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Cascadian Therapeutics Reports First Quarter 2017 Financial Results Conference Call Scheduled for Today at 8:30 a.m. ET

On May 9, 2017 Cascadian Therapeutics, Inc. (NASDAQ:CASC), a clinical-stage biopharmaceutical company, reported financial results for the first quarter ended March 31, 2017 (Press release, Cascadian Therapeutics, MAY 9, 2017, View Source [SID1234518921]).

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"In the first quarter, we continued to build a solid management team and the financial foundation that will help us execute our core objectives over the next several years," said Scott Myers, President and CEO of Cascadian Therapeutics. "We are focused on enrolling HER2CLIMB, our pivotal study of tucatinib in combination for late-stage HER2-positive metastatic breast cancer for patients with and without brain metastases. We are very pleased with the current pace of enrollment and are expanding HER2CLIMB globally."

First Quarter and Recent Highlights

In April 2017, the Company announced data highlights from presentations of preclinical data for the Company’s investigational orally bioavailable, potent and selective checkpoint kinase 1 (Chk1) inhibitor known as CASC-578 and data from the first public presentation on the Company’s preclinical antibody program targeting the immune checkpoint receptor TIGIT. These data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2017.

In March 2017, the Company announced the appointment of Robert W. Azelby to the Company’s Board of Directors. Mr. Azelby is a biotechnology and pharmaceutical industry veteran. The Company also announced that Richard L. Jackson, Ph.D., retired from the Board.

In January 2017, the Company closed an $88 million net public offering of common and Series E preferred stock. The net proceeds, along with cash on hand, support the development of tucatinib, the registrational HER2CLIMB trial through top-line data, with funds to carry on operations for a period of time thereafter. On May 8, 2017, in connection with the registration rights agreement entered into for the Series E preferred stock issued in this financing, the Company filed a required resale S-3 registration statement to allow the holder of these preferred shares to sell shares of common stock issuable upon conversion of the preferred shares. The S-3 relates to these shares and does not provide for any future issuance of new common shares for financings.
First Quarter Financial Results

Cash, cash equivalents and investments totaled $136.1 million as of March 31, 2017, compared to $62.8 million at December 31, 2016, an increase of $73.3 million, or 116.7 percent. The increase was primarily due to the result of net proceeds of $88.0 million from the Company’s January 2017 financing offset by cash used to fund operations of $14.6 million.

Net loss attributable to common stockholders for the first three months ended March 31, 2017 was $12.4 million, or $0.30 per share, compared to a net loss attributable to common stockholders of $12.9 million, or $0.81 per share, for the same period in 2016. The $0.5 million decrease in net loss attributable to common stockholders for the quarter was primarily due to a decrease in general and administrative expense of $3.7 million related to the retirement and separation of the former chief executive officer in the first quarter of 2016. This decrease was offset by higher research and development expenses of $2.3 million due to greater activity related to the development of the Company’s product candidate and a non-cash deemed dividend of $1.0 million related to the beneficial conversion feature on the Series E convertible preferred stock.
2017 Financial Outlook

Cascadian Therapeutics expects operating expenses in 2017 to be slightly higher than in 2016, primarily due to an increase in activities related to the ongoing worldwide HER2CLIMB pivotal trial. Cash used in operations for 2017 is expected to be approximately $50.0 million to $54.0 million.

Cascadian Therapeutics believes the above financial guidance to be correct as of the date provided and is providing the guidance as a convenience to investors and assumes no obligation to update it.

10-Q – Quarterly report [Sections 13 or 15(d)]

Novavax has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

10-Q – Quarterly report [Sections 13 or 15(d)]

Scynexis has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Scynexis, 2017, MAY 8, 2017, View Source [SID1234521707]).

First Quarter 2017 Financial Results and Business Highlights

On May 8, 2017 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), clinical-stage biopharmaceutical firm engaged in the development of effective immunotherapies for cancer and stem cell therapies for degenerative diseases, reported financial results for the first quarter ended March 31, 2017 and provided business highlights (Press release, Cellular Biomedicine Group, MAY 8, 2017, View Source [SID1234519117]).

"The first quarter of 2017 was very productive, with several key achievements, including the commencement of our second Phase I CAR-T clinical trial utilizing CBMG’s proprietary and optimized CD19 construct, for the treatment of adult patients with relapsed or refractory CD19+ B-cell Acute Lymphoblastic Leukemia (ALL)," commented Tony Liu, Chief Executive Officer of CBMG. "The award of $2.29 million from the California Institute for Regenerative Medicine (CIRM) to support pre-clinical studies of AlloJoinTM in the U.S., moves forward our endeavor into the U.S. market and the development of an off-the-shelf stem cell product to treat Knee Osteoarthritis (KOA). The signing of a collaboration with GE Healthcare Life Sciences China to establish a joint laboratory within our own GMP facilities in Shanghai credits our GMP stature and capabilities. We are determined to build on our accomplishments from the first quarter to continue to strengthen our innovative pipelines and move our clinical assets into later stage development. We believe we are ahead of the competitive curve in addressing the manufacturing barriers to delivering consistent clinical grade cell therapies which have the potential to address the large cancer and knee osteoarthritis markets."

First Quarter 2017 Financial Performance

Cash Position:Cash and cash equivalents as of March 31, 2017 were $33.4 million compared to $39.3 million as of December 31, 2016.
Net Cash Used in Operating Activities:Net cash used in operating activities for the first quarter of 2017 was $4.86 million, compared to $3.58 million for the same period in 2016.
G&A Expenses:General and administrative expenses for the first quarter of 2017 were $3.2 million compared to $2.8 million for the same period in 2016. The increase is in large part attributed to the rental increase, which resulted from the new leased facilities located in the "Pharma Valley" of Shanghai from January 1, 2017.
R&D Expenses:Research and development expenses for the first quarter of 2017 were $3.0 million, compared to $2.4 million for the same period a year ago. The increase was primarily attributable to headcount increases of R&D staff and increased expenses related to advancing assets into clinical trials.
Net Loss:Net loss allocable to common stock holders was $6.2 million, compared to $4.2 million for the same period in 2016.
Business & Technology Highlights of 2017 To Date

Commenced CALL-1 ("CAR-T against Acute Lymphoblastic Leukemia") Phase I clinical trial in China utilizing its optimized proprietary C-CAR011 construct of CD19 chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of patients with relapsed or refractory (r/r) CD19+ B-cell Acute Lymphoblastic Leukemia (ALL);
Awarded $2.29 million by California Institute for Regenerative Medicine (CIRM), California’s stem cell agency, to support pre-clinical studies of AlloJoinTM, CBMG’s "Off-the-Shelf" Allogeneic Human Adipose-derived Mesenchymal Stem Cells for the treatment of Knee Osteoarthritis in the United States;
On May 4, 2017, the Company received $1.2 million from the CIRM grant, the first of four disbursements
Completed expansion of its 30,000 square foot facility in Huishan High Tech Park in Wuxi, China, with 20,000 square feet of the Wuxi GMP facility dedicated to advanced stem cell culturing, centralized plasmid and viral vector production, cell banking and development of reagents;
Began construction of a new GMP facility in "Pharma Valley" in Shanghai Zhangjiang High-Tech Park, which will consist of 40,000 square feet dedicated to advanced cell manufacturing;
Established a strategic research collaboration with GE Healthcare Life Sciences China to co-develop certain high-quality industrial control processes in Chimeric Antigen Receptor T-cell (CAR-T) and stem cell manufacturing and to form a joint laboratory within CBMG’s new Shanghai Zhangjiang GMP-facility dedicated to the joint research and development of a functionally integrated and automated immunotherapy cell preparation system.

Sunesis Pharmaceuticals Reports First Quarter 2017 Financial Results and Recent Highlights

On May 8, 2017 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported financial results for the first quarter ended March 31, 2017. Loss from operations for the three months ended March 31, 2017 was $9.4 million (Press release, Sunesis, MAY 8, 2017, View Source;p=RssLanding&cat=news&id=2270692 [SID1234519080]). As of March 31, 2017, cash, cash equivalents and marketable securities totaled $35.2 million.

"Following recent regulatory developments, our reversible non-covalent BTK inhibitor, SNS-062, is the central focus of our development efforts and resources," said Daniel Swisher, President and Chief Executive Officer of Sunesis. "Data from SNS-062’s preclinical and healthy volunteer studies suggest a unique drug profile for this next-generation BTK inhibitor and the potential to overcome the key resistance mechanism of ibrutinib. SNS-062 has the potential to address this increasingly well-defined and prevalent unmet need in CLL and other B-cell malignancy patients with C481S mutations, and we look forward to dosing the first patient in our Phase 1B/2 study this quarter."

Mr. Swisher continued, "With regard to vosaroxin, we plan to continue to advance its development through investigator-sponsored group trials, and will carefully assess business development alternatives to support any future registration-directed studies. We expect that our current cash resources are sufficient to fund the company into June 2018."

First Quarter 2017 and Recent Highlights

Announced Withdrawal of Marketing Authorization Application (MAA) for Vosaroxin in Europe and Shifted Primary Development Focus to Non-Covalent Reversible BTK Inhibitor SNS-062. On May 1st, Sunesis announced the withdrawal of its European Marketing Authorization Application (MAA) for vosaroxin as a treatment for relapsed/refractory acute myeloid leukemia (AML) in patients aged 60 years and older. The decision followed recent interactions with the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP), during which the Company made an assessment based on feedback from its rapporteurs and input from its regulatory consultants that the committee was likely to formally adopt a negative opinion and a withdrawal of its application was the best option at this time. The Company also announced its plans to reduce its investment in its AML program and shift an increasing portion of resources to the Company’s kinase inhibitor pipeline, with an emphasis on timely prosecution of SNS-062.

Progress Toward Initiation of a Phase 1b/2 Trial of Non-Covalent Reversible BTK Inhibitor SNS-062 in Patients with B-Cell Malignancies. Sunesis continues to make progress toward the initiation of treatment in a Phase 1b/2 Trial evaluating its unique, proprietary, non-covalent reversible BTK-inhibitor SNS-062 in patients with B-cell malignancies. The Company has activated multiple clinical sites across the U.S., including at U.C. Irvine Cancer Center and The Ohio State University Comprehensive Cancer Center. These sites are beginning to actively identify patients. An additional three top U.S. centers, Dana-Faber Cancer Institute, MD Anderson Cancer Center and Weill Cornell Cancer Center, expected to be initiated this quarter. Sunesis expects to announce the dosing of the first patient this quarter.

Announced Poster Presentation on BTK Inhibitor SNS-062 at the AACR (Free AACR Whitepaper) Annual Meeting. In March, Sunesis announced a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2017 Annual Meeting. The poster, titled "SNS-062 demonstrates efficacy in chronic lymphocytic leukemia in vitro and inhibits C481S mutated Bruton tyrosine kinase" detailed results from The Ohio State University-sponsored preclinical study, conducted in collaboration with Sunesis, that examined the potency of SNS-062 versus ibrutinib and acalabrutinib, specifically relating to the C481S mutation.

Announced Progress in Ongoing Investigator-Sponsored Studies Evaluating Vosaroxin in Patients with Acute Myeloid Leukemia (AML). Sunesis announced today that the Vanderbilt University sponsored VITAL (Vosaroxin and Infusional Cytarabine for Frontline Treatment of Acute Myeloid Leukemia) study of vosaroxin in combination with cytarabine in patients with previously untreated AML has progressed from Stage 1 to Stage 2. The single-arm, open-label trial enrolled 17 patients in Stage 1 and, following a one-time interim analysis by the Data Safety Monitoring Board of responses exceeding a pre-defined efficacy threshold, is now proceeding to enrollment in Stage 2. In this stage, the trial will enroll at least 24 additional patients. The study is being expanded to four additional sites including Yale University, UCLA, Medical University of South Carolina and University of Alabama.

Sunesis also announced today that vosaroxin has been selected as a treatment arm in the Phase 2/3 BIG-1 (Backbone InterGroup-1) trial. BIG-1 is an open label, multicenter phase 2/3 study with multiple randomization phases at different stages of AML treatment that is designed to improve overall survival in younger patients (18 to 60 years). The vosaroxin portion of the trial, which is expected to begin dosing imminently, will enroll up to 200 patients with favorable or intermediate risk AML, who will receive consolidation therapy of intermediate dose cytarabine with vosaroxin. The study is being conducted at multiple French centers, led by the University Hospital of Angers under the direction of Professor Norbert Ifrah, and the University Institute of Hematology at the Hôpital Saint-Louis under the direction of Professor Hervé Dombret.

Announced Organizational Updates. In March, Sunesis announced two management additions: Judy Fox Ph.D. to the position of Chief Scientific Officer and Pietro Taverna, Ph.D. to Executive Director, Translational Medicine. In April, Eric Bjerkholt resigned from his position of Chief Financial Officer. Dan Swisher, our Chief Executive Officer, has assumed the CFO responsibilities on an interim basis.
Financial Highlights

Cash, cash equivalents and marketable securities totaled $35.2 million as of March 31, 2017, as compared to $42.6 million as of December 31, 2016. The decrease of $7.4 million was primarily due to $9.7 million of net cash used in operating activities offset by $2.2 million from sales of common stock through the company’s at the market facility. The Company expects that its current cash resources are sufficient to fund the company into June 2018.

Revenue for the three months ended March 31, 2017 was $0.7 million, as compared to $0.6 million for the same period on 2016. Revenue in each period was primarily due to deferred revenue recognized related to the Royalty Agreement with Royalty Pharma.

Research and development expense was $6.2 million for the three months ended March 31, 2017 and for the same period in 2016, primarily relating to the vosaroxin development program in each period.

General and administrative expense was $3.9 million for the three months ended March 31, 2017 as compared to $4.3 million for the same period in 2016. The decrease of $0.4 million in 2016 was primarily due to decrease in personnel expenses and commercial expenses.

Interest expense was $0.5 million for the three months ended March 31, 2017 as compared to $0.3 million and for the same period in 2016. The increase in the 2017 period was primarily due to the increase in the notes payable.

Net other income was $0.1 million for the three months ended March 31, 2017 and for the same period in 2016. The other income was primarily comprised of interest income from the short-term investments.

Cash used in operating activities was $9.7 million for the three months ended March 31, 2017, as compared to $10.7 million for the same period in 2016. Net cash used in the 2017 period resulted primarily from the net loss of $9.8 million and changes in operating assets and liabilities of $0.9 million, partially offset by net adjustments for non-cash items of $1.0 million.

Sunesis reported loss from operations of $9.4 million for the three months ended March 31, 2017, as compared to $9.9 million for the same period in 2016. Net loss was $9.8 million for the three months ended March 31, 2017, as compared to $10.1 million for the same period in 2016.
Conference Call Information