On July 20, 2022 Abbott (NYSE: ABT) reported financial results for the second quarter ended June 30, 2022 (Press release, Abbott, JUL 20, 2022, View Source [SID1234616789]).

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Second-quarter sales of $11.3 billion increased 10.1 percent on a reported basis and 14.3 percent on an organic basis, which excludes the impact of foreign exchange.
GAAP diluted EPS1 was $1.14 in the second quarter. Excluding specified items, adjusted diluted EPS was $1.43, which reflects growth of 22.2 percent compared to the prior year.
Global COVID-19 testing-related sales were $2.3 billion in the second quarter.
Abbott is raising its full-year 2022 EPS guidance. Abbott projects full-year diluted EPS on a GAAP basis of at least $3.50 and projected adjusted diluted EPS of at least $4.90.
2022 guidance includes projected COVID-19 testing-related sales of $6.1 billion, which includes sales of $5.6 billion through June 2022 and projected sales of $500 million over the next few months.
In April, Abbott announced U.S. Food and Drug Administration (FDA) approval of its Aveir single-chamber (VR) leadless pacemaker for the treatment of patients with slow heart rhythms. Aveir VR is the world’s only leadless pacemaker with a unique mapping capability to assess correct positioning prior to placement and was specifically designed to be expandable and retrievable when therapy needs evolve or the device needs to be replaced.
In May, Abbott announced U.S. FDA clearance of its FreeStyle Libre 3 system, which automatically delivers up-to-the-minute glucose readings and unsurpassed 14-day accuracy2 in the world’s smallest and thinnest3 wearable sensor.
In June, Abbott announced breakthrough device designation from the U.S. FDA for its first-of-its-kind glucose-ketone biowearable sensor development program, which will enable people with diabetes to continuously monitor glucose and ketones in one sensor, helping those at risk for developing a life-threatening complication called diabetic ketoacidosis.
"We achieved another quarter of strong growth and are raising our full-year EPS guidance," said Robert B. Ford, chairman and chief executive officer, Abbott. "Our new product pipeline has remained highly productive, and our diversified business has continued to be resilient in a challenging macro environment."

SECOND-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.

Second-quarter 2022 worldwide sales of $11.3 billion increased 10.1 percent on a reported basis and 14.3 percent on an organic basis.

Worldwide sales, excluding COVID-19 testing-related sales, decreased 0.3 percent on a reported basis and increased 4.1 percent on an organic basis in the quarter.4 Worldwide sales were negatively impacted by a voluntary recall and manufacturing shutdown initiated in February of certain infant formula products manufactured at one of Abbott’s U.S. plants. Excluding COVID-19 testing-related sales and the U.S. sales associated with the recalled products in the current and prior years, total worldwide sales increased 1.6 percent on a reported basis and 6.2 percent on an organic basis in the second quarter. 5

Worldwide Nutrition sales decreased 7.4 percent on a reported basis and 4.5 percent on an organic basis in the second quarter. Total worldwide Nutrition and Pediatric Nutrition sales were negatively impacted by a voluntary recall and manufacturing shutdown initiated in February of certain infant formula products manufactured at one of Abbott’s U.S. plants. On July 1, Abbott restarted partial production at the facility. Excluding the U.S. sales associated with these products in the current and prior years, total worldwide Nutrition sales increased 0.5 percent on a reported basis and 3.8 percent on an organic basis in the second quarter.6

In Adult Nutrition, Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading diabetes nutrition brand, led to global sales growth of 1.2 percent on a reported basis and 5.2 percent on an organic basis.

Worldwide Diagnostics sales increased 33.1 percent on a reported basis and 36.9 percent on an organic basis in the second quarter. Global COVID-19 testing-related sales were $2.3 billion in the quarter, led by sales of testing products in Rapid Diagnostics.

Sales in Core Laboratory and Molecular Diagnostics were impacted by year-over-year declines in COVID-19 testing-related sales in these businesses. Excluding COVID-19 testing-related sales, Core Laboratory Diagnostics sales decreased 3.1 percent on a reported basis and increased 2.3 percent on an organic basis and Molecular Diagnostics sales increased 17.9 percent on a reported basis and 22.3 percent on an organic basis in the second quarter.7

Established Pharmaceuticals sales increased 3.7 percent on a reported basis and 9.2 percent on an organic basis in the second quarter.

Key Emerging Markets include several emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies increased 1.8 percent on a reported basis and 7.1 percent on an organic basis, led by double-digit growth on a reported and organic basis in several geographies and therapeutic areas, including cardiometabolic, respiratory and central nervous system/pain management.

Other sales increased 10.3 percent on a reported basis and 16.7 percent on an organic basis in the quarter.

Worldwide Medical Devices sales increased 2.5 percent on a reported basis and 7.5 percent on an organic basis in the second quarter. Sales growth was negatively impacted by reduced cardiovascular and neuromodulation procedure volumes as a result of recent surges of COVID-19 in several geographies, healthcare staffing challenges and lockdowns in China that were implemented to control the spread of the virus.

In Diabetes Care, FreeStyle Libre sales were approximately $1.1 billion in the quarter, which represents sales growth of 18.7 percent on a reported basis and 25.6 percent on an organic basis.

ABBOTT’S EARNINGS-PER-SHARE GUIDANCE
Abbott is raising its projected full-year 2022 diluted earnings per share under GAAP to at least $3.50. Abbott forecasts specified items for the full-year 2022 of $1.40 per share primarily related to intangible amortization, costs related to a voluntary recall, expenses associated with acquisitions, restructurings and cost reduction initiatives and other net expenses. Excluding specified items, Abbott is raising its projected adjusted diluted earnings per share to at least $4.90 for the full-year 2022.

ABBOTT DECLARES 394TH CONSECUTIVE QUARTERLY DIVIDEND
On June 10, 2022, the board of directors of Abbott declared the company’s quarterly dividend of $0.47 per share. Abbott’s cash dividend is payable Aug. 15, 2022, to shareholders of record at the close of business on July 15, 2022.

Abbott has increased its dividend payout for 50 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 July 20, 2022 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported new regulatory designations for eltanexor, a novel oral, Selective Inhibitor of Nuclear Export (SINE) investigational compound being studied for the treatment of myelodysplastic syndromes (MDS): (i) the U.S. Food and Drug Administration (FDA) has granted fast track designation for the development program of eltanexor as monotherapy for the treatment of patients with relapsed or refractory intermediate, high-, or very high-risk MDS; (ii) the European Commission (EC) adopted the Committee for Orphan Medicinal Products (COMP) opinion to designate eltanexor as an orphan medicinal product for the treatment of MDS in the European Union (EU) (Press release, Karyopharm, JUL 20, 2022, View Source [SID1234616787]). Karyopharm also received orphan drug designation from the FDA in January 2022. MDS are a group of diseases characterized by ineffective production of the components of the blood due to poor bone marrow function with a risk of progression to acute myeloid leukemia.

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Karyopharm is currently investigating eltanexor in an ongoing open-label Phase 1/2 study in patients with relapsed/refractory MDS. Previously, Karyopharm reported initial data from the Phase 1 portion of this study evaluating single-agent eltanexor in patients with hypomethylating agent (HMA)-refractory MDS.

Approximately 15,000 people in the U.S.1 and 14,000 people in the EU2 are expected to be diagnosed with intermediate-to-high risk MDS in 2022. HMAs are the current standard of care for newly diagnosed, higher-risk MDS patients. However, only 40-60% of patients respond, with these responses typically lasting less than two years.3 The prognosis in HMA-refractory disease is poor, with a median overall survival of four to six months.4,5 There are currently no approved therapies for HMA- refractory MDS.

"These recent designations from the FDA and EC reinforce eltanexor’s potential to improve clinical outcomes for patients with relapsed/refractory MDS," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "We are dedicated to advancing our ongoing clinical trials and remain committed to bringing eltanexor to these patients and their families as a new treatment option."

Fast track is a process designed by the FDA to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions. Once a drug receives Fast Track designation, early and frequent communication between the FDA and the drug company is encouraged throughout the entire drug development and review process.

Orphan Medicinal Product Designation is granted by the EC to promote the development of drugs that target rare (less than 5 in 100,000 people across the EU), seriously debilitating and/or life-threatening diseases, and are expected to provide a significant benefit over existing authorized treatments. Orphan designation qualifies a company for certain incentives that apply across all stages of drug development, including the potential for ten years of market exclusivity following marketing approval, fee reductions, and eligibility for orphan drug grants.

About Eltanexor

Eltanexor (KPT-8602) is an investigational novel SINE compound that functions by binding with, and inhibiting, the nuclear export protein, XPO1, leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells.

In preclinical models, eltanexor has a broad therapeutic window with minimal penetration of the blood brain barrier and, therefore, has the potential to serve as another SINE compound for cancer indications. Following oral administration, animals treated with eltanexor show lower percentage of body weight loss and improved food consumption than animals similarly treated with selinexor. This allows more frequent dosing of eltanexor, enabling a longer period of exposure than is possible with selinexor.

Eltanexor is an investigational medicine and has not been approved by the United States Food and Drug Administration or any other regulatory agency.

On July 20, 2022 Celluris reported that Singapore Week of Innovation & Technology (SWITCH 2022) is the largest annual event dedicated to innovative companies in Southeast Asia (Press release, Celluris, JUL 20, 2022, View Source [SID1234616784]).

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Promoted by government agency Enterprise Singapore, the event brings together global business leaders, disruptive technology experts and startups and innovative entrepreneurs to discuss the latest technological trends in industries in key sectors: health and biomedicine; urban solutions and connectivity; and new technological frontiers.
Celluris was one of the 3 startups selected to participate in the Brazilian mission, representing what our country has developed in innovation in the biotech area.
Switch 2022 will take place from 25 to 28 October, and we were also nominated for the "fast-track" of the pitching competition "Slingshot", which takes place under switch 2022, which positions us in the semifinal phase (top 250) of the world competition.

On July 20, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, reported the completion of recruitment for the Phase I PROPELLER diagnostic trial evaluating its 64Cu-SAR-bisPSMA product candidate in patients with untreated, confirmed prostate cancer, scheduled for radical prostatectomy (Press release, Clarity Pharmaceuticals, JUL 20, 2022, View Source [SID1234616755]). A total of 30 participants have been enrolled in the trial across multiple clinical sites in Australia under the supervision of Lead Principal Investigator, Prof Louise Emmett, at St Vincent’s Hospital in Sydney.

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Clarity expects to report topline results data from the PROPELLER trial in the coming months following the completion of study assessments for all participants and once data analysis activities are finalised. The data will inform a planned registrational Phase III trial in participants with untreated, confirmed prostate cancer in the US.

Prof Louise Emmett commented, "The initial imaging data from the PROPELLER trial with the SAR-bisPSMA product looks very encouraging and we look forward to supporting the comprehensive analysis in due course. Having recently also seen the benefits of Clarity’s SAR-Bombesin product in breast and prostate cancer patients, there is now growing interest from oncology professionals in Targeted Copper Theranostics (TCTs), particularly due to the efficacy and added flexibility that Clarity’s copper-based products provide for patients. Coupled with the logistical benefits TCTs offer through on-demand distribution of ready-to-use products, these may be significant advantages in comparison to the current generation of radiopharmaceuticals. These benefits mean that critical imaging scans can be delivered to cancer patients on time and at a convenient location, representing a treatment paradigm focused on the needs of patients and their treating staff."

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are very pleased to have reached full recruitment in our PROPELLER trial. In this trial we are comparing the diagnostic efficacy of 64Cu SAR-bisPSMA to the prostate cancer tissue samples (i.e. histology), as well as seeing how the images compare to 68Ga-PSMA-11, a product that is currently approved in Australia and the United States. We are looking forward to seeing whether the image comparisons in the clinic follow our preclinical observations of higher uptake into tumours with our SAR-bisPSMA product. This is critical in providing a correct diagnosis, especially in patients with early disease. The data from the PROPELLER trial will then inform us on our Phase III trial protocol and commencement of this next trial in calendar year 2023. We look forward to further progressing our SAR-bisPSMA product to improve treatment outcomes for cancer patients."

About the PROPELLER Phase I trial
The PROPELLER trial is a Phase I Positron Emission Tomography (PET) imaging trial of participants with confirmed prostate cancer using Clarity’s optimised PSMA agent, 64Cu SAR-bisPSMA. It is a 30-patient multi-centre, blinded review, dose ranging, non-randomised study of 64Cu-SAR-bisPSMA administered to patients with confirmed prostate cancer prior to radical prostatectomy (NCT04839367)1. The trial will evaluate the safety, tolerability and efficacy of 64Cu SAR-bisPSMA in detecting prostate cancer at three dose levels. It will also compare the diagnostic properties of 64Cu SAR-bisPSMA against 68Ga PSMA-11, the standard of care for prostate cancer imaging in Australia.

Clarity’s SAR-bisPSMA clinical trial program overview

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two prostate-specific membrane antigen (PSMA) binding motifs to Clarity’s proprietary sarcophagene (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu for therapy).

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide2. The National Cancer Institute estimates in 2022 there will be 268,490 new cases of prostate cancer in the US and around 34,500 deaths from the disease3.

On July 19, 2022, Shanghai and Suzhou, China-Immunofoco, a leading company developing innovative cell therapy drugs, reported the innovative CAR-T candidate, IMC002, an autologous Claudin 18.2 specific cell therapy has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA), for the indication of gastric cancer (Press release, Immunofoco, JUL 19, 2022, View Source;c=show&id=27 [SID1234628620]).

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ODD is granted to drugs intended to treat rare diseases with a patient population less than 200,000 in the United States. Orphan drug designation qualifies sponsors for incentives such as tax credits for qualified clinical trials, exemption from user fees, and potential 7-years market exclusivity after approval.

IMC002 is an autologous CAR-T cell therapy based on an anti-claudin 18.2 VHH antibody with high specificity, with no cross-reactivity to Claudin 18.1. Preclinical data have shown that IMC002 is safe and efficacious, with superior safety profiles compared to product candidate of the same kind, indicating a higher dosage window in clinic setting.

"We are encouraged by the grant of ODD designation, which means the preclinical data were accepted bythe FDA and our data demonstrate the promise of treating gastric cancer with IMC002", said Crystal Sun, founder and CEO of Immunofoco, "we are going to submit IND applications both in China and U.S. and will move forward the clinical development as quickly as we can, thus the patients could benefit from this innovative therapy as early as possible."