BioPharma Services Announces Expansion into Late-Stage Patient Trials and Integration with HEALWELL's Artificial Intelligence Platform Capabilities to Become a Full-Service Next Generation CRO

Rhea-AI Summary

HEALWELL AI Inc. (TSX: AIDX) (OTCQX: HWAIF) has announced that its subsidiary, BioPharma Services Inc., is expanding into late-stage patient trials by integrating Canadian Phase Onward (CPO). This strategic move transforms BioPharma into a full-service Contract Research Organization (CRO), capable of managing clinical trials across all phases of drug development. The integration also involves incorporating HEALWELL's AI and data science capabilities to enhance research, disease detection, and patient identification.

Key benefits include:

• Expanded capabilities across all clinical trial stages
• Increased patient access through WELL Health's populations
• Enhanced research infrastructure with a robust referral network
• Integration of AI for improved patient identification and trial efficiency

BioPharma has completed over 2,200 clinical trials with approximately 250 pharma clients globally, including 4 of the top 25 largest pharmaceutical companies.

Positive

• Expansion into late-stage patient trials, becoming a full-service CRO
• Integration of AI capabilities for improved research and patient identification
• Access to larger patient populations through WELL Health's network
• Enhanced ability to conduct trials across all stages of drug development
• Potential for increased efficiency and cost reduction in clinical trials

Negative

• None.

• HEALWELL's subsidiary, BioPharma Services, is expanding into late-stage patient trials through the integration of Canadian Phase Onward, a dedicated clinical research site built within the framework of HEALWELL's Polyclinic Family and Specialty Medicine Facility.
• This strategic integration is a significant milestone, enhancing BioPharma's ability to manage clinical trials across all phases of drug development and making the business a full-service Contract Research Organization. The move also supports HEALWELL's broader vision of building out clinical research capabilities and leveraging synergies across its business lines to drive growth and innovation in healthcare.
• Biopharma will also be integrating with HEALWELL AI's leading edge data science and Artificial Intelligence platform to help advance research and development, disease detection and patient identification capabilities to support expedited patient trials.
• Biopharma has completed over 2,200 clinical trials since inception with approximately 250 pharma clients, globally. This includes 4 of the top 25 largest pharmaceutical companies in the world.

Toronto, Ontario--(Newsfile Corp. - September 19, 2024) - HEALWELL AI Inc. (TSX: AIDX) (OTCQX: HWAIF)("HEALWELL" or the "Company"), a healthcare technology company focused on AI and data science for preventative care, is pleased to announce its subsidiary, BioPharma Services Inc. ("BioPharma"), a leading Contract Research Organization ("CRO") specializing in early-phase clinical trials, is expanding into late stage patient trials through the integration of Canadian Phase Onward ("CPO"), a dedicated clinical research site built within the framework of HEALWELL's Polyclinic Family and Specialty Medicine Facility ("Polyclinic"). As the research arm of Polyclinic, CPO plays a pivotal role in facilitating patient enrolment and trial execution. This strategic integration is a significant milestone, enhancing BioPharma's ability to manage clinical trials across all phases of drug development and making the business a full-service CRO. The move also supports HEALWELL's broader vision of building out clinical research capabilities and leveraging synergies across its business lines to drive growth and innovation in healthcare.

Dr. Alexander Dobranowski, CEO of HEALWELL, commented, "BioPharma is an industry leader in early phase trials, and integrating them with our CPO division immediately leverages our synergies to create a more robust and complete end-to-end platform for life science customers. Given HEALWELL's access to significant patient populations, we have a unique opportunity to leverage our AI capabilities to efficiently find at-risk patients in need of access to clinical research. BioPharma is our clinical research engine, and has a strong competency and track record in first conducting early-stage trials in drug development, followed by CPO, which expands BioPharma's abilities into late-stage patient trials. Through these integrations, HEALWELL can now leverage AI to participate meaningfully across all stages of drug development, bringing immense value potential to at-risk patients and life science partners."

Anna Taylor, Managing Director at BioPharma, commented, "We are excited about the integration of Canadian Phase Onward's operation under BioPharma, which substantially enhances our clinical research capabilities as we expand our service offerings into late-stage patient trials. This integration not only broadens our reach into patient trials but also strengthens our capacity to deliver comprehensive clinical research services that are vital to our clients and the industry. Having the ability to conduct all stages of drug development allows us to become an end-to-end clinical trial solution, bringing more value to our life science customers."

HEALWELL is integrating CPO's research site operations under BioPharma, maximizing the site's established capabilities in patient enrollment, on-site operations and clinical trial execution. This strategic integration focuses solely on the research aspects of the Company's businesses, allowing BioPharma to grow its clinical trial capabilities without altering Polyclinic's core medical practice. It will allow BioPharma to expand its ability to conduct trials across all stages, initiating patient-centric studies while maintaining the strengths of both organizations. As BioPharma integrates these research resources, the company's commitment to excellence and patient care remains unchanged. Under the guidance of HEALWELL, BioPharma is poised to advance clinical research and provide new treatment possibilities globally.

Strategic Benefits of the Integration:

• Expanded Capabilities to Become a Full-Service CRO: By integrating CPO late-stage trial expertise, BioPharma can now offer comprehensive clinical trial services from early-phase to late-stage, enhancing its service offerings to its clients.
• Increased Patient Access: Paired with HEALWELL's access to WELL Health's patient populations and clinic platform, CPO's existing patient base and research capabilities provide immediate access to a diverse patient population, facilitating faster recruitment and enhancing trial diversity.
• Enhanced Research Infrastructure: Polyclinic provides a robust referral network of over 25 specialists and 20 family physicians. This setup not only facilitates patient recruitment but also ensures comprehensive care and potential access to novel treatment options for patients. With the addition of CPO's strong patient-centric model and existing operational success, BioPharma will leverage these assets to build a more robust, integrated clinical trial model under HEALWELL's direction.
• Growth of Clinical Research under HEALWELL: This strategic integration under HEALWELL supports a broader vision to expand clinical research capabilities and build a comprehensive, patient-focused model. It represents a significant step in BioPharma's growth, allowing the company to leverage synergies across its business lines to enhance its research capabilities and access a broader range of patient populations, including those with rare diseases.

Concurrent with the integration of CPO and BioPharma, BioPharma will also begin integrating some of the Company's AI capabilities into its service offerings. Using AI capabilities from HEALWELL's Khure Health and Pentavere Research Group business units, BioPharma expects to leverage its significant access to patient and provider populations, as well as its leading edge AI powered patient identification capabilities to modernize the way CROs search for and find patients leading to substantial increased efficiencies and reduction of costs.

CPO has been managing clinical trials and patient studies for over a decade, specializing in various fields, including psychiatry, pain management, endocrinology, gastroenterology, neurology, cardiology, and respiratory, among others. Through its collaboration with the Polyclinic Family and Specialty Medicine Facility, CPO ensures continuity of care for study patients by maintaining regular communication with each patient's physician. CPO will play a vital role for BioPharma, as the company will leverage its already functioning research site to access late-phase clinical trial operations, including patient enrollment directly from the family practice.

Dr. Alexander Dobranowski
Chief Executive Officer
HEALWELL AI Inc.

About HEALWELL AI

HEALWELL is a healthcare technology company focused on AI and data science for preventative care. Its mission is to improve healthcare and save lives through early identification and detection of disease. Using its own proprietary AI technology and competencies which includes data science, electronic health records and clinical research offerings, the Company is developing and commercializing advanced clinical decision support systems that can help healthcare providers detect rare and chronic diseases, improve efficiency of their practice and ultimately help improve patient health outcomes. HEALWELL is publicly traded on the Toronto Stock Exchange under the symbol "AIDX" and on the OTC Markets under the symbol "HWAIF". To learn more about HEALWELL, please visit healwell.ai.

About BioPharma Services

BioPharma Services is a leading contract research organization (CRO) based in Toronto, Canada, specializing in clinical trials. With a focus on scientific integrity, operational excellence, and adaptive processes tailored to each client's needs, BioPharma Services has established a reputation for delivering high-quality results in the pharmaceutical and biotech industries. BioPharma's comprehensive services also include Bioanalysis at their GLP Certified Laboratory, Scientific and Regulatory Affairs, Biostatistics and Safety Data Analysis (CDISC), Data Management and Medical Writing. Visit www.biopharmaservices.com for more details.

Forward-Looking Statements

Certain statements in this press release, constitute "forward-looking information" and "forward-looking statements" within the meaning of applicable Canadian securities laws and are based on assumptions, expectations, estimates and projections as of the date of this press release. Forward-Looking statements in this press release include statements with respect to, among other things, the expansion of BioPharma's service offerings, the anticipated benefits of the integration of the BioPharma and CPO research businesses, and the potential advantages of integrating the Company's artificial intelligence capabilities into those businesses. Forward-Looking statements are often, but not always, identified by words or phrases such as "to become", "is expanding", "in the process", "poised to", "growth", "future", "vision", "mission", "potential", "improve", "expect", "create" or variations of such words and phrases or statements that certain future conditions, actions, events or results "will", "may", "could", "would", "should", "might" or "can" be taken, occur or be achieved, or the negative of any of these term. Forward-Looking statements are necessarily based upon management's perceptions of historical trends, current conditions and expected future developments, as well as a number of specific factors and assumptions that, while considered reasonable by HEALWELL as of the date of such statements, are outside of HEALWELL's control and are inherently subject to significant business, economic and competitive uncertainties and contingencies which could result in the forward-looking statements ultimately being entirely or partially incorrect or untrue. Forward-Looking statements contained in this press release are based on various assumptions, including, but not limited to, the following: the Company's ability to successfully integrate the personnel, customers and capabilities of its subsidiaries and business divisions, and the time and cost associated with such integration; the ability of the Company and its subsidiaries to fulfill their obligations to, and to maintain and grow their relationships with, their customers and commercial partners; the effects of competition in the industry; the expected demand for the Company's products and services; trends in customer growth; the stability of general economic and market conditions; currency exchange rates and interest rates; the Company's ability to comply with applicable laws and regulations; the Company's continued compliance with third party intellectual property rights; technologies functioning as anticipated; customers adopting and using technologies as expected; and that the risk factors noted below, collectively, do not have a material impact on the Company's business, operations, revenues and/or results. By their nature, forward-looking statements are subject to inherent risks and uncertainties that may be general or specific and which give rise to the possibility that expectations, forecasts, predictions, projections, or conclusions will not prove to be accurate, that assumptions may not be correct, and that objectives, strategic goals and priorities will not be achieved.

Known and unknown risk factors, many of which are beyond the control of HEALWELL, could cause the actual results of HEALWELL to differ materially from the results, performance, achievements, or developments expressed or implied by such forward-looking statements. Such risk factors include but are not limited to those factors which are discussed under the section entitled "Risk Factors" in HEALWELL's most recent annual information form dated April 1, 2024, which is available under HEALWELL's SEDAR+ profile at www.sedarplus.com. The risk factors are not intended to represent a complete list of the factors that could affect HEALWELL and the reader is cautioned to consider these and other factors, uncertainties and potential events carefully and not to put undue reliance on forward-looking statements. There can be no assurance that forward looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Forward-Looking statements are provided for the purpose of providing information about management's expectations and plans relating to the future. HEALWELL disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise, or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law. All of the forward-looking statements contained in this press release are qualified by these cautionary statements.

For more information:

Stephanie Phillips
Marketing Communications Director, BioPharma Services Inc.
sphillips@biopharmaservices.com

Pardeep S. Sangha
Investor Relations, HEALWELL AI Inc.
Phone: 604-572-6392
ir@healwell.ai

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/223844

FAQ

What is the significance of BioPharma Services expanding into late-stage patient trials for HEALWELL AI (HWAIF)?

This expansion transforms BioPharma into a full-service Contract Research Organization, capable of managing clinical trials across all phases of drug development. It enhances HEALWELL's research capabilities and potential revenue streams.

How will the integration of AI affect BioPharma Services' operations for HEALWELL AI (HWAIF)?

The integration of AI is expected to improve research, disease detection, and patient identification capabilities. This could lead to more efficient clinical trials, faster patient recruitment, and potentially reduced costs for HEALWELL AI.

What is the track record of BioPharma Services in conducting clinical trials for HEALWELL AI (HWAIF)?

BioPharma Services has completed over 2,200 clinical trials since inception, working with approximately 250 pharma clients globally, including 4 of the top 25 largest pharmaceutical companies in the world.

How does the integration of Canadian Phase Onward benefit HEALWELL AI (HWAIF) and its subsidiary BioPharma Services?

The integration provides BioPharma with expertise in late-stage trials, access to a diverse patient population, and a robust research infrastructure. This enhances HEALWELL's overall clinical research capabilities and potential market reach.