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MEI Pharma Reports Second Quarter Fiscal Year 2018 Results

On February 8, 2018 MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, reported results for its second quarter ended December 31, 2017 (Press release, MEI Pharma, FEB 8, 2018, View Source [SID1234523844]).

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"We continue to build on the progress we reported last quarter with important advances in the clinical development programs across our pipeline," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "Already in 2018, the Food and Drug Administration cleared the Investigational New Drug Application for voruciclib, and pracinostat was awarded Orphan Drug Designation from the European Medicines Agency for the treatment of acute myeloid leukemia."

Dr. Gold added: "In the coming months we look forward to separate data readouts in three programs: pracinostat’s stage 1 of a Phase 2 dose-optimization study in myelodysplastic syndrome (MDS); ME-401’s single agent safety and efficacy in relapsed/refractory chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL); and ME-344’s interim results from a proof-of-concept study in combination with bevacizumab (marketed as Avastin) in human epidermal growth factor receptor 2 (HER2) negative breast cancer. In addition, we look forward to the initiation of our Phase 1 single-agent study with voruciclib in relapsed/refractory B lymphocyte malignancies."

Recent Program Highlights

Pracinostat

In January 2018, the European Medicines Agency granted Orphan Drug Designation to pracinostat, currently in a Phase 3 study in combination with azacitidine for the treatment of acute myeloid leukemia (AML) in adult patients unfit to induction chemotherapy.
MEI-401

In November 2017, the safety review committee found no dose limiting toxicities in the 180mg cohort again with a response rate in excess of 50%. We determined that no further dose escalation was required and we amended the Phase 1b study protocol to open a 45 mg lower dose cohort as well as an additional arm to evaluate the safety and efficacy of ME-401 in combination with rituximab (marketed as Rituxan) in patients with various B cell malignancies.
Voruciclib

In January 2018, the U.S. Food and Drug Administration cleared the company’s Investigational New Drug Application (IND) for voruciclib. Under this IND, MEI Pharma plans to initiate a Phase 1 study designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of voruciclib in patients with B-cell malignancies.
In December 2017, a preclinical study of voruciclib was published in the journal Nature Scientific Reports. Researchers found that the combination of voruciclib plus the BCL-2 inhibitor venetoclax (marketed as Venclexta) was capable of inhibiting two master regulators of cell survival, MCL-1 and BCL-2, and achieved synergistic antitumor efficacy in an aggressive subset of Diffuse Large B-cell Lymphoma (DLBCL).
Upcoming Milestones

Pracinostat

Expecting results from stage 1 of a Phase 2 dose-optimization study in MDS in the second quarter of 2018.
ME-401

Expecting results from a Phase 1b study in relapsed/refractory CLL and FL to be presented at a scientific meeting in the second quarter of 2018.
Voruciclib

Expecting to initiate a Phase 1 single-agent study in relapsed/refractory B cell malignancies and subsequently in a combination study with venetoclax (marketed as Venclexta) in the second quarter of 2018.
ME-344

Expecting interim results from the Phase 1 study in HER2 negative breast cancer in combination with bevacizumab (marketed as Avastin) in the second quarter of 2018.
Financial Highlights

As of December 31, 2017, MEI Pharma had $42.4 million in cash, cash equivalents and short-term investments, with no outstanding debt. The Company believes its cash position will be sufficient to fund operations into calendar year 2019.
Cash used in operating activities was $11.3 million for the six months ended December 31, 2017, compared to cash provided by operating activities of $5.0 million for the six months ended December 31, 2016. Included in cash expenditures for the six months ended December 31, 2017 was $1.9 million cash paid for the acquisition of voruciclib. Included in the cash provided by operating activities in the six months ended December 31, 2016 was the $15.0 million upfront payment from Helsinn for pracinostat.
Research and development expenses, including cost of research and development revenue, were $4.2 million for the three months ended December 31, 2017, compared to $3.4 million for the three months ended December 31, 2016. The increase was primarily due to the acquisition of voruciclib and increased costs for ME-401, offset by a reduction in expenses related to pracinostat.
General and administrative expenses were $2.4 million for the three months ended December 31, 2017, compared to $2.0 million for the three months ended December 31, 2016. The increase was primarily due to professional service costs incurred in the three months ended December 31, 2017 related to the Presage license agreement.
Revenues were $0.4 million for the three months ended December 31, 2017, compared to $17.2 million in the three months ended December 31, 2016. The decrease was related to activities performed pursuant to the Helsinn license agreement.
Net loss was $6.1 million, or $0.16 per share, for the three months ended December 31, 2017, compared to net income of $11.9 million, or $0.32 per share for the three months ended December 31, 2016.

Johnson & Johnson to Participate in the 2018 CAGNY Conference

On February 8, 2018 Johnson & Johnson (NYSE: JNJ) reported that it will participate in the 2018 CAGNY Conference on Thursday, Feb. 22, at The Boca Raton Resort, Boca Raton, FL. Jorge Mesquita, Executive Vice President, Worldwide Chairman, Consumer and Alison Lewis, Chief Marketing Officer, Consumer will represent the Company in a session scheduled at 2:00 p.m. (Eastern Time) (Press release, Johnson & Johnson, FEB 8, 2018, View Source [SID1234523842]).

This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.

A webcast and podcast replay will be available approximately two hours after the live webcast.

Immunomedics Announces Second Quarter Fiscal 2018 Results and Provides Corporate Update

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.

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.

Genocea to Host Fourth Quarter and Year End 2017 Financial Results Conference Call & Webcast on February 15, 2018 at 9 a.m. ET

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.

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.

Five Prime Therapeutics to Present at LEERINK Partners 7th Annual Global Healthcare Conference

On February 8, 2018 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, reported that Aron Knickerbocker, Chief Executive Officer, will present at the LEERINK Partners 7th Annual Global Healthcare Conference, Feb. 14, 2018, at 11:30 am ET (Press release, Five Prime Therapeutics, FEB 8, 2018, View Source [SID1234523833]).

The presentation will be webcast and may be accessed at the "Events & Presentations" section of the Company’s website at View Source or directly at View Source Five Prime will maintain an archived replay of the webcast on its website for 30 days after the conference.