On May 3, 2022 Agendia, Inc., a commercial-stage company focused on empowering decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes for breast cancer patients worldwide, reported the presentation of new data from ongoing clinical studies evaluating its comprehensive suite of genomic tests at the upcoming annual conference of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), to be held June 3-7, 2022 in Chicago, Illinois (Press release, Agendia, MAY 3, 2022, View Source [SID1234613435]).

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The data underscores Agendia’s clinical commitment to full transcriptome analysis and treatment of breast cancer for underserved populations, in addition to numerous sub-studies stemming from the company’s FLEX Registry, the study in the real world, multicenter, prospective and observational on breast cancer. Two abstracts selected by ASCO (Free ASCO Whitepaper) for oral discussion will present an analysis of the ImPrint genomic test, which is currently indicated for research use only, the I-SPY series of assays, and an analysis of FLEX for receptor breast cancer. positive hormones in black women classified by BluePrint .

The company believes that the FLEX Registry’s approach to cancer research is accelerating the generation of relevant data, aimed at redefining cancer treatment. Its patient-centered design and nationwide network of participating sites leverage Agendia’s infrastructure, enabling investigator-initiated sub-studies to produce notable results with the potential to advance science, such as this. is the case of the data presented at ASCO (Free ASCO Whitepaper) 2022.

Below is information related to the nine Agendia abstracts that have been accepted for discussion or poster sessions at the 2022 ASCO (Free ASCO Whitepaper) Annual Conference:

Poster Discussion Sessions

ImPrint immune signature to identify patients at high risk for breast cancer who may benefit from PD1 checkpoint inhibition in I-SPY2
Authors: Kuilman, MM., et al.
Presenter: Lorenza Mittempergher, PhD | R&D, Agendia NV
Session: Breast cancer – local/regional/adjuvant
Poster discussion: Monday, June 6, 2022 | 1: 15-2:45 p.m. CDT
Abstract No.: 514
Full transcriptomic analysis of hormone receptor positive breast cancer in black women classified as basal type by BluePrint
Authors: Reid, S., et al.
Presenter: Sonya A. Reid, MD, MPH | Vanderbilt University Medical Center
Session: Breast Cancer – Local/Regional/Adjuvant
Poster Discussion: Monday, June 6, 2022 | 1: 15-2:45 p.m. CDT
Abstract No.: 517
Sessions per poster

Whole transcriptome analysis of tumors with a discordant oncotype and MammaPrint results in the FLEX trial
Authors: Socoteanu, M., et al.
Session: Breast cancer – local/regional/adjuvant
Session date and time: Monday, June 6, 2022 | 8h00-11h00 CDT
Abstract No.: 556
Clinical Implications for Patients with Discordant Oncotype and MammaPrint Results
Authors: Socoteanu, M., et al.
Session: Breast cancer – local/regional/adjuvant
Session date and time: Monday, June 6, 2022 | 8h00-11h00 CDT
Abstract No.: 560
Investigation of a genomic signature for gene amplification of the transcription factor MAF and insufficient benefits of bisphosphonate for early breast cancer
Authors: Nasrazadani, A., et al.
Session: Breast Cancer – Local/Regional/Adjuvant
Session Date and Time: Monday, June 6, 2022 | 8h00-11h00 CDT
Abstract No: 559
Identification of transcriptional changes with MammaPrint and BluePrint in early-stage breast cancer after neoadjuvant chemotherapy
Authors: Chung, A., et al.
Session: Breast cancer – local/regional/adjuvant
Session date and time: Monday, June 6, 2022 | 8h00-11h00 CDT
Abstract No.: 585
Distribution of Breast Cancer Molecular Subtypes Based on Receptor Classifications: Lessons from the I-SPY2 Trial and the FLEX Registry
Authors: Cha, J., et al.
Session: Breast cancer – local/regional/adjuvant
Session date and time: Monday, June 6, 2022 | 8h00-11h00 CDT
Abstract No.: 592
FLEX, the transcriptomic project for 30,000 breast cancers: a platform for early stage breast cancer research using comprehensive genomic testing coupled with clinical data
Authors: Ma, C., et al.
Session: to be confirmed Session
date and time: Monday, June 6, 2022 | 8h00-11h00 CDT
Abstract No.: TPS612
Defining transcriptomic profiles of early-stage mucinous breast cancers: a FLEX
substudy Authors: Sivapiragasam, A., et al.
Session: Developmental Therapeutics – Molecular Targeting Agents and Tumor Biology
Session Date and Time: Sunday, June 5, 2022 | 8h00-11h00 CDT
Abstract No: 3134
Agendia will be sharing important updates on its Twitter , Facebook and LinkedIn pages throughout the conference. The program for the event is available on the ASCO (Free ASCO Whitepaper) 2022 website .

On May 3, 2022 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that management will participate in a fireside chat at the Bank of America Securities 2022 Healthcare Conference on Tuesday, May 10 at 7:00 p.m. ET /4:00 p.m. PT in Las Vegas (Press release, Arvinas, MAY 3, 2022, View Source [SID1234613361]).

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A live audio webcast of the presentation will be available here and on the Events + Presentations section of the Company’s website.

On May 3, 2022 Cerus Corporation (Nasdaq: CERS) reported that it has signed a ten-year agreement with Fresenius Kabi for the production of INTERCEPT Blood System sets (Press release, Cerus, MAY 3, 2022, View Source [SID1234613386]). This new contract replaces the current one with Fresenius Kabi that was set to expire in July 2025.

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"Our long-standing partnership with Fresenius Kabi has enabled us to ramp the adoption of our pathogen inactivation technology broadly around the globe, as we work to fulfill our mission of making the INTERCEPT Blood System the standard of care in transfusion medicine," said William ‘Obi’ Greenman, president and chief executive officer of Cerus. "After working together for more than 20 years, we are pleased to have extended our partnership commitment to meet the capacity requirements necessitated by the growth of our global business. This new cooperation secures numerous benefits for our companies, our customers and our shareholders, and it makes our supply chain more robust as we grow over the next decade."

Fresenius Kabi will continue producing sets for Cerus at its facility in La Châtre, France, and will also expand manufacturing operations to two new facilities, both located in the Caribbean. The addition of these sites will increase production volume for INTERCEPT Blood System sets and provide for the redundancy required for continuity of supply to Cerus’ large blood center and national transfusion service customers. Finally, with the expanded manufacturing footprint and increased production volumes, Cerus and Fresenius Kabi are focused on realizing additional economies of scale for both organizations.

"Cerus has been a valued partner, and we are excited to be announcing this next stage of our longstanding partnership with them today," stated Dr. Christian Hauer, Member of the Management Board Fresenius Kabi and President Fresenius Kabi MedTech. "With the INTERCEPT Blood System, Cerus offers a best-in-class pathogen reduction technology that many blood centers, hospitals, and patients across the globe rely on. We look forward to continuing to help Cerus transform the transfusion medicine field and improve blood safety and availability around the world with our high-quality products."

For over two decades, Cerus and Fresenius Kabi have collaborated to deliver pathogen inactivation for platelets and plasma around the globe, with cumulative doses of INTERCEPT blood components estimated to be in excess of 11 million since the products were first commercially launched.

On May 3, 2022 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported financial results for the first quarter ended April 3, 2022 (Press release, PerkinElmer, MAY 3, 2022, View Source [SID1234613402]).

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The Company reported GAAP earnings per share from continuing operations of $1.40, as compared to GAAP earnings per share from continuing operations of $3.37 in the same period a year ago. GAAP revenue for the quarter was $1.26 billion, as compared to $1.31 billion in the same period a year ago. GAAP operating income from continuing operations for the quarter was $255 million, as compared to $468 million for the same period a year ago. GAAP operating profit margin was 20.2% as a percentage of revenue, as compared to 35.8% in the same period a year ago.

Adjusted earnings per share from continuing operations for the quarter was $2.41, as compared to $3.72 in same period a year ago. Adjusted revenue for the quarter was $1.26 billion, as compared to $1.31 billion in the same period a year ago. Adjusted operating income from continuing operations for the quarter was $410 million, as compared to $542 million for the same period a year ago. Adjusted operating profit margin was 32.5% as a percentage of adjusted revenue, as compared to 41.4% in the same period a year ago.

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

"The company once again demonstrated its agility and resiliency so far in 2022, and I’m encouraged by our better-than-expected performance to start the year," said Prahlad Singh, president and chief executive officer of PerkinElmer. "My appreciation goes to all our employees who are not only continuing to execute at a high level for our customers, but who also are making a difference in their communities during these extraordinary times."

Financial Overview by Reporting Segment for the First Quarter

Discovery & Analytical Solutions

First quarter 2022 revenue was $602 million, as compared to $455 million in the same period a year ago. Reported revenue increased 33% and organic revenue increased 12% as compared to the same period a year ago.
First quarter 2022 operating income from continuing operations was $15 million, as compared to $43 million for the same period a year ago.
First quarter 2022 adjusted operating income was $127 million, as compared to $76 million for the same period a year ago.
Diagnostics

First quarter 2022 revenue was $657 million, as compared to $853 million for the same period a year ago. Reported revenue decreased 23% and organic revenue decreased 24% as compared to the same period a year ago.
First quarter 2022 operating income from continuing operations was $258 million, as compared to $441 million for the same period a year ago.
First quarter 2022 adjusted operating income was $301 million, as compared to $483 million for the same period a year ago.
Initiates Second Quarter and Raises Full Year 2022 Guidance

For the second quarter of 2022, the Company forecasts revenue of approximately $1.20-1.22 billion which includes the recognition of approximately $100 million of additional deferred revenue. Adjusted earnings per share in the second quarter of 2022 is expected to be in a range $2.00-2.05 which includes approximately $0.35 of earnings per share from the net impact of the recognition of deferred revenue and related costs.

For the full year 2022, the Company now forecasts revenue of $4.56-4.63 billion and adjusted earnings per share of $7.15-7.45.

Guidance for the second 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 first quarter 2022 results and its outlook for business trends during a conference call on May 3, 2022 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.

Use of Non-GAAP Financial Measures

In addition to financial measures prepared in accordance with generally accepted accounting principles (GAAP), this earnings announcement also contains non-GAAP financial measures. The reasons that we use these measures, a reconciliation of these measures to the most directly comparable GAAP measures, and other information relating to these measures are included below following our GAAP financial statements.

On May 3, 2022 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that it has initiated a process to review strategic alternatives with the goal of maximizing shareholder value (Press release, Sesen Bio, MAY 3, 2022, View Source [SID1234613419]). Potential strategic alternatives to be explored and evaluated during the review process may include the sale of the Company, a merger, acquisition or other business combination, a strategic partnership with one or more parties, or the licensing, sale or divestiture of some of the Company’s proprietary technologies. Pending any decision to undertake any strategic alternative, the Company is continuing its development activities in accordance with its existing business strategy.

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"Our strong cash position provides us the opportunity to carefully consider a wide range of potential strategic alternatives designed to maximize shareholder value," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "As we assess potential external strategic alternatives, we continue to seek to create value through the development of Vicineum for the treatment of non-muscle invasive bladder cancer. We plan to request a meeting with the FDA in the coming weeks to align on the remaining outstanding items related to an additional Phase 3 clinical trial."

As of March 31, 2022, the Company had $169.8 million in cash and cash equivalents, no outstanding debt and fewer than 0.2 million outstanding warrants. These amounts are preliminary and are subject to change upon completion of the Company’s financial statements for the quarterly period ended March 31, 2022.

About Vicineum
Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached to the antibody binding fragment until it is internalized by the cancer cell. This fusion protein design is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 clinical trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted the Company’s Biologics License Application (BLA) file for Vicineum for the treatment of BCG-unresponsive NMIBC, granted Priority Review for the BLA and set a Prescription Drug User Fee Act (PDUFA) date of August 18, 2021. On August 13, 2021, the Company received a Complete Response Letter (CRL) from the FDA regarding its BLA for Vicineum. After meeting with the FDA, the Company plans to conduct an additional Phase 3 clinical trial for Vicineum for the treatment of NMIBC in connection with the potential resubmission of a BLA. The Company plans to request a meeting with the FDA in the coming weeks to align on the remaining outstanding items related to the additional Phase 3 clinical trial. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. For this reason, the activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.