were largely offset by lower costs for STAR-221. Other increases in expense resulted from an increase in early-stage development activities, driven by Phase 2 activities for casdatifan. Non-cash stock-based compensation expense was $8 million for the second quarter 2025, compared to $10 million for the same period in 2024. For the second quarters 2025 and 2024, Arcus recognized gross reimbursements of $33 million and $40 million, respectively, for shared expenses from its collaborations. R&D expenses by quarter may fluctuate due to the timing of clinical manufacturing and standard-of-care therapeutic purchases with a corresponding impact on reimbursements. Arcus expects R&D expenses to decline commencing in the fourth quarter 2025 as costs related to the domvanalimab Phase 3 development program decrease significantly.
•General and Administrative (G&A) Expenses were $29 million for the second quarter 2025, compared to $30 million for the same period in 2024. The decrease was primarily driven by a decrease in compensation and personnel costs driven by lower stock-based compensation, partially offset by increased costs recognized in the quarter in connection with the Gilead Agreement. Non-cash stock-based compensation expense was $7 million for the second quarter 2025, compared to $10 million for the same period in 2024.
•Net income (Loss) was $— million for the second quarter 2025, compared to a $93 million net loss for the same period in 2024.