On March 12, 2024 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that the Korean Patent Office has issued a Notice of Patent Grant for a broad patent that covers the use of Genprex’s lead drug candidate, Reqorsa Immunogene Therapy, in combination with anti-PD-1 and PD-L1 antibodies through 2037 (Press release, Genprex, MAR 12, 2024, View Source [SID1234641064]).

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This patent will expand on the previously granted patents in the U.S., Japan, Mexico, Russia, Australia, Chile and China to cover the use of REQORSA in combination with immune checkpoint inhibitors, e.g., PD-1 and PD-L1 inhibitors. These patents are applicable to Genprex’s Acclaim-2 and Acclaim-3 clinical trials.

"We continue to secure exclusivity for our drug combinations of REQORSA with PD-1 antibodies, such as Keytruda and PD-L1 antibodies, such as Tecentriq, for the treatment of cancer in some of the largest markets," said Thomas Gallagher, Esq., Senior Vice President of Intellectual Property and Licensing at Genprex. "It is important that we continue to add to our global intellectual property estate and to build protection around our drug combinations as we advance REQORSA through the clinic."

The Acclaim-2 study is a Phase 1/2 clinical trial that has three portions – a Phase 1 dose escalation portion, a Phase 2a expansion portion, and a Phase 2b randomized portion. The Acclaim-2 trial uses a combination of REQORSA and Merck & Co.’s Keytruda in patients with late-stage non-small cell lung cancer (NSCLC) whose disease has progressed after treatment with Keytruda. Patients are treated at the 0.06 mg/kg dose level in the first cohort of patients and, subject to the Acclaim-2 SRC approval, will be treated at successive dose levels of 0.09 mg/kg and 0.12 mg/kg. Genprex expects to complete enrollment in the Phase 1 dose escalation portion of the Acclaim-2 study in the second half of 2024. Genprex was granted FDA Fast Track Designation for the Acclaim-2 patient population.

The Acclaim-3 study has two portions – a Phase 1 dose escalation portion and a Phase 2 expansion portion. In November 2022 Genprex filed with the FDA the protocol for the Phase 1/2 Acclaim-3 clinical trial using a combination of REQORSA and Genentech’s Tecentriq as maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC) who develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced. The Phase 1 portion of the Acclaim-3 study is open for enrollment, and Genprex expects to complete the Phase 1 portion of the study by the second half of 2024. Genprex was granted FDA Fast Track Designation and Orphan Drug Designation for the Acclaim-3 patient population.

On March 12, 2024 Domain Therapeutics ("Domain"), a clinical-stage global biopharmaceutical company developing innovative drug candidates in immuno-oncology targeting G Protein-Coupled Receptors (GPCRs), and Chime Biologics, a leading Contract Development and Manufacturing Organization (CDMO) that enables its partners’ success in biologics, reported the signing of a manufacturing service agreement for the production of Domain’s best-in-class Treg depleting anti-CCR8 antibody candidate, DT-7012 (Press release, Domain Therapeutics, MAR 12, 2024, View Source [SID1234641063]). This phase of manufacturing aims to deliver an effective therapeutic for cancer patients worldwide.

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Under the terms of the agreement, Chime Biologics will ensure stable cell line development (CLD) and DT-7012 candidate manufacturing to support clinical trials in strategic countries. Chime Biologics’ first global modular facility with single-use bioprocessing technology meets international cGMP standards with proven audit track records.

DT-7012 is a novel anti-CCR8 mAb depleting tumor-infiltrating Tregs, major immunosuppressive cells. Treg depletion with anti-CCR8 mAb has demonstrated a unique anti-tumor potency as a monotherapy.
DT-7012 has a proven best-in-class potential compared to other clinical-stage CCR8 antibodies, paving the way for effective GPCR-targeting immunotherapies, aiming to activate antitumor immunity for cancer patients unresponsive to other treatments. Phase I clinical studies of DT-7012 are expected to start in early 2025 for solid tumors and mid-2025 for cutaneous T-cell lymphoma (CTCL).

Dr. Jimmy Wei, President of Chime Biologics, commented: "We look forward to progressing this strategic partnership, which combines Domain’s leading anti-CCR8 antibody candidate with Chime Biologics’ CLD to commercial manufacturing expertise, contributing to the development of DT-7012 for various cancers".

Stephan Schann, Chief Scientific Officer of Domain Therapeutics, said: "We’re thrilled to collaborate with Chime Biologics, a great scientific and manufacturing expert, to advance DT-7012, our leading anti-CCR8 candidate, to the next development stage. This new GPCR-targeting immunotherapy has immense potential to unlock the immune system’s cancer fighting abilities and help patients globally. At Domain, we prioritize precision research and innovation and embrace new partnerships with organizations that share our vision and passion to advance immuno-oncology".

On March 12, 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 third quarter of fiscal 2024, ended January 31, 2024 (Press release, Champions Oncology, MAR 12, 2024, View Source [SID1234641061]).

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Third Quarter and Recent Highlights:

•Third quarter revenue of $12.0 million, a decline of 6%
•Gross margin declined to 35%
•College of American Pathologists (CAP) has awarded accreditation to US-based laboratory

Ronnie Morris, CEO of Champions, commented, "As discussed over the course of the year, we’re navigating through a challenging economic environment, specifically in the biotech sector, that began approximately one year ago. However, we still remain confident that the tide is turning and we will emerge stronger over the coming quarters." Morris added, "We remain actively engaged with investors in an effort to raise capital for our wholly owned subsidiary, Corellia, AI. Conjunctively, our two lead targets continue to progress with the potential of a licensing deal in the coming quarters."

David Miller, CFO of Champions, added, "In response to our lower revenue growth, we’re strategically right-sizing the business to reduce costs and improve short term results as we rebound to previous revenue levels. These reductions will not have a long-term impact on the business and we believe our quarterly results will gradually improve going forward."

Third Fiscal Quarter Financial Results

Total revenue for the third quarter of fiscal 2024 was $12.0 million compared to $12.8 million for the same period last year, a decrease of 5.9%. The decline in revenue was primarily from customer

Exhibit 99.1
cancellations in prior periods which led to lower study revenue in the third quarter. Total costs and operating expenses for the third quarter of fiscal 2024 were $14.6 million compared to $15.2 million for the third quarter of fiscal 2023, a decrease of $635,000 or 4.2%.

For the third quarter of fiscal 2024, Champions reported a loss from operations of $2.6 million, including $379,000 in stock-based compensation and $481,000 in depreciation and amortization expenses, compared to a loss from operations of $2.5 million, inclusive of $331,000 in stock-based compensation and $575,000 in depreciation and amortization expenses, in the third quarter of fiscal 2023. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported an adjusted EBITDA loss of $1.7 million for the third quarter of fiscal 2024 compared to an adjusted EBITDA loss of $1.6 million in the third quarter of fiscal 2023.

Cost of oncology solutions was $7.8 million for the three-months ended January 31, 2024, an increase of $150,000, or 1.9% compared to $7.7 million for the three-months ended January 31, 2023. The increase in cost of sales was primarily from an increase in compensation expense and mouse costs resulting from some operational inefficiencies. For the three-months ended January 31, 2024, total gross margin was 34.7% compared to 39.7% for the three-months ended January 31, 2023. The lower margin resulted primarily from a combination of a decline in revenue against relatively unchanged fixed costs and higher variable costs due to some operational inefficiencies.

Research and development expense for the three-months ended January 31, 2024 was $2.2 million, a decrease of $1.0 million or 31.7%, compared to $3.2 million for the three-months ended January 31, 2023. The decrease was primarily due to reduced investment in our target discovery program. Sales and marketing expense for the three-months ended January 31, 2024 was $1.8 million, a slight increase of $36,000, or 2.0%, compared to $1.8 million for the three-months ended January 31, 2023. General and administrative expense for the three-months ended January 31, 2024 was $2.8 million, an increase of $195,000, or 7.6%, compared to $2.6 million for the three-months ended January 31, 2023. The increase was primarily from compensation and recruiting expenses and an increase in bad debt reserves.

Net cash used in operating activities was approximately $920,000 for the three-months ended January 31, 2024 and was primarily due to our operational loss, offset by net changes in our working capital accounts and deferred revenue in in the ordinary course of business. Net cash used in investing activities was approximately $125,000 for investment in additional lab and computer equipment. There were no financing activities for the third quarter of fiscal year 2024.

Year-To-Date Financial Results

For the first nine months of fiscal 2024, revenue decreased 11.4% to $36.2 million compared to $40.8 million for the first nine months of fiscal 2023. The decline in revenue was primarily from customer cancellations in fiscal year 2023 resulting in lower study revenue during fiscal year 2024. Total costs and operating expenses for the first nine months of fiscal 2024 were $43.2 million compared to $43.5 million for the first nine months of fiscal 2023, a decrease of $296,000 or 0.7%.

For the first nine months of fiscal 2024, Champions reported a loss from operations of $7.1 million, including $855,000 in stock-based compensation and $1.4 million in depreciation and amortization expenses, compared to a loss from operations of $2.7 million, inclusive of $656,000 in stock-based compensation and $1.7 million in depreciation and amortization expenses, in the first nine months of fiscal 2023. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported an adjusted EBITDA loss of $4.8 million for the first nine months of fiscal 2024 compared to an adjusted EBITDA loss of $400,000 in the first nine months of fiscal 2023.

Exhibit 99.1

Cost of oncology solutions was $22.2 million for the nine-months ended January 31, 2024, a slight decrease of $43,000, or 0.2% compared to $22.2 million for the nine-months ended January 31, 2023. For the nine-months ended January 31, 2024, total gross margin was 38.7% compared to 45.6% for the nine-months ended January 31, 2023. The lower margin resulted from lower revenue against a generally unchanged cost base. The variable cost component of cost of sales did not decline meaningfully despite the lower study volume due to some operational inefficiencies.

Research and development expense for the nine-months ended January 31, 2024 was $7.5 million, a decrease of $1.2 million or 13.8%, compared to $8.7 million for the nine-months ended January 31, 2023. The decrease was primarily from reduced investment in our target discovery program. Sales and marketing expense for the nine-months ended January 31, 2024 was $5.3 million, a slight increase of $135,000, or 2.6%, compared to $5.2 million for the nine-months ended January 31, 2023. The increase was the result of an increase in compensation expense. General and administrative expense for the nine-months ended January 31, 2024 was $8.3 million, an increase of $811,000, or 10.8%, compared to $7.5 million for the nine-months ended January 31, 2023. The increase was primarily due to an increase in compensation and recruiting expenses and allowances for bad debt, offset by a reduction in IT costs.

Net cash used in operating activities was $4.3 million for the nine-months ended January 31, 2024. The cash used in operating activities was primarily due to the net loss from operations excluding non-cash expenses. Net cash used in investing activities was $950,000 and was primarily from investment in additional lab and computer equipment. Net cash used in financing activities was approximately $382,000 resulting from repurchases of common stock and was offset by proceeds received from options exercises.

The Company ended the quarter with cash and cash equivalents on hand of approximately $4.5 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 third quarter financial results. To participate in the call, please call 877-545-0523 (Domestic) or 973-528-0016 (International) and enter the access code 860900, or provide the verbal reference "Champions Oncology".
Full details of the Company’s financial results will be available by or before March 18, 2024 in the Company’s Form 10-Q at www.championsoncology.com.
* Non-GAAP Financial Information

On March 12, 2024 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company focused on the development of MasterKey therapies to treat patients with genetically defined tumors, reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update (Press release, Black Diamond Therapeutics, MAR 12, 2024, View Source [SID1234641060]).

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"The year 2023 was exciting, with generation of clinical data that positions BDTX-1535 as a potential first and best in class 4th generation EGFR TKI, and we recently began dosing first-line patients in a Phase 2 trial in NSCLC with non-classical mutations," said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "This year will be data rich across our pipeline, with Phase 2 data for BDTX-1535 in NSCLC, additional GBM results, and initial Phase 1 data for BDTX-4933 in non-G12C KRAS mutated NSCLC."

Recent Developments & Upcoming Milestones:

BDTX-1535:

In October 2023, Black Diamond presented a poster with updated clinical data at the European Organization for Research and Treatment of Cancer-National Cancer Institute-American Association for Cancer Research (EORTC-NCI-AACR) (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics from the dose escalation portion of the Phase 1 clinical trial of BDTX-1535 in patients with non-small cell lung cancer (NSCLC). The presentation included clinical data from 27 patients with advanced/metastatic NSCLC who received once daily doses ranging from 25mg to 400mg. These results demonstrated a favorable tolerability profile and durable responses in patients with NSCLC expressing both acquired resistance C797S and non-classical driver epidermal growth factor receptor (EGFR) mutations.
Following receipt of End of Phase 1 feedback from the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2023, Black Diamond initiated a Phase 2 cohort in first-line (1L) patients with non-classical EGFR mutations in early 2024. (NCT05256290)
Phase 0/1 "window of opportunity" clinical trial of BDTX-1535 began enrollment in October 2023 to evaluate the pharmacokinetic, pharmacodynamic, and clinical response in patients with recurrent high-grade glioma (HGG) with EGFR alterations and/or fusions who are undergoing a planned surgical resection. The trial is sponsored by the Ivy Brain Tumor Center in Phoenix, Arizona. (NCT06072586)
Top-line results disclosed in December 2023 from the Phase 1 dose escalation trial of BDTX-1535 in patients with relapsed/recurrent glioblastoma (GBM) showed clinical activity in heavily pretreated patients. BDTX-1535 was shown to be generally well tolerated, with no new safety signals observed.
Black Diamond anticipates the following upcoming key milestones for BDTX-1535:
Oral presentation describing real world data of the evolving EGFR mutation landscape in patients with NSCLC, and the MasterKey profile of BDTX-1535 addressing a broad spectrum of mutations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting on April 7, 2024.
Phase 2 clinical data in patients with NSCLC and non-classical driver or acquired resistance EGFR mutations in the third quarter of 2024.
Phase 1 dose escalation data in patients with relapsed/recurrent GBM, and initial results from the investigator sponsored "window of opportunity" trial in patients with recurrent HGG are expected to be presented at a medical meeting in the second quarter of 2024.
BDTX-4933:

In October 2023, Black Diamond presented a poster at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics detailing preclinical data for the clinical-stage MasterKey RAF inhibitor BDTX-4933, a brain-penetrant oral inhibitor of oncogenic alterations in KRAS, NRAS and BRAF. Preclinical results showed that BDTX-4933 potently and selectively inhibited the proliferation of tumor cells expressing a range of KRAS, NRAS and BRAF mutations, suggesting clear differentiation compared to other RAF inhibitors.
A Phase 1 clinical trial for BDTX-4933 was initiated in the second quarter of 2023 in patients with BRAF and select RAS/MAPK mutation-positive cancers, with an emphasis on patients with KRAS mutant NSCLC. The trial is currently in dose escalation with an update anticipated in the fourth quarter of 2024. (NCT05786924)
Financial Highlights

Cash Position: Black Diamond ended 2023 with approximately $131.4 million in cash, cash equivalents, and investments compared to $122.8 million as of December 31, 2022. Net cash used in operations was $66.7 million for the year ended December 31, 2023 compared to $85.1 million for the year ended December 31, 2022.
Research and Development Expenses: Research and development (R&D) expenses were $15.3 million for the fourth quarter of 2023, compared to $14.6 million for the same period in 2022. Research and development expenses were $59.4 million for the year ended December 31, 2023, compared to $64.4 million for the year ended December 31, 2022. The decrease in R&D expenses was primarily due to reduced spending on early discovery projects as we deepen our focus on our clinical-stage assets.
General and Administrative Expenses: General and administrative (G&A) expenses were $5.6 million for the fourth quarter of 2023, compared to $7.2 million for the same period in 2022, and $27.1 million for the year ended December 31, 2023, compared to $28.4 million for the year ended December 31, 2022. The decrease in G&A expenses was primarily due to a decrease in legal and other professional fees.
Net Loss: Net loss for the fourth quarter of 2023 was $19.4 million, as compared to $21.1 million for the same period in 2022. Net loss for the year ended December 31, 2023 was $82.4 million compared to $91.2 million for the year ended December 31, 2022.
Financial Guidance

Black Diamond ended 2023 with approximately $131.4 million in cash, cash equivalents and investments which the Company believes is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the second quarter of 2025.

On March 12, 2024 Aligos Therapeutics, Inc. (Nasdaq: ALGS, "Aligos"), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, reported recent business progress and financial results for the fourth quarter and full year 2023 (Press release, Aligos Therapeutics, MAR 12, 2024, View Source [SID1234641059]).

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"Last year we built the foundation for a critical 2024 by closing a $92 million PIPE from healthcare-dedicated institutional investors and successfully completing our Phase 2a enabling activities for ALG-055009," stated Lawrence Blatt, Ph.D., MBA, Chairman & CEO of Aligos Therapeutics. "In addition, we presented unprecedented antiviral activity from our ALG-000184 program for chronic hepatitis B (CHB). With these important accomplishments in hand, we are well positioned to deliver important planned milestones in 2024, which include releasing topline data in subjects with metabolic dysfunction-associated steatohepatitis (MASH) in the ALG-055009 Phase 2a study (HERALD) and completing Phase 2 enabling activities for ALG-000184 by the end of the year. We look forward to sharing our achievements with our stakeholders throughout this year."

Recent Business Progress

Aligos Portfolio of Drug Candidates

ALG-055009: Potential best-in-class small molecule THR-β agonist for MASH

Phase 2a enabling activities, including completion of supporting nonclinical/Phase 1 studies and manufacturing of drug supply, were completed
The Phase 2a HERALD protocol was filed with the FDA in Q4 2023
First subject dosed expected in Q2 2024 and topline HERALD data anticipated in Q4 2024
ALG-000184: Potential best-in-class small molecule CAM-E for CHB

Dosing continues in the ongoing Phase 1a/1b ALG-000184-201 study, with multiple subjects now having been dosed for >1 year (total planned dosing duration is 96 weeks). Interim data readouts are planned to be presented this year at the following conferences: Asian Pacific Association for the Study of the Liver (APASL), European Association for the Study of the Liver (EASL), and American Association for the Study of Liver Diseases (AASLD)
Phase 2 enabling activities, including regulatory interactions and drug supply manufacturing, are underway
ALG-097558: Potential best-in-class small molecule pan-coronavirus protease inhibitor

The ongoing Phase 1 first in human study is nearing completion of dosing (Q2), with topline data to be presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) Annual Meeting, occurring in April 2024
Phase 2 enabling activities are underway with financial support from the National Institute of Allergy and Infectious Diseases (NIAID)
Financial Results for the Fourth Quarter and Full Year 2023

Cash, cash equivalents and investments totaled $135.7 million as of December 31, 2023, compared with $125.8 million as of December 31, 2022. Additionally, in October 2023, we raised $92.1 million in gross proceeds in a private placement financing, before deducting placement agent’s fees and other expenses. Including the proceeds from the private placement financing, we continue to believe our cash balance provides sufficient cash to fund planned operations through the end of 2025.

Net losses for the three months ended December 31, 2023 were $27.9 million or basic and diluted net loss per common share of $(0.22), compared to net losses of $21.9 million or basic and diluted net loss per common share of $(0.51) for the three months ended December 31, 2022.

Net losses for the year ended December 31, 2023 were $87.7 million or basic and diluted net loss per common share of $(1.36), compared to net losses of $96.0 million or basic and diluted net loss per common share of $(2.25) for the year ended December 31, 2022.

Research and development (R&D) expenses for the three months ended December 31, 2023 were $22.3 million, compared with $19.1 million for the same period of 2022. The increase was primarily due third party expenses due to the milestone payments made as a result of dosing the first patient in a clinical trial. Total R&D stock-based compensation expense incurred for the three months ended December 31, 2023 was $1.5 million, compared with $1.9 million for the same period of 2022.

R&D expenses for the year ended December 31, 2023, were $73.0 million, compared with $85.1 million for the same period of 2022. The decrease was primarily due to a decrease in third-party expenses mainly related to our discontinued STOPs and ASO programs in 2022, partially offset by increases in our ongoing activities and related expenditures associated with our CAM clinical trial activities and MASH program, as well as the milestone payment to Katholieke Universiteit Leuven (KU Leuven) under its collaboration agreement related to the coronaviruses and the dosing of the first patient in a Phase 1 clinical trial. Total R&D stock-based compensation expense incurred for the year ended December 31, 2023 was $6.8 million, compared with $8.0 million for the same period of 2022.

General and administrative (G&A) expenses for the three months ended December 31, 2023 were $6.4 million, compared with $7.1 million for the same period of 2022. The decrease in G&A expenses for this comparative period is primarily due to a decrease in facility costs. Total G&A stock-based compensation expense incurred for the three months ended December 31, 2023 was $1.1 million, compared with $1.6 million for the same period of 2022.

G&A expenses for the year ended December 31, 2023, were $30.6 million, compared with $26.4 million for the same period of 2022. This was due to an increase in third-party expenses primarily due to higher legal and patent attorney costs, partially offset by a decrease in facility expenses. Total G&A stock-based compensation expense incurred for the year ended December 31, 2023 was $5.8 million, compared with $6.7 million for the same period of 2022.