On November 2, 2021 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported financial results for the third quarter ended October 3, 2021 (Press release, PerkinElmer, NOV 2, 2021, View Source [SID1234594121]).

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The Company reported GAAP earnings per share from continuing operations of $1.11, as compared to GAAP earnings per share from continuing operations of $1.57 in the third quarter of 2020. GAAP revenue for the quarter was $1.17 billion, as compared to $964 million in the third quarter of 2020. GAAP operating income from continuing operations for the quarter was $222 million, as compared to $248 million for the same period a year ago. GAAP operating profit margin was 19.0% as a percentage of revenue, as compared to 25.7% in the third quarter of 2020.

Adjusted earnings per share from continuing operations for the quarter was $2.31, as compared to $2.09 in the third quarter of 2020. Adjusted revenue for the quarter was $1.17 billion, as compared to $964 million in the third quarter of 2020. Adjusted operating income from continuing operations for the quarter was $359 million, as compared to $304 million for the same period a year ago. Adjusted operating profit margin was 30.8% as a percentage of adjusted revenue, as compared to 31.6% in the third quarter of 2020.

Adjustments for the Company’s non-GAAP financial measures have been noted in the attached reconciliations.

"I am proud of the team’s tireless efforts to proactively respond to and execute for our customers around the world, driving double digit core growth in all major regions during the third quarter," said Prahlad Singh, president and chief executive officer of PerkinElmer. "Just as importantly, we are embracing new opportunities as we welcome the latest additions to the PerkinElmer family and develop innovative solutions to push the boundaries of what’s possible."

Financial Overview by Reporting Segment for the Third Quarter

Discovery & Analytical Solutions

Third quarter 2021 revenue was $513 million, as compared to $424 million for the third quarter of 2020. Reported revenue increased 21% and organic revenue increased 10% as compared to the third quarter of 2020.
Third quarter 2021 operating income from continuing operations was $7 million, as compared to $43 million for the third quarter of 2020.
Third quarter 2021 adjusted operating income was $95 million, as compared to $62 million for the third quarter of 2020.
Diagnostics

Third quarter 2021 revenue was $654 million, as compared to $540 million for the third quarter of 2020. Reported revenue increased 21% and organic revenue increased 13% as compared to the third quarter of 2020.
Third quarter 2021 operating income from continuing operations was $238 million, as compared to $224 million for the third quarter of 2020.
Third quarter 2021 adjusted operating income was $287 million, as compared to $260 million for the third quarter of 2020.
Initiates Fourth Quarter Guidance and Raises Full Year 2021 Guidance

For the fourth quarter of 2021, the Company forecasts adjusted revenue of approximately $1.2 billion and adjusted earnings per share of $2.05.

For the full year 2021, the Company now forecasts adjusted revenue of $4.9 billion and adjusted earnings per share of $10.81.

Guidance for the fourth quarter and full year is provided on a non-GAAP basis and cannot be reconciled to the closest GAAP measures without unreasonable effort due to the unpredictability of the amounts and timing of events affecting the items the Company excludes from these non-GAAP measures. The timing and amounts of such events and items could be material to the Company’s results prepared in accordance with GAAP.

Conference Call and Webcast Information

The Company will discuss its third quarter 2021 results and its outlook for business trends during a conference call on November 2, 2021 at 5:00 p.m. Eastern Time. A live audio webcast of the call will be available on the Investors section of the Company’s website, www.perkinelmer.com.

On November 2, 2021 Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and gaseous NO (gNO) for the treatment of solid tumors, reported that Steve Lisi, Chairman and Chief Executive Officer of Beyond Air, will participate in the Piper Sandler 33rd Annual Virtual Healthcare Conference being held from November 30 – December 2, 2021 (Press release, Beyond Air, NOV 2, 2021, View Source [SID1234594138]). Beyond Air will provide a pre-recorded investor presentation and will be available for virtual one-on-one meetings during the conference.

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Presentation Details:

Date and Time: Investor presentation will be available for registered attendees via the Piper Sandler conference site from November 22 to December 2, 2021
Participation: Management will participate in additional 1-on-1 meetings virtually
Please contact your representative at Piper Sandler to schedule a virtual one-on-one meeting with Beyond Air during the conference.

On November 2, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported the latest expansion of the Personalis NeXT Platform adding several new features that are key to the understanding of the interactions between the tumor and the immune system and how they may influence a cancer patient’s response to therapy (Press release, Personalis, NOV 2, 2021, View Source [SID1234594157]).

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The new and improved features include:

InfiltrateID, a sophisticated analytics module that leverages the augmented gene expression data from the NeXT Transcriptome to detect the presence of eight immune cell populations within a tumor sample
RepertoireID now incorporates the characterization of the B-cell receptor repertoire, including the computing of isotype makeup, as a complement to the previously released T-cell receptor repertoire feature
SHERPA, further enhancing the performance of Personalis’ leading pan-allelic neoantigen prediction algorithm recently published in the Immunopeptidomics Special Issue of the journal Molecular & Cellular Proteomics
Personalis CMO and SVP of R&D, Richard Chen, MD, said, "With the ability to identify immune cell populations in the tumor, characterize the B-cell and T-cell receptor repertoires, and better predict neoantigens, we are further expanding the NeXT Platform for additional emerging oncology biomarkers. As we recently demonstrated with our NEOPS biomarker publication, combining both tumor and immune features into a composite biomarker can lead to better stratification of patient response to cancer therapy. These new NeXT Platform features open up opportunities to further enhance composite biomarkers like NEOPS."

These advanced machine learning and algorithmic tools paired with the unique assay design of the NeXT Platform, further Personalis’ goal of providing the most comprehensive genomic tumor profiling platform available. The NeXT Platform consolidates multiple biomarker assays into one, enabling a seamless path from translational research to companion diagnostics development.

On November 2, 2021 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, reported the Company will release its third quarter 2021 financial results before the market opens on Wednesday, November 10, 2021 (Press release, Synlogic, NOV 2, 2021, View Source [SID1234594193]). The press release will be followed by a conference call at 8:30 am ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review its financial results and provide a corporate update.

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The conference call dial-in numbers are (844) 815-2882 for domestic callers and (213) 660-0926 for international callers. The conference ID number for the call is 5450919. Participants may access the live webcast via a link on the Synlogic website in the Events Calendar of the Investors and Media section. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Company’s website.

Additionally, Aoife Brennan, M.B. Ch.B., Synlogic’s President and Chief Executive Officer, will present at the following banking conference:

Jefferies London Healthcare Conference, November 18th and 19th. The Company presentation will be available on demand.
Synlogic’s pre-recorded session will be available for the duration of the conference and a replay will be available for 30 days on the Company’s website.

On November 2, 2021 – OncoResponse, a clinical-stage biotech company advancing immunotherapies derived from the immune systems of elite cancer responders, reported initiation of a Phase 1/2 study of OR2805 in patients with advanced cancer. OR2805 is a fully human monoclonal antibody identified from an elite cancer responder using OncoResponse’s proprietary B-cell discovery platform (Press release, OncoResponse, NOV 2, 2021, View Source [SID1234609566]).

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The study will evaluate the safety, pharmacokinetics and preliminary anti-cancer activity of OR2805 in patients with advanced solid tumors alone and in combination with anti-PD-1 therapy. The trial will include a dose escalation phase, followed by several expansion cohorts. The role of potential biomarkers will be evaluated throughout the study, and more intensively in a separate biology cohort. ClinicalTrials.gov identifier: NCT05094804

"The initiation of our Phase 1 clinical trial of OR2805 represents a significant milestone for OncoResponse. OR2805 has the potential to reverse the inhibitory effect of tumor associated macrophages, or TAMs, and unlock a potent anti-tumor response," said Bob Lechleider, MD, Chief Medical Officer of OncoResponse. "Preclinical studies have demonstrated the ability of OR2805 to effectively counter the inhibitory activity of M2 macrophages, and we now intend to determine how that will translate to clinical activity. OncoResponse is dedicated to bringing novel and effective therapies that modulate the tumor microenvironment into the clinic to help patients who desperately need additional treatment options."

OR2805 is a fully human antibody discovered using B cells derived from an elite responder to checkpoint inhibitor (CPI) therapy. This antibody binds to CD163 which is highly expressed on tumor associated macrophages (TAMs) that create an immunosuppressive tumor microenvironment and inhibit anti-tumor T-cell responses. High frequency of CD163-expressing TAMs generally predicts an unfavorable prognosis in solid tumors.improve anti-tumor T-cell responses, the immunosuppression of TAMs, as a therapeutic strategy for monotherapy and in combination with CPI.

OncoResponse recently highlighted platform and preclinical data on OR2805 in an oral presentation "Using the Human Immune System to Identify Antibodies that Modulate the Tumor Microenvironment" at the Macrophage-Directed Therapies Summit. The presentation, by Kamal D. Puri, PhD, Chief Scientific Officer, can be accessed from the Publications page of the OncoResponse website.