ATAI

June 20, 2024

Cash, cash equivalents and short-term investments totaled $121.3 million as of March 31, 2024

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,

We have another profile for you to research for Friday’s session.

Pull up ATAI Immediately.

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.

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.

atai Life Sciences takes a holistic approach to “treat the patient, not the condition.” A leader in the mental health space, the company comes with experience and history of psychedelics, and is equipped to deliver the next generation of mental health medicines.

MAJOR CATALYSTS

Large Market Potential: Mental health disorders are one of the largest global health burdens; global market size in mental health was $380Bn in 2020 and is expected to grow to $509bn by 2028.
Clear Objective: atai’s objective is to achieve clinically meaningful and sustained behavioral change in mental health patients by developing rapid-acting and patient-centric pharmaceutical and digital treatment solutions.
Large Unmet Clinical Indications: atai’s clinical pipeline is currently in development to treat large and underserved patient populations, including those living with cognitive decline associated with schizophrenia, treatment-resistant depression, anxiety, and substance use disorders.
Multiple Shots on Goal: atai has 8 clinical stage drug development programs with a focus on compound classes with prior evidence in humans. Its diversified platform approach helps avoid binary risk and optimizes likelihood of success.
Significant Catalyst Event Potential: Company expects to deliver multiple R&D milestones anticipated across key clinical programs over next 2 years.
Strong Cash Position: Cash, cash equivalents and short-term investments totaled $121.3 million as of March 31, 2024.
Strong Market Validation: Validation of atai’s operating model and ability to capture value: IPO of COMPASS Pathways in 2020 and licensing deal between Otsuka and atai subsidiary Perception Neuroscience in 2021.
Compassionate Vision: To heal mental health disorders so that everyone everywhere can live a more fulfilled life.

ATAI tackles the mental health crisis with a unique de-risking approach focused on a diverse pipeline of compounds with prior evidence in humans

By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines to achieve clinically meaningful and sustained behavioral change in mental health patients.

Key Strategic Pillars

Rapid acting intervention: 1st, 2nd and 3rd generation compounds with the potential to show strong behavioral plasticity, rapid onset and more durable effects
Ongoing psychological support: Digital therapeutics deliver care to patients before, during and/or after initial treatment intervention
Precision mental health: The identification of patient sub-types using biological and digital biomarkers

You can read more about the company’s programs HERE.

atai’s diverse clinical pipeline gives multiple shots on goal with numerous upcoming R&D milestones

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 Reports First Quarter 2024 Financial Results and Corporate Updates

PUBLISHED

MAY 15, 2024 6:59AM EDT

First participant dosed in Phase 1b trial of VLS-01 with data expected in 2H’24; Phase 2 study in TRD patients anticipated to initiate around YE’24
Beckley Psytech’s Phase 2a study of BPL-003 in TRD patients showed rapid and durable antidepressant effects; Phase 2b topline data expected in 2H’24
Compass Pathways’ Phase 2 study of COMP360 in PTSD patients demonstrated durable improvement in symptoms; Phase 3 data of COMP360 in TRD patients expected in 4Q’24
Co-Founder Florian Brand to step down as CEO as part of a planned transition by YE’24 and to be succeeded by Co-Founder and current Chief Scientific Officer Srinivas Rao, M.D., Ph.D.
Cash, marketable securities, and committed term loan funding expected to fund operations into 2026

NEW YORK and BERLIN, May 15, 2024 (GLOBE NEWSWIRE) — atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced first quarter 2024 financial results, provided corporate updates and announced a transition in its leadership.Florian Brand (“Mr. Brand”), Co-Founder and current CEO, will step down as CEO by the end of this year. Co-Founder Srinivas Rao, M.D., Ph.D. (“Dr. Rao”), currently the Chief Scientific Officer, will be promoted to Co-CEO effective June 1, 2024 and intends to assume the role of CEO by the end of the year subject to appointment as required by local law.“I co-founded atai in 2018 with the bold mission to transform mental health care, and I am immensely proud of our accomplishments and continuous progress made across our R&D programs over the last six years. To that end, looking at the recent months, we have achieved many clinical milestones, with dosing in our VLS-01 Phase 1b program well underway and encouraging Phase 2 data readouts from both BPL-003 and COMP360,” said Mr. Brand.“As I prepare to turn my focus to new entrepreneurial ventures in other areas of significant unmet medical needs, I am confident in passing the torch to my Co-Founder Srini by year-end. His exceptional leadership and deep expertise in neuropsychiatric drug development have been pivotal to our success, and I am delighted that he will be leading atai into its next phase, where his experience in late stage clinical development will be especially relevant and impactful.”Dr. Rao brings over 24 years of knowledge and experience from diverse biotechnology and pharmaceutical roles, having held the titles of Chief Scientific, Medical, or Executive Officer at companies ranging from venture-backed startups to vertically integrated, publicly traded pharmaceutical companies.“It is an honor to follow in the footsteps of my dear friend and Co-Founder, Florian. I am deeply grateful for the opportunity to continue to work with him as Co-CEOs until the end of the year and build upon our shared vision, ensuring atai’s continued success in addressing challenging mental health conditions,” said Dr. Rao. “In the near-term this year, I look forward to several data milestones, including the Phase 2b readout of BPL-003 in TRD, Phase 3 data of COMP360 in TRD and the VLS-01 Phase 1b readout.”Founder and Chairman Christian Angermayer commented: “Since its inception in 2018, atai has been at the forefront of mental health innovation, driven by a commitment to deliver ground-breaking therapies to those in need, with a special focus on psychedelic substances.Florian successfully led the company from its early days through numerous R&D, business development and financing milestones, including an IPO in 2021. Florian’s leadership and execution focus have been foundational to the success of atai. We look forward to seeing the new heights he will achieve.As Florian transitions, we are deeply grateful for the enduring impact he made on our company, and while he will leave as CEO at the end of this year, he will always be part of the atai family and our success story. With his extensive experience in late stage drug development, Srini has the right profile and skillset to lead atai into its next evolutionary phase.”Corporate Updates

Florian Brand, Co-Founder and current CEO of atai, will assume the role of Co-CEO effective June 1, 2024 and will step down as CEO by the end of this year.
Co-Founder Srinivas Rao, currently the Chief Scientific Officer of atai, will be promoted to Co-CEO effective June 1, 2024, and intends to assume the role of CEO by the end of the year subject to appointment as required by local law.

Clinical HighlightsVLS-01: N,N-dimethyltryptamine (DMT) for Treatment-Resistant Depression (TRD)

VLS-01 is an oral transmucosal film (OTF) formulation of DMT designed to fit within the two-hour in-clinic treatment paradigm successfully established by Spravato®
In March 2024, we announced the initiation of dosing in a Phase 1b study that is designed to evaluate the relative safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of an optimized OTF formulation of VLS-01, compared to intravenous (IV) DMT.
Results of the Phase 1b study are anticipated in 2H 2024.
The Company plans to initiate a randomized, placebo-controlled Phase 2 trial of VLS-01 in TRD patients around YE’24.

BPL-003: 5-MeO-DMT for TRD as primary indication

Beckley Psytech’s BPL-003 is an intranasal formulation of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) designed to fit within an approximately two hour in-clinic treatment paradigm.
In March 2024, Part 1 of a Phase 2a open-label (OL) study showed that a single administration of BPL-003 resulted in rapid and durable antidepressant effects, with 45% of patients in remission three months after dosing. Acute effects resolved on average in less than two hours, and BPL-003 was found to be well-tolerated, with no serious adverse events reported.
In April 2024, Part 2 of the Phase 2a OL study initiated to investigate BPL-003 as an adjunctive therapy to Selective Serotonin Reuptake Inhibitors in TRD patients.
A randomized, controlled Phase 2b study of BPL-003 in TRD patients is underway with topline data expected in 2H 2024.

COMP360: Psilocybin Therapy for TRD as primary indication

Compass Pathways’ COMP360 is an oral formulation of synthetic psilocybin that is currently being evaluated in multiple clinical studies.
In May 2024, results from an OL Phase 2 study in 22 patients with PTSD showed that COMP360 met its primary safety endpoint and was well tolerated, with no serious adverse events. COMP360 demonstrated a rapid and durable improvement in PTSD symptoms.
- Week 4 and 12 reductions in the CAPS-5 total score of 29.9 and 29.5, respectively, were observed.
- The response rate, as defined by patients experiencing a ≥ 15-point improvement on CAPS-5 score, was 81.8% at week 4 and 77.3% at week 12.
- The remission rate, as defined by CAPS-5 total score of ≤ 20, was 63.6% at week 4 and 54.5% at week 12.
The Phase 3 program of COMP360 in TRD patients is composed of two pivotal trials, each with a long-term follow-up component. Pivotal Trial 1 (COMP005) topline data is expected in the fourth quarter of 2024 and Pivotal Trial 2 (COMP006) topline data is anticipated mid-2025.

Upcoming R&D Catalysts

1H’24
- ELE-101 MDD Phase 1/2a initial data
2H’24
- VLS-01 Phase 1b topline data
- BPL-003 AUD Phase 2a OL data (mid’24)
- COMP360 TRD Phase 3 Pivotal Trial 1 topline data
- BPL-003 TRD Phase 2b data
- IBX-210 OUD Phase 1/2a initiation
- VLS-01 TRD Phase 2 initiation (around YE’24)
2025
- RL-007 CIAS Phase 2b topline data (mid’25)
- COMP360 TRD Phase 3 Pivotal Trial 2 topline data (mid’25)

Consolidated Financial ResultsCash, cash equivalents, and short-term investments: As of March 31, 2024, the Company had cash, cash equivalents, restricted cash and short-term investments of $121.3 million compared to $154.2 million as of December 31, 2023. The decrease of $32.9 million was primarily driven by $22.6 million net cash used in operating activities and $10 million for the Beckley Psytech investment. The Company expects its cash, marketable securities and committed term loan facility with Hercules Capital, Inc. to be sufficient to fund operations into 2026.Research and development (R&D) expenses: R&D expenses were $11.5 million for the three months ended March 31, 2024, as compared to $19.3 million for the same prior year period. The year-over-year decrease of $7.8 million was primarily attributable to a decrease of $5.1 million in program-specific expenses and $2.6 million in R&D personnel. Within program-specific expenses, the decrease was primarily driven by more clinical trials, discovery expenses and manufacturing costs in prior year. During the quarter, the Company allocated capital resources to invest in the R&D activities of its Beckley Psytech strategic investment. The Company is anticipating R&D spend to increase as its R&D programs progress into later stage clinical trials.General and administrative (G&A) expenses: G&A expenses for the three months ended March 31, 2024 were $12.6 million as compared to $14.0 million in the same prior year period. The year-over-year decrease of $1.4 million was primarily attributable to $2.6 million decrease in personnel related expenses, $0.7 million net decrease of professional services and other administrative expenses, partially offset by a $1.9 million increase related to a prior year non-income tax refund. The Company is actively controlling G&A spend. The Company expects the reduction in G&A spend over prior years to continue.Net loss: Net loss attributable to stockholders for the three months ended March 31, 2024, was $26.7 million as compared to $33.1 million for the three months ended March 31, 2023.

NEWS

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MANAGEMENT

Florian Brand

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 M.D., Ph.D.

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

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.

Sahil Kirpekar, M.D.

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

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.

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