On August 13, 2024 Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, reported an update on the company’s development pipeline and announced financial results for the second quarter ended June 30, 2024 (Press release, Quince Therapeutics, AUG 13, 2024, View Source [SID1234645820]).

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Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, said, "We achieved a major clinical milestone during the second quarter of 2024 with the first patient enrolled in our pivotal Phase 3 NEAT clinical trial in Ataxia-Telangiectasia (A-T). As of today, we have enrolled seven patients with A-T across clinical sites in the U.S., U.K., and European Union. We are encouraged by this strong start and expect NEAT site activation and patient screening activities to accelerate over the next quarter."

Pivotal Phase 3 NEAT Clinical Trial

Dosed the first patient in the company’s Phase 3 NEAT (Neurologic Effects of EryDex on Subjects with A-T; IEDAT-04-2022/NCT06193200) clinical trial to evaluate the neurological effects of EryDex in patients with A-T in June 2024.
Enrolled seven patients with A-T in the NEAT clinical trial to date. Quince plans to enroll approximately 86 patients with A-T ages six to nine years old (primary analysis population) and approximately 20 patients with A-T ages 10 years or older.
NEAT is an international, multi-center, randomized, double-blind, placebo-controlled study to evaluate the neurological effects of the company’s lead asset, EryDex (dexamethasone sodium phosphate [DSP] encapsulated in autologous red blood cells), in patients with A-T.
Pivotal Phase 3 NEAT clinical trial is being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA).
Participants will be randomized (1:1) between EryDex or placebo and treatment will consist of six infusions scheduled once every 21 to 30 days. The primary efficacy endpoint will be measured by the change from baseline to last visit completion in a rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo.
Participants who complete the full treatment period, complete study assessments, and provide informed consent will be eligible to transition to an open label extension study.
Expect to report Phase 3 NEAT topline results in the fourth quarter of 2025 with a potential New Drug Application (NDA) submission to the FDA and a Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA) in 2026, assuming positive study results.
Pipeline and Corporate Updates

Granted Fast Track designation by the FDA for the company’s EryDex System for the treatment of patients with A-T based on the potential for EryDex to address a high unmet medical need in A-T.
Updated an initial patient sizing project based on third-party analysis from IQVIA Medical Claims (Dx), PharmetricsPlus (P+), and IQVIA Analytics, which confirmed that the number of diagnosed patients with A-T in the U.S. is estimated to be to approximately 4,600, an increase from previous estimates of approximately 3,400 diagnosed patients. There are currently no approved therapeutic treatments for A-T, and the market represents a $1+ billion peak commercial opportunity globally, based on the company’s internal estimates and assumptions.
Generating proof-of-concept clinical trial study designs to evaluate EryDex for the potential treatment of patients with Duchenne muscular dystrophy (DMD), including those with corticosteroid intolerance, who represent the majority of the DMD population. Quince plans to initiate a DMD proof-of-concept study in 2025, which the company expects to conduct utilizing capital efficient study approaches.
Planned participation at upcoming scientific congresses, including a poster presentation of EryDex safety data at the upcoming 53rd Child Neurology Society Annual Meeting in November 2024. Quince will also be a sponsor of and participate at the 2024 International Congress for Ataxia Research in November 2024 with two poster presentations, including growth and bone mineral density in patients with A-T treated with EryDex, and an analysis of the International Cooperative Ataxia Rating Scale (ICARS) subcomponent scores in patients with A-T.
Strengthening of leadership team with the addition of Brent Roeck as Vice President of Program and Alliance Management and Katie George as Executive Director Clinical Operations, bringing more than 50 years of collective experience across rare disease and the pharmaceutical and biotech industry to support Quince’s pivotal Phase 3 NEAT study and focus on strategic business partnerships.
Investigating other potential indications for EryDex where chronic corticosteroid treatment is – or has the potential to become – a standard of care, if there were not corticosteroid-related safety concerns. This evaluation process is expected to span across ataxias, neuromuscular indications, hematology, cancer, and autoimmune diseases, with a focus on rare diseases.
Evaluating potential strategic partnerships to out-license ex-U.S. rights to extend operational runway to support potential NDA approval of EryDex in the U.S., as well as further advance other potential indications and programs using the company’s proprietary Autologous Intracellular Drug Encapsulation (AIDE) technology platform.
Participating at the H.C. Wainwright 26th Annual Global Investment Conference the week of September 9, 2024. A webcast of the presentation will be accessible here.
Second Quarter and Year-to-Date 2024 Financial Results

Reported cash, cash equivalents, and short-term investments of $59.4 million for the second quarter ended June 30, 2024. Quince expects its existing cash runway to be sufficient to fund the company’s capital efficient development plan through Phase 3 NEAT topline results into 2026.
Expect strong cash position to fully fund lead asset, EryDex, through Phase 3 NEAT topline results in the fourth quarter of 2025 and prepare for potential NDA and MAA submissions in 2026, assuming positive study results. This includes approximately $20 million for the NEAT clinical trial and approximately $15 million in direct trial costs for an open label extension study.
Reported research and development (R&D) expenses of $4.2 million for the second quarter ended June 30, 2024. R&D expenses during the quarter primarily included start-up costs related to Phase 3 NEAT clinical trial activities and related manufacturing costs.
Reported general and administrative (G&A) expenses of $4.7 million for the second quarter ended June 30, 2024. G&A expenses for the quarter primarily included personnel-related and stock-based compensation expenses, commercial planning and new product planning expenses, and other professional administrative costs.
Reported a net loss of $27.7 million, or a net loss of $0.64 per basic and diluted share, for the second quarter ended June 30, 2024. During the quarter, Quince recognized a non-cash goodwill impairment charge of $17.1 million as the quantitative analysis resulted in the company’s fair value being below its carrying value. Weighted average shares outstanding for the quarter were 43.1 million.
Reported net cash used in operating activities of $17.1 million for the six months ended June 30, 2024, which included a net loss of $38.9 million for the period, adjusted for $24.0 million of non-cash items, including a $4.8 million change in the fair value of contingent consideration liabilities, $2.5 million in stock-based compensation, and a net decrease in current assets of $2.3 million, offset by a net decrease in accounts payable, accrued expenses, and other current liabilities of $0.1 million compared to the same period last year.

On August 13, 2024 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), 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 announced financial results for the second quarter of 2024 (Press release, PDS Biotechnology, AUG 13, 2024, View Source [SID1234645819]).

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"We are exiting the second quarter with momentum. We have aligned with the FDA on the design of the Phase 3 registrational trial of Versamune HPV + pembrolizumab compared to pembrolizumab as a potential treatment for first-line recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma ("HNSCC")," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "This clinical trial is supported by the maturing data from our VERSATILE-002 Phase 2 trial, including encouraging survival, disease control response rates and safety data. We look forward to the presentation of updated data from the VERSATILE-002 trial at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2024 Congress in September."

Kirk Shepard, M.D., Chief Medical Officer stated, "As a result of the recent VERSATILE-002 trial results, we have revised the statistical endpoints of the VERSATILE-003 Phase 3 trial to provide additional robustness to our trial design. Our goal now is to work with our clinical research organization to initiate the trial of the combination, which we believe has potential as the first targeted immunotherapy for HPV16-positive HNSCC. We anticipate that future studies of PDS01ADC have the potential to provide additional clinical benefit to an effective targeted immunotherapy."

Recent Developments

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Announced alignment with FDA to initiate Phase 3 VERSATILE-003 trial in HPV16-positive first-line recurrent or metastatic HNSCC.

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This trial will be designed to investigate the combination of Versamune HPV + pembrolizumab compared to pembrolizumab, and this design reflects updated statistical endpoints based on recent and more mature survival data from the VERSATILE-002 trial.

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PDS Biotech has initiated preparatory activities in connection with the planned start of the Phase 3 VERSATILE-003 trial in Q4 2024.

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Abstract by Jared Weiss, M.D., UNC Lineberger Cancer Center (Lead Investigator), presenting updated data from the VERSATILE-002 trial evaluating first-line treatment with Versamune HPV in combination with KEYTRUDA (pembrolizumab) in patients with HPV16-positive recurrent/metastatic HNSCC accepted for presentation at the ESMO (Free ESMO Whitepaper) Congress 2024.

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Provided a survival data update from the ongoing VERSATILE-002 trial in HPV16-positive HNSCC based on data cut from May 17, 2024.

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Median overall survival is 30 months, consistent with data cut as of November 30, 2023.

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Abstract by Adam Grippin, M.D., Ph.D., of the University of Texas MD Anderson Cancer Center presenting updated results from the IMMUNOCERV trial evaluating treatment of high-risk locally advanced cervical cancer with Versamune HPV in combination with chemoradiotherapy accepted for oral presentation at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2024.

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Abstract by Renee Donahue, Ph.D., of the National Cancer Institute presenting preliminary biomarker results from a Phase 2 trial evaluating treatment of biochemically recurrent prostate cancer with PDS01ADC in combination with enzalutamide accepted for oral presentation at the 12th Annual Meeting of the International Cytokine and Interferon Society 2024.

Second Quarter 2024 Financial Results
Reported net loss was approximately $8.3 million, or $0.23 per basic share and diluted share, for the three months ended June 30, 2024, compared to a net loss of $11.5 million, or $0.37 per basic share and diluted share, for the three months ended June 30, 2023. The decrease was due to lower operating expenses.

Research and development expenses decreased to approximately $4.5 million for the three months ended June 30, 2024, from $8.0 million for the three months ended June 30, 2023. The decrease of $3.5 million was primarily attributable to lower clinical trial and manufacturing costs.

General and administrative expenses decreased to approximately $4.2 million for the three months ended June 30, 2024, from approximately $4.7 million for the three months ended June 30, 2023. The decrease of $0.5 million was primarily attributable to lower personnel costs and professional fees.

Total operating expenses decreased to approximately $8.7 million for the three months ended June 30, 2024, from $12.7 million for the three months ended June 30, 2023.

Net interest expenses increased to approximately $0.5 million for the three months ended June 30, 2024, from $0.2 million for the three months ended June 30, 2023.

Cash and cash equivalents as of June 30, 2024, totaled approximately $57.7 million.

On August 13, 2024 Panbela Therapeutics, Inc. (OTCQB: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported a business update and provides financial results for the quarter ended June 30, 2024 (Press release, Panbela Therapeutics, AUG 13, 2024, View Source [SID1234645818]). As previously announced, management is hosting an earnings call today at 4:30 p.m. ET.

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Q2 2024 and Recent Highlights:

Clinical

• Phase 3 ASPIRE clinical trial received favorable third independent safety review: DSMB recommended continuation without modification.
• Completed Oral Presentation at Digestive Disease Week (DDW): Evaluation of the Safety and Efficacy of Eflornithine (Difluoromethylornithine, DFMO) in Patients with Gastric Premalignant Conditions in the High Incidence Areas of Latin American.
• Provided 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 the potential for improved survival outcomes for patients in the trial. Financial / Business
• Gained eligibility for quotation of common stock on the OTCQB.
• Issuance of a New Patent in the US and Canada for Claims of a Fixed Dose Combination of Eflornithine and Sulindac.

Jennifer K. Simpson, PhD, MSN, CRNP, President & CEO of Panbela, commented:

"In the second quarter, we continued to make significant progress in our clinical programs and corporate initiatives. Our Phase III ASPIRE clinical trial received a favorable third independent safety review, with the Data and Safety Monitoring Board (DSMB) recommending continuation without modification. We were also honored to have an oral presentation at Digestive Disease Week (DDW), where we evaluated the safety and efficacy of eflornithine (difluoromethylornithine, DFMO) in patients with gastric premalignant conditions in high incidence areas of Latin America. Furthermore, we recently announced revised timing for the interim data analysis of our ongoing ASPIRE trial, evaluating ivospemin (SBP-101) in combination with standard-of-care for metastatic pancreatic ductal adenocarcinoma (mPDAC).

Due to a lower-than-anticipated event rate, which suggests the potential for improved survival outcomes for patients in the trial, the analysis is now expected in Q1 2025. This is a testament to the potential of our lead candidate, ivospemin, and its ability to make a meaningful difference in the lives of patients with mPDAC. As we move forward, Panbela remains committed to advancing our clinical programs, exploring new indications, and creating value for our stockholders. With several key milestones on the horizon, including the highly anticipated overall survival interim analysis in our Phase III ASPIRE Trial, we are excited about the future and the potential impact our therapies can have on patients in need."

Second Quarter ended June 30, 2024 Financial Results General and administrative expenses were approximately $1.1 million in the quarter, compared to $1.6 million in the same period last year. The decrease is due primarily to reduced legal and compensation expense. Research and development expenses were approximately $7.0 million, compared to $4.2 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 $1.47 per diluted share, compared to a net loss of $5.8 million, or $159.15 per diluted share, in the same period last year. This increased loss is due to the incremental research and development expenses. Total cash was $59,000 as of June 30, 2024. Total current assets were $0.8 million and current liabilities were $16.8 million as of the same date.

In April, Panbela’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. In July, Panela secured a loan from this same partner for $1.5 million. Notes payable, plus accrued interest, on the balance sheet, the result of the acquisition of Cancer Prevention Pharmaceuticals, Inc., totaled approximately $4.3 million. The current portion of the notes payable plus accrued interest totaled approximately $1.1 million.

On August 13, 2024 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies, reported financial results for the second quarter ended June 30, 2024 (Press release, Nkarta, AUG 13, 2024, View Source [SID1234645816]).

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"Patients remain our focus, and early execution on our clinical trials across disease areas is a testament to that commitment," said Paul J. Hastings, CEO of Nkarta. "NKX019 has the potential to reach people living with a wide range of autoimmune diseases, and we will continue to evaluate ways to maximize our impact in this field. Our cellular engineering enables us to evaluate a reduced toxicity lymphodepletion regimen, to limit hospitalization and patient burden, and spare the complications of other agents."

Continued execution in clinical development of NKX019 for autoimmune diseases

Received clearance from FDA of second Investigational New Drug (IND) application for NKX019 in autoimmune disease, supporting the planned initiation of Ntrust-2, a clinical trial of NKX019 for the treatment of systemic sclerosis, myositis and vasculitis. Patients enrolled in Ntrust-2 will receive three doses of NKX019 on Days 0, 3, and 7 following lymphodepletion (LD) with single-agent cyclophosphamide (cy).
Initiation of an investigator-sponsored trial (IST) of NKX019 in systemic lupus erythematosus (SLE) with or without LN by researchers at Columbia University Irving Medical Center. Patients enrolled in the IST will receive three doses of NKX019 on Days 0, 7, and 14 following LD with single-agent cy.
Autoimmune milestones 2024-2025

Initiation of patient enrollment in Ntrust-2 clinical trial expected by year-end 2024.
Preliminary clinical data from Ntrust-1 and Ntrust-2 clinical trials planned for 2025.
Mid-year update for NKX019 in non-Hodgkin lymphoma (NHL)

Nkarta presented follow-up data from its Phase 1 clinical trial of NKX019 in relapsed/refractory NHL at the Pan Pacific Lymphoma Conference in July 2024, including follow-up on 4 patients who were retreated and re-entered complete response (CR), demonstrating the safety and encouraging effectiveness (4/4 CR) of retreatment.
Nkarta previously opened a cohort with a compressed (7-day) dosing schedule, where patients with large B-cell lymphoma (LBCL) who have progressed following CAR T therapy receive NKX019 on Days 0, 3, and 7 following LD with fludarabine (flu) and cy.
Nkarta has completed enrollment of patients into the 7-day dosing cohort in LBCL following CAR T and expects to announce data from this cohort in late-2024.
Future development of NKX019 in NHL will be contingent on favorable outcomes from the seven patients that have been treated in the new cohort.
Leadership Updates

In July 2024, Nadir Mahmood, Ph.D., joined Nkarta as President, and David R. Shook, M.D., was promoted to Chief Medical Officer, Head of Research & Development, with both executives reporting to Paul J. Hastings, Chief Executive Officer.
In June 2024, George Vratsanos, M.D., FACR, an accomplished biopharmaceutical executive with scientific and clinical expertise in immunology and autoimmunity, joined Nkarta’s Board of Directors.
Second Quarter 2024 and Recent Financial Highlights

Nkarta had cash, cash equivalents, restricted cash, and investments in marketable securities of $426.7 million as of June 30, 2024.
Research and development (R&D) expenses were $23.1 million for the second quarter of 2024. Non-cash stock-based compensation expense included in R&D expense was $2.2 million for the second quarter of 2024.
General and administrative (G&A) expenses were $7.6 million for the second quarter of 2024. Non-cash stock-based compensation expense included in G&A expense was $2.2 million for the second quarter of 2024.
Net loss was $25.0 million, or $0.34 per basic and diluted share, for the second quarter of 2024. This net loss includes non-cash charges of $6.7 million that consisted primarily of share-based compensation and depreciation expenses.
Financial Guidance

Nkarta expects its current cash and cash equivalents will be sufficient to fund its current operating plan into late 2027.
About NKX019
NKX019 is an allogeneic, cryopreserved, off-the-shelf immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed CAR for enhanced cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal B cells as well as those implicated in autoimmune disease and B cell-derived malignancies.

About Ntrust Clinical Trials in Autoimmune Disease
Ntrust-1 and Ntrust-2 are multi-center, open label, dose escalation clinical trials that build on academic studies of durable, drug-free remissions in patients with autoimmune disease after CD19-targeted cell therapy. Both trials will assess the safety of NKX019 in people living with autoimmune diseases as well as its ability to enable long-term remissions via a "reset" of the immune system through the elimination of pathogenic B cells. Per the trial protocols, patients receive three-dose cycles of NKX019 at 1 billion or 1.5 billion cells per dose following single-agent lymphodepletion with cyclophosphamide, an agent with an established safety profile across autoimmune diseases. Leveraging the engineering of NKX019, no patients in either trial will receive supplemental cytokines or antibody-based therapeutics. This approach is designed to evaluate the single-agent activity of NKX019 and facilitate a more rapid path to regulatory approval.

In the Ntrust-1 study, patients with refractory lupus nephritis receive NKX019 on Days 0, 7 and 14. Patients in Ntrust-1 may also receive additional cycles to restore response.

Once initiated, Ntrust-2 will enroll patients with systemic sclerosis (scleroderma), idiopathic inflammatory myopathy (myositis), and ANCA-associated vasculitis into parallel cohorts, and NKX019 will be dosed on Days 0, 3, and 7, a regimen that may be advantageous across all Nkarta clinical trials. Each trial is designed to initially enroll up to 12 patients.

On August 13, 2024 Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company developing novel, investigational engineered cytokine therapies designed to address areas of unmet need for patients with a variety of cancers, reported financial results for the second quarter of 2024 and provided a business update (Press release, Mural Oncology, AUG 13, 2024, View Source [SID1234645815]).

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"We’ve seen resurgent interest across the industry in cytokines as powerful tools to fight cancer and Mural is in a unique position to deliver promising drug candidates that have the potential to overcome the limitations of prior approaches," said Caroline Loew, Ph.D., Chief Executive Officer of Mural Oncology. "Since becoming an independent company late last year, we’ve rapidly worked to shape and grow a nimble organization focused on delivering meaningful new immunotherapy treatments to cancer patients. We believe each of our programs is engineered with a differentiated approach that we hope will play out significantly in the clinic starting early next year."

Recent Corporate Highlights and Upcoming Milestones

Mural appointed George Golumbeski, Ph.D., to its board of directors in July. Dr. Golumbeski currently serves as a partner at DROIA Ventures, a specialist biotech investment firm focused on therapeutics for oncology and genetic disease. Prior to DROIA, he served as President and Head of Corporate Development for GRAIL and Executive Vice President of Business Development for Celgene. He has nearly 30 years of extensive experience with strategic collaborations, M&A, in-licensing, out-licensing, and alliance management.
Mural’s late-stage clinical trials of nemvaleukin alfa continue to progress toward readouts in the first half of 2025. The company is focused on two foundational indications for nemvaleukin, where the majority of patients do not have any currently approved therapies.

ARTISTRY-7 is a potentially registrational, phase 3 clinical trial evaluating nemvaleukin in combination with pembrolizumab compared to investigators’ choice of chemotherapy in patients with platinum-resistant ovarian cancer. Patient enrollment in this trial is now complete. Mural continues to expect to report interim overall survival (OS) results based on approximately 75% of events in the first quarter of 2025. The company anticipates reporting final OS results in the second quarter of 2026.
Mural expects to report top-line data results from cohort 2 of ARTISTRY-6 in the first half of 2025. This is a potentially registrational, phase 2 clinical trial evaluating nemvaleukin as a monotherapy in patients with mucosal melanoma.
Mural is also evaluating a less-frequent intravenous (LFIV) dose of nemvaleukin in patients with cutaneous melanoma in cohort 3 (monotherapy) and cohort 4 (combination therapy) in ARTISTRY-6. The company expects preliminary data readouts in the monotherapy cohort in the first half of 2025, and in the combination cohort with pembrolizumab in the second half of 2025.
In June, Mural presented data from ARTISTRY-3, an evaluation of the LFIV dosing of nemvaleukin, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. This data from ARTISTRY-3 informed the LFIV dose currently being used in cohort 3 and cohort 4 of ARTISTY-6. In the ARTISTRY-3 trial, the company evaluated escalating LFIV infusions, all of which were generally well tolerated. The safety profile in all dosing schedules evaluated was consistent with nemvaleukin’s known mechanism of action, and no dose limiting toxicities were observed. Although administering higher doses per cycle than in previous trials evaluating nemvaleukin, no new safety signals were identified. The desired pharmacodynamic (PD) effects were also seen across all evaluated doses. Expansion of antitumor CD8+ T cells and natural killer (NK) cells was observed concurrent with minimal expansion of immunosuppressive regulatory T cells (Tregs).

Mural’s preclinical interleukin-18 (IL-18) and IL-12 programs remain on track, with nominations for both development candidates expected this year.

Mural’s enhanced IL-18 is engineered to deliver a more sustained immune response for cancer treatment. Native IL-18 is a potent immune-stimulating cytokine, but its efficacy is blunted by IL-18 binding protein (IL-18BP), a high affinity decoy receptor that binds with and neutralizes IL-18, thereby rendering it ineffective. Native IL-18 is also limited by its short half-life. Mural’s IL-18 variant contains mutations that eliminate binding to IL-18BP while minimally impacting the native IL-18 structure. The company has also fused IL-18 to protein scaffolds to extend the half-life and increase IL-18’s exposure. Together, Mural believes these have demonstrated a more durable immunological effect in preclinical studies.
The company’s enhanced IL-12 is engineered to leverage native IL-12’s anti-tumor potency while mitigating its hallmark toxicity. Native IL-12 is a highly potent pro-inflammatory cytokine, but because of its very narrow therapeutic index, it can also be incredibly toxic with systemic exposure. Mural’s IL-12 variant splits the molecule into two inactive monomers, and these individual subunits are then separately fused to antibody fragments and sequentially injected, which deliver and concentrate IL-12 specifically in the tumor microenvironment with the goal of limiting systemic exposure. In preclinical studies, Mural believes its engineered IL-12 achieved the desired reduction in serum while maintaining tumor concentrations providing the potential to reduce systemic toxicities.
Financial Results for the Quarter Ended June 30, 2024

Cash Position: As of June 30, 2024, cash, cash equivalents, and marketable securities were $204.7 million.
R&D Expenses: Research and development expenses were $27.5 million for the second quarter of 2024 compared to $42.5 million for the second quarter of 2023. The decrease in R&D expenses was primarily due to different team composition compared to the personnel allocated to us by Alkermes, our former parent, prior to the separation, as well as decreased spend on the ARTISTRY-1 and ARTISTRY-2 trials as activities related to these trials wound down in 2023 and decreased spend on the ARTISTRY-7 trial due to the timing of patient enrollment.
G&A Expenses: General and administrative expenses were $6.7 million for the second quarter of 2024 compared to $4.7 million for the second quarter of 2023. The increase in expenses was primarily due to costs associated with operating as a standalone company after the separation. This includes employee-related expenses and professional fees.
Net Loss: Net loss was $31.6 million for the second quarter of 2024 compared to $50.2 million for the second quarter of 2023.
Financial Guidance

The company reaffirms guidance that its cash, cash equivalents, and marketable securities are expected to fund its operations into the fourth quarter of 2025.
As noted previously, management forecasts lower operating expenses in 2025 versus 2024 due to the timing of clinical trial expenses.
About Nemvaleukin
Nemvaleukin alfa (nemvaleukin) is a novel, engineered cytokine designed to leverage antitumor effects of the IL-2 pathway while mitigating the hallmark toxicities that limit its use. Nemvaleukin selectively binds to the intermediate-affinity IL-2 receptor (IL-2R) and is sterically occluded from binding to the high-affinity IL-2R. Because of this molecular design, nemvaleukin treatment leads to preferential expansion of antitumor CD8+ T cells and natural killer cells, with minimal expansion of immunosuppressive regulatory T cells. Nemvaleukin is currently being evaluated in two potentially registrational late-stage trials.