On May 15, 2024 PDS Biotechnology Corporation, a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, reported a business update and reported financial results for the first quarter of 2024. The press release will be available in the Investor Relations section of the Company’s website at www.pdsbiotech.com (Press release, PDS Biotechnology, MAY 15, 2024, View Source [SID1234643337]).

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Recent Developments

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Hosted a Key Opinion Leader event on May 8, 2024 during which prominent experts in head and neck squamous cell cancer ("HNSCC") discussed positive, updated VERSATILE-002 data and the unmet need in HPV16-positive HNSCC. A replay of the event can be found here.

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Announced updated results from the VERSATILE-002 Phase 2 trial evaluating first line treatment of patients with HPV16-positive recurrent or metastatic HNSCC using Versamune HPV + KEYTRUDA (pembrolizumab) (n=53).

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Median overall survival is 30 months; Published results for immune checkpoint inhibitors are 7-18 months.

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The cohort met its primary endpoint of best overall response (BOR).

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BOR by investigator assessment is 34% (Combined Positive Score (CPS) ≥1; n=18/53); 48% (CPS≥20; n=10/21); Published results for ICIs are <20% (CPS>1) and <25% (CPS≥20).

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CPS is used to assess PD-L1 expression

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Progression free survival is 6.3 months (CPS≥1); 14.1 months (CPS≥20); Published results for immune checkpoint inhibitors 2-3 months.

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VERSATILE-002 data to date indicate a durable response in first line recurrent or metastatic HNSCC patients with CPS≥1.

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The combination of Versamune HPV + pembrolizumab was well tolerated.

Announced an updated clinical strategy with a two-part registrational trial focused on the triple combination of Versamune HPV + PDS01ADC + pembrolizumab as a first line treatment in HPV16-positive recurrent or metastatic HNSCC.

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PDS01ADC is the Company’s novel, investigational tumor-targeting IL-12-fused antibody-drug conjugate (ADC), which has shown promise in a clinical trial of Versamune HPV + PDS01ADC + an investigational ICI conducted by the National Cancer Institute.

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Part one of the clinical trial will focus on dose optimization with a data readout based on safety and objective response rate.

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The randomized second part of the trial will include an interim data readout with overall survival as its primary endpoint.

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Further strengthened management with the addition of Stephan Toutain, M.S., MBA, as Chief Operating Officer. Mr. Toutain brings extensive operational and commercial experience to PDS Biotech.

Versamune Platform Intellectual Property

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Company received patents granted by the Israel Patent Office and IP Australia that will extend protections for the Company’s novel investigational T cell activating Versamune platform through Dec. 2038 and Nov. 2036, respectively.

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The Israel Patent Office granted patent No. 275154 titled, "Methods and compositions comprising cationic lipids for stimulating type I interferon genes," extending protections for compositions using the Versamune platform and comprising of cationic lipid for activating type I interferons. This patent covers all formulations and compositions that include Versamune to activate a T cell response.

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IP Australia granted patent No. 2016354590 titled, "Lipids as synthetic vectors to enhance antigen processing and presentation ex-vivo in dendritic cell therapy." This patent covers the use of Versamune compositions that reduce the populations of immune suppressive cells in the tumor and its application for the development of dendritic cell-based approaches to immunotherapy.

First Quarter 2024 Financial Results
Reported net loss was approximately $10.6 million, or $0.30 per basic share and diluted share, for the three months ended March 31, 2024, compared to a net loss of $9.7 million, or $0.32 per basic share and diluted share, for the three months ended March 31, 2023. The increase was due to higher operating and net interest expenses.

Research and development expenses increased to approximately $6.7 million for the three months ended March 31, 2024, from $5.8 million for the three months ended March 31, 2023. The increase of $0.9 million was primarily attributable to an increase of $1.2 million in clinical studies and medical affairs offset by a decrease of $0.1 million in personnel costs, $0.1 million in professional fees and $0.1 million in manufacturing expenses.

General and administrative expenses decreased to approximately $3.4 million for the three months ended March 31, 2024, from approximately $3.6 million for the three months ended March 31, 2023. The decrease of $0.2 million was primarily attributable to an increase of $0.3 million in professional fees offset by a decrease of $0.5 million in personnel costs.

Total operating expenses increased to approximately $10.1 million for the three months ended March 31, 2024 from $9.4 million for the three months ended March 31, 2023.

Net interest expenses increased to approximately $0.5 million for the three months ended March 31, 2024 from $0.2 million for the three months ended March 31, 2023.

Cash and cash equivalents as of March 31, 2024, totaled approximately $66.6 million.

On May 15, 2024 Panbela Therapeutics, Inc., a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported a business update and reports financial results for the quarter ended March 31, 2024 (Press release, Panbela Therapeutics, MAY 15, 2024, View Source [SID1234643336]). As previously announced, management is hosting earnings call today at 4:30 p.m. ET.

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Q1 2024 and recent Highlights:
Clinical
Announced revised timing for the interim data analysis for its ongoing ASPIRE trial, evaluating ivospemin (SBP-101) in combination with standard-of-care for metastatic pancreatic ductal adenocarcinoma (mPDAC). The analysis is now expected in Q1 2025 due to a lower-than-anticipated event rate, which suggests high potential for improved survival outcomes for patients in the trial.

Poster presentation of Ivospemin (SBP-101) at AACR (Free AACR Whitepaper) highlighting the efficacy of SBP-101 in combination with doxorubicin to treat platinum-resistant ovarian cancer

ASPIRE trial has exceeded 50% enrollment; complete enrollment of approximately 600 patients anticipated by Q1 2025

Publication of Clinical Data: Phase 1 study of high-dose DFMO, celecoxib, cyclophosphamide and topotecan for patients with relapsed neuroblastoma: a New Approaches to Neuroblastoma Therapy trial. Br J Cancer 130, 788–797 (2024)

Financial / Business
• Gained eligibility for quotation of common stock on the OTCQB
• Closed $9.0 million public offering of common stock and warrants
• Issuance of a New Patent in the US and Canada for Claims of a Fixed Dose Combination of Eflornithine and Sulindac

"We were thrilled to announce that our ongoing ASPIRE trial, evaluating ivospemin (SBP-101) in combination with standard-of-care for metastatic pancreatic ductal adenocarcinoma, or mPDAC, is now expected to reach its interim data analysis in the first quarter of 2025, due to a lower-than-anticipated event rate, suggesting improved survival outcomes for patients in the trial. This gives us hope for meaningful advancements in mPDAC treatment beyond the incremental benefits seen with recently approved therapies," said Jennifer K. Simpson, PhD, MSN, CRNP, President & CEO of Panbela.

"In addition to the progress in our ASPIRE trial, which has now exceeded 50% enrollment with complete enrollment of approximately 600 patients anticipated by Q1 2025, we were pleased to present a poster highlighting the efficacy of SBP-101 in combination with doxorubicin for treating platinum-resistant ovarian cancer at AACR (Free AACR Whitepaper). We also welcomed the publication of clinical data from our Phase I study of high-dose DFMO, celecoxib, cyclophosphamide, and topotecan for patients with relapsed neuroblastoma in the British Journal of Cancer. On the financial and business front, we announced the transfer of our common stock to the OTCQB market and successfully closed a $9.0 million public offering. As we look ahead, Panbela remains steadfast in its commitment to improving patient outcomes and driving value for our stockholders, with several key catalysts on the horizon, including the highly anticipated overall survival interim analysis in our Phase III ASPIRE Trial."

First Quarter ended March 31, 2024 Financial Results
General and administrative expenses were approximately $1.2 million in the quarter, compared to $1.4 million in the same period last year. The decrease is due primarily to reduced legal and other professional services.

Research and development expenses were approximately $5.5 million, compared to $3.5 million in the same period last year. This increase is primarily due to significant growth in the number of active sites and enrollment in project ASPIRE.

Net loss in the quarter was approximately $7.1 million, or $2.28 per diluted share, compared to a net loss of $5.1 million, or $392.76 per diluted share, in the same period last year. This increased loss is due to the incremental research and development expenses.

Total cash was $262,000 as of March 31, 2024. Total current assets were $1.8 million and current liabilities were $10.5 million as of the same date. In April the Company’s partner in Pediatric Neuroblastoma, US WorldMeds, provided a nondilutive payment of approximately $0.8 million in exchange for a reduction in the potential future milestone payments.

Notes payable, plus accrued interest, on the balance sheet, the result of the acquisition of CPP, totaled approximately $4.2 million. The current portion of the notes payable plus accrued interest totaled approximately $1.3 million and was paid to the noteholder in the first quarter of 2024.

During the first quarter, the Company completed a registered public offering. Net proceeds from the raise, which closed on January 31, 2024, were approximately $8.1 million.

On May 15, 2024 Outlook Therapeutics, Inc., a biopharmaceutical company working to achieve regulatory approval for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of retinal diseases, reported financial results for the second quarter of fiscal year 2024 and provided a corporate update (Press release, Outlook Therapeutics, MAY 15, 2024, View Source [SID1234643335]). As previously announced, the Company will host its inaugural quarterly conference call and live audio webcast, on Thursday, May 16, 2024, at 8:30 AM ET (details below).

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"We are extremely pleased with our corporate, clinical, and regulatory progress. On the regulatory front, we continue to drive toward anticipated marketing authorization of ONS-5010 in the EU and have also submitted our marketing application for authorization in the UK. In the US, we are executing on our NORSE EIGHT clinical trial and advancing toward a topline data readout expected in the fourth quarter of calendar year 2024. On the financial front, assuming full exercise of the warrants issued in our recent private placement transactions, we believe we now have access to sufficient capital to take ONS-5010 through potential FDA approval and funding of the commercial launch," commented Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics. "We remain steadfast in our mission to enhance the standard of care in the retinal anti-VEGF space. On behalf of the entire team, I would like to thank all our partners and stakeholders for their continued support and look forward to what we believe will be an exciting remainder of the year for Outlook Therapeutics."

Lawrence Kenyon, Chief Financial Officer of Outlook Therapeutics, added, "Our adjusted financial results for the quarter met our expectations as we initiated the NORSE EIGHT clinical trial and began enrolling patients. We believe we are well positioned financially to continue executing on NORSE EIGHT enrollment, resubmission of the ONS-5010 BLA by the end of calendar 2024, and launch of ONS 5010 in 2025, if approved."

Upcoming Anticipated Milestones

MAA decision in the European Union (EU) for ONS-5010 anticipated in Q2 CY2024;
Full enrollment of NORSE EIGHT clinical trial in the US expected in Q3 CY2024;
Topline readout of NORSE EIGHT clinical trial planned in Q4 CY2024;
Resubmission of the ONS-5010 BLA targeted for the end of CY2024;
Planning underway for potential commercial launches in the EU and UK to begin in first quarter of CY2025; and
Potential for US FDA approval of ONS-5010 in 2025.

ONS-5010 / LYTENAVA (bevacizumab-vikg) Regulatory Update

As previously announced, following Type A meetings with the FDA in Q4 CY2023, the FDA informed Outlook Therapeutics that it can conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 3-month study of treatment naïve patients with a primary efficacy endpoint at 2 months (NORSE EIGHT). In January 2024, Outlook Therapeutics announced that it received written agreement on the NORSE EIGHT trial protocol and statistical analysis plan from the FDA under a SPA for NORSE EIGHT. The SPA also confirms in writing that if the NORSE EIGHT trial is successful, it would satisfy the FDA’s requirement for a second adequate and well-controlled clinical trial to fully address the clinical deficiency identified in the Complete Response Letter (CRL). In addition, through a Type A meeting and additional interactions, Outlook Therapeutics has identified the approaches needed to resolve the Chemistry, Manufacturing and Controls (CMC) comments in the CRL. Outlook Therapeutics has scheduled a series of Type C and Type D meetings with the FDA to address the open CMC items in the CRL and expects to resolve these comments prior to the expected completion of NORSE EIGHT.

NORSE EIGHT is a randomized, controlled, parallel-group, masked, non-inferiority study of approximately 400 newly diagnosed, wet age-related macular degeneration (wet AMD) subjects randomized in a 1:1 ratio to receive 1.25 mg ONS-5010 or 0.5 mg ranibizumab intravitreal injections. Subjects will receive injections at Day 0 (randomization), Week 4, and Week 8 visits. The primary endpoint is mean change in BCVA from baseline to week 8. Currently, over 30% of the required subjects have been enrolled in the study. Outlook Therapeutics continues to plan NORSE EIGHT enrollment completion in Q3 CY2024, with topline results expected to be reported, and the planned resubmission of the ONS-5010 BLA to occur, by the end of calendar year 2024.

In March 2024, the CHMP issued a positive opinion concerning the EU Marketing Authorization Application (MAA) of ONS-5010/LYTENAVA (bevacizumab gamma), an investigational ophthalmic formulation of bevacizumab for the treatment of wet AMD in the EU. The CHMP positive opinion was based on results from Outlook Therapeutics’ wet AMD clinical program for ONS-5010, which consists of three completed registration clinical trials – NORSE ONE, NORSE TWO and NORSE THREE, as well as studies and peer reviewed literature substituting or supporting certain tests and studies.

This positive opinion supports the grant of marketing authorization by the European Commission for Outlook Therapeutics’ application for ONS-5010 in the EU. The European Commission is expected to make a decision on approval within approximately 67 days following the CHMP opinion. The decision will apply automatically in all 27 EU Member States, and, within 30 days, also to Iceland, Norway and Liechtenstein. If approved, an initial ten years of market exclusivity in the EU is expected for ONS-5010/LYTENAVA.

Additionally, the Company recently announced the submission of its MAA to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK seeking authorization of ONS-5010/LYTENAVA (bevacizumab gamma) for the treatment of wet AMD. The submission was completed under the new International Recognition Procedure (IRP), which allows the MHRA to rely on a positive opinion by the CHMP concerning an application for grant of marketing authorization for the same product in the EU. The IRP is available for new UK MAAs of a medicinal product (having the same qualitative and quantitative composition, and the same pharmaceutical form) that has previously been authorized by a Reference Regulator (RR). In this case this is the EMA.

If ONS-5010/LYTENAVA (bevacizumab-vikg or bevacizumab gamma) is approved, Outlook Therapeutics expects to commercialize it as the first and only European Commission, MHRA or FDA approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the EU, UK, and United States. Authorization may also be sought in other European markets, Japan, and elsewhere. If approved, Outlook Therapeutics plans to commercialize ONS-5010/LYTENAVA (bevacizumab-vikg) directly in the US and is assessing both direct commercialization and partnering for ONS-5010/LYTENAVA (bevacizumab gamma) in Europe and other regions outside of the US.

Financial Highlights for the Fiscal Second Quarter Ended March 31, 2024

For the fiscal second quarter ended March 31, 2024, Outlook Therapeutics reported a net loss attributable to common stockholders of $114.3 million, or $8.01 per basic and diluted share, compared to a net loss attributable to common stockholders of $6.7 million, or $0.52 per basic and diluted share, for the same period last year. For the fiscal second quarter ended March 31, 2024, Outlook Therapeutics also reported an adjusted net loss attributable to common stockholders1 of $22.1 million, or $1.55 per basic and diluted share, as compared to an adjusted net loss attributable to common stockholders of $6.7 million, or $0.52 per basic and diluted share, for fiscal second quarter 2023.

Adjusted net loss attributable to common stockholders for the fiscal second quarter ended March 31, 2024 includes $34.1 million of warrant related expenses, $49.6 million of increase in fair value of warrant liability and $8.5 million of increase in fair value of convertible promissory notes. Adjusted net loss attributable to common stockholders was not materially different than net loss attributable to common stockholders for the fiscal second quarter ended March 31, 2023.

In March and April 2024, the Company closed its previously announced private placements of common stock and accompanying warrants. In addition to the upfront gross proceeds of $65 million, the Company has the potential to receive additional gross proceeds of up to $107 million upon the full cash exercise of the warrants issued in the private placements, before deducting placement agent fees and offering expenses.

As of March 31, 2024, Outlook Therapeutics had cash and cash equivalents of $47.2 million.

On May 15, 2024 Oncolytics Biotech, a leading clinical-stage company specializing in immunotherapy for oncology, reported that it has entered into a preliminary collaboration with the Global Coalition for Adaptive Research (GCAR) (Press release, Oncolytics Biotech, MAY 15, 2024, View Source [SID1234643333]). The purpose of the preliminary collaboration is to commence planning activities for the evaluation of pelareorep in the treatment of first-line metastatic pancreatic ductal adenocarcinoma (PDAC) as part of GCAR’s anticipated master protocol for metastatic pancreatic cancer. Activities are currently underway to finalize the seamless Phase 2/3 master protocol design that will evaluate multiple investigational therapies for the treatment of pancreatic cancer. An intent of the study is to produce registration-enabling data.

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"We are thrilled to collaborate with GCAR and are honored that pelareorep has been selected as the first therapeutic for evaluation in GCAR’s planned adaptive trial in pancreatic cancer patients. We believe this opportunity presents a strategic and efficient pathway forward for the development of pelareorep to address an urgent need for pancreatic cancer patients," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "GCAR’s anticipated trial design seeks to cut registrational study time and reduce trial costs, speeding up the journey to potentially deliver effective cancer treatment sooner. Through our interactions with GCAR, we have seen the strength of their capabilities and strong engagement with disease experts in pancreatic cancer. These attributes give us great enthusiasm to begin working together right away."

Meredith Buxton, PhD, MPH, Chief Executive Officer and President of GCAR, commented, "Our unwavering mission at GCAR is to accelerate the development of treatments for patients with deadly diseases such as pancreatic cancer. We believe that adaptive platform trials have the potential to achieve that mission and to be game-changing for patients. We are enthusiastic about collaborating with Oncolytics on our planned pancreatic cancer initiative, which was announced earlier this year, and we look forward to working with Oncolytics to advance our program."

Thomas Heineman, MD, PhD, Chief Medical Officer of Oncolytics shared, "The combination of pelareorep’s impressive results to date and GCAR’s innovative trial design creates a powerful path forward. This strategy, which includes leveraging GCAR’s extensive investigator network, enhances our ability to quickly and effectively advance the development of this pelareorep-based combination therapy for PDAC. Updated data from cohort 1 of the GOBLET study, presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023, showed that patients treated with pelareorep combined with a checkpoint inhibitor, gemcitabine, and nab-paclitaxel experienced a 62% objective response rate, nearly triple what has been seen in historical control trials.1-4 We hope to build on these results in GCAR’s forthcoming study that will employ GCAR’s broad and established network of clinical leaders in pancreatic cancer. I am very optimistic about our program and our collaboration with GCAR and look forward to advancing the evaluation of pelareorep as soon as possible."

On May 15, 2024 Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company, reported financial results for the quarter ended March 31, 2024 (Press release, Oncocyte, MAY 15, 2024, View Source [SID1234643332]).

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Recent Highlights

● Announced global commercialization partnership with Bio-Rad Laboratories, Inc.
● On track to ship research use only (RUO) GraftAssureTM transplant monitoring test kits to initial customers in Asia, the U.S., and the EU in 2Q 2024. IVD kits are under development for FDA submission.
● Raised $15.8 million in gross proceeds from equity private placement; as part of the financing, Bio-Rad purchased 8.99% of Oncocyte; new and existing investors invested as well.
● Reduced cash burn to $3.9 million, reflecting capital-efficient business model.

"In the first quarter of 2024, Oncocyte made significant progress toward commercializing its innovative blood-based diagnostic tests. That progress was bolstered by a $15.8 million equity private placement and a global strategic partnership with Bio-Rad Laboratories," said Josh Riggs, Oncocyte’s CEO. "We believe that the collaboration with Bio-Rad is pivotal for the upcoming launch of our GraftAssure RUO transplant rejection diagnostic test kit and central to our mission of developing and providing accessible point of care diagnostics and continuous innovation in transplant rejection monitoring."

"The Bio-Rad partnership validates the efficacy and market opportunity of our proprietary assays and enables us to rapidly enter the growing transplant monitoring market at key academic centers with GraftAssure RUO. It also lays the groundwork for broader commercial expansion. Together with Bio-Rad, we are developing regulated products including VitaGraft TM Kidney IVD, and preparing for clinical adoption. Additionally, our technology has been selected to support multiple Phase 2 clinical studies by pharmaceutical companies that are developing therapeutics to treat and manage anti-body mediated rejection. These therapeutic studies may unlock valuable new commercial applications."

"Building on the momentum of these achievements, we are preparing to ship to several initial commercial customers in the U.S., the EU, and Asia in Q2. We are encouraged by prospective customers’ positive response to GraftAssure’s superior affordability, turn-around-time, and ease of use. We are well-positioned to achieve numerous critical commercial and regulatory milestones throughout 2024 and into 2025. We also are continuing to advance the development of our oncology diagnostics pipeline products, DetermaIO and DetermaCNI. Lastly, in Q1 2024, our cash burn stayed low at $3.9 million , reflecting our cost-control measures and financial discipline. We continue to meet our goal of maintaining a low average quarterly burn rate below $5 million."

2024 First Quarter Financial Results

Net revenue for the three months ended March 31, 2024 was $176,000, a decrease of 41% compared to the same period in 2023, due to decreased revenue from our Pharma Services business.

Total cost of revenues for the three months ended March 31, 2024 was $274,000, a decrease of 5% compared to the same period in 2023. Total cost of revenues included $252,000 from the cost of diagnostic tests and testing services we performed for Pharma Services customers, with the remaining cost from noncash amortization expense.

Research and development expense for the three months ended March 31, 2024 was $2.2 million, an increase of 2% compared to the same period in 2023. The increase was driven by continued focused investment in developing kitted versions of assays including DetermaIOTM, VitaGraft and DetermaCNITM.

Sales and marketing expense for the three months ended March 31, 2024 was $846,000, an increase of 22% compared to the same period in 2023. The increase was primarily driven by a continued ramp in sales, marketing and commercialization activities related to the commercial launch of GraftAssure.

General and administrative expense for the three months ended March 31, 2024 was $2.7 million, a decrease of 22% compared to the same period in 2023. The decrease was primarily due to decreased stock-based compensation, personnel expenses, professional fees, and facilities and insurance expenses.

Loss from operations for the three months ended March 31, 2024 was $9.3 million, compared to income from operations of $5.9 million during the same period in 2023. The increased loss from operations was primarily due to the unrealized noncash change in fair value of contingent consideration. The 2024 loss from operations included a loss of $3.3 million from the change in fair value of contingent consideration, compared to a gain of $18.3 million in 2023. Excluding the change in fair value of contingent consideration, the 2024 loss from operations decreased 52% compared to 2023.

For Oncocyte’s complete financial results for the first quarter ended March 31, 2024, see the Company’s quarterly Form 10-Q to be filed with the Securities and Exchange Commission on May 15, 2024.