Bicycle Therapeutics to Present Immune Oncology CD137 Data on Multivalent and Tumour-targeted Bispecific Bicycles at Peptides Congress

On April 24, 2019 Bicycle Therapeutics, a biotechnology company pioneering a new class of therapeutics based on its proprietary bicyclic peptide (Bicycle) product platform, reported that Punit Upadhyaya, Ph.D., Senior Scientist at Bicycle, will present at the 6th Annual Peptides Congress in London (Press release, Bicycle Therapeutics, APR 24, 2019, View Source [SID1234535361]). The presentation, entitled "Bicycles as T-cell Modulators: Activation of CD137 Using Multivalent and Tumour-targeted Bicycle Peptides," will take place on Thursday, April 25, at 12:00 BST.

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"Our T-cell targeting Bicycles are set apart from other biological approaches because they are fully synthetic and modular, which is designed to enable the rapid creation of molecules with unique drug-like properties," said Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics. "We’re looking forward to sharing research showcasing that our multivalent and tumour-targeted bispecific Bicycles robustly activate CD137 positive T-cells in in vivo disease models as well as in patient-derived material."

BioCryst to Report First Quarter 2019 Financial Results on May 8

On April 24, 2019 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company will report its first quarter 2019 financial results on Wednesday, May 8, 2019 (Press release, BioCryst Pharmaceuticals, APR 24, 2019, View Source [SID1234535360]).

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BioCryst management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 1777029. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 1777029.

BERGENBIO ASA: INVITATION TO FIRST QUARTER PRESENTATION AND WEBCAST

On April 24, 2019 BerGenBio ASA (OSE:BGBIO), reported that it will announce its results for the first quarter on Wednesday, 8 May 2019 (Press release, BerGenBio, APR 24, 2019, View Source [SID1234535359]). A presentation by BerGenBio’s senior management team will take place at 10:00 am CET at:

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Felix Konferansesenter,
Bryggetorget 3,
0125 Oslo.

The presentation will webcast live and the link will be available at www.bergenbio.com in the section Investors/Financial Reports. A recording will be available shortly after the webcast has finished.

The results report and presentation will be available at www.bergenbio.com in the section: Investors/Financial Reports from 7:00 am CET the same day.

-Ends-

Contacts
Richard Godfrey CEO, BerGenBio ASA
+47 917 86 304

Rune Skeie, CFO, BerGenBio ASA
[email protected]
+47 917 86 513

International Media Relations

Mary-Jane Elliott, Chris Welsh, Jessica Hodgson, Nicholas Brown, Carina Jurs, Consilium Strategic Communications
[email protected]
+44 20 3709 5700

Media Relations in Norway

Jan Petter Stiff, Crux Advisers
[email protected]
+47 995 13 891

Thermo Fisher Scientific Reports First Quarter 2019 Results

On April 24, 2019 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the first quarter ended March 30, 2019 (Press release, Thermo Fisher Scientific, APR 24, 2019, View Source [SID1234535358]).

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First Quarter 2019 Highlights

First quarter revenue increased to $6.12 billion.
First quarter GAAP diluted earnings per share (EPS) increased 41% to $2.02.
First quarter adjusted EPS increased 12% to $2.81.
Launched a range of new products, including two Thermo Scientific instruments for materials analysis – the Nicolet Summit FTIR spectrometer and the Helios 5 DualBeam scanning electron microscope – and in specialty diagnostics, received FDA clearance for a new ImmunoCAP test for peanut allergy.
Recently opened new Customer Solution Centers in Beijing and Delhi to help scientists in the food and beverage industry develop advanced analytical workflows that improve food quality and safety.
Announced $150 million expansion of our pharma services sites in Italy and North Carolina to increase capacity and capabilities of our global sterile manufacturing network and meet growing customer demand for biologics development and manufacturing services.
Announced agreement to acquire Brammer Bio, a leader in viral vector manufacturing, for $1.7 billion, significantly expanding our capabilities in the fast-growing gene and cell therapy market.
Repurchased $750 million of stock and increased our dividend by 12 percent.
Adjusted EPS, adjusted operating income, adjusted operating margin and free cash flow are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of Non-GAAP Financial Measures."

"We’re pleased to deliver another quarter of excellent growth on the top and bottom line," said Marc N. Casper, president and chief executive officer of Thermo Fisher Scientific. "Our teams are strengthening our competitive position by successfully executing our growth strategy – a combination of launching great new products, leveraging our scale in high-growth and emerging markets, and enhancing our unique value proposition to be the strongest partner possible for our customers.

"I’m especially excited about our pending acquisition of Brammer Bio, which we announced in March. As a leader in viral vector manufacturing, Brammer Bio helps pharma and biotech customers deliver breakthrough gene and cell therapies to patients with rare diseases. We also continue to deploy capex to expand our pharma services capacity and capabilities in the U.S. and Europe to meet increasing customer demand and ultimately make a difference for countless patients and their families."

Casper added, "We’re off to a strong start, and we’re on track to deliver another outstanding year."

First Quarter 2019

Revenue for the quarter grew 5% to $6.12 billion in 2019, versus $5.85 billion in 2018. Organic revenue growth was 7%; acquisitions increased revenue by 1% and currency translation decreased revenue by 3%.

GAAP Earnings Results

GAAP diluted EPS in the first quarter of 2019 increased 41% to $2.02, versus $1.43 in the same quarter last year. GAAP operating income for the first quarter of 2019 grew to $0.92 billion, compared with $0.79 billion in the year-ago quarter. GAAP operating margin increased to 15.0%, compared with 13.4% in the first quarter of 2018.

Non-GAAP Earnings Results

Adjusted EPS in the first quarter of 2019 increased 12% to $2.81, versus $2.50 in the first quarter of 2018. Adjusted operating income for the first quarter of 2019 grew 7% compared with the year-ago quarter. Adjusted operating margin was 22.4%, compared with 22.0% in the first quarter of 2018.

2019 Guidance Update

Thermo Fisher is raising its 2019 revenue and earnings guidance to reflect strong operational performance and the acquisition of Brammer Bio, partially offset by a more adverse foreign exchange environment. The company is raising its revenue guidance to a new range of $25.17 to $25.47 billion versus its previous guidance of $24.88 to $25.28 billion. This would result in 3 to 5% revenue growth over 2018. The company is raising its adjusted EPS guidance to a new range of $12.08 to $12.22, versus its previous guidance of $12.00 to $12.20, for 9 to 10% growth year over year.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the company’s four business segments, as highlighted below. Since these results are used for this purpose, they are also considered to be prepared in accordance with GAAP.

Life Sciences Solutions Segment

In the first quarter of 2019, Life Sciences Solutions Segment revenue grew 7% to $1.61 billion, compared with revenue of $1.50 billion in the first quarter of 2018. Segment adjusted operating margin increased to 34.9%, versus 34.5% in the 2018 quarter.

Analytical Instruments Segment

Analytical Instruments Segment revenue grew 5% to $1.32 billion in the first quarter of 2019, compared with revenue of $1.26 billion in the first quarter of 2018. Segment adjusted operating margin increased to 21.3%, versus 19.6% in the 2018 quarter.

Specialty Diagnostics Segment

Specialty Diagnostics Segment revenue increased 1% to $0.96 billion in the first quarter of 2019, compared with revenue of $0.95 billion in the first quarter of 2018. Segment adjusted operating margin was 25.3%, versus 25.6% in the 2018 quarter.

Laboratory Products and Services Segment

In the first quarter of 2019, Laboratory Products and Services Segment revenue grew 4% to $2.51 billion, compared with revenue of $2.41 billion in the first quarter of 2018. Segment adjusted operating margin was 11.3%, versus 11.6% in the 2018 quarter.

Use of Non-GAAP Financial Measures

In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), we use certain non-GAAP financial measures, including adjusted EPS, adjusted operating income and adjusted operating margin, which exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs; restructuring and other costs/income; and amortization of acquisition-related intangible assets. Adjusted EPS also excludes certain other gains and losses that are either isolated or cannot be expected to occur again with any predictability, tax provisions/benefits related to the previous items, the impact of significant tax audits or events and the results of discontinued operations. We exclude the above items because they are outside of our normal operations and/or, in certain cases, are difficult to forecast accurately for future periods. We also use a non-GAAP measure, free cash flow, which is operating cash flow, excluding net capital expenditures, and also excludes operating cash flows from discontinued operations to provide a view of the continuing operations’ ability to generate cash for use in acquisitions and other investing and financing activities. We believe that the use of non-GAAP measures helps investors to gain a better understanding of our core operating results and future prospects, consistent with how management measures and forecasts the company’s performance, especially when comparing such results to previous periods or forecasts.

For example:

We exclude costs and tax effects associated with restructuring activities, such as reducing overhead and consolidating facilities. We believe that the costs related to these restructuring activities are not indicative of our normal operating costs.

We exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs. We exclude these costs because we do not believe they are indicative of our normal operating costs.

We exclude the expense and tax effects associated with the amortization of acquisition-related intangible assets because a significant portion of the purchase price for acquisitions may be allocated to intangible assets that have lives of 3 to 20 years. Based on acquisitions closed through the end of the first quarter of 2019, adjusted EPS will exclude approximately $3.23 of expense for the amortization of acquisition-related intangible assets. Exclusion of the amortization expense allows comparisons of operating results that are consistent over time for both our newly acquired and long-held businesses and with both acquisitive and non-acquisitive peer companies.

We also exclude certain gains/losses and related tax effects, the impact of significant tax audits or events (such as changes in deferred taxes from enacted tax rate changes or the estimated initial impacts of U.S. tax reform legislation), which are either isolated or cannot be expected to occur again with any predictability and that we believe are not indicative of our normal operating gains and losses. For example, we exclude gains/losses from items such as the sale of a business or real estate, gains or losses on significant litigation-related matters, gains on curtailments of pension plans, the early retirement of debt and discontinued operations.

We also report free cash flow, which is operating cash flow, excluding net capital expenditures, and also excludes operating cash flows from discontinued operations to provide a view of the continuing operations’ ability to generate cash for use in acquisitions and other investing and financing activities.

Thermo Fisher’s management uses these non-GAAP measures, in addition to GAAP financial measures, as the basis for measuring the company’s core operating performance and comparing such performance to that of prior periods and to the performance of our competitors. Such measures are also used by management in their financial and operating decision-making and for compensation purposes.

The non-GAAP financial measures of Thermo Fisher’s results of operations and cash flows included in this press release are not meant to be considered superior to or a substitute for Thermo Fisher’s results of operations prepared in accordance with GAAP. Reconciliations of such non-GAAP financial measures to the most directly comparable GAAP financial measures are set forth in the accompanying tables. Thermo Fisher does not provide GAAP financial measures on a forward-looking basis because we are unable to predict with reasonable certainty and without unreasonable effort items such as the timing and amount of future restructuring actions and acquisition-related charges as well as gains or losses from sales of real estate and businesses, the early retirement of debt and the outcome of legal proceedings. The timing and amount of these items are uncertain and could be material to Thermo Fisher’s results computed in accordance with GAAP.

Conference Call

Thermo Fisher Scientific will hold its earnings conference call today, April 24, 2019, at 8:30 a.m. Eastern time. To listen, dial (877) 273-7122 within the U.S. or (647) 689-5496 outside the U.S. You may also listen to the call live on our website, www.thermofisher.com, by clicking on "Investors." You will find this press release, including the accompanying reconciliation of non-GAAP financial measures and related information, in that section of our website under "Financial Results." An audio archive of the call will be available under "Webcasts and Presentations" through Friday, May 10, 2019.

Fate Therapeutics Announces Five Presentations at the American Society of Gene & Cell Therapy 22nd Annual Meeting

On April 24, 2019 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that Fate scientists and collaborators will present data highlighting the Company’s induced pluripotent stem cell (iPSC) product platform and its iPSC-derived cell product candidates at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 22nd Annual Meeting being held from April 28 – May 2, 2019 in Washington, D.C (Press release, Fate Therapeutics, APR 24, 2019, View Source [SID1234535357]).

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"Our strong scientific presence at ASGCT (Free ASGCT Whitepaper) demonstrates the unique value of our proprietary iPSC product platform for gene editing and the development of universal, off-the-shelf, engineered cell therapies," said Bob Valamehr, Ph.D., Chief Development Officer of Fate Therapeutics. "We look forward to showcasing the critical importance of characterizing and selecting a single clone from a heterogeneous population of engineered cells, our unmatched expertise in creating large numbers of clinical-grade NK cells and T cells from clonal master engineered iPSC lines, and the breadth of our highly-differentiated off-the-shelf cancer immunotherapy pipeline."

Three oral and two poster presentations will highlight several product candidates from the Company’s universal, off-the-shelf, iPSC-derived cancer immunotherapy pipeline, including NK cell product candidates FT500 for the treatment of advanced solid tumors and FT516 for the treatment of advanced hematologic malignancies. FT500 is the first-ever iPSC-derived cell therapy to be administered to patients in the U.S., and FT516 is the first-ever engineered iPSC-derived cell therapy allowed for clinical investigation in the world. The Company’s iPSC-derived, dual-targeted CD16-CAR19 NK cell product candidate FT596 and its iPSC-derived, TCR-less, TRAC-targeted, 1XX CAR19 T-cell product candidate FT819, which is being developed under a collaboration with Memorial Sloan Kettering Cancer Center led by Michel Sadelain, M.D., Ph.D., will also be featured.

2019 ASGCT (Free ASGCT Whitepaper) Oral Presentations

Workshop – CAR T and Related Immune Effector Cell Therapies
Title: iPSC-Derived Immune Effector Cells
Presenter: Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering, Memorial Sloan Kettering Cancer Center
Date and Time: Sunday, April 28, 2019, 3:30 PM – 6:00 PM
Location: Jefferson East
Session 132 – Induced Pluripotent Stem Cells
Title: Pluripotent Cell-Derived T and NK Cells as a Cornerstone Approach for Off-the-Shelf Cancer Immunotherapy
Presenter: Bob Valamehr, Ph.D., Chief Development Officer, Fate Therapeutics
Date and Time: Monday, April 29, 2019, 1:30 PM – 3:00 PM
Location: Monroe Room
Session 134 – NK Cells versus NKT Cells
Title: Clinical Development of NK Cell Cancer Therapy
Presenter: Sarah Cooley, M.D., Senior V.P., Clinical Translation, Fate Therapeutics
Date and Time: Monday, April 29, 2019, 1:30 PM – 3:00 PM
Location: Georgetown Room
2019 ASGCT (Free ASGCT Whitepaper) Poster Presentations

Poster 877 – iPSC Product Platform
Title: A Versatile Platform for Generation of Single-Cell Derived, Genetically Engineered, Fully Characterized Pluripotent Master Cell Lines as a Renewable Source for Off-the-Shelf Cell Therapy
First Author: Mochtar Pribadi, Ph.D., Scientist, Molecular Biology, Fate Therapeutics
Date and Time: Wednesday, May 1, 2019, 5:00 PM – 6:00 PM
Location: Columbia Hall
Poster 882 – CRISPR-based iPSC Generation
Title: A Novel Platform Combining Chemical and CRISPRa Approaches for the Generation of Human iPSCs
First Author: Jason Dinella, Ph.D., Scientist, Reprogramming Biology, Fate Therapeutics
Date and Time: Wednesday, May 1, 2019, 5:00 PM – 6:00 PM
Location: Columbia Hall
About FT500
FT500 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line. FT500 is being investigated in an open-label, repeat-dose Phase 1 clinical trial for the treatment of advanced solid tumors in up to 64 patients, both as a monotherapy and in combination with FDA-approved checkpoint inhibitor therapy. Despite the favorable response rates observed with checkpoint inhibitor therapy, the majority of patients do not respond and many responders relapse. One common mechanism of resistance to checkpoint inhibitor therapy is associated with loss-of-function mutations in genes critical for antigen presentation. A potential strategy to overcome resistance is through the administration of allogeneic NK cells, which have the inherent capability to recognize and directly kill tumor cells with these mutations.

About FT516
FT516 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a novel high-affinity (158V), non-cleavable CD16 (hnCD16) Fc receptor. CD16 mediates antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells. CD16 occurs in two variants, either with high (158V) or low (158F) affinity for the Fc domain of IgG1 antibodies. Numerous clinical studies with FDA-approved tumor-targeting antibodies, including rituximab, trastuzumab and cetuximab, have demonstrated that patients homozygous for the CD16 high-affinity variant (approximately 15% of patients) have improved clinical outcomes. In addition, the expression of CD16 can undergo considerable down-regulation in cancer patients, which significantly inhibits the immune system’s anti-tumor response. FT516 incorporates a novel CD16 Fc receptor, which has been modified to prevent its down-regulation and augment its binding to tumor-targeting antibodies for enhanced ADCC. The Company announced in February 2019 that the FDA allowed its FT516 IND application for the treatment of relapsed / refractory hematologic malignancies including in combination with certain FDA-approved monoclonal antibody therapies.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered in repeat doses to mediate more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf to treat many patients. As a result, the Company’s platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is fraught with batch-to-batch and cell-to-cell variability that can affect safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 100 issued patents and 100 pending patent applications.