On February 27, 2018 SELLAS Life Sciences Group Inc. (Nasdaq:SLS) (SELLAS), a clinical-stage biopharmaceutical company focused on novel cancer immunotherapies for a broad range of cancer indications, reported that data from the Phase 2 trial of its lead candidate, galinpepimut-S (GPS), in acute myeloid leukemia (AML) have been published in the current issue of Blood Advances (Press release, Sellas Life Sciences, FEB 27, 2018, View Source [SID1234524259]). GPS met its pre-specified primary endpoint of ≥34% actual overall survival (OS) rate at three years with a GPS-induced OS rate of 47.4%. Median disease-free survival (DFS) from first complete response was 16.9 months, while the overall survival (OS) from diagnosis has not yet been reached, but is predicted to be > 67.6 months. GPS targets the antigen, Wilms tumor 1 (WT1) protein, which has been ranked by the National Cancer Institute as the leading target for cancer immunotherapy.

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"These data follow on prior positive data in AML and various cancer indications, supporting the development of GPS as an important potential therapy in the treatment of AML and other cancers," said Angelos Stergiou, MD, ScD h.c., President & Chief Executive Officer of SELLAS. "We are encouraged by the collective supporting evidence generated by our Phase 1 and Phase 2 AML studies. We wholeheartedly appreciate the participation of patients and their families in all our clinical studies, as well as the exceptional physicians and study teams. We look forward to advancing GPS into a Phase 3 trial in AML."

For patients in the older cohort (age >60; n=13), median OS post-diagnosis was 35.8 months. Historical controls for comparable patients over sixty years of age who reach first complete remission (CR1) show median OS since initial diagnosis of 9.5-15.8 months.

"We were especially pleased with the findings in AML patients over sixty years of age, which are important considering the poor prognosis particularly for those patients, even with optimal use of current care standards" stated Peter Maslak, M.D., Chief, Immunology Laboratory Service at Memorial Sloan Kettering Cancer Center and Principal Investigator of the study.

The open-label Phase 2 study evaluated GPS in 22 adult patients with AML (median age – 64 years) in CR1. Patients received 6 vaccinations administered over 10 weeks with the potential to receive 6 additional monthly doses if they remained in CR1. Immune responses (IR’s) were evaluated after the sixth and twelfth vaccinations by CD4+ T-cell proliferation, CD8+ T cell interferon-γ secretion (ELISPOT) or the CD8-relevant WT1 peptide MHC tetramer assay (HLA-A*02 patients only).

"Older adults with AML who achieve complete remission (CR) are in critical need of new treatment options to prevent emerging relapses, especially in cases where allogeneic stem cell transplant is infeasible or is not predicted to improve outcome," stated Gert Ossenkoppele, M.D., Ph.D., professor of Hematology at the VU University Medical Center in Amsterdam, The Netherlands, and chair of the AML working party of HOVON (Dutch-Belgian Hematology Trial Group). "Results from this GPS Phase 2 study reinforce the potential of this innovative WT1-targeting immunotherapy in the post-CR maintenance setting. I look forward to co-leading the Phase 3 study in AML patients older than 60 years, currently being planned by SELLAS." Dr. Ossenkoppele did not participate in the GPS Phase 2 study.

In the study, GPS was well tolerated, with the most common side effects being Grade 1/2 injection site reactions (46%), fatigue (32%), and skin induration (32%). Fourteen patients (64%) completed more than six vaccinations, and nine (41%) received all 12 vaccine doses. Nine of 14 tested patients (64%) had an immune response (IR) in more than one of three assays used (one for CD4 or two for CD8).

The article, "Phase 2 trial of a multivalent WT1 peptide vaccine (galinpepimut-S) in acute myeloid leukemia," is available in the current issue of Blood Advances, a peer-reviewed medical journal published by the American Society of Hematology (ASH) (Free ASH Whitepaper). The complete article can be accessed here (View Source).

On February 27, 2018 Intensity Therapeutics, Inc., a privately held biotechnology company developing proprietary cancer immune-based drug products for direct intratumoral injection, reported completion of the first safety cohort (A) of the Company’s Phase 1/2 international clinical study evaluating lead product, INT230-6 (Press release, Intensity Therapeutics, FEB 27, 2018, View Source [SID1234524349]). Following intratumoral drug injections into superficial lesions in six patients with either ovarian, thyroid, head and neck or skin cancers, there were no dose limiting toxicities. The investigators reported three drug-related, local, mild-to-moderate reversible adverse events, no drug-related series adverse events, no systemic adverse events and no procedure-related adverse events. These results were consistent with the observed low systemic exposure levels of the active agents comprising INT230-6.

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Following the review of all patient data, the Study Steering Committee (SSC) decided to initiate treatment in patients with deep tumors (cohort B1) and to increase the frequency and dose for superficial tumors (cohort E). As a result, the study has now enrolled and dosed a sentinel patient’s deep tumor, a bile duct carcinoma in the liver.

"The Study Steering Committee’s decision to initiate INT230-6 injections into the deep tumor cohort and the treatment of our first such patient are important program milestones that demonstrate significant progress," said President and CEO, Lewis H. Bender. "We will now be able to test our drug in cancers with great unmet medical need such as pancreatic, liver, cholangiocarcinoma and even glioblastoma. These conditions do not typically respond to conventional therapies and long-term patient survival is quite poor."

"We are encouraged with the preliminary safety results of INT230-6 and are pleased by the observation of necrosis in the injected tumors even at low dose," said Chief Medical Officer Ian B. Walters, MD. "Our murine studies with INT230-6 have shown our drug’s ability to stimulate a strong adaptive immune response in addition to the direct tumor killing effect. Those results also indicated a substantial benefit when our drug is given with an anti-PD-1 agent. Thus, as part of our clinical study, we have planned a cohort that combines our INT230-6 with checkpoint blockade compounds such as anti-PD-1 antibodies. Intensity Therapeutics is grateful to the volunteers participating in our study. We look forward to collecting more data on INT230-6 in different cancer types and to presenting our results at a scientific conference as soon as possible."

About INT230-6

INT230-6 is a novel, anti-cancer drug for direct intratumoral injection. The product contains potent anti-cancer agents that disperse throughout tumors and diffuse into cancer cells. INT230-6 was identified from Intensity’s DfuseRxSM platform and is being evaluated in a clinical trial; IT‑01. In preclinical studies INT230-6 administration eradicated tumors by a combination of direct tumor kill coupled with recruitment of dendritic cells to the tumor micro-environment that induced anti-cancer T-cell activation. Treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responder animals with long-term, durable protection from multiple re-inoculations of the initial cancer and resistance to other cancers.

About Study IT-01

IT-01 is entitled A Phase 1/2 Safety Study of Intratumorally Administered INT230-6 in Adult Subjects with Advanced Refractory Cancers. The trial aims to enroll approximately 60 patients with different types advanced solid tumor malignancies in a multicycle dosing regimen. The study will be conducted in multiple countries and includes a cohort combining INT230-6 with an anti-PD-1 antibody. Currently the study is recruiting in the U.S. and in Canada. The study’s primary objective is to assess the safety and tolerability of multiple intratumoral doses of INT230-6. Secondary assessments are to understand preliminary efficacy of INT230-6 by measuring the injected and bystander tumor responses. The study will characterize the systemic pharmacokinetic profile of multiple doses of INT230-6’s drug substances after single and then multiple intratumoral injections. Exploratory analysis will characterize patient outcome, as well as evaluate various tumor and anti-tumor immune response biomarkers that may correlate with response. The trial includes several adaptive components that will allow for adjustments in patient groups, dosing schedule and dose volumes administered. Data will be used to assess the progression free and overall survival in subjects receiving INT230-6. Further information can be found at www.clinicaltrials.gov (NCT#03058289).

On February 26, 2018 Quentis Therapeutics Inc., a biotechnology company pursuing next-generation immuno-oncology research and drug development, reported that it debuted with the completion of a $48 million Series A financing co-led by founding investor Versant Ventures and by Polaris Partners and the affiliated LS Polaris Innovation Fund (Press release, Quentis Therapeutics, FEB 26, 2018, View Source [SID1234524356]). The syndicate also included AbbVie Ventures, Taiho Pharmaceutical Co., Ltd., Yonghua Capital, Alexandria Venture Investments and New York Ventures, the investment arm of Empire State Development.

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Quentis is pioneering first-in-class cancer immunotherapies that modulate endoplasmic reticulum (ER) stress response pathways in the tumor microenvironment. The Series A proceeds will support the advancement of Quentis’ lead program, a small molecule IRE1α inhibitor, into the clinic in 2019 and through clinical proof-of-concept. Additional uses of the capital include developing a pipeline of preclinical programs and building out Quentis’ team.

The company was enabled by Highline Therapeutics, a Versant Ventures Discovery Engine, under an agreement with Weill Cornell Medicine through its office of Biopharma Alliances and Research Collaborations to establish New York-based spinout companies to advance breakthroughs emerging from Weill Cornell Medicine research.

Quentis’ scientific foundation is based on landmark research conducted by Laurie Glimcher, M.D., previously Dean of Weill Cornell Medicine, now President and Chief Executive Officer of Dana-Farber Cancer Institute and Professor at Harvard Medical School, and Juan Cubillos-Ruiz, Ph.D., Assistant Professor of Microbiology and Immunology in Obstetrics and Gynecology at Weill Cornell Medicine. Drs. Glimcher and Cubillos-Ruiz’s research revealed critical roles that the ER stress response plays in compromising the immune system’s ability to detect and fight cancer.

Chronic activation of the ER stress response correlates with poor outcomes in multiple tumor types, including ovarian cancer, triple-negative breast cancer, pancreatic adenocarcinoma and glioblastoma. By modulating ER stress response pathways, Quentis aims to boost a patient’s own anti-cancer immunity and enable more patients to benefit from immunotherapy. The company is pursuing multiple ER stress pathway targets in the tumor microenvironment, as well as in other diseases where ER stress plays an important role.

"We’ve witnessed great progress in our ability to harness the immune system to fight cancer. However, despite these advances, the effectiveness of immunotherapy remains limited, and many patients and many types of cancer don’t respond to treatment," said Michael Aberman, M.D., president and CEO of Quentis Therapeutics. "The scientific community continues to learn about important mechanisms, like the ER stress response, that impact cancer immunity. At Quentis, we are excited to be part of the next generation of immuno-oncology companies that are pursuing new therapeutic approaches to hopefully enable more cancer patients to benefit from immunotherapy."

Dr. Aberman continued, "We are thrilled to introduce Quentis today, and we are grateful for the dedication and support of our investors and all those who have helped us reach this important milestone. We look forward to continuing to build out our team in the coming months as we advance toward entering the clinic in 2019."

"It is profoundly gratifying to see our discoveries on the key role played by the ER stress response in inhibiting effective anti-tumor immunity translate into the advancement of potentially meaningful medicines for patients," said Dr. Glimcher, a scientific co-founder of Quentis and chair of the company’s Scientific Advisory Board. "I look forward to continuing to work closely with the Quentis team as they advance development programs toward clinical study."

"Immunotherapy is changing the face of cancer treatment, but harsh conditions within tumors inhibit the protective activity of immune cells and present an impediment to broad efficacy with immunotherapies. We’ve made important strides in understanding how aberrant ER stress responses in cancer promote immune cell dysfunction, and we continue to expand our knowledge of this novel biology," said Dr. Cubillos-Ruiz, a scientific co-founder of Quentis and member of the company’s Scientific Advisory Board. "I look forward to seeing Quentis translate this maturing knowledge in the drug development setting."

"Quentis is assembling all the necessary elements to become a leading company in the ER stress response and immuno-oncology fields," said Carlo Rizzuto, Ph.D., a partner at Versant and a Quentis board member. "We have great confidence in Michael’s ability to build the company and advance its programs to develop new treatments for patients."

In connection with the financing, Amy Schulman, partner with Polaris Partners and LS Polaris Innovation Fund, will join Dr. Rizzuto, Michael A. Foley, Ph.D., Sanders Director, Tri-Institutional Therapeutics Discovery Institute, and Dr. Aberman on Quentis’ Board of Directors.

On February 26, 2018 Exelixis, Inc. (Nasdaq: EXEL) reported financial results for the fourth quarter and full year of 2017 and provided an update on progress toward fulfilling its key corporate objectives, as well as commercial and clinical development milestones (Press release, Exelixis, FEB 26, 2018, View Source;p=RssLanding&cat=news&id=2334686 [SID1234524181]).

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Exelixis is focused on maximizing the opportunity for its two internally discovered compounds, cabozantinib and cobimetinib, to improve care and outcomes for people with cancer around the world. In 2017, the company’s top priority was continuing to execute on the launch of CABOMETYX (cabozantinib) tablets, which saw added momentum in December when the U.S. Food and Drug Administration (FDA) expanded the product’s indication to encompass all patients with advanced renal cell carcinoma (RCC). CABOMETYX generated $90.4 million and $324.0 million in net product revenue during the fourth quarter and full year of 2017, respectively. COMETRIQ (cabozantinib) capsules for the treatment of patients with progressive, metastatic medullary thyroid cancer generated an additional $5.3 million and $25.0 million in net product revenue during the fourth quarter and full year of 2017, respectively. Total revenue was $120.1 million and $452.5 million for the fourth quarter and full year of 2017, respectively.

"2017 was an important year for Exelixis, underscored by substantial progress in the commercial, clinical, regulatory and financial components of our business, all of which fuel our mission to help cancer patients recover stronger and live longer," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. "Supported by revenue from the CABOMETYX franchise, we reinvested in our business by initiating new clinical trials, planning for future studies, and taking concrete steps to build a new generation of Exelixis medicines beyond cabozantinib and cobimetinib through resuming our internal drug discovery activities and pursuing targeted business development opportunities."

Dr. Morrissey continued: "Exelixis is already off to a productive start in 2018. We continue to make progress on our supplemental New Drug Application for cabozantinib as a treatment for advanced hepatocellular carcinoma, which we expect to complete in the first quarter. And earlier this month, at ASCO (Free ASCO Whitepaper)-GU, an updated analysis from the trial evaluating cabozantinib, in combination with nivolumab or with nivolumab plus ipilimumab, demonstrated high rates of durable responses in patients with previously treated metastatic urothelial carcinoma and metastatic RCC. We also continue to expect top-line results in the first half of this year from IMblaze370, Genentech’s phase 3 pivotal trial of cobimetinib in combination with atezolizumab in advanced colorectal cancer. At the same time, other Exelixis-discovered compounds are moving forward in the hands of our partners, including esaxerenone, for which Daiichi Sankyo plans to file a Japanese regulatory application for an essential hypertension indication in the first quarter. As we move through the year, we remain deeply committed to doing all we can to help the patients we serve and are grateful for the continued support of our stockholders."

Cabozantinib Highlights

FDA Approval of CABOMETYX Tablets for Previously Untreated Advanced RCC. In December, approximately two months ahead of the assigned Prescription Drug User Fee Act (PDUFA) action date, the FDA approved CABOMETYX tablets for an expanded indication for patients with advanced RCC. The FDA’s priority review and early approval of CABOMETYX for this indication was based on results from the randomized phase 2 CABOSUN trial in patients with previously untreated RCC, which demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus sunitinib, a current standard of care.

Strong Growth in Cabozantinib Franchise Net Revenue. Cabozantinib generated $95.7 million in net product revenue during the fourth quarter of 2017, an increase of 84 percent year-over-year. Full-year 2017 net product revenue was $349.0 million, an increase of 158 percent year-over-year.

Following Positive Top-Line Results, Phase 3 CELESTIAL Data in Advanced Hepatocellular Carcinoma (HCC) Presented at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Gastrointestinal Cancers Symposium (ASCO-GI). In October, Exelixis announced the CELESTIAL trial met its primary endpoint of overall survival (OS), with cabozantinib providing a statistically significant and clinically meaningful improvement in OS compared to placebo in patients with advanced HCC who had been previously treated with sorafenib and up to one additional therapy. Detailed results of the trial were later presented in a late-breaking oral session at ASCO (Free ASCO Whitepaper)-GI in January 2018. Based on these results, Exelixis plans to submit a supplemental New Drug Application (sNDA) to the FDA in the first quarter of 2018.

Amendment to Clinical Research Protocol for Phase 1b Trial of Cabozantinib in Combination with Atezolizumab in Patients with Locally Advanced or Metastatic Solid Tumors. In January 2018, Exelixis announced an amendment to the protocol for the phase 1b trial of cabozantinib in combination with atezolizumab in patients with locally advanced or metastatic solid tumors. The amendment added four new expansion cohorts to the trial, which now includes patients with non-small cell lung cancer and castration-resistant prostate cancer, in addition to previously included patients with RCC and urothelial carcinoma (UC). The primary objective in the expansion stage of this trial remains to determine the objective response rate (ORR) in each cohort.

Cabozantinib Data at the ASCO (Free ASCO Whitepaper) 2018 Genitourinary Cancers Symposium (ASCO-GU). In February, cabozantinib was the subject of 14 presentations at the 2018 ASCO (Free ASCO Whitepaper)-GU Symposium in San Francisco. Updated results from the ongoing phase 1 trial of cabozantinib in combination with nivolumab, with or without ipilimumab, in patients with refractory genitourinary tumors were the subject of a poster presentation with the two combination regimens demonstrating an acceptable tolerability profile, and high rates of durable responses in the previously treated metastatic UC and metastatic RCC cohorts. This phase 1 trial informed the design of CheckMate 9ER, the ongoing phase 3 pivotal trial of cabozantinib plus immunotherapy in patients with previously untreated RCC that is being conducted with Bristol-Myers Squibb (BMS).

Cabozantinib Data at the 2018 Multidisciplinary Head and Neck Cancers Symposium. In February, cabozantinib was the subject of an oral presentation at this medical meeting held in Scottsdale, Arizona. Investigators presented results from the ongoing investigator-sponsored phase 2 trial of cabozantinib in patients with radioiodine-refractory differentiated thyroid carcinoma (DTC) in the first-line setting. Exelixis plans to initiate a pivotal phase 3 study with cabozantinib in patients with advanced DTC later this year.

Cobimetinib Highlights

Phase 1b Results for the Combination of Cobimetinib and Atezolizumab in Metastatic Colorectal Cancer (CRC) at ASCO (Free ASCO Whitepaper)-GI. In January 2018, updated safety and efficacy results from the Genentech-sponsored phase 1b clinical trial of cobimetinib in combination with atezolizumab in patients with metastatic CRC were presented at ASCO (Free ASCO Whitepaper)-GI. The primary objectives for the study are the evaluation of the safety and tolerability of the combination. Secondary endpoints include investigator-assessed ORR, PFS by RECIST 1.1, and OS. Initial results reported from this study at ASCO (Free ASCO Whitepaper) 2016 led to the initiation of IMblaze370 (formerly COTEZO), a phase 3 pivotal trial of the combination or atezolizumab alone versus regorafenib in patients with unresectable locally advanced or metastatic CRC, for which Genentech has guided it expects top-line results in the first half of 2018. More information about IMblaze370 is available at www.clinicaltrials.gov.

First Patient Enrolled in Phase 3 Pivotal Trial in First-Line BRAF Wild-Type Melanoma. In December, Genentech confirmed enrollment of the first patient in IMspire170, the pivotal phase 3 trial studying the combination of cobimetinib and atezolizumab versus pembrolizumab in previously untreated BRAF wild-type melanoma. In addition to this study, in January 2017, Genentech initiated IMspire150 TRILOGY, a phase 3 pivotal trial evaluating the combination of cobimetinib, vemurafenib and atezolizumab versus cobimetinib plus vemurafenib in previously untreated BRAF V600 mutation positive patients with metastatic or unresectable locally advanced melanoma.

Corporate Highlights

Exclusive Licensing Agreement with StemSynergy Therapeutics, Inc. (StemSynergy) for the Discovery and Development of Novel Anticancer Therapies. In January 2018, Exelixis announced it had entered into an exclusive collaboration and license agreement with StemSynergy for the discovery and development of novel oncology compounds targeting Casein Kinase 1 alpha (CK1α), a component of the Wnt signaling pathway implicated in key oncogenic processes. Under the terms of the agreement, Exelixis will partner with StemSynergy to conduct preclinical and clinical studies with compounds from StemSynergy’s CK1α Activator Program. Exelixis paid StemSynergy aggregate upfront payments of $3.0 million and will pay up to $3.5 million in initial research and development funding. StemSynergy will be eligible for a variety of milestone payments for the first product to emerge from the collaboration, as well as single-digit royalties on worldwide sales.

Financial Community Briefing at ASCO (Free ASCO Whitepaper)-GI. In January 2018, Exelixis and Ipsen hosted a live briefing event for the financial community to discuss cabozantinib data presented at ASCO (Free ASCO Whitepaper)-GI. The replay of the briefing is now available on the News & Events / Event Calendar page at www.exelixis.com.

Update on Partnered Program with BMS. In October, Exelixis earned a $10.0 million milestone from BMS as part of the two companies’ worldwide collaboration for compounds targeting retinoic acid-related orphan receptor (ROR), a family of nuclear hormone receptors implicated in inflammatory conditions. The milestone was triggered by BMS’ filing of a Clinical Trial Authorization in Europe for a first-in-human study of a RORγt inverse agonist.

Fourth Quarter and Full Year 2017 Financial Results

Total revenue for the quarter ended December 31, 2017 was $120.1 million, compared to $77.6 million for the comparable period in 2016. Total revenue for the year ended December 31, 2017 was $452.5 million, compared to $191.5 million for the comparable period in 2016.

Total revenue for the quarter and year ended December 31, 2017 includes net product revenue of $95.7 million and $349.0 million, respectively, compared to $51.9 million and $135.4 million for the comparable periods in 2016. The increase in net product revenue primarily reflects the growth in product sales of CABOMETYX since the product’s launch in late April 2016.

Total revenue for the quarter and year ended December 31, 2017 also includes collaboration revenue of $24.4 million and $103.5 million, respectively, compared to $25.7 million and $56.1 million for the comparable periods in 2016. Collaboration revenue includes milestones earned for the quarter and year ended December 31, 2017 of $10.0 million and $57.5 million, respectively, compared to $20.0 million and $40.0 million for the comparable periods in 2016. Additional license, development, royalty and product supply revenue was recognized from the company’s collaboration agreements totaling $14.4 million and $46.0 million for the quarter and year ended December 31, 2017, respectively, as compared to $5.7 million and $16.1 million for the comparable periods in 2016.

Research and development expenses for the quarter ended December 31, 2017 were $32.2 million, compared to $23.8 million for the comparable period in 2016. Research and development expenses for the year ended December 31, 2017 were $112.2 million, compared to $96.0 million for the comparable period in 2016. The increase in research and development expenses for both the quarter and the year were primarily a result of increases in personnel expenses, clinical trial costs and consulting and outside services. The increase in personnel-related expenses was primarily a result of increases in headcount associated with our development efforts, our internal discovery program, and our medical affairs organization. The increase in clinical trial costs was predominantly due to start-up costs associated with CheckMate 9ER and start-up costs associated with our phase 1b trial of cabozantinib and atezolizumab in locally advanced or metastatic solid tumors; those increases were partially offset by decreases in costs related to METEOR, our completed phase 3 pivotal trial comparing CABOMETYX to everolimus in patients with previously treated advanced RCC. The increase in consulting and outside services was primarily in support of the company’s discovery and medical affairs organizations.

Selling, general and administrative expenses for the quarter ended December 31, 2017 were $46.2 million, compared to $13.0 million for the comparable period in 2016. Selling, general and administrative expenses for the year ended December 31, 2017 were $159.4 million, compared to $116.1 million for the comparable period in 2016. The increase in selling, general and administrative expenses for both the quarter and the year were primarily a result of increases in personnel expenses resulting primarily from an increase in general and administrative headcount to support the company’s commercial and research and development organizations, marketing activities and an increase in losses under the collaboration agreement with Genentech. In December 2016, Genentech changed its cost allocation approach under the agreement and accordingly selling, general and administrative expenses were offset with a recovery of $23.1 million and $13.3 million, during the quarter and year ended December 31, 2016, respectively, for disputed losses that had been recognized and recorded in prior periods.

Other income (expense), net for the quarter ended December 31, 2017 was $1.5 million compared to ($3.8) million for the comparable period in 2016. Other income (expense), net for the year ended December 31, 2017 was ($7.3) million compared to ($42.1) million for the comparable period in 2016. The increase in other income (expense), net, was primarily due to a $4.5 million and $24.4 million decrease in interest expense for the quarter and year ended December 31, 2017, respectively, as compared to the comparable periods in 2016, as a result of the repayment of the Secured Convertible Notes due 2018 (Deerfield Notes) in June 2017, the repayment of the Silicon Valley Bank term loan in March 2017, and the conversions and the redemption of the 4.25% Convertible Senior Subordinated Notes due 2019 (2019 Notes) during the third and fourth quarters of 2016. Other income (expense), net was also impacted by losses on extinguishment of debt of $6.2 million associated with the repayment of the Deerfield Notes in 2017 and $13.9 million associated with conversions and the redemption of the 2019 Notes during 2016.

Net income for the quarter ended December 31, 2017 was $38.5 million, or $0.13 per share, basic and $0.12 per share, diluted, compared to $35.1 million, or $0.12 per share, basic and diluted, for the comparable period in 2016. Net income for the year ended December 31, 2017 was $154.2 million, or $0.52 per share, basic and $0.49 per share, diluted, compared to a net loss of ($70.2) million, or ($0.28) per share, basic and diluted, for the comparable period in 2016. The transition to profitability was primarily due to the increase in net product revenue, reflecting the growth in product sales of CABOMETYX since the product’s launch in late April 2016, which was supplemented by the growth in our collaboration revenue and partially offset by the increase in operating expenses.

Cash and cash equivalents, short- and long-term investments and short- and long-term restricted cash and investments totaled $457.2 million at December 31, 2017, as compared to $479.6 million at December 31, 2016.

2018 Financial Guidance

The company is providing guidance that total costs and operating expenses for the full year will be between $430 million and $460 million. This guidance includes approximately $50 million of non-cash costs and expenses related primarily to stock-based compensation expense.

Basis of Presentation

Exelixis has adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31st. For convenience, references in this press release as of and for the fiscal periods ended December 29, 2017 and December 30, 2016 are indicated as being as of and for the periods ended December 31, 2017, and December 31, 2016, respectively.

Conference Call and Webcast

Exelixis management will discuss the company’s financial results for the fourth quarter and full year of 2017 and provide a general business update during a conference call beginning at 5:00 p.m. EST / 2:00 p.m. PST today, Monday, February 26, 2018.

To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 855-793-2457 (domestic) or 631-485-4921 (international) and provide the conference call passcode 6857848 to join by phone.

A telephone replay will be available until 8:00 p.m. EST on February 28, 2018. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 6857848. A webcast replay will also be archived on www.exelixis.com for one year.

BioMarin 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, BioMarin, 2018, FEB 26, 2018, View Source [SID1234524159]).

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