1stOncology™: Cancer Intelligence Service – Page 14337 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Vertex to Present at the Cowen Healthcare Conference on March 13

On March 12, 2018 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that management will present at the Cowen Healthcare Conference on Tuesday, March 13, 2018 at 12:00 p.m. ET (Press release, Vertex Pharmaceuticals, MAR 12, 2018, View Source [SID1234524687]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

The audio portion of management’s remarks will be available live through Vertex’s website, www.vrtx.com in the "Investors" section under the "News and Events" page. A replay of the conference webcast will be archived on the company’s website.

Varian Announces Second Quarter Fiscal Year 2018 Earnings Release Date

On March 12, 2018 Varian (NYSE: VAR) reported that it will report results for the second quarter of fiscal year 2018 after market close on Wednesday, April 25, 2018 (Press release, Varian Medical Systems, MAR 12, 2018, View Source [SID1234524685]). The news release will be followed by a teleconference available to all interested at 2:00 p.m. Pacific Time. To access the teleconference call and replay:

Teleconference: Access from within the U.S. by dialing 1-877-869-3847, and from outside the U.S. by dialing 1-201-689-8261.

Replay: Access from within the U.S. by dialing 1-877-660-6853 and from outside the U.S. by dialing 1-201-612-7415, and enter conference ID 13677574. The teleconference replay will be available until 8:00 p.m. ET, Friday, April 27, 2018.

Webcast: To access the live webcast and replay, visit the company website at: www.varian.com/investors and click on the link for Second Quarter Earnings Results.

For automatic e-mail alerts regarding Varian news and events, investors can subscribe on the company website: View Source

Teva to Present at the Cowen & Company 38th Annual Healthcare Conference

On March 12, 2018 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) will host a live audio webcast at the Cowen & Company 38th Annual Healthcare Conference in Boston, MA (Press release, Teva, MAR 12, 2018, View Source;p=RssLanding&cat=news&id=2337521 [SID1234524684]).

When:

Tuesday, March 13, 2018 at 11:20 AM ET

Who:

Michael McClellan, EVP & Chief Financial Officer
Teva Pharmaceutical Industries Ltd.

Where:

http://wsw.com/webcast/cowen46/teva

How:

Live over the Internet – log on to the Web at the address above and register for the event (approximately 10 minutes before). An archive of the webcast will be available on Teva’s Website at View Source

Syros Reports Fourth Quarter and Full Year 2017 Financial Results and Highlights Recent Accomplishments and Anticipated Milestones

On March 12, 2018 Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of genes, reported financial results for the fourth quarter and year ended December 31, 2017 and provided an update on recent accomplishments and planned upcoming events (Press release, Syros Pharmaceuticals, MAR 12, 2018, View Source [SID1234524683]).

"2017 was an important year for Syros, marked by clinical and preclinical data for SY-1425 and SY-1365 that lay a clear path forward for the further development of both programs," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "Additionally, our pioneering gene control platform continued to deliver, enabling us to expand our early-stage pipeline in cancer and monogenic diseases and enter into a collaboration with Incyte designed to allow us to benefit patients with diseases beyond our current areas of focus. We built on our strong foundation, adding to the leadership team and fortifying our cash position to fund our planned operations into 2020 and drive SY-1425 and SY-1365 to key value inflection points. As we enter 2018, we believe we are well-positioned to execute on our near-term and long-term goals to achieve our vision of becoming a fully integrated biopharmaceutical company with medicines that provide a profound and durable benefit for patients."

Upcoming Milestones

Syros plans to report clinical data in the fourth quarter of 2018 from a cohort in its ongoing Phase 2 trial evaluating SY-1425 in combination with azacitidine in RARA and IRF8 biomarker-positive newly diagnosed acute myeloid leukemia (AML) patients who are not suitable candidates for standard chemotherapy.
Syros plans to report clinical data in the fourth quarter of 2018 from a pilot cohort in its ongoing Phase 2 trial evaluating SY-1425 in combination with daratumumab in RARA and IRF8 biomarker-positive relapsed or refractory AML and higher-risk myelodysplastic syndrome (MDS) patients.
Syros plans to open expansion cohorts in mid-2018 in its ongoing Phase 1 trial of SY-1365 evaluating it as a single agent and in combination with carboplatin in multiple ovarian cancer patient populations. Based on emerging preclinical data showing anti-tumor activity of SY-1365 in hormone receptor-positive (HR-positive) breast cancer models, the Company announced today that it also plans to add an expansion cohort evaluating SY-1365 in combination with fulvestrant in HR-positive metastatic breast cancer patients who progress after treatment with a CDK4/6 inhibitor plus an aromatase inhibitor.
Syros plans to report clinical data in the fourth quarter of 2018 from the dose escalation portion of its ongoing Phase 1 trial of SY-1365 in advanced solid tumor patients.
Syros plans to select a new development candidate from its preclinical pipeline by the end of 2018.
Recent Platform and Pipeline Highlights

In January 2018, Syros announced that the U.S. Patent and Trademark Office issued two patents covering methods for stratifying patients with AML and MDS for treatment with SY-1425.
In January 2018, Syros announced a clinical supply agreement with Janssen Research and Development. Under the terms of the agreement, Janssen is supplying daratumumab for the combination dosing cohort in biomarker-positive relapsed or refractory AML and higher-risk MDS patients in Syros’ ongoing Phase 2 trial of SY-1425.
In December 2017, Syros presented initial clinical data from its ongoing Phase 2 trial of SY-1425 in biomarker-positive patients with AML and MDS at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, showing biological and clinical activity as a single agent and supporting ongoing development of SY-1425 in combination with other therapies:
Clinical activity was observed in 43% of evaluable relapsed or refractory AML and higher-risk MDS patients, including improvement in blood counts and reductions in bone marrow blasts.
Myeloid differentiation was observed, including the induction of CD38 in 85% of evaluable patients.
SY-1425 generally well-tolerated with chronic, daily dosing with the majority of adverse events being low grade.
In December 2017, Syros presented new preclinical data on SY-1365 at ASH (Free ASH Whitepaper). The data showed anti-tumor activity in leukemia and lymphoma cell lines and in vivo models of AML. Additionally, the data pointed to a potential biomarker of response to SY-1365 and demonstrated synergistic activity with venetoclax, a BCL2 inhibitor, in preclinical AML models.
In December 2017, Syros presented new preclinical data on SY-1365 at the San Antonio Breast Cancer Symposium (SABCS). The data demonstrated anti-tumor activity across a broad panel of breast cancer cell lines and pointed to potential biomarkers of response. Syros also presented on its analysis of regulatory regions of the genome in cancer stem cell-enriched triple negative breast cancer (TNBC) cell lines, which revealed key genes that may be involved in driving disease relapse and metastasis in TNBC and suggest potential new targets for future drug discovery and development.
Recent Corporate Highlights

Syros reported the appointment of Joseph J. Ferra as Chief Financial Officer.
In January 2018, Syros announced the closing of an underwritten public offering of 4,816,753 shares of common stock at a public offering price of $9.55 per share, including the exercise in full by the underwriters of their option to purchase additional shares of common stock. Syros received aggregate gross proceeds of approximately $46 million, before deducting underwriting discounts and commissions and estimated offering expenses. In connection with the offering, Incyte Corporation, exercised its right to purchase shares of Syros common stock directly from the company at the public offering price, in a concurrent private placement, resulting in proceeds of approximately $1.4 million.
In January 2018, Syros announced a global target discovery and validation collaboration with Incyte focused on myeloproliferative neoplasms (MPNs). Under the terms of the agreement, Syros will use its proprietary platform to identify novel therapeutic targets with a focus in MPNs. Incyte has options to obtain exclusive worldwide rights to intellectual property resulting from the collaboration for up to seven validated targets and, upon exercise of its options, will have exclusive worldwide rights to develop and commercialize any therapies under the collaboration that modulate those validated targets. Incyte paid Syros $10 million in upfront cash and purchased a total of $10 million in Syros common stock at a price of $12.61 per share. In addition, Syros could receive up to $54 million from Incyte in target validation and option exercise fees and up to $115 million in potential development, regulatory and commercial milestone payments per target for up to seven validated targets, plus low single-digit royalties on sales of products that result from the collaboration.
In November 2017, Syros announced the appointment of Jeremy P. Springhorn, Ph.D., as Chief Business Officer.
Fourth Quarter 2017 Financial Results

Cash, cash equivalents and marketable securities as of December 31, 2017 were $72.0 million, compared with $83.6 million on December 31, 2016. Cash, cash equivalents and short-term investments as of December 31, 2017 do not include the aggregate gross proceeds of approximately $46 million from Syros’ underwritten public offering of common stock, which closed in February 2018, the $1.4 million in proceeds from the private placement of stock with Incyte concurrent with the public offering, or the $10 million upfront payment and purchase of $10 million in Syros common stock received in January 2018 in connection with entry into the collaboration with Incyte.

For the fourth quarter of 2017, Syros reported a net loss of $15.3 million, or $0.58 per share, compared to a net loss of $11.0 million, or $0.47 per share, for the same period in 2016. Stock-based compensation included in the net loss was $1.3 million for the fourth quarter of 2017, compared to $0.7 million for the same period in 2016.

Research and development (R&D) expenses were $11.8 million for the fourth quarter of 2017, as compared to $8.4 million for the same period in 2016. Stock-based compensation included in R&D expenses was $0.5 million for the fourth quarter of 2017, compared to $0.2 million for the same period in 2016.
General and administrative (G&A) expenses were $3.7 million for the fourth quarter of 2017, as compared to $2.9 million for the same period in 2016. Stock-based compensation included in G&A expenses was $0.8 million for the fourth quarter of 2017, compared to $0.5 million for the same period in 2016.
Full Year 2017 Financial Results

For the full year ended December 31, 2017, net loss was $54.0 million, or $2.13 per share, as compared to a net loss of $47.7 million, or $4.05 per share, for the same period in 2016. Stock based compensation included in the net loss was $4.4 million for the year ended December 31, 2017, compared to $4.2 million for the same period in 2016.

R&D expenses were $41.9 million for the year ended December 31, 2017, as compared to $37.8 million for the same period in 2016. The increase was due to an increase in expenses from third parties that conduct research and development and preclinical activities on our behalf, including an increase in clinical development costs for SY-1425 and SY-1365, offset by a decrease in preclinical development work for SY-1365 as toxicology studies were completed and the Phase 1 clinical trial was initiated. Stock-based compensation included in R&D expenses was $1.7 million for the year ended December 31, 2017, compared to $3.0 million for the same period in 2016.
G&A expenses were $13.9 million for the year ended December 31, 2017, as compared to $10.5 million for the same period in 2016. The increase was largely due to an increase in employee-related costs, including salary, benefits and stock-based compensation, as well as increased consulting, licensing, and professional fees to support the overall growth of the Company. Stock-based compensation included in G&A expenses was $2.7 million for the year ended December 31, 2017, compared to $1.2 million for the same period in 2016.
Financial Guidance

Based on its current plans, Syros believes that its cash, cash equivalents and short-term investments as of December 31, 2017, together with cash received in connection with entry into the collaboration with Incyte and the underwritten public offering and concurrent private placement of common stock that closed in February 2018, will be sufficient to enable it to fund its planned operating expense and capital expenditure requirements into 2020.

Merrimack Provides Business Update and Reports 2017 Financial Results

On March 12, 2018 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK), a clinical-stage oncology company focused on biomarker-defined cancers, reported its fourth quarter and full year 2017 financial results for the period ended December 31, 2017 (Press release, Merrimack, MAR 12, 2018, View Source [SID1234524679]).

"2017 was a transformative year for Merrimack, in which we reset the company’s foundation to focus on our ten wholly owned clinical and preclinical programs, all targeting biomarker-defined cancers. We are very pleased with the advancements we have made across our pipeline, including today’s announcement to expand enrollment in the SHERLOC study, a randomized Phase 2 trial evaluating MM-121 in non-small cell lung cancer, and our recent dosing of the first patient in the SHERBOC study, a randomized Phase 2 trial evaluating MM-121 in post-menopausal metastatic breast cancer," said Richard Peters, M.D., Ph.D., President and Chief Executive Officer. "We are well-positioned to carry this momentum forward, with three clinical readouts expected in 2018, including randomized Phase 2 data from MM-141 and MM-121 and Phase 1 data from MM-310."

Fourth Quarter and Recent Highlights

Key events from the fourth quarter and more recently include:

As announced separately today, expansion of the enrollment target from 80 to 100 patients in the SHERLOC study, a randomized Phase 2 clinical trial evaluating MM-121 added to standard of care in patients with heregulin-positive non-small cell lung cancer. This augmentation of patient enrollment is driven by the faster than projected enrollment rate seen to date and will result in a strengthened statistical design of the study. Merrimack still expects to report top-line data from this trial in the second half of 2018;

First patient dosed in the SHERBOC study, a randomized, double-blind, placebo-controlled Phase 2 clinical trial evaluating MM-121 added to standard of care in patients with heregulin-positive, hormone-receptor-positive and HER2-negative post-menopausal metastatic breast cancer;

Appointment of George Demetri, M.D., to Merrimack’s Board of Directors. Dr. Demetri is currently a Senior Vice President for Experimental Therapeutics and Director of the Center for Sarcoma and Bone Oncology at Dana-Farber Cancer Institute, as well as a Professor of Medicine at Harvard Medical School, where he is also Co-Director of the Ludwig Center. He is a world-renowned expert in the clinical translation of innovative treatment strategies for cancer, and replaces John Mendelsohn, M.D., who had served on Merrimack’s Board since 2012;
Formation of a new Scientific Advisory Board (SAB) with extensive expertise in precision oncology, bioengineering, drug discovery and clinical development. Members include: Peter Blume-Jensen, M.D., Ph.D.; George Demetri, M.D.; Douglas Lauffenburger, Ph.D.; Peter Sorger, Ph.D.; and Josep Tabernero, M.D., Ph.D. The SAB will work closely with Merrimack’s senior management team to advance the company’s pipeline of targeted cancer therapies; and

Financially, closure of 2017 with $93.4 million in cash and cash equivalents and extinguishment of $60.8 million of convertible debt in the fourth quarter of 2017, resulting in a debt-free balance sheet.
Upcoming Milestones:

Merrimack anticipates the following upcoming clinical milestones:

Top-line results in the first half of 2018 from the CARRIE study, a randomized Phase 2 clinical trial evaluating MM-141, a bispecific antibody targeting the IGF-1 and HER3 receptors, added to standard of care in patients with front-line metastatic pancreatic cancer who have high serum levels of free IGF-1;

Top-line results in the second half of 2018 from the SHERLOC study, a randomized Phase 2 clinical trial evaluating MM-121, a fully human monoclonal antibody targeting the HER3 receptor, added to standard of care in patients with heregulin positive non-small cell lung cancer; and

Safety data and maximum tolerated dose in the second half of 2018 from the Phase 1 clinical study of MM-310, an antibody-directed nanotherapeutic (ADN) targeting the EphA2 receptor, in patients with solid tumors.
Fourth Quarter and Full Year 2017 Financial Results

The following summarizes Merrimack’s financial results for the three months and year ended December 31, 2017:

Research and development expenses from continuing operations for the three months ended December 31, 2017 were $12.4 million, compared to $25.6 million for the three months ended December 31, 2016. Research and development expenses from continuing operations for the year ended December 31, 2017 were $67.3 million, compared to $109.6 million for the year ended December 31, 2016. Research and development spending for the three months and year ended December 31, 2017 was less than expenditures over comparable periods in 2016, primarily due to Merrimack’s refocused clinical and preclinical pipeline;

General and administrative expenses for the three months ended December 31, 2017 from continuing operations were $4.7 million, compared to $11.0 million for the three months ended December 31, 2016. General and administrative expenses for the year ended December 31, 2017 from continuing operations were $28.5 million, compared to $32.1 million for the year ended December 31, 2016. General and administrative spending for the three months and year ended December 31, 2017 was less than expenditures over comparable periods in 2016, primarily due to a decrease in corporate expenses related to reduced headcount levels and stock-based compensation following the asset sale to Ipsen S.A.;

Net loss attributable to Merrimack’s continuing operations for the three months ended December 31, 2017 was $11.8 million, or $0.89 per share, compared to a net loss attributable to Merrimack’s continuing operations of $40.1 million, or $2.93 per share, for the three months

ended December 31, 2016. Net loss attributable to Merrimack’s continuing operations for the year ended December 31, 2017 was $74.8 million, or $5.66 per share, compared to a net loss attributable to Merrimack’s continuing operations of $154.5 million, or $12.33 per share, for the year ended December 31, 2016; and

As of December 31, 2017, Merrimack had 13.3 million shares of common stock, $0.01 par value per share, outstanding.
Financial Outlook

Merrimack continues to believe that its cash and cash equivalents of $93.4 million as of December 31, 2017 and potential net milestone payments anticipated from Shire will be sufficient to fund its planned operations into the second half of 2019.

Conference Call and Webcast

Merrimack will host a live conference call and webcast today, Monday, March 12, 2018 at 8:30 am ET, to provide an update on its operational progress and a summary of these financial results.

Investors and the general public are invited to listen to the call by dialing (877) 564-1301 (domestic) or (224) 357-2394 (international) five minutes prior to the start of the call and providing the passcode 8074029. A listen-only webcast of the call can be accessed in the Investors section of Merrimack’s website, investors.merrimack.com, and a replay of the call will be archived there for six weeks following the call.