Analyst Conference Summary

Opexa Therapeutics

conference date: May 12, 2015 at 1:30 PM Pacific Time
for quarter ending: March 31, 2015 (first quarter 2015)

Forward-looking statements

Overview: This clinical-stage development company has been vetted by a $3 million payment from Merck Serono for its potential multiple sclerosis therapy Tcelna, which has also been given Fast Track designation by the FDA. But revenue from product sales is years away.

Basic data (GAAP):

Revenue was $0.4 million, up slightly from $0.35 million year earlier. This was option revenue from Merck.

Net loss was $3.4 million, down slightly from $3.7 million year-earlier.

Diluted EPS was negative $0.12 per share, up slightly from negative $0.13 per share year-earlier.



Conference Highlights:

After the quarter ended Opexa raised $13.8 million gross, $12 million net, by selling about 25 million units consisting of a share of common stock and a warrant to buy an additional share.

In March Opexa received a $3 million payment from Merck Serono as part of an amendment to the existing option and license agreement for Tcelna for multiple sclerosis (MS). This was to provide further support for the Abili-T trial. Merck has an option to license global rights, except Japan, at which point they would pay a $25 million milestone and would pay for the Phase 3 trial. If commercialized royalty payments would be between 8% and 15%.

Opexa believes it now has cash to get it to Q4 2016, which should allow for reporting top line results for the Phase 2b trial (Abili-T) of Tcelna for secondary progressive MS (SPMS).

At April 30, 2015 all patients were enrolled in Abili-T and about 75% of patient visits had been completed. Most are now in their second year of treatment. The independent Data and Safety Monitoring Board towards the end of April recommended that the trial should continue. The FDA granted Fast Track status to Tcelna for SPSM.

An IND submission to the FDA for permission to begin a clinical trial of OPX-212 for NMO (neuromyelitis optica) is expected by the end of 2015.

Research and development expense was $2.6 million. General and administrative expense $1.0 million. Depreciation and amortization was $0.1 million. Leading to a GAAP operating loss of $3.4 million. Interest and other expense was negligible.

Cash and equivalents ended at $9.6 million. Cash burn was $1.1 million in the quarter. Deferred revenue was $2.2 million. Current liabilities were $5.3 million.


Rituxan use off-label in NMO effects vs. OPX-212? There are no approved treatments for NMO; Rituxan is used off-label. Rituxan might help by causing B-cell depletion, but there are several elements in play that 212 should effect. There are lesions with inflammation associated with monocytes and neutrophils, with recruitment dependent on T-cell support. We see T-cells as the orchestrater of the disease. But moderating the T-cell response we could moderate the B-cell antibody response and the inflammatory response.

Filing of IND for OPX-212, timeline after that? That is subject to FDA input. We are discussing clinical trial design with the FDA and medical experts. There is also a patient advocacy group we are in discussions with. It would likely be a Phase 1/2 dose ranging, open label study. We could start seeing data relatively quickly once the trial begins.

Other targets for your platform? We did an extensive analysis before choosing NMO. A number of other diseases look very exciting to us. MS was not an easy disease to go after, compared to some of the orphan and rare diseases. We are, behind the scenes, trying to demonstrate to pharmaceutical companies that we have a viable platform that can generate therapies for multiple disease indications. We are getting a lot of positive interest in the platform.

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Disclaimer: My analyst call summaries may include both our condensations of statements made by company representatives and my own analysis. They are not covered by any warranty. I cannot guarantee anything said by company representatives is true. I try not to make errors, but it is possible. This is investment journalism, not financial advice.

Copyright 2015 William P. Meyers