On February 28, 2024 PharmaMar reported total revenues of €158.2 million in 2023, compared with €196.3 million in the same period of the previous year (Press release, PharmaMar, FEB 28, 2024, View Source [SID1234640776]). Recurring revenues, which result from the sum of net sales plus royalties on sales made by our partners, totaled €124.1 million, compared with €156.0 million in 2022. These changes in revenues are mainly due to the introduction of generic trabectedin (Yondelis) products on the European market, which has put significant pressure on prices. Thus, Yondelis recorded net sales of €26.1 million at December 31st, 2023, compared with the €63.8 million reported the previous year.

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!

Revenues from Zepzelca (lurbinectedin) continued to grow. Both revenues in Europe and royalties from sales in the US recorded significant increases. Revenues from the early access program grew to €29.7 million at year-end, compared with €15.5 million in 2022. These revenues come mainly from France, although other early access programs are also open in countries such as Spain and Austria.

The increase in Zepzelca’s revenues in Europe reflects a positive adjustment made by the French authorities in relation to the previous year’s discounts.

In addition, revenues in Europe in 2023 reflect the first sales of Zepzelca in Switzerland since its commercial launch in the second half of the year.

The sale of raw materials of both Yondelis and Zepzelca to our partners is also included in recurring revenues. These sales reported revenues of €14.9 million at the end of 2023, compared with €21.4 million reported in the previous year. This difference is mainly due to the accumulation of stocks that some of our partners carried out in 2022.

It is important to highlight the growth in royalty revenues, which amounted to €52.2 million in fiscal year 2023. This revenue mainly includes royalties received from our partner Jazz Pharmaceuticals for lurbinectedin sales in the US, which amounted to €48.4 million, compared with the €46.9 million reported in 2022. Excluding the currency effect, royalty growth stood at 8%.

In addition to the royalties received from Jazz Pharmaceuticals, royalties on Yondelis sales from our partners in the US and Japan totaled €3.8 million in 2023, compared with €3.4 million in 2022.

Non-recurring revenues from licensing agreements amounted to €33.6 million at year-end 2023, compared with €40.2 million in the previous year. Most of this revenue came from Zepzelca licensing agreements for a total of €24.2 million, to which must be added the €9.4 million recorded in the last quarter of 2023 for the fulfillment of a commercial milestone under the contract signed with Janssen (Johnson & Johnson) for Yondelis in the United States.

At December 31st, 2023, R&D expenditure amounted to €99.3 million, an increase of 19% compared with the previous year. Of the total R&D investment in 2023, the amount earmarked for the oncology segment increased to €83.6 million compared with €68.1 million in 2022. This increase is largely related to the confirmatory Phase III trial of lurbinectedin in Small Cell Lung Cancer, called LAGOON, which is progressing in patient recruitment and where an additional effort is being made to open new centers. Part of this investment was also designated for a Phase IIb/III trial with lurbinectedin for the first-line treatment of Leiomyosarcoma, which began in the last quarter of the year. The Company continues to invest in the clinical development of other molecules at earlier stages. A Phase II clinical trial is under way with ecubectedin for solid tumors, and Phase I clinical trials are also under way with ecubectedin, PM534 and PM54 for the treatment of solid tumors.

Despite the pressure on Yondelis sales prices and the growing R&D effort, PharmaMar reported net income of €1.1 million at the end of 2023.

At 31st December 2023, PharmaMar Group had a cash and cash equivalents position of €168.6 million and a total debt of €39.9 million, which translates into net cash of €128.8 million. This cash position already reflects dividends paid and the €15 million acquisition in treasury stock, which the Company completed in January of this year 2024.

The Board of Directors of Pharma Mar, S.A. will propose to the General Shareholders’ Meeting the distribution of a dividend of €0.65 per outstanding share that will be charged to unrestricted reserves (share premium), with a maximum distribution amount set at 11,930,689.55 Euros.

PharmaMar Results Conference Call for Investors and Analysts

PharmaMar management will host a conference call and webcast for investors and analysts on Thursday February 29th, 2024 at 13:00 (CET).

The numbers to connect to the teleconference are: +34 91 901 16 44 (from Spain), +1 646 664 1960 (from the US or Canada) or +44 20 3936 2999 (other countries). Participants’ access code: 889062. Interested parties can also follow the webcast live via the following link: View Source

A recording of the teleconference can be accessed on PharmaMar’s website by visiting the Events Calendar section of the Company’s website www.pharmamar.com

On February 28, 2024 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported financial results for the fourth quarter and full year ended December 31, 2023 (Press release, Repare Therapeutics, FEB 28, 2024, View Source [SID1234640631]).

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!

"2023 was a year of substantial progress for Repare. We advanced each of the four programs in our portfolio and set the stage for meaningful data readouts and new clinical trial starts this year," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "In particular and as leaders and innovators in PKMYT1 inhibition, we look forward to data readouts across all ongoing lunresertib clinical trials in 2024 and are excited to begin a lunresertib and WEE1 combination clinical trial in partnership with Debiopharm."

2023 and Recent Portfolio Highlights:

Lunresertib
Presented initial positive data from its ongoing Phase 1 MYTHIC trial evaluating lunresertib (RP-6306) alone and in combination with camonsertib in patients with advanced solid tumors harboring CCNE1 amplification or FBXW7 or PPP2R1A deleterious alterations at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). Initial combination data included an overall RECIST response rate of 50% in ten patients with heavily pre-treated gynecological tumors at the preliminary recommended Phase 2 dose.
Announced a partnership with Debiopharm to explore the potential clinical synergy of Debio 0123, a highly selective clinical WEE1 inhibitor, and lunresertib, with dosing of the first patient expected to occur in the first half of 2024 and for which the companies have developed substantial pre-clinical validation. Repare will sponsor the global clinical trial as a new arm in the ongoing MYTHIC trial, with costs being shared equally by Debiopharm and Repare.
Camonsertib
Presented initial clinical data from the Phase 1/2 TRESR and ATTACC trials evaluating camonsertib (RP-3500) in combination with three poly (ADP-ribose) polymerase (PARP) inhibitors in a Clinical Trials Plenary Session at the 2023 AACR (Free AACR Whitepaper) Annual Meeting. Camonsertib, a potent and selective oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase), showed 48% overall clinical benefit rate in patients with advanced solid tumors across tumor types regardless of choice of PARP inhibitor or platinum resistance, with a favorable safety and tolerability profile. Data from the TRESR trial were also published in Nature Medicine highlighting the clinical benefit of camonsertib in advanced solid tumors.
Upon dosing of the first patient with camonsertib in Roche’s Phase 2 TAPISTRY trial (NCT04589845), Repare earned a $40 million milestone payment from its collaboration with Roche, which was subsequently received in February 2024. In October 2023, Roche also dosed the first patient in a camonsertib-based arm in its Phase 1b/2 clinical trial of multiple immunotherapy-based treatment combinations in participants with metastatic non-small cell lung cancer (Morpheus Lung; NCT03337698).
Since inception of the Roche camonsertib collaboration, Repare has earned a cumulative total of $182.6 million pursuant to the Roche collaboration agreement, including the upfront payment, the milestone payment, as well as additional reimbursements from Roche. In February 2024, Repare received written notice from Roche of their election to terminate the Roche collaboration agreement. The termination will become effective in May 2024, at which time Repare will regain global development and commercialization rights for camonsertib from Roche.
RP-1664
Dosed the first patient in the multicenter, open-label Phase 1 dose escalation trial of RP-1664 in adult and adolescent patients with TRIM37-high solid tumors in February 2024. Repare disclosed polo-like kinase 4 (PLK4) as the target of the RP-1664 development program and reported that RP-1664 demonstrated potent and selective inhibition of PLK4 and synthetic lethality in TRIM37-high tumor cells in preclinical studies.
RP-3467
Reported comprehensive preclinical data for RP-3467, a potential best-in-class Polθ ATPase inhibitor. RP-3467 demonstrated complete, sustained regressions preclinically in combination with PARP inhibitors, and compelling anti-tumor activity in combination with radioligand therapy and chemotherapy.
2024 Outlook:

Initiate a Phase 1/1b clinical trial of lunresertib and Debio 0123, a WEE1 inhibitor, in the first half of 2024 as a fourth arm of the ongoing MYTHIC clinical trial.
Report initial data from the Phase 1 MINOTAUR trial evaluating lunresertib in combination with FOLFIRI for the treatment of advanced solid tumors in the first half of 2024.
Disclose additional camonsertib clinical development plans beyond the TRESR and ATTACC clinical trials sponsored by Repare in the second quarter of 2024.
Report data from the dose expansion cohorts of the Phase 1 MYTHIC trial evaluating lunresertib in combination with camonsertib in selectively advanced solid tumors in the second half of 2024.
Report initial data from the Phase 1 MAGNETIC trial evaluating lunresertib in combination with gemcitabine for the treatment of advanced solid tumors in the second half of 2024. Enrollment in this trial is now closed.
Initiation of a Phase 1 dose finding trial of RP-3467 in the second half of 2024.
Fourth Quarter and Full Year 2023 Financial Results:

Cash, cash equivalents, and marketable securities: Cash, cash equivalents, and marketable securities as of December 31, 2023 were $223.6 million. In February 2024, Repare received a $40 million milestone payment from Roche upon dosing of the first patient with camonsertib in Roche’s TAPISTRY trial. The Company believes that its cash, cash equivalents, and marketable securities are sufficient to fund its operations into mid-2026.

Revenue from collaboration agreements: Revenue from collaboration agreements was $13.0 million and $51.1 million for the three- and twelve-month periods ended December 31, 2023, respectively, as compared to $18.2 million and $131.8 million for the three- and twelve-month periods ended December 31, 2022, respectively. The decrease in revenue for the three-month period was due to lower deferred revenue recognized from the Roche collaboration and the BMS collaboration. The decrease in revenue for the twelve-month period was primarily due to a decrease in revenue recognized under the Roche collaboration mainly as a result of the $108.0 million revenue recognized in 2022 pursuant to the satisfaction of the Company’s performance obligations for the issuance of the combined licenses and the clinical trial materials transferred. The decrease in the twelve-month period was partially offset by higher deferred revenue recognized from the BMS collaboration and the Ono collaboration.

Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $35.3 million and $133.6 million for the three- and twelve-month periods ended December 31, 2023, respectively, as compared to $29.9 million and $119.1 million for the three- and twelve-month periods ended December 31, 2022, respectively. The increase in Net R&D expenses for the three- and twelve-month periods were primarily due to higher personnel-related costs and direct external costs related to the progress of our lunresertib clinical program, as well as the advancement of preclinical programs into IND-enabling studies.

General and administrative (G&A) expenses: G&A expenses were $8.6 million and $33.8 million for the three- and twelve-month periods ended December 31, 2023, respectively, compared to $7.9 million and $32.6 million for the three- and twelve-month periods ended December 31, 2022, respectively. The increase in G&A expenses was primarily due to higher personnel-related costs, partially offset by lower D&O insurance premiums and reduced professional fees associated with the Roche collaboration agreement.
Net loss: Net loss was $28.0 million, or $0.67 per share, and $93.8 million, or $2.23 per share, in the three- and twelve-month periods ended December 31, 2023, respectively, and $31.7 million, or $0.75 per share, and $29.0 million, or $0.69 per share, in the three- and twelve-month periods ended December 31, 2022, respectively.
About Repare Therapeutics’ SNIPRx Platform

Repare’s SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.

On February 28, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, reported that the Company will participate in fireside chats at two upcoming investor conferences (Press release, BeiGene, FEB 28, 2024, View Source [SID1234640630]):

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!

TD Cowen 44th Annual Health Care Conference on Tuesday, March 5th, 2024 at 9:50 am ET; and

Leerink Partners Global Biopharma Conference on Monday, March 11th, 2024 at 10:00 am ET

Live webcasts of these events can be accessed from the investors section of BeiGene’s website at View Source, View Source, View Source Archived replays will be available for 90 days following the event.

On February 28, 2024 Sarah Cannon Research Institute (SCRI), one of the world’s leading oncology research organizations conducting community-based clinical trials, reported a collaboration with AstraZeneca, a global, science-led biopharmaceutical company, aimed at advancing innovative technology and operational synergies to enhance the delivery of oncology clinical trials (Press release, Sarah Cannon Research Institute, FEB 28, 2024, View Source [SID1234640629]).

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!

Working together, SCRI and AstraZeneca will implement modern solutions to accelerate clinical trial delivery timelines, reduce site burden, and enhance U.S. enrollment.

Genospace, a precision medicine platform, and SCRI Development Innovations collaborated on the development of a proprietary technology to seamlessly integrate data from the Electronic Health Record (EHR) to the Electronic Data Capture (EDC), EHR2EDC (E2E) systems for clinical trial data collection. To date, this advancement is decreasing site-based data entry time, reducing manual labor, lowering monitoring costs, improving data quality, and accelerating clinical trial decision-making overall.

Advancements of E2E and the focus on the deployment of SCRI’s new model will enable the synchronization of end-to-end clinical research management connecting more than 1,300 physicians who are providing access to clinical trials across multiple tumor types at more than 250 locations in 24 states across the U.S and reaching 1 in 5 patients with cancer through its affiliated sites.

"Improving end-to-end research operations will have great impact on the industry’s ability to increase the pace of drug development, without compromising quality," said Dee Anna Smith, Chief Executive Officer, SCRI. "Our collaboration with AstraZeneca has the potential to accelerate our mutual efforts to bring novel therapies to more people with cancer, through more physicians, across even more communities."

The traditional clinical trial delivery model and typical operational processes must evolve for research sites to keep pace with an increasingly complex drug development industry.

"Our ongoing commitment to personalized and effective medical interventions to people living with cancer means we are continually innovating to improve accessibility to trial participation and meet the current and future needs of clinical trial execution," said Michele Sample, Vice President, Clinical Operations, Oncology R&D, AstraZeneca. "Working with SCRI to enhance U.S. enrollment and streamline clinical trial data collection is a tremendous opportunity to increase the diversity of clinical trial participants in the U.S. and accelerate clinical trial delivery timelines. Our ambition is to bring new treatments to all patients more efficiently."

On February 28, 2024 Blue Earth Therapeutics, a Bracco company and emerging leader in the development of innovative next generation therapeutic radiopharmaceuticals, reported that it will be presenting at the upcoming B. Riley Securities’ Radiopharma Investor Conference (Press release, Blue Earth Therapeutics, FEB 28, 2024, View Source [SID1234640628]). The event will be held in New York, N.Y., on March 1, 2024. David Gauden, D. Phil., Chief Executive Officer of Blue Earth Diagnostics and Blue Earth Therapeutics, will present an overview of Blue Earth Therapeutics from 8:00 – 8:30 a.m. ET and participate in an expert panel discussion, "Opportunities and Challenges in 2024, Perspectives from Leaders in Radiopharma," from 9:15 – 9:50 a.m. ET. Dr. Dan Stevens, Vice President Clinical Development and Medical, Blue Earth Therapeutics, will participate in an expert panel, "Good But Not the Best Yet: Drug Designs to Beat Standard of Care," from 1:45 – 2:20 p.m. ET. The Company will also host 1:1 investor meetings at the conference.

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!

"Blue Earth Therapeutics continues to expand our leadership position in the rapidly growing area of radiopharmaceuticals," said David Gauden., D.Phil., Chief Executive Officer of the Company. "We are strongly positioned for continued progress across this exciting sector, and we look forward to sharing information about our innovative approach and next generation targeted radioligand therapy (RLT) technology at this important B. Riley Securities conference."