On April 28, 2021 iCo Therapeutics Inc. ("iCo" or the "Company") (TSXV: iCo) (OTCQB: iCoTF) reported that it has closed its previously announced private placement (the "Financing") in connection with its proposed business combination with Satellos Bioscience Inc. ("Satellos") by way of a plan of arrangement (the "Arrangement") in accordance with Section 192 of the Canada Business Corporations Act (Press release, iCo Therapeutics, APR 28, 2021, View Source [SID1234578569]). The completion of the Arrangement will result in the reverse takeover of the Company as defined in the policies of the TSX Venture Exchange ("TSXV") and the resulting entity will continue to operate in the life sciences industry under the name "Satellos Bioscience Inc." (the "Resulting Issuer").

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Pursuant to the Financing, the Company issued 85,294,117 subscription receipts (the "Subscription Receipts") at a price of $0.085 per Subscription Receipt for aggregate gross proceeds of approximately C$7.25 million. Each Subscription Receipt will entitle the holder thereof to receive, upon satisfaction of certain escrow release conditions, including without limitation, the completion of the Arrangement, and without payment of additional consideration, one common share of the Resulting Issuer (a "Resulting Issuer Share"). The proceeds from the Financing have been placed in escrow and, upon satisfaction of the escrow release conditions, will be used for research, development, and general corporate expenses of the Resulting Issuer.

The Resulting Issuer Shares issued in connection with the Financing will be subject to a hold period expiring 4 months and one day from the date of issuance in accordance with applicable Canadian securities laws. Additionally, in connection with the Financing, certain Resulting Issuer Shares issued to former shareholders of Satellos pursuant to the Arrangement will be subject to a lock-up agreement.

The Financing was led by Bloom Burton Securities Inc. and includes Richardson Wealth Ltd.

On April 28, 2021 Boston Scientific Corporation (NYSE: BSX) reported net sales of $2.752 billion during the first quarter of 2021 (Press release, Boston Scientific, APR 28, 2021, View Source [SID1234578606]). This represents growth of 8.2 percent on a reported basis, 5.6 percent on an operational1 basis and 5.9 percent on an organic2 basis, all compared to the prior year period. The company reported GAAP net income available to common stockholders of $327 million or $0.23 per share (EPS), compared to GAAP net income of $11 million or $0.01 per share a year ago, and achieved adjusted EPS of $0.37 for the period, compared to $0.28 a year ago.

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"We are pleased by the trajectory of our recovery," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "Our global team remains committed to helping patients and our customers by delivering a robust portfolio of innovative solutions, and that commitment will continue to fuel our future growth."

First quarter financial results and recent developments:

Reported net sales of $2.752 billion, representing an increase of 8.2 percent on a reported basis, compared to the company’s guidance range of 0 to 6 percent; 5.6 percent on an operational basis; and 5.9 percent on an organic basis, compared to the company’s guidance range of (3) to 3 percent, all compared to the prior year period.

Reported GAAP net income available to common stockholders of $0.23 per share compared to the company’s guidance range of $0.05 to $0.11 per share. Achieved adjusted EPS of $0.37 compared to the guidance range of $0.28 to $0.34 per share.

Achieved net sales growth in each reportable segment4, compared to the prior year period:
MedSurg: 11.1 percent reported, 8.6 percent operational and 9.5 percent organic
Rhythm and Neuro: 6.8 percent reported, 4.0 percent operational and 1.6 percent organic
Cardiovascular: 10.0 percent reported, 7.4 percent operational and organic

Achieved the following regional5 net sales growth, compared to the prior year period:
U.S.: 8.6 percent reported and operational
EMEA (Europe, Middle East and Africa): 9.4 percent reported and 1.9 percent operational
APAC (Asia-Pacific): 15.6 percent reported and 9.1 percent operational
Emerging Markets3: 16.0 percent reported and 13.2 percent operational

Received U.S. Food and Drug Administration (FDA) approval for the TheraSphere Y-90 Glass Microspheres for the treatment of patients with hepatocellular carcinoma, the most common type of primary liver cancer, and secured FDA Breakthrough Device designation for TheraSphere treatment for patients with glioblastoma, a type of brain cancer.6

Received approval for the Ranger Drug-Coated Balloon from Japan’s Ministry of Health, Labor and Welfare (MHLW) and initiated a full launch in the region.

Launched Vercise Genus Deep Brain Stimulation (DBS) System in the U.S. Additionally, the system is being used with the world’s first 16-channel directional leads—Cartesia X and HX leads—in the eXTend 3D Study in Europe.

Commenced U.S. launch of the WaveWriter Alpha portfolio of spinal cord stimulator (SCS) systems, consisting of four full-body MR conditional, Bluetooth-enabled devices, new FAST paresthesia-free therapy and all supported by Cognita Solutions—a suite of digital tools that helps physicians and patients navigate the pain management journey.

Surpassed 50,000 patients worldwide treated with the SENTINEL Cerebral Protection System, the first and only FDA-cleared device to protect patients from stroke risk during transcatheter aortic valve replacement (TAVR) procedures.

Published positive 12-month results from the PINNACLE FLX clinical trial in Circulation, demonstrating the next-generation WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device is a safe and effective alternative to oral anticoagulation therapy for stroke risk reduction in patients with non-valvular atrial fibrillation and increased risk of bleeding. The trial met its primary safety endpoint with a low adverse event rate of 0.5%, as well as its primary effectiveness endpoint with a 100% rate of LAA closure at 12 months.

Presented five-year outcomes from the EFFORTLESS study, the largest post-market registry of the Subcutaneous Implantable Defibrillator (S-ICD) System, further validating the long-term efficacy of the device. Results demonstrated 98% overall efficacy over five years, consistent with results of previous S-ICD studies and comparable to or higher than many large transvenous ICD studies.

Received FDA approval to modify the design of the ACURATE IDE trial—evaluating the ACURATE neo2 Aortic Valve System—to an "all-risk" protocol to study patients with severe, symptomatic aortic stenosis who are at low risk of open-heart surgery, in addition to those at intermediate, high and extreme risk.

Initiated the NEwTON AF IDE clinical trial to evaluate the safety and effectiveness of the INTELLANAV STABLEPOINT Ablation Catheter enabled with DIRECTSENSE Technology in patients with paroxysmal atrial fibrillation.

Named eighth on the Forbes list of America’s Best Employers for Diversity 2021, based on a survey of 50,000 Americans working for businesses with at least 1,000 employees.

Completed the acquisition of Preventice Solutions, Inc., a privately-held company which offers a full portfolio of mobile cardiac health solutions and services, for an upfront cash payment of ~$720 million, with up to an additional ~$230 million in a potential commercial milestone payment, given a preexisting 22 percent equity stake.

Completed the sale of the BTG Specialty Pharmaceuticals business to Stark International Lux S.A.R.L. and SERB SAS, affiliates of SERB, for ~$800 million in cash.

Announced a definitive agreement with an affiliate of Baring Private Equity Asia to acquire the global surgical business of Lumenis LTD., a privately-held company that develops and commercializes energy-based medical solutions, for an upfront cash payment of ~$1.07 billion, subject to customary closing conditions and adjustments.

Announced plans to host a virtual Investor Day business review meeting for the investment community on Wednesday, September 22, 2021.

1. Operational net sales growth excludes the impact of foreign currency fluctuations.

2. Organic net sales growth excludes the impact of foreign currency fluctuations and net sales from the recent acquisition of Preventice Solutions, Inc. (Preventice). Organic net sales growth rates also exclude the intrauterine health franchise, which we divested in Q2 2020 and the Specialty Pharmaceuticals business, which we divested in Q1 2021.

3. We define Emerging Markets as the 20 countries that we believe have strong growth potential based on their economic conditions, healthcare sectors and our global capabilities. Periodically, we assess our list of Emerging Markets countries, and effective January 1, 2021, modified our list to include the following countries: Brazil, Chile, China, Colombia, Czech Republic, India, Indonesia, Malaysia, Mexico, Philippines, Poland, Russia, Saudi Arabia, Slovakia, South Africa, South Korea, Taiwan, Thailand, Turkey and Vietnam. We have revised prior year amounts to conform to the current year’s presentation. The revision had an immaterial impact on previously reported Emerging Markets net sales.

4. We have three historical reportable segments comprised of Medical Surgical (MedSurg), Rhythm and Neuro, and Cardiovascular, which represent an aggregation of our operating segments that generate revenues from the sale of medical devices (Medical Devices).

5. On March 1, 2021, we completed the sale of the Specialty Pharmaceuticals business. Our consolidated net sales include Specialty Pharmaceuticals up to the date of the closing of the transaction. Specialty Pharmaceuticals net sales were substantially U.S. based and presented as a stand-alone operating segment alongside our Medical Device Reportable segments.

6. Consistent with Section 515B of the FD&C Act, devices designated as Breakthrough Devices will receive prioritized review (Section II.F).

Guidance for Full Year and Second Quarter 2021

The company now estimates net sales growth for the full year 2021, versus the prior year period, to be in a range of approximately 16 to 19 percent on a reported basis, and approximately 15 to 18 percent on an organic basis. Full year organic net sales guidance excludes the impact of foreign currency fluctuations and the acquisition of Preventice Solutions, Inc., with no prior period related net sales, as well as the intrauterine health franchise, which we divested in Q2 2020 and the Specialty Pharmaceuticals business, which we divested in Q1 2021. The company now estimates earnings on a GAAP basis in a range of $0.81 to $0.88 per share and estimates adjusted earnings, excluding certain charges (credits), of $1.53 to $1.60 per share.

The company estimates net sales growth for the second quarter of 2021, versus the prior year period, to be in a range of approximately 46 to 50 percent on a reported basis and approximately 44 to 48 percent on an organic basis. Second quarter organic net sales guidance excludes the impact of foreign currency fluctuations and the acquisition of Preventice, with no prior period related net sales, as well as the intrauterine health franchise, which we divested in Q2 2020 and the Specialty Pharmaceuticals business, which we divested in Q1 2021. The company estimates earnings on a GAAP basis in a range of $0.16 to $0.18 per share and adjusted earnings, excluding certain charges (credits), of $0.36 to $0.38 per share.

Conference Call Information

Boston Scientific management will be discussing these results with analysts on a conference call today at 8:00 a.m. ET. The company will webcast the call to interested parties through its website: www.bostonscientific.com. Please see the website for details on how to access the webcast. The webcast will be available for approximately one year on the Boston Scientific website.

On April 28, 2021 Clovis Oncology, Inc. (Nasdaq: CLVS) reported that its President and Chief Executive Officer, Patrick J. Mahaffy, will present at the Bank of America 2021 Health Care Conference on Tuesday, May 11, 2021, at 5:00 p.m. Eastern time (Press release, Clovis Oncology, APR 28, 2021, View Source [SID1234578632]).

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This conference is virtual and a live webcast of the presentation can be accessed through the investor relations section of the Company’s website at www.clovisoncology.com. Following the live presentation, a replay of the webcast will be available on the Company’s website for 30 days.

On April 28, 2021 Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that it will report first quarter 2021 financial results on Monday, May 3, 2021 (Press release, Karyopharm, APR 28, 2021, View Source,-2021 [SID1234578649]). Karyopharm’s management team will host a conference call and audio webcast at 8:30 a.m. ET on Monday, May 3, 2021, to discuss the financial results and other company updates.

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To access the conference call, please dial (888) 349-0102 (local) or (412) 902-4299 (international) at least 10 minutes prior to the start time and ask to be joined into the Karyopharm Therapeutics call. A live audio webcast of the call will be available under "Events & Presentations" in the Investor section of the Company’s website, View Source An archived webcast will be available on the Company’s website approximately two hours after the event.

On April 20, 2021 Lutris Pharma, a clinical stage biopharmaceutical company focusing on improving anti-cancer therapies by reducing dose limiting side effects, reported that results of a Phase1 study for its lead product, LUT014, assessing the safety, tolerability, and efficacy of topically administered LUT014 for the treatment of epidermal growth factor receptor (EGFR) inhibitor-induced acneiform lesions in metastatic colorectal cancer patients, were published in Cancer Discovery a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Lutris Pharma, APR 28, 2021, View Source [SID1234578691]).

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EGFR inhibitors, such as the anti-EGFR monoclonal antibodies cetuximab or panitumumab, are valuable therapeutic options in metastatic colorectal cancer. However, their use is often associated with skin toxicities, leading to potentially severe acne-like rashes on the face, chest and back, resulting in a reduced quality of life as well as treatment discontinuation. In fact, 70-80% of patients treated with EGFR inhibitors who developed a rash do not receive optimal anti-cancer treatment.[i]

LUT014 is a topical drug designed to ameliorate the skin toxicity of EGFR inhibitors. The Phase 1 clinical trial for assessing the safety, tolerability and initial efficacy of LUT014 was conducted in four leading centers in the US and two in Israel[ii], on 10 patients with metastatic colorectal cancer who had developed a grade 1 or 2 acneiform rash while being treated with cetuximab or panitumumab. Patients were divided into three dose cohorts, of 0.3, 1 or 2.5 mg/g and were treated for 28 days. In all dosage levels, LUT014 was well tolerated with no dose limiting toxicities. The acneiform rash improved in all the patients who started with grade 2 rash in the low and intermediate dose cohorts (6 patients), and the improvement was maintained a month after treatment cessation.

In light of the positive results, Lutris initiated a Phase 2, randomized, double-blind, placebo-controlled efficacy and safety study of topically administered LUT014 in metastatic colorectal cancer patients with EGFR inhibitor-induced acneiform lesions. The study is designed to include 117 patients in 20 centers in the US and Israel, who will be treated for 28 days with either LUT014 gel or a placebo. The primary outcome is the proportion of subjects in each treatment group who reached treatment success, defined as an improvement (decrease) of at least one grade in the severity of the acneiform lesions from baseline to day 28. Interim results are expected by the end of 2021.

Antoni Ribas, M.D., Ph.D., Professor of Medicine, Surgery, and Molecular and Medical Pharmacology at the University of California Los Angeles, contributing author, and founder and director at Lutris Pharma, said, "We are excited with the positive results and high response rate seen in this preliminary trial for LUT014 in treating skin toxicities of EGFR inhibitors. These promising results offer initial hope that the potential of EGFR inhibitors, a significant tool for the treatment of metastatic colorectal cancer, could be maximized with fewer adverse effects."

Lead author Mario E. Lacouture, MD, Director of the Oncodermatology Program at Memorial Sloan Kettering Cancer Center in New York City, noted, "EGFR is highly expressed in skin cells, and therefore inhibition of this pathway in patients with cancer often results in debilitating skin rash that is frequently pruritic or painful, and may decrease quality of life and cancer therapy dosing. The preliminary results of the Phase 1 trial are encouraging, and future trials have the potential to translate this therapy into a clinically available treatment option for patients experiencing these untoward events from cancer treatment."

Noa Shelach, PhD, MBS, CEO of Lutris Pharma, said, "Currently there is no approved therapy for acneiform rash that accompany EGFR inhibition in up to 90% of patients. Most of the patients are not optimally treated for their cancer and their quality of life is negatively affected. LUT014 is emerging as an extremely useful topical treatment for EGFR-related acneiform rash, with no systemic adverse effects. In fact, our analysis shows there is negligible absorption and minimal systemic exposure to the drug. While this clinical trial assessed the effect of LUT014 on inhibition of EGFR by therapeutic antibodies, it is also applicable to acneiform rash induced by EGFR inhibitors that are small molecules. We look forward to the interim results of our ongoing Phase 2 trial with LUT014 for treating skin toxicities of EGFR inhibition, expected by the end of the year."

About LUT014

LUT014 is a novel B-Raf inhibitor which is applied topically on the skin. The B-Raf protein is part of the EGFR pathway, and was shown to be mutated in some human cancers such as melanoma cancer. Blocking the B-Raf pathway in B-Raf mutated cancer cells leads to tumor shrinkage, but when the same pathway is blocked in normal, non-mutated cells, the opposite happens: the MAPK pathway is activated and cells start growing. This phenomenon is recognized as the paradoxical effect of B-Raf Inhibitors. LUT014 harnesses the paradoxical effect of B-Raf Inhibitors in order to reverse the effect of EGFR inhibitors on downstream proteins in the skin cells, thereby reducing dose-limiting acneiform lesions associated with EGFR inhibitor treatment. Lutris Pharma is currently assessing the effectiveness of LUT014 in two clinical studies: a Phase 2 study for reduction of dose-limiting acneiform lesions associated with EGFRI treatment of metastatic colorectal cancer, and a Phase 1/2 study for the treatment of radiation induced dermatitis in breast cancer patients.

About EGFR inhibitor-induced rash

EGFR (Epidermal Growth Factor Receptor) is a receptor on the surface of cells which is expressed in many normal epithelial tissues, including skin. The EGFR signaling pathway is one of the most important pathways that regulate growth, survival, proliferation, and differentiation of cells. B-Raf is protein encoded by the BRAF gene and is a downstream effector component of EGFR signaling pathway. EGFR is shown to be over-activated in various human cancers, including colorectal, lung, head & neck, urinary bladder, pancreatic and breast cancers. While over-activated, it elicits downstream phosphorylation and activation of the MAP Kinase pathway.

Drugs called EGFR inhibitors can block the EGFR signal responsible for cell growth. Among the various types of pharmacological therapies for cancer, EGFR inhibitors are increasingly being used both as primary therapy as well as in patients who have failed prior chemotherapy. Although effective as anti-cancer therapy leading to tumor shrinkage, EGFR inhibitors have a number of adverse reactions associated with their use. The majority of patients treated with EGFR inhibitors will experience dermatological side effects typically manifested as a papulopustular skin rash, also known as acneiform lesions, which can impact quality of life and affect adherence to therapy.