On May 12, 2016 Medigene AG (MDG1, Frankfurt, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T-cell immunotherapies for the treatment of cancer, reported financial results and corporate updates for the first quarter of 2016 (Press release, MediGene, MAY 12, 2016, View Source [SID:1234512338]).

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Major events since the beginning of 2016:
Immunotherapies:

Phase II of Phase I/II trial with DC vaccine for the treatment of acute myeloid leukaemia (AML) initiated following positive recommendation by DSMB
Early IIT clinical data for DC vaccines presented at AACR (Free AACR Whitepaper) by academic partner Oslo University
DC patent portfolio strengthened
Additional viral vector production capacities secured for clinical TCR studies
Research collaboration started with University of Lausanne for TCRs
Company:

Management change: CSO Prof Dolores Schendel appointed CEO/CSO, Dave Lemus takes over as COO
Strengthened management team with appointment of three Senior Vice Presidents
Key figures in the first quarter of 2016:

Increase in total revenue by 132% to €3,909 k (3M 2015: €1,686 k)
Increase in R&D expenses for immunotherapies by 64% to €1,907 k (3M 2015: €1,166 k)
EBITDA loss reduced by 54% to €939 k (3M 2015: €2,042 k)
Cash and cash equivalents and time deposits of €46,310 k as at 31 March 2016 (31 December 2015: €46,759 k)
Confirmation of financial guidance 2016
Prof. Dr Dolores Schendel, Chief Executive Officer of Medigene AG, comments: "In the first quarter of 2016, the clinical development of our immunotherapy programmes progressed further. We are making extensive efforts now towards putting into practice our first clinical studies with TCRs. As Medigene’s new CEO, I’m delighted about these important examples of progress."

Dave Lemus, Chief Operating Officer of Medigene AG, adds: "Medigene’s transformation into a leading immuno-oncology company begins increasingly to take shape. Accordingly, the planned increase in expenses for immunotherapy-driven research and development in the first quarter of 2016 evidences this change, and is enabled by the company’s positive financial condition."

Key figures in Q1 2016:

IN € K Q1 2016

Q1 2015

Change

Results of operations
Total revenue 3,909 1,686 132%
Veregen revenue 624 714 -13%
Other operating income 3,285 972 >200%
thereof gain on sale of intangible assets, net (EndoTAG) 2,365 0 -
Gross profit 3,594 1,418 153%
Selling and general administrative expenses -2,312 -1,740 33%
Research and development expenses -2,395 -1,932 24%
Operating result -1,113 -2,254 -51%
Net profit/loss for the period -1,387 -3,672 -62%
EBITDA -939 -2,042 -54%
Earnings per share (€) -0.07 -0.26 -73%
Personnel expenses -2,452 -1,758 39%

Cash flows
Net cash used in operating activities -1,064 -1,777 -40%
Net cash provided by/used in investing activities 626 -53 >-200%
Net cash used in financing activities -11 0 -

Balance sheet data as at 31 March 2016 and 31 December 2015
Cash and cash equivalents and time deposits 46,310 46,759 -1%
Total assets 110,095 113,531 -3%
Current liabilities 9,013 9,664 -7%
Non-current liabilities 12,970 13,879 -7%
Shareholders’ equity 88,112 89,988 -2%
Equity ratio (%) 80 79 1%

Employees as at 31 March 81 69 17%
FTE as at 31 March 75 62 20%

Medigene share as at 31 March
Total number of shares outstanding 19,688,202 13,956,417 41%
The Company generates its revenue and other operating income from its non-core business. Total revenue of the Company increased by 132% to €3,909 k in the reporting period (3M 2015: €1,686 k) on account of extraordinary effects related to the sale of EndoTAG agreed in December 2015.

Medigene increased research and development expenses by 24% in the first three months of 2016 to €2,395 k (3M 2015: €1,932 k). The increase in these expenses is mainly due to the intended increase in expenditure for preclinical and clinical trials for Medigene’s immunotherapies, which increased significantly by 64% to €1,907 k in the first three months of 2016 (3M 2015: €1,166 k).

In spite of higher development expenses for its immunotherapy programmes, Medigene reduced its EBITDA loss in the first three months of 2016 by 54% to €939 k (3M 2015: EBITDA loss of €2,042 k). Medigene’s EBITDA is derived from the net profit/loss for the period; it does not include any taxes, financial result, foreign exchange gains or losses, share of result of associates, or depreciation or amortisation.

Medigene reduced its net loss in the first three months of 2016 by 62% to €1,387 k (3M 2015: €3,672 k).

Medigene reduced its net cash used in operating activities significantly in the first three months of 2016 to €1,064 k (3M 2015: €1,777 k). This represents an average monthly cash outflow of €0.4 m in the first three months of 2016 (3M 2015: €0.6 m). The major part of the cash used was directed at research and development as well as sales and administration.

The cash and cash equivalents and time deposits of the Company amounted to €46,310 k as at the end of the reporting period (31/12/2015: €46,759 k).

Financial forecast 2016:
Medigene confirms its financial guidance for 2016 published in the 2015 annual report. In 2016, Medigene is planning to expand its clinical development programs, which will significantly increase R&D expenses in the field of immunotherapies to €9 – 11 m (2015: €5.5 m). The EBITDA loss is estimated to be €10 -12 m (2015: €9.5 m).

Medigene expects total Veregen revenue of €3 – 4 m (2015: €3.1 m), and stable or increasing total revenue for 2016 (2015: €6.8 m). Since this revenue is not generated in the Company’s core business of immunotherapies, these figures are not indicative of the same. This financial guidance does not include any possible proceeds from potential new partnership agreements, or any exchange rate fluctuation.

The detailed Q1 statement 2016 is available online at:
www.annualreport2015.medigene.com View Source

Press and analysts’ conference call: A press and analysts conference call (in English) will be held today at 3:00 pm CEST / 9:00 am EDT (USA) and will be webcast live. Please access the synchronized presentation slides and a recording via Medigene’s website, www.medigene.com.

On May 12, 2016 Varian Medical Systems (NYSE: VAR), leader in radiotherapy systems and software for the treatment of cancer, reporte that they have been selected by The Christie NHS Foundation Trust to provide Eclipse treatment planning software for the proton center currently under construction at the Manchester hospital (Press release, Varian Medical Systems, MAY 12, 2016, View Source [SID:1234512336]). Varian is already supplying treatment equipment for the two UK national proton centers being constructed at The Christie and at University College Hospital in London.

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"We selected Varian as the proton treatment planning software provider because of the technical excellence and strong connectivity of its systems, together with the fact that Varian is a well-established and reliable supplier of cancer treatment equipment and software," said Matthew Clarke, The Christie’s lead physicist for proton treatment planning. "The ability of the Eclipse system to enable robust optimization of treatment plans as well as truly adaptive planning based on images taken during the treatment were instrumental in our decision."

"The unrivalled connectivity of Varian’s software means everything is stored in one location and can be accessed across the site – there’s no need to keep importing and exporting information," added Matthew Clarke. "It means we can have a truly paperless department with overall workflow that is much more efficient than would be the case with independent systems. We are working closely with Varian to build a system that entirely meets our needs."

Steve Laws, Varian’s VP of software sales in EMEIA, said, "Varian is proud to have been selected to provide advanced treatment planning software for this major new facility. This decision recognizes our long-term commitment to the proton therapy market and our ability to offer a level of compatibility and technical excellence that no other oncology software provider can match."

The Christie NHS Foundation Trust has ordered 12 proton treatment planning licenses as well as three licenses for conventional radiotherapy planning. It is also expanding its current ARIA oncology information management network and adding Varian’s Velocity system, which offers large-scale archival image storage and management and serves as a centralized repository for all diagnostic, planning and delivery information. The site will also be the first UK adoption of Varian’s new FullScale virtualized platform which aids efficiency for a center’s IT, administrative and clinical staff.

Although patient treatments are not due to commence at The Christie Proton Center until the summer of 2018, the Eclipse system will be delivered considerably earlier as proton physicists intend to use the system to do parallel plans for patients who are currently sent to the U.S. for proton treatments. "These parallel plans will greatly increase our experience in proton planning using Eclipse," added Matthew Clarke.

On May 12, 2016 Sanofi reported that it has filed for premerger notification under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR) with the U.S. Department of Justice Antitrust Division and the Federal Trade Commission regarding its intention to acquire Medivation, Inc (Press release, Sanofi, MAY 12, 2016, View Source [SID:1234512334]). (NASDAQ: MDVN). As announced on April 28, 2016, Sanofi proposed to acquire Medivation for $52.50 per share, representing an all-cash transaction valued at approximately $9.3 billion.

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On May 12, 2016 OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) reported ts first quarter 2016 financial results and provided a summary of anticipated milestones (Press release, OncoGenex Pharmaceuticals, MAY 12, 2016, View Source [SID:1234512331]).

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Financial Results and Anticipated Near-term Milestones

As of March 31, 2016, the company’s cash, cash equivalents, and short-term investments were $46.1 million compared with $55.2 million as of December 31, 2015.

Based on current expectations, OncoGenex believes that its cash, cash equivalents, and short-term investments will be sufficient to fund its currently planned operations into the third quarter of 2017. Depending on timing of enrollment or event-driven final analyses, the expected key milestones and activities are as follows:

Custirsen
Announcing results from the AFFINITY trial, the phase 3 trial evaluating a survival benefit for custirsen in combination with cabazitaxel as second-line chemotherapy in approximately 630 patients with castrate-resistant prostate cancer. The final analysis for the intent-to-treat population is expected in the third quarter of 2016.
Announcing results from the ENSPIRIT trial, the phase 3 trial evaluating a survival benefit for custirsen in combination with docetaxel as second-line chemotherapy in approximately 700 patients with non-small cell lung cancer. The final survival analysis is expected in the first half of 2017.
Apatorsen
Announcing results from the Borealis-2 trial, an investigator-sponsored, randomized phase 2 trial evaluating apatorsen in combination with docetaxel treatment compared to docetaxel treatment alone in patients with advanced or metastatic bladder cancer. Final results are expected in the second half of 2016.
Announcing survival results from the Spruce trial, the investigator-sponsored, randomized, placebo-controlled phase 2 trial evaluating apatorsen treatment with carboplatin and pemetrexed chemotherapy in patients with previously untreated advanced non-squamous NSCLC. Overall survival results, including evaluation of patients with high baseline serum Hsp27 levels, are expected in the second half of 2016.
Completing a submission-ready investigational new drug application regarding apatorsen via intravesical administration in combination with Bacillus Calmette-Guerin (BCG) treatment in patients with non-muscle invasive bladder cancer.
Revenue for the three months ended March 31, 2016 and 2015 was $2.9 million and $1.4 million, respectively. The increased revenue in 2016 as compared to 2015 was due to higher collaboration revenue recognized on the deferred revenue as a result of higher ENSPIRIT costs. This was partially offset by a decrease in collaboration revenue recognized for the AFFINITY trial as a result of a decrease in associated clinical activities.

Total operating expenses for the three months ended March 31, 2016 and 2015 were $7.4 million and $6.4 million, respectively. Net loss for the three months ended March 31, 2016 and 2015 was $3.7 million and $4.5 million, respectively.

As of May 12, 2016 OncoGenex had 29,914,226 shares outstanding.

On May 12, 2016 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) reported financial results for the first quarter of 2016 (Press release, ImmunoCellular Therapeutics, MAY 12, 2016, View Source [SID:1234512328]).

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Andrew Gengos, ImmunoCellular Chief Executive Officer, commented: "We continue to make progress in all aspects of implementing our ICT-107 registration trial in patients with newly diagnosed glioblastoma. Over half of the targeted clinical sites in the US have been activated and are screening patients. We anticipate that all sites in the US can be activated by the middle of 2016. In Europe, the process of gaining regulatory approval for the trial and bringing clinical trial sites online is going very well. Clinical trial applications have been approved by the regulatory authorities in the Netherlands and the UK, and we are involved in interactions with the six other country authorities where the trial will be conducted. We also have received regulatory approval to start the trial in Canada. We expect to manufacture clinical supplies for the first qualifying patients in Canada and Europe in the third quarter. As the competitive landscape in newly diagnosed glioblastoma evolves, we continue to think that our phase 3 registration program, with the strong foundational support of placebo-controlled phase 2 data, is the best designed program underway in this indication. We are pleased with the progress we made in the first quarter, and believe that 2016 will be a year of accomplishment and value creation for our company."

For the quarter ended March 31, 2016, ImmunoCellular incurred a net loss of $5.6 million, or $0.06 per basic and diluted share, compared to a net loss of $1.4 million, or $0.02 per basic and diluted share, for the quarter ended March 31, 2015.

During the first quarter 2016, the Company incurred $4.7 million of research and development expenses compared to $2.1 million in the prior year quarter while general and administrative expenses remained relatively constant between periods. The $2.6 million increase in research and development expenses primarily reflects the additional expenses associated with the phase 3 trial of ICT-107. During the first quarter of 2016, the Company recorded a credit to other income of $500,000 related to reflect a write-down of the Company’s warrant liability, compared to a credit to other income of $1.8 million during the same period in 2015.

The Company also reported that cash used in operations in the first quarter of 2016 was $5.4 million compared to $3.0 million in the prior year quarter. The increase primarily reflects that additional research and development expenditures in the current year. As of March 31, 2016, the Company had $17.5 million in cash.