On December 7, 2017 AVEO Oncology (NASDAQ:AVEO) reported clinical updates for two of its oncology programs: FOTIVDA (tivozanib), the Company’s potent, selective, long half-life inhibitor of all three vascular endothelial growth factor (VEGF) receptors, and ficlatuzumab, the Company’s humanized IgG1 antibody that binds to the hepatocyte growth factor (HGF) ligand with high affinity and specificity to inhibit the biological activities of the HGF/c-Met pathway (Press release, AVEO, DEC 7, 2017, View Source;p=RssLanding&cat=news&id=2321570 [SID1234522414]).

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"We continue to build strong momentum in our oncology programs, including progress with our lead program, tivozanib, and the advancement of our other oncology programs, including ficlatuzumab and AV-203," said Michael Bailey, president and chief executive officer of AVEO. "With approval of tivozanib and commercial sales underway in Europe, we are squarely focused on the next two pillars of our tivozanib strategy: the potential for U.S. registration and additional immunotherapy combination studies. As these strategies unfold, 2018 is expected to be another transformative year, with anticipated top-line results in the TIVO-3 study of tivozanib in third line advanced renal cell carcinoma (RCC), as well as development of our earlier-stage programs, including the TiNivo study of tivozanib in combination with Opdivo, and the initiation of two ficlatuzumab investigator-sponsored studies."

Tivozanib Updates

Enrollment Complete in Phase 2 Portion of Phase 1/2 TiNivo Trial in Advanced RCC. AVEO announced today that enrollment of 21 patients is now complete, with one patient remaining in screening, in the Phase 2 portion of the TiNivo study, a Phase 1/2 multicenter trial of tivozanib in combination with Bristol-Myers Squibb’s OPDIVO (nivolumab), an immune checkpoint, or PD-1, inhibitor, for the treatment of advanced RCC. In the Phase 1 dose escalation portion of the trial, tivozanib was administered in two escalating dose cohorts, 1.0 and 1.5 mg daily, in combination with nivolumab at 240 mg every 2 weeks (n=6).

Phase 1 data from the study, which were presented at the 16th International Kidney Cancer Symposium, demonstrated that the combination of Opdivo and tivozanib was well tolerated up to the full dose and schedule of single agent tivozanib (1.5 mg daily), with no dose limiting toxicities. The most common adverse events (any grade) were hypertension, asthenia and decreased appetite. No grade 4 adverse events were reported. Two grade 3 events were reported beyond cycle 1 (stomatitis and increased ALT), which did not lead to study discontinuation and were managed concurrently. Best response at the time of presentation included a 67% (4/6) partial response (PR) rate and a 100% disease control rate (4 confirmed PR + 2 stable disease, 1 of which was unconfirmed). Additional results from the Phase 1 portion of the trial and initial results from the Phase 2 portion are expected to be presented at scientific meetings in the first half of 2018, including at the 2018 Genitourinary Cancers Symposium taking place February 8-10, 2018, and co-sponsored by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).
Ficlatuzumab Updates

Phase 2 Study of Ficlatuzumab in Combination with Cetuximab in HNSCC Initiated. The Company announced today the initiation of an investigator-sponsored randomized, multicenter Phase 2 trial of ficlatuzumab and cetuximab (ERBITUX), an EGFR-targeted antibody, in patients with cetuximab-resistant, metastatic head and neck squamous cell carcinoma (HNSCC). AVEO is partnered with Biodesix, Inc. on the developments of ficlatuzumab. The study will seek to confirm findings from a Phase 1 study where the addition of ficlatuzumab to cetuximab resulted in a disease control rate of 67%, and prolonged progression free and overall survival compared to historical controls, in addition to being well tolerated. This Phase 2 multi-center study, which is being conducted under the direction of Julie E. Bauman, MD, MPH, Professor of Medicine, Chief, Division of Hematology/Oncology, Associate Director of Translational Research, University of Arizona Cancer Center, is expected to enroll approximately 60 patients randomized to receive either ficlatuzumab alone or ficlatuzumab and cetuximab.
Phase 1b Study of Ficlatuzumab in Combination with Gemcitabine and Nab-paclitaxel in Pancreatic Cancer Initiated. The Company announced today the initiation of an investigator-sponsored Phase 1b study to test the safety and tolerability of ficlatuzumab when combined with Nab-paclitaxel and Gemcitabine in previously untreated metastatic pancreatic ductal cancer (PDAC). The goal of the study, which is based on preclinical findings demonstrating a synergistic effect of these drugs in a preclinical model of PDAC, is designed to determine maximum tolerated dose of ficlatuzumab when combined with gemcitabine and nab-paclitaxel. Secondary outcome measures include response rate and progression free survival. The study, which is being conducted under the direction of Kimberly Perez, M.D. at the Dana-Farber Cancer Institute, is expected to enroll approximately 30 patients.
About Tivozanib (FOTIVDA)

Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Hakko Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma in the European Union plus Norway and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications. Tivozanib has been investigated in several tumors types, including renal cell, colorectal and breast cancers.

About Ficlatuzumab

Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte growth factor (HGF) inhibitory antibody that binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities. AVEO and Biodesix, Inc. currently divide all worldwide development costs for ficlatuzumab and are seeking a commercialization partner. Ficlatuzumab is currently being evaluated in investigator-sponsored trials in squamous cell carcinoma

On December 7, 2017 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported that it will present at the BMO Capital Markets 2017 Prescriptions for Success Healthcare Conference at 11:00 a.m. ET on Thursday, Dec. 14, 2017, in New York City (Press release, Neurocrine Biosciences, DEC 7, 2017, View Source;p=RssLanding&cat=news&id=2321693 [SID1234522445]). Timothy P. Coughlin, Vice President Finance of Neurocrine Biosciences, will present at the conference.

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The live presentation will be webcast and may be accessed on the Company’s website at View Source A replay of the presentation will be available on the website approximately one hour after the conclusion of the event and will be archived for one month.

On December 7, 2017 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported the commercial availability of new Vantage 3D Hematology assays as well as the highlights of more than 45 nCounter-based research abstracts that will be presented at the 59th Annual Meeting of the America Society of Hematology being held December 9-12, in Atlanta (Press release, NanoString Technologies, DEC 7, 2017, View Source [SID1234522444]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The company announced the launch of new Vantage 3D hematology assays. Three of the studies presented at ASH (Free ASH Whitepaper) (Abstracts 1758, 2481 and 3945) include data from early access versions of NanoString’s Vantage 3D DNA:RNA:Protein Heme Assays, which are launching commercially at ASH (Free ASH Whitepaper). These assays enable simultaneous, multi-analyte analysis of single nucleotide variants (SNVs), RNA, protein, and phospho-protein. The assay includes curated content that covers clinically actionable SNVs and Indels, and provide comprehensive expression profiling of RNA, protein, and phospho-protein in key pathways including PI3K, JAK-STAT, BCR, and TCR signaling.

One of the presentations will be made by Dr. Sergio Rutella, M.D. Ph.D. FRCPath., Professor of Cancer Immunotherapy at the John van Geest Cancer Research Centre at Nottingham Trent University. Dr. Rutella stated, "AML is a rare disease and we need to maximize the amount of information we collect. We are using NanoString’s Vantage 3D DNA:RNA:Protein Heme Assay to capture information about single nucleotide variants, mutations, and new antigens that could be compiled into a ‘super signature’ to better characterize the disease and stratify the treatment of patients."

"Our customers and collaborators are presenting a record body of nCounter-based research at the 59th annual ASH (Free ASH Whitepaper) conference," said Brad Gray, president and chief executive officer of NanoString Technologies. "This research demonstrates the advances that are being enabled with the nCounter platform in subtyping lymphomas and optimizing regimens to achieve better clinical outcomes."

The ASH (Free ASH Whitepaper) Annual Meeting will include at least four oral presentations and forty-one posters in various leukemia, lymphoma, and myeloma malignancies that demonstrate the utility of the nCounter platform across the heme-oncology spectrum. In particular, NanoString’s collaborators in Diffuse Large B-Cell Lymphoma (DLBCL) are presenting 11 abstracts highlighting the potential clinical relevance of NanoString’s Lymphoma Subtyping Test (LST) and its potential for directing treatment decisions, including:

Results from the frontline prospective Phase III BIO-DLBCL04 study conducted by the Fondazione Italiana Linfomi (FIL). The results show that ABC subtype determined by the NanoString LST assay is associated with a worse outcome in untreated, poor-risk, young DLBCL (Abstract #4010).

Researchers from the European Institute of Oncology found that the NanoString LST robustly identifies DLBCL subgroups according to the Cell-of-Origin (COO). The molecular definition of the COO can be used to identify patients at high risk of poor outcome when treated with R-CHOP and who may benefit by intensified high dose chemotherapy or experimental new treatments (Abstract #3998).

Results from an exploratory biomarker analysis of the Phase 3 GOYA Trial comparing the efficacy and safety of obinutuzumab plus CHOP (G-CHOP) with R-CHOP in patients with previously untreated DLBCL. Using the NanoString LST assay and a new cutoff on the Linear Predictor Score (LPS), a new distinct molecular subgroup of GCB DLBCL, referred to as "strong-GCB", was identified. Results from the exploratory analysis show that treatment with G-CHOP confers substantial clinical benefit over R-CHOP in this new subgroup of DLBCL (Abstract #1543).
The table below includes a selection of 2017 ASH (Free ASH Whitepaper) abstracts that best illustrate the potential clinical utility of nCounter across multiple tumor types. You can learn more about the capabilities of the nCounter platform by visiting NanoString at booth #2465 at ASH (Free ASH Whitepaper).

On December 7, 2017 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company will be webcasting its corporate presentation at the BMO Capital Markets Healthcare Conference in New York, NY (Press release, Jazz Pharmaceuticals, DEC 7, 2017, View Source;p=RssLanding&cat=news&id=2321712 [SID1234522443]).

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Matt Young, executive vice president and chief financial officer, will provide an overview of the company and a business and financial update at the conference on Thursday, December 14, 2017 at 10:30 a.m. EST / 3:30 p.m. GMT.

A live audio webcast of the presentation may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast.

An archive of the webcast will be available for at least one week following the presentation on the Investors section of the company’s website at www.jazzpharmaceuticals.com.

On December 7, 2017 Enzo Biochem Inc. (NYSE:ENZ) reported improved operating results for the first fiscal quarter ended October 31, 2017, including year over year double digit revenue growth at Enzo Clinical Labs (Press release, Enzo Biochem, DEC 7, 2017, View Source [SID1234522442])

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First Quarter’s Highlights (Year Over Year):

· Total revenue in the first fiscal quarter increased to $27.7 million, or 5%, from $26.3 million in the prior year period.
· Clinical Labs revenue totaled $20.3 million, or an increase of 10% from $18.6 million a year ago.
· Gross profit increased 1%, with operating income improving $0.7 million, or 53%. Gross margin was 44%.
· The GAAP and non-GAAP net loss was $0.6 million or ($0.01) per fully diluted share, an improvement of $0.8 million, or 56% over the prior year’s net loss of $1.5 million or $(0.03) per fully diluted share.
· Total cash and cash equivalents at October 31, 2017 was $66.8 million, an increase of $2.7 million from July 31, 2017. Tight cost controls and efficiencies resulted in positive $2.6 million cash flow from operations in the quarter.
· During the quarter, the New York State Health Department issued conditional approval of the final three women’s health related molecular diagnostic tests which completes a 13-analyte panel, placing Enzo in a leading position to benefit from higher-margin proprietary women’s health diagnostics.
· Plant facilities in Farmingdale, NY, undergoing expansion to accommodate anticipated growth in manufacturing of growing roster of new molecular diagnostic assays and to increase laboratory capacity and to support GMP certification.

Barry Weiner, President, Comments:

"The first quarter of fiscal 2018 saw additional progress in moving aggressively towards our model as an integrated, growth-oriented molecular diagnostics company, and a low-cost medically related assay provider and reference service organization. Revenues continued to grow, spurred by double digit growth in the quarter at Clinical Labs, the result of expanded product and service capabilities and geographical expansion, along with increasing volume from our association with leading healthcare insurance providers. Sales, general and administrative costs (SG&A) are being held in check, even as product development and research efforts continue. We are also completing preparations to launch our marketing and sales program of our comprehensive products and reference services menu, while also adding to our Lab’s capability, particularly in the women’s health diagnostic field.

"We are preparing to offer one of the industry’s most advanced and well-rounded 13-analyte women’s health diagnostics panel, which last month was presented at the annual meeting of the prestigious Association for Molecular Pathology. The study our group reported on demonstrated that Enzo’s AMPIPROBE technology provides a new proprietary approach to creating clinically sensitive and specific multiplex real-time PCR assays, which, when run in tandem, can serve as a comprehensive panel for the accurate detection and identification of vaginitis-associated microorganisms. Enhanced by our proprietary AMPIPROBE technology, it offers faster, more specific and more sensitive molecular vaginitis testing, which we expect to improve diagnoses of vaginitis, a leading medical concern among women. Increasingly, when measured against the performance of similar assays, Enzo products continue to outperform, as reported recently in a leading diagnostic pathology publication, which cited our Polyview technology for viewing the clinical morphology of HPV specimens as having no false positives. That compared favorably to other leading competitive products that did have false positives in their tests.

"Our focus is on gaining sustained profitability and advancing healthcare in today’s challenging environment by providing affordable and reliable diagnostic testing. With Medicare reimbursement rates expected to decline materially over the next three years based on a new formula being adopted in place of one used over the past 30 years, the challenges are clear. Enzo’s transformative blueprint may help to alleviate this new challenge to the nation’s independent labs. This opportunity is reflected in our expanding line of medically related, versatile, highly efficient platforms and assays that are increasingly professionally recognized for their sensitivity and economics."

First Quarter Results
Total revenues increased to $27.7 million or 5% higher than the prior year period driven by increased Clinical labs services revenue from MDx tests. Gross profit was $12.2 million or 44% of total revenue. Total operating expenses were $12.9 million, a decline of $0.5 million or 4% over a year ago.

The GAAP and Non-GAAP net loss amounted to $(0.6) million, or $(0.01) per fully diluted share, compared to the year ago net loss of $(1.5) million or $(0.03) per fully diluted share, an improvement of $0.8 million. EBITDA and Adjusted EBITDA were essentially break even compared with a loss of $(0.6) million a year ago, a $0.5 million improvement year over year.

As of October 31, 2017 working capital amounted to $71.4 million, cash and cash equivalents totaled $66.8 million, up $2.7 million from three months earlier. Apart from capital leases, there was no debt.

Quarterly Segment Results

Enzo Clinical Labs revenues increased to $20.3 million, or 10%, from $18.6 million a year ago. As noted above, expansion of its diagnostics services to additional nearby geographical locations, the increased product mix of diagnostic tests, particularly in the women’s health field, and greater volume, all are contributing to its steady test and service growth. Gross profit increased to $8.3 million, from $7.7 million, with gross margin as a percentage of revenues at 41% for both the current and year ago quarters. Total operating expenses increased by 3.6%, to $6.9 million. Operating income amounted to $1.4 million, a nearly 40% increase.

Enzo Life Sciences revenues were $7.1 million compared to $7.4 million a year ago, a decline of $0.3 million or 5%. Gross profit approximated $4 million and gross margin as a percentage of revenue was 54%, compared to $4.4 million and 57%, respectively, a year ago. With the continued focus on reducing costs and improving efficiency, SG&A declined by 11%, to $2.6 million, with total operating expenses declining 12%, to $3.2 million.

Conference Call

The Company will conduct a conference call Friday, December 8, 2017 at 8:30 AM ET. The call can be accessed by dialing 1-888-459-5609. International callers can dial 1-973-321-1024. Please reference PIN number 3678737.

Interested parties may also listen over the Internet at: View Source

To listen to the live call on the Internet, please go to the web site at least fifteen minutes early to register, download and install any necessary audio software. For those who cannot listen to the live broadcast, a replay will be available approximately two hours after the end of the live call, through midnight (ET) on December 22, 2017. The replay of the conference call can be accessed by dialing 1-855-859-2056, and when prompted, use PIN number 3678737. International callers can dial 1-404-537-3406, using the same PIN number.

NON-GAAP Financial Measures

To comply with Regulation G promulgated pursuant to the Sarbanes-Oxley Act, Enzo Biochem attached to this news release and will post to the Company’s investor relations web site (www.enzo.com) any reconciliation of differences between non-GAAP financial information that may be required in connection with issuing the Company’s quarterly financial results.

The Company uses EBITDA as a measure of performance to demonstrate earnings exclusive of interest, taxes, depreciation and amortization. Adjustments to EBITDA are for items of a non-recurring nature and are reconciled on the table provided. The Company manages its business based on its operating cash flows. The Company, in its daily management of its business affairs and analysis of its monthly, quarterly and annual performance, makes its decisions based on cash flows, not on the amortization of

assets obtained through historical activities. The Company, in managing its current and future affairs, cannot affect the amortization of the intangible assets to any material degree, and therefore uses EBITDA as its primary management guide. Since an outside investor may base its evaluation of the Company’s performance based on the Company’s net loss not its cash flows, there is a limitation to the EBITDA measurement. EBITDA is not, and should not be considered, an alternative to net loss, loss from operations, or any other measure for determining operating performance of liquidity, as determined under accounting principles generally accepted in the United States (GAAP). The most directly comparable GAAP reference in the Company’s case is the removal of interest, taxes, depreciation and amortization.

We refer you to the tables attached to this press release which includes reconciliation tables of GAAP to Non-GAAP net income (loss) and EBITDA to Adjusted EBITDA.