On May 8, 2018 Editas Medicine, Inc. (NASDAQ:EDIT), a leading genome editing company, reported that it will participate in a fireside chat at the Bank of America Merrill Lynch 2018 Health Care Conference on Tuesday, May 15, 2018, at 8 a.m. PT (11:00 a.m. ET) in Las Vegas, Nevada (Press release, Editas Medicine, MAY 8, 2018, View Source;p=RssLanding&cat=news&id=2347637 [SID1234526203]).

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A live webcast of the presentation will be available on the Investors & Media section of the Editas Medicine website at www.editasmedicine.com. An archived replay will be available for approximately 30 days following the presentation.

On May 8, 2018 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), a clinical-stage biotechnology company developing IPI-549, a first-in-class immuno-oncology product candidate that selectively inhibits phosphoinositide-3-kinase gamma (PI3K-gamma), reported that data from the ongoing clinical trial of IPI-549 will be presented in three events on June 4th during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Infinity Pharmaceuticals, MAY 8, 2018, View Source [SID1234526233]).

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Investor Event 6:30 a.m. CT – 7:30 a.m. CT
Infinity Pharmaceuticals will host an investor event on Monday, June 4, 2018, from 6:30 a.m. CT – 7:30 a.m. CT, with Dr. Ryan Sullivan from Massachusetts General Hospital, an investigator on the IPI-549 Phase 1/1b study, to review the IPI-549 data being presented at ASCO (Free ASCO Whitepaper). The event will be webcast live and can be accessed on the Investors/Media section of Infinity’s website at www.infi.com for 30 days following the event.

Poster Session 8:00 a.m. CT – 11:00 a.m. CT
Title: Initial results from first-in-human study of IPI-549, a tumor macrophage-targeting agent, combined with nivolumab in advanced solid tumors.
Session Title: Developmental Therapeutics – Immunotherapy
Session Date and Time: Monday, June 4, 2018, 8:00 a.m. CT – 11:00 a.m. CT
Poster Board: 227
Abstract Number: 3013
First Author:Ryan J. Sullivan, MD, Massachusetts General Hospital
Location: Hall A, McCormick Place convention center

Poster Discussion Session 11:30 a.m. CT – 12:45 p.m. CT
Title: Initial results from first-in-human study of IPI-549, a tumor macrophage-targeting agent, combined with nivolumab in advanced solid tumors.
Session Title: Developmental Therapeutics – Immunotherapy
Session Date and Time: Monday, June 4, 2018, 11:30 a.m. CT – 12:45 p.m. CT
Abstract Number: 3013
First Author:Ryan J. Sullivan, MD, Massachusetts General Hospital
Location: Hall B1, McCormick Place convention center

About IPI-549 and the Ongoing Phase 1/1b Study
IPI-549 is an investigational first-in-class, oral, immuno-oncology product candidate targeting tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition, thereby reducing pro-tumor macrophage function and increasing anti-tumor macrophage function. In preclinical studies, IPI-549 demonstrated the ability to reprogram macrophages from a pro-tumor (M2), immune suppressive function, to an anti-tumor (M1) immune activating function and enhance the activity of, and overcome resistance to, checkpoint inhibitors.[i], [ii] As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially additive or synergistic approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.

The ongoing Phase 1/1b study being conducted by Infinity is designed to evaluate the safety, tolerability, activity, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with Opdivo in approximately 200 patients with advanced solid tumors.[iii] The study includes monotherapy and combination dose-escalation components, in addition to monotherapy expansion and combination expansion components. The monotherapy dose-escalation and expansion components are complete. The combination dose-escalation component is also complete, and combination expansion cohorts are enrolling.

The combination expansion component of the study includes multiple cohorts designed to evaluate IPI-549 in patients with specific types of cancer, including patients with non-small cell lung cancer (NSCLC), melanoma and head and neck cancer whose tumors show initial resistance or initially respond to but subsequently develop resistance to immune checkpoint blockade therapy. The combination expansion component also includes a cohort of patients with triple negative breast cancer (TNBC) who have not been previously treated with immune checkpoint blockade therapy, a cohort of patients with mesothelioma, a cohort of patients with adrenocortical carcinoma and a cohort of patients with high baseline blood levels of MDSCs.

IPI-549 is an investigational compound and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On may 8, 2018 Cerus Corporation (Nasdaq: CERS) reported financial results for the first quarter ended March 31, 2018, and raised its full year guidance for product revenue (Press release, Cerus, MAY 8, 2018, View Source [SID1234526249]).

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First Quarter Highlights and Recent Events

First quarter product revenue of $13.6 million

Year-over-year Q1 worldwide disposable kit volume up over 100%

Raising full year product revenue guidance range to $53 million to $55 million from $51 million to $53 million

Cash and cash equivalents balance of $105.9 million at March 31, 2018

Received Canadian regulatory approval for INTERCEPT Blood Systems for platelets

Expanded enrollment sites for the phase 3 RedeS clinical trial of INTERCEPT-treated red blood cells into Texas and Florida
"The commercial momentum we experienced exiting 2017 continued into 2018 with first quarter product revenue of $13.6 million, exceeding our expectations. Global demand for platelet kits continued to be robust with first quarter platelet kit sales volumes more than doubling compared to the prior year, led by increased shipments in France and in the U.S.," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "Given the strong first quarter results and the current visibility into our commercial pipeline, we are raising our full year product revenue guidance range to $53 million to $55 million compared to our previous range of $51 million to $53 million."

"We continue to push forward with our mission to establish INTERCEPT as the global standard of care for transfused blood components," continued Greenman. "In the U.S., blood centers are continuing to increase production of INTERCEPT platelets to meet the ever growing hospital demand for pathogen-reduced platelets. In France, we gained additional regulatory approvals on our dual storage processing set for INTERCEPT platelets and shelf-life extension from five to seven days which should allow for increased blood center operational efficiencies and lower product wastage."

During the quarter, the Company’s development programs continued to progress with the Ultra-Performance Liquid Chromatography (UPLC) lot release assay achieving validation to support its anticipated CE Mark submission for INTERCEPT red cells, and the INTERCEPT cryoprecipitate program advancing the required stability studies for its planned premarket approval (PMA) supplement submission to the U.S. Food and Drug Administration (FDA).

Revenue

Product revenue for the first quarter of 2018 was $13.6 million, compared to $7.0 million during the same period in 2017. The increase in product revenue was driven by quarter-over-quarter increases in platelet kit demand, partially offset by declines in plasma kits and illuminator sales. Reported product revenue in the quarter also benefitted from favorable foreign currency exchange rates.

Government contract revenue from the Company’s Biomedical Advanced Research and Development Authority (BARDA) agreement was $3.5 million in the first quarter of 2018 compared to $1.4 million during the same period in 2017 as a result of increasing INTERCEPT red cell clinical and development activities. BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.

Gross Margins

Gross margins on product revenue for the first quarter of 2018 were 46%, compared to 47% for the first quarter of 2017. Gross margins on product sales remained relatively stable due to a variety of factors including economies of scale and lower costs due to increased platelet production, pricing for high volume customers, and foreign exchange rates.

Operating Expenses

Total operating expenses were $23.0 million for the quarter ended March 31, 2018, compared to $22.8 million for the quarter ended March 31, 2017.

Selling, general, and administrative expenses for the first quarter of 2018 remained relatively flat at $13.6 million, compared to $13.7 million for the first quarter of 2017 as the Company continued to leverage its existing commercial and back-office infrastructure.

Research and development (R&D) expenses for the first quarter of 2018 were $9.4 million compared to $9.2 million for the first quarter of 2017. Expenses associated with the clinical development of the Company’s INTERCEPT red blood cell program increased while non-BARDA related R&D expenses declined as the Company re-allocated R&D personnel to the BARDA activities.

Operating and Net Loss

Operating losses during the first quarter of 2018 were $13.4 million, compared to $18.1 million during the first quarter of 2017.

Net loss for the first quarter of 2018 was $13.9 million, or $0.11 per diluted share, compared to a net loss of $18.6 million, or $0.18 per diluted share, for the first quarter of 2017.

Cash, Cash Equivalents and Investments

At March 31, 2018, the Company had cash, cash equivalents and short-term investments of $105.9 million compared to $60.7 million at December 31, 2017.

At March 31, 2018, the Company had approximately $29.8 million in outstanding debt under its loan agreement with Oxford Finance. The loan agreement provides for an additional $10 million term loan (and, if drawn, an extension of the interest only period) upon the Company achieving pre-determined revenue levels. The Company achieved the pre-determined revenue levels as of March 31, 2018, but has not currently exercised its option on the additional $10 million term loan and interest only extension. The option expires on May 14, 2018.

QUARTERLY CONFERENCE CALL

The Company will host a conference call and webcast at 4:15 p.m. Eastern time today to discuss its financial results and provide a general business overview and outlook. To access the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the Company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 2366225. The replay will be available approximately three hours after the call through May 22, 2018.

On May 8,2018 AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported that the European Medicines Agency (EMA) has approved LYNPARZA (olaparib) tablets (300 mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy, regardless of BRCA status (Press release, Merck & Co, MAY 8, 2018, View Source [SID1234526267]).

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Dave Fredrickson, executive vice president, head of the oncology business unit at AstraZeneca, said, "With this new approval for LYNPARZA, we will now be able to offer more women with platinum-sensitive ovarian cancer, regardless of their BRCA status, a chance to achieve long-term disease control with an oral medicine that has a well-characterized safety and tolerability profile."

Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said, "This is an important development for the thousands of women in Europe living with advanced ovarian cancer, historically a difficult-to-treat disease. Working with AstraZeneca, we are able to bring this innovative, targeted treatment that helps delay progression of the disease to a broader group of women."

The EU approval was based on two randomized trials, SOLO-2 and Study 19, which showed that LYNPARZA reduced the risk of disease progression or death for platinum-sensitive relapsed ovarian cancer patients compared to placebo.

On May 8, 2018 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) reported a strategic collaboration with Carna Biosciences, Incorporated ("Carna"). Carna will access Evotec’s INDiGO platform to accelerate the development of its programme CB-1763, which is being developed for the treatment of blood cancer, through to the submission of an Investigational New Drug Application ("IND") with the U.S. Food and Drug Administration (Press release, Evotec, MAY 8, 2018, View Source [SID1234526179]).

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"We are excited to initiate IND-enabling studies for our next-generation non-covalent BTK inhibitor, CB-1763, in collaboration with Evotec", said Dr Masaaki Sawa, Chief Scientific Officer at Carna Biosciences. "We’ve been working with Evotec from last year and found they are a really reliable partner. We believe Evotec’s INDiGO programme and their team will help us to accelerate the development of our CB-1763 and we are confident that we will achieve our goal to reach IND-filing in the first half of 2019."

Dr Mario Polywka, Chief Operating Officer of Evotec, added: "This development of Carna’s key project directly reflects the success of our comprehensive and industry-unique INDiGO service. We are delighted to support Carna’s CB-1763 inhibitor programme, an innovative approach to blood cancer, through to the clinic. Additionally, working with Carna also highlights our increasing presence in the Japanese market."

Carna has another reversible BTK inhibitor in pre-clinical development, AS-871, a novel non-covalent BTK inhibitor targeting autoimmune diseases. AS-871 is also undergoing IND-enabling studies in collaboration with Evotec.

About Evotec’s INDiGO platform The INDiGO platform is a key value-generating component of Evotec’s broad EVT Execute business segment. INDiGO accelerates early drug candidates into the clinic by reducing time from nomination to regulatory submission in 52 weeks, and under circumstances, even less. We achieve accelerated development by tightly integrating traditional drug silos into a single project managed under one roof. The programme has been proven to reduce time and cost while achieving a quality data package for CTA/IND level regulatory filings.

Evotec’s INDiGO projects are managed by our most experienced, dedicated project managers and leading world-class drug development professionals implementing tailored development strategies designed specifically for the molecule, therapeutic area and strategic needs. The project plan is designed to integrate development areas: API Manufacture, Formulation Development, Clinical Supply, Safety Assessment, DMPK, Bioanalysis Studies and Regulatory Submission Documents Preparation.

ABOUT CARNA BIOSCIENCES, INC.

Carna Biosciences is a biopharmaceutical company focused on the discovery and development of kinase inhibitor drugs to address serious unmet medical needs. Carna has intensively focused its research efforts primarily in the areas of oncology and autoimmune/inflammation, where the company believes its extensive expertise in kinases can be most effectively leveraged. Taking advantage of Carna’s proprietary platform technologies and highly focused kinase expertise, the company continues to challenge to identify and develop innovative drugs. Carna is a publicly traded company in the JASDAQ of the Tokyo Stock Exchange with securities code 4572. For more information, please visit www.carnabio.com.

ABOUT CB-1763

CB-1763 is a highly selective, orally bioavailable, non-covalent inhibitor of Bruton’s tyrosine kinase (BTK) with a potential application in the treatment of blood cancer. Recent studies have indicated that the emergence of BTK mutations causes ibrutinib resistance. A selective and non-covalent BTK inhibitor is therefore highly demanded to overcome the emerging unmet medical need of ibrutinib resistance. CB-1763 is a next-generation non-covalent BTK inhibitor, designed to inhibit both BTK wild type and BTK C481 mutants in a highly selective and reversible manner.

MEDIA CONTACT:
CORPORATE PLANNING
CARNA BIOSCIENCES, INC.
TEL: +81-78-302-7075