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 Biognosys, an innovator and leader in next-generation proteomics technology and solutions for life sciences research, reported that they have entered a collaboration with Evotec, a life science company that discovers, develops, and provides highly effective therapeutics for patients, to advance the adoption of next-generation proteomics in drug discovery and clinical research (Press release, Biognosys, SEP 14, 2021, View Source [SID1234587637]).

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Evotec has been a long-term user of Biognosys’ software and kits within its research. The two companies are now working closely together to integrate Biognosys’ next-generation proteomics data analysis platform in drug discovery and clinical proteomics.

Under the extended partnership, Evotec will continue to utilize Spectronaut, Biognosys’ flagship data analysis software for data-independent acquisition (DIA) mass spectrometry (MS) based proteomics, in its research. The software employs advanced Search, Artificial Intelligence (AI), and Machine Learning (ML) algorithms to translate data into actionable insights for life science research. Spectronaut enables reproducible and precise quantification of thousands of proteins in a single experiment and provides multidimensional insights into protein expression, function, and structure across all major biological species and sample types.

Additionally, Evotec is implementing Biognosys’ unique workflow for mass spectrometry facility management. This workflow combines Biognosys’ proprietary QuiC software with its patented indexed Retention Time (iRT) technology and iRT Kit to generate near real-time readouts from mass spectrometry instrument raw files for quality control.

The collaboration uniquely combines Evotec’s partnered drug discovery and development business model and focus on data-driven precision medicine, and Biognosys’ expertise and know-how in applying next-generation proteomics to transforming drug discovery and development.

Kristina Beeler, PhD, CBO of Biognosys, comments: "We are excited to deploy the power of proteomics to address some of the key challenges of drug development and work closely with Evotec to de-risk therapeutic assets early on."

Christoph Schaab, PhD, SVP Head of Proteomics & Metabolomics at Evotec, comments: "Discovery proteomics is increasing its importance to derive functional insights in the early stages of the drug development pipeline. We are thrilled to integrate Biognosys’ proteomics data analysis expertise into Evotec’s pre-clinical and clinical development solutions for the benefit of our biopharma partners."

On September 14, 2021 Immunicom, Inc., a clinical-stage biotechnology company pioneering "subtractive" advanced cancer therapies, reported that promising preliminary data from trials investigating Immunopheresis therapy for metastatic, refractory, solid tumor cancer patients who previously failed multiple lines of therapy (Press release, Immunicom, SEP 14, 2021, View Source [SID1234587688]). The results presented by Immunicom’s Chief Medical Officer, Dr. Robert Segal, at the JCA-AACR Precision Cancer Medicine International Conference virtual joint conference established that Immunopheresis therapy administered to end-stage cancer patients was generally well-tolerated and has the potential for treating refractory malignancies.

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Immunicom’s ongoing clinical trials are in the most difficult to treat, late-stage cancer patients. Immunicom’s novel Immunopheresis therapy uses its proprietary subtractive LW-02 column to selectively remove immune-suppressive cytokines produced by cancer tumors.

"Standard cancer treatments are surgery, radiation or those that typically require the infusion of drugs, antibodies or proteins into the patient. Although chemotherapy and the available immunotherapy drugs can be effective, introducing these foreign substances into the body frequently leads to toxic side-effects, often severe enough to require that the dose be reduced or the therapy be discontinued entirely," said Immunicom’s Chief Medical Officer, Dr. Robert Segal. "At Immunicom, we have developed a novel approach to treat cancer by safely removing specific cytokines to boost the immune system to potentially fight cancer cells. The Immunopheresis therapy is an extracorporeal treatment and is thereby designed to be safer and with less risk of typical side-effects seen with standard chemotherapy and immunotherapy treatment regimens."

Dr. Segal’s presentation focused on results from over 1,100 Immunopheresis procedures conducted in 40 end-stage cancer patients from ongoing clinical trials, demonstrating the viability of this technology as a new treatment strategy. The multinational clinical trials are evaluating the LW-02 column for treating multiple cancers, including triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), metastatic melanoma, and renal cell carcinoma. The LW-02 column is being investigated both as a monotherapy and in combination with low-dose chemotherapy or the well-known immunotherapy checkpoint inhibitors Opdivo (Bristol-Myers Squibb) and Tecentriq (Roche). These trials are being conducted in collaboration with world-renowned research organizations and thought leaders including:

Poland – at Jagiellonian University of Krakow Hospital, under the direction of Principal Investigator, Professor Piotr Wysocki, MD, PhD;

Israel – at Sheba Medical Center’s Ella Lemelbaum Institute for Immuno-Oncology (Tel Aviv), under the direction of Dr. Ronnie Shapira, MD and Prof. Gal Markel, MD, PhD; and

Turkey – at Acıbadem Altunizade Hospital (Istanbul), a member of the Acıbadem/IHH Healthcare Group, under the direction of Principal Investigator, Prof. Dr. Gokhan Demir, MD, PhD.

Subtractive Therapy – Immunopheresis and the LW-02 Column

Immunicom’s innovative Immunopheresis approach uses the LW-02 column to extract specific immune-suppressive cytokines produced by cancer tumors. Selective removal of these targeted cytokines is intended to neutralize cancer’s ability to block a patient’s natural immune defense mechanisms which are significantly compromised in late-stage, metastatic disease and thereby "re-energizes the immune system to aggressively fight cancer." Immunopheresis is a "subtractive therapy," in contrast to drugs that are "additive." Subtractive therapy is meant to avoid the side effects, toxicity and negative impact on a patient’s quality of life typical of other cancer treatments.

Based on Immunicom’s clinical program, the LW-02 column could be used either in combination with other therapies or as a stand-alone treatment. The LW-02 Immunopheresis column has already received Breakthrough Device Designation for stage IV metastatic cancers from the U.S. Food and Drug Administration (FDA) and European regulatory clearance (CE Mark certification) for use in adults with advanced, refractory TNBC. Immunicom has obtained ISO 13485 certification for its manufacturing and related quality systems.

For an overview of how Immunopheresis breakthrough technology works, watch Immunicom’s How it Works video.

Immunopheresis and the LW-02 column is considered an investigational therapy by the U.S. FDA and other regulatory authorities. The clinical efficacy of the LW-02 column has not yet been demonstrated. Clinical investigations evaluating the clinical efficacy of the LW-02 column for TNBC are ongoing.

To view Dr. Segal’s presentation for the JCA-AACR Precision Cancer Medicine International Conference please see the conference website.

On September 14, 2021 Median Technologies (ALMDT: PA) reported that it will announce its H1 2021 results as well as its Q3 2021 business performance indicators on October 21, 2021 after trading close instead of October 14, 2021 after trading close (Press release, MEDIAN Technologies, SEP 14, 2021, View Source [SID1234587638]).

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On September 14, 2021 Bayer reported A post-hoc analysis of the Phase III ARAMIS trial presented at the 2021 AUA Annual Meeting assessing NUBEQA (darolutamide) in men with non-metastatic castration-resistant prostate cancer (nmCRPC) reinforces the established clinical profile.1,2 NUBEQA is indicated in the U.S. for the treatment of men with nmCRPC (Press release, Bayer, SEP 14, 2021, View Source [SID1234587689]).

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Research presented at the meeting found that NUBEQA plus androgen deprivation therapy (ADT) prolonged time to first prostate cancer-related invasive procedures, an exploratory endpoint (HR=0.416; 95% CI, 0.279-0.620), and was associated with a reduction in locally invasive procedures versus ADT alone (4.7% versus 9.6%). In a post-hoc analysis, NUBEQA plus ADT also delayed the time to deterioration in quality of life (QoL) in two of the six subscales of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-PR25): urinary symptoms (25.8 versus 14.8 months; HR=0.64; 95% CI, 0.54-0.76) and bowel symptoms (18.4 versus 11.5 months; HR=0.78; 95% CI, 0.66-0.92) versus ADT alone.1

In the Phase III ARAMIS trial primary analysis, serious adverse reactions in ≥ 1% of patients who received NUBEQA included urinary retention, pneumonia, and hematuria.

"Local symptoms from the prostate and surrounding tissues can be very detrimental to patients’ QoL. The occurrence of local symptoms and invasive procedures is very important in initial nmCRPC treatment discussions between patients and physicians," said Neal Shore, MD, FACS, Medical Director, CPI, Carolina Urologic Research Center. "The results on QoL and invasive procedures reinforce NUBEQA’s value in nmCRPC."

Data from the Phase III ARAMIS Trial

Previously published results in 1,509 patients from the Phase III ARAMIS trial demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median of 40.4 months (n=955) with NUBEQA plus ADT, compared to 18.4 months (n=554) for placebo plus ADT (p<0.001). MFS is defined as the time from randomization to the time of first evidence of blinded independent central review (BICR)-confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first.2

The six subscales of the EORTC-QLQ-PR25 are: urinary symptoms, bowel symptoms, hormone treatment-related symptoms, incontinence aid use, sexual activity and sexual functioning.

The proven tolerability of NUBEQA was supported by the three adverse reactions occurring more frequently in the NUBEQA arm (≥2% over placebo): fatigue (16% versus 11%), pain in extremity (6% versus 3%) and rash (3% versus 1%). NUBEQA was not studied in women and there is a warning and precaution for embryo-fetal toxicity.2

About NUBEQA (darolutamide)2

NUBEQA is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.2 A Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS) is ongoing. Information about this trial can be found at www.clinicaltrials.gov.

INDICATION FOR NUBEQA (darolutamide)

NUBEQA (darolutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

IMPORTANT SAFETY INFORMATION FOR NUBEQA (darolutamide)

Embryo-Fetal Toxicity: Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.

Adverse Reactions

Serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo. Serious adverse reactions in ≥1 % of patients who received NUBEQA were urinary retention, pneumonia, and hematuria. Overall, 3.9% of patients receiving NUBEQA and 3.2% of patients receiving placebo died from adverse reactions, which included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%) for NUBEQA.

Adverse reactions occurring more frequently in the NUBEQA arm (≥2% over placebo) were fatigue (16% vs 11%), pain in extremity (6% vs 3%) and rash (3% vs 1%).

Clinically significant adverse reactions occurring in ≥2% of patients treated with NUBEQA included ischemic heart disease (4.0% vs 3.4% on placebo) and heart failure (2.1% vs 0.9% on placebo).

Drug Interactions

Effect of Other Drugs on NUBEQA – Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity. Avoid concomitant use.

Combined P-gp and strong CYP3A4 inhibitors increase NUBEQA exposure, which may increase the risk of NUBEQA adverse reactions. Monitor more frequently and modify NUBEQA dose as needed.

Effects of NUBEQA on Other Drugs – NUBEQA inhibits breast cancer resistance protein (BCRP) transporter. Concomitant use increases exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use where possible. If used together, monitor more frequently for adverse reactions, and consider dose reduction of the BCRP substrate.

NUBEQA inhibits OATP1B1 and OATP1B3 transporters. Concomitant use may increase plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor more frequently for adverse reactions and consider dose reduction of these substrates.

Review the prescribing information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA.

For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information.

About Prostate Cancer

Prostate cancer is the second most commonly diagnosed malignancy in men worldwide.3 In 2020, about 192,000 men in the U.S. were diagnosed with prostate cancer and an estimated 33,000 have died from the disease.4 Prostate cancer is the fifth leading cause of death from cancer in men.3 Prostate cancer results from the abnormal proliferation of cells within the prostate gland, which is part of a man’s reproductive system.5 It mainly affects men over the age of 50, and the risk increases with age.6

Treatment options range from surgery to radiation treatment to therapy using hormone-receptor antagonists, i.e., substances that stop the formation of testosterone or prevent its effect at the target location.7 However, in nearly all cases, the cancer eventually becomes resistant to conventional hormone therapy.8

Castration-resistant prostate cancer (CRPC) is an advanced form of the disease where the cancer keeps progressing even when the amount of testosterone is reduced to very low levels in the body. The field of treatment options for castration-resistant patients is evolving rapidly for CRPC patients who have prostate cancer that has not spread to other parts of the body with rising prostate-specific antigen (PSA) levels despite a castrate testosterone level, which is called non-metastatic castration-resistant prostate cancer, or nmCRPC.9,10 About one-third of men with nmCRPC go on to develop metastases within two years.11 In men with progressive nmCRPC, a short PSA doubling time is correlated with shortened time to first metastasis and death.10

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.