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): October
21, 2015
Intellect
Neurosciences, Inc.
(Exact
Name Of Registrant As Specified In Its Charter)
Delaware
(State
or Other Jurisdiction of Incorporation)
333-128226 |
|
20-8329066 |
(Commission
File Number) |
|
(I.R.S.
Employer Identification No.) |
|
|
|
550
Sylvan Ave., Suite 101
Englewood
Cliffs, New Jersey |
|
07632 |
(Address
of Principal Executive Offices) |
|
(Zip
Code) |
(201)
608-5101
(Registrant’s
Telephone Number, Including Area Code)
(Former
Name or Former Address, if Changed Since Last Report)
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 (see General Instruction A.2. below):
| ☐ | 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 240.13e-4(c)) |
Item
8.01. Other Events.
On
October 20, 2015, Intellect Neurosciences, Inc. (the “Company”) issued a Letter to Shareholders from Elliot Maza,
Chairman and CEO regarding the strategic direction of the Company’s activities.
A
copy of the Letter to Shareholders that discusses this matter is filed as Exhibit 99.01 to, and incorporated by reference in,
this report. The information in this Current Report is being furnished and shall not be deemed “filed” for the purposes
of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that Section. The information
in this Current Report shall not be incorporated by reference into any registration statement or other document pursuant to the
Securities Act of 1933, except as shall be expressly set forth by specific reference in any such filing.
The following
exhibit is furnished as part of this Report on Form 8-K:
Exhibit |
|
Description |
|
|
|
99.01 |
|
Letter to Shareholders dated October
20, 2015 |
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.
Dated: October 21, 2015 |
INTELLECT NEUROSCIENCES, INC. |
|
|
|
|
By: |
/s/ Elliot Maza |
|
Name: Elliot Maza |
|
Title: Chief Executive Officer |
Exhibit 99.1
Intellect
Neurosciences, Inc. Issues Letter to Shareholders
NEW
YORK, October 20, 2015 (GLOBE NEWSWIRE) -- Intellect Neurosciences, Inc. (OTC:ILNS) a biopharmaceutical company engaged
in the discovery and development of disease-modifying therapeutic agents for the treatment and prevention of rare neurodegenerative
conditions, issued the following Letter to Shareholders from Elliot Maza, CEO.
Dear
Intellect Shareholder,
I
would like to update you regarding a recent strategic decision by our Board of Directors to direct our research efforts exclusively
to rare diseases.
Background
Founded
in 2005, Intellect’s roots trace back to Mindset Biopharmaceuticals, Inc. (“Mindset”) a company founded by Dr.
Daniel Chain focused on developing disease modifying therapeutic agents for the treatment and prevention of Alzheimer’s
disease (“AD”). Early business development successes at Intellect included granting non-exclusive, worldwide, royalty-bearing
licenses of the company’s AD immunotherapy patent estate to global pharmaceutical companies developing products intended
to treat AD.
OX1
– from AD to FA
Among
the assets that Intellect acquired from Mindset were the rights to OX1, a high affinity, copper binding molecule that protects
the body against free radicals. OX1 was discovered by scientists at NYU and South Alabama Medical Science Foundation. Mindset
had tested OX1 in 90 elderly healthy human subjects in Phase 1 trials. OX1 proved safe; no serious adverse events were reported.
Intellect’s intentions were to advance the development of OX1 for the treatment and prevention of AD.
In
the first quarter of 2011, Intellect’s Board of Directors agreed to management’s recommendation to pivot from advancing
OX1 for AD to Friedrich’s Ataxia (“FA”) a rare, hereditary, progressive, neurodegenerative disease caused by
a defective gene affecting energy production. Intellect’s decision to develop OX1 as a potential ground-breaking treatment
for FA resulted from the convergence of two independent lines of research over several years: one relating to the general properties
and mechanisms of action of OX1 and the other relating to the pathogenic mechanisms underlying FA, especially the important role
of oxidative stress. These parallel developments helped uncover the strong potential of OX1 as a disease-modifying treatment for
FA because of OX1’s unique multimodal antioxidant properties, which prevent damage to cell membranes and the oxidation of
proteins and DNA. We believed at the time, and continue to believe, that OX1 will prove disease modifying for FA and other neurodegenerative
diseases.
In
April 2011, we filed an orphan drug application with the Office of Orphan Products Development of the FDA to obtain Orphan Drug
Designation for OX1 for the treatment of FA. Our efforts were supported by the Friedreich’s Research Alliance (“FARA”)
the leading public, 501(c)(3), non-profit, tax-exempt organization dedicated to the pursuit of scientific research leading to
treatments and a cure for FA. Although our application was not acted upon because of a lack of sufficient supporting data in the
specified disease area of FA, the publicity generated in the pharmaceutical industry from our application stimulated significant
discussions with large pharmaceutical companies interested in OX1 as a potential disease-modifying treatment for FA. These discussions
culminated in a successful agreement in September 2011 with ViroPharma, Inc. (subsequently merged into Shire plc) pursuant to
which we granted to ViroPharma an exclusive license regarding our licensed patents and patent applications related to OX1 for
the treatment of FA and other diseases.
In
February 2013, ViroPharma filed an investigational new drug application to permit initiation of a single ascending dose Phase
1 study to evaluate the safety, tolerability and PK/PD of OX1 (renamed by ViroPharma as “VP 20629” and subsequently
by Shire as “SHP622”) in subjects with FA. The study commenced in the United States in August 2013 and was completed
in July 2015. Details of the study, entitled, “A Phase 1, Randomized, Double-blind, Placebo-controlled, Multicenter,
Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral
VP 20629 in Adult Subjects with Friedreich’s Ataxia”, may be found at: www.clinicaltrials.gov, identifier
NCT01898884.
As
of July 2015, the final cohort of the Phase 1 study was completed and enrollment was closed. It is likely that results from this
study will be shared by Shire later in 2015. Although there can be no assurance, we anticipate that Shire will continue the development
of SHP622 and seek Orphan Drug designation for the pharmaceutical product.
TauC3
– from AD to Rare Diseases
Caspase-cleaved
TauC3 (also known as delta tau) is an abnormal form of Tau protein. Tau is the main component of the neurofibrillary tangles of
AD, the pathological lesion that seems most directly related to disruption of neural systems.
In
2012, we licensed a TauC3 antibody from Northwestern University, acquiring exclusive global rights to develop and commercialize
the antibody. In January 2014, we announced top line data showing initial proof of concept in a preclinical AD model indicating
the antibody’s potential to be disease modifying. The data showed that the TauC3 monoclonal antibody effectively engaged
the target and reduced certain phosphorylated pathological forms of Tau, indicating that the treatment with the peripherally administered
antibody had an effect in the brain and potentially is disease modifying.
Earlier
this year, we announced the initiation of a sponsored research collaboration under the direction of Professor Bradley T. Hyman
MD, PhD, Director, Massachusetts Alzheimer’s Disease Research Center & Co-Director, Massachusetts General Hospital Memory
Disorders Unit & John B. Penney Jr. Professor of Neurology, Harvard Medical School. The research, which is ongoing, has yielded
important data regarding target engagement. We are preparing a new patent application encompassing this data, which will strengthen
our proprietary position in the TauC3 antibody.
Last
month, I proposed to our Board of Directors that we adjust the focus of our TauC3 research and pivot from AD to rare neurological
diseases that qualify for orphan drug status. My recommendation was based on several factors, including: the ongoing research
at Harvard, which is designed to examine the detailed molecular mechanism affecting propagation of Tau pathology in neurological
diseases; discussions with leading academics in the scientific community who are intimately familiar with TauC3 and the TauC3
antibody that we licensed from Northwestern; and discussions with potential strategic partners in the pharmaceutical industry
who expressed interest in our antibody if it were proven to be applicable to a rare disease.
I
am pleased to announce that our Board of Directors has agreed to my recommendation that we redirect the company’s strategic
focus. Accordingly, we are planning to test our TauC3 monoclonal antibody in several orphan disease preclinical models in the
near future.
As
a result of the foregoing, Intellect will focus its future research efforts exclusively on discovering and advancing therapeutic
agents for the treatment and prevention of rare neurological diseases. We believe that positioning the company as an “orphan
drug” discovery engine will enable us to unlock the true potential of our assets.
Adjusted
balance sheet – Surrender of convertible preferred stock
On
July 25, 2014, we entered into a stock purchase agreement with certain accredited investors whereby we issued 1,200 shares of
Series F Convertible Preferred Stock and warrants to purchase 9,600,000 shares of common stock for gross proceeds of $1.2 million
(the “Financing”).
In
connection with the Financing, one of our significant shareholders agreed to surrender all of its Series C Convertible
Preferred Stock with accrued dividends of approximately $7.2 million. The surrender of this stock for minimal consideration
results from efforts by our Board of Directors to align the enterprise value of the company as measured by the quoted value
of our fully diluted share count with what we believe to be the intrinsic value of the company’s assets. I thank this
shareholder for its cooperation.
I
look forward to updating you on developments related to Intellect’s programs in the future. Thank you for your support.
Sincerely,
/s/
Elliot Maza
Chief
Executive Officer and CFO
Safe
Harbor Statements Regarding Forward Looking Statements
The
statements in this letter made by representatives of Intellect Neurosciences relating to matters that are not historical facts,
including without limitation, those regarding future performance or financial results, the timing or potential outcomes of research
collaborations or clinical trials, any market that might develop for any of Intellect's product candidates and the sufficiency
of Intellect's cash and other capital resources, the continued development by Shire of SHP622 or its determination to seek Orphan
Drug designation for the pharmaceutical product of SHP622 are forward-looking statements that involve risks and uncertainties,
including, but not limited to, the likelihood that actual performance or results could materially differ, that future research
will prove successful, the likelihood that any product in the research pipeline will receive regulatory approval in the United
States or abroad, or Intellect's ability to fund such efforts with or without partners. Intellect undertakes no obligation to
update any of these statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak
only as to the date hereof. Accordingly, any forward-looking statements should be read in conjunction with the additional risks
and uncertainties detailed in Intellect's filings with the Securities and Exchange Commission, including those discussed in Intellect's
Annual Report on Form 10-K (file no. 333-128226) filed on October 13, 2015.