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Fortress Biotech Reports Second Quarter 2017 Financial Results and Recent Corporate Highlights

On August 9, 2017 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products, reported financial results and recent corporate highlights for the second quarter ended June 30, 2017 (Press release, Fortress Biotech, AUG 9, 2017, View Source [SID1234520115]).

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Dr. Lindsay A. Rosenwald, Fortress’ Chairman, President and Chief Executive Officer, said, "Fortress and our Fortress subsidiaries achieved important corporate and clinical milestones during the second quarter of 2017. Avenue Therapeutics completed a $38 million initial public offering, and is on track to initiate a Phase 3 clinical trial in the third quarter of IV tramadol in patients undergoing bunionectomy surgery. If approved, IV tramadol will be the only intravenous Schedule IV opioid for use in the United States. Avenue, along with Checkpoint Therapeutics, began trading their common shares on The NASDAQ Capital Market during the last week of June. In addition, Caelum Biosciences announced the dosing of the final patient in a Phase 1b clinical trial of its lead therapy, CAEL-101, in AL amyloidosis, with a data readout expected in the second half of 2017. Mustang Bio licensed three CAR T cell therapies from its research partner City of Hope, expanding its pipeline to five novel CAR T candidates."

Dr. Rosenwald continued, "Our strong business development engine continues to deliver on our goal of acquiring novel pharmaceutical and biotechnology products for development within Fortress and through our Fortress Companies. We look forward to continuing to execute on our business plan and reaching important milestones in the third quarter to add value for our shareholders."

Financial Results:

· As of June 30, 2017, Fortress’ consolidated cash and cash equivalents totaled $144.3 million, compared to $134.0 million at March 31, 2017, and $88.3 million at December 31, 2016, an increase of $10.3 million for the quarter and $56.0 million year-to-date. These totals as of June 30, 2017 exclude short-term investments of $20.0 million, restricted cash of $15.9 million and cash deposits with clearing organizations of $1.0 million.
· Net revenue totaled $50.7 million for the second quarter of 2017 and $95.4 million for the first six months of 2017, compared to $2.2 million for the second quarter of 2016 and $2.9 million for the first six months of 2016. Net total revenue for the second quarter ended June 30, 2017 includes $4.4 million of Fortress revenue and $46.3 million of revenue from National Holdings Corporation ("National"), which Fortress acquired in September 2016, with no revenue attributable to National prior to the acquisition.
· Research and development expenses were $11.7 million for the second quarter of 2017, of which $10.0 million was related to Fortress Companies, and $18.8 million for the first six months of 2017, of which $15.8 million was related to Fortress Companies. This compares to $6.3 million for the second quarter of 2016, of which $4.0 million was related to Fortress Companies, and $14.1 million for the first six months of 2016, of which $9.0 million was related to Fortress Companies. Non-cash stock-based compensation expense included in research and development for the second quarter of 2017 was $2.4 million, compared to $1.1 million for the second quarter of 2016, and $3.2 million for the first six months of 2017, compared to $2.4 million for the first six months of 2016.
· Research and development expenses from license acquisitions totaled $1.8 million for the second quarter of 2017 and $3.1 million for the first six months of 2017, compared to $2.0 million for the second quarter of 2016 and $2.1 million for the first six months of 2016.

· General and administrative expenses were $11.1 million for the second quarter of 2017, of which $7.0 million was related to Fortress Companies, and $21.4 million for the first six months of 2017, of which $12.8 million was related to Fortress Companies. This compares to $8.6 million for the second quarter of 2016, of which $3.7 million was related to Fortress Companies, and $16.6 million for the first six months of 2016, of which $6.6 million was related to Fortress Companies. Non-cash stock-based compensation expenses included in general and administrative expenses were $2.2 million for the second quarter of 2017, compared to $1.9 million for the second quarter of 2016, and $4.3 million for the first six months of 2017, compared to $3.5 million for the first six months of 2016.
· National’s operating expenses totaled $48.4 million for the second quarter of 2017 and $91.5 million for the first six months of 2017, with no expenses attributable to National prior to Fortress’ acquisition of the company in September 2016.
· Net loss attributable to common stockholders was $17.4 million, or $0.43 per share, for the second quarter of 2017, compared to a net loss attributable to common stockholders of $12.5 million, or $0.31 per share, for the second quarter of 2016. For the first six months of 2017, net loss was $29.3 million or $0.73 per share, compared to $24.7 million or $0.62 per share in the first six months of 2016.

Recent Fortress Biotech and Fortress Company Highlights:

Fortress Biotech, Inc.
· In June 2017, Ms. Robyn Hunter was named Chief Financial Officer of Fortress. Lucy Lu, M.D., Fortress’ former Chief Financial Officer, was appointed President and Chief Executive Officer of Fortress subsidiary Avenue Therapeutics, Inc.
· As of June 30, 2017, Fortress raised a total of $19.0 million in a Subordinated Note Financing; $15.7 million of the $19.0 million was raised in the second quarter of 2017. National Securities Corporation, a subsidiary of National, acted as the Placement Agent.

Avenue Therapeutics, Inc.
· In May 2017, Avenue received a Notice of Allowance from the U.S. Patent and Trademark Office ("USPTO") for a new patent application (U.S. Application No. 15/163,111) titled "Intravenous Administration of Tramadol." The patent application describes and claims a dosing regimen of intravenous ("IV") 50 mg tramadol that provides certain pharmacokinetic parameters that are similar to those of 100 mg tramadol HCl administered orally every six hours at a steady state. Issuance of the patent (U.S. Patent No. 9,693,949) occurred in July 2017. This patent application falls under Avenue’s licensing agreement with Revogenex Ireland Ltd.
· On June 30, 2017, Avenue completed its initial public offering of 6,325,000 shares of common stock, at a public offering price of $6.00 per share, for a total offering size of $37,950,000, before deducting underwriting discounts and offering expenses. The shares sold include 825,000 that were subject to an underwriters’ overallotment option, which was exercised and closed concurrently with the closing of the initial public offering. Avenue’s common stock began trading on The NASDAQ Capital Market under the ticker symbol "ATXI."
· Also in June 2017, Lucy Lu, M.D., was named President and Chief Executive Officer of Avenue, a position she held on an interim basis since the company’s inception.

Caelum Biosciences, Inc.
· In April 2017, the U.S. Department of Health & Human Services confirmed the transfer of two U.S. Food and Drug Administration ("FDA") Orphan Drug Designations for CAEL-101 from Columbia University ("Columbia") to Caelum. The designations cover use as a therapeutic agent for patients with AL amyloidosis and use as a radio-imaging agent in amyloidosis. Caelum in-licensed CAEL-101 from Columbia in January 2017.
· In May 2017, Columbia dosed the final patient in the Phase 1b trial of CAEL-101 in AL amyloidosis. As of July 2017, all patients completed treatment. Preliminary and full Phase 1b data are expected in the second half of 2017.
· Also in May 2017, Caelum entered a biopharmaceutical manufacturing agreement with Patheon N.V. for process development and current good manufacturing practices (cGMP) production to support Phase 2/3 studies of CAEL-101.
· In June 2017, Columbia filed a provisional patent application with the USPTO pertaining to CAEL-101 that, once converted into a U.S. non-provisional utility application, will provide composition of matter protection effective upon a grant of a U.S. patent. The legal protection offered by a granted U.S. patent will exceed any data exclusivity periods associated with Orphan Drug Designation and/or an original, branded-biologic product approved for marketing in the U.S. Just this month, Columbia filed a second provisional patent application with the USPTO to pursue additional method of treatment claims directed to surprising and positive outcomes observed from the Phase 1b trial of CAEL-101. If granted these new claims provide an additional layer of legal protection for the use of Caelum’s lead product candidate.

Checkpoint Therapeutics, Inc.
· In April 2017, Checkpoint presented preclinical data on CK-101, an epidermal growth factor receptor ("EGFR") inhibitor, and CK-301, an anti-programmed cell death ligand-1 ("PD-L1") antibody, in poster sessions at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting.
· In June 2017, Checkpoint’s common stock began trading on The NASDAQ Capital Market under the ticker symbol "CKPT."

Cyclacel Pharmaceuticals Reports Second Quarter 2017 Financial Results

On August 9, 2017 Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP) ("Cyclacel" or the "Company"), a clinical-stage biopharmaceutical company using cell cycle, transcriptional regulation and DNA damage response biology to develop innovative, targeted medicines for cancer and other proliferative diseases, reported its financial results and business highlights for the second quarter ended June 30, 2017 (Press release, Cyclacel, AUG 9, 2017, View Source [SID1234520114]).

The Company’s net loss applicable to common shareholders for the three months ended June 30, 2017 was $2.2 million or $0.50 per share, compared to net loss applicable to common shareholders of $3.0 million, or $1.01 per share for the second quarter of 2016. As of June 30, 2017, cash and cash equivalents totaled $13.6 million. Pro forma cash and cash equivalents as of June 30, 2017 totaled $27.4 million after including $13.8 million in proceeds, net of expenses, received in the Company’s underwritten offering completed on July 21, 2017.

"As a result of the completion of our recent offering, in which existing and new investors participated, we are able to advance the clinical investigation of CYC065, our Cyclin Dependent Kinase (CDK) 2/9 inhibitor, in selected, molecularly-defined patient populations," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "We have selected a recommended Phase 2 dose for CYC065 from part 1 of a dose-escalating, Phase 1, first-in-human, study of CYC065. Data from this study evidenced durable target engagement and Mcl-1 biomarker suppression at well tolerated doses with initial evidence of anticancer activity in patients with Mcl-1 and/or cyclin E overexpression or amplification. Our top priority is to finalize designs for a Phase 1/2 study testing CYC065 in combination with venetoclax, a Bcl-2 inhibitor approved for chronic lymphocytic leukemia, an indication in which we believe Mcl-1 suppression may be beneficial. In parallel, we will enroll a new part 2 of the Phase 1 study in patients with advanced solid tumors testing additional dosing schedules. We look forward to reporting our progress, commencement of these studies and data, as they arise."

Business Highlights

Transcriptional Regulation Program: CYC065 CDK inhibitor

Selected a recommended Phase 2 dose (RP2D) from part 1 of a dose-escalating, Phase 1, first-in-human, clinical study. RP2D was determined at dosing level 6, which enrolled 10 patients with advanced cancers. Prolonged reduction of the Mcl-1 biomarker was observed in 7 out of 9 evaluable patients for at least 24 hours following a single dose of CYC065, which was generally well tolerated. Preliminary anticancer activity was observed in three patients with Mcl-1, MYC and Mcl-1/cyclin E amplified cancers. The trial is being conducted at the Dana Farber Cancer Institute in Boston.

Part 2 of the study will enroll patients with advanced solid tumors, in particular cyclin E amplified tumors. Such tumors include subsets of high grade serous ovarian and uterine cancers. Part 2 will evaluate CYC065 in a more intensive schedule for 2 days per week, for 2 weeks of a three-week cycle. Biospecimens will be collected for assessment of biomarkers related to CYC065’s mechanism of action.
SEAMLESS Study

An abstract of the results of the Phase 3 study of oral sapacitabine in elderly patients with acute myeloid leukemia (AML) has been submitted to the American Society of Hematology (ASH) (Free ASH Whitepaper), and if accepted, will be the subject of an oral or poster presentation at the 59th ASH (Free ASH Whitepaper) Annual Meeting to be held December 9 – 12, 2017.
July Underwritten Offering

On July 21, 2017, the Company announced the closing of an underwritten offering, with net proceeds of approximately $13.8 million after deducting underwriting discounts and commissions and other estimated offering expenses, including full exercise of the underwriters’ overallotment option. The Company issued and sold in the offering (i) 3,154,000 Class A Units, each consisting of one share of the Company’s common stock, and a warrant to purchase one share of common stock, and (ii) 8,872 Class B Units, each consisting of one share of the Company’s Series A Convertible Preferred Stock convertible into 500 shares of common stock at the initial conversion price, and a warrant to purchase a number of shares of common stock equal to $1,000 divided by the conversion price. The price to the public in the offering was $2.00 per Class A Unit and $1,000 per Class B Unit.

Subsequent to the closing of the offering, holders of 7,613 (86%) shares out of 8,872 shares outstanding of Series A Preferred Stock elected to convert their shares into 3,806,500 shares of common stock. Following such conversions, 11,400,447 shares of common stock and 1,259 (14%) shares of Series A Preferred Stock remain outstanding as of August 8, 2017.
Financial Highlights
As of June 30, 2017, cash and cash equivalents totaled $13.6 million, compared to $16.5 million on December 31, 2016. After the July offering, pro forma cash and cash equivalents are $27.4 million.

Revenue for the three months ended June 30, 2017 were $0 compared to $0.2 million for the same period of the previous year. Revenue is primarily related to previously awarded grants from the UK government being recognized over the period to progress IND-directed preclinical development of CYC140, a novel, orally available, Polo-Like Kinase 1 (PLK 1) inhibitor, completed in November 2016.

Research and development expenses were $1.2 million compared to $2.6 million for the same period in 2016. The decrease was primarily due to reduced study and clinical supply costs associated with completion of the SEAMLESS study and completion of preclinical development of CYC140.

General and administrative expenses for the three months ended June 30, 2016 and 2017 remained flat at $1.3 million.

Other income (expense), net for the three months ended June 30, 2017 was $34,000, compared to $0.2 million for the same period of the previous year. The decrease in other income (expense) is primarily related to foreign exchange movements.

The UK government research & development tax credit for the quarter was $0.3 million, compared to $0.6 million for the same period of the previous year. During the quarter, we also recognized cash received for the 2016 tax credit of $1.8 million.

Net loss for the three months June 30, 2017 was $2.2 million compared to $3.0 million for the same period in 2016.

Argos Therapeutics Reports Second Quarter 2017 Financial Results and Recent Operational Highlights

On August 9, 2017 Argos Therapeutics Inc. (NASDAQ:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis precision immunotherapy technology platform, reported financial results for the second quarter ended June 30, 2017 and provided an update on the Company’s recent corporate and operational highlights (Press release, Argos Therapeutics, AUG 9, 2017, View Source [SID1234520113]).

"Despite what has clearly been a challenging period, Argos made substantial progress during the most recent quarter," stated Jeff Abbey, CEO of Argos Therapeutics. "First, we were pleased to have a constructive meeting with the FDA, which agreed with our decision to continue the Phase 3 ADAPT trial of Rocapuldencel-T for the treatment of metastatic renal cell carcinoma until we reach 290 events, the pre-specified number of events at which the analysis of overall survival, the primary endpoint, is to be conducted. We are grateful to our investigators and patients for their continued support of our efforts, and we look forward to our next planned analysis at 290 events, which we expect to occur during the first half of 2018."

"In addition, we are preparing a protocol amendment and a revised statistical analysis plan seeking to extend the final data analysis beyond 290 events, which the FDA has agreed to review. We believe that this extension would enable us to better account for the potential delayed treatment effect of Rocapuldencel-T. Also of note, Robert Figlin, MD, Professor and Chairman, Division of Hematology and Oncology at Cedars Sinai Medical Center, co-principal investigator of the ADAPT trial, will provide an overview of interim data from the ADAPT trial in an oral presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) annual meeting to be held September 8 — 12 in Madrid."

"Second, we were pleased to report positive immunogenicity data in our development program for AGS-004 for the treatment of HIV, which is funded by the NIH and the NIAID. We look forward to results from the current trial, which is being conducted at the University of North Carolina, to assess the potential ability of AGS-004, in combination with vorinostat, a latency-reversing agent, to eradicate the HIV virus in adult patients. Despite several effective therapies for HIV, there is currently no agent capable of eradicating the virus."

"Finally, we were pleased to complete a $6.0 million secured convertible note financing with our collaborator and largest shareholder, Pharmstandard. In addition, we took significant steps during the quarter to reduce our expense structure, including a substantial reduction of our workforce. These measures, coupled with proceeds we have recently raised through our at-the-market issuance facility, have enabled us to extend our operational runway. "

Second Quarter 2017 and Recent Operational Highlights:

In May 2017, the Company reported that the FDA agreed with the Company’s plan to continue the ADAPT trial until the Company reaches 290 events, the pre-specified number of events at which the analysis of overall survival, the primary endpoint, is to be conducted, and that the FDA agreed to review a protocol amendment and revised statistical analysis plan that would extend the trial beyond the originally planned 290 events, which the Company believes could enhance its ability to detect whether Rocapuldencel-T has a delayed treatment effect
In June 2017, the Company announced the closing of a $6.0 million secured convertible note financing with Pharmstandard
In July 2017, the Company reported positive immunogenicity data in its AGS-004 dendritic cell therapy program for the treatment of adult patients with acute HIV infection
Selected Second Quarter 2017 Financial Results

Revenue for the three months ended June 30, 2017 was $70,000 compared to $489,000 for the same period in 2016. The decrease in revenue for the second quarter of 2017 compared with the second quarter of 2016 resulted from lower reimbursement under the Company’s contract with the NIH and NIAID primarily related to the achievement of certain specified development milestones under the Company’s AGS-004 program during 2016.

Research and development expense for the three months ended June 30, 2017 was $5.1 million compared to $9.2 million for the same period in 2016. The decrease in research and development expense for the second quarter of 2017 compared with the second quarter of 2016 was primarily due to the Company’s decision to significantly reduce the size of its workforce engaged in research and development activities following the recommendation of the IDMC to discontinue the ADAPT trial.

General and administrative expense for the three months ended June 30, 2017 was $2.7 million compared to $3.4 million for the same period in 2016. The decrease in general and administrative expense for the second quarter of 2017 compared with the second quarter of 2016 was primarily due to reduced consulting and personnel costs.

Reflecting the factors noted above, net loss for the three months ended June 30, 2017 was $8.5 million compared to a net loss of $12.6 million for the same period in 2016.

Revenue for the six months ended June 30, 2017 was $175,000 compared to $635,000 for the same period in 2016. The decrease in revenue for the first half of 2017 compared with the first half of 2016 resulted from lower reimbursement under the Company’s contract with the NIH and NIAID primarily related to the achievement of certain specified development milestones under the Company’s AGS-004 program during 2016.

Research and development expense for the six months ended June 30, 2017 was $13.0 million compared to $18.7 million for the same period in 2016. The decrease in research and development expense for the first half of 2017 compared with the first half of 2016 was primarily due to reduced expenses associated with the Phase 3 ADAPT trial and the Company’s decision to significantly reduce the size of its workforce engaged in research and development activities following the recommendation of the IDMC to discontinue the ADAPT trial.

General and administrative expense for the six months ended June 30, 2017 was $6.6 million compared to $6.4 million for the same period in 2016. The increase in general and administrative expense for the first half of 2017 compared with the first half of 2016 was primarily due to increased personnel costs.

Additionally, the Company incurred impairment charges of $27.2 million and restructuring charges of $5.4 million during the six months ended June 30, 2017 related to the Company’s decision to discontinue preparation for commercial manufacturing and reduce the size of its workforce, which amounts were partially offset by a non-cash gain due to the decrease in the value of the warrant liability of $20.2 million.

Reflecting the factors noted above, net loss for the six months ended June 30, 2017 was $32.6 million compared to a net loss of $25.4 million for the same period in 2016.

As of June 30, 2017, cash and cash equivalents totaled $9.3 million.

Cempra Provides Corporate Update and Reports Second Quarter 2017 Financial Results

On August 9, 2017 Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing differentiated anti-infectives for acute care and community settings to meet critical medical needs in the treatment of infectious diseases, reported financial results for the quarter ended June 30, 2017 and provided an update on recent corporate developments (Press release, Cempra, AUG 9, 2017, View Source [SID1234520094]). The company will host a webcast and conference call today at 8:45 a.m. ET.

"We have achieved significant progress with the FDA, reaching an agreement on a smaller, more focused and efficient approach to generating a first cohort of solithromycin safety data to support our response to the CRL," said David Zaccardelli, Pharm.D., acting chief executive officer of Cempra.

"We have also progressed our discussions with the FDA on fusidic acid and the agency has agreed that an additional Phase 3 study, similar in design to the successful Phase 3 study we reported earlier this year, would support potential approval of fusidic acid in ABSSSI. This clarity on both programs is very helpful to us as we progress our next steps," Zaccardelli added.

Second Quarter 2017 and Recent Corporate Highlights

Solithromycin

Community-acquired bacterial pneumonia (CABP)

In the first quarter of 2017, we met with the U.S. Food and Drug Administration (FDA) to discuss the solithromycin complete response letter (CRL) and the FDA reiterated their request for additional clinical safety data prior to approval. Importantly, the FDA has stated that the Phase 3 trials provided evidence that oral and intravenous (IV) solithromycin are effective for the treatment of CABP. The FDA has not requested further efficacy data to support our response to the CRL.

Based on input from the FDA, we proposed a protocol that would obtain safety data from an initial cohort of 6,000 CABP patients treated for five days with oral solithromycin, along with 1,200 CABP patients treated with the standard of care (5:1 randomization), at the time we respond to the CRL. We would subsequently provide follow-on data from an additional 3,000 CABP patients treated for five days with oral solithromycin.

The FDA has communicated to us that this initial cohort of safety data with oral dosing, along with a satisfactory response to the manufacturing items raised in the CRL, would be acceptable to support a response to the CRL for the oral NDA and allow the FDA to evaluate the potential approval of oral solithromycin for CABP.

Inclusion/exclusion criteria have been defined in the safety protocol and incorporate exclusion of patients taking selected concomitant medications which may be associated with higher liver enzyme levels, based on data from the Phase 3 SOLITAIRE-ORAL study.

By eliminating the inclusion of IV formulation data in our initial response to the CRL, we expect to be able to conduct the safety study efficiently with the oral formulation and a dosing regimen that appeared to have a more favorable liver safety profile than IV dosing in our Phase 3 program. This approach also simplifies our response to manufacturing items in the CRL by focusing our response only on oral manufacturing. Additional safety data to support the potential approval of IV solithromycin would need to be provided under a separate study to be discussed with the FDA.

We continue to advance our manufacturing activities for solithromycin at Uquifa and we believe that the time required to accumulate clinical safety data will be the rate-limiting step in our timeline to respond to the CRL.

Based on the completed protocol for the proposed safety study, we are actively engaged with potential government and industry partners to identify non-dilutive funding to support the execution of the study.
Ophthalmic

We have an ongoing ophthalmic development program for solithromycin and are completing preclinical work to support a potential IND filing in 2018.

In the second quarter, we presented data at the annual meeting of the Association for Research in Vision and Ophthalmology highlighting topical ophthalmic formulations of solithromycin in preclinical models of activity, tolerability and pharmacokinetics in the eye.

We are exploring the potential effects of solithromycin to treat ophthalmic bacterial infection as well as dry eye.
Fusidic Acid

Based on the results we announced in the first quarter of 2017 from a successful Phase 3 study of fusidic acid in patients with acute bacterial skin and skin structure infections (ABSSSI), we met with the FDA in the second quarter to discuss the next steps required to bring fusidic acid to patients in the United States.

The FDA has agreed that a second Phase 3 study with a similar design to the first successfully completed Phase 3 study could support potential approval of fusidic acid in patients with ABSSSI. Additionally, a thorough QT and drug interaction studies would be required for an NDA submission.

We are also exploring the potential use of fusidic acid for the long-term oral treatment of refractory bone and joint infections, including prosthetic joint infections, caused by staphylococci, including S. aureus and MRSA. Currently, there is no optimal oral, chronic antibiotic for treating these infections. Enrollment in this 30 patient exploratory, open-label study completed in the second quarter. The primary endpoint of the study is clinical success six months after the start of treatment.
Evaluation of Strategic Business Opportunities

As we have announced in a separate press release today, Cempra and Melinta Therapeutics have entered into a definitive agreement under which Melinta will merge with Cempra.

Financial Results for the Three Months Ended June 30, 2017

For the quarter ended June 30, 2017, Cempra reported a net loss of $12.3 million, or $0.23 per share. During the same period in 2016, Cempra reported a net loss of $24.8 million, or $0.51 per share.

Research and development (R&D) expense in the second quarter of 2017 was $8.5 million, a decrease of 46.7 percent compared to the same quarter in 2016. The lower R&D expense was primarily due to a reduced headcount as a result of the corporate restructuring we implemented in the first quarter of 2017, as well as the completion of all major clinical studies by the end of 2016. General and administrative expense was $4.7 million, a 61.1 percent decrease compared to the quarter ended June 30, 2016, driven primarily by reduced headcount as a result of the reduction in workforce, as well as the discontinuation of commercial launch preparation activities that were ongoing at the same time in 2016.

As of June 30, 2017, Cempra had cash and equivalents of $187.0 million and 52.5 million shares outstanding.

As a result of the corporate restructuring we implemented in the first quarter of 2017, our research and corporate expenses trended significantly downward in the second quarter of 2017 and we expect to reduce second half 2017 expenses by more than 70 percent compared to the second half of 2016. These operating expense assumptions exclude the costs associated with any additional clinical trials with any of our product candidates.

Can-Fite Completes Patient Enrolment for its Phase II Study of Namodenoson in the Treatment of Liver Cancer

On August 9, 2017 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, reported that the Phase II liver cancer clinical trial for Namodenoson (CF102), a novel compound for the treatment of advanced hepatocellular carcinoma (HCC), has successfully enrolled and randomized all 78 patients planned in the clinical trial protocol (Press release, Can-Fite BioPharma, AUG 9, 2017, View Source [SID1234520092]).

"There is definitely a large unmet medical need for the patient population represented in our trial. These are patients who have not responded to first-line therapy with the current standard of care and experienced further disease progression, in addition to having underlying Child-Pugh Class B cirrhosis. In view of the unique nature of our target population, along with our orphan and fast track status, we believe that success in the current Phase II trial will position us for rapid progress towards registration," stated Can-Fite Medical Director, Dr. Michael Silverman. "We now look forward to confirming the encouraging Phase I/II results, which will pave the way for Can-Fite to bring a new treatment option to patients with advanced liver cancer."

The global Phase II study is being conducted in the U.S., Europe and Israel. Patients with advanced HCC, Child Pugh B, are treated twice daily with 25 mg of oral Namodenoson, the dose found to be the most efficacious in Can-Fite’s earlier Phase I/II study. The primary endpoint of the Phase II study is Overall Survival (OS). Secondary endpoints include Progression Free Survival (PFS), safety, and the relationship between outcomes and A3AR expression. As is standard in this indication, the primary endpoint of OS requires following the entire patient population until the statistically predetermined number of events occur. Can-Fite is following the survival data closely and will perform the survival analysis at the earliest possible opportunity.

Can-Fite’s prior Phase I/II study of Namodenoson in this indication successfully achieved its primary and secondary endpoints, with a good safety profile. Most of the patients enrolled in the Phase I/II study had failed prior treatment with Nexavar (sorafenib), the only drug currently approved for this indication.

Data also showed thatNamodenoson has a liver protective effect that is very unique compared to Nexavar and other drugs under development for HCC which have shown to induce hepato-toxicity.

According to Datamonitor, the market for hepatocellular carcinoma drugs is projected to reach $1.4 billion in 2019. Nexavar annual sales, as reported by Bayer, were €870 million in 2016.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. Can-Fite has received Orphan Drug Designation for Namodenoson in Europe and the U.S., as well as Fast Track Status in the U.S. as a second line treatment for hepatocellular carcinoma.