On February 20, 2020 NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, reported financial results for the quarter and full year ended Dec. 31, 2019 (Press release, NuVasive, FEB 20, 2020, View Source [SID1234554581]).

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Fourth Quarter 2019

Revenue increased 7.6% to $310.4 million, or 7.8% on a constant currency basis;
GAAP operating margin of 13.6%; Non-GAAP operating margin of 16.4%; and
GAAP diluted earnings per share of $0.55; Non-GAAP diluted earnings per share of $0.73.
Full Year 2019

Revenue increased 6.0% to $1.168 billion, or 6.6% on a constant currency basis;
GAAP operating margin of 10.5%; Non-GAAP operating margin of 15.8%; and
GAAP diluted earnings per share of $1.23; Non-GAAP diluted earnings per share of $2.47.
"NuVasive delivered strong financial results in 2019 with consistent, above-market growth of 6.0% over prior year," said J. Christopher Barry, chief executive officer of NuVasive. "In 2020, our primary growth drivers include continuing to lead in lateral spine surgery, further innovation in targeted spine segments and achieving scale in key global markets to drive value and deliver on our long-term commitments."

A full reconciliation of GAAP to non-GAAP financial measures can be found in the tables of this news release.

Fourth Quarter 2019 Results
NuVasive reported fourth quarter 2019 total revenue of $310.4 million, a 7.6% increase compared to $288.3 million for the fourth quarter 2018. On a constant currency basis, fourth quarter 2019 total revenue increased 7.8% compared to the same period last year.

For the fourth quarter 2019, both GAAP and non-GAAP gross profit was $227.1 million and GAAP and non-GAAP gross margin was 73.2%. These results compared to GAAP and non-GAAP gross profit of $202.2 million and GAAP and non-GAAP gross margin of 70.1%, for the fourth quarter 2018.

The Company reported GAAP net income of $29.9 million, or diluted earnings per share of $0.55, for the fourth quarter 2019 compared to GAAP net income of $12.2 million, or diluted earnings per share of $0.23, for the fourth quarter 2018. On a non-GAAP basis, the Company reported net income of $38.5 million, or diluted earnings per share of $0.73, for the fourth quarter 2019 compared to non-GAAP net income of $36.1 million, or diluted earnings per share of $0.69, for the fourth quarter 2018.

Full Year 2019 Results
NuVasive reported full year 2019 total revenue of $1.168 billion, a 6.0% increase compared to $1.102 billion for the full year 2018. On a constant currency basis, full year 2019 total revenue increased 6.6% compared to the full year 2018.

For the full year 2019, both GAAP and non-GAAP gross profit was $855.7 million and GAAP and non-GAAP gross margin was 73.3%. These results compared to GAAP and non-GAAP gross profit of $790.6 million and $791.6 million, respectively, and GAAP and non-GAAP gross margin of 71.8% and 71.9%, respectively, for the full year 2018. For the full year 2019, GAAP and non-GAAP operating expenses were $732.7 million and $670.7 million, respectively. These results compared to GAAP and non-GAAP operating expenses of $736.4 million and $624.8 million, respectively, for the full year 2018.

The Company reported GAAP net income of $65.2 million, or diluted earnings per share of $1.23, for the full year 2019 compared to GAAP net income of $12.5 million, or diluted earnings per share of $0.24, for the full year 2018. On a non-GAAP basis, the Company reported net income of $129.8 million, or diluted earnings per share of $2.47, for the full year 2019 compared to non-GAAP net income of $116.6 million, or diluted earnings per share of $2.23, for the full year 2018.

Annual Financial Guidance for 2020
The company estimates full year 2020 revenue growth to be in the range of 4.0% to 6.0%, GAAP diluted earnings per share in the range of $1.15 to $1.25 and non-GAAP diluted earnings per share in the range of $2.55 to $2.65.

On February 20, 2020 VBL Therapeutics (Nasdaq: VBLT) reported the launch of a phase 2 clinical trial of VB-111 in combination with nivolumab (Opdivo), an immune checkpoint inhibitor, in the treatment of metastatic colorectal cancer (Press release, VBL Therapeutics, FEB 20, 2020, View Source [SID1234554547]). The National Cancer Institute (NCI) will serve as the Investigational New Drug (IND) sponsor for this study and the IND application has been approved by the U.S. Food and Drug Administration (FDA). This new study will investigate if priming with VB-111 can drive immune cells into the tumor and turn the colorectal tumor from immunologically "cold" to "hot." The addition of nivolumab to VB-111 may further boost the anti-tumor immune response.

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"This phase 2 study is part of our strategy to broaden the potential indications for VB-111 and to explore its activity as part of combination therapies," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "We look forward to collaborating with NCI on this clinical trial, as we continue to generate data which adds to our understanding of VB-111’s mechanism of action and therapeutic potential. We were particularly encouraged by results in ovarian cancer demonstrating the recruitment of infiltrating T cells into a tumor following treatment with VB-111, turning the tumor ‘hot’. This important finding suggests that VB-111 may be applied to other ‘cold’ tumors, in which checkpoint inhibitors show limited or no efficacy, including colorectal cancer, for which there remains a major unmet need."

VBL and the NCI have entered into a Cooperative Research and Development Agreement (CRADA) under the direction of Tim F. Greten, M.D., Deputy Branch Chief & Senior Investigator of the Thoracic and GI Malignancies Branch (TGMB) and Co-Director of the NCI Center for Cancer Research (CCR) Liver Cancer Program. The goal of this open-label, single-arm phase 2 study is to evaluate VB-111 in combination with an anti-PD-1 inhibitor, nivolumab, in patients with metastatic colorectal cancer. In addition to safety and tolerability, this study will evaluate efficacy endpoints including Best Overall Response, as well as immunological and histologic readouts from tumor biopsies. For additional information refer to View Source

For patients interested in enrolling in this clinical study, please contact NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and/or the Web site: View Source

On February 20, 2020 Galectin Therapeutics Inc. (NASDAQ:GALT), a leader in the field of NASH therapeutics, reported the appointment of Pol F. Boudes, M.D. to the position of Chief Medical Officer (Press release, Galectin Therapeutics, FEB 20, 2020, View Source [SID1234554564]). In this position, Dr. Boudes will oversee Galectin’s global advanced clinical development of belapectin (GR-MD-02) for NASH cirrhosis, as well as all other company clinical and scientific initiatives. Dr. Boudes brings more than 25 years of experience in clinical drug development in liver-related diseases — most recently NASH — and immunology, endocrine, metabolic and orphan diseases.

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"Strengthening our executive team is a key development for the company, enhancing our future growth trajectory as we near launch of our NASH-RX trial, an adaptively-designed Phase 3 trial in NASH cirrhosis," said Dr. Harold H. Shlevin, CEO. "Dr Boudes’s diverse background in drug development, especially his experience in NASH and in related diseases, adds an important layer of expertise in relevant therapeutic areas and bolsters our ability to advance the development of our galectin-3 product assets. We are excited to have him join our team."

Chairman of Galectin, Mr. Richard E. Uihlein said, "On behalf of myself and the entire board, we are extremely pleased to have such a high quality Chief Medical Officer joining our excellent team. We believe the hiring of Dr. Boudes demonstrates the continued optimism and focus we collectively have on advancing our drug candidate through the planned upcoming trial in an effective and efficient manner."

Dr. Boudes will report directly to Galectin’s CEO Harold Shlevin, PhD. and serve as a member of the company’s executive management team.

"I am very excited to join at such an important moment," said Dr. Boudes. "The team at Galectin has done a remarkable job to advance the belapectin program with the planned initiation of a well-designed and innovative late-stage adaptive study. The drug candidate is anchored on a well-understood mechanism of action, and its effect in preventing the development of esophageal varices, if confirmed, could constitute a breakthrough for patients suffering from NASH cirrhosis and; potentially, other types of liver cirrhosis and other organ fibrosis." Dr. Boudes added, "It will also be an honor to work under the guidance of such an experienced and supportive board of directors."

Most recently, Dr. Boudes was CMO at CymaBay Therapeutics, where he worked on the company’s proprietary NASH compound and was instrumental in inventing and launching programs in rare liver diseases. Prior to CymaBay, Dr. Boudes was CMO at Amicus Therapeutics, a company focusing on rare lysosomal storage disorders. Following this experience, Dr. Boudes became a board member of Protalix BioTherapeutics, a company developing plant cell expressed recombinant proteins with improved therapeutic profiles, notably for lysosomal disorders. Additionally, he’s held positions of increased responsibilities in clinical development at Bayer HealthCare Pharmaceuticals, Wyeth Research, Hoffman-La Roche and Pasteur Merieux. Dr. Boudes has contributed to the approval of multiple drugs, both in the US and globally, across a variety of therapeutic indications.

A dual citizen of the US and France, Dr. Boudes earned his MD at the University of Marseilles, France. He completed his internship and residency in Marseilles and Paris and was an Assistant Professor of Medicine at the University of Paris. In this capacity he also participated in multiple clinical research programs as an investigator. He is certified by the Educational Commission for Foreign Medical Graduates (US) and board-specialized in endocrinology and metabolic diseases, internal medicine, as well as in geriatric diseases (Paris).

Dr. Boudes holds several records of invention and has contributed to multiple peer-reviewed publications, notably on improving the clinical development process. He served on the editorial review board for La Revue Prescrire, a leading European Drug Therapeutic Bulletin, and on several scientific advisory boards for drug development. He is a member of several professional organizations, including the American Association for the Study of Liver Disease, the European Association for the Study of Liver (Geneva, Switzerland), the American Diabetes Association, the Royal Society of Medicine (London, U.K.), and the American Medical Association.

On February 20, 2020 ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) reported that the Company plans to release its fourth quarter and year-to-date 2019 financial results on Thursday, February 27, 2020, before the opening of the U.S. financial markets (Press release, ANI Pharmaceuticals, FEB 20, 2020, View Source [SID1234554582]). The earnings press release will be accessible through the Investor Relations section of the Company’s website, www.anipharmaceuticals.com.

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Arthur S. Przybyl, President and Chief Executive Officer, and Stephen P. Carey, Vice President, Finance, and Chief Financial Officer, also plan to host a conference call to review those results starting at 10:30am Eastern Time on Thursday, February 27, 2020. The call will be open to the public and can be accessed through a conference line by dialing (866) 776-8875. The conference ID is 4783883.

A recording of the conference call will be available within two hours of the completion of the call and will remain accessible for a period of seven days following the call. To access the replay, dial (800) 585-8367. The access code for the replay is 4783883.

On February 20, 2020 Immatics Biotechnologies GmbH, a clinical-stage biopharmaceutical company active in the discovery and development of T-cell redirecting cancer immunotherapies, reported it has entered into a strategic collaboration agreement with GSK to develop novel adoptive cell therapies targeting multiple cancer indications (Press release, immatics biotechnologies, FEB 20, 2020, View Source [SID1234554549]).

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The companies will collaborate on the identification, research and development of next-generation T-Cell Receptor (TCR) Therapeutics with a focus on solid tumors. The parties will initially develop autologous T-cell therapies with the option to add allogeneic cell therapies using Immatics’ ACTallo approach. The companies intend to utilize proprietary TCRs identified by Immatics’ XCEPTOR TCR discovery platform and directed against two proprietary targets, which were discovered and validated by Immatics’ XPRESIDENT technology.

Under the terms of the agreement, Immatics will receive an upfront payment of 45 Million € (~$50 million) for two initial programs and is eligible to receive over $550M in development, regulatory and commercial milestone payments for each product as well as additional royalty payments. GSK obtains an option to select additional target programs to include in the collaboration. For each additional program, Immatics is entitled to option, milestone and royalty payments.

Immatics will have primary responsibility for the development and validation of the TCR Therapeutics up to designation of a clinical candidate. GSK will assume sole responsibility for further worldwide development, manufacturing and commercialization of the TCR Therapeutics with the possibility for Immatics to co-develop one or more TCR Therapeutics including the conduct of the first-in-human clinical trial upon GSK’s request.

"We are delighted to enter into this strategic collaboration with GSK – a partner who is already committed to adoptive cell therapies and TCR-T approaches," said Harpreet Singh, Chief Executive Officer of Immatics. "By combining Immatics’ world-leading target and TCR discovery platforms with GSK’s advanced manufacturing, development capabilities and a commitment to next-generation TCR-T technologies, both companies are joining forces to enable the development of effective novel therapies for cancer patients with high unmet medical need."

About Immatics’ Adoptive Cell Therapies
Adoptive Cell Therapy (ACT) has the potential to cure cancer. ACT is a treatment that uses natural or engineered T cells to fight tumors. Immatics has developed three innovative, proprietary approaches to produce Adoptive Cell Therapies: ACTolog, ACTengine and ACTallo.

About ACTallo
The ACTallo approach is based on genetically engineering allogenic gd donor T cells to recognize cancer cell targets as identified by Immatics’ XPRESIDENT platform. This allogeneic approach enables the development of immunotherapies that can be used ‘off-the-shelf’, for immediate treatment of the cancer patient.

About Immatics’ Technology Platforms
Immatics has developed an extensive and diverse cancer immunotherapy portfolio based on its unique target (XPRESIDENT) and T-cell receptor (XCEPTOR) discovery capabilities. XPRESIDENT is the most sensitive, accurate and highest-throughput technology capable of identifying targets in virtually any type of cancer. Immatics’ innovative TCR platform XCEPTOR is enabling the fast and efficient discovery and qualification of a large number of high-affinity and high-specificity T-cell receptors that can be used in T-cell engineering for Adoptive Cell Therapies.