On April 20, 2021 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that the Company will host a webcast conference call to report its first quarter 2021 financial results and provide an update on the company’s business and outlook on Tuesday, May 4, 2021 at 4:30 p.m. (ET) after the closing of the market (Press release, PTC Therapeutics, APR 20, 2021, https://ir.ptcbio.com/news-releases/news-release-details/ptc-therapeutics-host-conference-call-discuss-first-quarter-2021 [SID1234578255]).

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The call can be accessed by dialing (877) 303-9216 (domestic) or (973) 935-8152 (international) five minutes prior to the start of the call and providing the passcode 4292410. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the PTC website at View Source A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the company’s website for 30 days following the call.

On April 20, 2021 Case Western Reserve University and Atelerix Life Sciences Inc., a Charlottesville, Virginia-based biotechnology company, reported that they have signed a two-year option to license a novel family of small molecules called Active Thiol-Based Compounds (ATBC’s) to prevent or reverse life-threatening opioid-related side effects (Press release, Case Western Reserve University, APR 20, 2021, View Source [SID1234578254]).

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The lead compound, ATLX–0199 (also called sudaxine), will be first targeted at opioid-induced respiratory depression (OIRD) in the hospital setting.

A recent study by the medical technology company Medtronic found that 46% of surgical patients receiving opioids for post-operative pain-relief suffer one or more episodes of OIRD, presenting perhaps the most significant obstacle to discharge from intensive care units and the hospital generally.

"No compound now on the market is able to reverse OIRD without also eliminating pain relief—an unacceptable trade-off in the hospital setting," said David Kalergis, Atelerix CEO, co-founder and biotechnology entrepreneur. "This unmet need is well-recognized by medical practitioners, speeding the prospect of rapid adoption and reimbursement in this potential $1 billion market."

The ATBC family and ATLLX-0199 are the result of several decades of collaborative scientific discovery and research among the company’s three co-founders: Stephen Lewis, a professor in the Department of Pediatrics at the Case Western Reserve School of Medicine, Benjamin Gaston, formerly of Case Western Reserve and now Billie Lou Wood Professor of Pediatrics at Indiana University’s School of Medicine, and James Bates, associate professor of Anesthesia at the University of Iowa’s Carver College of Medicine. Bates will become chief medical officer of Atelerix.

Development of the technology has been supported by funding and technical assistance from the National Institutes of Health, Harrington Discovery Institute at University Hospitals and the National Heart, Lung, and Blood Institute’s Catalyze Program.

The ATBC technology harnesses new, cutting-edge understanding of the molecular pathways involved in the effects of opioids, both as a pain reliever and a source of life-threatening side-effects like suppressed breathing. Rather than affecting the opioid receptors directly, they target the inhibition of pathways responsible for the side effects, allowing a more selective therapeutic intervention.

Studies on animal models have shown that ATLX–0199 can be injected intravenously to immediately reverse the negative effects of opioids on breathing without causing withdrawal or reversing the effects of pain control. Long-term, the company expects to expand the technology for use in trauma and overdoses, as well as administering the drug nasally, through patches or other routes.

"As a practicing anesthesiologist, I deal with the problem of opioid-induced depression of breathing in my patients every day," Bates said. "In my new role as chief medical officer of Atelerix Life Sciences, I will be directly involved in developing a solution to this serious unmet medical need by helping speed sudaxine through the U.S. Food and Drug Administration-approval process and into widespread use in the hospital setting."

The two-year option to license agreement, managed through Case Western Reserve’s Technology Transfer Office (TTO), will allow pre-clinical testing of the technology, including safety profiling and feasibility of scaled-up manufacturing.

"After several years of supporting this project within the university, we believe our timely partnership with Atelerix will provide a product that will address the real needs of patients receiving opioids," said Stephanie Weidenbecher, TTO’s senior licensing manager. "Follow-on programs in trauma, military and overdose settings for sudaxine and other molecules in the ATBC family will present comparable opportunities."

On April 20, 2021 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a small molecule driven approach to targeting the microbiome to treat disease and improve human health, reported a research collaboration with researcher Robert Jenq, M.D. Professor of Genomic Medicine, at The University of Texas MD Anderson Cancer Center, to explore the potential of Kaleido’s novel Microbiome Metabolic Therapies (MMT) in preventing febrile neutropenia—a serious complication associated with hematopoietic stem cell transplantations (HSCT) (Press release, Kaleido Biosciences, APR 20, 2021, View Source [SID1234578253]).

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Approximately 60,000 patients undergo HSCT annually in the U.S. and Europe, which includes patients with myeloid disorders, lymphoid disorders and plasma cell disorders. Recent scientific findings have demonstrated that treatment regimens given to HSCT patients have a profound detrimental effect on their microbiome, putting them at increased risk of bacterial infections, febrile neutropenia and ultimately, graft-versus-host disease (GVHD).

"Today, standard-of-care for patients with hematological cancers includes radiation and chemotherapy to eliminate malignant cells. This may lead to significant side effects including severe damage to the gut epithelium, and major disruption to a patient’s microbiome," said Johan van Hylckama Vlieg, Chief Scientific Officer at Kaleido Biosciences. "Additionally, treatment combinations with broad-spectrum antibiotics used in the conditioning process, leave patients increasingly more susceptible to neutropenic fever. We are eager to work with Dr. Jenq to explore the potential of Kaleido’s MMTs to selectively support the restoration of the microbiome and gut barrier integrity, with the aim of ultimately improving treatment outcomes for patients undergoing HSCT."

Within the collaboration, selected MMTs will be evaluated in disease animal models developed by Dr. Jenq, to further explore the molecular mechanisms by which MMTs act on the microbiome and gut barrier function and support the identification of a lead compound from Kaleido’s compound library.

About Microbiome Metabolic Therapies (MMT)
Kaleido’s Microbiome Metabolic Therapies, or MMTs, are designed to drive the function and distribution of the microbiome organ’s existing microbes in order to decrease or increase the production of metabolites, or to advantage or disadvantage certain bacteria in the microbiome community. The Company’s initial MMT candidates are targeted glycans that are orally administered, have limited systemic exposure, and are selectively metabolized by enzymes in the microbiome. Kaleido utilizes its human-centric discovery and development platform to study MMTs in microbiome samples in an ex vivo setting, followed by advancing MMT candidates rapidly into clinical studies in healthy subjects and patients. These human clinical studies are conducted under regulations supporting research with food, evaluating safety, tolerability and potential markers of effect. For MMT candidates that are further developed as therapeutics, the Company conducts clinical trials under an Investigational New Drug (IND) or regulatory equivalent outside the U.S., and in Phase 2 or later development.

On April 20, 2021 Abbott (NYSE: ABT) reported financial results for the first quarter ended March 31, 2021 (Press release, Abbott, APR 20, 2021, View Source [SID1234578252]).

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First-quarter sales of $10.5 billion increased 35.3 percent on a reported basis and 32.9 percent on an organic basis, which excludes the impact of foreign exchange.
First-quarter GAAP diluted EPS was $1.00 and adjusted diluted EPS, which excludes specified items, was $1.32, reflecting 103.1 percent growth versus the prior year.1
Abbott projects full-year 2021 diluted EPS from continuing operations on a GAAP basis of at least $3.74. Projected full-year adjusted diluted EPS from continuing operations of at least $5.00 remains unchanged and reflects growth of more than 35 percent versus the prior year.2
Global COVID-19 testing-related sales were $2.2 billion in the first quarter, led by combined sales of $1.8 billion from Abbott’s BinaxNOW, Panbio and ID NOW rapid testing platforms.
First-quarter sales increased 7.6 percent on a reported basis and 5.7 percent on an organic basis, excluding COVID-19 testing-related sales.
In January, the U.S. Centers for Medicare & Medicaid Services expanded reimbursement coverage eligibility for Abbott’s revolutionary MitraClip device, which significantly increases the number of people who can benefit from this market-leading, minimally invasive heart device.
In March, Abbott announced the U.S. launch of NeuroSphere Virtual Clinic, a first-of-its-kind technology that allows patients to communicate with physicians, ensure proper settings and functionality, and receive new treatment settings remotely as needed.
In April, Abbott announced U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) of its BinaxNOW COVID-19 Ag Self Test for individuals with or without symptoms and without the need of a prescription.
"We’re off to a very strong start to the year, with all four of our major businesses achieving strong growth," said Robert B. Ford, president and chief executive officer, Abbott. "We’re particularly pleased with the growing momentum of several recently launched products and continue to forecast more than 35 percent EPS growth for the year."

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.

Following are sales by business segment and commentary for the first quarter 2021

* Total Q1 2021 Abbott sales from continuing operations include Other Sales of approximately $16 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
foreign exchange rates.

First-quarter 2021 worldwide sales of $10.5 billion increased 35.3 percent on a reported basis and 32.9 percent on an organic basis.

Worldwide Nutrition sales increased 6.9 percent on a reported basis and 6.4 percent on an organic basis in the first quarter. Strong performance of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading diabetes nutrition brand, led to global Adult Nutrition sales growth of 18.9 percent on a reported basis and 18.3 percent on an organic basis. In Pediatric Nutrition, sales growth was negatively impacted by a difficult comparison versus the first quarter of 2020 when consumers increased purchases in advance of stay-at-home directives as a result of COVID-19.

Worldwide Diagnostics sales increased 119.8 percent on a reported basis in the first quarter and increased 114.8 percent on an organic basis. Strong growth in the quarter was driven by demand for Abbott’s portfolio of COVID-19 diagnostics tests across its rapid and lab-based platforms. Global COVID-19 testing-related sales were $2.2 billion in the first quarter, led by combined sales of $1.8 billion from Abbott’s BinaxNOW, Panbio and ID NOW rapid testing platforms.

Excluding COVID-19 testing-related sales, Core Laboratory Diagnostics sales increased 10.7 percent and Molecular Diagnostics sales increased 31.5 percent on an organic basis in the first quarter.3

Established Pharmaceuticals sales increased 2.5 percent on a reported basis in the first quarter and increased 6.2 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 increased 1.0 percent on a reported basis in the quarter and increased 6.7 percent on an organic basis. Organic sales growth was led by strong growth across several geographies, including China, India and Brazil.

Other sales increased 7.8 percent on a reported basis in the quarter and increased 4.2 percent on an organic basis.

Worldwide Medical Devices sales increased 13.1 percent on a reported basis in the first quarter and increased 8.8 percent on an organic basis. Strong growth in the quarter was driven by continued recovery from the COVID-19 pandemic. In Diabetes Care, sales of FreeStyle Libre and Libre Sense were $829 million in the quarter. FreeStyle Libre now has more than 3 million users worldwide.

ABBOTT’S EARNINGS-PER-SHARE GUIDANCE
Abbott projects 2021 diluted earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) of at least $3.74. Abbott forecasts specified items for the full-year 2021 of $1.26 primarily related to intangible amortization, expenses associated with acquisitions, restructuring and cost reduction initiatives and other net expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be at least $5.00 for full-year 2021.

ABBOTT DECLARES 389TH CONSECUTIVE QUARTERLY DIVIDEND
On Feb. 19, 2021, the board of directors of Abbott declared the company’s quarterly dividend of $0.45 per share. Abbott’s cash dividend is payable May 17, 2021 to shareholders of record at the close of business on April 15, 2021.

Abbott has increased its dividend payout for 49 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 20, 2021 Invitae Corporation (NYSE: NVTA), a leading medical genetics company, reported that it will report its first quarter 2021 financial results on Tuesday, May 4, 2021 and will host a conference call and webcast that day at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss its financial results and recent highlights (Press release, Invitae, APR 20, 2021, View Source [SID1234578251]).

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To access the conference call and webcast, please register at the link below:
View Source

Upon registering, each participant will be provided with call details and a registrant ID. Reminders will also be sent to registered participants via email.

The live webcast of the call and slide deck, may be accessed here or by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast and conference call will be available shortly after the conclusion of the call and will be archived on the company’s website.

Following prepared remarks, management will respond to questions from analysts, subject to time limitations. We encourage our shareholders and those representing them to send in questions to [email protected].