On April 16, 2020 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported the formation of the Steering Committee for its Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in patients with acute myeloid leukemia (AML) who have achieved complete remission after second-line anti-leukemic therapy (CR2) (Press release, Sellas Life Sciences, APR 16, 2020, View Source [SID1234556380]).

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"We continue to make important progress toward ensuring that our Phase 3 AML trial is a well-executed pivotal study and are working diligently toward its timely execution despite the COVID-19 pandemic," said Dr. Angelos Stergiou, MD, ScD h.c., SELLAS’ President & Chief Executive Officer. "We are pleased that our internal clinical leadership team, which includes individuals with extensive late-stage hematology-oncology development experience, is now supplemented by a Steering Committee with deep and extraordinary international hematology experience."

The Steering Committee will provide scientific oversight and guidance of the practical aspects of the ongoing REGAL study. The Steering Committee will also review the results of the trial as they become available, analyze current clinical practices to identify AML patients most likely to benefit from entry to the study, design and implement the most efficient continued approaches to conducting the study and make recommendations regarding the monitoring of the clinical study in consultation with the independent data monitoring committee.

Dr. M. Yair Levy, MD, Director of Hematologic Malignancies at the Baylor University Medical Center commented, "Over the past several years, new treatment modalities have improved response rates in AML in the second line (salvage) setting, resulting in an increasing number of patients achieving complete remission (CR2). However, patients who successfully enter CR2 represent a clinical population for which there is an enduring unmet medical need, with a median overall survival of around five months. Currently, REGAL is the only Phase 3 study aiming at remission prolongation through maintenance post-CR2 therapy – other than allogeneic stem cell transplantation – that is actively enrolling patients in this setting."

"The REGAL trial is a rigorously designed study which will provide pivotal data assessing the potential contribution of maintenance therapy with galinpepimut-S, an innovatively engineered and promising WT1-targeting immunotherapeutic, in candidate AML patients in CR2. I look forward to reviewing the clinical and safety data as they become available and to serving as a member of its Steering Committee," concluded Dr. Levy.

The Steering Committee currently consists of three members:

Dr. Hagop Kantarjian, MD, Professor and Chair of the Department of Leukemia at The University of Texas MD Anderson Cancer Center, and Principal Investigator at MD Anderson for the multi-center Phase 3 REGAL study and Chair of the REGAL Steering Committee*

Dr. Javier Pinilla-Ibarz, MD, PhD, Director of Immunotherapy for Malignant Hematology at the H. Lee Moffitt Cancer Center and member of the SELLAS Scientific Advisory Board

Dr. Moshe Yair Levy, MD, Director of Hematologic Malignancies at the Texas Oncology – Baylor Charles A. Sammons Cancer Center
The Company previously reported initial data from the Phase 2a study of galinpepimut-S in AML patients in CR2 at a median follow-up of 19.3 months, showing median overall survival (OS) in vaccine-treated patients of 16.3 months vs. 5.4 months in a patient cohort contemporaneously treated with best standard therapy (p = 0.0175). The final analysis, at a median follow-up of 30.8 months, showed a median OS of 21 months in the GPS-treated patient cohort. A second previous Phase 2 study of galinpepimut-S in AML patients who achieved first complete remission (CR1) also met its primary endpoint with an OS rate at 3 years from first vaccination of 47%.

The REGAL study is an ongoing 1:1 randomized, open-label study comparing GPS monotherapy in the maintenance setting to investigators’ choice best available treatment in AML patients who have achieved hematologic complete remission, with or without thrombocytopenia (CR2/CR2p), after second-line antileukemic therapy and who are deemed ineligible for or unable to undergo allogeneic stem-cell transplantation. The primary endpoint is OS from the time of study entry. Secondary endpoints include leukemia-free survival, antigen-specific T-cell immune response dynamics, measurable residual disease by multigene array, and assessments of AML clonal evolution and inflammasome molecular signatures in the tumor microenvironment in bone marrow biopsy samples. The Company anticipates interim analysis for safety and futility in the fourth quarter of 2021.

For further information on enrolling in the REGAL study, please visit: View Source

*Dr. Kantarjian’s role on the steering committee is under review by MD Anderson’s Conflict of Interest Committee to ensure compliance with institutional policy.

On April 16, 2020 Perrigo Company plc (NYSE; TASE: PRGO) reported that it will release its first quarter financial results on Thursday, April 30, 2020 (Press release, Perrigo Company, APR 16, 2020, View Source [SID1234556379]). The Company will also host a conference call beginning at 8:30 a.m. (EST).

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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 #7953093. A taped replay of the call will be available beginning at approximately 12:00 p.m. (EST) Thursday, April 30, until midnight Thursday, May 7, 2020. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 10142899.

On April 16, 2020 Incyte (Nasdaq:INCY) reported that it has scheduled its first quarter financial results conference call and webcast for 8:00 a.m. ET on Tuesday, May 5, 2020 (Press release, Incyte, APR 16, 2020, View Source [SID1234556378]).

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The schedule for the press release and conference call/webcast is as follows:

Q1 2020 Press Release:
May 5, 2020 at 7:00 a.m. ET

Q1 2020 Conference Call:
May 5, 2020 at 8:00 a.m. ET

Domestic Dial-In Number:
877-407-3042

International Dial-In Number:
201-389-0864

Conference ID Number:
13702083

If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for the U.S. is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference ID number 13702083.

The live webcast with slides can be accessed at Investor.Incyte.com and will be available for replay for 30 days.

On April 16, 2020 Abbott (NYSE: ABT) reported financial results for the first quarter ended March 31, 2020 (Press release, Abbott, APR 16, 2020, View Source [SID1234556377]).

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First-quarter worldwide sales of $7.7 billion increased 2.5 percent on a reported basis and 4.3 percent on an organic* basis.
Reported diluted EPS from continuing operations under GAAP was $0.30 and adjusted diluted EPS from continuing operations, which excludes specified items, was $0.65 in the first quarter.
Due to uncertainties regarding the duration and impact of the coronavirus (COVID-19) pandemic, Abbott is suspending its previously announced annual guidance for 2020.
Abbott’s strong financial position is supported by a healthy balance sheet, including approximately $3.7 billion in cash, cash equivalents and short-term investments, and revolving credit facilities in place that could provide additional access to up to $5 billion, if needed.
Abbott recently launched three diagnostics tests for COVID-19, including molecular tests on its ID NOWTM rapid point-of-care platform and m2000TM RealTime lab-based platform, and a serology blood test for the detection of the antibody, IgG, on its lab-based immunoassay platforms.
Abbott recently announced CE Mark approvals for several cardiovascular devices, including TriClipTM, the world’s first minimally invasive, clip-based repair device for the treatment of tricuspid regurgitation, or leaky tricuspid heart valve; TendyneTM, a first-of-its-kind technology to replace a faulty mitral heart valve; and GallantTM implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices to help manage heart rhythm disorders.
During the quarter, Abbott announced expanded reimbursement coverage for FreeStyle Libre in Japan to include people with Type 2 diabetes that inject insulin multiple times per day.
"First and foremost, I want to thank our employees, our customers, and our suppliers for their extraordinary efforts to maintain supply of our critically important products to the people who need them, around the world," said Robert B. Ford, president and chief executive officer, Abbott. "It’s an unprecedented time and our colleagues are rising to it in unprecedented ways."

ABBOTT’S RESPONSE TO COVID-19
Abbott has mobilized its teams across multiple fronts to help stem the spread of the virus and support healthcare systems, patients, its employees and local communities. Most notably, the company has launched three critical new tests for COVID-19: the Abbott ID NOW COVID-19 molecular test, the fastest available molecular point-of-care test delivering results within 13 minutes and positive results in as little as five minutes, the Abbott RealTime SARS-CoV-2 molecular test, which runs on Abbott’s m2000 RealTime System located in hospital and reference laboratories, and a serology blood test for the detection of the antibody, IgG, on its lab-based immunoassay testing platforms. While molecular testing detects whether someone has the virus, antibody tests determine if someone was previously infected.

The company is supporting impacted frontline health workers, families and communities around the world with philanthropic donations to help address key needs, including providing personal protective equipment, patient care supplies and training. To protect its employees, most work is being conducted remotely and the company has implemented strict travel restrictions. Abbott has taken aggressive steps to limit exposure and enhance the safety of its facilities for employees working to continue to supply vital healthcare products to hospitals, healthcare professionals, laboratories and patients around the world.

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 impact of foreign exchange.

* Total Q1 2020 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 2020 worldwide sales of $7.7 billion increased 2.5 percent on a reported basis. On an organic basis, worldwide sales increased 4.3 percent.

Worldwide Diagnostics sales decreased 0.8 percent on a reported basis in the first quarter, including an unfavorable 1.5 percent effect of foreign exchange, and increased 0.7 percent on an organic basis. Core Laboratory Diagnostics sales growth was negatively impacted by lower routine testing volumes due to the coronavirus (COVID-19). Abbott recently launched three critical new tests for COVID-19: the Abbott ID NOW COVID-19 molecular test, the fastest available molecular point-of-care test delivering results within 13 minutes and positive results in as little as five minutes, the Abbott RealTime SARS-CoV-2 molecular test, which runs on Abbott’s m2000 RealTime System located in hospital and reference laboratories, and a serology blood test for the detection of the antibody, IgG, on its lab-based immunoassay testing platforms. While molecular testing detects whether someone has the virus, antibody tests determine if someone was previously infected.

a) 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 1.4 percent on a reported basis in the first quarter and increased 2.9 percent on an organic basis. Sales growth in both cardiovascular and neuromodulation businesses was negatively impacted by reduced procedure volumes due to the coronavirus (COVID-19) pandemic. Due to the critical nature of these products, the company anticipates strong demand when the availability of healthcare resources returns to normal levels.

In Diabetes Care, growth was led by FreeStyle Libre, with worldwide sales of more than $600 million in the quarter, an increase of 59.3 percent on a reported basis and 62.5 percent on an organic basis versus the prior year. During the quarter, Abbott obtained expanded reimbursement coverage for FreeStyle Libre in Japan to include people with Type 2 diabetes that inject insulin multiple times per day to manage their condition.

ABBOTT’S GUIDANCE FOR 2020
Due to uncertainties regarding the duration and impact of the coronavirus (COVID-19) pandemic, Abbott is suspending its previously announced annual guidance for 2020.

ABBOTT DECLARES 385TH CONSECUTIVE QUARTERLY DIVIDEND
On Feb. 21, 2020, the board of directors of Abbott declared the company’s quarterly dividend of $0.36 per share. Abbott’s cash dividend is payable May 15, 2020, to shareholders of record at the close of business on April 15, 2020.

Abbott has increased its dividend payout for 48 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 16, 2020 Veracyte, Inc. (Nasdaq: VCYT) reported preliminary, unaudited and unreviewed financial results for the first quarter ended March 31, 2020 and withdrew its previously issued full-year 2020 financial performance guidance (Press release, Veracyte, APR 16, 2020, View Source [SID1234556376]).

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First Quarter 2020 Financial Results

Based upon preliminary financial information, Veracyte expects to report first quarter 2020 total revenue in the range of $30.5 million to $31.5 million, compared to $29.5 million in the first quarter of 2019. First quarter 2020 testing and product revenue is estimated to be in the range of $30.0 million to $30.6 million, compared to $25.4 million in the first quarter of 2019. The company expects to report genomic test volume from our Afirma, Percepta and Envisia classifiers in the range of 10,500 to 10,600 tests for the first quarter, compared to 9,162 tests in the first quarter of 2019. The company expects to report cash and cash equivalents of approximately $153 million at March 31, 2020.

While first quarter genomic testing volume increased approximately 15% compared to the first quarter of 2019, the company began to see volume decline in the second half of March and its reported genomic testing volumes in the first fifteen days of April 2020 declined over 50%, compared to the same period in 2019.

"We are generally pleased with our first-quarter financial performance, despite the rapid onset of the COVID-19 pandemic and associated shelter-in-place orders towards the end of the quarter," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "However, during the second half of March, we experienced a significant decline in the volume of samples received, which has continued into April, resulting in a significant decline in revenue."

Business Response to COVID-19 Pandemic

"We have taken swift steps to protect our employees and the broader community, while ensuring our ability to deliver genomic test results to physicians and their patients who need them. Our CLIA lab is running and most of our employees are working remotely. Meanwhile, the pandemic continues to have an unprecedented impact on the broader economy and on our business, with significant reductions in patient visits to physician offices and with medical centers significantly restricting functions. Once shelter-in-place orders begin to lift, we anticipate that the return to ‘normal’ may take time for our customers and their patients. Given the significant challenges we face from these circumstances, we are taking actions now to reduce expenses and preserve the health of our business," said Ms. Anderson.

Actions that Veracyte is taking immediately to reduce costs include:

Veracyte’s chairman and chief executive officer is reducing her base pay and target bonus by 25% until the company can resume normal operations
Veracyte’s board of directors, executive leaders and certain other employees are taking a reduction in pay until the company can resume normal operations
Approximately 60 employees are being put on a temporary furlough with a current goal of bringing them back from furlough once the company’s business rebounds. Veracyte will continue at this time to provide furloughed employees certain benefits including covering employee healthcare contributions during the furlough. In addition, Veracyte has terminated a small number of employees.
Instituting a temporary hiring freeze
Securing vendor discounts and halting all nonessential outside spending
"By taking temporary but necessary cost-saving measures now, we believe we will be better positioned to emerge strongly from this situation," said Ms. Anderson. "Our confidence in Veracyte’s long-term positioning is boosted by the fundamental strength and diversification of our business, our strong balance sheet, our robust pipeline and our focus on helping patients to be diagnosed and treated sooner while avoiding unnecessary procedures – an approach that aligns with essential healthcare system needs."

Withdrawal of 2020 Financial Guidance

Due to uncertainties surrounding the impact of the COVID-19 pandemic, Veracyte is withdrawing its previously issued financial guidance for full-year 2020. Veracyte will provide further information to investors when it releases its first quarter 2020 results.

First Quarter Conference Call and Webcast Details

Veracyte will host a webcast and conference call on Wednesday, May 6, 2020 at 5:00 p.m. Eastern Time to discuss its first quarter 2020 financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source