On March 30, 2026 Medicilon reported a strategic cooperation signing ceremony with Suzhou Hailu Biotech, a wholly-owned subsidiary of Yangtze River Pharmaceutical Group. The collaboration will focus on deepening synergy in preclinical new drug R&D, project introduction, and global market expansion, with the goal of jointly building an efficient, open, and international R&D ecosystem spanning from source innovation to IND filing. This partnership is poised to lead the high-quality development and global advancement of China’s biomedical industry.

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Key executives from both organizations attended the ceremony and engaged in in-depth discussions on the cooperation’s vision and implementation roadmap. Representatives from Yangtze River Pharmaceutical Group included Ruwei Wang, Special Assistant to the Chairman and Head of the Group’s Pharmaceutical Research Institute; Jian Liu, Assistant to the Dean and Head of the Macromolecule Innovation Center; and Wenjun Shan, Head of the Small Molecule Innovation Center. From Medicilon, attendees included Chunlin Chen, Chairman and CEO; Jinna Cai, Director and Chief Business Officer; Guokai Chen, Director and Vice President of Investment & Financing; Jian Ge, Executive Vice President of the Preclinical Division; and Binbin Liu, Vice President of Operations.

Complementary Strengths to Accelerate One-Stop New Drug R&D

As a core biologic R&D platform and wholly-owned subsidiary of Yangtze River Pharmaceutical Group, Hailu Biotech has established a comprehensive macromolecule innovative drug R&D system covering target discovery, molecular design, and preclinical development. Leveraging its antibody discovery and engineering platforms, Hailu Biotech focuses on cutting-edge technologies such as monoclonal/bispecific antibodies, ADCs, and small nucleic acids, with a focus on oncology, metabolism, autoimmune diseases, and central nervous system disorders. The company is committed to addressing unmet clinical needs and delivering improved treatment options for patients through its leading technological capabilities.

Medicilon, a leading one-stop preclinical R&D CRO, offers end-to-end services spanning drug discovery, pharmaceutical research, and preclinical studies. The company operates a research system compliant with standards set by China’s NMPA, the U.S. FDA, OECD GLP, and AAALAC accreditation. Medicilon has also built specialized R&D service platforms for novel molecular drugs, including antibodies, ADCs, mRNA vaccines, small nucleic acids, PROTACs, and CGT. With a track record of mature technological platforms and successful cases, Medicilon has supported the global launch of multiple innovative drugs.

16 Years of Collaboration: From Project Partnership to Strategic Symbiosis
This strategic cooperation builds on a long-standing partnership between the two parties, which dates back to 2010. Over the past 16 years, Medicilon has established long-term cooperative relationships with Yangtze River Pharmaceutical Group and its subsidiaries, including Shanghai Haiyan Pharmaceutical Technology, Shanghai Hailu Biotechnology, Shanghai Haini Pharmaceutical, Nanjing Hailing Pharmaceutical, Guangzhou Hairui Pharmaceutical. Its services cover the entire preclinical R&D chain, encompassing small nucleic acids, small-molecule chemical drugs, and traditional Chinese medicines, empowering nearly 100 new drug R&D projects and supporting the approval and launch of key drugs such as Dezocine Injection, Omeprazole Enteric-coated Capsules, Levofloxacin Eye Drops, Ticagrelor Tablets, and Tacrolimus.

Shared R&D philosophies, aligned technical services, and consistent quality systems have fostered a mature and efficient collaboration mechanism between the two parties. This foundation of trust and business synergy has elevated their partnership from project-level cooperation to a strategic win-win alliance. Moving forward, the two parties will conduct customized R&D collaboration through flexible models such as commissioned R&D, FTE and FFS, covering one-stop preclinical services including early drug discovery, in vitro and in vivo efficacy studies, Chemistry, CMC, pharmacokinetics, safety evaluation, and regulatory registration. This integration will enable seamless process connection and efficient utilization of R&D resources.

"Bring In & Go Global": Building a Two-Way Ecosystem for Global Drug Outreach
In terms of business development, the two parties will jointly build a "bring in and go global" ecosystem to facilitate the integration of Chinese innovative drugs into the global market, featuring two-way empowerment and mutual promotion. To support global outreach, Medicilon will leverage its mature international platform and global network to connect Hailu Biotech with overseas partners, showcase innovative achievements through participation in top global industry conferences, and accelerate the overseas licensing and development of Hailu Biotech’s drug pipeline.
Meanwhile, Medicilon will use its international perspective and project resources to link Yangtze River Pharmaceutical Group with high-quality overseas innovative drug pipelines and targets, facilitating their development and equity cooperation in the Chinese market. Beyond accelerating the internationalization of individual projects, this ecosystem aims to create a sustainable two-way flow of technologies, resources, and markets, enhancing the global visibility and competitiveness of Chinese innovative drugs.

(Press release, Shanghai Medicilon, MAR 30, 2026, View Source [SID1234664154])

On March 30, 2026 Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function, reported financial results for the fourth quarter and year ended December 31, 2025, and provided recent business highlights.

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"2025 has been a year of focused execution across our clinical portfolio, with significant progress in trial enrollment, highlighted by the acceleration of our global Phase 3 CoMpass trial in early choroidal melanoma and continued enrollment in our Phase 1b/2 NMIBC trial," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura Biosciences. "Based on strong enrollment momentum, we now expect to complete CoMpass enrollment by mid-2026, with topline data anticipated in the second half of 2027. We believe bel-sar has the potential to become the first frontline, vision-preserving therapy for early choroidal melanoma. Our proof-of-concept trials to expand our ocular franchise also remain on track to deliver data in 2026. In NMIBC, we look forward to reporting initial three-month data mid-year to further define our potential as a frontline approach. We are also encouraged by our new formulation reaching 12-month stability, further expanding our opportunity in non-ocular solid tumors, starting with urologic oncology."

Recent Pipeline Developments

Early Choroidal Melanoma

Ongoing Phase 3 CoMpass Trial: CoMpass is the first registration-enabling study in early choroidal melanoma. This global, randomized Phase 3 trial is evaluating bel-sar versus a sham control using an enrichment strategy to enroll patients with documented tumor growth. Driven by strong global enrollment momentum, the Company now expects to complete enrollment by mid-2026, with topline data for the 15-month primary endpoint anticipated in the second half of 2027.

Our patient identification tool continues to expand, and we believe this growing pool of patients reflects the unmet need in early choroidal melanoma and the significant need for a vision preserving therapy.

Bel-sar has the potential to become the first frontline vision-preserving therapy in this setting. The Company previously received Orphan Drug Designation from the United States Food and Drug Administration (FDA) and the European Medicines Agency and Fast Track designation from the FDA for the treatment of early choroidal melanoma. The CoMpass trial is under a Special Protocol Assessment agreement with the FDA

Bladder Cancer

Ongoing Phase 1b/2 Trial: The ongoing trial evaluating additional doses and cycles of bel-sar across intermediate- and high-risk NMIBC patients continues to progress as planned, with initial 3-month clinical data expected in mid-2026.

The trial will evaluate two approaches: an immune ablative design and a neoadjuvant design. In the immune ablative approach, bel-sar is administered in two cycles without the need for a transurethral resection of the bladder tumor, or TURBT. In the neoadjuvant cohorts, bel-sar is administered in two cycles ahead of TURBT. For both approaches, the patients will be monitored for response assessments and reoccurrence at 3, 6, 9, and 12 months. The patients will also be monitored for safety.

Achieved 12-Month Stability of New Formulation for Use in Non-Ocular Solid Tumors, Beginning with Bladder Cancer: The Company has demonstrated 12-month stability for its new formulation designed for use in non-ocular solid tumors, beginning with urologic oncology. We believe this formulation reinforces the opportunity for product differentiation and, with simple refrigeration and no need for cold chain, is intended to support convenient in-office administration for urologists. The Company previously filed a patent application with the U.S. Patent and Trademark Office for this formulation, which, if issued, would be expected to provide patent coverage into 2046.

Metastases to the Choroid

The ongoing Phase 2 clinical trial of bel-sar in metastases to the choroid continues to enroll patients. The study is designed to include patients with choroidal metastases arising from a range of primary solid tumors and to evaluate early proof-of-concept based on a four-week efficacy endpoint. The Company remains on track to report early data from this trial in 2026.

Metastases to the choroid is an indication with high unmet medical need and no approved therapies, with an estimated incidence of approximately 20,000 patients annually across the United States and Europe. Bel-sar has the potential to treat a broad range of tumor types that metastasize to the choroid. The Company previously received FDA Fast Track designation for bel-sar in this indication.

Cancers of the Ocular Surface

The Company is initiating a Phase 1 proof-of-concept trial in Australia to assess safety, feasibility and tumor response through histopathologic evaluation at a 2–4-week time point. Development activities for this program are ongoing, with early proof-of-concept data expected in 2026.

Cancers of the ocular surface affect approximately 35,000 patients in the United States and Europe annually and are associated with a particularly high incidence in regions such as Australia. There are currently no approved therapies for these tumors.

Fourth Quarter and Full Year 2025 Financial Results

•
As of December 31, 2025, the Company had cash and cash equivalents and marketable securities totaling $144.2 million. The Company believes its current cash and cash equivalents and marketable securities are sufficient to fund its operations into the first quarter of 2027.

•
Research and development expenses were $21.9 million and $90.3 million for the three months and full year ended December 31, 2025, respectively, and $22.3 million and $73.3 million for the three months and full year ended December 31, 2024, respectively. The increase in the full year period was primarily due to ongoing clinical and clinical research organization (CRO) costs associated with the progression of our global Phase 3 trial of bel-sar in early choroidal melanoma and higher personnel expenses related to the growth of the Company.

•
General and administrative expenses decreased to $5.3 million and $22.5 million for the three months and full year ended December 31, 2025, respectively, from $5.5 million and $22.8 million for the three months and full year ended December 31, 2024, respectively. General and administrative expenses include $1.5 million and $1.4 million of stock-based compensation for the three months ended December 31, 2025 and 2024, respectively. The decrease in general and administrative expenses was primarily driven by reduced professional fees.

•
Net loss for the three months and full year ended December 31, 2025, was $25.6 million and $106.2 million, respectively, compared to $25.8 million and $86.9 million for the three months and full year ended December 31, 2024, respectively.

(Press release, Aura Biosciences, MAR 30, 2026, View Source [SID1234664019])

On March 30, 2026 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported its financial results for the full year and fourth quarter ended December 31, 2025, and is providing a business update to shareholders.

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Shaun Bagai, Chief Executive Officer of RenovoRx, commented, "2025 marked a key year as it was our first full year of RenovoCath commercialization, generating over $1 million in revenue and reflecting strong initial physician adoption and demand in a handful of active commercial cancer centers. We also learned many valuable lessons to finalize our go-to-market strategy that we are implementing and building out a team to drive commercial growth in 2026 and beyond."

Mr. Bagai continued, "We entered 2025 having just taken our initial steps towards commercialization, with no dedicated sales team and limited approved commercial cancer centers. We exited the year with a strong understanding of the market and a clear strategy supported by a focused and agile sales and marketing team. Our network of active commercial cancer center clients continues to grow, resulting in meaningful revenue generation. While we are still relatively early in the game, we believe we are beginning to unlock the broader commercial potential for RenovoCath as a stand-alone device. Adoption across U.S. cancer centers continues to build, driven by new and repeat orders, growing physician familiarity, and increasing procedural utilization. As of February 27, 2026, 12 U.S. cancer centers are utilizing RenovoCath, and 21 additional centers are evaluating the device, have completed evaluation, or are preparing for activation. These 33 centers represent a tripling of our near-term pipeline compared to the first quarter of 2025."

"Importantly, we established our commercial infrastructure in the fourth quarter of 2025, positioning us to scale in 2026 with a targeted focus on high-volume cancer centers. On top of this, we have significantly strengthened our balance sheet with $10 million in gross proceeds (net proceeds of $9.2 million) from recent financing led by new and existing institutional investors including insider participation, giving us $13 million in cash on hand as of today. We strongly believe we now have the funding, business plan, leadership, and infrastructure to propel execution across all of our activities as we drive towards important milestones, including breakeven operations and trial data."

"Simultaneously, we are advancing our pivotal Phase III TIGeR-PaC trial, which remains on track for full enrollment in the near term and with final results anticipated next year. We recently announced the achievement of a milestone by randomizing our 100th patient in the trial. As of March 24, 2026, 104 patients have been randomized with 72 events (deaths) observed. Our target of full enrollment by the middle of this year would ensure a minimum of 114 patients will be randomized. Our study protocol requires us to advance a minimum of 114 patients to randomization, so we are really in the home stretch of this trial. Moreover, our goal is to transition the 17 cancer centers that have used RenovoCath as part of the TIGeR-PaC trial to commercial customers for RenovoCath in the second half of 2026 after completion of TIGeR-PaC enrollment. Select TIGeR-PaC cancer centers have already begun using the TAMP (Trans-Arterial Micro-Perfusion) therapy platform, enabled by the RenovoCath device, for targeted drug-delivery in the treatment of patients diagnosed with solid tumors, giving us even more optimism for the expansion of our revenue potential," concluded Mr. Bagai.

RenovoCath Commercialization Update

RenovoRx achieved key milestones in the commercial launch of RenovoCath in 2025, its first full year of generating revenue. For the year ending December 31, 2025, the Company generated $1.1 million in revenue from RenovoCath sales, driven by both new cancer centers adopting the device and repeat orders from existing customers. This early commercial traction reflects increasing physician interest in targeted intra-arterial drug-delivery and shows that RenovoCath is becoming widely used within clinical workflows at leading, high-volume cancer centers. The Company also learned valuable lessons about cycle trends, activation timelines, customer preferences, and other commercial data which it expects to apply as it seeks to grow RenovoCath revenues in 2026 and beyond.

Adoption continued to expand across the United States, with 12 cancer centers actively utilizing RenovoCath as of early 2026 and a growing pipeline of additional centers evaluating the device, having completed evaluation or are preparing for activation. The Company is also observing repeat ordering patterns and increased procedural utilization among early adopters, reinforcing confidence in physician satisfaction and the potential for recurring revenue. RenovoRx believes these trends support the long-term commercial opportunity for RenovoCath as both a stand-alone device and a foundational platform for future drug-device combination therapies.

RenovoRx continues to estimate that the initial total addressable market (TAM) for RenovoCath as a stand-alone device represents an approximately $400 million peak annual U.S. sales opportunity, and ultimately a multi-billion-dollar potential as the platform expands into additional solid tumor indications.

Clinical Research and Scientific Programs Update

RenovoRx continues to advance its ongoing Phase III TIGeR-PaC clinical trial evaluating intra-arterial delivery of gemcitabine (IAG) via the RenovoCath device for the treatment of locally advanced pancreatic cancer (LAPC). The current protocol and statistical analysis plan for the TIGeR-PaC trial requires 114 randomized patients, with 86 events (deaths) necessary to complete the final analysis. As of March 24, 2026, 104 patients have been randomized and 72 events have occurred. RenovoRx anticipates completion of enrollment by the middle of 2026, ensuring a minimum of 114 patients will be randomized.

During 2025, the TIGeR-PaC trial reached a key milestone with the completion of the second pre-planned interim analysis. Following its review, the independent Data Monitoring Committee for the trial recommended that the study continue without modification, which the Company believes is an expression of confidence in the potential for a positive outcome in the trial overall. TIGeR-PaC remains the cornerstone of RenovoRx’s clinical development strategy and is designed to evaluate overall survival benefit with the potential to support a future New Drug Application submission, if successful.

The Company also continues to advance broader clinical programs by generating new data through post-marketing registry studies in solid tumors and continued support of investigator-initiated trials (IIT) in borderline resectable and metastatic pancreatic cancer, along with exploring physician interest in other areas. Registry and IIT studies achieve cost neutrality as capital-efficient studies providing meaningful data that may further broaden the application for the TAMP (Trans-Arterial Micro-Perfusion) therapy platform which is enabled by RenovoCath.

Fourth Quarter 2025 and Subsequent Key Highlights

During the fourth quarter of 2025, RenovoRx completed the initial buildout of its commercial infrastructure, including the launch of its sales and marketing team, and continued advancing its commercialization strategy.

RenovoRx strengthened its executive leadership team in February 2026 to support the commercial growth of RenovoCath with the appointment of Mark Voll as Chief Financial Officer. Mr. Voll brings more than 30 years of financial leadership experience with a proven track record of guiding high-growth public companies through periods of commercial buildout and strategic development. He has served as Chief Financial Officer for multiple publicly traded technology companies where he successfully led initiatives that scaled operations into high-growth businesses.

In February 2026, the Company established the RenovoCath Medical Advisory Board (MAB) to provide strategic clinical guidance in advancing the TAMP therapy platform across indications of high unmet medical needs. The MAB includes leading interventional oncology experts: Nadine Abi-Jaoudeh, MD of UCI Health, Mustafa Al-Roubaie, MD of Moffitt Cancer Center, Khashayar Farsad, MD, PhD of Oregon Health and Science University, Ripal Gandhi, MD of Baptist Health South Florida, Paula Marie Novelli, MD of University of Pittsburgh Medical Center and Jonathan Kessler, MD of City of Hope Comprehensive Cancer Center.

On March 20, 2026, RenovoRx closed on an oversubscribed private placement of common stock and revenue milestone warrants resulting in gross proceeds of $10 million to RenovoRx, before deducting placement agent fees and offering expenses with net proceeds of $9.2 million. The financing was led by new and existing high-quality institutional investors, and the Company intends to use the net proceeds from the private placement for working capital and general corporate purposes.

The net proceeds of the private placement provide RenovoRx with a total of approximately $13 million cash and cash equivalents in hand to drive its business towards the expected achievement of important milestones in 2026 and 2027.

Financial Highlights for the Full Year Ended December 31, 2025

Revenue for the year ended December 31, 2025, was $1.1 million, compared to $43,000 for the year ended December 31, 2024. Fiscal year 2025 marked our first full year of revenue of RenovoCath and early customer adoption across U.S. cancer centers.

Cash and cash equivalents were approximately $7.0 million as of December 31, 2025. Subsequent to year end, on March 20, 2026, the Company strengthened its balance sheet and closed a private placement offering with gross proceeds of $10 million and net proceeds of $9.2 million.

Research and development expenses were approximately $6.3 million for the year ended December 31, 2025, compared to approximately $6.0 million for the same period last year. The increase was primarily attributable to continued investment in the Company’s ongoing Phase III TIGeR-PaC clinical trial, as well as development activities related to the next generation of the RenovoCath device.

Selling, general, and administrative expenses were approximately $7.0 million for the year ended December 31, 2025, compared to approximately $5.0 million for the year ended December 31, 2024. The increase was primarily driven by the buildout of the Company’s commercial infrastructure, including sales and marketing capabilities, as well as higher professional services and personnel-related costs.

Net loss for the year ended December 31, 2025, was approximately $11.2 million, compared to approximately $8.8 million for the prior year.

Shares of common stock outstanding as of March 23, 2026 was 45,052,706.

Conference Call Details

Event: RenovoRx Fourth Quarter & Full Year 2025 Financial Results and Business Highlights Call
Date: Monday, March 30, 2026
Time: 4:30 p.m. ET
Live Call: 1-877-407-4018 (U.S. Toll Free) or 1-201-689-8471 (International)
Webcast: View Source

For interested individuals unable to join the conference call, a link to the recording will be available on RenovoRx’s Investor Relations website, and a dial-in replay will be available until April 13, 2026 and can be accessed by dialing 1-844-512-2921 (U.S. Toll Free) or 1-412-317-6671 (International) and entering replay pin number 13758677.

A question and answer session will occur at the end of the call, and a link to the recording of this presentation will be available on RenovoRx’s Investor Relations website after the event.

(Press release, Renovorx, MAR 30, 2026, View Source [SID1234664040])

On March 30, 2026 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported that the results from the Co-PSMA (NCT06907641)1 investigator-initiated trial (IIT) are now published in European Urology2, the official journal of the European Association of Urology (EAU) Congress 2026 with an impressive impact factor of 25.2.

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Gianluca Giannarini (MD), Associate Editor of European Urology, summarised the clinical relevance of the Co-PSMA trial, "This prospective phase II trial provides the first comparative evidence that 24-hour 64Cu-SAR-bisPSMA positron emission tomography (PET) / computed tomography (CT) significantly outperforms 68Ga-PSMA-11 PET/CT in detecting tumour deposits in men with early biochemical recurrence (BCR) after radical prostatectomy, with more than double the per-patient detection rate and substantially lower false-negative findings. Importantly, the increased detection rate translated into a 44% management change rate, underscoring the real-world therapeutic impact of improved lesion detection at low prostate-specific antigen (PSA) levels. For the uro-oncology community, these data suggest that delayed imaging with a bivalent prostate-specific membrane antigen (PSMA) ligand may redefine the diagnostic pathway in early biochemical recurrence, potentially enabling more precise and timely salvage treatment strategies."

As previously reported, the Co-PSMA trial met its primary endpoint, demonstrating that 64Cu-SAR-bisPSMA (next-day imaging) identified more than twice as many cancer lesions per patient than 68Ga-PSMA-11 (mean per patient lesion 1.26 vs. 0.48, respectively, p < 0.0001). The total number of lesions across all participants and proportion of participants with a positive scan were also higher with 64Cu-SAR-bisPSMA (63 vs. 24 total number of lesions and 78% vs. 36% of participants with a positive scan for 64Cu-SAR-bisPSMA [next-day imaging] vs. 68Ga-PSMA-11, respectively). The patient-level true positive rate also favoured 64Cu-SAR-bisPSMA next-day imaging (71% vs. 29% for 68Ga-PSMA-11)3.

Building on the data previously presented at the EAU Congress 20263, the publication provides further methodological and clinical insights supporting the interpretation of the findings. Notably, the median interval between 68Ga-PSMA-11 and 64Cu-SAR-bisPSMA imaging was only 2 days (interquartile range [IQR]: 1 – 8 days), ruling out differences in lesion detection due to disease progression. This result is corroborated by previous findings from the COBRA trial, which demonstrated that 64Cu-SAR-bisPSMA was able to detect prostate cancer lesions that were still undetectable 6 months later with standard of care (SOC) PSMA imaging agents4.

From an imaging perspective, acquisition times were consistent across 68Ga-PSMA-11 and both same-day and next-day 64Cu-SAR-bisPSMA scans, with PET scans acquired for 2 minutes per bed position. At 24 hours, 64Cu-SAR-bisPSMA demonstrated higher lesion uptake compared to 68Ga-PSMA-11 (median maximum standardised uptake value [SUVmax] 13.6 vs. 5.3), and lower background bladder activity (median SUVmax 12.0 vs. 34.5), improving tumour-to-background contrast. These imaging attributes, which allow better visualisation of the fossa and thus detection of low volume local recurrence, likely contributed to an almost perfect agreement across the three independent blinded readers for the 64Cu-SAR-bisPSMA scans, whereas the agreement was lower for 68Ga-PSMA-11. This means the readers reached the same conclusions when assessing the 64Cu-SAR-bisPSMA scans far more often than when assessing the 68Ga-PSMA-11 scans in a blinded fashion (almost perfect level of agreement for 64Cu-SAR-bisPSMA, Cohen’s Kappa 0.94 vs. 0.75 for 68Ga-PSMA-11).

Importantly, these imaging findings translated into clinically meaningful changes in patient care, with a marked difference between 64Cu-SAR-bisPSMA and 68Ga-PSMA-11 (planned management changes observed in 44% of patients following 64Cu-SAR-bisPSMA imaging). The two most common modifications in treatment plan were changes from observation to active treatment (12/22), and changes in the radiation field (9/22). Active planned management increased from 66% based on 68Ga-PSMA-11 results to 90% based on 64Cu-SAR-bisPSMA findings. This highlights the impact of 64Cu-SAR-bisPSMA on the management of patients with BCR and low PSA levels, a population in whom SOC PSMA PET scans frequently fail to visualise prostate cancer lesions.The authors of the Co-PSMA publication wrote, "This is the first time that a PSMA-targeted imaging agent has demonstrated significantly improved imaging characteristics compared to those currently available, potentially marking an important step forward in imaging technology akin to that seen in the evolution from 18F-Choline/Flucyclovine to PSMA-targeted PET/CT".

This leap in PET imaging technology has the potential to improve treatment decisions and outcomes in patients with biochemical results following radical prostatectomy2.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "SAR-bisPSMA is an outstanding agent, developed from the benchtop of Australian science with the clinical data now gaining significant momentum as we approach commercialisation. We have seen incredible results with evidence of improved diagnostic performance under every condition we have tested the agent, from the head-to-head PROPELLER study against 68Ga-PSMA-11 in pre-prostatectomy patients with only same-day imaging5, to the COBRA trial4 in BCR where any SOC imaging agent could have been used and participant selection criteria had no limitation on upper PSA levels (median 0.9 ng/mL, range 0.25 – 17.6), to this head-to-head Co-PSMA trial against 68Ga-PSMA-11 in BCR patients with low PSA (median 0.43, IQR: 0.31– 0.63). While we are still awaiting data from the registrational Phase III AMPLIFY trial6 and finishing recruitment into the pivotal CLARIFY study7 shortly, we are taking definitive steps towards entering the blockbuster PSMA PET market and are well prepared to better serve this patient population.

"Our team and collaborators have done the hard work and followed the highest standards of clinical research in developing this product to become the gold standard in PSMA PET imaging, and clinicians are recognising the added benefits of the improved diagnostic performance offered by 64Cu-SAR-bisPSMA. With our three Fast Track Designations for the one SAR-bisPSMA agent, we look forward to continuing our work with the US Food and Drug Administration (FDA) and submitting New Drug Applications (NDAs) for this product once we complete AMPLIFY and CLARIFY. Our supply and manufacturing strategy is also positioned to provide over 2 million doses of copper-64 per year at base capacity for commercial launch, which is over two times the total addressable market for PSMA PET, and we are continuing to build added capacity to facilitate efficiencies throughout the entirety of the US. Our team and collaborators are looking forward to getting 64Cu-SAR-bisPSMA to patients in need as soon as possible, and as always, we will continue to update the market on the progress of our programs."

About Co-PSMA
Co-PSMA (Comparative performance of 64Copper [64Cu]-SAR-bisPSMA vs. 68Ga-PSMA-11 PET CT for the detection of prostate cancer recurrence in the setting of biochemical failure following radical prostatectomy) was a Phase II IIT evaluating the performance of Clarity’s diagnostic product, 64Cu-SAR-bisPSMA, in a head-to-head comparison to SOC 68Ga-PSMA-11 in 50 patients with low PSA (0.2 – 0.75 ng/mL) who were candidates for curative salvage therapy. Eligible patients were required to have had radical prostatectomy with no salvage therapy. 68Ga-PSMA-11 PET/CT was followed by 64Cu-SAR-bisPSMA PET/CT (at 1 hour and 24 hours post-injection, same-day and next-day imaging, respectively) on the same digital PET camera.

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary SAR technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

(Press release, Clarity Pharmaceuticals, MAR 30, 2026, View Source [SID1234664020])

On March 30, 2026 Aktis Oncology, Inc. (NASDAQ:AKTS) (the "Company"), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large populations, including those not addressed by existing platform technologies, reported the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) applications for the Company to proceed to a Phase 1b clinical trial with AKY-25191. AKY-2519 is a miniprotein radioconjugate targeting B7-H3, which is expressed in several solid tumor types including prostate and lung cancers, and is the second clinical stage miniprotein radioconjugate discovered using Aktis’ proprietary platform. The Company’s lead miniprotein radioconjugate, AKY-1189, targeting Nectin-4, is currently enrolling patients in a Phase 1b clinical study. Aktis’ miniprotein radioconjugates are designed to selectively deliver actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to target-expressing tumors. The Company also provided business updates and reported financial results for the year ended December 31, 2025.

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"Aktis was founded to improve outcomes for cancer patients by pioneering a new class of targeted radiopharmaceuticals for prevalent tumor types that have historically been beyond the reach of this modality," said Matthew Roden, Ph.D., President and Chief Executive Officer of Aktis Oncology. "We continue to make significant progress on all fronts of our plan, including advancing the enrollment of our Phase 1b clinical trial of AKY-1189 in patients with Nectin-4 expressing tumors, which was granted FDA Fast Track designation in February, as well as the recent clearance of our IND applications for AKY-2519. We are excited to accelerate the AKY-2519 program to patients in need of improved treatment options, and now expect to commence a Phase 1b trial of AKY-2519 in mid-2026. This momentum, together with our proprietary miniprotein radioconjugate platform, supply chain infrastructure, and strong cash position, strengthens our leadership in targeted radiopharmaceuticals."

Dr. Roden continued, "AKY-1189 and AKY-2519 each represent significant patient impact opportunities, with the potential to address multiple indications across various tumor types. We are working urgently to generate the clinical data necessary to support registrational trials for both programs."

Business updates and anticipated key milestones

Pipeline
AKY-1189, a novel miniprotein radioconjugate designed to selectively deliver 225Ac to Nectin-4 expressing tumors, is in an ongoing Phase 1b clinical trial enrolling patients with locally advanced or metastatic urothelial cancer (mUC), breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer.

In February 2026, the FDA granted Fast Track designation for AKY-1189 for the treatment of adult patients with locally advanced or mUC who have progressed on or after prior systemic therapies.

AKY-2519, a miniprotein radioconjugate designed to selectively deliver 225Ac to B7-H3 expressing tumors, including prostate, lung and other solid tumors, is in an ongoing imaging and dosimetry clinical assessment of AKY-2519 to enable initial understanding of biodistribution and uptake in tumors and normal tissues.

In March 2026, the FDA cleared the IND applications for [64Cu]Cu-AKY-2519 (imaging) and [225Ac]Ac-AKY-2519 (therapeutic use) to proceed to a Phase 1b clinical trial.

Corporate
On January 8, 2026, the Company priced an initial public offering (IPO) of its common stock, raising $365.4M gross proceeds, before underwriting discounts and other offering-related expenses.

Anticipated key milestones for the next 12 months

AKY-1189: Preliminary data from Part 1 of the ongoing Phase 1b clinical trial are expected in the first quarter of 2027.
AKY-2519:
Results from clinical imaging and dosimetry assessment of AKY-2519 in patients with various solid tumors are expected in mid-2026.
Phase 1b clinical trial is expected to commence in mid-2026. The Company plans to provide further details on the overall clinical development strategy of AKY-2519 at that time.
Early pipeline: Two programs are tracking toward development candidate nomination and commencement of IND-enabling activities in the first quarter of 2027.
Corporate: In-house Good Manufacturing Practices (GMP) facility is expected to be operational in the second half of 2026 as part of the Company’s hybrid manufacturing strategy to expand capabilities and support clinical supply demand.
2025 financial results

Cash position: Cash, cash equivalents and marketable securities were $226.8 million as of December 31, 2025, compared to $297.2 million as of December 31, 2024. Subsequent to December 31, 2025, the Company completed its IPO, generating net proceeds of approximately $335.3 million, after underwriting discounts, commissions and offering-related expenses. As a result, the Company’s pro forma as adjusted cash position as of year-end 2025 was $562.1 million, reflecting cash, cash equivalents and marketable securities as of December 31, 2025, plus net proceeds from the January 2026 IPO. The Company believes that the pro forma as adjusted cash position will fund its operations into 2029.
Collaboration revenue: Collaboration revenue was $6.5 million for the year ended December 31, 2025, compared to $1.5 million for the year ended December 31, 2024. The increase was attributable to revenue recognized under the Company’s collaboration with Eli Lilly and Company, which was entered into in May 2024. In 2024, revenue recognition began in the fourth quarter, whereas a full year of revenue was recognized in 2025.
R&D expenses: Research and development expenses were $67.5 million for the year ended December 31, 2025, compared to $41.0 million for the year ended December 31, 2024. The increase was primarily driven by higher headcount, and increased program expenses to support the advancement of AKY-1189 in a Phase 1b clinical trial and AKY-2519 IND-enabling studies and clinical imaging and dosimetry assessment.
G&A expenses: General and administrative expenses were $13.7 million for the year ended December 31, 2025, compared to $12.6 million for the year ended December 31, 2024. The increase was primarily due to higher headcount to support the Company’s growing business.
Net loss: Net loss was $63.7 million for the year ended December 31, 2025, compared to $44.0 million for the year ended December 31, 2024. The increase in net loss was primarily driven by the increase in R&D expenses described above.

(Press release, Aktis Oncology, MAR 30, 2026, View Source [SID1234664041])