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Caladrius Biosciences Announces 2016 Fourth Quarter and Full Year Financial Results

On March 17, 2017 Caladrius Biosciences, Inc. (NASDAQ: CLBS) ("Caladrius" or the "Company"), a cell therapy company with a select therapeutic development pipeline focused on immune modulation and a subsidiary, PCT, a development and manufacturing partner for the cell therapy industry, reported financial results for the three and twelve months ended December 31, 2016 (Filing, Q4/Annual, Caladrius Biosciences, 2016, MAR 17, 2017, View Source [SID1234518175]).

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2016 and 2017 Year to Date Highlights
PCT:

•Executed a global collaboration and license agreement between PCT and Hitachi Chemical Co., Ltd. in connection with the sale of 19.9% of PCT to Hitachi Chemical Co. America, Ltd. ("Hitachi America") for $19.4 million; and

•Entered into a definitive agreement with Hitachi America whereby Hitachi America agreed to purchase Caladrius’ remaining 80.1% membership interest in PCT for $75 million, subject to potential adjustments, including based on PCT’s cash and outstanding indebtedness as of the closing of the sale, and a potential future milestone payment.
CLBS03:

•Awarded a grant from the California Institute for Regenerative Medicine (CIRM) for the development of CLBS03 for an aggregate amount of up to $12.2 million, payable upon the achievement of certain milestones, for the Company’s investigational cell therapy currently being evaluated as a treatment for recent onset type 1 diabetes (T1D);

•Initiated a Phase 2 trial, the Sanford Project: T-Rex Study (T-Rex Study), for CLBS03;

•Completed enrollment of the initial cohort of 18 subjects of the T-Rex Study and, following a favorable safety recommendation from the Data Safety Monitoring Board, resumed enrollment of the second and final cohort of the study;

•Received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration for CLBS03; and

•Expanded the strategic collaboration with Sanford Research beyond operational support for the CLBS03 clinical program.
CLBS12:

•Reached agreement with Japanese regulators on a development plan for CD34 cell therapy for critical limb ischemia (CLBS12) which would qualify the product for early conditional commercial approval upon successful execution.

Fourth Quarter Financial Highlights
Total revenues for the fourth quarter of 2016 increased 35% to $10.2 million compared with $7.6 million in the fourth quarter of 2015, primarily due to higher reported Clinical Services revenues at PCT.
Research and development (R&D) expenses for the fourth quarter of 2016 decreased 19% to $2.6 million compared with $3.2 million for the fourth quarter of 2015, primarily related to the discontinuation of non-core R&D programs announced at the beginning of 2016 and related reductions in R&D staffing and departmental costs, partially offset by costs related to the ongoing Phase 2 T-Rex Study.

Selling, general and administrative (SG&A) expenses were approximately $4.3 million for the fourth quarter of 2016 compared with $5.0 million for the same period in 2015, primarily due to lower operational and compensation-related costs during the 2016 fourth quarter.
The net loss attributable to Caladrius common stockholders for the three months ended December 31, 2016 was $6.0 million or $0.73 per share, compared to $33.2 million or $5.92 per share for same period in 2015.
Net loss for the fourth quarter of 2015 included the impairment of in-process R&D (IPR&D) valued at $34.3 million related to the Company’s decision to discontinue its Phase 3 study of CLBS20 in metastatic melanoma. This impairment was partially offset by the reversal of a related deferred tax liability and the reversal of a related contingent consideration milestone obligation. The net impact for these changes was a $24.7 million increase in net loss.

Full Year Financial Highlights
Total revenues for 2016 of $35.3 million represented an increase of 57% compared with $22.5 million for 2015. R&D expenses in 2016 were $15.1 million compared with $23.9 million in 2015. SG&A expenses for 2016 were $20.4 million compared with $30.0 million for 2015.
The net loss attributable to Caladrius common stockholders for 2016 was $32.7 million or $4.99 per share based on 6.5 million shares outstanding, compared to $80.9 million or $16.67 per share based on 4.9 million shares outstanding for 2015.
Net loss for 2015 included the impairments of IPR&D associated with our CLBS20 and CLBS10 clinical programs, valued at $43.7 million. These impairments were partially offset by reversals of related deferred tax liabilities, and the reversals of related contingent considerations obligations. The net impact for these changes was a $24.7 million increase in 2015 net loss.

Balance Sheet and Cash Flow Highlights
As of December 31, 2016, Caladrius had cash and cash equivalents of $14.7 million. The net cash used in operating activities for 2016 was $23.7 million. During 2016, the Company invested $2.8 million in capital expenditures primarily related to equipment and improvements for PCT’s Allendale, N.J. and Mountain View, CA manufacturing facilities.
Conference Call
Caladrius’ management will host a conference call for the investment community today, March 17, 2017, beginning at 8:30 a.m. Eastern time to review the financial results, provide a Company update and answer questions.
Shareholders and other interested parties may participate in the conference call by dialing 877-562-4460 (U.S.) or 513-438-4106 (international) and providing conference ID 95709222. The call will also be broadcast live on the Internet via the Company’s website at www.caladrius.com/events.
The webcast will be archived on the Company’s website for 90 days.

Elasmogen receives £1.2 M in grant and equity investment

On March 16, 2017 Elasmogen Ltd, developer of soloMERTM biologics, reported that it has received a Biomedical Catalyst Grant from the UK’s innovation agency, Innovate UK and matching investment from Deepbridge Capital and Scottish Investment Bank (the investment arm of Scottish Enterprise) totalling £1.2 M (Press release, Elasmogen, MAR 16, 2017, View Source [SID1234637761]). The funding will be used to develop ELN-21 and ELN-22, the companies’ next generation biologics for topical treatment of ocular disease. Current treatments for ocular diseases such as uveitis and macular degeneration require either systemic dosing or direct injection into the eye. soloMERs are Elasmogen’s proprietary humanized versions of shark VNARs, the smallest naturally occurring binding domains. The small size (11 kDa) and highly robust nature of soloMERs make them ideal for delivering topically applied sight saving therapies while reducing systemic side effects and eliminating the need for injections. "We have recently completed our proof of concept trials demonstrating the ability to deliver therapeutic concentrations of soloMERs to the back of the eye by topical delivery," said Elasmogen CEO Caroline Barelle. "Winning the Biomedical Catalyst grant along with the new investment will allow us to build on these results and prepare our anti-inflammatory and anti-autoimmune soloMERs for phase 1 clinical trials." "Use of corticosteroids for treatment of ocular inflammation carries the risk of significant side effects including glaucoma and cataracts," said John Forrester Clinical Professor of Ophthalmology, The Lions Eye Institute, Australia and University of Aberdeen, Scotland. "A fast acting, topically applied biologic that can reach all parts of the eye would provide significant benefit to uveitis and other ocular disease patients." Kerry Sharp, Head of the Scottish Investment Bank said, "We are pleased to be able to support Elasmogen, initially through our High-Growth Spinout Programme which helps researchers to take their ideas and inventions from the lab to the global marketplace, and now through matched investment from the Scottish Venture Fund. The company has made significant technical progress in a short space of time and its sight-saving auto-immune therapies have the potential to make a notable social, as well as commercial, impact. We look forward to working with Deepbridge Capital to further support and nurture the exciting opportunity presented by Elasmogen."

Provecs Medical closes immuno-oncology collaboration with Medac

On March 16, 2017 Provecs Medical GmbH, a cancer immunotherapy company developing novel treatments to modulate the tumor microenvironment, reported the closing of a partnership with oncology pharma company Medac Gesellschaft für klinische Spezialpräparate mbH (Press release, Provecs Medical, MAR 16, 2017, View Source [SID1234571468]). The partners aim to develop, manufacture and market Provec’s cancer immunotherapy lead product Immunalon for the treatment of urinary bladder cancer. Immunalon is being developed for the treatment of a wide range of solid cancers, including urinary bladder cancer. Financial details were not disclosed.

The collaboration combines Medac´s marketing expertise in oncology and hematology with Provecs´ development know-how, which is based on its proprietary ENVIRO technology platform for innovative immunotherapeutics.

ENVIRO is a unique, patented adenoviral platform for the targeted delivery of up to four biologicals combined in one product to the tumor site. This multivalent approach is designed to reprogram the barriers between the immune system and cancer by addressing up to four immune checkpoints simultaneously. Immunalon is Provecs Medical´s lead compound based on ENVIRO.

"It is known today that the activation and inhibition of immune cells is regulated by a wealth of molecules called checkpoint molecules," said Dr. Frank Schnieders, CEO of Provecs Medical. "Tumors establish control over checkpoints to deactivate immune cells directed against the cancer. We also know that blocking these inhibitory checkpoint molecules partially restores the immune system’s ability to control and sometimes eliminate cancer cells. Existing treatments are directed against single checkpoints only and therefore show limited efficacy. We are convinced that addressing up to four checkpoints with our ENVIRO approach makes it much more difficult for tumor cells to escape elimination."

Provecs achieved ex-vivo proof-of-concept for Immunalon using its EXVIRO platform, a unique primary cancer tissue platform for ex-vivo therapy simulation as well as pharmacodynamics and pharmacokinetics studies. This 3D tissue culture system uses patient-derived human cancer tissues to study the tumor microenvironment in its spatial context without disrupting the cellular relationships. Provecs is now developing a first-in-man study concept for Immunalon in a second indication.

"We are seeking partners for the development of Immunalon in other solid cancer indications with high medical need and a lack of standard therapies," Schnieders added.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Titan Pharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Mannkind has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Mannkind, 2017, MAR 16, 2017, View Source [SID1234521750]).

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Caladrius Biosciences Announces 2016 Fourth Quarter and Full Year Financial Results

Elasmogen receives £1.2 M in grant and equity investment

Provecs Medical closes immuno-oncology collaboration with Medac

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]