(Nasdaq: LGVN) Profile

OUR NEW PROFILE IS:   (NASDAQ: LGVN)

READ THE INVESTOR PRESENTATION HERE

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Hello Everyone,

I hope that you enjoyed the long weekend.  The Summer is unofficially over and we have seen liquidity return to the markets after Labor Day historically.   This often presents more opportunities to research emerging companies that have the potential to bounce.

Pull up LGVN and research it immediately.

LGVN is a clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions. Our lead investigational product is Lomecel-B™, which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young healthy adult donors. We believe that by using the same cells that promote tissue repair, organ maintenance, and immune system function, we can develop safe and effective therapies for some of the most difficult diseases and conditions associated with aging.

Longeveron was founded on the premise that the very cells within our bodies whose primary function is to repair, restore and regenerate damaged tissue and organs may be developed into a safe and effective “off-the-shelf” cell therapy to treat chronic aging-related diseases and other life-threatening conditions, to improve healthspan, and to extend longevity.

Since our founding in 2014, we have focused our efforts on generating clinical safety and efficacy data in our selected indications, building, staffing and equipping a state-of-the art GMP manufacturing and research and development facility, expanding our intellectual property portfolio, developing and expanding our manufacturing processes and capabilities.

Our programs have been awarded more than $16.2 million in grant funding from the National Institute on Aging (NIA) of the National Institutes of Health (NIH), National Heart Lung and Blood Institute (NHLBI) of NIH, the Alzheimer’s Association, and the Maryland Stem Cell Research Fund (MSCRF) of the Maryland TEDCO.

We manufacture our own product candidates for clinical research and product development in our GMP facility, comprised of eight clean rooms, two research and development laboratories, and warehouse and storage space. We have supply contracts with multiple third parties for fresh bone marrow, which we use to produce our lead therapeutic candidate called Lomecel-B™. From time to time we enter into contract development and manufacturing contracts or arrangements with third parties who seek to utilize our product development capabilities.

PIPELINE

LOMECEL-B™

Our lead investigational therapeutic candidate is a cellular therapy called Lomecel-B™. Lomecel-B is being evaluated in multiple clinical trials for aging-related chronic diseases and other life-threatening conditions under US FDA-approved Investigational New Drug (IND) Applications.

PROPRIETARY, SCALABLE, “OFF-THE-SHELF” CELLULAR THERAPY

KEY ADVANTAGES OF LOMECEL-B

• Superior efficacy for addressing inflammation

• Cells migrate to sites of tissue damage

• Enhanced safety as inherently Immuno-evasive

• Convenient off-the-shelf administration

HOW DOES LOMECEL-B WORK?

It is becoming increasingly clear that the therapeutic effects of allogeneic MSCs occurs through secretion of bioactive molecules and direct cell-to-cell contact at the site of inflamed and damaged tissue. There are several potential mechanisms of action believed to mediate therapeutic benefits:

• Release of growth factors and other proteins, such as anti-inflammatory cytokines. These have the potential to reduce inflammation, and stimulate nearby stem cells and other cells (called paracrine activity) to promote regenerative and repair responses.

• Engage in direct cell-cell interactions to induce positive pathways in contacted cells.

• Release exosomes, which have cargo consisting of RNA, proteins, and other molecules that can be taken up by other cells to provide beneficial effects.

• Potential to form nanotube bridges, which can allow the exchange of mitochondria and other cellular contents between cells.

SCIENCE

THERAPEUTIC AREAS

Hypoplastic Left Heart Syndrome (HLHS) Research Program

We are testing Lomecel-B as a potential combinatorial therapy candidate to surgical intervention for HLHS. The scientific goal underlying this study builds on surgical advances of the past thirty years, and is intended to address remaining obstacles to improving long-term cardiac function in HLHS patients.

HLHS is a congenital birth defect in which the left ventricle (one of the pumping chambers of the heart) is either severely underdeveloped or missing. As a consequence, babies born with this condition have severely diminished systemic blood flow, which requires children to undergo a complex, three stage heart reconstruction surgery process over the course of the first 5 years of their lives. While these children can now live into adulthood, early mortality is still extremely high in this population due to right ventricle failure, which is not meant for the increased load demanded for systemic circulation (blood circulation throughout the body). As such, there is an important unmet medical need to improve right ventricular function in these patients to improve both short-term and long-term outcomes.

We believe that Lomecel-B has potential as a combinatorial therapy with HLHS surgery to improve both short- and long-term clinical outcomes. We are evaluating whether a direct injection in the heart can improve right ventricle function by promoting regenerative and repair responses. In animal studies, this combinatorial approach resulted in a 10 – 15% improvement in right ventricle function.

RESULTS FROM THE ELPIS PHASE 1 TRIAL

This study met the primary safety endpoint:

KEY SUMMARY FINDINGS.

• No major adverse cardiac events (MACE), nor any treatment-related infections during the first month post-treatment.

• 100% of infants treated with Lomecel-B survived free of heart transplant, with follow-up ranging two to 3.5 years after cardiac surgery that included injection with Lomecel-B.

• This finding showed the potential of Lomecel-B for improving long-term clinical outcomes in HLHS patients.

• Based on these findings, In November of 2021, FDA granted Rare Pediatric Disease Designation (RPD) to Longeveron’s Lomecel-B for treatment of HLHS, as a drug for a “rare pediatric disease,” as defined in section 529(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360ff(a)(3)).

Recent Highlights

Lomecel-B™  for Hypoplastic Left Heart Syndrome (HLHS):

  • Announced achievement of exceeding 50% enrollment threshold for Phase 2 ELPIS II trial of Lomecel-B™ in HLHS.
  • Announced new long-term survival data from ELPIS I Trial of Lomecel-B™ for HLHS.
    • Children in the ELPIS I trial had 100% survival up to five years of age after receiving Lomecel-B™ compared to approximate 20% mortality rate observed from historical control data.
    • Data reinforce potential survival benefit of Lomecel-B™ for patients in this indication.

Lomecel-B™ for Alzheimer’s Disease:

  • In November 2022, Longeveron announced it had completed enrollment in its Phase 2a trial of Lomecel-B™ for the treatment of Alzheimer’s disease (AD). The Phase 2a trial, called the CLEAR MIND trial, is a 48 patient, 4-arm, parallel design, randomized (1:1:1:1) clinical trial of Lomecel-B™ and is intended to evaluate the safety of a single and multiple infusions of two different dose levels compared to placebo in patients with mild AD. The primary endpoint is safety as measured by the occurrence of serious adverse events (SAEs) within the first 30 days after administration of Lomecel-B™. The secondary and exploratory endpoints include brain volumetry by magnetic resonance imaging (MRI), biomarkers relevant to inflammation and endothelial/vascular systems, and measures of cognitive function.
  • The Company expects to share top line results from CLEAR MIND by October 2023.

Lomecel-B™  for Aging-Related Frailty:

  • Enrollment continues in the Company’s Phase 2 study evaluating Lomecel-B™ in patients with Aging-Related Frailty in Japan.
  • The Phase 2 clinical trial is a 3-arm, parallel design, randomized (1:1:1), placebo-controlled, double-blind infusion study of two different dose levels of Lomecel-B™. The trial is expected to enroll 45 patients and has a primary objective of evaluating the safety of Lomecel-B™ as a treatment for Aging-related Frailty.
  • The Phase 2 trial is being conducted in partnership with the National Center for Geriatrics & Gerontology (NCGG; Nagoya) and Juntendo University Hospital (Tokyo).

Corporate Updates

  • Leadership team strengthened with the appointments of Lisa Locklear as Chief Financial Officer and Dr. Nataliya Agafonova as Chief Medical Officer.
  • Board of Directors enhanced with the election of distinguished biotechnology and corporate management experts, Khoso Baluch, Jeffrey Pfeffer, and Wa’el Hashad at the Company’s June Annual Meeting of Stockholders.
  • On June 27, 2023 the Company filed a registration statement with the SEC to conduct a tradeable subscription rights offering for up to $30.0 million of shares of Class A common stock to stockholders and holders of warrants to purchase common stock as of a future record date to be determined. An amendment to the registration statement was filed with the SEC on July 28, 2023 with additional details regarding the proposed offering.

Longeveron Announces Achievement of Surpassing 50% Enrollment Threshold in Phase 2 ELPIS II Study of Lomecel-B™ in Hypoplastic Left Heart Syndrome

08/11/2023

Company Activates Additional Study Location to Expedite Enrollment Completion

Key Opinion Leader Webinar Highlighting the Potential for Lomecel-B™  in the Treatment of HLHS to be held Wednesday, August 16, 2023 at 10:00 AM ET

MIAMI, Aug. 11, 2023 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, announced today the Phase 2 ELPIS II trial, funded by the National Heart, Lung, and Blood Institute (NHLBI) and using the Company’s Lomecel-B™ asset in Hypoplastic Left Heart Syndrome (HLHS), has surpassed the 50% enrollment threshold. Additionally, the trial has activated its eighth clinical site location – one additional site beyond the seven originally planned — in order to try to expedite the completion of the trial enrollment.

HLHS is a congenital birth defect in which the left ventricle (one of the pumping chambers of the heart) is either severely underdeveloped or missing. As a consequence, babies born with this condition have severely diminished systemic blood flow (blood circulation throughout the body), which requires children to undergo a complex, three stage heart reconstruction surgery process over the course of the first 5 years of their lives. While these children can now live into adulthood, early mortality is still extremely high in this population due to right ventricle failure, which is not meant for the increased load demanded by the systemic circulation. As such, there is an important unmet medical need to improve right ventricular function in these patients to improve both short-term and long-term outcomes.

“Surpassing the 50% enrollment threshold is a significant milestone for the trial and more importantly for HLHS patients who are in such critical need of new therapeutic options to improve outcomes in this rare and life-threatening indication,” said Wa’el Hashad, Chief Executive Officer of Longeveron. “We look forward to continuing to execute on our clinical program for Lomecel-B™ and to do all possible to expedite completing enrollment in the ELPIS II trial.”

ELPIS II (NCT04925024) is a 38-participant, randomized (1:1) blinded, controlled Phase 2 clinical trial evaluating the safety and efficacy of intramyocardial injection of Lomecel-B™ in infants with HLHS who are undergoing Stage II reconstructive cardiac surgery. Lomecel-B™ for HLHS has previously received Fast Track, Rare Pediatric Disease, and Orphan Drug Designations from the U.S. Food and Drug Administration (FDA). ELPIS II is being funded by grants from the National Institutes of Health’s National Heart, Lung, and Blood Institute (NHLBI; Grant numbers UG3HL148318, U24HL148316), in collaboration with Longeveron.

NEWS

MANAGEMENT TEAM

WA’EL HASHAD CHIEF EXECUTIVE OFFICER

Wa’el Hashad joined Longeveron in the role of CEO on March 1, 2023, bringing with him more than 35 years of experience in the pharmaceutical and biotech industries.

Prior to joining Longeveron, Mr. Hashad was the President and CEO of Avanir Pharmaceuticals where he led all aspects of the company’s commercial initiatives and the product development pipeline. Avanir was fully integrated into Otsuka on December 22, 2022. In his career before Avanir, Mr. Hashad was the Chief Commercial Officer of Seres Therapeutics, where he spearheaded both strategy and development of various therapeutic types, including several microbiome-based therapies. Mr. Hashad is an accomplished leader, who has held senior leadership positions at Amgen, Boehringer Ingelheim and Eli Lilly and Company.

He has launched several successful brands in the U.S. and worldwide markets. His therapeutic expertise includes cardiovascular, neuroscience, endocrine and inflammatory diseases. He is passionate about innovation and advancing science. Mr. Hashad holds a Bachelor of Science in Pharmacy from Cairo University and a Master of Business Administration from University of Akron in Ohio

JOSHUA M. HARE, MD, FACC, FAHA CO-FOUNDER, CHIEF SCIENCE OFFICER AND CHAIRMAN

Dr. Hare co-founded Longeveron in 2014 and serves as Chairman of the Board of Directors, and Chief Science Officer. Dr. Hare is a double board-certified cardiologist (Cardiology and Advanced Heart Failure and Transplantation) and is the founding director of the Interdisciplinary Stem Cell Institute at the University of Miami’s Miller School of Medicine. He has obtained in excess of $25 Million in funding from the National Institutes of Health over the past 15 years to support basic research of cell therapy strategies. He is also a recipient of the Paul Beeson Physician Faculty Scholar in Aging Research Award, and is an elected member of the American Association of Physicians, The American Society for Clinical Investigation, and is an elected Fellow of the American Heart Association. Dr. Hare has also served in numerous leadership roles at the American Heart Association and at the Center for Scientific Review of the National Institutes of Health. Dr. Hare is also a co-founder of Vestion, Inc., and Heart Genomics, LLC, companies that hold cardio-related intellectual property. He received a BA from the University of Pennsylvania, and his MD from The Johns Hopkins University School of Medicine, and completed fellowships at Johns Hopkins and Brigham and Women’s Hospital, and was a Research Fellow at Harvard Medical School.

LISA LOCKLEAR CHIEF FINANCIAL OFFICER

Ms. Locklear joined Longeveron in the role of CFO on July 31, 2023. Before Longeveron, Lisa served as the Senior Vice President and CFO for Avanir Pharmaceuticals, a subsidiary of Otsuka. During her time at Avanir, Ms. Locklear was instrumental in enhancing the financial and technology-related processes, systems, and people during a period of rapid growth. Prior to Avanir, she held senior financial roles at GSN Games, CoreLogic, Ingram Micro, the Walt Disney Company, and Price Waterhouse (now PwC), with assignments in Paris and London.

Ms. Locklear has been recognized by the Healthcare Businesswomen’s Association with the Luminary Award, an honor that underscores her dedication to fostering the growth of other women’s careers and her unwavering commitment to the healthcare industry.

In addition to her professional career, Ms. Locklear serves on several philanthropic boards. She currently chairs the Board of Governors for the Gemological Institute of America (GIA) and serves on the boards of the Pacific Marine Mammal Center and the Orange County United Way, and is a member of the National Association of Corporate Directors (NACD).

Ms. Locklear holds a B.S. in plant science from the University of California, Davis, and an MBA from the University of California, Irvine. She is a licensed CPA (inactive) and is a member of the American Institute of Certified Public Accountants, the California Society of CPAs, and Financial Executives International.

NATALIYA AGAFONOVA, MD CHIEF MEDICAL OFFICER

Dr. Agafonova joined Longeveron in the role of CMO on July 1, 2023. Before Longeveron, she served as Clinical Development Lead, Senior Medical Director, and Product Development Chair at Otsuka Pharmaceuticals. Previously, she was the Clinical Development Lead and Senior Medical Director at Bristol-Myers Squibb. Dr. Agafonova previously held several senior leadership positions in clinical development and pharmacovigilance at Ardea Bioscience, Biogen, Amgen, and Genzyme Corporation.

Dr. Agafonova has extensive experience in therapeutic areas such as autoimmune, hematology, neuroscience, and oncology. Her cross-therapeutic expertise in drug development helped to bring several products to the U.S. and EU markets.

Prior to her industry experience, Dr. Agafonova served as a physician at the Ukrainian Research Institute of Oncology and Radiology.

Dr. Agafonova earned an M.D. from the Ukrainian National Medical University and completed her internal medicine residency at Kharkov State University Hospital in Ukraine.

PAUL LEHR, JD GENERAL COUNSEL AND SECRETARY

Paul Lehr (General Counsel and Secretary) joined Longeveronin 2016 and serves as General Counsel and Corporate Secretary. Over the past 20 years, Mr. Lehr has held senior legal and executive positions in corporate, non-profit, and research settings. Mr. Lehr started his legal career as a law clerk for a United States Federal Judge and thereafter practiced law at a leading Miami law firm for 5 years, with experience in healthcare and business. Thereafter, Mr. Lehr focused his efforts in the cardiac rehabilitation field as President and General Counsel of a non-profit research foundation and for-profit cardiac rehabilitation program. With the research serving as the foundation of the for-profit arm of the cardiac rehabilitation program, Mr. Lehr negotiated a master franchise agreement with a leading Indian healthcare operator with 100+ facilities across India and the Middle East, then co-lead negotiations with the Centers for Medicare & Medicaid Services to successfully secure CMS reimbursement of their intensive cardiac rehabilitation program. Mr. Lehr has also served since 2011 as CEO and co-founder of HeartGenomics, a biotech firm based on intellectual property Mr. Lehr licensed from the UM Miller School of Medicine. Mr. Lehr earned his B.A. from Brown University, and his J.D. with honors from University of Florida College of Law.

LISA MCCLAIN-MOSS VICE PRESIDENT, MANUFACTURING

Lisa McClain-Moss joined Longeveron in 2017. She has more than 20 years of experience in the cell and gene therapy space including GMP cleanroom operations. During this timeshe was involved in the development, manufacturing and scale up of biopharmaceutical products including viral vectors such as vaccinia and retroviruses, H5N1 influenza seed stock for the WHO as well as seed stocks for multiple strains of influenza, rAAV, monoclonal antibodies and cell and tissue expansion and banking. From September 2007 to August 2017 she served as the Director of Manufacturing at Cognate Bioservices. While at Cognate she led manufacturing operations in a GMP environment as well as implementation of new client processes from technology transfer to finished final product. From March 1999 to August 2007, she served at St. Jude Children’s Research Hospital starting with the production of vectors for clinical trials to Therapeutics Production Section Head providing oversight for GMP operations. From 1993 to 1999 she was a microbiologist at C. E. Kord Animal Diagnostic Laboratory providing diagnostic testing for multiple animal species. Lisa McClain-Moss received her BS in Biology/Microbiology from Tennessee Technological University.

JEROME BAILEY VICE PRESIDENT OF BUSINESS OPERATIONS

Jerome Bailey joined Longeveron in 2022 from Checkmate Pharmaceuticals (acquired by Regeneron), where he served as senior director of program management. Mr. Bailey brings to the company more than 30 years of operational leadership and program management experience in the biopharmaceutical industry, overseeing clinical trials from Phase 1 through Phase 4 across several therapeutic areas.

As the senior director of program management at Checkmate Pharmaceuticals Mr. Bailey led cross-functional project teams driving multiple oncology programs from candidate selection through clinical development. Before Checkmate Pharmaceuticals, he held roles of increasing responsibility at Parexel, where he led multiple global development programs across several therapeutic areas, including in oncology, hematology, pulmonary, and pediatric rare diseases. He also facilitated the product submission strategy across several major global markets for schizophrenia and hypertension. Prior to Parexel, Mr. Bailey held senior management roles at Applied Clinical Intelligence, Theorem Clinical Research, BDH Clinical Research, Covance, and Eli Lilly. Mr. Bailey began his career as a clinical researcher at Ayerst Laboratories, and later at Hoffman La Roche. Mr. Bailey holds a bachelor’s degree in the biological sciences from Rutgers University.

ANTHONY OLIVA, Ph.D SENIOR SCIENTIST

Anthony Oliva, Ph.D. has been with Longeveron since 2015. Dr. Oliva has over 20 years of basic and clinical research experience, has deep experience in regulatory affairs, and has been integral in leading Longeveron’s grant application and grant funding process. Prior to joining Longeveron, he held a faculty appointment at Florida International University. Dr. Oliva earned his B.A. in Biological Sciences from the University of Chicago, and his Ph.D. in Neuroscience from Baylor College of Medicine. He did his post-doctoral research at Oregon Health & Science University.

Sincerely,

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