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CTI BioPharma Reports Fourth Quarter and Full Year 2017 Financial Results

On March 7, 2018 CTI BioPharma Corp. (NASDAQ:CTIC) reported financial results for the fourth quarter and full year ended December 31, 2017 (Press release, CTI BioPharma, MAR 7, 2018, View Source;p=RssLanding&cat=news&id=2336850 [SID1234524503]).

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Clinical / Regulatory

In July 2017, the first patient was enrolled in PAC203, a Phase 2 clinical trial of pacritinib in patients with primary myelofibrosis who have failed prior ruxolitinib therapy and/or have thrombocytopenia, to evaluate the dose response relationship for safety and efficacy. The Company expects to complete an interim analysis of data in the second quarter of 2018, with full top-line data expected in the first quarter of 2019.
In January 2018, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a three-month extension for submitting responses to the Day 120 List of Questions (D120 LoQ) for the MAA for pacritinib. As a result of the extension, the Company anticipates submitting its response to the D120 LoQ in May 2018 and receipt of the CHMP’s opinion on the Marketing Authorization Application (MAA) in the third quarter of 2018.
In August 2017, enrollment was completed in the PIX306 Phase 3 trial of PIXUVRI (pixantrone). Top-line results are event-driven and are expected in the second quarter of 2018.
Financial and Partnerships

In February 2018, received gross proceeds of $69 million from an underwritten public offering of common stock. In June 2017, the Company received gross proceeds of $45 million through an underwritten public offering of preferred stock.
In January 2018, the Company reincorporated in the State of Delaware, triggering an automatic delisting of the Company’s common stock from the Borsa Italiana MTA exchange.
In January 2018 and again in June 2017, the Company announced that it received a $10 million milestone payment from Teva Pharmaceutical Industries Ltd. related to a regulatory approval milestone for TRISENOX.
In April 2017, the Company announced the expansion of the existing license and collaboration agreement with Servier, providing Servier with rights to PIXUVRI (pixantrone) in all markets except in the United States.
Board of Directors and Management

In September 2017, Laurent Fischer, M.D. was appointed Chairman of the Board of Directors. The Company also announced the appointment of David Parkinson, M.D. and Michael A. Metzger to the Board of Directors in 2017. Phillip M. Nudelman, Ph.D. and Jack W. Singer, M.D. resigned as members of the Board.
In March 2017, Adam Craig, M.D., Ph.D., was appointed President and CEO and a Director of the Company, succeeding Richard Love, who continues to serve on the Company’s Board. Additional management changes in 2017 included the promotion of David H. Kirske to Chief Financial Officer and Bruce J. Seeley to Chief Operating Officer.
"CTI BioPharma is now focused on the enrollment of patients in the PAC203 study of our lead compound, pacritinib, for the treatment of myelofibrosis. We are well-financed after recently completing an over-subscribed public offering of our common stock, and we believe we have sufficient cash to carry us through key clinical and regulatory milestones over the next 24 months," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. "We look forward to several key clinical and regulatory milestones in 2018, including an interim data analysis for the PAC203 study of pacritinib and top-line results in the PIX306 Phase 3 trial of PIXUVRI in the second quarter."

Fourth Quarter Financial Results

Total revenues for the fourth quarter and twelve months ended December 31, 2017, were $0.46 million and $25.1 million, respectively, compared to $9.1 million and $57.4 million for the respective periods in 2016. The decrease in total revenues for the twelve months of 2017 is primarily due to recognition of $32 million in milestone revenue related to pacritinib in the first quarter of 2016. Net product sales of PIXUVRI for the fourth quarter and twelve months ended December 31, 2017, were zero and $0.9 million, respectively, compared to $1.0 million and $4.1 million for the respective periods in 2016. The decrease in net product sales for the periods in 2017 compared to 2016, is primarily related to the April 2017 expansion of the PIXUVRI agreement with Servier under which they have rights in all markets except the United States.

GAAP operating loss for the fourth quarter and twelve months ended December 31, 2017, was $13.7 million and $39.5 million, respectively, compared to GAAP operating loss of $5.6 million and $49.2 million for the respective periods in 2016. Non-GAAP operating loss, which excludes non-cash share-based compensation expense, for the fourth quarter and twelve months ended December 31, 2017 was $12.3 million and $33.8 million, respectively, compared to non-GAAP operating loss of $3.5million and $35.8 million for the respective periods in 2016. Non-cash share-based compensation expense for the fourth quarter and twelve months ended December 31, 2017, was $1.4 million and $5.7 million, respectively, compared to $2.1 million and $13.3 million for the respective periods in 2016. The decrease in operating loss for the fourth quarter and twelve months of 2017 was due to a significant decrease in research and development and selling, general and administrative expenses primarily related to a decrease in pacritinib development costs as a result of the completion of the Phase 3 clinical studies in 2017 and a decrease in expenses for the manufacture of pacritinib and personnel costs. For information on CTI BioPharma’s use of non-GAAP operating loss and a reconciliation of such measure to GAAP operating loss, see the section below entitled "Non-GAAP Financial Measures."

Net loss for the fourth quarter of 2017 was $14.3 million, or ($0.33) per share, compared to a net loss of $6.4 million, or ($0.23) per share, for the same period in 2016. Net loss for the twelve months ended December 31, 2017, was $45.0 million, or ($1.24) per share, compared to a net loss of $52.0 million, or ($1.86) per share, for the same period in 2016.

As of December 31, 2017, cash, cash equivalents and restricted cash totaled $43.2 million, compared to $44.0 million at December 31, 2016.

Conference Call Information

CTI BioPharma management will host a conference call to review its fourth quarter and full year 2017 financial results and provide an update on business activities. The event will be held today at 1:30 p.m. PT / 4:30 p.m. ET / 10:30 p.m. CET. Participants can access the call at 1-800-289-0517 (domestic) or + +1 323-994-2084 (international). To access the live audio webcast or the subsequent archived recording, visit www.ctibiopharma.com. Webcast and telephone replays of the conference call will be available approximately two hours after completion of the call. Callers can access the replay by dialing 1-888-203-1112 (domestic) or +1 719-457-0820 (international). The access code for the replay is 2516357. The telephone replay will be available until March 14, 2018.

Conatus Pharmaceuticals Reports 2017 Financial Results and Program Updates

On March 7, 2018 – Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, reported financial results for the fourth quarter and full year ended December 31, 2017, and provided updates on its development programs (Press release, Conatus Pharmaceuticals, MAR 7, 2018, View Source [SID1234524502]).

Program Updates
In collaboration with Novartis, Conatus is conducting four randomized, double-blind, placebo-controlled Phase 2b clinical trials designed to evaluate emricasan treatment in various patient populations, including one clinical trial in patients whose transplanted livers were damaged by recurrent hepatitis C virus (HCV), and three EmricasaN, a Caspase inhibitOR, for Evaluation (ENCORE) clinical trials in patients with fibrosis or cirrhosis caused by nonalcoholic steatohepatitis (NASH):

POLT-HCV-SVR, initiated in the second quarter of 2014, in approximately 60 post-orthotopic liver transplant (POLT) recipients with liver fibrosis or cirrhosis post-transplant as a result of recurrent HCV infection who have successfully achieved a sustained viral response (SVR) following HCV antiviral therapy, with top-line results expected in the second quarter of 2018;

ENCORE-PH (for Portal Hypertension), initiated in the fourth quarter of 2016, in approximately 240 patients with compensated or early decompensated NASH cirrhosis and severe portal hypertension, with top-line results expected in the second half of 2018 followed by an integrated treatment extension period for clinical outcomes;

ENCORE-NF (for NASH Fibrosis), initiated in the first quarter of 2016, in approximately 330 patients with NASH fibrosis, with top-line results expected in the first half of 2019; and

ENCORE-LF (for Liver Function), initiated in the second quarter of 2017, in approximately 210 patients with decompensated NASH cirrhosis, with top-line results expected in the second half of 2019.
Results from the four ongoing emricasan clinical trials are expected to support the design of Phase 3 clinical efficacy and safety trials.

Pipeline Expansion Plans
Conatus may pursue the development of product candidates in liver disease and in other related disease areas. The company’s ongoing pipeline expansion activities include:

evaluation of the potential for the company’s pan-caspase inhibitor IDN-7314 as a treatment for primary sclerosing cholangitis (PSC), a disease affecting bile ducts in the liver, which can lead to cirrhosis and liver failure.

internal development of new preclinical product candidates leveraging its expertise with the caspase inhibition technology platform, and

evaluation for potential in-licensing or acquisition of external clinical-stage product candidates consistent with its product development and regulatory expertise.
Financial Results
Total revenues were $8.8 million for the fourth quarter of 2017 compared with $0.8 million for the fourth quarter of 2016, and $35.4 million for the full year 2017 compared with $0.8 million for the full year 2016. Total revenues consisted of collaboration revenues related to the Novartis agreement. The increases in revenues were a result of having a full fourth quarter and a full year of collaboration revenues in 2017 compared with 13 days of collaboration revenues in 2016.

Research and development expenses were $10.9 million for the fourth quarter of 2017 compared with $6.5 million for the fourth quarter of 2016. Research and development expenses were $43.2 million for the full year 2017 compared with $20.3 million for the full year 2016. The fourth quarter increase in research and development expenses was primarily due to the ramp up of the ENCORE-PH and ENCORE-LF clinical trials and new compound development. The full year increase in research and development expenses was primarily due to the ramp up of the ENCORE-NF, ENCORE-PH and ENCORE-LF clinical trials and new compound development.

General and administrative expenses were $2.3 million for the fourth quarter of 2017 compared with $3.5 million for the fourth quarter of 2016. General and administrative expenses were $9.7 million for the full year 2017 compared with $10.3 million for the full year 2016. The decrease in general and administrative expenses was primarily due to consulting and legal fees related to the execution of the Novartis agreement in December 2016.

The net loss for the fourth quarter of 2017 was $4.4 million compared with $9.1 million for the fourth quarter of 2016. The net loss for the full year 2017 was $17.4 million compared with $29.7 million for the full year 2016.

Cash, cash equivalents and marketable securities were $74.9 million at December 31, 2017, compared with $77.0 million at December 31, 2016, and a projected year-end 2018 balance of between $35 million and $40 million. The company believes that current financial resources, together with the anticipated reimbursements for 50% of the costs for the four ongoing clinical trials, without including any potential milestone payments under the Novartis collaboration, are sufficient to maintain operations through top-line results from all four Phase 2b clinical trials by the end of 2019, as well as to fund initial pipeline expansion activities.

Conference Call and Audio Webcast
Conatus will host a conference call and audio webcast at 4:30 p.m. Eastern Time today to discuss the financial results and provide a corporate update. To access the conference call, please dial 877-312-5857 (domestic) or 970-315-0455 (international) at least five minutes prior to the start time and refer to conference ID 7095658. A live and archived audio webcast of the call will also be available in the Investors section of the Conatus website at www.conatuspharma.com.

Clovis Oncology to Present at the Barclays Global Healthcare Conference

On March 7, 2018Clovis Oncology, Inc. (Nasdaq: CLVS) reported that Patrick J. Mahaffy, Chief Executive Officer and President, will present at the Barclays Global Healthcare Conference on Thursday, March 15, 2018 at 8:00 AM Eastern Time (Press release, Clovis Oncology, MAR 7, 2018, View Source;p=RssLanding&cat=news&id=2336864 [SID1234524501]). The conference will be held at the Loews Miami Beach Hotel in Miami.

A live webcast of the presentation can be accessed through the investor relations section of the Company’s website at www.clovisoncology.com. Following the live presentation, a replay of the webcast will be available on the Company’s website for 30 days.

Celldex Provides Corporate Update and Reports Full Year 2017 Results

On March 7, 2018 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported business and financial highlights for the fourth quarter and year ended December 31, 2017 (Press release, Celldex Therapeutics, MAR 7, 2018, View Source [SID1234524499]). The Company will host a conference call at 4:30 p.m. ET today to provide an in-depth update on its pipeline and upcoming milestones for 2018.

"2017 was a significant year for Celldex. Notably we completed enrollment in the METRIC study of glembatumumab vedotin for patients with triple negative breast cancer whose tumors overexpress gpNMB. We are hopeful that glemba will offer patients, families and caregivers a potential new option, where there are few approved therapies and none that target gpNMB, which is associated with a more aggressive form of the disease," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "We anticipate topline primary endpoint data from the study will be available in the second quarter of 2018."

"We also made considerable progress across our pipeline in the fourth quarter, including initiating the Phase 2 study of CDX-3379 in combination with Erbitux for patients with advanced head and neck squamous cell carcinoma and the Phase 1 study of CDX-1140, a CD40 agonist antibody that we believe holds great potential as an immune activating agent. Both of these antibodies are engineered to be best-in-class molecules. Recently, we completed enrollment in the glemba plus checkpoint inhibitor cohort in our Phase 2 metastatic melanoma study and also in all cohorts in the varlilumab plus Opdivo collaborative Phase 2 study with BMS. In 2018, we expect to present data across multiple programs and execute across our clinical pipeline of novel biologics to improve outcomes and change the standard of care for patients who suffer from life-threatening diseases."

Recent Highlights

Topline primary endpoint data from the METRIC study of glembatumumab vedotin in triple negative breast cancer anticipated in the second quarter of 2018: Enrollment was closed in August 2017 with 327 patients whose tumors overexpressed gpNMB. Patients were randomized 2 to 1 to either glembatumumab vedotin or to Xeloda (capecitabine). The primary endpoint of the study is progression-free survival (PFS), which is defined as the time from randomization to the earlier of disease progression or death due to any cause. The study calls for 203 progression events for evaluation of the primary endpoint, which will be assessed based on an independent, central reading of patient scans. The sum of the data, including the secondary endpoints of response rate, overall survival (OS), duration of response and safety, will be important in assessing clinical benefit. Efforts to ensure delivery of manufactured drug that is ready for commercialization and a companion diagnostic are underway. As previously disclosed, Celldex made the decision to stage some of the more costly work in these areas to begin after the Company has received results from the study. Assuming positive data, Celldex plans to work with the FDA on a regulatory strategy that would support submitting a Biologics License Application (BLA) in the second half of 2019.

Fourth arm added to glembatumumab vedotin Phase 2 study in metastatic melanoma: Enrollment has opened in a glembatumumab vedotin plus CDX-301 cohort for patients who failed checkpoint therapy. Enrollment recently completed in the glembatumumab vedotin plus checkpoint inhibitor cohort.

Enrollment complete in Phase 2 varlilumab/Opdivo collaborative study: Enrollment was completed in January 2018. Cohorts include colorectal cancer (n=21), ovarian cancer (n=58), head and neck squamous cell carcinoma (n=24), renal cell carcinoma (n=14) and glioblastoma (n=22). The primary objective of the Phase 2 cohorts is objective response rate (ORR), except glioblastoma, where the primary objective is the rate of 12-month OS. Secondary objectives include pharmacokinetic assessments, determining the immunogenicity of varlilumab when given in combination with Opdivo, evaluating alternate dosing schedules of varlilumab and further assessing the anti-tumor activity of combination treatment. Working with Bristol-Myers Squibb, data from the study will be presented at appropriate medical meetings in 2018.

Initiated Phase 2 study of CDX-3379/Erbitux in head and neck squamous cell carcinoma: In November 2017, Celldex opened enrollment to an open-label Phase 2 study in combination with Erbitux in approximately 30 patients with HPV negative, Erbitux-resistant, advanced head and neck squamous cell carcinoma. Patients must have been treated previously with an anti-PD1 checkpoint inhibitor, a population with limited options and a particularly poor prognosis. The primary objective of the study is ORR. Secondary objectives include assessments of clinical benefit rate, duration of response, PFS and OS, and safety and pharmacokinetics associated with the combination.

Ongoing Phase 1 study of CDX-014 expanded to include patients with ovarian cancer: Enrollment is ongoing in a Phase 1 study of CDX-014, an antibody-drug conjugate that targets TIM-1. The study initially enrolled patients with both clear cell and papillary renal cell carcinoma. In January 2018, we amended the protocol, expanding enrollment to include patients with ovarian clear cell carcinoma, an indication where TIM-1 expression is also upregulated, and enabling the evaluation of alternate dosing regimens. The study includes a dose-escalation portion across three separate cohorts to determine the maximum tolerated dose (MTD) followed by expansion cohorts of up to 15 patients each to assess the preliminary anti-tumor activity of CDX-014, as measured by ORR. Secondary objectives include safety and tolerability, pharmacokinetics, immunogenicity and additional measures of anti-tumor activity.

Initiated Phase 1 study of CDX-1140: A Phase 1 study of CDX-1140 was initiated in November 2017. The study is expected to enroll up to approximately 105 patients with recurrent, locally advanced or metastatic solid tumors and is designed to determine the MTD during a dose-escalation phase and to recommend a dose level for further study in a subsequent expansion phase. The expansion is designed to further evaluate the tolerability and biologic effects of selected dose(s) of CDX-1140 in specific tumor types. Secondary objectives include assessments of safety and tolerability, pharmacodynamics, pharmacokinetics, immunogenicity and additional measures of anti-tumor activity, including clinical benefit rate. The Company believes that the potential for CDX-1140 will be best defined in combination studies with other immunotherapies or conventional cancer treatments.
Fourth Quarter and Twelve Months 2017 Financial Highlights and 2018 Guidance

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2017 were $139.4 million compared to $140.5 million as of September 30, 2017. The decrease was primarily driven by fourth quarter cash used in operating activities of $19.5 million and partially offset by $18.4 million in net proceeds from sales of common stock under the Cantor agreement. At December 31, 2017, Celldex had 138.5 million shares outstanding.

Revenues: Total revenue was $3.5 million in the fourth quarter of 2017 and $12.7 million for the year ended December 31, 2017, compared to $1.9 million and $6.8 million for the comparable periods in 2016. The increase in revenue was primarily due to the manufacturing service agreements with the International AIDS Vaccine Initiative and Frontier Biotechnologies, Inc.

R&D Expenses: Research and development (R&D) expenses were $23.5 million in the fourth quarter of 2017 and $96.2 million for the year ended December 31, 2017, compared to $24.6 million and $102.7 million for the comparable periods in 2016. The decrease in R&D expenses for the year ended December 31, 2017, as compared to 2016, was primarily due to lower contract manufacturing and clinical trial costs of $9.9 million and $7.6 million, respectively, related to varlilumab and Rintega. These decreases were partially offset by increases in (i) glembatumumab vedotin contract manufacturing expenses of $2.7 million, (ii) glembatumumab vedotin, anti-KIT and CDX-3379 clinical trial costs of $3.6 million and (iii) personnel and facility costs related to the Kolltan acquisition.

G&A Expenses: General and administrative (G&A) expenses were $5.9 million in the fourth quarter of 2017 and $25.0 million for the year ended December 31, 2017, compared to $11.9 million and $36.0 million for the comparable periods in 2016. The decrease in G&A expenses for the year ended December 31, 2017, as compared to 2016, was primarily due to lower commercial planning costs of $4.5 million, lower stock-based compensation of $1.9 million and lower severance expense related to the Kolltan acquisition of $2.6 million.

In-Process Research and Development Impairment: The Company recorded a non-cash partial impairment charge of $13.0 million on the anti-KIT program IPR&D asset acquired from Kolltan during the year ended December 31, 2017 due to changes in the anti-KIT program projected development and regulatory timelines.

Income Tax Benefit: The Company recorded a non-cash income tax benefit of $24.3 million during the year ended December 31, 2017 relating to the partial impairment of the anti-KIT program IPR&D asset and the impact of the Tax Cuts and Jobs Act of 2017.

Gain on Fair Value Remeasurement of Contingent Consideration: The Company recorded a gain on the fair value remeasurement of contingent consideration related to the Kolltan acquisition of $0.8 million for the year ended December 31, 2017.

Net Loss: Net loss was $3.8 million, or ($0.03) per share, for the fourth quarter of 2017 and $93.0 million, or ($0.72) per share, for the year ended December 31, 2017, compared to a net loss of $32.3 million, or ($0.30) per share, and $128.5 million, or ($1.27) per share, for the comparable periods in 2016.

Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at December 31, 2017 combined with the (i) $6.1 million in net proceeds from sales of common stock under the Cantor agreement from January 1, 2018 through February 28, 2018 and (ii) anticipated proceeds from future sales of common stock under the Cantor agreement, are sufficient to meet estimated working capital requirements and fund planned operations through 2019. This could be impacted by clinical data results from the METRIC study and their impact on the pace of commercial manufacturing and the rate of expansion of commercial operations. This could also be impacted if Celldex elects to pay Kolltan contingent milestones, if any, in cash.

Webcast and Conference Call

Celldex executives will host a conference call at 4:30 p.m. ET today to discuss financial and business results and to provide an update on key 2018 objectives. The conference call and presentation will be webcast live over the internet and can be accessed by going to the "Events & Presentations" page under the "Investors & Media" section of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (866) 743-9666 (within the United States) or (760) 298-5103 (outside the United States). The passcode is 8296067.

A replay of the call will be available approximately two hours after the live call concludes through March 15, 2018. To access the replay, dial (855) 859-2056 (within the United States) or (404) 537-3406 (outside the United States). The passcode is 8296067. The webcast will also be archived on the Company’s website.

Xeloda is a registered trademark of Genentech, Inc. Opdivo is a registered trademark of Bristol-Myers Squibb. Erbitux is a registered trademark of Eli Lilly & Co.

Alexion to Present at the Cowen and Company 38th Annual Health Care Conference

On March 7, 2018 Alexion Pharmaceuticals (Nasdaq: ALXN) reported that management will present at the Cowen and Company 38th Annual Health Care Conference in Boston on Tuesday, March 13, 2018 at 9:20 a.m., ET (Press release, Alexion, MAR 7, 2018, http://news.alexionpharma.com/press-release/financial-news/alexion-present-cowen-and-company-38th-annual-health-care-conference [SID1234524497]).

An audio webcast of the presentation will be available live. You can access the webcast at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.