On November 9, 2017 Northern Biologics Inc., a developer of first-in-class immuno-oncology products, reported that Philip Vickers, Ph.D., is joining the company as CEO and a member of the board. Stefan Larson, Ph.D., who served as Northern Biologics’ founding CEO since 2014, will remain on the company’s board (Press release, Northern Biologics, NOV 9, 2017, View Source [SID1234521915]).

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Dr. Vickers is a preeminent R&D leader with more than two decades of experience in the biotech and pharmaceutical industry. Most recently, he served as global head of R&D and a member of the Executive Committee for Shire during a period of great growth and multiple regulatory approvals for the company. Under Dr. Vickers’ tenure the clinical development pipeline grew to approximately 40 programs.

Prior to joining Shire, Dr. Vickers held a range of R&D positions of increasing responsibility at Merck & Co. Inc., Pfizer Inc., Boehringer Ingelheim and Resolvyx Pharmaceuticals Inc. Dr. Vickers holds a Ph.D. in biochemistry from the University of Toronto.

"We feel very fortunate to have attracted someone of Phil’s reputation and caliber as the new leader of Northern Biologics. He brings critical experience and a track record in drug development to take Northern Biologics into its next phase of growth," said Brad Bolzon, Ph.D., chairman of Northern Biologics and Versant Ventures.

"I am very excited to lead Northern Biologics at a time that we are going through the critical stage of transitioning programs from research into clinical development," said Dr. Vickers. "Our lead antibody against LIF and our portfolio of novel therapeutic candidates have potential to impact areas of oncology where there is a significant unmet medical need."

Early next year, Northern Biologics will begin clinical testing of its lead immuno-oncology asset, MSC-1, in a range of cancers, working with world-leading cancer institutes in Canada, Europe and the U.S. MSC-1 is a humanized antibody against a soluble cytokine called LIF (see "About LIF" below) with the desired effects of blocking immunosuppression and inhibiting the self-renewal of cancer stem cells. In addition, the company’s pipeline includes several antibodies acting on other relevant oncology targets, including those within the TIGIT and the TIM-3 pathways.

"I would like to thank Stefan for guiding Northern through its launch phase and for setting the company on its current path to success," said Dr. Bolzon. "We are very pleased that Stefan is returning to Versant as a Venture Partner with responsibility for leading new investments within Ontario and the broader region of Eastern Canada."

About LIF

LIF, or leukemia inhibitory factor, is an exciting emerging target in the immuno-oncology space. Northern Co-Founder Joan Seoane first elucidated a role for the cytokine in cancer in a seminal 2009 publication in Cancer Cell. Since that time, several independent labs have verified and published the role of LIF in many cancers. For example, as part of the recent mounting evidence, researchers reported this fall that high levels of LIF occur in pancreatic tumors. Reports on several other LIF findings, including the elucidation of the MSC-1 binding site, are expected within the next few months.

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.

ImmunoGen has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, ImmunoGen, 2017, NOV 9, 2017, View Source [SID1234521837]).

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Caladrius Biosciences has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Caladrius Biosciences, 2017, NOV 9, 2017, View Source [SID1234521883]).

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