On May 11, 2021 Nuvo Pharmaceuticals Inc. (TSX:MRV; OTCQX:MRVFF) d/b/a Miravo Healthcare (Miravo or the Company), a Canadian focused healthcare company with global reach and a diversified portfolio of commercial products, reported Jesse Ledger, Miravo’s President & Chief Executive Officer and Mary-Jane Burkett, Miravo’s Vice President & Chief Financial Officer will be presenting at the Q2 Virtual Investor Summit (Press release, Nuvo Pharmaceuticals, MAY 11, 2021, View Source [SID1234580418]).

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DATE: Tuesday, May 18,, 2021

TIME: 2:00 p.m. ET

COMPLIMENTARY
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About The Investor Summit

The Investor Summit (formerly MicroCap Conference) is an exclusive, independent conference dedicated to connecting smallcap and microcap companies with qualified investors. The Q2 Investor Summit will take place virtually, featuring 80+ companies and over 300 institutional and retail investors.
Please visit the website at www.investorsummitgroup.com

On May 11, 2021 (ASX:PTX) reported a new research program with the Peter MacCallum Cancer Centre (Peter Mac) in Melbourne to advance its CAR-T programs utilising the OmniCAR platform (Press release, Prescient Therapeutics, MAY 11, 2021, View Source;utm_medium=rss&utm_campaign=prescient-signs-car-t-agreement-with-peter-mac-cancer-centre [SID1234580141]).

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The new program builds on the company’s existing research agreement with Peter Mac focusing on cell therapy enhancement programs.

The new agreement expands this relationship to include the development of the OmniCAR platform.

The company said it is developing three OmniCAR programs internally, including next-generation CAR-T therapies for acute myeloid leukaemia (AML), Her2+ solid tumours and glioblastoma multiforme (GBM).

Prescient said it is developing OmniCAR as a CAR-T platform, capable of being deployed by other CAR-T and oncology companies under licence to advance their own programs.

Under the terms of the new agreement, Prescient will have access to the expertise and facilities of Peter Mac, led by international CAR-T expert, Professor Phil Darcy, to undertake part of the OmniCAR preclinical development programs.

Prescient will own any resulting intellectual property from the work.

The company’s partnership with Peter Mac also now includes two post-doctoral scientists and two research assistants who are dedicated full time to Prescient work. Prescient has also secured grant funding of $100,000 from the federal government’s Innovation Connections scheme towards this research.

On May 11, 2021 Upsher-Smith Laboratories reported that (Press release, Upsher-Smith Laboratories, MAY 11, 2021, View Source [SID1234580140])

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Overall Japan: In February 2020, Sawai Pharmaceutical assembled a Crisis Management team and implemented thorough measures to prevent infection.
US: In March 2020, USL assembled a cross-functional Crisis Response Team to gather and review information and to develop and implement applicable policies and processes. USL transitioned to a remote working model, with the exception of critical workers who needed to remain on-site, and also shifted to a digitally based sales and marketing. Japan: Under the state of emergency declared by the government, due to medical institutions restricting inperson visits by Medical Representatives, the provision of medical information has shifted to delivery by online meetings, etc.

Sales of respiratory organ agents and antibiotics declined due to the decrease in the number of visits patients made to medical institutions. US: Shifted to digitally based sales and marketing due to restriction of in-person physician sales activities. Restriction of sales activities adversely impacted sales, including Tosymra, which was acquired in 2019. Japan: No significant impact on development schedule.

US: Several R&D projects have seen delays due to the shutdowns in US and OUS. Supply Chain Maintained stable supply function by thoroughly implementing infection prevention and control in Japan and the U.S. There has been no disruption in the importation of raw materials or logistics.Sawai’s Response to the Serious GMP Violation in the Japanese Generics Industry

2 Sawai’s internal action related to this matter Sawai’s action toward quality
・Our Quality Assurance Dept. internally disseminates all the product recall information of other companies and also shares Sawai products’ relevant information on the products related to the recall. (As needed.)
・In addition to information sharing, reconfirmed at all the factories a supervision system of accepting, weighing and adding APIs; a training system for factory workers; and a prevention system of mix-ups of APIs. (Implemented in Dec. 2020.
・Provided briefings on these cases to employees at all the factories and instruct to engage in operations strictly following procedures. (Implemented in Jan. 2021.
） To minimize quality-related risks, the following measures are taken;
・Ensure the quality of APIs in compliance with Good Manufacturing Practices (GMP).
・Implement a quality control system through constant confirmation of GMP compliance at manufacturing facilities. ・Adopt manufacturing and quality control measures based on the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S-GMP). Slight increase in net sales and the same level as the previous year in core operating income, despite the severe business environment in both Japan and the US.
 Operating income decreased due to impairment loss on intangible assets in the US.

On May 11, 2021 Nuvalent on Tuesday reported the completion of a $135 million Series B financing round led by Bain Capital Life Sciences (Press release, Nuvalent, MAY 11, 2021, View Source [SID1234580011]).

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The company’s founding investor, Deerfield Management, also participated in the round. New investors include Fidelity Management and Research Company, Wellington Management Company, Viking Global Investors, Janus Henderson Investors, Avoro Capital Advisors, Boxer Capital of Tavistock Group, Venrock Healthcare Capital Partners, Fairmount Funds Management, Driehaus Capital Management, and Logos Capital. Along with the financing, Andrew Hack, managing director of Bain Capital Life Sciences, will join the Nuvalent board of directors.

Nuvalent will use the funding to advance its two lead programs in non-small cell lung cancer: NVL-520, a ROS1-selective kinase inhibitor, and NVL-655 an ALK-selective kinase inhibitor. The financing will also support the firm’s discovery research pipeline, which includes three undisclosed candidates.

Preclinical studies on NSCLC samples presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s virtual annual meeting last month showed that both NVL-520 and NVL-655 had activity against resistance mutations that emerged in tumors treated with earlier generation ROS and ALK inhibitors.

The company expects to begin a Phase I/II trial of NVL-520 in ROS1-positive NSCLC patients in the second half of 2021 and a Phase I/II trial of NUV-655 in ALK-positive NSCLC patients in the first half of 2022.

"With this financing, we are well positioned to efficiently advance our parallel lead programs into clinical development and to accelerate the discovery of additional novel, selective compounds to meet medical needs in treatment-resistant cancers," Nuvalent CFO Alex Balcom said in a statement.

The Cambridge, Massachusetts-based firm was founded in 2017. In January, Nuvalent raised $50 million in a Series A financing round.

On May 11, 2021 Upsher-Smith Laboratories reported that Financial Summary for the Fiscal Year Ended March 31, 2021 (Press release, Upsher-Smith Laboratories, MAY 11, 2021, View Source [SID1234579908])

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1. Financial Highlights for the Fiscal Year Ended March 31, 2021 (April 1, 2020 to March 31, 2021)
(1） Consolidated Operating Results
(2) Consolidated Financial Position
(3) Consolidated Cash Flows

2. Cash Dividends

Consolidated Financial Statements and Selected Notes
(1) Consolidated Statements of Income and Consolidated Statements of Comprehensive Income

(2) Consolidated Statements of Financial Position

(3) Consolidated statements of Changes in Equity

(4) Consolidated Statements of Cash Flows