On November 7, 2024 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported its business update and financial position for the quarter ending September 30, 2024 (Press release, Transgene, NOV 7, 2024, View Source [SID1234655851]).

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!

Key events and upcoming milestones
TG4050: Neoantigen therapeutic cancer vaccine
Transgene and NEC will present promising new data from the ongoing randomized Phase I trial of the neoantigen individualized therapeutic cancer vaccine, TG4050 at SITC (Free SITC Whitepaper) 2024 on November 9, 2024 (see press release here). These data provide robust clinical proof of principle for Transgene’s lead candidate in the adjuvant head and neck cancer setting, a patient population at high risk of relapse.

Compelling 24.1-month median follow-up data presented showed that all 16 patients treated with TG4050 after completion of adjuvant standard of care remain disease-free and have not relapsed, comparing favorably to the observational arm which saw 3 out of 16 patients relapse. All patients treated with TG4050 developed specific immune responses against the selected personalized antigen targets, demonstrating the strong immunogenicity of the cancer vaccine, with both de novo and amplified responses. Additionally, immune responses are sustained over a 7-month period, covering the induction and boost periods.

In Q2 2024, Transgene started enrolling patients in the Phase II part of the expanded randomized Phase I/II trial investigating TG4050 in the adjuvant treatment of head and neck cancer (NCT04183166). Patient enrollment continues to progress at a good pace.

TG4050 is the only individualized neoantigen cancer vaccine currently being developed in a randomized trial in the adjuvant treatment of head and neck cancer.

TG4050 has potential applicability across a range of solid tumors where there remains a significant unmet medical need, despite the existing therapeutic options, including immunotherapies. As a result, Transgene is conducting preliminary work on a potential new Phase I trial in a further undisclosed indication.

TG4001 – Shared antigen cancer vaccine
In October 2024, Transgene announced that its randomized Phase II study evaluating TG4001 in combination with avelumab versus avelumab alone in patients with recurrent or metastatic HPV16- positive cervical and anogenital tumors did not meet its primary objective (improvement in progressionfree survival).

However, analysis of a pre-planned subgroup showed a positive efficacy trend in favor of the TG4001 containing regimen in cervical cancer patients, which requires further confirmation through additional analyses, including by PD-L1 status. These patients account for approximately half of the patients enrolled in the study. Transgene is currently evaluating the full study results in detail to determine the best way forward for this program and will communicate further once this is completed.

Oncolytic Viruses
BT-001 (intratumoral administration):
In September 2024, Transgene and its partner BioInvent presented preliminary Phase I/IIa data (NCT04725331) at ESMO (Free ESMO Whitepaper) (see press release here) showing that BT-001 induced tumor regression in patients unresponsive to prior anti PD(L)-1 treatment, both as monotherapy and in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab).

BT-001 replicated in the tumor and expressed the encoded GM-CSF and anti-CTLA-4 transgenes. Notably, BT-001 in combination with pembrolizumab showed first signs of efficacy in 2 out of 6 patients, with shrinkage of injected and non-injected lesions. In a reported case study, BT-001 treatment was able to modulate the tumor microenvironment, converting "cold tumors" into "hot tumors", and inducing T cell infiltration.

Transgene and BioInvent are finalizing the second cohort in the part B of the Phase I/IIa trial, to inform on the further development strategy.

TG6050 (intravenous administration):
The Phase I Delivir trial (NCT05788926), evaluating TG6050 in patients with advanced non-small cell lung cancer who have failed standard therapeutic options, completed the first two dose levels. Dose-limiting toxicity was observed in one patient in the third cohort and additional patients are being enrolled according to the protocol to complete this trial. Initial data are now expected in H1 2025.

Preclinical data, recently published in the Journal for ImmunoTherapy of Cancer (JITC), were awarded with the JITC Best Oncolytic and Local Immunotherapy Paper Award. The article on TG6050 demonstrates that it induces tumor regression in numerous "hot" and "cold" murine tumor models investigated in these studies. This antitumoral activity was further amplified when TG6050 was combined with an immune checkpoint inhibitor (article available here).

Cash, cash equivalents and other financial assets
Cash, cash equivalents and other financial assets stood at €14.0 million as of September 30, 2024, compared to €15.7 million as of December 31, 2023.

In the first nine months of 2024, Transgene’s cash burn amounted to €31.3 million compared to a cash burn of €13.8 million in the same period of 2023. The difference is explained by the July 2023 sale of Transgene’s remaining shares held in Tasly BioPharmaceuticals for a total amount of US$15.3 million (€14.3 million).

At of the end of July 2024, Transgene announced the conversion into shares of €33 million debt drawn down from the current account advance granted by the Company’s major shareholder TSGH (Institut Merieux), in accordance with the terms of an agreement signed for the first time in 2023. As a result, the share capital of Transgene held by TSGH increased from 59.7% to 69.1% of the outstanding shares. In carrying out this transaction, Transgene has strengthened its balance sheet, reduced its debt levels and its debt burden as a result of lower interest payments.

As of September 30, 2024, Transgene had the capacity to draw down €23.5 million from the current account advance provided by TSGH.

Transgene confirms financial visibility into Q4 2025, enabling the Company to deliver news flow on its portfolio progress over the next 12 months.

On November 7, 2024 Onchilles Pharma, a private biotech company pioneering pan-cancer therapeutics that leverage the ELANE pathway, reported the presentation of new preclinical data from its NEU-002 program at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, Onchilles Pharma, NOV 7, 2024, View Source [SID1234647942]). The event is being held virtually and at the George R. Brown Convention Center in Houston, Texas from November 6-10, 2024.

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 ELANE pathway is a novel innate immune mechanism that enables potent and selective immunogenic cell death of cancer cells irrespective of immunotype, genotype, anatomical origin while sparing healthy tissue. Onchilles Pharma has leveraged this pathway to develop N17350 and NEU-002, two leading therapeutic candidates designed for intratumoral and intravenous (IV) administration, respectively. N17350 is on track to start Phase 1 clinical trials in 2025 to validate the ELANE pathway in head & neck, skin, breast, and lung cancers.

At SITC (Free SITC Whitepaper) 2024, Onchilles Pharma presented new preclinical data on NEU-002, which allows targeting the ELANE pathway through systemic delivery. NEU-002 addresses the challenges of systemic delivery by overcoming inhibition from serine protease inhibitors and enhancing substrate specificity, thereby extending its potential to treat a broad range of solid tumor types that are well-suited for systemic administration.

Key Preclinical Data Highlights:

Enhanced Specificity and Activity: NEU-002 retains full enzymatic activity in plasma and shows improved substrate specificity, effectively cleaving CD95, its therapeutic target, while sparing known off-target substrates.
Selective Cancer Cell Killing: The NEU-002 candidates selectively induce immunogenic cell death in primary cancer cells derived from ovarian cancer patients, validating their selective killing properties in primary human tissue.
Durable Responses: In preclinical studies using the CT26 tumor mouse model, NEU-002 treatment generated complete responses with resistance to tumor rechallenge, suggesting the potential for immune memory formation.
"The data presented today mark a significant advancement in the systemic targeting of the ELANE pathway," said Lev Becker, Ph.D., Scientific Founder and Chief Scientific Officer of Onchilles Pharma. "The ability to selectively target cancer cells while inducing a sustained immune response could provide durable clinical benefits across a wide range of tumor types."

Court R. Turner, J.D., Co-Founder & Chief Executive Officer, added, "N17350 and NEU-002 represent a transformative approach in oncology, with the potential to redefine the standard of care. We are excited about advancing N17350 into a Phase 1 trial in 2025, providing the clinical proof-of-concept for targeting the ELANE pathway and delivering innovative cancer treatments to patients."

To download the poster, click here.

About the NEU-002 Program and the ELANE Pathway

Onchilles Pharma’s NEU-002 program stems from groundbreaking research by its scientific founder, Dr. Lev Becker, who identified the ELANE pathway as a novel innate immune mechanism where neutrophil elastase (ELANE) selectively kills cancer cells while sparing healthy cells. Published in Cell in 2021, these findings have laid the foundation for developing NEU-002, which is tailored for systemic IV delivery, and N17350, designed for intratumoral administration. By leveraging the ELANE pathway, these candidates offer a unique approach to treat cancer regardless of genetic background, anatomical origin, or immunotype, positioning them as potential game-changers in cancer therapy.

Looking Ahead: Clinical Validation in 2025

Onchilles Pharma plans to initiate a Phase 1 trial of its lead candidate, N17350, in 2025 to validate the ELANE pathway in humans. This trial will further explore the safety and efficacy of this innovative mechanism, representing a significant step toward realizing the potential of ELANE-based therapies.

On November 7, 2024 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported the presentation of data pertaining to two programs, including preclinical proof-of-concept for a novel T cell engager Switch-DARPin in solid tumors, and comprehensive biomarker analyses from the completed Phase 1 clinical trial of MP0317 (Press release, Molecular Partners, NOV 7, 2024, View Source [SID1234647977]). Posters will be presented at the 2024 Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held November 8–10 in Houston, TX, with the following details:

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!

Title: Unlocking precision: a next generation multi-specific CD3 Switch-DARPin with enhanced function to tackle the current limitations of T cell engagers in ovarian cancer
Abstract & Poster Number: 842

Title: Comprehensive biomarker analyses from a Phase 1 study reveals marked tumor microenvironment modulation in patients with advanced solid tumors treated with MP0317, a FAP-localized CD40 agonistic DARPin
Abstract & Poster Number: 612

Timing & Location: November 9, 2024 at 9 am – 8:30 pm CT; Exhibit Halls AB

Both posters will be made available on Molecular Partner’s website in the Scientific Documents section.

"Our Switch-DARPin platform provides a novel approach to tumor-localized T-cell engagement and costimulation through its logic-gated on/off Switch mechanism. We are excited to have the opportunity to add this MoA to our validated CD3 T cell engager approach," said Patrick Amstutz, Ph.D., CEO of Molecular Partners. "We hope to open therapeutic avenues for co-stimulating T-cell engagers, by rendering them silent in the circulation and activating them at the tumor site."

CD3 Switch-DARPin: Preclinical proof-of-concept for T cell engager with enhanced function in solid tumors

The Switch-DARPin platform provides a logic-gated "on/off" function (the "Switch") to multispecific DARPin candidates leading to immune activation only in the presence of defined antigens. This allows targeting the immune activation to tumors, increasing both efficacy and safety and opening up new opportunities for cancer treatment. T cell engagers (TCE) are a powerful class of immuno-oncology therapies but have faced a range of challenges such as high toxicity and limited specificity, particularly against solid tumors. By employing a multi-specific Switch-DARPin, Molecular Partners aims to bring additional dimensions of safety and potency to the fundamental TCE mechanism.

The data to be presented at SITC (Free SITC Whitepaper) provide further validation of the Company’s Switch-DARPin platform and preclinical proof-of concept that conditional T cell activation in solid tumors is feasible, as exemplified in preclinical ovarian cancer models. The presented multi-specific Switch-DARPin molecule comprises DARPins targeting:

CD3, to engage and activate T cells
CD2, a co-stimulator of CD3 on T cells
Mesothelin, a notable tumor antigen overexpressed across several cancer types, including ovarian cancer, and used as anchoring target for the Switch-DARPin
And the Switch-DARPin, which binds either to the tumor antigen EpCAM or to the CD3 DARPin mentioned above. In a default state, the whole molecule is in closed state (or Switched off), masking the CD3 DARPin and preventing immune activation. When tumor antigens mesothelin and EpCAM are present, the Switch-DARPin "switches" to bind EpCAM instead of the CD3 DARPin, thereby freeing the CD3 DARPin and allowing it to bind and activate T cells. T cell activation is further enhanced through co-stimulation by the CD2 DARPin.
This CD3 Switch-DARPin molecule effectively induces potent tumor regression in vivo, with reduced cytokine release, a significant toxicity event for TCEs in the clinic, compared to an unmasked CD3 with CD2 co-stimulation. In addition, co-engagement of CD2 leads to sustained T cell activation and cytotoxic capacity. Finally, masking of CD3 prevents T cell activation in the absence of tumor antigens, hence potentially allowing for "silent" TCEs outside of tumors. Taken together, masking CD3 may reduce the risk of CRS and provide a better safety profile to TCEs.

MP0317: Comprehensive biomarker data further support CD40 activation locally in tumor microenvironment

MP0317 is a CD40 agonist designed to activate immune cells specifically within the tumor microenvironment (TME) by anchoring to fibroblast activation protein (FAP) which is expressed in high amounts in the stroma of various solid tumors. This tumor-localized approach has the potential to deliver greater efficacy with fewer side effects compared to systemic CD40-targeting therapies.

The poster presents the results of a comprehensive biomarker analyses from the completed Phase 1 multi-center, open label, dose-escalation trial of MP0317 monotherapy in patients with advanced solid tumors. The research further demonstrates the ability of MP0317 to induce a targeted, tumor-localized CD40 activation and its suitability for Q3W (every three weeks) and Q1W (weekly) dosing. The CD40 pathway is activated in a broad-spectrum of cancer types and various tumor locations. Evidence of TME remodeling in patients treated with pharmacologically active doses is exemplified by increases in dendritic cells, M1 macrophages, plasma cells, and T follicular helper cells, as well as IFNγ downstream activation and an increased dendritic cell maturation gene signature score. Peripheral pharmacodynamic effects aligned with the MP0317 mode of action are also seen, including increases in CXCL10 chemoattractant, transient B-cell reduction, and activation in blood.

Molecular Partners is in discussion with leading academic centers regarding potential investigator-initiated combination trials of MP0317.

About DARPin Therapeutics
DARPin (Designed Ankyrin Repeat Protein) therapeutics are a new class of custom-built protein drugs based on natural binding proteins that open new dimensions of multi-functionality and multi-target specificity in drug design. The flexible architecture, intrinsic potential for high affinity and specificity, small size and high stability of DARPins offer benefits to drug design over other currently available protein-based therapeutics. DARPin candidates can be radically simple, with a single DARPin unit acting as the delivery vector to a specific target; or multispecific, with the possibility of engaging more than five targets, and combining multiple and conditional functionalities in a unique DARPin drug candidate. The DARPin platform is designed to be a rapid and cost-effective drug discovery engine, producing drug candidates with optimized properties and high production yields. DARPin therapeutics have been clinically validated across several therapeutic areas and developed through to the registrational stage.

On November 7, 2024 SOTIO Biotech, a clinical-stage immuno-oncology company owned by PPF Group, reported data supporting SOT201, its next-generation PD-1-targeting immunocytokine (Press release, SOTIO, NOV 7, 2024, View Source [SID1234647993]). The company also reported advancements in its BOXR cell therapy platform, introducing an innovative chimeric PGC-1α transgene to boost CAR T cell efficacy in patients with solid tumors. SOTIO will be presenting three posters highlighting these advancements at the 2024 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Meeting, taking place November 6–10 in Houston, TX, U.S.

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!

SOT201 is a PD-1-targeted and cis-acting attenuated IL-15 agonist designed to preferentially activate PD-1+CD8+ T cells, inducing superior anti-tumor effects and reinvigorating exhausted CD8+ T cells in PD-1 sensitive and resistant tumors. The VICTORIA-01 study is a Phase 1, open-label, dose escalation trial that aims to assess the safety, tolerability, and preliminary efficacy of SOT201 as a monotherapy for adults with advanced unresectable or metastatic solid tumors (NCT06163391). This trial is currently enrolling patients across six sites in the U.S., Belgium, Spain, and the Czech Republic. Four patients have been treated so far and the treatment was well tolerated.

SOTIO Chief Scientific Officer Martin Steegmaier, Ph.D., noted, "SOT201 demonstrates a superior ability to reinvigorate exhausted tumoral CD8+ T cells with a high cytotoxicity and minimal cellular exhaustion compared to the related cytokine PD1-IL2v. These data reinforce SOT201’s reduced off-target interactions and more durable anti-tumor efficacy in vivo, underscoring its potential to address current limitations in anti-PD-1 therapies, as we continue to enroll patients in the VICTORIA-01 study."

The third poster highlights a preclinical study of a chimeric PGC-1α transgene that enhances CAR T cell activity. Chimeric PGC-1α transduced cells displayed fewer dysfunctional mitochondria and improved glucose uptake compared to CAR T cell controls. "Furthermore, the chimeric PGC-1α enhanced CAR T anti-tumor efficacy with no overt signs of toxicity, suggesting that co-expression of CAR and the chimeric PGC-1α is a promising approach to improving CAR T cell efficacy in solid tumors," added Dr. Steegmaier.

Presentation materials will be available here on Sunday, November 10, after the conference concludes.

On November 7, 2024 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, reported recent and anticipated business highlights and announced its financial results for the third quarter ended September 30, 2024 (Press release, Cullinan Oncology, NOV 7, 2024, View Source [SID1234647926]).

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!

"We are making meaningful progress in executing our strategic plans for CLN-978 in autoimmune diseases while simultaneously advancing our oncology pipeline," said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics. "We have secured clearance from the U.S. Food and Drug Administration (FDA) for our IND application and Human Research Ethics Committee (HREC) approval in Australia to initiate our global Phase 1 study for CLN-978 in moderate to severe SLE. These important regulatory clearances position us to share initial clinical data for CLN-978 in the fourth quarter of 2025. We also continue to make significant progress in advancing our oncology portfolio, with data from two of our key programs expected in 2025. For CLN-619, we remain on track to share initial expansion data for endometrial and cervical cancers in the second quarter of 2025. We also completed enrollment of the pivotal Phase 2b study of zipalertinib ahead of schedule, and we plan to provide the results at mid-year 2025."

Portfolio Highlights

Immunology

•
CLN-978 (CD19xCD3 T cell engager): Systemic lupus erythematosus and rheumatoid arthritis
o
The company obtained health authority approvals to initiate its global Phase 1 study in moderate to severe SLE, securing U.S. FDA clearance of its IND application and HREC approval in Australia. Cullinan plans to share initial clinical data for SLE in the fourth quarter of 2025. The company also continues to engage with other global health authorities to expand the planned country and site footprint.
o
The company plans to initiate a sponsored clinical trial in rheumatoid arthritis (RA) in the second quarter of 2025. The trial will be designed and executed in collaboration with FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore, Rome in Italy.
o
Cullinan is presenting preclinical data at the upcoming American College of Rheumatology (ACR) Convergence 2024, taking place in Washington, D.C. from November 14-19, 2024.
Oncology

•
CLN-619 (Anti-MICA/MICB monoclonal antibody):Solid tumors and hematological malignancies
o
In September, Cullinan dosed the first patient in a Phase 1 study of CLN-619 in patients with relapsed/refractory multiple myeloma.
o
New biomarker and translational data from the monotherapy dose escalation portion of the Phase 1 study in solid tumors will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November.
o
The company continues enrollment of disease-specific expansion cohorts of its Phase 1 study in solid tumors, enrolling cervical, endometrial and non-small cell lung cancer (NSCLC) patients. Cullinan remains on track to report initial data in endometrial and cervical cancers in the second quarter of 2025.
o
Notably, the company was issued a key composition of matter patent by the United States Patent and Trademark Office, which is expected to extend protection until at least 2041, excluding possible patent term extension.

•
Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
o
At the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in September, Cullinan presented positive REZILIENT1 results in patients with EGFR ex20ins NSCLC who have progressed on or after prior amivantamab treatment. Zipalertinib demonstrated a consistent objective response rate of approximately 40% and a manageable safety profile.
o
In September, Cullinan successfully completed enrollment of the pivotal Phase 2b study ahead of schedule, which was originally planned for the end of this year. Cullinan plans to share the results of the pivotal Phase 2b study at mid-year 2025. Taiho continues enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC.
•
CLN-049 (FLT3xCD3 T cell-engaging bispecific antibody): AML and MDS
o
Following the clinical update in Q2 2024 and discontinuation of subcutaneous administration, enrollment continues with IV administration in the ongoing Phase 1 study in patients with relapsed/refractory AML and MDS.
•
CLN-617 (IL-2 and IL-12 cytokine fusion protein): Solid tumors
o
Enrollment continues in the ongoing Phase 1 study in patients with advanced solid tumors.
Corporate Updates

•
In the third quarter, the company added two rheumatology and immunology experts to its Scientific Advisory Board (SAB): Dr. Ricardo Grieshaber-Bouyer and Dr. Chaim Putterman. Dr. Grieshaber-Bouyer and Dr. Putterman’s expertise will further strengthen the company’s Scientific Advisory Board.
o
Dr. Grieshaber-Bouyer is head of the clinical trial unit at FAU Erlangen-Nurnberg Rheumatology and Immunology Department and cares for patients with rheumatic and immune-mediated diseases, in particular in the context of emerging therapies such as T cell redirecting therapies.
o
Dr. Putterman is Professor Emeritus of the Division of Rheumatology at Albert Einstein College of Medicine and Montefiore Medical Center, where his research focuses on mechanisms of autoimmunity, pathogenesis of kidney and neuropsychiatric disease in SLE, novel therapies for lupus, and SLE biomarkers.

Third Quarter 2024 Financial Results

•
Cash Position: Cash, cash equivalents, short- and long-term investments, and interest receivable were $639.0 million as of September 30, 2024. Cullinan continues to expect its cash resources to provide runway into 2028 based on its current operating plan.
•
R&D Expenses: Research and development expenses were $35.5 million for the third quarter of 2024, compared to $33.8 million for the same period in 2023.
•
G&A Expenses: General and administrative expenses were $13.3 million for the third quarter of 2024, compared to $11.0 million for the same period in 2023.
•
Net loss: Net loss was $40.6 million ($0.69 per common share) for the third quarter of 2024, compared to $39.2 million ($0.91 per common share) for the same period in 2023.