On February 26, 2019 ImaginAb, Inc., a clinical stage immuno-oncology imaging company, reported the appointment of Ian Wilson as Chief Executive Officer while Martyn Coombs steps down for family reasons, effective immediately (Press release, ImaginAb, FEB 27, 2019, View Source [SID1234534236]). In addition, Tim Irish has joined ImaginAb’s Board of Directors as an independent non-executive Director and Jeffrey Evelhoch, Ph.D. has joined the Company’s Scientific Advisory Board.

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Ian Wilson, CEO of ImaginAb said, "I am honored to take this leadership role at ImaginAb, and continue to build on the many successes we have achieved, most notably in the last two years. Our ImaginAb team extends a warm welcome to Tim and Jeff as they embark on their new Board roles. We look forward to leveraging their extensive experience within global pharmaceutical companies as we continue to expand our strategic relationships and our clinical programs."

With over 25 years of experience in the commercial development of in vivo medical diagnostics and imaging medical devices, Ian originally joined ImaginAb in early 2018 as Chief Operations Officer, driving clinical execution and R&D. Prior to that, he was CEO and Chief Technology Officer of Edinburgh Molecular Imaging Ltd., leading the development of novel optical imaging agents. Ian has also held positions at Xstrahl Ltd., as CTO and COO, and numerous roles at GE Healthcare including Portfolio and Strategy Manager and Head of Biology.

"I am delighted to be joining the ImaginAb Board of Directors, as the team forges its exciting path towards developing much-needed tools that can measure CD8 T Cells in patients. This vital technology will aid the whole immuno-oncology area in patient selection and management and drive us toward improved outcomes," said Mr. Tim Irish.

Tim Irish has worked in the life sciences industry for thirty years with a career spanning global health technology companies across Europe and North America, including GSK, GE and Philips. Between 2007 and 2015 Tim served on ten Boards, five as Chair, where he successfully executed two trade sales and raised significant equity financing, including an IPO. Since 2015 his governance portfolio covers Life Sciences and Healthcare, both public and private, including board roles as Senior Independent Director and Non-Executive Director at NICE, four European NED roles, and Professor of Practice at King’s College London’s School of Management and Business.

"ImaginAb’s application of precision imaging has the potential to increase our understanding of cancer immunology and may fundamentally change how cancer is treated," said Jeff Evelhoch, Ph.D. "I am excited to work with the other esteemed members of the ImaginAb Scientific Advisory Board to help advance this novel technology."

Jeff Evelhoch, Ph.D., is responsible for development and qualification of novel biomarkers, use of biomarkers to inform pipeline decisions and the development and deployment of companion diagnostics at Merck. Jeff joined Merck Research Laboratories in 2008 as Vice President and Head of Imaging and was named Vice President and Head of Translational Biomarkers in 2015. He joined Merck after four years at Amgen as Executive Director and Head of Imaging Sciences, which followed 2 years at Pfizer Global Research & Development and Pharmacia as Director of Structural Imaging.

On February 27, 2019 Perrigo Company plc (NYSE; TASE: PRGO) reported financial results for the fourth quarter and calendar year ended December 31, 2018 (Press release, Perrigo Company, FEB 27, 2019, View Source [SID1234533845]).

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Perrigo President and CEO Murray S. Kessler commented, "While 2018 was a difficult year for Perrigo, significant progress was made in the fourth quarter against the Company’s transformation plans. Market share in our consumer businesses were stable for the year, and the Company met its updated full-year 2018 guidance expectations despite an unusual equipment start-up issue at one of our facilities that resulted in a fourth quarter adjusted EPS headwind of approximately $0.08. It was also encouraging to see a meaningful, sequential improvement in the RX segment during the fourth quarter, as downward pricing pressure eased."

Kessler continued, "While the Company is facing a number of challenges, I am pleased with the rapid progress our team is making on its transformation plans and evolution from a healthcare company to a consumer self-care company. We are continuing to make significant progress with the separation of the RX business and recently received the $250 million milestone payment related to Tysabri."

Kessler concluded, "We look forward to sharing our strategy as well as providing demonstrable progress at our Investor Day presentation on May 9, 2019 in New York City. Investors can expect to see the Company’s plans for portfolio reconfiguration, capacity and technology investments, innovation initiatives, cost savings plans to help fuel growth, capital allocation plans, organizational effectiveness initiatives and calendar 2019 guidance at that time. While there is much work to do, I remain excited and confident in our ability to recapture the ‘Perrigo Advantage’ and bring the Company back to profitable and sustainable growth."

Refer to Tables I – VI at the end of this press release for a reconciliation of non-GAAP measures to the current year and prior year periods and additional non-GAAP information. The Company’s reported results are included in the attached Condensed Consolidated Statements of Operations, Balance Sheets and Statements of Cash Flows.

Calendar year 2017 net sales have been adjusted to exclude approximately $21 million of sales attributable to the divested Israel API business.

Reported net sales for calendar year 2018 were approximately $4.7 billion, which included new product sales of $170 million, partially offset by discontinued products of $66 million. Adjusted net sales decreased 4.6% on a constant currency basis. Unfavorable currency movements impacted net sales by $34 million.

Reported net income was $131 million, or $0.95 per diluted share, versus $120 million, or $0.84 per diluted share, in the prior year. Excluding charges as outlined in Table I, calendar year 2018 adjusted net income was $629 million, or $4.55 per diluted share, versus $703 million, or $4.93 per diluted share, last year.

Fourth Quarter Results

Fourth quarter 2017 net sales have been adjusted to exclude approximately $4 million of sales attributable to the divested Israel API business.

Net sales for the fourth quarter of calendar year 2018 were approximately $1.2 billion, which included new product sales of $51 million, partially offset by discontinued products of $16 million. Adjusted net sales decreased 5.1% on a constant currency basis. Unfavorable currency movements impacted net sales by $18 million.

Reported net income was $82 million, or $0.60 per diluted share, versus $73 million, or $0.52 per diluted share, in the prior year. Excluding charges as outlined in Table I, fourth quarter 2018 adjusted net income was $132 million, or $0.97 per diluted share, versus $180 million, or $1.28 per diluted share, for the same period last year.

CHC Americas segment net sales were down 4.1% compared to last year. Net sales in the analgesics and smoking cessation categories coupled with new product sales of $10 million, were more than offset by lower net sales in the animal health and nutrition categories. Discontinued products in the quarter were $10 million, of which $6 million related to the animal health business. Excluding the animal health business, CHC Americas net sales decreased approximately 1.9% on a constant currency basis.

CHC Americas’ fourth quarter reported gross profit margin was 29.5%. Adjusted gross profit margin was 30.4% or 560 bps lower than the prior year. The majority of this decline was due to an unusual equipment startup issue at one facility, higher input costs and greater operating inefficiencies, including service-related challenges.

Reported fourth quarter operating margin was 16.4%. Fourth quarter adjusted operating margin was 18.0%, lower than the prior year due primarily to adjusted gross margin flow through, partially offset by lower administrative expenses.

CHC International net sales were relatively flat, excluding $2 million in net sales from exited businesses in 2017 and unfavorable foreign currency movements of $17 million. Net sales in the diagnostics and analgesics categories, in addition to new product sales of $19 million, were mostly offset by lower net sales in the lifestyle and cough cold categories. The absence of net sales from discontinued products was $2 million.

Reported and adjusted gross margin decreased 110 bps versus a year ago due primarily to less favorable product mix.

Reported operating margin was (0.5)%. Adjusted operating margin decreased 240 basis points to 12.9%. Growth investments in advertising and R&D increased approximately 350 bps as a percentage of net sales compared to prior year. These increases were partially offset by lower selling and administrative expenses.

RX net sales were $222 million in the quarter, lower than the prior year due primarily to industry dynamics, including pricing pressure, supply constraints in a few products and discontinued products of $4 million. New product sales were $22 million.

Reported gross margin was 45.5%. Adjusted gross margin was 54.8%, or 160 bps higher than the same quarter last year, driven primarily by new product launches.

Reported operating margin was 30.5%. Adjusted operating margin was 39.2%, or 110 bps higher than the prior year due primarily to adjusted gross margin flow through while maintaining R&D dollar investments for growth.

Conference Call

The Company will host a conference call at 4:30 p.m. EST (1:30 p.m. PST), February 27, 2019. The conference call will be available live via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 888-317-6003, International 412-317-6061, and reference ID # 0121144. A taped replay of the call will be available beginning at approximately 8:00 p.m. (EST) Wednesday, February 27, 2019, until midnight March 6, 2019. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 10128203.

On February 27, 2019 Context Therapeutics, a clinical-stage biotechnology company, reported that new preclinical data on CTX-30916, a new PR antagonist, will be featured at the upcoming AACR (Free AACR Whitepaper) Annual Meeting taking place in Atlanta, Georgia (Press release, Context Therapeutics, FEB 27, 2019, View Source [SID1234533830]). The data will be presented during the Receptors and Growth Factors session on April 1, 2019 from 1:00 PM – 5:00 PM.

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At the conference Dr. Deepak Lala, Ph.D., Chief Technology Officer for Context Therapeutics and Dr. Tasir Haque Ph.D., Head of Chemistry for Context Therapeutics will present preclinical data highlighting the biochemical and cellular activity of CTX-30916 including its mechanism of action in inhibiting breast cancer cell proliferation. CTX-30916 is a next generation PR antagonist with potential for the treatment of breast, uterine, and ovarian cancers.

The poster details are as follows:

Poster Title: Identification of CTX-30916 as a new antagonist of progesterone receptor signaling pathways

Session Category: Molecular and Cellular Biology / Genetics

Session Title: Receptors and Growth Factors

Session Date and Time: Monday Apr 1, 2019 1:00 PM – 5:00 PM

Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 38

Poster Board Number: 4

Abstract Number: 2625

For more information on AACR (Free AACR Whitepaper) 2019, please visit View Source

On February 27, 2019 Bolt Biotherapeutics, Inc., a biotechnology company focused on unleashing the power of the immune system to achieve anti-tumor immunity in patients with its promising Immune-Stimulating Antibody Conjugate (ISAC) platform, reported the forthcoming presentation of preclinical data on its BoltbodyTM technology at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Conference (Press release, Bolt Biotherapeutics, FEB 27, 2019, View Source [SID1234533828]). The conference will be held March 29th through April 3rd in Atlanta, Georgia.

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Details relating to the presentation are as follows:
Abstract Title: TLR7/8 immune-stimulating antibody conjugates elicit robust myeloid activation leading to enhanced effector function and antitumor immunity in pre-clinical models.
Abstract Number: 1559
Date and Time: Monday, April 1, 2019, 8am – 12pm EDT
Session Category: Immunology Session Title: Therapeutic Antibodies
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 25, Poster Board 28

"We are pleased that the first public presentation of our BoltbodyTM technology will occur at the AACR (Free AACR Whitepaper) Annual Meeting," stated David Dornan, Ph.D., senior vice president of research at Bolt Biotherapeutics. "BoltbodyTM ISACs are a new class of therapeutics that harness the ability of toll-like receptor (TLR) agonists to convert cold tumors into immunologically hot tumors following systemic administration. We are rapidly advancing our lead BoltbodyTM therapeutic toward the clinic based upon the promising data."

"It is exciting to share the encouraging data generated by this unique technology which builds upon our growing understanding of the role of myeloid cells in generating effective anti-tumor immunity. Our poster will cover in vitro and in vivo data demonstrating that BoltbodyTM ISACs have the capacity to eliminate tumors in preclinical models," stated Ed Engleman, M.D., Bolt founder and co-director of the Immunology and Immunotherapy Research Program at the Stanford Cancer Institute.

About Bolt Biotherapeutics’ Immune-Stimulating Antibody Conjugate (ISAC) Platform Technology
The Boltbody platform consists of Immune-Stimulating Antibody Conjugates (ISAC) that harness the ability of TLR agonists to convert cold tumors into immunologically hot tumors (illuminating tumors to the immune system allowing them to be invaded by tumor killing cells). BoltbodyTM ISACs have demonstrated the ability to eliminate tumors following systemic administration in preclinical models and have also led to the development of immunologic memory.

On February 27, 2019 CRISPR Therapeutics (NASDAQ: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of the CRISPR team will present two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held March 29 to April 3, 2019, at the Georgia World Congress Center in Atlanta, GA (Press release, CRISPR Therapeutics, FEB 27, 2019, View Source [SID1234533813]).

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Title: Allogeneic CRISPR/Cas9 gene-edited CAR-T cells targeting CD33 show potent preclinical activity against AML cells (abstract #1428, poster)
Time and Date: Monday, April 1, 2019, from 8:00 a.m. to 12:00 p.m. ET
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 21

Title: Targeting multiple solid tumor types with anti-CD70 allogeneic CAR-T cells (abstract #3184, poster)
Time and Date:Tuesday, April 2, 2019, from 8:00 a.m. to 12:00 p.m. ET
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 22