Three Biotechs Deliver Catalysts to Watch

DENVER, July 15, 2026 (GLOBE NEWSWIRE) -- (247marketnews.com) – Today’s announcements from NeOnc Technologies (NASDAQ:NTHI), Ernexa Therapeutics (NASDAQ:ERNA), and VivoSim Labs (NASDAQ:VIVS) highlight three distinct pathways to potential value creation.

NeOnc Technologies

NeOnc Technologies (NASDAQ:NTHI) announced that it has received written feedback from the U.S. Food and Drug Administration regarding the chemistry, manufacturing, and controls (CMC) development program for its lead drug candidate, NEO212, a novel temozolomide-perillyl alcohol conjugate being developed for malignant brain tumors and other central nervous system cancers.

Rather than proceeding with its scheduled Type B End-of-Phase 1 meeting, the company elected to cancel the meeting after determining that the FDA's written responses were sufficiently detailed to serve as the official record. According to the FDA, NeOnc's proposed CMC strategy appears reasonable while outlining additional manufacturing, formulation, stability, and bioavailability work needed as the company transitions from its current capsule formulation to a tablet intended for late-stage clinical development.

Among the FDA's recommendations were completion of comparative manufacturing assessments if production methods change, execution of an in vivo relative bioavailability study to support the capsule-to-tablet transition, establishment of GMP manufacturing batches, development of dissolution testing methods, and completion of stability studies supporting future registration. The agency also indicated that the company's broader drug-product development plan may proceed in parallel with planned late-stage clinical development provided supporting data are submitted.

While the FDA feedback does not represent approval of NEO212 or agreement on future registrational trial design, it provides NeOnc with a clearer regulatory roadmap as management incorporates these requirements into its updated development strategy. The announcement reflects continued regulatory engagement as the company advances its lead oncology candidate toward later-stage development.

NeOnc Technologies is entering what could become one of its most catalyst-rich periods as investors await topline Phase 2a data from the fully enrolled NEO100-01 study, expected by the end of July. NEO100 has already received FDA Orphan Drug, Fast Track, and Rare Pediatric Disease Designations, providing regulatory advantages as development progresses.

The company continues emphasizing that future FDA interactions will depend upon forthcoming clinical data and that regulatory decisions remain subject to independent FDA review based on the totality of evidence. With the Phase 2a dataset approaching, investors will be watching closely for efficacy, safety, and guidance regarding potential future regulatory pathways.

NeOnc has also expanded internationally after receiving a second Investigational New Drug (IND) authorization from the Department of Health – Abu Dhabi, allowing additional clinical protocols evaluating NEO100 for recurrent high-grade gliomas across adult and pediatric development programs. The authorization complements the company's earlier UAE approval for NEO212, broadening its international clinical presence.

Investor attention has also focused on insider activity and institutional ownership. According to SEC filings, Chairman, President and CEO Amir Heshmatpour recently invested more than $500,000 through open-market purchases, with insider buying approaching $1 million over the past year. Meanwhile, institutional ownership has expanded, with public filings identifying firms including Bank of America, State Street, and Barclays among shareholders. Combined with access to previously disclosed financing facilities and multiple anticipated regulatory milestones during 2026, NeOnc remains a closely watched emerging CNS oncology company.

Ernexa Therapeutics

Ernexa Therapeutics (NASDAQ:ERNA) announced independently validated preclinical results for its lead cell therapy candidate ERNA-101, providing third-party confirmation of earlier research ahead of its planned IND submission later this year.

In an independent contract research organization study using a larger ovarian cancer model, ERNA-101 combined with anti-PD-1 therapy achieved complete tumor clearance and durable long-term survival in 10 of 15 treated animals (67%). Notably, no complete responses were observed in any of the remaining treatment groups, including ERNA-101 alone, anti-PD-1 monotherapy, or untreated controls.

The findings reinforce earlier work conducted at The University of Texas MD Anderson Cancer Center demonstrating that ERNA-101 selectively targets ovarian tumors while delivering engineered cytokines designed to recruit immune cells into tumors that traditionally evade immune detection. The independent reproduction of those findings strengthens confidence in the underlying mechanism of action while supporting the company's transition from preclinical development toward human clinical studies.

Ernexa remains on schedule to submit its IND application during the third quarter of 2026, with a first-in-human Phase 1 clinical trial anticipated during the fourth quarter. While preclinical success does not guarantee clinical efficacy, independent validation represents an important scientific milestone as the company prepares to enter clinical development and evaluate whether ERNA-101's combination strategy can translate into human patients.

VivoSim Labs

VivoSim Labs (NASDAQ:VIVS) announced two significant developments that strengthen both its financial outlook and commercial narrative. The company received a $5 million milestone payment from Eli Lilly (NYSE:LLY) tied to a previously divested inflammatory bowel disease program after the first patient was dosed in a Phase 2 clinical study being conducted by Eli Lilly.

Although Eli Lilly now controls development of the program, VivoSim remains eligible for up to an additional $45 million in future milestone payments if regulatory and commercial objectives are successfully achieved over time. The payment provides immediate non-dilutive capital while maintaining future upside tied to the program's continued advancement.

Separately, VivoSim issued guidance projecting more than 500% revenue growth during Fiscal Year 2027, driven by increasing pharmaceutical adoption of its New Approach Methodologies (NAMs) human tissue testing platform. Management attributes growing demand to the predictive performance of its three-dimensional human liver and intestine models, which are designed to improve preclinical safety testing before therapies advance into expensive human clinical trials.

The company's recent validation data showed its NAMkind™ Liver model achieved 91% predictive accuracy, while its intestinal models exceeded 90% sensitivity and overall predictive accuracy for drug-induced diarrhea. VivoSim is also expanding applications beyond traditional small molecules into antibody-drug conjugates, antibodies, siRNA therapies, and gene therapies. With the FDA continuing to encourage greater use of human-relevant NAM technologies as alternatives to animal testing, VivoSim believes the evolving regulatory landscape could accelerate commercial adoption of its platform.

Sources

• NeOnc Technologies (NASDAQ:NTHI) Investor Relations: https://neonc.com
  
  
• U.S. Food and Drug Administration (FDA): https://www.fda.gov
  
  
• Ernexa Therapeutics (NASDAQ:ERNA): https://www.ernexatx.com
  
  
• The University of Texas MD Anderson Cancer Center: https://www.mdanderson.org
  
  
• VivoSim Labs (NASDAQ:VIVS): https://www.vivosim.ai
  
  
• Eli Lilly and Company: https://www.lilly.com

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