On March 24, 2025 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that management will participate in the CG Horizons in Oncology Virtual Conference on April 7, 2025 at 10:00 a.m. ET (Press release, Delcath Systems, MAR 24, 2025, View Source [SID1234651371]). Investors interested in participating should contact their Canaccord representative.

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On March 24, 2025 Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, reported financial results for the third quarter ended December 31, 2024, and provided a business update (Press release, Bolt Biotherapeutics, MAR 24, 2025, View Source [SID1234651370]).

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"2024 was a transformational year for Bolt as we focused the company on efficient development of the programs that could be most impactful for patients," said Willie Quinn, Chief Executive Officer. "BDC-4182, our next-generation ISAC, is poised to enter the clinic in the second quarter. As the only ISAC targeting the validated tumor target claudin 18.2, we believe that BDC-4182 has the potential to offer a better option for patients with stomach and other claudin 18.2-expressing cancers. We are particularly excited about BDC-4182 as validation for our Boltbody ISAC approach. We’ve also completed enrollment and have cleared the DLT window for the highest dose level in the BDC-3042 Phase 1 dose escalation trial and will provide a data update next quarter at a medical meeting. BDC-3042 is our first-in-class dectin-2 agonist, and has potential across a broad range of solid tumors with high unmet medical need."

Recent Highlights and Anticipated Milestones

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Completed enrollment of the Phase 1 study of BDC-3042 in patients with advanced cancers. BDC-3042 is a proprietary agonist antibody that targets dectin-2, an immune-activating receptor expressed by tumor-associated macrophages (TAMs). This single-agent, dose-escalation Phase 1 clinical study is evaluating BDC-3042 in patients with metastatic or unresectable solid tumors including non-small cell lung cancer (NSCLC). BDC-3042 has been well tolerated with no dose-limiting toxicities (DLTs) and evidence of biological activity. Results from the trial will be presented at an upcoming medical meeting in the second quarter of 2025.
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Finalizing preparations for first-in-human trial of BDC-4182 in patients with gastric cancer. BDC-4182 is a next-generation BoltbodyTM ISAC clinical candidate targeting claudin 18.2, a clinically validated target in oncology with expression in gastric/gastroesophageal junction cancer, pancreatic cancer, and other tumor types. BDC-4182 has advanced into IND-enabling activities, supported by in vitro and in vivo experiments demonstrating potent anti-tumor activity in multiple preclinical models. BDC-4182 was tolerated in non-human primates at the highest dose tested (12mg/kg) with an acceptable safety profile. BDC-4182 outperformed cytotoxic claudin 18.2 ADCs, using MMAE or TOPO1, in syngeneic models. Key learnings were presented at SITC (Free SITC Whitepaper) 2024 and the dose escalation trial is planned to start in Australia in the second quarter of 2025.
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Collaborations with Genmab and Toray continue to progress. The Company continues to work with Genmab to discover and develop next-generation ISACs for the treatment of cancer. Genmab and the Company are working together to advance the collaboration’s first development candidate, and the collaboration also continues research and development on additional programs. The Toray collaboration combines the Company’s immunostimulatory linker-payloads with Toray antibodies targeting Caprin-1, a tumor-specific antigen that is strongly expressed on the cell membrane in multiple solid tumor types.
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Cash, cash equivalents, and marketable securities were $70.2 million as of December 31, 2024. Cash on hand is expected to fund multiple milestones and operations through mid-2026.

Fourth Quarter and Full Year 2024 Financial Results

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Collaboration Revenue – The Company recently reassessed its expected future performance obligations under the Genmab Agreement, and as a result reported no collaboration revenue for the quarter. Total collaboration revenue was $7.7 million for the fourth and full year ended December 31, 2024, respectively, compared to $2.1 million and $7.9 million for the same quarter and year in 2023,, respectively. Revenue in the comparative periods was generated from services performed under the R&D collaborations as we fulfill our performance obligations.

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Research and Development (R&D) Expenses – R&D expenses were $11.7 million for the quarter and $57.5 million for the full year ended December 31, 2024, respectively, compared to $16.3 million and $61.5 million for the same quarter and year in 2023, respectively. The decrease between the comparable periods was mainly due to a decrease in salary and related expenses primarily as a result of the May 2024 restructuring partially offset by an increase in contract manufacturing expenses.

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General and Administrative (G&A) Expenses – G&A expenses were $3.9 million for the quarter and $18.5 million for the full year ended December 31, 2024, respectively, compared to $5.5 million and $22.5 million for the same quarter and year in 2023, respectively. The decrease between the comparable periods was mainly due to a decrease in salary and related expenses primarily as a result of the May 2024 restructuring.

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Loss from Operations – Loss from operations was $16.9 million for the quarter and $73.0 million for the full year ended December 31, 2024, respectively, compared to $19.8 million and $76.2 million for the same quarter and year in 2023, respectively.

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
Bolt Biotherapeutics’ Boltbody ISAC platform harnesses the precision of antibodies with the power of the innate and adaptive immune system to generate a productive anti-cancer response. Each Boltbody ISAC candidate comprises a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant. The antibody is designed to target one or more markers on the surface of a tumor cell and the immune stimulant is designed to recruit and activate myeloid cells. Activated myeloid cells initiate a positive feedback loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This increases the population of activated immune system cells in the tumor microenvironment and promotes a robust immune response with the goal of generating durable therapeutic responses for patients with cancer.

On March 24, 2025 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, reported its Vice President of Business Development, Mathew Lazarus, will be presenting at the 2025 Cancer Advocacy Group of Louisiana ("CAGLA") NeauxCancer Conference taking place on March 27-29, 2025 at the The Roosevelt Hotel in New Orleans (Press release, Pasithea Therapeutics, MAR 24, 2025, View Source [SID1234651369]).

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Mr. Lazarus’s presentation will provide an overview of Pasithea’s next generation macrocyclic MEK inihibitor, PAS-004, including interim safety, tolerability and pharmacokinetic (PK) data from the Company’s ongoing open-label dose escalation Phase 1 study in advanced cancer patients with MAPK pathway-driven advanced tumors. He will discuss the Company’s latest progress in clinical development and how Pasithea is advancing its next-generation molecule to transform cancer and NF1 treatment.

Details of the presentation are as follows:

Event: 2025 CAGLA NeauxCancer Conference
Date: March 28, 2025
Time: 11:00 AM CDT
Location: The Roosevelt New Orleans
Webcast: CAGLA 2025 Livestreams

The CAGLA NeauxCancer Conference is a premier gathering of leading oncology researchers, industry executives, and medical professionals focused on groundbreaking developments in cancer treatment and care.

For more information about the conference, visit View Source

On March 24, 2025 Onconetix, Inc., (Nasdaq: ONCO) ("Onconetix" or the "Company"), (formerly Blue Water Biotech, Inc. (BWV)), a cancer diagnostics company focused on the research, development and commercialization of innovative solutions for oncology, reported that new clinical data of Proclarix was presented on March 23, 2025 during the 2025 European Association of Urology (EAU) congress, which data further demonstrates the strong clinical performance of Proclarix in a Danish cohort (Press release, Onconetix, MAR 24, 2025, View Source [SID1234651368]).

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The primary approach for early detection of prostate cancer is through testing serum levels of prostate-specific antigen (PSA). However, given the limited cancer specificity of PSA, Proclarix is addressing the urgent need for improved diagnosis by lowering the burden of potential over-detection of clinically insignificant prostate cancer resulting in unnecessary biopsies.

In the study presented, Proclarix was evaluated in prospectively collected samples from 808 patients with suspected prostate cancer. In the challenging subpopulation including 371 patients with an enlarged prostate and thus frequently presenting elevated PSA levels leading to false-positive results, a negative Proclarix test resulted in a probability of 5% or less for clinically significant cancer outperforming other diagnostic tools like %fPSA (14%, p=0.028) and the ERSPC (European Randomised Study of Screening for Prostate Cancer) risk calculator (20%, p=0.026). Proclarix avoided most biopsies (22%) and missing the least significant cancers (3 out of 101 patients). In the extended population including 654 patients with a PSA level of 2-20 ng/ml, the clinical performance of Proclarix was confirmed with a sensitivity of 96% and a significantly higher (p<0.001) specificity compared to both %fPSA and ERSPC risk calculator.

Primary investigator and presenter of the study, Ahmed H. Zedan, MD, PhD from Lillebaelt Hospital – University Hospital of Southern Denmark said: "Proclarix can be safely used to reduce performed biopsies by ruling out patients with clinically insignificant or no prostate cancer and by minimizing the risk of missing clinically significant cancer".

About Proclarix

Proclarix is CE-certified under In Vitro Diagnostic Regulation ("IVDR") and indicated for prostate cancer diagnosis in patients with normal digital rectal exam (DRE), enlarged prostate volume and elevated levels of PSA at 2-10 ng/ml. Proclarix is a risk score combining in-vitro assays for the quantitative detection of biomarkers with a proprietary algorithm to assess a patient’s risk of having clinically significant prostate cancer. Detection of prostate cancer-related biomarkers in blood serum using the Proclarix risk score has been demonstrated in multiple clinical studies to be a reliable indicator of the presence of clinically significant prostate cancer. Proclarix is included in both the European (EAU) and American (AUA) guidelines.

On March 24, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, reported its financial results for the fiscal year ended December 31, 2024 (Press release, Moleculin, MAR 24, 2025, View Source [SID1234651367]). As previously announced, the Company will host a conference call and live audio webcast to discuss the operational and financial results at 8:30 AM ET on Monday, March 24, 2025 (details below).

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"This last year proved to be a very productive and substantial year for Moleculin. We believe that we continue to successfully execute on activities for our MIRACLE trial, supported by a growing body of positive preliminary data and encouraging interactions with FDA and clinical sites," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "Looking ahead, we look forward to an exciting year with a number of potential value-driving milestones expected in the coming months. Importantly, with the clinical and regulatory progress made to date, we still expect to unblind preliminary data from the first 45 subjects in the second half of this year. Our team is dedicated to advancing the development of Annamycin and we look forward to providing additional updates."

Recent Highlights

Expanded global exclusivity for Annamycin with Notice of Intent to Grant for the European patent application titled, "Method of Reconstituting Liposomal Annamycin";
Received positive FDA guidance for acceleration of its registration-enabling MIRACLE trial for R/R Acute Myeloid Leukemia (AML) resulting in a smaller number of subjects in MIRACLE;
Received first country regulatory approval in Europe to begin enrolling for the MIRACLE trial;
Received US Institutional Review Board (IRB) approval for pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) and engaged a leading contract research organization (CRO); and,
Announced new preclinical findings demonstrating significant activity of Annamycin in Venetoclax resistant AML model.
Clinical Development Update

Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML)

The Company is currently evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as "AnnAraC") in a Phase 3 pivotal trial for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML). This Phase 3 "MIRACLE" trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) will be global, including sites in the US, Europe and the Middle East.

The MIRACLE study is a Phase 2B/3 clinical trial whereby data from the 2B portion will be combined with the Phase 3 portion. MIRACLE is subject to appropriate future filings with and potential additional feedback from the FDA and their foreign equivalents, utilizes an adaptive design whereby the first 75 to 90 subjects will be randomized (1:1:1) in Part A of the trial to receive high dose cytarabine (HiDAC) combined with either placebo, 190 mg/m2 of Annamycin, or 230 mg/m2 of Annamycin, which Annamycin doses were specifically recommended by the FDA in the Company’s end of Phase 1B/2 meeting. The amended protocol allows for the unblinding of preliminary primary efficacy data (Complete Remission or CR) and safety/tolerability of the three arms at 45 subjects, in addition to the conclusion of Part A (at 75 to 90 subjects). The first early unblinding will yield 30 subjects with Annamycin (190mg/m2 and 230/m2) and HiDAC and 15 subjects with just HiDAC. The Company expects to reach the first unblinding (45 subjects) in the second half of 2025, in addition to the second unblinding, which is expected in the first half of 2026. This accelerated estimated timeline is due to the positive response the Company received in meetings during December with potential investigators regarding recruitment for the trial.

Early activities include: Multiple first subjects in Ukraine are being screened and we expect to begin treatment by the end of March; Corresponding ethic committee approvals were received recently in Georgia and Egypt with the appropriate regulatory approvals remaining; and, multiple site evaluation and initiation visits are occurring and/or being scheduled.

For Part B of the trial, approximately 220 additional subjects will be randomized to receive either HiDAC plus placebo or HiDAC plus the optimum dose of Annamycin (randomized 1:1). The selection of the optimum dose will be based on the overall balance of safety, pharmacokinetics and efficacy, consistent with the FDA’s new Project Optimus initiative. For more information about the MIRACLE trial, visit clinicaltrials.gov and reference identifier NCT06788756.

Expected Milestones for Annamycin AML Development Program

1Q – 3Q 2025 – Update on MIRACLE trial site selection/approvals by countries
1Q 2025 – First subject enrolled and treated in MIRACLE trial
2025 – Recruitment update for MIRACLE trial
2H 2025 – Data readout (n=45) unblinded efficacy/safety review
2H 2025 – 2026 – Impact of data readout (n=45) on regulatory pathway; Recruitment update
1H 2026 – Interim efficacy and safety data (n=~75-90) unblinded and Optimum Dose set for MIRACLE trial
2027 – Begin enrollment of 3rd line subjects in MIRACLE2
2027 – Enrollment ends in 2nd line subjects
2028 – Primary efficacy data for 2nd line subjects in MIRACLE
2028 – Begin submission of a Rolling New Drug Application (NDA) for the treatment of R/R AML for accelerated approval on primary endpoint of CR from MIRACLE
2028 – Primary efficacy data for 2nd line subjects
2028 – Rolling NDA submission begins
Soft Tissue Sarcoma (STS) Lung Metastases

As previously announced, the Company completed enrollment in the Phase 2 portion of its U.S. Phase 1B/2 clinical trial evaluating Annamycin as monotherapy for the treatment of soft tissue sarcoma lung metastases. Subjects who had stable disease at the time of study discontinuation were followed for progression free response and overall survival. The clinical study report is finalized but not yet filed and is expected to be released by the end of April 2025.

Expected Milestones for Annamycin STS Lung Mets Development Program

1H 2025 – Final MB-107 data readout
2025 – Identify next phase of development / pivotal IIT (investigator-initiated-trial) program
Annamycin currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the European Medicines Agency (EMA).

Summary of Financial Results for the Full Year 2024

Research and development (R&D) expense was $17.7 million and $19.5 million for the years ended December 31, 2024 and 2023, respectively. The decrease in R&D of $1.8 million is mainly related to the $1.5 million WPD sublicense termination in 2023, which enabled the reacquisition of our intellectual property rights in certain territories, including parts of the European Union.

General and administrative (G&A) expenses were $8.8 million and $10.0 million for the years ended December 31, 2024 and 2023, respectively. The decrease in G&A of $1.2 million was mainly attributable to a decrease in regulatory and legal services, and consulting & advisory fees.

As of December 31, 2024, the Company had cash and cash equivalents of $4.3 million. The Company believes that the existing cash and cash equivalents as of December 31, 2024, along with $9.3 million in gross proceeds received as part of the February 2025 financing activities will be sufficient to fund our planned operations into the third quarter of 2025.

Conference Call and Webcast

Moleculin management will host its quarterly conference call and webcast for investors, analysts, and other interested parties on Monday, March 24, 2024 at 8:30 AM ET.

Interested participants and investors may access the conference call by dialing (877) 407-0832 (domestic) or (201) 689-8433 (international) and referencing the Moleculin Biotech Conference Call. The live audio webcast will be accessible on the Events page of the Investors section of the Moleculin website, moleculin.com, and will be archived for 90 days.