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Faron Pharmaceuticals kicks off second half with FDA announcement

Faron Pharmaceuticals Oy

Faron Pharmaceuticals Limited (AIM:FARN, OTC:FPHAF) CEO Markku Jalkanen and CFO James O'Brien speak to Thomas Warner from Proactive after the clinical stage biopharmaceutical company revealed its been granted orphan drug designation by the US Food and Drug Administration (FDA) for its bexmarilimab asset to treat acute myeloid leukaemia. The news was published alongside Faron's first-half results. Jalkanen gives an overview of how the company's BEXMAB study is progressing so far, highlighting the accelerated achievement of complete remission among patients who had limited options. Jalkanen stated that the treatment's dual action mechanism, stimulating the immune system and targeting cancer cells, was ideally designed for this context. He goes on to address the granting of orphan status from the FDA, before CFO James O'Brien speaks specifically about the company's finances. He says Faron has raised over €18 million this year, positioning itself strongly with cash reserves exceeding €12.8 million for future operations. He suggests that Faron is currently funded through to the end of the end of this calendar year with several options for extending the cash runway. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

September 01, 2023 08:03 AM Eastern Daylight Time

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News Release

BioHarvest Sciences latest financial numbers shows continued growth for flagship product VINIA

BioHarvest Sciences Inc.

BioHarvest Sciences CEO Ilan Sobel joined Steve Darling from Proactive to share significant achievements from the company's second-quarter results. Sobel highlighted key performance indicators that demonstrate BioHarvest's robust growth and strategic advancements. A standout achievement was the remarkable growth in revenue generated by the company's flagship product, VINIA. BioHarvest Sciences achieved $2.75 million in revenue from VINIA in 2Q 2023, marking an impressive 228% increase compared to the same quarter of the previous year. This revenue figure also represents a 27% growth compared to the previous quarter, Q1 2023. The strong revenue growth showcases the increasing demand and market acceptance of the VINIA product. Sobel emphasized the significant improvement in gross product margins for the quarter. The gross product margin increased to 40%, a substantial jump from 12% in Q2 2022. This improvement is attributed to scaling production and achieving operational efficiencies. BioHarvest Sciences anticipates that these margins will continue to rise as production continues to expand. The company's recurring revenue model was highlighted as a key driver of its success. Sobel discussed the growth in both new customers and total subscribers, demonstrating the power of this model to accelerate revenue growth and contribute to achieving profitability. Notably, the total active VINIA subscribers increased by a remarkable 620% compared to Q2 2022, showcasing the growing interest and adoption of the product. Contact Details Proactive Investors Canada +1 604-688-8158 na-editorial@proactiveinvestors.com

August 31, 2023 01:38 PM Eastern Daylight Time

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Avricore Health CEO feels company is set up for success with new partnerships and emerging markets

Avricore Health

Avricore Health CEO Hector Bremner discussed the company's significant growth, partnerships, and expansion into new markets during an interview with Steve Darling from Proactive. Bremner shared how these developments position Avricore Health for future success, with a strong focus on the company's flagship product, HealthTab. Bremner emphasized that the core of Avricore Health's operations centers around HealthTab, an innovative health monitoring solution. The company is working on expanding the reach of HealthTab by partnering with more pharmacies not only across Canada but also on a global scale. This expansion strategy aims to bring HealthTab's benefits to a wider audience and increase the company's market presence. Regarding financial performance, Bremner highlighted the impressive growth achieved by Avricore Health. Revenues for the first half of 2023 reached $1,177,290, representing a remarkable 437% increase compared to the same period in the previous year. This growth was attributed to the deployment of more HealthTab systems and increased tests sold. Additionally, the company's gross profit surged by 511% to $440,152, with a gross margin of 37.39% — outperforming the company's target margin of 30%. This performance underscores the solid fundamentals of the company and its ability to increase scale while simultaneously improving profitability. Avricore Health's success story also includes its recent selection by a collaborative effort involving the renowned Barts Heart Centre and the national cardiovascular charity HEART UK. The company was chosen to assess the feasibility of integrating cholesterol testing into community pharmacies in the UK. This initiative aims to complement opportunistic blood pressure checks, assess cardiovascular risk, and expand clinical services offered to patients. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

August 31, 2023 01:28 PM Eastern Daylight Time

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POLARISqb and Syntekabio sign MOU for Collaborative AI and Quantum-powered Drug Development Service

Syntekabio, Inc.

POLARIS qb, the first company in the world to develop a drug discovery engine that utilizes the optimization power of quantum computing, announced that it has signed an MOU with Syntekabio (KOSDAQ: 226330), an Artificial Intelligence (AI) based drug development company. The partnership, which will combine the companies’ vanguard drug research platforms, will provide a collaborative drug development service as well as develop new molecular leads. Through this business agreement, the two companies will discover active compounds with their respective AI and Quantum Computing platforms. Using these technologies, they will search for candidates with high druggability potential and offer these candidates to customers seeking novel molecular leads. POLARIS qb is a quantum computing-based drug development company in Durham, North Carolina. As a leader in applying quantum computing in the world of drug discovery, the company has shortened the timelines for finding novel drug-like leads by orders of magnitude. In addition, POLARIS qb has recently developed Quantum-Aided Drug Design (QuADD), a platform for generating new drug candidates using quantum annealing from exceptionally large molecular libraries. Using the increased optimization power of today’s quantum computers, this process can be accomplished in days rather than months. In this partnership they will leverage this optimization potential of quantum annealing computers, allowing the company to search a chemical space of 10 30 potential molecules, a space many times larger than other computational chemistry platforms. Based on its own cloud supercomputing infrastructure, Syntekabio prepares big genomic data and AI drug platform services for implementation throughout the entire life cycle of novel drug development processes. Their platform includes services from the discovery of active compounds to the development of pre-clinical stage drug candidates (called DDC Service: DeepMatcher® Drug Candidate Service), as well as genomic biomarker discovery and detection services. Syntekabio plans to diversify lead candidates by applying POLARIS qb 's QuADD platform in the lead generation stage of DDC service. In addition, the two companies plan to jointly market their offering to global markets with specific emphasis on the US, Europe, and Asia. Combining the advantages of POLARIS qb 's quantum-based system and Syntekabio's AI discovery platform enhances precision medicine. This partnership seeks to help develop treatments to address various conditions and diseases that affect millions around the globe. Shahar Keinan, co-founder and CEO of POLARIS qb, said, “QuADD is a quantum computing-based platform that is relevant to the pharma global market, representing a commercialized quantum product in the field of new drug design.” She added, "We expect to be able to find lead candidates quickly and efficiently in this partnership by providing new drug development services using Syntekabio's cloud supercomputer infrastructure and genome-based AI platform." Jongsun Jung, CEO of Syntekabio, said, "We are delighted that Syntekabio's DeepMatcher® and POLARIS qb 's QuADD can cooperate to provide a drug candidate discovery service. It will be of great help in expanding global business opportunities as we work together.” For more information about POLARIS qb and its offering, please visit: http://www.polarisqb.com/. For more information about Syntekabio and its offering, please visit: https://cloud.syntekabio. com/. Contact Details Ellie Woo, BD Director +1 212-371-2544 ellie.woo@syntekabio.com Company Website https://cloud.syntekabio.com/

August 31, 2023 09:00 AM Eastern Daylight Time

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NanoViricides progressing well with new Covid study

NanoViricides

Proactive research analyst John Savin speaks to Thomas Warner after publishing a research note about the latest Covid trial from development-stage antiviral company NanoViricides (NYSE-A:NNVC). The ongoing NV-CoV-2 Phase Ia clinical study is a key milestone in the development of Nanoviricides' (NV) novel and innovative anti-virus therapy, NV-CoV-2 uses a sophisticated polymer (NV-387) as the active ingredient to trap and disrupt viruses in the blood. The polymer is integrated into the product which has now entered a clinical trial in India. With 26 out of 36 non-COVID volunteers completing the single dose stage and 17 advancing to the multi-dose phase, the trial has achieved a significant milestone. The absence of safety concerns is noteworthy. The trial examines two administration routes: a gummy and a syrup. Crucially, the trial aims to determine blood levels and safety, laying the foundation for potential efficacy. A subsequent trial will involve 36 mild-to-moderate COVID-19 patients. Despite the emergence of new virus strains, NanoViricides remains optimistic, as the env 387 polymer may enhance binding effectiveness. Click the provided link to access John Savin's comprehensive research on this exciting development. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

August 31, 2023 08:00 AM Eastern Daylight Time

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hVIVO announces move to "good facility at a very good price"

hVIVO PLC

hVIVO PLC (AIM:HVO) chief executive Mo Khan speaks to Thomas Warner from Proactive after the specialist contract research organisation announced plans for a new state-of-the-art consolidated challenge trial facility at the life sciences hub in Canary Wharf, London. The expansion, largely funded by hVIVO clients, reflects a growing order book and increasing demand for its human challenge trial services, the company said in a statement. The move involves bringing together quarantine beds, laboratories, and corporate offices into one facility. Notably, the new space will accommodate up to 70 quarantine beds, a significant increase from the previous capacity. The enhanced laboratory space will enable more concurrent studies, fostering revenue growth. He notes that hVIVO's "hugely successful screening facilities in Plumbers Row in East London and in Manchester will remain at their current locations, but the rest of the company will be consolidating into one facility." The phased move is expected to be completed in Q2 of the coming year and promises expanded capabilities, operational efficiency, and sustained growth for hVIVO. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

August 31, 2023 05:48 AM Eastern Daylight Time

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HPS/PayMedix Establishes Advisory Board, Names Al Martino First Member

HPS|PayMedix

Health Payment Systems, Inc. (HPS) /PayMedix announced today the appointment of Al Martino to its Advisory Board. Martino joins as the company continues to build momentum around the national expansion of PayMedix, which is dedicated to solving the problem of high out-of-pocket costs for all by guaranteeing upfront payments to all in-network providers and little to no interest credit for all patients regardless of their individual credit histories. Martino brings over 30 years of healthcare experience to HPS/PayMedix and has occupied senior leadership and executive positions across the insurance and pharmacy benefits management industries. Prior to serving on the advisory board for HPS/PayMedix, Martino served as Senior Vice President at OptumRx where he was responsible for actuarial, pricing, and underwriting operations across all market segments on a national basis. In addition, he served as Senior Vice President of UnitedHealthcare overseeing their National Accounts, Public Sector, Private Exchange, and Student Resources businesses. He’s also held various leadership roles with Cigna Health.. In his role as an advisory board member, he will advise on new product development, pricing, and provide insight related to key business development initiatives. “Al’s expertise in the healthcare industry will be invaluable as we continue the national expansion of PayMedix,” said Tom Policelli, CEO of HPS/PayMedix. “His keen understanding of the complex nature of underwriting and pricing across both the insurance and pharmaceutical industries will be instrumental as we continue our work to simplify our broken healthcare payments system. His leadership and industry insight will be key as the PayMedix brand continues to grow.” “PayMedix is solving the problem of cost and complexity as it relates to healthcare billing with true intention,” Martino says. “Now more than ever the industry is looking for solutions that work and work for everyone. PayMedix is doing just that and I’m excited to be a part of that process.” About PayMedix PayMedix, which began as the financing arm of Wisconsin-based HPS over a decade ago, is the only company solving the problem of high out-of-pocket costs for everyone: providers, patients, employers and TPAs. By guaranteeing payments to providers and credit for all patients, PayMedix is changing the way people access, use, and pay for healthcare. PayMedix has processed more than $5 billion in medical payments for hospital systems and physician practices and can be implemented in conjunction with any PPO or HMO network. About HPS Health Payment Systems (HPS) is a privately held healthcare technology and services organization with solutions that reduce the cost and complexity of the healthcare payments process to benefit providers, employers, patients and TPAs. Headquartered in Milwaukee, Wisconsin, HPS has an independent network of 96 hospital facilities and 27,000 individual providers. Contact Details Kaitlynn Cooney +1 609-351-5944 kcooney@brodeur.com Company Website https://paymedix.com

August 30, 2023 08:00 AM Eastern Daylight Time

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Willow Bioscience shifts focus to opportunity with BioOxi bio-oxidation platform

Willow Biosciences Inc.

Willow Bioscience CEO Dr Chris Savile joined Steve Darling from Proactive to share news the company has embarked on a major strategic shift, focusing its commercial efforts on the BioOxi platform. To assist in this transition, Willow Biosciences has engaged an advisor to explore and evaluate potential opportunities. This move is part of a broader strategy that also encompasses a collaborative venture with a Nasdaq-listed biopharmaceutical company. Together, they are working to establish sustainable manufacturing routes for key intermediates and active pharmaceutical ingredients. Savile highlighted the company's achievements in executing successful commercial programs. Notably, four new programs linked to the BioOxi bio-oxidation platform technology were launched in April 2023. Willow Biosciences is now concentrating on partner-funded enzyme engineering engagements, a strategic shift aimed at enhancing cost efficiency and optimizing the pathway to revenue growth. This refocusing strategy aligns with the company's commitment to unlocking nearer-term and potentially larger revenue opportunities, particularly compared to its legacy strain engineering business. Furthermore, Savile shared insights into the company's operational evolution. Willow Biosciences has completed a seamless transition, consolidating its operations into a single, cost-efficient facility located in Sunnyvale, California. This facility not only caters to the present needs of the company but also accommodates future growth prospects. With ample laboratory space, Willow Biosciences can continue to expand its collaborative efforts while maintaining a financially prudent approach, in contrast to previous locations. bolstered by cost-effective operations and a focused commercial approach. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

August 29, 2023 01:39 PM Eastern Daylight Time

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FNIH and PathAI Forge Partnership to Advance Mucosal Healing in Ulcerative Colitis Research

PathAI

PathAI, a leading provider of AI-powered pathology tools to advance precision medicine, is pleased to announce that the Foundation for the National Institute of Health's (FNIH) Biomarkers Consortium - Mucosal Healing in Ulcerative Colitis project team has selected PathAI to be its technology partner to further the study of mucosal healing, bring AI-assisted precision to disease assessment, and drive cutting-edge research to facilitate the development of new therapies for ulcerative colitis (UC), a disease affecting 1 to 2 million in the US alone. 1, 2 “Ulcerative colitis is an increasingly prevalent chronic disease. The lack of standardized measurement and definition of mucosal healing poses a significant challenge for UC drug development, limiting treatment options for patients,” said James O’Leary, Director, Inflammation and Immunity at the FNIH. Though nearly 200 active clinical trials support on-going development of new treatments and therapies, 3 no standard histological measure exists. “Through this collaborative project with PathAI, together we aim to establish a reproducible methodology for histological measurement of mucosal healing in UC treatment.” PathAI’s groundbreaking AI product, AIM-HI UC (AI-based Measurement of Histological Index for Ulcerative Colitis), will serve as the exclusive platform for automated Geboes-based disease assessment for the consortium. This innovative approach will provide invaluable insights into mucosal healing, enabling better capture of true drug effect/signal-to-noise ratio for UC treatments. Furthermore, this partnership holds the potential to fuel biomarker development by unraveling the inflammatory microenvironment of ulcerative colitis. The FNIH Biomarkers Consortium brings together eight prominent biopharmaceutical companies, two prominent disease area foundations, academic partners, and the FDA in an unprecedented effort to standardize and enhance disease assessment in the field of ulcerative colitis. By selecting PathAI as its technology partner, the consortium aims to leverage PathAI’s expertise in AI algorithms to achieve a more accurate and reproducible scoring of mucosal healing and provide improved prediction of long-term patient outcomes. The project will culminate in a common protocol and white paper that will be submitted to the FDA to influence regulatory guidance for future UC clinical trials. "PathAI's algorithms will elevate our ability to investigate novel relationships, signatures, and biomarkers in UC" said Andy Beck, CEO of PathAI. "By embracing an AI-driven standardized approach, we increase accuracy and reduce scoring variability for therapeutic response assessment. We are excited to be part of this groundbreaking project, with the ultimate goal of accurately predicting long-term patient outcomes and driving industry-wide consensus." One distinguishing feature of AIM-HI UC is that it is built on exhaustive WSI tissue segmentation and cell classification models, providing a quantitative and objective basis for a normally subjective assessment. Compared to traditional pathologist scoring, AIM-HI UC has demonstrated higher accuracy in measuring critical Geboes metrics essential to histological healing, including GS2A, GS2B, and GS3. AIM-HI UC is intended for research use only, not for use in diagnostic procedures, serving as a secondary and/or exploratory endpoint in clinical trials. It enables the identification of histologic remission (GS<2) and histologic improvement (GS≤3.1). Additionally, it facilitates translational research and retrospective deployment. To learn more about AIM-HI UC and the underlying algorithm driving this groundbreaking research, please visit www.pathai.com/aim-hiuc or contact PathAI. Footnotes 1 https://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/multimedia/vid-20522485 2 https://www.asge.org/home/for-patients/patient-information/understanding-ulcerative-colitis 3 https://www.clinicaltrials.gov About PathAI PathAI is the only AI-focused technology company to provide comprehensive precision pathology solutions from wet lab services to algorithm deployment for clinical trials and diagnostic use. Rigorously trained and validated with data from more than 15 million annotations, its AI-powered models can be leveraged to optimize the analysis of patient samples to improve efficiency and accuracy of pathology interpretation, as well as to better gauge therapeutic efficacy and accelerate drug development for complex diseases. PathAI, which is headquartered in Boston, MA, and operates a CAP/CLIA-certified laboratory in Memphis, TN, is proud to have a team of 600+ innovative thinkers from around the globe. For more information, please visit www.pathai.com. About FNIH The Foundation for the National Institute of Health (FNIH) is a non-profit organization that provides critical support to the National Institutes of Health (NIH). FNIH works to advance biomedical research by fostering public-private partnerships and collaborations that accelerate the development of new treatments and therapies. Contact Details SVM Public Relations and Marketing Communications Maggie Naples +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

August 29, 2023 10:00 AM Eastern Daylight Time

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