Pacira BioSciences Reports Preliminary Net Product Sales for EXPAREL® and iovera° of $48.0 Million for November 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.

ImmunoPrecise Reports Financial Results and Recent Business Highlights for Second Quarter Fiscal Year 2022

On December 7, 2021 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (NASDAQ: IPA) (TSX VENTURE: IPA) a leader in full-service, therapeutic antibody discovery and development, reported that it will host a conference call to discuss its financial results and recent business highlights for second quarter fiscal year 2022 on December 13, 2021, after the close of market (Press release, ImmunoPrecise Antibodies, DEC 7, 2021, View Source [SID1234596542]). The financial results will be issued in a press release prior to the call. ImmunoPrecise management will host the conference call followed by a pre-submitted question-and-answer period.

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Investors interested in submitting questions ahead of the call are encouraged to email the Company’s investor relations contact.

The conference call will be webcast live and available for replay via a link provided in the Events section of the company’s IR pages at View Source

Please call the conference telephone number five minutes prior to the start time. An operator will register your name and organization.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Toronto Stock Exchange and Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

Kintara Therapeutics to Present at the MedInvest Oncology Investor Conference on December 9, 2021

On December 7, 2021 Kintara Therapeutics, Inc. (Nasdaq: KTRA), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that its Chief Executive Officer, Robert E. Hoffman, will present a corporate overview at the MedInvest Oncology Investor Conference, which is being held virtually on December 7 – 10, 2021 (Press release, Kintara Therapeutics, DEC 7, 2021, View Source [SID1234596541]).

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Mr. Hoffman will deliver his corporate presentation on Thursday, December 9, 2021 at 2:50 p.m. EST.

Mr. Hoffman will be available for one-on-one meetings throughout the conference.

Vincerx Pharma Receives Orphan Drug Designation from European Commission for VIP152 for the Treatment of Diffuse Large B-Cell Lymphoma

On December 7, 2021 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported that the European Commission has granted Orphan Drug Designation to VIP152, the Company’s PTEFb/CDK9 inhibitor, for the treatment of diffuse large B-cell lymphoma (DLBCL) (Press release, Vincerx Pharma, DEC 7, 2021, View Source [SID1234596540]).

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"The granting of Orphan Drug Designation for VIP152 in DLBCL realizes another significant regulatory milestone for Vincerx," said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx. "VIP152 has the potential to be an effective treatment for rare and highly refractory cancers, for which there is an unmet need in the current therapeutic landscape. We look forward to continued momentum with data presentations at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which include complete disease regression in DLBCL mouse models and modulation of key biomarkers in high-grade B-cell lymphoma cell lines and patients. In addition, we are presenting supportive preclinical mechanistic data in chronic lymphocytic leukemia."

The European Commission grants orphan drug designation for medicinal products intended to treat life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 people in the European Union and when no satisfactory method of diagnosis, prevention or treatment of the condition can be authorized. The designation provides certain benefits and incentives in the EU, including protocol assistance, fee reductions, and ten years of market exclusivity once the medicine is on the market.

Vincerx is currently advancing Phase 1b studies of VIP152 in MYC-driven relapsed or refractory aggressive lymphomas and advanced solid tumors. The ongoing Phase 1b expansion, first-in-human (FIH) study is in patients with advanced cancer and consists of two expansion arms. Arm 1 will enroll up to 40 patients with relapsed/refractory aggressive lymphoma, including DLBCL, transformed follicular lymphoma, and mantle cell lymphoma. Arm 2 will enroll up to 40 patients with advanced solid tumors, including patients with ovarian cancer, triple negative breast cancer, castration-resistant neuroendocrine prostate cancer, and any other solid tumor with MYC aberration. All patients must have confirmed MYC overexpression or translocation.

Odyssey Therapeutics Announces $218 Million Series A Financing to Advance Next Generation Inflammation and Oncology Medicines

On December 7, 2021 Odyssey Therapeutics, a biotechnology company pioneering next generation precision immunomodulators and oncology medicines, reported the completion of an oversubscribed $218 million Series A financing led by OrbiMed Advisors and co-led by SR One Capital Management with participation from Foresite Capital, Woodline Partners LP, Logos Capital, HBM Healthcare Investments, Colt Ventures, Creacion Ventures, and other institutional investors (Press release, Odyssey Pharmaceuticals, DEC 7, 2021, View Source [SID1234596539]). Carl L. Gordon, Ph.D., Managing Partner of OrbiMed Advisors, will join Odyssey’s board of directors. The financing will be used to advance multiple pipeline programs and Odyssey’s discovery platform aimed at expanding the druggable genome. Founded by Gary D. Glick, Ph.D., the company is led by a team of drug hunters and executives with an extraordinary track record of accomplishment in helping to bring more than 20 drugs to market.

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Anti-inflammation immunotherapies, such as anti-TNF antibodies and JAK inhibitors, and newer oncology immunotherapies and targeted therapies have improved the standard of care for some patients. However, numerous challenges including limited efficacy, inherent or acquired drug resistance, and mechanism-based toxicity restrict broader patient care and limit their benefits.

Building on these past approaches, Odyssey has developed a strategy to create a portfolio of product candidates that will go beyond the limitations of current medicines and enhance the standard-of-care for patients living with inflammatory diseases and cancer. The company is focused on targets and mechanisms that control validated signaling nodes that drive disease, with the goal of creating medicines that achieve optimal product profiles for patients. In addition, Odyssey is applying its highly integrated drug hunting engine and class-leading computational and data sciences platform to challenging, high-value targets with the potential to revolutionize treatment paradigms, but for which traditional discovery approaches have not succeeded.

"A renaissance in medicinal chemistry, coupled with new drug discovery technologies and an expanded understanding of the drivers of immune dysfunction and cancer, has created an unprecedented opportunity to discover new drugs with much greater potential for patients," said Gary D. Glick, Ph.D., Chief Executive Officer of Odyssey Therapeutics. "Odyssey has brought together the financing, technology, and a team with decades of success in drug discovery and development and is poised to capitalize on this opportunity and take precision therapies to the next level: providing patients with better medicines to improve their lives."

"Odyssey has assembled one of the strongest biotech teams I have seen," said Carl Gordon, Ph.D., CFA, OrbiMed Advisors. "Paired with its next-generation scientific approach, Odyssey is positioned to accelerate the discovery and development of transformative medicines to improve the lives of a broad range of patients living with inflammatory diseases and cancer."

Experienced leadership team with proven successes
Odyssey was founded by Dr. Glick and a group of world-renowned drug hunters and academic experts in immunology, cancer biology, synthetic and systems biology, and proteomics. With headquarters and labs in Boston, Odyssey is rapidly expanding with more than 90 scientists and staff.

Odyssey’s founding team has collectively made a number of the most important discoveries in immunology and cancer biology over the last 15 years. These key scientific insights underpin the discovery and rationale of several marketed drugs and medicines in clinical testing. Odyssey is leveraging this in-house intellectual capital not only to select targets but also to determine the therapeutic modality that will have the greatest clinical impact. To transform scientific insights into medicines, Odyssey is organized in a bottom-up manner that cuts across traditional disciplines and maximizes speed, efficiency, and rigor across the organization.

The Odyssey senior scientific management team includes:

Gary D. Glick, Ph.D., Founder, President, and Chief Executive Officer
Dr. Glick is a chemist and serial biotech entrepreneur with over 15 years’ experience in the biotech industry. He has founded several successful companies, including IFM Therapeutics. While CEO of IFM, the company progressed three programs from ideation to clinical development and executed several major transactions, including the sale of oncology assets to Bristol-Myers Squibb in a transaction valued more than $2.3 billion and the sale of an NLRP3 inhibitor program to Novartis for $1.6 billion. Prior to Odyssey, in 2020, he co-founded and launched Scorpion Therapeutics. Dr. Glick played an instrumental role in the conception and building of the company, and during his tenure as Chief Executive Officer, Scorpion raised $270 million across two financings within nine months of the company’s founding. Dr. Glick received his Ph.D. in Organic Chemistry from Columbia University and completed postdoctoral studies in Organic Chemistry at Harvard University.
Robert Abraham, Ph.D., Executive Vice President, Cancer Biology
Dr. Abraham is a veteran leader in oncology research and development. Prior to Odyssey, Dr. Abraham served as Chief Scientific Officer at Vividion Therapeutics, which was acquired in August 2021 by Bayer for $2 billion. Previously, he held the position of Senior Vice President and Group Head of the Oncology R&D Group in Pfizer Worldwide Research, Development, and Medical. While at Pfizer, he helped launch 10 new oncology medicines, including XALKORI, IBRANCE, BESPONSA, BOSULIF, BAVENCIO, MYLOTARG, TALZENNA, DAURISMO, and LORBRENA, benefiting hundreds of thousands of patients worldwide. Dr. Abraham received his Ph.D. in Pharmacology from the University of Pittsburgh.
Natalie Dales, Ph.D., Senior Vice President, Chemistry and Drug Discovery
Dr. Dales is an accomplished scientist with over 20 years’ small molecule drug discovery experience leading and mentoring teams in pharmaceuticals and biotech. Prior to Odyssey, Dr. Dales was an Executive Director and the Head of Portfolio and Strategy for the Global Discovery Chemistry Group at Novartis. She was also a senior advisor for the Novartis Genesis Labs, an internal innovation incubator which fostered and funded disruptive concepts to accelerate drug discovery. Prior to Novartis, she worked on oncology, cardiovascular, and metabolism programs at Millennium Pharmaceuticals. Dr. Dales received her Ph.D. in Organic Chemistry from the University of Wisconsin.
Joseph McDonald, Ph.D., Chief Data Officer
Dr. McDonald is a distinguished scientist and executive bringing more than 30 years’ experience in the biopharmaceutical industry. Prior to Odyssey, Dr. McDonald served as Executive Director of Machine-Learning and Physics-Based Simulation at BMS and Celgene. In previous roles at Celgene, Avila Therapeutics, and Pfizer, he led increasing roles of responsibility in computational chemistry, patent science, and chemical sample management. Dr. McDonald is also a co-author and inventor of more than 140 papers and applications. Dr. McDonald received his Ph.D. in Biophysics from Roswell Park Memorial Institute and completed postdoctoral studies in Computational Chemistry at Carnegie Mellon University.
Shifeng Pan, Ph.D., Executive Vice President, Head of Discovery
Dr. Pan is a leading medicinal chemist with more than 20 years’ experience. Prior to Odyssey, Dr. Pan served as the Executive Director of Discovery Chemistry at the Genomics Institute of the Novartis Research Foundation (GNF), where he oversaw GNF’s low molecular weight portfolio and all chemistry activities, including medicinal chemistry, chemical technologies, analytical chemistry, and DMPK. He led the discovery of ODOMZO, BRAFTOVI, and MAYZENT, and is the recipient of numerous awards for his accomplishments. Dr. Pan received his Ph.D. in Organic Chemistry from New York University and completed postdoctoral studies in Organic Chemistry at GNF.
David L. Pompliano, Ph.D., Co-Founder and Chief Innovation Officer
Dr. Pompliano is a drug discovery scientist, entrepreneur, and executive with more than 30 years’ experience in the biopharmaceutical industry. Before joining Odyssey, Dr. Pompliano co-founded and served as the Chief Scientific Officer of Revolution Medicines and Lodo Therapeutics, and served as the CEO of BioLeap. Prior to the biotech industry, he served as Worldwide Basic Head of Infectious Diseases at Merck and Vice President of Biology at GlaxoSmithKline, where he led drug discovery teams that produced pre-clinical credentials for more than 30 development candidates and five registered anti-infective and oncology drugs. Dr. Pompliano received his Ph.D. in Chemistry from Stanford University and completed postdoctoral studies in Enzymology and Molecular Biology at Harvard University.
Stephen Soisson, Ph.D., Executive Vice President, Structural Biology and Protein Therapeutics
Dr. Soisson is a leading structural biologist with more than 20 years’ drug discovery experience. Prior to Odyssey, Dr. Soisson served as the Executive Director and Global Head of Structural Chemistry and Structural Protein Sciences at Merck Research Laboratories (MRL) where he architected and oversaw Merck’s network-wide efforts to structurally enable all programs with three-dimensional molecular structures. During his tenure, the structure group contributed to the discovery of virtually all clinical candidates at MRL, including KEYTRUDA, BELSOMRA, and ISENTRESS. Dr. Soisson received his Ph.D. from Johns Hopkins School of Medicine and completed post-doctoral studies as a Damon Runyon-Walter Winchell Cancer Research fellow at Rockefeller University.
Odyssey’s board of directors includes:

Gary D. Glick, Ph.D., President and CEO, Odyssey Therapeutics
Carl L. Gordon, Ph.D., CFA, Managing Partner, OrbiMed Advisors
Jill Carroll, Partner, SR One Capital Management
Charles Baum, M.D., Ph.D., President, Founder, and Head of R&D, Mirati Therapeutics
Valerie Odegard, Ph.D., President and CSO, Silverback Therapeutics