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NeOnc Provides Business Update and Reports Q4 2025 Financial Results

On April 1, 2026 NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) ("NeOnc" or the "Company"), a multi-Phase 2 clinical-stage biopharmaceutical company developing novel therapies for central nervous system (CNS) cancers, reported financial results for the quarter and year ended December 31, 2025, and provided an update on recent operational achievements and upcoming milestones.

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Amir Heshmatpour, Chief Executive Officer, Executive Chairman, and President, commented:

"Q4 2025 and early 2026 marked important inflection points for NeOnc. We completed NEO212’s Phase 1 dose escalation and established a recommended Phase 2 dose of 610 mg, with early signs of possible anti-tumor activity in heavily pretreated patients.

In parallel, the NEO100 Phase 2a study in recurrent IDH1-mutant high-grade glioma is fully enrolled. Updated Phase 1/2a data suggested a 24% radiographic remission rate, 44% six-month progression-free survival, and no significant toxicity.

We also strengthened the balance sheet through a PIPE financing anchored by Cinctive Capital’s $10 million commitment, expanded the leadership team, and advanced our Middle East strategy through NuroMENA.

Looking ahead, we plan to hold a Type B End-of-Phase 1 FDA meeting for NEO212. We also expect a preliminary NEO100 Phase 2a data readout in approximately five months. We believe these near-term catalysts position NeOnc to deliver value-creating milestones for shareholders in the months ahead."

Fourth Quarter and Recent Highlights

Clinical Milestones & Data

NEO212 — Phase 1 Complete, RP2D Set at 610 mg:
Early signs of possible clinical efficacy, including potential durable disease control in heavily pretreated recurrent GBM and brain metastasis patients, observed even within the safety-focused phase
The company intends to request a Type B End-of-Phase 1 FDA meeting to align on a potential pivotal, registrational Phase 2 study
Exploring an Accelerated Approval pathway
First oral bio-conjugated temozolomide asset is mechanistically differentiated by its potential ability to overcome MGMT-mediated TMZ resistance.
NEO100 — Phase 2a Fully Enrolled: Completed enrollment in the NEO100 Phase 2a trial for IDH-1 mutant recurrent high-grade glioma, with an interim data readout expected in ~5 months (approximately August 2026).
Updated NEO100 Clinical Results Show Possible Durable Efficacy in Recurrent IDH1-Mutant Gliomas:
Expanded 25-patient cohort from Phase 1/2a and compassionate-use experience, intranasal NEO100
Suggested a 24% radiographic remission rate (6/25)—3× the ~8% historically seen with salvage therapies
44% six-month progression-free survival (vs. 21–31% historical benchmarks)
36% of patients (9/25) alive ≥18 months post-treatment initiation
No significant toxicity even under prolonged chronic dosing
Reinforces NEO100’s potential as a first-in-class, CNS-penetrant metabolic therapy for recurrent WHO Grade III/IV IDH1-mutant astrocytoma.
NEO100 & Ultrasound: Announced AI-driven findings demonstrating that ultrasound may enhance the potency of NEO100 against primary and metastatic brain tumors, pointing toward a potential combination approach.

Middle East Expansion (NuroMENA)

Executive Chairmanship: His Highness Sheikh Nahyan bin Zayed Al Nahyan assumed the role of Executive Chairman of NuroMENA, NeOnc’s UAE-based subsidiary, to advance a UAE-US partnership in brain cancer treatment.
Operational Agreements: NuroMENA executed a Master Services Agreement with M42’s IROS and expanded its Board of Directors.

Strengthening Leadership & Securing Growth Capital

PIPE Financing: Raised a PIPE investment anchored by a $10 million commitment from Cinctive Capital Management, strengthening the balance sheet to advance clinical priorities.
Chief Executive Officer: Named Amir Heshmatpour as CEO to lead the company’s next phase of clinical and corporate development.
Chief Accounting Officer: Appointed David Choi as CAO to oversee the Company’s accounting, financial reporting, internal controls, and corporate governance functions.
Scientific Advisory Board Expansion: Added two leading neuro-oncologists — Dr. David M. Ashley, Director of Duke’s Preston Robert Tisch Brain Tumor Center, and Dr. Alexandra M. Miller, Chief of Neuro-Oncology at NYU Langone’s Perlmutter Cancer Center — deepening the company’s scientific bench.

Investor & Media Engagement

Broadcast Exposure: Featured across multiple New to The Street segments on Bloomberg Television (U.S., MENA, and Latin America) and Fox Business, increasing visibility among retail and institutional audiences.
Investor Events & KOL Calls: Hosted multiple investor and key opinion leader conference calls presenting clinical data updates and participated in the New to The Street Accredited Investor Event at Hudson Yards, New York.

Financial Results for Q4 2025

G&A expenses: $4,818k vs. $1,680k in Q4 2024, reflecting expanded marketing, rent, travel, and Middle East partnership-related costs.
R&D expenses: $3,638k vs. $3,045k in Q4 2024, driven by active management of NEO100 trial sites, recruitment for NEO212, initiation of NEO100-3, and overall patient recruitment activity.
Net loss: $62.1 million or $3.20 per diluted share, compared to $11.9 million or $0.69 per diluted share in Q4 2024, primarily due to increased general and administrative expenses, as well as stock-based compensation expenses.

(Press release, Neonc, APR 1, 2026, View Source [SID1234664142])

Personalis to Participate in the 25th Annual Needham Virtual Conference

On April 1, 2026 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported that its management team will be participating in the 25th Annual Needham Virtual Conference on Wednesday, April 15, 2026.

(Press release, Personalis, APR 1, 2026, View Source [SID1234664141])

Janux Therapeutics Announces Development Candidate Nomination Under Bristol Myers Squibb Collaboration, Triggering $35 Million Milestone Payment

On April 1, 2026 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies, reported the nomination of a development candidate under its collaboration and exclusive worldwide license agreement with Bristol Myers Squibb. The milestone was achieved following the identification of a tumor-activated therapeutic, utilizing Janux’s TRACTr platform, targeting an undisclosed solid tumor antigen expressed across several human cancer types, triggering a $35 million milestone payment to Janux.

"This milestone underscores the strength of our approach to generating value through both internal innovation and strategic partnerships, and reflects the continued promise of our tumor-activated platforms," said David Campbell, Ph.D., President and Chief Executive Officer of Janux. "The nomination of a development candidate highlights our ability to translate platform insights into differentiated therapeutics in collaboration with leading oncology companies."

"We are pleased to reach this important milestone with Bristol Myers Squibb, which reflects strong collaboration between our teams and the disciplined execution of our research and development efforts," said Janeen Doyle, Chief Corporate and Business Development Officer of Janux. "Advancing a program to development candidate nomination represents a key step toward IND-enabling studies and clinical development."

Under the terms of the collaboration agreement, Janux is responsible for conducting preclinical development through IND submission. Bristol Myers Squibb will hold the IND and will be responsible for subsequent clinical development and global commercialization of products arising from the collaboration. Janux will remain actively involved in the program, supporting Bristol Myers Squibb through completion of the first Phase 1 clinical study.

In addition to the $35 million milestone payment associated with development candidate nomination, Janux is eligible to receive additional development, regulatory and commercial milestone payments, as well as tiered royalties on global product sales.

(Press release, Janux Therapeutics, APR 1, 2026, View Source [SID1234664140])

Zai Lab Announces Global Clinical Trial Collaboration and Supply Agreement to Evaluate Novel DLL3 ADC, Zocilurtatug Pelitecan, in Combination with a Bispecific T-cell Engager Therapy

On April 1, 2026 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported a global clinical trial collaboration with Amgen Inc. (NASDAQ: AMGN) to evaluate Zai Lab’s investigational delta-like ligand 3 (DLL3)-targeting antibody-drug conjugate (ADC), zocilurtatug pelitecan (zoci, formerly ZL-1310), in combination with Amgen’s IMDELLTRA (tarlatamab-dlle), a DLL3-targeting Bispecific T-cell Engager (BiTE) therapy in patients with extensive-stage small cell lung cancer (ES-SCLC).

As part of this collaboration agreement, Amgen will sponsor a global Phase 1b study to evaluate the safety and efficacy of zoci in combination with IMDELLTRA in patients with ES-SCLC. Zai Lab will retain full ownership of zoci and will supply Amgen with the study drug.

"In combination, this dual-targeting strategy has the potential to increase the rate and deepen responses both systemically and, in the brain, address resistance pathways, and unlock new treatment paradigms for patients with small cell lung cancer," said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. "These two approaches leverage complementary mechanisms — our ADC delivers a potent cytotoxic payload directly to DLL3-expressing tumor cells, while the T-cell engager is designed to activate T-cells by binding the same antigen and eliciting an immune response against the tumor."

Zoci is a DLL3-targeting ADC for small cell lung cancer. Zai Lab has presented data from a Phase 1/2 clinical trial of zoci at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium 2025 and the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting, demonstrating a high response rate in heavily pretreated SCLC patients, including strong intracranial activity, and a tolerable safety profile. Amgen’s IMDELLTRA received FDA approval and is currently marketed in the U.S. for the treatment of adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy. Please see full Prescribing Information, including Boxed Warnings, for IMDELLTRA.

About Zocilurtatug Pelitecan (zoci, formerly ZL-1310)

Zoci is a novel ADC in Zai Lab’s global oncology pipeline targeting DLL3, an antigen that is overexpressed in many neuroendocrine tumors, is typically associated with poor clinical outcomes, and is a validated therapeutic target for SCLC. Zoci comprises a humanized anti-DLL3 monoclonal antibody linked to a novel camptothecin derivative (a topoisomerase 1 inhibitor) as its payload. The compound was designed with a novel ADC technology platform called TMALIN, which leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies, including off-target payload toxicity.

Zoci is being evaluated in a global development program, which includes DLLEVATE, a pivotal trial to further evaluate the safety and efficacy of zoci compared to investigator’s choice single agent therapy in patients with relapsed ES-SCLC; a phase 1b/2 trial evaluating zoci in selected solid tumors including extrapulmonary neuroendocrine carcinoma; and a phase 1a/1b trial evaluating zoci as monotherapy and in combination with atezolizumab, an immune checkpoint inhibitor, for the treatment of ES-SCLC.

Zoci’s safety profile, coupled with compelling systemic and intracranial efficacy, supports its potential as a backbone ADC in first-line combination regimens, including those that reduce the burdens of chemotherapy. Zoci received FDA Orphan Drug Designation and FDA Fast Track Designation for the treatment of SCLC.

About Small Cell Lung Cancer (SCLC)

SCLC is one of the most aggressive and lethal solid tumors, accounting for ~15% of approximately 2.5 million patients diagnosed with lung cancer worldwide each year1,2. Two-thirds of all SCLC patients are diagnosed at extensive stage3, which is associated with high rates of relapse and poor prognosis. The outcomes of the patients with ES-SCLC are dismal, with median survival of approximately 12 months following initial therapy4 and a ~5-10% overall five-year survival rate5. Treatment options have historically been limited once a patient progresses. IMDELLTRA is the first DLL3-targeting bispecific T-cell engager therapy to demonstrate an overall survival benefit in this patient population. The combination of zocilurtatug pelitecan and IMDELLTRA has the potential to build on these gains by further improving efficacy while maintaining manageable safety.

(Press release, Zai Laboratory, APR 1, 2026, View Source [SID1234664139])

Frontier Medicines Announces Exclusive Licensing Agreement for FMC-220, a First-in-Class Covalent p53 Y220C Activator, with LG Chem, Ltd.

On April 1, 2026 Frontier Medicines Corporation, a clinical-stage precision medicines company unlocking the proteome to develop small molecule oncology and immunology drugs against previously undruggable disease-causing targets, reported that the Company has granted LG Chem, Ltd. ("LG Chem"), a leading global company headquartered in South Korea that specializes in life sciences as one of its core businesses, an exclusive worldwide license to develop and commercialize FMC-220 outside of Greater China, with Frontier retaining ownership and full control in Greater China. FMC-220 is Frontier’s first-in-class covalent p53 Y220C activator being evaluated for the treatment of solid tumor cancers with TP53 loss-of-function mutations.

"This partnership with LG Chem marks an exciting and pivotal step for Frontier and for the FMC-220 program, underscoring the promise of our proprietary Frontier Platform to address historically challenging targets and deliver differentiated, covalent precision therapies," said Chris Varma, Ph.D., co-founder, chairman, and chief executive officer of Frontier Medicines. "Through this collaboration with LG Chem, the FMC-220 program will continue to advance, progressing toward translating the encouraging preclinical data we have demonstrated to date for FMC-220 into meaningful impact for patients. We are thrilled to partner with LG Chem, whose global development and commercialization expertise will be instrumental in bringing this therapy to patients worldwide."

FMC-220 covalently binds the mutant cysteine residue introduced by the Y220C substitution in TP53. TP53 Y220C is a common missense mutation found in approximately 1-3% of cancers, particularly prevalent in solid tumors such as lung, breast, ovarian and colorectal cancers. Preclinical data presented at American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 showed that FMC-220 delivers unprecedented potency, selective engagement, and durable anti-tumor activity at low doses across a broad range of tumor models, including those harboring co-mutations such as those in KRAS.

Dr. Jeewoong Son, President of LG Chem Life Sciences Company, said, "FMC‑220 is an innovative approach that targets genetic mutations with limited existing treatment options," adding that the company will "work to validate its potential as a treatment option that could deliver benefits to patients."

Under the terms of the agreement, LG Chem will be responsible for regulatory filings, global clinical development, and commercialization in the licensed territories, and Frontier retains an option for enhanced financial participation through partial funding of the confirmatory clinical trial. Frontier will receive an upfront payment and is eligible to receive additional clinical, regulatory, and commercial milestone payments, and mid-single-digit to double-digit royalties on net sales.

FMC-220 was discovered using the Frontier Platform, integrating chemoproteomics and AI for covalent-based drug discovery. FMC-220 is the second potential first-in-class program to advance from the platform, following FMC-376, a dual ON/OFF KRASG12C inhibitor currently in clinical development.

(Press release, Frontier Medicines, APR 1, 2026, View Source [SID1234664138])