On March 27, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported its financial results for the fourth quarter and full year 2024 and provided a business update (Press release, AIM ImmunoTech, MAR 27, 2025, View Source [SID1234651517]). The Company will host a conference call and webcast on Tuesday, April 1, 2025 at 8:30 AM ET (details below).

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"Our team made significant strides in advancing our development programs along with our collaborators over the course of 2024. As we look ahead, we will continue to execute our corporate and clinical strategies to further establish the foundation upon which we can secure the successful future of AIM and our drug Ampligen for the treatment of major-market unmet medical needs. We are focused on the successful execution of a number of key milestones expected over the course of the next 18 months with the goal of building long-term stockholder value," commented AIM Chief Executive Officer Thomas K. Equels.

Recent Highlights

Announced plans to conduct clinical study of the combination of Ampligen and AstraZeneca’s FluMist as an intranasal vaccine for influenza, including avian influenza (bird flu); Paul Goepfert, MD, of the University of Alabama-Birmingham, has agreed to act as the Principal Investigator for the study.
Announced Ted D. Kellner and David Chemerow as new members of AIM’s Board of Directors.
Erasmus Medical Center Safety Committee granted approval to proceed with the Phase 2 portion of the Phase 1b/2 clinical trial involving AIM’s Ampligen and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of late-stage pancreatic cancer ("DURIPANC").
Commenced dosing in Phase 2 of the Phase 1b/2 DURIPANC clinical trial for treatment of late-stage pancreatic cancer.
Announced the final clinical study results for the "Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions" ("AMP-518") were published to ClinicalTrials.gov (See: NCT05592418).
Expanded patent portfolio with a U.S. compositions and methods patent for Ampligen for the treatment of endometriosis and a Netherlands compositions and methods patent covering Ampligen for use in the Post-COVID condition of fatigue.
Announced publication of data from Roswell Park Comprehensive Cancer Center’s Phase 1 study evaluating a combination therapy using Ampligen in early-stage triple-negative breast cancer (TNBC) in The Journal for ImmunoTherapy of Cancer.
Expected Upcoming, Value-Driving Milestones

Metastatic Pancreatic Ductal Adenocarcinoma

Phase 1b/2 Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab with TLR-3 Agonist Ampligen in Patients with Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy (DURIPANC) (NCT05927142); Funded through collaboration of AstraZeneca and Erasmus Medical Center

Q2/Q3 2026: Last patient enrolled in Phase 2
Refractory Melanoma

Phase 2 Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Ampligen, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma (NCT04093323); Grant funded by National Cancer Institute

H1 2025: First patient dosed
Stage 4 Triple Negative Breast Cancer

Phase 1/2a Study of Ampligen, Celecoxib and Interferon Alpha 2b with Pembrolizumab for the Treatment of Patients with Metastatic or Unresectable Triple Negative Breast Cancer (NCT05756166); Grant funded by Merck and National Cancer Institute

Q2 2026: Expected completion of enrollment
Advanced Recurrent Ovarian Cancer

Phase 2 Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer (NCT03734692); Grant funded by Merck

H1 2025: Completion of study, publication of data
Summary of Financial Highlights for Fiscal Year 2024

As of December 31, 2024, AIM reported cash, cash equivalents and marketable investments of $4.0 million, compared to $13.1 million as of December 31, 2023.
Research and development expenses for the year ended December 31, 2024, were $6.2 million, compared to $10.9 million for the year ended December 31, 2023.
General and administrative expenses for the year ended December 31, 2024, were $13.7 million, compared to $21.1 million for the year ended December 31, 2023.
Please refer to the full 10-K for complete details.

Conference Call and Webcast Details

The Company will host a conference call and webcast to discuss the Company’s Q4/FY2024 operational and financial results on Tuesday, April 1, 2025 at 8:30 AM ET.

The call will be hosted by Thomas K. Equels, Chief Executive Officer of AIM. Interested participants and investors may access the conference call by dialing (877) 407-9219 (domestic) or (201) 689-8852 (international) and referencing the AIM ImmunoTech Conference Call. The webcast will be accessible on the Events page of the Investors section of the Company’s website, aimimmuno.com, and will be archived for 90 days following the live event.

On March 27, 2025 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), reported financial results for the fourth quarter and full year ended December 31, 2024, and provided recent operational updates (Press release, ADC Therapeutics, MAR 27, 2025, View Source [SID1234651516]).

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"We achieved several key milestones in 2024, advancing our expansion trials with ZYNLONTA in combinations and in earlier lines of DLBCL therapy, progressing our early research solid tumor program to the IND-enabling stage and reducing operational spend while at the same time strengthening the balance sheet," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "We closed the year by fully enrolling our confirmatory LOTIS-5 DLBCL study, reported encouraging initial data from our LOTIS-7 DLBCL study and were pleased to see promising Phase 2 IIT data reported at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting evaluating ZYNLONTA in indolent lymphomas. We are confident in our path forward and believe we are well positioned for success as we progress toward additional pivotal milestones in 2025."

Fourth Quarter 2024 Operational Updates and Upcoming Milestones

•Full enrollment achieved in LOTIS-5. Enrollment for the Phase 3 confirmatory trial evaluating ZYNLONTA in combination with rituximab in patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) was completed in December 2024. The Company expects to provide updated data before the end of 2025, once the pre-specified number of progression-free survival (PFS) events is reached.
•Encouraging initial data from LOTIS-7. The Company reported positive initial data in December 2024 from the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy of ZYNLONTA in combination with the bispecific antibody glofitamab (COLUMVI) in patients with r/r non-Hodgkin Lymphoma (NHL). The best overall response rate (ORR) among the 18 r/r DLBCL efficacy evaluable patients was 94%, and the complete response rate (CRR) was 72%. These encouraging efficacy data were observed across patients with different numbers of lines and types of prior treatments. Initial safety data on all 29 r/r NHL patients suggest the combination is generally well tolerated with no dose-limiting toxicities across all dose levels. Enrollment of 40 patients in the dose expansion is expected to be completed in the second quarter of 2025. We expect to share data on a subset of patients in the second quarter of 2025 with a fuller, more mature data update anticipated during the second half of 2025.
•Promising data from the Phase 2 investigator-initiated trials evaluating ZYNLONTA in indolent lymphomas. Updated data from the investigator-initiated trials (IITs) of ZYNLONTA were presented at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2024. Both the Phase 2 clinical trial evaluating ZYNLONTA in combination with rituximab in patients with r/r follicular lymphoma (FL) and the Phase 2 clinical trial evaluating ZYNLONTA for the treatment of r/r marginal zone lymphoma (MZL) are ongoing and being conducted at the Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine. Results from both trials as presented at ASH (Free ASH Whitepaper) and the FL trial simultaneously published in Lancet Haematology can be found here. Additional data are expected to be shared at a medical conference and/or in publication with plans to engage regulatory agencies and evaluate compendia strategies.
•Abstracts to be presented in oral and poster presentations in April at AACR (Free AACR Whitepaper) 2025. An abstract on the Company’s Claudin-6 targeting ADC was accepted for oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025. Abstracts on the Company’s PSMA and ASCT2-targeting ADCs were also accepted for poster presentations at the meeting.

Fourth Quarter and Full Year 2024 Financial Results

•Product Revenues: ZYNLONTA reached commercial brand profitability in 2024, generating net product revenues of $16.4 million for the fourth quarter ended December 31, 2024, and $69.3 million for the full year of 2024 as compared to $16.6 million and $69.1 million for the same periods in 2023. The quarter-over-quarter decrease is driven by lower sales volume, partially offset by a higher selling price. The year-to-date increase is primarily attributable to a higher selling price and favorability in prior period GTN sales adjustments, partially offset by lower sales volume.

•Research and Development (R&D) Expense: R&D expense was $27.1 million and $109.6 million for the fourth quarter and full year ended December 31, 2024, respectively. This compares to R&D expense of $30.3 million and $127.1 million for the same periods in 2023. The decrease during both periods is due primarily to the implementation of productivity initiatives and focused investment in prioritized development programs.

•Selling and Marketing (S&M) Expense: S&M expense was $11.3 million and $44.0 million for the fourth quarter and full year ended December 31, 2024, respectively. This compares to S&M expense of $13.9 million and $57.5 million for the same periods in 2023. The quarter-over-quarter decrease in S&M expense was primarily due to lower marketing and advertising costs, partially offset by higher share-based compensation expense. The year-to-date decrease was primarily due to lower marketing and advertising costs as well as lower wages and benefits.

•General & Administrative (G&A) Expense: G&A expense was $9.6 million and $41.9 million for the fourth quarter and full year ended December 31, 2024, respectively. This compares to G&A expense of $11.3 million and $48.4 million for the same periods in 2023. The quarter-over-quarter decrease in G&A expense was primarily related to lower professional fees. The year-to-date decrease was primarily related to lower share-based compensation expense, professional fees and insurance premiums.

•Net Loss: Net loss for the quarter ended December 31, 2024, was $30.7 million, or a net loss of $0.29 per basic and diluted share, as compared to net loss of $85.0 million, or a net loss of $1.03 per basic and diluted share for the same period in 2023. Net loss for the full year ended December 31, 2024, was $157.8 million, or a net loss of $1.62 per basic and diluted share, as compared to net loss of $240.1 million, or a net loss of $2.94 per basic and diluted share for the full year ended December 31, 2023. The decrease in net loss during both periods is primarily attributable to lower income tax expense and lower operating expenses.

•Adjusted Net Loss: Adjusted net loss, which is a non-GAAP financial measure, was $26.5 million, or an adjusted net loss of $0.25 per basic and diluted share for the quarter ended December 31, 2024, as compared to an adjusted net loss of $79.5 million, or $0.97 per basic and diluted share, for the same period in 2023. Adjusted net loss for the full year ended December 31, 2024, was $111.4 million, or an adjusted net loss of $1.15 per basic and diluted share, as compared to net loss of $185.7 million, or an adjusted net loss of $2.27 per basic and diluted share for the full year ended December 31, 2023. The decrease in adjusted net loss during both periods is primarily attributable to lower income tax expense and lower operating expenses.

•Cash and cash equivalents: As of December 31, 2024, cash and cash equivalents were $250.9 million, compared to $278.6 million as of December 31, 2023. In May 2024 the Company completed an underwritten offering resulting in net proceeds of approximately $97.4 million, extending the expected cash runway into the second half of 2026.

Conference Call Details

ADC Therapeutics management will host a conference call and live audio webcast to discuss fourth quarter and full year 2024 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the conference call, please register here. The participant toll-free dial-in number is 1-800-836-8184 for North America and Canada. A live webcast of the call will be available under "Events & Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.

About ZYNLONTA

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at www.ZYNLONTA.com.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

On March 26, 2025 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi"), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, and City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States, reported progress from a phase 1 clinical trial utilizing Calidi’s CLD-101 investigational agent (neural stem cell-based oncolytic virotherapy) that is administered intracerebrally (Press release, Calidi Biotherapeutics, MAR 26, 2025, View Source [SID1234653216]). This trial is the first to evaluate the safety and therapeutic potential of a multiple-dose regimen of this novel virotherapy for recurrent high-grade glioma – among the most aggressive and deadly forms of brain cancer.

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Conducted by City of Hope, which has a National Cancer Institute-designated Comprehensive Cancer Center known for its pioneering research, this physician-sponsored phase 1 trial is assessing the safety and feasibility of delivering up to four weekly intracerebral doses of CLD-101. To date, 14 participants have been treated and all treatment has been well tolerated. The study is currently enrolling participants to the highest treatment schedule.

"We are optimistic about the initial results in these first 14 patients. I am especially encouraged by cohort 4 as we keep enrolling participants in this highest treatment schedule," said Dr. Jana Portnow, co-director of City of Hope’s Brain Tumor Program and the trial’s principal investigator. This clinical trial is now also open at Northwestern University Feinberg School of Medicine and Stanford University Hospitals, both globally recognized institutions in cancer research and treatment.

Dr. Karen Aboody, City of Hope professor in the Department of Stem Cell Biology and Regenerative Medicine, Division of Neurosurgery, has played a critical role in developing this approach alongside Dr. Portnow. Their collaboration secured a $12 million award from the California Institute for Regenerative Medicine (CIRM) to support this groundbreaking study.

"We are dedicated to improving clinical outcomes of cancer patients with the use of stem cell technology to deliver oncolytic virus payloads to cancer sites," said Allan Camaisa, CEO and Chairman of Calidi. "Together with our systemic, enveloped virus platform, I believe we are developing a portfolio of products to address glioblastoma, solid tumors and metastatic cancer."

Calidi licensed the technology from the University of Chicago, on behalf of City of Hope and University of Alabama. City of Hope has a financial interest in the technology.

Dr. Aboody, an inventor of the technology, has a financial interest in Calidi and is a paid advisory board member.

On March 26, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported that the Company will be presenting three posters at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place from April 25 th – 30 th at McCormick Place Convention Center, Chicago, IL (Press release, BriaCell Therapeutics, MAR 26, 2025, View Source [SID1234651957]). The details are listed below. The abstracts will be published in the online Proceedings of the AACR (Free AACR Whitepaper) .

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Poster 1:
Title: Bria-ABC[1] vs physician choice in late-stage MBC; early biomarker correlates of the randomized registration trial
Session Title: Late-Breaking Research: Clinical Research 4
Session Date and Time: 4/30/2025 9:00 AM – 12:00 PM CST
Location: Poster Section 49
Poster Board Number: 14
Abstract Presentation Number: LB408

Poster 2:
Title: Survival outcomes in a randomized phase 2 of Bria-IMT : An allogeneic whole cell cancer vaccine
Session Title: Phase II and Phase III Clinical Trials
Session Start: 4/28/2025 2:00 PM – 5:00 PM CST
Location: Poster Section 50
Poster Board Number: 18
Abstract Presentation Number: CT100

Poster 3:
Title: Bria-OTS+: A versatile therapeutic platform for inducing anti-cancer immunity
Session Category: Immunology
Session Title: Vaccines, In Situ Vaccines, and Vaccine Combinations
Session Date and Time: 4/28/2025 2:00 – 5:00 PM CST
Location: Poster Section 39
Poster Board Number: 29
Published Abstract Number: 3553

Following the presentation, copies of the posters will be made available at View Source .

On March 26, 2025 Innovent Biologics reported annual results announcement for the year ended 31 December 2024 (Filing, 3 mnth, DEC 31, Innovent Biologics, 2024, MAR 26, 2025, View Source [SID1234651499]).

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