On March 15, 2023 EpicentRx, a leading edge, clinical stage biopharmaceutical company, reported publication of results in the well-respected, international journal, Frontiers in Immunology, from a small 12 patient, 12-week, open label Phase 1 clinical trial called PRIMETIME (NCT02518958) (Press release, EpicentRx, MAR 15, 2023, View Source [SID1234628823]).

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PRIMETIME was a pilot study to evaluate the safety of RRx-001 and nivolumab in patients with advanced checkpoint inhibitor non-responsive tumors and no standard options. RRx-001 reprograms tumor associated macrophages (TAMs), which normally aid, and abet cancer cells, to go on the attack against them. The presence of TAMs in tumors is responsible for resistance to the anticancer effects of checkpoint inhibitors like nivolumab. This was the basis to combine RRx-001 and nivolumab since the addition of RRx-001 may drive efficacy in tumor types where checkpoint blockade monotherapy is traditionally ineffective.

The combination treatment was well tolerated with no dose limiting toxicities and demonstrated an unconfirmed response rate of 25% and a disease control rate of 67% across four different dose levels in 12 heavily pre-treated patients with non-immunogenic tumor types. The main side effect due to RRx-001 was infusion related discomfort (33%). The main "side effect" from the combination of RRx-001 and nivolumab, which is probably not really a side effect at all, was pseudoprogression (25%). This describes an apparent increase of tumor size on imaging due to immune cell infiltration in the absence of actual tumor progression.

Dr. Tony Reid, EpicentRx CEO and manuscript lead author, commented that "this was a 12 patient, limited duration study so the usual caveats apply with such a small sample size that was treated for such a short time. However, checkpoint inhibitors are only beneficial in a small subset of patients with particular tumor types like melanoma. In other so-called "cold" tumor types like pancreatic and prostate they aren’t effective at all. Because RRx-001 revs up TAMs to attack tumor cells, it may succeed where other drugs have not to sensitize these otherwise poorly immune checkpoint sensitive cancers, which is exciting."

About RRx-001
The lead EpicentRx small molecule, RRx-001 is a highly selective NLRP3 inhibitor with vascular normalization and tumor associated macrophage polarization properties that resensitizes tumors to previously administered therapies. RRx-001 is under investigation in a Phase 3 trial for the treatment of small cell lung cancer (SCLC), and in a Phase 2 trial for protection against oral mucositis in first line head and neck cancer. It is also under development as a treatment for neurodegenerative diseases like Parkinson’s and ALS/MND.

On March 15, 2023 Champions Oncology, Inc. (Nasdaq: CSBR), a leading global technology-enabled biotech that is transforming drug discovery through innovative AI-driven pharmaco-pheno-multiomic integration, reported its financial results for its third quarter of fiscal 2023, ended January 31, 2023 (Press release, Champions Oncology, MAR 15, 2023, View Source [SID1234628822]).

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Third Quarter and Recent Highlights:

•Record quarterly bookings
•Quarterly revenue of $12.8 million
•Adjusted EBITDA loss of $1.6 million, driven by a $1 million increase in R&D for our target discovery program
•Commenced in-vivo efficacy testing for therapeutic hits on lead programs

Ronnie Morris, CEO of Champions, commented, "Our third quarter results were weaker than we’ve been accustomed to delivering, impacted primarily by the macro-economic environment. Despite the financial performance, we continued to expand our platform and invest in on our drug discovery efforts." Morris added, "Our long-term strategy remains in-tact and we look forward to improving results in fiscal 2024."

David Miller, CFO of Champions, added, "As addressed last quarter, an increase in first half study cancellations would lead to a decline in third quarter revenue and profitability. We’re well positioned to absorb the short-term decline and remain positioned for the expected increase in bookings and revenue heading into fiscal 2024."

Third Fiscal Quarter Financial Results

Total revenue for the third quarter of fiscal 2023, was $12.8 million, a decrease of 3.2%, compared to $13.2 million for the same period last year. The decline in revenue resulted from an increase in cancellations during the first half of the year due to the macro-economic environment, which caused our customers to re-evaluate their spending budgets. Total costs and operating expenses for the third quarter of fiscal 2023 were $15.2 million compared to $12.4 million for the third quarter of fiscal 2022, an increase of $2.9 million or 23.2%.

For the third quarter of fiscal 2023, Champions reported a loss from operations of $2.5 million, including $331,000 in stock-based compensation and $575,000 in depreciation and amortization expenses, compared to income from operations of $830,000, inclusive of $310,000 in stock-based compensation and $396,000 in depreciation and amortization expenses, in the third quarter of fiscal 2022. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported an adjusted EBITDA loss for the quarter of $1.6 million, primarily driven by lower revenue and an increase in R&D spending for our target discovery program, compared to adjusted EBITDA of $1.5 million in the prior year period.
Cost of oncology solutions was $7.7 million for the three-months ended January 31, 2023, an increase of $1.3 million, or 20.2% compared to $6.4 million for the three-months ended January 31, 2022. The increase in cost of sales was primarily from compensation expenses. For the three-months ended January 31, 2023, total gross margin was 40% compared to 51% for the three-months ended January 31, 2022. The lower margin resulted from the aforementioned increase in compensation which was incurred to support the bookings growth that failed to convert to revenue due to cancellations.

Research and development expense for the three-months ended January 31, 2023 was $3.2 million, an increase of $1.0 million or 46.8%, compared to $2.2 million for the three-months ended January 31, 2022. The increase was primarily from compensation and lab supply expenses related to the investment in our therapeutic discovery platform. Sales and marketing expense for the three-months ended January 31, 2023 was $1.8 million, an increase of $212,000, or 13.7%, compared to $1.5 million for the three-months ended January 31, 2022. The increase was primarily due to an increase in compensation and conference expenses to support sales effort expansion. General and administrative expense for the three-months ended January 31, 2023 was $2.6 million, an increase of $342,000, or 15.4%, compared to $2.2 million for the three-months ended January 31, 2022. The increase was primarily due to depreciation and amortization expenses and IT related costs to support the growth of the business.

Net cash provided by operating activities was $1.6 million for the three months ended January 31, 2023. The cash generated from operating activities was primarily due to a decrease in accounts receivable, in the ordinary course of business, and an increase in deferred revenue due to solid bookings. The Company ended in the quarter in a strong cash position with cash on hand of $11.6 million and no debt.

Year-to-Date Financial Results

For the first nine months of fiscal 2023, revenue increased 12.6% to $40.8 million compared to $36.2 million for the first nine months of fiscal 2022. The increase in revenue was due to the expansion of our platforms and business lines. Total costs and operating expenses for the first nine months of fiscal 2023 were $43.5 million compared to $35.3 million for the first nine months of fiscal 2022, an increase of $8.2 million or 23.3%.

For the first nine months of fiscal 2023, Champions reported a net loss from operations of $2.7 million, including $656,000 in stock-based compensation and $1.7 million in depreciation and amortization

expenses, compared to income from operations of $918,000, inclusive of $724,000 in stock-based compensation and $1.1 million in depreciation and amortization expenses, in the first nine months of fiscal 2022. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported an adjusted EBITDA loss of $400,000 for the first nine months of fiscal 2023 compared to adjusted EBITDA of $2.7 million in the first nine months of fiscal 2022.

Cost of oncology solutions was $22.2 million for the nine-months ended January 31, 2023, an increase of $4.8 million, or 27.5% compared to $17.4 million for the nine-months ended January 31, 2022. The increase in cost of sales was primarily from compensation, mice and lab supply expenses resulting from the increase in study volume and expected strength in future bookings. For the nine-months ended January 31, 2023, total gross margin was 45.6% compared to 51.9% for the nine-months ended January 31, 2022. For the same respective periods, pharmacology services margin was 48.1% vs 53.0%. The decrease in gross margin was primarily attributable to an increase in study related expenses on lower than expected revenue conversion.

Research and development expense for the nine-months ended January 31, 2023 was $8.7 million, an increase of $1.9 million or 28.2%, compared to $6.8 million for the nine-months ended January 31, 2022. The increase was primarily from compensation, sequencing costs, and lab supplies as we increased investment in our therapeutic target discovery platforms. Sales and marketing expense for the nine-months ended January 31, 2023 was $5.2 million, an increase of $389,000, or 8.2%, compared to $4.8 million for the nine-months ended January 31, 2022. The increase was primarily due to an increase in compensation and conference related expenses to support the expansion of our sales efforts. General and administrative expense for the nine-months ended January 31, 2023 was $7.5 million, an increase of $1.1 million, or 17.9%, compared to $6.4 million for the nine-months ended January 31, 2022. The increase was primarily due to an increase in compensation and IT related expenses to support the overall infrastructure growth of the organization as well as depreciation and amortization expenses.

Net cash provided by operating activities was $4.7 million for the nine-months ended January 31, 2023. The cash generated from operating activities was primarily due to a decrease in accounts receivable and an increase in accounts payable due to timing differences in the ordinary course of business. Net cash used in investing activities was $2.1 million and was primarily from investment in additional lab and computer equipment.

Conference Call Information:
The Company will host a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT) to discuss its third quarter financial results. To participate in the call, please call 888-506-0062 (Domestic) or 973-528-0011 (International) and enter the access code 500542, or provide the verbal reference "Champions Oncology".
Full details of the Company’s financial results will be available by March 17, 2023 in the Company’s Form 10-Q at www.championsoncology.com.
* Non-GAAP Financial Information
See the attached Reconciliation of GAAP net income (loss) to Non-GAAP net income (loss) for an explanation of the amounts excluded to arrive at Non-GAAP net income (loss) and related Non-GAAP earnings (loss) per share amounts for the three and nine months ended January 31, 2023 and 2022. Non-GAAP financial measures provide investors and management with supplemental measures of operating

performance and trends that facilitate comparisons between periods before and after certain items that would not otherwise be apparent on a GAAP basis. Certain unusual or non-recurring items that management does not believe affect the Company’s basic operations do not meet the GAAP definition of unusual or non-recurring items. Non-GAAP net income (loss) and Non-GAAP earnings (loss) per share are not, and should not, be viewed as a substitute for similar GAAP items. Champions defines Non-GAAP dilutive earnings (loss) per share amounts as Non-GAAP net earnings (loss) divided by the weighted average number of diluted shares outstanding. Champions’ definition of Non-GAAP net earnings (loss) and Non-GAAP diluted earnings (loss) per share may differ from similarly named measures used by other companies.

On March 15, 2023 Celyad Oncology (Euronext & Nasdaq: CYAD) (the "Company"), a biotechnology company focused on the discovery and development of innovative technologies for chimeric antigen receptor (CAR) T-cell therapies, reported a non-cash impairment of its goodwill and intangible oncology assets (Press release, Celyad, MAR 15, 2023, View Source [SID1234628821]).

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This impairment comes as a result of the Company’s strategic shift in focus away from clinical development and the early stage nature of the implementation of the Celyad 2.0 strategy: shifting from an organization focused on clinical development to one prioritizing R&D discovery and the monetization of its intellectual property (IP) portfolio through partnerships, collaborations and license agreements. As, to date, no effective sublicence contract nor collaboration contract was concluded, some uncertainty exists on the timing and amount of the deal flow and associated short, medium and long term revenues.

Given this uncertainty, and per accounting standards, the Company will recognize a full impairment loss on the remaining value of goodwill, In Process Research and Development, and Horizon Discovery’s shRNA platform, resulting in a non-cash impairment of €20.5 million on a statutory basis and €35.1 million on a consolidated basis for the financial year ended December 31, 2022.

This accounting conclusion, which reflects the Company’s financial situation as of December 31, 2022, does not affect the Management’s commitment to continue the potential monetization of the Company’s IP. The conclusion of the impairment analysis and additional details will be provided with the publication of the Company’s fiscal year 2022 results on or around March 23, 2023.

The net assets of the Company as of December 31, 2022, on a BE-GAAP non-consolidated basis, have fallen below half of the Company’s capital. As a result, in accordance with Article 7:228 of the Belgian Code for Companies and Associations, the Board of Directors plans to submit for a vote, at its May 5, 2023 shareholders’ meeting, its business plan including a proposal to continue the Company’s activities. The Board of Directors will publish a detailed report regarding this proposal on or around April 3, 2023, together with the convocation with proposed resolutions for the shareholders’ meeting.

The audit for fiscal year 2022 has not yet been fully completed.

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.

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.