On July 29, 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 be attending the Canaccord Genuity 45th Annual Growth Conference on Tuesday, August 12, 2025 at The InterContinental Boston in Boston, MA (Press release, Delcath Systems, JUL 29, 2025, View Source [SID1234654595]).

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On July 29, 2025 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported financial results for the second quarter ended June 30, 2025, and provided a business update (Press release, Cardiff Oncology, JUL 29, 2025, View Source [SID1234654594]).

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"In the second quarter, we achieved an important milestone by completing enrollment in our ongoing CRDF-004 trial evaluating onvansertib plus standard of care for the treatment of first-line RAS-mutated mCRC," said Mark Erlander, Chief Executive Officer of Cardiff Oncology. "As we evolve into a late-stage clinical development company, we were excited to appoint Dr. Sidhu as our new Chief Medical Officer to provide expert guidance in advancing onvansertib through the registrational phase of development. We’re pleased to welcome him to the team and are confident that his expertise will be instrumental as we work toward bringing this potential therapy to patients."

Conference Call and Webcast on Clinical Data from Ongoing CRDF-004 Trial in mCRC

Cardiff Oncology will host a live conference call and webcast at 4:30 p.m. ET/1:30 p.m. PT on July 29, 2025 to share clinical data from the ongoing CRDF-004 trial in first-line RAS-mutated mCRC. Individuals interested in listening to the live conference call may do so by using the webcast link in the "Investors" section of the company’s website at View Source A replay will be available in the investor relations section on the company’s website following the completion of the call.

Company highlights for the quarter ended June 30, 2025, and subsequent weeks include:

•
Appointed Dr. Roger Sidhu as Chief Medical Officer
o
In June 2025, the company appointed Roger Sidhu, MD, as Chief Medical Officer. Dr. Sidhu is a veteran executive and clinician with over 20 years of experience and a strong track record of success in oncology research, development, and regulatory strategy.

•
Announced positive data from investigator-initiated trial of onvansertib in combination with paclitaxel in metastatic triple negative breast cancer (mTNBC) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2025
o
The Phase 1b study of onvansertib in combination with paclitaxel in mTNBC was led by Antonio Giordano, MD, PhD at Dana-Farber Cancer Institute, a principal teaching affiliate of Harvard Medical School. Onvansertib in combination with paclitaxel demonstrated a 40% objective response rate (ORR) by RECIST 1.1 at RP2D of 18mg/m2 (n=10), with two confirmed partial responses and two unconfirmed partial responses. The combination was well-tolerated and demonstrated a safe and manageable toxicity profile with myelosuppression being the most common adverse event. Overall, this clinical data further supports the potential exploration of the combination of onvansertib plus paclitaxel for the treatment of mTNBC.
•
Announced a second patent issuance from the United States Patent and Trademark Office (USPTO) for the treatment of mCRC for bev-naïve patients
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U.S. patent No. 12,263,173 has an expiration date of no earlier than 2043. The claims of the new patent cover the method of using onvansertib in combination with bev in any line of therapy for the treatment of mCRC patients who have not previously been treated with bev. The newly issued patent encompasses all mCRC patients, with RAS-mutated or RAS wild-type mCRC.
•
Announced completion of enrollment in Phase 2, randomized, CRDF-004 trial evaluating onvansertib + standard of care (SoC) for the treatment of first-line RAS-mutated mCRC
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The Phase 2 CRDF-004 trial reached the targeted enrollment of patients with first-line mCRC across 41 clinical sites in the U.S. The Company is holding a conference call today to share an update on the ongoing trial.

Second Quarter 2025 Financial Results:

Liquidity, cash burn, and cash runway

As of June 30, 2025, Cardiff Oncology had approximately $71.0 million in cash, cash equivalents, and short-term investments.

Net cash used in operating activities for the second quarter of 2025 was approximately $8.3 million, a decrease of $0.9 million from $9.2 million for the same period in 2024.

Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations into Q1 2027.

Operating results

Total operating expenses were approximately $14.9 million for the three months ended, June 30, 2025, an increase of $2.2 million from $12.7 million for the same period in 2024. The increase in operating expenses was primarily due to costs associated with our CRDF-004 clinical trial, other clinical programs and outside service costs related to the development of our lead drug candidate, onvansertib, as well as salaries and wages for key hires and additional stock option grants.

On July 29, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) (the "Company"), reported the pricing of a public offering of an aggregate of 2,000,000 shares of its common stock (or pre-funded warrants in lieu thereof), Class E warrants to purchase up to 2,000,000 shares of common stock, and Class F warrants to purchase up to 2,000,000 shares of common stock, at a combined public offering price of $4.00 per share (or $3.999 per pre-funded warrant) and accompanying warrants (Press release, AIM ImmunoTech, JUL 29, 2025, View Source [SID1234654593]). The warrants will have an exercise price of $4.00 per share, will be exercisable immediately upon issuance. The Class E warrants will expire on the fifth anniversary of the original issuance date, and the Class F warrants will expire on the eighteen-month anniversary of the original issuance date. The closing of the offering is expected to occur on or about July 30, 2025, subject to the satisfaction of customary closing conditions. Gross proceeds, before deducting placement agent fees and offering expenses, are expected to be approximately $8.0 million.

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Maxim Group LLC is acting as sole placement agent in connection with this offering.

The securities described above are being offered pursuant to a registration statement on Form S-1, as amended (File No. 333-284443) (the "Registration Statement"), which was declared effective by the Securities and Exchange Commission (the "SEC") on July 28, 2025. The offering is being made only by means of a prospectus which is a part of the effective Registration Statement. A preliminary prospectus relating to the offering has been filed with the SEC. Copies of the final prospectus relating to this offering, when available, will be filed with the SEC and may be obtained from Maxim Group LLC, 300 Park Avenue, 16th Floor, New York, NY 10022, at (212) 895-3745.

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

On July 29, 2025 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that its in-house discovered tyrosine kinase inhibitor, "LENVIMA" (generic name: lenvatinib mesylate), in combination with the anti-PD-1 antibody, pembrolizumab, and transarterial chemoembolization (TACE) has been approved by the National Medical Products Administration (NMPA) of China for unresectable, non-metastatic hepatocellular carcinoma (Press release, Eisai, JUL 29, 2025, View Source [SID1234654572]).

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This approval is based on interim analysis results from the pivotal Phase III LEAP-012 trial. The results of this trial were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress 2024 held in September 20241 and published in The Lancet in January 2025.2 In this trial, LENVIMA in combination with pembrolizumab and TACE (the "combination therapy") demonstrated a statistically significant and clinically meaningful improvement in one of the trial’s primary endpoints, progression-free survival (PFS), reducing the risk of disease progression or death by 34% (Hazard Ratio [HR]=0.66 [95% Confidence Interval (CI), 0.51-0.84]; p=0.0002) compared to TACE alone*.2 Median PFS was 14.6 months(95% CI, 12.6-16.7) in the combination therapy and 10.0 months (95% CI, 8.1-12.2) in TACE alone. 2 At this analysis, a trend toward improvement in overall survival (OS), the trial’s other primary endpoint, was observed for the combination therapy versus TACE alone (HR=0.80 [95% CI, 0.57-1.11]; p=0.087). 2

237 patients received the combination therapy and 241 patients received TACE alone.2 Treatment Emergent Adverse Events (TEAEs) occurred in 99.6% (n=236) of patients receiving the combination therapy versus 96.7% (n=233) of patients receiving TACE alone and led to the discontinuation of both study drugs in 13.1% (n=31) versus 4.1% (n=10) of patients, respectively.2 Grade 3, 4, or 5 TEAEs occurred in 82.3% (n=195) of patients receiving the combination therapy versus 47.7% (n=115) for TACE alone and TEAEs led to death in 4.2% (n=10) versus 2.5% (n=6) of patients, respectively.2

Liver cancer is one of the leading causes of cancer-related deaths worldwide.3 In 2022, it was estimated there were more than 865,000 new cases globally and 367,000 in China, with more than 757,000 deaths worldwide, including 316,000 in China.3,4 China is estimated to account for more than 40% of global new cases and deaths.3,4 Hepatocellular carcinoma (HCC) is the most common type of liver cancer, representing approximately 90% of primary liver cancer cases.5 TACE has been a standard of care for patients with unresectable, non-metastatic HCC for many years. However, since many patients experience disease progression within one year6,7,8,9, new treatment options have been sought.

LENVIMA monotherapy has been approved for the treatment of patients with unresectable HCC in more than 80 countries, including in Japan, the U.S., Europe and China and has made contributions to many patients to date. With this approval, it is expected that LENVIMA will further expand its contribution to patients with hepatocellular carcinoma in China.

Eisai positions oncology as a key therapeutic area and is aiming to discover innovative new medicines with the potential to cure cancer. Eisai is committed to expanding the potential clinical benefits of lenvatinib for cancer treatment, as it seeks to contribute to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families and healthcare professionals.

In March 2018, Eisai and Merck & Co., Inc., Rahway, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.

*TACE alone: In addition to TACE, oral placebo and intravenous placebo corresponding to LENVIMA and pembrolizumab were administered.

On July 28, 2025 Deciphera Pharmaceuticals, LLC, a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines, and Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "Ono"), reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of vimseltinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability (Press release, Deciphera Pharmaceuticals, JUL 28, 2025, View Source [SID1234654587]).

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The positive CHMP opinion is a scientific recommendation for marketing authorization and one of the final steps before the European Commission (EC), which has the authority to approve medicines in the European Union (EU), issues a decision on Deciphera’s marketing authorization application (MAA) for vimseltinib. This decision is expected in the second quarter of the fiscal year ending March 31, 2026.

"CHMP’s positive opinion is an important milestone for the TGCT community in the European Union (EU), where there are currently no approved treatments for TGCT, and for vimseltinib, which is now one step closer to potential EU regulatory approval," said Ryota Udagawa, President and Chief Executive Officer of Deciphera. "We look forward to building upon vimseltinib’s positive CHMP opinion as we work to bring this medicine to TGCT patients around the world in need of new treatment options."

The positive CHMP opinion is supported by compelling efficacy and safety results from the pivotal Phase 3 MOTION study of vimseltinib in patients with TGCT not amenable to surgery with no prior anti-CSF1/CSF1R therapy (prior therapy with imatinib or nilotinib allowed), compared to placebo, as well as the Phase 1/2 study of vimseltinib. In MOTION, vimseltinib demonstrated a statistically significant and clinically meaningful objective response rate (ORR) at Week 25 in the intent-to-treat (ITT) population, as assessed by blinded independent radiologic review (BIRR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), versus placebo (40% in vimseltinib arm vs 0% in placebo arm, p <0.0001). The primary endpoint was supported by statistically significant and clinically meaningful improvements in active range of motion, patient-reported physical functioning, and patient-reported pain observed in the vimseltinib arm compared to the placebo arm at week 25. The safety profile of vimseltinib is manageable and consistent with results previously disclosed in the Phase 1/2 clinical trial.

About vimseltinib

Vimseltinib is an oral switch-control tyrosine kinase inhibitor specifically designed to selectively and potently inhibit CSF1R. Vimseltinib has been developed using Deciphera’s proprietary switch-control kinase inhibitor platform. ROMVIMZA (vimseltinib) is a kinase inhibitor approved in the United States for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.

About Tenosynovial Giant Cell Tumor (TGCT)

TGCT is caused by a translocation in colony-stimulating factor 1 (CSF1) gene resulting in overexpression of CSF1 and recruitment of colony-stimulating factor 1 receptor (CSF1R)-positive inflammatory cells into the lesion. TGCT is a rare, non-malignant tumor that develops inside or near joints. TGCT is caused by dysregulation of the CSF1 gene leading to overproduction of CSF1. TGCT is also known as giant cell tumor of the tendon sheath (GCT-TS) or pigmented villonodular synovitis (PVNS), a diffuse-type of TGCT. TGCT is a locally aggressive neoplasm that can grow and cause damage to surrounding tissues and structures inducing pain, swelling, and limitation of movement of the joint. Surgery is the main treatment option; however, these tumors tend to recur, particularly in diffuse-type TGCT. If untreated or if the tumor continually recurs, damage and degeneration may occur in the affected joint and surrounding tissues, which may cause significant disability. For a subset of patients, surgical resection will potentially cause worsening functional limitation or severe morbidity, systemic treatment options are limited and a new therapeutic option for TGCT is needed.