Uncategorized – Page 16601 – 1stOncology™: Cancer Intelligence Service

ProNAi Therapeutics Reports First Quarter 2016 Results

On May 10, 2016 ProNAi Therapeutics, Inc. (NASDAQ: DNAI), a clinical-stage oncology company advancing novel therapeutics for patients with cancer and hematological diseases, reported its financial and operational results for the first quarter of 2016 (Press release, ProNAi Therapeutics, MAY 10, 2016, View Source [SID:1234512182]).

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"During the first quarter, we continued to advance our lead cancer drug, PNT2258, in two Phase 2 trials, Wolverine and Brighton, and we remain on track to report interim data from the Wolverine trial in third-line diffuse large B-cell lymphoma (DLBCL) in June 2016," said Dr. Nick Glover, President and CEO of ProNAi Therapeutics. "In addition, we continued to evaluate novel drug candidates for potential licensing or acquisition, with the vision of establishing a broad and diversified pipeline under our development. Supporting this vision, in the first quarter we further strengthened ProNAi’s core infrastructure by adding two industry veterans to our Board of Directors, Mr. Jeffrey H. Cooper and Mr. Tran Nguyen, and by opening an office in the San Francisco area where our world-class clinical development team resides led by Dr. Barbara Klencke."

First Quarter 2016 Financial Results (all amounts reported in U.S. currency)
Total operating expenses for the three months ended March 31, 2016 were $10.6 million compared to $6.7 million for the three months ended March 31, 2015. Total operating expenses included non-cash stock based compensation of $1.4 million and $0.2 million for the three months ended March 31, 2016 and 2015, respectively.

Research and development expenses increased to $6.6 million for the three months ended March 31, 2016 from $5.3 million for the three months ended March 31, 2015. These increases were primarily due to expenses related to the continuation of our PNT2258 clinical trials and an increase in personnel-related costs. These increased costs were partially offset by a decrease in third-party manufacturing costs for PNT2258.

General and administrative expenses increased to $4.0 million for the three months ended March 31, 2016 from $1.4 million for the three months ended March 31, 2015. These increases were primarily due to increased personnel-related costs and professional fees incurred in support of activities as a public company and corporate growth, and costs pertaining to business development activities.

For the three months ended March 31, 2016, ProNAi incurred a net loss of $10.5 million compared to a net loss of $8.0 million for the three months ended March 31, 2015. The net loss included a non-cash charge related to the change in fair value of preferred stock warrants of $1.3 million for the three months ended March 31, 2015.

At March 31, 2016, ProNAi had $140.9 million in cash and cash equivalents compared to $150.2 million in cash and cash equivalents at December 31, 2015.

At March 31, 2016, there were 30,174,778 shares of common stock issued and outstanding and stock options to purchase 4,153,460 shares of common stock issued and outstanding.

CAR-T cell therapy

CAR-T cell(Chimeric Antigen Receptor modified T cells) therapy is a newly emerging cellular immunotherapy technology (Company Web Page, Sinobioway Bioeconomy Group , MAY 10, 2016, View Source;second_id=3002 [SID:1234512236]). With molecular biological methods, it combines together the antibody fragment that identifies tumor-associated antigen(scFv), components of T cell receptor(CD3 ζ), costimulatory signal molecules for T cell activation(CD28, CD137 etc.) and junction fragments, to construct the chimeric antigen receptor(CAR). Then it introduces CAR into T cells by gene engineering techniques, thus acquiring the target killing capacity independent of MHC pathway.

Takeda Reports Results for Fiscal Year 2015 (April 2015 -March 2016) and Forecast for Fiscal Year 2016

On May 10, 2016 Takeda reported results for Fiscal Year 2015 (April 2015 -March 2016) and Forecast for Fiscal Year 2016 (Press release, Takeda, MAY 10, 2016, View Source [SID:1234512192]).

FY2015: A year of turnaround to sustained growth; achieved full year management guidance
Underlying revenue up +3.4% (reported revenue growing +1.7% to 1,807.4 billion yen), led by strong performances in Takeda’s growth drivers (GI, Oncology, CNS and Emerging Markets)
Underlying Core Earnings up +8.1% (reported operating profit recorded 130.8 billion yen), aided by cost discipline
Underlying Core EPS up +21.7% (reported EPS was 102 yen), growing 2.5x faster than underlying core earnings
Growth Drivers continued to be robust
Consolidated underlying revenue growth of Gastroenterology (GI), Oncology, Central Nervous System (CNS) and Emerging Markets – Takeda’s Growth Drivers – was +9.5% year-to-year
Underlying revenue of GI +23.6%, Oncology +1.0%* and CNS +37.3% year-to-year
Emerging Markets underlying revenue +4.8% year-to-year with continued growth in the key markets of China, Russia and Brazil
*Underlying growth of Oncology excluding VELCADE royalties was +4.4%

Broad portfolio of growing products offsets loss of exclusivity decline
ENTYVIO is on track to exceed $2 billion MAT* sales within FY2018
Encouraging uptake of NINLARO and TAKECAB
BRINTELLIX and ADCETRIS showed continued growth
AZILVA and LOTRIGA are contributing to the Japan business
*Moving Annual Total @ constant currency

Efficiency gains continue
Project Summit well exceeded full-year target resulting in 30 billion yen additional cost savings
Strong cash flow performance with Operating Free Cash Flow, excluding Actos settlement payment, reaching 230 billion JPY
FY2016 management guidance: A year of strategic focus to sustain growth
Underlying Revenue: Mid-single digit growth (%)
Underlying Core Earnings: Low- to mid-teen growth (%)
Underlying Core EPS: Low- to mid-teen growth (%)
Christophe Weber, President and Chief Executive Officer of Takeda, commented:
"FY2015 was a turnaround year. We achieved our management guidance for the second consecutive year, led by our growth drivers, and aided by the global launches of new products such as ENTYVIO and NINLARO. Takeda will continue to deliver innovative new medicines to patients, especially in our focused R&D therapeutic areas. Takeda aims to relentlessly execute our strategic roadmap to deliver our long-term aspiration, and will serve the needs of the patients, with the best in class agility and innovation."

Key figures for the full year of FY2015 (April 2015 –March 2016)

FY 2014
FY 2015
Growth
billion yen

Underlying2
Revenue
1,777.8
1,807.4
+1.7%
+3.4%
Operating Profit
-129.3
130.8
–
–
Core Earnings1
288.3
292.4
+1.4%
+8.1%
Net Profit3
-145.8
80.2
–
–
EPS
-185 yen
102 yen
–
–
Core EPS
225 yen
258 yen
+14.8%
+21.7%
1 Core Earnings is calculated from operating profit by excluding the impact of exceptional items, such as purchase accounting, amortization and impairment loss of intangible assets, restructuring costs and major litigation costs.
2 Underlying performance aims at understanding the real performance of the business. Underlying Revenue, Underlying Core Earnings, and Underlying Core EPS exclude the same as above and adjusted for acquisitions/divestments and foreign exchange.
3 Attributable to the owners of the company

Underlying revenue growth was mainly driven by Takeda’s Growth Drivers: Gastroenterology(GI), Oncology, and Central Nervous System (CNS) in addition to Emerging Markets. The Growth Drivers account for 52% of Takeda’s revenue. GI revenue grew by +23.6% year-to-year, driven by ENTYVIO. Oncology revenue increased by +1.0%, contributed by VELCADE, ADCETRIS and NINLARO, which has shown an encouraging start in the U.S. since it was launched in December,. Oncology revenue excluding VELCADE royalties grew +4.4%. CNS revenue, including BRINTELLIX, increased by +37.3%. Emerging Markets revenue grew by +4.8% year-to-year, led by Value Brands (branded generics and Over-The-Counter medicines), with steady growth in China (+11.1%), Russia (+6.2%) and Brazil (+5.7%). However, our future aspiration for growth in Emerging Markets remains strong, in high single digits. Performance in the U.S. (+12.4% year-to-year underlying revenue growth) also contributed to total revenue growth. In Japan, which remains under increasing generic pressure, underlying revenue declined -3.3% year-to-year, but AZILVA and LOTRIGA showed significant sales growth of +30.1% and +69.0%, respectively, year-to-year. In addition to these growing products, TAKECAB and ZAFATEK are expected to be key sales drivers in Japan after the lifting of the 2-week limit on the prescription period.

Consolidated operating profit was 130.8 billion yen, an increase of 260.1 billion yen compared to the previous year, which exceeded the raised forecast of 120 billion yen announced in February at the FY2015 3rd quarter earnings announcement. Selling, general and administrative expenses increased by 38.2 billion yen (+6.2%) compared to the previous year, mainly due to the increase in sales expenses related to new products in the U.S., but R&D expenses decreased by 36.2 billion yen (-9.5%). Amortization and impairment losses on intangible assets associated with products decreased by 51.3 billion yen (-29.1%), mainly due to 30.5 billion yen of COLCRYS impairment loss being recognized in 2014 compared to an 8.6 billion yen impairment reversal in fiscal 2015. Other operating income decreased by 82.1 billion yen (-76.6%), mainly due to 53.8 billion yen of revaluation of COLCRYS contingent consideration liability and 32.8 billion yen of the gains on sales of real estate being recognized in the previous year. Other operating expenses decreased by 277.8 billion yen (-86.2%), mainly due to 274.1 billion yen of loss on Actos litigation in the U.S. being recognized in the previous year.

Project Summit – a company-wide strategic initiative to increase efficiency – continued to produce results, with 30 billion yen of additional savings in FY2015, exceeding the full year target as a result of higher Procurement savings.

As part of its ongoing effort to improve R&D productivity, Takeda is focusing on its core therapeutic areas of Oncology, GI and CNS. Takeda will further strengthen its initiatives and commitment to lead innovation in medicines and provide innovative new drugs to patients around the world including in emerging markets.

FY2015 was positioned for Takeda as a year of turnaround to sustained growth, and Takeda sets the following management guidance for FY2016 as a year of strategic focus to sustain growth.

Management Guidance for FY2016

Underlying Growth (%)
Underlying Revenue
Mid-single digit
Underlying Core Earnings
Low- to mid-teen
Underlying Core EPS
Low- to mid-teen
Dividend per Share
180 yen
Reported Forecast for FY2016 (change vs. FY2015 results)

billion yen
FY 2016 1
Change
Revenue
1,720.0
-4.8%
R&D expenses
325.0
-6.0%
Operating Profit
135.0
+3.2%
Net Profit 2
88.0
+9.8%
EPS
112 yen
+9.8%
1 The exchange rate assumptions for FY2016 are 1US$=110 yen and 1 euro=125 yen
2 Attributable to the owners of the company

For more details on Takeda’s FY2015 full year results and other financial information, please visit View Source

About Takeda Pharmaceutical Company Limited

Vericel Reports First-Quarter 2016 Financial Results

On May 10, 2016 Vericel Corporation (NASDAQ:VCEL), a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, reported financial results for the first quarter ended March 31, 2016 (Press release, Vericel, MAY 10, 2016, View Source [SID:1234512238]).

Total net revenues for the quarter ended March 31, 2016 were approximately $14.1 million and included approximately $8.8 million of Carticel net revenues and approximately $5.3 million of Epicel net revenues. Total Carticel and Epicel net revenues increased 31% over the first quarter of 2015, with Carticel revenues increasing 24% and Epicel revenues increasing 46%, respectively, compared to the same period in 2015.

Gross profit for the quarter ended March 31, 2016 was $7.5 million, or 54% of net revenues, compared to $5.3 million, or 49% of net product revenues, for the first quarter of 2015.

Research and development expenses for the quarter ended March 31, 2016 were $3.5 million, compared to $4.4 million in the first quarter of 2015. The decrease in research and development expenses in the first quarter is primarily due to a reduction in clinical trial expenses.

Selling, general and administrative expenses for the quarter ended March 31, 2016 were $6.0 million compared to $5.5 million for the same period in 2015. The increase in SG&A expenses is primarily due to an increase in shared facility fees.

Loss from operations for the quarter ended March 31, 2016 was $2.0 million, compared to $4.6 million for the first quarter of 2015. Material non-cash items impacting the operating loss for the quarter included $0.5 million of stock-based compensation expense and $0.4 million in depreciation and amortization expense.

Other expense for the quarter ended March 31, 2016 was $1.7 million compared to less than $0.3 million for the same period in 2015. The change in other expense for the quarter is primarily due to the change in the fair value of warrants in the first quarter of 2016 compared to the same period in 2015.

Vericel reported an adjusted net loss for the quarter ended March 31, 2016 of $2.0 million dollars, or $0.08 per share, compared to an adjusted net loss of $4.5 million, or $0.19 per share, for the same period in 2015. The adjusted net loss excludes the non-cash change in the fair value of warrants and the non-cash accumulated dividend on the Series B convertible preferred stock. The adjusted earnings per share includes common shares reserved as treasury shares received in exchange for the Series A non-voting convertible preferred stock. Vericel’s GAAP net loss for the quarter ended March 31, 2016 was $3.7 million, or $0.24 per share, compared to a net loss of $4.9 million, or $0.27 per share, for the same period in 2015.

As of March 31, 2016, the company had $13.5 million in cash and cash equivalents compared to $14.6 million in cash and cash equivalents at December 31, 2015.

Recent Business Highlights
During and since the first quarter of 2016, the company:

Achieved 31% growth in total Carticel and Epicel net revenues in the first quarter, including 24% and 46% growth in Carticel and Epicel net revenues, respectively, versus the same period in 2015;
Achieved gross margins of 54% of total net revenues in the first quarter versus 49% in the same period in 2015;
Received U.S. Food and Drug Administration (FDA) approval of the Epicel Humanitarian Device Exemption (HDE) supplement, which revised the Epicel label to include pediatric patients and specify the probable benefit, mainly related to survival, for adult and pediatric patients, and allows the company to sell Epicel for profit on up to 360,400 grafts per year;
Submitted a Biologics License Application for MACI for the treatment of cartilage defects of the knee, which was accepted for review by the FDA with a PDUFA goal date of January 3, 2017;
Announced results from the company’s Phase 2b ixCELL-DCM clinical study of ixmyelocel-T in patients with advanced heart failure due to ischemic dilated cardiomyopathy, which were presented at the American College of Cardiology’s (ACC) 65th Annual Scientific Session and published in The Lancet;
Entered into a $10 million credit facility and $5 million term loan agreement with Silicon Valley Bank to access low-cost, non-dilutive capital for the company; and
Executed a service agreement with Dohmen Life Science Services, LLC for clinical- and patient-support services for Carticel and MACI, if approved.
"We had a very strong first quarter and made tremendous progress across all facets of our business," said Nick Colangelo, president and CEO of Vericel. "Our strong revenue growth and margin expansion reflect the success of our commercial team’s sales and marketing initiatives, and our clinical and regulatory team made substantial progress on our key clinical and regulatory priorities. We believe that these results position the company for strong growth moving forward."

Tokai Pharmaceuticals Reports First Quarter 2016 Financial Results

On May 10, 2016 Tokai Pharmaceuticals, Inc. (NASDAQ: TKAI), a biopharmaceutical company focused on developing and commercializing innovative therapies for prostate cancer and other hormonally driven diseases, reported company highlights and financial results for the quarter ended March 31, 2016 (Press release, Tokai Pharmaceuticals, MAY 10, 2016, View Source;p=RssLanding&cat=news&id=2166824 [SID:1234512193]).

"Over the past quarter we have made significant progress in our clinical development program for galeterone, as we continued to accelerate screening and enrollment in our ARMOR3-SV trial and expanded our Phase 2 trial to include additional mCRPC patients who have acquired resistance to enzalutamide," said Jodie Morrison, President and Chief Executive Officer of Tokai. "We have also strengthened our development team to sharpen focus on execution of our clinical trials, and we look forward to continued progress in the months ahead as we work with great urgency to meet the needs of patients who currently have limited therapeutic options."

Recent business highlights include:

Progress in ARMOR3-SV, a Phase 3 registration trial of galeterone in AR-V7+ mCRPC. Patient enrollment is ongoing in ARMOR3-SV, Tokai’s pivotal Phase 3 clinical trial evaluating whether administration of galeterone results in a statistically significant and clinically meaningful improvement in radiographic progression-free survival as compared to Xtandi (enzalutamide) in treatment-naïve metastatic castration-resistant prostate cancer (mCRPC) patients whose prostate tumor cells express the AR-V7 splice variant. AR-V7 is a truncated form of the androgen receptor that has been associated with poor response to commonly-used oral therapies for mCRPC. Over 100 clinical sites in eight countries are actively screening patients for potential eligibility to participate in ARMOR3-SV. Enrollment in ARMOR3-SV is expected to be completed by the end of 2016, and top-line data from the trial are anticipated by mid-2017.
Expansion of galeterone clinical development program. In March, patient dosing began in an expansion of the ongoing Phase 2 clinical trial of galeterone (ARMOR2) in mCRPC patients who have developed acquired resistance to enzalutamide. This expansion follows results observed in a patient who, following an initial response to enzalutamide, experienced a PSA drop of over 90 percent when treated with galeterone. This patient’s PSA response has remained at less than 0.1µg/L for over a year.
Strengthening of development team. Tokai enhanced its development capabilities with the addition of Kelly A. Lindert, M.D., as Executive Vice President and Head of Development responsible for the company’s clinical development, medical affairs, pharmacovigilance, regulatory affairs and quality assurance activities.
Financial Results

Cash and investments at March 31, 2016 were $54.3 million, as compared to $64.0 million at December 31, 2015.
Research and development expense for the quarter ended March 31, 2016 was $7.9 million, as compared to $10.6 million for the quarter ended March 31, 2015. Research and development expense in the first quarter of 2015 included a one-time fee paid to Qiagen Manchester Limited to access rights to its proprietary circulating tumor cell technology for use in the AR-V7 clinical trial assay. The decrease in research and development expense was also attributable to decreased manufacturing costs during the first quarter of 2016, partially offset by an increase in clinical trial costs associated with ARMOR3-SV.
General and administrative expense for the quarter ended March 31, 2016 was $3.5 million, as compared to $2.7 million for the quarter ended March 31, 2015. The increase in general and administrative expense was primarily attributable to increased headcount associated with operating as a public company, including related stock-based compensation expense.
Net loss was $11.4 million for the quarter ended March 31, 2016, or $0.51 per share, as compared to $13.3 million for the quarter ended March 31, 2015, or $0.59 per share.

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Category: Uncategorized

ProNAi Therapeutics Reports First Quarter 2016 Results

CAR-T cell therapy

Takeda Reports Results for Fiscal Year 2015 (April 2015 -March 2016) and Forecast for Fiscal Year 2016

Vericel Reports First-Quarter 2016 Financial Results

Tokai Pharmaceuticals Reports First Quarter 2016 Financial Results