Calidi Biotherapeutics Presents New Data on Its Differentiated Approach to In Situ T-Cell Engagers Including a New Candidate Targeting TROP-2 at the AACR Annual Meeting in April 2026

On April 20, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported new data at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in San Diego, California on April 19, 2026. The Company demonstrated new data on its approach of simultaneously activating T-cells while inducing the expression of T-cell engagers specifically in situ in the tumor microenvironment ("TME"). The poster is available here.

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RedTail is Calidi’s systemically delivered virotherapy platform designed to selectively target tumors, remodel the TME, and enable high-level expression of therapeutic genetic payloads directly at the tumor site while limiting peripheral exposure. CLD-401, the lead candidate derived from the RedTail platform, is engineered to express high levels of IL-15 superagonist ("IL-15 SA"), a known CD8⁺ T-cell, NK cell, and gamma delta (γδ) T-cell activator, in the TME. The Company expects to file an IND for CLD-401 by the end of 2026.

Data presented at the AACR (Free AACR Whitepaper) meeting showcased RedTail viruses that can express both a functional T-cell engager, capable of binding targeted solid tumor cells, and IL-15 SA at high concentrations, allowing for simultaneous T-cell activation and high expression in situ of a T-cell engager. T-cell engagers have shown exceptional efficacy in hematological malignancies but have failed to show clinical benefit in solid tumors where the TME inhibits immune cell infiltration and T-cell activity. By remodeling the TME and driving T-cell activation in concert with expression of a T-cell engager, RedTail is designed to overcome these historical limitations.

The Company is developing CLD-501, a lead candidate targeting TROP2, a cell-surface glycoprotein. TROP2 expression in normal tissue and the high potential for off-tumor / on-target toxicity has made it a difficult target for T-cell engagers. The RedTail approach confines expression of the T-cell engager to the TME, limiting off-tumor interactions. The Company is pursuing additional T-cell engager targets like EGFR, EpCAM, and Nectin-4.

"Data presented at AACR (Free AACR Whitepaper) show the advances we have made with the RedTail platform, our first lead, CLD-401, and our progress in addressing a central challenge in immuno-oncology: how to deliver tumor-specific T-cell engagers effectively in solid tumors" said Eric Poma, PhD, Chief Executive Officer of Calidi. "We believe RedTail represents a major breakthrough in the ability to deliver genetic payloads, including in situ T-cell engagers in a targeted fashion to distal sites of disease through systemic administration."

"The data we presented at AACR (Free AACR Whitepaper) highlight the ability of the RedTail platform to functionally overexpress complex biologics including cytokines and T-cell engagers, and profoundly alter the tumor microenvironment" said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. "This tumor-restricted approach enables targeting of antigens such as TROP2, something that has not been effectively accomplished with existing T-cell engager therapies.

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, APR 20, 2026, View Source [SID1234664584])

Prelude Therapeutics Announces Pricing of $90.0 Million Underwritten Offering

On April 20, 2026 Prelude Therapeutics Incorporated (Nasdaq: PRLD) ("Prelude" or the "Company"), a clinical-stage precision oncology company, reported the pricing of its underwritten offering of 18,018,014 shares of its voting common stock (the "Common Stock") at a price of $4.44 per share, and, in lieu of Common Stock to investors who so chose, pre-funded warrants to purchase up to 2,252,252 shares of its Common Stock at a price of $4.4399 per pre-funded warrant, which represents the per share offering price for the Common Stock less the $0.0001 per share exercise price for each such pre-funded warrant. Before deducting the underwriting discounts and commissions and estimated offering expenses, the total gross proceeds to Prelude are approximately $90.0 million. The offering is expected to close on or about April 21, 2026, subject to the satisfaction of customary closing conditions.

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The offering was led by new investor RA Capital Management with participation from Soleus Capital, as well as other new and existing healthcare dedicated investors.

Goldman Sachs & Co. LLC, Evercore ISI and Citizens Capital Markets are acting as the joint book-running managers for the offering.

The Company intends to use the net proceeds from the offering primarily for general corporate purposes, which may include funding research, preclinical and clinical development of its product candidates, increasing its working capital and capital expenditures.

A registration statement on Form S-3 relating to these securities was filed with the Securities and Exchange Commission ("SEC") on May 30, 2024, and was declared effective by the SEC on June 10, 2024. A prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC. These documents will be available on the SEC’s website at View Source You can also obtain the prospectus supplement and accompanying prospectus by contacting Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected]; or Citizens JMP Securities, LLC, 600 Montgomery Street, Suite 1100, San Francisco, CA 94111, by telephone at (415) 835-8985, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Prelude Therapeutics, APR 20, 2026, View Source [SID1234664551])

AlphaGen Therapeutics to Present Preclinical Studies of Two Next-Generation Alpha Therapies at AACR 2026

On April 20, 2026 AlphaGen Therapeutics (AlphaGen), a biopharmaceutical company that focuses on developing next-generation targeted alpha radiotherapies, reported that it will present preclinical data on two advanced radiopharmaceutical programs at the 2026 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), is being held in San Diego, California, from April 17–22.

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[212Pb]Pb-AG1002 is a next-generation non-agonist SSTR2-targeting alpha radiopharmaceutical. In preclinical studies, the compound demonstrated high binding affinity and a superior tumor-to-kidney (T/K) ratio compared to agonist radioligands. It showed robust tumor growth inhibition and survival benefit across multiple models with a very favorable safety profile.

[212Pb]Pb-AG1206 is a novel FAP-targeted alpha radioligand based on a macrocyclic peptide scaffold with picomolar binding affinity. The compound has rapid tumor accumulation and renal clearance, giving rise to high T/K ratio. It showed strong anti-tumor activity in multiple preclinical tumor models. Consistent with preclinical observations, patient imaging IIT showed strong tumor uptake and clean tissue background.

"We have developed a robust pipeline of novel and differentiated targeted alpha radiotherapies. We are pleased to showcase our exciting progress in two such programs at AACR (Free AACR Whitepaper) Annual Meeting 2026." said Dr. Mai-Jing Liao, CEO of AlphaGen Therapeutics. "The data to be presented underscore our commitment to advancing next-generation targeted alpha therapies and delivering significant improvements for patients with difficult-to-treat tumors."

[212Pb]Pb-AG1002,SSTR2-targeted alpha therapy

Title: Preclinical evaluation of [212Pb]Pb-AG1002, a next generation SSTR2-targeting, non-agonist radiopharmaceutical

Poster Link: Abstract 5811: Preclinical evaluation of [212Pb]Pb-AG1002, a next generation SSTR2-targeting, non-agonist radiopharmaceutical | Cancer Research | American Association for Cancer Research (AACR) (Free AACR Whitepaper)

Session: Radiopharmaceutical Platforms for Theranostic Precision Oncology

Category: Experimental and Molecular Therapeutics

Date/Time: Tuesday, April 21, 2026, 2:00 PM – 5:00 PM PDT

Poster #: 5811

[212Pb]Pb-AG1206,FAP-targeted alpha therapy

Title: [212Pb]Pb-AG1206, A novel fibroblast activation protein-targeted radioligand therapy demonstrated excellent efficacy and safety profile

Poster Link: Abstract 5810: [212Pb]Pb-AG1206, A novel fibroblast activation protein-targeted radioligand therapy demonstrated excellent efficacy and safety profile | Cancer Research | American Association for Cancer Research (AACR) (Free AACR Whitepaper)

Session: Radiopharmaceutical Platforms for Theranostic Precision Oncology

Category: Experimental and Molecular Therapeutics

Date/Time: Tuesday, April 21, 2026, 2:00 PM – 5:00 PM PDT

Poster #: 5810

(Press release, AlphaGen Therapeutics, APR 20, 2026, View Source [SID1234664568])

BriaCell Presents Positive Phase 3 Quality of Life and Phase 2 Biomarker Data at the 2026 AACR Meeting

On April 20, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported that it is presenting positive data in three clinical posters at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 17–22 at the San Diego Convention Center in San Diego, California. The presentations will include one poster featuring data from BriaCell’s ongoing pivotal Phase 3 study of Bria-IMT plus an immune checkpoint inhibitor (ClinicalTrials.gov identifier: NCT06072612), and two posters highlighting further analyses of Phase 2 data. Abstracts will be published in the online Proceedings of the AACR (Free AACR Whitepaper).

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"Standards of care in cancer are evolving rapidly as innovative immunotherapy approaches emerge with potentially better safety profiles than chemotherapy. Clinical data, including BriaCell’s, highlight that maintaining quality of life is an important treatment goal alongside efficacy and safety," stated lead author, Saranya Chumsri, MD, Principal Investigator of BriaCell Phase 3 study of Bria-IMT+CPI, and Professor of Oncology, Mayo Clinic.

"At BriaCell, we are focused on bringing novel therapeutics to cancer patients with unmet medical needs with the ultimate goal of improving patients’ lives," noted William V. Williams, MD, BriaCell’s President & CEO. "Our new quality of life data from the Phase 3 Bria-IMT + CPI study in patients with metastatic breast cancer who failed prior therapies show very positive trends, bringing us one step closer to transforming care for these patients."

Session Title: Phase II and Phase III Clinical Trials
Session: 4/20/2026 2:00-5:00 PM PST
Location: Poster Section 52
Poster Board Number: 1
Poster Number: CT137
Title: QOL Outcomes in Bria-ABC Late-Stage Metastatic Phase 3 Trial
Summary: Heavily pretreated metastatic breast cancer patients in the pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor maintained overall health status and key functional measures with a favorable safety profile. These findings are encouraging because they suggest meaningful preservation of quality of life for late-stage metastatic breast cancer patients with limited treatment options.

QOL largely preserved in a heavily pretreated population with prior antibody-drug conjugate (ADC), check point inhibitor (CPI), and cyclin-dependent kinase 4/6 (CDK4/6) inhibitor exposure
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Survey showed:
1) Global health status stable through early and mid-treatment
2) Emotional and cognitive functioning maintained; symptom burden stable
Safety profile and time-to-deterioration analyses support durable tolerability in a late-line setting
BriaCell clinical data supports feasibility of decentralized treatment approaches, including potential home self-administration strategies
Session Category: Clinical Research
Session: 4/19/2026 2:00-5:00 PM PST
Location: Poster Section 42
Poster Board Number: 5
Poster Number: 1065
Title: Mitosis in Circulating Tumor Cells Correlates with Highly Aggressive Disease in Metastatic Breast Cancer

Summary: Circulating tumor cells (CTCs) are a well-established non-invasive blood-based biomarker that can help stratify prognosis in patients with metastatic breast cancer (MBC), particularly in aggressive disease subtypes. Early pilot studies had identified a distinct subset of CTCs undergoing mitosis (dividing cells), whose presence appeared to correlate with worse survival outcomes. However, their prognostic significance and potential interaction with different treatment regimens have not been clinically evaluated. In this multi-institutional prospective study, patients with mitotic CTCs were found to have poorer outcomes than those with non-mitotic CTCs or no CTCs, but appeared to have overall survival benefit when treated with targeted therapy. Overall, these findings support mitotic CTCs as a novel potential prognostic biomarker in metastatic breast cancer.

Session Category: Clinical Research
Session Title: Biomarkers Predictive of Therapeutic Benefit 1
Session: 4/19/2026 2:00-5:00 PM PST
Location: Poster Section 40
Poster Board Number: 19
Poster Number: 1025
Title: Monitoring PD-L1 in tumor macrophage fusion cells in blood identifies high PD-L1 checkpoint inhibitor responses in metastatic breast cancer

Summary: Tissue biopsy PD-L1 combined positive score (CPS≥10) has been identified as a positive prognostic marker in metastatic breast cancer. However, a significant percentage of MBC patients with CPS <10 seem to benefit from immune check point inhibitor (ICI) therapy. Circulating tumor-macrophage fusion cells (TMFCs) express PD-L1 and changes in TMFC PD-L1 expression during ICI treatment may explain this outcome. This Phase 2 prospective study found no correlation between tumor PD-L1 CPS and clinical response while demonstrating that patients with PD-L1 positive TMFCs in their blood had significantly improved progression free survival. Monitoring PD-L1 in TMFCs may serve as a real-time biomarker to better indicate ICI response and further studies into the role of TMFC PD-L1 in predicting therapeutic response are ongoing.

Following the presentation, copies of the posters will be made available at View Source

(Press release, BriaCell Therapeutics, APR 20, 2026, View Source [SID1234664585])

Bicycle Therapeutics Provides Update on Nuzefatide Pevedotin and EphA2 Pipeline at the AACR Annual Meeting 2026

On April 20, 2026 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported updates from its EphA2 pipeline at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026.

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"EphA2 is a potentially high value target that is widely expressed in cancer and has been considered undruggable following the failure of multiple antibody-based approaches due to toxicity or insufficient efficacy. Encouraging results presented at AACR (Free AACR Whitepaper) demonstrate the potential of our Bicycle platform to drug this target with a generally well tolerated and differentiated safety profile and enhances our understanding of how best to deploy EphA2-targeted therapeutics," said Bicycle Therapeutics CEO Kevin Lee, Ph.D. "Nuzefatide pevedotin has demonstrated an emerging differentiated safety profile as a monotherapy and in combination with a checkpoint inhibitor, in over 150 patients to date. Consequently, using a combination of expression analysis, preclinical patient-derived xenograft efficacy studies, and human patient imaging, we have identified significant opportunities for this molecule in a number of cancers, including pancreatic cancer."

Dr. Lee added: "We have now identified 8mg/m2 Q2W as the preferred dose for monotherapy. Our strategy is to initially develop nuzefatide in pancreatic cancer where patients have limited available treatment options, and in parallel, to bring forward the next generation of EphA2-targeted radiotherapeutics to build on our foundational work in bladder and other EphA2-expressing tumors. Following this strategy, I am very pleased to announce that the first patient in our 2L+ pancreatic ductal adenocarcinoma Phase 2 study has been successfully dosed."

AACR Annual Meeting 2026 Data Highlights

Nuzefatide pevedotin (nuzefatide), formerly BT5528, a potentially first-in-class EphA2 targeting Bicycle Drug Conjugate (BDC), Phase 1/2 data in combination with nivolumab in metastatic urothelial cancer (mUC) patients. As of the February 9, 2026 data cutoff, results from the Phase 1/2 trial evaluating nuzefatide 6.5mg/m2 once every two weeks (Q2W) plus nivolumab 480mg once every four weeks (Q4W) in 14 patients with mUC who had previously progressed on a checkpoint inhibitor (10 while on enfortumab vedotin) showed:
40% confirmed overall response rate (ORR) (4/10) among patients with EphA2+ tumors and 100% confirmed ORR (3/3) among patients with EphA2+ tumors that were monomethyl auristatin E (MMAE)-naïve.
Patients who achieved a partial response (PR) or at least 16 weeks of stable disease (SD) were on treatment for a minimum of 56 weeks and most continued on treatment at the time of the data cut-off.
Nuzefatide in combination with nivolumab was generally well tolerated with no Grade ≥3 treatment-related adverse events (TRAEs) of clinical interest and no TRAEs of haemorrhage observed. Only one dose-limiting toxicity of Grade 3 fatigue that lasted for five days was reported and improved to Grade 1 without dose reduction.
In contrast to other EphA2-targeted agents, nuzefatide has demonstrated a positive emerging efficacy and safety profile in over 150 patients with hard-to-treat tumors to date. Further work has led Bicycle Therapeutics to determine 8mg/m2 Q2W as the preferred dose for the Phase 2 trial in patients with recurrent pancreatic ductal adenocarcinoma (PDAC).

Additional human imaging data of a Bicycle Imaging Agent (BIA) targeting EphA2 in patients with PDAC. The German Cancer Consortium (DKTK), part of a cooperative network with the German Cancer Research Center (DKFZ), presented human imaging data conducted with a Bicycle molecule targeting EphA2 labelled with gallium-68 (EphA2 BIA). Seven patients with histologically confirmed PDAC underwent PET/CT imaging up to three hours post injection of the EphA2 BIA. Data demonstrated rapid tumor uptake and excretion primarily via the kidneys in six out of seven patients. EphA2 BIA PET imaging successfully detected multiple liver, bone, lymph node, and peritoneal metastases.

These data are representative of the results seen in 15 out of 18 patients with PDAC who have undergone EphA2 BIA imaging to date. Bicycle Therapeutics believes these data validate the potential of EphA2 as a novel target in the treatment of cancer, demonstrate the translatability of preclinical data and highlight the potential of Bicycle molecules for targeted radioligand therapies and radiopharmaceutical imaging.
Preclinical assessment of nuzefatide anti-tumor activity in patient-derived xenograft (PDX) models of PDAC. Expression of EphA2 was found in all 16 PDAC PDX models. Of the 14 PDAC PDX models assessed for anti-tumor activity, 10 models were sensitive to nuzefatide, six of which showed high sensitivity. These data support the potential for nuzefatide to offer a novel option for the treatment of patients with PDAC.

In March 2026, Bicycle Therapeutics began enrolling patients in a Phase 2 clinical trial to evaluate efficacy, safety, and pharmacokinetics of nuzefatide in adult patients with recurrent PDAC, and the first patient was successfully dosed in April 2026.
Preclinical assessment of nuzefatide anti-tumor activity in cell-line-derived xenograft (CDX) models of head and neck squamous cell carcinoma (HNSCC). Nuzefatide demonstrated potent preclinical anti-tumor activity in EphA2-expressing CDX models of HNSCC.
The presentations are available in the Publications section of the Bicycle Therapeutics website.

(Press release, Bicycle Therapeutics, APR 20, 2026, View Source [SID1234664536])