On November 2, 2021 Perimeter Medical Imaging AI, Inc. (TSX-V:PINK) (OTC:PYNKF) (FSE:4PC) ("Perimeter" or the "Company"), a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address high unmet medical needs, reported approval of its Investigational Device Exemption ("IDE") application by the U.S. Food and Drug Administration ("FDA") to conduct a multi-center, randomized, double-arm study to evaluate the FDA breakthrough-device-designated Perimeter B-Series OCT imaging system that uses ImgAssist AI technology to identify regions of interest as compared with the current standard of care for patients undergoing breast conservation surgery (Press release, Perimeter Medical Imaging AI, NOV 2, 2021, View Source [SID1234594166]). It is anticipated that over 300 patients across 8 U.S. clinical sites will participate in the pivotal study to be led by Principal Investigator, Dr. Alastair Thompson at Baylor College of Medicine.

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Jeremy Sobotta, Perimeter’s Chief Executive Officer stated, "This IDE approval marks another important milestone in our ATLAS AI project, building upon the ‘Breakthrough Device Designation’ that we received in April, as we transition into clinical validation of the AI-enabled, next generation of our commercially available flagship OCT imaging technology. Trial start-up activities are already underway, with world-class sites and a number of the nation’s leading breast surgeons identified to participate in Perimeter’s pivotal study, which we anticipate initiating in mid-November at our first site at West Cancer Center’s Breast Center in Germantown, Tennessee under the direction of Dr. Richard E. Fine. Our hope is that the data generated from this trial supports our belief that Perimeter’s innovative OCT imaging technology will become a trusted tool for surgeons, resulting in better patient outcomes and lower healthcare costs."

Dr. Alastair Thompson, Principal Investigator and Professor, Section Chief of Breast Surgery and Olga Keith Wiess Chair of Surgery at Baylor College of Medicine and the Dan L Duncan Comprehensive Cancer Center said, "Currently, approximately one in four women who undergo breast conservation surgery require reoperation if their surgeon fails to get ‘clear’ margins. The goal of this pivotal study is to compare the use of Perimeter B-Series imaging technology with artificial intelligence against the standard of care and determine if it can improve surgeon’s ability to reduce re-operation rates for breast conservation surgery. Importantly, Perimeter’s novel imaging technology with AI fits into the routine surgical process with no additional imposition to the patient as it examines a tissue sample that is already being extracted. There is a strong medical need for tools to help surgeons identify if we have adequately removed the cancerous tissue real-time in the operating room and get it right the first time."

Dr. Richard E. Fine, Director of Education & Research, Margaret West Comprehensive Breast Center, West Cancer Center & Research Institute, commented, "I believe combining optical coherence tomography with artificial intelligence could represent the ‘next generation’ technology in specimen imaging. As breast cancer surgeons, we understand the physical, emotional, and financial stressors for patients that can come with needing a second surgery. The results from this study will not only help determine if this tool can assist physicians with improving patient outcomes but could also provide evidence of reducing the burden of additional costs within the overall healthcare system."

About Perimeter S-Series OCT

Cleared by the U.S. FDA, Perimeter S-Series Optical Coherence Tomography (OCT) is a novel medical imaging system that provides clinicians with cross-sectional, real-time margin visualization (1-2 mm below the surface) of an excised tissue specimen. Giving physicians the ability to visualize microscopic tissue structures "real time" in the operating room has the potential to result in better long-term outcomes for patients and lower costs to the healthcare system.

About Perimeter B-Series OCT with ImgAssist AI

Perimeter is advancing the development of its proprietary, next-gen "ImgAssist" artificial intelligence technology under its ATLAS AI project, which is made possible, in part, by a US$7.4 million grant awarded by the Cancer Prevention and Research Institute of Texas (CPRIT). The U.S. FDA granted Breakthrough Device Designation for Perimeter B-Series OCT coupled with ImgAssist AI, and Perimeter is conducting a randomized, multi-site, pivotal study to evaluate it against the current standard of care and assess the impact on re-operation rates for patients undergoing breast conservation surgery.

On November 2, 2021 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, NOV 2, 2021, View Source [SID1234594203]). This programme is part of the overall share repurchase programme of up to DKK 18 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 4 August 2021, Novo Nordisk has repurchased B shares for an amount up to DKK 3.3 billion in the period from 5 August 2021 to 1 November 2021. The programme is now concluded.

Since the announcement 25 October 2021, the following transactions have been made:

With the transactions stated above, Novo Nordisk owns a total of 22,633,347 B shares of DKK 0.20 as treasury shares, corresponding to 1.0% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 18 billion during a 12- month period beginning 3 February 2021. As of 1 November 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 23,826,181 B shares at an average share price of DKK 511.47 per B share equal to a transaction value of DKK 12,186,313,644.

On November 2, 2021 Leidos Holdings, Inc. (NYSE: LDOS), a FORTUNE 500 science and technology leader, reported financial results for the third quarter of fiscal year 2021 (Press release, Leidos, NOV 2, 2021, View Source [SID1234594069]).

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Roger Krone, Leidos Chairman and Chief Executive Officer, commented, "The third quarter marked another strong quarter for Leidos, with record levels of revenues, adjusted EBITDA, non-GAAP diluted EPS, and backlog. Our success is the direct result of building a business portfolio focused on vital missions and a workforce that is motivated to enhance those missions through technology, engineering, and science. As we described at our October Investor Day, we see continued success ahead based on our scale, positioning, and talented people."

Revenues for the quarter were $3.48 billion, up 7% compared to the prior year quarter. Excluding acquired revenues of $47 million, revenues increased 6% organically. Revenues grew across all reportable segments; the largest contributors were the increase in veterans’ disability examinations after the pause from the COVID-19 pandemic and the start-up of the Navy Next Generation IT contract.

Net income was $208 million, or $1.43 per diluted share. Net income was up 28% and diluted EPS was up 27% from the third quarter of fiscal year 2020. The weighted average diluted share count for the quarter was 143 million compared to 144 million in the prior year quarter. Net income margin increased from 5.0% to 6.0% year-over-year as a result of the strong program management and higher volumes on certain fixed price programs.

Adjusted EBITDA was $403 million for the third quarter, up 16% year-over-year; adjusted EBITDA margin increased from 10.7% to 11.6% over the same period consistent with the increase in operating income margin. Non-GAAP net income was $260 million for the third quarter, which was up 23% year-over-year, and non-GAAP diluted EPS for the quarter was $1.80, which was up 22% compared to the third quarter of fiscal year 2020.

Cash Flow Summary

In the third quarter of fiscal year 2021, Leidos generated $565 million of net cash provided by operating activities for an operating cash flow conversion ratio of 276%. After adjusting for payments for property, equipment and software, quarterly free cash flow was $541 million for a free cash flow conversion ratio of 211%. In addition, Leidos used $53 million in investing activities and used $209 million in financing activities.

During the third quarter of fiscal year 2021, Leidos made open market repurchases of common stock for an aggregate purchase price of $137 million and returned $51 million to shareholders as part of its regular quarterly cash dividend program. In addition, Leidos paid down $27 million of debt and completed a small, strategic acquisition for preliminary purchase consideration of approximately $36 million. As of October 1, 2021, Leidos had $587 million in cash and cash equivalents and $5.1 billion of debt.

On October 29, 2021, the Leidos Board of Directors declared that Leidos will pay a cash dividend of $0.36 per share on December 30, 2021 to stockholders of record at the close of business on December 15, 2021.

New Business Awards

Net bookings totaled $4.7 billion in the quarter, representing a book-to-bill ratio of 1.4. As a result, backlog at the end of the quarter was $34.7 billion, of which $7.3 billion was funded. Included in the quarterly bookings were several particularly important awards:

High-Resolution Three Dimensional (3D) Geospatial Information Operation and Technology Integration Program. Leidos was awarded a prime contract by the U.S. Army to support the Army Geospatial Center’s (AGC) Buckeye program. Under the contract, Leidos will continue to support AGC’s BuckEye mission. The BuckEye program provides mission critical unclassified high resolution color imagery and digital 3D terrain over all operationally relevant areas of the world. The single-award contract has a one-year base period of performance followed by three one-year options and a total estimated value of $600 million if all options are exercised.
Technical Signals Intelligence. Leidos was awarded a prime contract by the National Security Agency (NSA) to provide development and modernization efforts in support of the agency’s Technical Signals Intelligence (TechSIGINT) mission. Under the contract, Leidos will provide the technical services to develop, deploy and sustain a wide range of new and improved TechSIGINT collection, production and analysis capabilities. The single award contract has a five-year base period of performance and holds a ceiling value of $300 million.
Enduring Indirect Fires Protection Capability. Leidos was awarded a contract by the U.S. Army Program Executive Office Missiles and Space for the Enduring Indirect Fires Protection Capability (IFPC) to provide its mobile ground-based weapon system. Under the contract, Dynetics, a wholly owned subsidiary of Leidos, will produce a transportable system designed to engage and defeat Cruise Missile (CM) and Unmanned Aircraft System (UAS) threats. The award has an estimated value of $237 million over the next 2.5 years.
In addition, Leidos received prime positions on several indefinite delivery/indefinite quantity (IDIQ) contracts that provide competitive differentiation and channels for future growth but are not included in bookings or backlog beyond any awarded task orders. The largest of these IDIQs was:

Low-Energy Portal. Leidos was awarded a new prime contract by U.S. Customs and Border Protection (CBP) to provide Low-Energy Portal (LEP) systems for non-intrusive inspection (NII) of passenger vehicles at U.S.-Mexico land border crossings. Under the contract, Leidos will integrate, deploy and train CBP staff to use its VACIS LEP systems, incorporating Viken Detection’s OSPREY scanning technology. The multiple-award LEP contract has a total ceiling value of $390 million.
Forward Guidance

For information regarding adjusted EBITDA margin and non-GAAP diluted EPS, see the related explanations and reconciliations to GAAP measures included elsewhere in this release.

Leidos does not provide a reconciliation of forward-looking adjusted EBITDA margins or non-GAAP diluted EPS to net income attributable to Leidos shareholders, due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation. Because certain deductions for non-GAAP exclusions used to calculate projected net income attributable to Leidos shareholders may vary significantly based on actual events, Leidos is not able to forecast on a GAAP basis with reasonable certainty all deductions needed in order to provide a GAAP calculation of projected net income attributable to Leidos shareholders at this time. The amounts of these deductions may be material and, therefore, could result in projected net income attributable to Leidos shareholders and diluted EPS being materially less than projected adjusted EBITDA margins and non-GAAP diluted EPS.

Conference Call Information

Leidos management will discuss operations and financial results in an earnings conference call beginning at 8:00 A.M. eastern time on November 2, 2021. Analysts and institutional investors may participate by dialing +1 (877) 869-3847 (toll-free U.S.) or +1 (201) 689-8261 (international callers).

A live audio broadcast of the conference call along with a supplemental presentation will be available to the public through links on the Leidos Investor Relations website (View Source).

After the call concludes, an audio replay can be accessed on the Leidos Investor Relations website or by dialing +1 (877) 660-6853 (toll-free U.S.) or +1 (201) 612-7415 (international callers) and entering conference ID 13723845.

On November 2, 2021 Perrigo Company plc (NYSE; TASE: PRGO), a leading global provider of Quality, Affordable Self-Care Products, reported that its Board of Directors declared a quarterly dividend of $0.24 per share, payable on December 21, 2021 to shareholders of record on December 3, 2021 (Press release, Perrigo Company, NOV 2, 2021, View Source [SID1234594090]).

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On November 2, 2021 DURECT Corporation (Nasdaq: DRRX) reported financial results for the three months ended September 30, 2021 and provided a corporate update (Press release, DURECT, NOV 2, 2021, View Source [SID1234594108]).

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"I am proud of the progress we have made in expanding clinical trial sites and the pace of enrollment in the AHFIRM study, particularly given the challenges faced by many of the hospitals where our study is being conducted in dealing with the Delta variant surge." stated James E. Brown, DVM, President and CEO of DURECT. "I am also pleased with the progress made in our POSIMIR licensing process."

Third Quarter and Recent Business Highlights:

Continued progress in clinical study site openings – DURECT has increased the total number of planned sites for the Phase 2b AHFIRM study to 60+. Since the last earnings call, the Company has opened an additional 10 clinical trial sites. There are now 36 global AHFIRM study sites open, more than 50% of the planned locations.

Opening of first ex-US sites – DURECT also recently opened the first ex-US study sites in Australia. This marks the beginning of the ex-US expansion of the AHFIRM study.

USAN Council name approved – The United States Adopted Names (USAN) Council has approved ‘larsucosterol’ as the nonproprietary (generic) name for DUR-928.

Progress with POSIMIR partnering – POSIMIR licensing negotiations continue to advance.

Upcoming Key Milestones:

DURECT is focused on advancing DUR-928 (larsucosterol) for the treatment of AH

At the AASLD Liver Meeting November 12-15, Suthat Liangpunsakul, M.D. will present a poster reporting the growing prevalence of AH hospitalizations in the U.S., highlighting the growing unmet need for these patients.
With strong interest from hepatologists to join the study, we plan to continue to expand the AHFIRM study to more than 60 total clinical trial sites across the U.S., E.U., U.K., and Australia.
We expect to initiate ex-US dosing in the AHFIRM study in the coming weeks.
We are on track to complete a POSIMIR license deal with a U.S. partner who would subsequently launch the product.
We will determine next steps for larsucosterol in non-alcoholic steatohepatitis (NASH).
Financial highlights for Q3 2021:

Total revenues were $2.2 million and net loss was $10.0 million for the three months ended September 30, 2021, compared to total revenues of $1.8 million and net loss of $9.3 million for the three months ended September 30, 2020.
At September 30, 2021, cash and investments were $80.9 million, compared to cash, cash held in escrow and investments of $56.9 million at December 31, 2020. Debt at September 30, 2021 was $20.5 million, compared to $20.8 million at December 31, 2020
Conference Call:

We will host a conference call today at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time to discuss third quarter 2021 results and provide a corporate update:

The conference call will also be available by webcast on DURECT’s homepage at www.durect.com under the "Investors" tab. If you are unable to participate during the webcast, the call will be archived on DURECT’s website under "Event Calendar" in the "Investors" section.

About the AHFIRM Trial
Enrollment is ongoing in our Phase 2b study in subjects with severe acute AH to evaluate saFety and effIcacy of DUR-928 treatMent (AHFIRM). AHFIRM is a randomized, double-blind, placebo-controlled, international, multi-center Phase 2b study to evaluate the safety and efficacy of larsucosterol (also known as DUR-928) in approximately 300 patients with severe AH. The study is comprised of three arms targeting enrollment of approximately 100 patients each: (1) Placebo plus standard of care (SOC, which may include the use of methylprednisolone, a corticosteroid, at the discretion of the treating physician); (2) larsucosterol (30 mg); and (3) larsucosterol (90 mg). All patients in the trial receive supportive care. The primary outcome measure is 90-day survival rate for patients treated with larsucosterol compared to those treated with placebo plus SOC. The Company is targeting more than 60 clinical trial sites across the U.S., E.U., U.K., and Australia. Reflecting the life-threatening nature of AH and the lack of therapeutic options for this devastating condition, the FDA has granted larsucosterol Fast Track Designation for the treatment of AH. We believe demonstration of a robust survival benefit in the AHFIRM trial would support an NDA filing.