BIOTECH BREAKOUT REPORT
NASDAQ ALERT: AIkido Pharma Inc. (AIKI)
Can (AIKI) Run +2,701.76% Like 2020’s Biggest Biotech Win·ner?
Dear Fellow Trader,
Immediately turn your attention to AIkido Pharma Inc. (AIKI)
AIkido Pharma Inc. (AIKI) is an Artificial Intelligence-Cancer Fighting-Biotech
Company Like You’ve Never Seen Before.
My next alert is headquartered in one of the most affluent and highly educated communities in the United States--Bethesda, Maryland located in Montgomery County.
Is this by chance OR is there Strategic Reasoning for this Location?
You see, the Biotechnology industry in Montgomery County was born out of the Federal Research Laboratories at the National Institutes of Health, Food and Drug Administration (FDA), Walter Reed Army Institute of Research, the Uniformed Services University of the Health Sciences, and the National Institute of Standards and Technology (NIST).
These Federal Labs provide a critical mass Bioscience Labor Force, including Scientists who become entrepreneurs and founders of Biotech Firms.
Which brings us to our Biotech Breakout Alert: AIkido Pharma Inc. (AIKI)
Keep reading and You will see Exactly Why I am SO Excited about This Company.
?AIkido Pharma Inc. is a biotechnology development company with a diverse portfolio of early stage small-molecule anti-cancer therapeutics. The Spherix platform contains patented technology from leading universities and researchers which seek to develop their innovative drugs through strong partnership with world renowned institutions, such as The University of Texas and Wake Forest University.
Their diverse pipeline of therapeutics includes therapies for pancreatic cancer, acute myeloid leukemia (AML), and acute lymphoblastic leukemia (ALL).
Their pancreatic treatment has shown positive preclinical results for inhibiting pancreatic tumor growth in clinically relevant transgenic mouse models.
The drug has also demonstrated the potential to overcome tumor cell resistance to current chemotherapeutic drugs.
Their AML drug is a next generation targeted therapeutic designed to overcome multiple resistance mechanisms observed with the current standard of care.
In addition, they are constantly seeking to grow their pipe to treat unmet medical needs in oncology.
Let’s Dive in Deeper on AIkido Pharma Inc’s
Financials and Science behind the Company
?Source: SEC Filing
Over $28 Million as of June 30, 2020 - No Debt
?Inves·tment Highlights
• We are a drug development company partnering with universities to treat cancer and viral infections
• Strong Balance Sheet: Over $28 Million as of June 30, 2020 - No Debt - Nominal Outstanding Warrants
• Market Oppor·tunities: DHA - dFdC (Gem - DHA) for oral and/or IV cancer treatment licensed from UT at Austin:
• Global gemcitabine market expected to reach >$900M by 2027
• CAGR of nearly 7% from 2019 to 2027
• Source: Transparency Market Research Pan - Viral Drug Design licensed from University of Maryland at Baltimore:
• Preliminary proof of concept against coronavirus, flu, Ebola and others
• Global flu drug market alone projected to reach $993.7M by 2026, with a CAGR of 2.2%
• Source: Fortune Business Insights Solid tumor drug (G4 - 1) optioned from University of Kentucky and SRA funded by Aikido:
• The global solid tumor cancer treatment market was valued at $121.3B in 2018
• Expected to reach $ 424.6B by 2027 with CAGR of 15.0% from 2019 to 2027
Anticancer Therapy DHA - dFdC (Gem - DHA)
Licensed to drug and novel oral formulation; published proof of concept in mice
General Strategy: develop to a logical, profi·table monetization exit point
Manufacturing optimization well underway. We have hired:
• Regulatory experts to assist in pursuing the FDA’s 505(b)(2) approval pathway
• Contract manufacturing organization (CMO) for manufacturing, formulation, optimization
• Chemistry, manufacturing, controls (CMC) firm for oversight of CMO, ensuring quality per FDA regs, developing chemistry research plan and formulation development/optimization, FDA required facility audits
Current Status:
• CMO optimizing manufacture of Gem - DHA; positive results so far
• Formulation development to begin thereafter; both oral and IV formulations pursued in parallel
• Limited animal testing to begin in the latter stages of formulation development
• Will hire on contract research organization (CRO) for animal testing soon
• Pre - IND meeting with FDA anticipated Q1 or Q2 2021 depending on formulation results
Anticancer Therapy DHA - dFdC
Derivative of FDA - approved chemo drug gemcitabine
• Gem - DHA drug patent recently issued; expires 2035
• Solid lipid nanoparticles (SLNs) used for oral delivery
• Oral formulation patent application filed in June 2020
• Better activity than gemcitabine
• Safety profile promising in mice
• Greatly reduces drug resistance
• Unexpectedly concentrates in pancreas
UMB Antiviral Program
Pan - Viral Treatment Design – Corona, Influenza, Ebola
• We have licensed and funded an SRA ($3M over 2 yr ) to discover new computer - designed panviral treatments
• License includes patent applications on several candidates
• Nonprovisional patent application filed in June 2020
• SRA funds optimization of licensed candidates
• Lead scientist is well - known virologist Matthew B. Frieman, Ph.D.
• Dr. Frieman is working to identify novel and repurposed drugs,
antibodies and vaccines for Influenza virus, SARS - CoV , MERS - CoV and
SARS - CoV - 2 inhibition
• Source: https://www.medschool.umaryland.edu/profiles/Frieman - Matthew/
• We are working to increase our relationship with UMB and Dr. Frieman and add to our participation as oppor·tunities arise.
UMB Antiviral Program
• SKI complex ID’d as a potential broad - spectrum antiviral target
• Initial data suggested functional link between viral proteins and SKI
• Computer modeling ID’d potential drug binding pockets on SKI
• Computer modeling to design compounds to bind SKI pockets
• Screening ID’d specific compounds that inhibit various viruses
• Inhibited viruses include influenza, Ebola and Corona Pan
UK G4 - 1 for Solid Tumor Treatment
• Option to license and $67.5K SRA to study 30 - day survival in mice
vs. competitor drugs
• First option allowed to lapse in favor of funding this study in exchange for another option
• Option lasts until 45 days after results reported to us (extendable)
• Computer - designed drug isolated from ~340,000 candidates
• Effective against solid tumors, unlike competitors
• Excellent metabolic stability profile relative to competitors
• Works in cancers already resistant to competitor drugs
• Patent subject to our Option expires 2035
Machine Learning Project with UTSW
• Focus on stages of pancreatic ductal adenocarcinoma
• Time and materials SRA with UTSW with max of $152K
• Further agreement with BCII Biotech Ltd. ($150K total)
• Sister company to Cogia Biotech, a big - data, AI/ML company using AI algorithms in drug development *
• Assist in developing AI and ML iterative models
• Determine specific markers from six stages of PDA
?• To date, 2762 candidate markers screened and 120 best markers identified in 5 cell types
Wakeforest’s KPC34 for AML and ALL
• Licensed to KPC34 for treatment of AML and ALL
• Small target patient populations:
• Acute Myeloid Leukemia (AML) (~21K new/ yr )
• Acute Lymphoid Leukemia (~6K/ yr )
• Eligible for Orphan Drug Designation, providing 7 years market exclusivity
• Global market:
•AML: $701.6M in 2018, $1.54B (est.) in 2024, CAGR 14.0%
•ALL: $2.3M in 2018, $3.5M (est.) by 2026, CAGR 5.3%
Additional Research and Due Diligence:
AIkido Pharma Inc. (AIKI) Has Strong Partnerships with World Renowned Institutions, such as The University of Texas.
As I was doing my research and due diligence, I found 2X Very Interesting Facts about The University of Texas and How This Could Be a Potential Catalyst For Our Profiled Company: AIkido Pharma (AIKI).
?1. The Current Commissioner of the FDA has ties to the University of Texas.
Prior to joining the FDA, Dr. Hahn served as the chief medical executive (CME) at The University of Texas MD Anderson Cancer Center, a facility that cares for more than 140,000 patients a year. He has proven executive leadership that spans research, development, clinical trials, patient care, health system management and education. In his role as CME, he was responsible for day-to-day management of the institution, including business, clinical and faculty matters.
Why is this important to AIkido Pharma Inc?
You see, the FDA is the Ultimate Gatekeeper. As the regulatory body that approves new drugs for the U.S. market, as well as permitting human clinical trials, the Food and Drug Administration (FDA) is the ultimate gatekeeper for every biotech firm. The FDA requires that all companies establish to its satisfaction that a potential new drug is safe and effective for its stated purpose.
Investors need to understand the FDA process and requirements. In order to get FDA approval, Biotechs must establish a sufficient body of information that the drug is safe and effective. This is generally done through a series of at least three clinical trials. AIkido Pharma Inc. has a strong relationship with The University of Texas...And the current FDA Commissioner just served as the Chief Medical Officer of The University of Texas. (You See what I’m Saying Here?)
The University of Texas has a history of Producing a Massive Biotech Success Story. You see, back in the early 1990’s a Chemist named Jonathan Sessler founded a pharmaceutical research company called Pharmacyclics. The company's aim was advancing molecules Sessler had engineered in his University of Texas at Austin laboratory to target cancer.
Pharmacyclics was eventually sold
to Abb bVie for $21B
Could AIkido Pharma Inc. (AIKI) Be Onto A Major Breakthrough
?With The University of Texas?
The Current FDA Commissioner was Just the Chief Medical Officer of The University of Texas.
AIkido Pharma Inc. (AIKI)
Recent News:
AIkido Pharma Announces Publication of Artificial Intelligence-Machine Learning Sponsored Research Program for Pancreatic Cancer
NEW YORK, Dec. 9, 2020 /PRNewswire/ -- AIkido Pharma Inc. (Nasdaq: AIKI) ("AIkido" or the "Company") today announced the publication of positive results from its Artificial Intelligence/Machine Learning Sponsored Research Program in the field of Pancreatic Cancer.
Pancreatic ductal adenocarcinoma (PDA) is the third leading cause of cancer-related deaths in the US. PDA is increasing in frequency owing to its association with obesity, smoking, and type 2 diabetes.
PDA treatment is severely compromised because most diagnoses are made late in disease progression. Surgical resection remains the most effective therapeutic strategy but is restricted to early-stage diagnosis and is rarely, if ever, curative. In spite of the decades of research and recent advances, the five-year survival rate has only improved to 9%, and less than 20% of patients survive one year.
Thus, there is a pressing need for systematic and robust screens to develop novel, effective PDA therapeutics for early-stage disease and after successful surgical resection to delay or prevent relapse. AIkido's strategy to identify better therapeutics is to screen drugs in primary cell culture, followed by validation in a mouse model of early disease progression.
November 13, 2020
Lead compounds have anti-coronavirus activity, including against SARS-CoV and SARS-CoV2
NEW YORK, Nov. 13, 2020 /PRNewswire/ -- AIkido Pharma Inc. (Nasdaq: AIKI) ("AIkido" or the "Company") today announced the publication of positive results from a study of antiviral activity of FDA approved drugs in a peer-reviewed article in the Proceedings of the National Academy of Sciences of the United States of America (PNAS). The publication reports studies on newly discovered antiviral compounds that were developed using a computer modeling approach. The lead compounds were found to have broad-spectrum antiviral activity, inhibiting influenza virus, Ebola, Marburg, MERS-CoV, SARS-CoV, and SARS-CoV2, the virus that causes COVID-19.
Mr. Anthony Hayes, CEO of AIkido stated, "The results of this peer reviewed study provide encouraging data for Company's newly licensed compounds. I am particularly excited with the data that demonstrates inhibition of SARS-CoV2 by the lead compounds. This represents yet another solid validation of University of Maryland, Baltimore's (UMB) antiviral platform, to which we are the exclusive licensee. In addition, this article provides a significant amount of substantive information about the technology we have licensed from UMB. I encourage our shareholders who want more information about the technology to review the article."
The Company previously executed a Master License Agreement with UMB for specific antiviral compounds discovered by UMB that seek to inhibit replication of multiple viruses, including Influenza virus, SARS-CoV, SARS-CoV2, MERS-CoV, Ebolavirus and Marburg virus. The technology is covered by two patent applications already on file with the United States Patent and Trademark Office. The Company previously executed a Sponsored Research Agreement with UMB to support the development of the technology.
October 28, 2020
AIkido Pharma Inc. Provides Update on Its Next-Generation
Chemotherapeutic Treatment DHA-dFdC
Synthesis of Critical Chemical Intermediate for Drug Confirmed
NEW YORK, Oct. 28, 2020 /PRNewswire/ -- AIkido Pharma Inc. (Nasdaq: AIKI) ("AIkido" or the "Company") today provided an update on its preclinical work on its next-generation chemotherapeutic, DHA-dFdC, and the solid lipid nanoparticle (SLN) drug delivery system to treat pancreatic cancer, which the Company has licensed from the University of Texas at Austin.
Pancreatic cancer is the 4th leading cause of cancer deaths in the US and, partly because most cases are diagnosed at an advanced stage, the 5-year overall survival rate for those cases has remained only around 3%.
The Company is developing its drug product as an orally administered second-line treatment to target advanced pancreatic cancer.
The Company confirmed this week the successful synthesis of a critical intermediate compound for DHA-dFdC. Purification and isolation of this key intermediate were also completed and verified.
The Company is also in the process of optimizing the SLN delivery vehicle with respect to particle size and stability.
In addition, the Company recently expanded upon its agreement with Parimer Scientific to immediately begin manufacturing activities including the following:
Developing analytical methods for both raw materials and final drug product,
Producing an optimized process for batch scale-up of the drug,
Producing and delivering 20,000 mg of final drug product to be used in toxicology studies,
Performing initial short-term and long-term stability testing in the selected bulk container closure using ICH Q1A(R2) Stability Testing of New Drug Substances and Products,
Creating a drug substance reference standard, and
Establishing drug purity per the relevant FDA standards.
Under the expanded agreement, the final drug product will be manufactured using at minimum GLP practices per 21 CFR 58 and following the recommendations in the FDA's ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
Dr. Richard T. Pace, Principal Scientist at Parimer Scientific commented, "We are very gratified to have confirmed isolation of the crucial chemical intermediate for this drug. These results strongly indicate that developing a scalable process for drug manufacture will be achievable."
Anthony Hayes, CEO of AIkido stated, "These are the results we have been hoping for and they greatly increase my optimism about the scalability of this product. We plan to rapidly develop the process of drug incorporation into the SLN delivery particles and start preliminary biological testing, which should begin this quarter."
Board of Directors & Management
Robert J. Vander Zanden, Ph.D.
Chairman of the Board
Dr. Robert J. Vander Zanden, Board Member since 2004, was elected Chairman of the Board in early 2009. Having served as a Vice President of R&D with Kraft Foods International, he brings a long and distinguished career in applied technology, product commercialization, and business knowledge of the food science industry to Spherix. In his 30-year career, he has been with ITT Continental Baking Company as a Product Development Scientist; with Ralston Purina’s Protein Technology Division as Manager Dietary Foods R&D; with Keebler as Group Director, Product and Process Development; with Grupo Gamesa, a Frito-Lay Company, as Vice President, Technology; and with Nabisco as Vice President of R&D for their International Division. With the acquisition of Nabisco by Kraft Foods, he became the Vice President of R&D for Kraft’s Latin American Division. Dr. Vander Zanden retired from Kraft Foods in 2004. He currently holds the title of Adjunct Professor and Lecturer in the Department of Food, Nutrition, and Packaging Sciences at Clemson University, where he also is a member of their Industry Advisory Board. His focus on achieving product and process innovation through training, team building and creating positive working environments has earned him multiple awards for product and packaging innovation. Dr. Vander Zanden holds a Ph.D. in Food Science and an M.S. in Inorganic Chemistry from Kansas State University, and a B.S. in Chemistry from the University of Wisconsin – Platteville, where he was named a Distinguished Alumnus in 2002.Tim Ledwick
Board Member
Mr. Ledwick is currently the Chief Financial Officer of Management Health Solutions, a private equity-backed company that provides software solutions and services to hospitals focused on reducing costs through superior inventory management practices. In addition, since 2012 he has served on the board and Chair of the Audit Committee of Telkonet, Inc. (TKOI) a smart energy management technology company. From 2007 to 2011, Mr. Ledwick provided CFO consulting services to a $150mm services firm and, in addition, from 2007-2008 also acted as special advisor to The Dellacorte Group, a middle market financial advisory firm focused on transactions between $100mm and $1B. From 2002 through 2006, Tim was a member of the Board of Directors and Executive Vice President-CFO of Dictaphone Corporation playing a lead role in developing a business plan which revitalized the company, resulting in the successful sale of the firm and delivering a seven times return to shareholders. From 2001-2002, Ledwick was brought on as CFO to lead the restructuring efforts of Lernout & Hauspie Speech Products, a Belgium-based NASDAQ listed speech technology company, whose market cap had at one point reached a high of $9B. From 1999 through 2001, he was CFO of Cross Media Marketing Corp, an $80 mm public company headquartered in New York City, playing a lead role in the firm’s acquisition activity, tax analysis and capital raising. Mr. Ledwick is a member of the Connecticut Society of Certified Public Accountants and received his BBA in Accounting from The George Washington University and his MS in Finance from Fairfield University.
Greg Blattner
Board Member
Greg Blattner is a Director at Agio, a progressive Managed IT and Cybersecurity Services Provider. A noted leader in the alternative inves·tment technology space, Greg developed his career building and maintaining superior technology and operations solutions for Wall Street firms during a time when the industry’s technological complexity and data dependency experienced rapid evolution. Prior to Agio, Greg held Business Development and Operations Management positions at Reuters, American Express, JPMorgan, Morgan Stanley and Deloitte. He received his undergraduate degree from Iona College in New York.
Anthony C. Hayes, Esq.
CEO
Anthony C. Hayes is the CEO of AIkido Pharma Inc., a NASDAQ-traded (ticker: AIKI) technology commercialization company. Hayes began his tenure by overseeing AIkido’s transformation from a biotechnology company into a diversified corporate entity, committed to advancing innovation by participating in the development of new technologies across several sectors.
As CEO, Hayes developed and implemented a strategic plan to advance AIkido’s mission and objectives and to significantly promote company growth. He identified and brought about multimillion-dollar M&A acquisitions that resulted in some of the largest transactions in technology patents. Hayes is also involved in all aspects of investor relations, representing AIkido in shareholder meetings, at domestic and international conferences, and in television and print media (such as Bloomberg Television and Forbes).
An attorney and former partner of an Am Law 100 firm, Hayes previously co-founded and was managing member of JaNSOME IP Management LLC, an intellectual property monetization firm. JaNSOME provided consulting and advisory services to individuals and companies on best practices for monetization of the asset class.
President George W. Bush gave Hayes special recognition for creating the Wills for Heroes program, a national 501(c)(3), in response to the September 11 attacks (willsforheroes.com). Other honors include IAM IP Personality of 2013, American Board of Trial Advocates Young Lawyer of the Year and “20 Under 40” in Columbia, South Carolina.
Education: Juris Doctor from Tulane University Law School (1995); Bachelor of Arts in economics from Mary Washington College (1990)
Bar Memberships: District of Columbia; Florida; New York; South Carolina
Publications: “Avoiding the Post-Crisis Crisis: How to Prevent Post-Crisis Donation for Victims from Leading to Litigation” (ICMA Journal, January/February 2008)
5 Reasons Why Investors Love Biotech Stocks Like
AIkido Pharma Inc. (AIKI)
1. Potential for Massive Breakout
Investing in the biotechnology industry can prove to be overwhelmingly lucrative. Most clinical-stage stocks in this sector trade at prices under $5 per share. However, the successful launch of a new treatment option can send the stock soaring. If there’s ever a sector that creates milli·onaires, biotechnology is it.
2. The Feel-Good Effect
These days, investors make inves·tments for more than profit. In fact, there’s a trend of socially responsible investing sweeping the globe. With socially responsible investing, you look for and invest in companies that are making positive change in the world.
Some socially responsible investors look toward solar stocks for environmental change or financial-literacy stocks designed to remove the wealth divide. Others invest in biotech stocks, helping to fund the development of life-saving and life-changing treatment options. That’s something to feel good about. Cancer is one of the leading death-causing diseases... You probably know someone who has it.
3. Better Understanding of Medicine
When investing in any stock in any sector, it’s important to do your research. When doing this due diligence in the biotech industry, you’ll learn quite a bit about the human body, medicine, and the various ailments medicines are being designed to treat and cure. Scroll back through this report when you have time. You'd be ama·zed at some of the technology that AIkido Pharma Inc. has access to.
4. Interest in the Industry
Never before have so many eyes been on the biotech industry. The race is still on for a treatment or vaccine for COVID-19, the illness caused by the new coronavirus, and biotech companies are at the forefront.
5.High Chance for Acquisition
Since 2018, I counted 63 acquisitions of biotech companies based off this awesome list from Index. If you have ever had a stock get acquired, you know that there likely is going to be a Major Pop in share price as soon as that acquisition is announced, which is great for the owners of that company.
2020 was a Great Year for Biotech Inves·tors and Analysts
are Predicting 2021 Could be Even Bigger.
If you had bought NVAX in 2020, a $5K inves·tment could have turned into a Staggering $135K.
Could AIkido Pharma Inc. (NASDAQ: AIKI) Run +2,701.76% and be
Your Next Potential Massive Breakout?
Below are the 10 Best Performing Biotech Stocks of 2020
Catalyst for AIkido Pharma Inc. (AIKI) That Could
Send Shares Soaring This Week.
1. Strong Balance Sheet: Over $28 Million - Debt Free.
2. Currently Partnering and Building Strong Relationships with Major Universities.
3. Participating in the Flu Drug Market - Projected to $993.7M by 2026.
4. Participating in the solid tumor cancer treatment market - Expected to reach $424B 2027.
5. Biotechs provide Potential for Massive Profits, like NVAX that ran +2,701.76% in 2020.
6. An FDA Approval or positive feedback could send shares of AIKI through the roof.
7. AIKI and their team of partners are working on Breakthrough Artificial Intelligence for detecting Pancreatic Cancer -- any news, press releases or updates on this could cause the shares to go Parabolic.
Another big catalyst that could potentially send shares breaking out higher is Wall Streets leading provider of market data Barchart, which upgraded AIKI to a 80% Buy rating short-term, 100% Buy rating medium-term, 33% Buy rating long-term.
Barchart just Triggered 11 out of 12 Buy Signals across the short-term indicators, medium-term indicators and even the long-term indicators - See Below:
I strongly suggest you read the technicals immediately to learn why AIKI has the potential to breakout!
I strongly suggest you click here and read the technicals immediately to learn why AIKI has the potential to breakout!
Do Not Wait on AIKI this week, Recent Volume Increases Could be Indicating that a Massive Run Could be Coming…
Like I mentioned above, AIkido Pharma Inc. (AIKI) is Headquartered in close proximity to the FDA’s Headquarters in Maryland, AIkido Pharma Inc. has a Strong Partnership in place with The University of Texas, the new FDA’s Commissioner came from his position as the Chief Medical Officer at The University of Texas. Are there some synergies here that could massively benefit AIkido Pharma Inc. (AIKI) ? The Research Analyst in me seems to think so.
Pull Up AIKI (Right Now)... If AIKI makes a +2,701.76% Massive Run, You are going to hate yourself for missing out.
You need to be ready first thing this morning.
Pull up AIKI on your screen right now and start your research.
?Sincerely,
?Editor In Chief, OTCtipReporter Team
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