On November 6, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer reported it will present a poster on its proprietary VacDesignR computational tool at the upcoming ESMO (Free ESMO Whitepaper) AI & Digital Oncology 2025 conference, held in Berlin, Germany, from 12-14 November 2025.

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The presentation will highlight how VacDesignR streamlines the design and production of recombinant Modified Vaccinia Ankara (MVA)-based vectors, enabling faster and more reliable manufacturing of individualized neoantigen therapeutic vaccines (INTV).
The individualized immunotherapies developed through the myvac platform, currently being evaluated in a Phase I/II clinical trial (NCT04183166), are based on an MVA viral vector and their design already leverages the VacDesignR tool.

Developed in-house, VacDesignR is a computational design engine that optimizes recombinant plasmid architecture for MVA vectors, a core component of Transgene’s myvac platform. By minimizing unwanted homologous recombination and intelligently selecting peptide sequences for cassette assembly, VacDesignR significantly improves production reliability and vector quality.

Future iterations of VacDesignR will incorporate AI-based components to further improve performance and scalability, supporting Transgene’s strategy to accelerate production timelines for individualized therapeutic vaccines, including its lead candidate TG4050 designed to treat HPV-negative head and neck cancers following surgery and adjuvant therapy.

"Participating at the first edition of the ESMO (Free ESMO Whitepaper) AI & Digital Oncology meeting highlights Transgene’s pioneering role in combining viral vector-based individualized cancer vaccines with its vaccine design tool to optimize product performance and redefine the future of oncology treatment", commented Maurizio Ceppi, Chief Scientific Officer of Transgene.

Title of the abstract: "VacDesignR: a computational tool to optimize viral-based individualized neoantigen therapeutic vaccine production"

Title of the poster: "VacDesignR: a tool for optimizing recombinant poxvirus vaccine production"

Poster and Abstract number: 385P
Session: Drug development
Date: November 12, 2025
Author: B. Grellier
The poster presentation will take place on November 12 at ESMO (Free ESMO Whitepaper)-AI conference and will be available that day on Transgene’s website.

VacDesignR is a computer-assisted method protected through patent and patent applications derived from WO2021/130210.

(Press release, Transgene, NOV 6, 2025, View Source [SID1234659484])

On November 6, 2025 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported corporate updates and announced financial results for the quarter ended September 30, 2025. The Company continues to advance a portfolio that seeks to redefine access to cell therapy, bringing the power of CAR T earlier in disease, more reliably, and across a broader range of treatment settings.

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"With our unique allogeneic approach to CAR T, the field has the ability to shift from highly personalized, patient-specific therapies to a new era of readily available, off-the-shelf treatments that can reach more patients earlier in their disease and wherever they receive care," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "Having treated hundreds of patients, we’ve gained valuable insight into how ex vivo manufacturing enables more precise definition and control of our cell products before they reach patients, enhancing consistency, safety, and quality. This transformation is evident and goes far beyond incremental progress, it begins to establish a scalable allogeneic CAR T paradigm built to reach more patients, expand into broader care settings, and unlock the full potential of cell therapy."

Cema-Cel: Pivotal Phase 2 ALPHA3 1L Consolidation Trial in LBCL
The pivotal Phase 2 ALPHA3 trial with cema-cel is pioneering the use of allogeneic CAR T therapy in earlier-line treatment of LBCL, an approach that could expand access for patients before disease progression and simplify delivery across community and academic centers. By leveraging minimal residual disease (MRD) as a guide for treatment intervention, a rapidly emerging focus across oncology, the ALPHA3 trial aims to position Allogene at the forefront of a transformative shift toward earlier, more precise, treatment. More than 50 clinical sites are active across the United States and Canada, spanning both community cancer centers and leading academic institutions. Additional sites in Australia and South Korea are progressing toward activation and are expected to open in early 2026.

The next milestone will be the futility analysis comparing MRD conversion between the two arms comparing cema-cel after standard fludarabine and cyclophosphamide (FC) lymphodepletion versus observation, expected in the first half of 2026. At that time, the Company plans to share MRD conversion rates from the randomized portion of the study.

ALLO-329: CD19/CD70 Dual CAR with Dagger Technology in AID
The Phase 1 RESOLUTION trial with ALLO-329, a dual CD19/CD70 CAR incorporating Dagger technology, is enrolling in a basket trial across multiple autoimmune conditions, including systemic lupus erythematosus (with or without lupus nephritis), idiopathic inflammatory myopathies, and systemic sclerosis. In this dose-escalation study, two treatment regimens are being explored: one with reduced intensity cyclophosphamide-only lymphodepletion, and the other with no lymphodepletion at all, a potential breakthrough for improving tolerability and enabling treatment in a broader patient population.

With its built-in lymphodepletion coming from the Dagger technology as well as its ability to target both B cells and activated T cells, key drivers of autoimmune pathology, ALLO-329 represents one of the first to investigate how allogeneic CAR T could be uniquely suited to treat autoimmune disease at scale, with reduced or without lymphodepletion to facilitate a broader CAR T adoption in autoimmune indications. The first clinical update, expected in 1H 2026, will include biomarker data and clinical proof-of-concept data.

ALLO-316: TRAVERSE Trial in RCC
ALLO-316 remains the only allogeneic CAR T therapy to show clinically significant response rates and meaningful durability of response in a metastatic solid tumor. The TRAVERSE trial in renal cell carcinoma has completed enrollment in its Phase 1b cohort, evaluating ALLO-316 in heavily pretreated patients. Updated data presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting demonstrated early signs of efficacy and tolerability.

2025 Third Quarter Financial Results

Research and development expenses were $31.2 million for the third quarter of 2025, which includes $2.8 million of non-cash stock-based compensation expense.
General and administrative expenses were $13.7 million for the third quarter of 2025, which includes $5.9 million of non-cash stock-based compensation expense.
Net loss for the third quarter of 2025 was $41.4 million, or $0.19 per share, including non-cash stock-based compensation expense of $8.7 million.
The Company had $277.1 million in cash, cash equivalents, and investments as of September 30, 2025.
The Company continues to expect its cash runway to extend into the second half of 2027. Guidance for 2025 is an expected decrease in cash, cash equivalents, and investments of approximately $150 million. GAAP Operating Expenses are expected to be approximately $230 million, including estimated non-cash stock-based compensation expense of approximately $45 million. These estimates exclude any impact from potential business development activities.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 2:00 p.m. PT / 5:00 p.m. ET to discuss financial results and provide a business update. If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. The listen-only webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

(Press release, Allogene, NOV 6, 2025, View Source [SID1234659551])

On November 6, 2025 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported financial results for the third quarter ended September 30, 2025, and provided a review of recent program and corporate developments.

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"We are incredibly proud of the progress across our entire pipeline this quarter, most notably around our NDA submission for bitopertin in EPP at the end of September and subsequent receipt of the CNPV," said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. "Achieving this milestone is a strong testament to our team’s commitment to execution and dedication to bringing a potential new treatment option to the EPP patient community. We continue to work with the Agency on their review of our application, and we are furthering our commercial infrastructure in preparation for a potential launch."

"Beyond bitopertin, our broader pipeline is progressing well, as we expect new data from the Phase 2 trial of DISC-0974 in MF anemia by the end of the year and data from studies of DISC-3405 in PV and SCD next year. With a strong balance sheet providing cash runway into 2029, we are well-positioned to prepare for the anticipated launch of bitopertin and ultimately advancing towards our goal of delivering new treatment options to patients suffering from hematological diseases."

Recent Highlights and Anticipated Milestones:

Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator)

Submitted NDA for bitopertin in EPP seeking priority review and accelerated approval with reduction in protoporphyrin IX (PPIX) as the surrogate endpoint for approval supported by clinical results from BEACON and AURORA Phase 2 trials
Received the CNPV, which is designed to shorten the NDA review process to 1-2 months from NDA acceptance
Accelerating activities to support a potential US approval and launch in late 2025 or early 2026
Progressing confirmatory Phase 3 APOLLO clinical trial of bitopertin in adults and adolescents with EPP
DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression)

Initial data from Phase 2 RALLY-MF trial of DISC-0974 in patients with anemia of myelofibrosis (MF) to be presented at ASH (Free ASH Whitepaper) Annual Meeting in December, with topline data expected in 2026
Data from recently completed multiple-dose cohorts of Phase 1b study of DISC-0974 in patients with anemia of NDD-CKD to be presented at ASN Kidney Week
DISC-0974 was generally well-tolerated with substantial decreases in hepcidin, increases in iron, and improvements in markers of erythropoiesis
Meaningful hemoglobin increases observed in only a subset of patients were in part driven by those with higher baseline erythropoietin (EPO) levels
Disc is assessing options for the program based on full analysis of the data
Phase 2 study in patients with inflammatory bowel disease (IBD) and anemia anticipated to begin in Q1 2026
DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction)

Progressing ongoing Phase 2 study of DISC-3405 in patients with PV with initial data expected in 2026
Initiated Phase 1b study of DISC-3405 in patients with SCD in October 2025 with initial data expected in 2026
Third Quarter 2025 Financial Results:

Cash Position: Cash, cash equivalents, and marketable securities were $615.9 million as of September 30, 2025. In October 2025, Disc completed a public offering with net proceeds of approximately $211 million, extending cash runway into 2029.
Research and Development Expenses: R&D expenses were $50.3 million for the three months ended September 30, 2025, as compared to $24.7 million for the three months ended September 30, 2024. The increase in R&D expenses was primarily driven by the progression of Disc’s portfolio, including bitopertin’s clinical studies and drug manufacturing, the advancement of the DISC-0974 program, and increased headcount, as well as a payment of a $10.0 million milestone upon first administration to a patient in the Phase 2 trial of DISC-3405.
Selling, General and Administrative Expenses: SG&A expenses were $17.4 million for the three months ended September 30, 2025, as compared to $8.2 million for the three months ended September 30, 2024. The increase in SG&A expenses was primarily due to increased headcount including establishing infrastructure to support potential commercialization.
Net Loss: Net loss was $62.3 million for the three months ended September 30, 2025, as compared to $26.6 million for the three months ended September 30, 2024. The increase was primarily due to higher operating costs in the current period to support the continued advancement of our pipeline.

(Press release, Disc Medicine, NOV 6, 2025, View Source [SID1234659567])

On November 6, 2025 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported the publication of a peer-reviewed research paper in Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The scientific paper details the discovery and development of enozertinib (formerly ORIC-114), a highly brain-penetrant, orally bioavailable, irreversible inhibitor that targets EGFR exon 20 mutations with exquisite kinome selectivity.

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EGFR mutations are common oncogenic drivers in non-small cell lung cancer (NSCLC), and approximately 50% of patients may develop brain metastases over the course of their disease. Additionally, patients with non-classical EGFR mutations, such as insertions in exon 20, have a worse prognosis compared to patients with classical EGFR mutations. There remains an unmet need for a highly selective EGFR inhibitor that is also brain-penetrant to effectively treat and control intracranial disease.

The Cancer Research publication details preclinical data demonstrating enozertinib’s exquisite kinome selectivity, strong potency, brain-penetrance, and anti-tumor activity, including in intracranial lung cancer models, across a broad range of atypical EGFR mutant contexts. This publication also highlights a patient vignette in which treatment with enozertinib resulted in a sustained complete response of all systemic and brain metastases in a patient with NSCLC whose tumors harbored an EGFR exon 20 insertion mutation. To ORIC’s knowledge, enozertinib is the only EGFR exon 20 inhibitor to demonstrate a systemic complete response and CNS complete response in a patient with untreated, active brain metastases.

"These studies affirm our belief that enozertinib is uniquely positioned to address the unmet needs in patients with NSCLC driven by EGFR exon 20 and atypical mutations," said Melissa Junttila, PhD., vice president, head of biology at ORIC, and first author of the publication. "We look forward to sharing additional clinical data for enozertinib later this year and in mid-2026 and further elucidating its best-in-class potential."

The full manuscript, titled "Enozertinib is a Selective, Brain-Penetrant EGFR Inhibitor for Treating Non-small Cell Lung Cancer with EGFR Exon 20 and Atypical Mutations," is available online at Cancer Research.

ORIC anticipates the following upcoming data milestones for enozertinib in NSCLC:

December 2025: 1L EGFR exon 20, 2L EGFR exon 20, 2L+ HER2 exon 20 and 2L+ EGFR atypical data to be presented at ESMO (Free ESMO Whitepaper) Asia 2025
Mid-2026: 1L EGFR atypical data and 1L EGFR exon 20 combination with SC amivantamab data

(Press release, ORIC Pharmaceuticals, NOV 6, 2025, View Source [SID1234659583])

On November 6, 2025 Moderna, Inc. (NASDAQ:MRNA) reported financial results and provided business updates for the third quarter of 2025.

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"We delivered strong commercial and financial performance in the third quarter, supported by COVID vaccine sales following the successful launch of mNEXSPIKE and a significant improvement in expected 2025 operating expenses from our ongoing cost-reduction initiatives," said Stéphane Bancel, Chief Executive Officer of Moderna. "We remain highly focused on operational excellence and financial discipline to advance our pipeline and expand the reach of our commercial portfolio. We look forward to sharing further updates on our business and pipeline at our annual Analyst Day on November 20."

Recent progress includes:

Commercial Updates

COVID-19: The Company reported $971 million in COVID vaccine sales in the third quarter of 2025, which includes $781 million of U.S. sales and $190 million of international sales. The Company has received approval in 40 countries of its 2025-2026 formula for Spikevax. Moderna has also received U.S. Food and Drug Administration (FDA) approval of its 2025-2026 formula for mNEXSPIKE, the Company’s new COVID vaccine in all adults aged 65 and older, as well as individuals aged 12-64 years with at least one underlying risk factor. mNEXSPIKE is also approved in Canada and the Company has filed and is targeting 2026 approvals in Australia, the EU, Japan and Taiwan.

RSV: The Company reported $2 million in mRESVIA sales in the third quarter of 2025. mRESVIA, the Company’s vaccine for the prevention of lower respiratory tract disease (LRTD) caused by RSV, is approved for all adults aged 60 years and older in 40 countries. It is also approved in 31 of those countries for individuals 18-59 years of age who are at increased risk for disease.

Third Quarter 2025 Financial Results

Revenue: Total revenue for the third quarter of 2025 was $1.0 billion, a 45% decrease from $1.9 billion in the same period in 2024. The decline was primarily driven by a $847 million, or 47%, decrease in net product sales, mainly due to lower COVID vaccine sales. In the U.S., the decrease reflected reduced vaccination rates year over year. The third quarter of 2024 also included an approximately $140 million positive adjustment related to prior-period sales provision estimates, which did not recur in 2025. During the quarter, the Company initiated commercial sales in the U.S. of mNEXSPIKE, as part of the 2025-2026 respiratory virus season.Outside the U.S., revenue decreased primarily due to the completion of certain government contracts and the timing of deliveries.

Cost of Sales: Cost of sales for the third quarter of 2025 was $207 million, which included third-party royalties of $43 million and inventory write-downs of $67 million. Cost of sales decreased 60% compared to the same period in 2024, primarily reflecting lower inventory write-downs and reduced unutilized manufacturing capacity, as well as lower sales volume. As a percentage of net product sales, cost of sales was 21% compared to 28% in the third quarter of 2024. The improvement was mainly driven by productivity gains and efficiencies across manufacturing operations despite lower volumes.

Research and Development Expenses: Research and development expenses for the third quarter of 2025 were $801 million, a 30% decrease compared to the same period in 2024. The reduction was primarily driven by continued investment prioritization and efficiency gains in the execution of clinical trials. Last year’s results also included an expense related to the purchase of a priority review voucher.

Selling, General and Administrative Expenses: Selling, general and administrative expenses for the third quarter of 2025 were $268 million, a 5% decrease compared to the same period in 2024. The decline was primarily driven by reductions in consulting and external services across multiple functions, as well as lower digital and facility-related costs, reflecting the Company’s continued cost discipline and ongoing efforts to streamline operations.

Income Taxes: Income tax provisions for both periods were not material, as the Company continues to maintain a global valuation allowance against most of its deferred tax assets.

Net Income (Loss): Net loss was $(200) million for the third quarter of 2025, compared to net income of $13 million for the third quarter of 2024.

Earnings (Loss) Per Share: Loss per share was $(0.51) for the third quarter of 2025, compared to earnings per share of $0.03 for the third quarter of 2024.

Cash Position: Cash, cash equivalents and investments as of September 30, 2025, were $6.6 billion, compared to $7.5 billion as of June 30, 2025. The decrease during the quarter was primarily driven by seasonal impacts on working capital.

2025 Financial Framework

Revenue: The Company narrowed its 2025 projected revenue range from $1.5 to $2.2 billion to $1.6 to $2.0 billion, reflecting third quarter results and expectations for the remainder of the year.

Cost of Sales: Cost of sales for 2025 is expected to be approximately $0.8 to $0.9 billion, lowered from $1.2 billion.

Research and Development Expenses: Research and development expenses for 2025 are anticipated to be $3.3 to $3.4 billion, lowered from previous expectations of $3.6 to $3.8 billion.

Selling, General and Administrative Expenses: Selling, general and administrative expenses for 2025 are projected to be approximately $1.1 billion.

Income Taxes: The Company continues to expect its full-year tax expense to be negligible.

Capital Expenditures: Capital expenditures for 2025 are expected to be approximately $0.3 billion.

Cash and Investments: Year-end cash and investments for 2025 are projected to be $6.5 to $7 billion, increased from previous expectations of approximately $6 billion.

Recent Progress and Upcoming Late-Stage Pipeline Milestones

Respiratory vaccines:

Seasonal flu vaccine: In October 2025, Moderna presented Phase 3 efficacy and safety data for its seasonal flu vaccine (mRNA-1010) at IDWeek 2025, and Phase 3 relative vaccine efficacy in a high-risk subset of patients at The European Scientific Working Group on Influenza (ESWI) Conference 2025. The Company expects to complete submissions for approval of mRNA-1010 in the U.S., Canada, Australia and Europe by January 2026.

Seasonal flu + COVID vaccine: The Company presented Phase 3 immunogenicity subanalyses for its flu/COVID combination vaccine (mRNA-1083) for adults aged 50 years and older at ESWI 2025. The Company expects to refile with Health Canada in 2025 and is awaiting further guidance from U.S. FDA on refiling. Currently, the Company’s mRNA-1083 filing is under review with the European Medicines Agency (EMA).

Latent and other vaccines:

Norovirus vaccine: Moderna’s ongoing Phase 3 safety and efficacy study of its trivalent vaccine against norovirus (mRNA-1403) has not accrued sufficient cases and will now enroll a second Northern Hemisphere season (2025-2026) for additional case accruals. The timing of the Phase 3 readout will continue to be dependent on case accruals.

Cytomegalovirus (CMV) vaccine: After announcing that the Phase 3 study of mRNA-1647 did not meet its primary efficacy endpoint, Moderna is discontinuing development of its congenital CMV program. The Company will continue to evaluate mRNA-1647 in an ongoing Phase 2 trial of bone marrow transplant patients.

Oncology therapeutics:

Intismeran autogene: Moderna continues to make progress on advancing mRNA-4157 in the clinic.In collaboration with Merck, the Phase 3 clinical trial for adjuvant melanoma is fully enrolled. Two non-small cell lung cancer (NSCLC) Phase 3 studies for those with and without prior neoadjuvant treatment are enrolling. Separate randomized Phase 2 studies for high-risk muscle invasive and high-risk non-muscle invasive bladder cancer are enrolling, a Phase 2 study of first-line treatment for patients with metastatic melanoma is also enrolling, and a randomized Phase 2 study for adjuvant renal cell carcinoma is fully enrolled. Further, Moderna and Merck have launched a new Phase 2 study of first-line treatment for patients with metastatic squamous NSCLC.

mRNA-4359: The Phase 1/2 study of mRNA-4359, Moderna’s investigational mRNA-based therapy designed to elicit T-cell immune responses against tumor and immunosuppressive cells, is ongoing. Phase 1b data for mRNA-4359 was recently presented at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. The Phase 2 portion of the study, which includes cohorts in first-line metastatic melanoma and first-line metastatic NSCLC, is enrolling patients.

Rare disease therapeutics:

Propionic acidemia (PA) therapeutic: The Company recently presented final results from the Part 1 dose-escalation cohorts of its ongoing Phase 1/2 study and cumulative data from ongoing participants in the extension study of its investigational therapeutic for PA (mRNA-3927) at the International Congress of Inborn Errors of Metabolism (ICIEM) 2025. In the study, which is designed to evaluate safety and pharmacology in trial participants with PA, mRNA-3927 has been generally well-tolerated to date with no events meeting protocol-defined dose-limiting toxicity criteria. Previously presented results suggest potential decreases in annualized metabolic decompensation event (MDE) frequency compared to pre-treatment, and the majority of patients have elected to continue on the open label extension study. The Company’s PA candidate is in a registrational study and target enrollment has been reached.

Methylmalonic acidemia (MMA) therapeutic: Moderna recently shared interim data from the Phase 1/2 study of its investigational therapeutic for MMA (mRNA-3705) at ICIEM 2025. mRNA-3705 has been selected by the FDA for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program, and the FDA and Moderna have agreed on the pivotal study design. The Company expects to start a registrational study in 2026.

Moderna Corporate Updates

The Company opened its state-of-the-art manufacturing and R&D facility in the UK, which is now licensed by the Medicines and Healthcare products Regulatory Agency (MHRA)

Moderna announced the first made-in-Canada mRNA vaccines were delivered to Canadian provinces and territories

The Company’s manufacturing facility in Australia was recently granted its Good Manufacturing Practice (GMP) license from the Therapeutic Goods Administration (TGA)

Company Accolades

Moderna was recognized on BioSpace’s Best Places to Work in Biopharma ranking of large employers (fifth consecutive year)

Moderna was ranked as a top employer in the global biopharmaceutical industry by Science on the Science Careers’ 2025 Top Employers Survey (eleventh consecutive year)

Key 2025 Investor and Analyst Event Dates

Analyst Day: November 20

Investor Call and Webcast Information

Moderna will host a live conference call and webcast at 8:00 a.m. ET on November 6, 2025. To access the live conference call via telephone, please register at the link below. Once registered, dial-in numbers and a unique pin number will be provided. A live webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website.

Telephone: View Source

Webcast: View Source

The archived webcast will be available on Moderna’s website approximately two hours after the conference call and will be available for one year following the call.

(Press release, Moderna Therapeutics, NOV 6, 2025, https://feeds.issuerdirect.com/news-release.html?newsid=4949430645007740&symbol=MRNA [SID1234659611])