On August 10, 2026 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, reported financial and operating results for the second quarter ended June 30, 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our commitment to transforming the metastatic breast cancer treatment paradigm remains resolute as we continue to advance palazestrant as a potentially differentiated endocrine therapy across multiple regimens. Importantly, enrollment in our pivotal OPERA-01 Phase 3 trial is complete and we now expect to report top-line data in the first quarter of 2027," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Beyond palazestrant, we made significant progress with OP-3136, our novel KAT6 inhibitor. The initial monotherapy Phase 1 data, presented at ASCO (Free ASCO Whitepaper), demonstrated that OP-3136 was well-tolerated and showed evidence of anti-tumor activity across multiple dose levels and various tumor types. These data, taken together with our first clinical collaboration for OP-3136, established with Bayer to evaluate OP-3136 in combination with darolutamide in metastatic castration-resistant prostate cancer, reinforce our confidence in its potential as a best-in-class, differentiated option for patients with advanced solid tumors."

Bohen continued, "Supported by a strong balance sheet, we are intently focused on execution in the second half of the year as we ramp preparations for our first potential commercial launch of palazestrant as a monotherapy, work to establish palazestrant as a potential combination agent of choice in breast cancer, and continue our transformation into a fully integrated oncology company."

Recent Progress

Completed enrollment in the pivotal Phase 3 OPERA-01 trial of palazestrant as a monotherapy in patients with second or third-line estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC).
Presented initial Phase 1 clinical data for OP-3136 as a monotherapy in multiple solid tumor types and a trial-in-progress poster for the pivotal Phase 3 OPERA-02 trial evaluating palazestrant in combination with ribociclib in frontline ER+/HER2- MBC at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Announced a clinical trial collaboration and supply agreement with Bayer to evaluate OP-3136 in combination with darolutamide, Bayer’s androgen receptor inhibitor, in patients with metastatic castration-resistant prostate cancer (mCRPC).
Completed enrollment in the Phase 1b/2 study of palazestrant in combination with atirmociclib in ER+/HER2- MBC.
Advanced enrollment in the pivotal Phase 3 OPERA-02 trial and the Phase 1 study of OP-3136 as a monotherapy and in combination with fulvestrant and palazestrant in ER+/HER2- MBC.
Anticipated Upcoming Events

Initiate enrollment in the Phase 1b/2 study evaluating OP-3136 in combination with darolutamide in mCRPC in collaboration with Bayer in the fourth quarter of 2026.
Report top-line data from the pivotal Phase 3 OPERA-01 trial in the first quarter of 2027.
Second Quarter 2026 Financial Results
Cash, cash equivalents, and marketable securities as of June 30, 2026, were $461.1 million.

Net loss for the quarter ended June 30, 2026 was $63.2 million, as compared to $43.8 million for the quarter ended June 30, 2025. The increase in net loss for the second quarter was related to higher spending on clinical development and research and corporate-related activities related to late-stage clinical trials for palazestrant and the advancement of OP-3136.

GAAP research and development (R&D) expenses were $57.8 million for the quarter ended June 30, 2026, as compared to $43.9 million for the quarter ended June 30, 2025. The increase in R&D expenses was primarily related to increased spending on clinical development-related activities as we continue to advance palazestrant through late-stage clinical trials and OP-3136 in early-stage clinical studies, and increased personnel-related costs to support expanding development activities, including an increase in non-cash stock-based compensation expense of $5.2 million, mainly due to higher grant prices in 2026 and higher headcount. These increases were partially offset by the $10.0 million milestone expense related to the Aurigene agreement that was recognized in the same period in 2025.

Non-GAAP R&D expenses were $48.9 million for the quarter ended June 30, 2026, excluding $8.9 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $40.2 million for the quarter ended June 30, 2025, excluding $3.7 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

GAAP G&A expenses were $9.4 million for the quarter ended June 30, 2026, as compared to $4.0 million for the quarter ended June 30, 2025. The increase in G&A expenses was primarily due to higher corporate-related costs that reflect continued investment in personnel and corporate infrastructure to support our expanding late-stage clinical development activities and anticipated future commercial operations, including an increase in non-cash stock-based compensation expense of $3.0 million, mainly due to higher grant prices in 2026, and an increase in professional fees of $1.8 million.

Non-GAAP G&A expenses were $5.4 million for the quarter ended June 30, 2026, excluding $4.0 million non-cash stock-based compensation expense. Non-GAAP G&A expenses were $3.0 million for the quarter ended June 30, 2025, excluding $1.0 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

(Press release, Olema Oncology, AUG 10, 2026, View Source [SID1234669919])

On August 10, 2026 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported second quarter 2026 financial results and provided a corporate update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The second quarter of 2026 was without question the busiest and most consequential period in Alpha Tau’s history, and the momentum has only continued to accelerate since," said Alpha Tau CEO Uzi Sofer. "In the space of a few weeks we reported groundbreaking interim results in recurrent glioblastoma, completed enrollment in our first U.S. pivotal trial, presented compelling new pancreatic cancer survival data at both Digestive Disease Week and the ASCO (Free ASCO Whitepaper) Annual Meeting, and announced our first major U.S. commercial partnership. This Company continues to transform itself completely, from a single-asset clinical story into a broad, multi-indication platform with a partnered commercial pathway and a rapidly expanding global clinical footprint."

"What excites me most is that the pace is still building rather than slowing," continued Mr. Sofer. "Since the close of the quarter, we have treated the first immunocompromised recurrent cSCC patient in our ADMIRE study at Banner MD Anderson Cancer Center, treated the first glioblastoma patient ever to receive Alpha DaRT outside of the United States, as well as our first patient to receive glioblastoma treatment using two distinct injection trajectories, both at Hadassah University Medical Center, and reported a 100% objective response rate with 18.2-month median overall survival in our head and neck combination study with pembrolizumab, surpassing that study’s pre-specified threshold for success. With REGAIN now cleared to complete enrollment across additional leading U.S. centers and ReSTART fully enrolled, we have a dense sequence of milestones ahead of us that will culminate in several of the most important data readouts in our history around the end of this year."

"We have been receiving myriad inbounds from academic and medical centers around the world, expressing interest in exploring Alpha DaRT in treating an ever broader list of cancer indications, and with that input we have identified the next key indications that will keep us busy in the coming months. In parallel, we remain focused on continually increasing our manufacturing capabilities, both in our existing facilities as well as in a new facility we aim to build for our collaboration with Tolmar."

"Our collaboration with Tolmar validates both the technology and the scale of the commercial opportunity ahead of us, and it materially strengthens our position. With a strong balance sheet of $104.8 million to support our continued momentum, we are well-resourced to press forward across every one of our strategic priorities and we aim to translate this extraordinary period of progress into meaningful impact for patients."

Recent Corporate Highlights:

In July 2026, Alpha Tau reported positive results from a clinical study evaluating Alpha DaRT in combination with pembrolizumab (Keytruda) in elderly patients with locally advanced and metastatic head and neck squamous cell carcinoma (HNSCC), delivered in a podium presentation at the American Head and Neck Society (AHNS) 12th International Conference on Head and Neck Cancer in Boston. Among all nine evaluable patients, the combination produced a systemic objective response rate of 100%, including four complete responses and five partial responses, compared to just 19% from historical benchmarks for pembrolizumab monotherapy in this setting. Median overall survival of 18.2 months and median progression-free survival of 5.4 months compared favorably with historical benchmarks for pembrolizumab monotherapy of 12.3 months and 3.2 months, respectively. No Alpha DaRT-associated serious adverse events were observed, and the study was stopped after the recruitment of 11 patients, having surpassed its pre-specified threshold for success.
In July 2026, Alpha Tau announced the successful treatment of the first patient in its ADMIRE (Alpha DaRT Management for Immunocompromised patients with REcurrent cSCC) study, a clinical trial evaluating intratumoral Alpha DaRT in immunocompromised patients with recurrent cutaneous squamous cell carcinoma (cSCC), performed at Banner MD Anderson Cancer Center in Gilbert, Arizona. Immunosuppression is one of the strongest known risk factors for cSCC, and these patients are frequently excluded from clinical trials and often cannot safely receive checkpoint inhibitor immunotherapy.
In June 2026, Alpha Tau announced the successful treatment with Alpha DaRT of the first glioblastoma patient in Israel, and the first ever such treatment outside of the United States, performed at Hadassah University Medical Center in Jerusalem. Using the Company’s proprietary brain applicator under real-time stereotactic neuro-navigation, Alpha DaRT sources were precisely delivered to the recurrent tumor through a single, minimally invasive burr hole entry point into the brain, and the procedure was completed safely and without unexpected complications. The patient was treated under the ALL protocol, the Company’s broad-access study at Hadassah open to patients with solid tumors in any location of the body amenable to Alpha DaRT source delivery.
In June 2026, Alpha Tau announced that the FDA cleared the Company to proceed with enrollment of the final seven patients in its U.S. REGAIN (Recurrent Glioblastoma Alpha-DaRT Intratumoral Therapy) trial, following the FDA’s review of a pre-specified interim safety report on the first three patients treated. Two additional leading U.S. academic cancer centers were also approved to participate in the trial, expanding geographic access and clinical expertise for this indication, and the Company recommenced patient recruitment immediately. For more information, please see here: View Source
In June 2026, Alpha Tau and Tolmar International Ltd. announced a strategic collaboration agreement to develop and commercialize Alpha DaRT for the treatment of prostate cancer in the United States. Under the agreement, Tolmar holds exclusive rights to commercialize Alpha DaRT in the United States for prostate cancer indications for a term expected to extend for 20 years from first commercial sale, and also holds an option to expand into bladder cancer commercialization in the U.S., exercisable upon achievement of specified clinical criteria. At closing, Tolmar made a $20 million equity investment in Alpha Tau at $11.99 per share, a 25% premium to the 30-trading day volume-weighted average price prior to signature, and paid $15 million towards the construction of a new Alpha DaRT production facility in the U.S. The agreement further provides for up to $96.5 million in development and regulatory milestone payments for the initial indication and up to $65 million in commercial milestone payments. Alpha Tau will lead clinical development and be responsible for manufacturing and supply, with product sold to Tolmar at 60% of the onward net sales price, subject to certain adjustments.
In June 2026, Alpha Tau announced positive overall survival and safety results from a pooled analysis of three prospective Phase I/II clinical studies evaluating Alpha DaRT in patients with pancreatic cancer, presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting. Patients treated with Alpha DaRT after first-line chemotherapy reached median overall survival of 11.2 months in metastatic disease and 11.1 months in locally advanced disease, measured from the date of trial enrollment, compared to approximately 4 to 6 months and approximately 9 months, respectively, with second-line chemotherapy based on published historical data. Treatment-associated adverse events were observed in 36% of subjects and Grade 3 or higher adverse events in 9% of subjects, with no treatment-related deaths, all Grade 3 or higher events resolved, and no chronic adverse events observed.
In May 2026, Alpha Tau announced groundbreaking interim results as of May 3 from the U.S. REGAIN trial of Alpha DaRT in recurrent glioblastoma (GBM), conducted at The Ohio State University Comprehensive Cancer Center. In the first three patients treated, 100% local disease control, a 67% complete response rate (two complete responses and one stable disease with a 30% tumor reduction), and a favorable safety profile were observed, with only one associated grade 3 serious adverse event that resolved with administration of steroids. As of the data cut-off date, no patients had any local or distant recurrence or any residual symptoms from the procedure.
In May 2026, Alpha Tau announced the completion of patient enrollment in its U.S. multicenter pivotal ReSTART trial of Alpha DaRT for the treatment of recurrent cutaneous squamous cell carcinoma (cSCC), with 88 patients enrolled, making ReSTART the Company’s first U.S. pivotal study to complete enrollment – a critical milestone on the path toward potential FDA pre-market approval (PMA). Alpha DaRT has received Breakthrough Device Designation from the FDA for this indication, and the Company submitted the first module of its modular PMA application in January 2026. For more information, please see here: View Source
In May 2026, Alpha Tau treated the first patient in Italy with Alpha DaRT for locally advanced pancreatic cancer, in a feasibility and safety study conducted at the world-renowned Pancreas Institute of the University of Verona. The protocol is the first Alpha DaRT pancreatic cancer protocol worldwide to permit both endoscopic ultrasound (EUS)-guided and percutaneous delivery of Alpha DaRT sources, broadening physician access across multiple interventional specialties.
In May 2026, Alpha Tau presented updated pooled results from two first-in-human pancreatic cancer trials at Digestive Disease Week (DDW) 2026, with 100% local disease control observed in evaluable patients and a favorable safety profile. The oral presentation, delivered in the Pancreatic Cancer I: Diagnosis and Treatment session, marked the first time clinical results of Alpha DaRT in pancreatic cancer have been featured at a major international gastroenterology conference.
In April 2026, Alpha Tau announced FDA approval of an Investigational Device Exemption (IDE) supplement to expand its U.S. multicenter IMPACT pancreatic cancer pilot trial to include patients receiving gemcitabine with Abraxane (nab-paclitaxel). The supplement also adds ten newly diagnosed patients – five with unresectable locally advanced and five with metastatic pancreatic adenocarcinoma – bringing total planned enrollment to 40 patients. For more information, please see here: View Source
In April 2026, Alpha Tau successfully treated the first European pancreatic cancer patient with Alpha DaRT at CHU Grenoble Alpes, under the ACAPELLA multicenter trial in France evaluating Alpha DaRT in combination with capecitabine for patients with inoperable locally advanced pancreatic ductal adenocarcinoma who have completed first-line mFOLFIRINOX chemotherapy, a population for whom no standard consolidation therapy exists.
Expected Upcoming Milestone Targets:

Completion of patient recruitment in IMPACT pancreatic cancer pilot study in the U.S. in Q3 2026, with initial data targeted for late 2026 or early 2027. For more information, please see here: View Source
Completion of patient recruitment in REGAIN recurrent GBM trial in the U.S. in the second half of 2026, with additional data expected to be released by around the end of 2026. For more information, please see here: View Source
First patient treated in U.S. locally recurrent prostate cancer pilot trial in the second half of 2026. For more information, please see here: View Source
Top-line data in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma in late 2026 or early 2027. For more information, please see here: View Source
Financial Results for the Six Months Ended June 30, 2026

Research and Development expenses for the six months ended June 30, 2026 were $20.9 million, compared to $14.2 million for the same period in 2025, primarily due to increased employee compensation and benefits, including share-based compensation, increased clinical trial activity, and increased raw material purchases.

Marketing expenses for the six months ended June 30, 2026 were $0.6 million, compared to $0.9 million for the same period in 2025, primarily due to decreased employee compensation and benefits.

General and Administrative expenses for the six months ended June 30, 2026 were $5.7 million, compared to $3.9 million for the same period in 2025, primarily due to increased employee compensation and benefits, including share-based compensation, and higher professional fees.

Financial expenses, net, for the six months ended June 30, 2026 were $41.4 million, compared to financial income, net, of $0.3 million for the same period in 2025, primarily due to the remeasurement of warrants liability as the public trading prices of the Company’s ordinary shares and publicly traded warrants rose over the period.

For the six months ended June 30, 2026, the Company had a net loss of $68.8 million, or $0.76 per share, compared to a net loss of $18.8 million, or $0.25 per share, for the six months ended June 30, 2025.

Balance Sheet Highlights

As of June 30, 2026, the Company had cash and cash equivalents, short-term deposits and restricted deposits of $104.8 million, compared to $76.9 million at December 31, 2025.

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

(Press release, Alpha Tau Medical, AUG 10, 2026, View Source [SID1234669918])

On August 10, 2026 Perspective Therapeutics, Inc. ("Perspective," the "Company," "we," "us," and "our") (NYSE AMERICAN: CATX), a radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body, reported a business update and announced results for the quarter ended June 30, 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The team at Perspective is highly energized as we continue to build on the significant clinical progress we’re making across our pipeline, prepare for our first Phase 3 study, and advance our flagship Chicago manufacturing facility toward completion," said Thijs Spoor, Perspective’s CEO. "As precision oncology continues to evolve, long-term leadership will require differentiated science, integrated manufacturing, and the ability to reliably deliver these therapies at commercial scale. We are continuing to bring the platform that delivers."

Recent Program Updates

We advanced our four-program 212Pb pipeline, expanded our manufacturing network and attracted strong leadership.

Bamzireotide navoxetan (VMT-α-NET) in SSTR2-positive neuroendocrine tumors (NETs) and meningioma: 76 NETs patients across four cohorts and one meningioma patient treated as of July 31. ASCO (Free ASCO Whitepaper) 2026 interim data were consistent with prior findings and showed continued deepening of response. Updated data on NETs patients will be presented at ESMO (Free ESMO Whitepaper) on October 23. By late 2026, all 46 Cohort 2 patients will have had the opportunity for at least 60 weeks of follow-up, which is expected to inform the Phase 3 study design.

Preparing for a Phase 3 study evaluating a proposed cumulative 20 mCi (740 MBq) dose administered in up to four treatments every eight weeks. Additional dose cohorts could provide optionality and opportunity to further define VMT-α-NET’s therapeutic window. Phase 3 site activation targeted around year-end 2026, subject to regulatory feedback and protocol finalization.

Lapemelanotide zapixetar (VMT01) in MC1R-positive melanoma: 27 patients enrolled across multiple dose cohorts either as monotherapy or in combination with the immune checkpoint inhibitor nivolumab as of July 31. We are focused on a cumulative 9 mCi (333 MBq) dose administered in up to three treatments every eight weeks. Seven patients received this treatment regimen as a monotherapy, and six patients received this dose in combination with nivolumab.

Data presented at ASCO (Free ASCO Whitepaper) 2026 showed two partial responses among seven patients treated with 3.0 mCi monotherapy; safety data from 27 patients showed treatment was generally well tolerated. Six nivolumab combination patients are expected to reach at least 24 weeks of follow-up by late 2026.

PSV359 in FAP-α-positive solid tumors: 17 patients treated across three dose cohorts as of July 31. Cohort 3 opened and closed during 2Q 2026. The next clinical update is planned in 2027.

PSV594 in CCK2R-positive solid tumors: Preclinical data and first-in-human biodistribution observations support continued pre-IND development of PSV594.

Manufacturing: We expect the Chicago metro site to complete construction in early 2027, followed by the Los Angeles metro site in 2H 2027, expanding the network to four regional sites by the end of 2027. We believe we have sufficient capacity and isotope access to support ongoing studies and the planned VMT-α-NET Phase 3 study.

Corporate update: In July 2026, we announced that Paul Lyne, Ph.D. was appointed as Chief Science Officer.

Second Quarter 2026 Financial Summary

Cash, cash equivalents, and short-term investments as of June 30, 2026, were approximately $237 million as compared to approximately $145 million as of December 31, 2025. We believe our cash, cash equivalents, and short-term investments are sufficient to fund our current planned clinical milestones and operational investments into late 2027.

Research and development expenses were $21.5 million for the three months ended June 30, 2026, compared to $16.6 million for the three months ended June 30, 2025.

General and administrative expenses were $7.8 million for the three months ended June 30, 2026, compared to $7.7 million for the three months ended June 30, 2025.

Net loss for the three months ended June 30, 2026, was $26.8 million, or $0.22 per basic and diluted share, compared to a net loss of $21.5 million, or $0.29 per basic and diluted share, for the same period in 2025.

(Press release, Perspective Therapeutics, AUG 10, 2026, View Source [SID1234669917])

On August 10, 2026 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, and Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported a multi-part collaboration including: a clinical collaboration to evaluate drug combinations incorporating select clinical-stage oncology assets from BeOne with any of Revolution Medicines’ four clinical RAS(ON) inhibitors, and a separate regional rights agreement granting BeOne exclusive development and commercialization rights to these Revolution Medicines assets in select Asian markets.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Clinical collaboration will explore potential targeted combination approaches for patients with RAS-addicted cancers

Potential drug combinations for development as part of the clinical collaboration will include certain BeOne assets and Revolution Medicines’ four clinical RAS(ON) inhibitors: daraxonrasib, a RAS(ON) multi-selective inhibitor; zoldonrasib, a RAS(ON) G12D-selective inhibitor; elironrasib, a RAS(ON) G12C-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor. Planned combination studies include: BeOne’s MTA-cooperative PRMT5 inhibitor, BGB-58067, and an EGFR x MET x MET trispecific antibody, BG-T187, with either daraxonrasib or zoldonrasib.

Regional rights agreement leverages BeOne’s established R&D and commercial expertise and Revolution Medicines’ clinical stage RAS(ON) inhibitor portfolio

Under the regional rights agreement, Revolution Medicines has granted BeOne exclusive rights in select Asian markets to develop and commercialize or solely commercialize, depending on the market, these four clinical-stage RAS(ON) inhibitors. Revolution Medicines is eligible to receive development and sales milestone payments and tiered royalties on net sales in the partnered region. Revolution Medicines retains development and commercial rights to all its assets outside of the licensed territory, including Japan and South Korea. As part of this multi-part arrangement, BeOne will fund and conduct a global registrational Phase 3 study for one of Revolution Medicines RAS(ON) inhibitors using BeOne’s differentiated, fully in-house development superhighway, while Revolution Medicines continues to advance a broad range of global registrational studies across its portfolio.

John V. Oyler, Co-Founder, Chairman, and CEO, BeOne, said:
"We are pleased to enter this collaboration with Revolution Medicines, which gives BeOne the opportunity to evaluate combinations between assets from our oncology pipeline and four promising RAS(ON) inhibitors from Revolution Medicines. In parallel, the regional rights transaction allows us to use our global development superhighway capabilities and established commercial presence, with the goal of bringing more medicines to patients with difficult-to-treat cancers."

Mark A. Goldsmith, M.D., Ph.D., CEO and Chairman of Revolution Medicines, said:
"This arrangement with BeOne reflects our commitment to advancing RAS(ON) inhibitors for patients with RAS-addicted cancers around the world, including in regions where we have not previously had a presence, while exploring novel combination strategies that may further expand their potential impact. BeOne brings additional established global oncology development capabilities and a strong regional commercial footprint that can help us broaden the reach of our innovative RAS(ON) inhibitors as part of our ambitious global strategy."

(Press release, BeOne Medicines, AUG 10, 2026, View Source [SID1234669916])

On August 10, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the first patient has been dosed in a Phase II clinical study (AK146D1-202) evaluating AK146D1, the Company’s internally developed TROP2/Nectin-4 bispecific antibody-drug conjugate (bsADC), in combination with ivonescimab (the Company’s PD-1/VEGF bispecific antibody), for the treatment of advanced breast cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This study aims to explore the potential of Akeso’s "IO2.0 + ADC2.0" regimen in advanced breast cancer, with a particular focus on first-line treatment of HR+/HER2- breast cancer and triple-negative breast cancer (TNBC).

Breast cancer is the second most common malignancy worldwide, with approximately 2.3 million new cases diagnosed annually. Advances in molecular subtype-guided precision medicine—including targeted therapies, immunotherapies, and ADCs—have improved outcomes for patients with certain subtypes. Nevertheless, substantial opportunities remain to enhance both efficacy and safety. Persistent challenges such as resistance in later-line settings, limited availability of effective agents, and marked tumor heterogeneity continue to create significant and urgent unmet clinical needs. These include the limited efficacy of immuno-oncology approaches in PD-L1-negative patients and in those who develop resistance to anti-PD-1 therapy, as well as the safety constraints of ADCs that restrict both therapeutic benefit and the number of treatment lines that can be administered. Exploring novel targets, optimizing combination strategies, and identifying predictive biomarkers for efficacy and resistance remain critical priorities in breast cancer research.

Ivonescimab, a first-in-class PD-1/VEGF bispecific antibody, has shown strong clinical results compared to PD-1 inhibitor-based therapies across multiple Phase III studies. AK146D1 is a next-generation ADC candidate that has demonstrated potent antitumor activity and a favorable safety profile in early clinical studies. The combination of AK146D1 and ivonescimab has the potential to improve clinical efficacy while maintaining a manageable safety profile, potentially expanding treatment options for patients with advanced breast cancer.

Guided by its IO2.0 + ADC2.0 strategy, Akeso is driving the continuous evolution of treatment paradigms for major malignancies such as non-small cell lung cancer and breast cancer.

In the immuno-oncology field, Akeso has two approved bispecific antibodies for cancer treatment. The Company is actively evaluating ivonescimab and cadonilimab in combination with its proprietary next-generation ADC candidates. Increasingly, global partners recognize both ivonescimab and cadonilimab as preferred agents for combination regimens and breakthrough therapy explorations across a wide spectrum of tumor types.

In the ADC space, Akeso has built a differentiated pipeline of next-generation candidates, including AK146D1, AK138D1, AK157D1, and AK158D1 (a bispecific ADC), which are currently in clinical development. These agents are designed to address the narrow therapeutic window and safety limitations commonly associated with first-generation ADCs.

Building on the encouraging Phase II clinical data of ivonescimab in breast cancer, a Phase III study evaluating an ivonescimab-based combination as first-line treatment for TNBC is currently underway. In addition to AK146D1, Akeso is also conducting a Phase Ib/II study of its next-generation HER3 ADC (AK138D1) in combination with ivonescimab.

Akeso’s IO2.0 + ADC2.0 strategy utilizes multi-target and multi-mechanism combinations to harness the synergistic advantages of its pipeline assets. The Company is building a broad portfolio of combination therapies across multiple subtypes and treatment lines in major cancers. This approach seeks to improve clinical outcomes, address resistance challenges, and provide more effective treatment options for patients with advanced breast cancer.

Looking ahead, Akeso continues to advance additional IO2.0 + ADC2.0 combination therapies across a growing range of high incidence tumor indications.

About AK146D1 (TROP2/Nectin4 Bispecific ADC)

AK146D1 is an innovative bispecific antibody-drug conjugate (bsADC) developed by Akeso. It is composed of a bispecific antibody that simultaneously targets TROP2 and Nectin4, conjugated via a cleavable MC-AAA linker (maleimide-alanine-alanine-alanine) to the topoisomerase I inhibitor DXd.

Early research results indicate that AK146D1 for injection demonstrates potent biological activity and a favorable safety profile. A Phase II clinical study evaluating AK146D1 in combination with cadonilimab and ivonescimab for the treatment of multiple solid tumors is currently underway. This study represents an important component of Akeso’s IO2.0 + ADC2.0 strategy.

(Press release, Akeso Biopharma, AUG 10, 2026, View Source;adc2-0-strategy-first-patient-dosed-in-phase-ii-study-of-trop2nectin-4-bispecific-adc-ak146d1-combined-with-ivonescimab-in-breast-cancer-302846851.html [SID1234669915])