On September 14, 2021 Champions Oncology, Inc. (Nasdaq: CSBR), leaders in transformative technology solutions utilized in drug discovery and development, reported its financial results for its first quarter of fiscal 2022, ended July 31, 2021 (Press release, Champions Oncology, SEP 14, 2021, View Source [SID1234587719]).

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First Quarter and Recent Highlights:

Record quarterly revenue of $11.3 million, an increase of 18% year over year
Reported non-GAAP income from operations, excluding stock-based compensation, depreciation and amortization, of $422,000
Validated 6 therapeutic discovery targets
Ronnie Morris, CEO of Champions, commented, "On our year-end earnings call, we outlined the transformative strategic vision for Champions with the expansion of our services to include a Software as a Service ("SaaS") business and therapeutic target discovery platform. During the first quarter, we continued executing that strategy as we added new users to our SaaS platform and by advancing our therapeutic targets through the development pipeline."

David Miller, CFO of Champions, added, "During Q1 2022, we hit another quarterly revenue record surpassing $11 million for the first time. Operating income excluding stock compensation and depreciation expenses exceeded $400,000 even as we ramped up our R&D investment to support our new strategic initiatives."

First Fiscal Quarter Financial Results

For the first quarter of fiscal 2022, revenue increased 17.9% to $11.3 million compared to $9.5 million for the first quarter of fiscal 2021. The increase in revenue was due to a continued increase in sales, both in number and size of studies, and the expansion of our platforms and business lines. Total costs and operating expenses for the first quarter of fiscal 2022 were $11.4 million compared to $9.5 million for the first quarter of fiscal 2021, an increase of $1.9 million or 20.0%.

For the first quarter of fiscal 2022, Champions reported a loss from operations of $175,000, including $280,000 in stock-based compensation and $317,000 in depreciation and amortization expenses, compared to income from operations of $24,000, inclusive of $120,000 in stock-based compensation and $277,000 in depreciation and amortization expenses, in the first quarter of fiscal 2021. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported non-GAAP income from operations of $422,000 for the first quarter of fiscal 2022 compared to non-GAAP income from operations of $421,000 in the first quarter of fiscal 2021.

Cost of oncology solutions was $5.4 million for the three-months ended July 31, 2021, an increase of $60,000, or 1.1% compared to $5.3 million for the three-months ended July 31, 2020. For the three- months ended July 31, 2021, gross margin was 52.0% compared to 44.1% for the three-months ended July 31, 2020. The nominal increase in cost of sales was primarily due to reducing our reliance on outsourcing lab work by performing the work internally. The associated cost reduction offset the increase in compensation and lab supply expenses resulting from the increase in study volume. The nominal increase in cost of sales on revenue growth of $1.7 million led to the improvement in gross margin.

Research and development expense for the three-months ended July 31, 2021 was $2.3 million, an increase of $707,000 or 44.3%, compared to $1.6 million for the three-months ended July 31, 2020. The increase was primarily from compensation and lab supplies as we increased investment in our therapeutic discovery platforms. Sales and marketing expense for the three-months ended July 31, 2021 was $1.6 million, an increase of $366,000, or 30.3%, compared to $1.2 million for the three-months ended July 31, 2020. The increase was primarily due to compensation expense driven by the continued investment in expanding our business development team, including the addition of a dedicated SaaS business development team for our Lumin Bioinformatics platform. General and administrative expense for the three-months ended July 31, 2021 was $2.2 million, an increase of $772,000, or 55.9%, compared to $1.4 million for the three-months ended July 31, 2020. The increase was primarily due to an increase in compensation, which included $123,000 of additional stock compensation expense, as well as an increase in IT related expenses and depreciation and amortization.

Net cash provided by operating activities was $216,000 for the three-months ended July 31, 2021.The cash generated from operating activities was primarily due to operating income excluding stock compensation, depreciation and amortization expenses.

The Company ended the quarter with a strong cash position of $4.0 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 844-602-0380 (domestic) or 862-298-0970 (international) ten minutes ahead of the call and give the verbal reference "Champions Oncology."

Full details of the Company’s financial results will be available by Tuesday, September 14, 2021 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 for an explanation of the amounts excluded to arrive at Non-GAAP net income and related Non-GAAP earnings per share amounts for the three months ended July 31, 2021 and 2020. 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 and Non-GAAP earnings per share are not, and should not, be viewed as a substitute for similar GAAP items. Champions defines Non-GAAP dilutive earnings per share amounts as Non-GAAP net earnings divided by the weighted average number of diluted shares outstanding. Champions’ definition of Non-GAAP net earnings and Non-GAAP diluted earnings per share may differ from similarly named measures used by other companies.

On September 14, 2021 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in robotic energy-based therapies, reported that the company’s Focal One and ExactVu technologies were featured in several poster presentations at the American Urological Association (AUA) 2021 Annual Meeting, which was held virtually from September 10-13 (Press release, EDAP TMS, SEP 14, 2021, View Source [SID1234587704]). EDAP was a Gold sponsor of the event.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Details of two noteworthy presentations are as follows:

Title: Focal Ablation Versus Radical Prostatectomy for Intermediate-Risk Prostate Cancer: Interim Analysis of a Randomized Controlled Trial

Lead author: Eduard Baco, MD, Oslo University Hospital, Norway

Summary: This is the first randomized controlled clinical trial comparing focal therapy with robotic surgery. The data suggest that at one-year post treatment, Focal One achieved good oncological efficacy while preserving erectile function and urinary continence better than radical prostatectomy.

Title: High-Intensity Focused Ultrasound (HIFU) vs Radical Prostatectomy (RP) in the Curative Treatment of ISUP 1-2 Localized Prostate Cancer: Oncological Intermediate Results of the HIFI Study

Lead author: Pascal Rischmann, MD, Toulouse University Hospital, France

Summary: In this prospective comparative study sponsored by the French Association of Urology and financed by the French Ministry of Health, 3364 patients (HIFU: 1988, radical prostatectomy: 1376) were prospectively included across 42 French treatment centers. The intermediate results presented show a salvage-treatment-free survival rate significantly higher in the HIFU arm (97.5%) compared to the radical prostatectomy arm (90.3%).

"The data from these studies presented at this year’s AUA Annual Meeting once again strongly support high intensity focused ultrasound as an alternative to far more invasive radical prostatectomy," stated Marc Oczachowski, Chairman & Chief Executive Officer of EDAP. "In terms of both efficacy and long-term survival, Focal One offers patients a superior treatment option without the debilitating side effects associated with surgery. Data such as these, together with the growing roster of healthcare institutions in the US and elsewhere who champion our technology and the progress we are making securing reimbursement, are key to our long-term growth and we are pleased to add to the expanding body of evidence at this prestigious urology conference showing the many benefits of HIFU."

On September 14, 2021 Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and gaseous NO (gNO) for the treatment of solid tumors, reported that Steve Lisi, Chairman and Chief Executive Officer of Beyond Air, is scheduled to present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit being held virtually from September 20th to 23rd (Press release, Beyond Air, SEP 14, 2021, View Source [SID1234587703]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Presentation Details:

Date and Time: Wednesday, September 22, 2021 at 9:05 AM – 9:45 AM ET
Webcast: View Source
Participation: Management will participate in additional 1-on-1 meetings virtually
Please contact your representative at Oppenheimer to schedule a virtual one-on-one meeting with Beyond Air during the conference.

On September 14, 2021 Nordic Nanovector ASA (OSE: NANOV) reported the appointment of Erik Skullerud as Chief Executive Officer (CEO) (Press release, Nordic Nanovector, SEP 14, 2021, View Source [SID1234587700]). He will take up the position on 20 September 2021 and will be based in the company’s office in Zug, Switzerland, splitting his time between Zug and Nordic Nanovector’s head office in Oslo.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Mr Skullerud joins the Company from Element Consulting GmbH, a globally focused boutique advisory and consultancy specializing in the life science industry where he was co-founder and managing partner.

Prior to establishing Element Consulting, Mr Skullerud spent 25 years in the biopharma industry with increasing responsibility in global sales and marketing management roles. This included more than 15 years at Amgen, where his most recent role was as Marketing Director Europe Oncology/ Hematology. Prior to that, he worked for Bayer Pharma for seven years, most recently as Product Group Manager for Cardiovascular/ Diabetes Scandinavia.

Mr Skullerud has launched numerous highly innovative products in therapeutic areas such as oncology, haematology, cardiology, and nephrology and he has significant business management exposure to EU, Asian and US markets. As a consultant he has worked with some of the world’s top pharma and biotech companies as well as small, highly specialised start-ups on projects ranging from corporate strategy, through early to mid-stage launch and commercialization to late-stage life cycle projects.

Mr Skullerud is a Norwegian national and a Swiss resident. He has a BSc, Marketing, Finance and Management from Gothenburg Business School, University of Gothenburg and has been a Guest Lecturer, INSEAD MBA Program, Paris, France.

Jan H. Egberts, Chairman of Nordic Nanovector’s Board of Directors, said: "I am very pleased that Erik has agreed to join Nordic Nanovector. His commercial leadership experience combined with his knowledge of the oncology/haematology space will be vital as we evolve into a larger and more valuable business based on maximising the commercial potential of Betalutin. I would like to thank Malene Brondberg for stepping up to the role of Interim CEO over the last few months, a period when the company has made good progress in delivering on its key objectives. Malene will continue in her role as CFO."

Mr Skullerud added: "I am very much looking forward to this new role at Nordic Nanovector. I believe my experience from around the world in strategy, commercialisation, and sales and marketing can help the company achieve the next important stage of its development as we work to bring Betalutin to patients for the first time, a key step in realising the wider value of the business."

When joining Nordic Nanovector, Mr Skullerud will be granted 350,000 PSUs (performance share units).

For further information about the PSUs and the related warrants, see page 28 in the company’s annual report for 2020.

On September 14, 2021 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development reported their participation at the Bio-IT World Conference & Expo occurring virtually and in Boston, MA September 20-22, 2021 (Press release, Applied BioMath, SEP 14, 2021, View Source;expo-301376645.html [SID1234587699]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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John Burke, PhD, Co-founder, President and CEO of Applied BioMath will present "Applied BioMath Assess – An Early Feasibility Assessment Tool for Biotherapeutics" within the Software Applications and Services track on Tuesday, September 21st at 10:30 a.m. ET. In this presentation, Dr. Burke will demonstrate Applied BioMath Assess*, an interactive, web-based application that helps assess the difficulties and risks in developing a therapeutic very early-on. Dr. Burke will explain how Applied BioMath Assess can help project teams answer questions such as:

How does affinity impact target inhibition? Will it impact TMDD if membrane bound?
How does dosing interval impact success criteria?
How does target expression, especially in the site of action, impact design criteria?
How to think about therapeutic index prior to Lead Generation?
"Applied BioMath Assess provides rational go/no-go guidance while also helping project teams manage their resources efficiently," said Dr. Burke. "Our software has an exciting roadmap and will continue to evolve as we add new drug modality models and tools to best inform therapeutic R&D."

Additionally, Sharvari Gujja, Senior Principal Scientist, Bioinformatics at Applied BioMath will present a poster titled, "Leveraging ML/AI Tools for Robust Identification of Potential Biomarkers in Drug Response." The poster provides an overview of Applied BioMath’s open source, easy-to-use and flexible command line interface (CLI) to access the state-of-the-art Machine Learning and Deep Learning frameworks to build predictive models for assessing cancer drug response using gene expression data from The Cancer Genome Atlas Program (TCGA) and Genomics of Drug Sensitivity in Cancer (GDSC).