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COMPASS Pathways Is Accelerating Patient Access To Evidence-Based Innovation In Mental Health Care

COMPASS Pathways

By Faith Ashmore, Benzinga The Current Landscape Of Mental Health Is Failing Patients Mental health treatments often fail many patients, leaving them struggling to find relief and support. Patients in this category are often considered “treatment-resistant,” where multiple therapies have limited or no effectiveness. Many people with mental health conditions such as depression, anxiety or bipolar disorder encounter this frustrating reality. Despite their efforts to seek help, they are unable to find effective treatments that alleviate their symptoms and improve their quality of life. This failure of mental health treatments further exacerbates the marginalization experienced by individuals with these conditions. As their condition persists or worsens, they may face stigmatization, discrimination and isolation. Often, this is because treatment is looking at a singular tool for a heterogeneous or multiple-cause disease state. For example, some drugs on the market currently modulate serotonin, norepinephrine and dopamine transmission within the brain. For some patients, this helps maintain a healthy mental state – but for others, it not only fails to work but may cause undesirable side effects. Geoff Grammer, Chief Medical Officer of Greenbrook NeuroHealth Centers breaks down the current landscape, sharing, “If we think of depression, kind of like headache, there's a lot of things that cause headaches. If you came and saw me for a headache and I said, all I got is Tylenol, that's going to leave you wanting. Take migraines, for example, [Tylenol is not even a suitable drug to administer]. Often people need different classes of agents for that. So what we're beginning to see is people breaking away from that kind of very rigid [historical] model and bringing more tools to the front to give patients more options to try to address some of those variations in what's causing the disease.” How Are Mental Health Treatments Evolving? To address these issues, there is a pressing need for not only the development of better treatments but also improved access to them. It is crucial to ensure that individuals with mental health conditions have readily available and affordable access to a range of evidence-based therapies, such as psychotherapy, medication and alternative interventions. One investigational therapy that has emerged in recent years is psilocybin treatment, particularly for illnesses like treatment-resistant depression (TRD) or PTSD. Steve Levine MD, Senior Vice President of Patient Access and Medical Affairs, COMPASS Pathways, shares, “We need as many tools in the toolbox as possible because the demand is so great in psychiatry. And we're on the cusp of that, whether it's psychedelic treatments or other promising innovations that we will hopefully see approvals for in the coming years, as well as the infrastructure that's being built to deliver them. In the coming decade, I hope we will see increased access for patients in need of care and better tools to meet those needs coming together to make a difference for these patients.” COMPASS Pathways (NASDAQ: CMPS) is working hard on developing innovative treatments to better help patients with an urgent unmet need. Although further research is still needed to establish its efficacy and safety, the company’s initial findings are promising and they have progressed to a phase 3 program in TRD. The company’s innovative approach has received FDA Breakthrough Therapy designation in the U.S. and Innovative Licensing and Access Pathway designation in the UK for their investigational COMP360 psilocybin in treatment-resistant depression. Moreover, in late 2021, COMPASS Pathways announced the completion of a randomized, controlled double-blind phase 2b study of investigational COMP360 psilocybin treatment involving 233 patients with TRD in 22 sites across Europe and North America. As part of its goal to develop new and more effective treatment options for TRD and other difficult-to-treat mental health conditions, COMPASS is researching and developing an integrated digital and AI product ecosystem to potentially improve the prediction of patient outcomes, scale therapist training and gain a better understanding of TRD as an illness. While the vision is to use these tools in tandem with COMP360 psilocybin treatment if approved, they are being built with scalability and broad use in mind in order to help impact the treatment of a wide range of mental health disorders. Treatment-resistant patients are a high unmet need. There is a need not only for innovative treatments but also for companion technologies and programs to support patients. It is also crucial for psychedelic treatments to go through clinical trials to establish safety and efficacy and through formal FDA approval so patients can get access to care in a regulated medical system. COMPASS Pathways, along with peers like BioRestorative Therapies (NASDAQ: BRTX), are innovators in a growing market. Company BioCOMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). We have commenced a phase 3 clinical program of COMP 360 psilocybin therapy in TRD, the largest randomised, controlled, double-blind psilocybin therapy clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also conducting phase 2 clinical studies of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD) and anorexia nervosa. COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the United States. Our vision is a world of mental wellbeing. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details Stephen Schultz stephen.schultz@compasspathways.com

October 06, 2023 09:00 AM Eastern Daylight Time

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BiVictriX Therapeutics appoints combined CFO/CBO to boost out-licensing efforts

BiVictriX Therapeutics PLC

BiVictriX Therapeutics PLC (AIM:BVX, OTC:BVTXF) incoming chief financial officer Adrian Howd speaks to Thomas Warner from Proactive London about what he hopes to achieve in the new role, which is being combined with the newly-created position of chief business officer. Howd introduces himself, highlighting his 20+ years in the biotech sector and the roles he's played in several emerging biotech companies and investment ventures. At BiVictriX, he will lead negotiations with larger companies interested in their evolving products. Howd expresses his confidence in the potential of BiVictriX's product pipeline and its lead asset BVX001 in particular, saying that its "a molecule that looks really different to other products... the antibody drug conjugate space is fairly new... but its the fastest growing element of new cancer therapy." Despite challenges in the broader biotech sector, Howd expressed confidence in BiVictriX's future, praising its scientific approach and the achievement of the team so far. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

October 06, 2023 03:00 AM Eastern Daylight Time

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Safe Supply Streaming Co now trading on the Canadian Securities Exchange with ticker SPLY

Safe Supply Streaming Co Ltd

Safe Supply Streaming Co CEO Bill Panagiotakopoulos and advisor Ronan Levy joined Steve Darling from Proactive to share news that the company has commenced trading on the Canadian Securities Exchange under the ticker symbol 'SPLY.' The company, with its strong financial footing, is strategically aligned with pivotal drug policy reform movements around the world. Panagiotakopoulos explained that Safe Supply Streaming is a pioneering company that invests in the legal and regulated supply of drugs that were traditionally only accessible through illicit markets. The company is actively deploying capital to address the ongoing fentanyl crisis and emerging opportunities related to the coca plant. Levy says the company's focus is on investing in and incubating businesses throughout the safe supply value chain. This includes companies that offer products, solutions, and technologies to combat the physical, financial, and emotional damage caused by drug abuse. Safe Supply Streaming Co's commitment to drug policy reform and harm reduction positions it at the forefront of a critical global issue. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

October 05, 2023 01:30 PM Eastern Daylight Time

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Addex Therapeutics focused on securing new partnerships to fund promising treatments

Addex Therapeutics Ltd

Addex Therapeutics co-founder and CEO Tim Dyer speaks to Thomas Warner from Proactive about the work that the central nervous system-focused clinical-stage pharmaceutical company has been doing in the promising area of allosteric modulation. He explains that company is currently collaborating with Johnson & Johnson on a phase two study for epilepsy, with results expected in Q2 of the following year. Additionally, Addex is developing treatments for chronic cough, schizophrenia, and cognition, with the latter receiving a grant from the European Union. Dyer explains that the company's unique approach to allosteric modulation offers a competitive edge in drug discovery, setting them apart from competitors. Their long-term strategy revolves around advancing their programs and securing partnerships to ensure steady cash inflows, especially given the challenging capital market environment. With seven programs in the pipeline and two already partnered, Addex is poised for significant growth in the coming years. Dyer says that "at the moment we continue to move the programs forward... we're very focused today on securing cash inflows to keep the business going through partnerships." Contact Details Proactive United States Proactive United States +1 347-449-0879 action@proactiveinvestors.com

October 05, 2023 11:20 AM Eastern Daylight Time

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Shield Therapeutics' pricing will be "key metric" - Proactive Research Analyst

Shield Therapeutics PLC

Proactive Research Analyst Robin Davison speaks to Thomas Warner after publishing a new research note on iron defiency-focused commercial-stage specialty pharmaceutical company Shield Therapeutics. Davison gives an overview of what readers can expect from the note, highlighting Shield's recent half-year results and accompanying financing transactions. The company's burgeoning relationship with commercial partner Viatris is a key focus. While the product's trajectory is promising, Davison explains that Shield has been grappling with the challenge of drug reimbursements in the US, leading to the incurring of some costs. However, plans are underway to assist doctors in navigating this system, with a view to securing a higher average drug price. Davison suggests that Shield's ability to increase that average price will be a "key metric going forward." He concludes by saying that "the trajectory is going extremely well, [they' really just want to get the pricing issue sorted now and it should be a great story." Davison's research note is available on the Proactive website as is a interview with Shield Therapeutics' CEO Greg Madison. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

October 05, 2023 04:00 AM Eastern Daylight Time

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Northern Leaf "on the road in terms of sales" ahead of London listing

Northern Leaf

Northern Leaf CEO Don Perrott speaks to Thomas Warner from Proactive London about the Jersey-based medical cannabis company's progress towards a potential AIM-listing later this year. Perrott gives an overview of the business and its achievements since being incorporated in 2019, highlighting its 100,000 square-foot glasshouse facility that produces six to eight tonnes of medical cannabis annually and its its EU Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP certifications). He discusses the benefits the advantages of operating in Jersey, which include a supportive government and competitive electricity costs. Northern Leaf is gearing up for a listing on AIM in the fourth quarter, with substantial progress already made in its IPO preparations. Perrott emphasises the commitment to producing high-quality, consistent medical cannabis and says the company is "on the road in terms of sales" with a shipment already on its way to Australia and deliveries to the UK and Germany scheduled. Perrott also expresses confidence in Northern Leaf's ability to navigate an often complex regulatory environment, saying that the company is "on top of regulations" and embracing the opportunities being created. Contact Details Proactive UK Ltd Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

October 05, 2023 03:57 AM Eastern Daylight Time

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Shield Therapeutics "couldn't be more pleased" with Viatris collaboration

Shield Therapeutics PLC

Shield Therapeutics PLC (AIM:STX, OTCQX:SHIEF) CEO Greg Madison speaks to Thomas Warner after a busy week for the commercial stage pharmaceutical company, which included the release of its interim results and the announcement of a major fundraise. He highlights the success of the fundraise, which comprised US$20 million from a new senior debt facility as well as an equity fundraise (split between a share placing, a subscription and an offering to retail investors) that brought in an additional US$6 million. He explains that the new funding is going to be put to use in "paying off an existing loan, increasing our working capital needs and then certainly some commercial investments to accelerate the curve that we're seeing here." The curve he describes is the marked increase in demand for Shield's Accrufer product, which is a stable, non-salt based oral therapy for adults with iron deficiency that is designed to avoid some of the unwanted side-effects of conventional iron tablets. He says he "can't speak highly enough about the dedication and passion of [his] team at Shield, but also about our partner Viatris... we made an excellent choice... we couldn't be more pleased with the partnership and the collaboration we're seeing." Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

October 05, 2023 03:00 AM Eastern Daylight Time

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Nuformix to fund its unlicensed programs with NXP001 windfall

Nuformix PLC

Nuformix PLC (LSE:NFX) executive director Dr Dan Gooding speaks to Proactive after the pharmaceutical development company announced it is to receive new immediate and near-term milestone payments as part of an update to its NXP001 exclusive licensing agreement with Oxilio Ltd. Dr. Gooding explains that Oxilio has now purchased patents from Nuformix that it had previously been licencing, resulting in significant near-term payments to Nuformix. This financial boost will aid Nuformix in advancing their unlicensed programs, specifically NXP002 and NXP004. Despite the patent sale, Nuformix retains future value from NXP001 through development milestones and royalties. Dr. Gooding also highlights Nuformix's work with NXP002 on lung fibrosis, a severe disease with limited treatment options. He explains that Nuformix's approach of repurposing existing drugs means a reduction in research time and costs. NXP002 is a modified version of a drug initially approved in Japan for asthma and skin scarring treatment. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

October 05, 2023 03:00 AM Eastern Daylight Time

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NMTC Coalition, 700 Organizations Urge White House, Congressional Leadership to Make NMTC Program Permanent

New Markets Tax Credit Coalition

Today, the New Markets Tax Credit (NMTC) Coalition, a national membership organization of Community Development Entities (CDEs) and investors organized to advocate on behalf of the NMTC, released a letter signed by nearly 700 community development stakeholders to President Biden and Members of Congress in support of enactment of a permanent extension to the NMTC in end of the year tax legislation. Despite its efficacy and importance for businesses and community development projects, the NMTC program expires in 2025. Signatories on the letter include 275 community development organizations; 76 housing organizations; 140 nonprofits, shelters, schools, healthcare facilities, and community service providers; 166 businesses and community development-focused investors; and 31 state and national community development trade associations. “We strongly support making the NMTC permanent,” said Aisha Benson, President of the NMTC Coalition and President and CEO of Nonprofit Finance Fund. “We’ve seen the enormous impact NMTCs can have in strengthening communities across the country, as well as in our own work in Arkansas and Ohio. We are committed to ensuring no community is left behind and preserving one of the federal government’s most successful community development programs.” During this Congress, both the Senate and House introduced bills (S. 234 and H.R. 2539) with bipartisan support to make the NMTC extension permanent. Establishing permanence will provide certainty in delivering resources to low-income and marginalized communities, creating jobs, increasing economic opportunity, and improving lives at a time when underserved communities face significant challenges. Throughout its 20-year history, the NMTC has delivered more than $125 billion to rural and urban communities outside the economic mainstream, which has led to financing to more than 8,000 businesses and projects and over one million jobs. Establishing the NMTC as a permanent part of the tax code will provide certainty and further promote getting patient, flexible capital to low-income and marginalized communities, creating jobs, increasing economic opportunity, and improving lives at a time when the economic frailty of our underserved communities has never been more apparent. Established in 2000 in the Community Renewal Tax Relief Act (P.L.106-554), the New Markets Tax Credit is a bipartisan effort to stimulate investment and economic growth in low-income urban neighborhoods and rural communities. “With the continuing impacts from COVID-19, and the general economic uncertainty felt across the country, the New Markets Tax Credit is absolutely vital for many of America’s urban neighborhoods and rural communities and will provide billions of dollars for high-impact, community revitalization projects,” said Bob Rapoza, spokesperson for the NMTC Coalition. “Over the years, the credit has been instrumental in financing plant and equipment for small manufacturing businesses and patient, flexible capital to other small businesses, hospitals, healthcare centers, homeless shelters and other transformative projects that improve communities, create jobs and economic opportunity. A permanent extension of NMTC will provide more certainty to private sector investors, which will result in better pricing and more subsidy to hard-to-finance, essential projects.” For examples of how the NMTC is making an impact in each state, see the NMTC Coalition’s website, where you can find over 2,500 NMTC success stories organized by state and congressional district. About New Markets Tax Credit Program -- The New Markets Tax Credit (NMTC) was enacted in 2000 to stimulate private investment and economic growth in low-income urban neighborhoods and rural communities lacking the patient capital to support and grow businesses, create jobs, and sustain healthy local economies. Since its inception, the NMTC has generated more than one million jobs. Today due to NMTC, more than $120 billion is hard at work in underserved communities in all 50 states, the District of Columbia, Guam and Puerto Rico. For examples of how the NMTC impacts each state, see the NMTC Coalition’s project database and state fact sheets. For more information, visit www.NMTCCoalition.org. Contact Details Greg Wilson +1 571-239-7474 gregwilsonpr@gmail.com Company Website https://nmtccoalition.org/

October 04, 2023 12:27 PM Eastern Daylight Time

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