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Peregrine Pharmaceuticals Reports Financial Results for the Third Quarter of Fiscal Year 2017 and Recent Developments

On March 13, 2017 (GLOBE NEWSWIRE) — Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company committed to improving patient lives by manufacturing high quality products for biotechnology and pharmaceutical companies, and advancing its proprietary R&D pipeline, reported financial results for the third quarter of fiscal year (FY) 2017 ended January 31, 2017, and provided an update on its contract manufacturing business, preclinical and clinical pipeline, and other corporate developments (Press release, Peregrine Pharmaceuticals, MAR 13, 2017, View Source [SID1234518103]).

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Highlights Since October 31, 2016
"During the third quarter, Avid’s revenue growth continued, which is a strong indicator of the increasing value of this contract development and manufacturing organization (CDMO) business. The steady growth of this business over the past 5 years has been remarkable and we are pleased to see the trend continuing as we move through a number of process validations for clients, which we expect to spur further growth in the future as some or all of those products move to commercialization. We see Avid as a tremendously important asset with solid upside potential that is often overlooked as a value driver for the overall organization. With projected revenue of over $60 million for the current fiscal year, this is already a strong business in an industry that is expecting substantial growth over the next decade and we are excited about the future of the company," stated Steven W. King, president and chief executive officer of Peregrine, and president of Avid Bioservices. "An important component of our Avid growth strategy is capacity expansion within our Myford facility. We are currently on track to install two 2,000-liter bioreactors in the facility within the next few months with a book of business for the reactors already in place. We believe the total capacity potential of the facility, when operating in campaign mode, can exceed more than $75 million annually bringing us to well over $100 million in total potential revenue between our two manufacturing facilities, and giving us adequate capacity to continue Avid revenue growth through FY 2018.

"As we look to the future, based on current operations and projected demand from our existing clients, we have also recently secured additional space within the same building as our Myford facility for which we already have use as part of our existing operations but would also allow us to further expand capacity based on committed business. While we will only begin converting the space into manufacturing capacity once client commitments and other necessary financing is in place, this puts us in an excellent position for continuing to grow the business beyond the coming fiscal year."

Mr. King continued, "During the quarter, we also achieved a number of goals on the development front. These efforts are highlighted by the three clinical trials under our collaboration with the National Comprehensive Cancer Network (NCCN) which are advancing as planned, and we expect at least two of the trials to be initiated by mid-year. Additionally, we and our collaborators will be presenting a number of studies at the upcoming AACR (Free AACR Whitepaper) annual meeting including data from researchers at Memorial Sloan Kettering that support the ability of PS-targeting agents, including bavituximab, to significantly impact the tumor microenvironment, creating a more favorable environment for checkpoint inhibitors. Additionally, our collaborators at the University of Texas Southwestern Medical Center published positive proof-of-concept data for our recently-licensed exosome-based cancer detection platform, which could have broad potential for patients with cancer. Even though we have reduced our R&D expenditures, we are pleased that collaborations such as these are allowing us to continue the advancement of our therapeutic and diagnostic programs as we continue to evaluate the best ways for moving our bavituximab and other PS-targeting programs forward. The combined efforts of growing the Avid biomanufacturing business and these important collaborations are allowing us to make great strides on all fronts."

Avid Bioservices Highlights
"The Avid business continues to build momentum. During the third quarter of FY 2017, contract manufacturing revenue increased 61% to $10.7 million compared to the third quarter of FY 2016. Given this performance, and our expected fourth quarter results, we are increasing our full FY 2017 revenue guidance from $50 to $55 million, to $60 to $65 million," stated Paul Lytle, chief financial officer of Peregrine. "We are also pleased to report that we recently leased 42,000 square feet within the same building as our Myford facility, allowing us to leverage existing oversized utilities and infrastructure that should allow us greater operational efficiency and overall cost savings. While we design the new facility within this new space, it’s important to note that our two existing commercial facilities have sufficient capacity to continue to grow our contract manufacturing revenue in FY 2018."

The company is increasing its manufacturing revenue guidance for the full FY 2017 from $50 – $55 million, to $60 – $65 million.

Avid’s current manufacturing revenue backlog is $70 million, representing estimated future manufacturing revenue to be recognized under committed contracts. This backlog primarily covers revenue to be recognized during the remainder of fiscal year 2017 and fiscal year 2018.

Clinical Development Highlights

— The three clinical trials under the collaboration with the NCCN are advancing as planned.

Moffitt Cancer Center—A Phase I Trial of Sorafenib and Bavituximab Plus Stereotactic Body Radiation Therapy for Unresectable Hepatitis C Associated Hepatocellular Carcinoma. This protocol is approved and patient screening is expected soon.

Massachusetts General Hospital Cancer Center—Phase I/II Clinical Trial of Bavituximab with Radiation and Temozolomide for Patients with Newly Diagnosed Glioblastoma. This trial is on track to be initiated by mid-calendar 2017.

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins—Phase II Study of Pembrolizumab and Bavituximab for Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck. This trial is on track to be initiated by mid-calendar 2017.

— The company is continuing its comprehensive biomarker analysis of data collected in the Phase III SUNRISE trial.

Through this analysis, and as reported previously, Peregrine scientists have identified a correlation between overall survival and pre-treatment levels of the biomarker, beta-2 glycoprotein-1 (β2GP1).

The results of an analysis of pre-treatment interferon gamma (IFN-ɣ) will be the subject of a presentation at AACR (Free AACR Whitepaper) entitled:

IFN-ɣ Analysis in Blood and Tissue as a Potential Prognostic and/or Predictive Biomarker

Research Highlights

— Peregrine scientists and collaborators from Memorial Sloan Kettering Cancer Center will present preclinical results from multiple studies at the upcoming AACR (Free AACR Whitepaper) meeting in April. Each study evaluates the use of a bavituximab equivalent in combination with immune stimulating therapies. The following abstracts will be presented:

Memorial Sloan Kettering: Targeting Phosphatidylserine in Combination with Adoptive T Cell Transfer Eliminates Advanced Tumors without Off-Target Toxicities in a Melanoma Preclinical Model

Memorial Sloan Kettering (initial findings presented at SITC (Free SITC Whitepaper)): Phosphatidylserine Targeting Antibody in Combination with Tumor Radiation and Immune Checkpoint Blockade Promotes Anti-Tumor Activity in Mouse B16 Melanoma

Peregrine (initial findings presented at the 2016 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Meeting): Combinational Activity of LAG3 and PD-1 Targeted Therapies is Significantly Enhanced by the Addition of Phosphatidylserine Targeting Antibodies and Establishes an Anti-Tumor Memory Response in Murine Triple Negative Breast Cancer

— Collaborators from the University of Texas Southwestern Medical Center at Dallas, recently published positive proof-of-concept findings for Peregrine’s recently licensed exosome-based cancer detection platform in the peer-reviewed journal, Oncotarget. Results demonstrated that those patients with malignant ovarian cancer displayed significantly higher blood PS exosome levels than those with benign tumors, and the malignant and benign groups displayed significantly higher blood PS exosome levels than the healthy subjects.

Financial Highlights and Results

— Peregrine continues to execute its previously-announced strategy to reach sustained profitability by increasing contract manufacturing revenue while decreasing research and development expenses, with the goal of reaching profitability 15 months from now. During the first nine months of FY 2017, the company made significant progress toward this goal with contract manufacturing revenues increasing 55% compared to the first nine months of FY 2016 and research and development expenses decreasing by 50% compared to the first nine months of FY 2016.

Contract manufacturing revenue from Avid’s biomanufacturing services provided to its third-party customers increased to $10,747,000 for the third quarter of FY 2017 compared to $6,672,000 for the third quarter of FY 2016.

Total costs and expenses for the third quarter of FY 2017 were $18,544,000, compared to $23,576,000 for the third quarter of FY 2016. For the third quarter of FY 2017, research and development expenses decreased 60% to $5,989,000, compared to $15,156,000 for the third quarter of FY 2016. Cost of contract manufacturing increased to $7,974,000 in the third quarter of FY 2017 compared to $3,896,000 for the third quarter of FY 2016, primarily due to an increase in the cost of contract manufacturing associated with higher reported revenue. Also contributing to this increase and impacting gross margins for the period is the higher cost of operating the new Myford facility as well as the higher cost associated with performing process validation runs during the quarter. For the third quarter of FY 2017, selling, general and administrative expenses increased slightly to $4,581,000 compared to $4,524,000 for the third quarter of FY 2016 primarily due to the company’s growing manufacturing business.

Peregrine’s consolidated net loss attributable to common stockholders was $9,216,000 or $0.04 per share, for the third quarter of FY 2017, compared to a net loss attributable to common stockholders of $18,227,000, or $0.08 per share, for the same prior year quarter.

Peregrine reported $41,528,000 in cash and cash equivalents as of January 31, 2017, compared to $61,412,000 at fiscal year ended April 30, 2016.

More detailed financial information and analysis may be found in Peregrine’s Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.

Conference Call
Peregrine will host a conference call and webcast this afternoon, March 13, 2017, at 4:30 PM EDT (1:30 PM PDT).

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Peregrine Pharmaceuticals conference call. To listen to the live webcast, or access the archived webcast, please visit: View Source

Myriad Genetics Launches the EndoPredict® Test in the United States for Patients with Breast Cancer

On March 13, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that it has launched the EndoPredict test in the United States for patients with ER+ HER2- early-stage breast cancer(Press release, Myriad Genetics, MAR 13, 2017, View Source [SID1234518101]). EndoPredict is a second-generation test for assessing the 10-year risk of disease recurrence following surgery and for determining which patients can safely forgo adjuvant chemotherapy.

"Today’s launch strengthens our oncology product portfolio and represents a meaningful advancement in the treatment of patients with breast cancer," said Lloyd Sanders, general manager, Oncology, Myriad Genetic Laboratories. "Along with our best-in-class tests for hereditary cancer and our companion diagnostics, the launch of EndoPredict underscores our commitment to pioneering science, personalized medicine and patient care."

EndoPredict is supported by multiple prospective clinical studies and data from more than 3,500 patients with ER+ HER2- node negative and node positive early-stage breast cancer. The results of the clinical development program show that EndoPredict substantially outperforms the first generation breast cancer recurrence tests. EndoPredict was trained and validated using 10-year outcomes data and includes proliferation-related genes as well as hormone receptor-related genes, providing accurate assessment of early and late risk for recurrence and definitively classifies patients as low or high risk.

"Breast cancer is a complicated disease and there is a critical need for accurate breast cancer recurrence tests that help physicians determine which patients can safely forgo adjuvant chemotherapy," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories. "The launch of EndoPredict is an important advancement for patients and doctors. By automatically incorporating clinical features and generating an individualized patient test result, EndoPredict identifies a larger subset of true low-risk patients who may safely forgo adjuvant chemotherapy."

EndoPredict already is included in medical guidelines including the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) and the St. Gallen International Breast Conference. Additionally, the Integrated Oncology Network (ION) named EndoPredict as its preferred breast cancer recurrence test. Myriad is working with payers to making sure EndoPredict is a widely accessible to patients. So far, the test has received positive coverage decisions from 19 payers, bringing total coverage to over 70 million patients in the United States.

Follow Myriad on Twitter via @MyriadGenetics and stay informed about Company news and updates.

Clinical Data Supporting the Launch

Name of Trial # of
Patients Breast Cancer
Sub-Type Nodal Status 10-Year Distant
Metastasis Rate
for Low Risk
Group
Multicenter 964 ER+/HER2- NO, N+ 7.0 %
ABCSG-6 378 ER+/HER2- NO, N+ 4.0 %
ABCSG-8 1,324 ER+/HER2- NO, N+ 4.0 %
ATAC 928 ER+/HER2- NO, N+ 5.8 %
About Breast Cancer
Breast cancer is the second leading cause of mortality among women. A woman living in the United States has a 12.3 percent, or a 1 in 8, lifetime risk of being diagnosed with breast cancer. In 2017, invasive breast cancer will be diagnosed in more than 246,660 women.

Mylan Announces Global Settlement and License Agreements with Genentech and Roche on Herceptin®

On March 13, 2017 Mylan N.V. (NASDAQ, TASE: MYL) reported that Mylan has agreed to the terms of a global settlement with Genentech, Inc. and F. Hoffmann-La Roche Ltd. in relation to patents for Herceptin (trastuzumab), which provides Mylan with global licenses for its trastuzumab product (Press release, Mylan, MAR 13, 2017, View Source [SID1234518100]).

The global license will provide a clear pathway for Mylan to commercialize its trastuzumab product in various markets around the world, commencing on the license effective dates, which are confidential. The licenses pertain to all countries except Japan, Brazil and Mexico. In addition to eliminating any legal uncertainty over the launch of Mylan’s trastuzumab, the settlement eliminates further patent litigation expenses associated with Genentech and Roche.
Mylan has agreed to withdraw its pending Inter Partes Review (IPR) challenges against two U.S. Genentech patents (patent numbers 6,407,213 and 6,331,415) as part of the settlement.

Following this settlement and the recent acceptance of Mylan’s application for its proposed biosimilar trastuzumab with the U.S. Food and Drug Administration (FDA), Mylan anticipates potentially being the first company to launch a biosimilar to Herceptin in the U.S.

All other terms and conditions of the settlement and license agreement are confidential.
Mylan CEO Heather Bresch commented, "There is an unmet need for access to more affordable versions of biologic products such as trastuzumab. We look forward to enhancing access to this important treatment option, which complements our comprehensive cancer care offerings, in the U.S. and around the world. With 16 biosimilar products in development, we believe Mylan has one of the industry’s broadest portfolios of biosimilars and that we will be a leader in bringing high-quality biosimilar products to market given our ability not only to develop and manufacture such complex products, but also to navigate the intricate regulatory and legal environment and successfully commercialize these products on a global basis."

Mylan’s proposed biosimilar trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the proposed biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

In the U.S., Mylan’s Biologics License Application (BLA) for proposed biosimilar trastuzumab is currently under review by FDA. The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Sept. 3, 2017.
Mylan currently markets its trastuzumab products in 14 emerging markets and has submissions pending in the European Union and several additional emerging markets, in addition to the U.S.

Dynavax Reports Fourth Quarter and Year End 2016 Financial Results and Company Update

On March 13, 2017 Dynavax Technologies Corporation (NASDAQ: DVAX) reported financial results for the fourth quarter and year ended December 31, 2016 (Press release, Dynavax Technologies, MAR 13, 2017, View Source [SID1234518096]). The net loss for the year ended December 31, 2016 was $112.4 million, or $2.92 per share, compared to $106.8 million, or $3.25 per share, for the year ended December 31, 2015.

The Company had $81.4 million in cash, cash equivalents and marketable securities as of December 31, 2016, compared to $196.1 million at December 31, 2015. In addition, in the first quarter of 2017 the Company received proceeds of $23.3 million from sales of common stock under an at-the-market sales agreement.

"We are pleased with the continued progress of our immuno-oncology portfolio during 2016 and the recent promising clinical results from our combination trial in melanoma," said Eddie Gray, chief executive officer for Dynavax. "With the expansion of SD-101 into Phase 2 in both melanoma and head and neck cancer this quarter, our marketing application for HEPLISAV-B under review by the FDA and our strong cash balance, we are in position to deliver key outcomes for several programs during 2017."

Overview

During the last few years, the company has steadily advanced on its objective to evolve into an immuno-oncology company as it prepared for an anticipated launch of HEPLISAV-B. Following receipt of the HEPLISAV-B Complete Response Letter (CRL) from the FDA in November 2016, the company was restructured to focus resources on the immuno-oncology portfolio and to enable HEPLISAV-B to advance through the FDA review process to an approval decision.

Recent Progress

SD-101

In early March, Dynavax presented promising clinical data from the dose escalation phase of an ongoing Phase 1b/2 study investigating SD-101 in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy developed by Merck, known as MSD outside the United States and Canada, in patients with metastatic melanoma. Encouraging overall response rates and complete response rates in patients naïve to anti-PD-1 therapy were observed.

Based on the results of the initial dose escalation phase this trial is being expanded into Phase 2 studies in both melanoma and head and neck cancer. Patients will be enrolled in two cohorts, those naïve to anti-PD-1 treatment and patients who have progressive disease on anti-PD-1 therapy. The trial is designed to build on the encouraging results seen in the anti-PD-1 naïve patient group while allowing for continued dose escalation in patients who have progressive disease on anti-PD-1 therapies.

HEPLISAV-B

In February, Dynavax filed its responses to the November 2016 CRL issued by the FDA for HEPLISAV‐B, the company’s vaccine candidate intended for immunization against hepatitis B infection in adults 18 years of age and older. The FDA has established August 10, 2017 as the Prescription Drug User Fee Act (PDUFA) action date.

As part of the January restructuring, the company suspended manufacturing activities, commercial preparations and other longer term investment related to HEPLISAV-B during the regulatory review period and reduced its global workforce by approximately 40%. If the product is approved, Dynavax plans to satisfy anticipated initial demand from existing stockpiled inventory and to scale up commercial activities based on market demand and investment priorities.

Financials

Total revenues were $7.3 million for the fourth quarter of 2016 and $11.0 million for the full year of 2016 compared to $0.7 million and $4.1 million for the same periods in 2015. The increase was primarily due to recognition of $7.2 million under the research collaboration and license agreement with AstraZeneca related to the initiation of a Phase 2a clinical trial by AstraZeneca.

Research and development expenses were $18.4 million for the fourth quarter of 2016 and $84.5 million for the full year of 2016 compared to $20.9 million and $86.9 million for the same periods in 2015. This decrease was primarily due to a reduction in outside services expense associated with the completion of the HBV-23 clinical study in the fourth quarter of 2015, partially offset by an increase in headcount as well as regulatory and manufacturing activities in preparation for the anticipated commercial launch of HEPLISAV-B.

General and administrative expenses were $8.2 million for the fourth quarter of 2016 and $37.3 million for the full year of 2016 compared to $6.7 million and $22.2 million for the same periods in 2015. This increase was primarily due to costs related to preparation for the anticipated commercial launch of HEPLISAV-B including additional headcount, information technology systems and infrastructure to support commercial development as well as costs related to sourcing a debt financing commitment.

Adaptimmune Reports Fourth Quarter and Full Year 2016 Financial Results

On March 13, 2017 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported financial results for the fourth quarter and year ended December 31, 2016 (Press release, Adaptimmune, MAR 13, 2017, View Source [SID1234518082]).

"2016 was an important year for Adaptimmune during which we established substantial clinical momentum and significantly advanced our commercial-ready cell manufacturing process," commented James Noble, Adaptimmune’s Chief Executive Officer. "We now have four open INDs, including three for our wholly-owned SPEAR T-cells, for studies in 11 indications, 10 of which are solid tumors. This illustrates the breadth of our proprietary platform and marks further progress since the end of 2015 when we had two open INDs and studies ongoing in four indications. Given this progress, we are increasing our focus on our wholly-owned SPEAR T-cells, in particular the multi-tumor studies with our wholly-owned MAGE-A10 and MAGE-A4 SPEAR T-cell therapies, and we intend to deliver initial data from these studies beginning later this year."

Mr. Noble continued, "With respect to our NY-ESO program, I am delighted to confirm that the FDA has completed its review of our commercial-ready manufacturing process and permitted us to proceed with implementation of the process in our existing NY-ESO trials. We plan to implement this new process in our pilot clinical trials this year. And, we also continue to plan for initiation of the first registration study with a SPEAR T-cell therapy in sarcoma. In doing so, we will move ever closer to our goal of transforming the treatment of patients with serious diseases."

Full Year 2016 and Recent Highlights:

Opened two new INDs for wholly-owned SPEAR T-cell therapies (AFP, MAGE-A4); four INDs are now open, enabling a total of nine studies across 11 indications;
Opened two new clinical studies of SPEAR T-cell therapies (MAGE-A10 triple tumor study and a pilot study of NY-ESO in myxoid/round cell liposarcoma [MRCLS])
Received orphan designation in the United States (US) and European Union (EU), and EU Priority Medicines (PRIME) regulatory support for NY-ESO SPEAR T-cell in soft tissue sarcoma; and US Breakthrough Therapy Designation for NY-ESO SPEAR T-cell in synovial sarcoma;
Received FDA notification of permission to proceed with new cell manufacturing process for NY-ESO phase I/II studies;
Presented clinical data including updated median survival data for synovial sarcoma Cohort 1 (~18 months [80 weeks]), compared to ~13 months (56 weeks) as previously reported (CTOS 2016); Fludarabine requirement for preconditioning (ESMO 2016); and responses in synovial sarcoma patients with low NY-ESO expression (ESMO 2016);
Formed strategic alliance with MD Anderson Cancer Center to develop SPEAR T-cell therapies, including clinical studies of MAGE-A10 and MAGE-A4 SPEAR T-cell therapies;
Entered strategic collaboration with Merck to evaluate KEYTRUDA (pembrolizumab) in combination study with NY-ESO SPEAR T-cell therapy in multiple myeloma, with first site initiation anticipated in the first half of 2017;
Initiated strategic collaboration with Bellicum Pharmaceuticals to evaluate Bellicum’s GoTCR technology (inducible MyD88/CD40 co-stimulation) with Adaptimmune’s affinity-optimized SPEAR T-cells; and
Expanded strategic immunotherapy collaboration with GSK and announced GSK’s nomination of a second target, PRAME.

Financial Results for the Three and Twelve Month Period ended December 31, 2016

Cash / liquidity position: As of December 31, 2016, Adaptimmune had $158.8 million of cash and cash equivalents, and $22.7 million of short-term deposits representing a total liquidity position1 of $181.5 million. For the three months ended December 31, 2016, the increase in cash and cash equivalents was $18.3 million and the decrease in short-term deposits was $24.3 million, representing a decrease in total liquidity position of $6.0 million.
Revenue: Revenue represents the upfront and milestone payments, which are recognized over the period the Company delivers services to GSK. Revenue for the three months ended December 31, 2016 was $8.5 million compared to $4.0 million in the same quarter of the prior year. The increase in revenue was driven by achieving $17.4 million of milestones in the fourth quarter, which are recognized over the period the Company delivers services to GSK. Revenue for the twelve months ended December 31, 2016 was $14.2 million compared to $14.5 million in the prior year.
Research and development ("R&D") expenses: R&D expenses for the three and twelve months ended December 31, 2016 were $16.8 million and $63.8 million, respectively, compared to $16.6 million and $40.5 million for the three and twelve months ended December 31, 2015. The increases compared to both prior periods were primarily due to increased period-over-period costs associated with ongoing clinical trials of the Company’s NY-ESO and MAGE-A10 SPEAR T-cell therapies; preparation for studies with the Company’s SPEAR T-cell therapy targeting AFP and MAGE-A4; and increased personnel expenses.
General and administrative ("G&A") expenses: G&A expenses for the three and twelve months ended December 31, 2016 were $6.3 million and $23.2 million, respectively, compared to $5.5 million and $17.2 million for the three and twelve months ended December 31, 2015. The increases compared to both prior periods were primarily due to increased personnel costs.
Net loss: Net loss attributable to holders of the Company’s ordinary shares for the three and twelve months ended December 31, 2016 was $15.4 million ($(0.04) per ordinary share or $(0.22) per American Depositary Share) and $71.6 million ($(0.17) per ordinary share or $(1.01) per American Depositary Share), respectively.

1 Total liquidity position is a non GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below.

Financial Guidance
As of December 31, 2016, Adaptimmune had a total liquidity position1 of $181.5 million, made up of $158.8 million of cash and cash equivalents and $22.7 million of short-term deposits. The Company believes that this balance will fund operations through mid-year 2018. This guidance excludes the effect of any potential new business development activities.

Conference Call Information
The Company will host a live teleconference and webcast to provide an overview of its financial results and a business update at 8:00 a.m. EDT (12:00 p.m. GMT) today, March 13, 2017. The live webcast of the conference call will be available via the events page of Adaptimmune’s corporate website at www.adaptimmune.com. An archive will be available after the call at the same address. To participate in the live conference call, if preferred, please dial (877) 280-2296 (U.S.) or +44(0)20 3427 1912 or 0800 279 4992 (United Kingdom). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (7287304).

About Adaptimmune
Adaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products. The Company’s unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T‑cell platform enables the engineering of T-cells to target and destroy cancer, including solid tumors. Adaptimmune has a number of proprietary clinical programs, and is also developing its NY-ESO SPEAR T-cell program under a strategic collaboration and licensing agreement with GlaxoSmithKline. The Company is located in Philadelphia, USA and Oxfordshire, U.K. For more information, please visit View Source

Forward-Looking Statements
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 10, 2016, and our other SEC filings. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.

Total Liquidity Position (a non-GAAP financial measure)
Total liquidity position (a non-GAAP financial measure) is defined as cash and cash equivalents plus short-term deposits. Each of these components appears in the Consolidated Balance Sheet. The U.S. GAAP financial measure most directly comparable to total liquidity position is cash and cash equivalents as reported in the Consolidated Financial Statements.

(in thousands) December 31,
2016 December 31,
2015

Cash and cash equivalents $ 158,779 $ 194,263
Short-term deposits 22,694 54,620
Total Liquidity Position $ 181,473 $ 248,883

The Company believes that the presentation of total liquidity position provides useful information to investors because management reviews total liquidity position as part of its management of overall liquidity, financial flexibility, capital structure and leverage.

Condensed Consolidated Statement of Operations Three months ended December 31, Twelve months ended
December 31,
(unaudited, in thousands, except per share data) 2016 2015 2016 2015(1)

Revenue $ 8,536 $ 4,031 $ 14,198 $ 14,490

Research and development(2) (16,847 ) (16,619 ) (63,789 ) (40,457 )
General and administrative(2) (6,345 ) (5,513 ) (23,208 ) (17,156 )
Total operating expenses (23,192 ) (22,132 ) (86,997 ) (57,613 )
Operating loss (14,656 ) (18,101 ) (72,799 ) (43,123 )

Interest income 271 254 1,110 787
Other income (expenses), net (593 ) 1,015 1,002 2,967
Loss before income taxes (14,978 ) (16,832 ) (70,687 ) (39,369 )
Income taxes (436 ) 75 (892 ) (143 )
Net loss (15,414 ) (16,757 ) (71,579 ) (39,512 )

Deemed dividend on convertible preferred shares - - - (8,663 )
Net loss attributable to ordinary shareholders $ (15,414 ) $ (16,757 ) $ (71,579 ) $ (48,175 )

Net loss per ordinary share, basic and diluted (3) $ (0.04 ) $ (0.04 ) $ (0.17 ) $ (0.14 )

Weighted average ordinary shares outstanding,
Basic and diluted 424,720,404 424,711,900 424,713,997 337,375,528

(1) The statement of operations for the twelve months ended December 31, 2015 has been recast from our prior period financial statements to conform with our newly adopted calendar year end for comparative purposes

(2) Certain costs have been reclassified in prior periods to conform to the current period presentation. The net effect is to reduce G&A and increase R&D by $651,000 and $1,833,000 in the three and twelve months ended December 31, 2015, respectively.

(3) The dilutive effect of the following potentially dilutive equity instruments have been excluded from the diluted loss per share calculation because they would have an antidilutive effect on the loss per share for the period

Three months ended December 31, Year ended December 31,
2016 2015 2016 2015
Weighted average number of Share options 45,882,791 31,280,588 48,707,123 27,448,649

Condensed Consolidated Balance Sheets December 31, December 31,
(unaudited, in thousands) 2016 2015

Assets
Current assets
Cash and cash equivalents $ 158,779 $ 194,263
Short-term deposits 22,694 54,620
Accounts receivable, net of allowance for doubtful accounts of $- and $- 1,480 744
Other current assets and prepaid expenses (including current portion of clinical materials) 15,798 13,420
Total current assets 198,751 263,047

Restricted cash 4,017 4,508
Clinical materials 2,580 4,736
Property, plant & equipment, net 27,899 13,225
Intangibles, net 1,268 305

Total assets $ 234,515 $ 285,821

Liabilities and stockholders’ equity
Current liabilities
Accounts payable $ 11,350 $ 7,884
Accrued expenses and other accrued liabilities 17,528 7,518
Deferred revenue 11,392 12,487
Total current liabilities 40,270 27,889

Deferred revenue, non-current 24,962 22,939
Accrued expenses, non-current 3,141 -

Total liabilities 68,373 50,828

Stockholders’ equity
Common stock – Ordinary shares par value £0.001, 574,711,900 authorized and 424,775,092 issued and outstanding (2015: 574,711,900 authorized and 424,711,900 issued and outstanding) 683 682
Additional paid in capital 341,200 332,363
Accumulated other comprehensive loss (14,249 ) (8,139 )
Accumulated deficit (161,492 ) (89,913 )
Total stockholders’ equity 161,142 234,993
Total liabilities and stockholders’ equity $ 234,515 $ 285,821

Condensed Consolidated Cash Flow Statement Twelve months ended December 31,
(unaudited, in thousands) 2016 2015

Cash flows from operating activities
Net loss $ (71,579 ) $ (39,512 )
Adjustments for:
Depreciation 3,126 1,539
Amortization 160 71
Loss on disposal 122 -
Share-based compensation expense 8,821 9,858
Unrealized foreign exchange (gains) losses (1,314 ) (632 )
Changes in operating assets and liabilities:
Increase in receivables and other operating assets (6,533 ) (9,231 )
Decrease (increase) in non-current operating assets 2,221 (4,736 )
Increase in payables and deferred revenue 16,808 11,036
Net cash used in operating activities (48,168 ) (31,607 )

Cash flows from investing activities
Acquisition of property, plant & equipment (11,506 ) (12,745 )
Acquisition of intangibles (1,279 ) (210 )
Proceeds from sale of property, plant & equipment - 122
Maturity of short-term deposits 73,377 -
Investment in short-term deposits (42,837 ) (28,594 )
Net cash provided by (used in) investing activities 17,755 (41,427 )

Cash flows from financing activities
Proceeds from issuance of common stock upon initial public offering - 175,989
Proceeds from exercise of stock options 17 -
Net cash used in financing activities 17 175,989
Effect of currency exchange rate changes on cash and cash equivalents and restricted cash (5,579 ) (5,848 )
Net (decrease) increase in cash, cash equivalents and restricted cash (35,975 ) 97,107
Cash, cash equivalents and restricted cash at start of period 198,771 101,664
Cash, cash equivalents and restricted cash at end of period $ 162,796 $ 198,771