NUROSENE BUSINESS UPDATE

Rhea-AI Summary

Nurosene Health Inc. (CSE: MEND, OTC: MNNDF) announced a strategic shift to enhance its AI/ML offerings for the pharmaceutical industry via its subsidiary, NetraMark. The focus is on improving clinical trial success rates, which currently stand below 12% for Phase 1 trials. The company aims to leverage its NetraAI technology to tackle the low success rates in clinical trials, with over $40B spent on these processes annually. Nurosene is assembling a skilled executive team to accelerate commercialization efforts and capitalize on growing market opportunities.

Positive

• Focus on AI/ML solutions specifically aimed at improving clinical trial success rates.
• NetraAI technology developed to extract insights from small datasets, enhancing patient recruitment strategies.
• Strategic hiring of experienced professionals with significant backgrounds in the pharmaceutical industry.

Negative

• Current success rate for clinical trials remains below 12%, highlighting a significant industry challenge.
• Over 90% of clinical trials conducted from 1999 to 2021 had less than 1,000 participants, limiting data effectiveness.

TORONTO, Dec. 1, 2022 /PRNewswire/ - Nurosene Health Inc. ("Nurosene" or the "Company") (CSE: MEND) (Frankfurt: 8TV) (OTC: MNNDF), a company that is focused on being a leader in the development of Artificial Intelligence (AI) / Machine Learning (ML) solutions targeted at the pharmaceutical industry, is pleased to share the following business update.

"I am pleased to announce that Nurosene has made the strategic decision to focus its efforts on the continued development and rollout of next generation offerings that specifically benefit companies in the pharmaceutical industry, by utilizing technology developed by NetraMark (a wholly owned subsidiary of the Company). Specifically, the NetraAI platform extracts insights from patient data leading to predictive patient enrichment strategies to de-risk the clinical trial process. The Company's primary focus will be in support of this decision, as we move forward." – CEO of Nurosene, George Achilleos.

Summary points that support strategic decision

The industry problem - The pharmaceutical industry faces two (2) primary challenges that could benefit from the use of AI:

1. Problem 1 – Novel Molecule Discovery – There is a real challenge identifying molecules that address disease. The majority of life science AI technology companies focus in the area of molecule identification which involves the ingestion of massive biological data sets run through AI algorithms with the objective being to aid in the discovery of new molecules.
   
   
2. Problem 2 – Clinical Trial Execution – Once a molecule is identified, there is a very low rate of success getting through the clinical trial process. In fact, less than 12% of candidate medicines that make it into Phase 1 of a clinical trial are approved for commercial use¹.

The opportunity – At Nurosene, we believe there is a significant opportunity to address the very low rate of success in the clinical trial process, by using the NetraAI technology. The market for this is robust, growing and large. In the past twelve (12) months alone, there have been approximately 5,000 interventional clinical studies² launched. Further, Phase 1, 2, and 3 expenditures tally in excess of $40B USD³.

The challenge – Few companies have been able to apply AI methods to clinical trial de-risking, primarily due to the small data sets that exist in the majority of clinical trials, regardless of Phase. In fact, more than 90% of the clinical trials launched from 1999 – 2021 have less than 1,000 participants⁴. This presents a unique challenge in that traditional AI methods have not been statistically responsive to small datasets that can lead to statistically significant insights to be utilized for the purpose of enriching clinical trial patient population recruitment plans.

The solution – The NetraAI technology has been developed over the last five (5) years with the intent and capability to extract insights from small datasets that can create a mosaic of models/hypotheses that can shed light on various aspects of how patients relate to each other with respect to a given indication. This ultimately reveals hypotheses about which sets of genetic characteristics may best relate and respond to a drug in question.

Further, the Company has created specific offerings and supporting sales materials to aggressively begin to pursue commercialization efforts. To support this, the Company has put in place an executive team with deep experience within the pharmaceutical industry. In particular, and as previously announced, the Company has hired the following key individuals to help accelerate the objectives of the Company's business plan:

Josh Spiegel – President NetraMark – Mr. Spiegel has over 25 years of experience in finance, sales and corporate strategy, with a strong background in health care, business services and technology. Prior to joining NetraMark, Mr. Spiegel was the vice-president of business strategy at VeraSci, where he leveraged his experience to provide strategic planning and oversight of commercial operations, including the launch of the Pathway eClinical platform and positioned the company for a highly successful $330-million (U.S.) exit to WCG Clinical, a leader in the pharmaceutical services sector.

"I believe there is a significant opportunity to innovate on traditional methods used to derive clinical trial patient enrichment criteria. The underlying NetraAI algorithms used to drive statistically significant patient insights, using small datasets, is very compelling." – Josh Spiegel, President NetraMark.

Dr. Luca Pani – Chief Innovation and Regulatory Officer – Dr. Pani is an academic both at the University of Miami in the United States and in Modena, Italy, and the former director general of the Italian Medicines Agency (AIFA) (2011 to 2016), where he managed a multibillion-dollar budget for drug expenditures and negotiations on behalf of the Italian national health system. Dr. Pani was the vice-president for regulatory strategy and market access innovation at VeraSci, where, among other matters, provided scientific strategic planning on the FDA (U.S. Food and Drug Administration) qualification program for the Pathway eClinical platform.

Dr. DJ Cook – Chief Medical Officer – D.J. Cook MD, PhD is a neurosurgeon and neuroscientist at Queen's University where he is division head and chair of neurosurgery. Dr. Cook completed his MD, PhD and residency at the University of Toronto and undertook fellowship training at Stanford University in Cerebrovascular and Skull Base Surgery. Dr. Cook's present research is focused on the development of predictive imaging, physiological and behavioural biomarkers in stroke and traumatic brain injury. His work includes the use of multi-sequence MRI analysis using artificial intelligence algorithms to derive novel insights into mechanisms of disease and to monitor recovery and therapy.

For further details, including a projected revenue outlook, please see the most recent investor update presentation, found on the Company's Investor page at: https://nurosene.com/investors

About Nurosene

Nurosene is a company focused on being a leader in the development of Artificial Intelligence (AI) / Machine Learning (ML) solutions targeted at the Pharmaceutical industry.

Forward-Looking Statements

This press release contains "forward-looking information" within the meaning of applicable Canadian securities legislation including statements regarding our strategic focus going forward, the challenges in the pharmaceutical industry regarding novel molecule discovery and clinical trial execution, our view of the opportunity to address the low rate of success in clinical trial processes using NetraAI technology, the potential size of the market, the intent and capability of the NetraAI technology and the data it may produce, our commercialization efforts and proposal to accelerate our business plan, which are based upon Nurosene'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, Nurosene 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 Nurosene 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.sedar.com including our Management's Discussion and Analysis for the year ended September 30, 2021 along with the risk factors set out in the corporate presentation. 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.

¹Sources: PhRMA adaptation of DiMasi JA et al¹²; Tufts CSDD¹³; FDA^14
2Source: https://clinicaltrials.gov/
³PhRMA Membership Survey 2021
⁴https://www.who.int/observatories/global-observatory-on-health-research-and-development/monitoring/number-of-trial-registrations-by-year-location-disease-and-phase-of-development

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SOURCE Nurosene Health Inc.

FAQ

What strategic decision has Nurosene made for MNNDF on Dec. 1, 2022?

Nurosene announced a shift in focus to develop AI/ML solutions for the pharmaceutical industry, specifically targeting clinical trial enhancement.

How is Nurosene's NetraAI technology expected to impact clinical trials?

NetraAI aims to improve clinical trial success by deriving insights from small datasets, addressing challenges in patient recruitment.

What are the primary challenges faced by the pharmaceutical industry according to Nurosene's PR?

The industry struggles with novel molecule discovery and low success rates in clinical trial execution.

What is the current success rate for clinical trials mentioned in the MNNDF press release?

The press release states that less than 12% of candidates in Phase 1 clinical trials get approved for commercial use.

What market opportunity exists for Nurosene's AI solutions for MNNDF?

The pharmaceutical industry spends over $40B on clinical trials annually, representing a significant opportunity for AI solutions.