Champions Oncology Reports Quarterly Revenue of $13.1 Million

On July 24, 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 the fiscal year and fourth quarter ended April 30, 2023 (Press release, Champions Oncology, JUL 24, 2023, View Source [SID1234633381]).

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Fourth Quarter and Fiscal Year 2023 Financial and Recent Business Highlights:
•Fourth quarter revenue increased 2% to $13.1 million
•Record annual revenue of $53.9 million, an increase of 10% year-over-year
•Year-over-year fourth quarter and annual bookings increase of 15%
•Announced the formation of our wholly owned bio-tech subsidiary, Corellia AI, to develop novel therapeutics

Ronnie Morris, CEO of Champions, commented, "Overall we had another year of business expansion, developing our platforms and investing in our drug discovery efforts. As mentioned during the year, the down-turn in the economy, and specifically the biotech sector, was going to weigh on our year end results. However, demand for our services reaccelerated and our long term prospects are strong." Morris added, "launching our wholly owned subsidiary, Corellia, to advance our therapeutic discovery initiative is a significant milestone for Champions as we add early stage biotech capabilities utilizing our data to facilitate future growth."

David Miller, CFO of Champions added, "We realized another year of record annual revenue, growing to $54 million, coming in at the low end of our revenue guidance. As addressed during the year, an increase in study cancellations led to revenue growth below our historic performance rates and impacted profitability. While pressures still remain, our pipeline of opportunities has reaccelerated and we remain well positioned for a return to profitability in the second half of the current fiscal year and the long term."

Fourth Fiscal Quarter Financial Results

Total revenue for the fourth quarter of fiscal 2023 was $13.1 million, an increase of 2%, compared to $12.9 million for the same period last year. The increase in revenue was due to continued demand and larger study sizes for our pharmacology studies, including in-vivo and ex-vivo services. Total costs and operating expenses for the fourth quarter of fiscal 2023 were $15.6 million compared to $13.2 million for the fourth quarter of fiscal 2022, an increase of $2.4 million or 18%.

For the fourth quarter of fiscal 2023, Champions reported a loss from operations of $2.5 million, which includes $209,000 in stock-based compensation, $583,000 in depreciation and

Exhibit 99.1
amortization, and an $807,000 asset impairment charge compared to a loss from operations of $311,000, inclusive of $188,000 in stock-based compensation and $568,000 in depreciation and amortization in the fourth quarter of fiscal 2022. Excluding stock-based compensation, depreciation and amortization expenses, and an asset impairment charge, Champions reported an adjusted EBITDA loss for the quarter of $922,000, compared to adjusted EBITDA of $445,000 in the prior year period.

Cost of oncology solutions was $7.3 million for the three months ended April 30, 2023, an increase of $1.1 million, or 18% compared to $6.2 million for the three months ended April 30, 2022. The increase in cost of sales was primarily due to an increase in compensation and lab supply expenses. For the three months ended April 30, 2023, gross margin was 44% compared to 52% for the three months ended April 30, 2022. The lower margin resulted from the increase in compensation which was incurred to support bookings growth that failed to convert to revenue at the expected conversion rates.
Research and development expense was $2.9 million for the three months ended April 30, 2023, an increase of $263,000, or 10%, compared to $2.6 million in the prior year. The increase was primarily due to compensation and lab expenses as we increased investment in our drug discovery program. Sales and marketing expense for the three months ended April 30, 2023 was $1.8 million, an increase of $234,000, or 14%, compared to $1.6 million for the three months ended April 30, 2022. The increase was the result of an increase in compensation and marketing initiatives. General and administrative expense was $2.7 million for the three months ended April 30, 2023 compared to $2.8 million for the three months ended April 30, 2022, a slight decrease of $16,000, or 1%. An asset impairment charge of $807,000 was recorded as a one-time charge to write-off the remaining balance of the capitalized software development costs for our Lumin Bioinformatics SaaS platform.

Net cash used in operating activities for the quarter was approximately $693,000 resulting primarily from an operating loss and changes in our working capital accounts in the ordinary course of business. Net cash used in investing activities was $760,000 primarily from purchases of additional lab equipment. Net cash used in financing activities was approximately $75,000 related to the Company’s stock repurchase program. The Company ended the quarter with a strong cash position of $10.1 million and no debt.

Year-to-Date Financial Results

Total revenue for fiscal year 2023 was $53.9 million, an increase of 10%, compared to $49.1 million for fiscal year 2022. The increase in revenue was due to the expansion of our platforms, business lines, and demand for our services. Total operating expenses increased 22% to $59.1 million for fiscal year 2023, as compared to $48.5 million for the prior year.

For the twelve months ended April 30, 2023, Champions reported a net loss from operations of $5.3 million, inclusive of $864,000 in stock-based compensation expense, $2.2 million in depreciation and amortization expenses, and an asset impairment charge of $807,000 compared to income from operations of $607,000, inclusive of $912,000 in stock-based compensation expense and $1.6 million in depreciation and amortization expenses for the prior year. Excluding stock-based compensation, depreciation and amortization, and asset impairment, Champions reported an adjusted EBITDA loss of $1.3 million for fiscal year 2023 compared to adjusted EBITDA of $3.1 million in the prior year.

Cost of oncology solutions was $29.5 million for the twelve months ended April 30, 2023, an increase of $5.9 million or 25%, compared to $23.6 million, for the twelve months ended April 30, 2022. The increase in cost of oncology services was mainly due to an increase in compensation and supply expenses. Gross margin was 45% for the twelve months ended April 30, 2023 compared to 52% for the twelve months ended April 30, 2022. The lower margin resulted from the increase in compensation which was incurred to support bookings growth that failed to convert to revenue at the expected conversion rates due to an increase in study cancellations.

Research and development expense was $11.5 million for fiscal year 2023, an increase of $2.2 million, or 23%, compared to $9.4 million for the prior year. The increase was mainly due to the investment in therapeutic discovery programs with the increase coming primarily from compensation, lab supply expenses, and early drug development milestone expenses. Sales and marketing expense for fiscal year 2023 was $7.0 million, an increase of $623,000, or 10%, compared to $6.4 million for fiscal year 2022. The increase was primarily due to compensation expense driven by the continued expansion of our business development teams and marketing initiatives, including increased conference attendance due to the easing of Covid restrictions. General and administrative expense was $10.2 million for fiscal year 2023, an increase of $1.1 million, or 12%, compared to $9.1 million for fiscal year 2022. General and administrative expenses were primarily comprised of compensation, insurance, professional fees, IT, and depreciation and amortization expenses. The increase in general and administrative expense was primarily due to increases in IT expenses to support the overall growth of the company and an increase in non-cash depreciation and amortization expenses. A one-time asset impairment charge of $807,000 was recorded to write-off the remaining balance of our capitalized software development costs for our Lumin Bioinformatics SaaS platform.

Net cash generated from operations was $4.0 million for fiscal year 2023. Cash generated from operations was primarily due to changes in working capital accounts in the ordinary course of business and an increase in deferred revenue as a result of strong bookings. Net cash used in investing activities was $2.9 million primarily from investment in additional lab equipment. The Company ended the year in a strong cash position of $10.1 million and 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 fourth quarter financial results. To participate in the call, please call 877-545-0523 (domestic) or 973-528-0016 (international) ten minutes ahead of the call and enter the access code 477670. A replay of the call will be available by dialing 877-481-4010 (Domestic) or 919-882-2331 (International) and entering passcode: 48774, or by accessing the investors section of the company’s website within 72 hours.

Full details of the Company’s financial results will be available on, or before, Monday July 24, 2023 in the Company’s Form 10-K at View Source

BMF-219 Induces Complete Responses in Target Acute Myeloid Leukemia (AML) Patient Population

On July 24, 2023 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported preliminary topline data from its ongoing Phase I clinical trial, COVALENT-101, showcasing initial responses in relapsed/refractory AML patients with menin-dependent mutations (Press release, Biomea Fusion, JUL 24, 2023, View Source [SID1234633380]).

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In the COVALENT-101 study, BMF-219 is orally administered on a daily schedule in continuous 28-day cycles. The preliminary analysis as of July 13, 2023 of Dose Level 4 [500 mg once daily (non-CYP3A4 inhibitor arm) and 125 mg once daily (CYP3A4 inhibitor arm), both producing comparable exposures] showed CRs in 2 of 5 AML patients with known menin-dependent mutations (KMT2Ar/MLL1r, 1 patient; NPM1, 2-patients; MLL-PTD, 1-patient; and NUP98 fusion, 1-patient). These relapsed/refractory patients had a range of prior therapies (1 to 8) and two complete responses (1 CR, 1 CRi) were observed within the first two 28-day treatment cycles with BMF-219. Patients were previously treated with standard-of-care and investigational therapies including allogeneic bone marrow transplant. Both patients who achieved CRs continue on BMF-219 treatment. Dose Level 4 is the first dose level which focused primarily on enrolling patients with known menin-dependent mutations.

BMF-219 has been generally well tolerated with no QTc prolongation reported. At the time of this analysis, a total of 20 AML patients have received BMF-219 during the dose escalation portion of the COVALENT-101 study. Initially, patients were enrolled agnostic to mutational status; subsequently, the study protocol was amended to enrich for patients with AML harboring menin-dependent mutations.

Dose Level 4 was cleared with no dose-limiting toxicities observed, allowing for the continuation of dose escalation. Enrollment for Dose Level 5 has commenced to further optimize and explore the potential to improve upon these preliminary results. Completion of the dose escalation for the acute leukemia cohort is anticipated later this year. Biomea is planning to present additional clinical data from the COVALENT-101 study at an upcoming scientific conference, including comprehensive results from the acute leukemia patients dosed during the escalation phase.

"We are very excited to share these early findings confirming that our targeted, covalently binding menin inhibitor, BMF-219, can elicit profound and rapid responses in patients with menin inhibitor-sensitive acute leukemia even at this dose level, which we believe we can further build on," said Steve Morris, MD, Biomea’s Chief Medical Officer. "Notably these complete remissions were achieved within the first two cycles of BMF-219 therapy in relapsed/refractory AML patients who had limited therapeutic options and an overall poor prognosis. We are continuing to dose escalate and are looking forward to identifying the recommended Phase 2 dose within the next several months."

About BMF-219
BMF-219 is a covalently binding inhibitor of menin, a protein known to play an essential role in oncogenic signaling in genetically defined leukemias as well as in diabetes. Preclinically, BMF-219 has demonstrated in well-established acute leukemia cell lines robust downregulation of key leukemogenic genes in addition to menin itself. Additionally, BMF-219 has shown anticancer efficacy in multiple in vitro, in vivo, and ex vivo models of acute leukemia, multiple myeloma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia. BMF-219 is currently being evaluated in first-in-human clinical trials enrolling patients with specific menin-dependent mutations in liquid and solid tumors as well as patients with diabetes.

About COVALENT-101
COVALENT-101 is a Phase I, open-label, multi-center, dose-escalation and dose-expansion study designed to assess the safety, tolerability, and pharmacokinetics/pharmacodynamics of oral dosing of BMF-219 in patients with relapsed/refractory (R/R) acute leukemias —including subpopulations where menin inhibition is expected to provide therapeutic benefit (e.g., patients with MLL1/KMT2A gene rearrangements or NPM1 mutations). The study is designed to enroll subsets of acute leukemia patients who are receiving a CYP3A4 inhibitor and also those not receiving a CYP3A4 inhibitor. COVALENT-101 is also investigating the dosing of BMF-219 in other patient populations where preclinical studies have shown high menin dependence, such as multiple myeloma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. Additional information about this Phase I clinical trial of BMF-219 can be found at ClinicalTrials.gov using the identifier NCT05153330.

About Acute Myeloid Leukemia (AML)
AML is the most common form of acute leukemia in adults and represents the largest number of annual leukemia deaths in the U.S. and Europe. AML originates within the white blood cells in the bone marrow and can rapidly move to the blood and other parts of the body, including the spleen, central nervous system, and other organs. Approximately 30,000 people in the U.S. and Europe are diagnosed with AML each year, and the five-year overall survival rate in adults is roughly 29%. Among patients with relapsed/refractory disease, the need is greatest, as the overall survival is only approximately 3 to 9 months. It is estimated that upwards of 45% of AML patients have menin-dependent genetic drivers (MLL1-r, NPM1 mutant, and certain additional less common but recurrent gene mutations).

Actinium Pharma to Present at the 2nd Annual Targeted Radiopharmaceuticals Summit

On July 24, 2023 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, reported that the Company will participate in the 2nd Annual Targeted Radiopharmaceuticals Summit in Boston, July 25 – 27, 2023 (Press release, Actinium Pharmaceuticals, JUL 24, 2023, View Source [SID1234633378]). Actinium will present "Targeted Radiotherapeutics & Innovative Combinations to Alter the Treatment Outcome for Conditioning, Hematological & Solid Tumor Malignancies" on Thursday, July 27, 2023 at 12:30pm ET.

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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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Imugene’s B cell immunotherapy & oncolytic virotherapy platforms to be featured at ESMO Congress

On July 24, 2023 : Imugene Limited (ASX: IMU), a clinical stage immunooncology company, reported that its B cell immunotherapy HER-Vaxx and CF33 oncolytic virotherapy CHECKVacc will feature at the upcoming ESMO (Free ESMO Whitepaper) Congress, to be held in Madrid on 20-24 October 2023 (Press release, Imugene, JUL 24, 2023, https://mcusercontent.com/e38c43331936a9627acb6427c/files/cffc5686-3530-0415-25bc-3611c54b3cdd/Imugene_HER_Vaxx_and_CHECKVacc_to_be_Featured_at_ESMO.pdf [SID1234633375]).

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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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The European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress is the most influential oncology platform for clinicians, researchers, patient advocates, journalists, and healthcare industry representatives from all over the world.

The abstract titles have been announced for the symposium, with Imugene to feature in the following:

Poster Session

• #4720: HERIZON: A Phase 2 study of HER-Vaxx (IMU-131), a HER2-targeting peptide vaccine plus standard of care chemotherapy in patients with HER2+ advanced stomach Cancer — dose-dependent anti-cancer antibodies correlating with improved clinical outcome. Presenter: Dr Joshua Tobias, Medical University of Vienna. Poster Session

• #4581: Induction of an Inflammatory Tumor Microenvironment with Oncolytic Virus CF33-hNIS-antiPD-L1 Intratumoral Injection in Patients with Metastatic Triple Negative Breast Cancer (mTNBC). Presenter: Dr Jamie Rand, City of Hope.

Clarity reaches 50% recruitment milestone for Phase II SABRE prostate cancer trial

On July 24, 2023 Clarity Pharmaceuticals (ASX: CU6) ("Clarity", "the Company"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported that the Phase II US-based diagnostic 64Cu SAR-Bombesin trial (SABRE NCT05407311)1 for patients with prostate cancer has reached its fifty percent recruitment milestone, with 25 out of 50 participants enrolled and imaged (Press release, Clarity Pharmaceuticals, JUL 23, 2023, View Source [SID1234633382]).

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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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SABRE (Copper-64 SAR-Bombesin in Biochemical Recurrence of prostate cancer) is a Phase II Positron Emission Tomography (PET) imaging trial of participants with PSMA-negative biochemical recurrence (BCR) of prostate cancer following definitive therapy. It is a multi-centre, single arm, non-randomised, open-label trial of 64Cu-labelled SAR-Bombesin in 50 participants. The primary objectives of the trial are to investigate safety and tolerability of the product as well as its ability to correctly detect recurrence of prostate cancer.

Andrei Iagaru, MD, the Lead Principal Investigator for the trial, commented, "We have been working on Bombesin for many years now and I am very excited with the progress of the SABRE trial and the continued exploration and validation of the clinical benefits associated with the SAR-Bombesin agent. It gives hope to clinicians and patients who have no other suitable diagnostic options available due to their cancers having low or no PSMA expression. Being able to visualise the disease can change the entire treatment paradigm for these patients. Once we can see the cancer, clinicians can then find the most suitable therapeutic regiment to maximise treatment outcomes. Based on the promising preclinical and clinical data to date, SAR-Bombesin is an exciting new product for better managing these patients that have few options at present in the face of a devastating diagnosis. We look forward to recruiting the remaining 25 patients in the trial and further analysing the trial data."

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We continue to build significant positive data on our SAR-Bombesin product. In addition to the SABRE trial, we are actively recruiting participants to our theranostic trial, COMBAT, and have recently finished recruitment into an investigator initiated Phase II diagnostic trial, BOP, with this product. Subject to the outcome of the SABRE trial, Clarity is planning to launch a pivotal Phase III diagnostic trial for first product approval in the US.

"SAR-Bombesin has already resulted in improvements to the management of prostate cancer for patients that are PSMA-negative or have low PSMA expressing tumours and we hope to confirm its safety and efficacy in our clinical programs. We look forward to progressing the development of SAR-Bombesin and potentially providing a large patient population with accurate and precise detection and treatment of their prostate cancer,"

About SAR-Bombesin
SAR-Bombesin is a highly targeted pan-cancer radiopharmaceutical with broad cancer application. It targets the gastrin-releasing peptide receptor (GRPr) present on cells of a range of cancers, including but not limited to prostate, breast and ovarian cancers. GRPr is found in approximately 75-100% of prostate cancers, including prostate cancers that don’t express PSMA (PSMA-negative)2-6. The product utilises Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-Bombesin is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide7. The American Cancer Institute estimates in 2023 there will be 288,300 new cases of PC in the US and around 34,700 deaths from the disease8.

Approximately 20% of prostate cancers with BCR are PSMA-PET negative9-12. These patients are therefore unlikely to respond to therapeutic PSMA-targeted products and currently have few treatment options available to them. Given the prostate cancer indication is one of the largest in oncology, there is a significant unmet medical need in this segment. The SAR-Bombesin product could offer valuable imaging and therapeutic options for not only PSMA-negative patients, but also the large number of patients that have the target receptor on their cancers.