On November 14, 2016 Cleveland BioLabs, Inc. (NASDAQ:CBLI) reported financial results and development progress for the third quarter ended September 30, 2016 (Filing, Q3, Cleveland BioLabs, 2016, NOV 14, 2016, View Source [SID1234516629]).

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Cleveland BioLabs reported net income of $1.1 million, excluding minority interests, for the third quarter of 2016, or $0.10 per share, compared to a net loss, excluding minority interests, of $(3.1) million, or $(0.31) per share, for the same period in 2015. Net loss, excluding minority interests, for the first nine months of 2016 was $(1.4) million, or $(0.13) per share, compared to a net loss, excluding minority interests, of $(11.2) million, or $(1.93) per share, for the same period in 2015. The reduction in net loss for both periods due to operating results was attributable to increased revenues and lower costs with the most significant being a reduction in the non-cash adjustment to our warrant liabilities and reduced operating costs aligned with our streamlined focus primarily on pursuing a pre Emergency Use Authorization ("pre-EUA") for entolimod with the U.S. Food and Drug Administration ("FDA"). Additionally, the weighted average outstanding shares for the nine month period significantly increased, which thereby lowers the per share results, due to the issuance of approximately 6.5 million shares in July 2015.

As of September 30, 2016, the Company had $14.9 million in cash, cash equivalents and short-term investments, which, based on the Company’s current operational plan, is expected to fund the Company’s operating requirements beyond one year.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "The side-by-side analytical comparability analysis of two formulations of entolimod is on schedule to be completed in the fourth quarter of 2016. Once we have this data and once the FDA has finalized the biocomparability study design, the biocomparability study in non-human primates ("NHP") may commence. We expect the NHP study will require approximately 6 months to complete, and we will update guidance on this point after the FDA has completed its reviews and our vendors have confirmed timing."

"In addition, we are in ongoing discussions with the European Medicines Agency ("EMA") for a pediatric investigational plan ("PIP") for entolimod as a medical radiation countermeasure. A proposed PIP was filed with the EMA. The EMA requires an agreement on a PIP with the sponsor as a prerequisite to filing a Marketing Authorization Application ("MAA"). We cannot currently estimate when an agreement on the PIP will be reached or if any additional studies will be required for an MAA submission."

"Clinical oncology studies with entolimod, CBLB612 and Mobilan are progressing in the Russian Federation," added Dr. Kogan. "Recruitment was completed in a Phase 2 study of entolimod as a neo-adjuvant therapy in treatment-naïve patients with primary colorectal cancer and a Phase 2 study of CBLB612 as myelosuppressive prophylaxis in patients with breast cancer receiving doxorubicin-cyclophosphamide chemotherapy. The data from these studies are being analyzed. Panacela Labs is now dosing Mobilan in two dose-escalation Phase 1 studies evaluating single and double injection regimens administered directly into the prostate of patients with prostate cancer. All of these studies are supported by development contracts with the Russian Federation Ministry of Industry and Trade."

Further Financial Results

Revenue for the third quarter of 2016 increased to $1.1 million compared to $0.5 million for the third quarter of 2015. Revenue for the first nine months of 2016 increased to $2.5 million compared to $1.4 million for the first nine months of 2015. These increases were primarily attributable to work performed under contracts from the Department of Defense for the continued development of the entolimod as a medical radiation countermeasure.

Research and development costs for the third quarter of 2016 decreased to $1.1 million compared to $2.1 million for the third quarter of 2015. Research and development costs for the first nine months of 2016 decreased to $4.3 million compared to $5.2 million for the first nine months of 2015. The reduction in research and development costs for both periods is due to our streamlined focus primarily on pursuing a pre-EUA with the FDA.

General and administrative costs for the third quarter of 2016 decreased to $0.8 million compared to $1.3 million for the third quarter of 2015. General and administrative costs for the first nine months of 2016 decreased to $2.7 million compared to $5.2 million for the first nine months of 2015. This decrease was primarily attributable to reductions in personnel and outside professional costs.

As of October 31, 2016 the Company had approximately 11 million shares of common stock outstanding. In addition, the Company has approximately 0.2 million shares of common stock reserved for issuance pursuant to outstanding stock options with a weighted average exercise price of $42.50 and approximately 2.1 million shares of common stock reserved for issuance pursuant to outstanding warrants exercisable at a weighted average price of $11.04.

On November 14, 2016 Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies including dermatology, oncology, anti-inflammatory, and antibiotic applications, reported a general business update and announced select financial results for the first quarter of fiscal year 2017 ended September 30, 2016 (Filing, Q3, CellCeutix, 2016, NOV 14, 2016, View Source [SID1234516621]).

Recent Highlights

Management Team Additions

· Arthur P. Bertolino, MD, PhD, MBA – President and Chief Medical Officer

· Jane Harness – Vice President of Clinical Sciences and Portfolio Management

· Dr. LaVonne Lang – Vice President of Regulatory Affairs

Dr. Bertolino, Ms. Harness and Dr. Lang are distinguished in their respective fields and cumulatively bring about 70 years of drug development experience to Cellceutix earned during highly relevant positions at major pharmaceutical companies including Parke-Davis, Pfizer and Novartis. "In their brief time at Cellceutix, Dr. Bertolino, Ms. Harness and Dr. Lang have proven to be extremely valuable in efficiently moving our pipeline forward," said Leo Ehrlich, CEO of Cellceutix.

Portfolio Development

· Brilacidin (Inflammatory Bowel Disease)

· Initial comments received on the first patient in the Company’s Phase 2a trial of Brilacidin for ulcerative proctitis (UP) / ulcerative proctosigmoiditis (UPS), (Inflammatory Bowel Disease; IBD), showed a significant decrease in symptoms within one week of the lowest scheduled dose of Brilacidin therapy

· New data received during the current quarter shows clinically meaningful improvements in the first four patients of the first cohort who completed the trial at the lowest dosing level. The final two patients in the first cohort are currently receiving Brilacidin therapy

· In four patients evaluated to date, concentrations of Brilacidin in plasma were undetectable, meaning that risk of systemic exposure during localized treatment appears to be minimized

· Completion of the first cohort and start of second cohort is anticipated in December 2016

· Visiongain forecasts IBD medicines market to rise to $9.3 billion in 2019

1

· Brilacidin-OM (Oral Mucositis)

· Phase 2 trial evaluating the oral rinse Brilacidin-OM for treating and preventing chemoradiation-induced oral mucositis (OM) in head and neck cancer patients remains ongoing

· Interim analysis anticipated 1H 2017

· Data from UP/UPS trial provide evidentiary support to the anti-inflammatory activity of Brilacidin in localized therapy; Cellceutix is optimistic the lack of systemic exposure will translate to the OM trial

· Brilacidin (Anti-Infective)

· Phase 2b trial was successfully completed previously showing Brilacidin non-inferior with similar safety profile to blockbuster daptomycin in treating Acute Skin and Skin Structure Infections (ABSSSI)

· Now working with U.S. Food and Drug Administration on a Special Protocol Assessment (SPA) agreement – will be positioned to move into Phase 3 research upon finalizing SPA and securing funding as to not impede other pipeline developments

· Kevetrin (Solid Tumors)

· Phase 1 successfully completed previously in patients with advanced solid tumors

· Now preparing for Phase 2a study to better define the mechanism of action of Kevetrin, specifically the modulation of p53 within the tumor

· Phase 2a trial planned to be initiated

· Laboratory work being conducted to develop an oral formulation of Kevetrin with the goal of capitalizing on Kevetrin’s short half-life of only approximately two hours
· Oral dosing is the preferred method for patients; the value of a new oral drug can be significant

· An oral delivery formulation greatly increases ease of treatment and viability of multiple daily or weekly doses of Kevetrin

· Cellceutix is attempting to develop and commercialize not only the world’s first p53-modulating drug, but the first oral formulation of a p53-modulating drug

· Prurisol (Chronic Plaque Psoriasis)

· Phase 1 (healthy subjects) and Phase 2a (mild to moderate psoriasis patients) already successfully completed

· Phase 2b underway in patients with moderate to severe psoriasis

· Value of new oral treatment for psoriasis demonstrated by high valuations in recent M&A activity

· Interim analysis from the Phase 2b trial expected 1H 2017

"It was a great quarter for Cellceutix as we achieved some of the most important developments yet in the history of our Company. Specifically, we demonstrated limited systemic risk in localized Brilacidin therapy, with drug concentrations in plasma below the lower limit of quantification (<100 ng/mL); advancements have been made for an oral formulation of Kevetrin; and we are progressing in our clinical trials," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "These discoveries and advancements are proving the potential of our drug candidates and attracting attention from larger peers, as measured by the fact that we have engaged in more high level meetings recently than at any other time since inception. We have yet to fail in any clinical trial with any of our drug candidates and remain on target with our long-term goal to grow shareholder value by developing our drugs for hard-to-treat indications to provide relief for millions of people suffering worldwide. I believe that is more than ample reason to be excited about all that we have accomplished, our future and the litany of catalysts expected in 2017."

Financial Results for the First Quarter of Fiscal 2017

The current primary potential source of cash available to the Company, are equity investments through its equity purchase agreement with Aspire Capital. The Company has financed its operations to date through the sale of its common stock. The Company had raised approximately $8.2 million for the fiscal year ended June 30, 2016 and $1.9 million for the three months ended September 30, 2016, through its equity purchase agreement with Aspire Capital.

At September 30, 2016, the Company had approximately $5.6 million in cash compared to approximately $6.3 million in cash at June 30, 2016. Stockholders’ equity was approximately $2.1 million compared to approximately $3.0 million at June 30, 2016.

For the three months ended September 30, 2016, the Company’s net loss was approximately $3.0 million, or a loss of $0.02 per share compared to a net loss of $2.6 million, or a loss of $0.02 per share, for the three months ended September 30, 2015.

Stock-based compensation expense was $0.3 million for the three months ended September 30, 2016 compared to $0.1 million for the three months ended September 30, 2015. For the three months ended September 30, 2016, the Company’s cash flows used in operating activities were $2.6 million versus $2.1 million for the three months ended September 30, 2015. This is primarily due to an increase in our operating expenses, which includes research and development expenses, in 2016.

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On November 14, 2016 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported its financial results for the quarter ending September 30, 2016, the first quarter of the Company’s 2017 fiscal year (Press release, DelMar Pharmaceuticals, NOV 14, 2016, View Source [SID1234516612]). DelMar executive management will host a business update conference call and live webcast for investors, analysts and other interested parties on Tuesday, November 15, 2016 at 4:30 pm EST.

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"Looking back, 2016 has been a transformational year for our Company," stated Jeffrey Bacha, DelMar’s Chairman and chief executive officer. Our goals this year included listing our company’s shares on a national exchange, successfully completing our initial Phase I/II clinical trial in refractory GBM, preparing for a pivotal Phase III clinical trial and expanding our research efforts with VAL-083 into new indications."

RECENT CORPORATE HIGHLIGHTS

DelMar raised gross proceeds of approximately $7.2 million in a private placement and our common stock began trading on the Nasdaq Capital Markets under the symbol "DMPI";
DelMar confirmed that the Institutional Review Board ("IRB") at the University of Texas MD Anderson Cancer Center ("MD Anderson") approved our planned Phase II clinical study with VAL-083 in patients with GBM at first recurrence/progression;
DelMar reported promising data from our Phase I/II clinical trial of VAL-083 in refractory GBM at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") annual meeting; supporting the potential for an improved survival benefit for bevacizumab-failed GBM patients treated with VAL-083 in comparison to current salvage chemotherapy;
DelMar announced the successful completion of an ‘End of Phase II’ meeting with the FDA and confirmed plans to advance VAL-083 into a pivotal Phase III clinical trial for GBM patients whose tumors have progressed following treatment with bevacizumab;
DelMar entered into a collaborative research agreement with Accurexa, Inc. to explore local delivery of VAL-083 as a potential combination therapy for the treatment of brain tumors;
DelMar continued to report promising research results supporting the potential of VAL-083 in new indications:
Presented data supporting the effectiveness of VAL-083 against chemotherapy-resistant ovarian cancers, including data suggesting the potential for treatment synergy of VAL-083 combined with Astra Zeneca’s PARP inhibitor, Lynparza (olaparib), at the 11th Biennial Ovarian Cancer Research Symposium;
Presented new research results demonstrating that VAL-083 exhibits a distinct mode of action compared to other chemotherapies used in the treatment of newly diagnosed GBM patients at the European Association of Neuro-Oncology annual meeting;
Presented new non-clinical data supporting the differentiation of VAL-083 in the treatment of lung cancer in comparison to platinum and tyrosine kinase inhibitor treatments at the AACR (Free AACR Whitepaper) New Horizons in Cancer Research meeting;
Presented data indicating that VAL-083 offers potential therapeutic alternatives in difficult-to-treat pediatric brain tumors at the AACR (Free AACR Whitepaper) – Advances in Pediatric Research: From Mechanisms and Models to Treatment and Survivorship Conference.
DelMar continued to strengthen its intellectual property portfolio. DelMar now holds six issued US patents and seven issued patents outside of the US representing thirteen patent families in various stages of prosecution, and over 100 patent filings in total.
"We were very pleased with the outcome of our End-of-Phase II meeting and the guidance provided by the FDA," said Mr. Bacha. "The DelMar clinical team and our advisors have been developing a Phase III study protocol that would provide strong statistical power, enroll fewer than 200 patients, and is designed to reach its final endpoint in two years or less. We plan to submit the protocol to the FDA in the coming weeks, and subject to the FDA’s continued guidance and availability of funding, anticipate initiating a registration-directed Phase III study as soon as practicable."

DelMar is also pleased to confirm the accomplishment of critical steps toward initiating new clinical trials designed to position VAL-083 as an alternative to temozolomide in newly diagnosed GBM for patients whose tumors exhibit a high expression of MGMT, the DNA repair enzyme linked to failure of standard front-line chemotherapy and poor patient outcomes:

The MD Anderson IRB has approved the protocol of the Company’s planned Phase II Study of VAL-083 in patients with MGMT-unmethylated, bevacizumab-naive recurrent glioblastoma. DelMar anticipates completing study initiation activities and commencing the dosing of patients in the coming weeks.
The Company is also completing the final remaining steps required for initiation of an international clinical trial in newly diagnosed GBM patients with high expression of MGMT.
"Importantly, these two new Phase II trials are largely supported through our collaborators, so their initiation will not materially impact our near-term cash expenditures," stated Mr. Bacha. "Our current working capital will support DelMar’s operations for at least the next twelve months and, while our planned Phase III clinical trial will require additional financing, we have the opportunity to expand our clinical research efforts in GBM and to continue advancing our research into new indications without an immediate need to raise additional funds."

EXPECTED NEAR-TERM MILESTONES

Commence treating patients at MD Anderson with VAL-083 in a Phase II clinical study of GBM patients with high expression of MGMT at first recurrence/progression;
Submit a Phase III protocol to the FDA proposing a pivotal, multi-center, randomized clinical trial of VAL-083 in GBM patients who have failed both standard chemo-radiation and bevacizumab;
Initiate a Phase II clinical trial in China in newly-diagnosed GBM patients as an alternative to temozolomide in patients with high expression of MGMT;
Expand DelMar’s clinical research with VAL-083 in new solid tumor indications, subject to financial resources;
Present our research results at international peer-reviewed scientific meetings;
Continue to pursue pre-clinical research that further differentiates VAL-083 from established chemotherapeutic regimens, and to identify opportunities for combination therapy;
Maximize the value of the VAL-083 pipeline through collaborations with industry leaders in attractive oncology markets; and
Continue to build our intellectual property portfolio.

On November 14, 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 third quarter ended September 30, 2016 (Press release, Cyclacel, NOV 14, 2016, View Source [SID1234516611]).

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The Company’s net loss applicable to common shareholders for the third quarter ended September 30, 2016 was $3.0 million, or $0.86 per basic and diluted share, compared to net loss applicable to common shareholders of $2.8 million, or $0.95 per basic and diluted share for the third quarter ended September 30, 2015. As of September 30, 2016, cash and cash equivalents totaled $18.0 million.

"SEAMLESS, a Phase 3 study of oral sapacitabine capsules, represents one of the largest clinical trials conducted in elderly patients with AML who are unfit for or refused intensive chemotherapy. Following completion of follow-up at the beginning of the quarter, we have been conducting data validation operations," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "We are pleased to report that this process is nearing completion following which the database will be locked and transferred to our statistical analysis vendor. We anticipate reporting top line results late in the fourth quarter of 2016 or in early 2017."

"The collection and processing of SEAMLESS Phase 3 data represent many years of effort in our search to offer a new treatment regimen for this older patient population. We will soon analyze the data and determine whether the results warrant regulatory submissions," said Dr. Judy Chiao, VP, Clinical Development and Regulatory Affairs. "We are grateful to the patients, their families, the investigators and their teams for their valuable contributions to this study."

"During the quarter data presented at a pediatric cancer meeting demonstrated that CYC065, our second generation Cyclin Dependent Kinase (CDK) inhibitor, prolonged survival in MYCN-addicted neuroblastoma models. The data further validate the mechanism of CYC065 and provide a rationale for clinical investigation in neuroblastoma with MYCN amplification, a major oncogenic driver of this childhood cancer. MYC family proteins are important therapeutic targets in other oncology indications, including certain solid tumors, leukemias and lymphomas. Early clinical and preclinical data from our DNA damage response program suggest that our transcriptional CDK inhibitors may have a synergistic effect with other anticancer agents, including sapacitabine. We look forward to reporting new data from our ongoing clinical studies of sapacitabine and seliciclib in BRCA positive patients and of CYC065 in patients with solid tumors," continued Mr. Rombotis.

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 for or refused intensive chemotherapy; cleaned and validated dataset being finalized and database lock imminent.
DNA damage response program

The Phase 1 combination of sapacitabine and seliciclib is continuing enrollment in an extension study in an enriched population of BRCA positive patients with advanced 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. The sixth dose escalation level has been reached.

Preclinical data presented at the Childhood Cancer Meeting 2016 demonstrated effectiveness of CYC065 against neuroblastoma models with an overexpression and amplification of MYCN, a driver of neuroblastoma.
KEY UPCOMING MILESTONES

SEAMLESS study

Report top-line data and determination of submissibility to regulatory authorities, anticipated late fourth quarter 2016 or early 2017.
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.
Initiate 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.
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 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.
THIRD QUARTER 2016 FINANCIAL RESULTS

Cash and cash equivalents totaled $18.0 million as of September 30, 2016 compared to $20.4 million at December 31, 2015. Approximately $5.2 million was raised from the sale of common stock through the Company’s at-the-market facility with FBR Capital Markets. A further $1.5 million was received in October 2016 through this facility, resulting in a proforma cash balance as of September 30, 2016 of $19.5 million. Based on current plans, the Company estimates that it has capital resources to fund operations through the second quarter of 2018.

Revenue for the three months ended September 30, 2016 was $0.2 million, compared to $0.7 million for the same period of the previous year, with the decrease primarily related to grant revenue related to CYC065, for which the grant ended in December 2015.

Research and development expenses were $2.4 million for the three months ended September 30, 2016 and $2.9 million for the three months ended September 30, 2015.

General and administrative expenses were $1.3 million for the three months ended September 30, 2016 and $1.2 million for the three months ended September 30, 2015.

On November 14, 2016 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, reported financial results for the three and nine months ended September 30, 2016

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CASI PHARMACEUTICALS REPORTS THIRD QUARTER 2016 FINANCIAL RESULTS.

As of September 30, 2016, CASI had cash and cash equivalents of approximately $24.1 million.

CASI reported a net loss for the third quarter of 2016 of ($1.7 million), or ($0.03) per share. This compares with a net loss of ($1.6 million), or ($0.05) per share, for the same period last year. For the first nine months of 2016, the reported net loss was ($6.8 million), or ($0.15) per share as compared to ($5.5 million), or ($0.17) per share for the first nine months of 2015.

Commenting on these results, Sara B. Capitelli, CASI’s Vice President, Finance, said, "Our third quarter 2016 financial results were in line with expectations. Research and development expenses increased during the 2016 period compared with the previous year primarily due to costs associated with our ENMD-2076 fibrolamellar carcinoma trial which began in late 2015. As we continue to execute our regulatory, clinical and business development plan, we expect operating expenses to increase for the remainder of 2016."

Ken K. Ren, Ph.D., CASI’s Chief Executive Officer, stated, "I am pleased with our third quarter financial results. In October, we completed the last closing ($7.8 million) of our previously announced financing, and also completed an additional $3.0 million financing. Participants in the financing included our existing shareholders represented on our Board of Directors. In addition to a positive financial outlook, we look forward to further advancing our proprietary clinical candidate ENMD-2076, as well as MARQIBO, ZEVALIN and EVOMELA in China, and securing additional in-license assets to expand our pipeline. Proceeds from the recent financings will help accelerate these activities."