On February 18, 2025 CEL-SCI Corporation (NYSE American: CVM) reported financial results for three months ended December 31, 2024, as well as key recent clinical and corporate developments (Press release, Cel-Sci, FEB 18, 2025, View Source [SID1234650353]).

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"CEL-SCI is very uniquely positioned at this moment as an immuno-oncology company with a vast amount of data from the largest Phase 3 head and neck cancer study ever performed, with statistically significant evidence that our drug can successfully fight cancer and extend lives in head and neck cancer," stated CEL-SCI CEO, Geert Kersten. "We hope to deliver a new standard of care to patients while substantially transforming our company’s valuation to reflect what we believe to be the intrinsic value of our cancer drug. The statistical analysis shows that our very soon to be initiated small confirmatory Registration Study has a very high chance of success and we will have indications of efficacy as early as 2026. Should the pre-surgical tumor responses mirror what we saw in the Phase 3 data, we believe we will be on the path for accelerated and/or conditional approval for Multikine next year."

Corporate and Clinical Developments include:

The U.S. FDA concurred with CEL-SCI’s plan to use of PD-L1 as a biomarker to select patients for a Phase 3 confirmatory trial. The study is designed to confirm the observation in our previous head and neck cancer Phase 3 trial that patients with low PD-L1 expression are most likely to have favorable outcomes from Multikine therapy. These patients, when treated with Multikine in the completed Phase 3 study, had a 5-year survival of 73% vs. 45% in the control group with a p-value of 0.0015. PD-L1 is a widely used biomarker for cancer patient selection for checkpoint inhibitors, which appear to work best for patients with high PD-L1 expression. Since Multikine has been shown to be more effective in patients with low PD-L1 expression, Multikine is uniquely positioned to benefit an estimated 70% of head and neck patients who have low PD-L1 expression.
The strong data from our completed Phase 3 study and the biological rationale for the use of Multikine in the treatment of head and neck cancer suggest a high likelihood of success for the confirmatory Registration Study. These data and rationale include:
Multikine shows pre-surgical tumor regression in head and neck cancer in just 3 weeks – confirmed by pathology at surgery:
Multikine led to significant rates of tumor regression prior to surgery.
There was no tumor regression observed in the control group that did not receive Multikine.
Pre-surgical tumor regressions confirmed at surgery forecast survival benefit.
The patient population for the Registration Study is likely to show significant survival prolongation.
Phase 3 Registration Study patient population selection is based on:
Strong statistical significance with respect to overall survival vs controls in 114 patients in the Phase 3 study.
Analysis of the patients in this group was pre-defined in the statistical analysis plan (SAP).
Strong biological rationale for the results seen in these patients based on Multikine’s mechanism of action (MOA) which brings about a strong and sustainable immune response and does not require overcoming PD-L1 blockade.
Ergomed, a clinical research organization (CRO) with a strong track record of fast enrollment and high-quality study delivery, is selected as the CRO for CEL-SCI’s confirmatory Registration Study. Ergomed has been a strategic partner and collaborator with CEL-SCI for over 10 years and was instrumental in successfully completing the prior Phase 3 study.
Financial Results

During the three months ended December 31, 2024, research and development expenses were $4.4 million, approximately the same as the three months ended December 31, 2023. General and administrative expenses for the first quarter of fiscal 2025 were $2.5 million compared to $2.1 million in the first quarter of fiscal 2023. Net loss was $7.1 million for three months ended December 31, 2024 compared to $6.7 million in the prior year period. Cash spent during the quarter was $5.1 million. Net loss per common share narrowed by 21% to $0.11 for the three months ended December 31, 2024, compared to $0.14 for the three months ended December 31, 2023.

On February 18, 2025 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported that it has entered into definitive agreements for the purchase and sale of an aggregate of 1,810,000 shares of common stock at a purchase price of $1.50 per share, in a private placement to accredited investors and certain Company directors (Press release, MAIA Biotechnology, FEB 18, 2025, View Source [SID1234650352]). Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $1.87 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing one year following issuance and have a term of six years from the initial issuance date. The securities being sold to the Company director participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about February 20, 2025, subject to the satisfaction of customary closing conditions.

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The gross proceeds from the offering are expected to be $2,715,000, prior to offering expenses payable by the Company. The Company intends to use the net proceeds received from the private placement to fund the starting cost for Part C of the Phase II trial THIO -101 and for working capital.

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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 February 18, 2025 Aadi Bioscience, Inc. (NASDAQ: AADI) reported the appointment of David Dornan, PhD as the Company’s Chief Scientific Officer (CSO) (Press release, Aadi Bioscience, FEB 18, 2025, View Source [SID1234650351]). Dr. Dornan contributes more than two decades of experience in oncology drug discovery and development, with deep expertise in antibody-drug conjugates (ADCs) and other targeted cancer therapies.

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"David’s extensive experience in ADC development and track record of translating novel oncology discoveries into clinical programs make him an ideal leader as we seek to rapidly advance our newly in-licensed ADC portfolio," said David Lennon, PhD, President and CEO of Aadi Bioscience. "We are thrilled to welcome David to our growing ADC-experienced team, which also boasts board members from leading ADC companies, Behzad Aghazedeh, former CEO and Executive Chair of Immunomedics, and recently appointed Baiteng Zhao, PhD, co-founder and former Chairman and CEO of ProfoundBio."

Dr. Dornan joins Aadi at a pivotal time as the company implements a new strategic plan, which was first announced in December 2024, including three proposed transactions: the sale of FYARRO and its associated infrastructure to Kaken Pharmaceuticals for $100 million in cash; the in-licensing of a thoughtfully selected, promising portfolio of ADCs from WuXi Biologics; and a $100 million private placement financing to help facilitate the development of these ADC assets. Aadi filed its definitive proxy statement on January 31, 2025, in connection with the Company’s upcoming Special Meeting of Stockholders which is scheduled to be held on February 28, 2025. The proxy statement includes proposals on the sale of FYARRO and the financing.

"The field of ADCs is undergoing a transformation and we believe that Aadi is well-positioned to contribute with a creative tumor-targeting strategy that utilizes a next-generation linker-payload platform," said David Dornan, PhD, CSO of Aadi Bioscience. "What drew me to Aadi wasn’t just its cutting-edge science—it’s the unwavering commitment to translating innovation into real impact for patients. With a pipeline targeting PTK7, MUC16 and SEZ6, we have an opportunity to redefine what is possible in cancer treatment. I’m eager to collaborate with this outstanding team to accelerate the development of therapies that can truly make a difference in patients’ lives."

Dr. Dornan has a successful track record of shepherding drugs from discovery stage through the clinic for advanced modalities, including ADCs, encompassing numerous Initial New Drug (IND), New Drug Application and Biologic License Application filings. Most recently, he served as CSO at Elevation Oncology where he spearheaded the company’s strategic pivot toward a portfolio of ADCs, including the in-licensing and nomination of differentiated ADC assets. As the CSO of Bolt Biotherapeutics he led the cutting-edge research and development of novel immune-stimulating ADCs and immune agonist antibodies that led to multiple INDs and clinical trials. Previously, he was the Director and Head of Oncology Research at Gilead Sciences where he oversaw the identification, validation and translation of oncogenic targets into biologic and small molecule therapeutics. Dr. Dornan began his industry career at Genentech where he spent a decade in roles of increasing responsibility focused on target discovery and validation efforts for numerous tumor antigen targets and ADCs, including POLIVY (polatuzumab vedotin-piiq), an ADC approved by the US Food and Drug Administration for the treatment of diffuse large B-cell lymphoma.

On February 18, 2025 AVEO Oncology, an LG Chem company ("AVEO"), is a biopharmaceutical company that is trying to provide differentiated solutions to improve cancer patients lives, reported two posters during the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) meeting highlighting continued data for tivozanib, a next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) designed to block the VEGF pathway by selectively inhibiting all three VEGF receptors (Press release, AVEO, FEB 18, 2025, View Source [SID1234650350]).

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"Following the TiNivo-2 study results presentation at ESMO (Free ESMO Whitepaper) 2024 and publication in The Lancet, we were excited to share this data with the oncology community at ASCO (Free ASCO Whitepaper) GU 2025," said Michael Bailey, president and Chief Executive Officer. "These data build on the robust clinical evidence for tivozanib generated over different studies that have consistently demonstrated clinical benefit and tolerability in the advanced RCC population."

Poster title: "Integrated efficacy and safety exposure response (ER) analysis of tivozanib (TIVO) for the treatment of renal cell cancer (RCC)." – (Abstract: 461; Poster: D29)

AVEO presented data from an exploratory analysis evaluating the efficacy and safety exposure response relationship of tivozanib from three Phase 3 trials that have been conducted with TIVO: TIVO-1, TIVO-3, and TiNivo-2. The objective of the analysis was to better understand the relationship between tivozanib exposure with progression free survival (PFS), tumor size (TS), and hypertension (HTN) using pharmacokinetic (PK) and exposure response (ER) modeling in metastatic renal cell carcinoma (RCC). The analysis demonstrated a strong correlation between higher exposure of tivozanib and improvements in PFS while the exposure level of both the standard dose of 1.34 mg dose and low dose 0.89 mg of tivozanib was associated with a similar incidence of hypertension.

Poster Title: "Patient-reported outcomes (PROs) for tivozanib (TIVO) + nivolumab (NIVO) vs TIVO monotherapy in patients with renal cell carcinoma (RCC) following an immune checkpoint inhibitor (ICI): results of the phase 3 TiNivo-2 study." – (Abstract: 459; Poster: D27)

AVEO presented a poster with data from an exploratory analysis evaluating patient reported outcomes (PROs) from the TiNivo-2 study. TiNivo-2 is a randomized, Phase 3 trial designed to assess the efficacy and safety of a PD-1 inhibitor combination following disease progression on or after prior PD-1/PD-L1 therapy. While the study did not meet its primary endpoint of demonstrating a benefit of adding nivolumab to tivozanib versus tivozanib alone after prior immune checkpoint inhibitor (ICI) exposure, clinically meaningful outcomes were observed with tivozanib monotherapy (1.34 mg) as a second-line (2L) and third-line (3L) treatment following ICI therapy. The analysis used the Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index-Disease-Related Symptoms (FKSI-DRS) and European Organization for Research and Treatment of Cancer (EORTC) QLQ C30 questionnaires, administered at baseline, day 1 of each cycle, and at the end of treatment, to collect patient outcomes.

The analysis indicated that tivozanib maintained the FKSI-DRS and EORTC QLQ-C30 mean scores over time in both treatment arms. Importantly, in the tivozanib monotherapy arm, the proportion of patients who had improvement in FKSI-DRS and EORTC QLQ-C30 scores was numerically better in patients receiving 2L versus 3L treatment, while the portion of patients with a deterioration was smaller in the 2L than in the 3L.

INDICATIONS
FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
Hypertension was reported in 45% of patients (22% ≥ Grade 3). Hypertensive crises were reported in 0.8% of patients. Do not initiate FOTIVDA in patients with uncontrolled hypertension. Monitor for hypertension and treat as needed. Reduce the FOTIVDA dose for persistent hypertension not controlled by anti-hypertensive medications. Discontinue FOTIVDA for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

Cardiac failures were reported in 1.6% of patients (1% ≥ Grade 3); 0.6% of events were fatal. Monitor for signs or symptoms of cardiac failure during treatment with FOTIVDA. Manage with dose interruption, dose reduction, or discontinuation.

Cardiac ischemia were reported in 3.2% of patients; 0.4% of events were fatal. Arterial thromboembolic events were reported in 2.0% of patients, including death due to ischemic stroke (0.1%). Closely monitor patients at risk for, or who have a history of these events. Discontinue FOTIVDA in patients who develop severe arterial thromboembolic events, such as myocardial infarction and stroke.

Venous Thrombotic Events (VTE) were reported in 2.4% of patients, including 0.3% fatal events. Closely monitor patients who are at increased risk for these events. Discontinue in patients who develop serious VTEs.

Hemorrhagic Events were reported in 11% of patients; 0.2% of events were fatal. Use FOTIVDA with caution in patients who are at risk for or who have a history of bleeding.

Proteinuria was reported in 8% of patients (2% = Grade 3). Monitor during treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or interrupt treatment. Discontinue in patients who develop nephrotic syndrome.

Gastrointestinal (GI) Perforation including fatal cases, has been reported in patients receiving FOTIVDA. Monitor for symptoms of GI perforation or fistula formation periodically throughout treatment with FOTIVDA. Permanently discontinue FOTIVDA in patients who develop severe or life-threatening GI perforation.

Thyroid Dysfunction events were reported in 11% of patients (0.3% ≥ Grade 3). Monitor thyroid function before and during treatment with FOTIVDA.

Wound Healing Complications: Withhold FOTIVDA for at least 24 days prior to elective surgery and do not administer for at least 2 weeks after major surgery and until adequate wound healing is observed.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS) can occur with FOTIVDA. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue if signs or symptoms of RPLS occur.

Embryo-fetal Toxicity: FOTIVDA can cause fetal harm. Advise patients of the potential risk to a fetus, to avoid becoming pregnant and to use contraception during treatment and for one month after the last dose of FOTIVDA. Advise males with female partners of reproductive potential to use effective contraception during treatment and for one month after the last dose of FOTIVDA.

Allergic Reaction to Tartrazine: FOTIVDA 0.89 mg capsule contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.

ADVERSE REACTIONS
Common adverse reactions include fatigue/asthenia, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis.

Serious adverse reactions include bleeding (3.5%), venous thromboembolism (3.5%), arterial thromboembolism (2.9%), acute kidney injury (2.3%), and hepatobiliary disorders (2.3%).

DRUG INTERACTIONS
Avoid coadministration with strong CYP3A4 inducers.

USE IN SPECIFIC POPULATIONS
Advise women not to breastfeed during treatment and for at least 1 month after the last dose.

The recommended dosage for patients with end-stage renal disease has not been established.

Reduce the FOTIVDA dose for patients with moderate hepatic impairment. The recommended dosage in patients with severe hepatic impairment has not been established.

To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for FOTIVDA (tivozanib).

About FOTIVDA (tivozanib)
FOTIVDA (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021, for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies, based on data from the TIVO-3 trial comparing FOTIVDA to sorafenib. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner Recordati UK Ltd. for the treatment of adult patients with advanced RCC. FOTIVDA was discovered by Kyowa Kirin.

On February 18, 2025 Photocure ASA (OSE:PHO) reported Hexvix/Cysview revenues of NOK 128.6 million in the fourth quarter of 2024 (Q4 2023: NOK 114.2 million) and EBITDA of NOK 8.5 million (NOK 29.9 million) (Press release, PhotoCure, FEB 18, 2025, View Source [SID1234650349]). Photocure expects product revenue growth in the range of 7% to 11% and year-over-year EBITDA improvement in 2025. While the company is not providing a specific EBITDA guidance range, Photocure expects continued operating leverage flow-through in its core commercial business and significant growth in milestones this year.

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"We delivered strong performance in the fourth quarter of 2024 with 13% growth in Hexvix/Cysview revenue, 11% unit sales growth, and EBITDA of NOK 8.5 million. For the full-year 2024, we grew product revenue by 10% and generated EBITDA of NOK 49.2 million. We continue to execute on growing our Hexvix/Cysview business and have consistently produced positive EBITDA over the last 7 quarters," says Dan Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 141.7 million in the fourth quarter of 2024 (NOK 142.5 million), and EBITDA* of NOK 8.5 million (Q4 2023: NOK 29.9 million), while Hexvix/Cysview revenues grew to NOK 128.6 million in the quarter (NOK 114.2 million). The EBIT was NOK 1.2 million (NOK 22.5 million) and the cash balance at the end of the period was NOK 293.8 million (NOK 259.5 million).

At the end of the fourth quarter of 2024, the installed base of rigid blue light cystoscopy (BLC) systems in the U.S. was 390, up 11% since the same period in 2023. This includes 18 ForTec Medical mobile towers. Photocure estimates that 25 flexible BLC towers remain in the U.S. market.

During the quarter, Olympus launched its high-definition blue light cystoscopy upgrade for its state-of-the-art Viscera Elite III endoscopic platform, which Photocure believes will increase the use of Hexvix in certain Nordic countries and elsewhere in Europe. Also, subsequently in February, Photocure provided an update from its collaboration with Richard Wolf disclosing that a flexible BLC interim solution is now available in Europe.

"We remain focused on the growth of our business and investing in opportunities that can take Photocure to the next level in 2025. Supporting our expected growth this year, our U.S. business is performing well as we continue to increase the base of active accounts using BLC, and mobile tower adoption is anticipated to outweigh remaining declines in flexible BLC usage. New therapeutics entering the market to treat NMIBC** are expected to continue raising the awareness of precision bladder cancer management and emphasizing the importance of better detection with BLC and Hexvix/Cysview. Additionally, the launch of Olympus’ upgraded BLC equipment in Europe is now underway, and our partnership with Richard Wolf is progressing well with a flexible BLC interim solution available sooner than expected," Schneider adds.

Photocure believes that the benefits of Blue Light Cystoscopy with Hexvix/Cysview offering superior detection and management of bladder cancer will continue to be adopted and become the standard of care. Photocure expects product revenue growth in the range of 7% to 11% and YoY EBITDA improvement in 2025. While the Company is not providing a specific EBITDA guidance range, Photocure expects continued operating leverage flow-through in its core commercial business and significant growth in milestones this year.

"We reported our strongest revenue ever in Q4 2024, and our full year revenue and EBITDA results demonstrate Photocure’s ability to execute through headwinds, generate growth and create significant opportunities for the Company," Schneider concludes.