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.

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 Aptose Biosciences Inc. ("Aptose" or the "Company") (OTC: APTOF, TSX: APS), a clinical-stage precision oncology company developing the tuspetinib (TUS)-based triple drug frontline therapy to treat patients with newly diagnosed AML, reported that the Cohort Safety Review Committee (CSRC) monitoring Aptose’s Phase 1/2 TUSCANY trial of TUS in combination with standard of care dosing of venetoclax and azacitidine (TUS+VEN+AZA triplet) has approved escalating from 120 mg TUS dose to 160 mg TUS dose based on its favorable review of safety and efficacy data from patients in the first three cohorts (40 mg, 80 mg, and 120 mg TUS dose levels) of the trial (Press release, Aptose Biosciences, AUG 6, 2025, View Source [SID1234654855]). Enrollment is open for dosing subjects at the 160 mg TUS dose level.

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Aptose also announced that it has received an additional advance of US$1.1M from Hanmi Pharmaceutical Co. Ltd. ("Hanmi"), as part of a US$8.5M loan facility agreement with Hanmi (the "Loan Agreement") announced prior on June 20, 2025 (press release here: View Source). To date, Aptose has received an aggregate of US$5.6M under the Loan Agreement.

The TUS+VEN+AZA triplet is being developed as a one-of-a-kind, safe and mutation agnostic frontline therapy to treat large, mutationally diverse populations of newly diagnosed AML patients who are ineligible to receive induction chemotherapy. Aptose reports that at the 120 mg TUS dose level, as with the prior reported 40 mg and 80 mg dose cohorts, no significant safety concerns or dose limiting toxicities (DLTs) have been reported in the TUSCANY trial, including no prolonged myelosuppression in Cycle 1 of subjects in remission.

All patients treated in the 120 mg dose cohort remain on study while enrollment is open for the 160 mg dose cohort. Aptose previously reported that the first two dose cohorts have demonstrated safety, CRs, and minimal residual disease (MRD) negativity across patients with diverse mutations in an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress (EHA 2025) in June (press release here: View Source).

"Data from three cohorts, with a 40, 80 or 120 mg dose of TUS in the TUS+VEN+AZA triplet, continue to build a strong case for TUS as a therapeutic option for some of the most difficult to treat AML populations," said Rafael Bejar, M.D., Ph.D., Chief Medical Officer of Aptose. "In particular, patients with adverse biallelic TP53 or FLT3-ITD mutations, and those without FLT3 mutations, were able to safely achieve complete remissions with MRD negativity. After review of the most recent safety and efficacy data, our CSRC recommended that we continue to escalate dosing."

TUSCANY: TUS+VEN+AZA Triplet Phase 1/2 Study

The tuspetinib-based TUS+VEN+AZA triplet therapy is being advanced in the TUSCANY Phase 1/2 trial with the goal of creating an improved frontline therapy for newly diagnosed AML patients that is active across diverse AML populations, durable, and well tolerated. Earlier APTIVATE trials of TUS as a single agent and in combination as TUS+VEN demonstrated favorable safety and broad activity in diverse relapsed or refractory (R/R) AML populations that went beyond the more prognostically favorable NPM1 and IDH mutant subgroups. Indeed, responses were also noted in R/R AML patients with highly adverse TP53 and RAS mutations, and those with mutated or unmutated (wildtype) FLT3 genes.

The TUSCANY triplet Phase 1/2 study, being conducted at 10 leading U.S. clinical sites by elite clinical investigators, is designed to test various doses and schedules of TUS in combination with standard dosing of AZA and VEN for patients with AML who are ineligible to receive induction chemotherapy. A convenient, once daily oral agent, TUS is being administered in 28-day cycles. Multiple U.S. sites are enrolling in the TUSCANY trial with anticipated enrollment of 18-24 patients by late 2025. Data will be released as it becomes available.

More information on the TUSCANY Phase 1/2 study can be found on www.clinicaltrials.gov (here: View Source).

On August 6, 2025 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported financial results for the second quarter ended June 30, 2025, and provided a business update (Press release, AnaptysBio, AUG 6, 2025, View Source [SID1234654854]).

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"Rosnilimab’s Phase 2b data in rheumatoid arthritis (RA) delivered a compelling safety and tolerability profile and JAK-like efficacy through six months that is durable for at least three months off-drug. The strength of the data, as well as positive feedback from the KOL community, gives us confidence in the transformational potential of rosnilimab. With enrollment completed in the Phase 2 ulcerative colitis (UC) trial, we look forward to reading out top-line data through Week 12 in Q4 2025, as well as potential additional six- and 12-month data from this trial in 2026," said Daniel Faga, president and chief executive officer of Anaptys. "Additionally, we are excited to announce the initial indication for our CD122 antagonist, ANB033, is celiac disease (CeD), a serious autoimmune disease triggered by the ingestion of gluten, affecting more than 2.1 million people in the U.S. but with no approved therapies. We believe ANB033’s MoA, inhibiting both IL-2 and IL-15 signaling, is well-suited to target the multiple pathogenic drivers of CeD. We plan to initiate a Phase 1b cohort by Q4 2025 and will discuss the program in depth at a dedicated R&D event later this year."

PORTFOLIO UPDATES

Rosnilimab (Pathogenic T Cell Depleter)

Announced positive data for rosnilimab from robust, 424-patient Phase 2b RA trial demonstrating –
Best-in-disease profile with JAK-like efficacy and monthly (Q4W) dosing in both three-month placebo-controlled and six-month​ blinded treatment period
Favorable safety and tolerability, particularly when compared to standard of care biologics or JAK inhibitors
Max response rates have not yet been observed; strict continuation criteria at three months in this Phase 2b trial excluded many patients who either achieved or were trending toward LDA and ACR50
Trial now complete with CDAI LDA responders at Week 28 demonstrating durable responses for at least 12-14 weeks off drug through Week 38
Data consistent with previously reported partial data results through Week 34
Supports potential for maintenance dosing with extended dosing intervals (e.g. Q8W or Q12W)
Safety profile remains favorable and consistent with previously reported data
Plan to present complete RA Phase 2b data at a future medical congress
Enrollment complete for global Phase 2 trial in moderate-to-severe UC (N=136, ~50% advanced therapy experienced)
Assessing Q2W and Q4W dose levels of subcutaneously administered rosnilimab vs. placebo (randomized 1:1:1)
Primary statistical analysis at Week 12 on well-established endpoints, including the primary endpoint of change from baseline in modified Mayo score (mMS) and key secondary endpoints, such as clinical response and remission on mMS
All patients in all three study arms treat-through to Week 24 and remain blinded to treatment arm. Placebo-treated patients who achieved clinical response on partial modified Mayo score (pmMS) at Week 12 remain on placebo, while placebo-treated patients who are non-responders are crossed over to the high dose Q2W rosnilimab treatment arm
Patients who are in clinical response on pmMS at Week 24 are eligible for an additional 26-week (50 weeks of total treatment) blinded treatment extension period (TEP)
Top-line data through Week 12, including primary and key secondary endpoints, on track for Q4 2025
Blinded surveillance data to date suggest a favorable safety and tolerability profile consistent with prior rosnilimab trials
ANB033 (CD122 antagonist)

Phase 1 trial ongoing in healthy volunteers
Plan to initiate Phase 1b cohort for ANB033 in initial indication, celiac disease, by Q4 2025
Additional information to be disclosed at ANB033-focused R&D event in Q4 2025
ANB101 (BDCA2 modulator)

Phase 1 trial ongoing in healthy volunteers
COLLABORATION UPDATES

GSK Immuno-Oncology Financial Collaboration

GSK announced strong commercial performance for Jemperli ($262 million/£196 million in Q2 2025 sales; $482 million/£370 million in 1H 2025 sales) with >19% USD and >12% GBP quarter-over-quarter growth
Anaptys anticipates triggering a one-time $75 million commercial sales milestone from GSK in 2025 once Jemperli achieves $1 billion in worldwide net sales in a calendar year
Substantial GSK investment in additional indications of Jemperli monotherapy and combinations ongoing –
AZUR-1 pivotal Phase 2 trial of dostarlimab monotherapy in patients with untreated stage II/III dMMR/MSI-H locally advanced rectal cancer
Top-line data in H2 2026
Jemperli received U.S. FDA Breakthrough Therapy Designation for this indication
AZUR-2 pivotal Phase 3 trial of perioperative dostarlimab monotherapy versus standard of care in participants with untreated T4N0 or stage III dMMR/ MSI-H resectable colon cancer ongoing
AZUR-4 Phase 2 trial of neoadjuvant dostarlimab plus capecitabine plus oxaliplatin (CAPEOX) versus CAPEOX alone in previously untreated T4N0 or stage III mismatch repair proficient/microsatellite stable resectable colon cancer ongoing
JADE pivotal Phase 3 trial of dostarlimab versus placebo as sequential therapy after chemoradiation in participants with locally advanced unresected head and neck squamous cell carcinoma (HNSCC) ongoing
GSK announced that COSTAR Lung Phase 3 trial did not meet primary endpoint of overall survival
Vanda Imsidolimab Financial Collaboration

Vanda anticipates FDA BLA submission for generalized pustular psoriasis (GPP) in 2H 2025
Anaptys eligible to receive up to $35 million for future regulatory approval, including a $5 million milestone upon U.S. FDA approval, and sales milestones, in addition to a 10% royalty on net sales
FINANCIAL UPDATES

Stock Repurchase Program and Cash Runway

The Company has repurchased a total of 2,853,836 shares of common stock (9.3% shares outstanding) with $55.5 million as of June 30, 2025 from its $75.0 million Stock Repurchase Program
Cash and investments of $293.7 million as of June 30, 2025, and reiterating cash runway through year-end 2027
Second Quarter 2025 Financial Results

Cash, cash equivalents and investments totaled $293.7 million as of June 30, 2025, compared to $420.8 million as of December 31, 2024, for a decrease of $127.1 million due primarily to operating activities and $55.5 million in shares repurchased, offset by $15.0 million received from Vanda Pharmaceuticals for the license of imsidolimab.
Collaboration revenue was $22.3 million and $50.0 million for the three and six months ended June 30, 2025, compared to $11.0 million and $18.2 million for the three and six months ended June 30, 2024. This was due primarily to Jemperli royalties increasing $11.0 million and $22.1 million for the three and six months ended June 30, 2025 and $9.7 million in revenue recognized for the Vanda license agreement.
Research and development expenses were $37.8 million and $79.0 million for the three and six months ended June 30, 2025, compared to $42.0 million and $79.0 million for the three and six months ended June 30, 2024. The decrease for the three months ended June 30, 2025, was primarily due to lower development costs for ANB032 and imsidolimab offset by higher costs relating to the Phase 2 trials in RA and UC for rosnilimab and the Phase 1 trials for ANB033 and ANB101. The R&D non-cash, stock-based compensation expense was $4.5 million and $8.9 million for the three and six months ended June 30, 2025 as compared to $3.5 million and $7.0 million in the same period in 2024.
General and administrative expenses were $10.6 million and $24.7 million for the three and six months ended June 30, 2025, compared to $9.3 million and $21.6 million for the three and six months ended June 30, 2024. The increase was due primarily to transaction costs associated with the Vanda Pharmaceuticals license agreement. The G&A non-cash, stock-based compensation expense was $4.8 million and $9.5 million for the three and six months ended June 30, 2025 as compared to $4.0 million and $10.7 million in the same period in 2024.
Net loss was $38.6 million and $78.0 million for the three and six months ended June 30, 2025, or a net loss per share of $1.34 and $2.62, compared to a net loss of $46.7 million and $90.6 million for the three and six months ended June 30, 2024, or a net loss per share of $1.71 and $3.35.

On August 6, 2025 Aligos Therapeutics, Inc. (Nasdaq: ALGS, "Aligos"), a clinical stage biotechnology company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, reported recent business progress and financial results for the second quarter 2025 (Press release, Aligos Therapeutics, AUG 6, 2025, View Source [SID1234654853]).

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"Initiation of the Phase 2 B-SUPREME study of ALG-000184 is well underway with regulatory approvals across a number of countries, including the US, China, Canada, Taiwan, UK, New Zealand, and Moldova," stated Lawrence Blatt, Ph.D., M.B.A., Chairman, President, and Chief Executive Officer of Aligos Therapeutics. "Site activations are in progress, subjects are being screened, and we expect dosing to commence in the coming weeks. This pertinent study is the next step in our journey to potentially deliver better therapies for patients living with HBV infection and create value for our stakeholders. The Phase 1 data showcasing 96 weeks of treatment presented at the EASL meeting suggests that ALG-000184 has the potential to replace standard of care treatment for chronic suppression of HBV infection and may become the backbone of treatments aimed at a functional cure. We remain excited about the potential of ALG-000184 and the entirety of our pipeline, including ALG-055009 which remains in discussions with potential partners."

Recent Business Progress

Pipeline Updates

ALG-000184: Potential first-/best-in-class small molecule CAM-E for chronic hepatitis B virus (HBV) infection

The Phase 2 B-SUPREME study (NCT04746183) of ALG-000184 in subjects with chronic HBV infection recently began obtaining regulatory approvals, activating global sites, and screening subjects. Dosing is expected to commence in the coming weeks.
The study is designed as a randomized, double-blind, active-controlled multicenter study evaluating the safety and efficacy of ALG-000184 monotherapy compared with tenofovir disoproxil fumarate in approximately 200 untreated HBeAg+ and HBeAg- adult subjects with chronic HBV infection for 48 weeks. The primary endpoint in the HBeAg+ part will be HBV DNA 96-week dosing recently completed in the Phase 1 study and data readouts, including post-treatment data, are planned for scientific conferences this year. Interim data from up to 96 weeks following an oral daily dose of 300 mg ALG-000184 in both HBeAg+ and HBeAg- subjects with chronic HBV infection were presented at the European Association for the Study of the Liver (EASL) Congress 2025.
ALG-000184 administered for up to 96 weeks was well tolerated by study participants, exhibited a favorable PK profile, and suggested potentially best-in-class antiviral activity.
In HBeAg+ subjects with a very high mean HBV DNA level of 8.0 log10 IU/mL at baseline, all experienced profound and persistent HBV DNA reductions after receiving an oral daily dose of 300 mg ALG-000184 monotherapy. At Week 48, 6 of 10 subjects (60%) achieved HBV DNA < LLOQ (10 IU/mL, target detected or target not detected). With treatment extension, this rate increased to 9 of 9 subjects (100%) at Week 96. Additionally, HBV DNA level continuously declined to < LLOQ (10 IU/mL, target not detected) in 5 of 9 subjects at Week 96.
In HBeAg- subjects, all 11 (100%) had rapid decline in HBV DNA levels and achieved sustained HBV DNA suppression (HBV DNA < LLOQ (10 IU/mL, target detected or target not detected)) by Week 24. The HBV DNA suppression level was maintained in the ALG-000184 monotherapy cohort for up to 96 weeks, with further decline in HBV DNA to < LLOQ (10 IU/mL, target not detected), observed in all subjects (8/8) at Week 96.
Multi-log10 reductions in HBsAg, HBeAg, and HBcrAg were observed in HBeAg+ subjects, and HBcrAg decline was observed in HBeAg- subjects.
In both patient populations in this study, ALG-000184 was well tolerated with no viral breakthrough observed and no known CAM resistant mutations identified with monotherapy treatment.
ALG-055009: Potential best-in-class small molecule THR-β agonist for metabolic dysfunction-associated steatohepatitis (MASH)

The Phase 2a HERALD data were presented at EASL 2025, demonstrating that ALG-055009 dose groups met the primary endpoint with statistically significant reductions in liver fat at week 12 as measured by MRI-PDFF.
Additionally, new data demonstrated substantial, dose-dependent reductions in liver fat were observed across all key subgroups with 12 weeks of once daily ALG-055009 treatment. Statistically significant improvements in atherogenic lipids were achieved with 12 weeks of ALG-055009 treatment. Reductions in lipids/lipoproteins were observed even in the context of stable GLP-1 agonist or statin use. This data suggests a potential added benefit of ALG-055009 for patients at risk for cardiovascular disease in addition to the previously reported liver fat lowering properties in a MASLD/MASH population.
As shared previously, ALG-055009 demonstrated a favorable tolerability profile with no evidence of clinical hyper/hypothyroidism. Incidence of gastrointestinal-related treatment emergent adverse events were similar in ALG-055009 dose groups compared to placebo. Specifically, similar rates of diarrhea were observed in ALG-055009 dose groups compared to placebo, with no dose-response. Significant reductions in atherogenic lipids, including LDL-C, lipoprotein (a), and apolipoprotein B, were also observed (Loomba et al, AASLD 2024).
The company is continuing to evaluate a variety of options to fund continued development, including potential out-licensing.
ALG-097558: Potential best-in-class ritonavir-free small molecule pan-coronavirus protease inhibitor

The AGILE platform study (NCT04746183) assessing ALG-097558 monotherapy or in combination with remdesivir in high-risk subjects with COVID-19 began in 2024.
The NIAID is sponsoring a drug-drug interaction and relative bioavailability study of ALG-097558 in healthy volunteers that began dosing in the second quarter of 2025.
The company expects any future development of ALG-097558 to be funded by external sources.
Financial Results for the Second Quarter 2025

Cash, cash equivalents and investments totaled $122.9 million as of June 30, 2025, compared with $56.9 million as of December 31, 2024. Our cash, cash equivalents and investments are expected to provide sufficient funding of planned operations into the second half of 2026.

Net loss for the three months ended June 30, 2025 was $15.9 million or basic and diluted net loss per common share of $(1.53), compared to net income of $5.1 million or basic and diluted net income per common share of $0.81 for the three months ended June 30, 2024.

Research and development (R&D) expenses for the three months ended June 30, 2025 were $14.0 million, compared with $21.1 million for the same period of 2024. The decrease was primarily due to a decrease in third-party expenses due to reduced clinical study costs as a result of the completion of the MASH Phase 2a clinical trial, partially offset by increased spend in the chronic HBV infection program. Total R&D stock-based compensation expense incurred for the three months ended June 30, 2025 was $0.6 million, compared with $1.2 million for the same period of 2024.

General and administrative (G&A) expenses for the three months ended June 30, 2025 were $5.6 million, compared with $6.4 million for the same period of 2024. The decrease in G&A expenses for this comparative period is primarily due to a decrease in third-party expenses including legal expenses. Total G&A stock-based compensation expense incurred for the three months ended June 30, 2025 was $0.5 million, compared with $0.9 million for the same period of 2024.

Interest and other income, net, was income of $1.2 million each for the three months ended June 30, 2025 and June 30, 2024.

Change in fair value of 2023 common warrants for the three months ended June 30, 2025 was income of $1.7 million compared with income of $30.4 million for the same period of 2024.