Dec 15, 2017
Executives
Paul Amdt - Managing Director, LifeSci Advisors Jason Slakter - Chief Executive Officer Sam Backenroth - Chief Financial Officer
Analysts
Operator
Greetings. And welcome to the Ohr Pharmaceutical Company’s Fiscal Year 2017 Conference Call.
At this time, all participants are in a listen-only-mode. [Operator Instructions] As a reminder, this conference is being recorded.
I would now like to turn the conference over to your host, Mr. Paul Amdt, Managing Director of LifeSci Advisors.
Thank you. You may begin.
Paul Amdt
Thank you, Melissa, and good morning everyone. This morning Ohr issued a press release with the financial results for the year in review, highlights for the fiscal year ended September 30, 2017.
If you did not yet receive this release, it is available on the Investor Relations section on the company's website at www.ohrpharmaceutical.com. This call is being webcast and a replay will be available.
As a reminder, information in today’s news release and on this conference call contain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words of expression reflecting optimism, satisfaction with current prospects, as well as words such as belief, intend, expect, plan, anticipate and similar variations identify forward-looking statements, but their absence does not mean that the statement is not forward-looking.
Such forward-looking statements are not a guarantee of performance and the company's actual results could differ materially with those contained in such statements. Several factors that could cause or contribute to such differences include our ability to raise sufficient funds to perform and conclude clinical trials, the financial resources available to us, our ability to negotiate and conclude any strategic partnership agreements, the future success of our scientific studies, our abilities to successfully develop products, rapid technological change in our marketplace, changes in demand for our future products, legislative, regulatory and competitive developments, and general economic conditions.
These factors are described in detail in the company's Annual Report on Form 10-K, which will be filed shortly, Form 10-Q, as well as additional filings with the SEC. These forward-looking statements speak only as of today's call, Friday, December 15, 2017.
The company undertakes no obligation to publicly update any forward-looking statements or supply new information regarding these circumstances after the release of this date. Participating on today's conference call from the company are Dr.
Jason Slakter, Chief Executive Officer; and Mr. Sam Backenroth, the Chief Financial Officer.
With that, I like to turn the call over to Dr. Slakter.
Please go ahead, sir.
Jason Slakter
Thank you, Paul. Good morning everyone and thank you for joining us today.
This is a very exciting time for everyone at Ohr as we approach the end of 2017 and eagerly await the topline results of the MAKO trial for Squalamine early next year. We remain focused on the product opportunity in wet-AMD and believe that Squalamine has the potential to become the first significant new treatment in more than a decade and establish a new standard of care in retinal disease.
We put considerable thought into the design of the MAKO study incorporating what we learned from the prior Phase 2 impact study together with what we understand about Squalamine’s mechanism of action, as well as the characteristics of the AMD population. One of the most important elements of this design is that we enroll the patient population that we believe will see the greatest potential benefit from Squalamine combination therapy.
Patient selection is critical in driving visual outcomes with combination therapy and not all patients maybe the best candidates. Analysis of the results from our prior Phase 2 impact study helped us determine that it was the size of the occult choroidal neovascularization or occult CNV present at the start of treatment that was the most important factor influencing the visual acuity benefits of Squalamine combination therapy.
Based on this analysis, we prospectively enrolled an enriched population in the MAKO study, which we feel has de-risked the trial. Furthermore, based on the unique properties of Squalamine we think there is a strong rationale for the drug to impact visual acuity in wet-AMD.
In addition to its inter-cellular side of action and activity against multiple angiogenic targets, Squalamine’s topical route of delivery and daily administration enables a sustained suppressive therapy for this chronic disease. We made a strategic decision earlier in the year to amend the MAKO study with the goal of completing the trial and reporting topline data by early calendar 2018, which is almost a year earlier than previously planned.
More than 200 subjects where enrolled in the MAKO study, which represents more than twice the number of patients identified in the sub-group of the Phase 2 impact study where Squalamine was most efficacious. It is this group that demonstrate an improvement in both mean visual acuity and proportion of three-line gainers and it is our goal to confirm these benefits in the MAKO study readout.
We remain in active business development discussions with several potential pharmaceutical partners regarding Squalamine and continue to see considerable interest. We believe that having the data readout for MAKO in the near term will benefit these discussions.
We completed two financings in fiscal 2017 raising a net of $6.8 million in December last year and a further net of $12.7 million in April for a combined total of $19.5 million. The most recent offering was led by existing investors and included the participation of senior management and members of the company's Board of Directors.
We are funded into April 2018, including the completion of the MAKO clinical trial and the data readout. I am also very happy to report that based on yesterday's closing price of our common stock, we have been above the $1 level for 10 consecutive trading days and therefore have regained compliance with the NASDAQ listing rules.
We expect to receive a letter from NASDAQ in the next few days conforming this fact. With that, I’d like to handover the call to Sam for a summary of our financials.
Sam?
Sam Backenroth
Thank you, Jason. For the year ended September 30, 2017 total operating expenses were approximately $23.8 million, consisting of $5.3 million in general and administrative expenses, $17.4 million of research and development expenses, and $1.2 million in depreciation and amortization.
This compares to total operating expenses of approximately $24.6 million, consisting of approximately $7.7 million in general and administrative expenses, $16.5 million in research and development expenses and $1.2 million in depreciation and amortization in the same period of 2016. For the year ended September 30, 2017, the company reported a net loss of approximately $23.8 million or $0.53 per share, compared to a net loss of approximately $25.8 million or $0.82 per share in fiscal year 2016.
At September 30, 2017, we had cash and cash equivalents of approximately $12.8 million. This compares to approximately $12.5 million at September 30 of the prior year.
For a more detailed description of the financials, please refer to our 10-K, which will be filed shortly. That completes my review of the financials.
I would now like to hand the call back over to Jason for final remarks. Jason?
Jason Slakter
Thanks Sam. Unfortunately, due to the proximity of us receiving data from the MAKO study we are not going to take questions on this call as we usually do.
I do want to thank everyone again for participating in today's call and following our progress at Ohr. I want to take this opportunity to also express my thanks to the people involved in the MAKO study, most particularly the patients who participated in this very critical clinical program.
We continue to be excited about the potential of Squalamine to help patients suffering from wet-AMD and look forward to updating the investment community once we receive the results of the MAKO study early in 2018. On the half of the entire team at Ohr, I want to wish you all a happy holiday season and a healthy and peaceful New Year.
Thank you.
Operator
Thank you. This concludes today's teleconference.
You may disconnect your lines at this time. Thank you for your participation.
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