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Lantern Pharma Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Updates

On March 30, 2026 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biopharmaceutical company leveraging its proprietary RADR artificial intelligence (AI) and machine learning (ML) platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported operational highlights and financial results for the fourth quarter and full year 2025 ended December 31, 2025, and provided an update on its portfolio of AI-driven drug candidates and AI platforms, RADR and withZeta.ai.

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"2025 was a defining year for Lantern Pharma as we achieved clinical validation across multiple programs while establishing the foundation for our next phase of growth," said Panna Sharma, CEO & President of Lantern Pharma. "The encouraging and developing LP-300 Phase 2 HARMONIC observations, combined with successful Phase 1a completion for LP-184 and FDA IND clearance for our pediatric CNS cancer program through Starlight Therapeutics, represent transformational milestones that validate and strengthen our AI-driven approach to precision oncology. Our full-year results reflect disciplined execution with a 19% reduction in total operating expenses year-over-year, even as we advanced multiple clinical programs through key inflection points and introduced a highly unique multi-agentic system aimed at conquering rare cancers. As we move into 2026, we are positioning to advance multiple high-value clinical programs, expand our RADR platform’s commercial reach and revenue potential globally through our new AI Center of Excellence in India and strengthen our balance sheet."

Clinical Pipeline Developments

Lantern’s AI-driven clinical pipeline encompasses multiple drug candidates across solid tumors, blood cancers, and pediatric oncology, with a combined estimated annual market potential exceeding $15 billion. The portfolio includes a Phase 2 clinical program (LP-300), multiple programs advancing toward Phase 1b/2 trials (LP-184), an ongoing Phase 1 trial in hematologic malignancies (LP-284), and a planned Phase 1 pediatric CNS cancer trial (STAR-001) through Starlight Therapeutics. Each program has been guided by the RADR platform’s AI-driven insights. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2–3 years and at approximately $1.0–2.5 million per program.

LP-300 HARMONIC Trial: Continued Progress and Strategic Momentum

The Phase 2 HARMONIC trial continued to advance through the fourth quarter and into early 2026, with ongoing patient enrollment and follow-up across clinical sites in the United States, Japan, and Taiwan. The trial evaluates LP-300 in combination with standard-of-care chemotherapy (carboplatin + pemetrexed) in never-smokers with NSCLC adenocarcinoma who have progressed after tyrosine kinase inhibitor (TKI) therapy.

Key Milestones:

● Japan Enrollment Completed: In July 2025, Lantern completed targeted enrollment in Japan ahead of schedule across five clinical sites including the National Cancer Center Tokyo, validating the company’s strategic expansion into regions with significantly higher rates of never-smoker NSCLC.

● Data Presented at JLCS: During Q4 2025, clinical investigators presented data from the ongoing HARMONIC trial at the 66th Annual Meeting of the Japan Lung Cancer Society, including results from both Asian and U.S. patient cohorts.

● Safety Lead-In Results: The trial has previously demonstrated encouraging results in its initial safety lead-in cohort, showing an 86% clinical benefit rate and 43% objective response rate among the first seven patients enrolled in the United States, including one patient who achieved a durable complete response in target cancer lesions with survival continuing for nearly two years.

● Enrollment Progress: The trial continues to enroll patients in Taiwan, where more than 50% of lung cancer cases occur in never-smokers, and across U.S. sites.

● FDA Engagement — Type C Meeting: In March 2026, Lantern submitted a Type C meeting package to the FDA regarding the ongoing Phase 2 HARMONIC study. The meeting, currently scheduled for mid-May 2026, seeks FDA feedback and concurrence on proposed protocol amendments to the study.

The proposed amendments to the HARMONIC study include: (i) focusing future enrollment to patients with EGFR exon 21 L858R mutation (a subtype of tyrosine kinase mutations); (ii) increasing the maximum number of LP-300 treatment cycles from six to eight; and (iii) converting the current randomized study design to a Phase 2 single-arm Simon two-stage study by discontinuing enrollment into the control arm. The proposed amendments are supported by a preliminary analysis of study data suggesting that patients with the EGFR exon 21 L858R mutation may derive greater clinical benefit from the LP-300 triplet regimen; the evolution of the treatment landscape for TKI-refractory NSCLC that has made continued randomization to the control arm increasingly challenging; and historical safety data indicating that up to eight cycles of LP-300 at the current dose level did not alter the established safety profile of the drug. There can be no assurance that the FDA will concur with the proposed amendments, and any changes to the study protocol will be subject to FDA review and clearance during and after the Type C meeting planned for mid-May.

Lantern is actively exploring collaboration and partnering opportunities both globally and regionally to maximize LP-300’s commercial potential in multiple geographies. Additional clinical data updates from the HARMONIC trial are expected in the first half of 2026.

Never-smoker NSCLC is increasingly recognized as a distinct disease entity with unique clinical and genomic characteristics, representing a global market opportunity estimated at over $4 billion annually. Currently, there are no therapies specifically approved for never-smoker NSCLC patients.

LP-184: Phase 1a Completion and Advancement Toward Phase 1b/2 Trials

In Q4 2025, Lantern reported additional positive LP-184 Phase 1a results showing durable disease control in heavily pre-treated advanced cancer patients as the company is positioning to advance its precision oncology program into multiple biomarker-guided Phase 1b/2 trials. The Phase 1a trial (NCT05933265), which enrolled 63 patients, achieved all primary endpoints with a 48% clinical benefit rate at or above the therapeutic dose threshold and provided further confirmation of LP-184’s unique mechanism of action.

Key Phase 1a Highlights:

● Biomarker Validation: Marked tumor reductions observed in patients with DNA damage repair mutations including CHK2, ATM, BRCA1, and STK11/KEAP1 alterations, validating RADR-driven insights regarding the mechanism of LP-184.

● Recommended Phase 2 Dose: Successfully established RP2D of 0.39mg/kg with favorable safety profile.

● Activity in Difficult-to-Treat Cancers: Notable clinical benefits in glioblastoma multiforme (GBM), gastrointestinal stromal tumor (GIST), and thymic carcinoma.

Phase 1b/2 Development Plans (subject to additional funding):

● Triple-Negative Breast Cancer (TNBC): Phase 1b/2 study targeting a potential annual market exceeding $4 billion.

● NSCLC with STK11/KEAP1 Co-mutations: Biomarker-guided study, potential annual market approaching $1.5 billion.

Investigator Led Study:

● Bladder Cancer: Investigator-led clinical study planned to initiate in Denmark in PTGR1 overexpressing bladder cancers with DNA damage repair mutations.

Starlight Therapeutics: FDA IND Clearance for Pediatric CNS Cancer Trial

In early 2026, the FDA cleared the IND for Starlight Therapeutics’ planned Phase 1 pediatric CNS cancer trial of STAR-001 (LP-184) in Atypical Teratoid Rhabdoid Tumor (ATRT) and other rare pediatric cancers. STAR-001 has received both Rare Pediatric Disease Designation and Orphan Drug Designation from the FDA for ATRT, along with additional designations for hepatoblastoma, rhabdomyosarcoma, and malignant rhabdoid tumors.

These designations provide potential pathways for FDA Priority Review Vouchers (PRVs) upon a potential approval. PRVs have historically been sold or transferred for significant value, with recent transactions in the range of $100 million to $150 million or more, representing a potentially meaningful source of non-dilutive value for Lantern and its shareholders independent of the commercial potential of the underlying therapy. The Rare Pediatric Disease Designation for ATRT, hepatoblastoma, rhabdomyosarcoma, and malignant rhabdoid tumors each independently qualifies for a potential PRV upon potential FDA approval and meeting other program conditions.

LP-284: Orphan Drug Designation and Clinical Advancement

In Q1 2026, LP-284 received FDA Orphan Drug Designation for soft tissue sarcomas, adding to existing designations for mantle cell lymphoma and high-grade B-cell lymphomas. In Q4 2025, Lantern presented clinical data at the 25th LL&M Congress showcasing a confirmed complete metabolic response in a heavily pretreated DLBCL patient. LP-284 benefits from composition of matter patents providing protection through 2039 in the majority of the major medicine markets (USA, EU, Japan, China, India, Mexico, Korea, and Australia).

RADR AI Platform: Global Expansion and Commercial Momentum

AI Center of Excellence in India

In early 2026, Lantern announced the initiation of an AI Center of Excellence in India to industrialize and grow the RADR platform, the withZeta.ai system and accelerate global development opportunities with biopharma companies looking to leverage AI as a service.

withZeta.ai: Market Opportunity, Scaling Strategy, and Vision

The withZeta.ai platform is architected to first address the unique challenges of rare cancer drug development, where fragmented data, small patient populations, and limited institutional knowledge have historically made therapeutic development economically and scientifically prohibitive. By aggregating and structuring insights across 438+ rare cancers into a unified AI co-scientist framework, withZeta.ai provides pharmaceutical and biotech researchers with capabilities that would otherwise require large, specialized teams and years of manual analysis.

Lantern’s longer term plan is to scale withZeta.ai beyond rare cancers into broader oncology indications and, subsequently, into rare diseases and other therapeutic areas through revenue generating collaborations with pharmaceutical companies. The platform’s multi-agentic architecture is designed to be extensible — the same collaborative AI agent framework that powers rare cancer insights can be configured and trained to address drug development challenges across neurology, immunology, metabolic diseases, and other complex therapeutic areas where data fragmentation and scientific complexity represent significant barriers to R&D productivity.

The global rare disease therapeutics market is projected to exceed $300 billion by 2028, and the broader pharmaceutical R&D outsourcing and AI-enabled drug discovery market represents an additional multi-billion-dollar opportunity. Lantern believes that withZeta.ai is positioned at the intersection of these high-growth markets, with a differentiated offering that combines proprietary oncology data, validated AI algorithms, and a practical co-scientist user experience designed for bench scientists and clinical development teams.

"2026 can be a critical year for the commercialization of our AI platforms to support broad-based drug development and scientific productivity in R&D," said Mr. Sharma. "We are building for a future where AI co-scientists are commonplace in knowledge work across the pharmaceutical and biotech industries — augmenting human expertise, accelerating discovery timelines, and dramatically improving the economics of drug development. We believe this represents a potential near-term market opportunity of $20 to $50 billion, and withZeta.ai is our first agentic-based commercial product designed to capture a meaningful share of that market. The early engagement from a broad range of organizations in our beta program validates both the demand and the differentiation of our approach."

Other AI Platform Highlights

● predictBBB.ai: 94.1% accuracy for blood-brain barrier permeability prediction; five of top eleven positions on the Therapeutic Data Commons Leaderboard. This tool has been significantly enhanced to encompass a wider range of molecular and structural analysis aimed at molecules and medicines.

● LBx-AI Liquid Biopsy: 86% accuracy for predicting treatment response in NSCLC; 0.76 Pearson correlation for PD-L1 level inference from ctDNA.

R&D Investment by Program (Full Year 2025):

For the year ended December 31, 2025, our approximate research and development costs by project were: LP-300 ($4.6M), LP-184 ($4.3M), LP-284 ($1.2M), RADR Platform ($1.0M), and other programs ($0.4M), totaling approximately $11.5 million.

(Press release, Lantern Pharma, MAR 30, 2026, View Source [SID1234664023])

Aurinia Pharmaceuticals to Acquire Kezar Life Sciences for $6.955 in Cash per Share Plus a Contingent Value Right

On March 30, 2026 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH), a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs, reported it has entered into a definitive merger agreement (the "Merger Agreement") to acquire Kezar Life Sciences, Inc. (NASDAQ: KZR), a biotechnology company focusing on small-molecule therapeutics to treat unmet needs in autoimmunity and cancer, for $6.955 in cash per share of Kezar common stock, plus one non-transferable contingent value right ("CVR"), which represents the right to receive: (i) potential payments relating to the ongoing clinical development or disposition of zetomipzomib; (ii) certain proceeds relating to Kezar’s collaboration with Everest Medicines and Kezar’s sale of its Sec61-based discovery and development program to Enodia Therapeutics; and (iii) 100% of Kezar’s closing net cash in excess of $50 million, net of certain post-closing CVR-related expenses.

Following a strategic review process conducted by the Kezar board of directors with the assistance of Kezar’s management and external legal and financial advisors, the Kezar board of directors has unanimously: (i) determined that the acquisition by Aurinia is in the best interests of Kezar and its stockholders; and (ii) approved the execution and delivery of the Merger Agreement and the consummation of the transactions contemplated thereby.

Zetomipzomib, Kezar’s lead product candidate, is a first-in-class immunoproteasome inhibitor in development for patients with autoimmune hepatitis (AIH), lupus nephritis and systemic lupus erythematosus (SLE). Zetomipzomib demonstrated clinically meaningful and durable steroid-sparing remissions in the PORTOLA Phase 2 AIH study. Kezar had positive interactions with the US Food and Drug Administration (FDA) in a recent Type C meeting aimed to accelerate the development of zetomipzomib in AIH.

"We are pleased to conclude our strategic review process with this agreement with Aurinia, which will provide immediate liquidity to our shareholders, as well as ongoing participation in the value of zetomipzomib. With its successful track record developing and commercializing treatments for autoimmune diseases, Aurinia is well positioned to continue the development of this novel therapeutic agent," said Chris Kirk, Chief Executive Officer of Kezar.

Pursuant to the terms of the Merger Agreement, Aurinia will, through its wholly owned subsidiary, Aurinia Pharma U.S., Inc., and its merger subsidiary, Aurinia Merger Sub, Inc., commence a tender offer (the "Offer") by April 13, 2026, to acquire all outstanding shares of Kezar common stock. The closing of the Offer is subject to certain conditions, including the tender of shares of Kezar common stock representing at least a majority of the total number of outstanding shares, Kezar having closing net cash

in excess of $50 million, net of certain post-closing CVR-related expenses and other customary closing conditions. Immediately following the closing of the Offer, Kezar will be acquired by Aurinia, and all remaining shares not tendered in the Offer, other than shares owned directly or indirectly by Aurinia or Kezar or a subsidiary thereof or validly subject to appraisal, will be converted into the right to receive the same cash and CVR consideration per share as is provided in the Offer.

Tang Capital Partners, LP, which holds approximately 9.0% of Kezar’s outstanding common stock, has signed a tender and support agreement under which it has agreed to tender its shares in the Offer and support the transaction. The transaction is expected to close in the second quarter of 2026.

Advisors

TD Cowen served as exclusive financial advisor and Cooley LLP served as legal counsel to Kezar.

(Press release, Kezar Life Sciences, MAR 30, 2026, View Source [SID1234664022])

Immix Biopharma Announces Enrollment Completion of BLA-Enabling Relapsed/Refractory AL Amyloidosis Trial NEXICART-2, and Upcoming Milestones

On March 30, 2026 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), the global leader in relapsed/refractory AL Amyloidosis, reported that NEXICART-2 enrollment is complete, meeting Company guidance, with topline results expected in Q3 2026, followed by BLA submission and planned commercial launch.

"In AL Amyloidosis, the immune system produces toxic light chains that clog up the heart, kidney and liver, causing organ failure and death. In our trials, we have seen that one-and-done NXC-201 eliminates the source of these toxic light chains. If approved, NXC-201 would be the first FDA approved treatment for relapsed/refractory AL Amyloidosis," said Ilya Rachman, MD, PhD, Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, "We are grateful to patients, families, caregivers, investigators, and credit our team’s tireless efforts. Building on our positive interim readout at ASH (Free ASH Whitepaper) 2025, topline NEXICART-2 results are expected in Q3, driving BLA submission and planned commercial launch."

In addition to meeting guidance for NEXICART-2 enrollment completion and announcing topline NEXICART-2 results expected Q3 2026, Immix has onboarded a commercial-experienced Chief Medical Officer, Richard Graydon, MD, PhD. Dr. Graydon is a board-certified hematologist-oncologist with over 20 years of experience in clinical development, most recently at Merck & Co. and Johnson & Johnson, where he led new and supplemental new drug applications and biologics license applications for 7 approved drugs including DARZALEX, CARVYKTI, KEYTRUDA, and IMBRUVICA. Dr. Graydon received his MD and PhD from Stanford University and trained at Harvard’s Massachusetts General Hospital.

About NEXICART-2
NEXICART-2 (NCT06097832) is a multi-site U.S. Phase 2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory AL Amyloidosis, with a registrational design. NEXICART-2 is a 40-patient study.

About AL Amyloidosis
AL amyloidosis is a devastating disease where the immune system, that’s supposed to protect, instead continuously produces toxic light chains, clogging up the heart, kidney and liver, causing organ failure and death.

The number of patients in the U.S. with relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron, et al Blood Cancer Journal, to approximately 38,500 patients in 2026.

The Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research.

About NXC-201
NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy with a "digital filter" that is designed to filter out non-specific activation. NXC-201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 has been awarded Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) by the FDA, and Orphan Drug Designation (ODD) by the US FDA and in the EU by the EMA.

(Press release, Immix Biopharma, MAR 30, 2026, https://immixbio.com/immix-biopharma-announces-enrollment-completion-of-bla-enabling-relapsed-refractory-al-amyloidosis-trial-nexicart-2-and-upcoming-milestones/ [SID1234664021])

Co-PSMA data published in the European Urology journal

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.

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])

Aura Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights

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.

"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

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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.

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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.

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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.

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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])