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.

On February 18, 2025 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company," or "Plus Therapeutics"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported that it has closed a private placement with aggregate initial upfront proceeds of approximately $3.7 million and received a $2.0 million advance payment from CPRIT as part of its existing $17.6 million grant award (Press release, Plus Therapeutics, FEB 18, 2025, View Source [SID1234650348]). The funding from the private placement and the CPRIT advance will support the Company’s clinical development of Rhenium (186Re) Obisbemeda for leptomeningeal metastases (LM), as well as further development of the Company’s CNSide LM diagnostic test as a pivotal trial endpoint.

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"We are grateful for the enthusiasm and ongoing support from both existing investors and key funding agencies, including CPRIT, the National Institutes of Health, and the U.S. Department of Defense," said Marc H. Hedrick, M.D., Plus Therapeutics’ President and Chief Executive Officer. "This capital, along with expected grant allocations later in 2025, is expected to fully support the completion of two planned LM trials, strategically positioning the company for a pivotal trial in 2026."

Private Placement Financing

The private placement comprised the issuance and sale of secured convertible promissory notes, or Funding Notes, in the aggregate amount of $3,362,251 and common stock purchase warrants to purchase up to an aggregate of 3,002,009 shares of the Company common stock at an exercise price of $1.12 per share. The notes have a maturity date of one year from the closing of the financing and are convertible in future financings of the Company or into common stock at the election of the investors. The financing includes participation from AIGH Capital Management LLC with additional participation from existing healthcare-focused institutional investors.

The accompanying Warrants will be exercisable until the five-year anniversary of the closing of the financing.

The Notes are convertible, under certain circumstances, to shares of common stock of the Company at an exercise price of $1.12 per share. The Notes are senior, secured obligations of the Company. The Notes bear interest at the rate of ten percent (10%) per annum, payable on the last business day of each quarter, except as provided therein.

The gross proceeds to the Company from the private placement were approximately $3.7 million, before deducting offering expenses payable by the Company. The Company currently intends to use the net proceeds from the private placement for general corporate and working capital purposes.

The securities offered in the private placement and described above were offered in transactions not involving a public offering under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and/or Rule 506(b) of Regulation D promulgated thereunder and have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities in the private placement may not be reoffered or resold in the United States except pursuant to an effective registration statement with the SEC or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

CPRIT Funding Advance

In addition to the $3.7 million private placement financing from existing investors, the Company announced a $2.0 million advance payment from CPRIT as part of its existing $17.6 million grant award. The funding will support and accelerate the Company’s clinical development of Rhenium (186Re) Obisbemeda for the ReSPECT-LM P2a single-dose expansion trial and further develop the Company’s CNSide LM diagnostic test as a key pivotal trial endpoint.

To date, the Company has received multiple disbursements under its CPRIT grant. Following this $2.0 million advance payment, approximately $5.2 million remains from the original $17.6 million grant award.

Exchange and Financing Waiver

On February 13, 2025, the Company also issued secured convertible promissory notes, or Exchange Notes, in the aggregate amount of $3,188,922 in exchange for existing investors agreeing to cancel 3,543,247 Series A common stock purchase warrants issued by the Company in May 2024 and waive certain existing restrictions on the Company’s ability to raise capital. The terms of the Exchange Notes are substantially similar to the terms of the Funding Notes.

Additional information on the terms of the Funding Notes, Warrants, Exchange Notes and related matters can be found in the Company’s Current Report on Form 8-K that is being filed by the Company on February 18, 2025.

About Leptomeningeal Metastases (LM)

LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.

About Rhenium (186Re) obisbemeda

Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. Rhenium (186Re) obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT).

On February 18, 2025 Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics, Triclonics and ADClonics), for cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to petosemtamab in combination with pembrolizumab for the first-line treatment of adult patients with recurrent or metastatic programmed death-ligand 1 (PD-L1) positive head and neck squamous cell carcinoma (r/m HNSCC) with combined positive score (CPS) ≥ 1 (Press release, Merus, FEB 18, 2025, View Source [SID1234650347]).

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This second BTD designation follows the initial receipt of BTD and Fast Track designation for petosemtamab for the treatment of patients with r/m HNSCC whose disease has progressed following treatment with platinum-based chemotherapy and an anti-programmed cell death protein 1 (anti-PD-1) antibody announced in May 2024 and August 2023, respectively.

BTD is supported by updated data from the ongoing phase 1/2 open-label, multicenter trial evaluating petosemtamab in combination with pembrolizumab in 1L HNSCC expressing PD-L1 (CPS≥1) (NCT03526835). Data for this cohort was initially presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2024, which demonstrated a 67% response rate among 24 evaluable patients. The oral presentation was detailed in our press release, Merus’ Petosemtamab in Combination with Pembrolizumab Interim Data Demonstrates Robust Response Rate and Favorable Safety Profile in 1L r/m HNSCC (May 28, 2024). In the BTD application, Merus provided updated interim clinical data on efficacy, durability and safety of the cohort of petosemtamab with pembrolizumab in 1L PD-L1+ r/m HNSCC.

"We believe petosemtamab’s second BTD continues to validate its potential to become a new standard of care for patients with r/m HNSCC and underscores our commitment to accelerate development of petosemtamab for these patients," said Fabian Zohren, M.D., Ph.D., Chief Medical Officer of Merus. "Importantly, this designation indicates the interim clinical data we shared with the FDA demonstrates petosemtamab’s potential for substantial improvement over available therapies in the 1L PD-L1+ setting."

BTD is intended to expedite the development and review of a medicine to treat a serious or life-threatening condition, where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on clinically significant endpoints over available therapies. BTD allows for more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review, and eligibility for rolling review and priority review. With this BTD, Merus plans to engage in these discussions with the FDA in an expedited manner as we move toward our goal of a potential Biologics License Application (BLA) submission.

About LiGeR-HN1
LiGeR-HN1, a phase 3 trial, will evaluate the safety and efficacy of petosemtamab in combination with pembrolizumab, compared to pembrolizumab in 1L PD-L1+ r/m HNSCC patients. The trial is open to adult patients eligible to receive pembrolizumab as 1L monotherapy with tumors expressing PD-L1, CPS ≥1. The primary endpoints are overall response rate as assessed by BICR based on RECIST v1.1 and overall survival. Secondary endpoints are duration of response and progression free survival. Merus plans to enroll approximately 500 patients in the trial.

About LiGeR-HN2
LiGeR-HN2, a phase 3 trial, will evaluate the safety and efficacy of petosemtamab compared to investigator’s choice of methotrexate, docetaxel, or cetuximab in 2/3L r/m HNSCC patients. The trial is open to adult patients that have progressed on or after anti-PD-1 therapy and platinum-containing therapy. The primary endpoints are overall response rate as assessed by BICR based on RECIST v1.1 and overall survival. Secondary endpoints are duration of response and progression free survival. Merus plans to enroll approximately 500 patients in the trial.

About Head and Neck Cancer
Head and neck squamous cell carcinoma (HNSCC) describes a group of cancers that develop in the squamous cells that line the mucosal surfaces of the mouth, throat, and larynx. These cancers begin when healthy cells change and grow in an unchecked manner, ultimately forming tumors. HNSCC is generally associated with tobacco consumption, alcohol use and/or HPV infections, depending on where they develop geographically. HNSCC is the sixth most common cancer worldwide and it is estimated that there were more than 930,000 new cases and over 465,000 deaths from HNSCC globally in 2020.1 The incidence of HNSCC continues to rise and is anticipated to increase by 30% to more than 1 million new cases annually by 2030.2 HNSCC is a serious and life-threatening disease with poor prognosis despite currently available standard of care therapies.

About Petosemtamab
Petosemtamab, or MCLA-158, is a Biclonics low-fucose human full-length IgG1 antibody targeting the epidermal growth factor receptor (EGFR) and the leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5). Petosemtamab is designed to exhibit three independent mechanisms of action including inhibition of EGFR-dependent signaling, LGR5 binding leading to EGFR internalization and degradation in cancer cells, and enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) activity.

On February 18, 2025 Sonnet BioTherapeutics Holdings, Inc. (the "Company" or "Sonnet") (NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, reported its abstract has been accepted for poster presentation at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) IO Conference taking place on February 23-26, 2025 at the JW Marriott in Los Angeles, CA (Press release, Sonnet BioTherapeutics, FEB 18, 2025, View Source [SID1234650346]).

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Details of the poster presentation are as follows:

Session: Poster Session B
Abstract title: Combination immunotherapy with an albumin-binding interleukin-12 fusion protein that extends cytokine half-life, targets the tumor microenvironment, and enhances therapeutic efficacy
Session Date and Time: Tuesday, February 25, 2025 from 1:45-4:45 PM PT

For more information about the conference, please visit the event website.

On February 18, 2025 Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the "Company"), a clinical-stage biotechnology company pioneering mRNA cell therapies for autoimmune diseases, reported that its management expects to participate in the following investor conferences in February and March (Press release, Cartesian Therapeutics, FEB 18, 2025, View Source [SID1234650345]):

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A fireside chat at the H.C. Wainright & Co. 3rd Annual Cell Therapy Virtual Conference at 1:00 p.m. ET on Tuesday, February 25, 2025
A presentation at the TD Cowen 45th Annual Health Care Conference at 1:50 p.m. ET on Monday, March 3, 2025 in Boston, MA
A fireside chat at the Leerink Global Healthcare Conference at 8:40 a.m. ET on Monday, March 10, 2025 in Miami, FL
A live webcast of the presentation and fireside chats is expected to be accessible in the Events section of the Company’s website at www.cartesiantherapeutics.com, where an archived replay of the events will also be available for a limited time.