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Cerus Corporation Reports Fourth Quarter and Year End 2015 Results

On March 8, 2016 Cerus Corporation (NASDAQ:CERS) reported financial results for the fourth quarter and year ended December 31, 2015 (Press release, Cerus, MAR 8, 2016, View Source [SID:1234509417]).

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Recent company highlights include:
U.S. Progress –

Signed INTERCEPT platelet and plasma supply agreements with the American Red Cross, Roswell Park Cancer Institute, Blood Systems, Inc., OneBlood, Inc., LifeShare Blood Centers, ARUP, Inc., Rhode Island Blood Center, Shepeard Community Blood Center, Mississippi Valley Regional Blood Center, Community Blood Center

Received CMS permanent P-codes for outpatient hospital billing of pathogen-reduced platelets and plasma

AABB authorized use of the INTERCEPT Blood System for platelets to reduce the risk of transfusion-associated graft versus host disease

Began enrollment in the Phase IV PIPER Study, which Cerus is conducting as its FDA-required post-approval haemovigilance study

Announced a collaboration agreement with Haemonetics for the use of Acrodose platelet kits with the INTERCEPT Blood System for platelets

International Progress –
Regulatory approval obtained for use of the INTERCEPT Blood System for platelets and plasma in Brazil, Peru, and Colombia

Appointed new leadership for the Europe, Middle East and Africa region

Signed INTERCEPT platelet and plasma supply agreement with the National Transfusiology Center of Mongolia

Recognition of pathogen reduction as a Zika intervention –
The U.S. Food and Drug Administration’s (FDA) guidance document regarding Zika allows for the use of pathogen reduction to reduce transfusion risk and maintain local blood availability

The World Health Organization (WHO) guidelines for maintaining a safe and adequate blood supply during Zika virus outbreaks includes pathogen reduction technology for safeguarding platelet and plasma supplies in areas with active transmission

"The current Zika outbreak highlights the need for a proactive solution to secure the safety and availability of national blood supplies. The FDA and WHO have now recognized that pathogen reduction is an integral component to ensure that patients are protected from possible transfusion transmission of Zika, as well as dengue and chikungunya viruses," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "Looking ahead, with over 60% of the U.S. market now under contract and a long term agreement with the American Red Cross, we expect to begin to transition these contracts into revenue in 2016, and in Europe, we seek to initiate our launch planning for our INTERCEPT red cell system pursuant to our planned CE Mark submission in the second half of the year."

Revenue
Product revenue for the fourth quarter of 2015 was $9.7 million compared to revenue for the same period in 2014 of $9.6 million. This reflects a 22% year over year increase in INTERCEPT disposable kit demand. Revenue for the year ended December 31, 2015 was $34.2 million, compared to $36.4 million for the year ended December 31, 2014. INTERCEPT disposable kit demand over the full year time period grew by 15%, in line with our expectations.

Looking ahead, the Company expects 2016 global revenue in the range of $37 million to $40 million.

Gross Margins
Gross margins for the fourth quarter of 2015 were 36%, compared to 31% for the fourth quarter of 2014. Gross margins for the year ended December 31, 2015, were 31%, compared with 42% in the same period in 2014.

The Company recorded period charges for expiring inventory and certain minimum contractual purchase commitments which negatively impacted margins by approximately 10% and 7% for the quarter and year ended December 31, 2015, respectively. These types of charges impacted margins by less than 1% during the same periods of 2014. In addition, margins for the year ended December 31, 2015 were negatively impacted by the decline in the value of the Euro relative to the Company’s reporting currency, the US dollar, negatively impacting reported gross margins by approximately 5% when comparing the year ended December 31, 2015 to the comparable period in 2014.

Operating Expenses
Total operating expenses were $18.5 million and $71.8 million for the quarter and year ended December 31, 2015, respectively, compared to $15.9 million and $59.7 million for the quarter and year ended December 31, 2014, respectively. The continued buildout of a U.S. based commercial team following December 2014 FDA approvals drove the increase in operating expenses throughout 2015. In addition, label claim expansion activities over 2015 drove increased costs which were offset by the decline in activities incurred in 2014 to obtain those December approvals.

Operating and Net Loss
Operating losses during the fourth quarter of 2015 were $15.0 million, compared to $12.9 million during the fourth quarter of 2014, and $61.1 million compared to $44.5 million for years ended December 31, 2015 and 2014, respectively.

Net loss for the fourth quarter of 2015 was $14.8 million, or $0.15 per diluted share, compared to a net loss of $20.2 million, or $0.26 per diluted share, for the fourth quarter of 2014. Net loss for the year ended December 31, 2015, was $55.9 million, or $0.61 per diluted share, compared to a net loss of $38.8 million, or $0.61 per diluted share, for the same period of 2014.

Net losses for the fourth quarter of 2015 were impacted by the operating losses discussed above and mark-to-market adjustments of the Company’s then outstanding warrants to fair value, which contributed to the Company’s net losses by $1.1 million during the quarter ended December 31, 2015, compared to a contribution of $6.6 million to net losses during the comparable period in 2014. Net losses for the fourth quarter of 2015 were also favorably impacted by approximately $0.2 million of foreign exchange gains during the fourth quarter of 2015, compared to losses of $0.4 million during the corresponding prior period.

Net losses for the year ended December 31, 2015 were impacted by the operating losses discussed above and mark-to-market adjustments of the Company’s then outstanding warrants to fair value, which reduced the Company’s net losses by $3.6 million during the year ended December 31, 2015 compared to a reduction to net losses of $7.7 million during the comparable period in 2014. Net losses for the year were also impacted by foreign exchange losses of $0.4 million during the year ended December 31, 2015, compared to $1.3 million of foreign exchange losses during the year ended December 31, 2014.

At December 31, 2015, the Company had no remaining outstanding warrants and as such, does not expect mark-to-market adjustments going forward.

Cash, Cash Equivalents and Investments
At December 31, 2015, the Company had cash, cash equivalents and short-term investments of $107.9 million compared to $51.3 million at December 31, 2014. Included in the 2015 short-term investments are approximately $11.2 million of marketable equity securities, which had no recorded value at December 31, 2014.

At December 31, 2015, the Company had approximately $20 million in outstanding debt under its loan agreement with Oxford Finance.

Aduro Biotech Announces Fourth Quarter and Full Year 2015 Financial Results

On March 08, 2016 Aduro Biotech, Inc. (NASDAQ:ADRO) reported financial results for the year ended December 31, 2015 (Press release, Aduro BioTech, MAR 8, 2016, View Source;p=RssLanding&cat=news&id=2146953 [SID:1234509414]). Net loss was $39.2 million for the year ended December 31, 2015, or $0.88 per share, compared to a net loss of $17.0 million, or $53.06 per share for the year ended December 31, 2014.

Cash, cash equivalents and marketable securities totaled $431.0 million at December 31, 2015, compared to $119.5 million at December 31, 2014.

"2015 was a banner year for Aduro," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "We made tremendous progress on all fronts and are now uniquely positioned in the immunotherapy field with three differentiated and diverse platform technologies and a deep pipeline of assets in early and late stages of development. While our initial therapeutic priorities are in oncology, we believe the power of our technologies to regulate and temper the immune system also offers potential in autoimmune and infectious diseases."

Key 2015 Accomplishments
Corporate achievements

Raised gross proceeds of approximately $137 million in IPO

Signed collaboration with Novartis targeting STING pathway in oncology generating $200M cash up front, $50 million in equity investment and potential $500M in future milestones

Acquired BioNovion Holding B.V., a monoclonal antibody company; renamed to Aduro Biotech Europe

Clinical achievements

Published Phase 2a pancreatic cancer results in the Journal of Clinical Oncology

Initiated Phase 2b STELLAR clinical trial in pancreatic cancer

Completed enrollment in Phase 2b ECLIPSE clinical trial in pancreatic cancer

Received Orphan Drug Designation in the EU for CRS-207 and GVAX Pancreas in pancreatic cancer

Received Orphan Drug Designation in the US and EU for CRS-207 in mesothelioma

Completed enrollment in Phase 1b clinical trial in mesothelioma

Reported Phase 1b mesothelioma clinical trial results at ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper)/ECC 2015

Signed clinical trial agreement with Incyte to develop combination therapy in ovarian cancer

Initiated Phase 1 clinical trials in prostate (ADU-741) and lung cancer (ADU-214) in collaboration with Janssen

Significant Upcoming Milestones

Report top line results for Phase 2b ECLIPSE clinical trial in pancreatic cancer in the second quarter of 2016

Report interim results for Phase 2b STELLAR clinical trial in pancreatic cancer in the second half of 2016

Report top line results for Phase 1b clinical trial in mesothelioma in the first half of 2016

Initiate randomized Phase 3 clinical trial in mesothelioma in the first half of 2016

Initiate Phase 1 clinical trial in cutaneously accessible tumors with ADU-S100 in collaboration with Novartis in the first half of 2016

Initiate Phase 1 clinical trial in ovarian cancer in collaboration with Incyte in the first half of 2016

Financial Performance
Revenues were $34.4 million for the fourth quarter of 2015 and $73.0 million for the full year 2015, compared to $9.9 million and $13.4 million, respectively, for the same periods in 2014. The increase was primarily due to recognition of a portion of the upfront fees and development-related milestones achieved under the Janssen and Novartis agreements.

Research and development expenses were $22.7 million for the fourth quarter of 2015 and $58.6 million for the full year 2015, compared to $7.5 million and $23.5 million, respectively, for the same periods in 2014. This increase was primarily due to clinical development expenses mainly associated with our ongoing trials for our lead indication in pancreatic cancer, manufacturing costs of our clinical product candidates and compensation and related personnel expenses associated with continued workforce growth.

General and administrative expenses were $8.8 million for the fourth quarter of 2015 and $27.8 million for the full year 2015, compared to $3.5 million and $9.0 million, respectively, for the same periods in 2014. This increase was primarily due to increased consulting and outside professional services and personnel expenses to support the company’s expanding operations, including our acquisition of Aduro Biotech Europe.

Loss from remeasurement of fair value of warrants was zero for the fourth quarter of 2015 and $26.1 million for the year ended December 31, 2015, due to changes in the fair value of liability-classified warrants to purchase Aduro’s preferred and common stock. In April 2015, all such warrants ceased being liability-classified as the contingency surrounding the number of shares issuable upon the warrant exercise expired. In April 2015, all outstanding warrants were equity-classified and not subject to future remeasurement.

Jane Osbourn

IND filing of Medi4276, MedImmune’s first bispecific antibody-directed conjugate – a Biosuperior drug candidate with real potential to help certain types of breast cancer patients (2015) (Company Web Page, AstraZeneca, MAR 8, 2016, View Source [SID:1234509411]).

Sanofi Pasteur and Merck (Known as MSD Outside the United States and Canada) Announce Intent to End Joint Vaccines Operations in Europe, Sanofi Pasteur MSD, to Pursue Their Own Distinct Growth Strategies

On March8, 2016 Sanofi Pasteur and Merck, known as MSD outside the United States and Canada, reported their intent to end their joint vaccines operations in Europe (Press release, Merck & Co, MAR 8, 2016, View Source [SID:1234509409]). Upon concluding their joint venture, both companies plan to integrate their respective European vaccine businesses into their operations, independently manage their product portfolios and pursue their own distinct growth strategies in Europe.

The joint venture Sanofi Pasteur MSD, owned on a 50/50 basis by Sanofi Pasteur and MSD, was created in 1994 to develop and commercialize vaccines originating from both companies’ pipelines to improve and promote public health in 19 European countries. Over the past twenty years, Sanofi Pasteur MSD has launched numerous innovative vaccines originating from Sanofi Pasteur and MSD’s development pipelines, addressing key unmet medical needs and helping to protect millions of lives.

Sanofi Pasteur and MSD jointly issued the following statement: "We are proud of Sanofi Pasteur MSD’s successful 20-year history. Our joint venture has achieved considerable success over the past two decades from a public health and commercial perspective. After carefully considering our individual strategic priorities, alongside the economic and regulatory environments for vaccine operations in the European Union, we have mutually agreed that it is in our best interests to manage our vaccine product portfolios independently. We believe that focusing our efforts on opportunities unique to our respective companies will better position us to drive growth, execute in a more efficient manner and optimize vaccine coverage. By bringing vaccines more rapidly to market, both companies would deliver greater value to all stakeholders."

Sanofi Pasteur and MSD will ensure that any impact on employees as a result of the proposed changes to the business model will be managed responsibly. We are also focused on a smooth and orderly transition while achieving our public healthcare goals and upholding our commitments to our customers and business partners.

Sanofi Pasteur and MSD expect the project to be completed by the end of 2016, subject to local labor laws and regulations and regulatory approvals.

OncoSec Announces Second Quarter and YTD Results for Fiscal Year 2016 and Calendar 2016 Milestones

On March 8, 2016 OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported key corporate objectives as well as financial results for the second quarter and year to date ended January 31, 2016(Press release, OncoSec Medical, MAR 8, 2016, View Source [SID:1234509408]).

CORPORATE OBJECTIVES
"As we enter the next quarter, we are confident in our team’s mission to deliver safer and more effective intratumoral immunotherapies to provide long-term benefits for cancer patients. The fundamental goal of our technology, ImmunoPulse IL-12, is to promote a systemic, tumor-specific immune response. We believe this holds the greatest potential to provide meaningful clinical benefit to patients and investment value to OncoSec’s shareholders," said Punit Dhillon, President and CEO of OncoSec. "Our objectives over the next year are focused on establishing clinical response data to support the combination rationale for ImmunoPulse IL-12 with anti-PD-1/PD-L1 as well as identifying a new lead candidate to expand our ImmunoPulse platform and deliver multiple immune molecules in a single treatment."

OncoSec’s development milestones and value drivers over the next 12 months include:

Complete patient enrollment in the Phase II combination trial of ImmunoPulse IL-12 with anti-PD-1 in patients with metastatic melanoma
Present preliminary clinical and biomarker data from our Phase II melanoma clinical trials at upcoming scientific conferences; data to be used to finalize development strategy
Identify novel "multi-gene" combination ImmunoPulse candidate
Complete triple negative breast cancer pilot study as proof-of-concept and present interim data
Present data from our preclinical programs, including studies with our existing industry collaborators
FINANCIAL RESULTS
For the second quarter of fiscal 2016 and the six months ended January 31, 2016, OncoSec reported a net loss of $7.0 million and $14.1 million, or $0.42 per share and $0.89 per share, respectively, compared to a net loss of $4.6 million and $8.7 million, or $0.38 per share and $0.71 per share, respectively, for the same periods last year. The increase in net loss for the year ended January 31, 2016, compared with the same period in 2015, resulted primarily from (i) an increase of $3.1 million in personnel costs, inclusive of non-cash stock-based compensation (ii) an increase of $1.3 million in clinical studies costs due to the progression of patient treatments in all of our clinical programs, (iii) an increase of $0.5 million related to outside services primarily associated with discovery research and next generation electroporation device development and (iv) an increase of $0.5 million in facility costs which consists primarily of rental expense due to the relocation of our Corporate headquarters, which includes onsite laboratory space. There were no revenues for the three and six months ended January 31, 2016 or January 31, 2015.

Research and development expenses were $4.1 million and $7.8 million for the second quarter of fiscal 2016 and the six months ended January 31, 2016, respectively, compared to $2.9 million and $5.4 million for the same periods in 2015. General and administrative expenses were $2.9 million and $6.3 million for the second quarter of fiscal 2016 and the six months ended January 31, 2016, compared to $1.7 million and $3.3 million for the same period in 2015.

At January 31, 2016, OncoSec had $28.8 million in cash and cash equivalents, as compared to $32.0 million of cash and cash equivalents at July 31, 2015. OncoSec expects these funds to be sufficient to allow it to continue to operate its business for at least the next 12 months.