On July 30, 2024 PharmaMar Group (MSE: PHM) reported a total revenue of €80.8 million, representing a 1% increase compared to the €80.2 million reported in the first half of 2023 (Press release, PharmaMar, JUL 30, 2024, View Source [SID1234645168]). Recurring revenue, which results from net sales plus royalties received from our partners, increased by 2% to €68.5 million, compared to €67.3 million for the same period of the previous year.

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Oncology sales totalled €42.0 million compared to €43.3 million in the previous year. This difference, which has been offset by the increase in royalties, is mainly due to Yondelis sales, which totalled €9.8 million up to June 30th 2024, compared to €14.2 million recorded in the same period of the previous year.

Revenue from lurbinectedin in Europe under the early access amounted to €12.3 million in the first half of 2024, compared to €21.0 million recorded up to June 30th, 2023.

As of June 2023, the income under this program (€21.0 million) reflected the positive effect of the accounting reversal made in the first half of 2023 due to the excess provision for deductions corresponding to the 2022 fiscal year. If we eliminate this effect, lurbinectedin revenue in Europe under the early access would have increased by approximately 16% in the first half of this year.

Additionally, there have been commercial sales of Zepzelca in Europe amounting to €4.7 million.

Revenue from the sale of API (raw materials) for both Zepzelca and Yondelis to our partners also increased significantly during the first half of this year. Thus, as of June 30th, sales of raw materials reached €15.2 million, representing an 85% growth compared to the same period of the previous year. This increase reflects our partners’ preparation for commercial activity.

As of June 30th, 2024, royalty income amounted to €26.5 million, representing a 16.2% increase compared to the same period of the previous year. This income includes royalties received from our partner Jazz Pharmaceuticals for Zepzelca sales in the U.S., which increased by 15% to €24.2 million. The royalties for the second quarter of 2024 are an estimate, as the information on sales made by Jazz is not available at the time of publication of this report. Any discrepancies will be corrected in the next quarter.

In addition to the royalties received from Jazz Pharmaceuticals, there are royalties from Yondelis sales from our partners in the U.S. and Japan amounting to €2.3 million in the first half of 2024, compared to €1.8 million recorded in the same period of the previous year.

Regarding non-recurring income from license agreements, at the end of the first half of 2024, it amounted to €12.3 million, of which €11.5 million correspond to the portion of deferred income from the 2019 agreement with Jazz Pharmaceuticals related to Zepzelca.

R&D investment reached €51.3 million in the first half of 2024, representing a 10% increase compared to the previous year. Of the total R&D investment in these first six months of 2024, the amount allocated to the oncology segment increased by 20% to €46.7 million, compared to €39.0 million recorded in the first half of 2023. This increase is directly related to the progress of activities related to ongoing clinical trials, mainly the LAGOON trial (phase III clinical development for Small Cell Lung Cancer) and the SaLuDo trial (phase IIb/III clinical development for Leiomyosarcoma); both with lurbinectedin. Additionally, the Company continues to invest in the clinical development of other molecules at earlier stages. In this regard, there are two phase II clinical trials underway with ecubectedin in solid tumors, as well as phase I clinical trials with PM534 and PM54 for the treatment of solid tumors.

In the first half of 2024, the net profit was €3.5 million.

As of June 30th, 2024, the PharmaMar Group has cash and equivalents amounting to €139.6 million and has reduced total debt by 8.8% since December 2023, to €36.3 million. Thus, the net cash position stands at €103.3 million.

PharmaMar management will host a conference call and webcast for investors and analysts on July 31st, 2024, at 13:00 CET (07:00 AM, New York time) as follows: The numbers to connect to the teleconference are 1 646 664 1960 (from USA or Canada), +34 91 901 16 44 (from Spain) and +44 20 3936 2999 (other countries). Participants’ access code: 805724. Interested parties can also follow the conference call live via the following link: View Source

The recording of the teleconference will be available for thirty days and it can be accessed on PharmaMar’s website by visiting the Events Calendar section of the Company’s website www.pharmamar.com

On July 30, 2024 City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States, and Institute for Follicular Lymphoma Innovation (IFLI) reported a $2 million, three-year collaboration to study spontaneous remission in follicular lymphoma, the most common, slow-growing non-Hodgkin’s lymphoma (Press release, City of Hope, JUL 30, 2024, View Source [SID1234645186]).

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Raju K. Pillai, M.D., City of Hope associate clinical professor, Department of Pathology, and director, Pathology Research Services Core Laboratories, and Steven T. Rosen, M.D., executive vice president and director emeritus of City of Hope’s comprehensive cancer center and its Beckman Research Institute, professor, Department of Hematology & Hematopoietic Cell Transplantation, and Ted Schwartz Family Distinguished Chair in Hematologic Malignancies, will lead the research. The collaboration aims to understand the tumor microenvironment in patients whose follicular lymphoma goes into remission without any treatment while being monitored over time.

City of Hope will analyze patient samples of follicular lymphoma and spontaneous remission of follicular lymphoma with leading-edge technologies, such as spatial proteomics and transcriptomics, as well as machine learning techniques to help explain why spontaneous remission of follicular lymphoma occurs in a rare number of patients and not in others. The study aims to determine the most relevant prognostic genetic, transcriptomic and microenvironmental factors involved in spontaneous remission of follicular lymphoma.

"Spontaneous remission in follicular lymphoma is not understood and we are excited and humbled to collaborate and support City of Hope’s prestigious team to leverage their expertise and suite of technologies and assays to better understand this phenomenon," said Michel Azoulay, M.D., M.B.A., IFLI’s chief medical officer. "IFLI is committed to funding innovative research projects, such as these important studies at City of Hope, to better understand follicular lymphoma and how we can improve treatments and outcomes for follicular lymphoma patients."

"The clinical spectrum of follicular lymphoma, which ranges from spontaneous regression on one end to highly aggressive disease at the other end, is influenced by the immune microenvironment to a large extent," Dr. Pillai said. "With IFLI’s support, we can study follicular lymphoma, leveraging City of Hope’s omics and spatial biology expertise to shed more light on why and how spontaneous remission occurs, with the goal that our discoveries will translate to advances in diagnostics and the next generation of therapies for patients with follicular lymphoma."

"I have shared the joy of my patients who have spontaneously achieved remission, and I have shared the worry, anguish and frustration of my patients whose follicular lymphoma has progressed or transformed," Dr. Rosen added. "I am thrilled to join with Dr. Pillai, IFLI and other collaborators to help answer the question ‘Why certain patients and not all?’"

On July 30, 2024 Chemomab Therapeutics Ltd. (Nasdaq: CMMB) ("Chemomab" or the "Company"), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, reported that it had closed a private placement that resulted in gross proceeds of approximately $10 million to the Company, before deducting offering expenses payable by the Company (Press release, Chemomab, JUL 30, 2024, View Source [SID1234645150]).

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Pursuant to the terms of the transaction, the Company sold a total of 8,097,167 ADSs and pre-funded warrants in lieu of ADSs. The purchase price per ADS was $1.235. The private placement did not include warrant coverage. Both existing investors and new investors participated in the private placement, including HBM Healthcare Investments, OrbiMed and Sphera Biotech Master Fund LP.

Oppenheimer & Co. Inc. acted as Capital Markets Advisor to the Company for the private placement. Other advisors to the Company in the private placement included LifeSci Capital and Maxim Group.

The offer and sale of the securities sold in the private placement were made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended, and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. As part of the private placement, the Company and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file a registration statement with the Securities and Exchange Commission (the "SEC") registering the resale of the ADSs, including ADSs issuable upon exercise of the Pre-Funded Warrants, issued in the private placement.

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 July 30, 2024 Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (Processa or the Company), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for Next Generation Capecitabine (NGC-Cap), its lead product candidate (Press release, Processa Pharmaceuticals, JUL 30, 2024, View Source [SID1234645169]). The IND supports the initiation of a Phase 2 clinical trial in patients with advanced or metastatic breast cancer, which is expected to begin enrollment this quarter.

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"We are proud to achieve this significant milestone for NGC-Cap and look forward to entering the clinic for the treatment of advanced or metastatic breast cancer, where capecitabine is a standard of care. We previously demonstrated in our Phase 1b study that NGC-Cap is more potent than monotherapy capecitabine, providing up to 5-10 times more 5-fluorouracil exposure to cancer cells. This greater exposure resulted in a greater efficacy, with a safety profile better or similar to existing monotherapy with capecitabine," stated David Young, PharmD, Ph.D., President of Research and Development. "Initial data from the Phase 2 trial are expected mid-2025."

"Although capecitabine is among the most widely used chemotherapy drugs, particularly for the treatment of solid tumors, there remains the need for a more effective chemotherapy treatment with fewer or less-severe side effects," he added. "We believe that NGC-Cap can fulfill this need."

Breast cancer is the second most common cancer and a leading cause of cancer-related death. More than 2 million cases of breast cancer were diagnosed in 2022 with more than 665,000 deaths globally. The five-year survival rate for those diagnosed with metastatic disease is approximately 30%.

The Phase 2 study will be a global multicenter, open-label, adaptive design trial comparing two different doses of NGC-Cap to FDA-approved monotherapy capecitabine in approximately 60 to 90 patients with advanced or metastatic breast cancer. The trial is designed to evaluate the safety-efficacy profile of NGC-Cap versus monotherapy capecitabine, to determine the potential optimal dosage regimens of NGC-Cap as required by the FDA Project Optimus Initiative and to evaluate the possibility of personalizing NGC-Cap therapy. Processa expects to enroll the first patient into this trial in the third quarter of 2024.

About Capecitabine Administered with PCS6422 (NGC-Cap)

NGC-Cap combines the administration of PCS6422, the Company’s irreversible dihydropyrimidine dehydrogenase (DPD) enzyme inhibitor, with low doses of capecitabine. Capecitabine is the oral prodrug of 5-FU, and along with 5-FU is among the most widely used chemotherapy drugs, particularly for the treatment of solid tumors. When metabolized (after oral ingestion) it becomes 5-FU in the body, which, in turn, metabolizes to molecules called anabolites that actively kill duplicating cells, such as cancer cells, and to molecules called catabolites that only cause side effects. The presence of the DPD enzyme plays an integral role in the undesirable conversion of 5-FU to catabolites while simultaneously decreasing tumor exposure to 5-FU and it’s anabolites.

The NGC-Cap Phase 1b study evaluated ascending doses of capecitabine when combined with a fixed dose of PCS6422 in patients with advanced, relapsed or refractory progressive gastrointestinal tract cancer. These patients had to relapse from or fail all other treatments. NGC-Cap demonstrated greater 5-fluorouracil (5-FU) exposure and lower fluoro-beta-alanine (FBAL) exposure with a better or similar side effect profile compared with monotherapy capecitabine, as well as preliminary anti-tumor activity. In all evaluable patients who received one dose of PCS6422 and seven days of capecitabine, partial responses or stable disease was observed in 66.7% (8 out of 12) of patients with progression-free survival of approximately 5 to 11 months across these patients.

On July 30, 2024 LTZ Therapeutics, an immunotherapy-focused biotech company, reported the completion of the company’s Series A financing of over $20 million, to advance the development of its Myeloid Engager pipeline to treat cancer and autoimmune diseases (Press release, LTZ Therapeutics, JUL 30, 2024, View Source [SID1234645187]). This round was led by new investor Lapam Capital and includes new investment participation from GL Ventures. In addition, the company has received continued investment from K2 Venture Partners and Shunwei Capital. The closing of this round brings LTZ’s total funding to approximately $50 million since the company was founded in 2022.

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Proceeds from the financing will be used to accelerate development of LTZ’s pipeline, supporting the company’s Investigational New Drug (IND) process, initiating the Phase 1 clinical study of LTZ’s lead asset LTZ-301 as well as the IND-enabling work of its second asset, LTZ-232. The company will also use the new capital to further advance other programs in discovery and to expand its team.

"This round represents an important step forward in the development of our novel Myeloid Engager Platform for cancer and other conditions with unmet medical needs," said Robert Li, Ph.D., Founder and CEO of LTZ. "At the heart of our approach is the fusion of reverse translational science with a deep understanding of tumor microenvironment (TME) biology, especially myeloid biology. We’ve made significant progress this past year, not only validating the company’s platform in various preclinical test systems including cancer patient-derived organoid models, but also advancing our lead asset LTZ-301 from discovery to an IND-enabling stage. We are thankful for the ongoing support of our scientific team, advisory board and our syndicate of investors, making all of our accomplishments possible."

Macrophages appear to be one of the most prevalent immune cell populations in TME of various hematologic and solid tumors. Therefore, effectively engaging and activating macrophages to kill cancer cells represents significant therapeutic potential for patients. Based on reverse translational research to inform new discoveries and the emerging myeloid biology of TME in a broad range of cancer types, LTZ is developing its own novel Myeloid Engager Platform to primarily enhance the phagocytic function of monocytes and macrophages to foster anti-tumor immunity.

"LTZ comprises a highly skilled and passionate team that brings together a unique complement of expertise," said Zhihua Yu, Founding Partner at Lapam Capital. "We are excited about the reverse translational approach LTZ is taking to maximize the drugability of their assets. LTZ’s Myeloid Engager Platform and their pipeline have the potential to greatly impact the future of immunotherapy development, aiming to rebalance the immune system and improve patient outcomes. The preclinical results thus far carry promising clinical benefits and suggest applicability of LTZ’s model for a wide spectrum of cancer indications (liquid and solid) and autoimmune diseases, where the unmet need is incredibly high."