On September 11, 2024 Pfizer Inc. (NYSE: PFE) reported to showcase potential practice-changing research and next-generation candidates across its robust Oncology portfolio at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024, being held September 13-17 in Barcelona (Press release, Seagen, SEP 11, 2024, View Source [SID1234646514]). Data from more than 50 company-sponsored, investigator-sponsored and collaborative research abstracts, including more than 10 oral and mini-oral presentations, will be presented across the company’s tumor areas and core scientific modalities, as well as a potential treatment for a cancer-related condition.

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"At this year’s ESMO (Free ESMO Whitepaper), we are looking forward to demonstrating our progress toward delivering next-generation biologics and novel combinations that have the potential to be new standards of care for patients," said Chris Boshoff, Chief Oncology Officer and Executive Vice President, Pfizer. "Our key data presentations highlight our scientific leadership in developing targeted therapies, including small molecules and antibody-drug conjugates, across our core tumor areas, including breast, bladder and thoracic cancers."

"At ESMO (Free ESMO Whitepaper), Pfizer will share important data highlighting our commitment to transforming outcomes for patients living with lung cancer, including longer-term follow-up results from the BRAFTOVI + MEKTOVI PHAROS study in BRAF V600E-mutated metastatic non-small cell lung cancer," said Karin Tollefson, Chief Oncology Medical Officer, Pfizer. "We are also looking forward to sharing progress on our industry-leading pipeline of new molecules, including encouraging early results for two novel, investigational antibody-drug conjugates and preliminary data on a novel combination of Pfizer’s next-generation CDK inhibitors."

Key research includes a late-breaking presentation of updated results from the pivotal Phase 2 PHAROS* study of BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) in patients with BRAF V600E-mutant metastatic non-small cell lung cancer (mNSCLC). Longer-term efficacy and safety data will be presented, following the initial primary overall response results (ORR) that supported the FDA approval for BRAFTOVI + MEKTOVI in this indication in 2023 and the recent approval by the European Commission in August 2024. Further, Pfizer will share updated data from the safety lead-in of the ongoing Phase 3 BREAKWATER trial, showing antitumor activity of BRAFTOVI + cetuximab + FOLFIRI in patients with untreated BRAF V600E-mutant metastatic colorectal cancer (mCRC) in a mini-oral presentation.

Additionally, Pfizer will present a late-breaking Proffered Paper Presentation on the Phase 2 efficacy and safety results for its GDF-15 inhibitor, ponsegromab, in patients with cancer-associated cachexia, highlighting the company’s commitment to improving the treatment journey for people living with cancer. Cancer cachexia is a common, life-threatening wasting condition characterized by severe weight loss. The condition affects patients with advanced cancers and can greatly impact a patient’s ability to tolerate cancer treatment and quality of life. Despite its severity, there are no FDA-approved treatments for cachexia. i,ii

Pfizer will also present early clinical-stage research for a number of priority pipeline areas, including encouraging Phase 1 results of the potential first-in-class antibody-drug conjugate (ADC) candidate SGN-PDL1V (PF-08046054) in NSCLC and head and neck squamous cell carcinoma (HNSCC); initial data for the investigational ADC disitamab vedotin in combination with KEYTRUDA (pembrolizumab) in human epidermal growth factor receptor 2 (HER2)-expressing locally advanced or metastatic urothelial cancer (la/mUC); and the first data combining atirmociclib, our highly-selective cyclin-dependent kinase 4 (CDK4) inhibitor (CDK4i), with a novel CDK2 inhibitor (CDK2i) in hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer (MBC) from a Phase 1 dose-escalation study.

Key ESMO (Free ESMO Whitepaper) Presentations

Genitourinary Cancer

PADCEV + KEYTRUDA**: additional analysis from the pivotal EV-302 trial continues to support the combination as a new standard of care for patients with previously untreated la/mUC. An exploratory analysis shows PADCEV + KEYTRUDA showed consistent progression free survival (PFS), overall survival (OS), and ORR versus chemotherapy regardless of Nectin-4 or PD-L1 expression.
Disitamab Vedotin: preliminary efficacy and safety data for disitamab vedotin in combination with KEYTRUDA highlights Pfizer’s continued commitment to developing novel therapeutics to meet the needs of patients with bladder cancer. Results from the safety run-in of the ongoing Phase 2 trial showed encouraging early efficacy and a safety profile consistent with previously presented data in treatment-naive patients with HER2-expressing la/mUC.
Thoracic Cancer

SGN-PDL1V (PF-08046054): encouraging Phase 1 results will be presented for PDL1V, a novel, investigational vedotin ADC directed to PD-L1-expressing solid tumors. Data from the dose-escalation and dose optimization cohorts of the ongoing Phase 1 study show PDL1V as monotherapy was generally well tolerated with no unexpected adverse events, and encouraging antitumor activity was observed in patients with heavily pretreated NSCLC and HNSCC.
Breast Cancer

Atirmociclib (PF-07220060) + PF-07104091 : initial data from a dose-escalation study evaluating the innovative combination of atirmociclib, a potential first-in-class CDK4-selective inhibitor, with PF-07104091, a novel CDK2-selective inhibitor, showed a manageable safety profile and encouraging efficacy in patients with heavily pretreated HR+/HER2- breast cancer. These early results highlight the potential of Pfizer’s strategy to advance atirmociclib as a future CDK inhibitor backbone therapy that may address treatment resistance with first generation CDK4/6i, subject to clinical success and regulatory approval. The CDK4i+2i combination is continuing to be explored in an ongoing Phase 1b/2 dose escalation and dose expansion study (NCT05262400).
Additional information on the Pfizer-sponsored abstracts, including date and time of presentation, follow in the chart below.

Pfizer is continuing its commitment to help non-scientists understand the latest findings with the development of abstract plain language summaries (APLS) for company-sponsored research being presented at ESMO (Free ESMO Whitepaper), which are written in non-technical language. Those interested in learning more can visit www.Pfizer.com/apls to access the summaries starting September 16, 2024.

BREAST CANCER

Mini Oral Presentation (Abstract 618MO)
Saturday, September 14, 2:45 PM-4:15 PM CEST

Phase 1b/2 first-in-class novel combination trial of next generation CDK4-selective inhibitor PF-07220060 and next generation CDK2-selective inhibitor PF-07104091 in HR+ HER2- metastatic breast cancer and advanced solid tumors

Yap et al

Poster Presentation (Abstract 413P)
Monday, September 16, 9:00 AM-5:00 PM CEST

Longitudinal circulating tumor DNA (ctDNA) dynamics in Phase 1/2a study of the first-in-class CDK4-selective inhibitor, PF-07220060, in combination with endocrine therapy in patients with HR+/HER2− metastatic breast cancer (mBC) who progressed on prior CDK4/6 inhibitors

Yap et al

Poster Presentation (Abstract 359P)
Monday, September 16, 9:00 AM-5:00 PM CEST

Overall survival of palbociclib (PAL) + endocrine therapy (ET) in Japanese patients with hormone receptor-positive (HR+)/ human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) in the 1st line (1L) or 2nd line (2L) setting: A multicenter observational study

Nakayama et al

Poster Presentation (Abstract 354P)
Monday, September 16, 9:00 AM-5:00 PM CEST

Synergistic preclinical efficacy through combination of the CDK4 and CDK2 selective inhibitors, PF-07220060 and PF-07104091, respectively, in HR+ HER2- breast cancer

Anders et al

Poster Presentation (Abstract 356P)
Monday, September 16, 9:00 AM-5:00 PM CEST

Real-world effectiveness in subgroups of palbociclib + endocrine therapy in HR+/HER2- ABC patients: Interim Results of the PERFORM study

Pfeiler et al

EARLY PIPELINE

Oral Presentation, Proffered Paper (Abstract 607O)
Friday, September 13, 4:00 PM-5:30 PM CEST

Interim results of a Phase 1 study of SGN-PDL1V (PF-08046054) in patients with PDL1-expressing solid tumors

Oliva Bernal et al

GASTROINTESTINAL CANCER

Mini Oral Presentation (Abstract 515MO)
Saturday, September 14, 2:45 PM-4:15 PM CEST

Encorafenib + cetuximab (EC) + FOLFIRI for BRAF V600E-mutant metastatic colorectal cancer (mCRC): updated results from the BREAKWATER safety lead-in (SLI)

Tabernero et al

GENITOURINARY CANCER

Mini Oral Presentation (Abstract 1966MO)
Sunday, September 15, 8:30 AM-10:00 AM CEST

EV-302: Exploratory analysis of nectin-4 expression and response to 1L enfortumab vedotin (EV) + pembrolizumab (P) in previously untreated locally advanced or metastatic urothelial cancer (la/mUC)

Powles et al

Poster Presentation (Abstract 1968P)
Sunday, September 15, 9:00 AM-5:00 PM CEST

Study EV-103 dose escalation/cohort A (DE/A): 5y follow-up of first-line (1L) enfortumab vedotin (EV) + pembrolizumab (P) in cisplatin (cis)-ineligible locally advanced or metastatic urothelial carcinoma (la/mUC)

Rosenberg et al

Poster Presentation (Abstract 2001P)
Sunday, September 15, 9:00 AM-5:00 PM CEST

Epidemiology and treatment patterns of patients with locally advanced or metastatic urothelial cancer in France: a non-interventional database study

Joly et al

Poster Presentation (Abstract 1638P)
Sunday, September 15, 9:00 AM-5:00 PM CEST

Enzalutamide (ENZA) with or without leuprolide in patients (pts) with high-risk biochemically recurrent (hrBCR) prostate cancer (PC): EMBARK post hoc analysis by age

Shore et al

Poster Presentation (Abstract 1626P)
Sunday, September 15, 9:00 AM-5:00 PM CEST

Incidence of hematologic toxicities in the homologous recombination repair (HRR)-deficient population of the TALAPRO-2 trial and their potential association with germline vs somatic origin of HRR gene alterations

Azad et al

Poster Presentation (Abstract 1637P)
Sunday, September 15, 9:00 AM-5:00 PM CEST

Efficacy of talazoparib and enzalutamide in metastatic castration-resistant prostate cancer (mCRPC) patients previously treated with androgen receptor pathway inhibitors (ARPI) or docetaxel – post hoc analysis from both cohorts in TALAPRO-2 study

Agarwal et al

Poster Presentation (Abstract 1633P)
Sunday, September 15, 9:00 AM-5:00 PM CEST

Phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) vs placebo (PBO) + ENZA as first-line (1L) treatment in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): TALAPRO-2 (TP-2) China cohort

Zeng et al

Mini Oral Presentation (Abstract 1967MO)
Sunday, September 15, 8:30 AM-10:00 AM CEST

Preliminary efficacy and safety of disitamab vedotin (DV) with pembrolizumab (P) in treatment (Tx)-naive HER2-expressing, locally advanced or metastatic urothelial carcinoma (la/mUC): RC48G001 Cohort C

Galsky et al

MELANOMA

Poster Presentation (Abstract 1071TiP)
Saturday, September 14, 9:00 AM-5:00 PM CEST

Phase 1 study of the investigational CD228 x 4-1BB costimulatory antibody Anticalin bispecific SGN-BB228 (PF-08046049) in advanced melanoma and other solid tumors

Dummer et al

SUPPORTIVE AND PALLIATIVE CARE

Oral Presentation, Proffered Paper (Abstract LBA82)
Saturday, September 14, 2:45 PM-4:25 PM CEST

Efficacy and safety of ponsegromab, a first-in-class, monoclonal antibody inhibitor of growth differentiation factor-15, in patients with cancer cachexia: A randomized, placebo-controlled, Phase 2 study

Crawford et al

THORACIC CANCER

Mini Oral Presentation (Abstract LBA56)
Saturday, September 14, 10:15 AM-11:45 AM CEST

Updated efficacy and safety from the Phase 2 PHAROS study of encorafenib plus binimetinib in patients with BRAF V600E-mutant metastatic NSCLC (mNSCLC)

Riely et al

Poster Presentation (Abstract 1398TiP)
Saturday, September 14, 9:00 AM-5:00 PM CEST

Be6A Lung-01, a Phase 3 study of sigvotatug vedotin (SV), an investigational antibody-drug conjugate (ADC) versus docetaxel in patients (pts) with previously treated non-small cell lung cancer (NSCLC)

Peters et al

Poster Presentation (Abstract 1279P)
Saturday, September 14, 9:00 AM-5:00 PM CEST

First-line lorlatinib vs crizotinib in Asian patients with ALK+ non-small cell lung cancer (NSCLC): 5-year outcomes from the CROWN study

Wu et al

*The PHAROS trial is conducted with support from Pierre Fabre.

**Pfizer and Astellas have a clinical collaboration agreement with Merck to evaluate the combination of PADCEV and KEYTRUDA in patients with previously untreated metastatic urothelial cancer.

Prescribing Information for Pfizer Medicines

Please see full Prescribing Information for PADCEV.

Please see full Prescribing Information for BRAFTOVI and full Prescribing Information for MEKTOVI.

On September 11, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that Joseph Romanelli, president, Human Health International, is scheduled to participate in a fireside chat at the Bank of America 2024 Global Healthcare Conference on Wednesday, Sept. 18, 2024, at 6:40 a.m. EDT / 11:40 a.m. BST (Press release, Merck & Co, SEP 11, 2024, View Source [SID1234646512]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink.

On September 11, 2024 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported a corporate and REM-001 clinical study update (Press release, Kintara Therapeutics, SEP 11, 2024, View Source [SID1234646511]).

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Corporate Updates

In April 2024, Kintara and TuHURA Biosciences, Inc. ("TuHURA") entered into definitive merger agreement (the "Merger Agreement"), pursuant to which Kayak Mergeco, Inc., Kintara’s wholly-owned subsidiary, will merge with and into TuHURA, with TuHURA surviving the merger and becoming Kintara’s direct, wholly-owned subsidiary (the "Merger").

Kintara’s existing stockholders will own approximately 5.45% of combined company’s common stock at the closing of the proposed Merger on a pro forma fully diluted basis, inclusive of the contingent value rights ("CVRs") to receive shares of common stock of the combined company upon the achievement of enrollment of a minimum of 10 patients in the REM-001 study with such patients each completing 8 weeks of follow-up on or before December 31, 2025 (the "Milestone").

Special Meeting of Stockholders (the "Special Meeting") to obtain stockholder approval of the proposals set forth in Kintara’s proxy statement for the Special Meeting required to allow for completion of the proposed Merger with TuHURA will be held virtually on Friday, September 20, 2024, at 9:00 a.m., Eastern Time via live audio webcast. In order to attend, register in advance at www.viewproxy.com/kintarasm/2024 by 11:59 p.m., Eastern Time, on September 19, 2024. Kintara stockholders of record on August 14, 2024 (the "Record Date") are eligible to vote even if not a stockholder after the Record Date.

Stockholders immediately prior to the closing of the proposed Merger, even if not a stockholder on the Record Date, are eligible to receive CVRs, entitling such holders to receive shares of common stock of the combined company upon achievement of the Milestone.

Vote By Phone: Please call Alliance Advisors, Kintara’s proxy solicitor, toll-free, at (866) 619-8907, if in North America. International voters can call +1 (551) 210-9859. You can also contact Alliance Advisors if you have any questions about voting.

Vote By Internet: Vote at www.proxyvote.com using your control number by following the instructions shared by your broker, bank or other nominee.

If you are a Robinhood holder, proxy voting emails are sent by [email protected] and voting is hosted by Say Technologies. You will be able to vote and view materials directly from your email.
REM-001 Clinical Study Update

As of September 10, 2024, the REM-001 study in patients with cutaneous metastatic breast cancer (CMBC) has enrolled four of the 10 patients needed to reach the minimum patient enrollment to assess safety and appropriate Phase 3 dose with several other patients identified as study candidates at Kintara’s clinical sites, the Memorial Sloan Kettering Cancer Center and the Montefiore Medical Center, the University Hospital for Albert Einstein College of Medicine.

Consistent with REM-001’s safety profile, no treatment-related safety issues have been identified to-date, and assessment of the appropriate Phase 3 dose is ongoing.

CMBC represents an unmet medical need, as there currently are no approved or effective therapies. REM-001 may potentially offer these patients a much needed treatment option. The majority of the cost associated with the REM-001 study is being covered by a $2.0 million Small Business Innovation Research (SBIR) grant Kintara was awarded previously from the National Institutes of Health.
Without the completion of the proposed Merger with TuHURA, Kintara may not have adequate financial resources to continue the REM-001 study or operate its business and may be required to seek the protection of the bankruptcy courts. Kintara stockholders are urged to vote their shares before the Special Meeting on September 20, 2024.

On September 11, 2024 Ichnos Glenmark Innovation (IGI), an alliance between Ichnos Sciences Inc., a global fully-integrated clinical-stage biotech company developing multispecifics in oncology, and Glenmark Pharmaceuticals Ltd., reported that Nature Cancer published a research article describing the preclinical development of ISB 2001, a first-in-class trispecific antibody targeting BCMA and CD38 on myeloma cells and CD3 on T cells (Press release, Ichnos Sciences, SEP 11, 2024, View Source;utm_medium=rss&utm_campaign=igi-announces-publication-in-nature-cancer-on-isb-2001-igis-innovative-trispecific-antibody-for-relapsed-refractory-multiple-myeloma [SID1234646510]). ISB 2001 is currently being investigated in a Phase 1 clinical study in relapsed/refractory multiple myeloma (r/r MM).

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"Despite advances with monoclonal antibodies and earlier-generation bispecifics, a high relapse rate and resistance to currently available therapeutics are persistent challenges in treating multiple myeloma," said Cyril Konto, M.D., President, Executive Director and CEO of IGI. "The publication of ISB 2001 preclinical data in Nature Cancer supports the differentiation and mechanism of action of IGI’s multispecific antibody. These comprehensive findings underscore the therapeutic potential of ISB 2001, now in Phase 1 clinical testing, and we look forward to sharing our continued progress."

Key findings of the Nature Cancer article, "ISB 2001 trispecific T cell engager shows strong tumor cytotoxicity and overcomes immune escape mechanisms of multiple myeloma cells" include the following

The data demonstrate that ISB 2001 can overcome resistance mechanisms by dual tumor targeting via binding and cytotoxicity of tumor cells with low expression of CD38 or BCMA.
ISB 2001’s architecture is optimized to support robust killing of tumor cells while limiting CD38 on-target, off-tumor activity.
ISB 2001 demonstrated increased killing of tumor cells compared to BCMA-targeted T cell engagers in vitro, in vivo and ex vivo; induced complete tumor regression in humanized mouse models; and demonstrated superior potency compared to standard combination of therapies.
"We leveraged our proprietary BEAT platform to create a highly specific antibody that increases binding to MM cells while minimizing off-target activity," said Mario Perro, Ph.D., Head of Biologics Research at IGI. "These preclinical data demonstrate the potential of a trispecific approach to augment immune cell activation and achieve more precise tumor targeting and killing."
The paper can be found at View Source

ISB 2001 – Mechanism of Action
ISB 2001 is the first T cell-engaging antibody that simultaneously targets BCMA and CD38 on MM cells. It is a trispecific antibody based on BEAT (Bispecific Engagement by Antibodies based on the TCR) technology, a proprietary platform allowing maximal flexibility and manufacturability of full-length multispecific antibodies. ISB 2001 combines three proprietary antigen-binding arms, each targeting a different antigen, with one arm binding to the epsilon chain of CD3 on T cells, and the other two binding BCMA and CD38 on MM cells. Its fragment crystallizable (Fc) domain was fully silenced to suppress Fc effector functions. ISB 2001 redirects CD3+ T lymphocytes to kill tumor cells expressing BCMA and CD38. Targeting of two different tumor-associated antigens instead of one allows for avidity binding to MM cells expressing very low levels of BCMA and CD38.

On September 11, 2024 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 first quarter of fiscal 2025, ended July 31, 2024 (Press release, Champions Oncology, SEP 11, 2024, View Source [SID1234646509]).

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First Quarter Highlights:

•Total revenue increased 12% to $14.1 million
•Margin improved to 50%
•Adjusted EBITDA of $2.0 million
•Net income of $1.3 million

Ronnie Morris, CEO of Champions, commented, "As outlined on our year-end earnings call, we’re cautiously optimistic that we’ve weathered the worst of the business downturn and we’re poised to emerge leaner and stronger. Our first quarter’s performance provided further evidence that we’re on a strategic course to more consistently deliver the results we have been striving to achieve." Morris added, "Our comprehensive platform, unique data, and strong team are the key ingredients for future growth that will drive long-term returns for our shareholders."

David Miller, CFO of Champions, added, "The first quarter saw a return to profitability as revenue increased 12% to $14.1 million while we reduced total costs by more than $2.0 million. The revenue increase, combined with mostly unchanged cost of oncology services, lifted our margin to 50%." Miller added, "While there will be some revenue and margin volatility over the coming quarters, our cost reductions should enable us to remain profitable on an adjusted EBITDA basis."

Exhibit 99.1
First Fiscal Quarter Financial Results

Total revenue for the first quarter of fiscal 2025 was $14.1 million compared to $12.6 million for the same period last year, an increase of 12%. Operational improvements and efficiencies implemented in the prior year led to an increase in our bookings to revenue conversion percentage contributing to the revenue growth. Total costs and operating expenses for the first quarter of fiscal 2025 were $12.7 million compared to $15.1 million for the first quarter of fiscal 2024, a decrease of $2.4 million or 15.8%.

For the first quarter of fiscal 2025, Champions reported income from operations of $1.3 million, including $258,000 in stock-based compensation and $449,000 in depreciation and amortization expenses, compared to a loss from operations of $2.6 million, inclusive of $423,000 in stock-based compensation and $445,000 in depreciation and amortization expenses, in the first quarter of fiscal 2024. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported an adjusted EBITDA income of $2.0 million for the first quarter of fiscal 2025 compared to an adjusted EBITDA loss of $1.7 million in the first quarter of fiscal 2024.

Cost of oncology services was $7.1 million for the three-months ended July 31, 2024, a decrease of $612,000, or 8.0% compared to $7.7 million for the three-months ended July 31, 2023. The decrease in cost of oncology services was primarily from a decline in outsourced lab services. For the three-months ended July 31, 2024, total margin was 49.7% compared to 38.8% for the three-months ended July 31, 2023. The improved margin resulted primarily from a combination of an increase in revenue on a lower cost base due to operational efficiencies implemented and other cost reduction initiatives.

Research and development expense for the three-months ended July 31, 2024 was $1.5 million, a decrease of $1.3 million or 47.9%, compared to $2.8 million for the three-months ended July 31, 2023. The decrease was primarily due to reduced investment in research and development, including our target discovery program. Sales and marketing expense for the three-months ended July 31, 2024 was $1.7 million, a slight decrease of $17,000, or 1.0%, compared to $1.7 million for the three-months ended July 31, 2023. General and administrative expense for the three-months ended July 31, 2024 was $2.5 million, a decrease of $413,000, or 14.0%, compared to $2.9 million for the three-months ended July 31, 2023. The decrease was primarily from a reduction in compensation and recruitment expenses.

Net cash provided by operating activities was approximately $311,000 for the three-months ended July 31, 2024 and was primarily due to our operational income, offset by net changes in our working capital accounts in the ordinary course of business. There were no investing activities for the first quarter of fiscal 2025. Net cash used in financing activities for the three-months ended July 31, 2024 was approximately $37,000 resulting from financing lease payments.

The Company ended the quarter with cash on hand of approximately $2.9 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 726315, or provide the verbal reference "Champions Oncology".
Full details of the Company’s financial results will be available by or before September 16, 2024 in the Company’s Form 10-Q at www.championsoncology.com.