Earnings Labs

Compugen Ltd. (CGEN)

Q2 2018 Earnings Call· Wed, Aug 1, 2018

$2.73

-6.51%

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by. Welcome to Compugen's Second Quarter 2018 Results Conference Call. At this time, all participants are in a listen-only mode. An audio webcast of this call is available in the Investor section of Compugen's website at www.cgen.com. As a reminder, today’s call is being recorded. I would now like to introduce Elana Holzman, Compugen's Director of Investor Relations and Corporate Communications. Please go ahead.

Elana Holzman

Management

Thank you operator. Thank you for joining us today. With me from Compugen are Dr. Anat Cohen-Dayag, President and CEO; Dr. Henry Adewoye, Chief Medical Officer; and Ari Krashin, CFO and COO. Before we begin, I would like to read the following regarding forward-looking statements. During the course of this conference call, the company may make projections and other forward-looking statements regarding future events, future business outlook, anticipated progress of Compugen's pipeline program, and financing related matters. We wish to caution you that such statements reflect only the company's current expectations and that actual events or results may differ materially. You are kindly referred to the risk factors and cautionary language contained in the documents that the company filed with the Securities and Exchange Commission including the company's most recent Annual Report on Form 20-F, filed March 27, 2018. The company undertakes no obligation to update any projections or forward-looking statements in the future. Also please note that in his prepared comments Henry will refer to a slide describing the clinical protocol of COM701 Phase 1 study. This slide can be found in a link in today's press release or in slide 24 in our corporate presentation which can be found in the Investor Relations section of our website. I will now turn the call over to Anat.

Anat Cohen-Dayag

Management

Thank you Elana. Good morning and good afternoon everyone. I would like to welcome you to our second quarter 2018 corporate and financial update. I would also like to welcome Dr. Henry Adewoye to today's call. Henry joined Compugen in late March as our Chief Medical Officer, a newly created position at Compugen and assumed overall responsibility of our clinical stage pipeline programs. Henry joined us from Gilead Sciences and brings to Compugen over 20 years of clinical experience having led multiple oncology and hematology clinical trials at global pharmaceutical and biotech companies including several drug approvals Since arriving at Compugen Henry has been instrumental in leading our efforts with the FDA bringing to a quick resolution the clinical hold that followed our IND submission, finalizing the trial protocol, and clearing the path for the initiation of our Phase 1 trial for COM701 with first patient dosing expected in early fall. In parallel Henry has been working to create the required infrastructure to run the phase 1 trials. We are engaging prominent clinical investigators from leading U.S. medical centers in the field of cancer immunotherapy who will most effectively execute our clinical strategy and explore the full potential of COM701. On the call today Henry will provide an overview of our phase 1 trial protocol and clinical strategy and we will review the operational aspects of our clinical trial preparations. Following Henry's comments Ari will provide the financial update after which we will open the call for the Q&A session. The first half of 2018 marked the transformational period for Compugen. Several weeks ago the FDA cleared both our IND application for COM701 as well as Bayers IND application for BAY 1905254. Initiating trials for these two programs in 2018 is a significant milestone for our company. Also the [indiscernible]…

Henry Adewoye

Management

Thank you Anat for the warm welcome and thank you everyone for joining us today. I am excited to be part of Compugen's management team and join today's call to provide you with an update on the clinical protocol for COM701 and operational aspects of our preparations for the clinical study. Compugen has made significant strides transitioning a predictive target discovery company to a clinical stage company and Anat has assembled an experienced, high achieving, and goal oriented team to lead these efforts which has put personnel, systems, and processes in place to better position us for the clinical development of novel immuno-oncology drugs. As part of the team I will lead the clinical strategy of the organization and the clinical development of molecules in our pipeline. Our Phase 1 study will be conducted in the United States. Details of the participating sites and the overall study design will be accessible on clinicaltrials.gov. The participating clinicians all expressed high interest in COM701 and in our pre-clinical data and have relevant experience running oncology clinical trials in general and in particular in the field of immuno-oncology. As recently disclosed we expect our first patient to be dosed in early fall. As an affirmation our Phase 1 protocol is designed to address the scientific and clinical rationale of the COM701 program. Also the biomarker strategy implemented in the protocol is based on our understanding of the biological pathway of PVRIG and our supportive clinical data. What is particularly noteworthy about our program is that our pre-clinical expression data supports its potential efficacy into tumor types that are PDL-1 negative which tend to be more resistant or refractory to PD-1 inhibitors. This is even more important, given the changing landscape of cancer treatment reflected in the increasing number of approvals for the PD-1…

A - Ari Krashin

Management

Thank you Henry and welcome to Compugen. We are delighted to have you on our team. Our financial results for the second quarter of 2018 and for the six month period ending June 30, 2018 released today continue to reflect a higher level of expenses associated with COM701 and COM902. Research and development expenses represent approximately 80% of our total expenses totaling approximately $8 million for the second quarter of 2018 compared to $7.1 million in the second quarter of 2017. The increase in R&D expenses is attributed mostly to pre-clinical activities mainly manufacturing cost relating to COM902 program as we move forward to IND filing plan for 2019 as well as activities related to COM701 in preparation for the start of our clinical trials. Net loss for the second quarter of 2018 was $10.2 million or $0.19 per diluted share compared to a net loss of $9.2 million or $0.18 per diluted share for the second quarter of 2017. As of June 30, 2018 we had approximately $43.1 million in cash and cash related accounts with no debt. At the current level of cash expenditures, our current cash resources are sufficient to support our activities until the end of the second quarter of 2019 without taking into consideration the anticipated milestones from buyer upon first patient dosing in 2018 person to the bio-collaboration or other potential cash consideration from other business arrangements. Thank you all and we will now open the call for questions. Operator.

Operator

Operator

[Operator Instructions]. The first question is from Mark Breidenbach of Oppenheimer. Please go ahead.

Mark Breidenbach

Analyst

Hey, thanks for taking the question and congrats on the progress towards getting COM701 into the clinic later this fall. With the COM701 protocol now finalized I was hoping maybe Henry or Anat can fill us in on a little bit of information on dosing? Can you maybe just outlined the new starting dose for this trial and also could you tell us what the highest specified dose is in the protocol, to me you don't hit any real piece first?

Henry Adewoye

Management

Thank you very much Mark. So as the dose of the COM701 will be using under studying is proprietary. We will not be able to disclose this during this call. But be assured that what we will be looking for will be DLT defining toxicities within the 21 day DLT toxicity window.

Mark Breidenbach

Analyst

Okay, so with the accelerated titration design you have mentioned earlier, am I understanding correctly that the early dose cohorts will be single patient only and then you will eventually shift to three plus three design once you get to a therapeutically relevant range?

Henry Adewoye

Management

That's correct Mark.

Mark Breidenbach

Analyst

Okay, okay and one final question from me with the Bayer ILDR2 antibody, is it safe to assume that Bayer will be controlling all the news flow from Phase 1 trial and is it realistic to expect that we could see any early data from this trial in 2019?

Anat Cohen-Dayag

Management

Of course Bayer is solely responsible now for the clinical trial and all the activities with respect to this program. So for sure with all means that they will control any news with respect to this program and we cannot relate to it, we cannot therefore commit to it, and that's from our perspective. The only thing that we can say is that when we will achieve milestones payments this will be disclosed but other than that we are just solely responsible for this.

Mark Breidenbach

Analyst

Okay, understood. Thank you again for taking the questions and congrats.

Anat Cohen-Dayag

Management

Thank you Mark.

Operator

Operator

The next question is from Lucy Codrington of Jefferies. Please go ahead.

Lucy Codrington

Analyst

Hi there, thank you for taking my questions. I just have a couple. The first relates to the COM701 study, when might we see first data from this trial and also how many patients are you anticipating taking part in the trial? And that my second question just relates to the Bayer milestones, can you give us an indication as to the size of this milestone? Thank you.

Anat Cohen-Dayag

Management

Okay, so I will start with Bayer milestone, with the second question. We cannot disclose the amount, it is confidential and as we didn't disclose that prior time which is usually filing a 6-K and this is what we'll do and we'll get the milestone there the next milestone which is a first patient dosing. With respect to time lines in general it is premature for us to say anything that relates to give any guidance with respect to the trial. We're now focusing in order to make sure that we start first patient dosing in early fall as we disclosed. As you are aware the timelines for a trial are related to or are tied into many parameters. It depends of course on the size of the trial but also on the type of patient population, the inclusion exclusion criteria, the rate of enrolment, the number of sites, and we cannot really at this stage state relate to it. That's on this front. Henry do you have anything to add.

Henry Adewoye

Management

Yes, with regards to your question on the number of patients for the study, typically studies of this nature around between 100 to 150 patients. So that's a range that we're expecting.

Lucy Codrington

Analyst

Okay, that is very helpful. Thank you.

Operator

Operator

[Operator Instructions]. The next question is from Richard McKee [ph] of First Associates. Please go ahead.

Unidentified Analyst

Analyst

Hi, thank you for taking my call. I had a question Bayer had included some information in one of their presentations earlier this year about your products effect for autoimmune disease. My understanding is they aren’t actually licensed to use it for auto immune disease and I'm wondering if you are looking into either expanding your license with them for that or finding additional partners to treat those?

Anat Cohen-Dayag

Management

Just to make sure that the information is accurate, Bayer did not license to us so the arrangements with Bayer relates to us licensing to them the rights to develop antibody therapeutics against the drug target and we kept the rights internally for Compugen for the development of an [indiscernible] for autoimmune diseases. And of course we cannot relate to any type of discussions with Bayer or anyone else and this relates to a business development activities of the company.

Unidentified Analyst

Analyst

Okay, but I haven't heard anything from you about trying to develop that lately, is this something you are hoping to license to someone else?

Anat Cohen-Dayag

Management

This is a program that is in our pipeline and it is part of the pipeline slide that is in our corporate presentation. So yes, it is a program in our pipeline. And as I said we're not commenting about a business development activity that we do -- not with this one or any other program in our pipeline.

Unidentified Analyst

Analyst

Okay, thank you.

Operator

Operator

This concludes the question-and-answer session. I will now turn the call back to Compugen's President and CEO, Dr. Cohen-Dayag would you like to make your concluding statements.

Anat Cohen-Dayag

Management

Thank you. The first half of 2018 was transformational for Compugen as we became a clinical stage company. We're excited to have two drug candidates COM701 and BAY 1905254 addressing new immune checkpoints which we identified purely through computational discovery, beginning Phase 1 studies later this year. We hope that it will become life changing for many cancer patients who fail to respond to existing cancer immunotherapy treatments. We would like to thank our shareholders who have supported this company in weakness, Compugen evolved over the years to reach this day of being a clinical stage company. We are excited to embark on this next stage of our corporate development and we look forward to continuing sharing with you our future accomplishments. Thank you.

Operator

Operator

Thank you. This concludes the Compugen Ltd Second Quarter 2018 Financial Results Conference Call. Thank you for your participation. You may go ahead and disconnect.