On June 14, 2022 Dren Bio, Inc. ("Dren Bio" or the "Company") reported the completion of their $65 million Series B financing, pushing the Company’s total capital received to date over $156 million (Press release, Dren Bio, JUN 14, 2022, View Source [SID1234615961]). Following the financing, Dren Bio is well-capitalized to reach multiple key inflection points across both its drug discovery programs over the coming years.

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"We are truly grateful for all the support we continue to receive from such an outstanding syndicate of investors," said Nenad Tomasevic, Ph.D., Chief Executive Officer of Dren Bio. "This financing comes at the perfect time as we prepare to initiate the first clinical trial evaluating DR-01, our lead asset, in patients with Large Granular Lymphocytic leukemia or cytotoxic lymphomas in mid-2022. In addition to advancing DR-01, the proceeds from this latest round will also enable us to further expand the development of our internal pipeline using our proprietary Targeted Myeloid Engager and Phagocytosis Platform."

The Series B financing was co-led by Aisling Capital and HBM Healthcare Investments, with participation by new marquee investors Pfizer, ArrowMark Partners and Revelation Partners. There was also significant participation in the round by Dren Bio’s existing insiders SR One, 8VC, Taiho Ventures, BVF Partners, Mission BioCapital and Alexandria Venture Investments, amongst others. In connection with the closing of the financing, the Company announced that Andrew Schiff, M.D., of Aisling Capital, and Chandra P. Leo, M.D., of HBM Partners, will join its Board of Directors.

"We were thoroughly impressed by Dren Bio’s diversified R&D portfolio that encompasses two distinct therapeutic antibody programs including their attractive proprietary platform," said Dr. Schiff, Managing Partner at Aisling Capital. "We are excited by the opportunity to support Dren Bio in progressing on their mission to deliver revolutionary therapies to patients with severe unmet needs, starting with difficult-to-treat cancers."

Dr. Leo, of HBM Partners, added, "Over the last 18 months, Dren Bio has delivered robust preclinical data for their lead asset DR-01 and for their unique technology to induce myeloid cell engagement and phagocytosis. With this new financing, the Company is well positioned to rapidly advance DR-01 towards clinical proof-of-concept and to demonstrate the broad potential of their highly differentiated platform."

Proceeds from the financing will enable Dren Bio to continue advancement of its broad internal pipeline comprised of multiple development candidates approaching the clinic. The Company’s lead asset, DR-01, is designed to precisely eliminate a subset of immune cells which are the underlying cause of certain hematologic malignancies and well-defined autoimmune disorders, both of which will be evaluated using its current funding. Dren Bio’s position as an emerging leader in the antibody therapeutics space is further strengthened by the exceptional prospects of its Targeted Myeloid Engager and Phagocytosis Platform. Bispecific antibodies generated using the proprietary platform have been shown to produce effects that are well-differentiated from other competing technologies including T cell engagers, antibody-dependent cellular cytotoxicity ("ADCC") antibodies and antibody-drug conjugates. In addition to their profound and multi-pronged mechanism of action, initial development candidates have been very well tolerated in non-human primates, which should enable their utilization in both oncology and non-oncology indications. With its current funding, Dren Bio now has the opportunity to demonstrate the vast potential of its platform to produce therapies for a wide array of patients.

On June 14, 2022 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 May 2022 (Press release, Pacira Pharmaceuticals, JUN 14, 2022, View Source [SID1234615959]). EXPAREL net product sales were $44.9 million, compared with $41.2 million for May 2021. The company also reports average daily growth rates for EXPAREL to account for differences in the number of selling days per reporting period. EXPAREL average daily sales for the month of May 2022 were 104 percent of May 2021. The number of EXPAREL selling days were 22 in May 2022 and 21 in May 2021. Net product sales of iovera° were $1.1 million for the month of May 2022, compared with $1.0 million for May 2021.

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"EXPAREL utilization continues to expand and support the market’s transition to outpatient sites of care. Importantly, EXPAREL is consistently and significantly outperforming the elective surgery market’s recovery, which is facing pockets of persistent pandemic-related disruptions and labor shortages," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "In addition, ZILRETTA is performing well, with a steady increase in new users and more than 220 accounts added year-to-date. For iovera°, the broad rollout of our Generation-2 device is now underway, and we expect the product to return to more robust year-over-year growth later this year."

"Our state-of-the-art training facility in Tampa continues to broaden interest in all three products and accommodates the market’s growing demand for best-practice education around regional blocks.
With the established growth and long-term potential of our product portfolio, we remain highly confident in our outlook for strong revenue and earnings growth as we further cement our leadership position in non-opioid pain management," continued Mr. Stack.

Since early 2020, the company’s revenues have been impacted by COVID-19 and pandemic-related challenges that included the significant postponement or suspension in the scheduling of elective surgical procedures due to public health guidance and government directives. While the degree of impact has diminished during the course of the pandemic due to the introduction of vaccines and the lessening of elective surgery restrictions, certain pandemic-related operational challenges persist. It remains unclear how long it will take the elective surgery market to normalize or if restrictions on elective procedures will recur due to future COVID-19 variants or otherwise.

The company is not providing 2022 revenue or gross margin guidance at this time given the continued uncertainty around COVID-19 and the pace of recovery for the elective surgery market. To provide

greater transparency, the company is reporting monthly intra-quarter unaudited net product sales for EXPAREL and iovera° 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. 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. Pacira completed its acquisition of Flexion Therapeutics on November 19, 2021, which added ZILRETTA (triamcinolone acetonide extended-release injectable suspension) to its commercial offering.

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 second quarter or full year 2022.

On June 14, 2022 Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL), reported that the company invites investors, analysts, and media to a live-streamed R&D Event with a subsequent question and answer session on June 20 at 12:30 CEST (Press release, Isofol Medical, JUN 14, 2022, View Source [SID1234615958]).

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Isofol will shortly present top-line results from the multi-center, global Phase III AGENT study investigating arfolitixorin in combination with 5-FU, oxaliplatin and bevacizumab in advanced, metastatic colorectal cancer (mCRC). The purpose of the event is to provide investors, analysts, and media with a better understanding of the current treatment landscape; medical need for colorectal cancer patients; clinical, regulatory and market access demands; and an update on the AGENT study. Speaking at the R&D Event will be Isofol´s CEO Ulf Jungnelius MD, CMO/CSO Roger Tell MD, and Professor Sebastian Stintzing MD, Charité Universitätsmedizin, Division of Hematology, Oncology and Tumor Immunology. The event will be held in English.

Agenda for the R&D Event

The AGENT study – its design, patient population, endpoints, and an update including the current status of the study and upcoming topline results
The medical need for colorectal cancer patients
The current colorectal cancer treatment landscape and the clinical use of current treatments
Clinical, regulatory, and market access demands for introducing new treatments for colorectal cancer
Q&A-session
The event will be livestreamed and can be followed via a link that will be published on Isofol’s webpage shortly

Questions can be asked prior to the event by sending an email to [email protected] or during the webcast via a chat function. The webcast will also be available on demand on Isofol’s corporate website after the event.

Date and time
June 20, 2022, from 12:30-14:00 p.m. CEST

Webcast link
A link to the webcast will be published on Isofol’s webpage shortly.

On June 14, 2022 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported that it has advanced a partnership with Invicro LLC (Invicro), a global, industry-leading imaging CRO, and part of REALM IDx, Inc., to develop an artificial intelligence (AI) platform to accompany Telix’s PSMA-PET imaging agent, Illuccix (kit for the preparation of gallium Ga 68 gozetotide) – known as TelixAI (Press release, Immudex, JUN 14, 2022, View Source [SID1234615957]).

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TelixAI seeks to increase the efficiency and reproducibility of clinicians’ imaging assessments using advanced analysis capabilities with an initial focus on prostate cancer. The platform is designed to do this by automatically separating healthy versus abnormal tracer uptake and then classifies lesions as either visceral (soft tissue) or bone lesions.

Invicro has a depth of experience in AI, machine learning and algorithm development for medical imaging. Its industry leading medical image analyst team consists of over fifty medical image processing scientists. The commercial objective of the development partnership is the submission to the United States Food and Drug Administration (FDA) 510(K) approval for software as a medical device.

A demonstration of the TelixAI was presented this week at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting being held in Vancouver, BC from June 11-14.

Telix Chief Scientist, Dr. Michael Wheatcroft said, "We are pleased to be advancing the TelixAI platform with Invicro, which aims to further enhance the utility of molecular imaging starting with Illuccix. Our investment in TelixAI is expected to extend into multiple applications for Telix’s late-stage imaging assets, including TLX250-CDx, which is currently completing a Phase III pivotal trial in renal cancer imaging."

CEO of Invicro, Matt Silva, Ph.D., continued, "Invicro is delighted to bring our deep expertise in PET imaging, AI and machine learning and take this collaboration with Telix’s Research and Innovation team into the next stage. We are excited about the possibility of bringing this software to realization with Illuccix and for the potential impact on clinicians’ decision-making and patient outcomes with Telix’s broad theranostic pipeline."

On June 14, 2022 Almac Group, the global contract pharmaceutical development and manufacturing organisation, has today (Tuesday 14th June) reported its highest ever end-of-year results for revenue, profit, and employee numbers (Press release, Almac, JUN 14, 2022, View Source [SID1234615956]).

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In their financial results for year ending 30 September 2021, Almac recorded a £58 million (8.6%) rise in turnover from £677 million in 2020 to £735 million in 2021. Pre-tax profits were recorded at £81 million, up from £64 million (27.1% increase) for the same period the previous year.

The report also detailed an increase in Almac’s average employee figures from 5,466 to 5,783 (5.8%) during the period of October 2020 to September 2021. Current employee numbers for the Group now sits at over 6,500 and a current global recruitment drive will increase the total number to over 8,000 over the next three years, with over 1,000 of these new roles planned for Northern Ireland.

Privately owned Almac is committed to re-investing all profits back into its business and today announces a £200 million global capital investment plan to meet increased client demand over the next three years.

Investment will take place in existing Almac locations in Northern Ireland, other sites in the UK, Europe, North America and Asia.

Almac is at the forefront of developing, manufacturing, testing and distributing essential medicines to vulnerable patients around the world. During this financial year the group was involved in the development of over 300 life-saving drugs spanning more than 20 therapeutic areas including oncology, cardiology, immunology, gene therapy and neurology. Almac was also instrumental in supporting over 200 research projects for COVID-19 vaccines and treatments.

Alan Armstrong, Almac Group CEO, said: "I am hugely proud of our achievements in the last financial year. I am incredibly grateful to every one of our employees for their part in delivering these outstanding results as we continue our vital work developing life-saving and life-enhancing medicines for our clients and patients.

"Almac is committed to re-investing all our profit back into the business to ensure we are market leading for clients and offer the best possible work environment for our people.

"For our clients, we are investing £200 million on expansion to ensure we remain the global leaders in our industry and give them, and ultimately patients across the world who receive benefit from these therapeutics, the best possible offering from Almac."