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CYCLACEL PHARMACEUTICALS REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS

On August 9, 2018 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer biology, reported financial results and business highlights for the second quarter 2018 (Press release, Cyclacel, AUG 9, 2018, View Source [SID1234528821]).

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The Company’s net loss applicable to common shareholders for the three months ended June 30, 2018 was $1.9 million. As of June 30, 2018, cash and cash equivalents totaled $19.8 million.

"Phase 1 data presented for CYC065, our lead CDK inhibitor, at the recent American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting highlighted CYC065’s potential for durable suppression of Mcl-1, a protein that enables cancer cells to survive," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel." The oral presentation provided proof of the drug’s mechanism in patients with advanced solid tumors. Durable suppression of Mcl-1 for at least 24 hours was demonstrated in 11 of 13 patients after a single dose of CYC065 at the recommended Phase 2 level. Suppression of the Mcl-1 mediated survival pathway leads to rapid induction of apoptosis in Mcl-1 dependent cancer cells. CYC065’s mechanism has also been shown to reverse drug resistance associated with the addiction of cancer cells to cyclin E, a partner protein of CDK2. In furtherance of these findings, we will shortly initiate a CYC065 study in combination with venetoclax in patients with relapsed/refractory chronic lymphocytic leukemia, or CLL. We are also planning additional studies in advanced leukemias. During the quarter, we also achieved an important objective with the FDA’s clearance of the IND for CYC140, an internally-discovered, novel inhibitor of Polo-like-kinase 1, or PLK1."

Key Company Highlights

·Patient enrollment continues for part 2 of the CYC065 monotherapy Phase 1 study in patients with advanced solid tumors. Part 2 is evaluating an increased dosing frequency of 2 days per week for 2 weeks of a three-week cycle. Part 2 will also look to evaluate the efficacy of CYC065 in Mcl-1, MYC or cyclin E amplified cancers through the monitoring of select biomarkers relevant to CYC065’s mechanism of action.

·Cyclacel continues to prepare for initiation of a Phase 1 clinical trial evaluating CYC065 in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL. A poster presented at the 2018 AACR (Free AACR Whitepaper) highlighted preclinical data supporting the enhanced effect of combination therapy with CYC065 and venetoclax in CLL tumor samples, including those with 17p deletions. A CYC065-venetoclax combination regimen was active in two CLL samples resistant to either agent alone supporting the hypothesis that dual targeting of Mcl-1 and Bcl-2 dependent mechanisms could induce synergistic cell death.

·Patient enrollment continues for part 3 of the Phase 1 combination study evaluating sapacitabine and seliciclib (Cyclacel’s first-generation CDK inhibitor) in patients with advanced cancer, including BRCA positive breast, ovarian and pancreatic cancer patients. The objective of part 3 of the study is to test a revised dosing schedule to evaluate safety and initial efficacy.

·Cyclacel has submitted briefing documents and scheduled meetings with certain European regulatory authorities with the objective of determining a potential regulatory pathway for sapacitabine in elderly AML. The Company believes that the subgroup findings from the Phase 3 SEAMLESS study have defined a patient population for whom the sapacitabine regimen may represent an improvement over low intensity treatment by decitabine alone.

·The U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for CYC140, the Company’s internally-discovered, novel inhibitor of Polo-like-kinase 1, or PLK1. A first-in-human Phase 1 study is being planned.

Key Upcoming Business Objectives

·Initiate Phase 1b clinical trial evaluating CYC065 in combination with venetoclax in patients with relapsed or refractory CLL;

·Start enrollment in a Phase 1b/2 IST of sapacitabine and an approved PARP inhibitor combination treatment in patients with BRCA mutant breast cancer;

·Initiate CYC065 Phase 1b in advanced leukemias;

·Provide a clinical update from part 2 of the Phase 1 study evaluating CYC065 monotherapy in patients with advanced cancers;

·Conduct EU regulatory authority meetings regarding the SEAMLESS study of sapacitabine in elderly AML;

·Initiate Phase 1 trial evaluating CYC140, a PLK1 inhibitor; and

·Provide clinical update and complete enrollment of part 3 of the Phase 1 study of the sapacitabine and seliciclib combination in BRCA positive, breast, ovarian and pancreatic cancer patients.

Financial Highlights

As of June 30, 2018, cash and cash equivalents totaled $19.8 million, compared to $23.9 million as of December 31, 2017. The decrease of $4.1 million was primarily due to net cash used in operating activities.

Research and development expenses were $1.2 million for each of the three months ended June 30, 2018 and 2017.

General and administrative expenses were $1.3 million for each of the three months ended June 30, 2018 and 2017.

Other income, net for the three months ended June 30, 2018 was $0.1 million compared to $34,000 for the same period of the previous year.

The United Kingdom research and tax credits were $0.5 million for the three months ended June 30, 2018 compared to $0.3 million for the same period in 2017.

Net loss for the three months ended June 30, 2018 was $1.9 million compared to $2.2 million for the same period in 2017.

Conference call information:

US/Canada call: (877) 493-9121 / international call: (973) 582-2750

US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406

Code for live and archived conference call is 4689089

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.

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]).

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]).

"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]).

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.