On April 24, 2025 Merck & Co reported its First-Quarter 2025 Financial Results (Presentation, Merck & Co, APR 24, 2025, View Source [SID1234653383]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On April 24, 2025 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other MAPK pathway driven indications, reported the acceptance of an abstract for a poster prenstation at the Annual Meeting of the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) taking place May 30 – June 3, 2025, in Chicago, Illinois (Press release, Pasithea Therapeutics, APR 24, 2025, View Source [SID1234652108]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company will present updated interim clinical data from its onging Phase 1 clinical trial of PAS-004 in patients with MAPK pathway driven advanced solid tumors.

"We are pleased to present interim clinical data of PAS-004 through cohort 4A and 4B, that to date has demonstrated clinical activity, target engagement, and a favorable safety profile," said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. "We believe PAS-004’s emerging profile may achieve the sweet spot between PK, PD and tolerability and may make PAS-004 an ideal candidate for the treatment of NF1 related cutaneous and plexiform neurofibromas as well as a potential candidate for treatment of various cancers and MAPK pathway driven diseases."

Presentation and poster details

Title: Phase 1 dose-escalation study of the safety and pharmacokinetics of PAS-004, a macrocyclic MEK inhibitor, for the treatment of patients with MAPK pathway–driven advanced solid tumors
Session: Poster Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Poster Board: 440
Date and Time: 6/2/2025, 1:30 – 4:30 PM CDT

The full abstract will be available on the ASCO (Free ASCO Whitepaper) website on May 22, 2025, at 5:00 p.m. ET.

The ongoing Phase 1 clinical trial is a multi-center, open-label, dose escalation 3+3 study design to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition (NCT06299839).

On April 24, 2025 Debiopharm Research & Manufacturing S.A. (Debiopharm, www.debiopharm.com), a Swiss-based global biopharmaceutical company aiming to cure cancer and infectious diseases, and Oncodesign Services (www.oncodesign-services.com), a leading CRO specialized in drug discovery and preclinical services, reported the execution of a license agreement for the use of the AbYlink technology for preclinical services (Press release, Debiopharm, APR 24, 2025, View Source [SID1234652124]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

AbYlink is a regio-selective bioconjugation technology ideally suited for preparing conjugates for use in therapeutic and non-invasive diagnostic applications. Oncodesign Services will use this cutting-edge technology to prepare antibody chelator conjugates for use in preclinical studies to gain insights into the predictive effectiveness of novel treatment approaches in Molecular Radiotherapy, and particularly Radioimmunotherapy in the context of cancer. A joint poster will be presented at the AACR (Free AACR Whitepaper) Annual Meeting 2025 to demonstrate the use of the non-invasive technology in Radioimmunotherapy, targeting animal models bearing HER2+ tumors.

"We have demonstrated the effectiveness of this powerful technology to rapidly and covalently conjugate any off-the-shelf antibody in a single step with an imaging agent. Our strategic collaboration with Oncodesign Services allows broader access to and usage of non-invasive imaging applications and provides an innovative solution to biotech and pharma partners to integrate imagery in the development of new antibody- and ADC-based therapeutics," commented Frédéric Lévy, Chief Scientific Officer at Debiopharm.

Aidan Synnott, CEO of Oncodesign Services, said, "We are pleased to integrate this cutting-edge technology into our portfolio for our clients. The AbYlink technology gives the advantage of generating reproducible batches of bioconjugated antibodies and ADCs that secure specificity and efficacy of targeted radiotherapy."

About AbYlink

AbYlink is a versatile and rapid regio-selective chemical conjugation technology for use to prepare diagnostic or therapeutic conjugates. This one-step method results in stable conjugation at defined and invariable sites on the Fc domain of an antibody or the like, with no impact on antigen-binding regions. It enables a seamless and reproducible conjugation of payloads (e.g., a chelator for radiolabeling, a fluorescent dye or a drug) to antibodies or ADCs. The universal applicability of the technology has been demonstrated for various antibody isotypes and payloads.

On April 24, 2025 Hoffmann-La Roche reported the company continues good momentum into 2025 with 6% (CER) sales growth in the first quarter (Press release, Hoffmann-La Roche, APR 24, 2025, View Source [SID1234654044]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On April 24, 2025 PharmaMar Group (MSE: PHM) reported 19% growth in recurring revenues in the first quarter of 2025 (Press release, PharmaMar, APR 24, 2025, View Source [SID1234652109]). This revenue, which is the sum of net sales plus royalties received from our partners, amounted to €37.8 million as of March 31st, 2025. This increase was mainly driven by the good performance of lurbinectedin revenues in both Europe and the US.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As of March 31st, 2025, total oncology revenues increased by 22% to €23.1 million, compared with €19.0 million in the same period of last year. This increase was due to the positive performance of lurbinectedin revenues in Europe, where revenues recorded under the compassionate use program – mainly in France – rose 26% to €8.0 million, compared to €6.3 million as of March 31, 2024. In addition, commercial sales of Zepzelca in Switzerland amounted to €4.3 million in the first quarter of the year, compared with €4.2 million in the same period of 2024.

Also, raw material sales of both Yondelis (trabectedin) and lurbinectedin to our partners amounted to €5.7 million, representing an increase of 72.3% compared to the €3.3 million recorded in the same period of the previous year.

Sales of trabectedin in Europe through March 31st, 2025, remained stable at €5.2 million.

At the end of the first quarter of 2025, oncology royalty revenues amounted to €14.7 million, an increase of 16% over the same period of the previous year. This growth was led by royalties received from our partner Jazz Pharmaceuticals for lurbinectedin sales in the US, which increased by 9% to €12.7 million[1].

In addition to the royalties received from Jazz Pharmaceuticals through March 31st, 2025, royalties on trabectedin sales from our partners in the U.S. and Japan totaled €2.0 million, almost double the €1.1 million recorded in the first quarter of 2024.

With regard to non-recurring revenues from licensing agreements, at the end of the first quarter of 2025, these amounted to €1.0 million, compared with €6.0 million as of March 31st, 2024. Both figures come from the recognition as revenue of a portion of the deferred revenue from the 2019 agreement signed with Jazz Pharmaceuticals in relation to Zepzelca.

In the current fiscal year, the annual imputation of income related to this agreement is estimated at €4 million, while the total for the previous year was approximately €23 million. Of the total €300 million of income received in 2020 in connection with this agreement, 93% has already been taken to income in recent years. The remaining 7% will be recognized in future fiscal years.

As a result, PharmaMar Group reported 2% growth in total revenues in the first quarter of 2025, to €38.9 million.

PharmaMar Group R&D expenditure amounted to €21.3 million, 22% less than in the first quarter of 2024.

Of total R&D expenditure in the period, the oncology segment accounted for €19.8 million, compared with €24.6 million at March 31st, 2024. This change is mainly due to the completion of recruitment in December 2024 for the LAGOON Phase III clinical trial with lurbinectedin in small-cell lung cancer.

In the RNAI segment 1.5 million was allocated, compared with €2.6 million in the same period of the previous year. This variation is due to the completion in the first months of 2024 of the PIVO1 phase III clinical trial with tivanisiran for dry eye disease.

In addition, the Company continues to invest in the clinical development of three molecules at earlier stages. Two Phase II clinical trials are underway with ecubectedin, as well as Phase I clinical trials with PM534 and PM54, all for the treatment of solid tumors.

EBITDA improved, compared to the same period of the previous year, standing at- € 1.1 M compared to € -2.7 M in the first quarter of 2024.

Net income, as of March 31st, 2025, stands at -€3.9 M compared to a profit of € 2.3 as of March 31st, 2024. This difference is due to the positive financial results recorded in March 2024 in addition to a positive income tax balance.

At March 31st 2025, the PharmaMar Group recorded a cash and cash equivalents balance of €142.2 million, with total financial debt of €48.5 million. As a result, the net cash position at end of the first quarter of 2025 was €93.7 million.