On September 24, 2020 Flagship Pioneering reported the launch of Valo Health, LLC (Valo), a drug discovery technology company setting out to transform how oncology, neurodegenerative, and cardiovascular disease drugs are created, developed, and approved (Press release, Flagship Ventures, SEP 24, 2020, View Source [SID1234567634]).

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Founded and initially capitalized by Flagship Pioneering in 2019, Valo received additional funding from investors, bringing total financing to nearly $100m. Valo’s Opal Computational PlatformTM is a first-of-its-kind, end-to-end drug development platform, which integrates machine learning, cloud computing, and data to create an entirely new drug discovery and development process.

"New biological and chemical experimental platforms and the application of advanced computing to integrate human data can shave years off drug development and improve the likelihood of success" said Noubar Afeyan, Ph.D., founder and CEO of Flagship Pioneering. "In a pharmaceutical industry where failure is too often the rule, our goal with Valo is to change how drugs are developed and to bring more predictive confidence to clinical trial design and execution."

Valo’s Opal Computational PlatformTM allows the company’s scientists to analyze human data to uncover previously unsuspected associations between genetic markers and disease with a human-centric framing, enabling the integrated discovery and development of proprietary new molecules.

"At the core of Valo’s approach is a recognition that human-centric data coupled with leading-edge compute can enable a transformation in how drugs are created, reducing cost and time, while increasing confidence," said Valo CEO David Berry, who is also a General Partner at Flagship Pioneering. "We founded Valo with the goal of redefining the drug development process so that we can treat some of the world’s most challenging illnesses more quickly and more effectively than ever before."

During its first year, Valo completed two major acquisitions to help drive the company’s strategy. Numerate, acquired in September 2019, and assets from FORMA Therapeutics, acquired in March 2020. Numerate’s engineers, now part of Valo’s team, created a platform with over 30,000 models and over 70 trillion molecules that powered more than 25 drug programs. Through FORMA Therapeutics, Valo acquired a highly skilled team, research and development compounds and libraries, a global intellectual property portfolio, and two early discovery labs.

"Valo is taking a groundbreaking approach to solving some of the most complex and dynamic issues in drug development," said Ron Hovsepian, Valo Board Chairman, and Flagship Executive Partner. "David Berry’s leadership as an innovator positions Valo to shape how the next generation of drugs will come to market. We are excited to see what comes next."

On September 24, 2020 Palatin Technologies, Inc. (NYSE American: PTN) reported that it will announce its fourth quarter and fiscal year end 2020 operating results on Monday, September 28, 2020 before the open of the U.S. financial markets (Press release, Palatin Technologies, SEP 24, 2020, View Source [SID1234565619]).

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Palatin will also conduct a conference call and live audio webcast hosted by its executive management team on September 28, 2020 at 11:00 a.m. ET. The conference call will include a review of the company’s operating results and an update on programs under development.

Schedule for the Operating Results Press Release, Conference Call / Audio Webcast

The audio webcast and replay can be accessed by logging on to the "Investors-Webcasts" section of Palatin’s website at View Source

On September 24, 2020 Medtronic plc (the "Company") (NYSE: MDT) reported that its wholly-owned subsidiary, Medtronic Global Holdings S.C.A. ("Medtronic Luxco"), has priced an offering (the "Offering") of €1,250,000,000 principal amount of 0.000% senior notes due 2023, €1,000,000,000 principal amount of 0.000% senior notes due 2025, €1,000,000,000 principal amount of 0.375% senior notes due 2028, €1,000,000,000 principal amount of 0.750% senior notes due 2032, €1,000,000,000 principal amount of 1.375% senior notes due 2040, and €1,000,000,000 principal amount of 1.625% senior notes due 2050 (collectively, the "Notes") (Press release, Medtronic, SEP 24, 2020, View Source [SID1234565618]). All of Medtronic Luxco’s obligations under the Notes will be fully and unconditionally guaranteed by the Company and Medtronic, Inc., a wholly-owned indirect subsidiary of Medtronic Luxco, on a senior unsecured basis.

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The net proceeds of the Offering will be used to repay Medtronic Luxco’s outstanding Floating Rate Senior Notes due 2021 at maturity on March 7, 2021 and to redeem all or a portion of certain series of outstanding senior notes issued by Medtronic Luxco, Medtronic, Inc. and Covidien International Finance S.A., a wholly-owned indirect subsidiary of the Company. Any remaining net proceeds of the Offering will be used for repayment of other indebtedness and general corporate purposes. The Offering is expected to close on September 29, 2020, subject to customary closing conditions. The joint book-running managers for the Offering are Barclays Bank PLC, BofA Securities Europe SA, Mizuho Securities Europe GmbH and Deutsche Bank Aktiengesellschaft.

The Offering is being made only by means of a prospectus dated February 28, 2020 and prospectus supplement (together, the "Prospectus"). You may get these documents for free by visiting EDGAR on the Securities and Exchange Commission website at www.sec.gov. Alternatively, copies of the Prospectus for the Offering may be obtained by contacting Barclays Bank PLC, toll-free at +1-888-603-5847, BofA Securities Europe SA, at +33(0) 1 8770 0000, Mizuho Securities Europe GmbH, at +44 20 7248 3920 or [email protected], or Deutsche Bank Aktiengesellschaft, at +1-800-503-4611.

On September 24, 2020 Precision Optics Corporation, Inc. (OTCQB: PEYE), a leading designer and manufacturer of advanced optical instruments for the medical and defense industries, reported operating results on an unaudited basis for its fourth quarter and fiscal year ended June 30, 2020 (Press release, Precision Optics, SEP 24, 2020, View Source [SID1234565617]).

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The Company previously announced preliminary fourth quarter and fiscal year 2020 revenue on August 13, 2020.

Fourth quarter fiscal 2020 highlights:

Revenue for the quarter ended June 30, 2020 was $2.24 million compared to $2.38 million in the same quarter of the previous fiscal year, a decrease of 6%. Revenue for the quarter was down year over year on an actual and pro forma basis due to impacts of the COVID-19 pandemic.
Gross margins for the quarter were 29% compared with 31% in the same quarter of the previous fiscal year. This decline in margin was primarily driven by lower revenue and impacts of COVID-19.
Operating expenses decreased more than $300,000 during the fourth quarter of fiscal 2020 compared to the third quarter of fiscal 2020.
Net loss of $323,085 during the quarter included $75,567 of stock-based compensation.
The Company’s cash balance at June 30, 2020 was $1.1 million reflecting the Company’s aggressive cash management initiatives, coupled with proceeds from an equity financing in April 2020 and receipt of funding under the PPP.
Fiscal year 2020 highlights:

Revenue for the fiscal year ended June 30, 2020 was $9.9 million compared to $6.8 million in the previous fiscal year, an increase of 46% driven primarily by Ross Optical operating as a division of Precision Optics for the entire year. Revenue for the year was down year over year on a pro forma basis due to impacts of the COVID-19 pandemic.
Gross margins for the fiscal year ended June 30, 2020 were 34% compared to 31% for the previous fiscal year.
Net loss of $1,426,150 during the fiscal year included $547,345 of stock-based compensation.
On April 14, 2020 the Company raised $250,000 from existing accredited investors with the sale of 200,000 shares at a purchase price of $1.25 per share. On May 7, 2020 the Company received an $809,000 loan from the Small Business Administration (SBA) Paycheck Protection Program.
Precision Optics’ CEO, Joseph Forkey, commented, "Our financial results for the fourth quarter and fiscal year were consistent with our preliminary results announced in mid-August, reflecting the positive contributions from our Ross Optical acquisition offset by impacts to certain aspects of our operations due to COVID-19. We believe the near-term disruptions that we experienced in the third and fourth quarters of fiscal 2020 due to COVID-19 have begun to subside with an expectation that we will see improvements in first quarter fiscal 2021 revenue and gross margins, as compared to the fourth quarter of fiscal 2020."

Dr. Forkey continued, "Our three recently commercialized production programs all continue at levels similar to recent months and we are advancing other programs in development toward production. There are also a number of new opportunities we are pursuing with combined significant revenue potential. One program including prototype deliveries for a new defense / aerospace customer is a great example of the successful integration of Ross Optical. There are clearly macro challenges in the economy but we believe continued execution in our core business plus investment in high opportunity products and markets will lead to strong growth in our business going forward."

The following table summarizes the fourth quarter and fiscal year (unaudited) results for the periods ended June 30, 2020 and 2019:

Conference Call Detailsp0o
The Company has scheduled a conference call to discuss the fourth quarter and fiscal year 2020 financial results for Thursday, September 24, 2020 at 5:00 p.m. EDT.

Call-in Information: Interested parties can access the conference call by dialing (844) 735-3662 or (412) 317-5705.

Live Webcast Information: Interested parties can access the conference call via a live Internet webcast, which is available at View Source

Replay: A teleconference replay of the call will be available until October 1, 2020 at (877) 344-7529 or (412) 317-0088 confirmation # 10147933. A webcast replay will be available at View Source

On September 24, 2020 XiangXue Life Sciences reported that it received US permission to start a Phase I trial of its high affinity specific T-cell receptor candidate, TCRT-ESO-A2 (Press release, Xiangxue Life Sciences, SEP 24, 2020, View Source [SID1234565602]). The molecule is China’s first TCR-T candidate to target solid tumors, aiming at tumors that are NY-ESO-1 positive in HLA-A*02:01 positive patients. XLifeSc is a subsidiary of Guangzhou XiangXue Pharma that focuses on TCR therapies for cancer. TCRT-ESO-A2 is being developed globally (ex-China) by Axis Therapeutics, a JV formed by XLifeSc and Athenex, a US-China biopharma.

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