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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.

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"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])

Aprea Therapeutics Announces Oversubscribed $30 Million Private Placement

On March 30, 2026 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers, reported that it has entered into a securities purchase agreement for an oversubscribed private placement financing that is expected to result in total gross proceeds of approximately $30 million to the Company before deducting placement agent fees and other private placement expenses (the "Offering").

The private placement was led by Soleus Capital with participation from other new investors, including Vestal Point Capital and Squadron Capital Management, existing investors and certain insiders of the Company.

In connection with the Offering the Company plans to sell (i) pre-funded warrants to purchase up to an aggregate of approximately 37.2 million shares of common stock ("Pre-Funded Warrants"), for a purchase price equal to $0.808, minus $0.001 per Pre-Funded Warrant, and (ii) warrants to purchase up to an aggregate of approximately 37.2 million shares of common stock. The warrants to be issued will have an exercise price of $0.683 per share, will be exercisable immediately upon issuance, and will expire on the earlier of (i) December 31, 2029, and (ii) 30 calendar days after the exercise of a holder’s Pre-Funded Warrant on a pro rata basis.

The gross proceeds to the Company from the Offering are estimated to be approximately $30 million before deducting the placement agent’s fees and other estimated Offering expenses. The Company intends to use the upfront net proceeds from the private placement for general corporate purposes and for research and development expenses. The Offering is expected to close on or about March 31, 2026, subject to the satisfaction of customary closing conditions.

In addition to the existing biomarker-enriched cohorts under evaluation in the ongoing ACESOT-1051 Phase 1 trial, Aprea plans to use commercially reasonable efforts to seek enrollment of at least 50 patients with uterine serous carcinoma (USC), as well as patients with Cyclin E-overexpressing, platinum-resistant ovarian cancer (PROC) in order to further assess APR-1051 in selected patient populations with high unmet medical need. The Company currently anticipates completing dose escalation of the ACESOT-1051 trial in the second quarter of 2027 and currently expects that the proceeds from the Offering will be sufficient to extend its cash runway into the first quarter of 2028, in each case, based on the Company’s current business plans and assumptions.

Oppenheimer & Co. Inc. is acting as the lead placement agent for the private placement. Maxim Group LLC is acting as co-lead placement agent for the private placement.

The offer and sale of the foregoing securities are being made in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder, and the securities have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the securities purchased in the private placement.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

(Press release, Aprea, MAR 30, 2026, View Source [SID1234664018])

Aprea Therapeutics Highlights Positive Emerging Clinical Activity for WEE1 Inhibitor, APR-1051, with a Confirmed Partial Response in the Ongoing Phase 1 ACESOT-1051 Trial

On March 30, 2026 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers, reported the confirmation of a partial response (PR) in its ongoing ACESOT-1051 trial evaluating APR-1051, a potent and selective WEE1 kinase inhibitor.

The confirmed PR was observed in a patient with PPP2R1A-mutated endometrial cancer who is currently being treated at the 220 mg once daily dose level. Aprea announced on February 18, 2026 that, at their first imaging assessment, this patient achieved a 50% reduction in target lesion size (meeting RECIST criteria for partial response) as well as a reduction in CA-125 levels. This response was subsequently confirmed at the second image assessment, with an additional 9.5% reduction in target lesion size, and a reduction in CA-125 to 40.2U/ml (from 362 U/mL at baseline).

ACESOT-1051 is a biomarker focused Phase 1 trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of APR-1051 in patients with advanced solid tumors harboring cancer-associated genetic alterations. A total of 24 patients have been treated to date, at doses ranging from 10 mg to 220 mg once daily. Two patients have achieved partial responses, both with endometrial cancers harboring PPP2R1A mutations. One of these responses has been confirmed, as described above. Both patients remain on treatment.

Five other patients in ACESOT-1051 have achieved a best overall response of stable disease, including patients with HPV+ head and neck squamous cell carcinoma (HNSCC), colorectal and endometrial cancers with relevant genomic alternations. APR-1051 has been generally safe and well tolerated with the most common adverse events reported as Grade 1 or 2, primarily consisting of nausea and fatigue.

"The data emerging from the ACESOT-1051 trial continue to support the clinical potential of APR-1051, with confirmation of a partial response in the 220 mg cohort indicating evidence of sustained anti-tumor activity," said Eugene Kennedy, MD, Chief Medical Advisor at Aprea. "APR-1051 appears to be generally well-tolerated with an encouraging therapeutic window and overall, these findings strengthen our confidence in the ability of this candidate to successfully target WEE1 in genetically defined cancers, where patients face significant unmet need."

Dose escalation is ongoing, with plans to advance to Dose Level 9 (300 mg once daily) in the second quarter of 2026. In parallel, the company plans to enroll additional patients as specified in the protocol based on the understanding that their tumor types or specific mutations gives them an increased probability of responding to this class of potential therapeutics. This includes patients with uterine serous carcinoma (a subset of endometrial), colorectal and HPV+ tumors. For more information on ACESOT-1051, refer to ClinicalTrials.gov NCT06260514.

(Press release, Aprea, MAR 30, 2026, View Source [SID1234664017])