On September 8, 2022 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer and other indications, reported that management is scheduled to present at the H.C. Wainwright 24th Annual Global Investment Conference on Wednesday, September 14, 2022 at 12:30 PM EDT (Press release, Pieris Pharmaceuticals, SEP 8, 2022, View Source [SID1234619308]). A webcast of the company’s presentation will be available at this link.

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On September 8, 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 first quarter of fiscal 2023, ended July 31, 2022 (Press release, Champions Oncology, SEP 8, 2022, View Source [SID1234619305]).

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First Quarter and Recent Highlights:

•Record quarterly revenue of $13.7 million, an increase of 22% year over year
•Adjusted EBITDA of $450,000
•Record quarterly bookings
•Series of antibody hits established in Alloy Therapeutics partnership

Ronnie Morris, CEO of Champions, commented, "We continued to deliver on our long-term vision in the first quarter by growing our service business while investing in transformative opportunities. Our bookings reached a quarterly record high and we achieved an important milestone in our target discovery program."

David Miller, CFO of Champions, added, "We began our first quarter of fiscal 2023 with another quarterly revenue record reaching $13.7 million, representing 22% year over year growth. Our adjusted EBITDA, which excludes stock-based compensation and depreciation expenses, was $450,000 and we anticipate EBITDA expansion over the course of the year."

First Fiscal Quarter Financial Results

Total revenue for the first quarter of fiscal 2023, was a record $13.7 million, an increase of 22.1%, compared to $11.3 million for the same period last year. The increase in revenue was due to continued

Exhibit 99.1
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 first quarter of fiscal 2023 were $14.0 million compared to $11.4 million for the first quarter of fiscal 2022, an increase of $2.6 million or 22.8%.

For the first quarter of fiscal 2023, Champions reported a loss from operations of $284,000, including $206,000 in stock-based compensation and $528,000 in depreciation and amortization expenses, compared to a loss from operations of $175,000, inclusive of $280,000 in stock-based compensation and $317,000 in depreciation and amortization expenses, in the first quarter of fiscal 2021. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported adjusted EBITDA for the quarter of $450,000 compared to $422,000 in the prior year period.
Cost of oncology solutions was $7.1 million for the three-months ended July 31, 2022, an increase of $1.7 million, or 30.7% compared to $5.4 million for the three-months ended July 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 July 31, 2022, gross margin was 49% compared to 52% for the three-months ended July 31, 2021. The lower margin resulted from an increase in study related expenses in advance of the revenue recognition and from SaaS expenses that were capitalized in the prior year period.

Research and development expense for the three-months ended July 31, 2022 was $2.9 million, an increase of $583,000 or 25.3%, compared to $2.3 million for the three-months ended July 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 July 31, 2022 was $1.7 million, an increase of $118,000, or 7.5%, compared to $1.6 million for the three-months ended July 31, 2021. The increase was primarily due to compensation expense. General and administrative expense for the three-months ended July 31, 2022 was $2.4 million, an increase of $244,000, or 11.3%, compared to $2.2 million for the three-months ended July 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 used in operating activities was $195,000 for the three-months ended July 31, 2022. The cash utilized in operating activities was primarily due to a reduction in our accounts payable and accrued liability balances during the ordinary course of business. Net cash used in investing activities was $754,000 and primarily for the purchase of lab and computer equipment.

The Company ended the quarter with a strong cash position of $8.1 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 888-506-0062 (Domestic) or 973-528-0011 (International) and enter the access code 618777, or provide the verbal reference "Champions Oncology".
Full details of the Company’s financial results will be available by Monday, September 12, 2022 in the Company’s Form 10-Q at www.championsoncology.com.
* Non-GAAP Financial Information

Exhibit 99.1
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, 2022 and 2021. 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 8, 2022 Alpha Tau Medical Ltd. ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported the acceptance of two landmark pre-clinical studies in major peer-reviewed journals, both demonstrating the significant potential synergies between Alpha DaRT therapy and standard-of-care solid tumor therapies used today (Press release, Alpha Tau Medical, SEP 8, 2022, View Source [SID1234619304]).

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"We are very excited to have these fantastic results recognized by two leading journals in our field," said Alpha Tau CEO Uzi Sofer. "The potential synergy between Alpha DaRT and immunotherapies continues to be a strong area of focus for Alpha Tau, both in our ongoing pre-clinical work as well as in our endeavors to run multiple human clinical trials examining such combinations, including the trial currently underway combining Alpha DaRT with pembrolizumab in recurrent unresectable or metastatic head & neck squamous cell carcinoma patients. Similarly, the promising results for GBM patients are a key priority for Alpha Tau, as we continue to focus on advancing our solution for this deadly disease as quickly as possible. Armed with our Breakthrough Device Designation from the FDA in recurrent GBM, we have been progressing swiftly in large animal studies using our specially designed radial applicator for use in the brain, with the intent to begin a human clinical study in the near future."

Ronen Segal, CTO at Alpha Tau added, "These two significant studies continue to build on the ever-growing body of evidence that the Alpha DaRT may offer not only a compelling local radiation therapy solution, but also provide a broader systemic benefit through interaction with the immune system, and our incorporation of more advanced immunological analyses has improved our understanding of these amazing mechanisms. We also are impressed by the synergies we see with other mechanisms such as anti-angiogenesis and continue to explore those in parallel as well."

The first study, published in the International Journal of Radiation Oncology, Biology, Physics (known as the Red Journal) examines the transcriptional profile activated by Alpha DaRT, and its potential to enhance responsiveness to immune checkpoint inhibition of the programmed cell death protein 1 (PD-1) blockade. These results demonstrate potential synergies with immune stimulation in mice and support the further exploration of the Alpha DaRT as a compelling local radiation therapy with the potential to induce antitumor immunity.

In this pre-clinical study, Squamous Cell Carcinoma ("SCC") tumor-bearing mice were treated with Alpha DaRT in combination with an anti-PD1 therapy ("aPD-1"). This group was compared to groups of mice treated with either Alpha DaRT or aPD-1 as a monotherapy, as well as to a control group. The efficacy of the treatment was evaluated over time, and the immune level of activation was analyzed through immunophenotyping and immunohistochemical staining sixteen days after Alpha DaRT source insertion.

The group treated with Alpha DaRT in combination with aPD-1 demonstrated delayed tumor development, higher T-effector cell infiltration with enhanced cytotoxic potential, and reduced systemic Myeloid-Derived Suppressor Cells ("MDSCs") than either monotherapy alone. Gene expression and gene set enrichment analysis of mRNA levels seven days after Alpha DaRT insertion indicated that Alpha DaRT upregulated indicators of cell death, interferon signaling and myeloid related transcription, while downregulating indicators of DNA repair and cell proliferation. Moreover, immunophenotyping analysis at this timepoint showed that Alpha DaRT induced dendritic cell activation and affected the distribution of MDSC populations. Altogether, those findings demonstrated that the Alpha DaRT may offer tumor cell destruction via additional pathways beyond the immediate local impact of generating double-strand DNA breaks in tumor cells.

This study’s authors conclude that Alpha DaRT can promote a "hot" tumor microenvironment and changes in immune suppression that lead to a potentiation of aPD-1 blockade-induced effector T-cell function and improved treatment efficacy. The authors observe that this study provides a rationale for investigating the combination of Alpha DaRT and aPD-1 clinically in SCC patients.

The second study, accepted for publication by Frontiers in Oncology in its Radiation Oncology section, examines the use of Alpha DaRT in treating human glioblastoma multiforme ("GBM") xenografts, together with Temozolomide ("TMZ"), a standard-of-care chemotherapy, or Bevacizumab, a standard-of-care antiangiogenic therapy, both commonly used in treating GBM.

The results demonstrated that the combination of alpha radiation with TMZ doubled the cytotoxic effect of each of the treatments alone, and the surviving fraction of cancer cells treated by TMZ in combination with alpha irradiation was lower than alpha- or x-ray irradiation as monotherapies, or than by x-ray combined with TMZ. In addition, the treatment of GBM-bearing mice with Alpha DaRT and TMZ delayed tumor development more efficiently than the monotherapies. The studies further confirmed that, unlike other radiation types, alpha radiation did not increase the secretion of VEGF, a potent angiogenic factor that promotes tumor growth.

With respect to the combination of Alpha DaRT with anti-angiogenic therapy, Bevacizumab treatment introduced several days after Alpha DaRT implantation improved tumor control, compared to Bevacizumab or Alpha DaRT as monotherapies. The combination was also shown to be superior when starting Bevacizumab administration prior to Alpha DaRT implantation in large tumors relative to the size of the Alpha DaRT source. Bevacizumab induced a decrease in the endothelial cell marker CD31 staining in conjunction with the Alpha DaRT treatment, and increased the diffusive spread of Radium-224 daughter atoms in the tumor tissue, while decreasing their clearance from the tumor through the blood.

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

On September 8, 2022 Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported that an abstract about its lead program fostroxacitabine bralpamide (fostrox) and the potential efficacy in primary liver cancer has been accepted for presentation at the SITC (Free SITC Whitepaper) 37th Annual Meeting, held November 10-12, 2022, in Boston, USA (Press release, Medivir, SEP 8, 2022, View Source [SID1234619302]).

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The abstract, titled "Fostrox (MIV-818) in combination with anti-PD-1 shows increased efficacy in nonclinical tumour models in vivo" will be presented at the conference by Fredrik Öberg, CSO at Medivir. The presentation includes study results outlining the potential for enhanced anti-tumour effects when an anti-PD1 antibody is combined with fostrox.

"Fostrox induces DNA damage and tumour cell death, potentially leading to increased tumour antigen presentation and an increased immune response, generating potential for combining with a checkpoint inhibitor like anti-PD-1. Our results confirm that fostrox has the potential to be combined with anti-PD-1 antibodies for improved efficacy in patients with primary liver cancer," says Fredrik Öberg.
"Primary liver cancer is a disease with significant unmet need and combining treatments with different and additive mechanisms of action will be critical to improve outcomes for patients. Fostrox has a unique, liver targeted approach and these results further support our belief that it has a strong potential for attractive combinations", says Jens Lindberg, CEO at Medivir AB.
The abstract and the poster will be available on Medivir’s website after the presentation.

About fostrox

Fostroxis a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC and other forms of liver cancer. Fostrox has completed a phase 1b monotherapy study, and a combination study in HCC currently ongoing.

About primary liver cancer

Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are 42,000 patients diagnosed with primary liver cancer per year in the US and current five-year survival is 11 percent. HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

On September 8, 2022 Caris Life Sciences(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, reported that the company and partners within its Precision Oncology Alliance (POA) will collectively present nine studies covering a diversity of tumor types and genomic alterations at the 2022 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress from September 9-13, 2022 (Booth #407) (Press release, Caris Life Sciences, SEP 8, 2022, View Source [SID1234619301]).

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"The depth and range of research being presented by Caris and the POA demonstrates the value this collaboration brings to the broader oncology community," said Chadi Nabhan, M.D., MBA, FACP, Chairman of the Caris Precision Oncology Alliance. "The study findings provide critical insights into cancer biology and treatment outcomes that will help drive further clinical research and better inform diagnoses, clinical and therapeutic decision-making for oncology practices."

"Enabling clinicians to make the best treatment choices, researchers to discover novel cancer biology, and the biopharmaceutical industry to develop the next breakthrough medicines are foundational goals of Caris," said David Spetzler, M.S., Ph.D., MBA, President and Chief Scientific Officer of Caris. "Data presented at this year’s ESMO (Free ESMO Whitepaper) Congress highlight the value of Caris’ comprehensive approach to molecular profiling built from our extensive data along with our AI-driven platform – which combines data from DNA (Whole Exome), RNA (Whole Transcriptome), and protein profiling with real-world clinical evidence from over 400,000 lifetime cases – to better understand the biological hallmarks of cancers and ultimately improve outcomes for all cancer patients."

The Caris Precision Oncology Alliance includes 70 cancer centers and academic institutions worldwide. These institutions have early access to the extensive database and artificial intelligence platform within Caris to establish evidence-based standards for cancer profiling and advance research in cancer precision medicine. By leveraging the comprehensive genomic, transcriptomic and proteomic profiling available through Caris molecular profiling, Caris seeks to provide this network with the ability to prioritize therapeutic options and determine which clinical trial opportunities may benefit their patients. POA members are also able to integrate with a growing portfolio of biomarker directed trials sponsored by biopharma. Additionally, POA member institutions have access to Caris CODEai, the most comprehensive data solution in the industry with cancer treatment information and clinical outcomes data for over 275,000 patients covering over 1 million data points per patient.

Data to be presented by Caris and the POA include an oral presentation focusing on transcription factor expression in extra-pulmonary small cell carcinomas. Other notable topics explored in these abstracts include next generation sequencing of large real-world tumor databases, genomic and immune mapping of patients undergoing experimental therapies in clinical trials and investigations of changing tumor microenvironments for solid tumors:

Comparative Expression of Driver Transcription Factors in Extra-Pulmonary Small Cell Carcinoma (Abstract Number: 899MO)
September 12, 2022, 09:05-09:10 CEST
Pan-tumor survey of RET fusions as detected by next-generation RNA sequencing identified RET+ colorectal carcinoma as a unique molecular subset of CRC (Abstract Number: 72P)
September 10, 2022, 10:00-11:00 CEST
Pan-tumor survey of ROS1 fusions detected by next-generation RNA sequencing (Abstract Number: 105P)
September 10, 2022, 10:00-11:00 CEST
The Heterogeneic Molecular Landscape of Ovarian Cancer Metastases (OCM) (Abstract Number: 594P)
September 11, 2022, 13:00-14:00 CEST
The Molecular and Immune Landscape of Recurrent Head and Neck squamous cell Carcinoma (HNSCC) in Patients Undergoing Definitive Therapy (Abstract Number: 699P)
September 11, 2022, 14:00-15:00 CEST
CLEC3B mRNA expression levels are linked to distinct genetic backgrounds, transcriptomic signatures and survival in NSCLC (Abstract Number: 1723P)
September 11, 2022, 16:00-17:00 CEST
Tumor Microenvironment (TME) of HRAS Mutated Non-Small Cell Lung Cancer (NSCLC) (Abstract Number: 1066P)
September 12, 2022, 12:00-13:00 CEST
Comprehensive molecular profiling of squamous non-small cell lung cancer by smoking status (Abstract Number: 1052P)
September 12, 2022, 12:00-13:00 CEST
Genomic characteristics and clinical outcomes of HRAS-mutated urothelial bladder cancer (Abstract Number: 1771P)
September 12, 2022, 15:00-16:00 CEST
Poster and abstract summaries of this research will be available onsite at Caris’ booth #407. The full abstracts are available through the official ESMO (Free ESMO Whitepaper) website.