Sanofi Files Investor Presentation Regarding Proposed Acquisition of Medivation

On June 8, 2016 Sanofi today reported that it has filed an investor presentation with the U.S. Securities and Exchange Commission ("SEC") in connection with its proposed acquisition of Medivation, Inc. (NASDAQ: MDVN) (Press release, Sanofi, JUN 8, 2016, View Source [SID:1234513242]). This presentation is available on the Investor Relations section of Sanofi’s website.

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Among other things, the presentation notes:
The proposed transaction would provide compelling strategic and financial benefits for Sanofi and Medivation shareholders;

Sanofi’s proposal is not subject to any financing condition and the company is confident in its ability to receive all necessary regulatory approvals;

Combining with Medivation would accelerate Sanofi’s strategic priority of rebuilding a competitive position in oncology;

Sanofi has stated on several occasions that if Medivation were to engage and provide information, it would be in a position to increase its offer and is confident that it would be able to offer significant additional value;

Sanofi is willing to enter into a customary confidentiality agreement with Medivation, which would include a reasonable standstill to give time for Medivation to conduct a sale process;

The consent solicitation process allows Medivation shareholders to demonstrate support for a transaction by removing and replacing the Medivation Board with directors committed to acting in the best interest of maximizing value for Medivation shareholders;

Sanofi believes there is a clear path to completion: the record date to determine Medivation shareholders entitled to give their written consent has been established as June 1, 2016; Sanofi expects the initial Hart-Scott-Rodino (HSR) waiting period to expire on June 13, 2016; Sanofi anticipates filing definitive consent solicitation materials in mid-June 2016; and Sanofi signed a consent on
June 3, 2016 for the shares it owns in Medivation and therefore expects that the 60-day consent solicitation period will conclude no later than August 1, 2016; and

Sanofi believes that Medivation’s shareholders overwhelmingly support the sale of Medivation and want Medivation to engage with Sanofi.

Cantargia AB: Cantargia receives patent approval in Japan for solid tumours

On June 8, 2016 Cantargia AB reported that its patent application for IL1RAP as target molecule for antibody-based therapies and diagnostics of solid tumours has been approved by the Japan Patent Office (JPO) (Press release, Cantargia, JUN 8, 2016, View Source [SID:1234513154]).

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The patent approval (patent no. 5940093) refers to the company’s method of using IL1RAP as target molecule for treatment of the vast majority of solid tumours. The approved patent includes those diseases which Cantargia has chosen to focus its initial development activities on, i.e. lung cancer and pancreatic cancer, as well as other major diseases such as breast cancer, colorectal cancer and prostate cancer. The patent’s validity extends to 2032. The patent also provides protection for several different antibody-drug conjugates targeted to IL1RAP and for associated diagnostic methods.

"The approval of the patent is of great strategic significance for Cantargia and the future commercialisation of our CAN04 product candidate", CEO Göran Forsberg says. "Having received approval in Japan, we now have protection for treatment of solid tumours in both Europe and Japan, which are two of the largest pharmaceutical markets".

Kite Pharma to Highlight Key Data from CAR T-Cell Therapy Pipeline in Oral Presentations at the 2016 European Hematology Association (EHA) Annual Congress

On June 8, 2016 Kite Pharma, Inc. (Nasdaq:KITE) ("Kite"), a clinical-stage biopharmaceutical company focused on developing engineered autologous T-cell therapy (eACT) products for the treatment of cancer, reported three oral presentations relating to its clinical programs will be delivered at the upcoming 2016 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress in Copenhagen, Denmark, June 9-12, 2016 (Press release, Kite Pharma, JUN 8, 2016, View Source [SID:1234513140]).

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"We are excited to showcase the progress we have made with personalized T-cell immuno-oncology for people with refractory lymphoma and to share our understanding of the outcomes for this patient population who have limited or no treatment options," said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer of Kite. "These data are important to advance our novel breakthrough personalized treatments and ultimately address critical unmet medical needs."

Updated data from Phase 1 of Kite’s ZUMA-1 study of KTE-C19 in patients with chemorefractory non-Hodgkin lymphoma (NHL) will be presented in an oral presentation. An additional oral presentation will feature data from the SCHOLAR-1 study, the first and largest meta-analysis of outcomes in patients with chemorefractory diffuse large B-cell lymphoma (DLBCL), an aggressive and common form of NHL that is difficult to treat. Patients with chemorefractory DLBCL have not responded to prior treatment with chemotherapy or have relapsed within a year after autologous stem cell transplantation.

Data from a Phase 1-2a study evaluating anti-CD19 CAR T-cell therapy after low-dose chemotherapy in people with advanced lymphoma will also be highlighted in an oral presentation. This study is being conducted as part of a Cooperative Research and Development Agreement (CRADA) between Kite and the National Cancer Institute (NCI).

Kite also recently announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) has granted access to its newly established Priority Medicines (PRIME) regulatory initiative for KTE-C19 in the treatment of patients with refractory DLBCL. PRIME provides early and enhanced regulatory support to optimize regulatory applications and speed up the review of medicines that address a high unmet need. KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a chimeric antigen receptor (CAR) designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias.

Oral presentations at the 2016 EHA (Free EHA Whitepaper) Annual Congress:

Results from SCHOLAR-1: Outcomes in patients with refractory aggressive diffuse large B-cell lymphoma (DLBCL)

Date: Saturday, June 11, 2016, 5:00 – 5:15 PM CEST
Location: Hall A1
Abstract Number: S481
Presenter: Christian Gisselbrecht, M.D., The Lymphoma Academic Research Organisation (LYSARC), Pierre-Bénite, France

Updated results from ZUMA-1: A phase 1-2 multicenter study evaluating the safety and efficacy of KTE-C19 (anti-CD19 CAR T cells) in refractory aggressive B-cell Non-Hodgkin Lymphoma (NHL)

Date: Sunday, June 12, 2016, 8:45 – 9:00 AM CEST
Location: Hall A1
Abstract Number: S791
Presenter: Tanya Siddiqi, M.D., City of Hope National Medical Center, Duarte, CA

Low-dose chemotherapy followed by anti-CD19 chimeric antigen receptor (CAR) T cells induces remissions in patients with advanced lymphoma

Date: Sunday, June 12, 2016, 9:00 – 9:15 AM CEST
Location: Hall A1
Abstract Number: S792
Presenter: Stephanie L. Goff, M.D., Surgery Branch, Center for Cancer Research, The National Cancer Institute, Bethesda, MD

About Kite’s ZUMA Clinical Programs for KTE-C19

KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a CAR that is designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias. Kite is currently enrolling four pivotal studies (also known as ZUMA studies) for KTE-C19 in patients with various B-cell malignancies.

Study Phase Indication Status
ZUMA-1
NCT02348216 Phase 2 Pivotal
(N=112) Chemorefractory DLBCL, PMBCL, TFL Phase 2 enrolling
ZUMA-2
NCT02601313 Phase 2 Pivotal
(N=70) Relapsed/refractory MCL Phase 2 enrolling
ZUMA-3
NCT02614066 Phase 1/2 Pivotal
(N=75) Relapsed/refractory Adult ALL Phase 1/2 enrolling
ZUMA-4
NCT02625480 Phase 1/2 Pivotal
(N=75) Relapsed/refractory Pediatric ALL Phase 1/2 enrolling

DLBCL = diffuse large B-cell lymphoma
PMBCL = primary mediastinal B-cell lymphoma
TFL = transformed follicular lymphoma
MCL = mantle cell lymphoma
ALL = acute lymphoblastic leukemia

Immune Design Releases New PFS, OS and TME Data from Trials of Three Immuno-Oncology Product Candidates

On June 08, 2016 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported updated results from clinical trials of three immuno-oncology product candidates demonstrating promising and potentially clinically meaningful anti-tumor immune responses for Immune Design’s lead products (Press release, Immune Design, JUN 8, 2016, View Source [SID:1234513139]). This includes data presented at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting and involves Immune Design’s two distinct immunotherapy applications — the ‘Specific Antigen’ and ‘Endogenous Antigen’ Approaches.

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"The data reflect single agent Phase 1 studies and provide strong rationale for continued development, including our ongoing randomized Phase 2 studies," said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer. "We believe both of our approaches are disruptive and have the potential to impact the immunotherapy treatment landscape."

LV305 & CMB305: Specific Antigen Approach Targeting NY-ESO-1 Positive Tumors — Emerging Profile of Prolonged Survival Benefit

LV305 Phase 1 single agent trial completed in 24 patients with advanced or metastatic sarcoma cancers expressing NY-ESO-1 (ASCO abstract #3093)
Median overall survival (OS) has not been reached. One-year survival is 81%.
Median progression free survival (PFS) is 4.6 months.
14 patients (58%) had clinical benefit: One patient (4%) had a late-onset partial response and 13 patients (54%) had stable disease.
7/11 patients with pretreatment progressive disease (PD) had SD or PR following LV305.
Safety profile is very favorable, with only Grade 1/2 adverse effects (AEs).
CMB305 Phase 1 single agent trial ongoing in patients with NY-ESO-1 positive soft tissue sarcomas (preliminary analysis of first 14 patients)
Median OS has not been reached. 93% (13/14 patients) survival to date.
Median PFS is 5.5 months.
Best response to date is stable disease (10/14, 71%)
Safety profile is very favorable, with only Grade 1/2 AE
G100: Intratumoral Immune Activation Approach: Transforming "cold" tumors to "hot" tumors

G100 single agent and in combination with radiation in patients with Merkel cell carcinoma (ASCO Abstract #3021)
In final results from 10 patients, G100 produced a 50% overall response rate (ORR) per protocol, including a pathologic complete response (CR) following single agent G100 alone.
Four patients remain relapse-free in long-term follow up (range 13+ to 27.5+ months).
Analysis of the tumor microenvironment (TME) in G100-treated patients demonstrates the transformation of a "cold" to a "hot" tumor: increase of innate immune molecules that favor immune cell chemotaxis; increased NK cells and M1 macrophage markers; and dendritic cell antigen presentation. In addition, trafficking of CD4 and CD8 T cells from the stroma into the tumor bed was observed.
These changes in the TME were most prominent in the G100 responding patients.
No treatment-related AEs where observed; all AEs were grade 1/2.

8-K – Current report

On June 8, 2016 Enzo Biochem, Inc. (NYSE:ENZ) reported results for the third fiscal quarter and nine months ended April 30, 2016, with strong across the board advances (Filing, Q3, Enzo Biochem, 2016, JUN 8, 2016, View Source [SID:1234513138]).

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Highlights

Enzo Clinical Labs revenues grew by 16% over the prior year period reflecting increased throughput activity and focus on molecular diagnostics, now accounting for approximately 50% of its revenues.
Enzo Life Sciences revenues grew 22% sequentially over the prior quarter as domestic sales improved and the focus on higher margin reagents and other products yielded favorable results.
Total revenues advanced 10%, gross margins increased and net loss was reduced sharply.
Liquidity continues to improve, with the cash on hand today increasing to over $50 million, as compared to $18.1 million at the close of fiscal 2015.

Operating results for the Company’s third fiscal quarter ended April 30, 2016 continued to benefit from Enzo’s strategic management plan, emphasizing: esoteric diagnostic testing services, development of competitive genetic-based diagnostic cost-effective product platforms for use in-house and for sale nationwide, higher margin life science products, and increasing market share based on high quality diagnostic services, including expanding portfolio of women’s health products.
Approval of the new Candidiasis assay marks the third such approval in roughly a year, demonstrating Enzo’s strength in developing high quality proprietary assays. Enzo’s technology pipeline is robust, with other assays soon to be submitted for regulatory approval.
Subsequent to the end of the third quarter, Enzo announced that its subsidiary, Enzo Life Sciences, Inc., had reached a settlement with Life Technologies Corporation, a subsidiary of Thermo Fisher Scientific Inc. (TMO), resulting in a $35 million payment to Enzo, which is included in current cash balance.

Barry Weiner, President, Commented:

"This has been another quarter of significant progress for Enzo, as we continue to execute on our strategic plan. Again this quarter we demonstrated strong financial results and benefits of our integrated operating structure. The Clinical Labs Division remains on a solid growth trend, with molecular diagnostics increasingly predominant in its activities, as physician-clients recognize its unique capabilities and especially the Lab’s ability to provide services, assays and tests, particularly in the realm of women’s health issues. Enzo’s program to develop new tests for our AmpiProbe, FlowScript and other platforms is successfully moving forward rapidly, underscored by the New York State Department of Health’s conditional approval just three months after submission of our AmpiProbe Candidiasis assay, which follows similar authorization in the past year or so for our HCV and FlowScript assays.

"Meanwhile, Life Sciences is achieving improved results following several challenging quarters, during which it has aggressively moved to reposition itself by narrowing its product mix to concentrate on improved profitability, while also adding staff more experienced with the operations. We have become a specialized assay supplier as part of our integrated strategic plan to deliver highly efficient, cost effective diagnostics and assays for our own use and sale to independent labs.

"The proprietary platforms and accompanying assays, in addition to being highly cost effective in this challenging reimbursement environment, provide more sensitive diagnostics and allow for multiple testing of specimens, saving expenses and reducing patient discomfort. The three recently approved assays are part of a broad line of lower cost diagnostic products under development by Enzo to address the critical needs of clinical laboratories resulting from increasing pressure from steadily declining reimbursement rates. In addition to selling these highly effective and compatible platforms and their assays, we are positioning ourselves as a "go to" reference lab for independent labs nationwide with costs that we anticipate will be lower for them than doing so on their own.

From an operating viewpoint, we are effectively containing expenses, despite the necessity to expand sales, research and production staffs as we broaden our footprint. Legal expenses have been trending down, though one case remains on the trial docket in New York Federal Court. Our efforts to prevail on patent infringements in the Delaware court have thus far proved satisfactory, with seven cases still pending. The results are evident in our strong cash position, which ensures our ability to forcefully build our positioning and marketing of proprietary amplification and detection platforms, and their related assays. Recent patent litigation settlements further highlight the importance of our Company’s intellectual property, giving us a decided advantage in being able to further assay development independently, while adding to our financial strength and ability to capitalize on our goals."

3Q16 Results

With both Enzo Clinical Labs and Enzo Life Sciences posting positive revenue gains, total revenues increased to $26.4 million, from $24.0 million a year ago, a 10% increase. Cost of goods was approximately even year over year based on a percentage of revenues. Gross margin improved $1 million, or 9%, to $11.4 million, while gross profit as a percentage of revenue essentially remained even at 43.3% and 43.7%, respectively. Selling, general and administrative expenses (SG&A) increased slightly, to $10.9 million, from $10.2 million, reflecting increased selling expenses and higher Lab related costs due to new business, but as a percentage of revenues, SG&A improved to 41%, from 42% a year ago. Legal expenses declined 17%, to $1.6 million, although year ago results also reflected approximately $0.2 million in net legal settlements. There were no legal settlements in the fiscal 2016 third quarter.

Net loss amounted to ($2.1) million, compared to a year ago net loss of ($2.9) million, a $0.8 million improvement. Basic and fully diluted per share loss equaled ($0.05), versus ($0.06) last year. On a non-GAAP basis, the net loss per fully diluted share was ($0.04) compared to ($0.07) per fully diluted share in the prior year period. The EBITDA loss (earnings before interest, taxes, depreciation and amortization), a non GAAP measure, improved by approximately $0.9 million, to $1.1 million.

As of April 30, 2016, current assets totaled $55.2 million, compared with current liabilities of $21.7 million, a current ratio of 2.54-to-1. Cash and cash equivalents amounted to $32.4 million. Subsequent to receiving proceeds from the recent Delaware patent infringement case settlement with Life Technologies, cash and cash equivalents were over $50 million.

Segment 3Q16 Results

Enzo Clinical Labs posted its third straight quarter of double digit revenue growth, with total revenues of $18.2 million, up 16% from last year’s $15.7 million. Despite higher variable sales costs and expenses related to the expanding volume, gross margin increased 18%, to $7.0 million, from $5.9 million a year ago. Gross profit as a percentage of revenue was 38.6%, up from 37.9%. Variable expenses related to higher sales commissions and customer support resulted in SG&A increasing to $6.0 million, from $4.9 million. Nonetheless, operating income was up 6%, to $0.3 million.

With an improved order flow, Enzo Life Sciences revenues increased to $8.0 million, from $7.9 million, a year ago. Efforts to reposition the segment to achieve the Company’s growth strategies are showing positive results as revenues of higher margin products grew, while reducing those of lower margins. Life Sciences is also increasingly focused on the development and eventual production of new assays in conjunction with Clinical Labs. Thus, while revenues slowed in recent periods, in part, too, because of reduced funding in private and government oriented research, the third fiscal 2016 quarter marked a notable improvement. As a result, gross margins remained steady, at approximately $4.4 million, vs. the year ago $4.6 million, while gross profit on product sales as a percentage of revenues was essentially flat. Operating income amounted to $0.9 million, compared with $1.0 million last year.

Fiscal Nine Months Results

For the year to date, total revenues were ahead 6%, to $76.2 million, with Clinical Labs up 14% and Life Sciences off 6%. Cost of goods sold amounted to $42.7 million, $2.3 million greater than a year ago, and represented 56% of total revenues, in line with a year ago. Gross margin advanced $2 million, to $33.5 million, with gross profit as a percentage of revenues equal to 44% for both periods. R&D expenditures increased 7%, to $2.6 million, SG&A, largely reflecting increased Clinical Lab volume, was up 8%, to $32.4 million, and legal expenses declined 22%, to $5.6 million. With net legal settlements through April 2016 of $18.5 million, operating income amounted to $9.6 million, compared with a year ago loss of ($9.8) million, when legal settlements totaled $0.2 million, a $19.4 million improvement. Fully diluted per share earnings amounted to $0.20, compared with a year ago net loss per fully diluted share of ($0.24). EBITDA totaled $12.4 million, an improvement of $20.3 million from the year ago EBITDA loss of ($7.9 million).