On March 4, 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 data from the dose-escalation portion of its Phase 1/2 clinical trial for NEO212, the Company’s novel oral bio-conjugated therapy and will host a conference call to discuss the data today at 9:00am ET.

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NeOnc has formally notified the FDA that the Phase 1 dose-escalation portion of the NEO212-01 Phase 1/2 clinical trial has reached Maximum Tolerated Dose (MTD) at Cohort 5 (810 mg, Days 1–5, 28-day cycle) following a second Dose-Limiting Toxicity. In accordance with protocol-defined stopping rules, dose escalation has been halted, no further patients will be enrolled at 810 mg, and the Recommended Phase 2 Dose (RP2D) has been set at 610 mg (Cohort 4). For the Phase 2a metastasis cohort, the starting dose will be 400 mg (Cohort 3).

Notably, although Phase 1 was mainly designed to assess safety, tolerability, and identify the MTD, promising signs of clinical efficacy appeared during this phase of the study. These efficacy signs—including indications of lasting disease control in heavily pretreated patients with recurrent GBM and brain metastases—were observed within the dose-escalation groups.

The emergence of measurable anti-tumor activity in Phase 1 offers early clinical confirmation of NEO212’s therapeutic potential and supports the Company’s progress into the Phase 2 segment of the trial.

"These early efficacy signals, observed even within a dose-escalation safety study, provide meaningful clinical validation of NEO212’s therapeutic potential," said Amir Heshmatpour, Chairman and CEO of NTHI. "With RP2D now established, we believe NeOnc is entering Phase 2 with positive clinical momentum and a clear development pathway."

The transition into Phase 2 will focus on further assessing efficacy at the RP2D in specific expansion cohorts, aiming to generate strong clinical data to support potential accelerated development pathways in recurrent CNS cancers.

Importantly, this represents the first clinical readout of NeOnc’s bioconjugated temozolomide (TMZ) platform in an oral formulation, demonstrating NeOnc’s drug-engineering capabilities beyond its established intranasal delivery platform. The data validate the Company’s ability to optimize CNS penetration and therapeutic exposure across both intranasal and oral modalities. NeOnc intends to request a Type B (End-of-Phase 1) FDA meeting to review safety, PK/PD, preliminary efficacy, RP2D justification, Phase 2 design modifications, and a potential Accelerated Approval pathway. Supporting regulatory materials, including MedWatch Form FDA 3500A and Form FDA 1571, have been submitted via eCTD, ensuring regulatory transparency and alignment as the program transitions into Phase 2 development.

Mr. Heshmatpour, continued:

"This clinical data readout represents a meaningful advancement relative to the historical standard of care in brain cancer, temozolomide (TMZ), originally developed by Merck (NYSE: MRK). Importantly, we have successfully engineered and clinically evaluated a bio-conjugated oral formulation of TMZ, NEO212, and have established the Recommended Phase 2 Dose (RP2D). Achieving dose confirmation is a critical milestone that substantially de-risks the program and positions us for the next stage of development.

We believe NEO212 has the potential to meaningfully improve upon conventional TMZ by enhancing therapeutic performance while maintaining the practicality of oral administration. With this milestone achieved, we are preparing to engage the U.S. Food and Drug Administration to align on the design of what we anticipate will be a pivotal, registrational Phase 2 study, subject to FDA feedback and approval.

If successful, this program could redefine the treatment paradigm for glioblastoma, astrocytoma, and other aggressive CNS malignancies."

NEO212 is specifically designed to overcome a key biological limitation of TMZ: MGMT-mediated resistance. Preclinical studies have shown that NEO212 effectively inactivates and promotes the degradation of O6-methylguanine-DNA methyltransferase (MGMT), a crucial DNA repair enzyme that causes TMZ resistance. Standard TMZ treatment does not significantly lower MGMT levels and remains vulnerable to MGMT-driven DNA repair in brain tumors. This mechanistic difference may be especially important for TMZ-resistant and MGMT-high recurrent glioblastoma patients, offering a strong biological reason to advance NEO212 into Phase 2 development in the post-TMZ setting.

Mr. Heshmatpour added:

"This marks our first clinical readout of a bio-conjugated oral oncology asset and validates the broader scientific foundation of our platform. Supported by approximately ten issued patents and patent applications across the NEO212 and NEO100 programs, we believe our intellectual property portfolio provides meaningful long-term strategic protection.

Our immediate priority is regulatory engagement and disciplined execution toward a pivotal registrational pathway. We remain focused on advancing differentiated CNS therapies that can create durable clinical value for patients and sustainable long-term value for shareholders."

Founder, Dr. Thomas Chen, Vice-Chairman and Chief Medical Officer noted that, "The determination of the RP2D at 610 mg is a scientifically significant achievement. It confirms that our bio-conjugation technology allows for high-dose delivery of therapeutic agents with a manageable toxicity profile. We are now positioned to explore the efficacy of this optimized dose in our upcoming Phase 2 expansion."

Dr. Henry Friedman of Duke University emphasized the importance of this milestone, stating, "Establishing a safe and tolerable dose is the foundation of any successful oncology program. The identification of the RP2D for NEO212 allows NeOnc to proceed with confidence into efficacy studies for a patient population in desperate need of new oral therapies."

NEO212 is NeOnc’s first oral chemical conjugated chemotherapy drug, uniquely combining Temozolomide (TMZ), the current standard of care for glioblastoma and other brain cancers (marketed as Temodar), with NEO100 (a proprietary form of perillyl alcohol (POH), which is owned and patented by NeOnc). This proprietary conjugation is designed to overcome the limitations of TMZ, including resistance and limited efficacy, by enhancing blood-brain barrier penetration and antitumor activity.

Conference Call Details:

Date: March 4, 2026
Time: 6:00 a.m. PT / 9:00 a.m. ET
Webcast: A live webcast can be accessed at: View Source or by visiting View Source

(Press release, Neonc, MAR 4, 2026, View Source [SID1234663272])

On March 4, 2026 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported the closing of its previously announced underwritten public offering of 20,000,000 shares of its common stock at a public offering price of $1.50 per share for aggregate gross proceeds of $30 million, prior to deducting underwriting discounts and other offering expenses. In addition, the Company has granted the underwriters a 30-day option to purchase up to an additional 3,000,000 shares of common stock at the public offering price per share, less the underwriting discounts to cover over-allotments, if any.

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The offering was structured as a straightforward common stock only investment with no warrant coverage and was led by healthcare-dedicated investors alongside existing shareholders.

Konik Capital Partners, LLC, a division of T.R. Winston & Company acted as the sole book-running manager for the offering.

MAIA intends to use the net proceeds from the offering to conduct clinical trials and for working capital and general corporate purposes.

The securities described above were offered and sold pursuant to a "shelf" registration statement on Form S-3 (File No. 333-273984), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on August 15, 2023, and declared effective on August 23, 2023.

The offering was made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A prospectus supplement describing the terms of the public offering has been filed with the SEC and forms a part of the effective registration statement.

Copies of the prospectus supplement and the accompanying prospectus relating to this offering may be obtained, on the SEC’s website at View Source or by contacting Konik Capital Partners LLC, a division of T.R. Winston & Company, at 7 World Trade Center, 46th Floor, New York, NY 10007, Attention: Capital Markets Team, Email: [email protected].

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

(Press release, MAIA Biotechnology, MAR 4, 2026, View Source [SID1234663271])

On March 4, 2026 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported that new data evaluating DecisionDx-Melanoma’s i31-SLNB test result for prediction of sentinel lymph node (SLN) positivity will be presented at the Society of Surgical Oncology (SSO) 2026 Annual Meeting, being held March 5-7 in Phoenix.

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"The initial reports from the same prospective, multicenter study confirmed the performance of DecisionDx-Melanoma to both (i) impact sentinel lymph node biopsy (SLNB) decision-making and (ii) identify patients at low risk of nodal metastasis," said Rebecca Critchley-Thorne, Ph.D., vice president, research and development, at Castle Biosciences. "The data being presented at SSO 2026 further extend this growing body of evidence supporting the use of DecisionDx-Melanoma to guide risk-aligned management decisions consistent with National Comprehensive Cancer Network guideline risk thresholds, including whether to forgo, consider or pursue SLNB."

Castle will share the following ePoster at SSO: EP49: The integrated 31-gene expression profile test identifies patients with T1b–T2a cutaneous melanoma who can safely avoid sentinel lymph node biopsy.

DecisionDx-Melanoma’s i31-SLNB algorithm integrates the independent 31-GEP score with key clinicopathologic factors, including Breslow thickness, ulceration, mitotic rate and age. This integrated approach was developed and independently validated to provide more precise risk estimation than staging criteria alone. By combining tumor biology with traditional clinical features, the algorithm generates a personalized likelihood of SLN positivity, supporting risk-aligned shared decision-making for SLNB, a surgical staging procedure commonly used to assess nodal metastasis risk.

ePosters will be available for viewing in the SSO 2026 Exhibit Hall, on the SSO Annual Meeting website and within the SSO Mobile App. The ePoster gallery will be accessible to registered attendees.

For more information on DecisionDx-Melanoma and the poster above, please visit Castle at booth #321.

About DecisionDx-Melanoma
DecisionDx-Melanoma is a gene expression profile (GEP) test designed to analyze tumor biology to deliver a personalized risk assessment for patients with stage I–III cutaneous melanoma, enhancing risk stratification beyond American Joint Committee on Cancer (AJCC) staging alone. By combining molecular insights with select clinicopathologic features, the test provides two distinct outputs: a personalized risk of sentinel lymph node (SLN) positivity and a personalized risk of recurrence and/or metastasis. This clinically actionable information is designed to help guide risk-aligned patient management decisions, including SLN biopsy consideration, follow-up intensity, imaging and referrals.

DecisionDx-Melanoma is supported by more than 50 peer-reviewed publications, including prospective studies and meta-analyses, and was developed in collaboration with more than 100 leading U.S. institutions. The test has been clinically validated in more than 10,000 patient samples, ordered more than 220,000 times since launch, and has been shown to be associated with improved patient survival. Learn more at www.CastleBiosciences.com.

(Press release, Castle Biosciences, MAR 4, 2026, View Source [SID1234663270])

On March 4, 2026 ImmunoScape Pte. Ltd., an A*STAR spin-out backed by Amgen Ventures and EDBI that is developing next-generation TCR-based cancer immunotherapies, reported the execution of a Memorandum of Understanding (MOU) with a premier NCI-designated Comprehensive Cancer Center in the United States, renowned globally for its pioneering history in cellular immunotherapy. This partnership will fast-track ImmunoScape’s "Seed and Boost" platform into the clinic. Concurrently, the company announced a strategic investment from Leonardo DiCaprio.

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Accelerating the "Seed and Boost" Clinical Program

Under the terms of the MOU, ImmunoScape will partner with the cancer center to launch an investigator-initiated clinical trial targeting Wilms Tumor 1 (WT1) positive solid tumors. The trial will focus on four difficult-to-treat indications: ovarian, mesothelioma, and other high-unmet need solid tumors such as pancreatic and colorectal cancers. The study is scheduled to dose its first patients by September 2026.

This program leverages ImmunoScape’s differentiated "Seed and Boost" strategy to solve the persistence and exhaustion challenges common in traditional cell therapies:

The Seed: Autologous T-cells engineered with a high-affinity TCR targeting the intracellular antigen WT1.
The Boost: A clinical stage fusion protein (Immuno-STAT technology) that selectively expands and activates the WT-1 targeting T-cells in the patient, mimicking the natural immune synapse while leaving all other T-cells untouched.
"We are honored that a major U.S. Cancer Center has agreed to partner with us to fast-track our Seed and Boost therapeutic approach into a clinical trial," said Michael Fehlings, PhD, CEO of ImmunoScape. "Their experts see the potential that this novel new approach may bring to patients in need."

The Chair of ImmunoScape’s Scientific Advisory Board, Dr. Evan Newell, PhD, also commented, "Cancer patients need new innovative therapies, and this sense of urgency is driving our efforts to test patients before the end of 2026."

Strategic Investment from Leonardo DiCaprio

Highlighting the global urgency for novel cancer interventions, Leonardo DiCaprio has joined ImmunoScape’s roster of investors to support the development of this platform.

"ImmunoScape is pioneering innovative cancer therapies, and its upcoming clinical trials targeting pancreatic, ovarian, and mesothelioma cancers are highly encouraging," said Leonardo DiCaprio. "Through this investment, I hope to play a small role in helping accelerate their development."

Scientific Validation and Leadership

The company also announced that its scientists have been selected to present their groundbreaking work at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2026, underscoring the scientific community’s interest in the "Seed and Boost" mechanism.

"ImmunoScape’s Seed and Boost therapeutic approach has the potential to transform how we treat difficult solid tumor cancers," said Adrian Bot, MD, PhD, ImmunoScape Board Member and former Chief Scientific Officer of both Kite Pharma and Capstan Therapeutics. "It may be able to simultaneously improve treatment efficacy, improve the patient experience, and lower therapeutic costs."

Reflecting on the company’s evolution, Mr. Choon Peng Ng, Chairman and Co-founder of ImmunoScape, added, "From our company’s origins as a spin-out of Singapore’s A*STAR Research Agency to today, we are thrilled that the team’s Singapore-based research has led us to this milestone of a major clinical trial against difficult cancers."

(Press release, immunoSCAPE, MAR 4, 2026, View Source [SID1234663267])

On March 4, 2026 Senhwa Biosciences, Inc. (TPEx: 6492), a clinical stage company focusing on development of first-in-class therapeutics for oncology, rare diseases, and infectious diseases, reported the signing of a major strategic Memorandum of Understanding (MOU) with CellType, an AI-driven biotech company backed by Y Combinator (Winter 2026).

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Under this partnership, the two companies will integrate CellType’s proprietary AI platform to accelerate the clinical development and global commercialization strategy of Senhwa’s core asset, Silmitasertib (CX-4945).

Prior to formalizing the collaboration, the foundational research underlying CellType’s technology was conducted at Yale University in collaboration with Google DeepMind, where researchers computationally predicted and experimentally validated a novel immune-modulatory mechanism of CX-4945. This strategic alliance marks a transformative milestone for Senhwa: CX-4945 is evolving from a single-target small molecule into a platform-enabling asset—"CX-4945 2.0." Through AI-driven deep data validation, Senhwa aims to expand potential indications, significantly enhance clinical success probability, and strengthen the asset’s attractiveness for partnerships with international pharmaceutical companies for licensing discussion.

In parallel, CellType will feature CX-4945 as the flagship case study of its AI platform, showcasing real-world validation results to global investors—demonstrating how AI can fundamentally transform traditional drug development models, reduce R&D risk, and amplify therapeutic value.

Senhwa Chairman Benny T. Hu stated:

"By integrating CellType’s cutting-edge AI foundation models—capable of reasoning about biology at the cellular level, and rooted in pioneering research from Yale University and Google DeepMind—into Senhwa’s clinical-stage core asset, we are not simply accelerating development—we are redefining the strategic positioning of CX-4945. This collaboration represents Senhwa’s official entry into the next phase of AI-driven drug development. We highly recognize CellType’s scientific excellence and global vision, and we look forward to unlocking new therapeutic possibilities for cancer patients worldwide while delivering sustainable, long-term structural value growth for our shareholders."

AI-Driven Mechanistic Breakthrough

CellType was founded by computational biologist Dr. David van Dijk. The company is backed by Y Combinator (Winter 2026). Its proprietary AI platform applies large language models to single-cell gene expression—the first of its kind—enabling sophisticated decoding of complex tumor microenvironment (TME) signaling.

Through the original research collaboration with Google DeepMind at Yale University, researchers screened over 4,000 compounds and identified CX-4945 as a highly promising candidate. AI-predicted findings were subsequently validated in interdisciplinary laboratories at Yale University. Results indicate that beyond its known mechanism, CX-4945 demonstrates previously unrecognized immune-modulatory potential—including amplification of immune activation, enhancement of tumor antigen presentation, and conversion of "cold tumors" into "hot tumors." These properties may significantly improve immunotherapy efficacy and help overcome resistance challenges.

Six-Month Pilot Program and Strategic Framework

Under the MOU, the parties will initiate a six-month pilot program focused on:

Indication expansion strategies, Biomarker discovery and validation, Combination therapy synergy evaluation in the context of immuno-oncology and new targets for treating different types of cancers and Establishment of an AI-driven translational validation framework.

This collaboration not only position CX-4945 as a core immune-sensitizing molecule in immuno-oncology but also establishes Senhwa as CellType’s founding strategic partner. The agreement preserves flexibility for deeper collaboration structures in the future, including joint ventures, co-development, or licensing arrangements.

Market Opportunity and Strategic Outlook

The global cancer immunotherapy market is entering a high-growth phase, with industry forecasts projecting the market to reach approximately US$305.8 billion by 2033. Despite rapid expansion, overcoming immunotherapy resistance and optimizing the tumor microenvironment remain among the most critical and value-defining challenges in oncology.

This partnership extends beyond a technical pilot—it sends a clear signal to global capital markets: the valuation paradigm of CX-4945 is accelerating, and AI is emerging as a powerful multiplier of clinical success probability.

Looking ahead, Senhwa and CellType will continue to deepen their collaboration, advancing CX-4945 from an innovative therapeutic candidate to a core AI-enabled immunotherapy platform asset—jointly redefining the next key inflection point in cancer immunotherapy and creating enduring value for shareholders, partners, and patients worldwide.

(Press release, Senhwa Biosciences, MAR 4, 2026, View Source [SID1234663266])