TORONTO, Dec. 18, 2025 (GLOBE NEWSWIRE) -- NetraMark Holdings Inc. (the "Company" or "NetraMark") (CSE: AIAI) (OTCQB: AINMF) (Frankfurt: PF0) a premier artificial intelligence (AI) company that is transforming clinical trials with AI powered precision analytics in the pharmaceutical industry, today provided a business update highlighting significant progress across commercial execution, regulatory engagement, and scientific validation. Collectively, these milestones strengthen the Company's growth trajectory and reinforce NetraMark's positioning in AI-driven clinical trial optimization.
Key highlights:
- Contract Backlog Increases: NetraMark's contract backlog increased to approximately C$2.5 million during the quarter driven by new project commitments and continued commercial momentum. This growth reflects increasing demand for the Company's NetraAI platform and supports NetraMark's previously stated objective of reaching C$8 - $10 million in contract backlog by mid 2026.
- Major Channel Partner Onboarding: Following the execution of a master services agreement with Worldwide Clinical Trials (Worldwide) on April 3, 2025, NetraMark completed Worldwide's onboarding and quality assurance process in mid-October. As a result, NetraMark can now be actively included in Worldwide's Phase 2 and Phase 3 bids across Central Nervous System (CNS) and Oncology, expanding the Company's access to late-stage clinical development opportunities through a global Contract Research Organization.
- Regulatory Milestone - U.S. Food and Drug Administration (FDA) Critical Path Innovation Meeting (CPIM): In December, NetraMark completed a CPIM with the FDA. The CPIM was a non-regulatory, non-binding scientific exchange during which the FDA provided feedback on NetraAI-NetraMark's explainable AI/ML platform-and discussed its application as an enrichment methodology in clinical trial design. The FDA provided feedback on NetraAI's approach to pre-specified, a-controlled predictive enrichment and discussed considerations for identifying responder-enriched subgroups while maintaining control of Type I error, consistent with FDA enrichment guidance. The FDA also discussed how NetraAI differs from complex adaptive designs, Bayesian methods, or computer-simulation-based approaches that are excluded from eligibility for the FDA's Model-Informed Drug Development (MIDD) Paired Meeting Program, and suggested that NetraMark consider exploring the MIDD Paired Meeting Program as an avenue for scientific dialogue alongside a pharmaceutical sponsor. CPIM discussions are drug-product independent and do not constitute FDA endorsement of NetraAI or any product or service provided by the Company.
- Nature Portfolio Publication: On December 8, 2025, NetraMark announced that its scientific study highlighting NetraAI was accepted for publication in npj Digital Medicine, part of the Nature Portfolio. The peer-reviewed paper, co-authored with researchers from the U.S. National Institute of Mental Health (NIMH), demonstrates how NetraAI's explainable methodology identified clinically meaningful "Persona" subgroups in a Phase II depression trial, resulting in improved patient stratification and treatment-response interpretation. Acceptance by a high-impact Nature journal provides third-party validation of NetraMark's scientific approach.
- Strategic Research Collaboration - CAMH: During the quarter, NetraMark, in collaboration with the Centre for Addiction and Mental Health (CAMH), was awarded a prestigious Ontario Research Fund - Research Excellence (ORF-RE) Award, recognizing innovative research partnerships in Ontario. Under this collaboration, NetraAI is being deployed within CAMH's secure computing environment to analyze genetic and epigenetic data in schizophrenia and major depressive disorder. The work is focused on identifying explainable patient subpopulations and is expected to further strengthen NetraAI's capabilities in psychiatric indications and its relevance for pharmaceutical sponsors.
George Achilleos, Chief Executive Officer of NetraMark stated:
"This quarter reflects disciplined execution across key areas of our business. We are seeing growing commercial traction, constructive scientific engagement with the FDA regarding NetraAI's regulatory positioning, and increasing third-party validation through peer-reviewed publication and academic recognition, including our recent research award with CAMH. Completion of our onboarding with Worldwide Clinical Trials further expands our commercial reach and strengthens our route to market. Together, these milestones reinforce that our approach is both novel and increasingly aligned with the direction of modern clinical development. We remain focused on entering into new contracts, shortening sales cycles, and helping sponsors de-risk late-stage trials while advancing effective therapies for patients."
Outlook
With a strong start to fiscal 2026, NetraMark is reiterating its previously stated guidance of achieving C$8-$10 million in booked contract backlog by mid-2026.
This outlook is subject to the assumptions set out below and supported by a growing base of direct client engagements, expanding channel partnerships, and an active pipeline of late-stage opportunities. The Company enters 2026 with increasing commercial momentum and a solid foundation for expected continued growth.
About NetraAI
In contrast to other AI-based methods, NetraAI is uniquely engineered to include focus mechanisms that separate small datasets into explainable and unexplainable subsets. Unexplainable subsets are collections of patients that can lead to suboptimal overfit models and inaccurate insights due to poor correlations with the variables involved. The NetraAI uses explainable subsets to derive insights and hypotheses (including factors that influence treatment and placebo responses and adverse events), potentially increasing the likelihood of a clinical trial's success. Many other AI methods lack these focus mechanisms and assign every patient to a class, often leading to "overfitting", which drowns out critical information that could have been used to improve a trial's chance of success.
About NetraMark
NetraMark is a company focused on being a leader in the development of Generative Artificial Intelligence (Gen AI)/Machine Learning (ML) solutions targeted at the Pharmaceutical industry. Its product offering uses a novel topology-based algorithm that can parse patient datasets into subsets of people who are strongly related across several variables simultaneously. This allows NetraMark to use a variety of ML methods, depending on the character and size of the data, to transform the data into powerfully intelligent data that activates traditional AI/ML methods. The result is that NetraMark can work with much smaller datasets and accurately segment diseases into different types, as well as accurately classify patients for sensitivity to drugs and/or efficacy of treatment.
Non-IFRS Financial Measure - Contract Backlog
This press release makes reference to "contract backlog", which is a non-IFRS financial measure. Contract backlog is defined as the total revenue associated with signed contracts for NetraAI services where services have not been completed and revenue has not been recognized under IFRS. Revenue will be recognized in alignment with data readouts tied to these contracts. As such, while backlog growth will be realized in the near term, actual revenue recognition will follow project-specific timelines. Management believes contract backlog is useful as it provides visibility into committed future revenue from signed contracts. However, contract backlog is not a recognized measure under IFRS, does not have a standardized meaning, and may not be comparable to similar measures used by other companies. Contract backlog should not be considered in isolation or as a substitute for IFRS measures.
Financial Outlooks Information
This press release contains "financial outlooks" within the meaning of applicable Canadian securities laws ("FOFI"), specifically the target of C$8-10 million in contract backlog by mid-2026. FOFI is based on the assumptions and subject to the risks set out below in respect of forward-looking statements including with respect to continued demand for NetraAI, the expected rate of conversion of active sales opportunities to signed contracts based on historical conversion rates; the potential expansion of channel partnerships through the Worldwide relationship; continued market adoption of AI-driven clinical trial methodologies and no material adverse changes in market or regulatory conditions. The Company's actual results may differ materially from this FOFI. Management believes the FOFI has been prepared on a reasonable basis, reflecting management's best estimates and judgments. The FOFI was approved by management on December 17, 2025, for the purpose of informing investors about the Company's business prospects. However, because this information is subjective and subject to numerous risks and assumptions, it should not be relied on as necessarily indicative of future results. Except as required by applicable securities laws, the Company undertakes no obligation to update such FOFI. Readers are cautioned that the FOFI contained in this news release should not be used for purposes other than for which it is disclosed herein, and such information is ?presented for ?illustrative purposes only and may not be an indication of the Company's actual ?financial position or ?results of operations.?
Forward-Looking Statements
This press release contains "forward-looking information" within the meaning of applicable Canadian securities legislation including statements regarding the Company's contract backlog targets, including the objective of reaching C$8-10 million in booked contract backlog by mid-2026; expected commercial momentum and growth trajectory; the potential applications and benefits of the NetraAI platform; the ability of NetraAI to identify patient subpopulations, inform precision-enrichment strategies, enhance clinical trial decision-making, reduce placebo interference, and optimize trial enrichment; expectations regarding channel partnerships and market access opportunities, including through Worldwide Clinical Trials; expectations regarding sales cycles and pipeline conversion; the potential impact of regulatory engagement, scientific publications, and research collaborations; the capabilities of the Company's technology; and the Company's business objectives and development plans, which are based on NetraMark's current internal expectations, estimates, projections, assumptions and beliefs, and views of future events. Forward-looking information can be identified by the use of forward-looking terminology such as "expect", "likely", "may", "will", "should", "intend", "anticipate", "potential", "proposed", "estimate" and other similar words, including negative and grammatical variations thereof, or statements that certain events or conditions "may", "would" or "will" happen, or by discussions of strategy. Forward-looking information includes estimates, plans, expectations, opinions, forecasts, projections, targets, guidance, or other statements that are not statements of fact. The forward-looking statements are expectations only and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results of the Company or industry results to differ materially from future results, performance or achievements. Any forward-looking information speaks only as of the date on which it is made, and, except as required by law, NetraMark does not undertake any obligation to update or revise any forward-looking information, whether as a result of new information, future events, or otherwise. New factors emerge from time to time, and it is not possible for NetraMark to predict all such factors.
When considering these forward-looking statements, readers should keep in mind the risk factors and other cautionary statements as set out in the materials we file with applicable Canadian securities regulatory authorities on SEDAR+ at www.sedarplus.ca including our Management's Discussion and Analysis for the year ended September 30, 2024. These risk factors and other factors could cause actual events or results to differ materially from those described in any forward-looking information.
The CSE does not accept responsibility for the adequacy or accuracy of this release.
Contact Information: Swapan Kakumanu - CFO | swapan@netramark.com | 403-681-2549
