On May 12, 2022 Morphic Therapeutic (Nasdaq: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, reported two key executive appointments. Dr. Bruce Rogers has been named President of Morphic Therapeutic and Dr. Blaise Lippa, has been named Chief Scientific Officer (Press release, Morphic Therapeutic, MAY 12, 2022, View Source [SID1234614397]). Dr. Rogers previously served as Morphic’s Chief Scientific Officer and Dr. Lippa served as Morphic’s Senior Vice President and Head of Molecular Discovery.

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"Bruce Rogers has been an invaluable leader on the team that built the MInT discovery platform and has been a tireless champion of a science-driven enterprise focused on patients," commented Praveen Tipirneni, MD, Chief Executive Officer of Morphic Therapeutic. "Bruce has the scientific expertise, strategic vision plus innate sense of teamwork to drive Morphic to greater success as we advance MORF-057 in clinical studies for inflammatory bowel disease while reaping the benefits of the MInT platform in additional indications. On behalf of the Board of Directors and the entire Morphic team, it is my great pleasure to congratulate him on the well-deserved appointment to President and I look forward to our continued partnership as Morphic grows in its mission to create integrin medicines."

"I am extremely humbled by the opportunity to lead the Morphic Team that has made such tremendous scientific and clinical achievements in our short history. I believe that we still have a great deal to accomplish, and my objective is to expand upon our culture of teamwork, collaboration, tenacity, and hypothesis-driven challenge that characterizes Morphic today in our efforts to bring integrin targeted medicines to patients," commented Bruce Rogers, President of Morphic Therapeutic.

"Blaise is a chemistry-driven drug designer first, who utilized his broader scientific skills to significantly contribute to the expansion of our MInT platform, enabling for Morphic a sustained ability to discover small molecule drugs against targets where only biologics had succeeded before," continued Bruce. "Expanding his role to lead all of discovery research is a recognition of his capabilities, talents, and contributions to Morphic."

Blaise Lippa commented, "MORF-057, the first wholly owned candidate generated by the MInT Platform, has achieved great success thus far. However, the integrin receptor family and the MInT Platform provide enormous opportunities to expand Morphic’s portfolio of therapeutic programs. I am honored to lead the efforts of the Research team as we continue to push scientific boundaries to create truly transformative medicines that broadly impact human health."

Bruce Rogers has served as Morphic’s Chief Scientific Officer since 2016. Prior to Morphic, Dr. Rogers was the Head of Neuro-Opportunities at Pfizer, where he led a team focused on entrepreneurial approaches to long standing CNS biology challenges. Bruce spent over 16 years in positions of increasing responsibility within the medicinal chemistry organization at Pfizer and Pharmacia, and during his time there led multiple discovery and early clinical development teams, with his group advancing over a dozen small molecule candidates into clinical trials. Bruce has co-authored more than 60 scientific publications, reviews and abstracts and is a co-inventor on over 80 patents and patent applications. He holds a BA in chemistry from the University of Minnesota and a PhD in organic chemistry from the University of California. He was a National Institutes of Health postdoctoral fellow at the University of California at Irvine prior to joining the pharmaceutical industry.

Blaise Lippa previously served as Morphic’s Senior Vice President of Molecular Discovery and was part of the founding team at Morphic. Prior to this, Blaise was a Senior Director of Medicinal Chemistry at Cubist Pharmaceuticals for seven years until the company’s acquisition by Merck. There he led teams that advanced
multiple compounds to the clinic and served on a development team that achieved an NDA. Blaise began his career at Pfizer nine years earlier, where he conducted advanced drug design in multiple therapeutic indications, and initiated a project that led to the approved drug Daurismo (glasdegib) for leukemia. Blaise is an author of over 60 publications and patents. Blaise holds dual BSc degrees in chemistry and molecular biology from the University of Michigan, and a PhD from Stanford University.

On May 12, 2022 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported its financial results for the quarter ended March 31, 2022 (Press release, Moleculin, MAY 12, 2022, View Source [SID1234614396]). The Company also provided an update on its portfolio of oncology drug candidates for the treatment of highly resistant tumors and viruses.

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"We have continued to make excellent progress across our entire pipeline since the start of 2022, paving the way for important data readouts throughout this year," commented Walter Klemp, Chairman and CEO of Moleculin. "Importantly, our clinical and regulatory strategies have expanded significantly outside of the U.S. and we recently bolstered the expertise of our leadership team to drive our EU clinical trials forward. Our development programs for Annamycin in STS lung mets and AML, as well as WP1122 for COVID-19 and GBM continue to advance. With the progress we’ve made and the milestones ahead, 2022 is poised to be an important year for not only providing more clarity for each clinical program’s path towards registration, but also an opportunity to unlock value for all stakeholders, and importantly, addressing unmet needs for people with highly resistant tumors and viruses."

Recent Highlights
Received required authorizations for an amendment to commence a Phase 1a clinical trial of WP1122 in the United Kingdom (UK) for the treatment of COVID-19.
Received allowance from the Polish Department of Registration of Medicinal Products (URPL), as well as the requisite Ethics Committee approval, to proceed with its Phase 1/2 clinical trial in Poland of Annamycin (L-ANN) in combination with Cytarabine (Ara-C) in the treatment of subjects with acute myeloid leukemia (AML) who are refractory to or relapsed after induction therapy.
Engaged Wolfram C. M. Dempke, MD, PhD, MBA as its European Chief Medical Officer and part-time contractor for its European clinical trials.
Received IND clearance to conduct Phase 1 study of WP1066 for the treatment of recurrent malignant glioma.
Presented preclinical data at the AACR (Free AACR Whitepaper) 2022 Annual Meeting demonstrating Annamycin exhibited robust antitumor activity in experimental colorectal cancer liver and lung metastasis models.
Launched new corporate branding and website.
Programs Update
Next Generation Anthracycline – Annamycin
Annamycin is the Company’s next-generation anthracycline that has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin, as well as demonstrating the ability to avoid the multidrug resistance mechanisms that typically limit the efficacy of doxorubicin and other currently prescribed anthracyclines. Importantly, Annamycin has also demonstrated a lack of cardiotoxicity in multiple human clinical trials, including ongoing trials for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases, and the Company believes that the use of Annamycin may not face the same usage limitations imposed on doxorubicin, one of the most common currently prescribed anthracyclines. Annamycin is currently in development for the treatment of AML and STS lung metastases and the Company believes it may have the potential to treat a number of additional indications.

Annamycin currently has Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of STS lung metastases, in addition to Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia.

For more information about the Phase 1b/2 study evaluating Annamycin for the treatment of STS lung metastases, please visit clinicaltrials.gov and reference identifier NCT04887298.

Upcoming Milestones Expectations
Q2 2022: Commence Phase 1/2 study in Europe for the treatment of AML evaluating combination therapy of Annamycin + Ara-C.
Q2 2022: Commencement of an investigator-funded, second Phase 1b/2 clinical trial of Annamycin in sarcoma lung metastases in Europe.
Q2 2022: Report topline data from Phase 1b portion of ongoing Phase 1b/2 study of Annamycin for the treatment of sarcoma lung metastases in the US.
Metabolism/Glycosylation Inhibitor – WP1122
WP1122, the Company’s lead metabolism/glycosylation inhibitor, is a prodrug of a well-known glucose decoy called 2-deoxy-D-glucose (2-DG), currently being developed by an unrelated third party in India for inhibition of viral replication and disease manifestations in humans infected with SARS-CoV-2, the virus responsible for COVID-19. The Company is also evaluating WP1122 for the treatment of Glioblastoma Multiforme (GBM). The mechanism of action of 2-DG includes both the inhibition of glycolysis and the disruption of glycosylation, two processes that are important to both viral activity and tumor development. WP1122 was developed as a 2-DG prodrug to provide a more favorable pharmacological profile, and was found to have greater potency than 2-DG alone in preclinical models where tumor cells require higher glycolytic activity than normal cells. WP1122 has also been shown to have a more potent antiviral effect than 2-DG against SARS-CoV-2 in MRC-5 cells (one of the most common human-derived cell lines used for antiviral research) in culture.

COVID-19

The Company has received authorization from the Medicines and Healthcare Products Regulatory Agency (MHRA) to commence a Phase 1a clinical trial of WP1122 in the United Kingdom (UK). The Company also received a favorable opinion from the London – Riverside Research Ethics Committee in the UK to begin the study, which is expected to be conducted at the Medicines Evaluation Unit in Manchester, United Kingdom. In May 2022, the Company received approval from both the Riverside Ethics Committee and the MHRA for its amended study protocol to update the dilution of the oral solution to achieve full dissolution of WP1122. No risk/benefit to the study was affected because of this change. The Phase 1a study in healthy human volunteers will investigate the effects of a single ascending dose (SAD) and multiple days of ascending dosing (MAD) of WP1122 administered as an oral solution. Dose escalation will take place in sequential SAD cohorts, and MAD will start as soon as SAD has completed at least 3 dosing cohorts in which WP1122 is found to be safe and well-tolerated. This study in healthy volunteers will explore safety and pharmacokinetics (PK), and subsequent clinical development will be in patients infected with SARS-CoV-2 to further evaluate safety and establish a favorable risk/benefit profile. The Company expects to enroll approximately 80 healthy volunteers in the United Kingdom.

Glioblastoma Multiforme

Additionally, Moleculin recently received IND clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 open label, single arm, dose escalation study of the safety, pharmacokinetics and efficacy of oral WP1122 in adult patients with GBM, which the Company expects to commence in 2022.

Upcoming Milestones Expectations
Q2 2022: Commence recruitment in Phase 1a study of WP1122 for the treatment of COVID-19 in the UK.
H2 2022: Potential to launch Phase 2 study of WP1122 for the treatment of COVID-19 outside of the US.
2022: Identify investigators interested in initiating a Phase 1 open label, single arm, dose escalation study of the safety, pharmacokinetics and efficacy of oral WP1122 in adult patients with GBM.
Ongoing preclinical development work in additional anti-viral indications such as HIV, Zika, and Dengue. Collaborations targeted for 2022.
Summary of Financial Results for the First Quarter 2022
Research and development (R&D) expense was $4.6 million and $4.1 million for the three months ended March 31, 2022 and 2021, respectively. The increase of $0.5 million is mainly related to increased clinical trial activity as described above, a license termination fee, and costs related to manufacturing of additional drug product.

General and administrative expense was $2.4 million and $1.9 million for the three months ended March 31, 2022 and 2021, respectively. The increase of $0.5 million is mainly related to an increase in regulatory legal services, consulting and advisory fees.

For the three months ended March 31, 2022 and 2021, the Company reported a net loss of $6.9 million and $4.4 million, respectively, and had net cash flows used in operating activities of $4.8 million and $3.6 million, respectively.

The Company ended the quarter with $66.1 million of cash. The Company believes that this cash is sufficient to meet its projected operating requirements, which include a forecasted increase over its current R&D rate of expenditures, into 2024.

On May 12, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that six abstracts demonstrating the ability of its genomic and immuno-oncology diagnostic tests and technology to improve outcomes for cancer patients will be shared at the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Veracyte, MAY 12, 2022, View Source [SID1234614395]). The meeting will take place in person and virtually from June 3-7, in Chicago.

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"The findings being presented at the ASCO (Free ASCO Whitepaper) annual meeting expand the performance and utility data for our clinical tests, while demonstrating the role our novel immuno-oncology offerings may play in advancing new frontiers in personalized medicine," said Marc Stapley, Veracyte’s chief executive officer. "We are especially excited to present new data focused on determining which patients with metastatic non-small cell lung cancer may benefit from immune checkpoint inhibitors – an important clinical need that is not being met with current biomarker testing."

On May 12, 2022 Purple Biotech Ltd. ("Purple Biotech", or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies by overcoming tumor immune evasion and drug resistance, reported financial results for the first quarter ended March 31, 2022 (Press release, Purple Biotech, MAY 12, 2022, View Source [SID1234614394]).

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"We were focused in the clinical advancement of our promising first in class oncology drug candidates during this quarter," said Gil Efron, President and Chief Financial Officer of Purple Biotech. "For NT219, we completed enrollment in the fourth dose level of the monotherapy arm of the ongoing Phase 1/2 clinical trial and will soon start the last dose level planned in the dose escalation part of the monotherapy arm. For CM24, we will soon initiate the expansion arms of the study. We had $42.2 million in cash, cash equivalent, short and long-term deposits at the end of the first quarter this year and we are well positioned to execute our plans."

Financial Results for the Three Months Ended March 31, 2022

Research and Development Expenses were $6.0 million, an increase of $1.1 million, or 22%, compared to $4.9 million in the same period of 2021. The increase was mainly due to CMC expenses in support of our clinical studies.

Sales, General and Administrative Expenses were $1.4 million, compared to $1.7 million in the same period of 2021, a decrease of $0.3 million. The decrease was mainly due to a decrease in employee equity-based compensation (ESOP) costs.

Operating Loss from continuing operations was $7.3 million, an increase of $0.8 million, or 12%, compared to $6.5 million in the same period of 2021.

On a non-IFRS basis (as reconciled below), adjusted operating loss was $7.0 million, an increase of $1.2 million, compared to $5.8 million in the same period of 2021, mainly due to a decrease in Selling, General and Administrative expenses offset by an increase in R&D expenses.

Net Loss for the first three months ended March 31, 2022 was $7.3 million, or $0.41 per basic and diluted ADS, compared to a net loss of $6.6 million, or $0.38 per basic and diluted ADS, in the same period of 2021. The increase in net loss was mainly due to an increase of $0.8 million in operating expenses. Adjusted net loss for the first three months ended March 31, 2022 was $7.0 million, an increase from $5.8 million in the first three months ended March 31, 2021.

During the three months ended March 31, 2022, the Company sold, under the Open Market Sale Agreementsm with Jefferies LLC, approximately 59 thousand ADSs, at an average price of $3.932 per ADS. Net proceeds to the Company, were approximately $0.22 million, net of issuance expenses.

On May 12, 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 April 2022 (Press release, Pacira Pharmaceuticals, MAY 12, 2022, View Source [SID1234614393]). EXPAREL net product sales were $44.8 million, compared with $43.1 million for April 2021. EXPAREL average daily sales for the month of April 2022 were 109 percent of April 2021. 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 21 in April 2022 and 22 in April 2021. Net product sales of iovera° were $1.1 million for the month of April 2022, compared with $1.5 million for April 2021.

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"We are pleased to report solid EXPAREL growth as we support the market transition to outpatient sites of care, with utilization expanding and significantly outperforming the elective surgery market amidst pockets of persistent operating disruptions and healthcare labor shortages," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "ZILRETTA and iovera° are gaining traction and we expect improving sales trends for both products as the year progresses and we build awareness around their value as both complementary and standalone non-opioid solutions for managing osteoarthritis. Importantly, we continue to execute from a position of financial strength having recently reported adjusted EBITDA of $53.8 million in the first quarter of 2022 and having ended the first quarter with a significant cash position. As such, we remain highly confident in our outlook for robust revenue and earnings growth as we cement our leadership position and deliver patients innovative, non-opioid solutions along the neural pain pathway."

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 financial 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.