TuHURA Biosciences, Inc. Initiates Phase 1b/2a Study of IFx-Hu2.0 as an Adjunctive Therapy to Keytruda® (pembrolizumab) in First Line Treatment for Metastatic Merkel Cell Carcinoma of Unknown Primary Origin (MCCUP)

On May 5, 2025 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA" or the "Company"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, reported the initiation of its Phase 1b/2a trial of IFx-Hu2.0, TuHURA’s lead innate immune agonist, in patients with MCCUP who would not be eligible for the Company’s planned Phase 3 accelerated approval trial, which is targeted to begin enrollment later in Q2 2025 (Press release, TuHURA Biosciences, MAY 5, 2025, View Source [SID1234652520]). IFx-Hu2.0 is designed to overcome primary resistance to checkpoint inhibitors (CPIs) like Keytruda and has demonstrated systemic anti-tumor specific immune responses (abscopal effect) when injected intratumorally into cutaneous, subcutaneous, or accessible nodal lesions in its prior Phase 1 and 1b trials in melanoma and advanced or metastatic Merkel cell carcinoma (MCC).

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"Like our planned Phase 3 accelerated approval trial, this Phase 1b/2a trial will also investigate the ability of IFx-Hu2.0 to increase the anti-tumor response rate when used alongside Keytruda in first line treatment of CPI naïve, metastatic MCC. However, unlike the planned Phase 3 study, these are patients without skin lesions who present with metastatic deep-seated tumors in the liver, lungs or retropertitoneum (abdomen). Up to 30% of patients with MCC present without primary lesions in the skin, so this trial will not only provide safety, feasibility, and efficacy data, but may also expand the potential number of addressable patients who may benefit from IFx-Hu2.0," said James Bianco, M.D., President and Chief Executive Officer of TuHURA Biosciences.

"If feasibility and safety is demonstrated for IFx-Hu2.0 and Keytruda when radiologically administered to deep-seated tumors, we plan to extend enrollment to a variety of non-MCC cancers that are known not to respond or respond poorly to CPIs. Since the underlying biology of why tumors don’t respond to CPIs is for the most part the same, then the mechanism of how IFx-Hu2.0 overcomes that resistance to CPIs should be independent of the type of cancer treated. We have previously demonstrated that IFx-Hu2.0 can overcome CPI resistance in melanoma, squamous cell, and Merkel cell carcinoma, three unrelated types of skin cancers. If successful, this trial could expand the potential benefit of IFx-Hu2.0 to a wide variety of cancers," added Dr. Bianco.

The Phase 1b/2a trial of IFx-Hu2.0 is a multicenter, open-label trial designed to assess the safety and feasibility of IFx-Hu2.0 as adjunctive therapy to pembrolizumab in adult patients with non-cutaneous MCC. The trial is designed to enroll a total of nine non-cutaneous MCC patients with either hepatic, pulmonary, or retroperitoneal lesions, enrolling three patients per lesion type (NCT06940440). Each patient will receive IFx-Hu2.0 (0.1 mg) injected into a single visceral tumor once a week for three weeks. Within 48 hours of the first IFx-Hu2.0 injection, patients will receive pembrolizumab, followed by pembrolizumab every three weeks for six months. The primary endpoint of the study is safety and feasibility of IFx-Hu2.0 adjuvant therapy evaluated 28 days following the last dose of IFx-Hu2.0, or Day 49 from the first IFx-Hu2.0 infusion. The study will also evaluate key secondary endpoints, including efficacy per RECIST 1.1 criteria at three months and six months. Data from the trial is anticipated by the end of Q4 2025 or early Q1 2026.

TuHURA is also preparing to initiate a single, randomized, placebo-controlled Phase 3 accelerated approval trial of IFx-2.0 administered as an adjunctive therapy to Keytruda (pembrolizumab) versus Keytruda plus placebo in first-line treatment for checkpoint inhibitor-naïve patients with advanced or metastatic MCC (NCT06947928). The primary endpoint in the Phase 3 trial will be overall response rate (ORR) at approximately 24 weeks, with a secondary endpoint of progression free survival (PFS) per RECIST 1.1 criteria. The Company has reached agreement with U.S. Food and Drug Administration (FDA) on requirements for lifting a partial clinical hold on this trial and believes it will meet the requirements in Q2 2025. TuHURA currently anticipates initiating the Phase 3 registrational trial in Q2 2025.

Based on data generated in TuHURA’s Phase 1b trial of IFx-Hu2.0 in CPI naïve patients with advanced or metastatic MCC who progressed receiving CPI therapy, FDA’s Oncology Center of Excellence (OCE), consistent with the FDA’s Project Front Runner Initiative, asked the Company to consider a first-line randomized placebo controlled trial of Keytruda plus placebo or IFx-Hu2.0. The FDA also agreed that the trial could be conducted under their accelerated approval pathway with the use of Objective Response Rate (ORR) as the primary endpoint. The FDA also asked the Company to consider incorporating into its accelerated approval trial a key secondary end point of Progression Free Survival (PFS), which, if successfully achieved without a detriment to overall survival at the time of analysis, may result in the Company not being required to conduct a post approval confirmatory trial, and this single trial could potentially fulfill requirement for regular approval. The Company and the FDA have entered into a Special Protocol Assessment Agreement for the planned Phase 3 trial.

Quarterly report [Sections 13 or 15(d)]

On May 5, 2025 Corcept Therapeutics reported the first quarter 2025 results (Filing, 3 mnth, MAR 31, Corcept Therapeutics, 2025, MAY 5, 2025, View Source [SID1234653770]).

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Theralase® Clinical Data Presented at Canadian Bladder Cancer Forum and American Urological Association

On May 5, 2025 Theralase Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase" or the "Company"), a clinical stage pharmaceutical company dedicated to the research and development of small molecules and their formulations, able to be activated by light, radiation, sound and/or other drugs, intended for the safe and effective destruction of various cancers, bacteria and viruses, reported that its latest interim clinical data was recently presented at the Canadian Bladder Cancer Forum 2025 and the American Urological Association 2025 Annual Meeting (Press release, Theralase, MAY 5, 2025, View Source [SID1234653900]).

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The interim clinical data from Theralase’s multicenter Phase II Bacillus Calmette-Guérin ("BCG")-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") study ("Study II") was presented by Dr. Girish Kulkarni in podium presentations. Dr. Kulkarni, M.D., Ph.D., FRCSC is a urologic surgeon in the Department of Surgical Oncology, Princess Margaret Cancer Centre, University Health Network, a professor in the Department of Surgery at the University of Toronto and the lead principal investigator in the Theralase study.

The interim clinical data presented represents world-class safety and efficacy in the treatment of BCG-Unresponsive NMIBC CIS with a light-activated small molecule. Numerous patients have demonstrated durations of response of 3 years or greater, with 1 patient demonstrating a duration of response of over 7 years, after a single treatment.

Study II Interim Clinical Data1:
Theralase has enrolled and treated 79 patients in Study II, who have been provided the primary Study Procedure (therapeutic dose of Theralase’s lead small molecule RuvidarTM light-activated by the TLC-3200 medical laser system), with completion of enrollment expected by mid-2025.

81% (64/79) of treated patients have completed the clinical study or have been prematurely removed by the PI according to the clinical study protocol are used in the efficacy analysis below.

Performance to Primary Objective:
For the primary endpoint, 62.5% (40/64) of patients treated demonstrated a Complete Response ("CR") (negative cystoscopy and negative urine cytology) at any point in time).

Including patients, who demonstrated an Indeterminate Response ("IR") (negative cystoscopy and positive or suspicious urine cytology), the Total Response increases to 68.8% (44/64).

Primary Endpoint Performance (CR at any Point in Time)
# % Confidence Interval (95%)
Complete Response ("CR") 40 62.5% [43.1, 81.9]
Total Response (CR and IR) 44 68.8% [48.5, 89.1]
Performance to Secondary Objective:
For the secondary endpoint, 45.0% (18/40) of patients, who achieved a CR, maintained their CR response for at least 12 months (450 days from date of Study Procedure).

Secondary Endpoint Performance (Duration of CR) (450 Days)
# % Confidence Interval (95%)
Complete Response ("CR") 18 45.0% [24.2, 65.8]
Performance to Tertiary Objective:
For the tertiary endpoint, 100% (64/64) of patients experienced no Serious Adverse Events ("SAEs") directly related to the Study Drug or Study Device.

Tertiary Endpoint Performance (Safety) (450 Days)
# %
Safety 64 100.0%
25.0% (10/40) of patients who achieved a CR, continue to demonstrate a CR at 24 months from the date of the Study Procedure.

20.0% (8/40) of patients who achieved a CR continue to demonstrate a CR at 36 months from the date of the Study Procedure.

33% (1/3) of patients enrolled in the Phase Ib NMIBC clinical study2 treated once with the Study Procedure has demonstrated a sustained CR lasting over 7 years.

Serious Adverse Events

For 79 patients treated in Study II, there have been 15 Serious Adverse Events ("SAEs") reported:

1 – Grade 1 (resolved within 9 days)
3 – Grade 2 (resolved within 1, 1 and 33 days, respectively)
7 – Grade 3 (resolved within 1, 2, 3, 4, 4, 82 and unknown days, respectively)
3 – Grade 4 (resolved within 3, 6 and 8 days, respectively)
1 – Grade 5
Theralase believes all SAEs reported to date are unrelated to the Study II Drug or Study II Device.

Pending regulatory approval, this innovative technology represents a significant opportunity for an advancement in bladder cancer treatment, with only one treatment, by providing a safe and effective therapy for patients, who have exhausted their standard of care therapeutic options and are facing radical cystectomy (bladder removal).

Arkady Mandel, M.D., Ph.D., D.Sc., Chief Scientific Officer, Theralase stated, "I am delighted that the interim clinical data of Study II continues to demonstrate both high safety and high efficacy in the treatment of patients diagnosed with BCG-Unresponsive NMIBC CIS. Management of BCG-Unresponsive NMIBC CIS is and remains an unmet need and I look forward to the completion of enrollment in the clinical study this summer, which pending regulatory approval could provide an opportunity for patients to receive this treatment as part of routine clinical practice in both Canada and the United States. What we have learned in our research is that Theralase’s light-activated small molecule, Ruvidar, is able to destroy cancer through the production of reactive oxygen species and stimulation of the immune system by blocking multiple immune checkpoints, such as: CD474 (a dominant macrophage checkpoint signal on cancer cells that signals the immune system whether to destroy them or leave them alone), PD-L15 (a protein that acts as a "brake" on the immune system, preventing T cells from attacking cancer cells) and the recently discovered reduction of deubiquitinating enzymes6 (an important class of enzymes, which have been linked to numerous cancers and neurogenerative diseases)."

Roger DuMoulin-White, B.Sc., P.Eng., Pro.Dir., President and Chief Executive Officer, Theralase stated, "The presentation of the interim clinical data to the urological community at the major Canadian and American conferences provides the global urologist community and healthcare professionals, an opportunity to see firsthand the strong clinical data that the uro-oncologists involved in the clinical study have been able to deliver with the Theralase technology. RuvidarTM has proven to be a very versatile small molecule, with its ability to destroy cancer, bacteria and viruses, when activated by light, radiation, sound or even other drugs. Pending regulatory approval, the latest clinical data presented supports the use of light-activated Ruvidar by the urology community to safely and effectively treat patients inflicted with BCG-Unresponsive NMIBC CIS, helping to revolutionize the treatment landscape for bladder cancer. As Theralase wraps up the Phase II NMIBC clinical study in 2025 with a Health Canada and FDA regulatory submission planned in late 2026, I look forward to working with our world-class scientists, researchers and medical doctors in the commencement of numerous new clinical studies, focused on hard to treat viral infections, such as herpes simplex virus lesions (cold sores), through to some of the deadliest and most difficult to treat cancers in the world, such as: glioblastoma multiforme, non-small cell lung cancer, pancreatic cancer, leukemia, muscle invasive bladder cancer and colorectal cancer."

About Carcinoma In-Situ:
CIS of the bladder is an aggressive type of NMIBC characterized as a flat, high-grade tumour confined to the urothelial layer. NMIBC comprises approximately 75% to 80% of all bladder cancers, with CIS found in about 10% of cases.7

Management of CIS of the bladder remains a complex and challenging endeavor due to its high rate of recurrence and progression. Although it is typically grouped with other NMIBCs, its higher grade and aggressiveness make it a unique clinical entity. Intravesical BCG is the standard first-line treatment given its superiority to other agents; however, high rates of BCG failure highlight the need for additional therapies.8

CIS in the bladder is associated with a less favourable prognosis. It is more likely to recur after treatment. There is also a greater risk of CIS developing into Muscle Invasive Bladder Cancer ("MIBC").

Castle Biosciences Reports First Quarter 2025 Results

On May 5, 2025 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported its financial results for the first quarter ended March 31, 2025 (Press release, Castle Biosciences, MAY 5, 2025, View Source [SID1234652503]).

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"We are pleased with the exceptional start to the year, marked by continued growth in test report volume and revenue in the first quarter," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We believe our ongoing success reflects both the high clinical value that our clinicians receive from our tests coupled with consistent execution and teamwork across our therapeutic areas.

"We saw strong overall growth in our core revenue drivers. And in this month of May, Skin Cancer Awareness Month, I’m especially pleased DecisionDx-Melanoma recently achieved a significant milestone, surpassing 200,000 test orders since the launch of the test. This milestone is certainly expected, given the highly compelling data demonstrating DecisionDx-Melanoma is shown to be associated with improved patient survival, and I am extremely proud of the entire Castle team. We are grateful to the clinicians and patients who achieved this milestone with us.

"We believe our first-quarter results demonstrate our leadership across our proprietary, first-to-market test portfolio and unwavering commitment to impacting patient outcomes. Looking ahead, as we continue to drive forward our growth initiatives, we are raising our 2025 total revenue guidance to $287-297 million, compared to the previous guidance of $280-295 million."

First Quarter Ended March 31, 2025, Financial and Operational Highlights
•Revenues were $88.0 million, a 21% increase compared to $73.0 million in the first quarter of 2024.
•Adjusted Revenues, which exclude the effects of revenue adjustments related to tests delivered in prior periods, were $87.2 million, a 22% increase compared to $71.3 million for the same period in 2024.
•Delivered 24,402 total test reports in the first quarter of 2025, an increase of 17% compared to 20,888 in the same period of 2024:
◦DecisionDx-Melanoma test reports delivered in the quarter were 8,621, compared to 8,384 in the first quarter of 2024.
◦DecisionDx-SCC test reports delivered in the quarter were 4,375, compared to 3,577 in the first quarter of 2024.
◦MyPath Melanoma test reports delivered in the quarter were 926, compared to 998 in the first quarter of 2024.
◦TissueCypher Barrett’s Esophagus test reports delivered in the quarter were 7,432, compared to 3,429 in the first quarter of 2024.

◦IDgenetix test reports delivered in the quarter were 2,578, compared to 4,078 in the first quarter of 2024.
◦DecisionDx-UM test reports delivered in the quarter were 470, compared to 422 in the first quarter of 2024.
•Gross margin was 49%, and Adjusted Gross Margin was 81%, compared to 78% and 81%, respectively, for the same periods in 2024. Gross margin for the first quarter 2025 was impacted in large part due to the one-time adjustment of an acceleration of amortization expense of approximately $20.1 million during the three months ended March 31, 2025. During the first quarter of 2025, we made the decision to discontinue the IDgenetix test offering, effective May 2025. This change resulted in a change in estimated remaining useful life of IDgenetix.
•Net cash used in operations was $6.0 million, compared to net cash used in operations of $6.8 million for the same period in 2024.
•Net loss, which includes non-cash stock-based compensation expense of $11.2 million, was $25.8 million, compared to a net loss of $2.5 million for the same period in 2024.
•Net loss per share, basic and diluted, was $(0.90) and Adjusted Net Loss per Share, Basic and Diluted, was $(0.20) compared, in each case, to $(0.09), for the same periods in 2024.
•Adjusted EBITDA was $13.0 million, compared to $10.5 million for the same period in 2024.

Cash, Cash Equivalents and Marketable Investment Securities
As of March 31, 2025, the Company’s cash, cash equivalents and marketable investment securities totaled $275.2 million.

2025 Outlook

Castle Biosciences is raising its guidance for anticipated total revenue in 2025. The Company now anticipates generating between $287-297 million in total revenue in 2025, compared to the previously provided guidance of between $280-295 million.

First Quarter and Recent Accomplishments and Highlights

Dermatology
•DecisionDx-Melanoma: The Company announced its achievement of surpassing a significant milestone of 200,000 DecisionDx-Melanoma test orders. See the Company’s news release from April 28, 2025, for more information.
•DecisionDx-Melanoma: The Company announced the publication of a new study in Cancer Diagnosis & Prognosis demonstrating that DecisionDx-Melanoma outperforms both American Joint Committee on Cancer (AJCC) staging and the clinicopathologic and gene expression (CP-GEP) test in identifying patients at low risk of sentinel lymph node (SLN) positivity who may consider forgoing sentinel lymph node biopsy (SLNB) surgery. The new study provides an analysis of the accuracy of CP-GEP and DecisionDx-Melanoma in identifying patients with less than a 5% risk of SLN positivity, in T1-T2 tumors specifically, across five CP-GEP and four DecisionDx-Melanoma validation studies. Using a weighted average across all studies, patients classified as low risk by CP-GEP had an SLN positivity rate of 6.2%, exceeding the 5% NCCN threshold for ruling out SLNB. In contrast, patients identified as low risk by DecisionDx-Melanoma had a 2.8% SLN positivity rate, a significant improvement over AJCC staging. Overall, CP-GEP did not perform as well as staging alone, while DecisionDx-Melanoma outperformed staging, further demonstrating its ability to improve clinical decision-making and, ultimately, outcomes. See our press release from April 30, 2025, for more information.

•DecisionDx-Melanoma: The Company announced the recent publication of two papers in the World Journal of Surgical Oncology and Cancer Medicine sharing reports from the prospective, multicenter DECIDE study demonstrating the significant impact of the Company’s DecisionDx-Melanoma test on SLNB decision-making for patients with melanoma. Consistent with prior studies, published results from Castle’s DECIDE study support that DecisionDx-Melanoma can accurately identify patients with less than 5% risk of sentinel lymph node (SLN) positivity, who can safely consider forgoing the SLNB surgical procedure, and who are also unlikely to experience disease progression. See the Company’s news release from April 3, 2025, for more information.

•DecisionDx-Melanoma: The Company presented new data supporting the clinical value of the DecisionDx-Melanoma test in guiding risk-aligned management of patients with melanoma at the 11th World Congress of Melanoma and 21st European Association of Dermato-Oncology (EADO) Congress, which was held April 3-5, 2025, in Athens, Greece. The new study data demonstrated the significant risk stratification provided by DecisionDx-Melanoma in a real-world cohort of patients with stage IIB-IIC cutaneous melanoma (CM) to help guide adjuvant therapy, and the role of the test in prompting use of imaging surveillance in early-stage patients at high risk of metastasis to the central nervous system (CNS). See the Company’s news release from April 1, 2025, for more information.

•DecisionDx-Melanoma: The Company also presented new data on its DecisionDx-Melanoma test at the National Comprehensive Cancer Network (NCCN) 2025 Annual Conference, which was held March 28-30 in Orlando, Florida. Specifically, as part of Castle’s ongoing collaboration with the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) Program Registries, new data presented new validation of the DecisionDx-Melanoma test’s risk-stratification performance in patients with thin/early-stage CM tumors (stage I-IIA). In a large, unselected real-world cohort of 6,892 patients classified as low risk by the American Joint Committee on Cancer Eighth Edition (AJCC8) staging system, the test identified individuals at higher risk of death. In multivariable analysis that included key AJCC8 staging criteria such as tumor thickness and ulceration as well as age and mitotic rate, the data demonstrated that the DecisionDx-Melanoma test is a significant predictor of both melanoma-specific and overall mortality. These findings highlight the test’s significant, independent risk-stratification capabilities, designed to help identify patients at greater predicted risk than indicated by AJCC8 staging alone who may benefit from enhanced surveillance and management to potentially improve outcomes. See the Company’s news release from March 28, 2025, for more information.

•DecisionDx-Melanoma: Additionally, the Company presented new data on its DecisionDx-Melanoma test for patients with skin cancers at the 2025 AAD Annual Meeting, which took place from March 7-11 in Orlando, Florida. A poster from Castle’s ongoing collaboration with the National Cancer Institute’s SEER Program Registries provided an updated validation of the risk-stratification performance of the DecisionDx-Melanoma test. The study encompassed an additional year’s worth of data and approximately 4,800 more patients than the initial study by Bailey et al. In a large, unselected real-world cohort of nearly 10,000 patients who received the DecisionDx-Melanoma test as part of their clinical care, this study demonstrated the significant independent risk stratification provided by the test, beyond AJCC8 stage, and its association with improved survival relative to matched patients who did not receive testing. See the Company’s news release from March 7, 2025, for more information.

•DecisionDx-SCC: The Company also presented new data on its DecisionDx-SCC test at the NCCN 2025 Annual Conference in Orlando with an abstract that was selected as a Top Five Abstract at the meeting. Specifically, a study assessed how integrating the DecisionDx-SCC test with Brigham & Women’s Hospital (BWH) staging within NCCN guidelines can improve prognostic accuracy. An analysis of a new, combined multi-center cohort of 1,412 high-risk SCC patients, with one or more NCCN High-Risk or Very-High-Risk factors, showed that DecisionDx-SCC significantly enhanced metastatic risk stratification in NCCN High- and Very-High-Risk patient populations (p < 0.001). The test significantly improved BWH staging’s risk prediction accuracy (p < 0.001). Compared to the broader NCCN risk stratification, when DecisionDx-SCC was combined with BWH staging, Class 1 (low risk) test results showed a nearly two-fold decrease in metastatic risk and Class 2B (highest risk) results showed more than a five-fold increase in risk in lower-stage (BWH T1/T2a) NCCN High-Risk patients. These findings show that DecisionDx-SCC can significantly refine risk assessment when used with established staging methods, enabling more accurate, personalized treatment decisions based on a patient’s predicted metastatic risk. See the Company’s news release from March 28, 2025, for more information.
•DecisionDx-SCC: Additionally, the Company presented new data on its DecisionDx-SCC test for patients with skin cancer at the 2025 AAD Annual Meeting in Orlando. The study presented provided a validation of the ability of the DecisionDx-SCC test to predict metastatic risk in a novel, independent cohort of patients with high-risk SCC tumors (n=515). In the study, DecisionDx-SCC and BWH staging were both significant predictors of metastasis (p < 0.05). Overall, the study data provided further evidence that DecisionDx-SCC provides significant risk stratification (p < 0.001) of patients at higher risk of SCC metastasis to guide personalized, risk-aligned treatment decisions. See the Company’s news release from March 7, 2025, for more information.
Gastroenterology
•The Company announced it signed a definitive agreement to acquire Previse. Previse is a gastrointestinal health company with a primary focus on chronic acid reflux related diseases, including esophageal cancer. See the Company’s news release from May 5, 2025, for more information.

•The Company announced supporting key educational programs and initiatives throughout the month of April in recognition of Esophageal Cancer Awareness Month. Castle collaborated with the Esophageal Cancer Action Network (ECAN), the American Foregut Society (AFS) and The Gut Doctor Podcast LLC to promote esophageal cancer prevention, education and advocacy. See the Company’s news release from April 8, 2025, for more information.
Mental Health
•During the first quarter of 2025, the Company made the decision to discontinue its IDgenetix test offering, effective May 2025.
Corporate
•The Company earned a Top Workplace USA award for the fourth year in a row, underscoring Castle’s position as a leader in creating an exemplary workforce culture. See the Company’s news release from April 7, 2025, for more information.

Conference Call and Webcast Details
Castle Biosciences will hold a conference call on Monday, May 5, 2025, at 4:30 p.m. Eastern time to discuss its first quarter 2025 results and provide a corporate update.

A live webcast of the conference call can be accessed here:View Source or via the webcast link on the Investor Relations page of the Company’s website,
View Source Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until May 26, 2025.

To access the live conference call via phone, please dial 833 470 1428 from the United States, or +1 404 975 4839 internationally, at least 10 minutes prior to the start of the call, using the conference ID 040892.

There will be a brief Question & Answer session following management commentary.

Cue Biopharma to Participate in Fireside Chat at the Citizens Life Sciences Conference

On May 5, 2025 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer, reported that it will participate in a fireside chat at the Citizens Life Sciences Conference being held in New York, May 7-8, 2025 (Press release, Cue Biopharma, MAY 5, 2025, View Source [SID1234652521]).

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During the fireside chat, Cue Biopharma will discuss progress on its programs from the Immuno-STAT platform including the CUE-100 series, CUE-401, and CUE-501, which was recently partnered with Boehringer Ingelheim for T cell mediated targeted depletion of specific B cells to address autoimmune and inflammatory diseases.

Citizens Life Sciences Conference
Presentation Date: Thursday, May 8, 2025
Presentation Time: 11:00 a.m. EDT – 11:25 a.m. EDT
Presenter: Daniel Passeri, Chief Executive Officer
Webcast Link: View Source

A live and archived webcast of the fireside chat will be available in the News and Publications section of the Company’s website. The webcast will be archived for 30 days.