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Novocure Announces Fourth Quarter and Full Year 2018 Operating Statistics, Preliminary Net Revenues and Provides Company Update

On January 7, 2019 Novocure (NASDAQ: NVCR) reported operating statistics and preliminary, unaudited net revenues and cash balances for the fourth quarter and full year 2018 (Press release, NovoCure, JAN 7, 2019, View Source [SID1234532545]). Novocure plans to discuss these results with investors at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco. The company also highlighted anticipated clinical and regulatory milestones, announced national reimbursement in Sweden and confirmed a Contractor Advisory Committee (CAC) meeting date set by the durable medical equipment (DME) Medicare Administrative Contractors (MACs).

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Novocure announces fourth quarter and full year 2018 operating statistics, preliminary net revenues and provides company update

(1) An "active patient" is a patient who is on Optune under a commercial prescription order as of the measurement date, including patients who may be on a temporary break from treatment and who plan to resume treatment in less than 60 days.

(2) A "prescription received" is a commercial order for Optune that is received from a physician certified to treat patients with Optune for a patient not previously on Optune. Orders to renew or extend treatment are not included in this total.

(3) The preliminary, unaudited results described in this press release are estimates only and are subject to revision until the company reports its full financial results for the fourth quarter 2018 on Feb. 28, 2019.

"We continued to drive Optune adoption in the fourth quarter with full year 2018 preliminary net revenues of $248.0 million, representing annual growth of more than 40 percent. Prescriptions for patients with newly diagnosed GBM grew to approximately 950 in the fourth quarter, driving our 16th consecutive quarter of active patient growth since the initial presentation of our EF-14 data," said William Doyle, Novocure’s Executive Chairman. "Notably, we also expanded our geographic reach with national reimbursement in Sweden and Zai Lab’s recent launch of Optune in Hong Kong."

"At Novocure, we are working to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy," continued Mr. Doyle. "With an application at the FDA for mesothelioma and ongoing or planned phase 3 pivotal trials in brain metastases, non-small cell lung cancer, pancreatic cancer and ovarian cancer, we believe GBM represents just the tip of the iceberg for Tumor Treating Fields. We look forward to providing a full company update and discussing our 2018 financial results on our February conference call."

Fourth quarter 2018 operating statistics and preliminary financial highlights

There were 2,383 active patients on Optune at December 31, 2018, representing 30 percent growth compared to December 31, 2017, and 6 percent growth compared to September 30, 2018.

In the United States, there were 1,637 active patients on Optune at December 31, 2018, representing 24 percent growth compared to December 31, 2017.
In Germany and other EMEA markets, there were 654 active patients on Optune at December 31, 2018, representing 28 percent growth compared to December 31, 2017.
In Japan, there were 92 active patients on Optune at December 31, 2018, representing 4,500 percent growth compared to December 31, 2017.
Additionally, 1,315 prescriptions were received in the quarter ended December 31, 2018, representing 21 percent growth compared to the same period in 2017, and 6 percent growth compared to the quarter ended September 30, 2018. Prescriptions for newly diagnosed GBM continued to grow, with approximately 950 Optune prescriptions in the fourth quarter written for patients with newly diagnosed GBM.

In the United States, 941 prescriptions were received in the quarter ended December 31, 2018, representing 16 percent growth compared to the same period in 2017.
In Germany and other EMEA markets, 322 prescriptions were received in the quarter ended December 31, 2018, representing 15 percent growth compared to the same period in 2017.
In Japan, 52 prescriptions were received in the quarter ended December 31, 2018, representing 5,100 percent growth compared to the same period in 2017.
On a preliminary, unaudited basis, for the quarter ended December 31, 2018, net revenues were $69.6 million, representing 30 percent growth compared to the fourth quarter 2017, and full year 2018 net revenues were $248.0 million, representing annual growth of more than 40 percent compared to 2017.

At December 31, 2018, on a preliminary, unaudited basis, Novocure had $140.6 million in cash and cash equivalents and $105.3 million in short-term investments, for a total balance of $245.9 million in cash, cash equivalents and short-term investments. This represents an increase of $18.2 million in cash and investments since September 30, 2018.

Anticipated clinical and regulatory milestones

FDA approval for unresectable malignant pleural mesothelioma (2019)
Initiation of phase 3 pivotal trial in recurrent ovarian cancer (2019)
Zai Labs initiation of phase 2 pilot trial in gastric cancer (2019)
Data from phase 2 pilot HEPANOVA trial in advanced liver cancer (2020)
Interim analysis of phase 3 pivotal LUNAR trial in non-small cell lung cancer (2020)
Data from phase 3 pivotal METIS trial in brain metastases (2021)
Interim analysis of phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2021)
Final data from phase 3 pivotal LUNAR trial in non-small cell lung cancer (2021)
Interim analysis of phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2022)
Novocure has received initial comments from the FDA on its October 2018 Humanitarian Device Exemption (HDE) application for approval in malignant pleural mesothelioma and is currently preparing its response.

Other company updates

Novocure announced today that it has finalized a pricing and reimbursement agreement for Optune in Sweden. Reimbursement decisions in Sweden are supported by a comprehensive health technology assessment. With defined reimbursement now established in Sweden, Novocure’s efforts will turn to building adoption.

Novocure also announced today that the DME MACs will host a CAC meeting on March 6, 2019. The CAC meeting is intended to provide a formal mechanism for healthcare professionals to be informed of and participate in the development of the local coverage determination (LCD) for Optune for the treatment of newly diagnosed GBM. Following the CAC meeting, the DME MACs will draft and publish a proposed LCD for public comment.

Fourth quarter and full year 2018 financial results conference call

Novocure will host a conference call and webcast to discuss fourth quarter and full year 2018 financial results on Thursday, Feb. 28, 2019 at 8 a.m. EDT. Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 3956899.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call.

Biological Dynamics to Present at Biotech Showcase 2019 During Annual J.P. Morgan Conference in San Francisco

On January 7, 2019 Biological Dynamics, a company committed to improving global health outcomes through empowering global communities with accessible cancer diagnostics, reported the company will present at the Biotech Showcase 2019 conference, taking place during the annual J.P. Morgan Healthcare Conference on January 7-9 at the Hilton San Francisco Union Square (Press release, Biological Dynamics, JAN 7, 2019, View Source [SID1234532544]).

Raj Krishnan, Ph.D., CEO of Biological Dynamics, will present at the Biotech Showcase as follows:

Date: Tuesday, January 8, 2019
Time: 1:30 p.m. (PST)
Room: Franciscan B
Venue: Hilton San Francisco Union Square Hotel, 333 O’Farrell Street, San Francisco, Calif.

Dr. Krishnan will present an overview of Biological Dynamics’ innovative cancer diagnostics platform, Verita, as well as the company’s plans to transition into a commercial-stage company and further the development of a smartphone-enabled diagnostics platform.

Biotech Showcase is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and executives in one place. This event takes place during the industry’s most prevalent healthcare investor conference, the annual J.P. Morgan Healthcare Conference

Adimab Partner Innovent Receives Product Approval for PD-1 Antibody for Hodgkin’s Lymphoma

On January 7, 2019 Adimab, LLC, the global leader in the discovery and optimization of fully human monoclonal and bispecific antibodies, reported that its partner Innovent Biologics has received BLA approval in China for an antibody against PD-1 to treat Hodgkin’s Lymphoma (Press release, Adimab, JAN 7, 2019, View Source [SID1234532543]).

Adimab and Innovent initiated a partnership in 2013 to discover antibodies against multiple targets selected by Innovent. The partnership has been expanded multiple times to add additional programs and to access Adimab’s bispecifics capabilities. Innovent currently has 12 programs in development derived from the Adimab Platform. The PD-1 program, which Innovent has partnered with Lilly, was initiated in the spring of 2013.

On December 27th, 2018, Innovent and its co-development partner, Eli Lilly, announced that Tyvyt (fully human anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab injection) has been granted approval for market authorization by the National Medical Products Administration of China ("NMPA", formerly the China Food and Drug Administration) for the treatment of patients with classical Hodgkin’s lymphoma (cHL) that has relapsed or refractory (r/r) after two or more lines of systemic chemotherapy (r/r cHL).

"Innovent has been an outstanding partner. Their ability to go from inception to an approved drug in five years is impressive by any standard. Innovent has a deep pipeline of quality programs and we expect them to be a major player in the Chinese pharmaceutical industry for years to come," said Tillman Gerngross, Chief Executive Officer and Co-Founder of Adimab.

"Adimab’s technology helped generate one of the most competitive PD-1 programs in the industry and the quality of the antibody allowed Innovent’s PD-1 program to go from initiating discovery to approval in China in less than six years," said Dr. Michael Yu, the Founder, Chief Executive Officer and Chairman of Innovent. "Adimab has been one of our most important partners. The quality of their work and professionalism are exceptional."

About Tyvyt (sintilimab injection)

Tyvyt (sintilimab injection) is an innovative drug co-discovered by Innovent and Adimab, jointly developed by Innovent and Eli Lilly and Company in China. Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to the PD-1 molecule on the surface of T-cells, blocks the PD-L1 (Programmed Cell Death-1 Ligand-1, PD-L1 pathway) and reactivates T-cells to kill cancer cells. Tyvyt (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company.

Gamida Cell Announces 2019 Goals and Provides Company Update

On January 7, 2019 Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, reported expected milestones for 2019, which highlight the company’s progress advancing its clinical development candidates: NiCord, an investigational universal bone marrow donor source in late-stage development for patients with hematologic malignancies (blood cancers), and NAM-NK, an investigational, cell-based cancer immunotherapy in development in patients with non-Hodgkin lymphoma and multiple myeloma (Press release, Gamida Cell, JAN 7, 2019, View Source [SID1234532542]).

Gamida Cell expects to complete patient enrollment in its Phase 3 clinical study of NiCord in the second half of this year. The international, randomized, multi-center study is designed to evaluate the safety and efficacy of NiCord compared to standard umbilical cord blood for allogeneic hematopoietic stem cell (bone marrow) transplant in approximately 120 patients with no available matched donor. The company also expects to report additional data from the ongoing Phase 1 study of NAM-NK at a medical meeting during the first half of 2019.

Today Gamida Cell also announced the appointment of Thomas Klima to the newly created role of chief commercial officer. Mr. Klima brings nearly 20 years of global experience in the pharmaceutical industry with expertise in cellular therapy, hematology, oncology and transplantation. During his career, he has played key roles in building commercial organizations and leading multiple successful product launches. Additionally, the company announced that Nurit Benjamini, an experienced financial executive, has been appointed to Gamida Cell’s board of directors and will chair the board’s audit committee.

"We are intently focused on advancing NiCord, which has potential to expand and improve bone marrow transplants, giving patients a chance for a cure. We are on track to complete enrollment by the end of this year, with topline data from the Phase 3 study anticipated in first half of 2020," stated Julian Adams, Ph.D., chief executive officer at Gamida Cell. "We are also continuing to build a pipeline based on our proprietary nicotinamide, or NAM, technology and plan to report additional data from the ongoing Phase 1 study of NAM-NK in the coming months."

"We have also augmented our team with two new experienced individuals. I’m pleased to welcome Tom Klima, who will join as chief commercial officer, and Nurit Benjamini, who will serve as an independent director on the company’s board. Their experience and contributions will be invaluable as we advance toward anticipated commercialization," Dr. Adams continued.

Mr. Klima most recently served as head of global commercial planning and operations at Atara Biotherapeutics, prior to which he played a key role as senior vice president and chief commercial officer at Navidea Biopharmaceuticals Ltd. Mr. Klima also served as head of sales and commercial operations at Algeta U.S. and led the successful commercial build-out and launch of Xofigo. Before Algeta, he held various commercial leadership positions at Dendreon. Mr. Klima began his pharmaceutical career at Eli Lilly where he held several positions of increasing responsibility and participated in the global launch of Cymbalta. Mr. Klima earned a B.A. in Business Administration and Marketing from Western State College.

Ms. Benjamini has served as chief financial officer of TabTale Ltd. since 2013. Previously, she held a number of chief financial officer positions, including at Wix.com Ltd., Sigma Designs Israel Ltd. and Compugen Ltd. She has served as a director at RedHill Biopharma Ltd., BioLine Rx and Allot Communications. Ms. Benjamini holds a BA in Economics and Business and an MBA in Finance from Bar Ilan University, Israel.

Expected 2019 Milestones

Gamida Cell expects to achieve the following milestones this year:

Present additional data from the Phase 1 study of NAM-NK in first half of 2019
Report early data from the Phase 1/2 study of NiCord in patients with severe aplastic anemia data in the first half of 2019
Complete patient enrollment in the Phase 3 study of NiCord in patients with high-risk hematologic malignancies in the second half of 2019
2019 Financial Outlook

Gamida Cell ended 2018 with cash, cash equivalents and available-for-sale securities of approximately $60 million (unaudited). The company expects that such funds will support the company’s capital needs through the data readout for the Phase 3 clinical study of NiCord, which is expected in the first half of 2020. This cash runway guidance is based on the company’s current operational plans and excludes any additional funding that may be received or business development activities that may be undertaken.

Gamida Cell intends to provide additional financial guidance for 2019 when it reports its fourth quarter and full-year 2018 financial results in March 2019.

About NiCord

NiCord, the company’s lead clinical program, is under development as a universal bone marrow transplant solution for patients with high-risk hematologic malignancies. NiCord has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration, making it the first bone marrow transplant alternative to receive this designation. It has also received U.S. and EU orphan drug designation. A Phase 3 clinical study evaluating NiCord in patients with leukemia and lymphoma is ongoing in the United States, Europe and Asia.1 For more information on clinical trials of NiCord, please visit www.clinicaltrials.gov.

About NAM-NK

Gamida Cell applied the capabilities of its NAM-based cell expansion technology to highly functional NK cells to develop NAM-NK, an innate immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. NAM-NK addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. NAM-NK is in Phase 1 development through an investigator-sponsored study in patients with refractory non-Hodgkin lymphoma and multiple myeloma.2

NiCord and NAM-NK are investigational therapies, and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

bluebird bio and Inhibrx Announce Collaboration to Research, Develop and Commercialize CAR T Cell Immunotherapies

On January 7, 2019 bluebird bio, Inc. (Nasdaq: BLUE) and Inhibrx, Inc. (Inhibrx) reported that they have entered into an exclusive license agreement to research, develop and commercialize chimeric antigen receptor (CAR) T cell therapies using Inhibrx’s proprietary single domain antibody (sdAb) platform to multiple cancer targets (Press release, bluebird bio, JAN 7, 2019, View Source [SID1234532541]). The small size of sdAbs may enable the generation of more complex CAR T cell products such as those designed to combine additional functions into a single CAR molecule or recognize multiple tumor antigens simultaneously.

"Access to the Inhibrx sdAb binder technology will allow us to combine the advancements we’ve made with our T cell therapy platform with their sdAb binder technology to generate novel cellular therapies with the potential to help patients in their fight against cancer," said Philip Gregory, D. Phil., chief scientific officer, bluebird bio. "The technology from Inhibrx adds to our growing portfolio of tools and technologies that we can combine with our internal lentiviral vector, CAR and T cell expertise to discover potential new product candidates designed to recognize tumor-specific proteins expressed by cancer cells and kill them upon engagement."

"We are pleased to have formalized our relationship with bluebird bio, allowing us to couple our proprietary sdAb platform with a leading cell therapy platform," said Brendan Eckelman, Chief Scientific Officer and Executive Vice President of Corporate Strategy of Inhibrx. "Together with bluebird bio, we have generated compelling proof of concept preclinical data on the utility of incorporating our sdAbs into bluebird bio’s constructs for CAR-T cell generation."

Under the terms of the license agreement, Inhibrx will provide bluebird bio the exclusive worldwide rights to develop, manufacture and commercialize certain cell therapy products containing sdAbs directed to various cancer targets. bluebird bio will be responsible for the clinical development and commercialization of the cancer-targeting CAR-T products. Inhibrx received a $7.0 million upfront payment and is also entitled to receive specified developmental milestone payments as well as percentage tiered royalties on future product sales.