XBiotech has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, XBiotech, 2017, MAR 16, 2017, View Source [SID1234521576]).

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On March 16, 2017 Mast Therapeutics, Inc. (NYSE MKT: MSTX) reported it has set a date for a special meeting of its stockholders to vote on matters related to the proposed merger with Savara Inc. (Savara), a privately-held, clinical-stage specialty pharmaceutical company focused on the development and commercialization of novel therapies for the treatment of serious or life-threatening rare respiratory diseases (Press release, Mast Therapeutics, MAR 16, 2017, View Source [SID1234518206]).

The special meeting will be held at 9:00 a.m., local time, on April 21, 2017 at 3611 Valley Centre Drive, Suite 500, San Diego, California 92130. Mast’s stockholders of record as of the close of business on March 13, 2017 are entitled to receive notice of, and to vote at, the special meeting.

The merger has been unanimously approved by the boards of directors of both companies and the board of directors of Mast unanimously recommends that its stockholders vote "FOR" the special meeting proposals described in the proxy statement/prospectus/information statement declared effective by the Securities and Exchange Commission on March 15, 2017, a copy of which will be provided to Mast stockholders of record as of March 13, 2017. The proposed merger is expected to close promptly after the Mast special meeting scheduled for April 21, 2017, subject to the approval of the stockholders of each company and the satisfaction or waiver of the other closing conditions in the merger agreement between the companies.

The combined company would advance a pipeline of novel inhalation therapies for the treatment of diseases with significant unmet medical needs, featuring three product candidates, each in advanced stages of clinical development:

•
AeroVanc, an inhaled dry-powder vancomycin to treat chronic methicillin-resistant Staphylococcus aureus (MRSA) pulmonary infection in cystic fibrosis (CF) in preparation for a pivotal Phase 3 study;

•
Molgradex, an inhaled nebulized GM-CSF to treat pulmonary alveolar proteinosis (PAP) currently in Phase 2/3 development; and

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AIR001, an inhaled nebulized sodium nitrite solution to treat heart failure with preserved ejection fraction (HFpEF) currently in Phase 2 development.

Select Anticipated Upcoming Development Milestones

•
Closing of proposed merger in Q2/2017.

•
Initiate a pivotal Phase 3 study of AeroVanc in Q3/2017.

•
Complete negotiations with the U.S. Food and Drug Administration (FDA) on the requirements for a pivotal clinical study of Molgradex in the U.S. in Q3/2017.

•
Announce strategy related to Molgradex program expansion for the treatment of a rare lung infection in 2017.

•
Announce top-line results from Phase 2/3 study of Molgradex, expected to be registration-enabling for the treatment of PAP in Europe and Japan, in Q1/2018.

•
Announce results from ongoing Phase 2 study of AIR001 for the treatment of HFpEF being conducted by the Heart Failure Clinical Research Network in Q1/2018.

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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 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 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.