OUR NEW PROFILE IS: (NASDAQ: ATAI)
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$273 million in cash, cash equivalents and short-term investments at end of 2022 and access to a term loan facility of up to an additional $160 million provide anticipated runway into the first half of 2026
ATAI offers a diverse pipeline of drugs and a focus on compounds with prior evidence in humans, upcoming inflection points (multiple Phase 1 and Phase 2 proof-of-concept trial readouts are expected in the next two years)
With prominent backing from venture capitalists, including billionaires Peter Thiel and Christian Angermayer, atai Life Sciences ranks among the biggest biotech stocks focused on the development of mental health treatments
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Hello Everyone,
ATAI is a clinical-stage biotechnology company pioneering the development of novel and effective mental health therapeutics. Founded in 2018 as a response to the significant unmet need and lack of innovation in neuropsychiatry, atai is dedicated to developing compounds with prior evidence in humans, particularly those that have been overlooked and not rigorously studied, such as psychedelics.
ATAI is developing medicines to treat large and underserved patient populations, including those living with cognitive decline associated with schizophrenia, anxiety, depression and substance use disorders.
ATAI’s cash position is among the strongest in the psychedelic medicine space, with approximately $273M (as of December 31, 2022) and access to up to an additional $160M via term loan facility providing an anticipated runway into H1 2026.
Co-Founded in 2018 by CEO Florian Brand, a serial entrepreneur named by Endpoints News, Business Insider and Fortune Magazine as a 20/30/40 under 40 in healthcare and biotech, this company began with a personal story.
After watching loved ones struggle with mental health issues, Brand realized that patients across the world were not getting the treatments they needed.
ATAI’s pipeline includes 8 clinical stage drug development programs with a focus on compound classes with prior evidence in humans; this approach involves a pharmacologically diverse pipeline to avoid binary risk while optimizing likelihood of success.
The Potential of Psychedelics
Psilocybin (a hallucinogenic compound) and DMT (a powerful and rapid acting psychedelic present in ayahuasca) have been highly buzzed about in the mental health arena for their potential as a long-lasting, highly effective treatment.
ATAI Life Sciences is embarking on the study of these and other drugs for their potential to effectively and rapidly treat many mental health disorders that are resistant to treatment.
ATAI is a leader in the mental health pharmaceutical market as the company works to deliver on its clinical strategies with immense market potential.
Today, the global mental health market size has reached US$ 380 Billion. Looking forward, IMARC Group expects the market to reach $509 Billion by 2028, exhibiting a growth rate (CAGR) of 3.4% between 2023-2028.
The growing, underserved mental health space leads us to atai Life Sciences. The company has an innovative approach to solve the real and growing problem of mental health disorders with a unique digital approach.
Addressing Depression, Anxiety, Addiction, and other Mental Health Disorders with a compassionate mission. atai is zooming in on robust categories in the mental health treatment market.
Schizophrenia
Problem: Cognitive impairment is a core feature of schizophrenia for the 24m people who live with it. 98% of patients with schizophrenia perform worse on cognitive tests than expected. There are no FDA approved therapies for Cognitive Impairment Associated with Schizophrenia (CIAS).
Atai’s answer: atai is investigating RL-007, a novel compound that has shown pro-cognitive effects in numerous Phase 1 and 2 studies.
Anxiety
Problem: Anxiety disorders are the most comment mental health concern in the United States and not only do less than half of those affected receive treatment, but currently approved medications come with significant side effects and/or risk of dependence.
Atai’s answer: atai is investigating deuterated etifoxine, a patent protected version of etifoxine, a drug approved for anxiety in more than 40 countries with benzodiazepine-like effects but without the sedative effects and addictive potential.
Depression
Problem: Depression affects more than 300m people and is the 2nd leading cause of disability worldwide. Only about 1/3 of patients respond to existing treatments and standard-of-care drugs like SSRIs come with significant side effects ranging from weight gain to suicidality.
Atai’s answer 1: COMP360 (patented protected synthetic psilocybin) is in late-stage studies for treatment-resistant depression.
Atai’s answer 2: atai is studying VLS-01 (oral thin film DMT) for treatment-resistant depression.
Substance Use Disorder
Problem: Over 20m people live with a substance use disorder (SUD) in the US. Since the drug epidemic started in 1999, there have been over 900,000 overdose fatalities. For an already vulnerable population, COVID-19 severely exacerbated the crisis for those with a SUD. Drug overdose deaths shot up ~30% with close to 93,000 deaths in 2020, nearly 70,000 of which involved opioids. With only 2 FDA approved treatments for OUD, options are limited, and relapse rates are as high as 75%.
Atai’s answer: atai is studying DMX-1002, an oral formulation of ibogaine, a naturally occurring psychedelic compound isolated from a West African shrub. In uncontrolled studies, Ibogaine has demonstrated rapid and sustained efficacy for OUD.
atai Life Sciences Investment Thesis: A Uniquely Positioned Leader In Mental Health Drug Development with Compelling De-risked Approach and Trading Below Cash
Atai has a market cap of ~$207M as of March 17, 2023 despite cash balance of $304m as of September 30, 2022, an aprox. $80M stake in COMPASS Pathways as of March 17, 2023 and multiple clinical stage drug candidates in development that tackle the mental health crisis
atai Life Sciences Announces First Subject Dosed in the Phase 1 IV-to-Subcutaneous Bridging Study of PCN-101 (R-Ketamine)
NEW YORK and BERLIN, April 13, 2023 (GLOBE NEWSWIRE) — atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, announced that the first subject has been dosed in Perception Neuroscience’s Phase 1 intravenous-to-subcutaneous bridging study of PCN-101 (R-ketamine).
This Phase 1 open-label study is designed to assess the safety, tolerability, and pharmacokinetic profile of 60mg, 90mg and 120mg of PCN-101 delivered subcutaneously as compared to 60mg of PCN-101 delivered intravenously (IV). The trial will enroll approximately 16 healthy volunteers across the four cohorts and is expected to be completed in the middle of 2023.
In January 2023, atai announced results from the Phase 2a proof-of-concept study evaluating a single IV administration of PCN-101 in patients with treatment-resistant depression across three arms – 30mg, 60mg and placebo. While the results did not reach statistical significance on the primary endpoint, PCN-101 demonstrated an encouraging safety profile and signals of efficacy across all timepoints out to two weeks, potentially indicating a sustained duration of effect.
This IV-to-subcutaneous bridging study will potentially inform dosing regimens of the new subcutaneous formulation that may optimize the therapeutic index—the balance of safety, tolerability and efficacy—of PCN-101 in future studies, thereby supporting further exploration of the potential of R-ketamine as a rapid acting anti-depressant for at-home use.
atai continues to work with Perception Neuroscience to explore strategic partnership options.
About Perception Neuroscience, Inc.
Perception Neuroscience is a New York City- based biopharmaceutical company committed to developing therapies for neuropsychiatric diseases. Perception’s mission is to provide substantially more effective treatment solutions to serious psychiatric disorders. The company is a majority-owned subsidiary of atai Life Sciences AG.
PCN-101 is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid-acting antidepressant activity and anti-suicidal effects. Pharmacologically, PCN-101 is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. Depression model studies in rodents suggest that R-ketamine could possess more durable effects than S-ketamine and a more favorable safety and tolerability profile.
atai Life Sciences Announces Key Clinical Pipeline and Corporate Updates
- RL-007: First patient dosed in the on-going phase 2b study in cognitive impairment associated with schizophrenia
- GRX-917: Intention to progress GRX-917 into a phase 2 study in an anxiety disorder as the next step in clinical development
- COMP360: Recently announced acceleration of the Pivotal Trial 1 (COMP 005) part of the phase 3 program, with top line data now expected in the summer of 2024
- Corporate: As a result of our recent restructuring and pipeline updates, the company has extended its cash runway, which is now expected into 1H 2026
NEW YORK and BERLIN, March 06, 2023 (GLOBE NEWSWIRE) — atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, provided key clinical pipeline and corporate updates.
“The dosing of the first patient in the phase 2b study of RL-007 in CIAS earlier this quarter exemplifies the execution capabilities of our team as we advance our programs into later-stage clinical studies,” said Florian Brand, CEO and Co-Founder of atai. “Along these lines, we are excited to announce the updated clinical strategy for GRX-917. The compound will progress directly into a phase 2 study in patients living with an anxiety disorder to accelerate development and generate the robust clinical data needed to inform a potential future registration.”
Mr. Brand continued, “As part of our efforts to further focus our capital allocation towards generating meaningful clinical readouts in the near-term and to optimize our operational efficiency, we reduced our team by approximately 30%. I am grateful for the dedication of the team members impacted by this decision and their contributions towards our mission.”
Pipeline Updates
RL-007 (Pro-Cognitive Neuromodulator for Cognitive Impairment Associated with Schizophrenia (CIAS))
- The first patient was recently dosed in the phase 2b study of RL-007 in patients with CIAS. Initial results from this study are expected in the 2nd half of 2024.
- The phase 2b study is a randomized, placebo-controlled, double-blind, 3-arm study evaluating 20mg and 40mg of RL-007 vs placebo in approximately 230 patients with CIAS. The primary endpoint of the US-based study is the MATRICS Consensus Cognitive Battery neurocognitive composite score at 6-weeks.
- RL-007 is an orally available compound that modulates cholinergic, glutamatergic and GABA-B receptors, thereby putatively altering the excitatory/inhibitory balance in the brain to produce pro-cognitive effects. It has previously been evaluated in 10 clinical studies with over 500 unique participants dosed to-date and in which it was well tolerated at all doses tested.
- Notably, in four clinical studies that assessed cognition, including one in patients with CIAS, the compound consistently demonstrated pro-cognitive effects.
GRX-917 (Deuterated Etifoxine for Anxiety Disorders)
- The clinical development plan has been updated to now proceed with a phase 2 study in patients. The updated plan is anticipated to generate the robust clinical data needed to best support potential registration. More details on the clinical development plan will be provided upon initiation of the study.
- The updated plan follows the positive results from the phase 1 single and multiple ascending dose study of GRX-917. In this trial, GRX-917 was well-tolerated. Additionally, GRX-917 had an improved pharmacokinetic profile relative to etifoxine and provided pharmacodynamic evidence of GABA receptor target engagement through qEEG.
- GRX-917 is a deuterated version of etifoxine, a drug used for anxiety and first approved in France in 1979. Etifoxine has a rapid onset and efficacy comparable to leading benzodiazepines, like alprazolam and lorazepam, which are currently considered standard of care. In contrast to these benzodiazepines, however, and based on more than 40 years of the use of etifoxine in clinical practice, etifoxine appears to be non-addictive and does not seem to have the same sedation and other common adverse events. It is believed that etifoxine achieves its anxiolytic activity by increasing endogenous production of brain neurosteroids like allopregnanolone.
PCN-101 (R-Ketamine for Treatment-Resistant Depression)
- In January 2023, in conjunction with the phase 2a study results of PCN-101, atai announced it would further evaluate the data and work with its subsidiary Perception Neuroscience (“Perception”) to determine next steps for the program.
- atai will continue to support Perception’s development of PCN-101 through the IV-to-subcutaneous bridging study, which is currently on-track to be completed in the middle of 2023. In parallel, atai continues to work with Perception Neuroscience to explore strategic partnership options.
- PCN-101 is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid-acting antidepressant activity and anti-suicidal effects. Pharmacologically, PCN-101 is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. Both depression model studies in rodents and clinical data suggest that R-ketamine could possess more durable effects than S-ketamine despite a lower affinity to the NMDA receptor and potentially a more favorable safety and tolerability profile.
COMP360 (Psilocybin Therapy for Treatment-Resistant Depression)
- On February 28th, COMPASS Pathways (“COMPASS”) announced an acceleration of the Pivotal Trial 1 (COMP 005) part of the phase 3 program in treatment-resistant depression, with top line data now expected in the summer 2024.
- COMP360 is a proprietary formulation of synthetic psilocybin that is administered in conjunction with psychological support. Previously, COMPASS 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.
Corporate Updates
- As part of a strategic review of its pipeline and to enhance operational efficiency and focus, the Company has reduced its workforce by approximately 30%.
- The majority of the cost savings will result from a workforce reduction in general and administration and non-clinical development.
- The Company has extended its cash runway, which is now expected into 1H 2026.
NEWS
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GlobeNewswire•13 days ago
NEW YORK and BERLIN, April 13, 2023 (GLOBE NEWSWIRE) — atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, announced that the first subject has been dosed in Perception Neuroscience’s Phase 1 intravenous-to-subcutaneous bridging study of PCN-101 (R-ketamine). This Phase 1 open-label study is designed to assess the safety, tolerability, and pharmacokinetic profile of 60mg, 90mg and 120mg of PCN-101 d
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GlobeNewswire•last month
atai’s development candidates, such as RL-007 and GRX-917, all represent significant opportunities to address unmet medical needs of patients living with mental health conditionsContinued operational progress on robust clinical pipeline, with multiple phase 1 and phase 2 proof-of-concept datasets expected in the next two years$273 million in cash, cash equivalents and short-term investments at end of 2022 and access to a term loan facility of up to an additional $160 million provide anticipated
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GlobeNewswire•2 months ago
RL-007: First patient dosed in the on-going phase 2b study in cognitive impairment associated with schizophreniaGRX-917: Intention to progress GRX-917 into a phase 2 study in an anxiety disorder as the next step in clinical developmentCOMP360: Recently announced acceleration of the Pivotal Trial 1 (COMP 005) part of the phase 3 program, with top line data now expected in the summer of 2024Corporate: As a result of our recent restructuring and pipeline updates, the company has extended its cash r
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GlobeNewswire•2 months ago
NEW YORK and BERLIN, March 01, 2023 (GLOBE NEWSWIRE) — atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, will participate in the Cowen 43rd Annual Health Care Conference. Details of the company’s panel participation are as follows: Cowen 43rd Annual Health Care Conference Format: Neuropsych Corporate Panel Date and Time: Monday, March 6th, 12:50 p.m. – 1:20 p.m. ET Location: Boston, MA A live webc
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News Direct•3 months ago
When psychedelics were first studied more than 50 years ago, researchers discovered that they were useful in assisting people in exploring a greater sense of self. After a half-century hiatus, scie…
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GlobeNewswire•4 months ago
GRX-917 (deuterated etifoxine) was well-tolerated with no dose-limiting toxicities and only mild adverse effects comparable to that of placebo in both single and multiple ascending doses, as previously announced as preliminary results during atai’s R&D day.Final results demonstrate target engagement of GRX-917 via dose-related activation of quantitative electroencephalography (qEEG) frontal beta power, a biomarker for GABA-A receptor-associated anxiolytic activity, consistent with GRX-917’s puta
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GlobeNewswire•4 months ago
NEW YORK and BERLIN, Jan. 06, 2023 (GLOBE NEWSWIRE) — atai Life Sciences (NASDAQ: ATAI) (“atai” or “the Company”), a clinical-stage biopharmaceutical company focused on mental health, announced that, while PCN-101 (R-ketamine) demonstrated signals of efficacy across all timepoints out to two weeks, Perception Neuroscience’s Phase 2a clinical trial did not meet its primary endpoint of a statistically significant change from baseline in participants’ MADRS (Montgomery-Åsberg Depression Rating Sc
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GlobeNewswire•4 months ago
– This two-part phase 1 trial in healthy volunteers was designed to assess the safety, pharmacokinetics, and analgesic activity of KUR-101 – KUR-101 was well tolerated and demonstrated analgesic activity in two experimental pain models – An assessment of the respiratory impact of KUR-101 was inconclusive as the positive control, oxycodone, failed to separate from placebo – KUR-101, a deuterated derivative of mitragynine, is a low-potency, partial mu-opioid receptor (MOR) agonist designed to prod
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GlobeNewswire•4 months ago
The phase 2b proof-of-concept trial will evaluate the novel compound, RL-007, for pro-cognitive effects in patients with Cognitive Impairment Associated with Schizophrenia (CIAS).The trial was initiated and has begun patient screening this month with first-patient-in anticipated by end-of-year.There are currently no FDA-approved medications for CIAS, a major cause of disability in 80% of patients with schizophrenia1.Topline results are expected in the first half of 2024. NEW YORK and BERLIN, Dec
MANAGEMENT
Florian Brand is the co-founder and Chief Executive Officer of atai Life Sciences. Prior to joining atai, Florian was starting and building user-centric technology companies as a serial entrepreneur.
Florian suffered from anxiety in his youth and was able to achieve remission through a combination of psychotherapy and robust meditation practice. It was ultimately his experiences seeing his friends and loved ones failed by the mental healthcare system that inspired him to join the movement to transform the treatment landscape for patients who have been unable to find relief in currently available therapies.
In 2022, Florian was recognized in Fortune’s 40 Under 40 list spotlighting influential individuals shaping business and Business Insider’s 30 Under 40 in Healthcare. Florian was also featured in Endpoint News’ list of 20 Under 40 Innovators in Biotech in 2021. He is a proud member of the Founders Pledge, a global community of mission-aligned entrepreneurs dedicated to doing good.
“We know that mental healthcare is likely the single largest unmet medical need in the world. We know that what’s out there now isn’t working. And we know that there are better options. So, let’s bridge the gap together.”
Srinivas Rao is the Chief Scientific Officer at atai Life Sciences. Dr. Rao has over 19 years of professional experience in the pharmaceutical and biotechnology industries. Prior to atai, Dr. Rao has held the titles of Chief Scientific, Medical, or Executive Officer at companies ranging from venture-backed startups to vertically-integrated, publicly-traded pharmaceutical companies.
Dr. Rao completed an internship in Internal Medicine at Yale-New Haven Hospital. He received his Ph.D. in neurobiology from Yale Graduate School and his M.D. from Yale School of Medicine. He holds both a Bachelor of Science and Master of Science degree in Electrical Engineering from Yale College and Yale Graduate School, respectively.
Rolando Gutiérrez-Esteinou, M.D.
Rolando Gutiérrez-Esteinou is the Chief Medical Officer at atai Life Sciences since 1 January 2021. Dr. Gutiérrez-Esteinou has over 25 years of professional experience in the pharmaceutical and biotechnology industries. Prior to atai, Dr. Gutiérrez-Esteinou has held various titles of Chief Medical Officer, SVP or VP in Clinical Development, Project Management, Medical Affairs, and Pharmacovigilance at Novartis, J&J and BMS, and small biotech companies, as well as serving as therapeutic area head in Neuroscience at Covance, a large clinical research organization.
Dr. Gutiérrez-Esteinou is a graduate of the National Autonomous University of Mexico School of Medicine, in Mexico City, and completed a medicine internship and a residency in Adult Psychiatry at Harvard Medical School. He was the recipient of a Fogerty International Fellowship at the National Institute of Mental Health in the Experimental Therapeutics Branch.
Stephen Bardin joined atai Life Sciences in 2022.
Previously, Stephen was Senior Vice President, Finance and Operations at BridgeBio Pharma, Inc. where he was responsible for a broad range of finance topics, including financing strategy and execution, M&A transactions, FP&A, financial operations, and IT.
Prior to that, he worked in finance and corporate development at Myovant Sciences where he was responsible for the evaluation of business development opportunities, financing transactions, investor relations, financial operations, and special projects.
Stephen holds a Bachelor’s degree in Biomedical Engineering from Duke University and an MBA from the Stanford Graduate School of Business.
Dr. Kirpekar joined atai in 2022 after more than eight years at Otsuka Pharmaceutical Co., Ltd., most recently as the Head of Business Development and Co-chair of the Global Business Development Committee.
During his tenure, Dr. Kirpekar helped build a successful pipeline of assets in CNS and beyond and was responsible for closing transactions with a total value of more than USD 2.7 billion. Notable accomplishments during his time at Otsuka also include the successful commercial launch of two drugs, Abilify Maintena (Aripiprazole) and Jinarc (Tolvaptan), and contributing to the organization’s digital strategy and leading their evolving thinking in precision psychiatry. He also collaborated closely with atai on certain strategic investments during this time.
Prior to Otsuka, Dr. Kirpekar built and executed commercial and market access strategies for biopharmaceutical companies globally as a strategy consultant at Double Helix Consulting (McCann Consulting). He also served as a market analyst for the World Health Organization and has co-founded a company building a drug delivery device focused on adherence. Dr. Kirpekar is a trained physician and holds an MPhil from the University of Cambridge (where he is subsequently an honorary lecturer).
Anne Johnson joined atai Life Sciences in 2021 as Vice President, Global Controller.
Previously, Anne was a Controller at Aruvant, an International Biotechnology Company, focusing on gene therapies for rare diseases. Prior to this, she has held a number of senior leadership roles within the CFO office, include Corporate Controller at Chimerix, Inc and VP Finance at Xanodyne Pharmaceuticals.
She holds a B.Sc in Accounting from the University of North Carolina at Wilmington and is an AICPA qualified accountant.
Sincerely,
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