BIND Therapeutics' (BIND) CEO Scott Minick on Q1 2014 Results - Earnings Call Transcript

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 |  About: BIND Therapeutics, Inc. (BIND)
by: SA Transcripts

Operator

Good day, ladies and gentlemen. Thank you for standing by. Welcome to BIND Therapeutics first quarter 2014 financial results conference call. At this time, all participants are in a listen only mode. This call is being webcast live on the Investors and Media section of BIND's webcast at ir.bindtherapeutics.com. This call is property of BIND Therapeutics and recordings, reproductions or transmissions of this call without the express written consent of BIND Therapeutics is strictly prohibited. As a reminder, today's call is being recorded.

I would now like to introduce Paul Cox of Stern Investor Relations. Sir, the floor is yours. You may begin when ready.

Paul Cox - Stern Investor Relations

Good morning. A press release with the company's first quarter 2014 financial results became available earlier this morning and can be found on the Investors and Media section of the company's website at ir.bindtherapeutics.com.

Before we begin, I will read BIND Therapeutics' Safe Harbor regarding forward-looking statements. During today's call, we may make forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These may include statements about our future expectations, clinical development, preliminary clinical results, regulatory timelines, the potential success of our product candidates, financial projections, 2014 milestones and upcoming events and presentations.

Actual results may differ materially from those indicated by these statements as a result of various important factors including those discussed in the Risk Factors section in our Annual Report on Form 10-K filed with the Securities & Exchange Commission on March 25, 2014 and other reports filed with the SEC. Any forward-looking statements represent our views as of today only. We may update these statements in the future, but we disclaim any obligation to do so.

Joining me on the call today is Scott Minick, President and Chief Executive Officer of BIND Therapeutics who will discuss recent company highlights. Following Scott, Andrew Hirsch, BIND's Chief Operating Officer and Chief Financial Officer will provide a brief update on BIND's 014 clinical development and will then review the company's financial results for the first quarter of 2014, after which we will open the call for Q&A.

For Q&A, we will be joined on the call by Steve Zale, BIND's Vice President of Development. Before we begin, I would like to note that the company will --

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-- New York on May 19, the Jefferies 2014 Global Healthcare Conference in New York on June 2 and the JMP Securities Healthcare Conference in New York taking place from June 24 to June 25.

I would now like to turn the call over to Scott Minick.

Scott Minick

Thank you, Paul, and good morning, everyone. We are very pleased with the way the year has started for BIND. First let me start with BIND-014. We are initiating a 20 patient study in non-small cell lung cancer patients who --

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-- or summary approval, as well as to explore biomarkers that might predict improved response to BIND-014 treatment. Andrew will provide more details on our expanded BIND-014 clinical program later in the call.

Secondly our three poster presentations at ACR generated substantial interest in the medical and scientific community. In the first presentation, we shared a promising early relationship between the level of PSMA expression and tumor response to BIND-014. If this early finding is validated in additional patients, we may use it in further trials for patient selection to maximize the effectiveness of BIND-014. Our second poster presented the results of the Phase 1 weekly dose scheduled dose escalation study of 27 late stage and metastatic patients, and showed a promising tolerability in clinical responses. Finally, we and our collaborators at AstraZeneca generated very strong interest when we presented preclinical results of our Accurin Aurora B kinase inhibitor showing that we were able to both reduce toxicity and increase efficacy relative to AstraZeneca's parent drug. Importantly, we were able to significantly reduce the severe bone marrow toxicity seen in this entire class of drugs to a level similar to untreated controls.

The last piece of good news that I would like to share with you this morning, is that we have nominated Charles Rowland, most recently the Chief Financial Officer of ViroPharma for election to our Board of Directors at our annual meeting of stockholders to be held later this month, Charlie has a wealth of both biotech and big pharma experience in finance, business development and in accounting. As part of ViroPharma, Charlie had senior management responsibilities at Endo pharmaceuticals, Pharmacia, Novartis and BMS and we are excited to be working with him and expect him to make important contributions to BIND-014.

I will now turn the call over to Andrew to provide more detail on the clinical development of BIND-014 progress on our collaboration programs and review the financial results for first quarter.

Andrew Hirsch

Thanks, Scott. First, let me start with BIND-014, our lead Accurin currently in Phase 2 clinical development for second line non-small cell lung cancer in chemotherapy naïve metastatic castrate resistant prostate cancer. As a reminder, BIND-014 is a prostate specific membrane antigen with PSMA targeting Accurin that contains docetaxel, one of the most widely used cancer chemotherapy agents. PSMA is a cell surface protein expressed on prostate cancer cells and the abnormal blood vessels surrounding many types of non-prostate solid tumors including non-small cell lung cancer.

Last week, we completed enrollment in our Phase 2 non-small cell lung cancer trial on the once every three week schedule and have initiated enrollment in the weekly schedule. If you recall, we are evaluating two dosing schedules in our current Phase 2 lung cancer trial, 60 milligrams per meter squared dosed on day one of a 21 day schedule and 40 milligrams per meter squared dosed on day one, eight and 15 of a 28 day schedule. We expect to report the topline data on this trial, as well as our Phase 2 trial in chemotherapy naïve metastatic castrate resistant prostate cancer in the second half of this year.

In the lung cancer Phase 2 trial, we employed a standard two-stage trial design with stopping rules that we did not cross a prespecified threshold response rate in the first 20 patients. We also built into the stopping rules in the non-small cell lung cancer trial, an evaluation of patients with KRAS mutant tumors given the historical lack of activity of docetaxel in this patient population. We would downward bias the trial.

The KRAS gene is involved in regulating cell division and belongs to a class of genes known as oncogenes, which when mutated, have the potential to cause normal cells to become cancerous. As you may know, non-small cell lung cancer patients with KRAS mutations have a poor prognosis and typically do not respond to docetaxel treatment. In the most recent study by AstraZeneca of selumetinib plus docetaxel versus docetaxel alone in KRAS mutant non-small cell lung cancer patients, the 43 patient docetaxel monotherapy arm showed zero responses.

Looking across multiple studies, the average response rate of docetaxel in this patient population is approximately 5%. Based on these data, we determined that if we did not see any responses in non-small cell lung cancer patients with the KRAS mutation in the first 20 patients, we would have excluded this patient population from the remainder of the trial. Nonetheless, we included them in the first 20 patients to see if we were able to show a differentiated response to BIND-014 when compared to docetaxel.

When we performed this prespecified evaluation, we observed that of the six KRAS mutant patients we have treated with BIND-014, two demonstrated a confirmed partial response and two patients had durable stable disease, which we define as lasting 12 weeks or longer. The remaining two patients had progressive disease. While the patient numbers are small, we and our investigators are excited about this finding given the lack of approved therapeutics in this population and the apparent differentiation from conventional docetaxel. As a result, we are initiating a single arm open label 20 patient trial in non-small cell lung cancer patients with KRAS mutations, which should begin enrolling patients in early Q3.

We have identified a number of possible mechanisms for why KRAS mutant patients may have improved responses on BIND-014 based on published observations of the KRAS mutation we associated with macropinocytosis, angiogenesis's information, all of which may create a tumor environment that would favor uptake of our nanoparticle based therapy. We have recently filed a number of patent applications related to this preliminary finding.

We also launched another Phase 2 trial to explore BIND-014 efficacy in additional tumor types and to explore potential biomarkers to maybe predictable a response to BIND-014, including PSMA expression, tumor permeability and particle accumulation. We plan to start a trial in four tumor types, cervical, bladder, cholangio and neuroendocrine cancer. This trial is designed to enroll approximately 25 patients in each tumor type to evaluate efficacy. There is a significant unmet medical need in each of these tumor types and three of them represent a potential opportunity for accelerated approval due to unmet medical needs and available approved therapies. In addition, we will be exploring the biomarkers for PSMA expression, tumor permeability and particle accumulation across all four tumor types.

Lastly we continue to make progress with our collaborators on their programs, including working on the pre-IND enabling activities for our collaboration with AstraZeneca. We are excited by these early clinical results, the next steps in the BIND-014 development program and our collaboration programs and we look forward to updating you later this year on both these programs and on our next proprietary pipeline of candidates, as we continue to evaluate combinations of targeting ligand in therapeutic payloads that have the potential to improve cancer treatment.

Now, let me turn to our financial results. Earlier this morning we issued a press release detailing our financial results for the first quarter of 2014. I will review the financial highlights and speak to our cash balance and our financial guidance. For the first quarter of 2014, we reported a net loss of approximately $8.3 million compared to a net loss of approximately $6.3 million for the same quarter in 2013. Total revenue for the first quarter of 2014 was approximately $1.6 million comprised of $1.4 million of collaboration revenue and $165,000 of grant revenue. That compares to total revenue in the same quarter of 2013 of approximately $1.5 million of collaboration revenue.

Research and development expenses in the first quarter were $6.8 million, a 21% increase over the comparable prior year period. This increase was driven primarily by an increasing compensation and benefits expense, including stock-based compensation for our research and development personnel. The headcount growth was driven by our activities supporting our internal pipeline and collaborations.

G&A expense for the first quarter was $3.3 million representing a 66% increase over the same quarter of 2013. This increase was driven primarily by stock based compensation in salary and benefits for general and administrative personnel, as well as increases in external consulting, insurance expenses and recruiting fees.

We ended the quarter with $68.7 million in cash, cash equivalents and marketable securities. This represents a decrease of approximately $8.7 million at the end of last year. Based on our current operating plans, we expect that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operations through at least mid 2015 as we have previously guided.

With that, let's open up the call for questions.

Question-and-Answer Session

Operator

Sure thing, sir. (Operator Instructions). It looks like our first phone question will come from the line of Eric Schmidt with Cowen and Company. Sir, your line is open. Please go ahead.

Eric Schmidt - Cowen and Company

Good morning. Thanks for taking my question. Thanks for the very efficient update. Let's see, Andrew, in terms of the lung cancer trial, it sounds like you must have passed a broader futility hurdle as well. Is that correct?

Andrew Hirsch

Correct, yes. We have been increasing focus on completed enrollment on the Q3 weekly schedule. We cleared that.

Eric Schmidt - Cowen and Company

And can you tell us what that hurdle was in the overall population?

Andrew Hirsch

No. We are not disclosing what that was.

Eric Schmidt - Cowen and Company

Okay. In terms of the KRAS subsets, were there other subsets that you looked at in addition to KRAS that also had similar hurdles, if you will?

Andrew Hirsch

No. That was the only one based on the levels of recent data, specifically the one that's published in the paper by Professor Johnny on the selumetinib trial that concerned on selumetinib. That's why we looked at that subset.

Eric Schmidt - Cowen and Company

Okay. Does prostate cancer study also have a similar futility hurdle at 20 patients?

Andrew Hirsch

No, we didn't put one in there simply because the endpoint was a six-month endpoint and we really didn't want to hold enrollment while we waited for six months. We were able to convince the investigators to feel comparable, given the Phase 1 data and the known activity of docetaxel in that patient population.

Eric Schmidt - Cowen and Company

Okay, and then last question on the KRAS subset trial that you are looking to initiate, I think you said in Q3, could you provide some more details on the size of that, power and whether you think there is opportunity for accelerated approval there?

Andrew Hirsch

Yes. So its 20 patients single arm open label, really trying to get a signal. There is no, compared to arm, we think from a power perspective, given the benchmark rate of docetaxel, its powered appropriately to show a difference based on the body of data of docetaxel. Obviously any discussion which we haven't had yet (inaudible) will be with FDA, which given the high unmet need and really the lack of approved therapy and poor prognosis for these patients, we and our advisors believe that there is a potential there. But of course any Phase 3 design will be the result of the discussion of the signal that we see in that Phase 2 trial plus discussions of the agencies.

Eric Schmidt - Cowen and Company

Great. Thanks and congrats on the progress.

Andrew Hirsch

Great. Thanks, Eric.

Operator

Thank you, sir. It looks like our next phone question will come from Joel Sendek with Stifel. Please go ahead, sir. Your line is now open.

Joel Sendek - Stifel

Hi. Thanks. At ACE [ph] here, we picked up some comments that docetaxel might be leaking out from the Accurin. Can you talk a little bit about that, whether that's an issue or not?

Andrew Hirsch

Joel, can you just clarify what the leaking out in what?

Joel Sendek - Stifel

Just causing, presumably there should be a lot less toxicity and the fact that there is tox, and people that we talked to, there were some speculation that that toxicity might be due to the docetaxel leaking out from the Accurin? Is that possible at all?

Andrew Hirsch

No. so let me just clarify. The release mechanism for the docetaxel from a particle is a (inaudible) release. So even if intentionally as soon as BIND-014 is infused into a patient, the drug starts coming out of particle once it's in the bloodstream. The art of what we do is controlling that release kinetics to it slow way down, so that as the particle circulates and accumulates at the tumor, the majority of those particle the drug then comes out, but you still are getting some systemic exposure. So I guess that it is true that there is drugs leaking out but that's intentional and that's why you see some toxicities and not others. That's a theory and we back this up with data that CMAX toxicity is relative toxicity. It should be reduced given that you still have a consistent low level of exposure in the plasma but anything really AUC associated may be similar, but that really is going to depend on the mechanism of the payload and what drives those toxicities.

Joel Sendek - Stifel

Understood. Okay. Thanks a lot.

Operator

Thank you, sir. (Operator Instructions). It looks like we have another question in queue and it will come from the line of Mike King with JMP Securities. Please go ahead. Your line is open.

Mike King - JMP Securities

God morning. Thanks for taking the question and congrats on your progress. Just a couple of quick questions. Just curious, if we are going to see more on the KRAS patients? Will we see more durability going forward because 12 weeks seems to be short? And also with regard to, I would say, I guess it's the same question or similar question on the PRs, what kind of timeframe are we looking at there and have those been confirmed?

Andrew Hirsch

Sure. So let me just clarify, its 12 weeks or longer. So what I can tell you is that the patients that had PRs, both of them will now receive six cycles of therapy, and this is at the Q3 weekly schedule. So that's 21 day cycle. And both of those responses were fairly robust. They weren't just crossed the 30% threshold. One of the patients with stable disease has been on therapy for 10 cycles and actually remained on therapy and then the others stay of these patients, have been on for three cycles but also remains on therapy. And then the one of the PRs was six cycles, but is no longer on therapy. So we are pretty confident that they are pretty durable and pretty robust responses.

Mike King - JMP Securities

Okay. Is there a plan to present these data somewhere at a conference this year?

Andrew Hirsch

Yes. I mean that's what we are evaluating that right now and looking at the appropriate medical conference to do that.

Mike King - JMP Securities

Okay, and then just one final question with regard to the other tumor types that you have said that it makes sense to explore BIND-014's activity. When did you say you might start seeing those trials?

Andrew Hirsch

Probably around the same timeline. We are working to initiate both the KRAS trial, as well as this trial, and additional four tumor types at the same time. So it should be around the Q3 timeline.

Mike King - JMP Securities

Okay. All right. Great. Thanks very much.

Andrew Hirsch

Thanks, Mike.

Operator

Thank you, sir. Presenters, at this time, I am currently showing no additional phone questions. I like to run the call back over to management for any additional or closing remarks.

Scott Minick

Well, thanks everyone for participating in today's call and for your questions and we look forward to updating you all again soon.

Operator

Thank you, presenters and thank you, ladies and gentlemen. This concludes today's presentation. Thank you again for your participation. You may now disconnect. Everyone have a great day.

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