On 13 November 2024 Photocure ASA (OSE:PHO) reported Hexvix/Cysview revenues of NOK 120.1 million in the third quarter of 2024 (Q3 2023: NOK 107.3 million), and EBITDA of NOK 5.0 million (NOK 3.3 million) for the Company (Press release, PhotoCure, NOV 13, 2024, View Source [SID1234649493]). Photocure reiterates its 2024 financial guidance and continues to expect consolidated product revenue growth of 6% to 9% in constant currency and positive EBITDA excluding business development expenses.

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"We delivered solid performance in the third quarter, generating 12% Hexvix/Cysview revenue growth and NOK 5.0 million in EBITDA. Year-to-date, we have reported 9% growth in product revenues. Our business segments in North American and Europe both generated positive contributions during the quarter, and we made progress on key initiatives that we are pursuing to accelerate our growth going forward," says Dan Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 120.2 million in the third quarter of 2024 (NOK 107.5 million), and EBITDA* of NOK 5.0 million (NOK 3.3 million), driven by revenue growth in North America and Europe. Hexvix/Cysview revenues ended at NOK 120.1 million in the quarter (Q3 2023: NOK 107.3 million). The EBIT was NOK -2.2 million (NOK -3.9 million) and the cash balance at the end of the period was NOK 291.1 million.

At the end of the third quarter of 2024, the installed base of rigid BLC systems in the U.S. was 387, up 13% since Q3 2023. This includes 18 mobile towers owned by ForTec Medical. Photocure estimates that 25 flexible BLC towers remain in the U.S. market. Photocure also entered into a strategic agreement with Richard Wolf GmbH to develop and commercialize a next-generation flexible blue light cystoscope based on Richard Wolf’s system blue technology with the goal to reintroduce and grow the use of BLC with Cysview/Hexvix in the surveillance setting.

"We are also positioning for the future with our Richard Wolf partnership to develop and commercialize a state-of-the-art flexible high-definition blue light system. This partnership is focused on ensuring that physicians and patients have reliable access to high quality BLC equipment in the surveillance setting. The development project is well underway, with the goal to bring a new flexible BLC system to patients globally as soon as possible. Additionally, the Karl Storz’ Citizen’s Petition to have BLC equipment reclassified in the U.S. from Class 3 to Class 2 is another significant opportunity that we continue to monitor and pro-actively support," 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 reiterates its 2024 guidance and continues to expect consolidated product revenue growth of 6% to 9% in constant currency, positive EBITDA excluding business development expenses, and new and upgraded Saphira installations in the U.S. in the range of 55 to 70 towers.

"With our business continuing to show steady growth, industry trends in our favor, and a number of initiatives underway that can enable Hexvix/Cysview to grow faster, I believe that Photocure is well-positioned to deliver value to patients and our shareholders in the coming quarters," Schneider concludes.

On November 13, 2024 CEL-SCI Corporation reported that it recently reached an agreement with Dr. Nabil F. Saba, MD, FACP to serve as the confirmatory global Phase III clinical trial Lead, as a member of the Study Steering Committee, for CEL-SCI’s upcoming confirmatory registration study for Multikine in newly diagnosed head and neck cancer (Press release, Cel-Sci, NOV 13, 2024, View Source [SID1234648263]).

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Dr. Saba is a nationally and internationally recognized expert in head and neck cancer and is professor and vice chair in the Department of Hematology and Medical Oncology at Emory University School of Medicine, and the Inaugural Lynne and Howard Halpern Chair in Head and Neck Cancer Research at Emory University School of Medicine. He holds a joint appointment as professor in the Department of Otolaryngology at Emory University School of Medicine. He serves as director of the Head and Neck Cancer Medical Oncology Program and is co-leader of the Multidisciplinary Head and Neck Program at Winship Cancer Institute of Emory University.

Dr. Saba’s work is focused on translational research and the study and development of novel therapeutic agents and modalities. He has served as principal investigator in more than 50 clinical trials and chairs national as well as investigator initiated multi-institution studies focusing on novel approaches for treating head and neck and esophageal cancer. Dr. Saba has also been instrumental in establishing the head and neck cancer research working group at Winship Cancer Institute and is the contact principal investigator of the Lead Academic Participating Site (LAPS) grant of the NCI’s National Clinical Trials Network (NCTN).

Dr. Saba has been elected for two terms as chair and chair emeritus of the National Cancer Institute’s task force for recurrent metastatic head and neck cancer and chaired the Rare Tumors Task Force of the National Cancer Institute’s Head and Neck Cancer Steering Committee. He is an active member of the NRG Oncology and Eastern Cooperative Oncology Group Head and Neck Cancer Core Committees, and chairs two NCI cooperative group trials in the field of head and neck oncology under the ECOG-ACRIN group. Dr. Saba has received competitive NIH funding investigating novel genomic approaches in HPV related and unrelated OPCA and is the recipient of intramural funding studying this disease. He has published more than 290 peer reviewed manuscripts and textbook chapters and is editor of two textbooks: "Esophageal Cancer: Prevention, Diagnosis and Therapy" published in two editions and "Sino-Nasal and Skull Base Malignancies". He is associate editor of JNCI, and Head Neck and served as a member of the ASCO (Free ASCO Whitepaper) Guidelines Committee.

On November 13, 2024 Pulmatrix ("Pulmatrix") (Nasdaq: PULM), a clinical-stage biopharmaceutical company, reported a merger agreement with Cullgen Inc. ("Cullgen"), a privately-held, clinical-stage biopharmaceutical company applying its proprietary targeted protein degradation uSMITE platform to discover and advance therapeutics for the treatment of cancer and other diseases (Press release, Pulmatrix, NOV 13, 2024, View Source [SID1234648284]). Cullgen utilizes its proprietary technology platform, uSMITE, featuring novel E3 ligands, to build the next generation of targeted protein degraders and degrader-antibody conjugates ("DACs").

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In 2023 Cullgen completed a Series C financing led by AstraZeneca-CICC Venture Capital Partnership, and also announced a strategic partnership with Astellas Pharma Inc.

About the Proposed Transaction

Subject to the terms and conditions of the merger agreement, and upon the closing of the merger, pre-merger Pulmatrix stockholders are expected to own approximately 3.6% of the combined company, and pre-merger Cullgen stockholders are expected to own approximately 96.4% of the combined company which will operate under the name Cullgen Inc., be headquartered in San Diego, CA and trade on The Nasdaq Capital Market (Nasdaq). Pulmatrix stockholders will also receive a special cash dividend to the extent that Pulmatrix’s net cash at closing exceeds $2.5 million, subject to certain adjustments.

The transaction is expected to close by the end of March 2025, subject to obtaining stockholder and CSRC approval.

Management and Board of Directors

At the effective time of the merger, the executive officers of the combined company will be led by Ying Luo, Ph.D. Cullgen’s Chairman and CEO. The Cullgen Board of Directors will be supplemented by one representative of Pulmatrix.

Ying Luo, Ph.D., commented, "I’m delighted to announce this planned merger with Pulmatrix, which comes at a pivotal moment in the evolution of our company as we advance our pipeline of targeted protein degraders into clinical development for cancer and other diseases. Listing on Nasdaq will help fuel our growth and enable us to unlock the full potential of our technology platform, including our plans to develop and advance degrader-antibody conjugates and additional targeted protein degraders into the clinic."

Peter Ludlum, Interim Chief Executive Officer of Pulmatrix, added, "Following a thorough evaluation of strategic alternatives, the Pulmatrix board of directors and management team believe that this anticipated transaction represents an opportunity to deliver value to our stockholders. We anticipate that this merger will allow our stockholders to participate in Cullgen’s promising research and development activities and also provide a benefit in the form of a potential dividend component immediately prior to the close of the merger. Prior to transaction closing, we will attempt to increase cash available for the special dividend by divesting corporate assets including PUR1800, PUR3100, and the patent portfolio for iSPERSE."

Cullgen Pipeline Overview and Development Milestones

Cullgen currently has three degrader programs that are in or about to initiate Phase 1 clinical testing. CG001419 is a first-in-class, selective, clinically active, oral pan-TRK degrader that is being studied in two separate clinical trials—one for solid tumors, and the other for the treatment of acute and chronic pain. With respect to the cancer trial, Cullgen has dosed ten patients thus far with no observed dose-limiting toxicity, treatment-related serious adverse events or grade ≥ 3 treatment related adverse events. Regarding the pain trial, Cullgen recently received HREC (Australia) approval to begin enrolling patients to evaluate the safety and pharmacokinetic characteristics of CG001419 in healthy volunteers. Cullgen anticipates enrolling the first patient in early 2025. This program aims to provide a new non-opioid non-NSAID analgesic which can fulfill unmet medical needs in the field of pain.

Cullgen is also evaluating CG009301, a GSPT1 degrader for the treatment of blood cancers including relapsed/refractory acute myeloid leukemia (AML), higher-risk myelodysplastic syndrome (HR-MDS), and acute lymphoblastic leukemia (ALL). Cullgen has received IND allowance from the China CDE for this product candidate and Cullgen anticipates dosing the first patient in the first quarter of 2025. CG009301 also has the potential to be used for the treatment of solid tumors harboring MYC amplification.

In addition to these three clinical programs, Cullgen is also advancing several other targeted protein degraders and DACs, predominantly for the treatment of cancer and autoimmune disease, including a program targeting a cell cycle protein that has been partnered with Astellas Pharma Inc.

Webcast Information

Management will host an informational webcast that will be made available to access at 12:00 pm ET today. A link to the webcast can be found in the Investor Events and Presentations section of the Pulmatrix website at and in the News & Events section of Cullgen’s website at .

On November 13, 2024 Servier reported that it will present data at the Annual Meeting for the American Society of Hematology (ASH) (Free ASH Whitepaper), December 7-10, 2024 in San Diego, California. Data presentations will focus on the company’s clinical and preclinical studies in IDH-mutated acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), providing new insights on existing programs and a better understanding of the challenges faced by people living with hematological malignancies (Press release, Servier, NOV 13, 2024, View Source [SID1234648308]).

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"Servier is driven to deliver innovative therapies for diseases where patient needs are not yet sufficiently met and where we believe we can have the greatest positive impact," said Becky Martin, PhD, Chief of Medical at Servier Pharmaceuticals. "We look forward to sharing data at this year’s ASH (Free ASH Whitepaper) annual meeting that build upon our expertise in developing medicines for patients living with hematological malignancies, including IDH-mutated AML and MDS."

On November 13, 2024 PhotoCure reported its quarterly results (Presentation, PhotoCure, NOV 13, 2024, View Source [SID1234649494]).

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