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Vistagen Poised To Begin Phase 1 Trial Of A Fast-Acting Antidepressant Nasal Spray In First Quarter Of 2023

VistaGen

By Rachael Green, Benzinga In the race to create faster-acting, safer antidepressants, Vistagen (NASDAQ: VTGN) is starting the year strong as it gets ready to launch a Phase 1 Trial of its novel pherine nasal spray for Major Depressive Disorder (MDD). The trial, involving the Company’s newly optimized formulation of PH10, is intended to confirm the favorable safety profile of PH10 established in three previous clinical studies conducted in Mexico, including a published Phase 2A study for the treatment of MDD. After receiving a “study may proceed” letter from the U.S. Food and Drug Administration (FDA) last November followed by a Fast-Track designation from the FDA in December, the late clinical-stage biopharmaceutical company is ready to start the Phase 1 trial in the first quarter of 2023. Upcoming Phase 1 Clinical Trial Will Prepare Vistagen’s Drug Candidate PH10 for Phase 2B Research On November 30, Vistagen announced that it had received a “study may proceed” letter from the FDA for PH10 as a treatment for MDD. The following week, the FDA granted Fast-Track designation to the pherine-based nasal spray. The FDA’s fast track program, meant to bring promising new treatments for serious conditions to patients sooner, makes Vistagen’s drug eligible for more frequent meetings and communications with the FDA – which can help ensure a smoother development and review process and, potentially, an earlier drug approval date. The FDA’s decision to grant Fast-Track designation was based on Vistagen’s previous preclinical and clinical research on PH10. In an earlier Phase 2A study of PH10, for example, the MDD treatment was found to significantly reduce depressive symptoms in participants after only one week of treatment and at the eight-week study endpoint. The upcoming Phase 1 study will enroll 12 participants in a double-blind, placebo-controlled clinical trial with topline data expected by the end of the first quarter. The goal of the study is to confirm the favorable safety data demonstrated in earlier clinical trials and lay the groundwork for a Phase 2B study of PH10 in MDD. On December 21, Vistagen announced its acquisition of Pherin Pharmaceuticals, a clinical-stage company developing a pipeline of pherine drug candidates. The acquisition will give Vistagen full ownership of the intellectual property rights for both PH10 and its Phase 3 pherine drug candidate, PH94B, allowing the company to stop paying royalties and milestone payments for the compounds. The deal will also add three new pherine drug candidates to Vistagen’s pipeline. PH10 Is Designed To Be A Fast-Acting Antidepressant With Minimal Side Effects In the past few years, research activity in the MDD space has picked up significantly as companies explore several new treatment options with different mechanisms of action. That’s because the currently approved antidepressants aren’t working for millions of people, leaving a massive unmet need that drug developers are racing to fill. “Nearly two-thirds of diagnosed and treated depression patients do not achieve remission with first-line therapy. With 21 million adults in the U.S. suffering at least one major depressive episode in the past year, potentially millions of individuals are not getting the help they need,” said Vistagen CEO Shawn Singh in a statement about the upcoming Phase 1 trial for the MDD treatment. While some exciting progress has been made, Vistagen hopes its drug candidate, PH10, can address some of the shortcomings of the latest alternatives to hit the market. PH10 is one of two pherine nasal sprays currently in development at Vistagen. Pherines are a new class of synthetic chemosensory messenger drug candidates that may be able to provide fast-acting relief for depression and anxiety symptoms and several other unmet medical needs. For the treatment of depression, PH10 is designed to activate chemosensory neurons in the nose that can then activate the limbic system, the areas of the brain involved in emotional response. Researchers hypothesize that it does this possibly by triggering the release of more dopamine, serotonin, and norepinephrine, three hormones that play a role in mood and happiness. This mechanism of action sets it apart from other drugs in development for depression. COMPASS Pathways, PLC (NASDAQ: CMPS), for example, is working on COMP 360 – a psilocybin-based therapy for treatment-resistant depression – which has shown promise in recent clinical trials. In one Phase 2b study, a single high dose of the psilocybin compound was able to provide immediate symptom improvement with results lasting up to 12 weeks. However, being a psychedelic, the treatment requires psychological support from a specialty-trained therapist during a psilocybin therapy session. While it may be helpful in the long run, the time-consuming process isn’t as convenient as a standalone medication that could be taken daily or as needed without interrupting the rest of the day. Meanwhile, Relmada Therapeutics, Inc. (NASDAQ: RLMD) is developing REL-1017, a compound that works by blocking the N-Methyl-D-aspartate (NMDA) receptor in the brain. The daily oral treatment is meant to work similarly to ketamine-derived treatments like Johnson & Johnson’s (NYSE: JNJ) recently approved Spravato, but without the psychotropic effects. However, the late-stage biotech announced top-line results from its Phase 3 trial of the drug candidate last October, noting that it failed to achieve its primary endpoint of significantly reducing depression symptoms compared to a placebo. PH10, on the other hand, does not require the same systemic uptake to produce its fast-acting effects, according to Vistagen. The compound doesn’t cause the same psychotropic side effects as ketamine-based treatments but has still managed to demonstrate rapid-onset and significant lasting results in the clinical studies completed so far. As trials progress, it could be worth keeping on the company as it leverages its recent wins to bring its drug to market quickly for the millions suffering from depression. This article was originally published on Benzinga here. Vistagen (Nasdaq: VTGN) is a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other CNS disorders. The Company is advancing therapeutics with the potential to be faster-acting, and with fewer side effects and safety concerns, than those that are currently available. Vistagen’s clinical-stage candidates are targeting multiple forms of anxiety and depression. PH94B and PH10 belong to a new class of drugs known as pherines, which are investigational neuroactive steroid nasal sprays designed with a novel rapid-onset mechanism of action that activates chemosensory neurons in the nasal passages and can impact the olfactory-amygdala neural circuits without systemic uptake or direct activity on CNS neurons in the brain. Vistagen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety and depression. This post contains sponsored advertising content. This content is for informational purposes only and not intended to be investing advice. Contact Details Mark Flather- Investor Relations mflather@vistagen.com Company Website https://www.vistagen.com/

January 19, 2023 08:30 AM Eastern Standard Time

AmeriLife Announces Key Organizational Changes on Heels of Strong Growth & Expansion

AmeriLife

Following three years of record-breaking growth and expansion, AmeriLife Group, LLC (“AmeriLife”) today announced a strategic, organizational restructuring with the creation of two new, distinct distribution groups – Wealth and Health – an evolved structure designed to deliver more focused growth along with the resources needed to continue to grow AmeriLife’s industry-leading partners. Wealth will be led by AmeriLife’s Chief Distribution Officer Mike Vietri, reporting to AmeriLife Chairman and CEO Scott R. Perry. Health will be led by newly appointed Chief Distribution Officer and former president of AmeriLife’s Life & Health Brokerage Distribution Scotty Elliott, reporting to AmeriLife’s Chief Operating Officer Tim Calvert. “This reorganization represents a natural evolution of our strategy. Five years ago, AmeriLife embarked on a journey to build the capabilities that we would need to deliver on our mission of offering a full suite of insurance and retirement solutions to provide people peace of mind, enabling them to live longer, healthier lives,” said Perry. “Through execution of our organic and inorganic growth plans, we are now at a stage where we’ve assembled comprehensive capabilities across the spectrum of Health and Wealth to deliver a platform of products and technology that agents and advisors can utilize to effectively deliver holistic solutions to the market, engaging with consumers through their channels of choice. “We are fortunate to have a talented and experienced group of senior leaders at the helm of this new structure to optimize this platform. Additionally, the new structure provides a laser focus on our two core areas of business, affording even greater growth and profitability opportunities within Wealth and Health.” Wealth Distribution Over the past seven years, Vietri has grown AmeriLife’s distribution organization to over $9 billion in overall premium, $7.2 billion in assets under management, and more than 120 affiliates and agencies nationwide. Given his depth of knowledge and experience in the wealth management and financial services industries, and considering the growing demands of the organization, Vietri’s focus, going forward, will be on AmeriLife’s annuities, underwritten life, and wealth and retirement advisory verticals. Saybrus, TruChoice Financial Group, ICON and Brookstone will remain key to AmeriLife’s overall Wealth strategy. Vietri will continue to report to Perry, while AmeriLife Benefits and AmeriLife’s Career Agency will continue to report to Vietri under their current leadership. Additionally, AmeriLife’s Distribution Centers of Excellence, including Distribution Analytics, Distribution Operations, and its Business Revenue Group (BRG), will continue to report to Vietri and maintain their enterprise focus. AmeriLife’s Wealth-focused affiliates will continue to report to Denny Southern. “Over the last few years, AmeriLife’s efforts to add to its wealth-focused services and solutions has set us up for continued growth in the space at exactly the right time,” said Vietri. “I’m incredibly excited for the realignment of our organization. In particular, I’m thrilled to lead AmeriLife’s Wealth Distribution at time when our offerings align perfectly with consumers’ needs and our holistic approach to wealth management and retirement planning ensures customers never outgrow our advisors.” Health Distribution Elliott joined AmeriLife in 2019 with a focus on distribution business development, and was elevated soon thereafter to lead AmeriLife’s Life & Health Brokerage Distribution, overseeing field distribution initiatives, carrier partnerships, and IMO and FMO relationships. Reporting to Calvert, Elliott will take on AmeriLife largest and fastest-growing business. Their stewardship of Health will allow AmeriLife to deliver even greater strategic efficiencies – at scale – to ensure sustainable growth for its partners. In his new role, Elliott will continue lead AmeriLife’s Medicare and Simplified Issue Life verticals, as well as assume accountability of AmeriLife’s Direct-to-Consumer distribution arm, which will continue to be led by Jim Palmer. “I’m humbled by the opportunity to lead AmeriLife’s Health Distribution,” said Elliott. “I’m forever indebted to Scott and Mike for their support and leadership, and hope to make them proud with this new venture. I also want to commend the talented group of affiliates that comprise AmeriLife. They are the reason we are experiencing so much success, and I’m eager to serve them for years to come.” Since 2020, AmeriLife has added 65 affiliates serving more than 350,000 agents and advisors nationwide. While its Life & Health business has more than doubled in size during the same time period, the company remains equally focused on growth opportunities and synergies within its wealth-focused lines of businesses, strengthened by the recent addition of TruChoice Financial Group, its joint venture ICON with AIMCOR Group, and evidenced by more than $8 billion in annuities premiums and more than $7 billion in assets under management as of the end of 2022. Added Perry: “I couldn’t be happier for Mike and Scotty as they assume their new leadership roles and pursue more ways to serve and support our trusted and talented affiliate partners, which will allow them to achieve new levels of growth and success.” ### About AmeriLife AmeriLife’s strength is its mission: to provide insurance and retirement solutions to help people live longer, healthier lives. In doing so, AmeriLife has become recognized as the leader in developing, marketing, and distributing life and health insurance, annuities and retirement planning solutions to enhance the lives of pre-retirees and retirees across the United States. For more than 50 years, AmeriLife has partnered with top insurance carriers to provide value and quality to customers served through a distribution network of over 350,000 insurance agents and advisors and more than 100 marketing organizations and insurance agency locations nationwide. For more information, visit AmeriLife.com, and follow AmeriLife on Facebook and LinkedIn. Contact Details Media Jeff Maldonado +1 321-297-1112 jmaldonado@amerilife.com Partnership Inquiries Patrick Nichols +1 727-726-0726 pnichols@amerilife.com Company Website https://amerilife.com/

January 18, 2023 02:50 PM Eastern Standard Time

Centre for Neuro Skills Offers “Continued Care Program” for Patients with Brain Injuries

Centre for Neuro Skills

Approximately 3 million Americans are affected by an acquired brain injury every year. Traumatic brain injury (TBI) and stroke are the leading causes of acquired brain injury. More than 5 million Americans live with disabilities due to a TBI and often require rehabilitative care. Centre for Neuro Skills (CNS), a leader in brain injury rehabilitation services, today announced the offering of its Continued Care Program, which will provide all-encompassing care after active rehabilitation therapy for patients recovering from a brain injury or stroke by offering assisted living, residential and supported living options while empowering patients to regain motor skills so they can achieve the highest level of independence possible. The new facets of the program include: Assisted Living Residential Residential Care Supported Living Enrichment Center Brain injury rehabilitation has proven to be effective, returning a substantial number of people to productive and satisfying lives, but some individuals who experience brain injury or stroke cannot recover full independence due to disturbances in cognition, mood and behavior. These consequences of brain injury and stroke can lead to isolation, depression and re-hospitalization as well as caregiver stress and burnout. Continued Care Programs can meet the long-term needs of individuals with chronic disabilities, providing specialized care that decreases risk for re-hospitalization, promoting life satisfaction and quality of life and reducing life-time costs. “Centre for Neuro Skills’ Continued Care program introduces patients to new experiences, provides them access to valuable community resources and challenges them to adapt and grow beyond their current limitations,” said Dr. Mark Ashley, CEO and founder of Centre for Neuro Skills. “CNS’ experienced staff are committed to the overall well-being of each patient, empowering patients to enjoy dignified, productive lives and dedicated to helping them achieve the best possible quality of life.” Assisted Living Residential CNS Assisted Living Residential patients typically transition from the Inpatient Residential program. In Assisted Living Residential, patients: Live in a CNS residence close to the clinic Attend the CNS Enrichment Center May or may not still receive some therapies Receive transportation to and from CNS-sponsored activities Residential Care In residential settings, CNS can provide full-time or part-time care, helping patients to practice and strengthen skills obtained in its clinical facilities while residing in a secure, home-like CNS residence nearby. Each day, patients are transported between the CNS residence and clinic by its certified Transportation Services Department. A broad range of skills are taught and modeled, including, but not limited to: Safety at home and in the community Self-care Money and time management Proper medication use Social activities Behavior management Supported Living CNS’ Supported Living focuses on maintaining the patient outcomes achieved in active therapy. Patients receiving this care may have transitioned from Inpatient Residential, Day Treatment or Assisted Living Residential treatment options. Patients in Supported Living have schedules consisting of a broad range of personalized CNS services tailored to their ongoing needs. Enrichment Center CNS’ Assisted Living Residential or Supported Living patients can use the Enrichment Center, a space in the clinic that offers scheduled, structured and age-appropriate activities for patients to maintain the outcomes achieved in active therapy. Activities are centered around the patient’s personal interest and capabilities while focusing on therapeutic endeavors, engagement opportunities and skill building. *** About Centre for Neuro Skills Centre for Neuro Skills is an experienced and respected world leader in providing intensive rehabilitation and medical programs for those recovering from all types of brain injury. CNS covers a full spectrum of advanced care from residential and assisted living to outpatient/day treatment. Founded by Dr. Mark Ashley in 1980, CNS has seven locations in California and Texas. For more information about Centre for Neuro Skills, visit: www.neuroskills.com, Facebook, Twitter, LinkedIn, YouTube. Media, please note: Visual assets, including photos, are available. To request an interview with CNS leadership or clinical staff, please contact Robin Carr at 415.766.0927 or CNS@landispr.com. # # # Contact Details Landis Communications Inc. Robin Carr +1 415-766-0927 cns@landispr.com Company Website https://www.neuroskills.com/

January 18, 2023 07:10 AM Pacific Standard Time

KAFL Insurance Resources Becomes Newest ICON Affiliate

AmeriLife

AIMCOR Consolidated LLC (“ICON”), a joint venture between AIMCOR Group, LLC (“AIMCOR”) and AmeriLife Group, LLC (“AmeriLife”), announced today that it has acquired KAFL Insurance Resources (“KAFL”), one of the largest brokerage general agencies (BGAs) in the northeast. Per the agreement, terms of the deal were not disclosed. “As the dynamics of insurance brokerage evolve, today’s value proposition needs to include more services and resonate with the non-traditional insurance advisor,” said Peter Skelton, corporate advisor of KAFL Insurance Resources. “As we looked to find the right strategic partner to enhance technology and expand distribution access, ICON stood out as the ideal partner, aligned with our core values of Innovation, Collaboration, Integrity and Respect. Simply put, ICON has a different message and different value than what we found in the market and KAFL is proud to become an ICON affiliate.” Founded in 1991 in Rochester, N.Y., KAFL’s national sales and service teams specialize in partnering with financial professionals, agents and affiliates to provide agency, business consulting, marketing and new business support services for a variety of products, including underwritten life, disability, long term care, annuities, employee benefits and other senior market products. As part of ICON, KAFL will continue to be a leading AIMCOR member and become ICON’s primary hub for central solutions and services, helping to support the growth of its fellow ICON affiliates and expand access to underwritten life products across AmeriLife’s distribution channels. With the closing of this deal, Peter Skelton and Lorrie Gibbons will become principals in ICON and part of its corporate senior leadership team while continuing to oversee KAFL’s affiliated locations. “We are so excited to share the news of our partnership with ICON. Our talented team has worked hard over the years to create strong operational processes that we look forward to building upon together by offering an expanded product suite and access to more resources that will make it easier for our producers to write business,” said Lorrie Gibbons, president and CEO of KAFL. “As our business and industry continue changing, ICON gives us the confidence of knowing that we can continue our successes and growth into the future!” “With the addition of KAFL’s breadth of expertise, talent and operational capabilities to ICON, we’re positioned to accelerate our efforts of building the necessary infrastructure to better support our AIMCOR and AmeriLife partners, grow the adoption of individual protection solutions, and expand product access across our collective distribution networks,” said Marc Verbos, president of ICON. “Our partnership with KAFL marks a significant milestone in our journey of building an industry-leading distribution company, and is a testament to our ability to deliver meaningful value to our affiliates.” “We’re creating a truly unique and attractive value proposition for the BGA that is looking to affiliate with a national marketing organization that offers an expanded choice in ownership structure, operating model, product and distribution access,” commented AIMCOR president & CEO John Ziambras. “ICON’s continued growth further validates our journey to evolve AIMCOR into a best-in-industry NMO that continues to deliver unparalleled value to our members.” “KAFL has a strong portfolio and applies just the kind of comprehensive, holistic approach that AmeriLife strives to add to its best-in-class distribution network,” added Mike Vietri, AmeriLife’s Chief Distribution Officer. “We’re excited to welcome the KAFL team to ICON and are excited to support their continued expansion and growth ambitions.” ### About KAFL Insurance Resources KAFL Insurance Resources is passionate about their role in creating long-lasting partnerships within a nationally-focused, multi-line general agency built on values of integrity, respect, accountability, innovation and collaboration. They offer a well-rounded portfolio to create a holistic approach to supporting their producers and creating peace of mind with all partners by providing access to innovative tools and resources to make doing business easier, while remaining dedicated to providing a customized team approach that ensures personalized service to help producers, agents, and financial professionals grow their business. For more information, visit KAFL.com. About ICON ICON (“AIMCOR Consolidated LLC”) is a joint venture between AIMCOR Group, LLC and AmeriLife Group, LLC. By combining the power of a premier national marketing organization (“NMO”) with capital resources, innovative technology, a multi-product platform and a robust suite of centralized shared services, ICON offers brokerage general agencies (BGAs) a different way to stay competitive and evolve their business. ICON helps its partners focus on long-term sustainability by helping reduce risk, gain access to capital, and empower their ability to deliver a comprehensive portfolio of products and services, all while supporting their producers so that they can better scale their business, protect their legacy, and enhance their service offerings. Contact Details AmeriLife Media Relations Jeff Maldonado +1 321-297-1112 jmaldonado@amerilife.com ICON Media Relations Mike English +1 866-428-0180 mike.english@aimcorgroup.com Partnership Inquiries Patrick Nichols +1 727-726-0726 pnichols@amerilife.com Company Website https://amerilife.com/

January 18, 2023 09:00 AM Eastern Standard Time

GROUNDWORK BIOAG EXPANDS NORTH AMERICAN TEAM TO SUPPORT FARMER DEMAND FOR MYCORRHIZAL INOCULANTS

Groundwork BioAg

Groundwork BioAg announced today that industry leader Andrew Duff has joined as General Manager - North America. Duff’s more than 20 years of experience in biostimulants, seed technology and U.S. crop production will help the company accelerate the adoption of its Rootella mycorrhizal inoculants and meet demand for biological solutions in mainstream crops, such as corn, soybean and cotton. “The demand from mainstream growers for more biological and regenerative solutions continues to increase,” said Hanan Dor, Chief Commercial Officer at Groundwork BioAg. “The United States remains an important growth market for us and essential to producing more sustainable food for the world. As a well-respected leader in agriculture and a life-long farmer, we believe Andrew is the right person to help us to expand our strategic partnerships, meet grower demand for our Rootella product portfolio and accelerate our carbon sequestration projects to help all farmers tap into existing carbon markets.” In this newly created role, Duff will lead the company’s existing operations established in 2016 and ensure a direct line of communication with North American distribution partners and growers, following another consecutive year of growth for Groundwork BioAg. “I am incredibly excited to join Groundwork BioAg at such a pivotal time in agriculture when many farmers and industry partners are adopting new solutions that address climate concerns and sustainability goals,” said Duff. “Groundwork BioAg is on the forefront of climate-smart agriculture and is bringing products to the farm that improve profitability today and for generations to come.” Growing up on a farm in the Mississippi Delta, Duff brings a wealth of knowledge and in-depth experience in agriculture spanning across distribution, manufacturing and production with an expertise in major crop inputs. Previously, Duff led global strategy for biostimulants at Verdesian Life Sciences. In addition, he served in leadership roles at Pinnacle Agriculture and Monsanto. He attended business school at the University of Mississippi and earned a law degree and MBA from Mississippi College. Duff is currently based in Southaven, Mississippi. About Groundwork BioAg Groundwork BioAg, a global bioagriculture company, leverages the natural power of mycorrhizal fungi to improve the productivity, sustainability and profitability of commercial agriculture and expand regenerative agriculture practices. Groundwork BioAg is the first to use innovative techniques to solve challenges inherent in high-volume mycorrhizal inoculant production. We will not rest until every hectare of arable land is protected by mycorrhizae and every farmer benefits from higher crop yields while preserving our soils. For more information, visit www.groundworkbioag.com. Contact Details AgTech PR for Groundwork BioAg Nicole Prenger nicole@agtechpr.com Company Website https://www.groundworkbioag.com

January 18, 2023 08:00 AM Central Standard Time

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PDG Announces New Vision on Sales Transformation Solutions  for Life Sciences

PDG

Performance Development Group (PDG), a leader in providing business performance solutions, announces that it is “Bringing Success to Life” with an expanded sales performance solution set specifically for commercial organizations within life sciences. The new solution includes leadership development (coaching and accountability excellence), field force optimization, and business execution (leading and lagging metrics for success). Sales performance is a critical capability and one of the highest priorities for pharmaceutical, biotech, and medical device organizations. The dynamics and unpredictability of these industries are very high, and the margin for error is thinner than ever before. The evolving marketplace is highly regulated and complex, competition is fierce, and sales teams are constantly expected to adapt with limited information. As a result, the industry needs a dedicated performance solutions partner who understands these challenges across therapeutic areas and can clear a path to help them compete. “The sales organization within life sciences requires a focus like no other. We have seen complexity over the years and feel that this new business focus will allow us to deliver unique insights into the skills necessary to succeed like nobody else can,” said Sean Frontz, Global Practice Leader, Sales Performance, PDG. PDG has a long tradition of delivering business performance solutions to life science organizations. With this new business focus, PDG brings a team of experienced industry experts who understand how to shape solutions that are specific to each organization’s business goals. “With PDG’s increased focus and expertise on improving sales performance for life sciences organizations, we now have a unique ability and perspective to help our life sciences clients navigate ever-changing market dynamics and enable commercial teams to achieve and exceed their goals,” said Dave Manning, Founder and Managing Partner, of PDG. About PDG Since 2002, PDG has been helping the world’s leading life science organizations reach new heights in sales performance. PDG is laser-focused on driving measurable business results for business execution, sales transformation, leadership development, onboarding, employee engagement, and change management. To learn more, visit www.performdev.com Contact Details Performance Development Group Mercy Ehrler +1 610-854-4400 mehrler@performdev.com

January 18, 2023 09:00 AM Eastern Standard Time

Poolbeg Pharma announces expansion of POLB 001 into oncology

Poolbeg Pharma PLC

Poolbeg Pharma PLC (AIM:POLB, OTCQB:POLBF) CEO Jeremy Skillington speaks to Proactive's Thomas Warner after announcing that the company has submitted a patent application for the use of POLB 001 in a new oncological indication. Skillington explains the reasons for the strategic expansion and reveals more about his vision for the molecule in the long term. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

January 18, 2023 08:10 AM Eastern Standard Time

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Sharps Technology Is Commercializing The Future Of Specialty Syringe Systems For The Healthcare Industry Through Its Next-Gen Polymer-Based Products

Sharps Technology Inc.

By David Willey, Benzinga Sharps Technology, Inc. (NASDAQ: STSS) recently announced that the Company will be commercializing cutting-edge prefillable syringe system products to provide new solutions to customers in the healthcare and pharmaceutical market. Sharps is advancing its product strategy with a transformative partnership with Nephron Pharmaceuticals that was announced in November 2022, and will co-manufacture its specialized systems at Nephron’s facility in South Carolina starting in 2023. Over the last 20 years, the pharmaceutical syringe operational model has shifted from the use of glass vials and bulk disposable syringes to next-generation prefillable syringes, increasing prefillables from 15% to 85% share. This has contributed to market expectations of $15.7 Billion in revenue for 2030 from $5.6 Billion reported in 2020 for prefillables. Potential customers and companies in the space include syringe system manufacturers such as Becton Dickson and Co. (NYSE: BDX), Cardinal Health (NYSE: CAH),, and Terumo Corporation (OTC: TRUMY). Sharps’ specialty polymer-based syringe systems are in significant demand and the company will serve healthcare and pharmaceutical customers that recognize the advantages of non-glass products. Prefillable or ready-to-use syringes drive down the total cost of ownership for pharmaceutical companies by simplifying the supply chain and reducing product waste. Key advantages of prefillable syringe systems address contamination issues for the broader healthcare market, improving drug shelf life while reducing unnecessary packaging, and providing best-in-class solutions to get drugs to patients more efficiently. Through its recent product launch announcement, Sharps is addressing multiple problems in the syringe system market by modernizing the prefillable space with its polymer-based product line. The Company has developed a high-quality alternative solution to glass syringes through the use of inert polymers such as Cyclic Olefin Polymer (COP) and Cyclic Olefin Copolymer (COC), which offers a high-quality solution as compared to traditional glass syringe systems. These polymer syringes have many of the same characteristics as current pharmaceutical glass designs to support long-term drug stability and increase shelf life for customers in the pharmaceutical segment. Polymer syringes can also be made into custom configurations, which function to eliminate breakage, minimize dead space, reduce contamination, and support the development of custom devices including autoinjectors. Sharps is also making a silicone-free prefillable product that addresses silicone interaction issues for the broader healthcare market. Currently, syringes are commonly made with medical-grade silicone, but utilizing siliconeand can result in drug contamination, adding a need for costly inspections every time syringes are filled. Sharps’ silicone-free solution removes the risk of interaction with biologics and eliminates the need for product inspections and potential product waste issues. Major Partnership with Nephron Pharmaceuticals Advances Manufacturing and Product Launches Though Sharps is currently a pre-revenue company, the Company is transitioning from a research and development company into commercial operations through a major partnership signed with Nephron Pharmaceuticals in November 2022. This collaboration will boost Sharps’ ability to reach out to the prefillable syringe market With manufacturing, sales and marketing solidified, the company is confident in its ability to execute on multiple revenue opportunities in the growing prefillable market. Initial demand will be supported by manufacturing capacity of 20+ million units, with additional capacities that can be scaled by 2025 with an additional 100 million units annually. Products will be manufactured utilizing state-of-the-art injection molding technologies with highly automated assembly lines. The products will be sterilized using an eco-friendly clean sterilization option easily adaptable for the pharmaceutical market. Sharps' systems will utilize ISO Standard Nest and Tubs that will be compatible with existing fill-finish technologies to provide a drop-in solution for the industry. Sharps believes this increased production capacity and distribution will allow it to fill a growing market that is looking for innovative prefillable solutions. The partnership is part of Nephron’s InjectEZ program to increase manufacturing out of its South Carolina operations. The use of Nephron’s manufacturing facility will advance Sharps’ development strategy by two years and the Company will get full access to Nephron’s lab capabilities, providing Sharps with the opportunity to continue to innovate for ongoing product development. Robert Hayes, Sharps Chief Executive Officer, recently commented: “Following years of research and development, Sharps is now in a position to commercialize and support the future of specialty syringe drug filling technology. The opportunity to advance our product and manufacturing strategy to include high-value prefillable syringe products will significantly accelerate our revenue growth for 2023 and beyond. The launch of these products could not come at a better time to support a market that is in demand for products produced in the USA that provide specialized solutions for customers that need options for their drug-filling operations. We look forward to providing updates as we commence manufacturing in South Carolina and introduce our new products to the market.” To learn more about Sharps Technology, visit its website. This article was originally published on Benzinga here. Sharps Technology is a medical device and pharmaceutical packaging company specializing in the development and manufacturing of innovative drug delivery systems. The company’s product lines focus on low waste and ultra-low waste syringe technologies that incorporate both passive and active safety features. These features protect front line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. Sharps Technology has extensive expertise in specialized prefilled syringe systems and ready to use processing. The company has a manufacturing facility in Hungary and has partnered with Nephron Pharmaceuticals to expand its manufacturing capacity in the US. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Adam Holdsworth- TraDigital IR adam@tradigitalir.com Company Website http://sharpstechnology.com/

January 17, 2023 10:00 AM Eastern Standard Time

InDevR raises $9 Million in Series B Financing and Partners with bioMérieux

InDevR

InDevR, Inc., a provider of best-in-class analytical technologies for vaccines and biotherapeutics, announced that it has raised $9 million in series B financing. Adjuvant Capital has invested $4 million, and bioMérieux – a worldwide leader in in vitro diagnostics and microbiological quality control solutions for the food and pharmaceutical industries – $5 million. Together, these investments will support InDevR’s commercial expansion and ongoing development of new reagent kits for its VaxArray ® platform. bioMérieux will also become the exclusive distributor of the VaxArray portfolio in Europe, and Michael Reynier, Senior Vice President of Pharma Quality Control at bioMérieux, will join the company’s board of directors. VaxArray is based on a versatile and multiplexed microarray technology, with specific recognition and quantification of antigens, antibodies or nucleic acids, including mRNA. This technology complements bioMérieux’s expertise in applying immunoassays to vaccine production, as Michael explained: “We quickly recognized the high quality of InDevR's products and team, and realized that we share a common vision and mindset. This partnership reflects our desire to expand our offerings with high value-added solutions for pharmaceutical companies.” Glenn Rockman, Managing Partner at Adjuvant Capital, commented: “InDevR has already successfully developed critical quality attribute (CQA)/QC tools for pneumococcus, polio, measles and rubella vaccines, as well as for mRNA vaccines. We have been impressed with InDevR’s efficiency and dedication, and we are delighted to continue supporting the company alongside the experienced team at bioMérieux.” Kathy Rowlen, CEO at InDevR, said: “I am grateful for the opportunity to continue our successful partnership with Adjuvant Capital, and to work with the talented team at bioMérieux. The expertise at bioMérieux, combined with our innovation engine, will ensure that our CQA/QC tools are backed by a trusted partner who understands the needs of the highly regulated pharma industry.” VaxArray has also recently proven to be an excellent solution for mRNA CQA/QC testing, providing high specificity and sensitivity while eliminating the need for extracting mRNA from lipid nanoparticles. 1 Kathy added: “We are on a mission to revolutionize CQA/QC testing for vaccines and therapeutics. VaxArray provides us with the means to align the rapid advancement of mRNA vaccines and cell and gene therapies with more efficient, standardized and cost-effective analytical tools. And the partnership with bioMérieux accelerates our efforts to achieve this goal.” About InDevR – Based in Boulder, CO, InDevR is a life science tools company that provides powerful analytical test kits for CQA and QC testing for vaccines and biotherapeutics. References Gao RY, Riley CM, Toth E, et al. Rapid Identity and Quantity CQA Test for Multivalent mRNA Drug Product Formulations. Vaccines. 2022;10(10):1704. doi:10.3390/vaccines10101704 Contact Details kdm communications limited Annette Barnard +44 1480 405333 pressreleases@kdm-communications.com

January 17, 2023 08:00 AM Mountain Standard Time

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