On May 10, 2022 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported first quarter 2022 financial results and recent portfolio updates (Press release, SQZ Biotech, MAY 10, 2022, View Source [SID1234614125]).

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"Our year is off to an exciting start with the FDA IND clearance to initiate clinical trials of our eAPCs – our multifunctional mRNA-based investigational cell therapy that targets solid tumors by engineering multiple T cell signals simultaneously," said Armon Sharei, Ph.D., Chief Executive Officer and Founder at SQZ Biotechnologies. "We were also delighted by the recent FDA Fast Track Designation for our lead APC clinical candidate, which had promising clinical results in 2021, providing the potential to accelerate its registrational path. We look forward to continued progress on the evolution of our technology platform and unique therapeutic pipeline with anticipated clinical data across our APC, eAPC, and AAC trials in the second half of this year."

First Quarter 2022 and Recent Portfolio Updates

SQZ Antigen Presenting Cell ("APC") Platform in Oncology

Granted FDA Fast Track Designation for lead cell therapy candidate SQZ-PBMC-HPV; the designation is designed to accelerate the development and review of treatments for serious or life-threatening diseases
Published peer reviewed preclinical research supporting the development of SQZ APC cancer vaccine therapeutic programs in the Journal of Immunology
Continued enrollment of high dose monotherapy and combination with checkpoint inhibitors in the Phase 1/2 trial of SQZ-PBMC-HPV
SQZ Enhanced Antigen Presenting Cell ("eAPC") Platform in Oncology

Received FDA IND clearance to initiate a Phase 1/2 clinical trial (COMMANDER-001) of the first eAPC therapeutic candidate in patients who have HPV16+ solid tumors
Initiated enrollment of monotherapy stage of the COMMANDER-001 trial
SQZ Activating Antigen Carriers ("AAC") Platform in Oncology

Continued enrolling and opening additional sites for the monotherapy stage of the ENVOY-001 Phase 1/2 (SQZ-AAC-HPV-101) trial
SQZ Tolerizing Antigen Carriers ("TAC") Platform in Immune Tolerance

Published peer reviewed preclinical research in Frontiers in Immunology supporting potential SQZ TAC platform therapeutic development across a variety of complex autoimmune diseases
Progressed studies supporting anticipated TAC IND submission for celiac disease in the first half of 2023; company’s point-of-care manufacturing system intended to produce clinical batches
SQZ Potential Pipeline Expansion Research

Awarded $2 million grant from the National Institutes of Health that will support the development of cell engineering methods to reprogram immune cells directly into dopamine-producing neurons as a potential novel therapeutic approach for the treatment of Parkinson’s disease
First Quarter 2022 Financial Highlights

Revenue for the quarter ended March 31, 2022, was $2.9 million compared to $5.5 million for the same period in 2021
Research and development expenses for the quarter ended March 31, 2022, were $17.0 million compared to $14.7 million for the same period in 2021; the increase was primarily due to higher development and manufacturing costs associated with our clinical-stage product candidates, as well as increased personnel-related costs to support continued progress with the Company’s pipeline
General and administrative expenses for the quarter ended March 31, 2022, were $6.9 million compared to $6.1 million for the same period in 2021; the increase was primarily due to higher personnel and other corporate-related costs, including stock-based compensation expense and other costs related to operating as a public company
Net loss for the quarter ended March 31, 2022, was $21.0 million, compared to $15.4 million for the same period in 2021
As of March 31, 2022, the Company had cash and cash equivalents of $122.9 million and anticipates this will be sufficient to fund operating expenses and capital expenditure requirements into the second half of 2023

On May 10, 2022 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), a leading global pharmaceutical company providing medicines to nearly 200 million people daily, reported that published its 2021 ESG Progress Report (Press release, Teva, MAY 10, 2022, View Source [SID1234614141]). The report details how Teva further integrated ESG into its business strategy—implementing a strengthened ESG governance structure and setting 13 ambitious targets related to access to medicines, ethics, environment and responsible supply chain, some of which are now linked to the company’s financing strategy and executive compensation.

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"As one of the world’s largest manufacturers of generic medicines, ESG is integral to the long-term strategy of our company and is part of everything we do," said Kåre Schultz, President & CEO of Teva. "Our ESG Progress Report details our actions in 2021, which include issuing a $5 billion sustainability-linked bond, tying our financing strategy to access to medicines and environmental targets. We are in a unique position to help create a healthier future, bringing our essential medicines within reach for more people and reinforcing business integrity through our compliance and ethics policies and trainings."

This year’s ESG Progress Report offers a comprehensive view of ESG at Teva, with new disclosures related to scope 3 emissions, pay equity and the company’s responsible supply chain, and continues to align with leading reporting standards—the Global Reporting Initiative (GRI), Sustainability Accounting Standards Board (SASB) and Task Force on Climate-Related Financial Disclosures (TCFD).

The ESG Progress Report shares Teva’s progress, including:

Integrating ESG further into the business with a $5 billion sustainability-linked bond (SLB): Upon issuance, Teva’s SLB was the largest in the world, the first in the pharmaceutical industry linked to both social and environmental targets and the first from a generic medicines company. The SLB holds Teva accountable to reducing scope 1 and 2 GHG emissions by 25% and increasing access to essential medicines for patients in low- and middle-income countries (LMICs) by 150% by the end of 2025.
Making medicines available and accessible to those who need them: Teva has launched four access to medicines programs to-date, 50% of its 2025 target, including an expanded partnership with Direct Relief and Global HOPE to provide critical treatments for children with cancer and blood disorders across sub-Saharan Africa and new programs in France, Israel and Ghana. Last year, the company also had 585 marketing authorizations approved in LMICs and donated more than $487 million worth of medicines.
Minimizing environmental impact across Teva’s business and value chain: Since 2019, Teva has reduced its scope 1 and 2 GHG emissions by 13%, more than half of its 2025 target. Since 2020, the company also reduced its scope 3 GHG emissions by 5% (20% of 2030 target), increased its total proportion of energy from renewable sources by 4% (to 33%) and improved energy efficiency by 6%. In this same timeframe, it achieved an 8% reduction in both waste from operations and water withdrawal in areas projected to be in water stress.
Fostering an inclusive workplace: Last year, the representation of women in executive and senior management positions at Teva increased by 1.8%. The company also trained nearly 90% of employees on how to foster an inclusive culture.
Promoting ethics and operating with integrity: Teva trained more than 20,000 employees (99.6% of those assigned) on ethics. The company published three new position statements outlining its stance on patient safety, responsible supply chain and risk management. Teva was also ranked in the top 1% in the EcoVadis sustainable procurement assessment as a result of its efforts to make more responsible decisions regarding supply chain partners.
Teva’s ESG performance continues to improve across key rating indices—including S&P Global, ISS ESG, EcoVadis and FTSE4Good—which listed Teva among the top 10-20% of companies in its industry in 2021.

On May 10, 2022 Iktos, a company specialized in Artificial Intelligence (AI) for new drug design and Sygnature Discovery, a leading integrated drug discovery CRO headquartered in Nottingham, UK, with expertise across a range of therapeutic and biological target classes reported a collaboration agreement in AI for new drug design (Press release, Iktos, MAY 10, 2022, View Source [SID1234614046]).

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Under the 3-year agreement, Sygnature will deploy Iktos’ de novo generative design software Makya, which will be used by Sygnature scientists to facilitate rapid and efficient design of novel compounds and accelerate hit-to-lead/lead optimisation, reinforcing Sygnature Discovery’s drug design expertise delivering its integrated drug discovery solutions to its world-wide customer base.

In the recent years, Iktos has emerged as one of the world leaders in AI for drug design, establishing multiple collaborations with renowned pharmaceutical companies and successfully developing the AI software platforms Makya for new drug design and Spaya for synthesis planning.

Makya, a generative AI-driven de novo design software for Multi-Parametric Optimization (MPO), is available either as a SaaS platform or for implementation on customer premises or in the customer’s Virtual Private Cloud (VPC). Makya’s user-friendly interface enables it to be used by medicinal or computational chemists, and Makya can also be operated as a Python package through a Jupyter notebook interface. Makya is based on Iktos’ generative AI technology, which helps bring speed and efficiency to the drug discovery process by automatically designing virtual novel molecules that have desired activities for treating a given disease. It is a novel solution, validated through many collaborations, to one of the key challenges in drug design: the rapid identification of molecules that simultaneously satisfy multiple parameters, such as potency, selectivity, safety, and project-specific properties.

Sygnature Discovery serves its growing customer base with fully integrated drug discovery services from target validation through to preclinical candidate selection. The company has a relentless focus on quality and continually looks to improve on its ability to deliver novel therapeutics to the clinic.

Colin Sambrook-Smith, Director of Computational Sciences at Sygnature Discovery commented:

"Late stage lead optimisation projects routinely generate substantial data sets which are ideally placed for exploitation by AI and Machine Learning technologies. Our experience with the Iktos Makya AI/ML technology demonstrates that it generates high quality compound ideas, the QSAR models can be rapidly updated, and the interface allows us to distribute the software broadly and quickly. We believe that Makya will allow us to blend our proven medicinal and computational chemistry expertise with the benefit of AI/ML technologies to impact compound design. This is why we have selected Makya to enhance how we help our customers with their lead optimisation projects, with a view to reducing the number of compounds required to identify pre-clinical candidates and so keep overall costs and timelines down."

"We are very pleased to collaborate with Sygnature Discovery, they truly are a leading integrated drug discovery CRO and with a great track record. We are excited and proud to announce our first multi-year collaboration deal in the dynamic CRO sector and to have Sygnature’s scientists use our software to speed up their customers’ discovery programs," said Yann Gaston-Mathé, Co-founder and CEO of Iktos. "We are more than ever committed to make our technology available to biopharma companies around the world and maximize the impact of AI on the productivity of drug discovery."

On May 10, 2022 Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) reported financial results for its fiscal second quarter ended March 31, 2022 (Press release, Arrowhead Research Corporation, MAY 10, 2022, View Source [SID1234614078]). The company is hosting a conference call today, May 10, 2022, at 4:30 p.m. ET to discuss the results.

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Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 3791265.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 3791265.

Selected Recent Events

Initiated the PALISADE Phase 3 clinical study to evaluate the efficacy and safety of ARO-APOC3, Arrowhead’s investigational RNA interference (RNAi) therapeutic designed to inhibit the production of apolipoprotein C-III (APOC3), a key regulator of triglyceride metabolism, in adults with familial chylomicronemia syndrome
Completed enrollment of 204 patients in the Phase 2b ARCHES-2 clinical study of ARO-ANG3, our investigational medicine designed to reduce production of angiopoietin-like protein 3 ANGPTL3 as a potential treatment for patients with mixed dyslipidemia
ARCHES-2 is expected to be complete around the end of 2022 and topline data are anticipated to be available in the first half of 2023
Initiated the Phase 2 GATEWAY clinical study of ARO-ANG3, Arrowhead’s investigational medicine designed to silence the hepatic expression of angiopoietin-like protein 3 (ANGPTL3), in patients with homozygous familial hypercholesterolemia (HoFH)
Initiated a Phase 1/2 study of ARO-C3, Arrowhead’s investigational medicine designed to reduce production of complement component 3 (C3) as a potential therapy for various complement mediated diseases, in up to 24 adult healthy volunteers, up to 24 adult patients with paroxysmal nocturnal hemoglobinuria (PNH), and up to 14 adult patients with complement-mediated renal disease
Filed Clinical Trial Applications (CTA) requesting regulatory clearance to begin clinical studies for two new investigational medicines designed to treat various muco-obstructive and inflammatory pulmonary conditions
ARO-MUC5AC, an investigational RNAi therapeutic designed to inhibit the production of mucin 5AC (MUC5AC)
ARO-RAGE, an investigational RNAi therapeutic designed to inhibit the production of Receptor for Advanced Glycation End products (RAGE)
Formed a joint venture, Visirna Therapeutics, with Vivo Capital to expand the reach of innovative medicines in Greater China
Broke ground on construction of a new drug manufacturing facility and announced awards of up to $18.5 million in tax incentives from the city of Verona and the Wisconsin Economic Development Corporation

On May 10, 2022 Bio-Techne Corporation (NASDAQ:TECH) reported that Exosome Diagnostics, a Bio-Techne brand, will have a major scientific presence at the annual American Urological Association Conference (AUA) taking place May 13-16 in New Orleans, LA (Press release, Bio-Techne, MAY 10, 2022, View Source [SID1234614094]). Exosome Diagnostics will have two poster presentations, including a podium presentation, six in-booth scientific presentations, and a live symposium with American icon, National Baseball Hall of Famer, and former Baltimore Orioles player "Iron Man" Cal Ripken, Jr. with leading urologist, Dr. Ronald Tutrone of Medical Director of Clinical Research at Chesapeake Urology in Baltimore, Maryland.

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Scientific presentations include:

A Combined Biomarker/mpMRI Approach Provides Enhanced Clinical Information Prior to Prostate Biopsy by Dr. Alexander Kretschmer et al. on Friday, May 13, 2022, 1:00 pm – 3:00 pm, Room 245, Ernest N. Morial Convention Center

Development of Exosome-based Plasma RNA Biomarkers for High-Risk Prostate Cancer by Dr. Sandra Gaston, et al. on Saturday, May 14, 2022, 10:30 am – 11:45 am, Room 222, Ernest N. Morial Convention Center

Validation of a urinary exosome mRNA signature for the diagnosis of human kidney transplant rejection by Dr. Rania El Fakih on Sunday, May 15, 2022, 7:00 am – 8:15 am, Room 228, Ernest N. Morial Convention Center

Exosome’s Chief Scientific Officer, Dr. Johan Skog, will lead the in-booth scientific presentation series with recently published results of the association of the ExoDx Prostate (EPI) test with post-prostatectomy outcome. Additional presentations include results of the ExoDx Prostate test clinical utility study as well as a 2.5 year follow-up and interim analysis of subjects who participated in the study and will conclude with the combined performance of the ExoDx Prostate test and MRI in the early detection of prostate cancer.

Cal Ripken, Jr. returns to partner with Exosome Diagnostics and Bio-Techne as an ambassador and advocate of the ExoDx Prostate test, which became part of Cal’s own prostate cancer journey. During his live appearances at the AUA, Cal will use his high-profile platform and strong reputation among men in his age group to raise awareness of the importance of early detection of prostate cancer.

"We are so pleased to have a robust scientific presence at the AUA, and excited to continue our campaign with an American baseball legend, Cal Ripken, Jr.," stated Kim Kelderman, President of Diagnostics and Genomics Segment of Bio-Techne. "Cal is a great example of the powerful role our ExoDx Prostate test plays in the prostate cancer journey. We look forward to continuing to provide this important tool to the millions of men and their families who are facing difficult choices in the management of this disease."

One in nine American men will be diagnosed with prostate cancer during his lifetime. Prostate cancer (PCa) is the second leading cause of cancer death among American men and is the most commonly diagnosed cancer. The American Cancer Society estimates that 268,000 men will be diagnosed with prostate cancer in 2022 and projects that ~34,000 men will die from the disease. Currently, nearly 3.6 million American men are living with the disease – only slightly less than the population of Los Angeles.

The EPI test is a urine-based genomic test that helps inform the prostate biopsy decision. This liquid biopsy test has a positive coverage decision from Medicare and is included in the National Comprehensive Cancer Network (NCCN) guidelines for early detection of prostate cancer in men for both initial and repeat biopsy. It is performed by Exosome Diagnostics in its CLIA, ISO, NY certified and CAP-accredited laboratory located in Waltham, Massachusetts. The EPI test is a risk assessment tool that assists physicians and their patients with determining if a prostate biopsy is needed when presented with an ambiguous PSA test result, thereby reducing complications from unnecessary and invasive procedures. The ExoDx Prostate is the leading test for at-home collection, enabling thousands of patients unable to travel to their healthcare professional for a routine office visit to assess prostate cancer risk.