On November 9, 2018 VBI Vaccines Inc. (NASDAQ: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported financial results for the third quarter ending September 30, 2018, and provided a corporate update (Press release, VBI Vaccines, NOV 9, 2018, View Source [SID1234531205]).

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"The last few months have seen meaningful progress across our portfolio, marked by achievements in our Sci-B-Vac Phase 3 studies, PROTECT and CONSTANT, and early data from our Phase 1/2a study of VBI-1901 in recurrent glioblastoma (GBM)," said Jeff Baxter, President and CEO. "We have now completed vaccination and enrollment in the PROTECT and CONSTANT studies, respectively, with an exceptionally low drop-out rate, and no safety signals observed or reported to-date. These accomplishments support the clean safety profile of Sci-B-Vac and reaffirm the timeline for top-line data from the PROTECT and CONSTANT trials, expected to read out mid-year 2019 and around the 2019 year-end, respectively."

Mr. Baxter continued, "Additionally, we are encouraged by the early immunologic data we’ve seen from our Phase 1/2a study of VBI-1901 in recurrent glioblastoma (GBM), which has shown evidence of robust boosting of CMV-specific immunity in some subjects in both the low-dose and intermediate-dose cohorts. With the addition of two top neuro-oncology sites, Dana-Farber Cancer Institute and Massachusetts General Hospital, we expect to complete enrollment in the high-dose cohort quickly. Thanks to the dedication and achievements of the entire VBI team, the fundamentals of the company remain strong and on-track as we head into a critical and exciting first half of 2019."

Recent Highlights and Upcoming Milestones

Formation of Three Scientific and Clinical Advisory Boards

● In September, VBI announced the creation of three Scientific and Clinical Advisory Boards (SABs) comprised of leading global experts in immunology and vaccinology. The SABs will work closely with VBI’s management team to develop and advance the Company’s hepatitis B, cytomegalovirus (CMV), and glioblastoma (GBM) vaccine programs.

Appointment of Chief Financial Officer and Head of Business Development

● In August, VBI appointed Christopher McNulty as Chief Financial Officer and Head of Business Development, bringing with him a strong background in licensing transactions, capital markets and financing strategy, and public company corporate finance in the biopharmaceutical and medical device fields.

Sci-B-Vac for Hepatitis B

● The Company’s prophylactic Hepatitis B vaccine, Sci-B-Vac, is currently being evaluated in a global, pivotal Phase 3 clinical program, the results of which are intended to support future regulatory and marketing authorization submissions in the U.S., Europe, and Canada. The program consists of two concurrent Phase 3 studies:
● PROTECT Study: A head-to-head immunogenicity study against Engerix-B.

○ In October, VBI announced completion of vaccination, with the last subject receiving the final vaccination.
○ Patients in the PROTECT study were vaccinated with a low drop-out rate of 4.5%, reinforcing the safety and tolerability of the vaccine.
○ The independent Data and Safety Monitoring Board (DSMB) reviewed all PROTECT safety data available to-date and did not observe or report any safety signals.
○ Top-line data from the PROTECT study are expected mid-year 2019.
● CONSTANT Study: A lot-to-lot consistency study.
○ VBI completed enrollment in the CONSTANT study, with the last subject receiving the first vaccination in November.
○ Top-line data from the CONSTANT study are expected around the 2019 year-end.

VBI-1901 for Glioblastoma (GBM)

● The Phase 1/2a study of VBI-1901 in recurrent GBM is ongoing, with early immunologic data to be presented in a poster discussion at the Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO) on November 16, 2018.
○ Early data from the low- and intermediate-dose cohorts of VBI-1901 are encouraging, with robust boosting of CMV-specific immunity, directed against multiple antigens, observed in some subjects in both cohorts.
○ In September 2018, VBI announced that the DSMB unanimously recommended continuation of the study without modification after review of all safety data from the fully-enrolled, intermediate-dose patient cohort.
○ Following the DSMB recommendation, VBI initiated patient enrollment in the high-dose cohort of Part A of the study, the dose-escalation phase.
○ VBI expects to complete enrollment in the high-dose study arm later in 2018, at which point a final, pre-specified DSMB review will occur before initiation of enrollment in Part B of the Phase 1/2a study.
○ VBI expects to report more extensive immunologic data and 6-month overall survival and progression-free survival from all dose cohorts in Part A of the Phase 1/2a in the first half of 2019.

VBI-1501 for Congenital Cytomegalovirus (CMV)

● Following the positive safety and immunogenicity data from the Phase 1 randomized, observer-blind, placebo-controlled study evaluating the safety and immunogenicity of VBI-1501 in May 2018, discussions are ongoing with regulatory bodies to determine the design of a Phase 2 dose-ranging study.
● Further details are expected to be announced by the end of 2018.

Third Quarter 2018 Financial Results

○ VBI ended the third quarter of 2018 with $26.0 million in cash and cash equivalents compared with $67.7 million as of December 31, 2017. Net cash used in operations for the nine months ended September 30, 2018 was $38.0 million.

○ Revenue for the third quarter of 2018 was $0.26 million and was primarily attributable to sales of Sci-B-Vac in Israel and in Europe on a named-patient basis. Revenue for the third quarter of 2017 was $0.19 million and was primarily attributable to sales of Sci-B-Vac in Israel.

○ Research and development expenses were $10.5 million for the third quarter of 2018, as compared to $5.2 million for the same period in 2017. The increase was primarily due to the continuation of the Phase 3 program for Sci-B-Vac and the Phase 1/2a clinical study for VBI-1901 in recurrent GBM patients.

○ General and administrative expenses were $3.5 million for the third quarter of 2018 as compared to $2.8 million for the same period in 2017. The increase was primarily due to allocation of expenses from costs of revenues related to the modernization and capacity increases of our manufacturing facility in Rehovot, Israel, human resources expenses, and stock-based compensation expenses.

○ Net loss and net loss per share for the third quarter of 2018 were $15.4 million and $0.24 respectively, compared to a net loss of $9.8 million and a net loss per share of $0.24 for the third quarter of 2017.

On November 9, 2018 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the third quarter ended September 30, 2018 and recent company developments (Press release, Manhattan Pharmaceuticals, NOV 9, 2018, View Source [SID1234530992]).

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "We are pleased by the progress made in the third quarter of 2018, most notably the completion of full enrollment in the current cohorts of the UNITY-NHL trial, as well as in the ULTIMATE Phase 3 program in MS. We now have five Phase 3 or registration directed trials fully enrolled across our three major indications of interest, CLL, NHL and MS, and look forward to significant value creating data releases in 2019 and 2020." Mr. Weiss, continued, "This is just the beginning for TG as we solidify the foundation and look towards the future of building proprietary triple combination therapies with our in-house early stage pipeline."

Recent Developments and Highlights

●ASH Presentations: Announced two triple therapy data abstracts were accepted for presentation at the upcoming 60th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting.
●ULTIMATE Trials: Completed full enrollment into the ULTIMATE I & II Phase 3 trials, evaluating ublituximab in relapsing form of MS, which are being conducted under Special Protocol Assessment (SPA) agreement with the FDA.
●Ublituximab Data in Multiple Sclerosis: Presented final data from the Phase 2 trial of ublituximab in RMS at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Annual Meeting in Berlin, Germany.
●UNITY-NHL: Completed enrollment in the current arms of the UNITY-NHL trial, including the Follicular Lymphoma, Marginal Zone Lymphoma, and Diffuse Large B-Cell Lymphoma cohorts.

Financial Results for the Third Quarter 2018

●Cash Position: Cash, cash equivalents, investment securities, and interest receivable were $97.8 million as of September 30, 2018.

●R&D Expenses: Research and development (R&D) expenses were $33.4 million and $107.1 million for the three and nine months ended September 30, 2018, respectively, compared to $27.1 million and $76.5 million for the three and nine months ended September 30, 2017. The increase in R&D expense is primarily attributable to an increase in clinical trial expenses of $4.4 million and $20.1 million, respectively, during the three and nine months ended September 30, 2018, as compared to prior periods. In addition, included in R&D expenses for the three and nine months ended September 30, 2018 are $5.0 million and $16.4 million, respectively, of manufacturing and CMC expenses for Phase 3 clinical trials and potential commercialization. Also included in R&D expense for the nine months ended September 30, 2018 was $4.0 million of non-cash stock expense recorded in conjunction with the licenses to the BTK and CD47/CD19 programs.

●G&A Expenses: General and administrative (G&A) expenses were $1.0 million and $13.2 million for the three and nine months ended September 30, 2018, respectively, as compared to $4.5 million and $11.3 million for the three and nine months ended September 30, 2017. The decrease in G&A expenses for the three months ended September 30, 2018 relates to a decrease in non-cash compensation expense related to equity incentive expense recognized during the three months ended September 30, 2018 as a result of a decrease in the measurement date fair value of certain consultant restricted stock.

●Net Loss: Net loss was $34.0 million and $119.6 million for the three and nine months ended September 30, 2018, respectively, compared to a net loss of $31.5 million and $87.6 million for the three and nine months ended September 30, 2017, respectively. Excluding non-cash items, the net loss for the three and nine months ended September 30, 2018 was approximately $34.1 million and $104.2 million.

●Financial Guidance: Net cash utilized for operating activities during the nine months ended 2018 was approximately $95.2 million. The Company believes its cash, cash equivalents, investment securities, and interest receivable on hand as of September 30, 2018 will be sufficient to fund the Company’s planned operations through the end of 2019.

Conference Call Information

The Company will host an investor conference call today, November 9, 2018, at 8:30am ET, to discuss the Company’s third quarter 2018 financial results and provide a business outlook for the remainder of 2018.

In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Third Quarter 2018 Earnings Call. A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.

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On November 9, 2018 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported preliminary data from its ongoing Phase 1 dose-escalation study of AB122 (Press release, Arcus Biosciences, NOV 9, 2018, View Source [SID1234531103]). The data are being presented today during a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in Washington, D.C.

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"Preclinical data previously demonstrated that AB122 has biological, pharmacokinetic and pharmacodynamic properties similar to those of the approved anti-PD-1 antibodies and the dose-escalation data presented today represent an important step in confirming these results in patients," said Joyson Karakunnel, MD, MSc, FACP, Vice President of Clinical Development at Arcus. "These results support the selection of 240 mg as the AB122 dose for administration every 2 weeks (Q2W); we continue to enroll patients in the Phase 1 study to identify the appropriate doses for administration every 3 weeks (Q3W) or every 4 weeks (Q4W)."

"Since Arcus’s inception, we believed it was important to ensure access to an anti-PD-1 antibody to maximize the value of our internally discovered product candidates, which guided our decision to in-license AB122 from WuXi Biologics, one of the leading biologics manufacturing companies," said Terry Rosen, Ph.D., Chief Executive Officer at Arcus. "Our development strategy for AB122 is focused on its development in combination with our other product candidates, including AB928, our dual adenosine receptor antagonist, AB680, our small molecule CD73 inhibitor, and AB154, our anti-TIGIT antibody."

Design of the Phase 1 Dose-Escalation Study for AB122

The Phase 1 dose-escalation study for AB122 is designed to evaluate the safety, immunogenicity, pharmacokinetic, pharmacodynamic and clinical activity profile of AB122. The Company is evaluating three dosing regimens with the goal of identifying doses of AB122 that can be administered Q2W, Q3W or Q4W.

As of the cutoff date of October 5, 2018, 20 patients had been treated:

For the Q2W dosing regimen, doses of 80 mg (n=3), 240 mg (n=6), and 360 mg (n=1) were evaluated. 240 mg was identified as the recommended dose for this regimen, based on receptor occupancy data.
For the Q3W dosing regimen, a dose of 360 mg (n=5) is being evaluated. This cohort continues to enroll patients with the goal of identifying a recommended dose for this regimen.
For the Q4W dosing regimen, a dose of 480 mg (n=5) is being evaluated. This cohort also continues to enroll patients with the goal of identifying a recommended dose for this regimen.
Results from the Phase 1 Dose-Escalation Study

As of the data cutoff date:

The following tumor types were enrolled: ovarian (7), colorectal (3), endometrial (3), gastroesophageal (2), bladder (1), head and neck (1), breast (1), non-small cell lung (1), and prostate (1).
Time on study ranged from 0.8 to 9.9 months.
AB122 was well tolerated at all doses evaluated. The majority of treatment emergent adverse events (TEAEs), regardless of causality in all subjects, were Grade 1/2, the most common of which were fatigue (55%) and diarrhea and nausea (25% each). Three patients experienced serious adverse events (SAEs), none of which were considered related to AB122: Grade 2 lower respiratory tract infection, Grade 2 fever and Grade 3 elevated liver function tests secondary to cholelithiasis.
Data from the three patients in the 80 mg Q2W and six patients in the 240 mg Q2W cohorts showed that AB122 achieved full and sustained receptor occupancy on peripheral blood T cells across all time points in the majority of patients. These data are consistent with published data for approved anti-PD-1 antibodies.
Of the 16 response-evaluable patients, two patients demonstrated a reduction in tumor size: a patient with head and neck cancer in the 80 mg Q2W cohort and a patient with ovarian cancer in the 360 mg Q2W cohort.
Disease control rate was 50% in the evaluable patient population. Stable disease was achieved in patients with colorectal cancer (2), ovarian cancer (1) and head and neck cancer (1).
Ongoing and Planned Clinical Trials for AB122

Arcus is planning to initiate an expansion cohort which will evaluate AB122 in non-small cell lung cancer with the objective of confirming that AB122 has similar clinical activity to that of the approved PD-1 antibodies. AB122 is also being evaluated in combination with AB928, as well as with AB154, in Phase 1/1b dose-escalation trials.

Details of Arcus’s Poster Presentation is as Follows:

Title: Preliminary results from an ongoing Phase 1 study of AB122, an anti-programmed cell death-1 (PD-1) monoclonal antibody, in patients with advanced solid tumors.
Poster Number: P673; Abstract ID: 10638
Poster Presentation Hours: Friday, Nov. 9, from 12:45 – 2:15 pm and 6:30 – 8 pm ET
Poster Hall Location: Hall E

This poster presentation, as well as the Company’s eight other posters being presented at SITC (Free SITC Whitepaper), will be available on Arcus’s corporate website at View Source

About AB122

AB122 is a fully human IgG4 antibody that potently and selectively blocks the interaction of PD-1 with its ligands, PD-L1 and PD-L2. The biochemical, biological and preclinical properties of AB122 have been shown to be similar to those of the marketed anti-PD-1 antibodies nivolumab and pembrolizumab. In August 2017, Arcus entered into a license agreement with WuXi Biologics for an exclusive license to develop, use, manufacture, and commercialize AB122 worldwide except for China and five other countries outside of the U.S., Europe and Japan. In November 2017, dosing was initiated in Australia for the Phase 1 trial of AB122 in cancer patients. AB122 is also being evaluated in combination with AB928, the Company’s dual adenosine receptor antagonist, in a Phase 1/1b dose-escalation trial. Preliminary data from this trial are expected in the second quarter of 2019. The Company expects AB122 to form the backbone of many of its intra-portfolio combinations.

On November 9, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) reported that data from three separate trials are being presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in Washington D.C (Press release, NewLink Genetics, NOV 9, 2018, View Source [SID1234531173]). Data from a Phase 1a clinical trial of NLG802, a prodrug of indoximod, as well as biomarker data from two Phase 2 studies of indoximod in combination therapy are being presented in poster sessions today and tomorrow, November 9th and 10th, from 8:00AM to 8:00PM ET. These posters with full data sets are provided on the company’s website in the "Posters & Presentations" section under the "Investors & Media" tab.

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"We are delighted to be able to present these data supporting both activity of indoximod within the tumor microenvironment and the higher exposure levels obtained by indoximod prodrug, NLG802, supporting the potential for these drugs to elicit therapeutic responses and improve the lives of patients with cancer," said Charles J. Link, Jr, MD, Chairman and Chief Executive Officer.

Phase 1 Clinical Trial of NLG802, Indoximod Prodrug with Enhanced Pharmacokinetic Properties
Preliminary data from a Phase 1a study of NLG802, a prodrug of indoximod, are being presented today by Olivier Rixe, MD, PhD, Professor of Medicine, University of New Mexico Comprehensive Cancer Center, Albuquerque, NM in a poster session (P331). Co-author, Eugene Kennedy, MD, Chief Medical Officer, NewLink Genetics, will be present Friday, November 9th, 12:45-2:15PM and 6:30-8:00PM, to discuss these data.

NLG802 is being evaluated in an ongoing standard 3+3 dose escalation Phase 1a study in patients with recurrent advanced solid malignancies. The purpose of this trial is to assess the safety, maximum tolerated dose, and pharmacokinetic properties of this drug candidate. As of October 3rd, the cutoff date for these data, 11 patients were enrolled in this study in three separate dose cohorts, 180 mg BID, 363 mg BID, and 726 mg BID.
Key findings from these preliminary data:

NLG802, was well tolerated, with no unexpected safety signals.

At the time of analysis, neither maximum tolerated dose (MTD), nor maximum biologically achievable dose (MBAD) had been reached.

NLG802 produced 4-fold increase in CMAX and AUC after a single dose, and a 4-5.5 fold increases in CMAX and AUC after continuous BID dosing compared with the molar equivalent of indoximod dosing.

The Immunogenic Impact of Indoximod on the Tumor Microenvironment of Patients with Advanced Melanoma
Biopsy data from a Phase 2 study of indoximod plus checkpoint inhibition from patients with advanced melanoma are being presented today by Jiayi Yu, PhD, Senior Scientist, NewLink Genetics, in a poster session (P142). The author will be present Saturday, November 10th, 12:20-1:50PM and 7:00-8:30PM to discuss these data.
In this study, patients with unresectable advanced melanoma underwent pretreatment tumor biopsy followed by a repeat biopsy after cycle 3 of indoximod plus pembrolizumab. Fourteen pairs of tumor specimens (6 patients with objective response and 8 non-responders) underwent RNA sequencing analysis and immunofluorescence staining to
assess immune activity in the tumor microenvironment (TME), to define changes in the tumor genomic profile and gene expression. Baseline samples from the trial were used for predictive biomarker assessment (N = 38).
Key findings from these biopsy data:

Compared to published studies, these biopsy data suggested indoximod exclusively contributed to immunologic and metabolic changes in the TME.

Indoximod in combination therapy may contribute to immunologic and metabolic changes in a different manner than anti-PD-1 alone.

Decreased IDO1 in Ki67- cells supports indoximod’s mechanism of action (MOA).

Patients with high IDO expression showed a trend towards both higher rate of response to treatment and longer progression-free survival (PFS), results which were independent of PD-L1 expression.

Previously published results from this Phase 2 study of indoximod plus pembrolizumab for patients with advanced melanoma may be found on the company’s website under "Posters & Publications" in the "Investors & Media" section.
Effects of indoximod plus gemcitabine/nab-paclitaxel on tumor microenvironment of patients with metastatic pancreas cancer
Biopsy data from a Phase 2 study of indoximod plus chemotherapy for patients with metastatic pancreatic cancer are being presented today by Jiayi Yu, PhD, Senior Scientist, NewLink Genetics, in a poster session (P706). Co-author, Gabriela Rossi, PhD, Vice President, Biologics Development, NewLink Genetics, will be present Saturday, November 10th, 12:20-1:50PM and 7:00-8:30PM to discuss these data.
In this study, treatment-naïve patients with metastatic pancreatic cancer underwent pre-treatment tumor biopsy with a repeat biopsy on week 8. Sixteen pairs of tumor specimens (8 patients with objective response, and 8 non-responders) underwent RNA sequencing analysis and immunohistochemistry (IHC) staining to assess immune activity in the tumor microenvironment.
Key findings from these biopsy data indicate that indoximod plus standard-of-care (SOC) chemotherapy:

Tumor samples observed to have increased recruitment of intratumoral T cells.

Increased recruitment of innate immune cells (NK cells) in responding patients.

Downregulated Treg population and IDO expression in the TME.

Increased both innate and adaptive immune responses in TME of these patients, supporting indoximod’s MOA.

Previously published results from this Phase 2 study of indoximod plus gemcitabine/nab-paclitaxel for patients with metastatic pancreatic cancer may be found on the company’s website under "Posters & Publications" in the "Investors & Media" section.
About Indoximod
Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target, suppressing immune response and allowing for immune escape by degrading tryptophan with the resultant production of kynurenine. Indoximod reverses the immunosuppressive effects of low tryptophan and high kynurenine through mechanisms that include modulation of the AhR-driven transcription of genes that control immune function. This results in increased proliferation of effector T cells, increased differentiation into helper T cells rather than regulatory T cells, and downregulation of IDO expression in dendritic cells. Indoximod is being evaluated in combination with treatment regimens including chemotherapy, radiation, checkpoint blockade and cancer vaccines across multiple indications including recurrent pediatric brain tumors, DIPG, and AML.

About NLG802

NLG802 is a prodrug of indoximod. NLG802 has been shown in preclinical trials to increase bioavailability and exposure to indoximod above the levels achievable by direct administration of indoximod. NLG802 is currently being evaluated in clinical trials.

On November 9, 2018 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will be presenting at the following investor conference during November and invited investors to participate by webcast (Press release, Exact Sciences, NOV 9, 2018, View Source [SID1234531189]).

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Jefferies 2018 London Healthcare Conference, London
Presentation and Q&A session on Thursday, Nov. 15 at 2:40 p.m. GMT, 9:40 a.m. EST
Evercore ISI HealthconX, Boston
Fireside chat on Tuesday, Nov. 27 at 12:30 p.m. EST