On December 13, 2021 Celyad Oncology SA (Euronext & Nasdaq: CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, reported that data from the Phase 1 CYCLE-1 trial of CYAD-02 for the treatment of relapsed or refractory (r/r) acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) and the Phase 1 IMMUNICY-1 trial of CYAD-211 for the treatment of r/r multiple myeloma were presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Celyad, DEC 13, 2021, View Source [SID1234597050]). The data support the potential and versatility of non-gene edited short hairpin RNA (shRNA) technology for the development of next-generation CAR T therapies.

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"Our presentations at this year’s ASH (Free ASH Whitepaper) conference continue to support the potential of our shRNA technology platform to have an impact in the CAR T space without the potential risks recently associated with gene-editing technologies," said Dr. David Gilham, Chief Scientific Officer of Celyad Oncology. "Data from our CYAD-02 program indicate that a single shRNA can target two independent genes to optimize CAR T cell phenotype, a utility that we believe is unique among currently available gene-expression control technologies. Additionally, the initial observations of cell engraftment, lack of GvHD, and initial signs of clinical activity in the early stages of our first-in-human allogeneic CYAD-211 clinical study underpin the broad potential applicability of shRNA as a platform technology. As we continue to explore these individual product candidates and now focus upon evaluating clinical activity, this clinical proof of principle gives us high confidence to develop further novel clinical candidates based upon our novel shRNA platform."

Filippo Petti, Chief Executive Officer of Celyad Oncology, added, "This is an exciting time for our company as we continue to validate the multifaceted approach of our shRNA technology. Continued progress with the CYAD-02 program demonstrates the power of shRNA in an autologous setting and serves as a strong foundation for any potential partnership with the program. We also have clear direction for our CYAD-211 program, where we plan to initiate enhanced lymphodepleting regimens to increase cell persistence to potentially maximize clinical benefit from the therapy. As we continue to build on our solid foundation in the allogeneic CAR T space, we remain committed to developing a new paradigm of therapy for these patients."

Key Highlights from the ASH (Free ASH Whitepaper) Annual Meeting

CYAD-02 and CYCLE-1 Phase 1 Trial Update

Data from autologous NKG2D receptor CAR T candidate CYAD-02 using shRNA shows a single shRNA can target two independent genes to enhance the phenotype of the CAR T cells

A favorable tolerability profile for CYAD-02 with a low rate of Grade ³ 3 cytokine release syndrome in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome (r/r AML / MDS)

The dual knockdown of genes MICA/MICB with a single shRNA has a positive contribution to the initial clinical activity of CYAD-02 as compared to the first-generation, autologous NKG2D receptor CAR T, CYAD-01

Two MDS patients achieved a marrow complete response at dose level 3

Of the eight patients with stable disease, four had anti-leukemic activity

Comparison of cellular kinetics for CYAD-02 and CYAD-01 trend towards increased engraftment and persistence of CYAD-02 versus CYAD-01, potentially associated with the knockdown of MICA/MICB and reduced fratricide in vivo

CYAD-211 and IMMUNICY-1 Phase 1 Trial Update

Trial observations from allogeneic shRNA-based anti-BCMA CAR T candidate CYAD-211 support the continued development of shRNA-based allogeneic CAR T therapies as a feasible approach to overcome potential drawbacks and risks associated with autologous and gene-edited allogeneic CAR T therapies

CYAD-211 demonstrated a good tolerability profile and evidence of clinical activity in the dose-escalation segment with three out of 12 total patients with relapsed or refractory multiple myeloma (r/r MM) evaluated for activity achieving partial response, one in each dose-level, while eight patients had stable disease

All patients had detectable CYAD-211 cells in the peripheral blood; preconditioning chemotherapy led to earlier-than-expected recovery of host lymphocytes limiting persistence of CAR T cells

The next segment of the IMMUNICY-1 trial will evaluate enhanced lymphodepleting regimens with the aim to improve persistence. In addition, the protocol also allows for CYAD-211 redosing in certain patients

Enrollment in the cohorts evaluating enhanced lymphodepletion is ongoing. Additional data from the CYAD-211 IMMUNICY-1 trial are expected in mid-2022

Conference Call and Webcast Details

Celyad Oncology will host a conference call to discuss the update from ASH (Free ASH Whitepaper) on Monday, December 13, 2021 at 2:30 p.m. CET / 8:30 a.m. EST. The conference call can be accessed through the following numbers:

United States: #1 877-407-9208

International: #1 201-493-6784

The conference call will be webcast live and can be accessed here. The event will also be archived and available on the "Events" section of the company’s website. Please visit the website several minutes prior to the start of the broadcast to ensure adequate time for registration to the webcast.

On December 13, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported a summary of its poster presentation at the 2021 ASH (Free ASH Whitepaper) Annual Meeting evaluating GRASPA (eryaspase) in acute lymphoblastic leukemia (ALL) as well as the acceptance of two abstracts evaluating eryaspase in advanced pancreatic cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI), which will be held January 20-22, 2022, both in San Francisco, CA and virtually (Press release, ERYtech Pharma, DEC 13, 2021, View Source [SID1234597045]).

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On December 13, 2021 Champions Oncology, Inc. (Nasdaq: CSBR), a leading global technology-enabled biotech that is transforming drug discovery through innovative pharmacology, biomarker, and data platforms, reported its financial results for its second quarter of fiscal 2022, ended October 31, 2021 (Press release, Champions Oncology, DEC 13, 2021, View Source [SID1234597042]).

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Second Quarter and Recent Highlights:

•Record quarterly revenue of $11.8 million, an increase of 17% year over year
•Reported non-GAAP income from operations, excluding stock-based compensation, depreciation and amortization, of $743,000
•Gross margin improved to 52%

Ronnie Morris, CEO of Champions, commented, "We had another quarter of milestone achievements for the Company as we saw strong operating results in our research service business and continued to expand the customer base of our SaaS Lumin platform." Morris added, "We’re advancing our therapeutic targets along the drug discovery pipeline and we’re excited about their progress and transformative potential for Champions."

David Miller, CFO of Champions, said, "We achieved another quarterly revenue record reaching $11.8 million. Additionally, by improving efficiencies and reducing certain costs, we improved our gross and operating margins all while continuing to increase R&D investment to support longer term strategic initiatives."

Second Fiscal Quarter Financial Results

Exhibit 99.1
For the second quarter of fiscal 2022, revenue increased 17% to $11.8 million compared to $10.1 million for the second quarter of fiscal 2021. The increase in revenue was due to continued demand for our pharmacology studies and the expansion of both our platform and product lines, driving an increase in sales, both in number and size of studies. Total costs and operating expenses for the second quarter of fiscal 2022 were $11.5 million compared to $10.1 million for the second quarter of fiscal 2021, an increase of $1.4 million or 14.0%.

For the second quarter of fiscal 2022, Champions reported net income from operations of $263,000, including $134,000 in stock-based compensation and $346,000 in depreciation and amortization expenses, compared to income from operations of $7,000, inclusive of $85,000 in stock-based compensation and $307,000 in depreciation and amortization expenses, in the second quarter of fiscal 2021. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported non-GAAP income from operations of $743,000 for the second quarter of fiscal 2022 compared to non-GAAP income from operations of $399,000 in the second quarter of fiscal 2021.
Cost of oncology solutions was $5.6 million for the three-months ended October 31, 2021, a decrease of $35,000, or (0.6)% compared to $5.6 million for the three-months ended October 31, 2020. For the three-months ended October 31, 2021, gross margin was 52.4% compared to 44.2% for the three-months ended October 31, 2020. Total cost of sales remained flat as we reduced the level of outsourcing required. The cost reduction more than offset the increase in compensation and lab supply expenses resulting from the increase in study volume.

Research and development expense for the three-months ended October 31, 2021 was $2.3 million, an increase of $649,000 or 39.3%, compared to $1.7 million for the three-months ended October 31, 2020. The increase was primarily from compensation and sequencing costs as we increased investment in our therapeutic target discovery platform. Sales and marketing expense for the three-months ended October 31, 2021 was $1.6 million, an increase of $292,000, or 21.7%, compared to $1.3 million for the three-months ended October 31, 2020. The increase was primarily due to compensation expense driven by the continued investment to expand our salesforce, including the addition of a dedicated SaaS business development team for our Lumin Bioinformatics platform. General and administrative expense for the three-months ended October 31, 2021 was $2.0 million, an increase of $507,000, or 34.5%, compared to $1.5 million for the three-months ended October 31, 2020. The increase was primarily due to an increase in compensation and IT related expenses.

Net cash generated from operating activities for the quarter was $1.2 million resulting from increased operating income excluding stock compensation and other non-cash related expenses. Net cash used in investing activities was $495,000 primarily from investment in additional lab equipment and software development. The Company ended the quarter with a strong cash position of $4.8 million. The Company has no debt.

Year-to-Date Financial Results

For the first six months of fiscal 2022, revenue increased 17% to $23.0 million compared to $19.7 million for the first six months of fiscal 2021. 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 2022 were $23.0 million compared to $19.6 million for the first six months of fiscal 2021, an increase of $3.3 million or 17%.

Exhibit 99.1
For the first six months of fiscal 2022, Champions reported net income from operations of $88,000, including $414,000 in stock-based compensation and 663,000 in depreciation and amortization expenses, compared to income from operations of $31,000, inclusive of $205,000 in stock-based compensation and $584,000 in depreciation and amortization expenses, in the first six months of fiscal 2021. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported non-GAAP income from operations of $1.2 million for the first six months of fiscal 2022 compared to non-GAAP income from operations of $822,000 in the first six months of fiscal 2021.
Cost of oncology solutions was $11.0 million for the six-months ended October 31, 2021, a slight increase of $25,000, or 0.2% compared to $11.0 million for the six-months ended October 31, 2020. For the six-months ended October 31, 2021, gross margin was 52.2% compared to 44.2% for the six-months ended October 31, 2020. The improvement in gross margin was primarily attributable to decreasing the Company’s reliance on outsourcing while continuing to grow revenue.

Research and development expense for the six-months ended October 31, 2021 was $4.6 million, an increase of $1.4 million or 41.8%, compared to $3.2 million for the six-months ended October 31, 2020. 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, 2021 was $3.2 million, an increase of $658,000, or 25.7%, compared to $2.6 million for the six-months ended October 31, 2020. The increase was primarily due to compensation expense driven by the continued investment in expanding our business development teams. General and administrative expense for the six-months ended October 31, 2021 was $4.1 million, an increase of $1.3 million, or 44.9%, compared to $2.9 million for the six-months ended October 31, 2020. The increase was primarily due to an increase in compensation as well as an increase in IT related expenses to support the overall infrastructure growth of the organization.

Net cash provided by operating activities was $1.4 million for the six-months ended October 31, 2021.The cash generated from operating activities was primarily due to operating income excluding stock compensation, depreciation and amortization expenses. Net cash used in investing activities was $1.5 million and was primarily from investment in additional lab equipment and software development.

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 877-545-0320 (Domestic) or 973-528-0002 (International) and enter the access code 694190 ten minutes ahead of the call.
Full details of the Company’s financial results will be available by Tuesday, December 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 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 and six months ended October 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

Exhibit 99.1
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 December 13, 2021 Immatics N.V. (NASDAQ: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, and Bristol Myers Squibb (NYSE: BMY), reported that they have entered into a license, development and commercialization agreement (the "agreement") for Immatics’ TCR Bispecific candidate, IMA401 (Press release, FierceBiotech, DEC 13, 2021, View Source [SID1234597041]).

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Under the terms of the agreement, Immatics will receive an upfront payment of $150 million as well as up to $770 million in development, regulatory and commercial milestone payments, in addition to tiered double-digit royalty payments on net sales of IMA401. Immatics retains the options to co-fund U.S. development in exchange for enhanced U.S. royalty payments and/or to co-promote IMA401 in the US.

IMA401 is the most advanced product candidate in Immatics’ TCR Bispecifics pipeline, called TCER (T Cell Engaging Receptors), in which one binding region targets MAGEA4/8, a highly prevalent antigen in multiple solid tumors, and the other region engages and activates T cells. In preclinical proof-of-concept studies, IMA401 has shown anti-tumor activity with complete remissions in various in vivo tumor models including patient-derived xenograft models. The agreement outlines a development plan under which both companies will collaborate to advance the program through clinical development.

In November 2021, Immatics filed a Clinical Trial Application (CTA)1 with Paul-Ehrlich-Institute (PEI), the German federal regulatory authority, for the development of IMA401. The clinical trial, which is planned to commence in the first half of 2022, will enroll patients across various solid tumor types.

"At Immatics, we are committed to our goal of delivering meaningful clinical benefits to cancer patients, and based on the promising preclinical data, we see remarkable potential for our TCER platform" said Carsten Reinhardt, M.D., Ph.D., Chief Development Officer at Immatics. "We are delighted to extend our existing collaboration with Bristol Myers Squibb to the IMA401 program and view this as an important validation of the therapeutic potential of our TCER approach. Bristol Myers Squibb’s global clinical development and commercialization capabilities in oncology make them the ideal partner for the further development of IMA401."

"We are pleased to expand our collaboration with Immatics to now include IMA401," said Teri Foy, Senior Vice President, Research and Early Development, Immuno-Oncology and Cell Therapy at Bristol Myers Squibb. "TCERs are an important, emerging modality for solid tumors with the potential for cell therapy-like efficacy in an off-the-shelf platform offering potentially broader patient access. We look forward to advancing IMA401 into the clinic to further assess its potential as an innovative medicine to help patients prevail over serious diseases."

Immatics entered a strategic collaboration in 2019 with Celgene Corporation, a wholly owned subsidiary of Bristol-Myers Squibb Company, to develop novel adoptive cell therapies. This new collaboration to develop Immatics’ Bispecific candidate TCER IMA401 complements ongoing cell therapy activities – both therapeutic modalities built on Immatics’ capabilities to identify novel targets and develop high-affinity, target-specific TCRs. The terms of the current agreement regarding Immatics’ TCER IMA401 program exclude any MAGEA4/8 targets for cell therapy. The agreement is subject to customary clearance by antitrust regulators.

1 Clinical Trial Application – the European equivalent of an Investigational New Drug (IND) application

About IMA401
IMA401 is Immatics’ half-life extended TCER molecule that targets an HLA-A*02-presented (human leukocyte antigen) peptide derived from two different cancer-associated proteins, melanoma-associated antigen 4 and/or 8 ("MAGEA4/8"). MAGEA4/8 is highly prevalent in several solid tumor types including squamous non-small-cell lung carcinoma, head and neck squamous cell carcinoma, bladder, uterine, esophageal and ovarian carcinomas, as well as melanoma, sarcoma subtypes and other solid cancer types.

About TCER
Immatics’ TCER molecules are antibody-like "off-the-shelf" biologics that leverage the body’s immune system by redirecting and activating T cells towards cancer cells expressing a specific tumor target. To do so, the proprietary biologics are engineered to have two binding regions. The first region contains an affinity- and stability-improved TCR that binds specifically to the cancer target on the cell surface presented by an HLA molecule. The second region is derived from an antibody domain that recruits endogenous T cells to the tumor to become activated. The design of the TCER molecules enables the activation of any T cell in the body to attack the tumor, regardless of the T cells’ intrinsic specificity. In addition, the TCER molecule has a Fc-part conferring stability, half-life extension and enhanced manufacturability.

On December 13, 2021 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance reported that preclinical data with ORIC’s small molecule inhibitor of CD73 in multiple myeloma at the American Society of Hematology (ASH) (Free ASH Whitepaper), in collaboration with Dr. Kenneth Anderson’s research laboratory at Dana-Farber Cancer Institute (Press release, ORIC Pharmaceuticals, DEC 13, 2021, View Source [SID1234597018]). The abstract and presentation are available for online viewing via the ASH (Free ASH Whitepaper) Annual Meeting website.

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"ORIC-533 has a differentiated profile, demonstrating stronger potency in a high AMP environment compared to benchmark CD73 inhibitors and adenosine receptor antagonists in preclinical studies," said Lori Friedman, chief scientific officer. "Based on a strong mechanistic rationale and compelling single agent activity in patient-derived autologous ex vivo assays, we are excited to pursue clinical development in multiple myeloma."

Multiple myeloma patient samples have demonstrated that the tumor environment is adenosine rich, and studies have shown that high CD73 and adenosine levels are associated with poor prognosis and therapeutic resistance.

The ASH (Free ASH Whitepaper) presentation focused on the role of adenosine signaling in immunosuppression in patients with relapsed or refractory multiple myeloma and the ability of ORIC’s small molecule inhibitor of CD73 to restore antitumor immune activity.

Key highlights from a series of experiments utilizing bone marrow aspirates from patients with multiple myeloma include:

CD73 inhibition addressed adenosine mediated immunosuppression, which stimulated T-cell proliferation, T-cell activation, and activation of plasmacytoid dendritic cells in ex vivo assays derived from patients with multiple myeloma.
ORIC’s small molecule inhibitor of CD73 overcame immunosuppression and triggered significant lysis and cell death of multiple myeloma cells by autologous T-cells from the bone marrow microenvironment.
ORIC’s CD73 inhibitor demonstrated single agent activity, comparing favorably to standard of care therapies, in bone marrow-derived mononuclear cell assays from relapsed or refractory myeloma patients.
The company plans to pursue a single agent clinical development plan for ORIC-533 in multiple myeloma and initiate a Phase 1 trial in the fourth quarter of 2021.

Additional Pipeline Updates:

ORIC-114 EGFR/HER2 Inhibitor

ORIC-114 is a brain penetrant, orally bioavailable, irreversible inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations. The company recently disclosed that ORIC-114 induced tumor regressions in a subcutaneous HER2 positive breast cancer xenograft model. In a new study, ORIC-114 demonstrated significant tumor growth inhibition in an intracranial HER2 positive breast cancer model, with superior antitumor activity versus tucatinib. The CTA has been filed in South Korea, and initiation of a Phase 1 trial is expected in early 2022.

ORIC-944 PRC2 Inhibitor

ORIC-944 is a potent and selective allosteric inhibitor of polycomb repressive complex 2 (PRC2) that targets its regulatory embryonic ectoderm development (EED) subunit and has demonstrated single agent efficacy in multiple enzalutamide-resistant prostate cancer models in preclinical studies. The IND was cleared by the FDA in December, and initiation of a Phase 1 trial is expected in early 2022.

Webcast and Conference Call Details

ORIC will host a conference call and webcast, today at 5:30 p.m. ET. To participate in the conference call, please dial (833) 651-0991 (domestic) or (918) 922-6080 (international) and refer to conference ID 7989199. A live webcast and audio archive of the conference call will be available through the investor section of the company’s website at www.oricpharma.com. The webcast will be available for replay for 90 days following the presentation.

About ORIC-533

ORIC-533 is a highly potent, orally bioavailable small molecule inhibitor of CD73, a key node in the adenosine pathway believed to play a central role in resistance to chemotherapy and immunotherapy-based treatment regimens. ORIC-533 has demonstrated greater potency in preclinical studies compared to an antibody approach, as well as other small molecule inhibitors of CD73 and adenosine receptor antagonists. Preclinical data demonstrated that ORIC-533 binds CD73 with high affinity and effectively blocks adenosine-driven immunosuppression in a high AMP environment, reflective of AMP levels observed in tumors. In preclinical studies, nanomolar concentrations of ORIC-533 efficiently rescued cytotoxic T-cell function in the presence of high AMP concentrations, as well as in ex vivo bone marrow aspirates from relapsed or refractory multiple myeloma patients.