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Fate Therapeutics to Webcast Conference Call Reporting First Quarter 2018 Financial Results

On May 3, 2018 Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that the Company will host a conference call and live audio webcast on Thursday, May 10, 2018 at 5:00 p.m. ET to report its first quarter 2018 financial results and provide a corporate update (Press release, Fate Therapeutics, MAY 3, 2018, http://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-webcast-conference-call-reporting-first-3 [SID1234526070]).

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In order to participate in the conference call, please dial 877-303-6235 (domestic) or 631-291-4837 (international) and refer to conference ID 5592629. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

Emergent BioSolutions Reports First Quarter 2018 Financial Results

On May 3, 2018 Emergent BioSolutions Inc. (NYSE:EBS) reported financial results for the quarter and three months ended March 31, 2018 (Press release, Emergent BioSolutions, MAY 3, 2018, View Source;p=RssLanding&cat=news&id=2346979 [SID1234526068]).

Q1 2018 AND RECENT BUSINESS ACCOMPLISHMENTS

Procurement Contract

Awarded a contract valued at up to $26 million over 12 months by the Centers for Disease Control and Prevention for the continued supply of VIGIV [Vaccinia Immune Globulin Intravenous (Human)] into the U.S. Strategic National Stockpile. VIGIV is the only therapeutic licensed by the U.S. Food and Drug Administration for the treatment of complications due to smallpox vaccination.
Product Development

Completed Mutual Recognition Procedure for market authorization of BioThrax (Anthrax Vaccine Adsorbed) in five Concerned Member States within the European Union – Italy, the Netherlands, Poland, the U.K. and France.
Initiated, together with Valneva, a Phase 1 clinical trial in the U.S. to evaluate the safety and immunogenicity of VLA1601, our vaccine candidate against Zika virus, using Valneva’s validated expression platform. Initial data from this trial is expected in late 2018 or early 2019.
Initiated a Phase 2 dose-ranging study to evaluate the safety, pharmacokinetics, and clinical benefit of FLU-IGIV, an anti-influenza immune globulin being developed as an intravenous treatment for serious illness caused by influenza A infection in hospitalized patients, and developed on the Company’s hyperimmune platform, on which several marketed antibody therapeutics have been licensed, including Anthrasil [Anthrax Immune Globulin Intravenous (human)] and VIGIV. The clinical study will continue to enroll patients through the next influenza season and is expected to be completed in 2019.
2018 FINANCIAL PERFORMANCE

(I) Quarter Ended March 31, 2018 (Unaudited)

Revenues

Total Revenues

For Q1 2018, total revenues were $117.8 million, a slight increase over 2017. Total revenues reflect a delay in the timing of BioThrax deliveries as previously disclosed by the Company on February 22, 2018. In addition, Q1 2018 total revenues were impacted by the delay in the delivery of some ACAM2000, (Smallpox (Vaccinia) Vaccine Live) shipments during the quarter. The Company has commenced delivery and expects to complete all delayed Q1 deliveries by the end of the second quarter.

Product Sales

For Q1 2018, product sales were $75.8 million, a decrease of 8% as compared to 2017. The decrease is principally attributable to lower BAT [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)] and BioThrax sales, partially offset by an increase in other product sales, principally attributable to sales of ACAM2000 and Raxibacumab (Anthrax Monoclonal Antibody), both of which were acquired in Q4 2017.

Contract Manufacturing

For Q1 2018, revenue from the Company’s contract manufacturing operations was $26.1 million, an increase of 48% as compared to 2017. The increase primarily reflects the completion of a milestone related to the expansion of certain contract manufacturing capabilities at the Company’s Lansing site.

Contracts and Grants

For Q1 2018, contracts and grants revenue was $15.9 million, a decrease of 8% as compared to 2017. The decrease primarily reflects a reduction in revenue associated with the successful completion of multiple U.S. government development contracts as well as reduced R&D activities related to certain ongoing funded development programs.

Operating Expenses

Cost of Product Sales and Contract Manufacturing

For Q1 2018, cost of product sales and contract manufacturing was $58.0 million, an increase of 25% as compared to 2017. The increase is primarily attributable to sales of ACAM2000 and Raxibacumab, both of which were acquired in Q4 2017, partially offset by lower sales of BAT and BioThrax.

Research and Development (Gross and Net)

For Q1 2018, gross R&D expenses were $29.1 million, an increase of 42% as compared to 2017. The increase primarily reflects increased contract development services performed for NuThraxTM (anthrax vaccine adsorbed with CPG 7909 adjuvant) and the introduction of costs associated with development work related to the technology transfer of the Raxibacumab manufacturing process to the Company’s Bayview manufacturing site in Baltimore.

For Q1 2018, net R&D expense (calculated as gross research and development expenses minus contracts and grants revenue) was $13.2 million, an increase of $10 million as compared to 2017, reflecting increased investment in countermeasure development programs not currently funded in whole or in part by third-party partners, notably costs associated with the Raxibacumab technology transfer, the FLU-IGIV flu therapeutic Phase 2 trial, the ZIKV-IG Zika therapeutic Phase 1 trial preparations, and the UNI-FLU universal flu vaccine preclinical effort, among others.

Selling, General and Administrative

For Q1 2018, selling, general and administrative expenses were $40.2 million, an increase of $5 million as compared to 2017, attributable primarily to increased stock compensation and professional services costs.

Income Taxes

For Q1 2018, the tax benefit in the amount of $4.5 million includes a discrete benefit of $2.3 million related to stock compensation activity resulting in an effective tax rate of 48%. Excluding the discrete benefit, the Q1 2018 effective tax rate was 24%.

Net Income (Loss) & Adjusted Net Income (Loss)

For Q1 2018, the Company recorded a net loss of $4.9 million, or $0.10 per diluted share, versus net income of $10.5 million, or $0.23 per diluted share, in 2017. (1)

For Q1 2018, the Company recorded an adjusted net loss of $1.6 million, or $0.03 per diluted share, versus net income of $14.3 million, or $0.29 per diluted share, in 2017. (1) (2)

The Company is also reaffirming its full year 2018 operational goals:

Advance NuThrax development to enable Emergency Use Authorization filing with the FDA in 2018
Complete ACAM2000 deliveries; establish a multi-year follow-on contract with the U.S. government
Deliver Raxibacumab doses under current contract; advance technology transfer to the Company’s Bayview facility in Baltimore, Maryland
Progress pipeline to have at least four product candidates in advanced development
Complete an acquisition that generates revenue within 12 months of closing
Q2 2018 FINANCIAL FORECAST

The Company forecast for Q2 2018 total revenue is $205 million to $230 million. This forecast reflects the deliveries of BioThrax and ACAM2000 previously expected in the first quarter as well as continued deliveries of both products in the second quarter.

FOOTNOTES

(1) See "Calculation of Diluted Earnings Per Share."
(2) See "Reconciliation of Net Income to Adjusted Net Income and EBITDA" for a definition of terms and a reconciliation table.
(3) Reflects an estimated tax rate that includes the expected effects of the United States Tax Cuts and Jobs Act of 2017 on the Company’s 2018 income tax provision.
(4) "Net revenue" is computed as Total Revenue minus Contracts & Grants Revenue.

CONFERENCE CALL AND WEBCAST INFORMATION

Company management will host a conference call at 5:00 pm (Eastern Time) today, May 3, 2018, to discuss these financial results. This conference call can be accessed live by telephone or through Emergent’s website:

Live Teleconference Information:
Dial in: [US] (855) 766-6521; [International] (262) 912-6157
Conference ID: 93329114
Live Webcast Information:
Visit View Source for the live webcast feed.
A replay of the call can be accessed at www.emergentbiosolutions.com under "Investors."

Editas Medicine Announces First Quarter 2018 Results and Update

On May 3, 2018 Editas Medicine, Inc. (NASDAQ:EDIT), a leading genome editing company, reported financial results for the first quarter ended March 31, 2018, and provided an update on recent achievements and upcoming events (Press release, Editas Medicine, MAY 3, 2018, View Source;p=RssLanding&cat=news&id=2346904 [SID1234526067]).

"We made steady progress in advancing our pipeline of CRISPR medicines toward the clinic and in building the company overall," said Katrine Bosley, President and Chief Executive Officer of Editas Medicine. "Our LCA10 program remains on track to file an IND by mid-2018, our leading experimental cell medicine in oncology is advancing towards an IND filing in our Celgene collaboration, and we have strong data in many of our earlier programs. In addition, we have significantly strengthened our Board of Directors with Jim Mullen joining as Chairman of the Board. All in all, 2018 is shaping up to be a transformative year for Editas and for the patients we aim to help."

Recent Achievements and Outlook

EDIT-101 for Leber Congenital Amaurosis type 10 (LCA10) on track for mid-2018 Investigational New Drug (IND) application filing. Editas has prepared what it believes is a strong package of preclinical data to support the IND filing. In data presented at the Association for Research in Vision and Ophthalmology 2018 Annual Meeting (ARVO Meeting), the Company demonstrated in transgenic mice that EDIT-101 caused predicted therapeutic levels of editing at adeno-associated virus doses that were safe and well tolerated in ocular gene therapy trials from other sponsors. At the American Society of Gene & Cell Therapy 21st Annual Meeting (ASGCT Meeting), the Company will demonstrate that EDIT-101 was well tolerated in a study of non-human primates.

Expanding oncology collaboration with Juno Therapeutics, Inc., a Celgene Company (Celgene). Editas is announcing today an expansion of its collaboration with Celgene to develop and commercialize chimeric antigen receptor and engineered T cell receptor medicines including Celgene’s lead program for human papillomavirus-associated solid tumors. As a result of the expansion and progress of the collaboration, Editas will receive an additional $10 million in cash and will be eligible to receive a fourth independent milestone and royalty stream.

Advancing research programs for recurrent ocular herpes simplex virus type 1 (HSV-1) and Usher syndrome type 2A (USH2A). The Company presented preclinical in vivo proof-of-concept data for its recurrent ocular HSV-1 program at the ARVO Meeting. Using the Company’s CRISPR gene editing approach in rabbits, HSV-1 viral load was reduced by 75% and corneal lesions by 91% relative to control. In addition, Editas and collaborators at Massachusetts Eye and Ear will present in vitro data at the ASGCT (Free ASGCT Whitepaper) Meeting validating the Company’s approach to deletion of exon 13 to treat USH2A.

Designing a potentially superior medicine for sickle cell disease and beta-thalassemia. Editas scientists have identified multiple sites at the beta-globin locus that regulate fetal hemoglobin induction, designed potent lead molecules, and demonstrated that these molecules drive upregulation of fetal hemoglobin in human mobilized peripheral blood stem cells. Data from this program will be presented at the upcoming ASGCT (Free ASGCT Whitepaper) Meeting.

Strong balance sheet to advance the Company through multiple value inflection points. The Company held cash, cash equivalents, and marketable securities of $359 million as of March 31, 2018, providing at least 24 months of funding for operating expenses and capital expenditures without any assumption of cash received from milestones or additional financings.
Strengthened organization with appointment of James C. Mullen and Jessica Hopfield, Ph.D., to Board of Directors. Mr. Mullen has been named Chairman of the Board of Directors and brings more than 30 years of experience in the biotechnology industry. He previously served as the Chief Executive Officer and President of Biogen, Inc., and as the Chief Executive officer of Patheon N.V. Dr. Hopfield is a former Partner of McKinsey & Company with more than 20 years of experience in healthcare.
Upcoming Events

Editas will participate in the following upcoming investor conferences:

Bank of America Merrill Lynch 2018 Health Care Conference, May 15-17, Las Vegas.
Editas will also participate in the following upcoming scientific and medical conferences:

TIDES 2018: Oligonucleotide and Peptide Therapeutics, May 7-10, Boston; and
American Society of Gene & Cell Therapy 21st Annual Meeting, May 16-19, Chicago.
First Quarter 2018 Financial Results

Cash, cash equivalents, and marketable securities at March 31, 2018, were $358.8 million, compared to $329.1 million at December 31, 2017.

For the first quarter ended March 31, 2018, net loss attributable to common stockholders was $30.9 million, or $0.67 per share, compared to $31.1 million, or $0.85 per share, for the same period in 2017.

Collaboration and other research and development revenues were $3.9 million for the quarter ended March 31, 2018, compared to $0.7 million for the same period in 2017. The $3.2 million increase was attributable to a $2.9 million increase in revenue recognized pursuant to our strategic alliance with Allergan Pharmaceuticals International Limited and a $0.3 million increase in reimbursable research and development expenses primarily resulting from the adoption of Accounting Standards Codification, Topic 606, Revenue From Contracts With Customers.
Research and development expenses were $21.3 million for the quarter ended March 31, 2018, compared to $19.0 million for the same period in 2017. The $2.3 million increase was primarily attributable to a $7.1 million increase in process and platform development costs and the acquisition of certain non-capitalized intangible assets, a $1.4 million increase in employee related expenses, a $0.3 million increase in stock-based compensation expenses, a $0.4 million increase in facility-related expenses and a $0.3 million increase in other expenses. This increase was partially offset by a $7.3 million decrease in sublicensing and success payment expenses.
General and administrative expenses were $14.2 million for the quarter ended March 31, 2018, compared to $12.3 million for the same period in 2017. The $1.9 million increase was primarily attributable to a $1.5 million increase in intellectual property legal expense and patent-related fees, a $0.4 million increase in stock-based compensation expenses, a $0.4 million increase in other expenses, and a $0.2 million increase in employee related expenses. This increase was partially offset by a $0.7 million decrease in professional service expenses.
Conference Call

The Editas management team will host a conference call and webcast today, May 3, 2018, at 5:00pm ET. To access the call, please dial 844-348-3801 (domestic) or 213-358-0955 (international) and provide the passcode 6079429. A live webcast of the call will be available on the Investors & Media section of the Editas Medicine website at www.editasmedicine.com and a replay will be available approximately two hours after its completion.

Delcath Announces Another DSMB Recommendation for Phase 3 Focus Trial

On May 3, 2018 Delcath Systems, Inc. (OTCQB:DCTHD), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that the independent Data Safety Monitoring Board (DSMB) of the Phase 3 FOCUS clinical trial for Patients with Hepatic Dominant Ocular Melanoma has completed another review of safety data for treated patients in the trial (Press release, Delcath Systems, MAY 3, 2018, View Source;p=RssLanding&cat=news&id=2346786 [SID1234526066]). The DSMB has again recommended that the study continue without modification.

The FOCUS Trial is evaluating the efficacy, safety and pharmacokinetics of Melphalan/HDS versus best alternative standard of care in 240 patients with metastatic ocular melanoma (OM). The primary objective of the study is a comparison of overall survival between the Melphalan/HDS treatment arm and best alternative care arm comprised of selected therapies; secondary objectives include overall progression-free survival and objective response rate, each as determined by the Investigator, while exploratory objectives include progression-free survival, objective response rate, hepatic progression free survival and hepatic objective response rate all as determined by blinded Independent Central Review, and quality of life measures. The FOCUS Trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) to support marketing approval in the U.S.

"The DSMB’s continued recommendation to proceed without modification with the FOCUS Trial as planned confirms once again our own observations of the safety profile of PHP therapy based on prior research and our commercial experience with CHEMOSAT in Europe," said Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath. "Given that safety concerns with the previous generation product and procedure were the primary issue in the FDA’s previous assessment, we are pleased with the safety profile demonstrated by our therapy in the trial thus far."

CTI BioPharma Reports First Quarter 2018 Financial Results

On May 3, 2018 CTI BioPharma Corp. (NASDAQ:CTIC) reported financial results for the first quarter ended March 31, 2018 (Press release, CTI BioPharma, MAY 3, 2018, View Source;p=RssLanding&cat=news&id=2346898 [SID1234526065]).

In March 2018, results from the Phase 3 PERSIST-2 clinical trial of pacritinib were published online in JAMA Oncology. The randomized, international, multicenter study compared the efficacy and safety of pacritinib at two dose levels, compared with best available therapy, which included ruxolitinib (a JAK1/JAK2 inhibitor), in patients with myelofibrosis and thrombocytopenia (defined as platelet counts ≤100 x 109/L).

Upcoming Milestones

In the second quarter of 2018, the interim analysis of the PAC203 study of pacritinib in patients with myelofibrosis will be conducted by an Independent Data Monitoring Committee. Full top-line data from the study is expected in the first quarter of 2019.
The Company expects to submit responses to the Day 120 List of Questions to the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in May 2018.
Top-line results of the PIX306 Phase 3 trial of PIXUVRI in patients with aggressive B-cell or grade 3 follicular Non-Hodgkins Lymphoma are event-driven and are expected in the third quarter of 2018.
"We look forward to several important milestones over the next months, as we continue to make progress in the clinical development of pacritinib and PIXUVRI," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. "We also significantly strengthened our cash position during the first quarter of 2018, which will carry us through key clinical and regulatory milestones into 2020."

First Quarter Financial Results

Total revenues for the first quarter ended March 31, 2018 were $10.5 million compared to $0.8 million for the same period in 2017. The increase in total revenues was primarily due to recognition of $10.0 million in milestone revenue from Teva Pharmaceutical Industries Ltd. related to the achievement of a milestone for FDA approval of TRISENOX for first line treatment of acute promyelocytic leukemia. We had no net product revenues of PIXUVRI for the first quarter of 2018 compared to $0.6 million for the same period in 2017. The decrease in net product sales for the period in 2018 compared to 2017, was 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 first quarter of 2018 was $4.3 million compared to $19.3 million for the same period in 2017. Non-GAAP operating loss, which excludes non-cash share-based compensation expense, for the first quarter of 2018, was $3.0 million compared to $17.5 million for the same period in 2017. Non-cash share-based compensation expense for the first quarter of 2018 was $1.3 million compared to $1.8 million for the same period in 2017. The decrease in operating loss for the first quarter of 2018 was primarily due to a $10.0 million milestone revenue from Teva Pharmaceutical Industries Ltd. as well as a decrease in selling, general and administrative expenses related to personnel costs and legal fees. 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 titled "Non-GAAP Financial Measures."

Net loss attributable to common stockholders for the first quarter of 2018 was $4.1 million, or ($0.08) per share, compared to $19.8 million, or ($0.71) per share, for the same period in 2017.

As of March 31, 2018, cash and cash equivalents totaled $104.6 million, compared to $43.2 million as of December 31, 2017.

Conference Call Information

CTI BioPharma management will host a conference call to review its first quarter 2018 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. Participants can access the call at 1-866-548-4713 (domestic) or +1 323-794-2093 (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 9956153. The telephone replay will be available until Thursday, May 10, 2018.