On December 12, 2023 Ichnos Sciences, a global clinical-stage biotechnology company developing innovative multispecific immune cell engager antibodies in oncology, reported data during three poster presentations at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) 2023 Annual Meeting and Exposition in San Diego, California (Press release, Ichnos Sciences, DEC 12, 2023, View Source [SID1234638492]).

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The studies showcased encouraging safety profiles, dose-dependent pharmacokinetics, and efficacy signals, marking significant progress in the fight against relapsed or refractory multiple myeloma.

"The results of these studies are a validating mile marker for our proprietary BEAT1 multispecific platform’s innovative mechanism of action," said Eugene Zhukovsky, Ichnos’ Chief Scientific Officer. "Our platform shows promise to unleash a powerful combination that can specifically target multiple surface proteins of tumor cells. This novel approach means stronger and more specific binding of immune cells to tumor cells, offering a beacon of hope for patients in dire need of treatment options as they face challenging hematologic malignancies."

1. Dose Escalation of ISB 1342, a Novel CD38xCD3 Bispecific Antibody, in Patients with Relapsed / Refractory Multiple Myeloma (RRMM):

Safety and tolerance: Demonstrated treatment with ISB 1342 was manageable at higher dose levels evaluated, with mild to moderate CRS, no ICANS, and no increased risk of infection observed.
Dose-dependent pharmacokinetics and biomarkers: Following IV infusion, ISB 1342 showed dose-linear increase in serum exposures across the evaluated dose range. Increases in several T-cell activation-related biomarkers (CD69 by flow, and serum cytokines withing 24hrs, such as IFNg, TNFa, IL-2, IL-6 and IL-10), were consistently observed following ISB 1342 dosing supporting proof of mechanism.
Efficacy signals: Positive results in patient groups at higher dose levels (8 and 16 μg/kg cohorts) align with predicted effectiveness based on a sophisticated preclinical quantitative system pharmacology (QSP) model, supporting the drug’s potential success in treating multiple myeloma.
2. Initial Dose Escalation of ISB 1442, a Novel CD38 Biparatopic x CD47 Bispecific Antibody, in Patients with Relapsed / Refractory Multiple Myeloma (RRMM):

Safety and tolerance: Demonstrated treatment with ISB 1442 was well tolerated at the dose levels evaluated, with observed clinical cytokine release syndrome (CRS) events being low grade and potentially related to macrophage activation following ISB 1442 administration.
Dose-dependent pharmacokinetics: Showed dose-linear increase in serum concentration up to DL 3 (60 mg), followed by a super-proportional increase in serum exposure most evident between DL3 (60 mg) and DL4 (150 mg).
Mechanism of action: Increase in macrophage-associated markers are consistent with a potential mechanism of action involving macrophage activation enhanced by the effector function modifications incorporated into the design of ISB 1442.
3. A Phase 1, First-in-Human, Dose Escalation and Dose-Expansion Study of a BCMAxCD38xCD3 Targeting Trispecific Antibody ISB 2001 in Subjects with Relapsed / Refractory Multiple Myeloma (RRMM):

ISB 2001 debut: A BCMAxCD38xCD3 trispecific antibody1 based on Ichnos’ proprietary TREAT2 platform, which promotes strong avidity induction and enables efficient and potent killing of multiple myeloma (MM) cells. Dual TAA targeting with ISB 2001 may overcome escape mechanisms associated with BCMA and CD38 targeted therapies, including approved T cell engagers, ADC or cell therapies.
Study design: Phase 1 study (NCT05862012) employing a subcutaneous dosing strategy with a step-up dosing approach, aiming to confirm efficacy and tolerability in patients with RRMM. The first-in-human dose was derived using advanced preclinical modeling, emphasizing safety with a preemptive step-up dosing strategy.
Future direction: The study is currently open for enrollment. Part 2 aims to confirm safety, select the recommended Phase 2 dose (RP2D), and explore secondary and exploratory endpoints.
All three of Ichnos’ presentations and corresponding data are available for review on the Ichnos website. More information about the three oncology assets highlighted at the meeting, and the rest of Ichnos’ pipeline can be found at this link.

On December 12, 2023 Galapagos NV (Euronext & NASDAQ: GLPG) reported additional encouraging clinical data from the ongoing Phase 1/2 CD19 CAR-T studies, EUPLAGIA-1 with GLPG5201 and ATALANTA-1 with GLPG5101, in patients with relapsed/refractory chronic lymphocytic leukemia (rrCLL), with or without Richter transformation, and non-Hodgkin lymphoma (rrNHL), during two poster sessions at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place in San Diego, from 9-12 December (Press release, Galapagos, DEC 12, 2023, View Source [SID1234638491]).

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"We are very pleased to share promising new data from our ongoing CD19 CAR-T cell therapy programs, which further highlight that treatment with both GLPG5201 and GLPG5101 has the potential to deliver clinically meaningful results in these severely compromised patient populations. We are particularly encouraged that the results suggest that a vein-to-vein time of only seven days with fresh CAR-T cells is feasible, which would address the urgent needs of cancer patients who cannot afford to wait for treatment," said Dr. Jeevan Shetty, Head of Clinical Development Oncology at Galapagos. "These results demonstrate the potential of our innovative development and manufacturing approach in CAR-T cell therapy to transform the lives of patients. This data bolsters our confidence in the GLPG5201 and GLPG5101 programs for the treatment of patients with rrCLL and rrNHL, and the potential of our CAR-T pipeline beyond these initial indications."

Galapagos has an interactive booth (#3419) at the ASH (Free ASH Whitepaper) congress and will organize a Company Showcase in room 5 A (at the congress center, upper level) on 9 December at 11:30 am PT/22:30 CET, focusing on Galapagos’ 7-day vein-to-vein, fresh-to-fresh CAR-T manufacturing model at the point-of-care. In addition, Galapagos will host a media round table on 10 December at 7:30 am PT/16:30 CET at the Hilton Gaslamp Quarter San Diego, with experts discussing innovative approaches in CAR-T treatment that have the potential to transform the lives of patients around the world, and a KOL event for analysts and investors on 10 December at 11:00 am PT/20:00 CET at the Marriott Gaslamp Quarter San Diego.

GLPG5201 in rrCLL with or without Richter transformation (RT)
Patient recruitment of the Phase 1 dose-finding part of EUPLAGIA-1 has been completed and as of 6 September 2023 (cut-off date), 15 patients (6 at dose level 1 (DL1); and 9 at dose level 2 (DL2)) were enrolled, all of whom were diagnosed with rrCLL, with 9 of 15 with RT. Efficacy data as of Day 28 are available for 14 patients; 1 patient did not yet reach the Day 28 follow-up visit at the time of the analysis. The results (cut-off date: 6 September 2023) included in the poster are summarized below:

GLPG5201 showed an encouraging safety profile with most treatment emergent adverse events (TEAEs) of Grade 1 or 2, mostly hematological. Cytokine release syndrome (CRS) Grade 1 or 2 was observed in 47% of the patients, and no CRS Grade ≥ 3 or any immune effector cell-associated neurotoxicity syndrome (ICANS) were observed. No deaths were reported.
Overall, 13 of 14 efficacy evaluable patients responded to treatment (Objective Response Rate (ORR) of 93%) and 8 of 14 patients achieved a Complete Response Rate (CRR of 57%). 8 of 9 patients with RT responded to treatment (ORR of 89%) and 6 of 9 RT patients achieved a Complete Response (CRR of 67 %). At time of analysis, 10 of 13 of responding patients (77%) were in ongoing response with a median follow-up of 6 months; 2 of 3 patients who progressed after an initial response had confirmed CD19-negative disease.
On the higher dose level (DL2), 8 of 8 patients responded to treatment (ORR of 100%), 5 of 8 patients achieved a Complete Response (CRR of 63%), and 6 of 6 patients with RT responded to treatment (ORR of 100%).
DL2 was selected as the recommended dose for the Phase 2 part of the study.
The data suggest that Galapagos’ CAR-T point-of-care manufacturing platform can deliver fresh product in a median vein-to-vein time of seven days.
Strong and consistent in vivo CAR-T expansion levels and a product consisting of early phenotype T cells were observed in all doses tested.
GLPG5101 in rrNHL
To further build a robust data package, patient recruitment of the Phase 1 dose-finding part of ATALANTA-1 is ongoing. As of 1 September 2023 (cut-off date), 14 heavily pre-treated rrNHL patients with diffuse large B cell lymphoma, mantle cell lymphoma and indolent lymphoma were enrolled (7 at DL1 and 7 at DL2). In parallel, enrollment of the Phase 2 expansion study is ongoing, and the first 9 patients have been dosed. The results (cut-off date: 1 September 2023) included in the poster are summarized below:

Phase 1 part of the study:
GLPG5101 showed an encouraging safety profile. Most TEAEs were Grade 1 or 2 and the majority of the few Grade ≥ 3 events hematological. No CRS Grade > 3 and no ICANS Grade ≥ 2 were observed.
12 of 14 evaluable patients responded to treatment (ORR of 86%), with 11 of 14 patients achieving a Complete Response (CRR of 79%). 6 of 7 patients treated with the higher dose level (DL2) responded to treatment (ORR of 86%) and achieved a Complete Response (CRR of 86%). At the time of the analysis, 8 of 12 responding patients (67%) had an ongoing response, with a duration up to 15 months (median follow-up of 8.6 months); 2 of the 4 patients who progressed after an initial response had a CD19 positive relapse and 1 had confirmed CD19-negative disease.
Phase 2 part of the study:
GLPG5101 showed an encouraging safety profile with most TEAEs of Grade 1 or 2; the majority of Grade ≥ 3 events were hematological. No CRS Grade > 2 and ICANS was seen in one patient (Grade 3).
6 of 7 evaluable patients responded to treatment (ORR of 86%) and a Complete Response was observed in 4 of 7 patients (57%). At the time of the analysis, all 6 responding patients (100%) had an ongoing response with a median follow-up of 3.2 months.
The data suggest that Galapagos’ point-of-care platform can deliver fresh product in a median vein-to-vein time of seven days.
Strong and consistent in vivo CAR-T expansion levels and a product consisting of early phenotype T cells were observed in all doses tested.
Natalia Tovar, MD, PhD, Hospital Clinic de Barcelona, Institut d’Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), University of Barcelona (Spain) presented the analysis on the Phase 1 part EUPLAGIA-1 in patients with rrCLL, with or without RT. Marie José Kersten, MD, PhD, Professor of Hematology and Head of the Department of Hematology at the Academic Center in Amsterdam (The Netherlands) presented the analysis on the Phase 1 and Phase 2 parts of ATALANTA-1 in patients with rrNHL.

The poster presentations are available in the poster hall and the ASH (Free ASH Whitepaper) website:

Abstract Title Authors Presentation details
Seven-day Vein-to-Vein Point-of-Care Manufactured CD19 CAR T Cells (GLPG5201) in Relapsed/Refractory CLL/SLL including Richter’s Transformation: Results from the Phase 1 Euplagia-1 Trial Natalia Tovar, Valentin Ortiz-Maldonado, Nuria Martinez-Cibrian, Sergi Betriu, Daniel Esteban, Ana Triguero, Nadia Verbruggen, Anna D.D. van Muyden, Maike Spoon, Margot J. Pont Abstract
Poster Number: 2112
Date: 9 Dec, 5:30–7:30 pm PT
Session: Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster I
Seven-day Vein-to-Vein Point-of-Care Manufactured CD19 CAR T Cells (GLPG5101) in Relapsed/Refractory NHL: Results from the Phase 1 Atalanta-1 Trial Marie José Kersten, Kirsten Saevels, Sophie Servais, Yves Beguin, Joost Vermaat, Nadia Verbruggen, Anna DD Van Muyden, Margot J Pont, Maria T Kuipers, Sébastien Anguille Abstract
Poster Number: 2113
Date: 9 Dec, 2023, 5:30–7:30 pm PT
Session: Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster I
About Galapagos’ innovative approach to CAR-T manufacturing near the point-of-care
Galapagos’ decentralized, innovative point-of-care CAR-T manufacturing platform consists of a proprietary end-to-end xCellit workflow management and monitoring software system, a decentralized, functionally closed, automated manufacturing platform for cell therapies (using Lonza’s Cocoon) and a proprietary quality control (QC) testing and release strategy. The combination of these three core components allows for the administration of a fresh product, a median vein-to-vein time of seven days (i.e. the time between T-cell collection and CAR-T infusion), and greater physicians oversight throughout the process.

About the EUPLAGIA-1 study (EudraCT 2021-003815-25)
EUPLAGIA-1 is an ongoing Phase 1/2 open-label, multi-center study evaluating the feasibility, safety, and efficacy of point-of-care manufactured GLPG5201 in patients with relapsed/refractory lymphocytic leukemia (rrCLL) and small cell lymphocytic lymphoma (rrSLL), with or without Richter transformation (RT). GLPG5201 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as intravenous infusion of a fresh product candidate in a single fixed dose. Patients with CD19+ rrCLL or rrSLL with ≥2 lines of prior therapy are eligible to participate, and patients with RT are eligible regardless of prior therapy. The primary objective of the Phase 1 part of the study was to evaluate safety and determine the recommended dose for the Phase 2 part of the study. The dose levels that were evaluated in the Phase 1 part of the study are 35×106 (DL1), and 100×106 (DL2) CAR+ viable T cells.

About chronic lymphocytic leukemia
Chronic lymphocytic leukemia (CLL) is one of the chronic lymphoproliferative disorders (lymphoid neoplasms). It is characterized by a progressive accumulation of functionally incompetent lymphocytes, which are usually monoclonal in origin. CLL affects B-cells in the blood and bone marrow.1 RT is an uncommon clinicopathological condition observed in patients with CLL. It is characterized by the sudden transformation of the CLL into a significantly more aggressive form of large cell lymphoma and occurs in approximately 2-10% of all CLL patients. CLL usually follows an indolent course and is an incurable disease. Patients who develop relapsed and refractory disease and become resistant to new agents have a dismal prognosis and a high unmet medical need for new therapeutic options such as CAR-T cells. With estimated incidence of 4.7 new cases per 100,000 individuals, CLL is the most prevalent lymphoid malignancy and is the most common adult leukemias in the US and in Europe.2

About the ATALANTA-1 study (EudraCT 2021-003272-13)
ATALANTA-1 is an ongoing Phase 1/2, open-label, multicenter study to evaluate the feasibility, safety, and efficacy of point-of-care manufactured GLPG5101, a CD19 CAR-T product candidate, in patients with relapsed/refractory non-Hodgkin’s lymphoma (rrNHL). GLPG5101 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as an intravenous infusion of a fresh product candidate in a single fixed dose. Each enrolled patient will be followed for 24 months. The primary objective of the Phase 1 part of the study was to evaluate safety and to determine the recommended dose for the Phase 2 part of the study. Secondary objectives include assessment of efficacy and feasibility of point-of-care manufacturing of GLPG5101. The dose levels that were evaluated in Phase 1 are 50×106 (DL1) and 110×106 (DL2) and 250×106 (DL3) CAR+ viable T cells.

The primary objective of the Phase 2 part of the study is to evaluate the Objective Response Rate (ORR) while the secondary objectives include Complete Response rate (CRR), duration of response, progression free survival, overall survival, safety, pharmacokinetic profile, and feasibility of point-of-care manufacturing.

About non-Hodgkin’s lymphoma
Non-Hodgkin’s lymphoma is a cancer originating from lymphocytes, a type of white blood cell which is part of the body’s immune system. Non-Hodgkin’s lymphoma can occur at any age although it is more common in adults over 50 years old. Initial symptoms usually are enlarged lymph nodes, fever, and weight loss. There are many different types of non-Hodgkin’s lymphoma. These types can be divided into aggressive (fast-growing) and indolent (slow-growing) types, and they can be formed from either B lymphocytes (B cells) or in lesser extent from T lymphocytes (T cells) or Natural Killer cells (NK cells). B-cell lymphoma makes up about 85% of non-Hodgkin’s lymphomas diagnosed in the US. Prognosis and treatment of non-Hodgkin’s lymphomas depend on the stage and type of disease.

On December 12, 2023 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, reported initial combination study data from its TakeAim Lymphoma trial including 5 primary CNS lymphoma (PCNSL) patients (Press release, Curis, DEC 12, 2023, View Source [SID1234638489]).

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"We are very pleased with the initial emavusertib/ibrutinib combination data from the TakeAim Lymphoma study. We are particularly excited about the activity in relapsed/refractory PCNSL and the meaningful benefit emavusertib may provide in combination with BTKi," said James Dentzer, President and Chief Executive Officer of Curis.

As of October 12th, the TakeAim Lymphoma trial has enrolled and treated 19 Non-Hodgkin Lymphoma (NHL) patients, with a combination of emavusertib and ibrutinib; with emavusertib doses ranging from 100 mg to 300 mg BID. The initial data reveal encouraging efficacy, demonstrating multiple objective responses in both BTK-naïve and BTK-experienced patients.

Patients with PCNSL who had a history of failed BTKi therapy showed a particularly noteworthy response: 3 out of 5 evaluable PCNSL patients achieved a Complete Response (CR), with durability ranging from 0.3 – 8.9 months. These data underscore the potential of emavusertib to re-sensitize patients to BTKi therapy, marking a significant advancement in Non-Hodgkin Lymphoma treatment.

Consistent with our previous findings, the emavusertib/ibrutinib combination demonstrates a manageable and acceptable safety profile, with no observed dose-limiting toxicities (DLTs) in the 200 mg cohort and 2 reversible DLTs (stomatitis and syncope) in the 300 mg cohort.

About emavusertib (CA-4948)

Emavusertib is a small molecule IRAK4 inhibitor. IRAK4 plays an essential role in the toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways, which are frequently dysregulated in patients with cancer. TLRs and the IL-1R family signal through the adaptor protein MYD88, which results in the assembly and activation of IRAK4, initiating a signaling cascade that induces cytokine and survival factor expression mediated by the NF-κB protein complex. Preclinical studies targeting IRAK1/4 in combination with FLT3 have demonstrated the ability to overcome the adaptive resistance incurred when targeting FLT3 alone. Further, emavusertib has shown anti-tumor activity across a broad range of hematologic malignancies including monotherapy activity in patient-derived xenografts and synergy with both azacitidine and venetoclax.

About TakeAim Lymphoma Study

TakeAim Lymphoma Study (NCT03328078) – study is open for enrollment.

On December 12, 2023 Circio Holding ASA (OSE: CRNA) reported that partner IOVaxis Therapeutics of Nantong, China, has filed the updated TG01 investigational new drug (IND) application with the Chinese National Medical Products Administration (NMPA), with an expected review period of sixty days (Press release, Circio, DEC 12, 2023, View Source [SID1234638488]).

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IOVaxis has an exclusive option agreement to license mutant RAS cancer vaccines TG01 and TG02 for China, Hong Kong, Macau, and Singapore, see link to press release here. Within two weeks of TG01 IND approval by the NMPA, IOVaxis may exercise its exclusive license option and trigger a USD 3m milestone payment to Circio.

Dr. John Wang, CEO of IOVaxis Therapeutics, said: "Following broad additional pre-clinical characterization of the TG01 product, we have now filed a substantially expanded IND-package, which we are confident meets the requirements of the NMPA. We have been impressed by previous clinical data for TG01 and are eager to bring this innovative mutant RAS immunotherapy to patients in China. Once we have the IND approval, we intend to initiate a phase 1 study in pancreatic cancer as soon as possible, and then rapidly expand to other KRAS indications and combinations."

The NMPA requested additional pre-clinical characterization of TG01 following review of the initial TG01 IND filing in 2021. The requested studies have now been performed and included in the resubmitted IND-package. The expected response time is sixty days from the submission date. Following IND-approval, IOVaxis may exercise its exclusive license option for TG01 and TG02 within 14 days.

Dr. Erik Digman Wiklund, CEO of Circio Holding ASA, added: "This partnership with IOVaxis is an important component of our aim to bring TG01 development forward through strategic collaborations in multiple settings and geographies. Dr. Wang and his team have shown strong commitment to meet the requirements of the Chinese regulatory authorities and generated a substantial pre-clinical data package to support the filing. We are very pleased to have such a dedicated partner and expect that the IND will now be accepted in China, as it has already been in Europe and the USA."

On December 12, 2023 Champions Oncology, Inc. (Nasdaq: CSBR), a global preclinical and clinical research services provider that offers end-to-end oncology solutions, reported its financial results for its second quarter of fiscal 2024, ended October 31, 2023 (Press release, Champions Oncology, DEC 12, 2023, View Source [SID1234638487]).

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Second Quarter and Recent Highlights:

•Second quarter revenue of $11.6 million, a decline of 19%
•Revised fiscal year 2024 revenue guidance to be generally in-line with last year’s results
•Strong quarterly bookings
•European lab received ISO accreditation and ATS certification
•Hired Brady Davis as President to develop new strategic initiatives

Ronnie Morris, CEO of Champions, commented, "As discussed during our first quarter earnings call, we’re navigating through a challenging economic environment, specifically in the biotech sector, that began approximately one year ago. While our short-term results were weaker than we’re accustomed to delivering, demand for our services has re-accelerated and we will emerge stronger over the coming quarters as we’re witnessing positive trends in customer spending and a reduction in cancellations." Morris added, "Our drug discovery initiative, operating under a wholly owned subsidiary, Corellia AI, continues to progress as we’re building therapeutic programs around two lead targets while other, new targets are being identified. We remain actively engaged with investors in an effort to raise capital to support and accelerate these programs."

David Miller, CFO of Champions, added, "As we’ve guided over the last several quarters, the increase in study cancellations during fiscal year 2023, primarily stemming from the economic impact on our customers’ R&D budgets, would lead to lower revenue in the first half of 2024, pressuring margins and profitability. Results were a bit weaker than expected and, as a result, we’re reducing our year-end

Exhibit 99.1
revenue guidance and anticipating our year over year revenue growth will be generally flat. However, we believe our quarterly results will gradually improve going forward and, long term, we are well-positioned for continued growth as the underlying fundamentals of our business are strong, our sales pipeline is healthy, and our balance sheet is sound."

Second Fiscal Quarter Financial Results

Total revenue for the second quarter of fiscal 2024 was $11.6 million compared to $14.3 million for the same period last year, a decrease of 19.0%. The decline in revenue was primarily from customer cancellations in prior quarters which led to lower study revenue in the second quarter. Total costs and operating expenses for the second quarter of fiscal 2024 were $13.5 million compared to $14.3 million for the second quarter of fiscal 2023, a decrease of $746,000 or 5.2%.

For the second quarter of fiscal 2024, Champions reported a loss from operations of $2.0 million, including $53,000 in stock-based compensation and $484,000 in depreciation and amortization expenses, compared to income from operations of $7,000, inclusive of $119,000 in stock-based compensation and $560,000 in depreciation and amortization expenses, in the second quarter of fiscal 2023. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported an adjusted EBITDA loss of $1.4 million for the second quarter of fiscal 2024 compared to adjusted EBITDA of $686,000 in the second quarter of fiscal 2023.

Cost of oncology solutions was $6.6 million for the three-months ended October 31, 2023, a decrease of $825,000, or 11.1% compared to $7.4 million for the three-months ended October 31, 2022. The decrease in cost of sales was primarily from a reduction in compensation and supply expenses along with lower outsourced lab service costs. For the three-months ended October 31, 2023, total gross margin was 42.8% compared to 47.9% for the three-months ended October 31, 2022. The lower margin resulted primarily from a decline in top line revenue against relatively unchanged fixed costs within cost of sales.

Research and development expense for the three-months ended October 31, 2023 was $2.5 million, a slight decrease of $89,000 or 3.4%, compared to $2.6 million for the three-months ended October 31, 2022. For the second quarter of fiscal year 2024, approximately $1.2 million of the Company’s R&D expense was directed towards our target discovery program. Sales and marketing expense for the three-months ended October 31, 2023 was $1.8 million, a slight increase of $95,000, or 5.6%, compared to $1.7 million for the three-months ended October 31, 2022. General and administrative expense for the three-months ended October 31, 2023 was $2.6 million, a slight increase of $73,000, or 2.9%, compared to $2.5 million for the three-months ended October 31, 2022.

Net cash provided by operating activities was approximately $600,000 for the three-months ended October 31, 2023 and was primarily due from increases in accounts receivable collections and deferred revenue. Net cash used in investing activities was approximately $150,000 for investment in additional lab and computer equipment. Net cash provided by financing activities was approximately $200,000 primarily from proceeds from options exercises.

Year-To-Date Financial Results

For the first six months of fiscal 2024, revenue decreased 13.9% to $24.1 million compared to $28.0 million for the first six months of fiscal 2023. The decline in revenue was primarily from customer cancellations in fiscal year 2023 resulting in lower study revenue in the first half of fiscal year 2024.

Total costs and operating expenses for the first six months of fiscal 2024 were $28.6 million compared to $28.3 million for the first six months of fiscal 2023, an increase of $338,000 or 1.2%.

For the first six months of fiscal 2024, Champions reported a loss from operations of $4.5 million, including $476,000 in stock-based compensation and $929,000 in depreciation and amortization expenses, compared to a loss from operations of $277,000, inclusive of $325,000 in stock-based compensation and $1.1 million in depreciation and amortization expenses, in the first six months of fiscal 2023. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported an adjusted EBITDA loss of $3.1 million for the first six months of fiscal 2024 compared to adjusted EBITDA of $1.1 million in the first six months of fiscal 2023.

Cost of oncology solutions was $14.3 million for the six-months ended October 31, 2023, a decrease of $193,000, or 1.3% compared to $14.5 million for the six-months ended October 31, 2022. For the six-months ended October 31, 2023, total gross margin was 40.7% compared to 48.3% for the six-months ended October 31, 2022. The lower margin resulted from lower revenue against a generally unchanged cost base.

Research and development expense for the six-months ended October 31, 2023 was $5.3 million, a slight decrease of $183,000 or 3.3%, compared to $5.5 million for the six-months ended October 31, 2022. The decrease was primarily from a reduction in core product R&D expenses. Approximately $2.5 million of the Company’s R&D expense was directed towards our target discovery program for the first half of fiscal year 2024. Sales and marketing expense for the six-months ended October 31, 2023 was $3.5 million, a slight increase of $99,000, or 2.9%, compared to $3.4 million for the six-months ended October 31, 2022. General and administrative expense for the six-months ended October 31, 2023 was $5.5 million, an increase of $615,000, or 12.5%, compared to $4.9 million for the six-months ended October 31, 2022. The increase was primarily due to an increase in compensation and recruiting expenses offset by a reduction in IT costs.

Net cash used in operating activities was $3.4 million for the six-months ended October 31, 2023. The cash used in operating activities was primarily due to an increase in net loss from operations excluding non-cash expenses. Net cash used in investing activities was $800,000 and was primarily from investment in additional lab equipment. Net cash used in financing activities was approximately $382,000 and was primarily from repurchases of common stock related to our stock buy-back program offset by proceeds from options exercises.

The Company ended the quarter with cash and cash equivalents on hand of approximately $5.5 million. The Company has no debt.

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 888-506-0062 (Domestic) or 973-528-0011 (International) and enter the access code 589886, or provide the verbal reference "Champions Oncology".
Full details of the Company’s financial results will be available by December 13, 2023 in the Company’s Form 10-Q at www.championsoncology.com.