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.

On May 3, 2022 RefleXion Medical, a therapeutic oncology company pioneering the use of biology-guided radiotherapy (BgRT)* for all stages of cancer, reported the enrollment of the first patient into its PREMIER registry, a prospective, real-world evidence clinical outcomes registry for patients with all stages of cancer, at the University of Texas (UT) Southwestern in Dallas (Press release, RefleXion Medical, MAY 3, 2022, View Source [SID1234613436]).

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The PREMIER registry was created to collect data to demonstrate the impact of the RefleXion X1 radiotherapy system, the first-ever system with onboard fast fan-beam KVCT, on patients with all solid tumor and lymphoma cancer types. The registry will expand to include BgRT procedures, a new radiotherapy treatment modality that uses signals detected from positron emission tomography (PET) to guide radiotherapy. The X1 is the first and only system designed with onboard PET detectors. The PREMIER registry will assess health-related quality of life, acute and long-term side effects in patients, and cancer-related outcomes.

"We believe that adapting radiotherapy plans based on how the tumor responds to the first radiation dose will be a key component in bringing together radiotherapy with drug therapies, such as targeted and immune-oncology agents," said Tu Dan, M.D., assistant professor in the Department of Radiation Oncology at UT Southwestern Medical Center. "However, to fully understand the utility of this approach, robust and accurate data collected through longitudinal endpoints in prospective registries, such as RefleXion’s PREMIER registry, are imperative."

The PREMIER registry will include extensive baseline data as well as follow-up data collected at the end of treatment, and then again at three, six, nine, 12, 18 and 24 months. The registry will enroll a minimum of 750 patients from a minimum of four sites throughout the United States.

"Our prospective registry will capture and organize an unprecedented level of data including patient, demographic, tumor, biomarker, imaging and treatment information for all stages of cancer," said Sean Shirvani, M.D., MPH, chief medical officer at RefleXion. "Our hope is that collecting this rich repository of information before, during, and after treatment will enable our clinical partners to investigate and identify the factors that best determine cancer outcomes, which may then arm patients with the information they need to make better decisions around their care."

Prospective registries define specific information and characteristics in advance, before data collection or the impacts of a treatment are known, including the check-in interval for patient follow-up. Known as longitudinal data over time, this improves data accuracy because it minimizes the dependency on patient recall. Therefore, prospective registries can draw closer associations between the treatment delivered and a patient’s outcome.

On May 3, 2022 NanOlogy LLC, a clinical-stage interventional oncology drug company, reported that results from a clinical trial of topical submicron particle paclitaxel (SOR007) in cutaneous metastases of breast cancer (CMOBC) have been published in Breast Cancer Research and Treatment (Press release, NanOlogy, MAY 3, 2022, View Source;utm_medium=rss&utm_campaign=nanology-publishes-results-from-a-phase-1-2-clinical-trial-of-its-topical-investigational-drug-in-the-treatment-of-cutaneous-metastases-of-breast-cancer [SID1234613461]).

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The research article entitled Phase 1/2 Study of Topical Submicron Particle Paclitaxel for Cutaneous Metastases of Breast Cancer presents final safety and response data from the multi-site study (NCT03101358). Clinical investigators included Mario Lacouture, MD (Memorial Sloan Kettering Cancer Center), Julie Lang, MD (formerly USC Norris Comprehensive Cancer Center; currently Cleveland Clinic), and Sant Chawla, MD (Sarcoma Oncology Research Center).

The dose escalation/expansion trial enrolled 23 subjects across the three sites, 21 of whom had CMOBC. Three concentrations of SOR007 were evaluated (0.15%, 1.0%, and 2.0%) applied twice daily for 28 or 56 days. The primary endpoint of the study was safety and tolerability. Secondary endpoints included lesion response, lesion pain reduction, and pharmacokinetic (PK) analysis.

SOR007 was well tolerated at all concentrations allowing the 2.0% concentration to continue to the dose expansion phase of the trial. No confirmed drug-related serious adverse events were recorded, local skin reactions were minor, and systemic absorption of paclitaxel was negligible.

Lesion response was evaluated by dimensional change (RECIST 1.1) with 19 subjects evaluable at 28 days and 8 evaluable at 56 days. At the 28-day and 56-day assessments, overall response rate was 16% (3/19) and 25% (2/8), respectively. Similarly, 15/19 (79%) and 6/8 (75%) were progression free. Some lesion pain reduction was observed in 7/11 (64%) of subjects who reported pain at baseline.

Approximately 168,000 people are living with metastatic breast cancer in the United States and up to a quarter (40,000) may develop cutaneous metastases (BCRF [2021]; Krathen [2003] South Med J). CMOBC are progressive malignant skin lesions that can cause severe local pain, ulceration, disfigurement, discharge, malodor, bleeding, and infection. The negative impact to quality of life for these patients can be devastating.

NanOlogy is considering partnership strategies for further development and commercialization of SOR007, which has therapeutic potential in CMOBC and other dermal cancers.

"Cutaneous metastases are extremely troublesome for the patient and oncologist alike as the lesions are a daily reminder of the underlying metastatic disease and there are few treatment options currently available," said Mario Lacouture, MD, Director, Oncodermatology Program, Memorial Sloan Kettering Cancer Center. "In this Phase 1/2 clinical trial, SOR007 showed promising signs of preventing lesion progression and reducing lesion pain. Further clinical research is warranted to confirm these findings."

In addition to SOR007, NanOlogy clinical programs have advanced tumor-directed investigational drugs in pancreas, lung, bladder, peritoneal, ovarian, and prostate cancers.

The NanOlogy therapeutic platform is based on a proprietary supercritical precipitation technology that converts oncology active ingredients into stable large surface area microparticles of pure drug optimized for tumor-directed therapy and continuous drug release. Taxane particles are covered by composition of matter patents issued in the US (US 9,814,685, US 10,507,195, US 10,993,927, and US 11,123,322) Canada, Europe, Japan, China, Russia, and Australia all valid through June 2036. The topical formulation is covered by formulation and method of treatment patents issued in the US (US 10,449,162, US 10,918,606, US 10,555,898, US 10,842,736, & US 11,191,717) and Japan. The composition and formulation patents form the foundation of an extensive intellectual property portfolio protecting NanOlogy investigational drugs, methods, and technology.