On November 9, 2017 Galena Biopharma, Inc. (NASDAQ: GALE), a biopharmaceutical company developing hematology and oncology therapeutics that address unmet medical needs, reported its financial results for the quarter ended September 30, 2017 (Press release, Galena Biopharma, NOV 9, 2017, View Source [SID1234521868]).

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"The merger process with SELLAS Life Sciences Group, Ltd. remains on track as our registration statement on Form S-4 went effective on November 6, 2017, which includes the proxy statement/prospectus relating to Galena’s special meeting of stockholders to be held on December 15, 2017. The proxy statement/prospectus includes the proposals we are asking stockholders to approve in connection with the merger," said Stephen F. Ghiglieri, Interim Chief Executive Officer and Chief Financial Officer. "In the proxy statement/prospectus, we also introduce the leadership team and new board of directors for the combined company, and we are confident in their ability to advance the assets through multiple ongoing and planned clinical trials. The completion of the merger will create a new chapter for Galena shareholders with opportunities for more near-term value creation."

Mr. Ghiglieri continued, "During the third quarter, we reached two important clinical milestones with the completion of enrollment in both of our NeuVax (nelipepimut-S) combination trials. For the HER2 1+/2+ trial, we look forward to the interim efficacy analysis that is scheduled to be performed by the Data Safety Monitoring Board (DSMB) in the first quarter of 2018. The primary endpoint for the 1+/2+ and the 3+ studies is disease-free survival after 24 months, and we expect these results in the fourth quarter of

FINANCIAL REVIEW

Operating loss from Galena’s development programs and general and administrative expenses, classified as continuing operations, during the third quarter of 2017 was $4.5 million, including $0.2 million in non-cash stock-based compensation, compared to an operating loss of $6.5 million, including $0.5 million in non-cash stock-based compensation for the third quarter of 2016. Operating loss for the nine months ended September 30, 2017 was $14.5 million, including $0.6 million in non-cash stock-based compensation, compared to an operating loss of $24.7 million, including $1.8 million in non-cash stock-based compensation for the same period in 2016.

Loss from continuing operations for the third quarter of 2017 was $6.2 million, or $0.15 per basic and diluted share, including $1.7 million in non-operating expense. Loss from continuing operations for the third quarter of 2016 was $4.3 million, or $0.41 per basic and diluted share, including $2.1 million in non-operating income. Loss from continuing operations for the nine months ended September 30, 2017 was $15.6 million, or $0.45 per basic and diluted share, including $1.1 million in non-operating expense. Loss from continuing operations for the nine months ended September 30, 2016 was $9.2 million, or $0.97 per basic and diluted share, including $15.6 million in non-operating income. Non-operating expense during the three and nine months ended September 30, 2017 includes a one-time impairment loss on goodwill and intangible assets of $5.2 million. The impairment loss recognized during the third quarter of 2017 is a non-cash expense and adjusts the carrying value of our intangible assets to approximate fair value based on an interim impairment analysis performed in connection with the preparation of our condensed consolidated financial statements for the three and nine months ended September 30, 2017. Non-operating expense during the three months and nine months ended September 30, 2017 also includes $0.6 million and $2.2 million, respectively, of interest expense related to our debenture and a litigation settlement of $1.3 million for the nine months ended September 30, 2017. The goodwill and impairment loss, interest expense, and litigation settlement included in non-operating expense during the three

months and nine months ended September 30, 2017 is partially offset by non-cash gains from the reduction in Galena’s warrant liability of $4.1 million and $7.8 million respectively.

Income from discontinued operations from Galena’s former commercial business for the third quarter of 2017 was $0.1 million, or $0.00 per basic and diluted share, compared to loss from discontinued operations of $2.6 million, or $0.25 per basic and diluted share, for the same period of 2016. Income from discontinued operations during the third quarter of 2017 was driven by an insurance recovery of $0.7 million for legal fees previously paid that was partially offset by a settlement for product returns reached with a former customer for one of our former commercial products. Loss from discontinued operations for the nine months ended September 30, 2017 was $10.6 million, or $0.31 per basic and diluted share, compared to $8.9 million, or $0.93 per basic and diluted share, for the same period of 2016. Loss from discontinued operations during the nine months ended September 30, 2017 includes an accrual for a one-time civil payment settlement of approximately $7.6 million, which was recognized in the first quarter of 2017 in current liabilities of discontinued operations, related to the oral agreement in principle with the U.S. Attorney’s Office for the District of New Jersey (USAO NJ) and the Department of Justice (DOJ). The civil payment will be paid by Galena in four equal, quarterly installments; the first payment was made in the third quarter of 2017.

Net loss for the third quarter of 2017 was $6.1 million, or $0.15 per basic and diluted share, compared to net loss of $6.9 million, or $0.66 per basic and diluted share for the third quarter of 2016. Net loss for the nine months ended September 30, 2017 was $26.2 million, or $0.76 per basic and diluted share, compared to $18.0 million, or $1.90 per basic and diluted share, for the same period of 2016.

Galena had cash and cash equivalents of approximately $12.9 million as of September 30, 2017, compared with $18.1 million as of December 31, 2016. During the nine months ended September 30, 2017, Galena used $26.2 million in operating activities offset by $15.5 million in net proceeds from issuance of common stock and warrants to purchase common stock in February 2017, and $5.7 million in redemptions of the debenture principally paid by Galena in shares of common stock which facilitated the release of $5.5 million of restricted cash.

On November 9, 2017 VistaGen Therapeutics Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders, reported its financial results for its second fiscal quarter ended September 30, 2017 (Press release, VistaGen Therapeutics, NOV 9, 2017, View Source [SID1234521908]).

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The Company also provided an update on its corporate progress and recently achieved milestone for AV-101, its oral CNS drug candidate in Phase 2 development, initially as a new generation adjunctive treatment for major depressive disorder (MDD).

"The FDA’s recent authorization to proceed under our AV-101 IND application is a significant milestone in our Phase 2 program focused on MDD," commented Shawn Singh, Chief Executive Officer of VistaGen. "With that authorization, we are now one step closer towards our goal of commencing our 180-patient, multi-center, double-blind, placebo-controlled Phase 2 adjunctive treatment study in the first quarter of 2018."

Milestones achieved during the quarter:
In October 2017, the U.S. Food and Drug Administration (FDA) authorized the Company to proceed under its Investigational New Drug (IND) application with its planned 180-patient, multi-center, double-blind, placebo-controlled Phase 2 study to assess the safety, tolerability and efficacy of AV-101 as an orally administered adjunctive treatment for adult MDD patients with an inadequate response to standard, FDA-approved antidepressants. Dr. Maurizio Fava of Harvard Medical School will be the Principal Investigator of this study, expected to begin in the first quarter of 2018 with completion expected at the end of 2018.

Recent Operational Highlights:
Intellectual Property Accomplishments

The European Patent Office granted a European Patent for AV-101 relating to the treatment of depression, Parkinson’s disease levodopa-induced dyskinesia (PD LID) and use of multiple dosage forms to treat these CNS disorders. The patent has been validated in Belgium, Denmark, France, Germany, Ireland, Italy, Portugal, Spain, Switzerland and the United Kingdom. It will be in effect until January 2034.
The Company received a Notice of Allowance from the U.S. Patent and Trademark Office for U.S. Patent Application No. 14/775,287 related to certain methods of production for AV-101.
The corresponding patent application related to methods of production for AV-101 was also granted in China.
Bolstered Clinical Team with Industry Expert

The Company appointed David Rotella, Ph.D. to the Scientific Advisory Board of VistaStem Therapeutics, the Company’s wholly owned subsidiary focused on utilizing the Company’s stem cell technology, to assist in advancing VistaStem’s small molecule drug rescue objectives and in evaluating other CNS-focused programs intended to expand VistaGen’s drug development pipeline. Dr. Rotella has extensive academic research and pharmaceutical industry experience in both medicinal chemistry and drug discovery, including key leadership roles on teams at Wyeth, Pfizer and Bristol-Meyers focused on drug candidates to fight cancer, cardiovascular disease, metabolic disorders, and neurodegenerative diseases.
Financial Results for the Fiscal Quarter Ended September 30, 2017:
Net loss for the fiscal quarter ended September 30, 2017 was approximately $5.0 million, including non-cash expenses of approximately $2.1 million, compared to $3.1 million for the fiscal quarter ended September 30, 2016, which included non-cash expenses of approximately $0.7 million.

Research and development expense totaled approximately $2.4 million for the fiscal quarter ended September 30, 2017, compared with approximately $1.6 million for the fiscal quarter ended September 30, 2016. The increase in year-over-year research and development expense was attributable to the Company’s increased focus on the continuing nonclinical and clinical development of AV-101 and ongoing preparations to launch its AV-101 MDD Phase 2 adjunctive treatment study.

General and administrative expense was approximately $2.6 million in the fiscal quarter ended September 30, 2017, compared to approximately $1.5 million in the fiscal quarter ended September 30, 2016, reflecting increased professional services expenses and noncash expense attributable to the grant of common stock for services, noncash warrant modification expense and, to a lesser extent, salary and benefits and noncash stock compensation expenses.

At September 30, 2017, the Company had cash of approximately $1.76 million, compared to approximately $1.63 million as of June 30, 2017. In September 2017, the Company completed an underwritten public offering of shares of its common stock and warrants. The gross proceeds from this offering were approximately $2.4 million, resulting in net proceeds of $2.0 million, after deducting the underwriting discount and offering expenses.

About VistaGen
VistaGen Therapeutics, Inc. (NASDAQ: VTGN) is a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other CNS disorders. VistaGen’s lead CNS product candidate, AV-101, is in Phase 2 development, initially as a new generation oral antidepressant drug candidate for MDD. AV-101’s mechanism of action is fundamentally different from all FDA-approved antidepressants and atypical antipsychotics used adjunctively to treat MDD, with potential to drive a paradigm shift towards a new generation of safer and faster-acting antidepressants. AV-101 is currently being evaluated by the NIMH in a small Phase 2 monotherapy study in MDD being fully funded by the NIMH and conducted by Dr. Carlos Zarate Jr., Chief, Section on the Neurobiology and Treatment of Mood Disorders and Chief of Experimental Therapeutics and Pathophysiology Branch at the NIMH. VistaGen is preparing to launch a 180-patient Phase 2 study of AV-101 as an adjunctive treatment for MDD patients with an inadequate response to standard, FDA-approved antidepressants, with Dr. Maurizio Fava of Harvard University as Principal Investigator. AV-101 may also have the potential to treat multiple CNS disorders and neurodegenerative diseases in addition to MDD, including neuropathic pain, epilepsy, Huntington’s disease, PD LID and other disorders where modulation of the NMDA receptors, activation of AMPA pathways and/or key active metabolites of AV-101 may achieve therapeutic benefit.

BioTime has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, BioTime, 2017, NOV 9, 2017, View Source [SID1234521845]).

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Genomic Health has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Genomic Health, 2017, NOV 9, 2017, View Source [SID1234521911]).

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On November 9, 2017 Medigene AG (FSE: MDG1, Frankfurt, Prime Standard, TecDAX), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies for the treatment of cancer, reported its financial results for the first nine months of 2017 (Press release, MediGene, NOV 9, 2017, View Source [SID1234521817]).

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Major events:
– Clinical trial application submitted for its first study with proprietary T cell receptor (TCR)-modified T cells, MDG1011 – Study start expected for end of 2017
– Automated high throughput screening platform for the identification and validation of T cell receptors (TCRs) and neoantigens presented at various international conferences
– Preclinical data on Medigene’s first immunotherapy MDG1011 presented at AACR (Free AACR Whitepaper)
– Academic partner Oslo University presented additional data on compassionate use for DC vaccines against acute myeloid leukemia (AML) at AACR (Free AACR Whitepaper)
– Medigene raised EUR 20.7 m gross proceeds through placement of new shares with institutional investors in May

Key figures:
– Growing revenue from core business immunotherapies (bluebird bio partnership) of EUR 3,435 k (9M 2016: EUR 0 k) – collaboration progressing according to plan
– Increased total revenue of EUR 7,176 k (9M 2016: EUR 7,052 k); non-recurring gain in previous year from the sale of EndoTAG rights was largely offset by revenue from the partnership with bluebird bio
– Research and development expenses increased as planned to EUR 11,073 k (9M 2016: EUR 7,985 k) due to progress in proprietary immunotherapy programs
– Thereby EBITDA loss increased as planned to EUR 10,143 k (9M 2016: EUR 9,095 k) and net loss to EUR 10,690 k (9M 2016: net loss of EUR 5,725 k positively influenced by special effect / sale of financial assets of EUR 4,242 k in 2016)
– Cash, cash equivalents and time deposits of EUR 55,374 k as at September 30, 2017 (12/31/2016: EUR 52,630 k)
– Confirmation of financial guidance 2017

Prof. Dolores Schendel, CEO/CSO at Medigene AG, commented: "Medigene has made important progress in the past three quarters. We look forward to start the clinical development of our core program MDG1011, a TCR-based immunotherapy, which is expected to commence by the end of the year. In parallel, we are continuing the phase II part of the clinical trial with our DC vaccines, in which all patients will soon be included. In addition, development cooperation with bluebird bio is progressing very well and we are confident that we will be able to report concrete results of this collaboration in the coming months."

Dr. Thomas Taapken, CFO of Medigene AG, adds: "We are fully on track with our financial result. This demonstrates Medigene’s consistent commitment to the speedy implementation and expansion of our immunotherapy programs. Progress in collaboration with bluebird bio is already evident in increasing revenue from our core business immunotherapies. This underlines the power of our TCR platform which also fuels our own development programs we are driving forward independently."

Financial guidance 2017
Medigene confirms its financial guidance for 2017 as published in the 2016 annual report. The forecast reflects Medigene’s continued focus on the core business of immunotherapies.

– Revenues: The Company is expecting to generate total revenue of EUR 8 – 10 m in 2017. This forecast does not include future milestone payments from the existing R&D partnership with bluebird or revenue from any potential new transactions.
– R&D expenses: Due to the progress of Medigene’s clinical development programs in the field of immunotherapies and a further increase in headcount, Medigene is forecasting rising research and development expenses in the amount of EUR 16 – 18 m.
– Planned EBITDA loss of EUR 16 – 18 m in fiscal year 2017.
– For 2017, Medigene anticipates cash utilization to be EUR 23 – 27 m, partly due to non-recurring effects such as investments in laboratory infrastructure. This forecast does not include any cash inflows from possible future milestone payments from the existing R&D partnership with bluebird bio or from potential new transactions.
– Based on its current planning, the Company has sufficient financial resources for well beyond the forecast horizon of two years and up to the time that data from the DC trial and TCR trials become available.

The full version of the quarterly statement 9M-2017 can be downloaded here: www.medigene.com/investors-media/reports-presentations/

Conference call and webcast: A telephone conference (webcast) in English will be held today at 3:00 pm CEST (Munich/Frankfurt) / 9:00 am EDT (New York) and transmitted live in the internet. Access and transmission of the synchronized presentation slides and a recording of the presentation is available on the homepage of Medigene at www.medigene.com/investors-media/reports-presentations/webcasts/