On April 17, 2019 Abbott (NYSE: ABT) reported financial results for the first quarter ended March 31, 2019 (Press release, Abbott, APR 17, 2019, View Source [SID1234535159]).

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!

First-quarter worldwide sales of $7.5 billion increased 2.0 percent on a reported basis and 7.1 percent on an organic* basis.
Reported diluted EPS from continuing operations under GAAP was $0.38 in the first quarter.
Adjusted diluted EPS from continuing operations, which excludes specified items, was $0.63, above the previous guidance range.
Abbott projects full-year 2019 diluted EPS from continuing operations on a GAAP basis of $1.95 to $2.05. Projected full-year adjusted diluted EPS from continuing operations remains unchanged at $3.15 to $3.25, reflecting double-digit growth at the mid-point.
During the quarter, Abbott received U.S. FDA approval for a new, expanded indication for its market-leading MitraClip device to treat clinically significant secondary mitral regurgitation, a leaky heart valve resulting from advanced heart failure.
In January, Abbott announced U.S. FDA approval of its TactiCath Contact Force Ablation Catheter, Sensor Enabled, which is designed to help physicians accurately and effectively treat atrial fibrillation, a form of irregular heartbeat.
In March, Abbott obtained CE Mark for its Alinity m (molecular) diagnostics system and testing assays, providing market-leading speed and accuracy to help laboratories meet the growing demand for infectious disease testing.
"We’re right on track with our expectations to start the year," said Miles D. White, chairman and chief executive officer, Abbott. "All of our key long-term growth drivers are performing well and we’re targeting another year of strong sales and earnings growth."

* See note on organic growth below.

FIRST-QUARTER BUSINESS OVERVIEW
Note: Management believes that measuring sales growth rates on an organic basis is an appropriate way for investors to best understand the underlying performance of the business.

Organic sales growth:

Excludes the prior year first-quarter results for a non-core business within U.S. Adult Nutrition, which was discontinued during the third quarter 2018; and
Excludes the impact of foreign exchange.
Following are sales by business segment and commentary for the first quarter:

* Total Q1 2019 Abbott sales from continuing operations include Other sales of $15 million.

n/a = Not Applicable.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

First-quarter 2019 worldwide sales of $7.5 billion increased 2.0 percent on a reported basis. On an organic basis, worldwide sales increased 7.1 percent. Refer to table titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Worldwide Nutrition sales increased 2.0 percent on a reported basis in the first quarter. On an organic basis, sales increased 6.7 percent. Refer to table titled "Non-GAAP Reconciliation of Adjusted Historical Revenue" for a reconciliation of adjusted historical revenue.

Worldwide Pediatric Nutrition sales increased 3.5 percent on a reported basis in the first quarter, including an unfavorable 3.2 percent effect of foreign exchange, and increased 6.7 percent on an organic basis. International Pediatric Nutrition sales increased 5.4 percent on a reported basis and 11.2 percent on an organic basis in the first quarter. Sales performance in the quarter was led by strong growth in Asia and Latin America, including broad-based growth across Abbott’s portfolio of infant and toddler brands.

Worldwide Adult Nutrition sales increased 0.1 percent on a reported basis in the first quarter, and increased 6.8 percent on an organic basis. International Adult Nutrition sales increased 3.9 percent on a reported basis and 11.1 percent on an organic basis in the first quarter. Sales performance in the quarter was led by strong growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading diabetes-specific nutrition brand.

Worldwide Diagnostics sales increased 0.2 percent on a reported basis in the first quarter, including an unfavorable 4.2 percent effect of foreign exchange, and increased 4.4 percent on an organic basis.

Core Laboratory Diagnostics sales increased 4.1 percent on a reported basis and 9.9 percent on an organic basis in the first quarter. Sales performance in the quarter was led by above-market growth in the U.S. and internationally, where Abbott is achieving continued strong adoption of its Alinity family of innovative and highly differentiated diagnostic instruments.

Molecular Diagnostics sales decreased 8.4 percent on a reported basis in the first quarter, including an unfavorable 3.3 percent effect of foreign exchange, and decreased 5.1 percent on an organic basis. International sales growth in Molecular and Rapid Diagnostics was negatively impacted in the quarter by certain non-governmental organization (NGO) purchasing patterns in Africa. During the quarter, Abbott obtained CE Mark for its Alinity m (molecular) diagnostics system and several testing assays, providing market-leading speed and accuracy to help laboratories meet the growing demand for infectious disease testing.

Point of Care Diagnostics sales decreased 4.8 percent on a reported basis in the first quarter, including an unfavorable 0.6 percent effect of foreign exchange, and decreased 4.2 percent on an organic basis.

Rapid Diagnostics sales decreased 4.0 percent on a reported basis in the first quarter, including an unfavorable 2.6 percent effect of foreign exchange, and decreased 1.4 percent on an organic basis. Strong sales growth in several areas of the business, including cardio-metabolic testing and Abbott’s ID-NOW TM infectious disease testing platform, was offset by a difficult comparison versus the first-quarter of 2018 when sales were abnormally high due to a strong flu season.

Established Pharmaceuticals sales decreased 4.9 percent on a reported basis in the first quarter, including an unfavorable 10.3 percent effect of foreign exchange, and increased 5.4 percent on an organic basis.

Key Emerging Markets include India, Brazil, Russia and China along with several additional emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies decreased 5.2 percent on a reported basis in the first quarter, including an unfavorable 12.5 percent effect of foreign exchange, and increased 7.3 percent on an organic basis led by growth in several markets.

Other sales decreased 4.2 percent on a reported basis in the first quarter, including an unfavorable 3.3 percent effect of foreign exchange, and decreased 0.9 percent on an organic basis. As expected, Other sales growth was negatively impacted in the quarter by the recent discontinuation of a non-core, low-margin supply agreement.

Includes drug-eluting stents, balloon catheters, guidewires, vascular imaging/diagnostics products, vessel closure, carotid and other coronary and peripheral products.

Worldwide Medical Devices sales increased 5.5 percent on a reported basis in the first quarter and increased 9.5 percent on an organic basis, led by double-digit growth in Electrophysiology, Heart Failure, Structural Heart and Diabetes Care.

In Electrophysiology, in January, Abbott announced U.S. FDA approval of its TactiCath Contact Force Ablation Catheter, Sensor Enabled, which is designed to help physicians accurately and effectively treat atrial fibrillation, a form of irregular heartbeat.

In Heart Failure, growth was driven by rapid U.S. market adoption of Abbott’s HeartMate 3 left ventricular assist device following FDA approval as a destination (long-term use) therapy in late-2018. In March, Abbott announced data from its MOMENTUM 3 clinical study, the largest randomized controlled trial to assess outcomes in patients receiving a heart pump to treat advanced heart failure, which demonstrated HeartMate 3 improved survival and clinical outcomes in this patient population.

Growth in Structural Heart was broad-based across several areas of the business, including MitraClip, Abbott’s market-leading device for the minimally invasive treatment of mitral regurgitation (MR), a leaky heart valve. During the quarter, Abbott received U.S. FDA approval for a new, expanded indication for MitraClip to treat clinically significant secondary MR as a result of underlying heart failure. This new indication significantly expands the number of people with MR that can be treated with the MitraClip device.

In Diabetes Care, sales increased 34.4 percent on a reported basis and 42.0 percent on an organic basis in the first quarter. Sales growth in the quarter was led by FreeStyle Libre, Abbott’s revolutionary continuous glucose monitoring system, with worldwide sales of $379 million, an increase of 70.2 percent on a reported basis and 80.1 percent on an organic basis versus the prior year. During the quarter, Abbott released real-world data from nearly 500,000 users that shows higher rates of scanning with its FreeStyle Libre system improves glucose control for people living with diabetes.

ABBOTT’S EARNINGS-PER-SHARE GUIDANCE

Abbott projects 2019 diluted earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) of $1.95 to $2.05. Abbott forecasts net specified items for the full year 2019 of $1.20 per share. Specified items include intangible amortization expense, acquisition-related expenses, charges associated with cost reduction initiatives and other expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $3.15 to $3.25 for the full year 2019.

Abbott is issuing second-quarter 2019 guidance for diluted earnings per share from continuing operations under GAAP of $0.47 to $0.49. Abbott forecasts specified items for the second quarter 2019 of $0.32 per share primarily related to intangible amortization, acquisition-related expenses, cost reduction initiatives and other expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $0.79 to $0.81 for the second quarter.

ABBOTT DECLARES 381ST CONSECUTIVE QUARTERLY DIVIDEND

On Feb. 22, 2019, the board of directors of Abbott declared the company’s quarterly dividend of $0.32 per share. Abbott’s cash dividend is payable May 15, 2019, to shareholders of record at the close of business on April 15, 2019.

Abbott has increased its dividend payout for 47 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

On April 17, 2019 OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, and Duke University School of Medicine, reported that they have entered into a collaborative research agreement to evaluate the use of OncoSec’s proprietary TAVOPLUS (enhanced IL-12 DNA-plasmid) in combination or sequence with a HER2-plasmid vaccine administered with OncoSec’s novel intratumoral delivery system (Press release, OncoSec Medical, APR 17, 2019, View Source [SID1234535161]). The research will be led by Herbert Kim Lyerly, M.D., George Barth Geller Professor, Professor of Immunology, Surgery and Pathology at Duke University School of Medicine.

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!

"We are eager to expand our immunotherapy research in breast cancer through this collaboration with OncoSec. We have previously demonstrated, in a variety of breast cancer models, that local delivery of IL-12 stimulates an anti-breast cancer immune response with applicability beyond end-stage cancer. This delivery system has the potential to be a foundational therapeutic in the treatment of early-stage disease," said Dr. Lyerly. "The translational work with TAVOPLUS has been very encouraging and we are excited to explore the potential of OncoSec’s IL-12 plasmid delivery technology to enhance immune responses targeting HER2+ tumors and to elicit superior T-cell and B-cell responses to HER2 in a variety of preclinical breast cancer models."

Under the terms of the agreement, OncoSec will provide its proprietary TAVO (IL-12 plasmids) and its new electroporation generator, APOLLO, using lower voltage and a longer pulse width which greatly increased DNA-plasmid cellular transfection rates, to Duke University’s Center for Applied Therapeutics. Duke University investigators will conduct preclinical studies using plasmid vaccines targeting HER2 in combination with plasmid vaccines and TAVO in a newly developed endogenous mouse model of HER2+ breast cancer. Additionally, Duke investigators will use TAVO with their high-intensity ultrasound tumor ablation models to explore the impact of IL-12 delivery on the development of systemic immunity.

On April 17, 2019 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that it will host a key opinion leader (KOL) breakfast symposium focused on the unmet need, treatment landscape and opportunities for selective cyclin-dependent kinase 7 (CDK7) inhibition in ovarian and breast cancers on Wednesday, April 24, 2019 from 8:30 – 10:30 a.m. ET in New York City (Press release, Syros Pharmaceuticals, APR 17, 2019, View Source [SID1234535180]). Syros is currently evaluating SY-1365, a first-in-class selective CDK7 inhibitor, in a Phase 1 clinical trial as a single agent and in combination with other therapies in multiple ovarian and breast cancer patient populations.

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 event will feature presentations from Dejan Juric, M.D., Medical Oncologist and Director at the Termeer Center for Targeted Therapies, Massachusetts General Hospital and Charles A. Leath, III, M.D., M.S.P.H., Professor in the Division of Gynecologic Oncology and Ellen Gregg Shook Culverhouse Chair in Gynecologic Oncology at the University of Alabama Medical Center. Additionally, members of the Syros management team will provide an overview of SY-1365, including preclinical and clinical data supporting its ongoing development in ovarian and breast cancer patients, and SY-5609, its oral selective CDK7 inhibitor, which is expected to enter a Phase 1 oncology study in early 2020.

A live webcast of the event will be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following each presentation.

On April 17, 2019 Precision BioSciences (Nasdaq: DTIL) ("Precision"), a genome editing company dedicated to improving life (DTIL) through its proprietary ARCUS genome editing platform, reported it has dosed the first patient in the Phase 1/2a clinical trial of PBCAR0191, its first gene-edited allogeneic anti-CD19 chimeric antigen receptor (CAR) T cell product candidate (Press release, Precision Biosciences, APR 17, 2019, View Source [SID1234535181]). Precision is developing PBCAR0191 in collaboration with Servier, an international pharmaceutical company. PBCAR0191 is made from donor-derived T cells that are modified using Precision’s ARCUS genome editing technology. These edits are designed to generate CAR T cells that specifically recognize CD19, an important target in several B-cell cancers, and to prevent graft-versus-host disease, a significant complication associated with existing donor-derived cell-based therapies. This CAR T cell product candidate is being evaluated in adult patients with relapsed or refractory ("R/R") non-Hodgkin lymphoma ("NHL") or R/R B-cell precursor acute lymphoblastic leukemia (B-ALL) as an off-the-shelf cell therapy. The first patient dosed in this trial is being treated for R/R NHL, and Precision believes this is the first U.S.-based clinical trial to evaluate an allogeneic CAR T therapy for NHL.

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!

This multi-center, open label study of PBCAR0191 is expected to enroll up to 80 patients and several dose levels of PBCAR0191 will be investigated. Clinical sites include City of Hope, Moffit Cancer Center, Dana-Farber Cancer Institute and MD Anderson Cancer Center. The primary objective of the trial is to evaluate the safety of PBCAR0191 and determine the maximum tolerated dose. Secondary objectives include evaluating the anti-tumor activity of PBCAR0191. Precision will also evaluate the expansion, trafficking and persistence of PBCAR0191 in treated patients. Lymphodepletion will be conducted several days prior to PBCAR0191 infusion. Patient outcomes will be collected for up to one year.

On April 17, 2019 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, reported that clinical data from the SHRINK and alloSHRINK Phase 1 trials, evaluating the safety of NKG2D-based autologous and allogeneic CAR-T candidates, CYAD-01 and CYAD-101, respectively, will be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 21st World Congress on Gastrointestinal Cancer (WCGIC) to be held on July 3-6, 2019, in Barcelona, Spain (Press release, Celyad, APR 17, 2019, View Source [SID1234535199]).

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!

"We are delighted for the opportunity to present updated data at the upcoming WCGIC from both our autologous and allogeneic NKG2D-based clinical candidates for the treatment of refractory metastatic colorectal cancer" noted Frédéric Lehmann, Head of Global Clinical Development and Medical Affairs at Celyad. "We continue to build upon our clinical experience in the treatment of solid tumors with these novel immunotherapies and the oral presentation at WCGIC represents a special milestone to highlight preliminary data from the industry’s first trial investigating an ‘off-the-shelf ‘ CAR-T candidate for the treatment of solid tumors. In addition, the comparable trial designs between SHRINK and alloSHRINK as well as the similar CAR constructs provide insight into autologous and allogeneic approaches in an advanced solid tumor indication."

Presentation Details:

Abstract #631: Phase 1 studies assessing the safety and clinical activity of autologous and allogeneic NKG2D-based CAR-T therapy in metastatic colorectal cancer

Session: Short Oral Presentation

Background on CYAD-01 and CYAD-101

CYAD-01 is an investigational CAR-T therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) based on NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands expressed on tumor cells. CYAD-101 is an investigational, non-gene edited, allogeneic (donor derived) CAR-T therapy that co-expresses the NKG2D CAR of CYAD-01 and the novel inhibitory peptide TIM (T cell receptor [TCR] Inhibiting Molecule). The expression of TIM reduces signalling of the TCR complex which is responsible for Graft versus Host Disease (GvHD).

Background on SHRINK and alloSHRINK Trials

SHRINK is an open-label, dose-escalation Phase 1 trial assessing the safety and activity of CYAD-01 administered concurrently with FOLFOX (combination of 5-fluorouracil, leucovorin and oxaliplatin) chemotherapy in patients with metastatic colorectal cancer (mCRC). Patients will receive six cycles of FOLFOX chemotherapy every two weeks and three administrations of CYAD-01 every two weeks.

alloSHRINK is an open-label, dose-escalation Phase 1 trial assessing the safety and clinical activity of CYAD-101 administered concurrently with FOLFOX chemotherapy in patients with refractory mCRC. Similar to the SHRINK trial for CYAD-01, patients will receive six cycles of FOLFOX chemotherapy every two weeks and three administrations of CYAD-101 every two weeks.