Earnings Labs

Capricor Therapeutics, Inc. (CAPR)

Q3 2021 Earnings Call· Tue, Nov 9, 2021

$34.07

-2.95%

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Transcript

Operator

Operator

Greetings, and welcome to the Capricor Therapeutics Third Quarter 2021 Earnings Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host Mr. AJ Bergmann, Chief Financial Officer. Please go ahead, sir.

AJ Bergmann

Analyst

Thank you. Before we start, I would like to state that we will be making certain forward-looking statements during today’s presentation. These statements may include statements regarding, among other things, the efficacy, safety and intended utilization of our product candidates, our future R&D plans, including our anticipated conduct and timing of preclinical and clinical studies, our plans to present or report additional data, our plans regarding regulatory filings, potential regulatory developments involving our product candidates and our possible uses of existing cash and investment resources. These forward-looking statements are based on current information, assumptions and expectations that are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These and other risks are described in our periodic filings made with the SEC, including our quarterly and annual reports. You are cautioned not to place undue reliance on these forward-looking statements and we disclaim any obligation to update such statements. With that, I will turn the call over to Linda Marbán, CEO. Linda Marbán: Thank you, AJ. Good afternoon and thank you for joining us for our third quarter conference call. Today I will provide an update on our two pipeline programs. First, CAP-1002, which is our allogeneic cell therapy currently in late-stage clinical development to treat Duchenne muscular dystrophy and severe COVID-19. I will also provide an update on our emerging platform technology involving exosomes as drug delivery vehicle. First I will discuss CAP-1002 and DMD. In late September, we presented our final data from the HOPE-2 Phase 2 clinical trial at a late-breaking session of the World Muscle Society. The data conclusively showed that the trial had its primary efficacy endpoints of the Performance of the Upper Limb or PUL mid level 1.2…

AJ Bergmann

Analyst

Thank you, Linda. This afternoon’s press release provided a summary of our third quarter of 2021 financials on a GAAP basis. You may also refer to our quarterly report on Form 10-Q, which we expect to become available in the next few days and will be accessible on the SEC website, as well as in the Financial section of the company website. As of September 30, 2021, the company’s cash and cash equivalents totaled approximately $40.8 million, compared to approximately $32.7 million on December 31, 2020. Based on our current pipeline and operating plan, the company’s cash position is expected to be sufficient to support operations for at least two years. Turning now to the financials. Over the first nine months of 2021, our net cash used in operating activities was approximately $11.2 million. For the third quarter of 2021, excluding stock-based compensation, our research and development expense was approximately $2.4 million, compared to approximately $2.6 million in Q3 2020. Again, excluding stock-based compensation, our general and administrative expense was approximately $1.1 million in Q3 2021 and approximately $900,000 in Q3 2020. Net loss for the first nine months of 2021 was approximately $13.8 million compared to a net loss of approximately $9.5 million for the first nine months of 2020. We will now open the line up for questions. Operator, will you please open the line up for questions?

Operator

Operator

[Operator Instructions] Our first question comes from the line of Joe Pantginis with H.C. Wainwright. Please proceed with your question.

Joe Pantginis

Analyst

Hi, Linda and AJ, good afternoon. Thanks for taking the question. A few questions if you don’t mind. Let’s start with HOPE-3. Obviously, the path forward for this study is iterative lots of FDA feedback and discussions that you’ve had. Previously, you’ve discussed you may be not moving forward with this study unless it’s in the hands of a partner. Today you are talking about evaluating potential options. So I guess, I’ll ask the question this way, is this something that you could potentially now bring forward yourself based on the FDA feedback and the cash runway that you delineated today? Linda Marbán: Thanks, Joe. It’s always a pleasure to hear from you. Thank you so much. So, are incredibly encouraged by the data from HOPE-2. And we are now developing the plan to get HOPE-3 start and we are working on initiating the sites, getting startup activities going and we are poised to enroll patients. So, we hope you and others will stay tuned to how we decide to that.

Joe Pantginis

Analyst

Understood. Okay. And I guess, however it moves forward, I guess, can you talk about the manufacturing readiness to be able to deliver products for the study and anything that’s still outstanding and when you look at the macro environment right now from a manufacturing standpoint, or any of your ongoing operations are there any impacts from the global supply chain issues? Linda Marbán: Yes. Thanks for that. No, we are very lucky that we had planned on manufacturing for HOPE-3 a while ago. So, in terms of supply chain, we are in very good shape. We are in good shape to begin the study at the BLA and there will be no issues regarding products. In terms of the commercial development of the cells, we are working and continue to plan on working closely with FDA through HOPE-3 and into the BLA period, so that we are ready with commercial supply when the drug is launched. And so, this is an area of active activity for our team at this time.

Joe Pantginis

Analyst

Got it. Got it. And then, it’s definitely nice to see a full enrollment of INSPIRE today. Hey, a little forward-looking obviously, pending a positive data, is there anything that you can maybe describe as potential next steps? Linda Marbán: Yes. So, obviously, the data tells the story. So, we’ll be excited to look at the data ourselves and of course share it and based on what the data shows we will evaluate next steps and keep everyone update as to that plan.

Joe Pantginis

Analyst

Got it. Got it. And then, I am certainly intrigued always with the exosomes platform. The platform that you have here and the BD potential around that, so, I guess, of course this depends on what cash spend that you have or don’t have around HOPE-3. But since you have two years of cash right now, it seems like you’d be able to deliver a lot of both pre-clinical and potentially early clinical data over the next two years. Is there some sort of framework that you can provide us to the level of visibility that the exosomes platform could deliver? Linda Marbán: Yes. So, we have been planning carefully to give the exosome to good runway. We have several targets that are in development including the vaccine that I spoke about today regarding for COVID and also for future vaccine development. There are other programs that are in pre-clinical assessment as we speak and we look forward to providing update to that as it becomes available. I will add here that the exosomes are now the platform upon which we’re building the delivery of biologics that’s in the nucleic acids such as RNA which our first target could be proteins, it could be small molecules, exosome display is also a possibility where you can coat the exosome on the outside of the protein and drive either other types of vaccines or potentially protein replacement therapy. So, their opportunities are large. What we’ve been able to do is narrow it down to a few specific targets that we are actively engaged in and we’ll provide updates on that really in the first part of next year.

Joe Pantginis

Analyst

Thank you, Linda. Linda Marbán: Thanks, Joe.

Operator

Operator

Thank you. [Operator Instructions] There are no further questions at this time. I’d like to turn the call back over to Ms. Linda Marbán for closing remarks. Linda Marbán: Yes, thank you very much for joining us for our third quarter update. We look forward to providing updates as they become available on our pipeline program, CAP-1002 and the exosomes. And thank you for your time today.

Operator

Operator

Thank you. This concludes today’s teleconference. You may now disconnect your lines at this time. Thank you for your participation and have a wonderful day.