On November 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 third quarter ended September 30, 2017 (Press release, Fortress Biotech, NOV 9, 2017, View Source [SID1234521867]).

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Dr. Lindsay A. Rosenwald, Fortress’ Chairman, President and Chief Executive Officer, said, "Fortress enjoyed strong third quarter performance, beginning with the formation of a new gene therapy subsidiary company, Aevitas Therapeutics. Fortress’ other subsidiaries also continued to achieve important corporate and clinical milestones during the quarter. Avenue dosed the first patient in its pivotal Phase 3 study of IV tramadol for the management of moderate to moderately severe pain in patients following bunionectomy surgery. Additionally, Checkpoint dosed the first patient in its Phase 1 clinical study evaluating the safety and tolerability of its anti-PD-L1 antibody, CK-301, in selected recurrent or metastatic cancers. The FDA also granted Orphan Drug Designation to Checkpoint’s third-generation EGFR inhibitor, CK-101, for the treatment of EGFR mutation-positive NSCLC. Mustang Bio has continued to make meaningful progress throughout the quarter, with its common stock commencing trading on the NASDAQ Global Market, and the licensing of a CD20 CAR T cell therapy from the Fred Hutchinson Cancer Research Center, expanding its pipeline to six novel CAR T candidates."

Dr. Rosenwald continued, "We look forward to oral data presentations on both Mustang Bio’s and Caelum Biosciences’ clinical programs at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December, and plan to continue delivering on meaningful milestones for the remainder of the year."

Financial Results:

· As of September 30, 2017, Fortress’ consolidated cash, cash equivalents and short-term investments totaled $154.6 million, compared to $88.3 million at December 31, 2016, an increase of $66.3 million year-to-date. The September 30, 2017 consolidated cash, cash equivalents and short-term investments total excludes restricted cash of $16.9 million and cash deposits with clearing organizations of $1.0 million.
· Net revenue totaled $46.9 million for the third quarter of 2017 and $142.3 million for the first nine months of 2017, compared to $1.0 million for the third quarter of 2016 and $3.9 million for the first nine months of 2016. Net total revenue for the third quarter ending September 30, 2017 includes $2.5 million of Fortress revenue and $44.4 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 $15.9 million for the third quarter of 2017, of which $14.2 million was related to Fortress Companies, and $34.7 million for the first nine months of 2017, of which $29.1 million was related to Fortress Companies. This compares to $7.3 million for the third quarter of 2016, of which $5.5 million was related to Fortress Companies, and $21.4 million for the first nine months of 2016, of which $15.8 million was related to Fortress Companies. Non-cash stock-based compensation expense included in research and development for the third quarter of 2017 was $1.6 million, compared to $0.9 million for the third quarter of 2016, and $4.8 million for the first nine months of 2017, compared to $3.4 million for the first nine months of 2016.
· Research and development expenses from license acquisitions totaled $0.3 million for the third quarter of 2017 and $3.4 million for the first nine months of 2017, compared to $1.0 million for the third quarter of 2016 and $3.1 million for the first nine months of 2016.
· General and administrative expenses were $15.1 million for the third quarter of 2017, of which $10.9 million was related to Fortress Companies, and $36.5 million for the first nine months of 2017, of which $23.8 million was related to Fortress Companies. This compares to $8.9 million for the third quarter of 2016, of which $3.8 million was related to Fortress Companies, and $25.4 million for the first nine months of 2016, of which $11.5 million was related to Fortress Companies. Non-cash stock-based compensation expenses included in general and administrative expenses were $2.6 million for the third quarter of 2017, compared to $2.0 million for the third quarter of 2016, and $6.9 million for the first nine months of 2017, compared to $5.4 million for the first nine months of 2016.
· National’s operating expenses totaled $47.7 million for the third quarter of 2017 and $139.2 million for the first nine 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 $27.1 million, or $0.67 per share, for the third quarter of 2017, compared to a net loss attributable to common stockholders of $13.0 million, or $0.32 per share, for the third quarter of 2016. For the first nine months of 2017, net loss attributable to common stockholders was $56.5 million or $1.39 per share, compared to a net loss attributable to common stockholders of $37.7 million or $0.94 per share in the first nine months of 2016.

On November 9, 2017 Endocyte, Inc. (NASDAQ:ECYT), a biopharmaceutical company developing targeted therapeutics for personalized cancer treatment, reported that the company’s management team will present at the Jefferies 2017 London Healthcare Conference on Wednesday, Nov. 15, 2017, at 8:40 a.m. GMT (Press release, Endocyte, NOV 9, 2017, View Source [SID1234521863]).

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A live audio webcast of the Company’s presentation can be accessed by visiting "Events & Presentations" under the Investors & News section of Endocyte’s website at www.endocyte.com. The webcast will be archived shortly after the live event, and a replay will be available on the Company’s website for 90 days following the conference.

On November 9, 2017 Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing novel product candidates based on its Targeted Protein Therapeutics (TPTs) platform, reported that it will host a live conference call and webcast at 4:30 p.m. ET on Tuesday, November 14, 2017 to report its third quarter 2017 financial results and provide a corporate update (Press release, Eleven Biotherapeutics, NOV 9, 2017, View Source [SID1234521862]).

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To access the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) at least five minutes prior to the start time and refer to conference ID 3890769. An audio webcast of the call will also be available on the Investors & Media section of the Company’s website, www.elevenbio.com. An archived webcast will be available on the Company’s website approximately two hours after the event and will be available for 30 days.

On November 9, 2017, Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing novel product candidates based on its Targeted Protein Therapeutics (TPTs) platform, reported that Stephen Hurly, President and Chief Executive Officer, will present a company overview at the Stifel 2017 Healthcare Conference in New York on Wednesday, November 15, 2017 at 3:30 p.m. EST (Press release, Eleven Biotherapeutics, NOV 9, 2017, View Source [SID1234521861])Eleven Biotherapeutics, Inc. (NASDAQ:EBIO).

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A live webcast can be accessed from the Investors & Media section of Eleven’s website, www.elevenbio.com. An archived replay of the webcast will be available on the Company’s website for 90 days after the conference.

On November 9, 2017 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported financial results for the quarter ended September 30, 2017, and provided an overview of recent accomplishments and plans (Press release, CytRx, NOV 9, 2017, View Source [SID1234521860]).

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"The third quarter of 2017 was transformative for CytRx," said Steven A. Kriegsman, CytRx’s Chairman and CEO. "We executed a global strategic licensing transaction for aldoxorubicin, placing this clinically validated, post-Phase 3 asset into the hands of NantCell, Inc. to file the planned New Drug Application with the U.S. FDA. Further, NantCell is laying the groundwork to develop aldoxorubicin in combination with other anti-cancer agents, including immunotherapies and other innovative cell-based approaches, and recently communicated their plans to submit Investigational New Drug (IND) Applications to the U.S. FDA combining aldoxorubicin with certain immunotherapy protocols in patients with pancreatic and breast cancer."

Mr. Kriegsman continued, "Internally, our efforts and resources have been refocused on generating new candidates from our proprietary LADR (Linker Activated Drug Release) technology platform where our goal is to create a new class of rationally designed, breakthrough anti-cancer drugs with the potential to address a broad range of tumor types. Selection of a highly potent drug conjugate to bring into the clinic is at the forefront of our strategy heading into 2018, and we remain opportunistic in seeking out strategic alliances with big pharma."

Third Quarter 2017 and Recent Highlights

Highlighted Progress of LADR Candidates and Future Oncology Pipeline. In November 2017, CytRx provided an update on its R&D activities surrounding its proprietary LADR (Linker Activated Drug Release) Technology Platform. To date in 2017, the Company’s drug discovery laboratory, located in Freiburg, Germany, has tested over 75 rationally designed drug conjugates, and four lead candidates have been selected based on in vitro and animal preclinical studies, stability, and manufacturing feasibility. The Company’s goal is to nominate the next LADR candidate for clinical development in the first quarter of 2018 and to present these important preclinical data at an upcoming scientific meeting during the first half of 2018. Additional animal efficacy and toxicology testing of these lead candidates is underway, and CytRx’s goal is to file the first LADR-discovered, ultra-high potency conjugate IND for clinical trials in 2018.

Completed Reverse Stock Split. On November 1, 2017, CytRx completed a 1-for-6 reverse stock split of its issued and outstanding common stock. The split-adjusted shares of CytRx’s common stock will continue trading on the Nasdaq Capital Market under the Company’s existing symbol "CYTR," provided that the Company continues to comply with the Nasdaq listing requirements. The reverse stock split reduced the number of common shares outstanding to approximately 27.6 million as of the effective date. Authorized shares were also proportionally reduced to approximately 41.7 million, and the Company’s preferred stock was reduced to approximately 0.8 million shares. The reverse stock split was approved by the Company’s stockholders at a Special Meeting held on October 27, 2017.

Completed Strategic Realignment of Clinical Development Team. In November 2017, the Company announced a strategic realignment of its development team to focus its efforts on generating new drug candidates from its LADR Technology Platform. Hurley Consulting Associates, who have been providing strategic consulting to CytRx, will lead the company’s development and regulatory activities. Concurrently, the position of Senior Vice President of Drug Development has been eliminated, and Shanta Chawla, M.D., has retired.

Announced Upcoming NantCell INDs. In October 2017, CytRx announced that aldoxorubicin licensee NantCell, Inc. (a private subsidiary of NantWorks, LLC) plans to submit IND applications combining aldoxorubicin with its immunotherapy protocols for clinical trials in pancreatic and breast cancers. The planned clinical trials will enroll patients with cancers resistant to standard therapy and will employ adaptive designs allowing for expansion of treatment cohorts and modification of patient treatments based on tumor profiling and individual patient responses over time.

Completed Strategic Licensing Transaction with NantCell for Development of Aldoxorubicin. In July 2017, CytRx and NantCell executed a strategic licensing agreement for the global rights to aldoxorubicin. NantCell, led by Dr. Patrick Soon-Shiong, who developed and commercialized Abraxane, an albumin-mediated cytotoxic agent, received exclusive rights to develop and commercialize aldoxorubicin for all indications. Under the terms of the agreement, NantCell purchased $13 million of CytRx common stock at a per share price of $6.60 (split-adjusted), representing approximately a 92% premium to the market price at the time of the transaction. CytRx is eligible to receive up to an additional $343 million in regulatory and commercial milestones, plus increasing double-digit royalties on sales for aldoxorubicin’s lead indication of soft tissue sarcomas, and mid to high single-digit royalties for any additional indications. CytRx also issued NantCell a warrant to purchase on a split-adjusted basis up to 500,000 shares of common stock at $6.60 over the next 18 months. CytRx has been actively working with the NantCell team to transition the aldoxorubicin program, including both completed and ongoing studies.

Third Quarter 2017 Financial Results

CytRx reported cash, cash equivalents and short-term investments of $46.0 million as of September 30, 2017. During the third quarter, CytRx entered into a global strategic licensing agreement for aldoxorubicin with NantCell and received a strategic investment of $13.0 million. Concurrent with the closing of the aldoxorubicin license agreement, CytRx amended its existing long-term loan and made payments of $10 million during the quarter to the lender.

Net loss for the quarter ended September 30, 2017, was $5.1 million, or $(0.19) per share, compared with a net loss of $12.2 million, or $(0.80) per share, for the quarter ended September 30, 2016, a reduction of $7.1 million. During the third quarter of 2017, the Company recognized a non-cash gain of $3.8 million on the fair value adjustment of warrant derivative liability related to warrants issued in 2016, compared to a non-cash gain of $0.2 million during the third quarter of 2016 related to now expired warrants.

Research and development (R&D) expenses were $4.8 million for the third quarter of 2017, including approximately $2.6 million for aldoxorubicin, $1.0 million for pre-clinical development of new albumin-binding, ultra-high potency cancer drugs (Freiburg lab), and approximately $1.2 million for non-cash expenses and general operations of our clinical programs. This is a reduction of approximately 47 percent compared to R&D expenses of $8.9 million for the third quarter of 2016.

General and administrative (G&A) expenses were $3.4 million for the third quarter of 2017, compared with $2.8 million for the third quarter of 2016.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical company specializing in research and clinical development of novel anti-cancer drug candidates that employ linker technologies to enhance the accumulation and release of drug at the tumor. Aldoxorubicin, CytRx’s most advanced drug conjugate, is an improved version of the widely used chemotherapeutic agent doxorubicin and has been out-licensed to NantCell, Inc. CytRx is also rapidly expanding its pipeline of ultra-high potency oncology candidates at its laboratory facilities in Freiburg, Germany, through its LADR (Linker Activated Drug Release) technology platform, a discovery engine designed to leverage CytRx’s expertise in albumin biology and linker technology for the development of a new class of potential breakthrough anti-cancer therapies.