EpimAb Biotherapeutics Announces Four Upcoming Presentations at the 2025 American Association for Cancer Research Annual Meeting

On March 31, 2025 EpimAb Biotherapeutics, a clinical stage biotechnology company specializing in the development of bispecific antibodies and T-cell engagers, reported the company will be presenting four poster presentations at the upcoming 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place in Chicago, Illinois, from April 25-30, 2025, at the McCormick Place Convention Center (Press release, EpimAb Biotherapeutics, MAR 31, 2025, View Source [SID1234654053]).

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The posters will feature: 1) Clinical results for EMB-01, an EGFR x cMet bispecific antibody, in colorectal cancer; 2) Preclinical data for EM1031, a novel KLK2 x CD3 bispecific T-cell engager; 3) Preclinical data for a novel LY6G6D x CD3 bispecific T-cell engager and 4) Preclinical data for a novel TCR based bispecific platform.

Details for the presentations are as follows:

EMB-01 EGFR x cMet bispecific antibody

Title: EMB-01, an EGFR/cMET bispecific antibody, in metastatic colorectal cancer: Results from an International Phase Ib/II study
Presentation number: CT168
Presentation Date: Tuesday, April 29, 2025
Presentation Time: 9:00AM – 12:00PM, local time (Location: Poster Section 49 Board Number 8)
EM1031 KLK2 x CD3 bispecific T-cell engager

Title: EM1031, a novel KLK2 x CD3 bispecific T-cell engager with highly effective efficacy in preclinical models
Presentation number: 3520
Presentation Date: Monday, April 28, 2025
Presentation Time: 2:00PM – 5:00PM, local time (Location: Poster Section 38 Board Number 28)
LY6G6D x CD3 bispecific T-cell engager

Title: A novel LY6G6D x CD3 bispecific T-cell engager demonstrates better tumor killing and minimal cytokine release than a benchmark molecule
Presentation number: 7317
Presentation Date: Wednesday, April 30, 2025
Presentation Time: 9:00AM – 12:00PM, local time (Location: Poster Section 40 Board Number 3)
TCR based bispecific platform

Title: Development of a novel TCR based bispecific platform for cancer therapy
Presentation number: 5446
Presentation Date: Tuesday, April 29, 2025
Presentation Time: 2:00PM – 5:00PM, local time (Location: Poster Section 15 Board Number 4)
"We are very pleased to share the promising efficacy signal of EMB-01 in Phase Ib/II clinical study for colorectal cancer as a poster presentation at the AACR (Free AACR Whitepaper) Annual Meeting, and 3 preclinical TCE assets and platform with differentiated efficacy and safety profile in solid tumors," said Dr. Chengbin Wu, Founder and CEO of EpimAb. "The results of these studies are also providing validation of our TCE & bispecific technology platform in solid tumors, and we will further leverage this expertise to advance novel therapies for diseases with significant unmet need."

Calidi Biotherapeutics Reports Fourth Quarter and Full-Year 2024 Financial Results and Recent Operational Highlights

On March 31, 2025 Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi"), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, reported its fourth quarter and full-year 2024 operating and financial results and reviewed recent business highlights (Press release, Calidi Biotherapeutics, MAR 31, 2025, View Source [SID1234653217]).

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"Calidi continues to make great progress on all three of our platforms; our systemic asset CLD-400 proved it can deliver a gene therapy payload to targeted tumors, we filed an IND for our solid tumor asset CLD-201, and our CLD-101 program treating high-grade glioma is advancing in two Phase 1 trials," said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics. "We think our multi-modal mechanism of action is a game changer in treating multiple deadly cancers, including metastatic cancer and lung cancer, solid tumors and high-grade glioma."

Fourth Quarter 2024 and Recent Corporate Developments

New data showed that a single dose of a tumor-selective triple knockout ("3KO") RT virus genetically engineered to encode a specific immune-boosting payload (undisclosed) increased the antitumor immune response. These increased shifts in immune composition, driven by virotherapy encoding a payload, ultimately led to complete eradication of certain tested tumors in the preclinical model.
In March 2025, Calidi filed an IND for a company sponsored, open label dose escalation trial of CLD-201 in adult patients with solid tumors, specifically with the indications of breast cancer, head & neck squamous cell carcinoma, and soft tissue sarcoma.
In February 2025, Northwestern University hospital started recruiting for the CLD-101 Phase 1 clinical trial in patients with newly diagnosed high-grade glioma, an aggressive and often fatal form of brain cancer. This physician-led and NCI sponsored clinical trial, led by prominent experts Dr. Maciej Lesniak and Dr. Roger Stupp, builds on the promising results from a prior Phase 1 trial involving 12 patients treated with a single dose of CLD-101 published in the prestigious journal The Lancet Oncology.
City of Hope and Calidi announced the 14th patient treated in a physician-sponsored Phase 1 trial assessing the safety and feasibility of a multi-dosing regimen to treat recurrent high-grade glioma. This program has secured $12 million award from the California Institute for Regenerative Medicine (CIRM) to support this groundbreaking study.
Upcoming Anticipated Milestones

Q2 2025: Payload and lead candidate information revealed on CLD-400 systemic platform
Q2 2025: First patient dosed in CLD-101 Phase 1 trial in collaboration with Northwestern University for newly diagnosed high-grade glioma patients
Q3 2025: First patient dosed in CLD-201 Phase 1 trial
Fourth Quarter 2024 Financial Results

The company reported a net loss attributable to common stockholders of $4.1 million, or $0.27 per share, for the three months ended December 31, 2024, compared to a net loss attributable to common stockholders of $8.2 million, or $0.23 per share, for the same period in 2023.

Research and development expenses were $1.8 million for the three months ended December 31, 2024, compared to $4.0 million for the comparable period in 2023, respectively.

General and administrative expenses were $2.2 million for the three months ended December 31, 2024, compared to $5.9 million for the comparable period in 2023, respectively.

Full Year 2024 Financial Results

The company reported a net loss attributable to common stockholders of $23.8 million, or $2.97 per share, for the year ended December 31, 2024, compared to a net loss attributable to common stockholders of $29.2 million, or $17.33 per share, for the year ended December 31, 2023.

Research and development expenses were $8.9 million for the year ended December 31, 2024, compared to $13.0 million for the year ended December 31, 2023, respectively.

General and administrative expenses were $12.9 million for the year ended December 31, 2024, compared to $16.0 million for the year ended December 31, 2023, respectively.

The company had approximately $9.6 million in cash and $0.2 million in restricted cash as of December 31, 2024, compared to $1.9 million in cash and $0.2 million in restricted cash as of December 31, 2023.

CASI Pharmaceuticals Announces Fourth Quarter and Full-Year 2024 Business and Financial Results

On March 31, 2025 CASI Pharmaceuticals, Inc. (NASDAQ:CASI), ("CASI" or the "Company"), a Cayman incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported business and financial results for the fourth quarter ended December 31, 2024, and provided an update on key highlights for 2024 (Press release, CASI Pharmaceuticals, MAR 31, 2025, https://feeds.issuerdirect.com/news-release.html?newsid=5642877492672387&symbol=CASI [SID1234652235]).

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Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "2024 was a transformative year for CASI as we strategically pivoted our company toward the development of CID-103 for organ transplant rejection and autoimmune disease. CID-103 is an anti-CD38 antibody with the potential to be a best-in-class treatment for a myriad of autoimmune diseases as well as antibody mediated rejection (AMR). We are encouraged by our clinical progress, achieving a milestone with the first Immune Thrombocytopenia (ITP) patient dosed in January 2025. Simultaneously, we are diligently working towards resolution of the FDA renal allograft AMR clinical hold."

Dr. He continued, "As we advance into 2025, we remain firmly committed to progressing CID-103 at an accelerated pace. We expect to reach multiple important milestones this year. Our focused approach and prudent capital allocation position CASI to deliver sustainable long-term value creation for both patients and shareholders."

Key Business Highlights

CASI reported the fourth quarter revenue of $13.4 million and full-year revenue of $28.5 million.

Received a proposal with respect to the acquisition of CASI’s China business from Dr. Wei-Wu He on June 21, 2024.

Completed a $15.0 million private placement financing with leading healthcare investors including Venrock Healthcare Capital Partners, Foresite Capital, Panacea Venture and Dr. Wei-Wu He, on July 15, 2024.

Pipeline and Program Updates

Received FDA IND clearance of ITP on May 15, 2024.

Received CTA approval from China’s NMPA on ITP on October 24, 2024.

First patient dosed in Phase 1/2 clinical trial in ITP on January 3, 2025. Patient enrollment and treatment continues.

Upcoming Milestones

Anticipate FDA feedback on clinical hold for AMR in Q2, 2025.

Target IND submission for Aplastic Anemia in Q2, 2025.

Report the interim data from the ongoing ITP phase 1 study in mid-2025.

Anticipate finalizing the equity transfer agreement regarding Precision Autoimmune Therapeutics ("PAT") in Q2 2025. Upon completion of this transaction, CASI will have the sole global ownership of all indications in CID-103.

Product and Pipeline Highlights

CID-103 (Anti-CD38 antibody)

CID 103 is a full human IgG1 anti-CD38 monoclonal antibody recognizing a unique epitope that has demonstrated an encouraging preclinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies, and which we have exclusive global rights. CID 103 is being developed for the treatment of patients with chronic Immune Thrombocytopenia (ITP), renal allograft antibody mediated rejection (AMR). In May 2024, we announced the clearance of IND application with the US FDA for the initiation of a phase 1/2 study of CID-103 in adults with ITP. In October 2024, the Center for Drug Evaluation (CDE) approved the Clinical Trial Application (CTA) for a phase 1/2 study of CID-103 in patients with chronic ITP in China. The Chinese ITP study is part of the global development program which has been approved by the US FDA in May 2024. In January 2025, CASI announced the first patient was enrolled and dosed in the ITP clinical study. Furthermore, we are making steady progress towards resolution of the FDA clinical hold.

EVOMELA (melphalan for injection)

On December 3, 2018, CASI received the NMPA approval for importation, marketing and sales in China for EVOMELA , and on August 12, 2019, CASI announced the commercial launch of EVOMELA in China. Prior to EVOMELA’s entry into the Chinese market, an average of 800 stem cell transplants per year were conducted in the multiple myeloma (MM) treatment setting. Following EVOMELA’s launch in August of 2019, CASI worked closely with KOLs to improve market awareness and expedite adoption in the Chinese market. In 2023, nearly 10,000 patients were treated with EVOMELA. In 2024, the launch of an undifferentiated generic formulation of melphalan for injection product by a Chinese domestic manufacture has presented challenges, resulting in a decline of EVOMELA sales.

FOLOTYN (Pralatrexate)

On July 31, 2023, CASI entered into a tripartite assignment agreement with Mundipharma International Corporation Limited ("MICL"), Mundipharma Medical Company (MMCo), and Acrotech Biopharma Inc. (Acrotech) for the commercialization of FOLOTYN (Pralatrexate) in China. FOLOTYN (Pralatrexate) is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This product was approved by both the FDA and China’s NMPA for PTCL. CASI announced the first patient was dosed with FOLOTYN in China on February 15, 2024.

Fourth Quarter and Full-Year 2024 Financial Results

Revenue for the fourth quarter of 2024 was $13.4 million, representing a 94% increase compared to $6.9 million in the same period last year. The quarterly growth reflects a successful execution of commercial strategy implemented in the second half of the year. Full-year revenue was $28.5 million, compared to $33.9 million in 2023, a decrease of 16%. The annual performance was impacted by intensified competition following the market entry of domestically produced injectable melphalan, which created pricing pressure throughout the year.

R&D expenses for the fourth quarter was $3.7 million, a 61% increase from $2.3 million in the same period last year. The increase is primarily for the development of CID-103, supporting the company’s focused pivot toward opportunities in organ transplant rejection and autoimmune indications. Full-year R&D expenses was $8.9 million, compared to $9.9 million in 2023, representing a decrease of 10%. The reduction primarily resulted from lower amortization expenses following the decision to write off generic portfolio at the end of 2023.

G&A expenses for the fourth quarter of 2024 was $7.1 million, compared to $6.4 million in the same period in 2023, a 11% increase. This quarter-over-quarter increase is primarily attributable to legal expenses associated with ongoing arbitration proceedings with Juventas. Full-year G&A expenses was $23.6 million, compared to $25.4 million in 2023, representing a decrease of 7%. This year-over-year improvement demonstrates the effectiveness of our operational efficiency initiatives and cost control measures, reinforcing our commitment to disciplined financial management.

Net loss for the year ended December 31, 2024 was $39.3 million compared to $26.3 million for the year ended December 31, 2023.

As of December 31, 2024, CASI had cash and cash equivalents of $13.5 million compared to cash and cash equivalents plus short term investments of $29.1 million as of December 31, 2023.

Further information regarding the Company, including its Annual Report on Form 20-F for the year ended December 31, 2024, can be found at www.casipharmaceuticals.com. The Company will provide a hard copy of its annual report containing the audited consolidated financial statements, free of charge, to its shareholders upon request. Requests should be directed to Investor Relations Department, CASI Pharmaceuticals, Inc., Rm 1701-1702, China Central Office Tower 1, No.81 Jianguo Road Chaoyang District, Beijing, 100025, China.

Annual and sustainability report 2024

On March 31, 2025 Swedish Orphan Biovitrum reported its annual report for the year 2024 (Presentation, Swedish Orphan Biovitrum, MAR 31, 2025, View Source [SID1234652119]).

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Entry into a Material Definitive Agreement

On March 31, 2025, Atara Biotherapeutics, Inc., (the "Company") entered into an Amendment (the "Amendment") to the Amended and Restated Commercialization Agreement dated October 31, 2023 (the "Agreement") with Pierre Fabre Medicament ("Pierre Fabre") (Filing, 8-K, Atara Biotherapeutics, MAR 31, 2025, View Source [SID1234651804]). Under the terms of the Amendment, as of March 31, 2025, the Company has completed the transfer of all manufacturing responsibility to Pierre Fabre and Pierre Fabre will be, at its cost, responsible for manufacturing and supplying tabelecleucel for development and commercialization worldwide. Pierre Fabre has also agreed to assume the costs related to remediation of the third-party manufacturing facility to address the U.S. Food and Drug Administration’s (the "FDA") requests to support resubmission of the BLA for tab-cel.

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In exchange for accelerating the transfer of all manufacturing responsibility and assumption of such remediation costs by Pierre Fabre, among other things, the Company agreed to reduce the amount of certain potential future regulatory and commercial milestone payments under the Agreement. The Amendment did not change any of the royalties the Company is eligible to receive under the Agreement. Pursuant to the Amendment, the Company is now entitled to receive an aggregate of up to $550.0 million in additional potential milestone payments upon achieving certain regulatory and commercial milestones relating to tab-cel, including up to $40.0 million in potential regulatory milestones in connection with the approval by the FDA of a BLA for tab-cel under the terms of the Agreement (as amended by the Amendment).

The foregoing summary of the Amendment does not purport to be complete and is qualified in its entirety by reference to the Amendment, a copy of which will be filed with the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2025.