Ascentage Pharma Group International H1 Earnings Call Highlights

Key Points

• First-half revenue rose 29.3% year over year to $44.5 million, including $41.6 million in product sales. Ascentage ended June with $279.4 million in cash and reiterated that its runway extends through the end of 2027.
• Research and development spending increased to $102.8 million as the company advanced nine global registrational studies, while management said operating expenses may have peaked. Enrollment for key lisaftoclax and olverembatinib trials is expected to conclude by late 2026 or early 2027, supporting potentially multiple NDA filings in 2027.
• Ascentage is expanding commercial capabilities outside China and advancing its pipeline, including lisaftoclax, olverembatinib, APG-5918 and APG-3288. Takeda’s olverembatinib agreement could generate up to $1.2 billion in milestone payments plus tiered royalties.

Ascentage Pharma Group International NASDAQ: AAPG reported first-half 2026 revenue growth as it continued investing in global registrational studies for its hematology-oncology pipeline and began building commercial capabilities outside China.

Total revenue for the six months ended June 30 was $44.5 million, up 29.3% on a constant-currency basis from $32.6 million a year earlier, according to Chief Financial Officer Veet Misra. Product sales accounted for $41.6 million of total revenue. The company ended the period with $279.4 million in cash and reaffirmed that its cash runway extends through the end of 2027.

Chairman and Chief Executive Officer Dajun Yang said the company is focused on becoming a “leading global, fully integrated hematology oncology company,” supported by two products approved in China and a portfolio of global clinical programs. Ascentage said it is advancing nine registrational trials, including four cleared by both the U.S. Food and Drug Administration and the European Medicines Agency.

Investment in Global Studies Raises Expenses

Research and development expense rose to $102.8 million in the first half, from $73.8 million in the prior-year period, reflecting enrollment activity across multiple global registrational programs. Selling and distribution expense increased to $33.4 million from $19.2 million, driven by marketing and commercial investment behind the company’s products. Administrative expense was $17.5 million, compared with $13.9 million a year earlier, primarily due to restricted stock unit expense.

Misra said operating expenses have reached their peak as the company moves through the later stages of trial enrollment. He said the company expects its existing cash to support enrollment completion, clinical data generation and multiple anticipated new drug application filings.

During the call, management also addressed potential future financing and partnership opportunities. Misra said the company has sought flexibility through its dual listing and is not under pressure to pursue a single financing path. He added that partnerships may be considered where appropriate.

Lisaftoclax Programs Advance Toward Enrollment Milestones

Ascentage highlighted lisaftoclax, a selective BCL-2 inhibitor approved in China for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma previously treated with a BTK inhibitor. Yang said the company is conducting four global registrational studies of the drug.

Chief Medical Officer Yifan Zhai said enrollment has been completed in the GLORA-2 study in frontline CLL/SLL and is nearing completion in GLORA-3, a study of lisaftoclax in combination with azacitidine in acute myeloid leukemia. The company expects enrollment in its remaining global registrational trials, including GLORA-4 in frontline high-risk myelodysplastic syndromes, to finish by the end of 2026 or early 2027.

GLORA-4 is evaluating lisaftoclax plus azacitidine against azacitidine alone in high-risk MDS and has been cleared in multiple jurisdictions, including the U.S., Europe, China and Japan. Yang said the company expects to potentially file as many as three NDAs in the second half of 2027, including filings related to its lead programs.

Management emphasized lisaftoclax’s daily dose ramp-up schedule and stated that its observed safety profile and drug-drug interaction characteristics could differentiate it from other BCL-2 inhibitors. Yang noted that comparisons discussed on the call were not head-to-head studies.

In China, Yang said lisaftoclax has passed an initial review for inclusion in the National Reimbursement Drug List and is on the final product list for expert review. He said the company expects a final reimbursement decision later in the process, while noting that price remains a consideration. National reimbursement could improve hospital access and reduce patient out-of-pocket costs, management said.

Olverembatinib Studies Target CML and Ph-Positive ALL

The company’s other approved product in China, olverembatinib, is a third-generation BCR-ABL inhibitor for chronic-phase chronic myeloid leukemia. Yang said tens of thousands of patients have been treated with the drug in China and that some patients have remained on therapy for nearly a decade.

Ascentage is advancing POLARIS-2, a global study in chronic-phase CML patients who have received at least two prior tyrosine kinase inhibitors. The study includes a randomized comparison of olverembatinib against bosutinib, as well as a single-arm cohort for patients with the T315I mutation. The company expects enrollment to conclude by the end of 2026 or early 2027.

Zhai said the POLARIS-2 primary endpoint is the major molecular response rate at 24 weeks and that patients who fail the control arm may cross over to olverembatinib. Yang said the company expects an NDA filing based on the six-month major molecular response rate after the final patient is enrolled.

POLARIS-1 is a global Phase III study in newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia. Yang said the planned NDA filing endpoint is the three-month minimal residual disease-negative complete response rate. The company also cited earlier study data for olverembatinib in heavily pretreated CML patients, including patients previously treated with ponatinib or asciminib.

Takeda holds an exclusive option to license olverembatinib outside Greater China and certain other territories. Yang said Takeda paid $100 million upfront and made a $75 million equity investment under the 2024 agreement. The potential deal includes up to $1.2 billion in aggregate payments and tiered royalties ranging from 12% to 19%, management said.

Commercial and Pipeline Plans

Ascentage appointed Faiçal Miyara as chief business officer and Jim Ziegler as chief commercial officer. Miyara previously held oncology business-development roles at companies including Lilly, Pfizer, Sanofi, Ipsen, Kadmon and IO Biotech. Ziegler said his immediate priorities include establishing commercial strategy, market access and related capabilities for potential launches in the U.S. and other markets.

Beyond its two approved products, the company discussed clinical-stage assets including MDM2 inhibitor APG-115, EED inhibitor APG-5918 and BTK degrader APG-3288. Yang said Ascentage plans to present data from the Phase I APG-5918 program at the American Society of Hematology meeting this year. The company does not expect to present Phase I data for APG-3288 at ASH, but said it may have data to share at the European Hematology Association meeting in 2027.

Management said APG-3288 is being studied in the U.S. and China in patients previously exposed to BTK inhibitors, and that the company plans to file investigational new drug applications for autoimmune indications, including multiple sclerosis.

About Ascentage Pharma Group International (NASDAQ:AAPG)

Ascentage Pharma Group International is a clinical‐stage biopharmaceutical company focused on developing small‐molecule therapeutics that modulate programmed cell death pathways, including the Bcl‐2 family and the MDM2–p53 axis. Its pipeline features orally bioavailable inhibitors such as APG-2575, a selective Bcl-2 inhibitor, and APG-115, a potent MDM2 antagonist, both aimed at reactivating apoptosis in cancer cells across hematologic malignancies and solid tumors.

Founded in 2008 by biotechnology entrepreneur Dr.

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