Caladrius Biosciences' (CLBS) CEO David Mazzo on Q2 2017 Results - Earnings Call Transcript

| About: Caladrius Biosciences, (CLBS)

Caladrius Biosciences, Inc. (NASDAQ:CLBS)

Q2 2017 Earnings Conference Call

August 10, 2017 04:30 PM ET

Executives

Anne Marie Fields - LHA, Investor Relations

John Menditto - Executive Director of Investor Relations and Corporate Communications

David Mazzo - President and Chief Executive Officer

Joseph Talamo - Senior Vice President and Chief Financial Officer

Analysts

Steve Brozak - WBB Securities

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

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

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

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

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 compensation expense due to the acceleration of employee equity stock and option award vesting triggered by the sale of PCT.

In contrast, last year’s second quarter equity compensation expenses are only $253,000. Excluding equity compensation G&A expense was down 19% compared to the prior year’s second quarter and reflects favorably our continuing efforts to manage expenses conservatively.

The net loss from continuing operations for the second quarter of 2017 was $2 million compared with $7.7 million of second quarter of 2016. The net loss from continued operations for the first half of 2017 was $8.7 million and this is down from $19.5 million for the first half of 2016.

Both the three and six month 2017 losses include a tax benefit of $5.9 million, which is directly related to the tax expense included in discounted operation that I'll discuss momentarily.

Based on accounting guidelines, the gain on the PCT cell will trigger a tax expense in discounted operations; however, the Company anticipates that the tax expense in discounted operations will be offset by the tax benefit to be booked in our 12-month continuing operations results.

The Company is projecting full net operating loss carry forward utilization to offset any taxable income related to PCT cell and only expects an alternative minimum tax expense and payment of approximately $500,000 in 2017.

Net loss from continuing operations attributable to Caladrius' common stockholders for the second quarter of 2017 was $0.22 per share and this compares with a net loss of $1.30 per share for the same period in 2016. The net loss from continuing operations attributable to Caladrius' common stockholders for the first half of 2017 $0.99 per share versus $3.32 per share for the same period in 2016.

Now turning to our financial results from discounted operations. Income from discounted operations for the three and six months ended June 30, 2017 were $40.5 million and $37.3 million respectively. Both periods included a $51.7 million gain on the sale of PCT, this compares with a loss from discounted operations of $152,000 and $432,000 for the 3 and 6 months ended June 30, 2016.

The $51.7 million gain on the sale of our remaining 80.1% interest in PCT is based on $79.4 million of total consideration recognized on the transaction representing the $75 million of base consideration plus an additional $4.4 million as a positive cash adjustment at the time of the closing per the terms of the purchase agreement.

The total consideration was paid in exchange for the net book value of PCT assets, net assets less liability sold of $24.4 million as of the closing date. Transaction related cost included retention obligations to transferring PCT employees of $6.9 million and were netted against total proceeds. We also book the favorable $3.7 million adjustment in the gain calculation to unwind the cumulative portion of Hitachi's existing non-controlling interest prior to sale.

We reported a tax provision of $11.6 million in connection with this sale; however, the Company's specialty utilized it's net operating loss carry forwards to offset the gain resulting zero tax payment obligation other than the small $500,000 aforementioned also alternative minimum tax obligation.

Income from discontinued operations attributable Caladrius common stock holders for the second quarter of 2017 was $4.56 per share compared with the loss from discontinued operations of $0.03 per share for the same period 2016.

Net loss from discontinued operations attributable to Caladrius common stock holders for the first half of 2017 was $4.38 per share compared with a loss from discontinued operations of $0.08 per share for the same period of 2016.

Moving on to our balance sheet and cash flow. As previously mentioned our cash and marketable securities totaled $59.4 million as of June 30, 2017 with all long-term debt eliminated. We also have an additional $5 million in restricted cash that has been placed in an escrow international account related to the PCT sale to cover potential indemnification claims over the next 12 months.

Following the close of this in second quarter we received $4.4 million from Hitachi as the final net cash settlement in the Hitachi transaction.

During the second quarter we also received $5.7 million in an upfront payment in connection with the up to $12.2 million from grant we announce earlier this year, which will be based on the achievement of certain milestones related to the proportion of subjects enrolled overall as well as in California. In addition to manufacturing and development cost incurred in California.

We also received $2 million from Sanford Research with the early delivery to them of the second tranche of securities related to their equity investment in Caladrius in September of 2016.

Based on our existing programs and projections, we expect to have greater than $50 million in cash and marketable securities at the end of 2017, with less than $5 million of projected CLBS03 external spending obligations after 2017 to reach the completion of the T-Rex study excluding any further sum funding.

We are confident our cash balances and additional grant funding along with continued disciplined expense management will allow us to fund our current business plan with runway beyond 2018.

With that, let me turn the call back to Dave.

David Mazzo

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 to detect the 0.2 picomol per mL difference and area under the curve mean C-Peptide between the active and placebo arms. This landmark study is novel and that it’s also includes work involve extensive and immune profile and participates to better elucidate the mechanism of action of CLBS03.

Enrollment of the first 19 patients was completed in August 2016 and the evaluation produced favorable safety data, which allowed us to continue enrollment of the second cohort of subject last fall.

The study has been conductive at the leading clinical centers throughout the United States including Joslin Diabetes Center and strong interest in its innovative program has allowed to us enroll and treat patients rapidly.

Recently we were pleased to announce the achievement of the 50% enrollment milestone in the study with achievement of the 56 patient. There is a specified interim analysis of safety and potential early therapeutic effect that will occur after the six month post treatment follow-up visit of this group of patients and we expect to announce those results in early 2018.

As a remainder, our research partner in T-Rex study, Sanford Research continues to provide support to the study by the covering the operational costs at their two clinical sites in addition to having made a $5 million equity investment in Caladrius in September of 2016.

The study is also subsidized by two noteworthy grant, first the Juvenile Diabetes Research Foundation granted Benaroya Research Institute at Virginia Mason in Seattle a $620,000 grant to support Benaroya scientist and their collaborators in their analysis of the impact of CLBS03 therapy on the immune system of treated participants in the T-Rex Study to better understand the therapies mechanism of action. This grant to Benaroya directly offsets costs that Caladrius otherwise would have been incurred as part of our clinical trial.

Second, we are particularly pleased that the T-Rex Study supported by a grant of up to $12.2 million from the California Institute for Regenerative Medicine. As Joe mentioned, we received an initial $5.7 million payment during the second quarter and we expect to receive our first milestone payment of approximately $2 million when we enroll our 10th patient in California into the T-Rex study, which is anticipated before the end of this year.

Our confidence in the program is supported by several published studies including early clinical work conducted by Dr. Stephen Gitelman, a leading pediatric endocrinologist at UCSF and Chairman of the Executive Theory Committee for the T‑Reg Study. Dr. Gitelman, along with Dr. Kevan Herold at Yale University, conducted a Phase I study funded by the Juvenile Diabetes Research Foundation on what is now known as CLBS03 that demonstrated T-Reg therapy to be well tolerated, durable and preserving of beta cell function in children. Their study was published in clinical immunology.

In addition a study in Diabetic Adults published in Science Translational Medicine in November 2016 provided supplementary evidence for safety and tolerability of otologists expanded polyclonal T-Reg cell therapy while showing that the T-Regs retained to T-cell receptor diversity and demonstrated enhanced functional activity.

And finally a European study in children published in Clinical Immunology and the Journal of Translational Medicine provided a preliminary indication of therapeutic effect to T-Regulatory cells as the treatment for patients with Type 1 diabetes.

On the regulatory front, our CLBS03 program is the recipient of a number of important international regulatory designations including FDA Orphan Drug status, EU Advanced Therapeutic Medicinal Product Classification and FDU First Track designation which represents the first Type 1 diabetes program ever to receive this distinction.

This regulatory recognition taking in combination with the cited results from previous clinical studies continues to feel our enthusiasm for advancing this novel T1D therapeutic approach. We reported the completing of the six month interim analysis that may inform us as to the continued safety and potential early therapeutic signal of CLBS03 and early onset T1D noting that the primary efficacy endpoint is planned to be evaluated if all patients have completed the one year follow-up visit of their treatment.

Results from this Phase II study are expected to provide critical therapy performance information that will help us and/or potential partner decide whether and how to design and execute the most efficient economical and rapid registration study or studies to culminate development and achieve registration of the therapy.

Let’s turn now to other pipeline opportunities. We continue to carefully and rigorously evaluate additional clinical development indication based on our T-Regulatory cell and CD34 platforms and will invest in other promising pipeline technologies into our programs based on an ongoing thorough data driven evaluation process.

Our consideration of new indications in autoimmune disease and/or cardiovascular disease based on our existing technology platforms will be strongly influenced by the availability of funding grants or collaborations to support the proposed work.

We look forward to the completion and data read out from studies T conducted by Jeff Bluestone in collaboration with Dr. Flavio Vincenti at UCSF that are evaluating autologous T-Reg as a treatment for subclinical rejection following kidney transplant in the study sponsored by the National Institute Allergy and Infectious Diseases as well as the study evaluating autologous T-Reg as a treatment for dermal lupus. Caladrius owns intellectual property rights for both of these indications and those data will inform our decision of whether to pursue further development in these indications.

Turning now to our CD34 plus technology. CD34 cell therapy is supported by a robust body of clinical evidence having been investigated in clinical studies encompassing over 700 patients with more 400 of them receiving CD34 cell therapy exposure.

Significant opportunities exist across multiple underserved cardiovascular indications such as critical limb ischemia, a coronary macro vascular dysfunction and refractory angina. The potential of CD34 cell therapy is also supported by preclinical data demonstrating improved micro circulation and by Phase II studies that consistent show benefits in safety and function.

We are actively pursuing our CD34 technology as the treatment for no option CLI in Japan as there is early supportive data in this indication and we can leverage Japan’s new Regenerative Medicine Law that provides a regular path to early condition approval.

CLI or critical limb ischemia is a severe obstruction of the arteries that markedly reduces blood flow to the extremities principally the feet and legs. CLI can lead to pain, skin ulcers and dermal sores and if not successfully addressed eventually amputation. No option CLI means the pharmacotherapy is no longer working and that amputation of a limb or limbs is the next step in treatment of these patients.

CLBS12 is our CD34 cell therapy for CLI and its is based on previous studies of autologous CD34 cell therapy for no option CLI patients in both Japan and the U.S. in which researchers found that CD34 cell injection at comparable doses are safe, led to improvement in CLI free status and improved amputation free survival.

Our Phase II clinical program and CMC strategy were designed in constant with the Japanese PMDA and we reached in the agreement that positive results from the study should qualify CLBS12 for early conditional commercial approval in Japan for this indication.

The agreed trial is a 35 patient pivotal Phase II prospective, randomized controlled, open-label multicenter study and no option CLI patients to be conducted in Japan. Those randomized to treatment will be dosed with CLBS12 through intramuscular injection in addition to receiving standard of care. Patients randomized with the control arm will receive standard of care pharmacotherapy alone.

It was agreed that the primary endpoint of this study is prime to continuous with CLI free status, which is defined as two consecutive monthly visits without disease progression. This is a highly clinically relevant endpoint and encompasses the broader spectrum of improvement when time to amputation or amputation free survival which are the typical end points in these studies. Also because this is an open-label study, we will be able to monitor patients and evaluate progress in real time.

Based on the substantial clinical data from four prior trials in CLI and claudication, we believe that CD34 cell therapy is not only safe, but it can help improve quality of life and potentially treat patients with this life-threatening condition and this is what we intend to demonstrate through this pivotal Phase II trial.

The study as expected the cost between $7 and $8 million of approximately three years with initial investment of about $2.5 million in the first year. We expect to initiate this study in late 2017 or early 2018 and with favorable outcomes we would seek to out license this product candidate in Japan.

In addition to CLI, we plan to explore the broader aspect of our CD34 cell therapy platform, which has the potential to be effective in the treatment of other cardiovascular diseases. We have submitted an SBIR grant application to the NIH for our CD34 cell therapy to treat coronary micro vascular dysfunction.

A disease that results in reduced blood flow to the heart muscle resulting in pain and dysfunction. We expect the decision on this funding in the coming months and if positive, our goal will be to initiate a 20 patient Phase II study before the end of the year or early in 2018.

Moving forward, our strategy will emphasize the advancement of our clinical pipeline and diversification of our product candidate portfolio. We expect to achieve value creating milestones that position us for significant growth throughout the balance of the year and beyond. These milestones include reporting enrollment of the 10th patients in California in the T-Reg study, which involvement triggers at $2 million milestone payment.

Reporting during early 2018 top line data from the interim analysis of the Phase II T-Rex study accepting the early therapeutic effect of CLBS03 in Type 1 Diabetes. Initiating the planned 35 patients Phase II trial in Japan in no option critical limb ischemia. Receiving additional grants for our CLBS03 and CD34 platforms in multiple indications and pursuing licensing opportunities for CLI in Japan and for other pipeline programs globally.

So in closing, as I said earlier, we are excited to be turning our full attention to our mission of advancing Caladrius as a development focused biopharmaceutical Company, we have two compelling technology platform on which to build and we are well on our way to fully implementing a number of important clinical programs in the areas of unmet need.

And while we are committed to executing our clinical programs and advancing them through to their next development milestone and decision point, we remain opportunistic about integrating other assets into our pipeline to potentially create both near and long-term value for our shareholders.

Before we now move to questions, I will take this opportunity to thank you our loyal shareholders for your continued interest and support as we transition Caladrius to a development focused biopharmaceutical Company.

Additionally, I also expand our gratitude to the patient, their families and the physicians who participate in our clinical programs with the hope of improving not only their own outcome, but also the outcomes of future patients. None of the progress we have made would have been possible without all of your support.

And with overview operator, we are now ready to take questions.

Question-and-Answer Session

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

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

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

Well thank you again for taking the question.

Operator

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

Unidentified 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

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

Okay. Great. Thank you so much.

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

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

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

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