Business Context and Reporting Period
This Form 6-K, dated May 17, 2013, serves as a Notice of Annual General Meeting (AGM) for Morria Biopharmaceuticals PLC (commonly known as Celsus Therapeutics). The filing updates shareholders on the company's transition to a U.S. public reporting entity, recent management changes, and clinical progress. The AGM is scheduled for June 20, 2013, to approve audited financial statements for the year ended December 31, 2012, and several corporate resolutions.
Key Financial Metrics
The filing does not provide specific revenue, profit, or cash flow figures for the reporting period, as the company is a pre-revenue biopharmaceutical entity. However, it discloses the following financial activities:
- Debt Repayment: On January 2, 2013, the Company fully repaid USD $1,100,000 in Senior Secured Convertible Notes issued in April 2012.
- Capital Structure: The Board proposes increasing the share reserve for the 2007 Stock Option Plan by 2,500,000 shares, bringing the total aggregate shares issuable under the plan to 3,865,000.
- Liquidity and Trading: The Company has minimal trading activity in the U.S. and intends to pursue additional equity financings. It is establishing a Level II American Depositary Receipt (ADR) program with Deutsche Bank Trust Company Americas.
Material Changes and Operational Updates
Significant developments since the last reporting period include:
- Corporate Name Change: The Board resolved to change the trade name to "Celsus Therapeutics" and seeks shareholder approval to change the registered name to "Celsus Therapeutics Plc."
- Management Appointments: Dr. Gur Roshwalb was appointed Chief Executive Officer (March 2013), and Dr. Alan Harris joined as full-time Chief Medical Officer (July 2012).
- Board Expansion: The Board recommends the appointment of Fredric Price and Robert Doman as new Class A Directors to leverage their biopharmaceutical leadership experience.
- Clinical Results: On May 8, 2013, the Company announced positive, statistically significant results from the first cohort of the MRX-6 Phase II trial for contact dermatitis. The 2.0% dose showed a 56% improvement in symptoms versus 24% for vehicle control (p < 0.0001), with 70% of patients achieving clinically significant benefit.
Guidance, Outlook, and Risks
Development Outlook:
- MRX-6 (Dermatitis): Preclinical work (manufacturing, synthesis, toxicity) is expected to begin in Q3 2013 to support a U.S. Investigational New Drug (IND) filing in 2014, with U.S. trials anticipated in H2 2014.
- MRX-4 (Allergic Rhinitis): Regulatory filings and preclinical testing are expected in H2 2013, with a return to clinical testing in 2014.
- Pipeline Expansion: Preclinical work for ophthalmology and cystic fibrosis programs is planned for H2 2013, with potential clinical trials in 2014 or 2015.
Risks and Contingencies:
- Listing Uncertainty: The Company intends to apply for listing on the NASDAQ Capital Market but notes there is no assurance it will qualify or be listed.
- Lock-Up Provisions: A six-month lock-up period on share transfers commenced on January 24, 2013, and ends July 24, 2013, restricting liquidity for certain shareholders.
- Funding Dependence: Future clinical and preclinical work is explicitly stated as "funding permitting."
Investor Verification Checklist
- Verify the audited financial statements for the year ended December 31, 2012, referenced in the AGM notice but not included in this filing.
- Confirm the status of the NASDAQ Capital Market listing application and the ticker symbol change from MRRBY.
- Review the full text of the amended 2007 Stock Option Plan and the new "Drag Along" provisions in the Articles of Association.
- Monitor the timeline for the U.S. IND filing for MRX-6, currently projected for 2014.
- Check for updates on the second cohort data for the MRX-6 Phase II trial, expected by year-end 2013.