On February 8, 2018 Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing neoantigen cancer vaccines, reported that it will host a conference call and live audio webcast on Thursday, February 15, 2018 at 9:00 a.m. ET to discuss financial results for the fourth quarter and year end 2017 (Press release, Genocea Biosciences, FEB 8, 2018, View Source [SID1234523835]). Genocea management will also provide an update on the Company’s recent progress and upcoming milestones.

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Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and refer to conference ID number 7396178. To join the live webcast, please visit the investor relations section of the Genocea website at View Source

A webcast replay will be available on the Genocea website beginning approximately two hours after the event, and will be archived for 30 days.

On February 9, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that it has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) for apalutamide, an investigational, next generation oral androgen receptor (AR) inhibitor for the treatment of patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC) (Press release, Johnson & Johnson, FEB 8, 2018, View Source [SID1234523894]).

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The submission is based on data from the pivotal SPARTAN Phase 3 clinical trial which assessed the safety and efficacy of apalutamide versus placebo in men with nmCRPC who have a rapidly rising prostate specific antigen (PSA) level, despite receiving continuous androgen deprivation therapy (ADT). The SPARTAN clinical trial showed a significantly decreased risk of distant metastasis or death (definition of the primary endpoint, metastasis free survival) by 72 percent, compared to placebo in combination with ADT (HR = 0.28; 95% CI, 0.23-0.35; P < 0.0001) and improved median metastasis-free survival (MFS) by over two years (difference of 24.3 months) in patients with nmCRPC whose PSA is rapidly rising. The results were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) in San Francisco (Abstract 161). Study findings were simultaneously published in The New England Journal of Medicine.

"The results of the SPARTAN trial are the first to show that metastases can be delayed in patients with castration-resistant prostate cancer, suggesting that apalutamide could become a new standard of care for patients with high-risk non-metastatic CRPC," said Dr Simon Chowdhury, Consultant Medical Oncologist, Guy’s and St Thomas’ Hospitals, and a SPARTAN study investigator.

SPARTAN, a Phase 3, randomised, double-blind, placebo-controlled, multicenter study, enrolled 1,207 patients with non-metastatic castration-resistant prostate cancer and was conducted at 332 sites in 26 countries in North America, Europe, Asia-Pacific and Australia. Patients were randomised 2:1 to receive apalutamide in combination with androgen deprivation therapy (ADT) (n = 806), or placebo in combination with ADT (n = 401).

Apalutamide in combination with ADT decreased the risk of distant metastasis or death by 72 percent, compared to placebo in combination with ADT (HR = 0.28; 95% CI, 0.23-0.35; P < 0.0001).1 The median MFS was 40.5 months for apalutamide in combination with ADT compared to 16.2 months for placebo in combination with ADT, prolonging MFS by over two years. MFS benefit was consistently seen across all subgroups of patients.1

"At Janssen we are committed to transforming prostate cancer management. By treating earlier and delaying the cancer from spreading we aim to improve outcomes for patients with this devastating disease," said Dr Ivo Winiger-Candolfi, Oncology Solid Tumor Therapy Area Lead, Janssen-Cilag International NV. "We look forward to working with the European Medicines Agency to bring this potential new treatment option to patients in the European Union as soon as possible."

"Delaying prostate cancer from metastasising is critical. Once the cancer starts to spread, a patient’s overall health, well-being and prognosis change drastically," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head of Oncology at Janssen Research & Development, LLC. "It’s exciting to see apalutamide data at ASCO (Free ASCO Whitepaper) GU and these strong results truly underscore Janssen’s commitment to addressing unmet needs for treatment across all stages of disease progression."

In addition to significantly improving metastasis free survival, apalutamide in combination with ADT, compared to placebo in combination with ADT, demonstrated clinical improvement across all secondary endpoints, with statistically significant improvements in time to metastasis (TTM; median of 40.5 months in the apalutamide arm compared to median of 16.6 months in the placebo arm) and progression-free survival (PFS; median of 40.5 months compared to median of 14.7 months in the placebo arm). Treatment with apalutamide significantly decreased the risk of symptomatic progression by 55 percent compared with placebo (HR = 0.447; 95% CI: 0.315, 0.634; P <0.0001). Apalutamide was associated with a 30 percent risk reduction of death compared to placebo at this early interim analysis for overall survival (OS) (HR = 0.70; P = 0.07).1 In exploratory endpoints, apalutamide in combination with ADT, compared to placebo in combination with ADT, also achieved a 94 percent risk reduction in time to PSA progression (HR = 0.06; 95% CI, 0.05-0.08; P <0.0001), and a 51 percent risk reduction in second progression-free survival (PFS2) (HR = 0.49; P < 0.001). The combination of apalutamide and ADT was tolerable, with maintenance of overall health-related quality of life.

The most common Grade 3/4 treatment-emergent adverse events (TEAEs) for apalutamide in combination with ADT versus placebo in combination with ADT were rash (5.2 percent vs. 0.3 percent), fall (1.7 percent vs. 0.8 percent) and fracture (2.7 percent vs. 0.8 percent). Treatment discontinuation due to adverse events was 11 percent in the apalutamide arm compared to 7 percent in the placebo arm. Rates of serious adverse events (SAEs) were similar in the apalutamide in combination with ADT arm versus placebo in combination with ADT arm (25 percent vs. 23 percent respectively).

About Non-Metastatic Castration-Resistant Prostate Cancer

Non-metastatic castration-resistant prostate cancer (CRPC) refers to a disease stage when the cancer no longer responds to medical or surgical treatments that lower testosterone, but has not yet been discovered in other parts of the body using a bone scan or CT scan.2 Features include: lack of detectable metastatic disease; rapidly rising prostate-specific antigen while on androgen deprivation therapy (ADT) and serum testosterone level below 50 ng/dL.2 Ninety percent of patients with non-metastatic CRPC will eventually develop bone metastases, which can lead to pain, fractures and spinal cord compression.3 The relative 5-year survival rate for patients with distant stage castration sensitive or castration resistant prostate cancer is 30 percent.4,5 While it is critical to delay the onset of metastasis in patients with non-metastatic CRPC, there are currently no FDA or EMA approved treatments.6

About Apalutamide

Apalutamide is an investigational, next-generation oral androgen receptor (AR) inhibitor that blocks the androgen signaling pathway in prostate cancer cells. Apalutamide inhibits the growth of cancer cells in three ways: by preventing the binding of androgen to the AR; by stopping the AR from entering the cancer cells; and by preventing the AR from binding to the DNA of the cancer cell.

On February 8, 2018 Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, reported that it will webcast a business overview and update by Randall C. Schatzman, Ph.D., president and chief executive officer at each of the following upcoming healthcare conferences (Press release, Alder Biopharmaceuticals, FEB 8, 2018, View Source [SID1234524148]):

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Leerink Partners 7th Annual Global Healthcare Conference at 10:00 a.m. ET on Thursday, February 15, 2018 in New York, NY.

RBC Capital Markets 2018 Healthcare Conference at 9:30 a.m. ET on Wednesday, February 21, 2018 in New York, NY.
A live audio webcast of each event can be accessed on the Events & Presentations page of the Investors section of Alder’s website at View Source, or by following the link below in your web browser. An archived replay of the webcast will be available on Alder’s website for at least 30 days after the live event concludes.

Leerink Link: View Source
RBC Link: https://www.veracast.com/webcasts/rbc/healthcare2018/79104202338.cfm

On February 8, 2018 Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) reported financial results for the fourth quarter and full year of 2017. Total revenues for the full year of 2017 were $3.551 billion, a 15 percent increase compared to 2016 (Press release, Alexion, FEB 8, 2018, View Source [SID1234523813]). The negative impact of foreign currency on total revenues year-over-year was 1 percent or $28.6 million, net of hedging activities. On a GAAP basis, diluted earnings per share (EPS) for the full year of 2017 was $1.97, a 12 percent increase versus the prior year, inclusive of $286.5 million of expenses related to the previously announced restructuring activities. Non-GAAP diluted EPS for the full year of 2017 was $5.86 per share, a 27 percent increase versus the prior year.

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Total revenues in the fourth quarter were $909.7 million, a 9.5 percent increase compared to the same period in 2016. The benefit of foreign currency on total revenues year-over-year was less than 1 percent or $0.1 million, net of hedging activities. On a GAAP basis, diluted EPS in the quarter was $0.13 per share, a 68 percent decrease versus the prior year, inclusive of $95.1 million of expenses related to the previously announced restructuring activities and $45.8 million related to U.S. tax reform. Non-GAAP diluted EPS for the fourth quarter of 2017 was $1.48 per share, a 17 percent increase versus the prior year.

"2017 was a year of rapid transformation for Alexion as we continued to advance our global leadership in rare diseases and position Alexion for the future. I am proud of our accomplishments and performance in 2017, which include strengthening the leadership team and Board of Directors, achieving regulatory approvals for Soliris for the treatment of patients with gMG in the US, Europe and Japan, completing enrollment in the ALXN1210 PNH Phase 3 trials and the Soliris NMOSD Phase 3 trial, strengthening our global patent portfolio for Soliris and continuing to achieve double-digit revenue and volume growth," said Ludwig Hantson, Chief Executive Officer of Alexion. "We enter 2018 with a well-defined strategy to build long-term sustainable value for shareholders. I look forward to providing updates on our progress throughout the year."

Full Year 2017 Financial Highlights

Soliris (eculizumab) net product sales were $3,144.1 million, compared to $2,843.2 million in 2016, representing an 11 percent increase. Soliris volume increased 11 percent year-over-year.
Strensiq (asfotase alfa) net product sales were $339.8 million, compared to $209.4 million in 2016, representing a 62 percent increase. Strensiq volume increased 74 percent year-over-year.
Kanuma (sebelipase alfa) net product sales were $65.6 million, compared to $29.1 million in 2016, representing a 125 percent increase. Kanuma volume increased 136 percent year-over-year.
GAAP cost of sales was $454.2 million, inclusive of restructuring related expenses of $152.1 million, compared to $258.3 million in 2016. Non-GAAP cost of sales was $285.8 million, compared to $236.4 million in 2016.
GAAP R&D expense was $878.4 million, inclusive of restructuring related expenses of $16.3 million, compared to $757.2 million in 2016. Non-GAAP R&D expense was $736.3 million, compared to $690.0 million in 2016.
GAAP SG&A expense was $1,094.4 million, inclusive of restructuring related expenses of $10.9 million, compared to $953.0 million in 2016. Non-GAAP SG&A expense was $927.8 million, compared to $829.3 million in 2016.
GAAP income tax expense was $104.5 million, compared to $176.8 million in 2016. GAAP income tax expense includes a $45.8 million charge related to U.S. tax reform. The charge from U.S. tax reform includes a transition tax expense of $177.9 million and deferred tax expense related to the new GILTI minimum tax of $165.4 million, partially offset by the $297.5 million benefit of revaluing balance sheet taxes. Non-GAAP income tax expense was $186.7 million, compared to $182.8 million in 2016. Both GAAP and non-GAAP income tax expense for 2017 include a benefit from the conclusion of a routine IRS audit for the years 2013 and 2014.
GAAP diluted EPS was $1.97 per share, inclusive of restructuring and related expenses of $286.5 million, compared to $1.76 per share in 2016. Non-GAAP diluted EPS was $5.86 per share, compared to $4.62 per share in 2016.
Fourth Quarter 2017 Financial Highlights

Soliris net product sales were $791.9 million, compared to $748.7 million in the fourth quarter of 2016, representing a 6 percent increase. Soliris volume increased 6 percent year-over-year.
Strensiq net product sales were $95.6 million, compared to $70.5 million in the fourth quarter of 2016, representing a 36 percent increase. Strensiq volume increased 43 percent year-over-year.
Kanuma net product sales were $21.9 million, compared to $11.0 million in the fourth quarter of 2016, representing a 99 percent increase. Kanuma volume increased 82 percent year-over-year.
GAAP cost of sales was $144.6 million, inclusive of restructuring related expenses of $69.1 million, compared to $67.6 million in the same quarter last year. Non-GAAP cost of sales was $72.5 million, compared to $62.3 million in the same quarter last year.
GAAP R&D expense was $265.0 million, inclusive of restructuring related expenses of $15.3 million, compared to $205.9 million in the same quarter last year. Non-GAAP R&D expense was $188.6 million, compared to $186.1 million in the same quarter last year.
GAAP SG&A expense was $296.4 million, inclusive of restructuring related expenses of $4.5 million, compared to $258.5 million in the same quarter last year. Non-GAAP SG&A expense was $245.2 million, compared to $234.0 million in the same quarter last year.
GAAP income tax expense was $59.3 million, compared to $11.7 million in the same quarter last year, driven primarily by the $45.8 million charge related to U.S. tax reform. Non-GAAP income tax expense was $46.8 million, compared to $37.7 million in the same quarter last year.
GAAP diluted EPS was $0.13 per share, inclusive of restructuring and related expenses of $95.1 million, compared to $0.41 per share in the same quarter last year. Non-GAAP diluted EPS was $1.48 per share, compared to $1.26 per share in the fourth quarter of 2016.
Board of Directors Update

In the last six months, Alexion has appointed four new independent directors with deep biopharmaceutical experience to its Board of Directors: Deborah Dunsire, M.D., Paul A. Friedman, M.D., Francois Nader, M.D. and Judith Reinsdorf, J.D. Alexion also previously announced that Directors M. Michele Burns, Alvin S. Parven and Ann M. Veneman, J.D. have advised the Board that they do not plan to stand for re-election at the Company’s next annual meeting of shareholders.

Research and Development

Complement Portfolio Updates

Soliris (eculizumab)- Generalized Myasthenia Gravis (gMG): In December 2017, the Ministry of Health, Labour and Welfare (MHLW) in Japan approved Soliris as a treatment for patients with gMG who are anti-acetylcholine receptor (AchR) antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin (IVIG) therapy or plasmapheresis (PLEX).

Soliris (eculizumab)- Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD): Enrollment is complete in the PREVENT study, a single, multinational, placebo-controlled Phase 3 trial of Soliris in patients with NMOSD. Alexion expects to report data in mid-2018.

ALXN1210- Paroxysmal Nocturnal Hemoglobinuria (PNH): Enrollment is complete in a Phase 3 trial comparing ALXN1210 administered intravenously every eight weeks to Soliris in complement inhibitor treatment-naive patients with PNH and in a Phase 3 PNH Switch study of ALXN1210 administered intravenously every eight weeks compared to patients currently treated with Soliris. Alexion expects to report data from these studies in the second quarter of 2018.

ALXN1210- Atypical Hemolytic Uremic Syndrome (aHUS): Enrollment and dosing are ongoing in a Phase 3 trial with ALXN1210 administered intravenously every eight weeks in complement inhibitor treatment-naive adolescent and adult patients with aHUS. Enrollment is expected to be complete in the second quarter of 2018 and Alexion expects to report data from this study in the fourth quarter of 2018. Enrollment and dosing are also ongoing in a Phase 3 trial of ALXN1210 in pediatric patients with aHUS.

ALXN1210- Subcutaneous: Alexion plans to initiate in late 2018 a single, PK-based Phase 3 study of ALXN1210 delivered subcutaneously once per week to support registration in PNH and aHUS. In December 2017, Alexion entered into a collaboration and license agreement with Halozyme Therapeutics, Inc. that enables the Company to use Halozyme’s ENHANZE drug-delivery technology in the development of subcutaneous formulations for its portfolio of products, including a next-generation subcutaneous formulation of ALXN1210 to potentially further extend the dosing interval to once every two weeks or once per month.

2018 financial guidance assumes the following:

A foreign currency benefit, net of hedging activities, of $45 million to $55 million
Unfavorable Soliris revenue impact of $90 million to $110 million from ALXN1210 and other clinical trial recruitment versus prior year
GAAP effective tax rate of 15 to 17 percent; non-GAAP effective tax rate of 16 to 18 percent (both inclusive of Alexion’s provisional assessment of the impact of U.S. tax reform)
Alexion’s financial guidance is based on current foreign exchange rates net of hedging activities and does not include the effect of business combinations, license and collaboration agreements, asset acquisitions, intangible asset impairments, changes in fair value of contingent consideration or restructuring and related activity outside of the previously announced activities that may occur after the day prior to the date of this press release.

Alexion expects to incur additional restructuring and related expenses of approximately $30 million to $70 million related to the 2017 restructuring activities. As the Company continues to execute its strategic business plan and global footprint, it may incur restructuring expenses in 2018 that are materially different from the current estimate.

Conference Call/Webcast Information:

Alexion will host a conference call/audio webcast to discuss the fourth quarter and full year 2017 results, at 10:00 a.m. Eastern Time. To participate in the call, dial 800-239-9838 (USA) or 323-794-2551 (International), passcode 7453141 shortly before 10:00 a.m. Eastern Time. A replay of the call will be available for a limited period following the call. The replay number is 888-203-1112 (USA) or 719-457-0820 (International), passcode 7453141. The audio webcast can be accessed on the Investor page of Alexion’s website at: View Source

On February 8, 2018 Immunomedics, Inc. (NASDAQ:IMMU) ("Immunomedics" or the "Company") reported financial results for the second quarter ended December 31, 2017 (Press release, Immunomedics, FEB 8, 2018, View Source [SID1234523837]). The Company also highlighted recent key progress and planned activities for its sacituzumab govitecan program. Please refer to the Company’s Quarterly Report on Form 10-Q filed today with the SEC for more details on the Company’s financial results.

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Michael Pehl, President and Chief Executive Officer, stated, "We made significant progress this quarter, taking the necessary steps to bring sacituzumab govitecan to market and achieving our vision of becoming a fully-integrated biopharmaceutical company. In December at the San Antonio Breast Cancer Symposium, we presented exciting Phase 2 results with sacituzumab govitecan, which were met with enthusiasm by clinicians around the world. The strength of the clinical profile of the sacituzumab govitecan program was recognized by Royalty Pharma, leading to an investment of $250 million and providing the necessary financial resources to carry out our strategic plan."

"We continue to work diligently on our BLA to be submitted to the FDA for accelerated approval," added Pehl. "I am pleased with the overall progress across clinical and manufacturing work streams, including successful validation runs. Our focus continues to be on compiling a BLA package that efficiently brings sacituzumab govitecan to market, and one that anticipates and addresses potential FDA requests going forward. As such, we now expect to file the BLA by the end of May 2018."

During the quarter, Immunomedics continued to expand its leadership team with the appointment of Dr. Morris Rosenberg as Chief Technology Officer. Dr. Rosenberg was previously responsible for overseeing manufacturing at Seattle Genetics for over 11 years and was instrumental in the development of Seattle Genetics’ ADC supply chain and the launch of Adcetris in 2011. Dr. Rosenberg has been a key consultant to Immunomedics for the past nine months, focusing on building an outstanding team and preparing for commercial launch, including a robust CMC package for BLA submission.

"Immunomedics’ compelling science, technological resources, and the strength of the leadership team is the right recipe for groundbreaking innovation at the Company," said Dr. Morris Rosenberg, Chief Technology Officer. "I am pleased to be joining a team that is building outstanding clinical, manufacturing and commercial infrastructure and taking so many meaningful steps toward effectively treating patients with significant unmet medical needs."

Recent Highlights

In December 2017, Immunomedics presented updated results of sacituzumab govitecan in mTNBC in an oral presentation during the 2017 San Antonio Breast Cancer Symposium. In 110 patients with relapsed or refractory mTNBC, an objective response rate of 31% and a median duration of response of 9.1 months was determined by an adjudication team of radiologists after a blinded, independent review.

In January 2018, as part of the Company’s strategy to broaden the development of sacituzumab govitecan in difficult to treat solid tumors beyond mTNBC and advanced urothelial cancer, Immunomedics announced a collaboration with the Carbone Cancer Center at the University of Wisconsin, to evaluate sacituzumab govitecan in patients with advanced prostate cancer in an investigator-sponsored Phase 2 trial.

In January 2018, Immunomedics announced a $250 million royalty funding and stock purchase agreement with Royalty Pharma. Immunomedics has agreed to sell tiered, sales-based royalty rights on global net sales of sacituzumab govitecan to Royalty Pharma for $175 million and Royalty Pharma has purchased $75 million in common stock of the Company. This transaction provides for sufficient cash to fund operations into 2020.
Key 2018 Objectives

Continue execution of the confirmatory Phase 3 ASCENT study in third line+ mTNBC; activation of first European centers is expected in the first half of 2018.

Continue development in mTNBC setting with PARP and/or PD-1/PD-L1 inhibitors.

Establish sacituzumab govitecan as a foundational therapy in advanced urothelial cancer, both as monotherapy and in combination.

Define registration and commercialization strategy in Europe; ensure the appropriate balance between bringing sacituzumab govitecan to patients as fast as possible while securing favorable reimbursement.

Establish commercial presence and ensure launch readiness for sacituzumab govitecan upon approval in mTNBC.

Second Quarter Fiscal 2018 Results

Total revenues for the quarter ended December 31, 2017, were $0.6 million, compared to $0.4 million for the same quarter last fiscal year, an increase of 55% due primarily to a $0.2 million increase in LeukoScan product sales in Europe. The Company intends to discontinue the sale of LeukoScan during the third quarter of fiscal 2018 to focus exclusively on its oncology portfolio of antibody-drug conjugates, unlabeled antibodies and immuno-oncology investigational products.

Total costs and expenses for the quarter ended December 31, 2017 were $30.0 million, compared to $15.7 million for the same quarter last fiscal year, an increase of $14.3 million, or 91% due primarily to a $12.8 million increase in research and development expenses including a $6.9 million increase in human resources and consulting costs to prepare for the regulatory submission and commercial launch of sacituzumab govitecan for patients with mTNBC and a $5.9 million increase related to the initiation of the Phase 3 ASCENT clinical trial for mTNBC.

The Company recognized $26.8 million in non-cash income during the quarter ended December 31, 2017, compared to $7.2 million in non-cash expense for the same quarter last fiscal year, a $34.0 million decrease in non-cash cost due to the decrease in the fair value of warrant liabilities.

Interest expense related to the 4.75% Convertible Senior Notes due 2020 was $0.3 million for the quarter ended December 31, 2017, compared to $1.4 million for the same quarter last fiscal year, a decrease of $1.1 million, or 79% due primarily to the accelerated exchange of $80 million Convertible Senior Notes for equity on September 21, 2017. Interest expense includes the amortization of debt issuance costs of $0.1 million and $0.2 million for the quarters ended December 31, 2017 and December 31, 2016, respectively.

Net loss attributable to stockholders was $2.5 million, or $0.02 per share, for the quarter ended December 31, 2017, compared to $24.4 million, or $0.23 per share, for the same quarter last fiscal year, a decrease of $21.9 million due primarily to the $34.0 million decrease in non-cash cost from the decrease in the fair value of warrant liabilities, offset partially by the $14.3 million increase in costs and expenses.

First Half Fiscal 2018 Results

Total revenues for the six months ended December 31, 2017, were $1.3 million, compared to $1.1 million for the same period last fiscal year, an increase of 18% due primarily to a $0.2 million increase in LeukoScan product sales in Europe.

Total costs and expenses for the six-month period ended December 31, 2017 were $52.3 million, compared to $31.4 million for the same period last fiscal year, an increase of 67% due primarily to a $15.5 million increase in research and development expenses resulting from an $8.2 million increase in consulting and contract services costs, a $5.7 million increase in costs related to initiating the Phase 3 ASCENT clinical trial, and a $1.7 million increase in labor related costs in connection with the preparation of the regulatory submission and commercial launch of sacituzumab govitecan. General and administrative expenses increased $4.0 million compared to the same period in the previous year, due primarily to a $2.1 million increase in legal and advisory fees associated with the proxy contest, and a $1.4 million increase in labor related costs.

The Company recognized $59.6 million in non-cash expense during the six-month period ended December 31, 2017, compared to $7.2 million in the same period in fiscal 2017, an increase of $52.4 million due to the increase in the fair value of warrant liabilities. The Company also recognized a $13.0 million non-cash loss on induced exchanges of $80 million of Convertible Senior Notes for equity.

Interest expense related to the Convertible Senior Notes was $2.9 million for the six-month period ended December 31, 2017, compared to $2.7 million for the same period last year, an increase of $0.2 million due primarily to a $1.4 million increase in the amortization of debt issuance costs offset partially by a $1.2 million reduction in interest expense related to the reduction in principal from the accelerated exchange of Convertible Senior Notes.

During the six-month period ended December 31, 2017, the Company received a $4.4 million insurance reimbursement related to legal costs incurred during the Company’s proxy contest in fiscal year 2017.

Net loss attributable to stockholders was $121.3 million, or $0.88 per share, for the six-month period ended December 31, 2017, compared to $40.6 million, or $0.41 per share for the same period last fiscal year, an increase of $80.7 million due primarily to the $52.4 million increase in non-cash expense, the $20.9 million increase in costs and expenses, and the $13.0 million non-cash loss on induced exchanges of debt, offset partially by the receipt of $4.4 million insurance reimbursement.

Cash, cash equivalents, and marketable securities totaled $139.7 million as of December 31, 2017.

"The $250 million funding from Royalty Pharma combined with our cash balance as of December 31, 2017 provides us with the resources required to support our next phase of growth as we focus on developing sacituzumab govitecan in mTNBC, advanced urothelial cancer and other indications of high unmet medical need, further building our clinical, medical affairs, commercial and manufacturing infrastructure and continuing operations into 2020," according to Michael R. Garone, Vice President Finance and Chief Financial Officer.

Conference Call
The Company will host a conference call and live audio webcast today at 5:00 p.m. Eastern Time to discuss financial results for the second quarter of fiscal year 2018, and review key clinical developments and planned activities. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 1988406. The conference call will be webcast via the Investors page on the Company’s website at View Source Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company’s website for approximately 30 days.