On March 8, 2018 Servier, Pfizer Inc. (NYSE: PFE) and Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Euronext Growth: ALCLS – Nasdaq: CLLS), reported that results from the two phase 1 trials with UCART19, the allogeneic anti-CD19 CAR T-cell product being developed by Servier and Pfizer, will be presented during the European society for Blood and Marrow Transplantation (EBMT) Annual Meeting to be held from March 18 to 21, 2018 in Lisbon, Portugal (Press release, Cellectis, MAR 8, 2018, View Source [SID1234524556]).

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Results from the CALM (UCART19 in Advanced Lymphoid Malignancies) study will be presented during an oral session by Reuben Benjamin, MD, PhD, Principal Investigator and consultant hematologist at King’s College Hospital, London, United Kingdom, on March 21, 2018 at 9:30 am (Room 5A). The CALM study is an open label, dose-escalation study designed to evaluate safety, tolerability and antileukemic activity of UCART19 in adult patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).

Presentation title: First-in-human study with UCART19, an allogeneic anti-CD19 car T-cell product, in high-risk adult patients with CD19+ R/R B-cell ALL: preliminary results of CALM study1

The PALL (Pediatric Acute Lymphoblastic Leukemia) study is a phase 1, open label, study to evaluate the safety and the ability of UCART19 to induce molecular remission in pediatric patients with relapsed or refractory B-ALL. PALL was initiated in the UK in June 2016. Paul Veys, MD, PhD, Director of the Bone Marrow Transplant Unit at Great Ormond Street Hospital (GOSH), London, United Kingdom, will share data during an oral session on March 21, 2018 at 11:40 am (Auditorium IV).

Presentation title: Gene-edited allogeneic CAR19 T-cells (UCART19) induce molecular remission ahead of allo-sct in high risk pediatric patients with CD19+ relapsed/refractory B-cell Acute Lymphoblastic Leukemia2

Servier is the sponsor of both studies. In 2015, Servier acquired exclusive rights from Cellectis for UCART19, which is being codeveloped by Servier and Pfizer.

1 & 2 Abstracts are available on the EBMT website: View Source

About UCART19

UCART19 is an allogeneic CAR T-cell product candidate being developed for treatment of CD19-expressing hematological malignancies, gene edited with TALEN. UCART19 is initially being developed in acute lymphoblastic leukemia (ALL) and is currently in Phase I. The current approach with UCART19 is based on the preliminary positive results from clinical trials using autologous products based on the CAR technology. UCART19 has the potential to overcome the limitation of the current autologous approach by providing an allogeneic, frozen, "off-the-shelf" T cell based medicinal product.

In November 2015, Servier acquired the exclusive rights to UCART19 from Cellectis. Following further agreements, Servier and Pfizer began collaborating on a joint clinical development program for this cancer immunotherapy. Pfizer has been granted exclusive rights by Servier to develop and commercialize UCART19 in the United States, while Servier retains exclusive rights for all other countries.

About Servier

Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). With a strong international presence in 148 countries and a turnover of 4.152 billion euros in 2017, Servier employs 21,600 people worldwide. Entirely independent, the Group reinvests 25% of its turnover (excluding generic drugs) in research and development and uses all its profits for development. Corporate growth is driven by Servier’s constant search for innovation in five areas of excellence: cardiovascular, immune-inflammatory and neuropsychiatric diseases, cancer and diabetes, as well as by its activities in high-quality generic drugs.

More information: www.servier.com

Pfizer Inc.: Working together for a healthier world

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube, and like us on Facebook at Facebook.com/Pfizer.

PFIZER DISCLOSURE NOTICE

The information contained in this release is as of March 7, 2018. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about a product candidate, UCART19, including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated trial commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing clinical data; whether and when drug applications may be filed for UCART19 with regulatory authorities in any jurisdiction; whether and when any such applications may be approved by regulatory authorities, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted and, if approved, whether UCART19 will be commercially successful; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of UCART19; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 10-Q and Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

On March 8, 2018 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers for patient enrichment, today reported financial results and provided a corporate update for the quarter and year ended December 31, 2017 (Press release, Jounce Therapeutics, MAR 8, 2018, View Source [SID1234524974]).

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"2017 was an important year of execution for Jounce, and our first year as a publicly-traded company. Our corporate progress this past year started with our initial public offering in January 2017 and expanded to the growth of our team and Board as well as our capabilities to support our broader pipeline mission. On the clinical front, we executed on the development of our lead program, JTX-2011, achieving several milestones," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "We continue to make progress towards realizing our vision of transforming the treatment of cancer by delivering first-in-class immunotherapies that provide long-lasting benefits. With this tenet guiding our long-term growth, our goal is to leverage the great progress we have made to date and execute on our key value drivers for 2018."

Clinical and Research Highlights:
Phase 1/2 ICONIC Trial

The Phase 1/2 ICONIC trial remains on track and preliminary efficacy data are expected to be reported in the second quarter of 2018.

Two of the Phase 2 combination cohorts in the ICONIC trial, gastric cancer and triple negative breast cancer (TNBC), have met the target enrollment with completion of at least one efficacy assessment. The preliminary efficacy data have been submitted as an abstract for the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The abstract includes both monotherapy and combination preliminary efficacy data from these two tumor types. These data are expected to mature between the abstract submission date and the ASCO (Free ASCO Whitepaper) meeting, and therefore the Company expects to provide data on additional patients, longer-term follow-up, and additional biomarker information.

In 2018, the JTX-2011 program is expected to expand by initiating a new combination study within the adaptive ICONIC trial. While continuing to evaluate combination cohorts with a PD-1 inhibitor, a new combination is expected to begin with JTX-2011 and a CTLA-4 inhibitor. The Company believes that the inducible nature of ICOS, or Inducible T cell CO-Stimulator, will be a potential cornerstone of Jounce’s strategy in combination trials. By combining with other approved therapies, JTX-2011 may potentially maximize the benefit of immunotherapeutic approaches across a broad spectrum of indications.

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JTX-4014

Jounce remains on track to file an Investigational New Drug, or IND, in 2018 for JTX-4014, its internal anti-PD-1 antibody. The Company views JTX-4014 as an important component of its pipeline given its belief that combination therapy will be a mainstay of cancer immunotherapy.

Next Development Candidate

Jounce continues to focus on its discovery programs both within and outside of its Celgene collaboration. The first tumor associated macrophage candidate, coming from Jounce’s Translational Science Platform, has advanced into IND-enabling activities. Therapies targeting these innate immune cells may potentially complement existing T cells-focused approaches, thereby providing benefit to patients with less inflamed or colder tumors.

Corporate Highlights:

In December 2017, Jounce was added to the NASDAQ Biotechnology Index as a result of meeting the eligibility requirements, including minimum market capitalization and average daily trading volume, among other criteria.

Fourth Quarter and Full Year 2017 Financial Results:

Cash Position: As of December 31, 2017, cash, cash equivalents and investments were $257.9 million, compared to $257.4 million as of December 31, 2016. This increase was primarily due to the $106.4 million in net proceeds from Jounce’s initial public offering (IPO), offset by operating costs during the year. Overall, Jounce utilized $105.9 million in net cash for the full year 2017.

Collaboration Revenue: Collaboration revenue was $13.0 million for the fourth quarter of 2017, compared to $20.3 million for the same period in 2016 and $71.6 million for the full year 2017, compared to $37.2 million for the same period in 2016. Collaboration revenue represents the revenue recognition relating to the $225.0 million upfront payment received in July 2016 upon the execution of Jounce’s global strategic collaboration with Celgene.

Research and Development (R&D) Expenses: R&D expenses were $18.6 million for the fourth quarter of 2017, compared to $10.7 million for the same period in 2016 and $67.8 million for the full year 2017, compared to $34.9 million for the same period in 2016. The increase in R&D expenses for both the fourth quarter of 2017 and the full year 2017 was due to increased employee compensation costs related to increased headcount, clinical costs related to the Phase 1/2 ICONIC trial of JTX-2011 and external research and development costs, primarily attributable to the manufacture of clinical trial materials and related activities.

General and Administrative (G&A) Expenses: G&A expenses were $6.0 million for the fourth quarter of 2017, compared to $4.7 million for the same period in 2016 and $23.1 million for the full year 2017, compared to $16.8 million for the same period in 2016. The increase in G&A expenses for both the fourth quarter of 2017 and the full year 2017 was primarily due to increased employee compensation costs related to increased headcount, facilities costs and other costs attributable to operating as a public company. In addition, the increase in G&A expenses for the full year 2017 was offset by $2.0 million of legal and accounting costs written off during 2016 as a result of the postponement of the IPO. The IPO was originally postponed for a period significantly

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in excess of 90 days, and as a result, the previously-capitalized costs were written off to G&A expenses.

Net (Loss) Income: Net loss was $9.4 million for the fourth quarter of 2017, or a basic and diluted net loss per share attributable to common stockholders of $0.29. Net income was $5.5 million for the same period in 2016, or basic net income per share attributable to common stockholders of $0.11 and diluted net income per share attributable to common stockholders of $0.05. The change is primarily attributable to operating income recognized for the fourth quarter of 2016 as compared to an operating loss incurred for the fourth quarter of 2017. Net loss was $16.4 million for the full year 2017, or a basic and diluted net loss per share attributable to common stockholders of $0.57 compared to $13.7 million for same period in 2016, or a basic and diluted net loss per share attributable to common stockholders of $11.00. The decrease in net loss per share attributable to common stockholders is primarily due to an increase in shares of common stock outstanding post-IPO.

Financial Guidance:
Based on its current plans, Jounce expects cash burn on operating expenses and capital expenditures for the full year 2018 to be approximately $80.0 million to $100.0 million. The Company expects to record approximately $50.0 million to $60.0 million in collaboration revenue in 2018 from the continued recognition of the Celgene upfront payment received in 2016.

Given the strength of its balance sheet, Jounce continues to expect its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements for at least the next 24 months.

Conference Call and Webcast Information:
Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 6198947. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days.

Cautionary Note Regarding Forward-Looking Statements:
Various statements in this release concerning Jounce’s future expectations, plans and prospects, including without limitation, Jounce’s expectations regarding operating expenses, capital expenditures, collaboration revenue and other financial results, release of data from the Phase 1/2 ICONIC trial, expansion of the JTX-2011 program, the filing of an IND for JTX-4014 and the timing, progress and results of preclinical studies and clinical trials for Jounce’s product candidates and any future product candidates may constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward looking statements, which often include words such as "anticipate," "believe," "estimate," "expect," "intend," "may," "on track," "plan," "predict," "target," "potential" or similar terms, variations of such terms or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Actual results may

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differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Jounce’s ability to successfully demonstrate the efficacy and safety of its product candidates and future product candidates, the preclinical and clinical results for its product candidates, which may not support further development and marketing approval, the potential advantages of Jounce’s product candidates, the development plans of its product candidates, actions of regulatory agencies, which may affect the initiation, timing and progress of pre-clinical studies and clinical trials of its product candidates, Jounce’s ability to obtain, maintain and protect its intellectual property, Jounce’s ability to manage operating expenses, Jounce’s ability to maintain its collaboration with Celgene, as well as those risks more fully discussed in the section entitled "Risk Factors" in Jounce’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission as well as discussions of potential risks, uncertainties, and other important factors in Jounce’s subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise

On March 8, Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX), ("Foamix"), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, reported that David Domzalski, Chief Executive Officer, will present a corporate overview and business update at the Barclays Global Healthcare Conference 2018, taking place March 13-15 at the Lowe’s Miami Beach Hotel in Miami, Florida (Press release, Foamix, MAR 8, 2018, View Source [SID1234524539]).

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Barclays Global Healthcare Conference 2018
Date: Wednesday, March 14
Time: 10:45am Eastern Time
Location: Lowe’s Miami Beach Hotel
Webcast: https://cc.talkpoint.com/barc002/031318a_as/?entity=42_2H5CIPS

On March 8, 2018 Medtronic plc (NYSE:MDT), the global leader in medical technology, reported it will participate in the 38th Annual Cowen and Company Healthcare Conference on Tuesday, March 13, 2018, in Boston, Massachusetts (Press release, Medtronic, MAR 8, 2018, View Source;p=RssLanding&cat=news&id=2337134 [SID1234524563]).

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Mike Coyle, executive vice president and president of Medtronic’s Cardiac and Vascular Group (CVG), will answer questions about the company beginning at 9:20 a.m. EDT (8:20 a.m. CDT).

A live audio webcast of the presentation will be available on March 13, 2018, by clicking on the Investor Events link at View Source An archive of the session will be available on the same webpage later in the day.

On March 8, 2018 Selecta Biosciences, Inc. (NASDAQ:SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by avoiding unwanted immune responses, reported that it will report its fourth quarter and full year 2017 financial results before the open of the U.S. financial markets on Thursday, March 15, 2018 (Press release, Selecta Biosciences, MAR 8, 2018, View Source [SID1234524633]).

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At 8:30 a.m. ET that day, Selecta will host a conference call and live audio webcast to discuss these results and provide a corporate update. Investors and the public can access a live and archived webcast of this call via the Investors & Media section of the company’s website, View Source Individuals may also participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10116990.