On November 9, 2017 Immunomedics, Inc. (NASDAQ:IMMU) ("Immunomedics" or the "Company") reported financial results for the first quarter ended September 30, 2017 (Press release, Immunomedics, NOV 9, 2017, View Source [SID1234521872]). The Company also highlighted recent key progress and planned activities for its IMMU-132 development program. Please refer to the Company’s Quarterly Report on Form 10-Q filed today with the SEC for more detail on the Company’s financial results.

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Dr. Behzad Aghazadeh, Chairman of the Board of Directors, stated, "During the quarter and over the course of the year, we have made significant progress toward preparing a BLA for accelerated approval of IMMU-132, our breakthrough therapy candidate for the treatment of late-stage metastatic triple-negative breast cancer (mTNBC). IMMU-132 has shown a remarkable response rate in patients and we remain sharply focused on bringing this promising treatment to market as soon as possible. Notably, in the quarter, we completed a number of successful meetings with the FDA including a CMC and a pre-BLA meeting, where we received positive feedback on our proposed submission plans. As such, we remain on track to meet our stated goal of submitting our BLA filing in the first quarter."

In a separate release today, Immunomedics also announced that its Board of Directors has voted to appoint Michael Pehl as President and Chief Executive Officer ("CEO"), effective December 7, 2017. Mr. Pehl has also been appointed to the Board of Directors, effective as of the commencement date of Mr. Pehl’s employment. Immunomedics additionally announced that Brendan Delaney has been appointed Chief Commercial Officer ("CCO"), effective November 10, 2017. Michael Garone, current Chief Financial Officer ("CFO") and Interim CEO, will resume his role as CFO upon the commencement of Mr. Pehl’s tenure.

Dr. Aghazadeh added, "We are thrilled to have found in Mr. Pehl the right leader to guide the next phase of transformation for Immunomedics. His track record of successfully navigating the approval and commercialization of breakthrough oncology drugs is exemplary. Further, we are confident that we are adding someone with the strategic vision, operational expertise, execution ability, and capacity for communication across various stakeholders to help us maximize the value of IMMU-132 and the broader pipeline for both patients and investors.

"The addition of Mr. Delaney in the role of CCO is also a major step forward, as he is one of the top commercial leaders in the marketplace. His experience managing cross-functional teams and successfully launching high-value oncology drugs will be key as we continue the evolution of Immunomedics into a commercial-stage biotechnology company."

Mr. Pehl most recently served as President, Hematology & Oncology, at Celgene Corporation ("Celgene"), and prior to that was Head of Global Marketing for the Company in both the United States and in Europe. Mr. Delaney was most recently at Celgene where he served as Vice President, U.S. Commercial Hematology Oncology. For additional information on their backgrounds, the full release on their appointments can be found here: View Source

Recent Program Highlights for IMMU-132

In September, Immunomedics presented results of IMMU-132 in metastatic urothelial cancer who have relapsed or are refractory to chemotherapies and immune checkpoint inhibitors (IOs), at the European Society for Medical Oncology 2017 Congress (ESMO) (Free ESMO Whitepaper). The confirmed objective response rate (ORR) among 41 intention-to-treat patients was 34%, including two confirmed complete responses and 12 confirmed partial responses. For the 14 patients who progressed after prior IO therapy, the confirmed ORR was 29%.

In October, Immunomedics opened the ASCENT trial; the Phase 3 confirmatory trial of IMMU-132 in patients with mTNBC, and first patient has been dosed.

In November, the abstract on updated results from the Phase 2 study of IMMU-132 in patients with mTNBC was accepted for an oral presentation at the 2017 San Antonio Breast Cancer symposium (SABCS).

In November, a second abstract on the Phase 3 ASCENT trial design has also been accepted for poster presentation at the same SABCS conference.
Balance Sheet Improvement

On September 21, 2017, Immunomedics completed the exchange of $80 million in aggregate principal amount of our 4.75% Convertible Senior Notes due 2020 (Convertible Senior Notes) for newly issued shares of our common stock, pursuant to privately negotiated exchange agreements entered into between the Company and a limited number of holders of the Convertible Notes.
Litigation Update

On November 2, 2017, Immunomedics, venBio Select Advisor LLC, a Delaware limited liability company, Dr. David M. Goldenberg, a director of the Company and the Company’s Chief Scientific Officer and Chief Patent Officer, Ms. Cynthia L. Sullivan, a director of the Company and the Company’s former President and Chief Executive Officer, Mr. Brian A. Markison, a director of the Company, and Greenhill & Co., Inc. and Greenhill & Co., LLC, entered into a stipulation and agreement of settlement, compromise, and release (the "Settlement Agreement"). The terms and conditions of the Settlement Agreement reflect the terms and conditions of the binding settlement term sheet entered into on May 3, 2017, by and among the Company, venBio, Goldenberg, Sullivan and Markison, in order to resolve certain legal actions. Please refer to the Company’s Current Report on Form 8-K filed on November 8, 2017 with the SEC for more detail on the Settlement Agreement.

As part of the agreement, Dr. Goldenberg will remain a director of the Company while stepping down from his role as Chief Scientific Officer and Chief Patent Officer.
Dr. Aghazadeh added, "We would like to thank Dr. Goldenberg and Ms. Sullivan for all of their contributions and look forward to continuing to work with Dr. Goldenberg in his capacity as a director. With this litigation behind us, we can now fully turn our attention to bringing IMMU-132 to market, and positioning the business for the next phase of growth and building out the leadership of the organization."

First Quarter Fiscal 2018 Results

Total revenue was $0.7 million for both quarters ended September 30, 2017 and September 30, 2016.

Total costs and expenses for the first quarter ended September 30, 2017 were $22.3 million, compared to $15.7 million for the same quarter in fiscal 2017, an increase of approximately 42%. The increase was due primarily to a $4.0 million increase in general and administrative expenses related to professional and legal fees, due primarily to the Company’s proxy contest in fiscal 2017, strategic planning activities, and increased associated legal expenses; and a $2.8 million increase in research and development expenses related to increased number of staffing for the preparation of regulatory submission and launch of IMMU-132 in the United States, including preparing and filing the BLA with the FDA, initiating the Phase 3 ASCENT clinical trial for mTNBC, and continuing large scale manufacturing and process validation.

The Company recognized $86.4 million in non-cash expense during the first quarter ended September 30, 2017, due to the increase in the fair value of warrant liabilities resulting from the increase in the share price of the Company’s stock during the quarter. The Company also recognized a $13.0 million non-cash loss on induced exchanges of debt related to the Convertible Senior Notes. There was no warrant-related expense in fiscal 2017.

Interest expense related to the Convertible Notes was $2.6 million for the first quarter ended September 30, 2017, compared to $1.4 million for the same quarter in fiscal 2017, an increase of approximately 86%. The increase was due primarily to a $1.4 million increase in the amortization of debt issuance costs related to the Convertible Notes exchange.

Net loss attributable to stockholders was $118.7 million, or approximately $0.97 per share, for the first quarter ended September 30, 2017, compared to $16.2 million, or approximately $0.17 per share, for the same quarter in fiscal 2017, an increase of approximately 633%. The increase was due primarily to the warrant- and Convertible Senior Notes-related non-cash expense/loss of approximately $99.6 million; an increase in general and administrative expenses as well as research and development expenses; and the increase in the amortization of the debt issuance costs, offset partially by the receipt of $4.4 million in non-recurring insurance reimbursement related to legal costs incurred from the fiscal 2017 proxy contest.

Cash, cash equivalents, and marketable securities totaled $139.6 million as of September 30, 2017.

Michael R. Garone, CFO and Interim CEO, stated, "Our prudent financial management has enabled us to solidify a cash runway for at least the next twelve months – supporting our plan to prepare for the regulatory submission and launch of IMMU-132 for patients with mTNBC in the United States. This includes preparing and filing the BLA with the FDA as planned in the first quarter, conducting the Phase 3 ASCENT clinical trial for mTNBC, and continuing large scale manufacturing and process validation. We look forward to sharing the results from our single-arm Phase 2 study with IMMU-132 in mTNBC at SABCS."

Conference Call
The Company will host a conference call and live audio webcast today at 5:00 p.m. Eastern Time to discuss financial results for the first quarter of fiscal year 2018, and review key clinical developments and planned activities. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 7899497. The conference call will be webcast via the Investors page on the Company’s website at www.immunomedics.com/investors.shtml. Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company’s website for 30 days through December 8, 2017.

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 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.