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).

Oncothyreon Announces Corporate Name Change to Cascadian Therapeutics (NASDAQ: CASC)

On June 08, 2016 Oncothyreon Inc. (NASDAQ:ONTY), a clinical-stage biopharmaceutical company, reported that the Company is changing its name to Cascadian Therapeutics, Inc. and will trade on the NASDAQ Global Select Market under the new ticker symbol "CASC," effective at market open on June 9, 2016 (Press release, Oncothyreon, JUN 8, 2016, View Source [SID:1234513127]).

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The new name reflects the change in the Company’s focus from therapeutic vaccines to advancing targeted treatments for cancer. The Company’s lead product candidate, ONT-380, is an orally bioavailable, highly selective small molecule HER2 inhibitor being developed as a combination therapy to treat HER2+ advanced or metastatic breast cancer.

"We chose to implement a new name to emphasize our organization’s transformation and vision for the future," said Scott Myers, President and CEO of Cascadian Therapeutics. "By incorporating the imagery of the Cascade Mountains, our goal was to highlight our Company’s heritage, but more importantly, to underscore our transition away from therapeutic vaccines to developing innovative targeted therapies for cancers, with a lead indication for metastatic HER2+ breast cancer. HER2CLIMB, our Phase 2 randomized, double-blind, placebo-controlled trial, was also named in the spirit of our mission to improve outcomes in this disease. We look forward to providing an update on this important program at our upcoming R&D Day."

On June 14th at 2 p.m. Eastern, the Company will present updated data from the ongoing "Triplet" Phase 1b trial, in addition to the future product development plans for ONT-380, at the Company’s R&D Day in New York City. The webcast will be available on the Events and Presentations Page of the Company’s website at www.cascadianrx.com.

No action is required by stockholders with respect to the name change. The Company’s common stock has been assigned a new CUSIP number of 14740B 101 in connection with the name change. Outstanding stock certificates are not affected by the name change and will not need to be exchanged.

Cantargia receives Notice of Allowance from USPTO on IL1RAP in acute lymphatic leukemia

On June 8, 2016 Cantargia AB reported that the United States Patent and Trademark Office ("USPTO") has issued a Notice of Allowance on Cantargia AB’s ("Cantargia") patent application regarding IL1RAP as a target molecule for antibody therapy of acute lymphatic leukemia (ALL) (Press release, Cantargia, JUN 8, 2016, View Source [SID:1234513153]).

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The patent application with application number 13/390,459 which has now obtained Notice of Allowance by the USPTO concerns the company´s method to use IL1RAP as a target molecule for the treatment of hematological cancers. As a first step the USPTO plans to issue a patent on IL1RAP as a target molecule for antibody based therapy of ALL. As a subsequent step Cantargia is preparing a divisional application to obtain granted claims on areas outside ALL. This means that the examination will continue around the other parts of the original application, ie other hematological forms of cancer.

The issuance of a Notice of Allowance indicates that the USPTO intends to approve the company’s patent application. Certain administrative steps remain before the patent is formally granted.

"Our patent portfolio is progressing and the information from USPTO gives further validation of IL1RAP as a unique target molecule" says Göran Forsberg, CEO of Cantargia AB. "It is a welcome notice, as USA is the biggest market for cancer therapies."

Advaxis Announces First Patient Dosed in Phase 2 Trial Evaluating AXAL in Anal Cancer

On June 08, 2016 Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, reported dose administration for the first patient in the first stage of its Phase 2 clinical trial of their FAWCETT study, testing the Company’s lead immunotherapy candidate, axalimogene filolisbac (AXAL), in patients with persistent or recurrent metastatic anal cancer (Press release, Advaxis, JUN 8, 2016, View Source [SID:1234513150]).

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The multi-center, open-label, two-stage study is designed to evaluate the efficacy and safety of AXAL as a monotherapy in patients with HPV-associated metastatic anal cancer who have received at least one prior treatment regimen for the advanced disease. Stage 1 of the trial will enroll 31 patients with anal cancer whose disease recurred after receiving treatment. Patients will receive AXAL 1×109 colony forming unit (CFU) doses every three weeks for up to two years.

In collaboration with Brown University Oncology Research Group, AXAL has been evaluated in high-risk, locally advanced anal cancer with concurrent standard chemotherapy and radiation treatment. Preliminary data show treatment with AXAL indicated a clinical complete response and no recurrence in all 10 patients who completed the treatment regimen.

"The FAWCETT study is an important step in the development program for AXAL," said Daniel J. O’Connor, President and Chief Executive Officer at Advaxis. "People living with anal cancer desperately need new treatment options, which is why Advaxis is pursuing two areas of evaluation, including monotherapy with AXAL and a second study with an immune checkpoint inhibitor in combination with AXAL."

The FAWCETT (Fighting Anal-Cancer with CTL Enhancing Tumor Therapy) study was named in honor of Farrah Fawcett, who passed away due to HPV-associated anal cancer. In 2015, the Farrah Fawcett Foundation honored Advaxis with its inaugural "Medical Visionary Angel Award" based on the Company’s clinical research and efforts to treat this disease, initiating a partnership among the organizations.

About Anal Cancer

Anal cancer is a fairly rare form of cancer in the United States, but the number of new anal cancer cases has been rising for years. The risk of being diagnosed with anal cancer in one’s lifetime is about 1 in 500. According to the American Cancer Society, approximately 7,270 new cases of anal cancer were diagnosed and about 1,010 people died of the disease in 2014.

About Axalimogene Filolisbac

Axalimogene filolisbac (AXAL) is Advaxis’ lead Lm Technology immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, AXAL showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the Company’s Lm Technology. AXAL has Orphan Drug Designations in the U.S. for the treatment of invasive cervical cancer, head and neck cancer and anal cancer.

About the Farrah Fawcett Foundation

The mission of the Farrah Fawcett Foundation is to provide funding for cutting edge cancer research, to support prevention and awareness, and to help those struggling with cancer today. Farrah Fawcett was diagnosed with anal cancer in 2006 and established the Foundation before her death in 2009. For more information, visit www.thefarrahfawcettfoundation.org and follow them on Facebook.

APTOSE BIOSCIENCES AND CRYSTALGENOMICS ANNOUNCE EXCLUSIVE AGREEMENT FOR NON-COVALENT BTK / FLT3 / AURK INHIBITOR

On June 08, 2016 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS) and CrystalGenomics, Inc. (KOSDAQ:083790) reported an exclusive global option and license agreement focused on the development of CG026806 (CG’806), a first-in-class, highly potent, non-covalent small molecule inhibitor of the Bruton’s tyrosine kinase (BTK), FMS-like tyrosine kinase 3 (FLT3) and the Aurora kinases (AURK) (Press release, Aptose Biosciences, JUN 8, 2016, View Source [SID:1234513135]). Further to enacting the agreement, Aptose expects to undertake Investigational New Drug (IND) enabling studies immediately, and, if it exercises its option under the agreement, to initiate a Phase 1 clinical trial by mid 2017.

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The potential option exercise would occur prior to submission of an IND application in the U.S. Upon exercise of the option, Aptose will own global rights to develop and commercialize the program outside of Korea and China – the Licensed Territory. Total deal value is up to $303 million USD, inclusive of development, regulatory and commercial-based milestones. CrystalGenomics will also receive a single-digit royalty on sales in the Licensed Territory.

CG‘806 has the potential to serve as a transformational agent for multiple forms of cancer, particularly those resistant to current BTK inhibitors or those that possess the FLT3-ITD alteration. BTK plays a critical role in B-cell hematologic malignancies, such as chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL), and certain autoimmune diseases. FLT3, including the Internal Tandem Duplication (ITD), a mutation of the FLT3 gene, occurs in approximately 30-35% of patients with acute myeloid leukemia (AML). Aurora kinases participate in the epigenetic phosphorylation of histones and are key drivers in a series of hematologic malignancies and solid tumors.

"CG’806 offers a unique capacity through a non-covalent, reversible mechanism to inhibit wild type and mutant forms of the validated BTK, FLT3 and AURK targets, but with the discretion to offer a robust safety profile," commented Avanish Vellanki, Senior Vice President and Chief Business Officer of Aptose. "Indeed, we are impressed by the ability of once-daily oral dosing of CG’806 to demonstrate tumor eradication in the absence of toxicity in murine xenograft models of human hematologic malignancies," added William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose.

"We are excited to work with the Aptose team, which is uniquely qualified to accelerate development of our BTK/FLT3/AURK inhibitors, including our lead compound CG’806," said Joong Myung Cho, Ph.D., Chairman and Chief Executive Officer of CrystalGenomics. "With a demonstrated commitment to high scientific and development standards, Aptose and its clinical advisors recognize the potential of this class of anticancer compounds and will make clinical development a priority."

"The in vivo potency of CG’806 shows unprecedented potential," said Michael Andreeff, M.D., Ph.D., Professor of Medicine, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center (MDACC), and a member of the Aptose Scientific Advisory Board. "The combination of this candidate’s potency with a stellar in vivo safety profile gives us enthusiasm for CG’806 as a therapeutic option for patients with AML, CLL and other malignancies."