Mannkind 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, Mannkind, 2017, MAR 16, 2017, View Source [SID1234521750]).

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Titan Pharmaceuticals 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 .

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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 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.