On May 22, 2025 Novita Pharmaceuticals, Inc. ("Novita"), a privately held, clinical-stage pharmaceutical company dedicated to developing novel cancer drugs through its proprietary fascin inhibitor technology, reported additional results from its Phase 2 study (NCT05023486) evaluating NP-G2-044 in combination with SOC anti-PD-1 therapy in patients with advanced solid tumors resistant to prior anti-PD-1 therapy at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Novita Pharmaceuticals, MAY 22, 2025, View Source [SID1234653337]). The oral presentation, titled "Durable responses in ICI-refractory or acquired resistance: Phase 2 study of NP-G2-044 combined with anti-PD-1 therapy", further supports the potential therapeutic benefit of NP-G2-044 in combination with immune checkpoint inhibitors (ICIs) to block metastasis and enhance immune response.

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"We are encouraged by the continued positive data from our Phase 2 trial of NP=G2-044, which highlight the therapeutic opportunity of our first-in-class fascin inhibitor for patients with advanced and metastatic solid tumors," said Jillian Zhang, Ph.D., President & Chief Scientific Officer of Novita. "Continued safety and durable efficacy findings across multiple tumor types speak to the impact of our novel therapy, as we see favorable response rates and no new metastases from more than half of patients. These data set the foundation for our Phase 3 study of NP-G2-044 + PLD in platinum resistant ovarian cancer, which we plan to start enrolling later this year."

Among the 45 patients treated with NP-G2-044 as of the most recent data cutoff (April 23, 2025), all had progressed on prior anti-PD-(L)1 therapies, with a median number of 2 prior lines, and with 20% of patients having at least 4 prior lines. The anti-PD-1 Combination RP2D for NP-G2-044 was 1600 mg QD with 4-week cycles. The primary endpoint was objective response rate (ORR), and secondary endpoints included progression-free survival (PFS), metastasis-free interval (MFI), overall survival (OS), safety, and tolerability.

Key highlights include:

A Disease Control Rate of 76% (includes patients with Stable Disease and Objective Responses).
An ORR of 21% including three patients with Partial Response (PR) and four patients with Complete Responses (CR) including two Pathologic Complete Responses.
Results indicate durable responses and tumor control in a significant proportion of patients across at least seven cancer types, including cases converted from ICI-non-responsive to ICI-responsive.
Long lasting objective responses have been observed across multiple tumor types, with four patients in ongoing treatment, two of which show duration lasting more than 80 weeks in pancreatic cancer and endometrial cancer.
55% of all patients show no new metastases.
Notable outcomes include continued CR in a cervical cancer patient, target lesion CR in an endometrial cancer patient, pathological CRs in a pancreatic cancer patient and a patient with gastroesophageal junction adenocarcinoma, clinical CR in a cutaneous squamous cell carcinoma patient, and PRs in non-small cell lung cancer and cholangiocarcinoma.
Increased T-cell infiltration and enhanced proliferation as well as expanded activated dendritic cells (DCs) in the tumor microenvironment were observed, supporting the therapeutic function of fascin inhibition and immune activation.
An amendment to the study is currently underway to open additional cohorts, which will aim to further evaluate the combination of NP-G2-044 with anti-PD-1 therapy across patient populations and solid tumor subtypes. Future analysis will also explore biomarkers for response prediction and mechanisms of resistance, guiding personalized approaches in treatment-resistant cancer. Novita plans to share additional data from the Phase 2 expansion cohort of NP-G2-044 in combination with ICI in the second half of 2025 with enrollment in its pivotal Phase 3 study of NP-G2-044 + PLD in platinum resistant ovarian cancer expected to begin in the third quarter of 2025.

On May 22, 2025 Taiho Pharmaceutical Co., Ltd. reported that its U.S. subsidiary, Taiho Oncology, Inc., will present the results of a Phase 1/2 clinical trial of the combination regimen of decitabine and cedazuridine plus venetoclax for acute myeloid leukemia (AML) in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held May 30 through June 3 in Chicago (Press release, Taiho, MAY 22, 2025, View Source [SID1234653716]).

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This Phase 1/2 trial evaluated the safety and efficacy of an oral administration regimen of decitabine-cedazuridine paired with venetoclax in 101 adult　AML patients who were ineligible for first-line induction chemotherapy.
Study results
Complete remission (CR), which was the primary endpoint of the study, was 46.5%, and CR with incomplete hematologic recovery rates was 63.4%. Median time to CR was 2.4 months. Median CR duration was not reached; among patients who achieved it, 80% maintained that status at 6 months and 75.3% at 12 months. Median OS was 15.5 months.

98% of patients reported treatment-emergent adverse events of grade 3 or higher*, most commonly febrile neutropenia (49.5%), anemia (38.6%) and neutropenia (35.6%). The 30- and 60-day mortality rates were 3% and 9%, respectively.
*Revsied on June 4
About acute myeloid leukemia (AML)
AML is a disease in which the proliferation of leukemia cells inhibits the normal production of blood in the bone marrow. It is the most common type of acute leukemia in adults, and its incidence increases with age. There is a need for less toxic treatment methods for elderly patients who have difficulty receiving first-line induction chemotherapy.
About decitabine-cedazuridine
This combination is the world’s first oral DNA methylation inhibitor combined with a novel metabolic inhibitor that inhibits the breakdown of decitabine when administered orally.
It was approved in the U.S. and Canada in 2020 for the indications of myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML), and in Europe in 2023 for the indication of AML.

On May 21, 2025 AstraZeneca reported its ambition to eliminate cancer as a cause of death with new data across its diverse, industry-leading portfolio and pipeline at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, 30 May to 3 June 2025 (Press release, AstraZeneca, MAY 21, 2025, View Source [SID1234653255]).

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More than 80 abstracts will feature 20 approved and potential new medicines from the Company including two plenary presentations, one special late-breaking oral abstract session and 19 additional oral presentations. Highlights include:

SERENA-6 Phase III trial of camizestrant in combination with widely approved cyclin-dependent kinase (CDK) 4/6 inhibitors in the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumours have an emergent ESR1 mutation (Plenary #LBA4). Camizestrant is an investigational, next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist. This is the first positive Phase III trial for a next-generation oral SERD in this 1st-line setting and the first positive Phase III trial for camizestrant.
MATTERHORN Phase III trial of perioperative Imfinzi (durvalumab) plus FLOT chemotherapy in patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers (Plenary #LBA5).
DESTINY-Breast09 Phase III trial of Enhertu (trastuzumab deruxtecan) in combination with pertuzumab in the 1st-line treatment of patients with HER2-positive metastatic breast cancer (Oral Abstract #LBA1008).
DESTINY-Gastric04 Phase III trial of Enhertu in patients with 2nd-line HER2-positive unresectable and/or metastatic gastric and GEJ cancers (#LBA4002).
NeoADAURA Phase III trial of neoadjuvant Tagrisso (osimertinib) with or without chemotherapy in resectable, early-stage EGFR-mutated non-small cell lung cancer (NSCLC) (Oral Abstract #8001).
TROPION-Lung02: Computational pathology biomarker analyses of the TROPION-Lung02 Phase Ib trial of Datroway (datopotamab deruxtecan) plus pembrolizumab with or without platinum chemotherapy as 1st-line treatment for patients with advanced NSCLC without actionable genomic alterations (Oral Abstract #8501).
KOMET Phase III trial of Koselugo (selumetinib) in adults with neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas (Rapid Oral Abstract #3014).
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "Two key breast cancer presentations at ASCO (Free ASCO Whitepaper) will highlight the progress we are making with our innovative medicines and pipeline to change the treatment landscape. For camizestrant, SERENA-6 is the first pivotal Phase III trial to use circulating tumour DNA to inform a treatment switch, pioneering this technology in the first-line setting to delay disease progression in HR-positive, HER2-negative advanced breast cancer. In addition, DESTINY-Breast09 for Enhertu in combination with pertuzumab is the first trial in more than a decade to demonstrate superiority over first-line standard of care across a broad HER2-positive metastatic patient population."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "The MATTERHORN data for perioperative Imfinzi in gastric and gastroesophageal junction cancers are a further example of our successful strategy to move immunotherapy into early stages of cancer where cure is the treatment goal. This is the seventh consecutive year AstraZeneca medicines will be featured in an ASCO (Free ASCO Whitepaper) plenary session, an extraordinary milestone which underscores the strength of our industry-leading oncology portfolio and pipeline across many types of cancer."

AstraZeneca is collaborating with Daiichi Sankyo Company Limited to develop and commercialise Enhertu and Datroway, with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Koselugo (selumetinib), and with HUTCHMED to develop and commercialise Orpathys (savolitinib).

Key AstraZeneca presentations during ASCO (Free ASCO Whitepaper) 20251

Lead Author

Abstract Title

Presentation details (CDT)

Antibody drug conjugates

Shitara, K

Trastuzumab deruxtecan (T-DXd) vs ramucirumab (RAM) + paclitaxel (PTX) in second-line treatment of patients (pts) with human epidermal growth factor receptor 2-positive (HER2+) unresectable/metastatic gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJA): Primary analysis of the randomized, phase 3 DESTINY-Gastric04 study.

Abstract #LBA4002

Oral Abstract Session

31 May 2025

3:24pm

Tolaney, SM

Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for first-line (1L) treatment of patients (pts) with human epidermal growth factor receptor 2–positive (HER2+) advanced/metastatic breast cancer (a/mBC): Interim results from DESTINY-Breast09.

Abstract #LBA1008

Oral Abstract Session

2 June 2025

7:30am

Dent, R

Exploratory biomarker analysis of trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy (TPC) in HER2-low/-ultralow, hormone receptor-positive (HR+) metastatic breast cancer (mBC) in DESTINY-Breast06 (DB-06).

Abstract #1013

Oral Abstract Session

31 May 2025

3:23pm

Levy, BP

TROPION-Lung02: Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab (pembro) with or without platinum chemotherapy (Pt-CT) as first-line (1L) therapy for advanced non-small cell lung cancer (aNSCLC).

Abstract #8501

Oral Abstract Session

1 June 2025

8:12am

Waqar, SN

First-line (1L) datopotamab deruxtecan (Dato-DXd) + rilvegostomig in advanced or metastatic non-small cell lung cancer (a/mNSCLC): Results from TROPION-Lung04 (cohort 5).

Abstract #8521

Poster Session

31 May 2025

1:30pm

Tumour drivers and resistance

Turner, NC

Camizestrant + CDK4/6 inhibitor (CDK4/6i) for the treatment of emergent ESR1 mutations during first-line (1L) endocrine-based therapy (ET) and ahead of disease progression in patients (pts) with HR+/HER2– advanced breast cancer (ABC): Phase 3, double-blind ctDNA-guided SERENA-6 trial.

Abstract #LBA4

Plenary Session

1 June 2025

2:41pm

Lu, S

Savolitinib (Savo) combined with osimertinib (osi) versus chemotherapy (chemo) in EGFR-mutant (EGFRm) and MET-amplification (METamp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI): Results from a randomized phase 3 SACHI study.

Abstract #LBA8505

Oral Abstract Session

1 June 2025

9:48am

Levy, BP

Efficacy and CNS results from a randomized subset of the phase 2 SAVANNAH study comparing savolitinib (savo) + osimertinib (osi) combination with savo + placebo (PBO).

Abstract #8513

Rapid Oral Abstract Session

2 June 2025

8:06am

Chaft JE

Neoadjuvant (neoadj) osimertinib (osi) ± chemotherapy (CT) vs CT alone in resectable (R) epidermal growth factor receptor-mutated (EGFRm) NSCLC: NeoADAURA.

Abstract #8001

Oral Abstract Session

2 June 2025

3:12pm

Immuno-oncology & bispecifics

Janjigian, YY

Event-free survival in MATTERHORN: a randomized, phase 3 study of durvalumab plus 5-fluorouracil, leucovorin, oxaliplatin, and docetaxel chemotherapy (FLOT) in resectable gastric/gastroesophageal junction cancer (GC/GEJC).

Abstract #LBA5

Plenary Session

1 June 2025

3:13pm

Powles, T

Circulating tumor DNA (ctDNA) in patients with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA

Abstract #4503

Oral Abstract Session

1 June 2025

10:45am

Reck, M

Associations of post-surgical MRD status with neoadjuvant ctDNA dynamics, genomic mutations, and clinical outcomes in patients with resectable NSCLC (R-NSCLC) from the phase 3 AEGEAN trial.

Abstract #8009

Rapid Oral Abstract Session

1 June 2025

4:30pm

Barbie, DA

Clinical and molecular characteristics of early progressors (EPs) and long-term progression-free survivors (LTPs) from the phase 3 ADRIATIC trial of consolidation durvalumab (D) vs placebo (P) after concurrent chemoradiotherapy (cCRT) in limited-stage small-cell lung cancer (LS-SCLC).

Abstract #8014

Rapid Oral Abstract Session

1 June 2025

5:12pm

Mayadev, J

Ultrasensitive detection and tracking of circulating tumor DNA (ctDNA) and association with relapse and survival in locally advanced cervical cancer (LACC): Phase 3 CALLA trial analyses.

Abstract #5502

Oral Abstract Session

2 June 2025

8:48am

Westin, SN

Durvalumab plus carboplatin/paclitaxel followed by durvalumab with or without olaparib as first-line treatment for endometrial cancer: Longitudinal changes in circulating tumor DNA.

Abstract #5512

Rapid Oral Abstract Session

3 June 2025

8:30am

Erinjeri, JP

Outcomes by baseline tumor burden using the 6-and-12 score in EMERALD-1: a phase 3 study of durvalumab (D) ± bevacizumab (B) with transarterial chemoembolization (TACE) in embolization-eligible unresectable hepatocellular carcinoma (uHCC).

Abstract #4083
Poster Session

31 May 2025

9:00am

Cascone, T

Neoadjuvant durvalumab (D) + chemotherapy (CT) + novel anticancer agents and adjuvant D ± novel agents in resectable non-small-cell lung cancer (NSCLC): Updated outcomes from NeoCOAST-2.

Abstract #8046

Poster Session

31 May 2025

1:30pm

Zhou, J

First-line rilvegostomig (rilve) plus chemotherapy (CTx) in advanced biliary tract cancer (BTC): Primary analysis of GEMINI-Hepatobiliary substudy 2 Cohort A.

Abstract #4080

Poster Session

31 May 2025

9:00am

Xu, R

ARTEMIDE-Gastric01: a phase 3 randomized study of rilvegostomig with fluoropyrimidine and trastuzumab deruxtecan (T-DXd) as first-line (1L) treatment for locally advanced or metastatic HER2-positive gastric or gastroesophageal junction cancer (GC/GEJC).

Abstract #TPS4204

Poster Session

31 May 2025

9:00am

Mathias, C

ARTEMIDE-Lung03: a phase 3, randomized, double-blind, multicenter, global study of rilvegostomig or pembrolizumab in combination with platinum-based chemotherapy as first-line treatment for patients with metastatic non-squamous non-small-cell lung cancer whose tumors express PD-L1.

Abstract #TPS8653

Poster Session

31 May 2025

1:30pm

Cell therapy

Yoo, C

RHEA-1: First-in-human (FIH) study of AZD9793, a first-in-class CD8-guided T cell-engager (TCE) for glypican-3-positive (GPC3+) advanced or metastatic hepatocellular carcinoma (HCC).

Abstract #TPS4215

Poster Session

31 May 2025

9:00am

Kim, TM

Safety and Efficacy of AZD0486, a CD19xCD3 T-cell Engager, in Relapsed or Refractory Diffuse Large B-cell Lymphoma.

Abstract #7046
Poster Session

1 June 2025

9:00am

Shadman, M

TITANium: An open-label, global multicenter Phase 1/2 study of AZD5492, a first-in-class subcutaneous CD8-guided tri-specific T-cell engager (TCE), in patients (pts) with relapsed or refractory (r/r) B-cell malignancies.

Abstract #TPS7091

Poster Session

1 June 2025

9:00am

Le Gouill, S

SOUNDTRACK-E: A Phase 1/2 Open-label Multicenter Study to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or Combination Therapy in Patients With Mature B-cell Malignancies.

Abstract #TPS7083

Poster Session

1 June 2025

9:00am

Rare disease medicines

Chen, AP

Efficacy and safety of selumetinib in adults with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibroma (PN): Primary analysis of KOMET (NCT04924608), a Phase 3, international, randomized, placebo-controlled study.

Abstract #3014

Rapid Oral Abstract Session

2 June 2025

8:00am

On May 21, 2025 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the "Company"), a late-clinical stage biotechnology company pioneering nanotherapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, reported an update on operational progress and announced financial results for the first quarter of 2025 (Press release, Nanobiotix, MAY 21, 2025, View Source [SID1234653271]).

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"We are pleased with the execution across the JNJ-1900 (NBTXR3) development programs and are excited for the important milestones ahead. NANORAY-312 continues to advance in head and neck cancer, with our ongoing global transfer of sponsorship moving toward completion, and the recent expansion of development into lung cancer through the CONVERGE study. We were also pleased by the updated clinical data further supporting expansion into indications including lung cancer amenable to re-irradiation recently presented by MD Anderson at ESTRO and ELCC, respectively and locally advanced or borderline resectable pancreatic cancer," said Laurent Levy, co-founder of Nanobiotix and chairman of the executive board.

Operational Highlights

Ongoing Randomized Phase 2 Study in Unresectable Stage 3 NSCLC (CONVERGE)
First patient dosed in the Johnson & Johnson-sponsored Phase 2 randomized CONVERGE study evaluating JNJ-1900 (NBTXR3) for patients with unresectable stage 3 non-small cell lung cancer ("NSCLC") in 1Q2025
NSCLC Amenable to Re-irradiation (Phase 1 Study MDA 2020-0123 sponsored by MD Anderson)
Presented first data showing a favorable safety profile and early signals of efficacy from the completed dose escalation part of a Phase 1 study evaluating radiotherapy-activated JNJ-1900 (NBTXR3) as a second or later line (2L+) therapy at the 2025 European Lung Cancer Conference (ELCC).
Amendment to global licensing agreement for JNJ-1900 (NBTXR3) extended cash runway to mid-2026 with a meaningful reduction in cash burn expected moving forward
Removed the vast majority of the funding obligation for NANORAY-312 and released Johnson & Johnson from select future potential milestone payments, while safeguarding hundreds of millions in potential milestone and royalty payments for lead programs for Nanobiotix
Subsequent events

Locally Advanced or Borderline Resectable Pancreatic Cancer (Phase 1 Study MDA 2019-1001 sponsored by The University of Texas MD Anderson Cancer Center ("MD Anderson"))
Presented full results from the completed dose escalation and dose expansion parts of a Phase 1 study evaluating JNJ-1900 (NBTXR3) demonstrating encouraging oncologic outcomes and a favorable safety profile supporting further exploration in a randomized study at the 2025 Annual Meeting of the European Society for Radiotherapy and Oncology (ESTRO 2025)
Recruitment ongoing in new cohort evaluating JNJ-1900 (NBTXR3) combined with standard-of-care chemotherapy followed by concurrent chemoradiation ("CCRT" – with capecitabine or 5-FU) with first patient already injected
First Quarter Financial Updates

Cash and Cash Equivalents: based on the current operating plan and financial projections, Nanobiotix anticipates that the cash and cash equivalents of €39.8 million as of March 31, 2025, will fund its operations into mid-2026.

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company.

On May 21, 2025 CEL-SCI Corporation ("CEL-SCI" or the "Company") (NYSE American: CVM), a clinical stage cancer immunotherapy company, reported that it intends to offer to sell shares of its common stock (and/or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof) in an underwritten public offering (Press release, Cel-Sci, MAY 21, 2025, View Source [SID1234653286]). All of the shares of common stock (and/or Pre-Funded Warrants) are being offered by the Company. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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The Company intends to use the net proceeds from this offering to fund the continued development of Multikine*, for general corporate purposes, and working capital.

ThinkEquity is acting as sole book-running manager for the offering.

The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-265995), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on July 1, 2022 and declared effective on July 15, 2022. The offering will be made only by means of a written prospectus. A preliminary prospectus supplement and accompanying base prospectus describing the terms of the offering has been or will be filed with the SEC on its website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying base prospectus relating to the offering may also be obtained from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. Before investing in this offering, interested parties should read in their entirety the preliminary prospectus supplement and the accompanying base prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such preliminary prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.