On May 9, 2024 MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company evaluating novel drug candidates to address known resistance mechanisms to standard-of-care cancer therapies, reported results for the three and nine months ended March 31, 2024, and highlighted recent corporate events (Press release, MEI Pharma, MAY 9, 2024, View Source [SID1234643003]).

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"Over the past several months, MEI has received encouraging clinical data for voruciclib and ME-344 supporting the further development of these programs," said David Urso, president and chief executive officer of MEI Pharma. "The clinical focus for the rest of the year will be voruciclib, our oral CDK9 inhibitor. We anticipate providing updates from the clinical trial evaluating voruciclib in combination with venetoclax in patients with relapsed/refractory AML, a study designed to provide additional evidence of the anti-leukemic activity of this combination, during the remainder of calendar 2024."

Mr. Urso continued: "While venetoclax is an established option for patients with AML and is increasingly used as a standard treatment, the disease typically progresses and patients require therapy after venetoclax, which consistently yields limited benefit. While treatments targeting specific patient populations with mutations such as FLT3 and IDH and the menin inhibitors may be an option for some relapsed/refractory AML patients, the majority of patients do not have therapeutically actionable mutations. We believe that voruciclib in combination with venetoclax has potential, as a mutation-agnostic therapy, to benefit the largest number of patients with relapsed/refractory AML."

Select Third Quarter Fiscal Year 2024 and Recent Highlights

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In January 2024, MEI presented a Trials in Progress poster of the Phase 1b study of ME-344, an investigational inhibitor of mitochondrial oxidative phosphorylation ("OXPHOS"), evaluating the combination with bevacizumab (Avastin) in refractory metastatic colorectal cancer patients at the 2024 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium.

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In March 2024, the MEI reported initiation of enrollment in an expansion cohort in the ongoing Phase 1 study evaluating voruciclib, its investigational selective oral cyclin-dependent kinase 9 ("CDK9") inhibitor, in combination with venetoclax (Venclexta), a B-cell lymphoma 2 ("BCL2") inhibitor, in relapsed and refractory ("R/R") acute myeloid leukemia ("AML") patients. The decision to open the expansion cohort was based on initial data demonstrating anti-leukemic activity, including complete responses in heavily pretreated patients. Additionally, at doses of 100 mg or more, initial results from correlative biomarker assay analyses of available samples from patients treated with the combination demonstrated anticipated decreases of myeloid leukemia cell differentiation protein ("Mcl-1"), including progressively greater decreases in Mcl-1 in patients achieving a response compared to patients with stable disease or progressive disease. We also observed expected increases in Mcl-1 after administering venetoclax and subsequent anticipated decreases in Mcl-1 after administering voruciclib, supporting our hypothesis that voruciclib, as an inhibitor of CDK9, regulates Mcl-1 and therefore may address the increase of Mcl-1 levels associated with venetoclax. There was no evidence of overlapping toxicity with venetoclax and no dose limiting toxicities were observed.

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In April 2024, MEI reported that 25% of evaluable patients with relapsed metastatic colorectal cancer in Cohort 1 of the Phase 1b study evaluating ME-344, an investigational inhibitor of mitochondrial oxidative phosphorylation, in combination with bevacizumab (Avastin) had no disease progression at Week 16. This landmark analysis exceeded the 20% threshold set in the Clinical Study Protocol to add an additional 20 patients to the study via the initiation of Cohort 2. The combination was also observed to be generally well-tolerated to date. While the threshold was met to proceed to Cohort 2, following a strategic review the Company decided to continue to advance ME-344 via its ongoing development of a new formulation rather than through the addition of a new cohort of patients. The Company has already initiated research and development activity of the new formulation with the goal of increasing biological activity, improving convenience of administration and increasing the commercial opportunity.

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In April 2024, MEI reported that its Board of Directors unanimously aligned on a strategy to prioritize clinical development of voruciclib and enable development of a new ME-344 formulation for the potential of a future Phase 1 study. Additionally, the Company’s Board of Directors unanimously determined not to proceed with a second return of capital under the October 31, 2023, Anson Funds and Cable Car Capital cooperation agreement in order to conserve resources and align strategic investment, and thereby extend the Company’s operational cash runway.

Expected Drug Candidate Pipeline Developments

Voruciclib – Oral CDK9 inhibitor in Phase 1 Study

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MEI expects to report clinical data from additional dose escalation and expansion cohorts of the ongoing Phase 1 clinical trial evaluating voruciclib plus venetoclax in patients with R/R AML during the remainder of calendar 2024.

The Company has completed patient enrollment of the dose expansion cohort evaluating a 300 mg dose of voruciclib administered daily for 14 consecutive days in a 28-day cycle in combination with standard dose venetoclax. Additionally, MEI is enrolling dose escalation cohorts evaluating up to four dose levels of voruciclib starting at 150 mg administered daily for 21 consecutive days in a 28-day cycle in combination with venetoclax.

ME-344 –Inhibitor of Mitochondrial OXPHOS in Phase 1b Study

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MEI has initiated research and development activity of a new ME-344 formulation with the goal of increasing biological activity, improving convenience of administration and increasing the commercial opportunity. The Company expects to provide an update on our formulation efforts in the first half of calendar 2025.

Select Third Quarter and Nine Months Financial Results for Fiscal Year 2024

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As of March 31, 2024, MEI had $56.6 million in cash, cash equivalents, and short-term investments with no outstanding debt.

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For the nine months ended March 31, 2024, cash used in operations was $32.5 million, compared to $41.2 million during the nine months ended March 31, 2023. The decrease is primarily due to the timing of payments on operating liabilities, as compared to the prior period combined with a lower clinical spend due to the wind down of the zandelisib program resulting from the discontinuation of development activities announced in December 2022.

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Research and development expenses decreased by $9.9 million to $5.2 million for the quarter ended March 31, 2024, compared to $15.1 million for the quarter ended March 31, 2023. The decrease was primarily related to a reduction in zandelisib program costs, as well as reduced personnel and related costs from our reductions in headcount. These decreases were partially offset by increases related to clinical trials, reformulation and manufacturing costs associated with ME-344 and increased clinical costs for the ongoing clinical study with voruciclib.

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General and administrative expenses decreased by $2.6 million to $4.6 million for the quarter ended March 31, 2024, compared to $7.2 million for the quarter ended March 31, 2023. The decrease was primarily related to reduced personnel and related costs from our reductions in headcount, as well as lower external legal expenses.

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MEI recognized no revenue for the quarter ended March 31, 2024, compared to $5.9 million for the quarter ended March 31, 2023. The decrease in revenue was due to all remaining noncash deferred revenue associated with the Kyowa Kirin Commercialization Agreement having been recognized in the first quarter of fiscal year 2024 due to the termination of that agreement in July 2023.

The Company believes its cash balance is sufficient to fund operations for at least the next 12 months.

On May 9, 2024 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, reported financial results for the quarter ended March 31, 2024, and provided a corporate update (Press release, Tempest Therapeutics, MAY 9, 2024, View Source [SID1234643019]).

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"The positive data and mechanistic analysis presented in the first quarter build on the positive preclinical and clinical data package for TPST-1120, further confirming and reinforcing our excitement about the potential of TPST-1120 in liver and kidney cancers, as well as other indications, and our confidence in the program as it moves closer to a pivotal Phase 3 study in first-line HCC," said Stephen Brady, president and chief executive officer of Tempest.

Recent Highlights

TPST-1120 (clinical PPARα antagonist):
Reported new preclinical data at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrating that TPST-1120 reduces kidney cancer (RCC) growth as a monotherapy, while also showing increased inhibition when combined with frontline chemotherapy and immunotherapy. These data further support the clinical benefit observed in the TPST-1120 Phase 1 data presented in an oral presentation at ASCO (Free ASCO Whitepaper) 2022.
Published positive data from Phase 1 Trial of TPST-1120 in patients with advanced solid tumors in the Journal of Cancer Research Communications. Data showed that TPST-1120 demonstrated clinical activity, including tumor shrinkage, even in PD-1 inhibitor-refractory and immune-compromised cancers, and was well tolerated both as monotherapy and in combination with nivolumab. These data complement the positive Phase 1b/2 data reported in October 2023 from a global randomized study of TPST-1120 in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC.
Presented new preclinical data showing potent anti-tumor activity in several cancer models treated with TPST-1120 alone or with immune checkpoint inhibitors at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2024 Spring Scientific Meeting. The presentation also covered experimental results that corroborated clinical biomarker data from patients with advanced solid tumor cancers treated in the Phase 1 clinical trial of TPST-1120 in multiple solid tumor indications, which showed statistically significant, exposure-dependent elevations in expression levels of multiple immune-related genes, and patients exhibiting objective responses displayed increased circulating free fatty acids (FFA), both of which are in-line with the proposed TPST-1120 mechanism of action.
Potential Future Milestones

TPST-1120 (clinical PPARα antagonist)
Expect to announce updated data from the ongoing randomized study in first-line HCC patients in 2024.
Plan to advance TPST-1120 into a registrational Phase 3 study in first-line HCC patients, subject to obtaining feedback from the FDA.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist)
Plan to advance TPST-1495 into a Phase 2 study in patients with Familial Adenomatous Polyposis ("FAP") in 2024 under the auspices of the Cancer Prevention Clinical Trials Network and funded by the National Cancer Institute ("NCI") Division of Cancer Prevention, subject to final approval of NCI.
Expect to report data from the combination arm at the two highest TPST-1495 doses in patients with advanced endometrial cancer, where prostaglandin signaling is implicated, in 2024.
Financial Results

First Quarter 2024

Tempest ended the quarter with $32.3 million in cash and cash equivalents, compared to $39.2 million on December 31, 2023.
Net loss and net loss per share for the quarter ended March 31, 2024, were $7.9 million and $0.36, respectively, compared to $7.6 million and $0.55, respectively, for the same period in 2023.
Research and development expenses for the quarter were $4.3 million compared to $4.7 million for the same period in 2023. The $0.4 million decrease was primarily due to a decrease in costs incurred from contract research organizations and third-party vendors.
General and administrative expenses for the quarter were $3.6 million compared to $2.9 million for the same period in 2023. The $0.7 million increase was primarily due to share-based compensation expenses and consulting services.
Based on its current cash and operating plan, Tempest expects to have sufficient resources to fund operations into the second quarter of 2025.

On May 9, 2024 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported financial results for the quarter ended March 31, 2024, and highlighted recent corporate progress (Press release, Tyra Biosciences, MAY 9, 2024, View Source [SID1234643096]).

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"During the first quarter of 2024, we focused on execution across our pipeline including delivering on our near-term milestones for TYRA-300 in both achondroplasia and oncology," said Todd Harris, CEO of TYRA. "In oncology, the TYRA-300 clinical profile continues to mature in SURF301, and our clinical team is focused on Part B dose expansion to evaluate multiple dosing regimens of TYRA-300. We believe this work will support future Phase 2 studies in NMIBC and metastatic urothelial carcinoma, where we see tremendous opportunity for an oral FGFR3-selective inhibitor. In achondroplasia, we remain on track to submit our IND in the second half of 2024 to support our planned Phase 2 study."

First Quarter 2024 and Recent Corporate Highlights

Strengthened Board with New Appointments. On May 7, 2024, TYRA announced changes to its Board of Directors with the appointments of Susan Moran, M.D., M.S.C.E. and S. Michael Rothenberg, M.D., Ph.D. as independent directors, and the resignation of Isan Chen, M.D.
TYRA-300

SURF301 Phase 1/2 Study for Oncology Continued to Advance. The SURF301 Phase 1 study for oncology (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors) (NCT05544552) continued to advance. The study is a multi-center, open label study designed to determine the optimal and the recommended Phase 2 dose (RP2D) of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. TYRA expects that the Phase 1 portion of SURF301 will provide data to inform the appropriate dosing schedule of TYRA-300 in future studies in metastatic urothelial carcinoma (mUC) and non-muscle invasive bladder cancer (NMIBC). Part A of SURF301 is complete and the expansion cohorts in Part B are evaluating potentially therapeutic once daily and twice daily doses, in preparation for future Phase 2 studies in NMIBC and mUC. TYRA remains on track to report initial results from its SURF301 Phase 1 portion at a scientific congress in the second half of 2024.

Phase 2 Achondroplasia (ACH) Study Planning Continued to Advance. TYRA remains on track to submit an Investigational New Drug application (IND) to the FDA in the second half of 2024 for the initiation of a Phase 2 clinical trial testing multiple doses of TYRA-300 to support children with achondroplasia. TYRA expects that the primary objective of this study will be to assess safety and tolerability in children with achondroplasia and determine the dose(s) for further development. TYRA also expects that secondary objectives will include evaluating change in growth velocity, growth proportionality and pharmacokinetics (PK). TYRA is also planning exploratory assessments of clinical outcomes and quality of life measures, and an evaluation of biomarkers to determine dose-response relationships to TYRA-300.
TYRA-200

Phase 1 SURF201 Study Continued to Advance. The SURF201 (Study in PrevioUsly treated and Resistant FGFR2+ Cholangiocarcinoma and Other Advanced Solid Tumors) (NCT06160752) continued to advance. The study is a multi-center, open label study designed to evaluate the safety, tolerability, and PK of TYRA-200 and determine the optimal and maximum tolerated dose (MTD) and RP2D, as well as evaluate the preliminary antitumor activity of TYRA-200.
TYRA-200 is an FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations. The SURF201 study is currently enrolling and dosing adults with unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating FGFR2 gene alterations.

Corporate

Closed a $200M Private Placement Financing. In February 2024, TYRA completed a private placement financing, pursuant to which it sold shares of its common stock and pre-funded warrants to purchase its common stock to new and existing institutional and accredited investors for gross proceeds of approximately $200 million.
SNÅP Platform and Pipeline

TYRA continued to advance its in-house precision medicine discovery engine, SNÅP, to develop therapies in targeted oncology and genetically defined conditions.
TYRA nominated its third candidate for clinical development, TYRA-430, an FGFR4/3 selective inhibitor for FGF19+/FGFR4-driven cancers. TYRA is focused on completing IND-enabling studies for this program.
Fourth Quarter and Full Year 2023 Financial Results

First quarter 2024 net loss was $18.2 million compared to $11.9 million for the same period in 2023.
First quarter 2024 research and development expenses were $17.2 million compared to $10.4 million for the same period in 2023.
First quarter 2024 general and administrative expenses were $5.1 million compared to $3.9 million for the same period in 2023.
As of March 31, 2024, TYRA had cash, cash equivalents, and marketable securities of $382.5 million. The company’s current cash, cash equivalents and marketable securities on hand allow TYRA to execute on its plans through at least 2026.
About TYRA-300

TYRA-300 is the Company’s lead precision medicine program stemming from its in-house SNÅP platform. TYRA-300 is an investigational, oral, FGFR3-selective inhibitor currently in development for the treatment of cancer and skeletal dysplasias, including achondroplasia. In oncology, TYRA-300 is being evaluated in a multi-center, open label Phase 1/2 clinical study, SURF301 (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors). SURF301 (NCT05544552) was designed to determine the optimal and MTD and the RP2D of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. SURF301 is currently enrolling adults with advanced urothelial carcinoma and other solid tumors with FGFR3 gene alterations. In skeletal dysplasias, TYRA-300 has demonstrated positive preclinical results, and the Company expects to submit an IND in the second half of 2024 for the initiation of a Phase 2 clinical study in pediatric achondroplasia. In July 2023 and January 2024, the FDA granted Orphan Drug Designation (ODD) and Rare Pediatric Designation (RPD) to TYRA-300, respectively, for the treatment of achondroplasia.

About TYRA-200

TYRA-200 is an investigational, oral, FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations currently in development for the treatment of cancer. TYRA-200 is being evaluated in a multi-center, open label Phase 1 clinical study, SURF201 (Study in PrevioUsly treated and Resistant FGFR2+ Cholangiocarcinoma and Other Advanced Solid Tumors). SURF201 (NCT06160752) was designed to determine the optimal and MTD and the RP2D of TYRA-200, as well as to evaluate the preliminary antitumor activity of TYRA-200. SURF201 is currently enrolling adults with advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating alterations in FGFR2.

On May 9, 2024 Akoya Biosciences, Inc. (Nasdaq: AKYA), The Spatial Biology Company, and NeraCare, a leading developer of laboratory tests for the prognosis of melanoma patients, reported an exclusive agreement today under which the parties will develop market opportunities for combining Akoya’s PhenoImager HT platform and NeraCare’s Immunoprint assay for patient stratification and therapy selection in early-stage melanoma patients (Press release, Akoya Biosciences, MAY 9, 2024, View Source [SID1234642972]).

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Melanoma is the leading cause of skin cancer-related deaths, with over 235,000 new diagnoses globally every year. Recent approvals of immune- and targeted therapies have greatly expanded the available treatment options for adjuvant therapy. Nonetheless, a significant number of early-stage melanoma patients remain at high risk of relapse and mortality without access to such therapies. As the majority of melanoma patients are diagnosed with early stage disease, there is a critical unmet medical need to identify those at-risk patients to potentially enable earlier access to life-saving therapeutic agents.

"NeraCare’s Immunoprint assay has demonstrated robust clinical performance in identifying early-stage melanoma patients at high risk of relapse through multiple, independent, prospective and retrospective clinical studies. The Immunoprint high-risk patient group has a risk of relapse comparable to those patients in later stages with approved adjuvant therapies. Therefore, the Immunoprint high-risk patient group is ideally suited to potentially benefit from these therapeutic options that would usually only be administered in later stages. We believe Immunoprint is in a class of its own in terms of the potential to positively impact patients’ lives," said Daniel von Janowski, Co-Founder of NeraCare.

At this year’s ASCO (Free ASCO Whitepaper) Annual Meeting, updated clinical data from the MELARISK-001 study in stage IB/IIA will be presented.

"We are pleased to partner with Akoya Biosciences, a leader in spatial biology. The PhenoImager HT platform, with its powerful multiplex immunofluorescence capabilities, is an excellent match for our Immunoprint assay. This combination enables precise and efficient spatial phenotyping while using a minimal number of tissue sections," said Friedrich Ackermann, Co-Founder of NeraCare.

"We are thrilled to partner with NeraCare in efforts to bring this game changing test to market and drive better patient care. Our collaboration is a testament to the power that spatial multiplexing can bring beyond research and into the clinic," said Brian McKelligon, CEO of Akoya Biosciences. "Immunoprint has demonstrated unparalleled clinical utility to identify high risk patients, and our collaboration is a critical first step towards helping to serve the unmet need to increase therapeutic intervention for patients with this life-threatening disease."

On May 9, 2024 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells, reported a business and financial update for the first quarter 2024 (Press release, Cue Biopharma, MAY 9, 2024, View Source [SID1234642988]).

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Recent Business Highlights

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CUE-101 abstract accepted for an oral presentation and poster presentation at the upcoming 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting scheduled for May 31-June 4, 2024.
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CUE-102 abstract accepted for a poster presentation at the upcoming 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting scheduled for May 31-June 4, 2024.
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Advanced preclinical CUE-401 program, in collaboration with Ono Pharmaceutical, with potential for broad application across multiple autoimmune and inflammatory diseases.
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Expanded pipeline to include the preclinical CUE-500 series for the treatment of autoimmune and inflammatory diseases via T cell-mediated B cell depletion.
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Immuno-STAT platform posters for oncology and autoimmune diseases accepted for presentation at PEGS Boston Summit 2024 to be held May 13-14.

"We have made significant progress during the first quarter on several fronts, including further advancement of our CUE-101 clinical trial and a meeting with the FDA to define a registrational path forward for the program, as well as continued advancement of the Phase 1 clinical trial for CUE-102," said Daniel Passeri, chief executive officer of Cue Biopharma. "Additionally, important progress has been made advancing our autoimmune program CUE-401, in collaboration with Ono Pharmaceutical, and expanding our autoimmune pipeline with the bispecific Immuno-STAT CUE-500 series designed to redirect virus-specific T cells to deplete B cells in autoimmune and inflammatory diseases. We believe our strategy of demonstrating the transformative breakthrough potential of our platform to address a broad spectrum of indications from cancer and autoimmune disease positions us well to potentially deliver value creation for our shareholders."

First Quarter 2024 Financial Results

The Company reported collaboration revenue of $1.7 million and $0.2 million for the three months ended March 31, 2024 and 2023, respectively. The increase was due to revenue earned from our Collaboration and Option Agreement with Ono Pharmaceutical, which was executed in February 2023.

Research and development expenses were $10.2 million and $9.4 million for the three months ended March 31, 2024 and 2023, respectively. The increase was primarily due to an increase in clinical trial expenses.

General and administrative expenses were $4.2 million for both the three months ended March 31, 2024 and 2023.

As of March 31, 2024, the Company had $41.0 million in cash and cash equivalents. We expect our current cash and cash equivalents to fund operations into the first quarter of 2025.