CymaBay Therapeutics to Participate in Upcoming Investor Conferences in March

On March 5, 2018 CymaBay Therapeutics, Inc. (Nasdaq:CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported that management will participate in upcoming investor conferences, including the 30th Annual ROTH Conference, the H.C. Wainwright 2nd Annual NASH Investor Event, and the Oppenheimer & Company 28th Annual Healthcare Conference (Press release, CymaBay Therapeutics, MAR 5, 2018, View Source [SID1234524415]).

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30th Annual ROTH Conference 2018
Date: Monday, March 12
Time: 9am Pacific Time
Location: Ritz Carlton, Laguna Niguel, CA

H.C. Wainwright 2nd Annual NASH Investor Event
Date: Monday, March 19
Time: 9:20am Eastern Time
Location: St. Regis Hotel, New York, NY
Webcast: View Source

Oppenheimer & Company 28th Annual Healthcare Conference
Date: Tuesday, March 20
Time: 9:10am Eastern Time
Location: Westin New York Grand Hotel, NY
Webcast: View Source

ArQule Reports Fourth Quarter and Full Year 2017 Financial Results

On March 5, 2018 ArQule, Inc. (NASDAQ: ARQL) reported its financial results for the fourth quarter and full year of 2017 (Press release, ArQule, MAR 5, 2018, View Source [SID1234524407]).

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For the quarter ended December 31, 2017, the Company reported a net loss of $7,760,000 or $0.09 per share, compared with net loss of $6,820,000 or $0.10 per share, for the quarter ended December 31, 2016. The Company reported a net loss of $29,203,000 or $0.39 per share, for the year ended December 31, 2017, compared with a net loss of $22,718,000 or $0.33 per share, for the year ended December 31, 2016.

At December 31, 2017, the Company had a total of approximately $48,036,000 in cash and marketable securities.

Key Highlights

ARQ 531, orally bioavailable, potent and reversible BTK inhibitor, is recruiting on schedule in the phase 1a trial. Initial phase 1a data will be presented at American Association for Cancer Research (AACR) (Free AACR Whitepaper) which will be held April 14 through April 18, 2018.
Miransertib, lead proprietary AKT inhibitor, is recruiting at three sites for Overgrowth Diseases. The phase 1/2 trial for Overgrowth Diseases evaluating patients with PROS and Proteus syndrome, age two and older in the U.S. and EU, continues to dose.
Data supporting miransertib in combination with the aromatase inhibitor, anastrozole, for the treatment of advanced endometrial cancer will be presented at AACR (Free AACR Whitepaper). Phase 1b trial conducted at Memorial Sloan Kettering presents potential clinical path forward in this hard to treat disease setting.
Derazantinib, a pan-FGFR inhibitor, continues to enroll on schedule in a registrational trial for FGFR2 fusion driven intrahepatic cholangiocarcinoma (iCCA). The recruitment of patients needed to perform the interim analysis is expected to be completed by year-end.
ArQule has granted a Roivant Sciences Ltd. subsidiary an exclusive license to develop and commercialize derazantinib in the People’s Republic of China, Hong Kong, Macau, and Taiwan. Deal terms include an upfront payment to ArQule of $3 million and an additional $2.5 million development milestone within the first year. ArQule is also eligible for regulatory and commercial milestones and royalties on future sales of derazantinib in Greater China.
2018 Goals

ARQ 531 – BTK Inhibitor

Complete phase 1a trial in refractory B-cell malignancies
Publish foundational pre-clinical paper including chemical and crystal structure
Present initial phase 1a data at AACR (Free AACR Whitepaper) and additional data later this year
Miransertib – AKT Inhibitor Rare Diseases

Initiate registrational program in Proteus syndrome
Publish NIH phase 1 trial findings and compassionate use case reports
Miransertib and ARQ 751 – AKT Inhibitors Oncology

Present data from phase 1b in oncology for miransertib
Present data from phase 1a in oncology for ARQ 751
Derazantinib – FGFR Inhibitor

Complete dosing of patients needed to conduct interim analysis in registrational trial in 2nd line iCCA
Explore opportunities in additional tumor types
"During 2017 we have worked diligently to advance all the assets in our proprietary pipeline, and we are now in the position to make 10 presentations at AACR (Free AACR Whitepaper) in April demonstrating our commitment to precision medicine," said Paolo Pucci, Chief Executive Officer of ArQule. "2018 has the prospect of being a pivotal year for ArQule as we see a complete data set from the phase 1a trial of our BTK inhibitor, ARQ 531, launch a registrational program in Proteus syndrome, and explore emerging late-stage opportunities in oncology with our AKT program."

"For ArQule the scientific highlights of 2017 were achieving, in collaboration with the NIH, clinical proof of concept with miransertib in Proteus syndrome, initiating a registrational trial with derazantinib and initiating a phase 1 trial for ARQ 531," said Dr. Brian Schwartz, M.D., Head of Research and Development and Chief Medical Officer at ArQule. "Consistent with our strategy we are now preparing to launch a registrational program for Proteus syndrome, as well as continuing with our ongoing trials for our BTK inhibitor, ARQ 531, and derazantinib. In addition, the data to be presented at AACR (Free AACR Whitepaper) for miransertib in combination with anastrozole will highlight a new opportunity."

Revenues and Expenses

Revenues for the quarter ended December 31, 2017, were zero, compared with revenues of $1,187,000 for the quarter ended December 31, 2016. Revenues for the year ended December 31, 2017 were zero compared with revenues of $4,709,000 for the year ended December 31, 2016. Research and development revenue in 2016 includes revenue from the Daiichi Sankyo tivantinib development agreement and the Kyowa Hakko Kirin exclusive license agreement.

Research and development expenses in the fourth quarter of 2017 were $4,721,000, compared with $6,242,000 for the fourth quarter 2016. Fiscal 2017 research and development expenses were $19,468,000 compared with $20,042,000 for fiscal 2016.

Research and development expense decreased $1.5 million in the fourth quarter of 2017 compared to the fourth quarter of 2016 primarily due to lower outsourced clinical and product development costs of $1.0 million, professional fees of $0.3 million and labor related costs of $0.2 million. Research and development expense decreased $0.6 million in 2017 primarily due to lower labor costs.

General and administrative expenses in the fourth quarter of 2017 were $1,849,000, compared with $1,808,000 for the fourth quarter of 2016. General and administrative expenses for fiscal 2017 were $7,551,000, compared to $7,563,000 for fiscal 2016.

2018 Financial Guidance

For 2018, ArQule expects revenue to range between $3 and $4 million. Net use of cash is expected to range between $26 and $28 million for the year. Net loss is expected to range between $27 and $30 million, and net loss per share to range between $(0.30) and $(0.34) for the year. ArQule expects to end 2018 with between $23 and $25 million in cash and marketable securities.

Conference Call and Webcast

ArQule will hold its fourth quarter and full year financial results call today, March 5, 2018 at 9:00 a.m. ET. The live webcast can be accessed in the "Investors and Media" section of our website, www.arqule.com, under "Events and Presentations." You may also listen to the call by dialing (877) 868-1831 within the U.S. or (914) 495-8595 outside the U.S. A replay will be available two hours after the completion of the call and can be accessed in the "Investors and Media" section of our website, www.arqule.com, under "Events and Presentations."

VistaGen Therapeutics to Present at Oppenheimer’s 28th Annual Healthcare Conference on March 21, 2018

On March 5, 2018 VistaGen Therapeutics Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for depression and other central nervous system (CNS) disorders, reported that Shawn Singh, Chief Executive Officer, will present at Oppenheimer’s 28th Annual Healthcare Conference in New York City at 8:00 a.m. Eastern Time on Wednesday, March 21, 2018 (Press release, VistaGen Therapeutics, MAR 5, 2018, View Source [SID1234524401]).

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For more information about the conference, or to schedule a one-on-one meeting with VistaGen’s management, please contact your Oppenheimer representative directly, or visit the conference website: View Source

Vericel Reports Fourth Quarter and Year End 2017 Financial Results and Provides Full Year 2018 Financial Guidance

On March 5, 2018 Vericel Corporation (NASDAQ:VCEL), a leader in advanced cell therapies for the sports medicine and severe burn care markets, reported financial results and business highlights for the fourth quarter and year ended December 31, 2017 and full year 2018 financial guidance (Press release, Vericel, MAR 5, 2018, View Source [SID1234524400]).

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Fourth Quarter 2017 Financial Highlights

Total net revenues increased 41% to $23.4 million compared to $16.5 million in the fourth quarter of 2016; excluding license revenue, net revenue increased 34% to $22.2 million;

Gross margins of 64% compared to gross margins of 54% in the fourth quarter of 2016;

Operating income of $1.2 million, compared to operating loss of $5.9 million in the fourth quarter of 2016;

Net income of $0.3 million, or $0.01 per share, compared to net loss of $6.2 million, or $0.34 per share, in the fourth quarter of 2016; and

•As of December 31, 2017, the company had $26.9 million in cash compared to $23.0 million in cash at December 31, 2016.
Full Year 2017 Financial Highlights

•Total net revenue increased 18% to $63.9 million compared to $54.4 million in 2016; excluding license revenue, net revenue increased 15% to $62.8 million;

•Gross margins of 53% compared to gross margins of 48% in 2016;

•Operating loss of $15.0 million, compared to operating loss of $19.2 million in 2016; and

•Net loss of $17.3 million, or $0.52 per share, compared to net loss of $19.6 million, or $1.18 per share, in 2016.

Recent Business Highlights
During and since the fourth quarter of 2017, the company:

•Achieved record fourth quarter revenues and the third straight quarter of 30% or greater revenue growth versus the same quarter of the prior year;

•Trained approximately 600 surgeons on the MACI (autologous cultured chondrocytes on porcine collage membrane) surgical procedure to date;

Increased MACI biopsies 48% in the fourth quarter of 2017 compared to the same period in 2016, the second consecutive quarter with over 40% growth versus the same quarter of the prior year;

Expanded the MACI sales force from 28 to 40 sales territories;

Achieved significant growth in burn centers utilizing Epicel (cultured epidermal autografts), with 40 burn centers utilizing Epicel in 2017 compared to 20 centers in 2014 when the business was acquired;

•Launched the MACI "It’s Your Move" campaign with world champion swimmer, five-time Olympian, best-selling author and recent MACI patient Dara Torres to empower patients with knee pain to seek treatment;

•Entered into an expanded $25 million debt facility providing approximately $8 million of incremental capital; and

•Initiated collaboration with Innovative Cellular Therapeutics (ICT), receiving $5.1 million for the purchase of warrants and an upfront license fee.
"We had record fourth quarter revenues and achieved both positive operating income and net income for the quarter, an important milestone for the company," said Nick Colangelo, president and CEO of Vericel. "Our record fourth quarter revenues represent the third straight quarter of 30% or higher revenue growth compared to the same quarter of the prior year, and this strong growth and margin expansion were driven by both the accelerating uptake of MACI as well as substantial growth for Epicel in the quarter."
Fourth Quarter 2017 Results
Total net revenues for the quarter ended December 31, 2017 were $23.4 million, which included $16.1 million of MACI net revenue and $6.1 million of Epicel net revenue, compared to $12.8 million of Carticel (autologous cultured chondrocytes) net revenue and $3.8 million of Epicel net revenue, respectively, in the fourth quarter of 2016. Total net revenues for the quarter ended December 31, 2017 also included $1.2 million in license revenue related to the company’s collaboration agreement with ICT. Total net revenues increased 41% compared to the fourth quarter of 2016, with MACI revenue increasing 26% and Epicel revenue increasing 62%, respectively, compared to the same period in 2016. Excluding license revenue, net revenues increased 34% compared to the fourth quarter of 2016.
Gross profit for the quarter ended December 31, 2017 was $15.0 million, or 64% of net revenues, compared to $8.9 million, or 54% of net revenues, for the fourth quarter of 2016.
Total operating expenses for the quarter ended December 31, 2017 were $13.8 million compared to $14.8 million for the same period in 2016. Operating expenses for the quarter

December 31, 2016 included $2.6 million from the write-off of commercial use rights related to Carticel. Given the approval of MACI in December 2016 and the replacement of Carticel with MACI, it was determined that the Carticel-related intangible asset was fully impaired as of December 31, 2016. Excluding the impairment, the increase in fourth quarter operating expenses is primarily due to an increase in the MACI sales force during 2017 as well as case management services to support MACI.
Income from operations for the quarter ended December 31, 2017 was $1.2 million, compared to a loss of $5.9 million for the fourth quarter of 2016. Material non-cash items impacting the operating income for the quarter included $0.7 million of stock-based compensation expense and $0.4 million in depreciation expense.
Other expense for the quarter ended December 31, 2017 was $0.9 million compared to $0.3 million for the same period in 2016. The change in other expense for the quarter is primarily due to the loss on extinguishment of debt associated with the expanded long-term debt facility which closed in December 2017.
Vericel’s net income for the quarter ended December 31, 2017 was $0.3 million, or $0.01 per share, compared to a net loss of $6.2 million, or $0.34 per share, for the same period in 2016.
Full Year 2017 Results
Total net revenues for the year ended December 31, 2017 were $63.9 million, including $43.9 million of Carticel and MACI net revenues, $18.9 million of Epicel net revenue and $1.2 million in license revenue. Total net revenues for the year ended December 31, 2017 increased 18% over 2016.
Gross profit for the year ended December 31, 2017 was $33.6 million, or 53% of net revenues, compared to $26.1 million, or 48% of net revenues, for the year ended December 31, 2016.
Total operating expenses for the year ended December 31, 2017 were $48.6 million compared to $45.3 million in 2016. Operating expenses for the year ended December 31, 2016 included $2.6 million from the write-off of commercial use rights related to Carticel. The increase in operating expenses during 2017 is primarily due to an increase in the MACI sales force, expenses for marketing initiatives related to the launch of MACI, and an increase in case management services to support MACI.
Loss from operations for the year ended December 31, 2017 was $15.0 million, compared to a loss of $19.2 million in 2016. Material non-cash items impacting the operating loss for the year included $2.7 million of stock-based compensation expense and $1.6 million in depreciation expense.
Other expense for the year ended December 31, 2017 was $2.3 million compared to $0.3 million in 2016. The change in other expense is primarily due to the loss on extinguishment of debt associated with the expanded long-term debt facility which closed in December 2017 and the interest expense related to the outstanding revolver and credit term loans.

3

Vericel’s net loss for the year ended December 31, 2017 was $17.3 million, or $0.52 per share, compared to a net loss of $19.6 million, or $1.18 per share, in 2016.
As of December 31, 2017, the company had $26.9 million in cash compared to $23.0 million in cash at December 31, 2016.
Full Year 2018 Financial Guidance
The company expects total net product revenues for the full year 2018, excluding additional license revenue, to be in the range of $73 million to $78 million compared to total net product revenue, excluding license revenue, of $62.8 million in 2017. The company also expects the seasonality of MACI and Epicel revenues for 2018 to be in line with prior years, wherein total product quarterly revenues were, on average, 21%, 25%, 21%, and 33% in the first through the fourth quarters.
"We successfully executed the launch of MACI and expanded Epicel utilization in 2017," added Mr. Colangelo. "These successes, combined with a strong balance sheet and an expanded sales force in 2018, have positioned the company for continued strong revenue growth in the years ahead."
Conference Call Information
Today’s conference call will be available live at 8:30am Eastern time in the Investor Relations section of the Vericel website at View Source." target="_blank" title="View Source." rel="nofollow">View Source Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software if necessary. To participate in the live call by telephone, please call (877) 312-5881 and reference Vericel Corporation’s fourth-quarter 2017 earnings call. If calling from outside the U.S., please use the international phone number (253) 237-1173.
If you are unable to participate in the live call, the webcast will be available at View Source until March 5, 2019. A replay of the call will also be available until 11:30am (EST) on March 10, 2018 by calling (855) 859-2056, or from outside the U.S. (404) 537-3406. The conference ID is 4899311.

Synlogic to Webcast Presentation at the Cowen and Company 38th Annual Health Care Conference

On March 5, 2018 Synlogic(Nasdaq:SYBX) reported that JC Gutiérrez-Ramos, Ph.D., Synlogic’s president and chief executive officer, will present a corporate update at the Cowen and Company 38th Annual Health Care Conference at 3:30 p.m. ET on Monday, March 12, 2018, in Boston, MA (Press release, Synlogic, MAR 5, 2018, View Source [SID1234524399]).

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A live webcast of the presentation can be accessed under "Event Calendar" in the Investors & Media section of the Company’s website. An archived webcast recording will be available on the Synlogic website for approximately 30 days after the event.