Analysis Group Team Publishes Real-World Evidence in Sequencing of Radium-223 Radiotherapy for Patients with Metastatic Castration Resistant Prostate Cancer

On October 22, 2020 Analysis Group, a global leader in health economics and outcomes research (HEOR), reported the publication of a study addressing the question of when radium-223 should be given to patients with metastatic castration resistant prostate cancer (mCRPC) (Press release, Analysis Group, OCT 22, 2020, View Source [SID1234568893]). The retrospective analysis, published in the Nature journal Prostate Cancer and Prostatic Diseases, focuses on the question of whether radium-223 should be administered before or after patients receive chemotherapy.

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Currently, sequencing decisions are made without treatment selection tools such as validated biomarkers of response, and are based on both patient-provider discussions of overall treatment goals and risk-benefit assessments. This approach has led to widely varying patterns in the contemporary use of radium-223 amid a growing number of treatment options for patients with mCRPC.

Analysis Group Managing Principal Mei Sheng Duh, Manager Rachel Bhak, Consultant Caroline Korves, and Senior Analyst Mu Cheng, in collaboration with investigators from the University of California San Diego, the Dana-Farber Cancer Institute, and Bayer Healthcare Pharmaceuticals, analyzed clinical data from 2013–2018 about treatment patterns in patients treated with radium-223 pre- vs. post-chemotherapy. The results demonstrated that administration of radium-223 pre-chemotherapy increased the likelihood of completion of radium-223 treatment. However, radium-223 treatment pre- or post-chemotherapy and with or without combination therapy did not result in significant differences in overall survival.

"This was a non-interventional, retrospective, longitudinal chart review study of patients at the Dana-Farber Cancer Institute in Boston," said Dr. Duh. "The treatment patters and decisions we studied were particularly difficult to compare given the varied treatment decisions. While the results of the study are clinically relevant, future studies should be done at a scale greater than a single, tertiary cancer center."

The study, "Treatment of Metastatic Castration Resistant Prostate Cancer with Radium-223: A Retrospective Study at a US Tertiary Oncology Center," was published in the August 2020 issue of Prostate Cancer and Prostatic Diseases. Coauthors include Rana McKay of the University of California San Diego, Rebecca Silver and Mary-Ellen Taplin of the Dana-Farber Cancer Institute, and Sreevalsa Appukkuttan and Stacey J. Simmons of Bayer Healthcare Pharmaceuticals. Funding was provided by Bayer Healthcare Pharmaceuticals.

Longevity Acquisition Corporation Announces Signing of Definitive Merger Agreement

On October 22, 2020 Longevity Acquisition Corporation (NASDAQ: LOAC) (the "Company" or "LOAC"), a publicly-traded special purpose acquisition company (SPAC), reported that it has signed a definitive merger agreement with 4D pharma PLC (AIM: DDDD, "4D pharma" or "4D") (Press release, Longevity Biotech, OCT 22, 2020, View Source [SID1234568889]). Upon completion of the merger, shareholders of LOAC will receive American Depositary Shares (ADSs) of 4D and LOAC will become a wholly-owned subsidiary of 4D, subject to customary closing conditions, including that 4D American Depositary Shares ("ADSs") will be approved to be listed and tradable on Nasdaq.

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4D pharma’s Live Biotherapeutic Products (LBPs) are orally delivered single strains of bacteria that are naturally found in the healthy human gut. The Company has six clinical programs, namely a Phase I/II study of MRx0518 in combination with Keytruda (pembrolizumab) in solid tumors, a Phase I study of MRx0518 in a neoadjuvant setting for patients with solid tumors, a Phase I study of MRx0518 in patients with pancreatic cancer, a Phase I/II study of MRx-4DP0004 in asthma, a Phase II study of MRx-4DP0004 in patients hospitalized with COVID-19, and Blautix in Irritable Bowel Syndrome (IBS) which has completed a successful Phase II trial. Preclinical-stage programs include candidates for CNS disease such as Parkinson’s disease and other neurodegenerative conditions, and autoimmune diseases. The Company has a research collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, USA, to discover and develop Live Biotherapeutics for vaccines.

Mr. Matthew Chen, Chief Executive Officer of LOAC remarked, "We are truly excited about the merger with 4D pharma. Our team reviewed many opportunities in a variety of industries, and determined that the transaction with 4D would provide the greatest value to our shareholders. 4D is developing promising novel biotherapeutics to address unmet medical needs. We are impressed by the 4D management team’s track record in drug development and partnership building in the pharmaceutical industry. We are very excited about the future prospects of the combined company."

Duncan Peyton, Chief Executive Officer of 4D pharma, stated, "A Nasdaq listing allows 4D to capitalize on increased interest from US healthcare investors in recent years, providing access to a much larger pool of specialist capital, and increasing our global profile and exposure. Nasdaq is a very positive environment for growing, innovative biotech companies. The merger with LOAC accelerates and de-risks our entry into the US, while providing immediate access to additional funds to support our pipeline. The increased exposure of a US listing will also support ongoing partnering discussions across our pipeline."

Transaction Details

At closing, LOAC will merge with and into 4D Pharma BVI Limited ("Merger Sub"), a wholly owned subsidiary of 4D pharma plc, with Merger Sub continuing as the surviving company. At the effective time of the merger, each of LOAC’s ordinary shares issued and outstanding prior to the effective time of the merger (excluding shares held by 4D and LOAC and dissenting shares, if any) will be automatically converted into the right to receive certain per share merger consideration (as defined below), and each warrant to purchase LOAC’s ordinary shares and right to receive LOAC’s ordinary shares that is outstanding immediately prior to the effective time of the merger will be assumed by 4D pharma and automatically converted into a warrant to purchase ordinary shares of 4D pharma and a right to receive ordinary shares of 4D pharma, payable in 4D pharma ADSs, respectively. The per share merger consideration will consist of 7.5315 ordinary shares of 4D pharma, payable in 4D pharma ADSs (each ADS representing 8 ordinary shares), for each issued and outstanding ordinary shares of LOAC immediately prior to the closing.

The closing conditions of the merger include, among others, the approval of the merger by LOAC’s existing shareholders and approvals from 4D shareholders, the approval for listing of 4D pharma’s ADSs on the Nasdaq Stock Market, and LOAC having at least $11,750,000 of net tangible assets and at least $14,600,000 in cash at the closing.

Upon and immediately following the consummation of the merger, it is anticipated that the shareholders of LOAC prior to the closing will collectively own approximately 13.1% of outstanding ordinary shares of the combined entity.

Concurrently with the execution of the merger agreement, LOAC entered into certain backstop agreements with Whale Management Corporation, the sponsor of LOAC, 4D pharma and certain investors, pursuant to which the investors have committed to provide financial backing to the Company immediately prior to the closing in the event of share redemptions at LOAC in the aggregate amount of up to $14,600,000. On the same date and upon receipt of the principal, LOAC also issued unsecured convertible promissory notes to certain investors in the aggregate principal amount of $1,860,000 in connection with the merger agreement which will be paid by the combined company following closing.

Upon the execution of the Merger Agreement and the receipt of the proceeds from the convertible notes, Messrs. Matthew Chen, Teddy Zheng, Yukman Lau and Pai Liu resigned from their positions of Chief Executive Officer, Chief Financial Officer, director of the Company’s board of directors (the "Board"), and director of the Board, respectively. On the same date, the Board appointed Alex Lyamport as CEO and director of the Board, Matthew Chen as CFO, and Nicholas H. Adler and Jerry L. Hutter as directors of the Board, to fill in the vacancies created by the resignations. Our Board currently consists of two existing directors of the Board, Messrs. Matthew Chen and Jun Liu, and three newly appointed directors, Messrs. Alex Lyamport, Nicholas H. Adler and Jerry L. Hutter. Following completion of the Merger, existing 4D pharma Directors will continue to serve in their current roles in the combined entity.

From the date of execution of the merger agreement through the closing, LOAC shall use all reasonable efforts to remain as a public company on, and for its securities to be tradable over the Nasdaq Capital Market. 4D shall use all reasonable efforts to apply for a listing of 4D ADSs on, and for 4D ADSs to be tradable over, the Nasdaq stock market.

Chardan Capital Markets LLC is acting as financial advisor to LOAC. Hunter Taubman Fischer & Li LLC, Addleshaw Goddard LLP and Ogier are acting as legal counsels to LOAC. Wilson Sonsini Goodrich & Rosati, Professional Corporation, and Pinsent Masons LLP are acting as legal counsels to 4D.

The description of the transaction contained herein is only a summary and is qualified in its entirety by reference to the definitive agreement relating to the transaction, a copy of which will be filed by LOAC with the Securities and Exchange Commission (the "SEC") as an exhibit to a Current Report on Form 8-K.

Hansa Biopharma interim report Jan-Sep 2020

On October 22, 2020 Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, reported its business update and interim report for January – September, 2020 (Press release, Hansa Biopharma, OCT 22, 2020, View Source [SID1234568888]).

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Highlights for the third quarter 2020

The EU Commission granted conditional approval for Idefirix (imlifidase) in highly sensitized kidney transplant patients in the European Union. Idefirix is the Company’s first approved drug and will transform Hansa Biopharma into a commercial stage biopharmaceutical company.
Entered exclusive agreement with Sarepta Therapeutics to develop and promote imlifidase as pre-treatment ahead of gene therapy in select indications. The agreement with Sarepta includes an upfront payment and will potentially generate milestone payments to Hansa totaling up to USD 397.5m plus royalties on imlifidase enabled gene therapy sales. All imlifidase sales will be booked by Hansa.
Anti-GBM: Reported positive high-level data from investigator-initiated phase 2 trial with imlifidase to treat anti-GBM disease with two-thirds of patients achieving dialysis independence six months after treatment. The positive data marks an important milestone for the Company’s expansion of imlifidase outside transplantation.
US trial in kidney transplantation: Recruitment of first patient expected in H1 2021, given the continued impact of the COVID-19 pandemic in the US and the timeline to finalize the study protocol. Potential BLA submission is expected by 2023 under the accelerated approval path.
Pipeline: Enrollment in both phase 2 studies in GBS and AMR have been temporarily halted for the past months due to the COVID-19 pandemic. Reinitiation of enrollment expected in Q4 2020 under a risk-based site-by-site approach. Completion of enrollment in both studies is expected in the second half of 2021.
Hansa Biopharma AB certified as a Great Place to Work following the results of a company-wide employee survey and a review of policies.
SEK 1.1bn (USD 121m) raised in a directed share issue of 4.4 million ordinary shares. The share issue was multiple times oversubscribed due to high demand from US, European and Swedish institutional investors. The capital raised will help finance the Company’s R&D pipeline as well as fund the launch and commercialization of imlifidase in kidney transplantation.
Max Sakajja, VP Corporate Development, appointed to a new role as VP International Markets to prepare Hansa Biopharma’s expansion strategy outside the EU. The role reports into the CCO and is part of Hansa’s broader leadership team.
Investments in R&D and SG&A increased in the third quarter to SEK 71m (Q3’19: SEK 47m) and SEK 52m (Q3’19: SEK 46m), respectively. Cash position was SEK 1,476m at the end of September 2020. Cash flow from operating activities for the third quarter ended at SEK 5m (Q3’19: SEK -80m).
Søren Tulstrup, President and CEO of Hansa Biopharma, comments

"Hansa Biopharma’s evolution into a fully integrated biopharmaceutical company took a major step forward in the third quarter following the conditional approval of Idefirix (imlifidase) by the European Commission for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor.

The European approval serves as a validation of the potential of our proprietary drug development platform and will transistion Hansa Biopharma into the next phase as a commercial stage biopharmaceutical company.

We are also excited about the progress of our efforts beyond transplantation. In July we announced the achievement of another landmark milestone with the exclusive agreement with Sarepta Therapeutics to develop and promote imlifidase as a potential pre-treatment prior to the administration of gene therapy. The agreement with Sarepta is exclusive for the use in Duchenne and and Limb-Girdle indications and serves as a validation of our enzyme technology as we expand beyond transplantation.

Late Septermber we also announced positive high-level data from the investigator-initiated phase 2 trial with imlifidase to treat anti-GBM disease. Data from the trial shows that imlifidase leads to rapid clearance of anti-GBM antibodies, with two-thirds of patients achieving dialysis independence six months after treatment. We are very encouraged by the positive outcome as anti-GBM is the first IgG-mediated disease outside transplantation, where imlifidase has been shown to stop an immunologic attack.

Our strong progress across our platform of immunomodulatory enzymes has also been recognized by our investors, as our investor base has continued to expand in Sweden and internationally. End of September, the number of shareholders has increased to more than 18,000 investors, with 45% of the shares now owned by international investors and institutions. We see this as a testimony to our recent progress and a strong and growing international interest in Hansa Biopharma.

While an exciting and transformative year has impacted us in a postive way, we are still seeing negative effects due to the widespread impact from the COVID-19 pandemic. Enrollment in the phase 2 studies in GBS and AMR has been temporarily halted for the past months, and we expect to reinitiate enrollment of these studies in the fourth quarter 2020 under a risk-based, site-by-site approach.

In the US, the proposed study protocol for a randomised controlled trial (RCT) targeting highly-sensitized kidney patients was submitted to the FDA in June, 2020. Discussions are currently ongoing with the FDA and, once the final protocol has been agreed upon, we will proceed to set up centers in the US and start to enroll patients. Given the continued impact of the COVID-19 pandemic and the timeline for finalization of the study protocol, we expect recruitment of the first patient to be in the first half of 2021 with a potential BLA submission in 2023.

Lastly, I also want to highlight that Hansa Biopharma AB recently got certified as a Great Place to Work. This certification reflects our efforts to build a strong organization through attracting, developing and retaining the very best talent in the industry as we continue our growth trajectory and development into a fully integrated biopharmaceutical company.

I look forward to keeping you updated on the progress of our journey."

Upcoming milestones and news flow

Q4 2020 Kidney transplantation EU: Commercial launch

H1 2021 Kidney transplantation US: First patient dosed / RCT

H1 2021 NiceR: Completion of GMP process; initiate IND-enabling tox studies

H2 2021 AMR Phase 2 study: Complete enrollment

H2 2021 GBS Phase 2 study: Complete enrollment

2022 Kidney transplantation US: Complete enrollment / RCT

H2 2022 AMR Phase 2 study: Data read out

H2 2022 GBS Phase 2 study: Data read out

2023 Kidney transplantation US: 12 months follow-up on eGFR completed / RCT

2023 Kidney transplantation US: BLA submission

Capital Markets Day

Hansa Biopharma to host Capital Markets Day on Thursday October 29, 2020 in Copenhagen

The CMD event will be focused around Hansa Biopharma’s transformation into a fully integrated and commercial stage biopharmaceutical company and will highlight the potential of the Company’s unique antibody-cleaving enzyme platform beyond transplantation in areas such as autoimmunity and gene therapy.

The event will feature both senior management and external guest speakers. The event will be livestreamed and available for all viewers on our web at View Source

If you wish to participate in the CMD virtually, kindly sign up using the following link View Source

No conference call scheduled on Oct 22, 2020

Since Hansa Biopharma will host its Capital Markets Day a week later than the Q3’2020 report it has been decided to incoporate relevant elements and updates from the third quarter into the CMD program and presentations rather than hosting a seperate Q3 conference call. There will be opportunites to ask questions during the Capital Markets Day.

Alligator Bioscience AB (publ): Interim report January-September 2020

On October 22, 2020 Alligator Bioscience reported that (Press release, Alligator Bioscience, OCT 22, 2020, View Source [SID1234568887])

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Encouraging clinical safety data for ATOR-1017

The Phase I study with ATOR-1017 has progressed exceptionally well and in August we presented interim data that showed a good safety profile at clinically relevant dose levels. The dose evaluation will continue with yet higher doses and we expect to present safety and potentially efficacy data from the entire study in the spring of 2021. At the same time, we have shown strong Proof of Mechanism data for mitazalimab, while the ATOR-1015 program reported side effects at high dose levels.The nature of the reactions have lead to a need to re-design the planned clinical trial in malignant melanoma and to perform additional preclinical investigations. We will now focus our clinical investments to ATOR-1017 and mitazalimab. Both programs have first-in-class potential, and will move into clinical Phase II during 2021", commented CEO Per Norlén.

SIGNIFICANT EVENTS JULY – SEPTEMBER

Mitazalimab:

Positive biomarker data demonstrating Proof of Mechanism in clinical Phase I study performed by Janssen.
Clinical development program defined. The CTA for the upcoming Phase II study in pancreatic cancer is scheduled to be submitted in December 2020.
ATOR-1015:

Revised plan due to further evaluation of doses and adverse reactions, leading to delay of Phase Ib.
US composition of matter patent granted.
ATOR-1017:

Encouraging emerging safety data at clinically relevant dose levels in the ongoing Phase I study.
Preclinical:

Neo-X-Prime: New unique drug concept for tumorspecific treatment launched at 11th World Bispecific Summit.
Other:

Gayle Mills appointed Chief Business Officer.
SIGNIFICANT EVENTS AFTER THE END OF THE PERIOD

Clinical focus on ATOR-1017 and mitazalimab:

Preparations to bring ATOR-1017 and mitazalimab to Phase II efficacy studies in 2021.
ATOR-1015: A partner will be sought for further clinical studies.
FINANCIAL SUMMARY

July-September 2020

Net sales, SEK 0.0 million (4.3).
Operating result, SEK -30.6 million (-58.5).
Result for the period, SEK -30.8 million (-56.6).
Earnings per share before and after dilution, SEK -0.43 (-0.79).
Cash flow for the period, SEK -32.7 million (-47.3).
Cash and cash equivalents, incl. interest-bearing securities, SEK 137.0 million (302.2)
January-September 2020

Net sales, SEK 4.4 million (4.4).
Operating result, SEK -110.2 million (-155.2).
Result for the period, SEK -108.8 million (-150.3).
Earnings per share before and after dilution, SEK-1.52 (-2.11).
Cash flow for the period, SEK 42.6 million (-27.8).
During the first quarter, the holdings in corporate bonds and interest funds were divested, which had a positive effect on cash flow.

Read the complete report in the pdf below.

Alligator will host a conference call today at 2:00 p.m. CEST for investors, analysts and media, where CEO Per Norlén will present and comment on the Q3 interim report and the focus of the clinical operations. The conference will be held in English. All necessary information to listen-in and ask questions are available on the following link: View Source

West Announces Third-Quarter 2020 Results

On October 22, 2020 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the third-quarter 2020 and updated full-year 2020 financial guidance (Press release, West Pharmaceutical Services, OCT 22, 2020, View Source [SID1234568886]).

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Third-Quarter 2020 Summary (comparisons to prior-year period)

Net sales of $548.0 million grew 20.1%; organic sales growth was 18.2%.
Reported-diluted EPS of $1.09 increased 45%.
Adjusted-diluted EPS of $1.15 increased 46%.
Company is raising full-year 2020 net sales guidance to a new range of $2.10 billion and $2.11 billion.
Company is raising full-year 2020 adjusted-diluted EPS guidance to a new range of $4.50 and $4.55.
"Adjusted-diluted EPS" and "organic sales growth" are Non-U.S. GAAP measurements. See discussion under the heading "Non-U.S. GAAP Financial Measures" in this release.

"Third-quarter results were robust across the entire business, led by High-Value Products (HVP) and Biologics. Additionally, we benefited from incremental sales related to the COVID-19 pandemic including components used with treatments and supporting therapies as well as potential vaccines currently in clinical trials," said Eric M. Green, President and Chief Executive Officer. "I am proud of our team members for their relentless passion and sense of urgency to help our customers and the patients we jointly serve. Continued excellence in executing our market-led strategy and our global operations position us well for the remainder of the year and into 2021."

Proprietary Products Segment
Net sales grew by 22.1% to $421.5 million. Organic sales growth was 20.3%, with currency translation increasing sales growth by 180 basis points. HVP components represented over 65% of segment sales and generated double-digit organic sales growth.

Our Biologics market unit had strong double-digit organic sales growth, led by Flurotec, Daikyo and NovaPure film-coated components, as well as Westar and Envision components. Our Generics market unit posted high single-digit organic sales growth, and our Pharma market unit grew organic sales by mid-single digits. Both Generics and Pharma market units were led by sales of film-coated and Westar components.

Contract-Manufactured Products Segment
Net sales grew by 14.0% to $126.6 million. Organic sales growth was 11.7% with currency translation increasing sales growth by 230 basis points. Segment performance was led by strong sales of healthcare-related injection and diagnostic devices.

Financial Highlights (first nine months of 2020)
Operating cash flow was $323.8 million, an increase of 24.2%. Capital expenditures were $116.7 million. Free cash flow (operating cash flow minus capital expenditures) was $207.1 million, an increase of 20.4%.

Full-Year 2020 Financial Guidance
Full-year 2020 net sales guidance is expected to be in a range of $2.10 billion and $2.11 billion, compared to a prior range of $2.035 billion and $2.055 billion.

Organic sales growth is expected to be approximately 14% to 15%, compared to a prior guidance of 12%.
Net sales guidance includes an estimated full-year headwind of $4 million for the full-year 2020 based on current foreign exchange rates, compared to prior guidance of a headwind of $26 million.
Full-year 2020 adjusted-diluted EPS is expected to be in a range of $4.50 and $4.55, compared to a prior range of $4.15 and $4.25.
Full-year adjusted-diluted EPS guidance includes an estimated headwind of approximately $0.02 based on current foreign currency exchange rates, compared to prior guidance of a headwind of $0.07.
The revised guidance includes an $0.18 EPS impact from tax benefits from stock-based compensation in the first nine months of 2020.
For the remainder of the year, our EPS guidance range assumes a tax rate of 24% and does not include potential tax benefits from stock-based compensation. Any tax benefits associated with stock-based compensation beyond those recorded in the first nine months of 2020 would provide a positive adjustment to our full-year EPS guidance.
Third-Quarter 2020 Conference Call
The Company will host a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time today. To participate on the call please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 7564183.

A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the "Investors" section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

An online archive of the broadcast will be available at the website three hours after the live call and will be available through Thursday, October 29, 2020, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International) and entering conference ID 7564183.