Candel Therapeutics Announces Upcoming Data Presentations on its Oncolytic Viral Immunotherapies

On November 1, 2021 Candel Therapeutics, Inc. (Nasdaq: CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported its participation in upcoming medical and scientific conferences. Candel President and Chief Executive Officer, Paul Peter Tak, MD, PhD, FMedSci, and E. Antonio Chiocca, MD, PhD, FAANS, principal investigator for the CAN-3110 clinical trial, will present data and overviews pertaining to the company’s oncolytic viral immunotherapies at the 13th International Oncolytic Virus Conference (Press release, Candel Therapeutics, NOV 1, 2021, View Source [SID1234594027]). In addition, Patrick Y. Wen, MD, principal investigator, will present data on CAN-2409 from a phase 1 clinical trial in high-grade glioma at the 26th Annual Meeting of the Society for Neuro-Oncology (SNO).

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Details are as follows:

13th International Oncolytic Virus Conference Meeting
Date and Time: Friday, November 5, 2021, at 4:11 pm MT
Presenter: E. Antonio Chiocca, MD, PhD, FAANS
Oral Presentation Title: First in Human Clinical Trial of CAN-3110, An Oncolytic HSV Expressing ICP34.5, in Humans with Glioblastoma
Session Title: Scientific Session 5: Clinical Trials 1
13th International Oncolytic Virus Conference Meeting
Date and Time: Saturday, November 6, 2021, at 7:00 pm MT
Presenter: Paul Peter Tak, MD, PhD, FMedSci
Virtual Presentation Title: Leveraging Viral Oncolytic Immunotherapy Platform to Tip the Balance in Favor of the Immune System
Session Title: Special Session
26th Annual Meeting of the Society for Neuro-Oncology (SNO)
Date and Time: Friday, November 19, 2021, at 3:45 pm ET
Presenter: Patrick Y. Wen, MD
Oral Presentation Title: Phase 1 Clinical Trial of Oncolytic Viral Immunotherapy with CAN-2409 + Valacyclovir in Combination with Nivolumab and Standard of Care (SOC) in Newly Diagnosed High-Grade Glioma (HGG)
Abstract Number: CTIM-13
Details from the presentations will be available on the Candel website at View Source

About CAN-2409

CAN-2409, Candel’s most advanced oncolytic viral immunotherapy candidate, is a replication-deficient adenovirus that delivers the herpes simplex virus thymidine kinase (HSV-tk) gene to cancer cells. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. The intra-tumoral administration results in the release of tumor-specific neoantigens in the microenvironment. At the same time, the adenoviral serotype 5 capsid protein elicits a strong pro-inflammatory signal in the tumor microenvironment. This creates the optimal conditions to induce a CD8+ T cell mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity.

Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. Furthermore, CAN-2409 presents a favorable tolerability profile; more than 700 patients have been dosed to date, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events. Currently, Candel is evaluating the effects of treatment with CAN-2409 in localized, non-metastatic prostate cancer, non-small cell lung cancer, high-grade glioma, and pancreatic cancer in ongoing clinical trials.

About CAN-3110

CAN-3110 is an HSV replication-competent oncolytic virus engineered to enhance selective killing of cancer cells while sparing neighboring healthy cells. CAN-3110 selectively expresses ICP34.5, a key gene in HSV replication, in tumor cells that overexpress nestin, a cytoskeletal protein. Nestin is highly expressed in high-grade glioma cells and other tumor tissues, but it is absent in healthy adult brain tissue.

Candel is evaluating the effects of treatment with CAN-3110 in recurrent high-grade glioma.

For more information on this clinical study, please visit View Source

Legend Biotech Announces Extension of PDUFA Date for Cilta-Cel

On November 1, 2021 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global, clinical-stage biotechnology company developing and manufacturing novel therapies, reported that the U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act (PDUFA) target date for ciltacabtagene autoleucel (cilta-cel) to February 28, 2022 (Press release, Legend Biotech, NOV 1, 2021, View Source [SID1234594044]). Cilta-cel is a BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy being investigated for the treatment of adults with relapsed and/or refractory multiple myeloma. The Biologics License Application (BLA) was submitted by Legend Biotech’s collaboration partner Janssen Biotech, Inc. (Janssen).

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"We are working closely with Janssen and the FDA to facilitate an efficient and thorough review of the BLA for cilta-cel," said Ying Huang, Ph.D., Chief Executive Officer and Chief Financial Officer at Legend Biotech. "We remain confident that cilta-cel has shown great promise in patients with relapsed and refractory multiple myeloma, and we are focused on making this therapy available to them in the US as soon as possible."

The FDA notified Janssen on October 28, 2021 of the extension of the PDUFA date to allow sufficient time to review information recently submitted pertaining to an updated analytical method following an FDA information request. Legend and Janssen met with the FDA on November 1. No additional clinical data have been requested.

About Cilta-cel
Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 in the U.S. and Europe and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and in earlier lines of treatment. The design consists of a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies.

In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize cilta-cel. In December 2020, Legend announced initiation of rolling submission of Biologics License Application to the FDA seeking approval of cilta-cel for the treatment of relapsed and/or refractory multiple Myeloma, which was accepted under Priority Review in May 2021. Cilta-cel was previously granted Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, and Orphan Drug Designation in February 2019.

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.1 Although treatment may result in remission, unfortunately, patients will most likely relapse.2 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory.3 Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy.4,5 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.6 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses

Consolidated Financial Summary (IFRS) Fiscal 2021 Third Quarter

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Launch of Curaleaf International driven by the liberalisation of cannabis accelerating across Europe

On November 1, 2021 Curaleaf International (the "Company") (formerly EMMAC Life Sciences Group), part of Curaleaf Holdings (CNSX:CURA), Europe’s largest vertically integrated cannabis company, reported its official rebrand to the European market (Press release, EMMAC Life Sciences, NOV 1, 2021, View Source [SID1234593994]). It has been three years to the day since the UK Government’s landmark decision to legalise cannabis-based products for medicinal use, paving the way for further significant developments to the cannabis sector. In this time Curaleaf International has experienced exponential growth in cannabis revenues, as the demand for premium medicinal cannabis continues to grow.

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Curaleaf International’s cannabis flower products and extracted cannabis-based products now supply five separate markets, including Germany, Europe’s largest market for medicinal cannabis which is expected to be worth over €840 million by 20251. In the UK, specifically over the last 12 months, the number of patients using the Company’s products have increased fivefold.

Building on the momentum within the European medicinal cannabis market, Curaleaf International expects to see significant regulatory change across Europe for adult use (recreational) cannabis over the coming years with expectations that the total European cannabis market will be worth €3.2 billion by 20251. Curaleaf International expects the trends to follow that of Canada and the USA, which both started with the legalisation of medicinal cannabis before moving to legalise cannabis for adult use. With a population of approximately 740 million people, Europe presents a greater market size than that of North America.

The potential commercial impact of cannabis legalisation in Europe is significant. One in 10 Europeans use cannabis every year, while a quarter of people admit to having used cannabis at least once in their lifetime. The annual sales in illicit market cannabis are estimated at around €11 billion1. As highlighted in The European Cannabis Report: 6th Edition1, it is projected that sales of adult-use cannabis will reach €200 million by 2023, coming close to €800 million in 2025. Taking into account growth in the recreational sector due to decreasing stigma and ease of access, Prohibition Partners increased their total market estimate from €800 million to €3.2 billion by 20251.

The Company expects that over the next three to four years significant regulatory changes will occur across the continent. Recent progress has notably occurred in Switzerland, the Netherlands, Italy and Germany. Since May 2021, Switzerland allows the sale of adult use cannabis under a trial basis. In Zurich, the country’s largest city, consumers will be allowed to buy cannabis products from pharmacies and social clubs.3 In the Netherlands, 10 licences have been issued for a recreational cannabis pilot project to supply 79 "coffee shops" in 10 municipalities. In Germany, the largest market in Europe for medical cannabis, the likely new coalition Government under the SPD, Greens and FDP parties are all in favour of legalising adult use cannabis. Additionally, Italy could be the first European nation to make adult use cannabis legal. The country is due to have a referendum proposing the legalisation of adult use cannabis in 2022, with an expected result of 57% voting in favour of legalising4, the potentially €8 billion market presents a lucrative opportunity for first movers such as Curaleaf International.

With the anticipated regulatory changes across Europe, Curaleaf International believes this is a pivotal moment for the European cannabis industry. The Company is uniquely positioned within Europe with a fully vertically integrated model, handling every aspect of the process from seed to shelf. The Company has two operating EU-GMP processing facilities and import and distribution capabilities in place in the UK and Germany.

Commenting on the European opportunity, Antonio Costanzo, CEO of Curaleaf International, said: "We have seen good growth in medicinal cannabis across Europe, and building on this momentum, the official launch of Curaleaf International has been designed to create a European cannabis platform to capitalise on the rapidly emerging opportunities that are accelerating in line with regulatory change and cultural acceptance. The landscape in Europe is changing and we can see similar clear patterns to the progress in North America for adult use cannabis. As the only established fully integrated cannabis company in Europe, our first mover advantage gives us complete control over the supply chain, and this, coupled with our science led approach leaves Curaleaf International best positioned to capitalise on this potentially enormous market."

McKesson Reports Fiscal 2022 Second-Quarter Results

On November 1, 2021 McKesson Corporation (NYSE:MCK) reported strong second-quarter results for the period ended September 30, 2021 (Press release, McKesson, NOV 1, 2021, View Source [SID1234594011]).

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"Our enterprise strategy is enabling us to successfully navigate a dynamic environment. McKesson delivered strong second-quarter results, including double-digit Adjusted Operating Profit growth across all segments," said Brian Tyler, chief executive officer. "We remain committed to investing in our growth strategies of biopharma services and oncology ecosystems, while simultaneously increasing shareholder returns."

"We continue to play a central role in the COVID-19 response efforts. As a result of our strong first half performance and outlook for the remainder of the year, we are raising our previous guidance range for fiscal 2022 Adjusted Earnings per Diluted Share to $21.95 to $22.55."

Second-quarter revenues were $66.6 billion, an increase of 9% from a year ago, driven by growth in the U.S. Pharmaceutical segment, largely due to increased specialty volumes and market growth, partially offset by branded to generic conversions.

Second-quarter earnings per diluted share from continuing operations of $1.71 included an after-tax charge of $472 million primarily for the fair value remeasurement related to McKesson’s sale of certain European businesses to the PHOENIX Group. McKesson also incurred an after-tax loss of $141 million on debt extinguishment related to a recent tender offer in the second quarter of fiscal 2022. Second-quarter Adjusted Earnings per Diluted Share does not include these charges.

Second-quarter Adjusted Earnings per Diluted Share was $6.15 compared to $4.80 a year ago, an increase of 28%, driven by the contribution from COVID-19 vaccine distribution, kitting, and storage programs with the U.S. government and growth in the Medical-Surgical Solutions segment, partially offset by a higher tax rate compared to the prior year. Second-quarter Adjusted Earnings per Diluted Share also included pre-tax net gains of approximately $97 million, or $0.46 per diluted share, associated with McKesson Ventures’ equity investments, compared to $49 million in the second quarter of fiscal 2021.

For the first six months of the fiscal year, McKesson returned $1.4 billion of cash to shareholders, which included $1.3 billion of common stock repurchases and $134 million of dividend payments. During the first six months of the fiscal year, McKesson generated cash from operations of $170 million, and invested $279 million in capital expenditures, resulting in negative Free Cash Flow of $109 million.

Business Highlights

U.S. Pharmaceutical’s operational excellence and capabilities was demonstrated by the successful shipment of over 311 million COVID-19 vaccines on behalf of the U.S. government through October 28, 2021, including vaccine distribution in the U.S. and related to the U.S. government’s international donation mission.
Medical-Surgical Solutions recently expanded its partnership with the U.S. government to support the COVID-19 response efforts through an additional kitting and storage contract of COVID-19 ancillary supplies.
McKesson continued to progress in its planned exit from Europe:
Announced on November 1, 2021 an agreement to sell its retail and distribution businesses in the U.K. to Aurelius.
Recorded after-tax loss of $472 million related to the previously announced agreement to sell businesses in France, Italy, Ireland, Portugal, Belgium, and Slovenia to the PHOENIX Group.
U.S. Pharmaceutical Segment

Second-quarter revenues were $53.4 billion, an increase of 11%, driven by increased specialty volumes and market growth, partially offset by branded to generic conversions.
Second-quarter Segment Operating Profit was $760 million. Adjusted Segment Operating Profit was $735 million, an increase of 12%, driven by growth in distribution of specialty products to providers and health systems and the contribution from COVID-19 vaccine distribution.
Prescription Technology Solutions Segment

Second-quarter revenues were $932 million, an increase of 40%, driven by higher volumes of technology and service offerings to support biopharma customers and growth of prescription volumes.
Second-quarter Segment Operating Profit was $128 million. Adjusted Segment Operating Profit was $144 million, an increase of 38%, driven by core growth from access and adherence solutions.
Medical-Surgical Solutions Segment

Second-quarter revenues were $3.1 billion, an increase of 23%, driven by increased sales of COVID-19 tests and growth in the primary care business.
Second-quarter Segment Operating Profit was $296 million. Adjusted Segment Operating Profit was $319 million, an increase of 52%, driven by increased sales of COVID-19 tests, improvements in primary care patient visits, and the contribution from kitting, storage, and distribution of ancillary supplies for the U.S. government’s COVID-19 vaccine program.
International Segment

Second-quarter revenues were $9.1 billion. On an FX-Adjusted basis, revenues were $8.8 billion, a decline of 8%, driven by the contribution of McKesson’s German wholesale business to a joint venture with Walgreens Boots Alliance which was completed during the third quarter of fiscal 2021, partially offset by volume recovery in the pharmaceutical distribution and retail businesses.
Second-quarter Segment Operating Loss was ($146) million. On an FX-Adjusted basis, Adjusted Segment Operating Profit was $155 million, an increase of 34%, driven by the discontinued recording of depreciation and amortization on certain European assets included in the transaction with the PHOENIX Group, which were classified as held for sale beginning in the second quarter of fiscal 2022.
Company Updates

Dr. Richard H. Carmona, a former U.S. Surgeon General, joined McKesson’s Board of Directors as a new independent director and member of the Board of Directors’ Compensation and Compliance Committees effective September 6, 2021.
On September 4, 2021, McKesson announced that, under the previously announced proposed settlement agreement and process designed to resolve the opioid claims of state and local governmental entities, it was determined that enough states have agreed to settle to proceed to the next phase.
On September 28, 2021, McKesson announced that an agreement was reached with the Cherokee Nation. This settlement was negotiated in connection with ongoing negotiations toward a broad resolution of opioid-related claims brought by Native American tribes that, as previously disclosed by the companies, are not covered by the ongoing settlement process involving state and local governmental entities.
Fiscal 2022 Outlook

McKesson raised fiscal 2022 Adjusted Earnings per Diluted Share guidance to $21.95 to $22.55 from the previous range of $19.80 to $20.40 to reflect strong operating performance and increased contribution from the U.S. government’s COVID-19 vaccine distribution, kitting, and storage programs.

Fiscal 2022 Adjusted Earnings per Diluted Share guidance includes approximately $2.30 to $3.05 of impacts, which are attributable to:

$1.30 to $1.80 related to the U.S. government’s COVID-19 vaccine distribution, kitting, and storage programs;
$0.50 to $0.75 related to COVID-19 tests and impairments for personal protective equipment and related products;
$0.49 related to year-to-date gains or losses associated with McKesson Ventures’ equity investments.
Excluding the impacts of the above items from both fiscal 2022 guidance and fiscal 2021 results, indicates 20% to 29% forecasted growth.

Additional modeling considerations will be provided in the earnings call presentation.

Conference Call Details

McKesson has scheduled a conference call for today, Monday, November 1st at 4:30 PM ET to discuss the company’s financial results. The audio webcast of the conference call will be available live and archived on McKesson’s Investor Relations website at investor.mckesson.com.

McKesson Investor Day

McKesson will host its Investor Day on December 8th at 1:00 PM ET. The half-day event will include presentations from Brian Tyler, chief executive officer, Britt Vitalone, chief financial officer, and other members of McKesson’s leadership team. The video webcast and additional details will be available on McKesson’s Investor Relations website.

Upcoming Investor Events

McKesson management will be participating in the following investor conferences:

J.P. Morgan 40th Annual Healthcare Conference, January 10-13, 2022
Audio webcasts will be available live and archived on McKesson’s Investor Relations website. A complete listing of upcoming events for the investment community, including details and updates, will be available on McKesson’s Investor Relations website.

Non-GAAP Financial Measures

GAAP refers to the U.S. generally accepted accounting principles. This press release includes GAAP financial measures as well as Non-GAAP financial measures, including Adjusted Gross Profit, Adjusted Operating Expenses, Adjusted Other Income, Adjusted Loss on Debt Extinguishment, Adjusted Income Tax Expense, Adjusted Earnings, Adjusted Earnings per Diluted Share, Adjusted Segment Operating Profit, Adjusted Segment Operating Profit Margin, Adjusted Corporate Expenses, Adjusted Operating Profit, FX-Adjusted results and Free Cash Flow which are financial measures not calculated in accordance with GAAP. Refer to the "Supplemental Non-GAAP Financial Information" section of the accompanying financial statement tables for the definitions and usefulness of the Company’s Non-GAAP financial measures and the attached schedules for reconciliations of the differences between the Non-GAAP financial measures and their most directly comparable GAAP financial measures.

The Company does not provide forward-looking guidance on a GAAP basis as McKesson is unable to provide a quantitative reconciliation of this forward-looking Non-GAAP measure to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because McKesson cannot reliably forecast LIFO inventory-related adjustments, certain litigation loss and gain contingencies, restructuring, impairment and related charges, and other adjustments, which are difficult to predict and estimate. These items are inherently uncertain and depend on various factors, many of which are beyond the company’s control, and as such, any associated estimate and its impact on GAAP performance could vary materially.