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 AmpliPhi Biosciences Corporation (NYSEMKT: APHB), a global leader in the development of bacteriophage-based antibacterial therapies to treat drug-resistant infections, reported its financial results for the first quarter ended March 31, 2016 (Filing, Q1, AmpliPhi Biosciences, 2016 , MAY 12, 2016, View Source [SID:1234512411]).

"We have made significant progress in 2016, effectively executing on our clinical development and business strategies," said M. Scott Salka, CEO of AmpliPhi Biosciences. "We acquired additional bacteriophage assets, presented in vitro data for AB-PA01 for Pseudomonas aeruginosa, dosed our first patient and successfully completed the first cohort in our Phase I clinical trial of AB-SA01 for the treatment of Staphylococcus aureus infections in patients with chronic rhinosinusitis. We also saw our outstanding Series B Preferred stock be converted to Common, thereby streamlining our capital structure."

Highlights Demonstrate Progress in R&D, Governance, and Finance
· Acquired key bacteriophage assets from Novolytics in January 2016, broadening AmpliPhi’s IP portfolio and accelerating the development of our phage-based therapies
· AmpliPhi’s collaboration partner, the Westmead Institute’s Centre for Infectious Diseases and Microbiology, received an AUS $860,000 grant from the Australian Government to isolate and develop phages targeting E. Coli and Klebsiella. AmpliPhi will participate in the project by providing its proprietary expertise in bacteriophage isolation, characterization and manufacturing scale-up
· Appointed Steve Martin as Chief Financial Officer in January 2016, strengthening AmpliPhi’s financial and business management expertise
· Dosed the first patient in AmpliPhi’s Phase I clinical trial of AB-SA01 for the treatment of Staphylococcus aureus infections in patients with chronic rhinosinusitis
· The outstanding Series B Preferred stock was converted into common stock, streamlining AmpliPhi’s capital structure
· Presented in vitro data demonstrating that AB-PA01, AmpliPhi’s proprietary, investigational phage mix, was capable of effectively infecting and killing Pseudomonas aeruginosa (P. aeruginosa) clinical isolates from a global population of patients with and without cystic fibrosis, including multi-drug resistant strains of P. aeruginosa. AB-PA01 also demonstrated activity similar to meropenem in a murine model of acute lung infection
· Completed dosing of the first cohort in the Phase I clinical trial of AB-SA01 in patients with chronic rhinosinusitis. Three patients each received AB-SA01 twice daily for seven days; treatment was well tolerated and there were no apparent drug-related adverse events. The first patient in the second cohort has been dosed and will receive AB-SA01 twice daily for 14 days. We expect to report results from this study in the second half of 2016.

First Quarter 2016 Financial Results:
· Cash and cash equivalents as of March 31, 2016 totaled $6.2 million. AmpliPhi anticipates that its current financial resources will provide sufficient cash to fund operations into the third quarter of 2016
· Revenues related to sublicensing agreements from AmpliPhi’s former gene therapy program were $0.1 million for the quarter ended March 31, 2016 and for the same period in 2015
· Research and development expenses for the quarter ended March 31, 2016 totaled $2.0 million compared to $1.0 in the same period of 2015. The increase was primarily related to $0.2 million in higher compensation costs, $0.1 million of professional recruiting fees, and $0.4 million for the fair value from the assets acquired from Novolytics
· General and administrative expenses for the quarter ended March 31, 2016 were $2.6 million compared to $1.4 million for the same period of 2015. The increase was primarily attributable to an increase by $0.8 million in non-cash stock-based compensation related to two new executives, and $0.3 million in incremental legal, accounting and recruitment fees
· Loss from operations was $4.5 million during the three months ended March 31, 2016 which included $0.9 million of non-cash stock-based compensation, depreciation and amortization expense during the quarter
· There are currently 8.2 million shares of common stock outstanding
· AmpliPhi expects to file its Quarterly Report on Form 10-Q on May 12, 2016

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DpC, a unique small molecule invented by Des Richardson and David Lovejoy at the University of Sydney has been shown to dramatically impair the growth of cancer cells in preclinical models (Company Web Page, Collaborative Medicinal Development, MAY 12, 2016, View Source [SID:1234512305]).

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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 GenVec, Inc. (NASDAQ: GNVC) reported financial results for the first quarter ended March 31, 2016 (Press release, GenVec, MAY 12, 2016, View Source [SID:1234512307]). For the three months ended March 31, 2016, the company reported a net loss of $1.9 million, or $0.11 per share, compared with a net loss of $1.5 million, or $0.09 per share, for the three months ended March 31, 2015. The company ended the first quarter with $6.9 million in cash, cash equivalents, and liquid investments.

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"The recommendation to continue the Phase 1/2 study of CGF166 by the trial’s Data Safety Monitoring Board (DSMB) was an essential hurdle to pass," said Douglas J. Swirsky, president and CEO of GenVec. "The decision was based on a thorough and objective review of the available safety and efficacy data from all patients enrolled in the study. As a result, we believe the trial is on track to be completed in 2017 as previously expected."

"Our partnered pipeline continues to advance, and we expect our partner TheraBiologics to advance a second-generation neural stem cell-based cancer treatment utilizing our technology into the clinic later this year," Mr. Swirsky continued. "Our recent financing further enables GenVec to remain focused on finding new collaborations to maximize the value of our AdenoVerse gene delivery platform and we are excited by the response from potential partners."

Cash Position

As of May 10, 2016, the company had $10.6 million in cash, cash equivalents, and liquid investments (unaudited), which includes the proceeds of the company’s May 2016 financing.

Updated 2016 Guidance

For 2016, GenVec anticipates a cash burn between $6.0 million and $6.5 million and believes its existing resources are sufficient to fund operations into 2018.

Financial Results for the Three Months Ended March 31, 2016

Revenues for the three-month period ended March 31, 2016 were $0.3 million, which represents a decrease of 28% as compared to revenues of $0.4 million in the comparable prior year period.

The decrease in revenue for the three-month period ended March 31, 2016 is primarily attributable to the completion of our contract with the DHS related to our animal health program in February 2015. In connection with this contract we recognized $0.2 million in revenue in 2015 with no corresponding revenue in 2016. Also contributing to the decrease was a reduced work scope under our hearing loss and balance disorders program, which resulted in a $0.1 million reduction in revenue in the current period as compared to the same period in 2015. Partially offsetting these decreases was an increase in revenue from our malaria program of $0.2 million primarily attributable to our grant with the NIH. Work under this grant was completed in March 2016.

Operating expenses were $2.1 million for the three-month period ended March 31, 2016, which represents an increase of 11% as compared to $1.9 million in the comparable prior year period.

General and administrative expenses for the three-month period ended March 31, 2016 increased 9% with expense of approximately $1.4 million in 2016 as compared to $1.3 million in 2015. The increase is primarily attributable to higher personnel costs due to the expansion of our workforce by three full-time employees as compared to the same period in 2015.

Research and development expenses for the three-month period ended March 31, 2016 increased 14% with expense of approximately $0.7 million in 2016 as compared to $0.6 million in 2015. The increase is primarily attributable to higher professional, material, and facility costs.