Full Press Release Details
CELSUS THERAPEUTICS PLC
Company number 05252842
Notice of Annual General Meeting
THIS DOCUMENT IS IMPORTANT AND REQUIRES
YOUR IMMEDIATE ATTENTION.
If you are in any doubt as to what action
you should take, you are recommended to seek your own financial advice from your stockbroker or other independent adviser authorized
under the Financial Services and Markets Act 2000.
If you have sold or transferred all of
your shares in Celsus Therapeutics PLC, please forward this document, together with the accompanying documents, as soon as possible
either to the purchaser or transferee or to the person who arranged the sale or transfer so they can pass these documents to the
person who now holds the shares.
Notice of 2014 annual general meeting
of the company to be held on 19 June 2014
The Annual General Meeting of Celsus Therapeutics
plc (the "Company" or "Celsus") will be held on June 19, 2014, at 10:00 am BST, at our London
office, 53 Davies Street, Mayfair, London ("Annual General Meeting").
We are excited to update you on the corporate,
financial and product development progress that the Company has made since our last Annual General Meeting. This year has been
transitional for the Company with many notable achievements, including:
Celsus is a biopharmaceutical emerging
growth company focused on the development of non-steroidal, synthetic multi-functional anti-inflammatory drugs. Celsus has developed
a class of synthetic drugs termed Multi-Functional Anti-Inflammatory Drugs, representing a new therapeutic class and platform for
the treatment of a wide range of inflammatory diseases. The Company's business strategy is to expand and build a biopharmaceutical
business to focus on addressing the current need for safe and potent alternatives to steroids. The Company's lead product
candidate is MRX-6, a topical cream for treating atopic dermatitis (also known as eczema). A Phase II trial of MRX-6 will be carried
out in Israel and Argentina with data expected in the fourth quarter of 2014. Additionally, the Company expects to initiate a Phase
II clinical trial of MRX-6 in the US in atopic dermatitis in the first half of 2015.
Our management team and Board are prepared
to continue to implement our strategy and create shareholder value. We are pleased to share with you our results to date and look
forward to another pivotal year for the Company. For more detailed information on the Company, please see our Annual Report on
Form 20-F filed with the SEC and other SEC filings at our web site www.celsustx.com.
Please note that the Company sends and/or
supplies documents and information to you as a member of the Company via http://www.celsustx.com ( ("Website"). The Form 20-F, IFRS UK, and option plan are available on the Website (http://www.celsustx.com/corporate_governance.html document password "AGM2014"). The Company reserves the right, in circumstances which it deems necessary,
to send documents or information to shareholders in hard copy rather than by email or by publication on the Website.
We look forward to seeing you at the meeting
and providing you with an update on the Company. If you will not be able to attend the meeting, you are requested to complete and
return the proxy form in accordance with the instructions printed on it, as soon as possible, but in any event so as to be received,
at least 48 hours before the time fixed for the meeting. Completing the proxy form will not preclude you from attending the meeting
and voting in person should you decide to do so.
Re-appointments and new Board Members:
As set out in the attached Notice of Annual
General Meeting, the Board is proposing the re-appointment of Mr. Robert Doman and Mr. Allan Shaw as Class A directors. Both Mr.
Doman and Mr. Shaw have worked diligently in providing direction and experience to the Board and Celsus over the past year and
the Board of Directors' recommend that you vote in favor of these re-appointments of Class A Directors.
Furthermore, we are pleased to announce
that the Board has resolved to appoint Dr. Gur Roshwalb, our CEO, as a new Class A Director. The Board recommends that you vote
in favor of his appointment.
Further information about our Directors
is set forth in the attached document.
Finally, we would like to thank Professor
Saul Yedgar and Mr. Fredric Price for their service to the Board over the last year.
Research and Development Committee of
The Board has also created a Research and
Development Committee, the purpose of which is to leverage the vast clinical and commercial experience of our Board members to
guide the strategic direction of the Company. The committee will be chaired by Mr. Robert Doman, and its members will include Dr.
David Sidransky, Dr. Johnson Lau and our CEO, Dr. Gur Roshwalb.
2014 Equity Incentive Plan (ESOP)
In order to retain qualified individuals,
the Board previously established the 2007 Employees Stock Option Plan ("2007 Stock Option Plan"). The 2007 Stock
Option Plan was approved by the Board of Directors of the Company on August 28, 2007, subsequently amended on April 26, 2012 and
June 20, 2013. The Company currently has issued Options representing 2,831,690 Ordinary Shares under the 2007 Stock Option Plan
and the plan and each of its amendments can be viewed on the website.
In acknowledgement of the Company's
status as a NASDAQ Capital Market listed company, and in order to comply with new laws put in place since 2007, the Board deems
it adviseable to introduce a new equity incentive plan, to be called the 2014 Equity Incentive Plan (the "2014 Plan")
to enable the Company to continue to attract and retain professional personnel for the purposes of executing its clinical development
plan. It is proposed that the 2014 Plan will have an increased number of shares available under it, providing the authority for
the issuance of rights for 2,000,000 Ordinary Shares that have been allocated to the plan plus the rollover of 3,865,000 shares
currently authorized under the Company's 2007 Stock Option Plan under which options have not been issued. In addition, 2,831,690
Ordinary Shares representing options currently outstanding under the 2007 Stock Option Plan may be issued under the 2014 Plan if
such options are cancelled or expire unexercised. Accordingly, the total number of Ordinary Shares that may ultimately be issued
under rights granted under the 2014 Plan, including previous grants under the 2007 Stock Option Plan, shall not exceed 5,865,000
Ordinary Shares. The Board recommends that the Company's shareholders approve the Plan by voting in favor of the 2014 Plan.
This will represent an increase in the pool from the current 6.1 percent to 8.9 percent on a fully diluted ordinary share basis.
The Company's lead clinical candidate
product is MRX-6, a topical cream for treating atopic dermatitis (also known as eczema) which is currently in Phase II development.
Given the common biochemical mechanism of inflammatory diseases, over time we plan to expand the application of our technology
and product candidates to address other forms of inflammatory diseases including, potentially, ophthalmology, cystic fibrosis,
osteoarthritis and other inflammatory conditions.
In May 2013, Celsus announced positive
results from a double-blind, vehicle controlled trial of MRX-6 in the treatment of contact dermatitis of the hand, which demonstrated
a 56% improvement in symptoms (dryness, scaling, redness, pruritus and fissures) from baseline in the MRX-6 treated hand/forearm,
compared to a 24% improvement for vehicle ( placebo') treated hand/forearm (p < 0.0001). Clinically significant
benefit, defined as a 50 percent reduction in symptoms from baseline in the MRX-6 treated hand/forearm was seen in 67% of
We anticipate initiating a Phase II clinical
trial of MRX-6 in pediatric atopic dermatitis in Israel and Argentina, with results expected in the fourth quarter of 2014. We
intend to begin a full clinical program to develop MRX-6 in atopic dermatitis and other inflammatory skin conditions in the US
in the first half of 2015. Based on current projections, we expect to complete the manufacturing, synthesis, toxicity, and other
preclinical studies required to file a US IND in the fourth quarter of 2014. We also expect to begin pre-clinical work on our ophthalmology
and cystic fibrosis programs during the second half of 2014 and potentially begin clinical trials in late 2015 or early 2016.
This additional work would include, but
is not limited to, advancing lead compounds, pre-clinical toxicity studies, formulation and manufacturing. Finally, we may also
explore the potential of our compounds in other inflammatory conditions with preclinical and early manufacturing work taking place
in late 2014 and 2015. Potential licensing transactions are an avenue we continue to pursue in parallel with our clinical development
Appointment of Scientific Advisory Board
Based on our focus on clinical development
in dermatology, we have appointed a new dermatology Scientific Advisory Board ("SAB"). As announced on April
7, 2014 the SAB members include:
Dr. Jonathan Wilkin: Dr. Wilkin