On March 16, 2017 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported financial results for the second quarter and year to date ended January 31, 2017 (Press release, OncoSec Medical, MAR 16, 2017, View Source [SID1234518196]).

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"As we enter the next quarter, we are confident in our clinical and regulatory pathway for the development of our lead candidate, ImmunoPulse IL-12, which we believe holds the greatest potential for patients who are anti-PD-1 non-responders," said Punit Dhillon, President and CEO of OncoSec. "Since we’ve secured Fast Track designation, our main objectives are focused on initiating the Phase IIb registration-directed trial in Stage III/IV melanoma anti-PD-1 non-responder population and finalizing a drug supply agreement for this trial."

FINANCIAL RESULTS
For the second quarter of fiscal 2017 and the six months ended January 31, 2017, OncoSec reported a net loss of $5.4 million and $11.0 million, or $0.27 per share and $0.57 per share, respectively, compared to a net loss of $7.0 million and $14.1 million, or $0.42 per share and $0.89 per share, respectively, for the same periods last year. The decrease in net loss for the second quarter ended January 31, 2017, compared with the same period in 2016, resulted primarily from (i) a decrease in research and development expenses, mainly $1.2 million related to clinical trial costs that were lower due to a lower number of patient enrollments in a smaller number of actively enrolling trials as well as lower trial management costs; and, (ii) a decrease of $0.4 million related to lower salary and non-cash stock compensation costs. The decrease in net loss for the six months ended January 31, 2017, compared with the same period in 2016, resulted primarily from (i) a decrease in research and development expenses, mainly $1.8 million related to clinical trial costs and outside services that were lower due to a lower number of patient enrollments in a smaller number of actively enrolling trials as well as lower trial management costs; (ii) a decrease of $1.1 million related to lower salary and non-cash stock compensation costs; and, (iii) a decrease of $0.2 million related to lower accounting fees. There were no revenues for the three and six months ended January 31, 2017 or January 31, 2016.

Research and development expenses were $2.9 million and $6.0 million for the second quarter of fiscal 2016 and the six months ended January 31, 2017, respectively, compared to $4.1 million and $7.8 million for the same periods in 2016. General and administrative expenses were $2.5 million and $5.0 million for the second quarter of fiscal 2017 and the six months ended January 31, 2017, compared to $2.9 million and $6.3 million for the same period in 2016.

At January 31, 2017, OncoSec had $20.5 million in cash and cash equivalents, as compared to $28.7 million of cash and cash equivalents at July 31, 2016. OncoSec expects these funds to be sufficient to allow it to continue to operate its business for at least the next 12 months.

On March 16,2017 Oxford BioMedica plc (LSE: OXB), ("OXB" or "the Group") a leading gene and cell therapy group, reported preliminary results for the twelve months ended 31 December 2016 (Press release, Oxford BioMedica, MAR 16, 2017, View Source [SID1234518197]).

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HIGHLIGHTS (INCLUDING POST-PERIOD END)

OPERATIONAL

Leading LentiVector delivery platform for gene and cell therapy partnerships

Novartis collaboration progressing well with blockbuster potential product CTL019 close to market and second undisclosed CAR-T programme

Strategic alliance established with Orchard Therapeutics to develop and supply lentiviral vectors for ex vivo treatments

Immune Design collaboration expanded, including licence to use lentiviral vector-based products for in vivo treatments for cancer

New R&D collaboration with Green Cross LabCell focused on gene modified natural killer (NK) cell-based therapies

200 litre bioreactor production process established at commercial scale with potential to increase yield substantially and reduce cost of a patient dose

Transgene Repression In Vector Production (TRiP) system developed to enhance the production titres of a broad range of gene therapy vectors

State-of-the-art bioprocessing and laboratory facilities

Major capacity expansion completed

MHRA approval granted for GMP vector manufacture

Vector production volume increased by 54% compared with 2015

Progress with proprietary product development

Ground-breaking long-term results seen from follow-up studies of patients treated with OXB-101 (for Parkinson’s disease) and OXB-201 (for wet AMD)

OXB-102 (for Parkinson’s disease) and OXB-202 (for corneal graft rejection) ready to start Phase I/II studies following out-licensing / spin out

OXB-302 (for solid cancer tumours) pre-clinical proof-of-concept achieved and ready for further development following out-licensing / spin out

SAR422459 (licensed to Sanofi for Stargardt disease) in Phase II development

FINANCIAL

Gross income (1) increased by 64% to £30.8 million (2015: £18.8million)

Operating expenses excluding depreciation and amortisation and share based payments increased by 4% to £26.1 million (2015: £25.1 million)

EBITDA loss reduced to £7.1 million (2015: £12.1 million)

EBITDA loss in second six months reduced to £1.9 million (2015: £4.7 million)

Operating loss £11.3 million (2015: £14.1 million)

Net cash used in operating activities reduced to £5.1 million (2015: £13.1 million)

Capital expenditure £6.5 million (2015: £16.7 million)

Cash of £15.3 million (31 December 2015: £9.4 million) including $10 million (£8.1 million) ring-fenced under Oberland loan agreement

Fundraising of £17.5 million net

– Gross income is the aggregate of revenue (£27.8 million) and other operating income (£3.0 million) (2015: £15.9 million and £2.9 million respectively)

CORPORATE

Tim Watts, Chief Financial Officer, will leave the Board and the Group in September 2017. His successor, Stuart Paynter, will join the Group in August 2017.

Commenting on the Group’s 2016 full year results, John Dawson, Oxford BioMedica’s Chief Executive Officer, said:

"Oxford BioMedica has a world-leading lentiviral vector delivery (LentiVector) platform for gene and cell therapy which is becoming the platform of choice for lentiviral vector products. With state-of-the-art bioprocessing and laboratory facilities our gross income is growing rapidly and, as the manufacturer of the lentiviral vector for Novartis’ blockbuster-potential therapy CTL019, we look forward to the product’s launch as the Group will benefit from supplying the viral vector and a royalty on CTL019’s sales. Beyond Novartis, we have added new revenue-generating partnerships and collaborations during 2016 which are progressing well and are confident we can add further relationships during 2017. The process to spin-out or out-license our priority product development candidates is well underway and I am optimistic we will have success with this in 2017. We will continue to invest in our platform technology in order to consolidate our leadership position and in our gene and cell therapy product concepts so that we exploit our LentiVector platform to the full."

On March 16, 2017 Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, reported its financial results for the full-year ended December 31, 2016, and provided a corporate update (Press release, Protalix, MAR 16, 2017, View Source;p=RssLanding&cat=news&id=2254401 [SID1234518199]).

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"Recently, our Executive Vice President, Research and Development and two Principal Investigators that have been involved in our clinical trials of pegunigalsidase alfa for Fabry disease each gave presentations at the 13th Annual WORLDSymposium in San Diego on the data generated in our phase I/II clinical trial of pegunigalsidase alfa for the treatment of Fabry disease, and received very positive feedback from physicians and patient advocacy groups," said Moshe Manor, Protalix’s President and Chief Executive Officer. "Looking ahead into 2017, we anticipate reporting results from both the phase II clinical trial of alidornase alfa for the treatment of Cystic Fibrosis and the phase II clinical trial of OPRX-106 for the treatment of ulcerative colitis. In 2018, if we generate positive interim results from the pegunigalsidase phase II trial, we expect to begin the filing process for approval with the European Medicines Agency."

"Following a note exchange and private placement completed in December 2016, we have a strong cash position of approximately $63.3 million," said Yossi Maimon, Protalix’s Vice President and Chief Financial Officer. "We anticipate these funds will be sufficient to fund our operations into 2019."

2016 and Recent Clinical and Corporate Highlights

Pegunigalsidase alfa (PRX-102) for Fabry Disease

Announced positive six and twelve-month interim phase II data in March 2016 and reported final results of the trial in August 2016. This data was presented at the Society of Inborn Errors of Metabolism Annual Symposium in September 2016 and the 13th Annual WORLDSymposium in February 2017.

Enrolled the first patient in a global phase III clinical trial to support filings in the United States (U.S.) and Europe in October 2016. Completion of enrollment is expected during the second half of 2017, with interim data analysis anticipated in 2018 to support European Medicines Agency and other regulatory filings outside of the United States, which comprise approximately two-thirds of the market.
Alidornase alfa (PRX-110) for Cystic Fibrosis

Reported positive interim results from the first 13 patients treated in our phase II clinical trial in January 2017. Full results for all 16 patients enrolled in the study are expected in the first half of April 2017. Data from the study was accepted as an oral presentation at the 40th European Cystic Fibrosis Conference to be held in June 2017.
Oral anti-TNF (OPRX-106) for Ulcerative Colitis

Enrolled the first patient in a phase II clinical trial in November 2016. Full results are expected around year end.
Alfataliglicerase for Gaucher Disease

Granted pediatric approval of alfataliglicerase in Brazil for the treatment of Gaucher disease in children four years of age and older in November 2016.

Received letter detailing and confirming purchases of approximately $24 million of drug product from Fundação Oswaldo Cruz (Fiocruz), an arm of the Brazilian Ministry of Health in December 2016.
Full-Year 2016 Financial Results

For the year ended December 31, 2016, Protalix reported a net loss of $29.4 million, or $0.29 per share, basic and diluted, compared to a net loss of $27.3 million, or $0.29 per share, basic and diluted, for the year ended December 31, 2015 from continuing operations.

Protalix recorded total revenues of $9.2 million for the full-year 2016, compared to $4.4 million during the same period of 2015. The increase is attributable mainly to increased sales of drug substance to Pfizer Inc. for inventory build up.

Research and development expenses for full-year 2016 were $24.6 million, compared to $20.0 million for the same period in 2015. Selling, general and administrative expenses for the full-year 2016 were $9.4 million, compared to $7.3 million incurred for the full-year 2015. The increase is mainly attributable to increased activities in Brazil.

At December 31, 2016, Protalix had $63.3 million of cash and cash equivalents, compared to $76.4 million at December 31, 2015, which is currently projected to fund operations into 2019.

– Protalix exchanged $54.1 million principal amount of the Company’s $69.0 million 4.50% Senior Convertible Notes due 2018 for $40.2 million principal amount of newly issued 7.50% Senior Secured Convertible Notes due 2021 and approximately 23.8 million shares of common stock in December 2016.

– Concurrent to the note exchange, the Company sold $22.5 million principal amount of the 7.50% Senior Secured Convertible Notes due 2021 in a private placement.

On March 16, 2017 Provecs Medical GmbH, a cancer immunotherapy company developing novel treatments to modulate the tumor microenvironment, reported the closing of a partnership with oncology pharma company Medac Gesellschaft für klinische Spezialpräparate mbH (Press release, Provecs Medical, MAR 16, 2017, View Source [SID1234571468]). The partners aim to develop, manufacture and market Provec’s cancer immunotherapy lead product Immunalon for the treatment of urinary bladder cancer. Immunalon is being developed for the treatment of a wide range of solid cancers, including urinary bladder cancer. Financial details were not disclosed.

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The collaboration combines Medac´s marketing expertise in oncology and hematology with Provecs´ development know-how, which is based on its proprietary ENVIRO technology platform for innovative immunotherapeutics.

ENVIRO is a unique, patented adenoviral platform for the targeted delivery of up to four biologicals combined in one product to the tumor site. This multivalent approach is designed to reprogram the barriers between the immune system and cancer by addressing up to four immune checkpoints simultaneously. Immunalon is Provecs Medical´s lead compound based on ENVIRO.

"It is known today that the activation and inhibition of immune cells is regulated by a wealth of molecules called checkpoint molecules," said Dr. Frank Schnieders, CEO of Provecs Medical. "Tumors establish control over checkpoints to deactivate immune cells directed against the cancer. We also know that blocking these inhibitory checkpoint molecules partially restores the immune system’s ability to control and sometimes eliminate cancer cells. Existing treatments are directed against single checkpoints only and therefore show limited efficacy. We are convinced that addressing up to four checkpoints with our ENVIRO approach makes it much more difficult for tumor cells to escape elimination."

Provecs achieved ex-vivo proof-of-concept for Immunalon using its EXVIRO platform, a unique primary cancer tissue platform for ex-vivo therapy simulation as well as pharmacodynamics and pharmacokinetics studies. This 3D tissue culture system uses patient-derived human cancer tissues to study the tumor microenvironment in its spatial context without disrupting the cellular relationships. Provecs is now developing a first-in-man study concept for Immunalon in a second indication.

"We are seeking partners for the development of Immunalon in other solid cancer indications with high medical need and a lack of standard therapies," Schnieders added.

On March 16, 2017 Elasmogen Ltd, developer of soloMERTM biologics, reported that it has received a Biomedical Catalyst Grant from the UK’s innovation agency, Innovate UK and matching investment from Deepbridge Capital and Scottish Investment Bank (the investment arm of Scottish Enterprise) totalling £1.2 M (Press release, Elasmogen, MAR 16, 2017, View Source [SID1234637761]). The funding will be used to develop ELN-21 and ELN-22, the companies’ next generation biologics for topical treatment of ocular disease. Current treatments for ocular diseases such as uveitis and macular degeneration require either systemic dosing or direct injection into the eye. soloMERs are Elasmogen’s proprietary humanized versions of shark VNARs, the smallest naturally occurring binding domains. The small size (11 kDa) and highly robust nature of soloMERs make them ideal for delivering topically applied sight saving therapies while reducing systemic side effects and eliminating the need for injections. "We have recently completed our proof of concept trials demonstrating the ability to deliver therapeutic concentrations of soloMERs to the back of the eye by topical delivery," said Elasmogen CEO Caroline Barelle. "Winning the Biomedical Catalyst grant along with the new investment will allow us to build on these results and prepare our anti-inflammatory and anti-autoimmune soloMERs for phase 1 clinical trials." "Use of corticosteroids for treatment of ocular inflammation carries the risk of significant side effects including glaucoma and cataracts," said John Forrester Clinical Professor of Ophthalmology, The Lions Eye Institute, Australia and University of Aberdeen, Scotland. "A fast acting, topically applied biologic that can reach all parts of the eye would provide significant benefit to uveitis and other ocular disease patients." Kerry Sharp, Head of the Scottish Investment Bank said, "We are pleased to be able to support Elasmogen, initially through our High-Growth Spinout Programme which helps researchers to take their ideas and inventions from the lab to the global marketplace, and now through matched investment from the Scottish Venture Fund. The company has made significant technical progress in a short space of time and its sight-saving auto-immune therapies have the potential to make a notable social, as well as commercial, impact. We look forward to working with Deepbridge Capital to further support and nurture the exciting opportunity presented by Elasmogen."

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