On December 8, 2021 Cytovia Therapeutics, Inc., a biopharmaceutical company developing allogeneic "off-the-shelf" gene-edited iNK cells (NK cells derived from induced pluripotent stem cells, or iPSCs), CAR (Chimeric Antigen Receptor)-iNK cells, and Flex-NK cell engager multifunctional antibodies, reported that its scientific leadership will present at the following upcoming conferences (Press release, Cytovia Therapeutics, DEC 8, 2021, View Source [SID1234596617]):

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"We are proud of the scientific thought leadership of our colleagues Drs. Frankel, Li, and Kadouche, who will present Cytovia’s latest advances"

iPSC-Derived Cell Therapies Summit (Virtual Event)

Wednesday, December 8th, 2021, 9.30 AM
Demonstrating Safety & Efficacy of iPSC-derived Cells to Maximize Clinical Translation
(Industry Leaders’ Fireside Chat: Paving the Way For the Future of Cell Therapy with iPSCs)
Featuring Cytovia Therapeutics CMO Stanley Frankel

Wednesday, December 8th, 2021, 3PM
Advancing Clinical Trial Strategy for Successful Clinical Outcomes
(Developing iPSC-Derived NK Cell Therapies Against Solid Tumors)
Featuring Cytovia Therapeutics CSO Wei Li

Antibody Engineering & Therapeutics Conference (San Diego, California)

December 12th-15th, 2021
Dr. Jean Kadouche, Cytovia Therapeutics scientific co-founder and Global Head of Antibody R&D, will present the "Design, Manufacturing, and Activity of FLEX Immune Cell Engager Multi-functional Antibodies" poster on behalf of the Cytovia team.

"We are proud of the scientific thought leadership of our colleagues Drs. Frankel, Li, and Kadouche, who will present Cytovia’s latest advances," said Dr. Daniel Teper, CEO of Cytovia Therapeutics. "Cytovia is committed to translating disruptive innovation in cell therapy to create therapeutics that advance towards a cancer cure. Cytovia is the first biotech company to develop its own best-in-class gene-edited, iPSC-derived NK cells and NK Engager antibodies, with the potential to combine them for optimal clinical outcomes in both hematological and solid tumors."

On December 8, 2021 Propella Therapeutics, Inc. reported that it will be participating in the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium from February 17-19, 2022 (Press release, Propella Therapeutics, DEC 8, 2021, https://propellatx.com/2021/12/08/presentations-forthcoming-american-society-of-clinical-oncology-genitourinary-cancers-symposium-february-17-19-2022/ [SID1234596639]).

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On December 8, 2021 Shasqi, a clinical-stage biotechnology company developing precision activated oncology therapeutics with its proprietary Click Activated Protodrugs Against Cancer (CAPAC) Platform, reported that it has been awarded a second ‘Direct to Phase 2’ Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) (Press release, Shasqi, DEC 8, 2021, View Source [SID1234596618]). The $1.9 million grant will support a Phase 1b dose-expansion cohort in the company’s ongoing development program for its click-activated prodrug therapy, SQ3370. The safety and efficacy data from this cohort will support dose selection for the planned Phase 2 study of SQ3370 in patients with advanced soft tissue sarcoma.

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"The NCI has made two investments in our Phase 1 clinical studies of SQ3370, which will enable us to accelerate the development of SQ3370 and gather additional efficacy and safety data to inform our Phase 2 clinical trial design. We are grateful for the vision of the NCI and their support of SQ3370 and our click chemistry platform," said José M. Mejía Oneto, M.D., Ph.D., Founder and CEO of Shasqi. "The early data from our Phase 1 study of SQ3370 provides initial validation for our platform in humans, with an encouraging safety profile and initial hints of clinical activity. We believe we can improve the efficacy, safety, and biological effects of many existing cancer therapies and various modalities which are currently either too toxic to be used widely, have significant safety burden, or have limited efficacy due to a limited therapeutic window."

About CAPAC and SQ3370:

SQ3370 is the first click chemistry-based treatment to be tested in humans, and utilizes Shasqi’s proprietary CAPAC platform, an approach that activates cancer drugs at a tumor with decreased systemic toxicity. Shasqi is validating its platform with SQ3370, which is designed to activate a powerful chemotherapeutic, doxorubicin, at the site of the tumor. The investigational product is based on the chemical reaction between a drug protected through a trans-cyclooctene modification (a protodrug) and a tetrazine-modified biopolymer. The biopolymer is injected into the target tumor lesion, where it precisely activates an intravenously infused protodrug. Shasqi believes its click-chemistry approach can improve the efficacy and safety of many existing drugs and various modalities that have a limited therapeutic window.

On December 8, 2021 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that it has completed its acquisition of PPD, Inc. (Nasdaq: PPD), a leading global provider of clinical research services to the biopharma and biotech industry, for $17.4 billion (Press release, Thermo Fisher Scientific, DEC 8, 2021, View Source [SID1234596640]).

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"We are very excited to officially welcome our PPD colleagues to Thermo Fisher Scientific," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "Expanding our value proposition for our biotech and pharmaceutical customers with the addition of PPD’ s leading clinical research services advances our work in bringing life-changing therapies to market, benefitting patients around the world."

As previously announced, the transaction is expected to contribute $1.50 to Thermo Fisher’s adjusted earnings per share in 2022.1 Details of the 2021 impact will be provided during Thermo Fisher’s fourth quarter earnings call in early 2022.

Thermo Fisher continues to expect to realize total synergies of approximately $125 million by year three following close, consisting of approximately $75 million of cost synergies and approximately $50 million of adjusted operating income benefit from revenue-related synergies. In connection with the acquisition, Thermo Fisher will also assume approximately $3.0 billion in net debt of PPD. All assumed debt will be retired in connection with the closing of the transaction.2

With the addition of PPD, Thermo Fisher will offer a comprehensive suite of world-class services across the clinical development spectrum − from scientific discovery, to assessing safety, efficacy, and health care outcomes, to managing clinical trial logistics, to the development and manufacturing of the drug product.

In connection with the completion of the transaction, PPD’s common stock ceased trading on Nasdaq prior to the opening of trading today. PPD will become part of Thermo Fisher’s Laboratory Products and Services Segment.

1 Adjusted earnings per share is a non-GAAP measure that excludes certain items detailed later in this press release under the heading "Use of Non-GAAP Financial Measures."
2 This includes PPD’s outstanding 4.625% Senior Notes due 2025 and 5.000% Senior Notes due 2028 issued by Jaguar Holding Company II and PPD Development, L.P. and guaranteed by PPD, the holders of which have been notified that PPD will redeem all of such notes at the redemption prices specified in the governing indenture, plus interest through the redemption date December 18, 2021.

On December 7, 2021 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported preliminary unaudited net product sales for EXPAREL (bupivacaine liposome injectable suspension) and iovera° for the month of November 2021 (Press release, Pacira Pharmaceuticals, DEC 7, 2021, View Source [SID1234596543]). EXPAREL net product sales were $46.5 million, compared with $38.1 million for November 2020. EXPAREL average daily sales for the month of November 2021 were 122 percent of November 2020. The company reports average daily growth rates for EXPAREL to account for differences in the number of selling days per reporting period. The number of EXPAREL selling days were 20 in both November 2021 and November 2020. Net product sales of iovera° were $1.5 million for the month of November 2021, compared with $0.8 million for November 2020.

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"We are encouraged by EXPAREL’s robust growth in November with product utilization continuing to significantly outpace the recovery of the elective surgery market," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "Our team is driving strong results while at the same time advancing integration activities from the Flexion acquisition. We look forward to the significant opportunity and synergies we believe ZILRETTA will add to our commercial offering in 2022 and beyond. As we close out 2021, we look forward to delivering strong top- and bottom-line growth as we build upon our mounting momentum and leadership in non-opioid pain management to improve patient care along the neural pain pathway."

On November 19, 2021, Pacira completed its acquisition of Flexion Therapeutics, which added ZILRETTA (triamcinolone acetonide extended-release injectable suspension) to its commercial offering. Pacira is currently not reporting preliminary monthly ZILRETTA net product sales as the required adjustments for certain product rebate programs are calculated after the end of the quarter and, as a result, ZILRETTA net product sales for the months of November 2021 and 2020 are not included in the amounts above. In addition to pandemic-related challenges, Flexion previously reported that its sales were negatively impacted in the third quarter of 2021 by rebate program modifications and several unanticipated manufacturing batch failures that led to short-dated ZILRETTA inventory resulting in smaller order sizes and product returns. Pacira expects to exit 2021 with ZILRETTA quarterly sales tracking more in line with ZILRETTA second quarter of 2021 sales with sales trends improving thereafter as Pacira extends inventory dating, simplifies the rebate program, and completes integration activities in 2022.

The company’s net product sales were negatively impacted by the COVID-19 pandemic in 2020 due to the significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020, allowing EXPAREL sales to return to year-over-year growth in June 2020. However, while many restrictions have since eased and COVID-19 vaccines have become more widely available and administered to the general public, it is still unclear how long it will take the elective surgery market to normalize, or if restrictions on elective procedures will recur due to COVID-19 variant strains or otherwise.

The company has not provided 2021 financial guidance given the continued uncertainty around COVID-19 and the pace of recovery for the elective surgery market. To provide greater transparency, Pacira is reporting monthly intra-quarter unaudited net product sales for EXPAREL and iovera° and will continue to do so until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com.

The financial information included in this press release is preliminary, unaudited, and subject to adjustment. It does not present all information necessary for an understanding of the company’s financial results for the fourth quarter or full year 2021.