Earnings Labs

Lisata Therapeutics, Inc. (LSTA)

Q2 2017 Earnings Call· Thu, Aug 10, 2017

$3.17

-2.50%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

+2.56%

1 Week

+10.26%

1 Month

-2.05%

vs S&P

-4.63%

Transcript

Operator

Operator

Welcome to the Caladrius Biosciences Second Quarter 2017 Results Conference Call. At this time, all participants are in a listen-only mode. Following managements prepared remarks we will hold a Q&A session. [Operator Instructions] As a reminder, this conference is being recorded today August 10, 2017. I would now like to turn the call over to Anne Marie Fields. Please go ahead ma’am.

Anne Marie Fields

Analyst

Thank you. Good afternoon. This is Anne Marie Fields with LHA, Investor Relations firm for Caladrius. Thank you all for participating in today’s call. Joining me from Caladrius are Dr. David Mazzo, President and Chief Executive Officer and Joseph Talamo, Chief Financial Officer. In addition I would like to introduce John Menditto, who recently joined the Caladrius team as Executive Director of Investor Relations and Corporate Communications. Earlier today, Caladrius filed its Form 10-Q and issued news release, announcing the its financial results for the second quarter of 2017. If you have not received this news release if would like to be added to the Company’s e-mail distribution list, please call LHA in New York at 212-838-3777 and speak with Carolyn Currin or e-mail update@caladrius.com. Before we begin, I would like to remind you that comments made by management during this conference call will contain forward-looking statements that involve risks and uncertainties regarding the operation and future results of Caladrius. I encourage you to review the Company’s filings with the Securities and Exchange Commission including without limitation the Company’s Forms 10-K, 10-Q and 8-K which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Furthermore, the content on this conference call contains time sensitive information that is accurate only as of the date of live broadcast August 10, 2017. Caladrius Biosciences undertakes no obligation for revise or update any statements to reflect event or circumstances after the date of this conference call. With that said, I will turn the call over to John Menditto.

John Menditto

Analyst

Thanks, Anne Marie. Good afternoon, everyone and thank you all for joining us on today’s call. I’m very excited to be joining Caladrius and such a strong and diverse management team at such an exciting and critical time in defining the future of the Company. As a quick fact around I bring with me over 20 years of experience in the investor relations and communications field with organizations that have included Novartis, Medco Health Solutions and most recently Argos Therapeutics. I’m sure that I have crossed pass of many of you throughout my past experiences and look forward to working with all of you going forward. With that, I will turn the call over to David Mazzo for a review of the Company’s recent development. Please go ahead David.

David Mazzo

Analyst

Thank you, John, and welcome. And my thanks to each of you who joining us on this afternoon’s call. The first half of 2017 has been transformation of the Caladrius Biosciences and reflects the culmination of the metamorphosis based on a thorough strategic review of our Company with input from all of our major stakeholders including many of you on this call. As you recall at the end of May we were delighted to successfully close on Hitachi Chemicals acquisition of our remaining interest in our PCT contract development manufacturing subsidiary thus completing a business model evolution initiated more than a year ago. Through this transaction a number of things have been accomplished, namely we have emerged as a pure play development focused biopharmaceutical Company with two current technology platforms namely our T regulatory cells for the treatment of a variety of autoimmune diseases and our CD34 plus cells for the treatment of several cardiovascular and peripheral arterial disease. We have preserved a close working relationship with our former subsidiary PCT as our preferred development and manufacturing partner for our T-Regulatory platform giving us a discounted rate for both services for the next seven years. we have substantially stabilized and strengthened our financial position with an immediate capital infusion to fund our future operations and growth and finally we had positioned ourselves potentially to pursue other clinical indication based on our platform and potentially invest in other promising pipeline technologies and/or program based on ongoing objective, disciplined and data driven evaluation process. We are confident that the PCT transaction has unlocked substantial value for Caladrius and will support opportunities for near and longer term value creation. We are excited now to have to turn our attention to advancing this new chapter in our corporate development. But before I discuss our pipeline programs and clinical plans, allow me to turn the call over to Joe Talamo our Chief Financial Officer for additional commentary on the Hitachi transaction and a review of our 2017 second quarter financial results. Joe.

Joseph Talamo

Analyst

Thanks Dave and Good afternoon everyone. With the closing of the Hitachi transaction now behind us, Caladrius enters the second half of 2017 as a well funded and focused biopharmaceutical Company with nearly $60 million in cash and marketable securities as of June 30, additional committed cash funding to be received over the next 12 months and the elimination of long-term debt with Oxford Finance. With a solidified and strengthened balance sheet, we can now focus entirely on our R&D platform and other value creating opportunities. Prior to discussing our second quarter results, please not that our PCT operations are reported as discontinued operations through the May 18, 2017 transaction date and accordingly all remaining Caladrius operation will be reported as continuing operations. As a result, all PCT revenues, cost of revenues and expenses including our gain on disposition of the PCT subsidiary have been reported under a single discontinued operations line item in our income statement. In addition all prior period financial statement has been recast to confirm to the new presentation for comparative purposes. I will begin with providing commentary on our financial results from continuing operations. Second quarter of 2017 R&D expenses were $4.3 million down 5% compared to the prior year quarter, or first half of 2017 R&D expenses were $8 million and were down 24% compared with the first half of 2016. Our current year R&D expenses are almost entirely related to our immune modulation platform and specifically our Phase II T-Reg study. The higher prior year expenses were primarily due to legacy costs associated with non-core R&D programs that we discontinued at the beginning of 2016 and the related reductions in R&D staffing and departmental costs. Second quarter 2017 G&A expenses were at $3.4 million which included an unusually high $1.3 million of equity…

David Mazzo

Analyst

Thank you Joe. We are excited to be moving forward with this new chapter in our corporate development and believe that we will enhance our prospects for positive returns for our shareholders based on an improved risk profile that is diversified across technology platforms and medication indication. Allow me to begin with an update on our landmark U.S. Phase II study of CLBS03 as a treatment for recent onset Type 1 Diabetes. We continue to make steady progress according to plan with the Sanford project T-Rex study which is due conducted in partnership with Sanford Research, a non-profit research organization that is part of Sanford Health and that supports an emerging translational research center focused on finding cure for Type 1 Diabetes or T1D. As a recap, CLBS03 is the personalized autologous cell therapy consisting of each patient’s own regulatory T-cells or T-Reg, which have been expanded in number and functionally enhanced by proprietary method developed through a collaboration with Dr. Jeffrey Bluestone and renowned researchers at UCSF and for which Caladrius has exclusive rights to international portfolio have issued and pending patents for T1D and other indications. The T-Reg study is a perspective randomized placebo-controlled double-blind Phase II clinical trial to evaluate the safety and efficacy of CLBS03 and 111 adolescence aged eight to 17 with recent onset Type 1 diabetes. Patients are randomized into one of three groups to receive a single administration of either high dose of CLBS03 or low dose of CLBS03 or placebo. The key end points for the trial are the standard medical and regulatory end points for T1D trial and include preservation of C-peptide which is an accepted measure for pancreatic beta cell function as well as insulin use, severe hypoglycemic episodes, and glucose and hemoglobin A1c levels. The study is 80% powered…

Operator

Operator

Thank you sir. [Operator Instructions]. Your first question comes from the line of Steve Brozak from WBB. Your line is open sir.

Steve Brozak

Analyst

Hey good afternoon and thank you for taking the question. you mentioned the science translation study and it was just published out of Europe they are using T-Regs in Type 1 Diabetes. It made pretty big waves yesterday as on immunotherapy which obviously is getting a lot of attention right now. In speaking about this technology, could you tell us how more of this early study and along with the other studies you mentioned give further validation to Caladrius and what are your thinking on the regulatory perspectives going forward for this? Thanks and I will hop back in the queue.

David Mazzo

Analyst

Thanks Steve, I appreciate your question and thanks for joining as always. So the previous studies that were conducted in T-Regulatory cells, really focused in several areas. The initial studies that were Phase I studies that were conducted in adults really demonstrated a very strong safety profile, high degree of tolerance as one might expect for an autologous cell therapy and also durability of the cells, these cells were a radio labeled and through imaging we were able to or actually the people who conducted the study were able to measure those cells in the peripheral blood for even a year after the initial of therapy. The studies in science translation medicine coming out of Europe really focused on some early therapeutic worked on in recent onset Type 1 Diabetes, so this a patient population that is similar to the patient population that’s being studied in the T-Rex study, it was studies with doses were somewhat similar to what we are using in the T-Reg study. Although I will note that in the European study they were able to go to a higher combined cell count dose than we were allowed to do initially here in the United States based upon I think just early conservative FDA safety, I don’t say not really concerns, but really early safety questions. But now that study is ongoing or rather reported, we can see that the patient who did receive higher doses, did do very well, we had a number of patients in that trial who came off entirely and number of others who met the criteria for really reduced insulin amount or utilization. And so this really gave us a strong indication that in a double-blind controlled study we should have a good opportunity to replicate and so while the dosing is not exactly the same, its similar and we are looking forward to seeing the results of the six months follow-up that will give us the first indication of whether or not the study is replicating those early results.

Steve Brozak

Analyst

Well thank you again for taking the question.

Operator

Operator

[Operator Instructions] You next question comes from Yi Chen from H.C. Wainwright. Go ahead sir.

Unidentified Analyst

Analyst

Hi, This is [Mitchell] (Ph) on for Yi, thank you for taking the question. My question is upon favorable Phase II data in T1D, do you expect that one positive pivotal trial might be sufficient for regulatory approval.

David Mazzo

Analyst

Thanks Mitchell for getting on and please send our regards to Yi as well. At this point, it’s hard to know exactly what the regulatory requirements are, one could hope that based upon the 21st Century Cures Act that an accelerated path through approval of fast track designated product would become available, but at this point we have not had those discussions with FDA and so we are not exactly sure. I mean the traditional requirement would be two Phase I trials, but again this is cell therapy and a disease with no real cure if you will and so I think there is an opportunity for discussion once we see the magnitude of the therapeutic effect and if we continue to see the very favorable tolerance and safety profile that we have seen to-date.

Unidentified Analyst

Analyst

Okay. Great. Thank you so much.

Operator

Operator

There are no further questions at this time, I will return the call back to over to Dr. Mazzo for closing remarks.

David Mazzo

Analyst

Well again thank you all for participating on today's call. We look forward to making continued progress, executing our business strategy and to providing you with timely reports of our achievements. We appreciate your continued interest in and the support of Caladrius Biosciences and look forward to updating you again on our next quarterly conference call. Have a nice evening everyone, good-bye.

Operator

Operator

This concludes today’s call. You may now disconnect.