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.

On December 14, 2022 Avidity Biosciences presented its Virtual Investor and analyst event presentation (Presentation, Avidity Biosciences, DEC 14, 2022, View Source [SID1234625250]).

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On December 14, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, reported consolidated financial results for the fourth quarter and fiscal year ended September 30, 2022 (Press release, Applied DNA Sciences, DEC 14, 2022, View Source [SID1234625249]).

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"Applied DNA delivered four consecutive quarters of year-over-year revenue increases and a second consecutive record revenue year in fiscal 2022 while simultaneously executing on our long-term strategy and vision to build a diversified PCR-based DNA technologies company in biotechnology, clinical diagnostics, and supply chain traceability," stated Dr. James A. Hayward, president and CEO. "Over the past 12 months, our LineaRx subsidiary generated volumes of preclinical data to strengthen the case for the biotherapeutic industry’s adoption of enzymatically-produced linear DNA (linearDNA) for the manufacture of genetic medicines, expanded the menu of molecular diagnostic tests at our Applied DNA Clinical Labs ("ADCL") subsidiary, and moved to capitalize on U.S. federal enforcement of the Uyghur Forced Labor Prevention Act (the "UFLP Act") as a driver of broader CertainT platform adoption by the textiles industry.

"Strategically, we committed to our biotherapeutics opportunity as the chief driver of long-term shareholder value while working to evolve our ADCL and supply chain traceability segments towards positive cash flow to support the value-creating potential of our LinearDNA platform," continued Dr. Hayward. "Operationally, we undertook a detailed assessment to reduce costs associated with our largest COVID-19 testing contract, our chief driver of revenue. In fiscal 2023, we will continue to manage our costs associated with this contract, while at the same time, working to close sales opportunities for our to-be launched pharmacogenetic testing services. In our supply chain traceability segment, we worked to educate key policy makers, customers, and enforcement agencies on CertainT, our textile traceability platform, ahead of the implementation of the UFLP Act. As enforcement of the UFLP Act is expected to become ubiquitous at U.S. ports, we believe that CertainT is well positioned to help customers meet its compliance requirements."

Concluded Dr. Hayward, "Our strategic priorities in fiscal 2023 are twofold: first, we are focused on capturing new sales opportunities and effecting gross margin improvements in our ADCL and supply chain traceability segments empowered by the commercialization of our pharmacogenomics ("PGx") testing platform and the broader implementation of the UFLP Act, respectively; second, we are focused on making the necessary investments in our LinearDNA platform to support the growth of this business segment from a small-scale CRO to a larger-scale CDMO capable of capturing promising opportunities in genetic medicines, including the use of linearDNA IVT templates to produce mRNA therapeutics. Historically, the gating factor to broader linearDNA adoption has been our lack of cGMP production capacity which we are moving to remedy over the course of the fiscal year and expect to culminate in the establishment of an initial cGMP production capacity by the end of calendar year 2023."

Fourth Quarter 2022 Financial Highlights

Total revenues increased 17% to $3.6 million, which included $2.9 million in clinical laboratory service revenues (COVID-19 testing revenue). This compares with total revenues of $3.0 million in the prior fiscal year period, which included $1.6 million of COVID-19 testing revenue.

The year-over-year increase was offset by a decrease in product revenues of $713 thousand due to a decrease in sales of DNA concentrate within a textile supply chain, as well a decline in sales of our molecular diagnostics (MDx) test kits and supplies and a decrease in service revenue of $70 thousand.

Gross profit was $417 thousand, or 12%, compared to $992 thousand, or 33%, in the prior fiscal year period. The decline in gross margin was primarily the result of a higher portion of clinical laboratory service revenues coming from managed services testing contracts that carry higher costs compared to ADCL’s surveillance testing contracts. To a lesser extent, the decline was due to product sales mix as product revenues in the prior fiscal year period included sales of diagnostic test kit and supplies and DNA concentrate for supply chains serving the textiles industry that are at a higher gross margin.

Total operating expenses were $4.8 million compared to $5.5 million in the prior fiscal year period, reflecting the absence of a $822 thousand impairment charge related to goodwill and the remaining net book value of intangible assets incurred in the prior fiscal year period and to a lesser extent, decreases in research and development expenses of $313 thousand. The decrease in operating expenses was offset by an increase of $420 thousand in selling, general and administrative expenses attributable to an increase in insurance expense of approximately $209 thousand and an increase in bad debt expense of approximately $237 thousand for the reserve of a customer balance that was deemed to be uncollectible.

Operating loss was $4.4 million compared to an operating loss of $4.5 million in the prior fiscal year period.

Excluding non-cash expenses, Adjusted EBITDA was negative $3.4 million compared to negative $3.3 million in the prior fiscal year period. See below for information regarding non-GAAP measures.

Cash and cash equivalents of $15.2 million at September 30, 2022, include proceeds from a public offering conducted in the quarter of common stock and two series of warrants for gross proceeds of $12.0 million, and the exercise of warrants in connection with this offering for additional net proceeds of $3.7 million.

Fiscal 2022 Financial Highlights

Total revenues increased 101% to $18.2 million, which included $15.5 million in clinical laboratory service revenues (COVID-19 test revenue). This compares with total revenues of $9.0 million in the prior fiscal year period, which included $4.8 million of COVID-19 test revenue.

The year-over-year increase was offset by a decrease in product revenues of $1.4 million reflecting decreased sales of our MDx test kits and supplies to an ADCL COVID-19 customer and, to a lesser extent, a decrease in the sale of DNA concentrate for textiles supply chains recorded in the prior fiscal year period and a decrease in service revenues of $179 thousand reflecting research and developments projects completed in the prior fiscal year period.

Total operating expenses increased 7% to $19.0 million from $17.8 million in the prior fiscal year period. The increase is attributable to an increase in selling, general and administrative expenses of $2.3 million, offsetting a decrease in research and development expenses of $238 thousand and the absence of a $822 thousand impairment charge related to goodwill and the remaining net book value of intangible assets incurred in the prior fiscal year period.

Operating loss was $14.0 million compared to $13.3 million in the prior fiscal year period.

Excluding non-cash expenses, Adjusted EBITDA was negative $9.9 million compared to negative $10.1 million in the prior fiscal year period. See below for information regarding non-GAAP measures.

Warrants balance at September 30, 2022 stood at 7.3 million. Approximately 2.2 million of these warrants have exercise prices ranging from $2.80 to $2.84 per warrant share, which, if exercised, could result in exercise proceeds to the Company of approximately $6.3 million; 5.1 million of these warrants have an exercise price of $4.00 per warrant share, which, if exercised, could result in total exercise proceeds of approximately $20.3 million. Of the 5.1 million warrants, 2.1 million expire in September 2023, which, if exercised, would total proceeds of $8.4 million.

Fourth Quarter and Full Year Fiscal 2022 Conference Call Information

The Company will hold a conference call and webcast to discuss its fourth quarter and fiscal year 2022 financial results on Wednesday, December 14, 2022, at 4:30 PM ET. To participate on the conference call, please follow the instructions below. While every attempt will be made to answer investors’ questions on the Q&A portion of the call, not all questions may be answered.

To Participate:

· Participant Toll Free:1-844-887-9402

· Participant Toll: 1-412-317-6798

· Please ask to be joined to the Applied DNA Sciences call

Live and replay of webcast: View Source

Telephonic replay (available 1 hour following the conclusion of the live call through December 15, 2022):

· Participant Toll Free: 1-877-344-7529

· Participant Toll: 1-412-317-0088

· Participant Passcode: 2738600

Presentation slides will also be posted to the "News & Events" section of the Applied DNA website at View Source and embedded into the live webcast.

Information about Non-GAAP Financial Measures

As used herein, "GAAP" refers to accounting principles generally accepted in the United States of America. To supplement our condensed consolidated financial statements prepared and presented in accordance with GAAP, this earnings release includes Adjusted EBITDA, which is a non-GAAP financial measure as defined in Rule 101 of Regulation G promulgated by the Securities and Exchange Commission. Generally, a non-GAAP financial measure is a numerical measure of a company’s historical or future performance, financial position, or cash flows that either excludes or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented in accordance with GAAP. The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for, or superior to, the financial information presented in accordance with GAAP. We use this non-GAAP financial measure for internal financial and operational decision-making purposes and as a means to evaluate period-to-period comparisons of the performance and results of operations of our core business. Our management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the performance of our business by excluding non-cash expenses that may not be indicative of our recurring operating results. We believe this non-GAAP financial measure is useful to investors as they allow for greater transparency with respect to key metrics used by management in its financial and operational decision making.

"EBITDA"- is defined as earnings (loss) before interest expense, income tax expense and depreciation and amortization expense.

"Adjusted EBITDA"- is defined as EBITDA adjusted to exclude (i) stock-based compensation and (ii) other non-cash expenses.