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atai Life Sciences to Collaborate with Massachusetts General Hospital to Accelerate Discovery of Mechanisms Underlying Therapeutic Effects of Psychedelic Agents

NEW YORK, Jan. 26, 2021 /PRNewswire/ — atai Life Sciences (“atai” or the “Company”), a global biotech company developing psychedelic and non-psychedelic compounds for various mental health indications, today announced it has entered into a collaboration with Massachusetts General Hospital (“MGH”) and its new initiative, the Center for Neuroscience of Psychedelics, to advance novel mental health treatments through the study of mechanisms underlying the therapeutic effects of psychedelic agents.

“It is our privilege to partner with the MGH in collaboration with their newly established Center for Neuroscience of Psychedelics to further research the therapeutic potential of psychedelics to treat mental health disorders,” said Srinivas Rao, CSO & Co-Founder of atai. “Together, we can accelerate the study of mechanisms leveraging the MGH’s state-of-the-art approaches, tools and some of the greatest minds in neuroscience. This collaboration may lead to the discovery of novel mechanisms of neuroplasticity and development of more targeted treatments for mental illnesses, thereby pioneering the new frontier of precision mental health.”

Universally recognized as a leading academic medical center, the MGH is the original and largest teaching hospital of Harvard Medical School. The MGH recently established its Center for Neuroscience of Psychedelics to better understand how psychedelics enhance the brain’s capacity for change to optimize current treatments and create new treatments for mental illness.

The new center integrates and leverages the expertise of the MGH’s Department of Psychiatry, the Department of Radiology’s Athinoula A. Martinos Center for Biomedical Imaging, and the Center for Genomic Medicine’s Chemical Neurobiology Laboratory. The MGH Center for Neuroscience of Psychedelics is led by Jerrold F. Rosenbaum, MD, psychiatrist-in-chief emeritus, director of the Center for Anxiety and Traumatic Stress Disorders, and Stanley Cobb Professor of Psychiatry at Harvard Medical School; Bruce Rosen, MD, PhD, director of the Martinos Center and professor of Radiology at Harvard Medical School; and Stephen J. Haggarty, PhD, director of the Chemical Neurobiology Laboratory in the MGH Center for Genomic Medicine and associate professor of Neurology at Harvard Medical School.

“We are excited about the opportunity to evaluate compounds in atai’s pipeline that may prove to be effective in addressing unmet needs of patients with devastating psychiatric disorders,” said Dr. Rosenbaum. “There is accumulating evidence that psychedelics have unique disease-modifying potential. Understanding how these medicines enhance the brain’s capacity for change could lead to much-needed novel treatments for mental illness.”

“The relationship between atai and the MGH’s Center for Neuroscience of Psychedelics is built upon our shared goals of advancing the neuroscientific underpinnings of psychedelics on the way to meaningfully improving treatments for patients in need,” said Jacob Hooker, PhD, Phyllis and Jerome Lyle Rappaport MGH Research Scholar, director of Radiochemistry at the Martinos Center, and professor of Radiology at Harvard Medical School, who is co-leading, with Dr. Haggarty, the initial scope of the collaboration.

About atai Life Sciences
atai is a biotechnology company that was founded in 2018 as a direct response to the significant and growing unmet needs of mental health patients worldwide. atai is pioneering the development of more effective and potentially-disease modifying mental health treatments for patients sufferings from significant unmet medical needs. atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its business entities, seeking to effectively treat and ultimately heal mental health disorders. atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai is headquartered in Berlin, with offices in New York and San Diego. For more information, please visit www.atai.life.

Investor Contact:
Greg Weaver
atai – Chief Financial Officer
Email: greg.weaver@atai.life

Media Contact:
Anne Donohoe
KCSA Strategic Communications
Phone: +1 (212) 896-1265
Email: atai@KCSA.com

SOURCE atai Life Sciences

Related Links

http://www.atai.life

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atai Life Sciences Acquires Majority Stake in Recognify Life Sciences to Develop Novel Treatment for Cognitive Impairment Associated with Schizophrenia

— Phase II Clinical Trial Expected to Commence First Half of 2021 —

NEW YORK, Jan. 12, 2021 /PRNewswire/ — atai Life Sciences (“atai” or the “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced that it has acquired a majority stake in Recognify Life Sciences (“Recognify”), an entity developing a treatment for Cognitive Impairment associated with Schizophrenia (“CIAS”). Recognify’s lead compound, “RL-007”, previously called FSV7-007, has exhibited a modulating effect on three mechanisms that are central to learning and memory: the cholinergic, NMDA and GABA type B receptor systems.

Recognify’s RL-007 is a Phase II ready asset that has previously been evaluated in nine clinical studies – seven Phase I studies and two Phase II studies – with a total of 508 unique subjects having been dosed to date. Importantly, three of these clinical trials demonstrated improvements in verbal learning and memory, including in a large Phase II study of subjects with peripheral neuropathic pain.

RL-007 preliminarily exhibited pro-cognitive effects on exploratory endpoints in pain patients, an experimental cognitive paradigm, and healthy volunteers. Preclinically, it demonstrated pro-cognitive effects in healthy young animals, age-associated memory loss, and models of cholinergic-deficits. RL-007 also showed anxiolytic properties in animal models of unconditioned anxiety. Finally, it has been shown to enhance long term potentiation in rat hippocampal slices, indicating a direct action on mechanisms and brain regions involved with learning and memory processes.

“Millions of people suffer from CIAS globally, and it is a very damaging disorder that can often lead to dire consequences. In part, this is due to the cognitive deficits associated with the condition,” said Srinivas Rao, MD, PhD, Co-Founder & Chief Scientific Officer of atai Life Sciences. “Currently, there is a large patient population with unmet medical needs as there are no approved treatments for CIAS. We find the previous studies of RL-007 to be very promising in its modulating effect and look forward to launching our Phase II clinical trial focused on its use as a treatment of CIAS.”

“We are highly encouraged by the pro-cognitive results observed in the RL-007 clinical trials to date,” added Matthew Pando, PhD, CEO and Co-Founder of Recognify Life Sciences. “It is our privilege to join the atai family to further demonstrate the clinical potential of this compound, in particular, in the treatment of CIAS. atai will provide the necessary resources and support to advance Recognify Life Sciences to the next stage.”

“RL-007 is unique in that it enhances mechanisms of neuronal signaling, learning and memory, but apparently without the side effects associated with other compounds acting on these mechanisms,” said Dr. Thomas Südhof, Co-Founder of Recognify Life Sciences and 2013 Nobel laureate in Physiology or Medicine. “The combination of its pro-cognitive effects and safety profile make it an ideal candidate to treat CIAS patients and other fragile patient populations suffering from cognitive decline.”

About atai Life Sciences

atai is a clinical-stage biotechnology company aiming to transform the treatment of mental health disorders.  The Company was founded in 2018 as a direct response to the significant and growing unmet needs of mental health patients worldwide, lack of innovation and new insights into substances that may be overlooked or underused in the mental health treatment landscape, including psychedelic compounds and digital therapeutics. atai’s platform model combines funding, enabling technologies, supportive infrastructure and personnel with deep expertise to build programs focused on psychedelic and other compounds having differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai endeavors to responsibly accelerate the development of new medicines across its business entities, seeking to bridge the gap between what the mental healthcare system currently provides and what patients need. atai is headquartered in Berlin, with offices in New York and San Diego. For more information, please visit www.atai.life.

Investor Contact:
Greg Weaver
atai – Chief Financial Officer
Email: greg.weaver@atai.life

Media Contact:
Anne Donohoe
KCSA Strategic Communications
Phone: +1 (212) 896-1265
Email: atai@KCSA.com

SOURCE atai Life Sciences

Related Links

http://www.atai.life

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atai Life Sciences Appoints New Chief Financial Officer and Chief Medical Officer

Dr. Rolando Gutierrez-Esteinou & Greg Weaver to Join Executive Management Team

NEW YORK, Dec. 16, 2020 /PRNewswire/ — atai Life Sciences (“atai” or the “Company”), a global biotech company developing psychedelic and non-psychedelic compounds for various mental health indications, has announced the appointment of Greg Weaver as Chief Financial Officer (CFO) and Rolando Gutierrez-Esteinou as Chief Medical Officer (CMO).

Mr. Weaver joins atai with extensive experience in finance, having held numerous executive positions in the field of biotechnology. Greg’s career has focused on start-up through clinical development and commercial stage. He has guided over $1.1 billion in financing transactions during his career, participated in several public and private financings, providing financial guidance, strategic leadership and shareholder value. Prior to joining atai, Mr. Weaver was CFO at several successful companies, including SIRNA Therapeutics, ILEX Oncology, Oryzon, Prometic, and Eloxx Pharmaceuticals.

“Greg brings a wealth of experience with a proven track record in complex financial organizations, where he was responsible for a number of companies’ successful public offerings,” said atai CEO and Co-Founder Florian Brand. “As we continue to grow and evolve, Greg’s deep financial expertise and knowledge will be invaluable.”

Mr. Weaver holds a BS in accounting and finance from Trinity University and an MBA from Boston College’s Wallace E. Carroll Graduate School of Management.

“I am thrilled to join atai at this very exciting time, and to have the opportunity to serve with this exceptional team,” said Mr. Weaver. “It is clear that atai has a unique and compelling culture of innovation, empathy, and making a significant impact on behalf of mental health patients. I look forward to driving our shared vision of leaving no patient behind.”

Dr. Gutierrez-Esteinou is a seasoned pharmaceutical executive in neuroscience drug development and commercialization. Having become a psychiatrist some 30 years ago, Rolando was around during the breakthroughs of serotonin selective reuptake inhibitors (SSRIs) and atypical antipsychotics, some of which he helped develop.

During this time, he has held executive positions at world-renowned companies including Johnson & Johnson, Novartis, BMS, Takeda and Marinus in clinical development, project management, medical affairs and pharmacovigilance.

“Rolando’s three decades of experience in the neuroscience space and his true understanding of the potential of these compounds speaks directly to our values at atai,” said Dr. Srinivas Rao, atai Co-Founder and Chief Scientific Officer. “His depth of knowledge and experience in CNS drug development will contribute greatly in our efforts to move our portfolio forward.”

Dr. Gutierrez-Esteinou received his MD from the Universidad Nacional Autonoma de Mexico, and did his subsequent residency in the department of psychiatry as well as his fellowship in the department of neurochemistry at Harvard Medical School. Additionally, he completed his fellowship in experimental therapeutics at the National Institute of Mental Health (NIMH).

“I am very excited to join atai at a time when the development of psychedelics is progressing into later stages of clinical testing in multiple psychiatric conditions of high unmet need,” said Dr. Gutierrez-Esteinou. “The unique therapeutic effects of these investigational medicinal products will require innovation in the way studies are conceived, designed, implemented and analyzed so atai has assembled the team of specialists who can tackle these tasks.”

Dr. Gutierrez-Esteinou will be based in New Jersey and Mr. Weaver will be based in New York City.

About atai Life Sciences
atai is a biotechnology company founded in 2018 in response to the clear and growing unmet needs of mental health patients worldwide. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its business entities, seeking to effectively treat and ultimately heal mental health disorders. atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai is headquartered in Berlin, with offices in New York and San Diego. For more information, please visit www.atai.life.

Investor Contact:
Greg Weaver
atai – Chief Financial Officer
Email: greg.weaver@atai.life

Media Contact:
Anne Donohoe
KCSA Strategic Communications
Phone: +1 (212) 896-1265
Email: atai@kcsa.com

SOURCE atai Life Sciences

Related Links

http://www.atai.life

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INN: Psychedelic Trends 2020: The Heat is On

2020 marked the beginning of the psychedelics investment story as the capital markets fully embraced the alternative drug sector.

The idea of investing in a psychedelic drug company may have sounded unlikely before 2020.

But now investors are enjoying the dawn of a new alternative drug market that is trying to capitalize on the medical benefits of psychedelic substances.

In 2020, investors saw the arrival of a number of new public companies that are exploring various pathways in the psychedelics space, primarily operating under the promise of new medicine.

It’s no exaggeration to say that 2020 served as the launching pad for psychedelics in the eyes of the capital markets. And that included us, as here at the Investing News Network (INN) we launched our own psychedelics-focused vertical.

Read on to get a sense of the psychedelics trends that are setting the stage for this promising new industry, with commentary from insiders and experts.

Psychedelics trends 2020: Markets get their bets ready as listings erupt

As mentioned, this year catapulted a fresh stock universe into existence as a variety of new companies went public across different exchanges.

While it wasn’t the first of the year, the listing of Compass Pathways (NASDAQ:CMPS) was one of the biggest landmark events for the industry in 2020. The company was the first psychedelics operation to list directly on the NASDAQ, opening the door for others to follow.

“It’s shown to the world what insiders have known for a long time — that this vision of bringing psychedelic medicine to the world isn’t a pipe dream, it’s very real and it’s happening now,” Michael Hoyos, co-founding partner, Americas, with the Conscious Fund, previously told INN.

Fellow companies also celebrated Compass Pathways’ debut as the arrival of a new era.

“Compass’ successful IPO is further evidence that psychedelics are gaining traction as a viable solution for treating mental health and addiction,” JR Rahn, co-founder and co-CEO of Mind Medicine (MindMed) (NEO:MMED,OTCQB:MMEDF), said.

During an online talk in the leadup to the Compass Pathways listing, Bill Stern, managing partner at Venture Group Capital, said the listing looked set to “change the industry dramatically.”

Dugan Selkirk, media relations manager for Vancouver-based private firm Universal Ibogaine, was not elusive about the significance of the NASDAQ listing. “The top blew off with Compass Pathways’ mega IPO in the US markets, which has put the wind back into the sails of the industry, and we see this pattern continuing with momentum into 2021.”

Jos Schmitt, president and CEO of the NEO Exchange, told INN he believes investors have to get over any stigma surrounding these substances, because he believes the opportunity is too great to pass up.

Back in March, when MindMed went public, the NEO saw Canada’s first official listing of a company operating in the psychedelics space.

A fellow securities executive previously told INN he was unsure when he first heard about the psychedelics investment shot. “I will admit, I was a bit skeptical at first,” said Richard Carleton, CEO of the Canadian Securities Exchange (CSE).

Carleton changed his mind after seeing the research that has been conducted and meeting with companies directly to discuss the sector.

The CSE is now the capital markets home of nearly 30 listings related to the psychedelics industry.

Psychedelics trends 2020: Pandemic highlights need for mental health alternatives

Florian Brand, co-founder and CEO of privately held ATAI Life Sciences, told INN he came into 2020 expecting a natural progression of the interest in therapies using psychedelics. But instead the executive found a significant jump in attention, thanks in large part to the focus on mental health created by the effects of a global pandemic.

Brand said the uncertainty surrounding COVID-19 has “precipitated an increased focus on mental health and the failures of our current standards of care.”

Doug Drysdale, CEO of Cybin (NEO:CYBN), echoed Brand’s sentiment, saying he believes the pandemic accelerated the acceptance of using alternative methods to treat mental health issues.

“We are seeing a paradigm shift in the public view and complacency for the norm of Big Pharma traditional, (and) in many cases dangerous and non-effective, treatments,” Josh Bartch, CEO of Mydecine Innovations Group (CSE:MYCO), told INN.

Psychedelics trends 2020: Executives ask for patience in face of growing buzz

As the psychedelics industry first started to develop, it became clear that one of the most direct points of comparison would be with the cannabis industry.

“Had cannabis not come along, it probably would have been a longer road to be having some of these conversations,” Ronan Levy, co-founder and executive chairman of Field Trip Health (CSE:FTRP), previously told INN.

To a degree it’s understandable, as both are alternative drug markets exploring new uses in the face of strict regulations. But some members of the psychedelics industry have been quick to deter investors from believing psychedelics will see similar hype runs to those experienced in the cannabis industry.

This leaves the question of if investors should play the market or get ready for long-term bets only.

Payton Nyquvest, chairman and CEO of Numinus Wellness (TSXV:NUMI), previously told INN that anyone entering this space has to understand the long-term roadmap ahead. “There’s no quick pathway to be able to do this,” he said.

Brand said it’s the responsibility of psychedelics companies to fully research these compounds and learn their entire medical benefits, as well as the potential risks attached.

“Viewing psychedelics as a panacea is alluring, but in reality there’s risks we still need to quantify,” said Brand of ATAI Life Sciences. “It’s incumbent on us and others in the space to build out the data and support for safe and accessible treatment, and not let excitement get ahead of the hard work to build a sustainable, impactful industry.”

Drysdale told INN that in his view the most challenging aspect for the psychedelics market in 2020 was the pressure to gain credibility and attention due to the rush of companies going public.

“Psychedelics are leading with science, creating massive intellectual property (IP) opportunities, and both of these things rely on regulation holding the industry to standards and pace,” Kelsey Ramsden, president and CEO Mind Cure Health (CSE:MCUR,OTCQB:MCURF), told INN. “As a company who is in high-growth mode with fast-moving IP projects, being patient can be challenging.”

That sentiment of longevity for investments was echoed by Carleton, who said he sees the psychedelics market as a “pharma play.”

Hoyos told INN the industry needs to be careful to not repeat the mistakes made in the cannabis space, which led to a large part of the sector wanting to make a quick buck compared to growing steadily.

“For investing in the space, I think the full value will be realized in the longer term, but there will be opportunities for exit liquidity events a lot sooner,” Hoyos added.

Psychedelics trends 2020: Studies set path for changing perspectives

One of the biggest factors helping psychedelics is the launch and continuation of medical studies evaluating particular drug treatments based on psychedelics and boosting the legitimacy of the industry.

Timothy Ko, CEO at Entheon Biomedical (CSE:ENBI), told INN that 2020 will be remembered as a year in which the psychedelics industry established itself and came into the spotlight thanks to the work of those “who have historically utilized, researched and spoken for the value of psychedelic compounds.”

Investors will need to keep an eye on the development of several studies moving forward, as these will offer the most concrete answers on whose drugs are worth betting on. These studies, particularly those to obtain approval from the US Food and Drug Administration, are extremely lengthy and costly events for the companies in play.

“I think the challenge and gift of regulation resting in the balance of scientific proof is what will both make this a stable and rapidly growing investment sector,” Ramsden said.

Thanks to recognition from medical authorities, more investors are starting to look into what’s at stake with psychedelics.

Psychedelics trends 2020: Investor takeaway

The psychedelics industry found its groove in 2020 and discovered investors ready to listen and get involved. This growth in attention may be partially due to the effects of lockdowns and the uncertainty caused by COVID-19, but it is also backed by the medical research being conducted.

In 2020, investors discovered the enthusiasm for psychedelics goes well beyond college dorm rooms.

Don’t forget to follow us @INN_LifeScience for real-time news updates!

Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.

Editorial Disclosure: Cybin, Mind Cure Health, Numinus Wellness and Universal Ibogaine are clients of the Investing News Network. This article is not paid-for content.

The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.

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ATAI Life Sciences Announces Closing of $125 Million Series C Financing Round

Funding to support advancement of psychedelic and non-psychedelic compounds as well as innovative technologies to treat mental health disorders

Participants include Apeiron Investment Group, Peter Thiel, Catalio Capital Management, Future Ventures, Galaxy Investment Partners, Falcon Edge Capital and Pura Vida Pro LLC

NEW YORK, Nov. 23, 2020 /PRNewswire/ — ATAI Life Sciences (“ATAI” or the “Company”), a global biotech company developing psychedelic and non-psychedelic compounds for various mental health indications, today announced the successful closing of its $125 million Series C financing round, including $32 million of its 2020 convertible debt that converted in connection with the Series C. The round was co-led by Apeiron Investment Group, the family office of ATAI’s founder Christian Angermayer, Peter Thiel, and Catalio Capital Management; joined by other existing investors including Future Ventures and Galaxy Investment Partners, as well as new investors including Falcon Edge Capital and Pura Vida Pro, LLC.

Proceeds from the financing will be used primarily to fund pre-clinical and clinical development of ATAI’s existing mental health programs, to expand its drug candidate pipeline and further advance ATAI’s platform technologies. The Company expects the proceeds to provide the necessary runway to accomplish several key clinical milestones including Phase 2 data readouts for arketamine in treatment resistant depression at Perception Neuroscience and ibogaine in opioid use disorder at DemeRx, as well as the completion of Phase 1 and initiation of Phase 2 trials at four other programs.

“We are grateful to have the strong support of both new and existing investors, comprised of forward-thinking individuals that share in our belief that innovation in mental healthcare is urgently needed and possible,” said Florian Brand, CEO & Co-Founder of ATAI Life Sciences. “We believe that our psychedelic and non-psychedelic compounds have compelling therapeutic promise based upon a growing body of scientific evidence. This round of funding is another step towards our vision to effectively treat and ultimately prevent mental health disorders, bridging the gap between what the mental health system currently provides and what patients need.”

“With COVID-19 only accentuating the failures of existing standards of care, we are at an inflection point when it comes to seriously addressing this global mental health crisis,” said Christian Angermayer, Founder of ATAI. “I’m excited to continue my support of ATAI alongside an impressive group of investors. I’m proud of the best-in-class technology, tools and top-tier talent that has been established at ATAI to developing promising therapeutics to treat mental health disorders. ATAI’s progress to date has been astounding, and I’m thrilled at what is yet to come.”

“ATAI’s growth is a testament to the wide recognition of its founding mission, and a key element of the change in thinking we seek to catalyze across neuropsychiatric research and development,” said Jason Camm, Managing Director and Chief Medical Officer of Thiel Capital.

“Christian and the ATAI team have singlehandedly invented and created an entire sector, and have built with ATAI the leading company in it,” said George Petrocheilos, Co-Founder & Managing Partner of Catalio Capital Management. “Their work has the potential to change the lives of hundreds of millions of people, and we are proud to be an investor.”

About ATAI Life Sciences
ATAI is a biotechnology company founded in 2018 in response to the clear and growing unmet needs of mental health patients worldwide. ATAI is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. ATAI’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, ATAI aims to responsibly accelerate the development of new medicines across its business entities, seeking to effectively treat and ultimately heal mental health disorders. ATAI’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. ATAI is headquartered in Berlin, with offices in New York and San Diego. For more information, please visit www.atai.life.

Investor Contact:
Greg Weaver
ATAI – Chief Financial Officer
Email: greg.weaver@atai.life

Media Contact:
Anne Donohoe
KCSA Strategic Communications
Phone: +1 (212) 896-1265
Email: ATAI@KCSA.com

SOURCE ATAI Life Sciences

Related Links

https://www.atai.life/

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ATAI Life Sciences Announces Neuronasal Completes Pilot Study, Receives IND Clearance to Continue into Phase I Trials of mTBI Therapeutic

NEW YORK, Oct. 27, 2020 /PRNewswire/ — ATAI Life Sciences (“ATAI” or the “Company”), a global biotechnology company developing psychedelic and non-psychedelic compounds for various mental health indications, today announced that Neuronasal Inc. (“Neuronasal”) has completed its pilot study intended to show nose to brain delivery of N-acetylcysteine (NAC) in healthy volunteers. Additionally, Neuronasal has been granted Investigational New Drug (IND) clearance by the FDA to continue phase I clinical trial development in partnership with ATAI.

Concussions and other forms of mTBI represent a significant unmet medical need. With no currently approved treatments, patients often suffer acute symptomatology including headache, nausea, fatigue, depression, anxiety and irritability. In fact, approximately half of the 2.5 million people who are concussed every year in the United States alone develop long-term cognitive impairment. Also, the ongoing NINDS-funded TRACK-TBI initiative has recently revealed that concussion is associated with substantial increases in the rates of major depressive disorder, post-traumatic stress disorder, and other psychiatric and non-psychiatric conditions.

Typically, concussions are the result of physical trauma that disrupts brain tissue and blood supply, followed by focal vascular leakage, inflammation, the formation of reactive oxygen species (ROS) and the release of excessive amounts of glutamate. This, in turn, exhausts the pool of intracellular glutathione in brain and induces glutamate-mediated neuro-excitotoxic damage. In more severe cases, neuronal atrophy and necrosis can occur as well.

Neuronasal’s potentially ground-breaking proprietary treatment includes the intranasal delivery of low doses of N-acetylcysteine (NAC) to patients with acute mild traumatic brain injury (mTBI). NAC is a well-established compound that has been used safely for decades, mostly as a mucolytic and to treat acute paracetamol intoxication. NAC is stimulating the synthesis of glutathione that is the most abundant endogenous antioxidant, known to prevent oxidative damage to cellular components. In addition, NAC itself has direct antioxidant, anti-inflammatory, and free radical scavenging effects. Finally, NAC acts as an inhibitory glutamatergic modulator. All of these mechanisms are important in the context of mTBI.

NAC has the potential to disrupt the deleterious chain of events following mTBI. In soldiers exposed to explosive blast injury the probability of symptom resolution at 7 days increased from 41.9 to 86.2% when receiving NAC treatment within 24 hours post-blast.

Neuronasal’s intranasal approach enables direct nose-to-brain delivery, allowing for significantly lower doses and outpatient treatment. Given its apparent efficacy in disrupting the underlying neurochemical cascade, intranasal NAC has the potential to induce a fundamental shift in the natural course of the condition for hundreds of thousands of people.

“mTBIs are more than just uncomfortable and can result in everything from depression and anxiety to cognitive decline when left untreated,” said ATAI’s Chief Scientific Officer, Srinivas Rao. ”By developing an early intervention, we stand to disrupt a potentially disastrous disease trajectory.”

“We are pleased with our pilot trial results.” said Thomas Bradshaw, CEO of Neuronasal. “Our team is excited to move into Phase I clinical development with the support of the team at ATAI.”

About ATAI Life Sciences

ATAI is a biotechnology company founded in 2018 in response to the clear and growing unmet needs of mental health patients worldwide. ATAI acquires, incubates and efficiently develops innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. ATAI’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety and therapeutic potential. By pooling resources and best practices ATAI has been able to responsibly accelerate the development of new medicines across its business entities, aiming to effectively treat and ultimately heal mental health disorders. ATAI’s vision is to bridge the gap between what the mental healthcare system currently provides and what patients need. ATAI is headquartered in Berlin, with offices in New York and San Diego. For more information, please visit www.atai.life.

Media Contact: 
Anne Donohoe
KCSA Strategic Communications
Phone: +1 (212) 896-1265
Email: ATAI@KCSA.com

SOURCE ATAI Life Sciences

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ATAI Life Sciences launches EmpathBio to treat post-traumatic stress disorder with novel MDMA product

NEW YORK, Aug. 24, 2020 /PRNewswire/ — Today, ATAI Life Sciences (“ATAI” or the “Company”), a global biotech developing psychedelic and non-psychedelic compounds for various mental health indications, announced the launch of EmpathBio, a wholly-owned subsidiary developing derivatives of  3,4-methylenedioxy-methamphetamine (MDMA) for the treatment of post-traumatic stress disorder (PTSD) and other indications.

PTSD is a chronic condition characterized by recurring and intrusive thoughts or memories. Often co-occurring with major depression, PTSD has devastating effects on all aspects of an individual’s life. Indeed, one Danish study found that persons with PTSD were 13 times more likely to commit suicide than the general population.

In the US alone, an estimated 13 million people meet the criteria for a PTSD diagnosis. At present, the only FDA approved treatments for PTSD are selective serotonin reuptake inhibitors (SSRIs), namely sertraline hydrochloride (Zoloft) and paroxetine hydrochloride (Paxil). Unfortunately, not only does each come with significant side-effects, two-thirds of patients either do not response or have only a partial response to SSRIs.

MDMA itself is an amphetamine derivative that possesses complex pharmacology and is believed to act by increasing the release of monoamines like serotonin, norepinephrine and dopamine in the brain, as well as stimulating neurohormonal activity. These effects are thought to result in the anxiolytic, prosocial and empathic responses seen with MDMA administration in humans. As a result, MDMA is often classified as an entactogen rather than a typical psychedelic.

MDMA’s entactogenic effects typically last approximately six hours and are hypothesized to promote a sense of psychological safety which may allow patients to more effectively address their individual traumas during psychotherapy.  The derivatives of MDMA being developed by EmpathBio are expected to have similar effects.

“PTSD is a debilitating condition which affects millions worldwide,” said Florian Brand, CEO of ATAI Life Sciences. ”Entactogen-assisted psychotherapy promises to fundamentally change how we think about this notoriously difficult to treat disorder.”

The use of MDMA for PTSD has been the subject of extensive research by the Multidisciplinary Association of Psychedelic Research (MAPS) and phase III clinical trials are ongoing.  Published results from their phase II clinical trials showed that 56% of participants no longer met the criteria for PTSD two-months after the final MDMA-assisted psychotherapy session. Additionally, researchers followed up with 91 participants twelve months later and found that 67% still did not meet PTSD criteria.

EmpathBio is focused on developing MDMA derivatives with different pharmacological profiles than MDMA. The company believes that such changes may permit the entactogenic effects of MDMA to be separated from some of the known adverse effects. If successful, such an approach could help minimize some of the transient physiological changes caused by MDMA, potentially expanding the pool of PTSD patients who will be medically eligible for the therapy.

“While MDMA-assisted psychotherapy holds great promise for the treatment of PTSD, refinement of MDMA’s entactogenic pharmacology could provide for a greater therapeutic index,” said Glenn Short, CEO of EmpathBio. “We want to ensure that entactogen-assisted psychotherapy is available to all living with PTSD.”

Company Contact:
Allan Malievsky
ATAI Life Sciences
Phone: +1 (917) 974-1371
Email: Allan@ATAI.life

Investor Contact:
Allison Soss
KCSA Strategic Communications
Phone: +1 (212) 896-1267
Email: ATAI@KCSA.com

About ATAI Life Sciences
Founded by visionary entrepreneur Christian Angermayer, ATAI Life Sciences AG is a global biotech platform and company builder working to address significant unmet medical needs rooted in a lack of innovation in neuropsychiatry. Based in Berlin, London and New York, its vision is to cure mental health disorders, enabling people to live healthier and happier lives. www.atai.life

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ATAI and IntelGenx enter into Feasibility Agreement to develop pharmaceutical-grade polymeric film technologies for delivery of psychedelic medicines

NEW YORK, Aug. 20, 2020 /PRNewswire/ — Today, ATAI Life Sciences (“ATAI” or the “Company”), a global biotech developing psychedelic and non-psychedelic compounds for a variety of mental health indications, announced a Feasibility Agreement with IntelGenx Corp. (TSX V:IGX)(OTCQB:IGXT) (“IntelGenx”) for the development of novel formulations of pharmaceutical-grade psychedelics based on IntelGenx’s polymeric film technologies.

IntelGenx will conduct pre-development and formulation development work to design a prototype polymeric film formulation that will be investigated by ATAI in subsequent clinical trials. Additionally, the agreement describes the terms under which the Company and IntelGenx would enter into an exclusive license to commercialize the product globally.

“Given the breadth of the mental health crisis, it’s critical that we identify the most efficient methods of delivering psychedelic medicines,” said ATAI CEO Florian Brand. “We look forward to working with IntelGenx to ensure that ATAI’s family of compounds are accessible to all that need them.”

“We will leverage our VersaFilm® technology platform to design convenient and fast-acting formulations of ATAI’s compounds,” said Dr. Horst G. Zerbe, CEO of IntelGenx. “We are excited to work with ATAI to serve the millions of people living with mental illnesses, both by discovering novel delivery methods and potentially manufacturing ATAI’s clinical supply.”

Company Contact:
Allan Malievsky
ATAI Life Sciences
Phone: +1 (917) 974-1371
Email: Allan@ATAI.life

Investor Contact:
Allison Soss
KCSA Strategic Communications
Phone: +1 (212) 896-1267
Email: ATAI@KCSA.com

About ATAI Life Sciences
ATAI Life Sciences is a global biotech platform and company builder founded by Christian Angermayer. Based in Berlin, New York and San Diego, its vision is to cure mental health disorders, enabling people to live healthier and happier lives. www.atai.life

About IntelGenx
IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.

IntelGenx’s superior film technologies, including VersaFilm®, VetaFilm™ and transdermal, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions.

IntelGenx’s highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’s state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. www.intelgenx.com.    

Forward Looking Statements:
This document may contain forward-looking information about IntelGenx’ operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx’ plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words “may,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “could,” “would,” and similar expressions. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx’ actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading “Risk Factors” in IntelGenx’ annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities at www.sedar.com. ATAI and IntelGenx assume no obligation to update any such forward-looking statements.

Each of the TSX Venture Exchange and OTCQB has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

SOURCE ATAI Life Sciences

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ATAI Life Sciences to Host Virtual R&D Day on July 29, 2020

Featuring presentations from leading experts Dr. Amir Kalali, Global Clinical Development and Technology, and Dr. John Krystal, Yale School of Medicine

BERLIN and NEW YORK, July 22, 2020 /PRNewswire/ — ATAI Life Sciences AG, a global biotechnology company builder that envisions an end to mental illnesses, today announced that it will host a virtual Research and Development (R&D) Day for analysts and investors on Wednesday, July 29, 2020 from 12:00pm to 3:00pm ET.

From psychedelics to digital therapeutics, the R&D day will focus on how the Company is working to address significant unmet medical needs in the mental healthcare space.

The event will feature presentations by members of ATAI’s management team, along with leading experts, Amir Kalali, MD and John Krystal, MD.

Dr. Amir Kalali is recognized globally as a leading innovator at the intersection of life sciences and technology, advising companies in both sectors. He is known for his expertise in the digitization of the pharmaceutical industry. Previously, he was the Head of the Neuroscience Center of Excellence at IQVIA.  In this role, he was responsible for the enterprise-wide strategy for Neuroscience, encompassing drug development and health care services. He is a Professor of Psychiatry at the University of California San Diego, Editor of the journal Innovations in Clinical Neuroscience, and the Lead Editor of the book Essential CNS Drug Development, published by Cambridge University Press. He is the Founding Chairman of the Executive Committee of the International Society for CNS Drug Development (ISCDD), and Chairman and Chief Curator of the CNS Summit. He has been involved in initiatives by the Institute of Medicine Forum on Drug Discovery, Development, and Translation, as well as the NIH FAST and the NIH NCATS New Therapeutic Uses program. Dr. Kalali’s contributions to drug development have been recognized by multiple awards and being named to The Medicine Maker’s Power List and the PharmaVOICE 100 and the Inaugural Red Jacket award.

Dr. John Krystal is the Robert L. McNeil, Jr. Professor of Translational Research and Professor of Psychiatry, of Neuroscience, and of Psychology at Yale University. He is co-chair of the Neuroscience Forum (NeuroForum) of the National Academies of Sciences, Engineering, and Medicine and he edits the journal, Biological Psychiatry. He previously served on the NIMH National Mental Health Advisory Council and the NIAAA National Alcohol Advisory Council. Dr. Krystal is a leading expert in the areas of alcoholism, post-traumatic stress disorder, schizophrenia, and depression. His work links psychopharmacology, neuroimaging, molecular genetics, and computational neuroscience to study the neurobiology and treatment of these disorders. He is best known for leading the discovery of the rapid antidepressant effects of ketamine in depressed patients.

Webcast Information

To attend the live video webcast, please register or email KCSA Strategic Communications at ATAI@kcsa.com. For interested individuals unable to join the live event, please email Investor Relations at investorrelations@atai.life.

About ATAI Life Sciences
Founded by visionary entrepreneur Christian Angermayer, ATAI Life Sciences AG is a global biotech platform and company builder working to address significant unmet medical needs rooted in a lack of innovation in neuropsychiatry. Based in Berlin, London and New York, its vision is to cure mental health disorders, enabling people to live healthier and happier lives.

Media Contact:
Allan Malievsky
ATAI Life Sciences
Phone: +1 (917) 974-1371
Email: Allan@ATAI.life

Investor Contact:
Allison Soss
KCSA Strategic Communications
Phone: +1 (212) 896-1267
Email: ATAI@KCSA.com

SOURCE ATAI Life Sciences

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https://www.atai.life/

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ATAI Life Sciences takes on opioid crisis by acquiring Kures to develop novel therapeutics for opioid abuse

BERLIN and NEW YORK, July 9, 2020 /PRNewswire/ — ATAI Life Sciences AG, a global biotechnology company builder that envisions an end to mental illnesses, has acquired a majority stake in New York-based pharmaceutical company Kures, which targets the important intersection between pain and opioid use disorder. Additionally, Srinivas Rao, MD, PhD, Chief Scientific Officer of ATAI Life Sciences, has been appointed CEO of Kures.

“Joining ATAI’s platform comes with much more than a capital infusion,” said Dr. Rao. “Our model involves pooling resources, expertise and best practices from across the platform, helping our companies steer clear of the many pitfalls that come with breaking new ground in drug development.”

Kures’ flagship product, KUR-101, is a derivative of mitragynine, the major active alkaloid of the kratom plant. Used for centuries in Southeast Asia as a remedy for fatigue, pain, and myriad other conditions, kratom leaf has recently grown in popularity as an herbal medicine in the United States. Importantly, in addition to its traditional medicinal applications, consumers in the United States report that it may also be effective in ameliorating the symptoms of opioid withdrawal. Both mitragynine and KUR-101 are atypical opioid receptor modulators, boasting unique pharmacology that may make them safer than currently available opioids in treating pain. Additionally, Kures’ second asset, KUR-002, is under evaluation for the treatment of subsets of depression through a unique mechanism of action.

Kures has an exclusive license from Columbia University to develop small molecules discovered in the lab of Dr. Dalibor Sames in collaboration with the labs of Dr. Jonathan Javitch and Dr. René Hen to treat pain, opioid use disorder, and depression. Sames, a professor of chemistry, uses organic synthesis and molecular design to address challenges in neuroscience and brain medicine.

Given that the majority of opioid abuse starts with a prescription to manage pain, addiction and pain are fundamentally linked. While opioids are indeed effective for most forms of acute pain, they are associated with a variety of adverse effects, including risk of addiction, constipation, and respiratory depression, the latter being the main cause of death among opioid users. Of individuals prescribed at least 1 day of opioids, 6% are still taking them 1 year later. Moreover, it is estimated that 8-12% of individuals prescribed opioids for chronic pain ultimately develop opioid use disorder.

There are notable drawbacks to existing opioid maintenance therapies as well. In addition to respiratory depression and high abuse potential, methadone, a full mu-opioid receptor agonist, significantly impacts cardiovascular function and can induce life threatening arrythmias. Furthermore, it is only dispensed in highly structured clinical settings, severely limiting patient access. Buprenorphine, a partial agonist at mu-opioid receptors, is more widely available and has an improved pharmacological profile in terms of cardiac and respiratory safety, but retains significant abuse liability and promotes long-lasting dependence.

Therefore, by developing a potentially safer and more widely available alternative for both pain management and opioid maintenance therapy, ATAI and Kures are poised to address two key factors underlying the opioid epidemic. “We are very concerned about the opioid epidemic in the United States and are committed to developing approaches to both treat and prevent this condition,” said Florian Brand, CEO of ATAI.

“Kures is excited to have the resources and commitment of ATAI in advancing our promising therapeutic compounds,” added Andrew Kruegel, CSO and co-founder of Kures. “We look forward to working with the ATAI team to bring new treatment options to patients suffering from pain and mental illness.”

ATAI is recognized as the world’s leading – and largest – company in the field of psychedelic therapy. KUR-101 will join ATAI’s pipeline of ground-breaking mental health interventions such as arketamine and psilocybin, with additional high-impact compounds to be announced soon.

Company Contact:
Allan Malievsky
ATAI Life Sciences
Phone: +1 (917) 974-1371
Email: Allan@ATAI.life

Investor Contact:
Allison Soss
KCSA Strategic Communications
Phone: +1 (212) 896-1267
Email: ATAI@KCSA.com

About ATAI Life Sciences
Founded by visionary entrepreneur Christian Angermayer, ATAI Life Sciences AG is a global biotech platform and company builder working to address significant unmet medical needs rooted in a lack of innovation in neuropsychiatry. Based in Berlin, London and New York, its vision is to cure mental health disorders, enabling people to live healthier and happier lives.

SOURCE ATAI Life Sciences

Related Links

https://www.atai.life