Saiid Zarrabian - President and Chief Executive Officer
Scott Praill - Chief Financial Officer
Dennis Brown - Chief Scientific Officer
Gary Zwetchkenbaum - Plum Tree Consulting LLC
Ross Dimaggio - Union Square Advisors
Thank you all for joining us this afternoon for DelMar Pharmaceuticals’ Business Update Conference Call to discuss the Company’s Financial Results for the 2018 Fiscal Year. [Operator Instructions] Please note today’s call is being recorded and I will be standing by should you need any assistance.
I would like to remind our listeners that remarks made during this call may state management’s intentions, hopes, beliefs, expectations, or predictions of the future. These are forward-looking statements that involve risks and uncertainties. Forward-looking statements on this call are made pursuant to the Safe Harbor provisions of the Federal Securities Laws. These forward-looking statements are based on DelMar’s current expectations, and actual results could differ materially.
As a result, you should not place undue reliance on any forward-looking statements. Some of the factors that could cause actual results to differ materially from those contemplated by such forward-looking statements are discussed in the periodic reports DelMar Pharmaceuticals files with the Securities and Exchange Commission. These documents are available in the Investors Section of the Company’s Web site www.delmarpharma.com and on the Securities Exchange Commission’s Web site. We encourage you to review these documents carefully.
Joining me on the call today from the DelMar management team are Mr. Saiid Zarrabian, President and Chief Executive Officer; Mr. Scott Praill, Chief Financial Officer; and Dr. Dennis Brown, Founder and Chief Scientific Officer. Also joining us is Greg Johnson, an experienced clinical trial executive, who is serving in a senior consulting capacity to the company. Following the Company’s prepared remarks, the call will be opened up for the question-and-answer session.
It is now my pleasure to turn the call over to Mr. Saiid Zarrabian. Please go ahead.
Thank you very much. Good afternoon and thank you for taking the time to join us on today's teleconference. As many of you know the past fiscal year has been an instrumental period for the company. We have materially refined the clinical strategy for VAL-08, our therapeutic platform asset. Given this potential to address numerous solid tumor indications, we undertook measures to ensure that our organizational structure and operational process is functioning in the most efficient manner possible in terms of cost and execution.
In fact, I think it's important to share my view that the progress achieved in the last two quarters of fiscal year '18 ending June 30th on our clinical and corporate development process indicative of what we believe to be an optimal strategy to achieve near and long-term shareholder value for Delmar shareholders.
Being mindful of everyone's time, I will make today's remarks brief and to the point. To this end, I will focus my commentary on recent developments with Delmar's two ongoing Phase 2 biomarker driven clinical trials for MGMT-unmethylated GBM utilizing VAL-083, our first-in-class DNA-targeting agent, as well as to provide updates on our corporate development activities.
Starting with the corporate development first, we enhanced our Board's capability via the addition of two highly capable biotechnology experienced Board members as follows. Mr. Robert Hoffman was added as our new Chairperson, and Dr. Napoleone Ferrara was added as an Independent Board member of help augment the scientific expertise on our Board.
Mr. Hoffman has served as a Senior Executive at several biotech companies including most recently Heron Therapeutics, where he is currently Senior Vice President and Chief Financial Officer. His biotechnology and capital markets experience added to his public company and financial expertise is a highly valued asset for Delmar.
Dr. Ferrara is currently a distinguished Professor of Pathology and a distinguished adjunct professor of ophthalmology and pharmacology at the University of California, San Diego. Previously, over a 24-year period, he held increasingly senior positions at Genentech, Inc. He is a pioneer in the study of angiogenesis biology and identification of its regulators. Dr. Ferrara's lab is responsible for discovering the isolation and cDNA cloning of VEGF and demonstrated that VEGF was a major mediator of tumor angiogenesis leading to the development of Avastin.
In addition to enhancing our Board, in April 2018, we added a highly capable and well-recognized variant advisory board. This advisory board includes Dr. Bradley Monk, Arizona Oncology, U.S Oncology network; Dr. Maurie Markman, Cancer Center -- Treatment Centers of America, as well as Dr. Thomas Herzog, University of Cincinnati Cancer Institute.
Although our ovarian clinical program is currently on hold as per prior announcements, we are continuing to execute our planning exercise regarding a possible future trial, which may include VAL-083 for platinum-resistant ovarian patients either alone or in combination with a PARP inhibitor with the hopes that we can follow-up a successful GBM trial by expanding Delmar and VAL-083s opportunities.
Finally on the corporate development activity, we have engaged Oppenheimer as the strategic advisor to help DelMar explore and evaluate strategic opportunities which may accelerate to growth of the company and increase the potential of shareholder value generation.
Now turning to our clinical development activities, which includes DelMar's two Phase 2 biomarker driven clinical trials for MGMT-unmethylated GBM, I am pleased to report that starting the spring of 2018 our open-label second line Avastin-naive study being conducted at the MD Anderson Cancer Center has been enrolling at a faster pace than originally forecasted. As of September 21, 2018, 40 of the total of 48 patients have met have been enrolled.
As you may recall, the rationale for this second line recurrent GBM trial which was initiated in February of 2017, as well as our other open-label clinical study for first-line newly diagnosed MGMT-unmethylated GBM patients being conducted in Sun Yat-sen University Cancer Center, in Guangzhou, China which commenced at September of 2017 is based on the simple fact that approximately two-thirds of newly diagnosed GBM patients are grossly underserved via current therapies as they have tumors with an unmethylated MGMT promoter, which is correlated with high expression of the DNA repair enzyme MGMT.
It has been scientifically established that patients whose tumors exhibit high expression of MGMT have a poor prognosis and significantly shorter progression free survival and overall survival in comparison to patients with a methylated-MGMT promoter and a low MGMT Expression using currently approved therapies.
The goal of the MD Anderson study is straightforward. To determine the treatment with VAL-083 improves overall survival for those patients who have progressed on temozolomide compared to historical control. Based on recent increased enrollment rates, we are now forecasting full enrollment of this trial by year-end calendar year '18, which is some nine months earlier than originally planned.
Moving to our Phase 2 trial in newly diagnosed patients with MGMT-unmethylated GBM, which is being conducted at Sun Yat-sen University in China. As of September 21, 2018, we had enrolled 9 of total of up to 30 patients in the study, and we continue to enroll patients for this study. As a reminder, the patients in this trial are being treated with VAL-083 in combination with radiotherapy as a potential alternative to the current standard of care temozolomide radiation regimen, which forms the first-line treatment for this patient population.
From an operational standpoint, this trial is being conducted under the terms of our collaboration with Guangxi Wuzhou Pharmaceutical company. The study's principal clinical goals are to confirm the safety of the 3-day every 21 VAL-083 dosing regimen in combination with radiotherapy and to investigate progression free and overall survival outcomes in the -- of the combination of VAL-083 and radiotherapy again in MGMT-unmethylated GBM patients.
With respect to the full breadth of VAL-083 treatment potential, this is an area of particular passion for me and Dennis Brown, Delmar's cofounder and our Chief Scientific Officer. As we have stated before, VAL-083 may represent the great opportunity in treating multiple solid tumors in a broad range of oncology indications.
With the new data from our ongoing efforts supported by over 40 clinical trials completed by the National Cancer Institute in various indications, we will continue to evaluate additional indications where VAL-083 may provide better treatment options for these underserved patients, and we will strive to do so in a fiscally responsible fashion keeping in mind shareholder value creation and funding needs.
We at DelMar are working with our world-class partners at MD Anderson Cancer Center, at Sun Yat-sen University Cancer Center in China, as well as with our Ovarian Advisory Board to enhance the potential outcome for underserved oncology patients. Towards this goal, we appreciate the trust our stakeholders have placed upon us in our efforts to find ways to help our targeted population in the most cost and time effective way possible.
At this juncture, I will turn the call over to Scott Praill, our CFO, who will provide a summary of financial profile for the year ended June 30, 2018. Scott?
Yes. Thank you, Saiid, and thank you everyone for joining us this afternoon. We will provide a high-level review of our financial results for the year ended June 30, 2018. I would like to remind everyone that our full financial results for the year are available in our 10-K filed with the SEC at sec.gov. The annual 10-K report is also available on our Web site at delmarpharma.com under the Investors tab.
For the year ended June 30, 2018, the company reported a net loss of approximately $11.2 million or $0.54 per share compared to a net loss of approximately $8.1 or $0.74 per share for the year ended June 30, 2017.
Research and development expenses increased to approximately $7.1 million during the year ended June 30, 2018 compared to approximately $5 million for the year ended June 30, 2017. The increase in the current year was partially due to manufacturing costs for drug product as well as ongoing study costs for the company's two Phase 2 biomarker driven clinical studies as well as certain costs for our now parked STAR-3 Phase 3 study.
General and administrative expenses increased in the year ended June 30, 2018 to approximately $4 million from approximately $3.3 million for the year ended June 30, 2017, largely due to an increase in professional fees and personnel costs.
With respect to our cash resources, based on our updated budget that reflects the strategic direction of DelMar, we believe we’ve cash resources to fund our planned operations to the middle of calendar 2019. If anyone had any questions, I will be happy to answer during the Q&A session at the end of the call.
I would like to now pass the call back to Saiid.
Thank you. I would like to just quickly conclude by thanking our long-standing shareholders and stakeholders for their continued support as we head into fiscal year 2019. The Management and Board of DelMar pharmaceuticals remains excited and dedicated to executing the clinical and corporate growth plans outlined during today's call.
In addition, as part of informing our stakeholders regarding progress on our clinical and preclinical programs, we intend to provide an update regarding our ongoing Phase 2 studies as well as the continuing preclinical efforts at the upcoming SNO Conference in November 14th and 15th 2018 in New Orleans.
I will now turn the call over to the operator to commence the question-and-answer session of the teleconference.
Certainly. [Operator Instructions] Our first question comes from Gary Zwetchkenbaum with Plum Tree Consulting LLC. Please go ahead.
Q - Gary Zwetchkenbaum
Thank you. Good afternoon, Saiid. I wanted to ask you a two-part question. Why do you think the enrollment rates have increased at MD Anderson Cancer Center and what is the impact of this faster enrollment rate?
Thank you, Gary. Generally in biotechnology there's a trend where the second half enrollment is faster than the first half because there is a startup curve. But in this case I think it's more reflective of the positive attitude of the physicians, because in a conference call we had with them, we asked them the same exact question, and they stated that this was an attractive trial and they were having an easier time recruiting for this trial versus some of the other trials that they’re enrolling. So I think it's a combination of the second half of the trial speed up. But more importantly, I think the physicians at MD Anderson that are enrolling this are seeing more patients and able to get more patients enrolled in the trial. And of course, I’ve had slow enrollment answering your second question in my [indiscernible] and I’ve had faster enrollment and I know which one I like better. But to be candid, the results is at the current enrollment rate we should be enrolled by the end of December. Now this is a forecast. It's always hard to predict exactly when patients will enroll, but we have been enrolling patients over the last three months slightly more than three patients per month versus enrolling patients a little over one per month during the first 14, 15 months of this trial. We have eight more patients to enroll, 40 out of 48, which are once enrolled the trial will be fully enrolled and assuming we enrolled by the end of year that puts us nine months ahead of the original target. Now simply put, the reason that's important is two factors. One, we will get to data nine months earlier, but underneath that we will save a lot of capital needs that would be required to operate the company during those nine months while we wait for enrollment and the date to come out. So rapid enrollment not only gets you to the data faster which is always important, but it also reduces the cost to get to that data point with the operating capital at a company like ours would need for that extra nine months. So we think this faster enrollment rate in getting to data helps not only DelMar from getting to the data faster, but also creates a value proposition for the shareholders by requiring less capital to operate the company during those additional nine months which were in the original projections.
Thank you, Saiid. That’s good news to hear.
Thank you, Gary.
Thank you. We will go next to Ross Dimaggio with Union Square Advisors. Please go ahead.
Hi, Saiid. First congratulations on the expedited enrollment. And second I wonder if you could expand a little on the rationale and the thinking behind the engagement of [indiscernible]?
Thank you, Ross. That’s a great a great question. And I think any company, any small biotech should certainly be inwardly focused and focusing on driving the assets forward as fast as efficiently as possible, but also I think companies like our should also have an outboard [ph] view into are there partnerships and strategic relationships and assets out there that might accelerate and enhance a small company's outlook like DelMar. And this was something that I had envisioned doing when I took Interim CEO role last November, but I didn't really want to embark on looking at additional things until such time as we had put our new strategy in place, we had focused on the MGMT-unmethylated population because of the NCCN guideline saying that population really has no solution in the market right now, as well as getting our expenses under control and the fact that we have been able to now stretch our existing cash well into 2019. As per our 10-K, we said we have enough cash to last into the second half of -- I mean, I’m sorry, to the end of the first half of calendar year '19. It was the opportunity for me to go out there and take a look at what else we might be able to add to the soup here that would add value for our shareholders. And we thought that Oppenheimer because of their credibility in the backing markets, we considering a high-grade bank and their relationships with many, many companies in the biotech and pharmaceutical space might be able to help expand the strategy of DelMar with bringing in something that might help us further derisk the company, but also broaden the reach in respect to the indications we could go after. And that contract was something that we put in place after the operational activities of the company were under control and we kind of -- we’re running on all 12 cylinders.
Great. Thank you.
Thank you. It appears we have no additional questions at this time. I will turn it back to Saiid Zarrabian for any additional or closing remarks.
Thank you. In closing, I want to again thank the investors and the shareholders who have believed in us. I think we are continuing to drive the VAL-083 product forward. We are optimistic that at the SNO Conference, as I stated, November 14th and 15th, we will be providing an update on all the clinical activities. And as many of you know, it's much more valuable to provide scientific updates at the peer group meetings like SNO or at AACR [indiscernible] and random press releases here and there that make it lost. So our next major communications plan to be at SNO where we will be presenting multiple papers and they will certainly include the MD Anderson trial results update at that point. With that, I appreciate everyone's time. Thank you very, very much today and I'm sure we will have a conversation like this in mid-November for our September end close.
Thank you. This does conclude today's conference. We appreciate your participation. You may disconnect at any time, and have a great day.