UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

  

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): September 11 2020

 

AIKIDO PHARMA INC.
(Exact name of registrant as specified in its charter)

 

Delaware   000-05576   52-0849320

(State or other jurisdiction

of incorporation) 

 

(Commission
File Number) 

 

(I.R.S. Employer

Identification No.) 

 

One Rockefeller Plaza, 11th Floor, New York, NY   10020
(Address of principal executive offices)   (Zip Code)
 
Registrant’s telephone number, including area code: (703) 992-9325

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13a-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock, $0.0001 par value   AIKI   The Nasdaq Capital Market

 

 

 

 

 

Item 8.01Other Events.

 

On September 11, 2020, AIkido Pharma Inc., a Delaware corporation (the “Company”), issued a presentation deck (the “Presentation”) summarizing the Company’s current drug products for the H.C. Wainwright & Co., LLC Virtual Conference to take place on September 15, 2020. The Presentation is attached hereto as Exhibit 99.1, which is incorporated by reference in this Current Report.

 

Item 9.01.Financial Statements and Exhibits

 

d) Exhibits.

 

The exhibit listed in the following Exhibit Index is filed as part of this Current Report on Form 8-K.

 

Exhibit No.   Description
     
99.1   Presentation, dated September 11, 2020

 

1

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  AIKIDO PHARMA INC.
   
  By:  /s/ Anthony Hayes
  Name: Anthony Hayes
  Title: Chief Executive Officer

 

Dated: September 11, 2020

 

 

2

 

Exhibit 99.1

AIkido Pharma Inc. DEVELOPING AND COMMERCIALIZING INNOVATIVE DRUG PLATFORMS FOR IMPROVING ANTICANCER AND ANTIVIRAL THERAPIES NASDAQ: AIKI Darrell Dotson, VP & General Counsel September 2020

 

Safe Harbor This presentation contains "forward - looking statements" within the meaning of the “safe - harbor” provisions of the Private Securi ties Litigation Reform Act of 1995. These statements are identified by the use of words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “co ntinue”, “predict”, “potential” and similar expressions that are intended to identify forward - looking statements. Such statements involve known and unknown risks, uncertain ties and other factors that could cause the actual results of AIkido Pharma, (“ AIkido ” or “the Company”) to differ materially from the results expressed or implied by such statements, including changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Compan y’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Acc ord ingly, although the Company believes that the expectations reflected in such forward - looking statements are reasonable, there can be no assurance th at such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward - looking informa tion contained in this presentation, whether as a result of new information, future events or otherwise, after the date of this presentation or to reflect the occ urr ence of unanticipated events except as required by law. NASDAQ: AIKI 2

 

Investment 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 Opportunities: 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 p rojected 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 • E xpected to reach $ 424.6B by 2027 with CAGR of 15.0% from 2019 to 2027 • Source: ResearchAndMarkets NASDAQ: AIKI 3

 

Anticancer Therapy DHA - dFdC (Gem - DHA) NASDAQ: AIKI 4 Licensed to drug and novel oral formulation; published proof of concept in mice General Strategy: develop to a logical, profitable 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 (Gem - DHA) NASDAQ: AIKI 5 • 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 • Robust published mouse data: Gemcitabine FDA approved for: Breast Cancer NSCL Cancer Ovarian Cancer Pancreatic Cancer Docosahexaenoic Acid (DHA) Allows for o ral for mulation using SLNs • Naguib et al . ( 2016 ) NeoPlasia 18 : 33 - 48 • Valdes et al . ( 2017 ) Pharm . Res . 34 : 1224 - 1232 • Valdes et al. (2019) Int. J. Pharm. 570:118609 • Valdes et al. (2020) AAPS PharmSciTech 21:77

 

UMB Antiviral Program NASDAQ: AIKI 6 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 opportunities arise.

 

UMB Antiviral Program NASDAQ: AIKI 7 • 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 - Viral Treatment Design – Corona, Influenza, Ebola Sources: https://www.microbiologyresearch.org/content/journal/acmi/10.1099/acmi.ac2020.po0018 Weston et al. (July 2020) “ The SKI complex is a broad - spectrum antiviral drug target” J. Med. Microbiol. 69:844 - 873 See also https://www.prnewswire.com/news - releases/aikido - pharma - inc - announces - key - progress - in - computational - approaches - to - identify - virus - treatments - including - coronavirus - 301091089.html Source: https://www.cell.com/fulltext/S0092 - 8674(13)00888 - X Cell 2013 154814 - 826 DOI: (10.1016/j.cell.2013.07.017) Halbach et al. (2013) “ The Yeast Ski Complex: Crystal Structure and RNA Channeling to the Exosome Complex” Cell 154:814 - 826

 

UK G4 - 1 for Solid Tumor Treatment NASDAQ: AIKI 8 Source: https://pubs.acs.org/doi/10.1021/jm501344n Miller et al. (2015) J. Med. Chem 68:2036 - 41 • 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 NASDAQ: AIKI 9 • 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 * • A ssist 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 A I to Study Genetic Markers of Pancreatic Cancer Goal is Using Markers for Early Detection Source: US Natl Cancer Inst. See also: Bender (2020) Nature 579:S12 - S13 doi : 10.1038/d41586 - 020 - 00846 - 3 *See: https://www.cogia.de/en/cxm.html https://www.linkedin.com/company/cogia - intelligence/ https://www.prnewswire.com/news - releases/aikido - pharma - executes - artificial - intelligence - and - machine - learning - research - agreement - with - cogia - biotech - ltd - 301054142.html

 

Wakeforest’s KPC34 for AML and ALL NASDAQ: AIKI 10 • 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 • G lobal market: • AML: $701.6M in 2018, $1.54B (est.) in 2024, CAGR 14.0% (Source FinancialNews Media.com) • ALL: $2.3M in 2018, $3.5M (est.) by 2026, CAGR 5.3% (Source: Allied Market Research) Gemcitabine

 

Capital Structure Cap Table Common Stock 34,920,219 Warrants 734,501 Options 88,950 Convertible Preferred Stock 688 NASDAQ: AIKI 11 Clean Capital Table Deminimus Outstanding Warrants & Preferred Stock Share price $0.75 52 - week range $0.48 - $5.52 Market Cap $24.7M Insider Holdings 5.6% As of August 13, 2020 Total Fully Diluted Shares 35,744,358

 

Summary Balance Sheets $ in thousands As of June 30, 2020 As of December 31, 2019 Cash and cash equivalents $29,144 $948 Total assets $32,463 $1,129 Current liabilities $676 $68 Total liabilities $969 $750 Total liabilities and stockholders’ equity $32,463 $11,282 Total debt $0 $0 NASDAQ: AIKI 12 Significant Operating Capital & No Debt

 

Contacts NASDAQ: AIKI 13 Company Contact Anthony Hayes , CEO Aikido Pharma Inc. Tel 703.992.9325 | www.aikidopharma.com Investor Relations Brett Maas , Managing Director Hayden IR Tel 646.536.7331 | www.haydenir.com