On December 14, 2022 EpicentRx Inc. ("EpicentRx"), a leading-edge, clinical stage biopharmaceutical company that uses groundbreaking science to treat cancer and inflammatory-driven diseases, reported the publication of a randomized, Phase 2 trial which demonstrated a statistically significant and clinically meaningful progression-free survival (PFS) benefit for the small molecule NLRP3 inhibitor, RRx-001, plus irinotecan versus standard of care regorafenib in patients with advanced colorectal cancer (Press release, EpicentRx, DEC 14, 2022, View Source [SID1234625255]). The trial, ROCKET, included patients with third- or fourth-line colorectal cancer that previously received the irinotecan-containing chemotherapy regimen, FOLFIRI.

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The ROCKET data was published in the December 2022 issue of the journal Clinical Colorectal Cancer.

Regorafenib, a poorly tolerated multi-kinase inhibitor, was FDA-approved in third- or fourth-line colorectal cancer based on a Phase 3 study, which demonstrated a 6.4-month overall survival and a 1.9-month progression free survival.[1]

In the ROCKET trial, 34 patients were randomized 2:1 to receive a priming dose of RRx-001 4 mg IV weekly for two months followed by irinotecan, a chemotherapy agent, associated with a 40% rate of severe diarrhea, which they had previously received and failed, at a dose of 180 mg per meter squared given every two weeks until progression versus regorafenib 160 mg given by mouth, three weeks on/one week off until progression.

The median overall survival was 8.6 months for RRx-001 plus irinotecan and 4.7 months for regorafenib. Median progression free survival was 6.1 months for RRx-001 plus irinotecan vs. 1.7 months for regorafenib, a statistically significant result (two-sided log-rank test, p = 0.0030). Overall response rate was 20.8% for RRx-001 plus irinotecan vs. no response for regorafenib. Moreover, the toxicity profile of RRx-001 plus irinotecan was substantially improved compared with regorafenib. Also, there were no observed cases of severe diarrhea with irinotecan, likely due to protection of the gastrointestinal (GI) tract from RRx-001. Reduction or prevention of side effects from chemotherapy, like severe diarrhea, leads to less dose delays or dose reductions and consequently improves antitumor outcomes.

The prognosis for patients with CRC has historically been poor in later lines of therapy with response rates of approximately 1-2% and median PFS of approximately two months. [2]

According to EpicentRx CEO and practicing gastrointestinal oncologist, Dr. Tony Reid MD, PhD, "Granted, ROCKET was a small trial; however, as a GI oncologist, treatment with regorafenib is commonly associated with significant skin irritation and fatigue, among other symptoms. I think oncologists would welcome a better-tolerated, more active alternative for colorectal cancer patients that have progressed on front-line therapy. Hence, these results from ROCKET, if confirmed in a Phase 3 trial, would likely lead to additional options for third line colorectal cancer and beyond treatment."

About RRx-001
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 medical countermeasure for nuclear and radiological emergencies and as a treatment for neurodegenerative diseases like Parkinson’s and ALS/MND. For more information visit www.epicentrx.com.

As previously disclosed, on July 30, 2021, Exicure, Inc. (the "Company") entered into a Collaboration, Option and License Agreement with (the "Ipsen Collaboration Agreement") with Ipsen Biopharm Limited (the "Ipsen"), pursuant to which the Company granted to Ipsen exclusive access and options to license SNA-based therapeutics arising from two collaboration programs related to the treatment of Huntington’s disease and Angelman syndrome (Press release, Exicure, DEC 14, 2022, View Source [SID1234625257]).

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On December 12, 2022, the Company and Ipsen entered into a Mutual Termination Agreement (the "Ipsen Termination Agreement"), pursuant to which the parties mutually agreed to terminate the Ipsen Collaboration Agreement. Following such termination, the parties will jointly own R&D Term IP (as defined in the Ipsen Collaboration Agreement) and Patents Covering the R&D Term IP (as defined in the Ipsen Collaboration Agreement), with each party owning an equal, undivided interest in and to such R&D Term IP and patents.

Termination of AbbVie Collaboration Agreement

On November 13, 2019, the Company entered into a Collaboration, Option and License Agreement (the "AbbVie Collaboration Agreement"), with a wholly-owned subsidiary of Allergan plc, Allergan Pharmaceuticals International Limited ("Allergan"). On May 8, 2020, Allergan plc, including Allergan was acquired by AbbVie Inc. ("AbbVie"). Pursuant to the AbbVie Collaboration Agreement, the Company granted to AbbVie exclusive access and options to license SNA-based therapeutics arising from two collaboration programs related to the treatment of hair loss disorders.

On December 13, 2022, the Company and Allergan entered into a letter agreement (the "AbbVie Termination Agreement"), pursuant to which the parties mutually agreed to terminate the AbbVie Collaboration Agreement. Following such termination, the Company will transfer to Allergan all data, information, and reports made or generated by the Company in the course of performing activities under the Development Plan (as defined in the AbbVie Collaboration Agreement), and grant to Allergan all rights to transfer, publish, present, or otherwise publicly disclose any Collaboration Technology (as defined in the AbbVie Collaboration Agreement) and data made or generated by the Company in the course of performing activities under the Development Plan.

As a result of the respective terminations of the Ipsen Collaboration Agreement and the AbbVie Collaboration Agreement, the Company regains the ability to independently develop medicines targeting hair loss disorders, Angelman syndrome, and Huntington’s disease whilst Ipsen retains the right to re-enter into the collaboration with the Company in Huntington’s Disease and Angelman’s Syndrome.

The foregoing descriptions of the Ipsen Termination Agreement and the AbbVie Termination Agreement do not purport to be complete and are qualified in their entirety by reference to such agreements, copies of which are filed as Exhibits 10.1 and 10.2, respectively, hereto and incorporated by reference herein.

On December 14, 2022 Eli Lilly and Company (NYSE: LLY) and EVA Pharma reproted a collaboration to deliver a sustainable supply of high-quality, affordable human and analogue insulin to at least one million people living with type 1 and type 2 diabetes in low- to middle-income countries (LMICs), most of which are in Africa (Press release, Eli Lilly, DEC 14, 2022, View Source [SID1234625254]).

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In a first for Lilly, the company will supply its active pharmaceutical ingredient (API) for insulin at a significantly reduced price to EVA Pharma. Lilly will also provide a pro-bono technology transfer to enable EVA Pharma to formulate, fill and finish insulin vials and cartridges – establishing the company as a trusted manufacturer of these lifesaving products in Africa.

EVA Pharma expects to begin distribution of the African-made insulin products within 18 months and to reach one million people per year by 2030. This collaboration is part of the Lilly 30×30 initiative, which aims to improve access to quality healthcare for 30 million people living in limited-resource settings, annually, by 2030.

"Our new collaboration with EVA Pharma reflects Lilly’s deep commitment to making equitable and affordable access to insulin a reality for people living with diabetes in low- and middle-income countries," said Ilya Yuffa, president of Lilly International. "This latest initiative from Lilly will empower local manufacturing, finishing and distribution of quality insulin – in Africa – which will transform communities and make life better for people throughout the continent."

"EVA Pharma is committed to empowering the fight for health and well-being as a human right," said Riad Armanious, CEO of EVA Pharma. "People suffering from diabetes in LMICs experience daily challenges in accessing treatment. We feel blessed to collaborate with the team at Lilly. Combining our African reach, state-of-the-art facilities, and Lilly’s deep expertise in diabetes care, we aim to treat at least one million patients by 2030 who otherwise may not have access to life-saving medication."

According to the IDF Diabetes Atlas, the total number of people with diabetes in Africa is expected to increase 129% by 2045, reaching 55 million people.

WHO established the Global Diabetes Compact in 2021, a global initiative to support countries in implementing effective programs for the prevention and management of diabetes, one tenet of which includes engaging with the private sector to expand access to products that will improve the lives of people living with diabetes. The dialogues with WHO encourage implementation of and accountability for the commitments and contributions toward improving access to insulin.

"The success of these commitments to increase access for people living with diabetes is an important step in the right direction, but global engagement will need to be translated into implementation in regions and countries," said WHO Director for Noncommunicable Disease, Dr Bente Mikkelsen. "This is the starting point – the hope is to have insulin and diabetes devices as part of Essential Benefit Packages in low- and middle-income countries towards achieving Universal Health Coverage."

Lilly will work with EVA Pharma to ensure that their products meet the high-quality standards set for WHO prequalification, which has become a global symbol for safety, quality and efficacy.

On December 15, 2022 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that Eisai and Washington University School of Medicine in St. Louis reported to have entered into a comprehensive research collaboration agreement aiming to create potential novel treatments for neurodegenerative disorders, including Alzheimer’s disease (AD) and Parkinson’s disease (PD) (Press release, Eisai, DEC 14, 2022, View Source [SID1234625253]).

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Washington University is world leading in research on prevention, diagnosis, biomarkers and treatment of neurodegenerative diseases. The two organizations have been collaborating in AD research. The Phase II/III Tau NexGen Study conducted by the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by the University’s School of Medicine, is exploring the safety, tolerability, biomarkers and cognitive efficacy of Eisai’s anti-MTBR (microtubule binding region) tau antibody E2814 for the treatment of dominantly inherited Alzheimer’s disease (DIAD). In this study, the anti-amyloid beta (Aβ) protofibril antibody lecanemab (generic name, development code: BAN2401) was selected as the background anti-amyloid agent.

The collaboration strategically combines Washington University scientists’ expertise in the fundamental and clinical research in neurodegenerative diseases, such as dementia, with Eisai’s extensive experience in drug discovery and development. Using human biology, the aim is to create multiple novel therapeutic candidates as well as discover and identify biomarkers within the next five years. Eisai will have the option rights to develop and commercialize any compounds and biomarkers that meet certain criteria in terms of research and development milestones. In the case that Eisai chooses to exercise the options, Eisai will pay Washington University milestone payments and royalties on future sales of each licensed compounds.

Dr. Teiji Kimura, Ph.D., Academia and Industry Alliance Officer, Deep Human Biology Learning (DHBL) Office of Eisai, commented, "Patients living with neurodegenerative diseases, including Alzheimer’s disease and Parkinson’s disease, struggle with critical unmet medical needs, which is the reason neurology is a key therapeutic area for Eisai. By collaborating with world-leading research institutions such as Washington University in St. Louis, Eisai is working to fulfill our human health care mission and provide potential new and targeted disease-modifying therapies with the ultimate goal of achieving a world free of neurodegenerative disease."

On December 13, 2022 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 second quarter of fiscal 2023, ended October 31, 2022 (Press release, Champions Oncology, DEC 14, 2022, View Source [SID1234625252]).

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Second Quarter and Recent Highlights:

Record quarterly revenue of $14.3 million, an increase of 21% year over year
Adjusted EBITDA of $686,000
Discovery targets progressing along the development timeline; expectation to advance to
preclinical phase testing in calendar 2023

Ronnie Morris, CEO of Champions, commented, "We continued to deliver good financial results while simultaneously investing in the future growth of the business. Morris added, "while long term prospects remain strong, we experienced a slowdown in the pace of our bookings growth during the quarter. We attribute the slow down to the global economic environment as our customers reanalyzed their spending budgets. We’re monitoring the situation closely and we’re optimistic this is a short-term adjustment as we’ve seen a re-acceleration in the beginning of our third quarter."

David Miller, CFO of Champions, added, "We reached another revenue milestone for Champions exceeding $14 million for the first time. The increase to $14.3 million represents 21% year over year growth which was in-line with the projected growth rate for the year. However, due to the economic climate, we saw an increase in cancellations during the quarter which will impact the revenue in the second half of the year. Accordingly, we’re revising our full year growth target to be in the 10% – 15% range."

Second Fiscal Quarter Financial Results

Total revenue for the second quarter of fiscal 2023, was a record $14.3 million, an increase of 21.2%, compared to $11.8 million for the same period last year. The increase in revenue was due to continued demand for our services, leading to larger pharmacology studies in both our in-vivo and ex-vivo platforms. Total costs and operating expenses for the second quarter of fiscal 2023 were $14.3 million compared to $11.5 million for the second quarter of fiscal 2022, an increase of $2.8 million or 23.9%.

For the second quarter of fiscal 2023, Champions reported income from operations of $7,000, including $119,000 in stock-based compensation and $560,000 in depreciation and amortization expenses, compared to income from operations of $263,000, inclusive of $134,000 in stock-based compensation and $346,000 in depreciation and amortization expenses, in the second quarter of fiscal 2022. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported adjusted EBITDA for the quarter of $686,000 compared to $743,000 in the prior year period.

Cost of oncology solutions was $7.4 million for the three-months ended October 31, 2022, an increase of $1.8 million, or 32.7% compared to $5.6 million for the three-months ended October 31, 2021. The increase in cost of sales was primarily from compensation, mice and lab supply expenses for pharmacology studies, and an increase in compensation expense for our SaaS platform. For the three months ended October 31, 2022, total gross margin was 48% compared to 52% for the three-months ended October 31, 2021. Pharmacology services margin was 51% vs 53% in the year ago period. The lower margin resulted from an increase in study related expenses against lower than expected revenue conversion.

Research and development expense for the three-months ended October 31, 2022 was $2.6 million, an increase of $305,000 or 13.3%, compared to $2.3 million for the three-months ended October 31, 2021. 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 October 31, 2022 was $1.7 million, a slight increase of $60,000, or 3.7%, compared to $1.6 million for the three months ended October 31, 2021. General and administrative expense for the three-months ended October 31, 2022 was $2.5 million, an increase of $552,000, or 27.9%, compared to $2.0 million for the three-months ended October 31, 2021. 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 $3.3 million for the three months ended October 31, 2022. The cash generated from operating activities was primarily due to income from operations excluding stock-based compensation, depreciation and amortization expenses as well as an increase in accounts payable due to timing differences in the ordinary course of business. The Company ended in the quarter in a strong cash position with cash on hand of $10.8 million and no debt.

Year-to-Date Financial Results

For the first six months of fiscal 2023, revenue increased 21.6% to $28.0 million compared to $23.0 million for the first six 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 six months of fiscal 2023 were $28.3 million compared to $23.0 million for the first six months of fiscal 2022, an increase of $5.4 million or 23.3%.

For the first six months of fiscal 2023, Champions reported a net loss from operations of $277,000, including $325,000 in stock-based compensation and $1.1 million in depreciation and amortization expenses, compared to income from operations of $88,000, inclusive of $414,000 in stock-based compensation and $663,000 in depreciation and amortization expenses, in the first six months of fiscal 2022. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported adjusted EBITDA of $1.1 million for the first six months of fiscal 2023 compared to adjusted EBITDA of $1.2 million in the first six months of fiscal 2022.

Cost of oncology solutions was $14.5 million for the six-months ended October 31, 2022, an increase of $3.5 million, or 31.7% compared to $11.0 million for the six-months ended October 31, 2021. For the six-months ended October 31, 2022, total gross margin was 48.3% compared to 52.2% for the six months ended October 31, 2021. For the same respective periods, pharmacology services margin was 51.1% vs 52.8%. The decrease in gross margin was primarily attributable to an increase in study related expenses in advance of the revenue recognition and lower than expected revenue conversion.

Research and development expense for the six-months ended October 31, 2022 was $5.5 million, an increase of $888,000 or 19.3%, compared to $4.6 million for the six-months ended October 31, 2021. 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 six months ended October 31, 2022 was $3.4 million, a slight increase of $178,000, or 5.5%, compared to $3.2 million for the six-months ended October 31, 2021. General and administrative expense for the six-months ended October 31, 2022 was $4.9 million, an increase of $800,000, or 19.3%, compared to $4.1 million for the six-months ended October 31, 2021. 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 $3.1 million for the six-months ended October 31, 2022. The cash generated from operating activities was primarily due to an increase in income from operations excluding stock-based compensation and depreciation and amortization expenses as well as an increase in accounts payable due to timing differences in the ordinary course of business. Net cash used in investing activities was $1.4 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. EST (1:30 p.m. PST) to discuss its second quarter financial results. To participate in the call, please call 877-545-0523 (Domestic) or 973-528-0016 (International) and enter the access code 541646, or provide the verbal reference "Champions Oncology".

Full details of the Company’s financial results will be available by December 15, 2022 in the Company’s Form 10-Q at www.championsoncology.com.