Executives
Management
Chris Guiffre - President and Chief Executive Officer Gregg Beloff - Chief Financial Officer Alejandra Carvajal - Vice President, General Counsel
Daré Bioscience, Inc. (DARE)
Q2 2015 Earnings Call· Fri, Aug 7, 2015
$2.08
-5.02%
Same-Day
-0.51%
1 Week
-8.63%
1 Month
+18.02%
vs S&P
+24.35%
Executives
Management
Chris Guiffre - President and Chief Executive Officer Gregg Beloff - Chief Financial Officer Alejandra Carvajal - Vice President, General Counsel
Operator
Operator
Good afternoon, and welcome to the Cerulean Second Quarter 2015 Conference Call. This call is being recorded. My name is Amanda, and I will be your operator for today. With us today from the company are Chris Guiffre, President and Chief Executive Officer; Gregg Beloff, Chief Financial Officer; and Alejandra Carvajal, General Counsel. Mr. Guiffre, please proceed.
Chris Guiffre
President
Thank you, Amanda. Good afternoon, everybody, and thank you for joining Gregg, Alejandra and me for this call. To begin, I’ll ask Alejandra to comment on forward-looking statements that may be made during this call. Alejandra?
Alejandra Carvajal
Chief Financial Officer
Thanks, Chris. Certain remarks that we make during this call about the company’s future expectations, plans and prospects constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factors section of our most recent quarterly report on Form 10-Q, which is on file with the SEC and can be accessed on our website. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today, August 6, 2015. Back to you, Chris.
Chris Guiffre
President
Thanks, Alejandra. I’ll start my prepared remarks by introducing Gregg Beloff on his first quarterly call as our CFO. Gregg has been in life sciences since 1998, beginning his career on Wall Street as a healthcare investment banker. In 2001, he became CFO at ImmunoGen, a tumor targeting company that is one of the leaders in antibody drug conjugates, or ADCs. Since then, he served as CFO of public and private biotech companies. Gregg’s operational expertise and familiarity with Wall Street make him an ideal addition to our team as we continue our evolution as a public company. Gregg?
Gregg Beloff
Chief Financial Officer
Thanks, Chris. It’s great to join a team with so much momentum and so much opportunity just around the corner. I intend to help Cerulean accelerate its growth as a public company by leveraging the experience that I’ve accumulated in prior CFO roles in life sciences companies. I’m an entrepreneur at heart, so company building is a passion for me, and I feel fortunate to join Cerulean at this stage in its evolution. I’ll turn it back to you, Chris.
Chris Guiffre
President
We’re glad to have you, Gregg. I’ll point out that Gregg is the fourth executive team member we’ve added since going public. He joins Pam Strode, our VP of Regulatory Affairs; Alejandra Carvajal, our VP and General Counsel; and Tiffany Crowell, our VP of Clinical Operations, as the newest members of our team. We operate in a competitive environment, and we recognize that building a strong team is critical to our ability to capitalize on the significant opportunity that lies ahead of us. In addition to building the management team, we’ve been intentional about building a board that is well suited for a company that develops and commercializes oncology drugs. Shortly before going public, we recruited Paul Friedman, Bill Rastetter, and Bill McKee to our board. Shortly after our IPO, we recruited Susan Kelley and David Parkinson to our board. And just as the second quarter ended, we added Stuart Arbuckle to our board. Stuart is the Chief Commercial Officer at Vertex, and he is leading the watch of Orkambi. He joins our board as we begin to plan for the commercialization of CRLX101. His deep oncology commercialization experience from both Amgen and GSK will be invaluable to us as we evolve from an R&D company to a commercial enterprise. Now, let’s move to an update on the CRLX101 programs. The randomized Phase 2 trial studying the synergistic combination of CRLX101 and Avastin in patients with third and fourth line RCC continues to enroll well. And importantly, we expect to announce the last patient in, or LPI, this fall. We continue to remain on track to report the top line data from this study in the first half of 2016. The FDA granted this program fast track designation and if all continues to progress accordingly, we will launch our Phase…
Gregg Beloff
Chief Financial Officer
Thanks, Chris. Let me briefly highlight our financial results for the second quarter of 2015, which are included in the Form 10-Q that was filed after market closed today. For the second quarter, we had a net loss of $9.9 million compared to a net loss of $7.4 million for the second quarter of 2014. The increase in net loss for the 2015 period was due principally to expenses associated with our ongoing clinical development program, specifically those costs related to our Phase 2 RCC trial for CRLX101 and our Phase 1 trial for CRLX301, both of which commenced in 2014. We ended the second quarter with cash and cash equivalents that totaled $85.5 million. This figure includes proceeds from the follow-on offering completed in April and we believe that we will have the cash necessary to fund operations into 2017. We expect to achieve a number of key accomplishments well within that time span. In particular, during the rest of 2015 and into 2016, we are entering a data rich period that should provide important results in multiple studies of CRLX101 and CRLX301, and we expect to achieve the following milestones. First, we expect to announce the LPI in our Phase 2 randomized RCC trial this fall. We expect to announce additional interim data from the ovarian and rectal ISTs before year-end and we also expect to announce data from the Phase 1 portion of the Phase 1/2a trial of CRLX301 before year-end. We expect to announce Phase 1b data from the ovarian GOG trial in the first half of 2016. And finally, we expect to announce data from the randomized Phase 2 RCC trial in the first half of 2016. That ends the prepared portion of our remarks. With that, let’s open the call up for your questions. Amanda, please prepare the queue.
Operator
Operator
[Operator Instructions]
Chris Guiffre
President
It appears that our prepared remarks were so comprehensive that we have answered everyone’s questions. With that, I think it’s time to end the call today. So I’ll say thanks to everyone for joining us today. We look forward to reporting on our continued progress in November. Have a good night.
Operator
Operator
Ladies and gentlemen, thank you for participating in today’s conference. This does conclude the program and you may now disconnect. Everyone have a great day.