BIND Therapeutics' (BIND) CEO Scott Minick on Q2 2014 Results - Earnings Call Transcript

Aug.10.14 | About: BIND Therapeutics, (BIND)

BIND Therapeutics, Inc. (NASDAQ:BIND)

Q2 2014 Earnings Conference Call

August 7, 2014 8:30 AM ET

Executives

Paul Cox – IR

Scott Minick – President and CEO

Andrew Hirsch – CFO and COO

Analysts

Tom Schrader – Stifel

Mark Fram – Cowen & Company

Operator

Welcome to the BIND Therapeutics Second 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 Investor and Media section of BIND’s website at ir.BINDTherapeutics.com.

This call is property of BIND Therapeutics and recordings, reproduction or transmission of this call without the expressed 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.

Paul Cox

Good morning. The press release with the company’s second quarter 2014 financial results became available earlier this morning. It 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, preclinical and clinical development, preliminary clinical results, regulatory timelines, the potential success of our product candidates, financial projections, 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 most recent quarterly report on Form 10-Q filed with the Securities & Exchange Commission on May 8, 2014 and other reports filed with the SEC. Any forward-looking statements represent our views as of today only.

Joining me on the call today is Scott Minick, President and Chief Executive Officer of BIND Therapeutics who will discuss recent company highlights. And then 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 second quarter of 2014 after which we will open the call for Q&A.

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

Scott Minick

Thank you, Paul and good morning everyone. I am very pleased with the progress we’ve made during the second quarter of 2014. First, we’ve continued to make good progress on our lead proprietary program BIND-014.

As we reported on our last quarterly call, our Phase 2 trials in second-line non-small cell lung cancer and first line chemo-naïve metastatic castrate resistant prostate cancer are fully enrolled once every three weeks or Q3 weekly schedule. And enrollment continues as planned in the once weekly portion of the long-trial. We expect to report top-line data from both trials on the Q3 weekly schedule in the fourth quarter of this year and we plan to present the complete dataset at the appropriate upcoming medical meetings.

Second, in June, we entered into a research agreement with Roche to discover novel nanomedicines for the treatment of diseases in therapeutic areas outside oncology where we believe our platform has enormous potential.

Our current approach is to explore therapeutic areas outside of oncology with collaborators. I’m pleased that we’re now working with a collaborator like Roche, a global leader in biologically targeted therapies including antibody-drug conjugates in one set of non-oncology indications.

Importantly, while our previous collaborations have focused on improving the therapeutic index of a drug candidate from a collaborator’s pipeline, this Roche collaboration aims to utilize targeting ligands from Roche that the specific to the disease area of interest.

We can envision a promising pipeline of Accurins. Based on Roche payloads and targeting ligands if our collaboration is successful as well as extending our platforms in important new directions.

Lastly, we continue to work closely with AstraZeneca and Pfizer on those collaborations and have made great progress and look forward to updating you on those at a later date.

I will now turn the call over to Andrew to provide an update on the clinical development of BIND-014 and review the financial results for the second quarter of 2014.

Andrew Hirsch

Thanks Scott. First, let me start with BIND-014, our lead Accurin in currently in Phase 2 clinical development for second line non-small cell lung cancer and chemo-naïve metastatic castrate resistant prostate cancer.

As a reminder, BIND-014 is a prostate specific membrane antigen or PSMA targeted 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 found in many types of non-prostate solid-tumors, including non-small cell lung cancer.

As we reported on our last quarterly call, both the lung and prostate cancer trails are fully enrolled at the every three-week schedule or 60 mg per meter squared once every three weeks. And enrollment continues as planned in the once weekly dosing portion of the lung trial, which is 40 mg per meter squared on day 1, 8 and 15 of a 28-day schedule.

We expect to report top-line data from both trials on the every three-week dosing schedule in the fourth quarter of this year and we plan to present the complete dataset at the appropriate upcoming medical meetings.

We also continue to make good progress on initiating two additional Phase 2 trials, the KRAS mutant non-small cell lung cancer trial and the clinical trial exploring BIND-014 efficacy and biomarkers in cervical, bladder, neuroendocrine and cholangio cancers.

If you recall the KRAS trial was driven by early promising data from the Phase 2 trial in non-small cell lung cancer, where we saw a differentiated response to BIND-014 in a limited number of patients with this mutation when compared to the historical data with docetaxel.

We expect these trials will begin enrolling patients before the end of the year.

Now, let me turn to our financial results. Earlier this morning we issued a press release detailing our financial results for the second quarter of 2014. I’ll review the financial highlights and then speak to our cash balance and financial guidance.

For the second quarter of 2014 we reported a net loss of approximately $8.4 million compared to a net loss of approximately $5.9 million for the same quarter in 2013.

Total revenue for the second quarter of 2014 was approximately $2.5 million comprised of $2.2 million of collaboration revenue and $0.3 million of grant revenue. That compares to total revenue in the same quarter of 2013 of approximately $2.8 million of which $2.4 million was collaboration revenue and $0.4 million was grant revenue.

Included in revenue for the second quarter of 2014, was approximately $0.8 million of revenue related to the Amgen upfront payment that was previously recorded in deferred revenue. This amount was recognized as revenue upon notification from Amgen on June 28, that they would not be exercising their option to develop an Accurin incorporating the Amgen therapeutic payload.

Research and development expenses in the second quarter were $6.9 million a 16% increase over the comparable prior year period. This increase was driven primarily by headcount growth and the associated compensation and other expenses supporting our internal pipeline and collaborations.

G&A expense for the second quarter was $3.8 million representing a 54% increase over the same quarter of 2013. This increase was primarily due to operating of the public companies in September 2013, including associated compensation and other expenses.

We ended the quarter with $59 million in cash, cash equivalents, and marketable securities. This represents a decrease of approximately $10 million since the end of last quarter.

Based on our current operating plans, we expect that our existing cash, cash equivalents, and marketable securities and research and development funding, we expect to receive under our existing collaborations, excluding any milestone payments, will be sufficient to fund our operation expenses and capital expenditure requirements 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

(Operator Instructions). Our first question is from Tom Schrader of Stifel. You may begin.

Tom Schrader – Stifel

Good morning, congratulations on the quarter. I have a question about the Roche deal, you’ve talked a lot about it involving a lot of new targeting ligands. The first part of the question is, does each ligand, is that a new challenge, do you have to develop a whole new linker technology and develop new IP in that process or do you have kind of a general way to attach new targeting molecules?

Scott Minick

Great question. There is more than one answer on the attachment chemistry. So when we get to the stage of developing final products that is specific for each Accurin. But we do have some methods we’ve developed that I’ll say is more general that we can use across a variety of different ligands to do initial testing.

Tom Schrader – Stifel

And are those proprietary or is PLG chemistry pretty much out there?

Scott Minick

So, we do develop proprietary methods around each specific Accurin. So, some of the other methods we use earlier are in the public domain.

Tom Schrader – Stifel

Okay. And then, along the same lines, you’ve talked a lot about the peg layers sort of providing some immune invisibility. Does that translate to targeting ligands is pretty much anything in-play or is everything, do you have to test for immunogenicity. Do you get any leeway there?

Scott Minick

The FDA historically has wanted each product to go through specific testing probably going into the clinic. So, for regulatory reasons you would want to do that kind of testing.

Since we now work with a variety of different ligands, I think we’re seeing kind of a pattern but I don’t believe that the FDA anytime in the near future will start to accept a blanket of approval for the stealthiness of any targeting ligand.

Tom Schrader – Stifel

No, I expect not either. Thanks a lot.

Operator

Thank you. (Operator Instructions). Our next question comes from Mark Fram of Cowen & Company. You may begin.

Mark Fram – Cowen & Company

Hi, thanks for taking my questions. First is just kind of the mechanics of reporting the data from the ongoing Phase 2. Do we see those data separately as they come or is that going to be – they’re going to be released together?

Andrew Hirsch

Thank you, Mark. So, I think it truly depends on the timing sort of final data. It looks like there is point lining up to the other. But that’s a change that everybody can know the end-point for the prostate cancer for progression free survival point. And so, where we’re at is response rate for longing cells to kind of PSMA that emerges that might come later.

Mark Fram – Cowen & Company

Okay. And then, if you could just kind of discuss where your current thoughts are aligning on the kind of design of the KRAS trial in terms of the size and what that’s going to look like?

Andrew Hirsch

Yes. Is there an echo on the line when I’m speaking, by the way.

Mark Fram – Cowen & Company

(Inaudible).

Andrew Hirsch

No, I just hear it on my line, as long as you can hear me fine. So, in terms of the KRAS relatively initiating it’s going to be single arm kind of open label signal seeking trial. There is not going to be compared at this point. It will be kind of 20 patients with the potential option to expand into 40 depending on the signal that we see in the first 20.

Mark Fram – Cowen & Company

Okay, thank you.

Operator

Thank you. I’m showing no further questions at this time. I’d like to turn the conference back over to Scott Minick for closing remarks.

Scott Minick

All right. Thank you all for participating in today’s call. And we look forward to updating you again soon.

Operator

Ladies and gentlemen, this concludes today’s presentation. Thank you once again for your participation. You may now disconnect. Everyone have a great day.

Copyright policy: All transcripts on this site are the copyright of Seeking Alpha. However, we view them as an important resource for bloggers and journalists, and are excited to contribute to the democratization of financial information on the Internet. (Until now investors have had to pay thousands of dollars in subscription fees for transcripts.) So our reproduction policy is as follows: You may quote up to 400 words of any transcript on the condition that you attribute the transcript to Seeking Alpha and either link to the original transcript or to www.SeekingAlpha.com. All other use is prohibited.

THE INFORMATION CONTAINED HERE IS A TEXTUAL REPRESENTATION OF THE APPLICABLE COMPANY'S CONFERENCE CALL, CONFERENCE PRESENTATION OR OTHER AUDIO PRESENTATION, AND WHILE EFFORTS ARE MADE TO PROVIDE AN ACCURATE TRANSCRIPTION, THERE MAY BE MATERIAL ERRORS, OMISSIONS, OR INACCURACIES IN THE REPORTING OF THE SUBSTANCE OF THE AUDIO PRESENTATIONS. IN NO WAY DOES SEEKING ALPHA ASSUME ANY RESPONSIBILITY FOR ANY INVESTMENT OR OTHER DECISIONS MADE BASED UPON THE INFORMATION PROVIDED ON THIS WEB SITE OR IN ANY TRANSCRIPT. USERS ARE ADVISED TO REVIEW THE APPLICABLE COMPANY'S AUDIO PRESENTATION ITSELF AND THE APPLICABLE COMPANY'S SEC FILINGS BEFORE MAKING ANY INVESTMENT OR OTHER DECISIONS.

If you have any additional questions about our online transcripts, please contact us at: transcripts@seekingalpha.com. Thank you!