On September 13, 2023 RS Oncology, a clinical stage biotechnology company developing innovative therapies to eradicate mesothelioma and other diseases, reported it was part of a collaboration that recently shared new preclinical data at the IASLC 2023 World Conference on Lung Cancer in Singapore (Press release, RS Oncology, SEP 13, 2023, View Source [SID1234635140]). The data, presented by Dr. Dean Fennell, represented a partnership between RS Oncology and other lead research institutions, including the University of Leicester and the Cunniff Laboratory at the University of Vermont Cancer Center.

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Mesotheliomas can transform from a less aggressive epithelioid malignancy to a more aggressive sarcomatoid form. Using biphasic mesotheliomas as a model containing both epithelioid and sarcomatoid features, investigators at the University of Leicester, led by Dr. Fennell, conducted a geospatial analysis of patient tissues to explore the molecular signatures associated with the histological regions.

Using sophisticated spatial analysis tools coupled with machine learning approaches, the group found that the more aggressive sarcomatoid regions had distinct molecular signatures driving pro-tumor pathways, drug resistance, and increased metastatic potential. These findings were validated across an independent cohort of 150 mesothelioma patient tissues. Notably, tumor regions containing sarcomatoid tissue showed features of increased resistance to oxidative stress – a critical tumor cell adaptation for survival.

In collaboration with Dr. Brian Cunniff’s laboratory, the team then evaluated molecular signatures of human biphasic mesothelioma tumor cells following treatment with the irreversible PRX3 inhibitor RSO-021, which is currently being evaluated in a Phase 1/2 clinical trial in patients with malignant pleural effusion caused by advanced/metastatic solid tumors (NCT05278975). RSO-021 treatment reversed the gene signatures associated with epithelial-to-sarcomatoid transition, including downregulation of hypoxia, glycolysis, and epithelial-to-mesenchymal transition (EMT)-associated genes. These results suggest that this transition, thought to be unidirectional in nature, may be PRX3-dependent, druggable, and now reversible.

"Sarcomatoid tumors are highly resistant to anti-cancer therapies, and many patients run out of available treatment options. Our findings might have unveiled a druggable ‘Achilles Heel’ against this terrible disease," said Dr. Fennell, presenting author on the study. "The ability to treat such tumors with RSO-021 and revert them to epithelioid malignancies could delay or even prevent emergence of the most aggressive features associated with mesothelioma. Further, RSO-021 could potentially sensitize them to other treatments."

Presentation Details

Abstract Number: MA17.11

Session: MA17 – Current Standards and Future Directions in Mesothelioma

Title: Spatial Transformation in Mesothelioma Involves a Hypoxia-TGF Beta-EMT Axis that is Reversible via PRX3 Inhibition

Date: Tuesday, September 12, 10:45 AM UTC +8

On September 13, 2023 Purple biotech presented its corporate presentation (Presentation, Purple Biotech, SEP 13, 2023, View Source [SID1234635139]).

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On September 13, 2023 Leap Therapeutics presented its corporate presentation (Presentation, Leap Therapeutics, SEP 13, 2023, View Source [SID1234635138]).

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On September 13, 2023 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, reported that the Compensation Committee of the company’s Board of Directors granted one employee nonqualified stock options to purchase an aggregate of 14,000 shares of its common stock with an exercise price of $1.71, which is equal to the closing price of Gritstone’s common stock on September 6, 2023, the date of the grant (Press release, Gritstone Bio, SEP 13, 2023, View Source [SID1234635136]). These stock options are part of an inducement material to the new employees becoming an employee of Gritstone, in accordance with Nasdaq Listing Rule 5635(c)(4).

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The stock options will vest over a four-year period, with 25% of the options vesting on the first anniversary of the employees’ date of hire, and 1/48th of the options vesting monthly thereafter, subject to the employees’ continued employment with Gritstone on such vesting dates. The stock options are subject to the terms and conditions of Gritstone’s 2021 Employment Inducement Incentive Award Plan and the stock option agreement covering the grant.

On September 13, 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 first quarter of fiscal 2024, ended July 31, 2023 (Press release, Champions Oncology, SEP 13, 2023, View Source [SID1234635135]).

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First Quarter and Recent Highlights:

•First quarter revenue of $12.6 million, a decline of 9%
•Strong quarterly bookings
•Hosting Scientific Symposium in Boston, MA on September 26th

Ronnie Morris, CEO of Champions, commented, "As outlined on our year-end earnings call, the down-turn in the economy, and specifically the biotech sector, was going to weigh on the Company into the start of our new fiscal year. While this is playing out as expected, demand for our services has remained strong and we’re beginning to see a positive trend in customer spending and a reduction in cancellations. Morris added, "our drug discovery initiative, operating under a wholly owned subsidiary, Corellia AI, continues to progress as we’re building therapeutic programs around two lead targets while other, new targets are being identified. We are actively engaged with investors in an effort to raise capital to support and accelerate these programs."

David Miller, CFO of Champions, added, "As we indicated last quarter, the increase in study cancellations during fiscal year 2023 would lead to lower revenue in the first half of 2024, impacting profitability. As our bookings grow and cancellations decline, we anticipate increasing quarterly revenue over the remainder of the year and gradually improving financial performance."

First Fiscal Quarter Financial Results

Exhibit 99.1

Total revenue for the first quarter of fiscal 2024 was $12.6 million compared to $13.7 million for the same period last year, a decrease of 8.6%. The decline in revenue resulted from customer cancellations during fiscal year 2023 which led to lower revenue conversion in our first quarter. Total costs and operating expenses for the first quarter of fiscal 2024 were $15.1 million compared to $14.0 million for the first quarter of fiscal 2023, an increase of $1.1 million or 7.7%.

For the first quarter of fiscal 2024, Champions reported a loss from operations of $2.6 million, including $423,000 in stock-based compensation and $445,000 in depreciation and amortization expenses, compared to a loss from operations of $284,000, inclusive of $206,000 in stock-based compensation and $528,000 in depreciation and amortization expenses, in the first quarter of fiscal 2023. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported an adjusted EBITDA loss of $1.7 million for the first quarter of fiscal 2024 compared to adjusted EBITDA of $450,000 in the first quarter of fiscal 2023.

Cost of oncology solutions was $7.7 million for the three-months ended July 31, 2023, an increase of $632,000, or 9.0% compared to $7.1 million for the three-months ended July 31, 2022. The increase in cost of sales was primarily from outsourced lab services. For the three-months ended July 31, 2023, total gross margin was 38.8% compared to 48.7% for the three-months ended July 31, 2022. The lower margin resulted primarily from a higher expense base on lower revenue conversion percentages, with additional pressure stemming from the increase in outsourced services.

Research and development expense for the three-months ended July 31, 2023 was $2.8 million, a slight decrease of $94,000 or 3.3%, compared to $2.9 million for the three-months ended July 31, 2022. Approximately $1.2 million of the Company’s R&D expense was directed towards our target discovery program. Sales and marketing expense for both the three-months ended July 31, 2023 and July 31, 2022 was $1.7 million. General and administrative expense for the three-months ended July 31, 2023 was $2.9 million, an increase of $542,000, or 22.6%, compared to $2.4 million for the three-months ended July 31, 2022. The increase was primarily due to an increase in the provisions for bad debt and credit losses of approximately $160,000 and non-cash stock-based compensation expense.

Net cash used in operating activities was $4.0 million for the three-months ended July 31, 2023. The cash used in operating activities was primarily due to an increase in accounts receivable due to timing differences in the ordinary course of business and a decrease in deferred revenue as a result of study cancellations. Net cash used in investing activities was $670,000 from investment in additional lab and computer equipment. Net cash used in financing activities was $590,000 resulting from repurchases of common stock related to our stock buy-back program offset slightly by proceeds from options exercises.

The Company ended the quarter with cash and cash equivalents on hand of approximately $5.0 million. The Company has no debt.

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 first quarter financial results. To participate in the call, please call 888-506-0062 (Domestic) or 973-528-0011 (International) and enter the access code 417178, or provide the verbal reference "Champions Oncology".