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Lipocine Announces Financial and Operational Results for the Year Ended December 31, 2018

On March 6, 2019 Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, reported financial results for the year ended December 31, 2018 (Press release, Lipocine, MAR 6, 2019, View Source [SID1234534017]).

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Fourth Quarter 2019 and Recent Corporate Highlights

·Currently conducting an ABPM clinical study to assess TLANDO’s effect on blood pressure, if any. The study has enrolled 138 subjects and results are currently expected before the end of the first quarter of 2019.
·The Patent Trial and Appeal Board ("PTAB") of the United States Patent and Trademark Office ("PTO") granted Lipocine’s Priority Motion in the interference case with Clarus Therapeutics, and entered adverse judgment against Clarus. The PTAB ruling cancels all claims of the Clarus 8,828,428 patent. Clarus has filed an appeal of the PTAB judgement to the Court of Appeals for the Federal Circuit.
·Successfully completed a definitive phlebotomy study which supports the reliability of TLANDO clinical measurements conducted in the Phase 3 trials.
·Data from clinical trials of LPCN 1144 in potential non-alcoholic fatty liver disease ("NAFLD") patients were presented at the NASH-TAG Conference, January 2019, in Park City, UT.
·Data highlighting the association of hypogonadism and NAFLD and interim liver fat reductions with LPCN 1144 treatment were presented at the Keystone Symposia on Integrated Pathways of Disease in non-alchoholic steatohepatitis ("NASH") and NAFLD, January 2019 in Santa Fe, NM.
·Interim results from an ongoing sixteen-week Liver Fat Imaging study demonstrated meaningful liver fat reduction in patients treated with LPCN 1144. Liver fat changes were assessed using magnetic resonance imaging, proton density fat fraction ("MRI-PDFF") technique, a non-invasive quantitative biomarker of liver fat content.
oTreatment results showed post-treatment absolute and relative mean reductions in liver fat of 7.6% and 38%, respectively, from baseline levels.
oSixteen-week results from the study are currently expected before the end of the first quarter of 2019.
·Received clearance by U.S. Food and Drug Administration ("FDA") for an Investigational New Drug ("IND") application to initiate a Phase 2 clinical study of LPCN 1144 in patients with biopsy confirmed NASH.

Year Ended December 31, 2018 Financial Results

Lipocine reported a net loss of $11.7 million, or ($0.55) per diluted share, for the year ended December 31, 2018, compared with a net loss of $21.0 million, or ($1.05) per diluted share, in the year ended December 31, 2017.

Research and development expenses were $6.5 million for the year ended December 31, 2018, compared with $11.0 million for the year ended December 31, 2017. The decrease in research and development expenses year over year was primarily due to reduced costs associated with TLANDO which include decreased contract research organization expenses, decreased contract manufacturing expenses and decreased outside services and consulting costs. Additionally, there were significant decreases in contract manufacturing expenses associated with LPCN 1107.

General and administrative expenses were $5.3 million for the year ended December 31, 2018, compared with $10.2 million for the year ended December 31, 2017. The decrease in general and administrative expenses year over year was primarily due to decreased personnel costs related to an overall reduction in headcount resulting in lower stock compensation expense, bonus expense, and salary and related benefit costs in 2018. Additionally, expenses for pre-commercialization marketing and sales activities related to TLANDO decreased significantly.

As of December 31, 2018, the Company had unrestricted cash, cash equivalents and marketable securities aggregating $15.3 million, compared to $21.4 million at December 31, 2017.

Supernus to Present at the 2019 Cowen Health Care Conference

On March 6, 2019 Supernus Pharmaceuticals, Inc. (NASADQ: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, reported that the Company’s management will present an overview and Company update as well as host investor meetings at the 39th Annual Cowen Health Care Conference (Press release, Supernus, MAR 6, 2019, View Source [SID1234534016]).

Date: Wednesday, March 13, 2019

Time: 9:20 a.m. ET

Place: The Boston Marriott Copley Place, Boston, Mass.

Investors interested in arranging a meeting with the Company’s management during this conference should contact the conference coordinator.

A live webcast of the presentation can be accessed by visiting ‘Events & Presentations’ in the Investors Relations section on the Company’s website at www.supernus.com. An archived replay of the webcast will be available for 60 days on the Company’s website after the conference.

Zymeworks Reports 2018 Year-End Financial Results

On March 6, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported financial results for the year ended December 31, 2018 (Press release, Zymeworks, MAR 6, 2019, View Source [SID1234534014]).

"Over the past year, we have made significant progress advancing our own pipeline while our partners continued developing their assets using our technology," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "Our lead program, ZW25, continued to generate impressive clinical data and our second product candidate, ZW49, recently began a Phase 1 clinical trial. We also established our seventh and eighth pharmaceutical partnerships while our long-term partner, Eli Lilly, advanced two of their Azymetric bispecifics into the clinic."

Dr. Tehrani continued, "We entered 2019 with $200 million on our balance sheet, which will enable us to aggressively expand our clinical activities, and we look forward to providing updates throughout the year."

2018 Business Highlights and Recent Developments

ZW49 Investigational New Drug Application Accepted; Phase 1 Trial Underway
Zymeworks’ second product candidate, ZW49, a novel biparatopic HER2-targeted antibody drug conjugate (ADC), received clearance for a Phase 1 first-in-human clinical trial, which has begun enrollment in the United States.
Expanded Global Clinical Development for ZW25 and ZW49
Zymeworks expanded the ZW25 clinical trial into South Korea and also entered into a licensing agreement and collaboration with BeiGene to leverage their resources and expertise to accelerate the development of ZW25 and ZW49 in the Asia Pacific region (Zymeworks continues to own all rights in Japan).
Partner’s Programs Progress into the Clinic
Eli Lilly advanced two Azymetric immune-oncology bispecifics into the clinic triggering milestone payments to Zymeworks. Zymeworks currently has eight active collaborations that offer up to US$7.6 billion in potential milestone payments plus royalties.
Financial Results for the Year Ended December 31, 2018

Revenue in 2018 was $53.0 million as compared to $51.8 million in 2017. Revenue for both years was primarily comprised of non-recurring upfront fees, expansion payments and milestone payments from the Company’s licensing and collaboration agreements. Revenue for 2018 included: recognition of $23.5 million out of the $60.0 million upfront fee from BeiGene associated with a new licensing agreement; an $18.0 million upfront fee related to a second licensing agreement with Daiichi Sankyo; a $5.0 million upfront fee related to a new licensing agreement with LEO Pharma; a $4.0 million research program expansion fee from Celgene; a $2.0 million development milestone payment from Eli Lilly, and $0.5 million in research support payments from various collaborators. Revenue for 2017 included a $50.0 million upfront fee from Janssen and a $1.0 million milestone payment from Daiichi Sankyo, as well as $0.8 million in research support payments.

For the year ended December 31, 2018, research and development expenses were $56.7 million as compared to $41.7 million in the prior year. The change was primarily due to an increase in activities related to ZW25 clinical studies and associated manufacturing costs, as well as development activities for ZW49. There were also additional research and development activities, resulting in incremental headcount-related expense and non-cash stock-based compensation expense. Research and development expenses included non-cash stock-based compensation expense of $2.2 million from equity classified equity awards and a $2.0 million expense related to the non-cash mark-to-market revaluation of certain historical liability classified equity awards.

For the year ended December 31, 2018, general and administrative expenses were $29.5 million as compared to $18.6 million in the prior year. The change was primarily due to an increase in non-cash liability classified equity adjustments and stock-based compensation, as well as other increases in compensation and professional fees associated with year-on-year corporate growth. General and administrative expense included non-cash stock-based compensation expense of $3.7 million from equity classified equity awards and $5.4 million expense related to the non-cash mark-to-market revaluation of certain historical liability classified equity awards.

The net loss for the year ended December 31, 2018, was $36.6 million as compared to $10.4 million in 2017, primarily due to an increase in research and development expenses associated with our lead therapeutic candidates and other programs, general and administrative expenses, and the accounting impact of an increase of $6.9 million related to the non-cash mark-to-market revaluation of certain historical liability classified equity awards.

Zymeworks expects research and development expenditures to increase over time due to the ongoing development of product candidates and other clinical, preclinical, and regulatory activities. Additionally, Zymeworks anticipates continuing to receive revenue from its existing and future strategic partnerships, including technology access fees and milestone-based payments. However, Zymeworks’ ability to receive these payments is dependent upon either Zymeworks or its collaborators successfully completing specified research and development activities.

As of December 31, 2018, Zymeworks had $200.2 million in cash and cash equivalents and short-term investments.

Stemline Therapeutics to Present at the Cowen and Company 39th Annual Health Care Conference

On March 6, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that Ivan Bergstein, M.D., Stemline’s CEO, will present at the Cowen and Company 39th Annual Health Care Conference on Monday, March 11, 2019 at 4:50 PM ET at the Marriott Copley Place in Boston, MA (Press release, Stemline Therapeutics, MAR 6, 2019, https://ir.stemline.com/news-releases/news-release-details/stemline-therapeutics-present-cowen-and-company-39th-annual [SID1234534013]). A live webcast of the presentation can be viewed on the company’s website at www.stemline.com.

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, and other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About ELZONRIS
ELZONRIS (tagraxofusp), a CD123-directed cytotoxin, was approved by the Food and Drug Administration (FDA) on December 21, 2018 for the treatment of adult and pediatric patients, two years and older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In November 2018, the European Medicines Agency (EMA) granted ELZONRIS accelerated assessment to the marketing authorization application (MAA), which was submitted to, and validated by, the EMA in January 2019. ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).

Ophthotech to Present at the Cowen and Company 39th Annual Health Care Conference

On March 6, 2019 Ophthotech Corporation (Nasdaq: OPHT) reported that Kourous A. Rezaei, M.D., Chief Medical Officer of Ophthotech, will present an overview of the Company at the Cowen and Company 39th Annual Health Care Conference in Boston, MA, on Wednesday, March 13, 2019 at 9:20 a.m. Eastern Time (Press release, Ophthotech, MAR 6, 2019, https://investors.ophthotech.com/news-releases/news-release-details/ophthotech-present-cowen-and-company-39th-annual-health-care [SID1234534011]).

Investors and the general public are invited to listen to a live webcast of the presentation on the Events & Presentations section on the Ophthotech website at www.ophthotech.com. An archived replay of the webcast will be available on the website for 14 days after the conference.