CALADRIUS BIOSCIENCES, INC. (NASDAQ:CLBS) Files An 8-K Completion of Acquisition or Disposition of AssetsItem 2.01Results of Operations and Financial Condition.
The information in Item 7.01 is incorporated by reference.
Item 7.01Regulation FD Disclosure.
On August 10, 2017, Caladrius Biosciences, Inc. issued a press release in connection with its 2017 Second Quarter Financial Results. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 7.01 by reference.
The Company will conduct a conference call to review its financial results on August 10, 2017, at 4:00 p.m. Eastern Standard Time.
The information in this Item 7.01, including Exhibit99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this Item 7.01, including Exhibit99.1 attached hereto, shall not be incorporated by reference into any registration statement or other document to the Securities Act of 1933, except as otherwise expressly stated in such filing.
Item 9.01Financial Statements and Exhibits.
|
Exhibit No. |
Description |
|
99.1 |
Press release, dated August 10, 2017 |
to the requirements of the Securities Exchange Act of 1934, the registrant has dulycaused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
CALADRIUS BIOSCIENCES, INC. |
|
|
By: |
/s/ David J. Mazzo |
|
Name: |
David J. Mazzo, PhD |
|
Title: |
Chief Executive Officer |
Dated:August 10, 2017
Caladrius Biosciences Reports 2017 Second Quarter Results
Conference call begins today at 4:30 p.m. Eastern time
BASKING RIDGE, N.J., (August 10, 2017) – Caladrius Biosciences, Inc. (NASDAQ: CLBS) (“Caladrius” or the “Company”), a development-stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiology indications,announces results for the three and six months ended June 30, 2017.
Highlights of the 2017 second quarter and recent weeks include:
|
Completed the sale of Caladrius’ remaining 80.1% ownership interest in PCT to Hitachi America (Hitachi) for $75 million in cash during the second quarter plus an additional $4.4 million received in July 2017 as a final net cash settlement for a total of $79.4 million; |
|
Retired all outstanding debt (approximately $5 million) owed to Oxford Financial Services in conjunction with the closing of the sale of PCT to Hitachi; |
|
Reached 50% of subjects treated in The Sanford Project: T-Rex Study, a prospective, randomized, placebo-controlled, double-blind Phase 2 clinical trial to evaluate the safety and efficacy of CLBS03 as a treatment for recent-onset type 1 diabetes (T1D) triggering a prescribed interim analysis of therapeutic effect and safety culminating when the 56th patient reaches their 6-month follow-up visit; |
|
Joined the Russell Microcap®Index as part of the Russell indexes annual reconstitution, effectiveas of June 26, 2017; |
|
Quarterly cash burn from ongoing operations being actively managed through various strategic cost management initiatives with notable reductions in real estate costs. |
Management Commentary
“The sale of our remaining interest in PCT to Hitachi during the second quarter provides us with the capital and flexibility to advance our development pipeline,” stated David J. Mazzo, PhD, President and Chief Executive Officer of Caladrius.
“In addition to the sale of PCT, our Phase 2 T-Rex study of CLBS03 for the treatment of type 1 diabetes continues to advance on schedule. We reached the halfway point in treating subjects in the 111-patient study in July, triggering a pre-specified interim analysis of safety and potential early therapeutic effect to occur after the six-month post-treatment follow-up visit, and we expect to announce those topline results during the first quarter of 2018. We remain on track and optimistic to fully-enroll the T-Rex study by the end of 2017.
“We are excited about what lies ahead for Caladrius as we steadily manage our transition into a pure development-focused biopharmaceutical company,” concluded Dr. Mazzo.
Second Quarter Financial Highlights
Note: Effective with the sale of PCT to Hitachi in the second quarter, all PCT-related activities and gain on sale results will be reported as discontinued operations. All remaining operations will be reported as continuing operations. In addition, all prior year comparative financial results will restate PCT operations as discontinued operations.
Research and development (R&D) expenses for the second quarter of 2017 of $4.3 million were down 5% compared to prior-year’s second quarter. Our current R&D is now primarily focused on the ongoing Phase 2 T-Rex Study and preparations for other pipeline programs.
General and administrative (G&A) expenses for the second quarter of 2017 were $3.4 million, and included $1.3 million of equity compensation expense (compared with equity compensation expense of $253,000 in the prior year’s second quarter). The unusually high equity compensation expense in the current year second quarter was due to the acceleration of employee equity stock and option award vesting triggered by the sale of the Company’s PCT subsidiary to Hitachi. Excluding equity compensation, G&A expenses were down 19% compared to the prior-year’s second quarter.
The net loss from continuing operations for the second quarter of 2017 was $2.0 million, compared with the net loss from continuing operations of $7.7 million for the comparable 2016 period. The continuing operations net loss includes a tax benefit of $5.9 million, which partially offsets the tax expense reported in discontinued operations.
Income from discontinued operations during the second quarter of 2017 was $40.4 million, which includes a $40.2 million gain on the sale of PCT (net of $11.6 million taxes), compared with a loss from discontinued operations of $152,000 in the prior year’s second quarter.
Net loss per share from continuing operations attributable to Caladrius common stockholders for the second quarter of 2017 was $0.22 per share compared to net loss per share of $1.30 for the same period in 2016.
Six Month Financial Highlights
R&D expenses for the first half of 2017 decreased 24% to $8.0 million compared with $10.5 million for the first half of 2016. G&A expenses were $6.1 million for the first half of 2017 compared with $7.7 million for the same period in 2016.
The net loss from continuing operations for the first half of 2017 was $14.5 million, compared with the net loss from continuing operations of $19.5 million for the first half of 2016.
The net loss from continuing operations for the first half of 2017 was $8.6 million, compared with the net loss from continuing operations of $19.5 million for the comparable 2016 period. The continuing operations net loss includes a tax benefit of $5.9 million, which partially offsets the tax expense reported in discontinued operations.
Income from discontinued operations during the first half of 2017 was $37.3 million, which includes a $40.2 million gain on the sale of PCT (net of $11.6 million taxes), compared with a loss from discontinued operations of $432,000 in the prior year’s second quarter.
Net loss per share from continuing operations attributable to Caladrius common stockholders for the first half of 2017 was $0.99 per share compared to net loss per share of $3.32 for the same period in 2016.
Balance Sheet Highlights
As of June 30, 2017, Caladrius had cash, cash equivalents and marketable securities of $59.3 million compared with $7.1 million (excluding cash held at PCT) as of December 31, 2016. During the first half of 2017, the Company received $75 million in connection with the closing of the Hitachi transaction, of which $5.0 million was placed in an escrow account to cover potential indemnification claims over the next 12 months. The latter is recorded as restricted cash on the balance sheet. In addition, upon closing the transaction, $4.9 million was paid to Oxford Financial to retire all Caladrius’ outstanding debt including any remaining principal, interest and fee obligations. Following the close of the second quarter, the Company received an additional $4.4 million as a final net cash settlement of the PCT transaction for a total of $79.4 million received to date related to the transaction.
During the second quarter of 2017, the Company received $5.7 million in an upfront payment in connection with the up to $12.2 million CIRM grant announced earlier this year, which is based on reaching certain milestones. In addition, the Company received $2.0 million from Sanford Research in connection with a closing sale of the second tranche of securities About CALADRIUS BIOSCIENCES, INC. (NASDAQ:CLBS)
Caladrius Biosciences, Inc., formerly NeoStem, Inc., through its subsidiary, PCT, LLC, a Caladrius Company (PCT), provides development and manufacturing services to the cell therapy industry (which includes cell-based gene therapy). PCT specializes in cell and cell-based gene therapies. PCT offers development and manufacturing capabilities, quality systems, cell and tissue processing, logistics, storage and distribution and engineering solutions to clients with therapeutic candidates at all stages of development. The Company’s product candidate, CLBS03, is a T regulatory cell (Treg) clinical Phase II therapy targeting adolescents with recent-onset type 1 diabetes mellitus (T1DM) using the patient’s own numerically and functionally enhanced Tregs. This therapy is based on a platform technology for immunomodulation. The Company’s T Regulatory Cell Technology is applicable to multiple autoimmune and allergic diseases.
