BioNTech to Report Third Quarter Financial Results and Operational Update on November 9, 2021

On October 27, 2021 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported that it will announce its financial results for the third quarter on Tuesday, November 9th, 2021 (Press release, BioNTech, OCT 27, 2021, View Source [SID1234592000]). BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. ET (2.00 p.m. CET) to report its financial results and provide a corporate update for the third quarter 2021.

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The slide presentation and audio of the webcast will be available via this link.

To participate in the conference call, please dial the following numbers ten minutes prior to the start and provide the Conference ID:

Participants may also access the slides and the webcast of the conference call via the "Events & Presentations" page of the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

SpringWorks Therapeutics Announces the Initiation of an Expanded Phase 2 Cohort and Addition of New Sub-Studies to Existing Clinical Collaboration with GlaxoSmithKline Evaluating Nirogacestat in Combination with BLENREP in Patients with Relapsed or Refrac

On October 27, 2021 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported an update from its ongoing clinical collaboration with GlaxoSmithKline (GSK) evaluating nirogacestat, SpringWorks’ investigational gamma secretase inhibitor, in combination with BLENREP (belantamab mafodotin-blmf), GSK’s antibody-drug conjugate targeting B-cell maturation agent (BCMA), in patients with relapsed or refractory multiple myeloma (Press release, SpringWorks Therapeutics, OCT 27, 2021, View Source [SID1234591999]). The nirogacestat and BLENREP combination is being evaluated as a sub-study of GSK’s ongoing DREAMM-5 platform trial.

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The first combination dose level that evaluated 0.95 mg/kg Q3W BLENREP plus nirogacestat has been expanded based on encouraging preliminary data observed in the dose exploration Phase 1 portion of the nirogacestat DREAMM-5 sub-study. The expanded Phase 2 cohort is further exploring the safety and efficacy profile compared to a 2.5 mg/kg Q3W BLENREP monotherapy control arm, which is the same as the FDA approved monotherapy dose and schedule of BLENREP. In parallel, additional dose levels and schedules of BLENREP plus nirogacestat continue to be evaluated in the Phase 1 portion of the study.

In addition, two new sub-studies will evaluate the BLENREP plus nirogacestat combination with standard-of-care multiple myeloma therapies in the DREAMM-5 trial. These two new sub-studies will explore BLENREP plus nirogacestat in combination with pomalidomide and dexamethasone and in combination with lenalidomide plus dexamethasone. Data from these sub-studies may enable future clinical trials in earlier lines of multiple myeloma.

"We continue to remain intensely focused on advancing nirogacestat as a potential best-in-class cornerstone of BCMA combination therapy for patients with multiple myeloma and are pleased with the progress that has been made with our collaborator GSK," said Saqib Islam, Chief Executive Officer of SpringWorks. "We believe in the emerging role of nirogacestat as a BCMA potentiator and we look forward to working with GSK to advance the expanded program."

Gamma secretase inhibition prevents the cleavage and shedding of BCMA from the surface of multiple myeloma cells. In preclinical models, nirogacestat has been shown to increase the cell surface density of BCMA and reduce levels of soluble BCMA, thereby enhancing the activity of BCMA-targeted therapies.1 To date, SpringWorks has entered into clinical collaborations with six industry partners, including GSK, to evaluate nirogacestat in combination with BCMA therapies across modalities.

The platform study is being advanced pursuant to a non-exclusive global clinical trial collaboration agreement that SpringWorks and GSK entered into in June 2019 and that was amended in October 2021 to enable additional sub-studies to be conducted. Under the terms of the agreement, GSK is sponsoring and conducting the platform study to evaluate the safety, tolerability and preliminary efficacy of the combination and is assuming all development costs associated with the study other than expenses related to the manufacturing of nirogacestat and certain expenses related to intellectual property rights. SpringWorks and GSK have formed a joint development committee to help manage and oversee the clinical study.

About Nirogacestat

Nirogacestat is an investigational, oral, selective, small molecule gamma secretase inhibitor in Phase 3 clinical development for desmoid tumors, which are rare and often debilitating and disfiguring soft-tissue tumors. Gamma secretase cleaves multiple transmembrane protein complexes, including Notch, which is believed to play a role in activating pathways that contribute to desmoid tumor growth.

In addition, gamma secretase has been shown to directly cleave membrane-bound BCMA, resulting in the release of the BCMA extracellular domain, or ECD, from the cell surface. By inhibiting gamma secretase, membrane-bound BCMA can be preserved, increasing target density while reducing levels of soluble BCMA ECD, which may serve as decoy receptors for BCMA-directed therapies. Nirogacestat’s ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. SpringWorks is evaluating nirogacestat as a BCMA potentiator and has six collaborations with industry-leading BCMA developers to evaluate nirogacestat in combinations across modalities, including with an antibody-drug conjugate, two CAR T cell therapies, two bispecific antibodies and a monoclonal antibody. SpringWorks has also formed research collaborations with Fred Hutchinson Cancer Research Center and Dana-Farber Cancer Institute to further characterize the ability of nirogacestat to modulate BCMA and potentiate BCMA therapies using a variety of preclinical multiple myeloma models.

Nirogacestat has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of desmoid tumors and from the European Commission for the treatment of soft tissue sarcoma. The FDA also granted Fast Track and Breakthrough Therapy Designations for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis

Thermo Fisher Scientific Reports Third Quarter 2021 Results

On October 27, 2021Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the third quarter ended October 2, 2021 (Press release, Thermo Fisher Scientific, OCT 27, 2021, View Source [SID1234591998]).

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Third Quarter 2021 Highlights

Third quarter revenue increased 9% to $9.33 billion.
Third quarter GAAP diluted earnings per share (EPS) was $4.79.
Third quarter adjusted EPS was $5.76.
Another quarter of high-impact innovation with a number of product launches, including the Applied Biosystems QuantStudio Absolute Q Digital PCR System to enable advancements in oncology, cell and gene therapy and other research applications, the Thermo Scientific TSQ Plus Triple Quadrupole mass spectrometer (MS) portfolio to offer faster throughput and increased sensitivity across a range of applications including biopharma, food safety and environmental analysis, the Thermo Scientific Vanquish Neo UHPLC System and Thermo Scientific PepMap Neo Columns to provide increased sensitivity in low-flow liquid chromatography and designed for use in proteomics, precision medicine and translational research.
The company continued to expand capacity and capabilities to better serve customers. Our Pharma Services business brought additional capacity online to support vaccine and therapy production. In South Korea, we opened a Bioprocess Design Center, to advance bioprocessing innovation and collaboration with biopharma customers, and as part of the previously announced strategic partnership with CSL Limited, we assumed operating responsibility of a new state-of-the-art biologics site in Lengnau, Switzerland. Additionally, in partnership with the U.S. Department of Defense, we are building a new manufacturing site in North Carolina to ensure reliable domestic production of pipette tips which are used for liquid handling in research and diagnostic laboratories.
Building on our environmental social and governance initiatives and to further enable customers to achieve their own sustainability goals, the company committed to expand use of ACT Label for its entire cold temperature storage portfolio by the end of 2021. Additionally, the company extended its support of COVID-19 testing at historically black colleges and universities (HBCUs) to deliver accurate COVID-19 testing to all students and staff, helping to ensure campus safety and the ability to confidently deliver in-person learning.
Adjusted EPS, adjusted operating income, adjusted operating margin and free cash flow are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of Non-GAAP Financial Measures."

"Our incredibly strong performance in the third quarter demonstrates our proven growth strategy powered by our PPI Business System," said Marc N. Casper, chairman, president, and chief executive officer of Thermo Fisher Scientific. "We continue to deliver exceptional performance in revenue, earnings and free cash flow. And we are launching innovative new products and expanding our capabilities and capacity to enhance our customer value proposition."

Casper added, "Our team executed at a very high level during the first nine months of the year, and we are on track to deliver another outstanding year and set the company up for an even brighter future."

Third Quarter 2021

Revenue for the quarter grew 9% to $9.33 billion in 2021, versus $8.52 billion in 2020. Organic revenue growth was 7%; acquisitions increased revenue by 1% and currency translation increased revenue by 1%. Organic revenue growth from the base business was 10%. COVID-19 response revenue was $2.05 billion.

GAAP Earnings Results

GAAP diluted EPS in the third quarter of 2021 was $4.79, versus $4.84 in the same quarter last year. GAAP operating income for the third quarter of 2021 was $2.28 billion, compared with $2.43 billion in the year-ago quarter. GAAP operating margin was 24.4%, compared with 28.5% in the third quarter of 2020.

Non-GAAP Earnings Results

Adjusted EPS in the third quarter of 2021 increased 2% to $5.76, versus $5.63 in the third quarter of 2020. Adjusted operating income for the third quarter of 2021 was $2.78 billion, compared with $2.80 billion in the year-ago quarter. Adjusted operating margin was 29.8%, compared with 32.9% in the third quarter of 2020.

2021 Guidance Update

Thermo Fisher is raising its 2021 revenue and earnings guidance. The company is raising its revenue guidance by $1.2 billion to $37.1 billion; this would result in 15% revenue growth over 2020. The company is raising its adjusted EPS guidance by $1.30 to $23.37, which would represent 20% growth year over year.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the company’s four business segments, as highlighted below. Since these results are used for this purpose, they are also considered to be prepared in accordance with GAAP.

Life Sciences Solutions Segment

Life Sciences Solutions Segment revenue grew 9% to $3.72 billion in the third quarter of 2021, compared with revenue of $3.42 billion in the third quarter of 2020. Segment adjusted operating margin was 48.9%, versus 54.9% in the 2020 quarter.

Analytical Instruments Segment

Analytical Instruments Segment revenue grew 11% to $1.48 billion in the third quarter of 2021, compared with revenue of $1.34 billion in the third quarter of 2020. Segment adjusted operating margin was 17.8%, versus 12.8% in the 2020 quarter.

Specialty Diagnostics Segment

Specialty Diagnostics Segment revenue was $1.36 billion in the third quarter of 2021, compared with revenue of $1.43 billion in the third quarter of 2020. Segment adjusted operating margin was 22.7%, versus 27.9% in the 2020 quarter.

Laboratory Products and Services Segment

Laboratory Products and Services Segment revenue grew 12% to $3.49 billion in the third quarter of 2021, compared with revenue of $3.11 billion in the third quarter of 2020. Segment adjusted operating margin was 11.0%, versus 11.4% in the 2020 quarter.

Use of Non-GAAP Financial Measures

In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), we use certain non-GAAP financial measures, including adjusted EPS, adjusted operating income and adjusted operating margin, which exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs; restructuring and other costs/income; and amortization of acquisition-related intangible assets. Adjusted EPS also excludes certain other gains and losses that are either isolated or cannot be expected to occur again with any predictability, tax provisions/benefits related to the previous items, and the impact of significant tax audits or events. We exclude the above items because they are outside of our normal operations and/or, in certain cases, are difficult to forecast accurately for future periods. We also use a non-GAAP measure, free cash flow, which is operating cash flow, excluding net capital expenditures to provide a view of the continuing operations’ ability to generate cash for use in acquisitions and other investing and financing activities. We believe that the use of non-GAAP measures helps investors to gain a better understanding of our core operating results and future prospects, consistent with how management measures and forecasts the company’s performance, especially when comparing such results to previous periods or forecasts.

For example:

We exclude costs and tax effects associated with restructuring activities, such as reducing overhead and consolidating facilities. We believe that the costs related to these restructuring activities are not indicative of our normal operating costs.

We exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs. We exclude these costs because we do not believe they are indicative of our normal operating costs.

We exclude the expense and tax effects associated with the amortization of acquisition-related intangible assets because a significant portion of the purchase price for acquisitions may be allocated to intangible assets that have lives of up to 20 years. Based on acquisitions closed through the end of the third quarter of 2021, adjusted EPS will exclude approximately $3.36 of expense for the amortization of acquisition-related intangible assets. Exclusion of the amortization expense allows comparisons of operating results that are consistent over time for both our newly acquired and long-held businesses and with both acquisitive and non-acquisitive peer companies.

We also exclude certain gains/losses and related tax effects, the impact of significant tax audits or events (such as changes in deferred taxes from enacted tax rate changes), which are either isolated or cannot be expected to occur again with any predictability and that we believe are not indicative of our normal operating gains and losses. For example, we exclude gains/losses from items such as the sale of a business or real estate, gains or losses on significant litigation-related matters, gains on curtailments of pension plans and the early retirement of debt.

We also report free cash flow, which is operating cash flow, excluding net capital expenditures to provide a view of the continuing operations’ ability to generate cash for use in acquisitions and other investing and financing activities.

Thermo Fisher Scientific’s management uses these non-GAAP measures, in addition to GAAP financial measures, as the basis for measuring the company’s core operating performance and comparing such performance to that of prior periods and to the performance of our competitors. Such measures are also used by management in their financial and operating decision-making and for compensation purposes.

The non-GAAP financial measures of Thermo Fisher Scientific’s results of operations and cash flows included in this press release are not meant to be considered superior to or a substitute for Thermo Fisher Scientific’s results of operations prepared in accordance with GAAP. Reconciliations of such non-GAAP financial measures to the most directly comparable GAAP financial measures are set forth in the accompanying tables. Thermo Fisher Scientific does not provide GAAP financial measures on a forward-looking basis because we are unable to predict with reasonable certainty and without unreasonable effort items such as the timing and amount of future restructuring actions and acquisition-related charges as well as gains or losses from sales of real estate and businesses, the early retirement of debt and the outcome of legal proceedings. The timing and amount of these items are uncertain and could be material to Thermo Fisher Scientific’s results computed in accordance with GAAP.

Conference Call

Thermo Fisher Scientific will hold its earnings conference call today, October 27, 2021, at 8:30 a.m. Eastern time. To listen, dial (833) 714-0931 within the U.S. or (778) 560-2662 outside the U.S. The conference ID is 6971977. You may also listen to the call live on our website, www.thermofisher.com, by clicking on "Investors." You will find this press release, including the accompanying reconciliation of non-GAAP financial measures and related information, in that section of our website under "Financial Results." An audio archive of the call will be available under "Webcasts and Presentations" through Friday, November 12, 2021.

United Therapeutics Corporation To Report Third Quarter 2021 Financial Results Before The Market Opens On Wednesday, November 3, 2021

On October 27, 2021 United Therapeutics Corporation (Nasdaq: UTHR) reported that it will report its third quarter 2021 financial results before the market opens on Wednesday, November 3, 2021 (Press release, United Therapeutics, OCT 27, 2021, View Source [SID1234591997]).

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United Therapeutics will host a public webcast Wednesday, November 3, 2021, at 9:00 a.m. Eastern Time. The webcast will be accessible via United Therapeutics’ website at View Source A rebroadcast of the webcast will be available for one week and can be accessed at the same location.

Bio-Path Holdings Announces Clearance of Investigational New Drug Application for Phase 1/1b Clinical Trial of Prexigebersen-A in Solid Tumors

On October 27, 2021 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that the U.S. Food and Drug Administration (FDA) has reviewed and cleared the Investigational New Drug (IND) application to initiate a Phase 1/1b clinical trial of prexigebersen-A (liposomal Grb2-A or BP1001-A) in patients with solid tumors, including ovarian, endometrial, pancreatic and triple negative breast cancer (Press release, Bio-Path Holdings, OCT 27, 2021, View Source [SID1234591996]).

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"This IND clearance for prexigebersen-A marks an important regulatory milestone for Bio-Path, as we progress our fourth drug candidate into the clinic. Given the formulation enhancements, encouraging pre-clinical data and safety profile we have seen to-date, we are eager to begin this first-in-human study," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "We are particularly encouraged as prexigebersen-A has been shown to enhance chemotherapy efficacy in preclinical solid tumor models and we look forward to confirming these earlier results."

Prexigebersen-A is a modified drug product with the same drug substance as prexigebersen but includes formulation enhancements to produce smaller drug nanoparticles. The goal of this product enhancement was to produce smaller drug nanoparticles that could pass through vasculature pore spaces, thereby enabling release of the drug product into the interior of the tumor to enhance drug effectiveness.

In April 2018, data were presented demonstrating the treatment of solid tumors in gynecologic malignancies with prexigebersen-A at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The data showed an eighty-six percent (86%) decrease in tumor burden (p<0.05), and multinodular burden (p<0.01) in the combination prexigebersen-A/paclitaxel group compared with control. In addition, there was no apparent toxicity with mice on combination therapy losing less weight than the control group. This work was subsequently published in the journal Oncotarget in 2020.

"Given the encouraging pre-clinical results that have been generated to-date, we are optimistic that prexigebersen-A may offer much needed respite to patients suffering with solid tumors who face limited treatment options," said Jorge Cortes, M.D., Director of the Georgia Cancer Center and Chairman of the Bio-Path Scientific Advisory Board.

The Phase 1/1b clinical trial is anticipated to be conducted at several leading cancer centers in the United States, including The University of Texas MD Anderson Cancer Center and the Mary Crowley Research Center. Eventually, we expect to have six sites to conduct the clinical trial. Initially, a total of six evaluable patients are scheduled to be treated with prexigebersen-A monotherapy in a standard 3+3 design, with a starting dose of 60 mg/m2. The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over twenty-eight days. The Phase 1b portion of the study will commence after successful completion of prexigebersen-A monotherapy cohorts and will assess the safety and efficacy of prexigebersen-A in combination with paclitaxel in patients with recurrent ovarian or endometrial tumors.

The IND review process was performed by the FDA’s Division of Oncology 1, Office of Oncologic Diseases and involved a comprehensive review of data submitted by the Company covering pre-clinical studies, safety, chemistry, manufacturing and controls, and the protocol for the Phase 1/1b clinical trial.