On March 24, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported a partnership with Avance Clinical, a full-service contract research organization (CRO) with a proven track record and experience in obtaining regulatory approval and clinical trial initiation in Australia. The partnership is focused on rapidly initiating a first-in-human clinical trial for CLD-401 in Australia. In parallel, the Company will pursue an IND filing with the FDA in 2026.

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CLD-401 is a genetically modified form of vaccinia virus that is systemically delivered, replicates only in tumor cells, and expresses high levels of IL-15 superagonist (IL-15 SA), an activator of innate and adaptive immune response, in the tumor microenvironment. The planned phase I will investigate the safety, pharmacodynamics, and efficacy of CLD-401 given as monotherapy in patients with solid tumors that have exhausted all other therapeutic options.

"We believe CLD-401 represents a unique mechanism of action in oncology," said Eric Poma, PhD, Chief Executive Officer of Calidi. "We are excited to work with Avance Clinical to initiate clinical studies as quickly as possible and bring this potential treatment option to patients whose disease is resistant to current therapies."

Calidi is currently conducting IND-enabling studies with CLD-401, the first lead candidate from its RedTail platform. The Company continues to expand the functionality of the RedTail platform and is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

(Press release, Calidi Biotherapeutics, MAR 24, 2026, View Source [SID1234663886])

On March 24, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that it has received clearance from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) to initiate Phase II clinical trials for AK146D1, a first-in-class Trop2 /Nectin4 bispecific antibody-drug conjugate (ADC), and AK138D1, an innovative HER3-targeting ADC.

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The studies will evaluate these two novel ADC candidates in combination with the Company’s pioneering immuno-oncology (IO) 2.0 bispecific antibodies, cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF), as well as other proprietary high-potential anti-tumor assets, including AK117 (anti-CD47 monoclonal antibody) and AK109 (anti-VEGF monoclonal antibody), across a spectrum of advanced solid tumors. This milestone marks a strategic acceleration of Akeso’s proprietary "IO 2.0 + ADC 2.0" combination platform into mid-stage clinical development.

These Phase II studies will leverage the cadonilimab and ivonescimab as foundational backbone therapies, capitalizing on their validated clinical profiles in checkpoint blockades and dual VEGF/PD-1 inhibition. The regimens center on Akeso’s internally discovered next-generation ADCs while exploring synergies with the company’s broader internal portfolio.

The convergence of immuno-oncology and ADC modalities has emerged as a high-conviction frontier in oncology therapy, offering the potential to overcome the limitations of monotherapy approaches – such as antigen escape, heterogeneous expression, and narrow therapeutic indices. Akeso holds a distinct global competitive advantage as the only company with two approved cancer immunotherapy checkpoint bispecific antibodies. By pairing these IO backbones with next-generation ADC candidates like AK146D1 and AK138D1, the Company is driving the next generation of combination therapy. AK146D1 and AK138D1 have been specifically designed to expand the therapeutic window and mitigate safety-related limitations of traditional ADCs. The progression of these "IO 2.0 + ADC 2.0" combinations into Phase II development is a significant step in establishing Akeso’s next-generation leadership in the global oncology landscape.

AK146D1 is a first-in-class bispecific ADC engineered to simultaneously target Trop2 and Nectin4, antigens that are frequently co-expressed in epithelial-derived malignancies such as lung, breast, and bladder cancers. This dual-targeting approach is designed to enhance selectivity, address tumor heterogeneity, and overcome the resistance mechanisms common in single-target ADC therapies. AK138D1 is a next-generation ADC targeting HER3, a receptor associated with tumor progression and resistance to established EGFR and HER2 treatments in various malignancies, including ovarian, colorectal, melanoma, and prostate cancers. Early-stage data for both AK146D1 and AK138D1 have demonstrated potent anti-tumor activity and a highly manageable safety profile.

Akeso continues to extend its global IO 2.0 leadership into broader, high-impact combination strategies. Beyond the "IO 2.0 + ADC 2.0" portfolio, the Company is advancing a comprehensive portfolio of novel combination approaches aimed at addressing major unmet clinical needs. These include IO 2.0 combinations with other immune checkpoint inhibitors (ICIs), mRNA-based personalized cancer vaccines (such as AK154), DNA-based therapeutics, and additional novel therapeutic platforms.

This milestone underscores Akeso’s disciplined execution in translating proprietary platform synergies into clinical progress, positioning the Company at the forefront of next-generation global oncology innovation.

(Press release, Akeso Biopharma, MAR 24, 2026, View Source;adc-2-0-strategy-with-phase-ii-initiation-of-novel-adcs-combined-with-ivonescimab-and-cadonilimab-302724222.html [SID1234663872])

On March 24, 2026 Radiopharm Theranostics (ASX: RAD, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, reported the second interim data from twenty patients in its U.S. Phase 2b clinical imaging trial of RAD 101 in brain metastases. RAD 101 is Radiopharm’s novel, small-molecule imaging agent targeting fatty acid synthase (FASN) and radiolabelled with Fluorine-18 for the diagnosis of suspected recurrent brain metastases from solid tumors of different origins.

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The second interim analysis showed that 90% (18/20) of the patients dosed with RAD101 achieved concordance between PET imaging and MRI (the primary endpoint). The results showed significant and selective tumor uptake in the brain metastases. Images confirm metabolic activity in brain metastases compared to equivocal MRI findings.

In addition, the first five patients with evaluable six-month follow-up and/or biopsy data show a positive trend for sensitivity and specificity (the secondary objectives). Sensitivity and specificity are two of the fundamental hallmarks of any diagnostic test including in imaging. They measure an imaging test’s ability to correctly identify patients with a disease (sensitivity, true positive rate), as well as patients without the disease (specificity, true negative rate).

"The strength and consistency of these interim results further validate the potential of RAD 101 to address one of the most challenging diagnostic gaps in neuro-oncology," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "With 90% concordance demonstrated to date and encouraging early signals in sensitivity and specificity, we are increasingly confident in RAD 101’s ability to support more accurate and timely treatment decisions for patients with brain metastases. We look forward to the final data readout from the full 30-patient study by June, which will guide our path toward a pivotal trial and, ultimately, toward bringing this important imaging agent to the clinicians and patients who need it."

RAD 101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin, including leptomeningeal disease.

In the U.S. alone, there are more than 300,000 patients diagnosed annually with cerebral metastases. The incidence of Intracranial Metastatic Disease (IMD) continues to increase, in part, due to improvements in systemic therapy resulting in a more durable control of the primary tumor. Contrast-enhanced Magnetic Resonance Imaging (CE-MRI) is the preferred method for imaging IMD, but has limitations, particularly in follow-up surveillance scans to optimise patient care.1

WEBINAR DETAILS

AUSTRALIA
Date: Wednesday 25 March 2026
Time: 9:00am AEDT

USA
Date: Tuesday 24 March 2026
Time: 6.00pm EDT

Presenters:

Riccardo Canevari – CEO & Managing Director
Dr Dimitris Voliotis – Chief Medical Officer
Dr. Harshad Kulkarni – BAMF Health, Grand Rapids, MI
Register for the webinar at the link below: View Source

Please submit any questions to: [email protected]

Upon registering attendees will receive an email containing information about joining the webinar. A recording will be available at the above link soon after the conclusion of the live session, with the replay to also be made available via Radiopharm’s website and social media channels.

About the Phase 2 Clinical Trial of RAD101

The U.S. multicenter, open-label, single arm Phase 2b clinical trial is evaluating the diagnostic performance of 18F-RAD101 in 30 individuals with confirmed recurrent brain metastases from solid tumors of different origins. The primary objective of the study is concordance between 18F-RAD101 positive lesions and those seen in conventional imaging (MRI with gadolinium) in participants with suspected recurrent brain metastases. Secondary endpoints are accuracy, sensitivity and specificity of RAD101 in identifying tumor recurrence versus radiation necrosis in previously stereotactic radiosurgery (SRS)-treated brain metastases.

About RAD101

RAD101 is the Company’s novel imaging small molecule that targets fatty acid synthase (FASN), a multi-enzyme protein that catalyses fatty acid synthesis and is overexpressed in many solid tumors, including cerebral metastasis. Targeting FASN activity may allow for the more accurate detection of cancer cells, representing a clinically relevant method for the imaging of brain metastases. Positive data from the Imperial College of London’s Phase 2a imaging trial of 18F-RAD101 in patients with brain metastases (both SRS pre-treated and treatment naïve patients) showed significant tumor uptake that was independent from the tumor of origin. The study further indicated that PET-MRI may potentially represent a non-invasive prediction of overall-survival, warranting larger studies.

(Press release, Radiopharm Theranostics, MAR 24, 2026, View Source [SID1234663887])

On March 23, 2026 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported its financial results for the full year 2025 and recent business highlights.

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"2026 is poised to be a pivotal year, propelled by disciplined clinical execution and initial data that we believe will showcase the vast potential of our proprietary ADC platform," said Jane Chung, Sutro’s Chief Executive Officer. "We recently completed dosing the third cohort in the Phase 1 trial of STRO-004, our potential best-in-class Tissue Factor ADC, and look forward to reporting initial data mid-year. In parallel, we are advancing STRO-006, our ITGB6 ADC, and accelerating STRO-227, our wholly owned dual-payload program targeting PTK7, toward IND submission this year. In addition, patient dosing has commenced under our collaboration with Astellas Pharma for our first partnered dual-payload iADC — marking the first dual-payload program from Sutro’s platform to enter the clinic. Supported by our recent financing, continued financial stewardship, and sharpened strategic focus, we believe we are well positioned to execute across all our programs and deliver differentiated ADCs with best-in-class potential that could redefine standards of care in oncology."

Wholly Owned Pipeline

STRO-004: The Company has completed dosing across three cohorts in the first-in-human Phase 1 trial evaluating STRO-004, a DAR8 Topo1 ADC targeting Tissue Factor (TF), with potential as best-in-class TF ADC. Initial clinical data are expected in mid-2026, including safety and tolerability. Sutro also expects to share pharmacokinetic exposure and potentially early signs of activity. In non-human primate studies, STRO-004 demonstrated a favorable preclinical safety profile, with a highest non-severely toxic dose (HNSTD) of 50 mg/kg — supporting a clinical starting dose of 1mg/kg.

STRO-006: A highly selective, DAR 8 Topo1 ADC targeting integrin β6 (ITGB6), STRO-006 is expected to enter clinical development in 2026 for the treatment of multiple solid tumors.

STRO-227: Sutro’s PTK7-targeting dual-payload ADC program, consisting of MMAE (DAR2) and Topo1 (DAR8), remains on track, with an IND submission targeted for 2026.

Next-Generation ADC Collaborations

Astellas: Two research and development programs are progressing under Sutro’s collaboration with Astellas focused on dual-payload immunostimulatory ADCs (iADCs).

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The first program, targeting TROP2, has entered the clinic and is actively dosing patients, triggering a $10 million milestone payment with receipt expected in the second quarter of 2026.
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The second program entered an IND-enabling toxicology study in the fourth quarter of 2025, triggering a $7.5 million milestone payment to Sutro.

Upcoming and Recent Industry/Medical Conferences

American Association for Cancer Research (AACR) (Free AACR Whitepaper), April 17-22, 2026, San Diego California

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Sutro’s strategic partner, Astellas Pharma, will present preclinical results from its TROP2-targeted iADC program in an oral presentation on Sunday, April 19, 2026 at 4:35-4:50 PM PT. The presentation, titled "ASP2998, a TROP2-targeted immunostimulatory antibody-drug conjugate (iADC) with dual payloads, demonstrates potent efficacy and a favorable safety profile in nonclinical models," highlights progress in the development of next-generation iADCs leveraging Sutro’s cell-free protein synthesis platform.
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Additionally, Sutro will present an oral presentation and multiple posters highlighting advances across its ADC pipeline and discovery platforms at AACR (Free AACR Whitepaper). The presentation details are as follows:
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Presentation: "STRO-004, an exatecan-based next-generation tissue factor (TF)-targeted ADC, demonstrates superior efficacy across TF-expressing solid tumors in a comprehensive single-mouse PDX trial"
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Presentation Date and Time: Sunday, April 19, 2026; 4:35-4:50 PM PT
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Poster: "Phase 1 open-label study to evaluate safety, pharmacokinetics, and preliminary anti-tumor activity of STRO-004 in adults with refractory/recurrent metastatic solid tumors"
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Session Date and Time: Monday, April 20, 2026; 9:00 AM-12:00 PM PT
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Poster: "STRO-006: An Integrin beta-6–targeting ADC demonstrates favorable safety profile and potent antitumor activity in preclinical solid tumors"
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Session Date and Time: Monday, April 20, 2026; 9:00 AM-12:00 PM PT
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Poster: "Preclinical characterization of STRO-227: A PTK7-targeting dual-payload ADC with topoisomerase 1 and tubulin inhibitors"
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Session Date and Time: Monday, April 20, 2026; 9:00 AM-12:00 PM PT
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Poster: "The HER2-targeting dual-payload antibody-drug conjugate combining a topoisomerase I inhibitor and a microtubule inhibitor demonstrates superior efficacy and overcomes resistance to single-payload ADCs in xenograft models"
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Session Date and Time: Monday, April 20, 2026; 9:00 AM-12:00 PM PT
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Poster: "Sutro’s Site-Specific Dual-Payload ADCs Combining TOPO1i and DNA Damage Response Inhibitors to Enhance Efficacy, Overcome Resistance, and Improve Safety"
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Session Date and Time: Tuesday, April 21, 2026; 9:00 AM-12:00 PM PT

16th World ADC London Summit, February 23-26, 2026, London, UK

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Sutro participated in a plenary and two panel discussions at the conference, covering topics including dual-payload innovation, key drivers of ADC differentiation, and ADC collaborations. For more details, read the full press release here.

Corporate Updates

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Sutro strengthened its cash position with an underwritten offering of 7,868,383 shares of its common stock at a price of $13.98 per share, resulting in gross proceeds of $110.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by Sutro. The Company’s cash runway is now expected into at least the second quarter of 2028, excluding additional anticipated milestones from Sutro’s existing collaboration.
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Sutro management, joined by KOL Anthony Tolcher, M.D., FRCPC, FACP, hosted a virtual R&D Day on Wednesday, November 12, highlighting the Company’s platform innovations and next-generation ADC pipeline. Key updates included the initiation of the Phase 1 study with STRO-004 and the selection of PTK7 as the target for its initial dual-payload candidate, STRO-227.

Full Year 2025 Financial Highlights

Cash, Cash Equivalents and Marketable Securities

As of December 31, 2025, Sutro had cash, cash equivalents and marketable securities of $141.4 million, as compared to $167.6 million as of September 30, 2025. With gross proceeds from the recent financing totaling $110.0 million, the Company’s cash runway is expected into at least the second quarter of 2028, excluding anticipated milestones from Sutro’s existing collaborations.

Revenue

Revenue was $102.5 million for the year ended December 31, 2025, as compared to $62.0 million for the year ended December 31, 2024, with the 2025 amount related principally to the Astellas and Ipsen collaborations. Future collaboration and license revenue under existing agreements, and from any additional collaboration and license partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones, and other agreement payments.

Research & Development (R&D) and General & Administrative (G&A) Expenses

Total R&D and G&A expenses for the year ended December 31, 2025 were $207.4 million, as compared to $300.5 million for the year ended December 31, 2024. The 2025 year includes non-cash expenses for stock-based compensation of $14.0 million and depreciation and amortization of $7.3 million, as compared to $24.7 million and $7.2 million, respectively, in the comparable 2024 period.

Restructuring Costs

The total cash payments and costs related to the further operational restructuring announced on September 29, 2025 are estimated to be approximately $4.1 million to $4.3 million, with a majority of these amounts paid in the fourth quarter of 2025. These estimates are subject to a number of assumptions and actual results may differ. The Company may also incur additional costs not currently contemplated due to events that may occur as a result of, or that are associated with, the corporate restructuring.

(Press release, Sutro Biopharma, MAR 23, 2026, View Source [SID1234663834])

On March 23, 2026 Senti Biosciences, Inc. (Nasdaq: SNTI) ("Senti Bio"), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, reported upcoming presentations featuring clinical and translational data from its SENTI-202 program at the 11th Annual Innate Killer Conference, taking place March 24–25, 2026 in San Diego, California.

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The presentations will include data from the ongoing Phase I clinical trial of SENTI-202, a first-in-class, off-the-shelf, logic-gated CAR NK cell therapy designed to selectively target CD33 and/or FLT3 while sparing EMCN-expressing healthy cells in adults with relapsed/refractory acute myeloid leukemia (AML).

The presentations details are as follows:

Clinical Data Presentation
Rochelle Emery, MD, Medical Director at Senti Bio, will present:
"Promising Phase I Clinical Trial Results from SENTI-202-101, a First-in-Class, CD33 and/or FLT3 & not EMCN, Selective Off-the-Shelf Logic Gated CAR NK Cell Therapy in Adults with R/R AML"

The presentation will highlight clinical data from the ongoing study evaluating the safety and preliminary anti-leukemic activity of SENTI-202.

Translational and Correlative Data Presentation
Enping Hong, PhD, Associate Director of Preclinical and Translational Science, will present:
"Promising Phase I Correlative SENTI-202 Data is Consistent with Clinical Activity & Unique Logic Gated Mechanism of Action"

The presentation will provide correlative analyses supporting observed clinical activity and the therapy’s logic-gated mechanism of action.

Workshop Participation
Brian Garrison, PhD, Vice President of Research and Translational Science, will lead a workshop titled:
"Harnessing Biomarker Discovery & Translational Tools to Accelerate NK Therapy Clinical Success"

The workshop will focus on strategies to advance NK cell therapy development through biomarker discovery and translational approaches.

(Press release, Senti Biosciences, MAR 23, 2026, View Source [SID1234663851])