Caladrius Biosciences Reports 2018 Second Quarter and First Six Months Financial Results

On August 9, 2018 Caladrius Biosciences, Inc. (Nasdaq: CLBS) ("Caladrius" or the "Company"), a development-stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiovascular indications, reported financial results for the three and six months ended June 30, 2018 and provides a business update (Press release, Caladrius Biosciences, AUG 9, 2018, View Source [SID1234528816]).

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Highlights of the 2018 second quarter and first six months include:

Received regenerative medicine advanced therapy ("RMAT") designation from the U.S. Food and Drug Administration ("FDA") for the Company’s late-stage CD34 cell therapy program CLBS14-RfA for the treatment of refractory angina, which is similar to breakthrough therapy designation, in that it provides increased agency meeting opportunities, the potential for accelerated approval and is reserved for therapies which treat a serious condition while showing preliminary evidence of addressing an unmet medical need;

Received SAKIGAKE designation from the Japan Ministry of Health, Labour and Welfare ("MHLW") for the proprietary CD34 cell therapy CLBS12 for the treatment of no-option critical limb ischemia ("CLI"), which reflects MHLW’s expectation of "prominent effectiveness" based on mechanism-of-action data from non-clinical and early clinical trials and provides an expedited path to potential conditional approval in Japan for products that show sufficient safety evidence and signals of efficacy in a Phase 2 study;

Sold our ownership interest in a non-core development-stage counter-flow centrifugation system to Hitachi Chemical Advanced Therapeutics Solutions for $2.5 million;

Continued enrollment in a Phase 2 clinical trial in Japan with CLBS12 for the treatment of no-option CLI;

Continued enrollment in a Phase 2 clinical trial with the CD34 cell therapy CLBS14-CMD for the treatment of coronary microvascular dysfunction ("CMD"); and

Continued follow-up analysis of The Sanford Project: T-Rex Study Phase 2 clinical trial of CLBS03 in type 1 diabetes after completing enrollment and reporting six-month results on 50% of trial subjects in the first quarter of 2018 that concluded the treatment is well-tolerated and non-futile for therapeutic effect.

Management Commentary

"During the second quarter, we continued to advance our CD34 cell therapy programs. We took a major step forward as we reactivated the Investigational New Drug Application ("IND") for CLBS14-RfA as the sponsor and now have three development programs targeting three indications for our CD34 technology. Additionally, with receipt of RMAT designation for CLBS14-RfA, we are afforded an opportunity to work with the FDA to more rapidly and efficiently advance the development of a therapeutic candidate with the potential to impact a condition with no known effective treatment options and high morbidity. We also advanced our Phase 2 clinical trial in Japan that is evaluating CLBS12 for the treatment of no-option CLI, a condition for which we were granted SAKIGAKE designation from the MHLW in early April. As a result, we now have two potential nearer-term commercial opportunities," said Dr. David J. Mazzo, President and Chief Executive Officer of Caladrius.

"I am also pleased to report that enrollment in our Phase 2 study of CLBS14-CMD for the treatment of coronary microvascular dysfunction continues to progress as expected and that we remain on track to complete patient follow-up and primary endpoint analysis of The Sanford Project: T-Rex Study with anticipated top-line results reported in early 2019," Dr. Mazzo continued. "Finally, as a result of continued fiscal discipline, augmented by $2.5 million of non-dilutive funding received from the sale to Hitachi Chemical Advanced Therapeutics Solutions in June of our rights to a counter-flow centrifugation cell processing device, our cash position remains strong."

Second Quarter Financial Highlights

Research and development expenses for the second quarter of 2018 were $2.1 million, a 50% decrease compared with $4.3 million for the second quarter of 2017. The decline was due to significantly lower costs in our CLBS03 clinical program in type 1 diabetes upon the completion of enrollment in December 2017, which was partially offset by costs related to the initiation of clinical trials in late 2017 and early 2018 for CLBS12 in critical limb ischemia and CLBS14-CMD in coronary microvascular dysfunction, respectively.

General and administrative expenses for the second quarter of 2018 were $2.1 million, compared with $3.4 million for the second quarter of 2017. The decrease was due to the sale of our counter-flow centrifugation system to Hitachi in the second quarter of 2018, which resulted in a one-time $1.4 million gain included in general and administrative expenses.

The net loss from continuing operations for the second quarter of 2018 was $4.1 million, or $0.42 per share, compared with $2.0 million, or $0.22 per share, for the second quarter of 2017.

Six Month Financial Highlights

Research and development expenses for the first six months of 2018 were $4.4 million, a 45% decrease compared with $8.0 million for the first six months of 2017. The decline was due to significantly lower costs in our CLBS03 clinical program in type 1 diabetes upon the completion of enrollment in December 2017, which was partially offset by costs related to the initiation of clinical trials in late 2017 and early 2018 for CLBS12 in critical limb ischemia and CLBS14-CMD in coronary microvascular dysfunction, respectively.

General and administrative expenses for the first six months of 2018 were $5.0 million, compared with $6.1 million for the first six months of 2017. The decrease was due to the sale of our counter-flow centrifugation system to Hitachi in the second quarter of 2018, which resulted in a one-time $1.4 million gain included in general and administrative expenses.

The net loss from continuing operations for the first six months of 2018 was $9.1 million, or $0.95 per share, compared with $8.7 million, or $0.99 per share, for the first six months of 2017.

Balance Sheet Highlights

As of June 30, 2018, Caladrius had cash, cash equivalents and marketable securities of $50.3 million, compared with $60.1 million as of December 31, 2017. Based on existing programs and projections, the Company continues to remain confident that its cash balances and additional grant funding, along with continued disciplined expense management, will allow it to fund its current business plan beyond 2019.

Conference Call

Caladrius’ management will host a conference call for the investment community today beginning at 4:30 p.m. Eastern time to review financial results, provide a Company update and answer questions.

Stockholders and other interested parties may participate in the conference call by dialing (866) 595-8403 (domestic), or (706) 758-9979 (international), and providing conference ID: 8899285. The call will also be broadcast live on the Internet via the Company’s website at www.caladrius.com/investors/news-events.

For those unable to participate on the live conference call, a replay will be available through August 15, 2018, and can be accessed by dialing (855) 859-2056 or (404) 537-3406. All listeners should provide the following replay access code: 8899285.

The webcast replay will be archived on the Company’s website for 90 days at www.caladrius.com.

ARCA BIOPHARMA ANNOUNCES SECOND QUARTER 2018 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

On August 9, 2018 ARCA biopharma, Inc. (Nasdaq:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, reported financial results for the quarter ended June 30, 2018 (Press release, Arca biopharma, AUG 9, 2018, View Source [SID1234528815]).

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"The second quarter of this year saw an important milestone for the Gencaro development program with the completion of an End-of-Phase 2 FDA meeting that provided important guidance for the next steps in our development of Gencaro as potentially the first genetically-targeted treatment for atrial fibrillation," commented Dr. Michael Bristow, ARCA’s President and Chief Executive Officer. "With work underway on completing the Gencaro Phase 3 trial protocol and continued progress with IND enabling activities for AB171 in PAD and HF, we believe ARCA is advancing our pipeline of genetically-targeted therapeutics to address the unmet medical needs of patients with cardiovascular disease."

Pipeline Update

Gencaro (bucindolol hydrochloride) – a pharmacologically unique beta-blocker and mild vasodilator being developed for the potential treatment of patients with atrial fibrillation (AF) and chronic heart failure with reduced left ventricular ejection fraction (HFrEF).

In April 2018, Medtronic, Inc. and ARCA agreed to extend their current U.S., Canadian and European Clinical Trial Collaboration Agreement for one additional year.

In May 2018, results from ARCA’s GENETIC-AF Phase 2B clinical trial were presented in a "Late Breaking Clinical Trials" oral presentation at the European Society of Cardiology (ESC) Heart Failure 2018 World Congress.

In June 2018, ARCA held an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to review the GENETIC-AF data and potential future Gencaro development plans.

FDA concurrence to proceed into Phase 3 was reached. ARCA anticipates submitting a Special Protocol Assessment (SPA) application for the proposed Gencaro Phase 3 clinical trial in the third quarter of 2018. Progress to Phase 3 is dependent on the Company receiving additional funding.
AB171 – a thiol-substituted isosorbide mononitrate being developed as a potential genetically-targeted treatment for heart failure (HF) and peripheral arterial disease (PAD).

Chemistry, manufacturing and controls (CMC) activities were continued in the second quarter.

IND-enabling non-clinical studies are anticipated to begin in the first half of 2019.
Second Quarter 2018 Summary Financial Results

Cash, cash equivalents and marketable securities totaled $9.6 million as of June 30, 2018, compared to $11.8 million as of December 31, 2017. ARCA believes that its current cash, cash equivalents and marketable securities will be sufficient to fund its operations, at its projected cost structure, through the end of the first quarter of 2019.

Research and development (R&D) expenses for the quarter ended June 30, 2018 totaled $1.2 million compared to $4.5 million for the corresponding period of 2017. The $3.3 million decrease in research and development expenses in the second quarter of 2018 as compared to the second quarter 2017 was primarily due to decreased clinical expenses following the completion of the GENETIC-AF clinical trial. The Company expects R&D expenses in 2018 to be lower than 2017 as the GENETIC-AF clinical trial has been completed.

General and administrative (G&A) expenses for the quarter ended June 30, 2018 were $1.0 million, relatively unchanged compared to the $1.1 million in the second quarter of 2017. ARCA expects G&A expenses in 2018 to be consistent with those in 2017 as it maintains administrative activities to support ongoing operations.

Total operating expenses for the quarter ended June 30, 2018 were $2.2 million compared to $5.6 million for the second quarter of 2017. The decrease in total operating expenses for the second quarter of 2018 was primarily due to the decrease in R&D expense due to the completion of the GENETIC-AF clinical trial.

Net loss was $2.1 million, or $0.15 per share, for the second quarter of 2018 compared to $5.5 million, or $0.59 per share, for the second quarter of 2017.

Arbutus to Present at the 2018 Wedbush PacGrow Healthcare Conference

On August 9, 2018 Arbutus Biopharma Corporation (Nasdaq: ABUS), an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, reported that Dr. Michael Sofia, Arbutus’ Chief Scientific Officer, will present a corporate update at the Wedbush PacGrow Healthcare Conference on Wednesday, August 15, 2018 at 2:30 pm – 3:00 pm ET in New York (Press release, Arbutus Biopharma, AUG 9, 2018, View Source [SID1234528814]).

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A live webcast of the presentation can be accessed through the Investor section of Arbutus’ website at www.arbutusbio.com. A replay of the webcast will be available for 90 days following the live presentation.

Entry into a Material Definitive Agreement.

On August 6, 2018, PRA Health Sciences, Inc. (the "Company") entered into an Underwriting Agreement (the "Underwriting Agreement") by and among the Company, the selling stockholder named therein (the "Selling Stockholder"), and Morgan Stanley & Co. LLC and Goldman Sachs & Co. LLC (the "Underwriters"), relating to an underwritten offering (the "Offering") of 6,500,000 shares (the "Shares") of the Company’s common stock, par value $0.01 per share, pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-209883), filed on March 2, 2016, as supplemented by the prospectus supplement dated August 6, 2018 (Filing, 8-K, PRA Health Sciences, AUG 9, 2018, View Source [SID1234528791]). All of the Shares are being sold by the Selling Stockholder. Pursuant to the Underwriting Agreement, the Underwriters purchased the Shares at a price of $101.01 per share in a transaction that was completed on August 9, 2018.

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Navidea Biopharmaceuticals Reports Second Quarter 2018 Financial Results

On August 8, 2018 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the second quarter of 2018 (Press release, Navidea Biopharmaceuticals, AUG 9, 2018, View Source [SID1234528788]). Navidea reported total revenues for the quarter of $542,000. Net loss attributable to common stockholders was $2.4 million.

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Michael Goldberg, M.D., President and Chief Executive Officer of Navidea BioPharmaceuticals, commented, "During the first half of the year, we continued to make significant progress executing on our strategy to develop imaging and therapeutics based on our activated macrophage targeting technology. We have generated additional clinical data with our imaging agents and progressed with our development efforts towards additional regulatory approvals. Macrophage Therapeutics is seeking to develop treatments for diseases where inflammation is a major contributing factor. Macrophage Therapeutics has an exclusive license from Navidea for all therapeutic uses of our propriety Manocept platform, while our diagnostics business is focused on the development and commercialization of precision imaging products for a large range of inflammatory related conditions. With the benefit of these corporate changes, we are well-positioned to create long-term value for our stakeholders as we focus the business and execute our mission of developing innovative immunodiagnostic agents and therapies that improve patient care."

Second Quarter 2018 Highlights and Subsequent Events

Signed exclusive license with Meilleur Technologies, Inc. ("Meilleur") a wholly-owned subsidiary of Cerveau Technologies, Inc. to conduct research using NAV4694, as well as an exclusive license for the development and commercialization of NAV4694 in Australia, Canada, China, and Singapore

Presented at the 8th Annual LD Micro Invitational Conference

Presented at the 2nd Annual NASH conference in Boston, MA

Financial Results

Our consolidated balance sheets and statements of operations have been reclassified, as required by current accounting standards, for all periods presented to reflect the line of business sold to Cardinal Health 414 in March 2017 as a discontinued operation. Accordingly, this discussion focuses on describing results of our operations as if we had not operated the discontinued operation during the periods being disclosed.

Total revenues for the second quarter of 2018 were $542,000 compared to $612,000 in the second quarter of 2017. Total revenues for the first six months of 2018 were $819,000 compared to $1.2 million for the same period in 2017. License revenue in 2018 was primarily related to the sublicense of NAV4694 to Meilleur; license revenue during 2017 was primarily related to the license of Tc99m tilmanocept to Sayre Therapeutics in India. Grant revenue in both 2018 and 2017 was primarily related to Small Business Innovation Research ("SBIR") grants from the National Institutes of Health ("NIH") supporting Manocept development.

Research and development ("R&D") expenses for the second quarter of 2018 were $1.1 million compared to $1.2 million in the second quarter of 2017. The net decrease was primarily due to reductions in drug project expenses related to NAV4694 and Manocept development costs, offset by increased therapeutics and Tc99m tilmanocept development costs. R&D expenses for the first six months of 2018 were $2.1 million compared to $1.9 million during the same period in 2017. The net increase was primarily due to net increases in drug project expenses related to NAV4694 and therapeutics development costs, offset by decreased Manocept and Tc99m tilmanocept development costs. The change in R&D expenses for both periods also included net decreased compensation related to decreased headcount.

Selling, general and administrative ("SG&A") expenses for the second quarter of 2018 were $1.8 million, compared to $4.2 million in the second quarter of 2017. SG&A expenses for the first six months of 2018 were $3.6 million, compared to $7.3 million during the same period in 2017. The net decrease for both periods was primarily due to decreased legal and professional services, a loss on disposal of assets related to our previous office space, termination costs related to the arbitration award to our former CEO, a loss on termination of our previous office lease, and decreased general office expenses such as depreciation, insurance and rent.

Navidea’s net loss attributable to common stockholders for the quarter ended June 30, 2018 was $2.4 million, or $0.02 per share (basic), compared to a net loss attributable to common stockholders of $5.2 million, or $0.03 per share, for the same period in 2017. Navidea’s net loss attributable to common stockholders for the six-month period ended June 30, 2018 was $9.1 million, or $0.06 per share (basic), compared to net income attributable to common stockholders of $80.4 million, or $0.50 per share, for the same period in 2017.

Navidea ended the second quarter of 2018 with $5.5 million in cash and investments, including the accelerated earnout payment of $6.0 million from Cardinal Health 414 which was received during the quarter.

Conference Call Details

Investors and the public are invited to access the live audio webcast through the link below. Participants who would like to ask questions during the question and answer session must participate by telephone. Participants are encouraged to log-in and/or dial-in fifteen minutes before the conference call begins.

Event:

Second Quarter 2018 Earnings and Business Update Conference Call

Date:

Thursday, August 16, 2018

Time:

5:00 pm (Eastern Time)

U.S. & Canada Dial-in:

877-407-0312

Conference ID:

13682395

Webcast

View Source

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.