Analyst Conference Summary

conference date: November 9, 2015 at 5:30 PM Pacific Time
for quarter ending: September 30, 2015 (third quarter, Q3 2015)

Forward-looking statements

Overview: Ocata Therapeutics is a clinical development stage biotechnology company specializing in regenerative medicine including ophthalmology.

Basic data (GAAP):

Revenue was $84 thousand.

Net loss was $3.8 million.

EPS (diluted) was $0.09.

Guidance:

none

Quarter & Conference Highlights:

In the quarter the first patient was enrolled in the Phase 2 clinical trial for Dry AMD. Control group will be untreated patients rather than an untreated eye of the treated patient. Will include 3 cohorts of 20 subjects, including a placebo group. Immune-suppression drug doses will separate the 2 active cohorts. It has been difficult to get patients that could meet all the criteria for study, and those criteria may be modified.

In a pre-clinical trial canine patients were treated with HMC (hemangio-derived mesenchymal cells) to achieve remission in a Crohn's disease model. The dogs were resistant to standard therapy.

Ocata received a grant in September from the NIH for photoreceptor progenitor cell therapy for retinitis pigmentosa.

Some patients have now successfully used Ocata's therapy for 4 years, including 3 years without immune suppression.

The SMD trial will have 100 patients. Will evaluate safety and efficacy of RPE cellular therapy. It will have an untreated control arm. It could be a pivotal trial, allowing for market authorization after completion, depending on results.

Entered into a $10 million loan facility with Silicon Valley Bank. Took $6 million, the other $4 million is dependent on reaching milestones.

Ocata ended the quarter with $32.1 million in cash and equivalents, $5.7 million in long-term debt, and $7.8 million in warrant liabilities. $19.3 million cash used in operations.

Believes there is enough cash to potentially reach inflection events (which would allow Ocata to raise more cash).

Operating expenses were $7.5 million, consisting of: $4.3 million research and development; $3.1 million general and administrative. Leaving a loss from operations of $7.4 million. Other expense was under $0.1 million. Adjustments to fair value of derivatives was $3.6 million.

At the AAO meeting this week there will be two presentations of data from our trials.

Q&A:

Details on patient issue in AMD trial? A key outcome is safety, so patients must be fit for the duration of therapy. We set the bar high. Too high for the patients to meet. There are a variety of lab criteria. It is not the visual criteria, but issues of old age. For instance, exposure to TB and other issues that could do poorly under immuno suppression would rule out patients.

We still expect to get the first cohort readout next summer.

Which criteria are you looking to modify? Renal status and cardiovascular status.

In our Phase 1 trial we had four sites. The plan is for 5 sites for the Phase 2 trial, one has been activated.

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