On November 13, 2017 Immunomedics, Inc., (NASDAQ: IMMU) ("Immunomedics" or the "Company") reported that its Board of Directors has voted to appoint Michael Pehl as President and Chief Executive Officer ("CEO"), effective December 7, 2017 (Press release, Immunomedics, NOV 13, 2017, View Source [SID1234522004]). He has also been appointed to the Board, effective as of the commencement date of Mr. Pehl’s employment. Immunomedics also announced that Brendan Delaney has been appointed Chief Commercial Officer ("CCO") at Immunomedics, effective as of November 10, 2017. Michael Garone, current Chief Financial Officer ("CFO") and Interim CEO, will resume his role as CFO.

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Discussing the addition of Mr. Pehl, Dr. Behzad Aghazadeh, Chairman of the Board of Immunomedics, stated, "Today’s announcement represents the culmination of an intensely thorough – but ultimately extremely rewarding – search process for the right leader to guide the next phase in the transformation of Immunomedics. As we undertook this task, the Board and I were focused on finding a best-in-class talent with a proven ability to successfully navigate the approval and commercialization of ground-breaking drugs in the oncology space – which we are confident IMMU-132 and other products in our pipeline will be. While Michael’s track record in this area speaks for itself, it was his less tangible qualities that made it clear he was the right choice. As we did our diligence, we repeatedly heard Michael lauded for his strategic vision, operational expertise and confident execution ability. Perhaps most importantly, we time and again heard him singled out for his unique capacity to effectively and compassionately communicate across a spectrum of audiences including patients, KOLs, investors, regulators and fellow team members. This is the type of singular leader we were looking for and are thrilled to have found for Immunomedics."

Mr. Pehl brings to Immunomedics a history of success as a global pharmaceutical leader. Most recently, he served as President, Hematology & Oncology, at Celgene Corporation ("Celgene"), and prior to that was the company’s Head of Global Marketing, Head of Hematology Europe and the first General Manager of Celgene in Germany. Over the course of his 11 years at Celgene, Mr. Pehl has launched multiple blockbuster drugs in the areas of hematology and oncology, including Revlimid, Pomalyst, and Abraxane.

Notably, he has demonstrated an exceptional acumen for realizing lifecycle opportunities and developing pipeline drugs, reflected by the steep revenue growth of Celgene’s Hematology and Oncology business. Under his leadership, Celgene developed and launched the Acute Myeloid Leukemia (AML) drug IDHIFA in industry-record time, and also built an industry-leading pipeline of late and early stage products to treat multiple high-unmet need conditions. Prior to his time as Celgene, Michael served in a number of commercial leadership positions at Amgen in Europe.

Michael Pehl, Immunomedics CEO-designee, stated, "This chance to lead Immunomedics represents a uniquely exciting point-in-time opportunity. Based on the public data on IMMU-132 and available information regarding the Company’s pipeline, I believe the antibody-drug conjugates of Immunomedics have a high likelihood of improving the lives of countless patients with significant unmet medical needs. Now more than ever, this is an absolute priority for me in my career."

Pehl continued, "I was also attracted to this role by the chance to help develop and instill a science based and patient centric culture of performance excellence at Immunomedics. The technology, science and talent the Company has at its disposal are world-class, and I am honored that Behzad and the Board have turned the reins over to me. While the U.S. and global approval and commercialization of IMMU-132 for metastatic triple negative breast cancer are a key goal for me and my team, we simultaneously will be focused on developing IMMU-132 in multiple solid tumor indications, thereby laying the foundation to transform Immunomedics into a recognized leader in the field of antibody-drug conjugates."

Immunomedics also announced today that Brendan Delaney has joined the Company as Chief Commercial Officer. Brendan was most recently Vice President, U.S. Commercial Hematology Oncology at Celgene. In this role, Brendan oversaw a team of roughly 400 professionals across sales, marketing and strategic alliances. Notably, under Brendan’s leadership, the revenue for the group grew to over $7 billion annually, representing a significant proportion of Celgene’s global revenue. Prior to this role, Brendan held a series of other senior-level marketing roles at Celgene. Before coming to Celgene he was at Novartis for five years, serving in a number of U.S. and global marketing roles within the Company’s oncology business unit. Over the course of his 22-year commercial career Brendan has been involved in the launch of nine new oncology products and indications.

In his role as CCO at Immunomedics, Brendan will be responsible for building out the Company’s commercialization team including sales, marketing, market access and pricing. He will report directly to Michael Pehl.

Dr. Aghazadeh said, "Brendan is one of the top commercial leaders in oncology, with deep experience managing cross-functional teams and successfully launching high-value oncology drugs. We believe he is the ideal candidate to lead the launch of the IMMU-132 franchise. Further, Brendan is a truly collaborative and strategic leader who understands how to optimally organize and deploy the commercial function of a top-tier biotech company, making him an excellent fit for where we are at Immunomedics – and more importantly – where we are going as we become a commercial organization ourselves."

Brendan Delaney, Chief Commercial Officer, Immunomedics, stated, "I am thrilled to take on the challenge of building a commercial unit from the ground up at Immunomedics. What makes the opportunity even more exciting is my belief that IMMU-132 will truly address a high unmet need for patients and potentially serve as foundational therapy for multiple solid tumor indications. Additionally, I have deep respect for Michael Pehl from our time working together at Celgene and cannot wait to collaborate to define and execute the commercial strategy at Immunomedics."

On November 13, 2017 Pfizer Inc. (NYSE: PFE) reported that Albert Bourla has been named Chief Operating Officer effective January 1, 2018 (Press release, Pfizer, NOV 13, 2017, View Source [SID1234522007]).

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"The naming of a Chief Operating Officer comes at a time when our business is strong as we continue to advance our strategy while also managing a dynamic and challenging external environment, said Ian Read, Pfizer Chairman and CEO.

"The addition of a COO will enable me to spend more time focusing on the company’s long term strategic direction, ensuring continued R&D productivity and engaging with government policy and industry leaders on key issues facing the future of the healthcare industry."

Albert Bourla, 56, has been the Group President of Pfizer’s Innovative Health Business since the beginning of 2016. Under his leadership revenues for the Pfizer Innovative Health business grew 11% operationally in 2016 and in the first nine months of 2017 have grown 9% operationally. Prior to his current position Dr. Bourla was the Group President for Pfizer’s Vaccines, Oncology and Consumer Healthcare businesses where he was instrumental in building a strong and competitive position in Oncology and expanded the company’s leadership in vaccines.

Over the course of his career Dr. Bourla has held a number of senior global positions across a range of businesses and geographies.

Read continued, "Albert is a proven and trusted leader with over two decades of leadership experience and a demonstrated track record for delivering strong business results. He possesses the right combination of skills, knowledge, strengths and a deep commitment to Pfizer’s culture that make him the clear choice to become Pfizer’s COO."

As General Manager of the company’s Established Products Business Unit he advanced the company’s efforts to build a strong post-patent business by spear-heading efforts that maximized the lifecycle of key brands following loss of exclusivity.

Prior to leading the Established Products business, Dr. Bourla was the Area President for Pfizer’s Animal Health business across Europe, Africa, and Asia Pacific where he successfully managed the integration of Wyeth’s Animal Health Business (Fort Dodge) with Pfizer in these global markets.

Dr. Bourla has significant scientific expertise. He is a Doctor of Veterinary Medicine and holds a PhD degree in the Biotechnology of Reproduction from the Veterinary School of Aristotle University.

Effective January 1, 2018 John Young, Group President, Pfizer Essential Health becomes Group President, Pfizer Innovative Health. Angela Hwang, Global President and General Manager for Pfizer Inflammation & Immunology will succeed John Young as Group President, Pfizer Essential Health.

Mr. Young has held a number of senior leadership positions across Pfizer including as President of the Primary Care Business. He is a scientist by training and has deep knowledge of the company’s innovative biopharmaceutical portfolio having led the commercial and clinical development of medicines in key therapeutic areas including cardiovascular disease, diabetes and pain.

Mr. Young received a BSc in Biological Science from Glasgow University and an MBA from Strathclyde Graduate Business School. He will report to Dr. Bourla and will continue to be a member of the company’s Executive Leadership Team.

Ms. Hwang joined the company in 1997 in the company’s Corporate Strategic Planning and Policy Group. Her experience includes leadership roles within the Innovative Health and Essential health businesses as Global President Pfizer Inflammation and Immunology, Regional head for U.S. Vaccines, Vice President of Emerging Markets for the Primary Care business and Vice President of the U.S. Brands business within Essential Health. In her current role she has been responsible for the growth of products such as Xeljanz and Eucrisa and building a strong pipeline around rheumatology, gastroenterology and dermatology.

Ms. Hwang received her Bachelor of Science in Microbiology and Biochemistry from the University of Cape Town and a Masters of Business Administration from Cornell University. She will become a member of the company’s Executive Leadership team and will report to Dr. Bourla.

Additional members of the Pfizer Executive Leadership team reporting to Dr. Bourla will be:

Kirsten Lund-Jurgensen – Executive Vice President and President Pfizer Global Supply

Rod MacKenzie – Executive Vice President, Chief Development Officer

Laurie Olson – Executive Vice President, Strategy and Commercial Operations

In addition to Dr. Bourla, the following members of Pfizer’s Executive Leadership team will continue to report to Ian Read:

Frank D’Amelio – Executive Vice President, Business Operations and Chief Financial Officer

Mikael Dolsten – Executive Vice President and President, Worldwide Research & Development

Chuck Hill – Executive Vice President, Worldwide Human Resources

Rady Johnson – Executive Vice President, Chief Compliance and Risk Officer

Doug Lankler – Executive Vice President, General Counsel

Freda Lewis-Hall – Executive Vice President and Chief Medical Officer

Sally Susman – Executive Vice President, Corporate Affairs

On November 13, 2017 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading immunotherapy company focused on developing treatments for autoimmune/inflammatory diseases and cancer, reported a corporate update and financial results for the third quarter ended September 30, 2017 (Press release, Alpine Immune Sciences, NOV 13, 2017, View Source [SID1234521994]).

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"The preclinical progress in our platform continues to be encouraging as a growing amount of data supports our vIgD platform’s unique potential to create first in class molecules for inflammatory and oncology indications," said Mitchell H. Gold, M.D., Executive

Chairman and Chief Executive Officer of Alpine. "This is an exciting time at Alpine and we look forward to additional, promising catalysts throughout the coming year."

Preclinical Highlights

Alpine presented preclinical data of its lead program, ALPN-101, at the 2017 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting on November 6, 2017 in San Diego, CA, and of some of its immuno-oncology programs at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (STIC) 32nd Annual Meeting on November 10, 2017 in National Harbor, MD.

At the 2017 ACR/ARHP Annual Meeting, Alpine’s poster disclosed preclinical studies evaluating ALPN-101 program dual ICOS/CD28 antagonists generated by the company’s variant immunoglobulin domain (vlgD) platform. ICOSL vIgD-Fc fusion proteins demonstrated potent activity in an animal model of rheumatoid arthritis and in a humanized mouse model of graft vs. host disease (GvHD), suggesting that ALPN-101 candidates could have potential clinical utility in multiple inflammatory diseases.

At the SITC (Free SITC Whitepaper) 32nd Annual Meeting, Alpine’s poster disclosed distinct preclinical data from multiple novel immuno-oncology programs, all also generated from its vlgD platform. Multiple formats of vIgD-based proteins were functionally active, utilizing multiple mechanisms of action. Some suppressed tumors in an animal model. The demonstrated versatility of the vlgD platform suggests it has the potential to contribute to the next generation of immuno-oncology therapeutics.

In addition, Alpine will present posters at the following upcoming scientific meetings in 2017:

40th Annual San Antonio Breast Cancer Symposium (SABCS)

Abstract Title: ICOSL Anti-HER2 V-mAbs: Localizing Engineered ICOSL Costimulatory Agonists to HER2+ Tumors and Through Trastuzumab
Abstract #: P1-09-10
Session Title: Treatment: Novel targets and Targeted Agents
Location: San Antonio, TX
Date: December 6, 2017
Time: 5:00 PM – 7:00 PM CT
American Society of Hematology (ASH) (Free ASH Whitepaper) 59th Annual Meeting

Abstract Title: Novel Variant lg Domain (vlgD) Proteins Generated Via Directed Evolution of IgSF Domains Have Therapeutic Efficacy in Animal Models of Graft Versus Host Disease
Abstract #: 1892
Session Title: 701. Experimental Transplantation: Basic Biology, Pre-Clinical Models: Poster I
Location: Atlanta, GA
Date: December 9, 2017
Time: 5:30 PM – 7:30 PM ET
Completion of Preferred Financing and Merger with Nivalis Therapeutics

On July 24, 2017, Alpine closed its merger with Nivalis Therapeutics, with the combined company named Alpine Immune Sciences, Inc., and began trading on the NASDAQ Global market on July 25, 2017 under the ticker symbol "ALPN."

Upon completion of the merger, Alpine had approximately $90 million in cash, cash equivalents, and short-term investments. This includes $17.0 million in proceeds from the purchase of Alpine convertible preferred shares immediately prior to the merger from current Alpine investors OrbiMed Advisors, Frazier Healthcare Partners, and Alpine BioVentures at a purchase price of $12.74 per share.

Third Quarter 2017 Financial Results

Alpine ended the third quarter of 2017 with $87.2 million in cash, cash equivalents, and short-term investments compared to $11.8 million as of December 31, 2016. Net cash used in operations for the nine months ended September 30, 2017 was $10.7 million.
Revenue for the third quarter of 2017 was $0.1 million compared to $0.7 million in the third quarter of 2016. Revenues in both periods are attributable to the collaboration agreement with Kite, a Gilead (NASDAQ:GILD) company. As previously announced, this research collaboration and license agreement was extended on October 20, 2017. The extended research term does not change the $530.0 million in potential research, clinical and regulatory milestones payable to Alpine. Kite will continue to have access to two programs from Alpine’s TIP technology for use in CAR-T and TCRs during the extended research term.
Research and development expenses for the third quarter of 2017 were $2.7 million compared to $0.8 million for the same period in 2016. The $1.9 million increase was primarily attributable to increased activity in preclinical studies and the addition of operational and research personnel related to expanding research and discovery programs.
General and administrative expenses for the third quarter of 2017 were $1.9 million compared to $0.3 million for the same period in 2016. The $1.6 million increase was primarily attributable to professional and legal service fees to support the merger with Nivalis and the associated expense of transitioning to a public company structure.
The excess of the estimated fair value of net assets acquired over the acquisition consideration paid for Nivalis resulted in a bargain purchase gain to the statement of operations. This is a non-cash item.
Cash Guidance

Based on current expectations following Alpine’s recent merger, the company expects to have cash to fund operations into 2020.

On November 13, 2017 BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported business highlights and financial results for the third quarter and first nine months of 2017 (Press release, BeiGene, NOV 13, 2017, View Source;p=RssLanding&cat=news&id=2316622 [SID1234521997]).

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"BeiGene has achieved several important milestones since the beginning of the third quarter. Our strategic collaboration with Celgene Corporation has transformed us into a commercial-stage company in China and is expected to enhance the potential of our investigational PD-1 inhibitor, BGB-A317. We have also made important clinical progress with the expansion of the global pivotal program for our BTK inhibitor BGB-3111, the initiation of the first Phase 3 study for BGB-A317 in China, and the completion of patient enrollment of our first China pivotal trials for both BGB-3111 and BGB-A317. In addition, we strengthened our balance sheet with the upfront payment and investment from Celgene as well as our public offering in August," said John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene.

"Looking ahead, we plan to present additional data on BGB-3111 at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December. We also look forward to initiating additional pivotal trials for our portfolio assets in the coming months," commented Mr. Oyler.

Third Quarter 2017 and Recent Business Highlights

Clinical Programs:

BGB-3111, an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK)

• Completed enrollment in the pivotal Phase 2 trial in China of BGB-3111 in relapsed/refractory mantle cell lymphoma;

• Initiated the following trials:

Global Phase 3 trial of BGB-3111 compared to bendamustine and rituximab in treatment-naïve chronic lymphocytic leukemia / small lymphocytic lymphoma patients;

Global pivotal Phase 2 trial of BGB-3111 in combination with GAZYVA (obinutuzumab) in relapsed or refractory follicular lymphoma patients; and

Pivotal Phase 2 trial in China of BGB-3111 in Waldenström’s macroglobulinemia.
BGB-A317, an investigational humanized monoclonal antibody against the immune checkpoint receptor PD-1

• Presented data from patients with gastric cancer, esophageal cancer, head and neck squamous cell carcinoma, and ovarian cancer enrolled in the global Phase 1 trial of BGB-A317 in patients with advanced solid tumors at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress;

• Presented preliminary Phase 1 data on BGB-A317 in Chinese patients with advanced tumors at the 20th Annual Meeting of the Chinese Society of Clinical Oncology;

• Completed enrollment in the pivotal Phase 2 trial of BGB-A317 in China in relapsed/refractory classical Hodgkin’s lymphoma;

• Completed enrollment in the global Phase 1a/1b trial of BGB-A317 in advanced tumors with a total of over 450 patients;

• Initiated the following trials:

Phase 3 trial in China of BGB-A317 as a second- or third-line treatment for patients with advanced lung cancer;

Pivotal Phase 2 trial in China of BGB-A317 in previously treated, PD-L1-positive, locally advanced or metastatic urothelial cancer;

Phase 2 trial in China of BGB-A317 in combination with chemotherapy as a first-line treatment for patients with advanced lung cancer; and

Phase 2 trial in China of BGB-A317 in combination with chemotherapy as a first-line treatment for patients with locally advanced or metastatic esophageal, gastric, or gastroesophageal junction carcinoma.
BGB-290, an investigational small molecule PARP inhibitor

• Presented updated data from the global Phase 1 trial of BGB-290 in patients with advanced solid tumors at the ESMO (Free ESMO Whitepaper) 2017 Congress;

• Initiated the following trials:

Global Phase 1 trial of BGB-290 in combination with temozolomide in locally advanced or metastatic solid tumors; and

Global Phase 1b/2 trial of BGB-290 in combination with radiation therapy and/or temozolomide in glioblastoma.
Corporate Development:

• Closed our global strategic collaboration with Celgene Corporation.

Expected Upcoming Milestones

BGB-3111 (BTK Inhibitor)

• Present additional Phase 1 data for BGB-3111 in non-Hodgkin’s lymphoma, updated Phase 1 data for the combination of BGB-3111 and Gazyva (obinutuzumab), and initial Phase 1 data for the combination of BGB-3111 and BGB-A317 at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Atlanta, GA, December 9-12, 2017.

BGB-A317 (PD-1 Antibody)

• Present initial Phase 1 data for the combination of BGB-3111 and BGB-A317 at the 59th ASH (Free ASH Whitepaper) Annual Meeting in Atlanta, GA, December 9-12, 2017; and

• Initiate Phase 3 trials of BGB-A317 in China in the fourth quarter of 2017 or the first quarter of 2018.

BGB-290 (PARP Inhibitor)

• Initiate a pivotal trial in China in the fourth quarter of 2017.

Third Quarter 2017 Financial Results

Cash, Cash Equivalents, and Short-Term Investments were $757.44 million as of September 30, 2017, compared to $407.43 million as of June 30, 2017 and $368.17 million as of December 31, 2016. The increase in the quarter was primarily attributable to the Celgene strategic collaboration. Funding from Celgene includes upfront licensing fees of $263.00 million, $92.05 million of which was received as of September 30, 2017 and the rest of which is payable in the fourth quarter of 2017, and an equity investment of $150.00 million. In addition, net proceeds from our August 2017 follow-on public offering contributed $188.52 million, after deducting underwriting discounts and offering-related expenses. These were partially offset by cash used in operating activities and for capital expenditures during the three months ended September 30, 2017.

The Company consolidates the BeiGene Biologics joint venture in its consolidated financial statements. As of September 30, 2017, cash, cash equivalents and short-term investments included $141.64 million of cash held by BeiGene Biologics.

Cash provided by operations for the three months ended September 30, 2017 was $6.60 million, compared to a use of cash of $24.28 million for the same period in 2016. The increase in cash flow from operating activities was primarily attributable to upfront licensing fees of the Celgene collaboration, which offset increased research and development (R&D) and selling, general and administrative (SG&A) expenses in the period. Capital expenditures for the quarter ended September 30, 2017 were $18.79 million, including $13.94 million attributable to BeiGene Biologics, compared to $6.68 million for the same period in 2016. The increase was primarily attributable to increased investment in our manufacturing facilities in Guangzhou and Suzhou.

Revenue for the three months ended September 30, 2017 was $220.21 million, compared to nil in the same period in 2016, and was comprised of $8.82 million of net product revenue and $211.39 million of collaboration revenue. The product revenues represent net product sales of Abraxane and Revlimid in China following the effective date of the Celgene transaction, August 31, 2017. The collaboration revenue recognized in the period relates to the upfront fee allocated to the BGB-A317 license element of the arrangement.

R&D Expenses for the three months ended September 30, 2017 were $87.66 million, compared to $30.11 million in the same period in 2016. The increase was primarily attributable to increased spending on clinical activities and manufacturing for BGB-3111, BGB-A317, and BGB-290 due to expansion of ongoing clinical programs and increased employee compensation-related expenses as a result of increased headcount to support a broader clinical program. R&D-associated share-based compensation expense was $10.38 million for the three months ended September 30, 2017, compared to $2.14 million for the same period in 2016, primarily due to increased headcount, higher share price, and increased expense attributable to non-employee consultant awards.

SG&A Expenses for the three months ended September 30, 2017 were $15.64 million compared to $4.72 million in the same period in 2016. The increase was primarily attributable to increased employee compensation-related expenses as a result of increased headcount, including personnel costs for the employees transferred from Celgene China and higher share price as well as higher professional service fees, including legal, finance and accounting fees related to the Celgene transaction, patent prosecution activities and costs to support our growing operations. In addition, SG&A-associated share-based compensation expense was $2.95 million for the three months ended September 30, 2017, compared to $0.64 million for the same period in 2016.

Net Income attributable to BeiGene, Ltd. for the three months ended September 30, 2017 was $117.39 million compared to a net loss of $35.49 million in the same period in 2016.

On November 13, 2017 Cellectis S.A. (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported its results for the three-month period ended September 30, 2017 and for the nine-month period ended September 30, 2017 (Press release, Cellectis, NOV 13, 2017, View Source [SID1234521998]).

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Earnings Call Details

Cellectis will host an earnings call on November 14, 2017 at 8:30am Eastern Time to discuss its financial results and provide a general business update.

Dial-In Numbers:

Live PARTICIPANT Dial-In (Toll-Free US & Canada): 877-407-3104

Live PARTICIPANT Dial-In (International): +1 201-493-6792

Replay Information:

Conference ID #: 13625168

Replay Dial-In (Toll Free US & Canada): 877-660-6853

Replay Dial-In (International): +1 201-612-7415

Expiration Date: 11/28/17

Webcast URL (Archived for 6 months): http://cellectis.equisolvewebcast.com/q3-2017

Third Quarter 2017 and Recent Highlights

Cellectis – Therapeutics

UCART123: Cellectis’ TALEN gene-edited, allogeneic CAR T product candidate in AML and BPDCN Patients

As of November 6, 2017, Cellectis announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold, previously announced on September 4, 2017, on both Phase 1 trials of UCART123 product candidate in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN). In connection with the lifting of the clinical hold, Cellectis agreed with the FDA to certain revisions to be implemented in Phase 1 UCART123 protocols. Cellectis is currently working with the investigators from Weill Cornell Medicine New York – Presbyterian Hospital and MD Anderson Cancer Center to obtain approval of the revised protocols from their respective institutional review boards in order to resume patient enrollment.

UCART19: TALEN gene-edited, allogeneic CAR T product candidate in ALL patients, exclusively licensed to Servier

Preliminary results of the first-in-human clinical trials of UCART19 will be presented at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting (the "ASH Annual Meeting") to be held from December 9 to 12, 2017 in Atlanta, GA. Results from the UCART19 clinical trial in adult ALL patients will be presented orally by Reuben Benjamin, principal investigator for the trial and consultant hematologist at King’s College Hospital, United Kingdom. Results from the UCART19 clinical trial in pediatric ALL patients will be presented during a poster session by Waseem Qasim, principal investigator for the trial and consultant in pediatric immunology and reader in cell and gene therapy at Great Ormond Street Hospital for Children, United Kingdom.

UCARTCS1, UCART22 & UCART123

Three abstracts regarding other Company’s off-the-shelf CAR T product candidates have been accepted for presentation at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting:

UCARTCS1: Universal SLAMF7-Specific CAR T-Cells As Treatment for Multiple Myeloma (oral presentation)
UCART22: Pre-clinical Activity of Allogeneic Anti-CD22 CAR T-Cells for the Treatment of B-cell Acute Lymphoblastic Leukemia (oral presentation)
UCART123 product candidate targeting Blastic Plasmacytoid Dendritic Cell Neoplasm (poster presentation)

Corporate Governance

On October 4, 2017, Mathieu Simon M.D., Executive VP and Chief Operating Officer, as been appointed as Interim Chief Medical Officer. In accepting this position, Dr. Simon assumes the responsibilities of Loan Hoang-Sayag, who left Cellectis to pursue other professional opportunities. Effective on October 11, 2017, Dr. Simon also resigned from his position as a member of the board of directors in order to focus on his additional responsibilities as Interim Chief Medical Officer.

Calyxt, Inc. – Cellectis’ plant science subsidiary

Products

Calyxt’s herbicide-tolerant wheat, its third wheat product candidate, and improved oil composition canola, its first canola product candidate, have advanced to Phase 1 of development. With these phase advancements, Calyxt now has a total of nine product candidates in Phase 1 of development or later across its five crops: soybeans, wheat, canola, potatoes and alfalfa.

The first of Calyxt’s two alfalfa product candidates has been designated as a non-regulated article under the "Am I Regulated?" Process by Biotechnology Regulatory Services of the Animal and Plant Health Inspection Service (APHIS), an agency of the USDA. The improved quality alfalfa is the sixth Calyxt product candidate to be confirmed as a non-regulated article by the USDA including its high oleic soybean, high oleic / low linolenic soybean, powdery mildew resistant wheat, cold storable potatoes and reduced browning potatoes.

Corporate

Initial Public Offering: On July 25, 2017, Calyxt completed an initial public offering of its common stock, selling an aggregate of 8,050,000 shares of common stock at a price of $8.00 per share (including 1,050,000 shares of common stock pursuant to the exercise by the underwriters of their option to purchase additional shares). Calyxt received net proceeds of approximately $58.0 million, after deducting underwriting discounts and commissions and offering expenses. As part of the IPO, Cellectis purchased 2,500,000 shares of common stock for a value of $20.0 million, which is included in the net proceeds that Calyxt received. Calyxt used $5.7 million of the proceeds to cover a portion of the outstanding obligations owed to Cellectis. Following Calyxt’s IPO, Cellectis owns 79.8% of the outstanding Calyxt’s common shares.

Sale Leaseback Transaction: On September 6, 2017, Calyxt consummated a sale-leaseback transaction including a lease agreement between Calyxt and a third party with respect to the Calyxt’s lease of certain real property and improvements located in Roseville, Minnesota for a term of twenty years with option to extend the term for up to an additional twenty years.

Headquarters Construction: Calyxt has broken ground on its new 40,000-square-foot headquarters, which will be housed on the 11-acre site in Roseville, together with state-of-the-art research completed approximately 11,000-square-foot greenhouses.

Financial Results

Cellectis’ consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board ("GAAP").

Effective in the third quarter of 2017, Cellectis changed the presentation currency of its consolidated financial statements from the euro to the U.S. dollar, in order to enhance comparability with peers, which primarily present their financial statements in U.S. dollar.

Third quarter 2017 Financial Results

Cash: As of September 30, 2017, Cellectis had $304.1 million in total cash, cash equivalents and current financial assets compared to $271.2 million as of June 30, 2017. This increase of $32.9 million reflects (i) an increase of $38.0 million attributable to Calyxt IPO, (ii) the net cash provided by investing activities of $6.1 million included $7.0 million of proceeds from Calyxt’s sale leaseback transaction and (iii) the unrealized positive translation effect of exchange rate fluctuations on U.S. dollar cash, cash equivalents and current financial assets of $3.1 million; partially offset by (iv) the net cash flows used by operating activities of $15.5 million.

Cellectis expects that its cash, cash equivalents and current financial assets of $304.1 million as of September 30, 2017 will be sufficient to fund its current operations into 2020.

Revenues and Other Income: During the quarters ended September 30, 2016 and 2017, we recorded $12.6 million and $7.3 million, respectively, in revenues and other income. This decrease of $5.4 million is mainly due to (i) a $5.0 million decrease in collaboration revenues of which $4.0 million represented revenue from payments by Servier during the quarter ended September 30, 2016 for the supply of raw materials and batches of UCART19 products, that did not recur during the quarter ended September 30, 2017, $0.6 million represented decreased recognition of upfront already paid to Cellectis and a $0.3 million decrease in research and development cost reimbursements, (ii) a $0.2 million decrease in license revenue and (iii) a $0.2 million decrease in research credit tax.

Total Operating Expenses: Total operating expenses for the third quarter of 2017 were $33.0 million, compared to $25.5 million for the third quarter of 2016. The non-cash stock-based compensation expenses included in these amounts were $12.8 million and $13.5 million, respectively.

R&D Expenses: For the quarters ended September 30, 2016 and 2017, research and development expenses increased by $4.9 million from $15.4 million in 2016 to $20.3 million in 2017. Personnel expenses decreased by $2.1 million from $10.3 million in 2016 to $8.1 million in 2017, primarily due to a $2.3 million decrease in non-cash stock based compensation expense, partly offset by a $0.2 million increase in wages and salaries. Purchases and external expenses increased by $6.8 million from $4.9 million in 2016 to $11.7 million in 2017, mainly due to increased expenses related to payments to third parties participating in product development, purchases of biological raw materials, expenses for process development and expenses associated with the use of laboratories and other facilities. Other expenses increased by $0.2 million for the third quarter of 2017 compared to the third quarter of 2016.

SG&A Expenses: During the quarters ended September 30, 2016 and 2017, we recorded $9.7 million and $12.2 million, respectively, of selling, general and administrative expenses. The increase of $2.4 million primarily reflects an increase of $2.2 million in personnel expenses from $7.4 million to $9.6 million, attributable, among other things, to an increase of $0.5 in wages and salaries and an increase of $1.6 million in non-cash stock-based compensation expense, as well as an increase of $0.3 million in purchases and external expenses.

Financial Gain (Loss): The financial loss was $1.2 million for the third quarter of 2016 compared with a financial loss of $3.4 million for the third quarter of 2017. The change in financial result was primarily attributable to an increase in net foreign exchange loss of $3.2 million due to the effect of exchange rate fluctuations on our U.S. dollar cash and cash equivalent accounts, partially offset by an increase of $0.8 million in fair value adjustment income on our foreign exchange derivatives and current financial assets and an increase of $0.2 million in interest received from our financial investment.

Net Income (Loss) Attributable to Shareholders of Cellectis: During the three months ended September 30, 2016 and 2017, we recorded a net loss attributable to shareholders of Cellectis of $14.1 million (or $0.40 per share on both a basic and a diluted basis) and net loss attributable to shareholders of Cellectis of $26.2 million (or $0.73 per share), respectively. Adjusted loss attributable to shareholders of Cellectis for the third quarter of 2017 was $13.3 million ($0.37 per share) compared to adjusted loss attributable to shareholders of Cellectis of $0.5 million ($0.02 per), for the third quarter of 2016. Adjusted income (loss) attributable to shareholders of Cellectis for the third quarter of 2017 and 2016 excludes non-cash stock-based compensation expense of $12.8 million and $13.5 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted income (loss) attributable to shareholders of Cellectis.

First Nine Months 2017 Financial Results

Cash: As of September 30, 2017, Cellectis had $304.1 million in total cash, cash equivalents and current financial assets compared to $ 291.2 million as of December 31, 2016. This increase of $12.9 million primarily reflects (i) the proceeds of $38.0 million as part of the Calyxt IPO, (ii) the net cash provided by investing activities of $2.3 million which includes $7.0 million of proceeds from Calyxt’s sale leaseback transaction and (iii) the unrealized positive translation effect of exchange rate fluctuations on U.S. dollar cash, cash equivalents and current financial assets of $13.1 million; partially offset by the net cash flows used by operating activities of $42.8 million.

Revenues and Other Income: During the nine-month period ended September 30, 2016 and 2017, we recorded $43.5 million and $26.7 million, respectively, in revenues and other income. This decrease of $16.8 million is mainly due to (i) a $16.9 million decrease in collaboration revenues of which $8.5 million represented one-time milestones revenues received during the second quarter of 2016 with the first patient dosed in the Phase 1 clinical trial for UCART 19, $4.8 million represented decreased recognition of upfront fees already paid to Cellectis and $1.5 million represented decrease in research and development cost reimbursements and $2.2 million represented decreased revenue from payment by Servier for the supply of raw materials and batches of UCART19 products, and (ii) a $0.4 million decrease in other licenses revenue, partially offset by (iii) an increase of $0.5 million in research tax credits.

Total Operating Expenses: Total-operating expenses for the nine-month period ended September 30, 2017 were $91.8 million, compared to $90.3 million for the nine months ended September 30, 2016. The non-cash stock-based compensation expenses included in these amounts were $38.9 million and $44.5 million, respectively.

R&D Expenses: For the nine months ended September 30, 2016 and 2017, research and development expenses increased by $0.3 million from $58.3 million in 2016 to $58.5 million in 2017. Personnel expenses decreased by $8.5 million from $36.4 million in 2016 to $27.9 million in 2017, primarily due to a $6.7 million decrease in non-cash stock based compensation expense, and a $1.9 million decrease in social charges on stock options grants partly offset by a $0.1 million increase in wages and salaries. Purchases and external expenses increased by $8.4 million from $20.7 million in 2016 to $29.1 million in 2017, mainly due to increased expenses related to payments to third parties participating in product development, purchases of biological raw materials, expenses for process development and expenses associated with the use of laboratories and other facilities. Other expenses increased by $0.4 million for the nine months ended September 30, 2017 compared to the nine months ended September 30, 2016.

SG&A Expenses: During the nine months ended September 30, 2016 and 2017, we recorded $31.1 million and $31.8 million, respectively, of selling, general and administrative expenses. The increase of $0.8 million primarily reflects (i) an increase of $1.1 million in personnel expenses from $23.9 million to $25.0 million, attributable to a $1.6 million increase in wages and salaries, a $1.1 million increase in non-cash stock based compensation expense, partly offset by a decrease of $1.6 million of social charges on stock options grants, (ii) a $0.2 increase in other expenses, partially offset by a $0.5 million decrease in purchases and external expenses.

Financial Gain (Loss): The financial loss was $7.1 million for the nine months ended September 30, 2016 compared with financial loss of $10.0 million for the nine months ended September 30, 2017. The change in financial result was primarily attributable to the effect of exchange rate fluctuations on our U.S. dollar cash and cash equivalent accounts for $7.3 million partially offset by the fair value adjustment on our derivative instrument and financial current asset for $4.2 million and the interest received from our financial investment for $0.2 million.

Net Income (Loss) Attributable to Shareholders of Cellectis: During the nine months ended September 30, 2016 and 2017, we recorded a net loss attributable to shareholders of Cellectis of $53.9 million (or $ 1.53 per share) and a net loss attributable to shareholders of Cellectis of $72.3 million (or $2.03 per share), respectively. Adjusted loss attributable to shareholders of Cellectis for the nine months ended September 30, 2017 was $33.3 million ($0.94 per share) compared to adjusted loss attributable to shareholders of Cellectis of $9.4 million ($0.27 per share), for the nine months ended September 30, 2016. Adjusted loss attributable to shareholders of Cellectis for the nine months ended September 30, 2017 and 2016 excludes a non-cash stock-based compensation expense of $38.9 million and $44.5 million, respectively. Please see "Note Regarding Use of Non-GAAP Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted net income (loss) attributable to shareholders of Cellectis.