Bristol Myers Squibb Announces Progress Toward Long-Term Inclusion & Diversity Goals and Health Equity Commitments

On March 15, 2023 Bristol Myers Squibb (NYSE: BMY) reported meaningful progress toward its global inclusion & diversity goals and health equity commitments, meeting and exceeding some goals ahead of schedule (Press release, Bristol-Myers Squibb, MAR 15, 2023, View Source;Diversity-Goals-and-Health-Equity-Commitments/default.aspx [SID1234628820]). In 2020, Bristol Myers Squibb (BMS) and the Bristol Myers Squibb Foundation, an independent charitable organization, each committed $150 million over five years, totaling $300 million to address health equity efforts by 2025.

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BMS and the Foundation are on track to achieve many of their respective goals and have exceeded some ahead of schedule. Progress against the four priority areas include:

Health Equity: BMS has made measurable progress against its goal to award $150 million to address health disparities. Nearly $100 million in distributed funding has reached more than 10 million people through programs and services. BMS is announcing $10 million in grants during 2023 to 17 U.S. organizations focused on addressing social determinants of health, including healthcare access and literacy to help close gaps and increase access to healthcare.
Increasing clinical trial diversity: In less than two years, more than half— 58%— of BMS’ clinical trial sites are now located in racially and ethnically diverse areas.This surpasses BMS’ initial goal of 25%. By embedding more clinical trial sites in diverse communities, BMS is helping enroll clinical trial populations that are more reflective of the broader patient populations and aligned with the epidemiology of the diseases we study.
Diversifying suppliers: BMS achieved its goal of spending $1 billion globally with diverse-owned businesses that create jobs and generate positive economic impact in diverse communities ahead of plan. This is against the company’s original goal to reach $1 billion in spending globally with diverse-owned businesses by 2025. Sustaining and building on this achievement will remain a priority. Investing in diverse suppliers enables BMS to close economic and healthcare gaps in diverse communities.
Diversifying company workforce: BMS has also made meaningful progress against the aspirational workforce representation goals announced in 2020, including the following:

More than doubled Black/African American executive (Vice President and above, VP+) representation in the U.S. to 6.1% from 3%, just exceeding the goal of reaching 6% by 2022

Increased the representation of global female executives (VP+) from 38.9% to 48.7%, nearly a 10% increase in two years, just below the goal of 50% by 2022

Increased the representation of Hispanic/Latino executives (VP+) in the U.S. from 3.7% to 6.1%, just below goal of 7.4% by 2022
BMS is announcing new aspirational workforce representation goals for Executive Directors and above (ED+) to strengthen our internal pipeline of talent and the next generation of leadership at BMS. These goals include:

Increase the representation of African/American Black leaders at the Executive Director level and above in the U.S. to 10% by end of 2025

Increase the representation of Hispanic/Latino leaders at Executive Director level and above in the U.S. to 11% by end of 2025
BMS achieved gender parity in the overall workforce population in 2015 and is close to achieving gender parity at the executive levels. Although BMS is not establishing forward-looking representation goals for employees who are female, Asian American and Pacific Islander, or employees that represent additional dimensions of diversity at this time, the company remains fully committed to the development, advancement and engagement of these groups. BMS believes this approach enables the company to engage a broader set of experiences, backgrounds and perspectives to drive equitable outcomes for all.

"Inclusion, diversity and health equity are not just our values; they are a critical driver of business performance with accountability owned by everyone," said Giovanni Caforio, M.D., Chairman of the Board and Chief Executive Officer, Bristol Myers Squibb. "Our expanded goals will enable us to drive a greater impact and build a more equitable future for our patients, colleagues, communities and industry."

"Our global inclusion, diversity and health equity goals are accelerating our progress towards integrating inclusive practices into processes, policies and systems to ensure we are addressing the root causes of inequity," said Pamela Fisher Chief Inclusion and Diversity Officer, Bristol Myers Squibb.

As part of the company’s health disparity commitments, the additional nearly $10 million in health equity grants will be dispersed among 17 U.S. nonprofit organizations in 2023. These organizations address social determinants of health across BMS’ key therapeutic areas, cardiovascular disease, hematology, oncology and immunology. These grants support various organizations working to improve health in the U.S. These organizations are developing and implementing innovative approaches and partnerships for addressing social determinants of health and integrating social care and healthcare to reduce health disparities.

The Foundation has also made significant progress against its goal to award $150 million to address health equity through a three-pronged approach. The Winn Award Program, established by the Foundation with a $100 million commitment, is currently training 114 early-stage investigator physicians, and it has provided an immersive experience in community-based clinical research to 44 medical students who will support the goals of advancing clinical research in underserved patient communities. The Foundation has awarded $45 million supporting thirty-two grants to advance health equity in cancer, cardiovascular disease, and immunology. The Foundation has also mobilized approximately $1 million in employee donations supporting social justice organizations.

BIO-TECHNE ANNOUNCES COMPLETION OF CELL AND GENE THERAPY CATAPULT PROCESS ANALYTICAL TECHNOLOGY (PAT) CONSORTIUM

On March 15, 2023 Bio-Techne Corporation (NASDAQ: TECH) reported it has completed its participation in the Cell and Gene Therapy Catapult Process Analytical Technology (Catapult PAT) consortium, a multi-year collaboration involving 24 partner companies, technology providers, therapy developers, and charities (Press release, Bio-Techne, MAR 15, 2023, https://investors.bio-techne.com/news/detail/358/bio-techne-announces-completion-of-cell-and-gene-therapy-catapult-process-analytical-technology-pat-consortium [SID1234628819]). The Catapult PAT consortium is the first initiative of this scale and functional expertise with member companies and organizations collaborating to develop cell and gene therapy-specific process analytical technologies.

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The PAT initiative began in January 2021 with a series of experiments designed to monitor process parameters of an exemplar 8-day T-cell expansion bioprocess using primary T-cells. Data were gathered from five independent analyses to generate an extensive, world-first dataset. An analysis of multiple cytokine targets was conducted using high-plex Luminex immunoassays and the precision multiplexing Ella platform from Bio-Techne. The automated workflow of the Ella platform proved to be particularly amenable to the efficiency, accuracy, and throughput demands inherent in a bioprocess manufacturing environment. With its robust performance in this project, the Cell and Gene Therapy Catapult plans to incorporate Ella into an existing CGT Catapult facility to further support scientists in the UK.

"As a leader in the forefront of innovative tools to measure cytokines, we are honored to be a part of the Catapult PAT initiative to help advance cell and gene therapy development," said Will Geist, President of Bio-Techne’s Protein Sciences Segment. "Bio-Techne remains excited about the potential of these advanced therapies to improve patient outcomes and treat a wide range of diseases that currently have very poor or ineffective treatments."

Established by Innovate UK, the Cell and Gene Therapy Catapult fosters collaborations between academia, industry, and healthcare providers to develop new technology and drive innovation. Catapult experts cover all aspects of advanced therapies, from research and development to clinical adoption and every step in between.

Alkermes to Participate in the Stifel 2023 CNS Days

On March 15, 2023 Alkermes plc (Nasdaq: ALKS) announced today that management will participate in a fireside chat as part of the Stifel 2023 CNS Days on Wednesday, March 29, 2023 at 9:00 a.m. ET (2:00 p.m. BST). The live webcast may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days (Press release, Alkermes, MAR 15, 2023, View Source [SID1234628817]).

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Kronos Bio Reports Recent Business Progress and Fourth-Quarter and Full-Year 2022 Financial Results

On March 15, 2023 Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, reported recent business progress and fourth-quarter and full-year 2022 financial results (Press release, Kronos Bio, MAR 15, 2023, View Source [SID1234628812]).

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"We have had an exciting start to 2023, with both the announcement of our discovery collaboration with Genentech and the dosing of our first patient in the expansion cohort of our Phase 1/2 study of KB-0742," said Norbert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio. "We look forward to building upon this strong momentum and sharing additional data from each of our clinical programs later this year and over the course of 2024. KB-0742 has the potential to help patients with a broad variety of solid tumors, and we anticipate reporting initial efficacy data from that program in the second half of this year. For lanraplenib, our Phase 1b/2 study in combination with gilteritinib seeks to address a significant unmet need in relapsed/refractory FLT3-mutated AML, and we anticipate providing initial data and a recommended Phase 2 dose later this year or early next year. We continue to focus on strong clinical execution as we work to bring innovative therapies to patients with cancer."

Fourth Quarter and Recent Company Updates

▪KB-0742

•In December 2022, Kronos Bio announced that it had selected the recommended phase 2 dose in its ongoing Phase 1/2 study of KB-0742 in solid tumors, after reaching the target engagement goal with an acceptable safety profile. The analysis further showed that KB-0742 continues to demonstrate a differentiated pharmacokinetic (PK) profile, with oral bioavailability, long half-life, and dose-proportional exposure across all four dose levels, and low to moderate variability between patients. The dose escalation portion of the study is continuing with the goal of identifying the maximum tolerated dose.
•The expansion portion of the trial is ongoing and includes Cohort A, for patients with MYC-amplified tumors, such as triple negative breast cancer, non-small cell lung cancer and ovarian cancer; and Cohort B, for patients with transcriptionally addicted cancers, including chordomas, sarcomas and small cell lung cancer. Both cohorts are enrolling, and in early 2023, the company dosed the first patient.
•Additional results from the dose escalation portion of the Phase 1/2 study and initial efficacy data from expansion portion are expected to be presented at a medical conference in the second half of 2023.

▪Lanraplenib

•In December 2022, the company presented preclinical data that demonstrated anti-leukemic activity of lanraplenib in combination with multiple targeted agents in patient-derived cell isolates and cell lines at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition. These data further support the biological rationale for SYK inhibition as a treatment for AML.
•Kronos Bio anticipates sharing initial data from the Phase 1b/2 study of lanraplenib in combination with gilteritinib in patients with relapsed/refractory FLT3-mutated acute myeloid leukemia (AML), along with a recommended Phase 2 dose (RP2D), in the fourth quarter of 2023 or first quarter of 2024.

▪Discovery Collaboration with Genentech

•In January 2023, Kronos Bio announced that it had entered into a discovery collaboration in the field of oncology with Genentech, a member of the Roche Group, focused on discovering and developing small-molecule drugs that modulate transcription factor targets selected by Genentech. Kronos Bio will lead discovery and research activities to a defined preclinical point when Genentech will have the exclusive right to pursue further preclinical and clinical development and commercialization.
▪Under the terms of the agreement, Kronos Bio received an upfront payment of $20 million and is eligible for additional payments, which could total up to $554 million, based on reaching certain milestones, including discovery, preclinical, clinical and commercial milestones, as well as tiered royalties on any potential products that are commercialized as a result of the collaboration.
Fourth-Quarter and Full-Year 2022 Financial Highlights

▪Cash, Cash Equivalents and Investments: With its ongoing and currently planned clinical programs and $247.9 million in cash, cash equivalents and investments as of December 31, 2022, the company anticipates sufficient resources to fund its planned operations into the second half of 2025. In January 2023, the Company entered into a Collaboration and License Agreement with Genentech, Inc., to initially collaborate on two discovery research programs in oncology. Pursuant to the Agreement, the Company received an upfront payment of $20.0 million from Genentech.

▪R&D Expenses: Research and development expenses were $23.2 million for the fourth quarter of 2022, which includes non-cash stock-based compensation expense of $3.6 million. For the full year of 2022, research and development expenses were $93.7 million, which includes non-cash stock-based compensation expense of $15.0 million.

▪G&A Expenses: General and administrative expenses were $10.5 million for the fourth quarter of 2022, which includes non-cash stock-based compensation expense of $4.1 million. For the full year of 2022, general and administrative expenses were $43.4 million, which includes non-cash stock-based compensation expense of $16.2 million.

▪Net Loss: Net loss for the fourth quarter of 2022 was $31.8 million, or $0.56 per share, including non-cash stock-based compensation of $7.7 million. Net loss for the full-year 2022 was $133.2 million, or $2.37 per share, including non-cash stock-based compensation expense of $31.1 million.

Alpine Immune Sciences to Report Fourth Quarter and Full Year 2022 Financial Results

On March 15, 2023 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, reported the Company will release fourth quarter and full year 2022 financial results on Thursday, March 23, 2023, after the close of market (Press release, Alpine Immune Sciences, MAR 15, 2023, View Source [SID1234628811]). The Company will host a corresponding conference call and live webcast at 4:30 p.m. ET/1:30 p.m. PT on the same day.

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Conference Call and Webcast Information

The link to the webcast will be available in the investor relations section of the Company’s website at View Source and a replay will be available on the Company’s website for 90 days following the live event.