On April 1, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported it will present new data at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in San Diego, California from April 17-22, 2026. The Company will demonstrate 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).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 SA, a known T and NK-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 will showcase 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 may overcome these historical limitations.

The Company is developing 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 the possibility of off-tumor interactions. The Company is pursuing additional T-cell engager targets like EGFR, EpCAM, and Nectin-4.

"We continue to advance the RedTail platform through our lead asset, CLD-401, and now through our work with T-cell engagers," said Eric Poma, PhD, Chief Executive Officer of Calidi. "We believe RedTail represents a major breakthrough in the ability to deliver genetic payloads in a targeted fashion to distal sites of disease through systemic administration."

"The data we will present at AACR (Free AACR Whitepaper) highlight the ability of the RedTail platform to functionally overexpress complex biologics likes 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. "The ability of the RedTail platform to induce high levels of expression of its genetic payloads only at the tumor can potentially overcome many of the limitations currently seen with cytokine and 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 1, 2026, View Source [SID1234664120])

On April 1, 2026 A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage immunotherapy company developing first-in-class logic-gated therapies for solid tumors, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for A2B543, an autologous CAR T-cell therapy designed for the treatment of germline heterozygous HLA-A*02 adults with recurrent unresectable, locally advanced, or metastatic solid tumors that express MSLN and have lost HLA-A*02 expression.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.1

"Receiving Fast Track designation for A2B543 from the U.S. FDA is a key milestone for A2 Bio in accelerating this promising precision CAR T-cell therapy for cancer patients," said Jim Robinson, chief executive officer of A2 Bio. "We are deeply committed to patients facing cancer and other devastating diseases, and we believe in the potential for A2B543 to address unmet needs in cancer therapy."

A2B543 is being investigated in the ongoing EVEREST-2 clinical study (NCT06051695) which is evaluating the safety and efficacy of A2B694 (Arm 1) and A2B543 (Arm 2) autologous logic-gated investigational cell therapies in patients with colorectal cancer, pancreatic cancer, non-small cell lung cancer, ovarian cancer, mesothelioma, and other solid tumors that express MSLN and have lost HLA-A*02 expression.

A2B543 is comprised of autologous Tmod cells expressing a MSLN-targeted CAR activator, an HLA-A*02-targeted blocker, and an inducible, membrane-tethered IL-12 (mem-IL-12) booster. The inducible mem-IL-12 booster, which activates only upon engagement with tumor antigens, is designed to enhance the long-term potency and persistence of Tmod while reducing toxicity associated with systemic IL-12.2

The A2 Bio proprietary Tmod technology platform provides selective killing of tumor cells and protection of normal cells via a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. This novel blocker technology enables precise, personalized, and effective T-cell targeting specifically against tumors.

For more information about A2 Bio clinical studies and how to enroll, visit www.a2bioclinicaltrials.com.

(Press release, A2 Biotherapeutics, APR 1, 2026, View Source [SID1234664136])

On April 1, 2026 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the completion of the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib. Based on the positive results from the PEAK trial, the bezuclastinib NDA was submitted under the FDA’s Real-Time Oncology Review (RTOR) program, which is intended to enable a more streamlined review process. Bezuclastinib was also granted Breakthrough Therapy Designation as a treatment for GIST earlier this year.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to complete our PEAK NDA submission which marks a significant step toward bringing a new therapy to patients with second-line GIST," said Andrew Robbins, President and Chief Executive Officer. "Based on the strength of the PEAK data, we believe the bezuclastinib combination has the potential to meaningfully change the treatment landscape for these patients. We are grateful to the patients, investigators, and study teams who made this possible."

Pivotal data from PEAK, a global, randomized Phase 3 clinical trial evaluating bezuclastinib in combination with sunitinib vs. sunitinib monotherapy in patients with GIST who have received prior treatment with imatinib, were reported in November 2025. As disclosed in the top-line results, the bezuclastinib combination demonstrated a substantial and highly statistically significant clinical benefit on the primary endpoint of progression free survival (PFS), reducing risk of disease progression or death compared to the current standard of care by 50% (hazard ratio of 0.50, 95% CI: 0.39 – 0.65). mPFS, as assessed by blinded independent central review, was 16.5 months for the bezuclastinib combination vs. 9.2 months for sunitinib monotherapy. Additionally, the bezuclastinib combination demonstrated an unprecedented ORR in imatinib-resistant patients, with 46% of patients treated with the bezuclastinib combination achieving an objective response compared to 26% of patients treated with sunitinib. The bezuclastinib combination was generally well tolerated, and no unique risks were observed with the novel combination when compared to the known safety profile of sunitinib. Data for overall survival remains immature.

At the time of data cutoff, based on the number of ongoing patients receiving treatment on the bezuclastinib combination arm, the estimated mean duration of treatment for the bezuclastinib combination is projected to exceed 19 months.

Cogent plans to present full results from the PEAK trial at a major medical meeting during the first half of 2026. Additionally, Cogent is on track this quarter to initiate a Phase 2 trial investigating the benefit of the bezuclastinib plus sunitinib combination for first-line GIST patients with exon 9 mutations who are naive to, or recently initiated treatment with, imatinib. The NDA submission with bezuclastinib in Advanced Systemic Mastocytosis (AdvSM) also remains on track for the first half of 2026.

Bezuclastinib – Expanded Access Program
Working with the FDA, Cogent has established active Expanded Access Programs (EAPs) for U.S. patients with GIST or SM who meet disease-specific criteria and could benefit from treatment with bezuclastinib or the combination of bezuclastinib and sunitinib. A growing number of sites now offer access to the bezuclastinib EAPs. For more information please visit: View Source

Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Cogent also announced today that, on March 30, 2026, the Compensation Committee of Cogent’s Board of Directors, made up entirely of independent directors, approved the grants of "inducement" equity awards to six new employees under the company’s 2020 Inducement Plan with a grant date of March 30, 2026. The awards were approved in accordance with Listing Rule 5635(c)(4) of the corporate governance rules of the Nasdaq Stock Market. The employees received, in the aggregate, (i) nonqualified options to purchase 21,100 shares of Cogent common stock and (ii) 15,700 restricted stock units (RSUs). Each option has a 10-year term, an exercise price equal to the closing price of Cogent’s common stock on the grant date, and a 4-year vesting schedule with 25% vesting on the 1-year anniversary of the grant date and the remainder vesting in equal monthly installments over the subsequent 36 months, provided such employee remains employed through each such vesting date. The RSUs vest annually in equal installments over 4 years from the grant date, provided such employee remains employed through each such vesting date.

(Press release, Cogent Biosciences, APR 1, 2026, View Source [SID1234664121])

On April 1, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) reported that it has extended the expiration of the tender offer to purchase all outstanding shares of common stock of Arcellx. The offer remains at a purchase price of (1) $115.00 per share, net to the seller in cash, without interest, subject to any withholding tax, plus (2) one contractual contingent value right (CVR), which represents the right to receive one contingent payment of $5.00 per CVR in cash, without interest, and subject to any withholding tax, payable on March 31, 2030, subject to cumulative worldwide sales of Arcellx’s anitocabtagene autoleucel (anito-cel) product exceeding $6.0 billion on or prior to December 31, 2029.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The tender offer, which was previously scheduled to expire at one minute after 11:59 p.m., Eastern Time, on April 2, 2026, has been extended to expire at 5:00 p.m., Eastern Time, on April 24, 2026. The transaction is anticipated to close during the second quarter of 2026, subject to the satisfaction or waiver of customary closing conditions, including the tender of a number of shares of Arcellx common stock that, together with shares already owned by Gilead, equals at least a majority of the then-outstanding Arcellx shares, the receipt of regulatory approvals and other customary offer conditions.

Computershare Trust Company, N.A., the depositary and paying agent for the tender offer, has advised Gilead that, as of 5:00 p.m., Eastern Time, on March 31, 2026, approximately 4,389,763 shares have been validly tendered and not validly withdrawn in the tender offer, representing approximately 7.5% of the outstanding shares as of such date and time. Holders that have previously tendered their shares do not need to re-tender their shares or take any other action in response to the extension of the tender offer. Questions or requests for assistance may be directed to Innisfree M&A Incorporated, the information agent for the tender offer, by calling toll free (877) 800-5182.

(Press release, Gilead Sciences, APR 1, 2026, View Source [SID1234664137])

On April 1, 2026 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported it will attend the Society of Interventional Radiology (SIR) 2026 Annual Scientific Meeting, taking place April 11–15, 2026, in Toronto, Canada.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

At the event, Delcath’s Hepatic Delivery System for use in percutaneous hepatic perfusion will be featured in three presentations.

On April 13, 2026, at 2:40 PM ET, Dr. Eric Wehrenberg-Klee, an interventional radiologist at Massachusetts General Hospital and Assistant Professor of Radiology at Harvard Medical School, will discuss his HEPZATO user experience at the SIR Innovation Hub;
On April 15, 2026, at 12:18 PM ET, Dr. David Eschelman, Professor of Radiology at Thomas Jefferson University, will present his initial commercial experience with percutaneous hepatic perfusion (PHP) for the treatment of liver metastases from uveal melanoma at Booth 701B; and
On April 15, 2026, at 12:27 PM ET, Dr. Mustafa Ege Seker, Research Fellow in the Department of Radiology, Section of Interventional Radiology from the University of Wisconsin, will present his preliminary clinical experience with percutaneous hepatic perfusion (PHP) for the treatment of liver metastases from uveal melanoma at Booth 701B.
The related abstracts are available at View Source under Scientific Meetings.

(Press release, Delcath Systems, APR 1, 2026, View Source [SID1234664122])