On June 15, 2026 Aptose Biosciences Inc. ("Aptose" or the "Company") (TSX: APS; OTC: APTOF), a clinical-stage precision oncology company, reported that data from its Phase 1/2 TUSCANY trial in newly diagnosed AML patients treated with tuspetinib (TUS) in combination with standard of care dosing venetoclax and azacitidine (TUS+VEN+AZA triplet) was presented yesterday in an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress (EHA 2026) in Stockholm, Sweden.

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The TUS+VEN+AZA triplet is being developed as a mutation agnostic frontline therapy to treat large, mutationally unrestricted and diverse populations of newly diagnosed AML patients who are ineligible to receive induction chemotherapy. Nikolai Podoltsev, MD, PhD, Associate Professor Medical Oncology & Hematology, Clinical Director, Malignant Hematology, Yale School of Medicine, and an investigator in the TUSCANY study, reported updated safety and efficacy data from the 80 mg and 120 mg dose cohorts, as well as new data from the 160 mg dose of TUS in the TUS+VEN+AZA triplet.

"While there have been recent successes with targeted therapy in AML treatment, our multi-targeted approach with tuspetinib in combination is showing significant efficacy across mutations that have been historically difficult to treat, including TP53 mutations, where we thus far have achieved CRs in all of the four subjects at the highest dose cohort," said Rafael Bejar, MD, PhD, Chief Medical Officer, Aptose. "As a safe and effective inhibitor of multiple growth factor signaling pathways, the TUS+VEN+AZA triplet is a first line combination therapy with the potential to improve outcomes in nearly all AML populations."

The oral presentation at EHA (Free EHA Whitepaper) included updated safety, complete remission, minimal residual disease (MRD) assessments, and longer duration of follow-up:

Presentation title: TUSCANY Study of Safety and Efficacy of Tuspetinib Plus Standard of Care Venetoclax and Azacitidine in Study Participants with Newly Diagnosed AML Ineligible for Induction Chemotherapy

Presenter: Nikolai Podoltsev, MD, PhD, Associate Professor (Medical Oncology & Hematology), Department of Internal Medicine; Clinical Director, Malignant Hematology, Associate Program Director, Hematology / Medical Oncology Fellowship Program, Yale School of Medicine

Key findings:

32 (29 response evaluable), newly diagnosed AML patients have received the TUS+VEN+AZA combination:
4 received the 40 mg dose of TUS, 12 received the 80 mg dose of TUS, 3 received the 120 mg dose of TUS, and 13 received the 160 mg dose

The overall CRc rate across dose levels in response evaluable (29) patients was 86.2%.
The MRD negative rate among all patients dosed was 62.5%; MRD negative rate in CR/CRh patients was 86.2%.

At the 160 mg TUS dose level (n=13):
The overall CRc rate was 76.9% (10 of 13 patients), including 8 of 11 (72.7%) with unmutated (or wildtype) FLT3
100 % composite complete remission in all 4 patients with TP53-mutation with complex karyotype (TP53-mut/CK)

Regardless of mutation status, TUS is active in newly diagnosed AML patients
MRD-negative responses achieved across diverse genetic populations, including adverse TP53 mutations and CK
Responses continue to evolve with 19 subjects remaining on treatment, including 6 that moved on to stem cell transplantation

TUS can be administered safely with standard-of-care dosing of VEN/AZA
TUS PK properties were not significantly altered by VEN, AZA, antifungals or food
No treatment-related deaths
No treatment-related adverse events of QTc prolongation, CPK elevations or differentiation syndrome
Abstracts are available on the EHA (Free EHA Whitepaper)2026 website here. The presentation is available on the Aptose website here.

TUSCANY: TUS+VEN+AZA Triplet Phase 1/2 Study

The tuspetinib-based TUS+VEN+AZA triplet therapy is being advanced in the TUSCANY Phase 1/2 clinical study with the goal of creating an improved frontline therapy for newly diagnosed AML patients that is active across diverse AML populations, durable, and well tolerated. Earlier APTIVATE trials of TUS as a single agent and in combination as TUS+VEN demonstrated favorable safety and broad activity in diverse relapsed or refractory (R/R) AML populations that went beyond the more prognostically favorable NPM1 and IDH mutant subgroups. Indeed, responses were also in R/R AML patients with highly adverse TP53 and RAS mutations, and those with mutated or unmutated (wildtype) FLT3 genes.

The TUSCANY Phase 1/2 study, being conducted at 10 leading U.S. clinical sites by elite clinical investigators, is designed to test various doses and schedules of TUS in combination with standard dosing of AZA and VEN for patients with AML who are ineligible to receive induction chemotherapy. A convenient, once daily oral agent, TUS, is being administered in 28-day cycles.

More information on the TUSCANY Phase 1/2 study can be found on www.clinicaltrials.gov (here).

(Press release, Aptose Biosciences, JUN 15, 2026, View Source [SID1234668735])

On June 15, 2026 CERo Therapeutics Holdings, Inc. (OTCQB: CERO) ("CERo" or the "Company"), an innovative cellular immunotherapy company advancing engineered T cell therapeutics designed to engage phagocytic mechanisms, reported a clinical update from investigators participating in the ongoing Phase 1 CERTAIN-T clinical trial evaluating CER-1236 in hematologic malignancies.

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Patient five in the trial had multiple refractory acute myeloid leukemia (AML) and, according to the treating investigator, had not previously achieved disease control sufficient to enable allogeneic stem cell transplantation prior to enrollment in the study. Following treatment with CER-1236 at a total dose of 4 million cells/kg, bone marrow blast counts were reported at 14% on Days 14 and 28 and 7% on Day 42. The patient subsequently underwent allogeneic stem cell transplantation on Day 71 following infusion. Allogeneic stem cell transplantation is generally considered a potentially curative therapeutic option for eligible patients with refractory hematologic malignancies and remains a critical component of treatment for many patients with relapsed or treatment-resistant disease.

The patient’s transplant course and longer-term clinical outcome remain under evaluation. These observations are preliminary, based on a limited number of patients, and no definitive conclusions regarding safety or efficacy can be made at this stage of the trial.

Chris Ehrlich, CEO of CERo, commented, "We continue to observe encouraging findings from the ongoing trial, with investigators reporting clinical improvement in two patients treated across the first two cohorts. Although formal response assessments remain ongoing, investigators have reported findings suggestive of clinical benefit following treatment with CER-1236. We look forward to continuing dose escalation and further evaluating CER-1236 in the ongoing Phase 1 study."

The observed safety profile across all treated patients remains consistent with clinical data previously presented at the Tandem Meetings in February, which reported no cytokine release syndrome ("CRS"), immune effector cell-associated neurotoxicity syndrome ("ICANS"), DLTs, or treatment-related severe adverse events during the DLT assessment window.

The Company has now treated six patients in the ongoing Phase 1 trial. In the most recent cohort of three patients, CER-1236 was administered at an increased dose level, with no dose-limiting toxicities ("DLTs") observed during the DLT assessment period. As previously reported, CERo has also observed expansion of infused CER-1236 cells following administration, and the Company continues to evaluate the pharmacokinetic and pharmacodynamic profile of CER-1236 as the study advances through dose escalation.

The Company has initiated the third planned cohort of the CERTAIN-T study, which is expected to evaluate the planned one billion cells/patient protocol and is currently screening patients for enrollment. The cohort is also expected to include patients with myelodysplastic syndromes ("MDS") and myelofibrosis ("MF"), reflecting the Company’s strategy to further evaluate CER-1236 in additional myeloid disease settings.

About the CERTAIN-T Trial

The first-in-human, multicenter, open-label Phase 1/1b CERTAIN-T study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of CER-1236 in patients with hematologic malignancies. The study initially enrolled patients with acute myeloid leukemia ("AML"), including relapsed/refractory AML, measurable residual disease AML, and newly diagnosed TP53-mutated AML, and has since expanded to include transfusion-dependent myelodysplastic syndromes ("TD-MDS"), high-risk myelodysplastic syndromes ("HR-MDS"), and post-JAK inhibitor myelofibrosis ("MF"). Primary endpoints include safety and tolerability. Secondary endpoints include pharmacokinetics and measures of clinical response, including overall response rate ("ORR"), complete response ("CR"), composite complete response ("cCR"), and measurable residual disease ("MRD").

(Press release, Cero Therapeutics, JUN 15, 2026, View Source [SID1234668751])

On June 15, 2026 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, reported it will participate as an exhibitor in the upcoming Children’s Tumor Foundation (CTF) 2026 NF Conference, held June 26-30, 2026, in Denver, Colorado.

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"Direct engagement with the clinical and academic NF1 community strengthens our commitment to develop better-tolerated therapies that can be used safely over the long term," said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. "We look forward to collaborating closely with CTF and the broader NF1 community to advance meaningful innovation and improve outcomes for individuals living with NF1."

Participants interested in meeting with Pasithea representatives are encouraged to contact us via the email below.

About Children’s Tumor Foundation’s NF Conference

The Children’s Tumor Foundation’s annual NF Conference is the premier event for the global NF research and clinical community, uniting experts and innovators dedicated to transforming outcomes for patients with NF. This includes NF1 and all types of schwannomatosis (SWN), such as NF2-related schwannomatosis (NF2-SWN), previously known as neurofibromatosis type 2.

About NF1- PN

Plexiform neurofibromas (PN) are tumors originating from the nerve sheath that grow through and around nerves and may involve multiple nerve branches. Thirty to fifty percent (30-50%) of patients with NF1 will harbor PNs, which can undergo malignant transformation. PN-related morbidities are primarily caused by the direct impact of the tumor on surrounding structures and can be life-threatening when they compress vital organs or when they become malignant.

(Press release, Pasithea Therapeutics, JUN 15, 2026, View Source [SID1234668736])

On June 15, 2026 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, reported first clinical proof-of-concept data for LB2501, its investigational in vivo CD19/CD20 dual-targeting CAR-T cell therapy, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). The results are being presented today in a late-breaking session at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress (Abstract #LB5006).

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In the ongoing Phase 1 study, a single infusion of LB2501 generated dose-dependent in vivo CAR-T expansion without lymphodepletion. At the higher dose level (DL2), LB2501 achieved a 100% objective response rate (ORR) (6/6) and an 83.3% complete response rate (CR) (5/6), with all responses ongoing at the time of data cutoff. LB2501 also showed a favorable safety profile, with no dose-limiting toxicities (DLTs), serious adverse events (SAEs), immune effector cell-associated neurotoxicity syndrome (ICANS), or deaths reported.

"In vivo CAR-T represents a compelling frontier in cell therapy, enabling the generation of CAR-T cells directly within the patient, with the potential to simplify treatment and expand access over time," said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. "LB2501 is our step toward realizing that vision and reflects further progress toward our goal of leading the future of cell therapy. Backed by the commercial and scientific foundation we have built with CARVYKTI, we are well-positioned to advance this next generation of CAR-T delivery. These early data, with deep responses from a single infusion across patients, give us confidence in the path ahead."

LB2501 Demonstrates In Vivo CAR-T Generation and Early Clinical Activity

In an ongoing Phase 1 study, 12 patients with R/R B-NHL received LB2501 across two dose levels, DL1 (n=6) and DL2 (n=6). Patients had received a median of three prior lines of therapy, and 58.3% were refractory to their most recent treatment. The open-label, multi-center, dose-escalation study is evaluating safety, recommended Phase 2 dose, pharmacokinetics, and preliminary efficacy in adults with R/R B-NHL. The study was conducted without lymphodepletion.

At DL2, LB2501 achieved a 100% ORR (6/6) and an 83.3% CR rate (5/6), with responses observed across patients with diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and follicular lymphoma (FL). Across both dose levels, the ORR was 50.0% (6/12), and the CR rate was 41.7% (5/12). At the time of data cutoff, all responses at DL2 were ongoing.

LB2501 showed a favorable safety profile. No DLTs, SAEs, ICANS, or deaths were reported. Infusion-related reactions (IRR) and cytokine release syndrome (CRS) were the most common adverse events of special interest and were all Grade 1–2. Infusion-related reactions occurred in 75.0% (9/12) of patients overall, with a median onset of 1.4 hours after infusion and a median recovery time of 18.6 hours. CRS occurred in 66.7% (8/12) of patients overall, with a median onset at Day 11 and a median duration of 4.5 days. IRR and CRS were all Grade 1–2, no patients required glucocorticoids for CRS management. Four patients received tocilizumab.

Pharmacokinetic analyses showed dose-dependent in vivo CAR-T expansion in 100% (6/6) of patients at DL2 and 83% (5/6) of patients at DL1. CAR-T cells remained detectable in peripheral blood for up to 116 days. Viral copy number in peripheral blood peaked immediately after infusion and decreased to undetectable concentrations within 24 hours.

Additional translational analyses further characterized the in vivo profile of LB2501. No evidence of non-specific transduction was detected in NK cells or other non-T/B/NK lymphocyte populations. Vector integrations were highly polyclonal and diverse. These findings support proof-of-concept for in vivo T-cell engineering, with polyclonal vector integration and rapid vector clearance.

"These early clinical findings are encouraging in a heavily pretreated relapsed or refractory B-cell non-Hodgkin lymphoma population," said Lei Fan, M.D., Ph.D., Professor, Doctoral Supervisor, and Administrative Director, Hematology Department, Jiangsu Province Hospital, Nanjing, China. "The responses observed at the higher dose level achieved a 100% objective response rate, together with a favorable safety profile and the absence of lymphodepletion, support further investigation of LB2501 as a novel in vivo CAR-T approach. The additional pharmacokinetic and translational findings presented at EHA (Free EHA Whitepaper) further support the feasibility of generating CAR-T cells directly within the patient." ‡

ABOUT LB2501
LB2501 is an investigational, potential first-in-class CD19/CD20 dual-targeting in vivo CAR-T therapy designed to generate CAR-T cells directly within the patient following a single intravenous infusion. It is being evaluated in an ongoing Phase 1, open-label study (NCT07002112) in patients with relapsed/refractory B-cell malignanciesi to assess safety, tolerability, and preliminary efficacy.[i]

ABOUT B-CELL NON-HODGKIN LYMPHOMA
Non-Hodgkin lymphoma (NHL) is a group of cancers that originate in lymphocytes, a type of white blood cell that plays a key role in the body’s immune system.ii B-cell lymphomas account for approximately 85% of NHL cases and arise from abnormal growth of B lymphocytes (B cells), which are responsible for producing antibodies. These malignancies include a range of subtypes that vary in aggressiveness, from slow-growing to highly aggressive disease.iii

While treatment advances have improved outcomes for some patients, those with relapsed or refractory B-cell NHL, particularly after multiple lines of therapy, often face limited options.

(Press release, Legend Biotech, JUN 15, 2026, View Source [SID1234668752])

On June 15, 2026 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE) reported that it has changed its corporate name to Faeth Therapeutics, Inc. (the "Company"). The Company’s common stock is expected to begin trading on the Nasdaq Capital Market under the new ticker symbol "FTH" on June 16, 2026, and the Company has launched a new corporate website at www.faeththerapeutics.com.

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On June 10, 2026, stockholders approved the conversion of the Company’s Series B preferred stock issued in connection with the February 2026 acquisition of Faeth Therapeutics and concurrent private placement. As a result, outstanding shares of the Company’s Series B convertible preferred stock will automatically convert into common stock effective at 5:00 p.m. ET on June 15, 2026, subject to certain beneficial ownership limitations set by each holder. The Company received approximately $200 million in gross proceeds from the private placement that closed concurrently with its February 2026 acquisition of Faeth.

"Starting tomorrow, we will begin trading on Nasdaq under our new name and ticker as a well-capitalized public company backed by a syndicate of leading life sciences investors, and focused on a clear set of clinical catalysts," said Anand Parikh, Chairman and Chief Executive Officer. "For two decades, drugs that block a single node of the PI3K/AKT/mTOR pathway have been undone by the tumor’s ability to route around them. PIKTOR represents our answer to this challenge: an all-oral regimen that patients can take at home, designed to inhibit PI3K-alpha, mTORC1 and mTORC2 at once, close the routes tumors may use to escape, and potentially drive deeper, more durable suppression, with the potential for a best-in-class profile. We believe we now have the capital and the team to put that approach to the test, beginning with topline Phase 2 data in advanced endometrial cancer, expected in the second half of this year, and interim Phase 1b/2 data in HR+/HER2- advanced breast cancer, expected in 2027."

Leadership and Board

Effective June 12, 2026, the Company appointed a new executive leadership team. Anand Parikh, a co-founder of Faeth who has led the company since its founding in 2019, has been appointed Chairman, President and Chief Executive Officer. Brian Stephenson, Ph.D., CFA, who previously served as the Company’s Head of Operations and Finance and as Chief Financial Officer of BridgeBio Pharma, Inc., has been appointed Chief Financial Officer. Oliver Maddocks, Ph.D., a co-founder of Faeth and a cancer-metabolism researcher, serves as Chief Scientific Officer, and Debbie Chirnomas, M.D., M.P.H., serves as Chief Medical Officer.

The Company’s board of directors consists of five members: Anand Parikh (Chair); Bob Holmen; Phillip B. Donenberg; Stephen M. Hahn, M.D.; and Saira Ramasastry. Dr. Hahn, the 24th Commissioner of the U.S. Food and Drug Administration and a former Faeth director, and Ms. Ramasastry, a life sciences strategic advisor and experienced public-company director, joined the board on June 12, 2026.

"In a career spent in oncology and at the FDA, I’ve learned how rarely a program pairs a high-prevalence target with a potentially differentiated mechanism," said Stephen M. Hahn, M.D., the 24th Commissioner of the U.S. Food and Drug Administration and a member of the Company’s board of directors. "I believe Faeth’s multi-node, all-oral approach to the PI3K/AKT/mTOR pathway is scientifically rigorous and aimed at a real unmet need. I’m looking forward to guiding the company through this next stage of clinical development."

About PIKTOR

PIKTOR is an investigational, proprietary, all-oral combination of serabelisib, a selective PI3K-alpha inhibitor, and sapanisertib, an mTORC1/mTORC2 inhibitor, designed to inhibit multiple nodes of the PI3K/AKT/mTOR pathway. According to published literature, this pathway is dysregulated in up to 50% of all solid tumors, making it one of the most prevalent therapeutic targets in oncology. PIKTOR is being evaluated in a Phase 2 trial in second-line advanced endometrial cancer (Study FTH-PIK-201), with topline data anticipated in the second half of 2026, and in a Phase 1b/2 trial in HR+/HER2- advanced breast cancer (Study FTH-PIK-101), in which the first patient was dosed in April 2026 and interim data is anticipated in 2027.

(Press release, Faeth Therapeutics, JUN 15, 2026, View Source [SID1234668737])