Cyclacel Pharmaceuticals Reports 2nd Quarter 2016 Financial Results

On August 10, 2016 Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) ("Cyclacel" or the "Company"), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, reported financial results and business highlights for the second quarter ended June 30, 2016 (Press release, Cyclacel, AUG 10, 2016, View Source [SID:1234514462]).

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The Company’s net loss applicable to common shareholders for the second quarter ended June 30, 2016 was $3.0 million, or $1.01 per basic and diluted share, compared to net loss applicable to common shareholders of $3.4 million, or $1.19 per basic and diluted share for the second quarter ended June 30, 2015. As of June 30, 2016, cash and cash equivalents totaled $15.9 million.

"Subsequent to the end of the quarter, we achieved a key milestone in our acute myeloid leukemia (AML) SEAMLESS Phase 3 study," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "The required number of events has been reached and preparations for final analysis and reporting of SEAMLESS outcomes are underway. Over the next several weeks, we will complete data cleaning and validation operations after which the database will be transferred to our statistical analysis vendor. We will subsequently report outcomes for the primary (overall survival) and secondary endpoints and determination of submissibility of the SEAMLESS data set to regulatory authorities in Europe and the United States.

In our DNA damage response program, durable antitumor activity was reported at an oral presentation at the 2016 ASCO (Free ASCO Whitepaper) Annual Meeting with a combination of sapacitabine and seliciclib, our CDK2/9 inhibitor, in heavily pretreated patients with breast, ovarian and pancreatic cancers who tested positive for BRCA mutations. A disease control rate of 35.6% was observed, with ongoing responding patients achieving treatment durations exceeding 1 and 4.7 years, respectively. We continue to enroll patients with solid tumors in a first-in-human, Phase 1 study of CYC065, our second-generation CDK2/9 inhibitor."

BUSINESS HIGHLIGHTS

SEAMLESS study

Phase 3 study of oral sapacitabine capsules alternating with intravenous decitabine compared to decitabine alone, as first-line treatment in patients aged 70 years or older with AML who are unfit or refused intensive chemotherapy, reached the number of events required for final analysis.
Preparations are underway for final analysis of study data.
DNA damage response program

Oral presentation of data at 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Phase 1 combination of sapacitabine and seliciclib as orally-administered treatment in 67 heavily-pretreated patients. Antitumor activity in subgroup of 45 patients with breast, ovarian and pancreatic cancers who tested positive for BRCA mutations. Disease control rate of 35.6% (1 CR, 5 PR and 10 SD). No CR or PR observed in BRCA negative patients.
Ongoing extension cohort in BRCA positive patients with breast cancer.
Cyclin dependent kinase (CDK) inhibitor program

Continued recruitment in Phase 1, first-in-human trial of CYC065, a CDK2/9 inhibitor, to evaluate safety, tolerability and pharmacokinetics in patients with solid tumors and lymphomas.
Corporate

Received notification from the Listing Qualifications Staff of NASDAQ that the Company regained compliance with the minimum bid price rule for continued listing on The NASDAQ Capital Market.
Effected a one-for-twelve reverse stock split of the Company’s outstanding shares of common stock.
Entered into an At Market Issuance Sales Agreement with FBR Capital Markets & Co. under which the Company may, from time to time, sell shares of the Company’s common stock.
Terminated Controlled Equity OfferingSM sales agreement with Cantor Fitzgerald & Co.
KEY UPCOMING MILESTONES

SEAMLESS study

Study database locked in preparation for final data analysis.
Report top-line data and determination of submissibility to regulatory authorities, anticipated in the fourth quarter 2016.
Progress the Paediatric Investigation Plan for sapacitabine with the European Medicines Agency.
DNA damage response program

Progress Phase 1 sapacitabine and seliciclib extension cohort in a breast cancer patient population enriched for BRCA mutations.
Plan to add Phase 1, part 3 to include BRCA mutation positive, pancreatic and ovarian cancer patients.
CDK Inhibitor Program

Report top-line results of the CYC065 Phase 1 trial in patients with solid tumors and lymphomas.
Report data when available from ongoing investigator sponsored trials (ISTs) evaluating seliciclib in patients with Cushing’s disease and rheumatoid arthritis. Additionally, seliciclib is being evaluated in cystic fibrosis though a license and supply agreement with ManRos Therapeutics.
Sapacitabine in myelodysplastic syndromes (MDS):

Plan a Phase 1/2 trial of sapacitabine in combination with other agents to determine safety and tolerability.
Plan a Phase 2 randomized controlled trial (RCT) of sapacitabine in combination with other agents following review of all relevant clinical data with mature follow-up.
SECOND QUARTER 2016 FINANCIAL RESULTS

Grant Revenue

Revenue for the three months ended June 30, 2016 was $0.2 million, compared to $0.3 million for the same period of the previous year. The revenue is related to previously awarded grants from the UK government being recognized over the period to progress CYC065 to IND and complete IND-directed preclinical development of CYC140, a novel, orally available, Polo-Like Kinase 1 (PLK 1) inhibitor.

Research and Development Expenses

Research and development expenses were $2.6 million for the three months ended June 30, 2016 and $2.6 million for the three months ended June 30, 2015.

General and Administrative Expenses

General and administrative expenses were $1.3 million for the three months ended June 30, 2016 and $1.3 million for the three months ended June 30, 2015.

Based on current plans, the Company estimates that it has capital resources to reach beyond the final analysis of SEAMLESS and continue existing programs through the first quarter of 2018.

Argos Therapeutics Reports Second Quarter 2016 Financial Results and Recent Operational Highlights

On August 10, 2016 Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer based on the Arcelis technology platform, reported financial results for the second quarter ended June 30, 2016 and provided an update on the Company’s corporate and operational highlights (Press release, Argos Therapeutics, AUG 10, 2016, View Source [SID:1234514461]).

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"The second quarter saw us continue to build on the accomplishments and momentum from the first quarter," said Jeff Abbey, president and chief executive officer. "In June, our Independent Data Monitoring Committee recommended the continuation of our ADAPT Phase 3 trial of our lead product candidate, AGS-003, in metastatic renal cell carcinoma. As a result of this positive decision, we were able to close on the $29.8 million second tranche of the financing we announced in March of this year. In addition, we were pleased to successfully complete a $50.0 million follow-on offering in early August. Together, these financings have provided the capital to advance key activities as we continue on the path toward our goal of becoming a fully-integrated commercial biotechnology company."

Mr. Abbey continued, "Specifically, we are advancing our plans for the build-out and equipping of a commercial manufacturing facility and expect to finalize our arrangements for the facility during the third quarter of 2016. We will then promptly begin the build out and equipping of the facility so that we will be in a position to submit a biologic license application (BLA) as expeditiously as possible following the availability of overall survival data from the ADAPT trial, provided that the data are supportive. We also intend to expand our clinical development activities in a measured manner as we explore additional oncology indications, including the ongoing trials of AGS-003 as neodjuvant therapy in renal cell carcinoma and in non-small cell lung cancer."

"In addition to our clinical development efforts with respect to AGS-003, during July the first patient was dosed in stage 2 of our adult eradication trial of AGS-004 in the treatment of HIV, which is the first clinical trial evaluating the ‘kick and kill’ approach employing a validated HIV latency-reversing drug combined with an individualized immunotherapy. We look forward to the results of this trial, as it represents another exciting opportunity for the application of our platform technology," added Mr. Abbey. "During the quarter, we were also pleased to announce our new research agreement with Adaptive Biotechnologies, which we believe will help to more precisely analyze target-specific immune activation enabled by Arcelis administration."

"Finally, we were pleased to announce the recent appointment of Dr. Richard D. Katz as chief financial officer," continued Mr. Abbey. "As a seasoned biotechnology finance executive, Rich brings a wealth of experience that will be extremely valuable as we continue to build the company and advance towards commercialization."

Second Quarter 2016 and Recent Operational Highlights:

In June 2016, the Independent Data Monitoring Committee (IDMC) recommended the continuation of the ADAPT Phase 3 study of AGS-003 in metastatic renal cell carcinoma
In June 2016, the company closed on the $29.8 million second tranche of March 2016 Financing
In June 2016, the company was added to the Russell 2000 Index
In June 2016, the company entered into a strategic research agreement with Adaptive Biotechnologies
In July 2016, announced the first patient had been dosed in the stage 2 of the adult eradication trial of AGS-004 in the treatment of HIV
In August 2016, the company completed a $50.0 million equity financing
Selected Second Quarter 2016 Financial Results

Net loss for the three months ended June 30, 2016 was $12.6 million, or $0.48 per share, compared to a net loss of $19.6 million, or $0.95 per share, for the same period in 2015. Net loss for the six months ended June 30, 2016 was $25.4 million, or $1.04 per share, compared to a net loss of $37.2 million, or $1.84 per share, for the same period in 2015.

Revenue for the three months ended June 30, 2016 totaled $0.5 million compared to $0.1 million for the same period in 2015. Revenue for the six months ended June 30, 2016 totaled $0.6 million compared to $0.3 million for the same period in 2015.

Research and development expense for the three months ended June 30, 2016 totaled $9.2 million compared to $16.1 million for the same period in 2015. Research and development expense for the six months ended June 30, 2016 totaled $18.7 million compared to $30.9 million for the same period in 2015.

General and administrative expense for the three months ended June 30, 2016 totaled $3.4 million compared to $2.9 million for the same period in 2015. General and administrative expense for the six months ended June 30, 2016 totaled $6.4 million compared to $5.3 million for the same period in 2015.

As of June 30, 2016, Argos’ cash, cash equivalents and short-term investments totaled $34.8 million compared to $7.2 million as of December 31, 2015.

Conference Call and Webcast Details

Argos executive management will host a conference call beginning at 4:30 p.m. Eastern Time today to discuss these results and to answer questions.

To participate by telephone, please dial (855) 433-0930 (Domestic) or (484) 756-4271 (International). The conference ID number is 60556076. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.argostherapeutics.com. The archived webcast will remain available on the Company’s website for twelve (12) months following the call.

About the Arcelis Technology Platform
Arcelis is a precision immunotherapy technology that captures both mutated and variant antigens that are specific to each patient’s individual disease. It is designed to overcome immunosuppression by producing a specifically targeted, durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to the treatment of a wide range of different cancers and infectious diseases, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized immunotherapies. The Arcelis process uses only a small disease sample or biopsy as the source of disease-specific antigens, and the patient’s own dendritic cells, which are optimized from cells collected by a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease-specific antigens. These activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma, and administered via intradermal injection as an individualized immunotherapy.

TARIS Biomedical® Launches Second Phase 1b Clinical Trial of TAR-200 (GemRIS™) in Patients with Bladder Cancer

On August 10, 2016 TARIS Biomedical, a company developing powerful and targeted new treatments for millions of patients suffering from difficult-to-treat bladder diseases, reported the initiation of a Phase 1b clinical trial of TAR-200 (GemRIS, Gemcitabine Releasing Intravesical System) in patients with non-muscle-invasive bladder cancer (NMIBC) (Press release, TARIS Biomedical, AUG 10, 2016, View Source [SID:1234514500]). The study, which is being conducted in Europe, is the second Phase 1b trial of TAR-200 in bladder cancer. TARIS announced the initiation of a study in muscle-invasive bladder cancer (MIBC) in July 2016. TAR-200, a drug-device combination product utilizing the TARIS System, is designed to release gemcitabine continuously into the bladder over 7 days.

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"Non-muscle-invasive bladder cancer, which represents 70-75% of newly diagnosed cases, is a serious disease with a profound impact on the lives of patients. The current management of this cancer includes repeated surgical and pharmacological interventions, as well as lifelong monitoring. Despite these efforts, many patients are still at risk of recurrence and, in some cases, progression to MIBC," said Christopher J. Cutie, MD, Chief Medical Officer of TARIS. "TAR-200 may ultimately offer a unique non-surgical approach in the management of this disease."

"The initiation of a second study of TAR-200 is another substantial milestone for our organization," said Purnanand Sarma, Ph.D., President and Chief Executive Officer of TARIS. "If successful, these two studies are designed to demonstrate the potential utility of TAR-200 across the entire spectrum of bladder cancer. We are very excited to advance these programs into the clinic and look forward to the results."

About the TAR-200 Phase 1b Trial
The Phase 1b open-label study will assess whether continuous, local exposure to gemcitabine using TAR-200 is safe and tolerable in patients with intermediate risk NMIBC. The study will also assess the preliminary efficacy and pharmacokinetics in this patient population. The study will be conducted at multiple sites in Europe and expects to enroll up to 30 patients after the diagnosis of NMIBC and before transurethral resection of bladder tumors (TURBT).

About TAR-200
TAR-200 (GemRIS) is TARIS’ first product candidate in bladder cancer. TAR-200 is a drug-device combination product designed to release gemcitabine continuously into the bladder over 7 days. Gemcitabine is commonly used to treat multiple cancers alone and in combination with other chemotherapeutic drugs.1 TARIS believes TAR-200 has the potential to set a new standard of care in bladder cancer, with enhanced efficacy and minimal systemic side effects compared to current approaches. TARIS is developing TAR-200 to address unmet needs in both muscle-invasive and non-muscle-invasive bladder cancer.

About Non-Muscle-Invasive Bladder Cancer
Bladder cancer affects roughly 2.7 million people worldwide, including nearly 600,000 in the United States.2 The National Cancer Institute estimates that there will be a total of nearly 77,000 new cases and 16,000 deaths due to this disease in 2016.3 When measured as a cumulative lifetime per patient cost, bladder cancer exceeds all other forms of cancer.4 The estimated U.S. national expenditure on bladder cancer was $4.3 billion in 2014. 5

Non-muscle-invasive bladder cancer (NMIBC) represents 70-75% of newly diagnosed cases. NMIBC tumors are confined to the innermost layers of the bladder wall, and have not progressed into the deeper muscle layer or beyond. These tumors are currently managed using local resection (transurethral resection of bladder tumors or TURBT) and local pharmacological intervention. While current treatments often eliminate the existing tumor(s), the disease frequently recurs, requiring lifelong monitoring and repeated intervention. Further, higher-risk tumors that recur or progress despite these therapies often require patients to undergo radical cystectomy (complete surgical removal of the bladder). Radical cystectomy is a major, life changing procedure, and many patients are medically unfit and/or unwilling to undergo this surgery.

Oncolytics Biotech® Inc. Reports Additional Data from Randomized Phase II Study of REOLYSIN® in Non-Small Cell Lung Cancer

On August 10, 2016 Oncolytics Biotech Inc. ("Oncolytics" or the "Company") (TSX:ONC) (OTCQX:ONCYF) (FRA:ONY) reported additional data from IND 211, a randomized, Phase II clinical study of REOLYSIN in patients with non-small cell lung cancer ("NSCLC") (Press release, Oncolytics Biotech, AUG 10, 2016, View Source [SID:1234514493]). The study enrolled patients with both non-squamous (adenocarcinoma) and squamous cell histology. Those with adenocarcinoma (n=75) were treated with REOLYSIN in combination with pemetrexed in the test arm versus pemetrexed alone in the control arm. Those with squamous cell histology (n=76) were treated with REOLYSIN in combination with docetaxel in the test arm versus docetaxel alone in the control arm. The study’s primary objective was progression free survival ("PFS"). Its secondary objectives included overall survival ("OS"), safety, and measurement of biomarkers that may be predictive of response.

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Results in Patients with Adenocarcinoma by Patient Gender
An analysis was performed of survival outcomes for patients with adenocarcinoma by gender. The PFS was statistically significantly better for female patients in the test arm (n=20) than for those in the control arm (n=16); median PFS was 5.39 months compared with 3.02 months, respectively (p=0.0201) (Figure A). The evolving OS showed a strong trend towards survival benefit for female patients in the test arm (n=20, six of whom remained alive at the time of the analysis) over those in the control arm (n=16, three of whom remained alive at the time of the analysis); median OS was 10.68 months compared with 7.59 months, respectively (p=0.145) (Figure B). By contrast, no PFS or OS benefit was noted for the male patients with adenocarcinoma.

"We are excited to see a statistically significant improvement in progression free survival for female patients with adenocarcinoma of the lung," said Dr. Brad Thompson, President and CEO of Oncolytics. "There is a significant unmet need for new therapies for non-small cell lung cancer patients."

Results in Patients with Adenocarcinoma by Patient Genetic Status
All patients were tested for biomarkers including those that are associated with the replication of the reovirus (namely, EGFR, Hras, Kras, Nras, Braf and/or p53 mutations) (the "target biomarkers"). Patients treated with REOLYSIN with one or more target biomarkers had a greater PFS (p=0.039) and OS (p=0.031) than patients treated with REOLYSIN without any of these biomarkers. The presence of these biomarkers may account, at least in part, for the difference between the survival outcomes for male and female patients; target biomarkers were present in a higher proportion of the female patients in the study than the male patients (66.7% versus 43.6%). As a result, pre-screening for target biomarkers in patients with adenocarcinoma of the lung is warranted.

Results in Patients with Squamous Cell Histology
The overall OS for patients with squamous cell histology continues to evolve. Target biomarkers were present in a smaller proportion of the overall patients with squamous cell histology (34.2% versus 54.7% of those with adenocarcinoma); therefore a larger patient population would be required to make statistical conclusions about the role of biomarkers in predicting response.

Next Steps
Based on the findings reported from IND 211, the Company intends to include preselection of patients using genetic screening in future study protocols.

About IND 211
IND 211 is an open-label, randomized, non-blinded two sided (adenocarcinoma and squamous cell carcinoma) Phase II study of intravenously administered REOLYSIN in patients with advanced or metastatic non-small cell lung cancer. Patients with squamous cell histology were treated with either REOLYSIN given in combination with docetaxel (test arm) or docetaxel alone (control arm). Patients with adenocarcinoma were treated with either REOLYSIN given in combination with pemetrexed (test arm) versus pemetrexed alone (control arm). After a patient safety run-in, a total of approximately 150 response-evaluable patients were enrolled. Preliminary data from this study were reported in May 2016. The study was sponsored by the Canadian Cancer Trials Group ("CCTG") at Queen’s University in Kingston, Ontario, formerly known as the National Cancer Institute of Canada ("NCIC") Clinical Trials Group.

About Non-Small Cell Lung Cancer
The American Cancer Society ("ACS") estimates that approximately 224,390 Americans will be diagnosed with lung cancer in 2016 and that 158,080 of them will die from the disease. Approximately 80% to 85% of lung cancer cases are non-small cell lung cancer. The ACS identifies multiple subtypes of non-small cell lung cancer based on the types of cells where they originate – adenocarcinoma accounts for about 40% of lung cancers and occurs more frequently in women than men; squamous cell carcinoma accounts for 25% to 30% of lung cancers; and large cell carcinoma accounts for 10% to 15% of lung cancers.