On August 13, 2025 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company outpacing cancer to help patients outlive their disease, reported financial results for the second quarter ended June 30, 2025, and provided several business updates (Press release, Immuneering, AUG 13, 2025, View Source [SID1234655196]).

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"We are excited to announce updated OS and PFS data from our ongoing Phase 2a trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients in the coming weeks. Last quarter we reported an exceptional 94% OS observed at 6 months in first-line pancreatic cancer patients treated with atebimetinib in combination with mGnP. To put that in perspective, in the pivotal study of standard of care GnP, the 6-month OS was only 67%, and dropped rapidly to only 50% by 8.5 months," said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering. "Our exceptional 6-month overall survival data in first-line pancreatic cancer patients is generating strong interest from leading pharmaceutical companies and top-tier investors, and we look forward to sharing the latest results."

"We are busy preparing for our Phase 3 pivotal trial, and have now submitted our end of phase 2 meeting request to FDA. In addition, the granting of our composition of matter patent for atebimetinib by the United States Patent and Trademark Office (USPTO) was an important milestone for our company. We expect the long patent runway we are forging for atebimetinib will support our efforts to maximize its therapeutic potential across multiple indications," Zeskind concluded.

Corporate Highlights

Reported Positive Overall Survival Data for Atebimetinib from Ongoing Phase 2a Trial in First-Line Pancreatic Cancer Patients: In June, Immuneering shared exceptional data from its ongoing Phase 2a trial of atebimetinib in combination with modified mGnP in first-line pancreatic cancer. The company reported that 94% OS and 72% PFS were observed at 6 months (n=34; patients treated at the 320 mg once-daily dose of atebimetinib), with median OS and PFS not yet reached. A markedly favorable tolerability profile was also observed. All results were reported using a data cutoff date of May 26, 2025. Subject to regulatory feedback, the company plans to initiate a pivotal trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients in 2026.

Granted U.S. Composition of Matter Patent for Atebimetinib: In July, the company was granted a composition of matter patent for atebimetinib by the USPTO, which is expected to provide exclusivity into 2042, with subsequent opportunity for patent term extension. The patent is the first granted in the U.S. for a deep cyclic inhibitor, a once-daily pill that aims to drive longer-lasting benefit by outpacing resistance mechanisms that cause cancer drugs to stop working. Additional patent applications for atebimetinib are pending, directed to compounds, pharmaceutical compositions, and methods of use, with expiration expected into 2044.

Third-Line Pancreatic Cancer Patient Passes 18-month Mark on Atebimetinib Monotherapy: Today, Immuneering is providing an update on a pancreatic cancer patient in the third-line setting who has received atebimetinib monotherapy for more than 18 months as a participant in the company’s Phase 1 trial and who remains on treatment. The patient – who previously experienced disease progression on first-line FOLFIRINOX and second-line Gem/Cis/nab-Pac – has been on atebimetinib monotherapy at 240 mg once daily and has maintained a partial response, including a 34% reduction in target lesions (RECIST sum of longest diameters) for a confirmed partial response, and a 96% reduction in peak CA 19-9 levels. Treatment continued to be well tolerated by the patient, with a ~16% weight gain observed.
Near-Term Milestone Expectations

Immuneering is planning for several near-term milestones related to atebimetinib, including to:

Announce updated OS and PFS data from first-line pancreatic cancer patients (n = 34) treated with atebimetinib + mGnP in Q3 2025
Receive regulatory feedback on pivotal study plans in Q4 2025
Initiate pivotal, randomized trial of atebimetinib in combination with mGnP in first-line pancreatic cancer in 2026
Initiate additional atebimetinib clinical trial combination arms in 2026
Second Quarter 2025 Financial Highlights

Cash Position: Cash and cash equivalents as of June 30, 2025 were $26.4 million, compared with $36.1 million as of December 31, 2024.

Research and Development (R&D) Expenses: R&D expenses for the quarter ended June 30, 2025 were $10.5 million, compared with $10.7 million for the quarter ended June 30, 2024. The decrease in R&D expenses was primarily attributable to decreases in spend for preclinical programs, decreases in clinical spend related to the IMM-6-415 program and decreases in personnel costs to support ongoing research and development activities, offset by higher clinical costs related to the Company’s lead atebimetinib program.

General and Administrative (G&A) Expenses: G&A expenses for the quarter ended June 30, 2025 were $4.3 million, compared with $4.3 million for the quarter ended June 30, 2024. The second quarter of 2025 costs were consistent with the comparable prior period.

Net Loss: Net loss attributable to common stockholders was $14.4 million, or $0.40 per share, for the quarter ended June 30, 2025, compared to $14.1 million, or $0.47 per share, for the quarter ended June 30, 2024.

2025 Financial Guidance

Based on cash and cash equivalents as of June 30, 2025, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into 2026.

On August 13, 2025 Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), a clinical-stage biopharmaceutical company and the global leader in precision targeting of PRAME, reported a business update and announced financial results for the quarter ended June 30, 2025 (Press release, Immatics, AUG 13, 2025, View Source [SID1234655195]).

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"The presentation of positive and extended follow-up Phase 1b data at ASCO (Free ASCO Whitepaper) has further strengthened our conviction in the transformative therapeutic potential of our PRAME cell therapy, anzu-cel, in patients with advanced cutaneous and uveal melanoma," said Harpreet Singh, Ph.D., Chief Executive Officer and Co-Founder of Immatics. "The advancement of the SUPRAME Phase 3 trial remains our top priority as we strive to bring anzu-cel to the market for patients with unmet medical need. In addition, Immatics is building the broadest PRAME franchise with the most PRAME indications and modalities. In the coming months, we look forward to delivering updates on our next-generation, half-life extended PRAME bispecific, IMA402, our second-generation PRAME cell therapy, IMA203CD8, as well as data beyond PRAME from IMA401, our bispecific targeting MAGEA4/8."

Second Quarter 2025 and Subsequent Company Progress

PRAME Franchise

Anzu-cel (IMA203) PRAME Cell Therapy – Market Entry in Advanced Melanoma
Anzu-cel (anzutresgene autoleucel), previously called IMA203, is Immatics’ lead PRAME cell therapy and will be the Company’s first PRAME therapy to enter the market in advanced melanoma. The current addressable patient population for anzu-cel’s first target indications, second-line or later (2L) cutaneous melanoma as well as metastatic uveal melanoma, includes ~9,000 patients2.

Phase 3 trial, SUPRAME, for anzu-cel (IMA203) in previously treated, advanced cutaneous melanoma

Immatics’ global, randomized, controlled, multi-center Phase 3 clinical trial, SUPRAME, is currently ongoing to evaluate the efficacy, safety and tolerability of anzu-cel PRAME cell therapy vs. investigator’s choice in patients with unresectable or metastatic cutaneous melanoma who have received prior treatment with a checkpoint inhibitor.
SUPRAME is designed as a well-controlled clinical trial evaluating anzu-cel as a monotherapy in a late-stage cutaneous melanoma patient population and is intended to generate robust data to support regulatory approval of anzu-cel as Immatics advances this PRAME cell therapy towards the market.
Primary endpoint for seeking full approval will be blinded independent central review ("BICR")-assessed (RECIST v1.1) progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), safety and patient-reported outcomes about quality of life.
Pre-specified interim and final data analyses will be triggered upon the occurrence of a defined number of events for PFS (progressive disease or death). Data from the interim analysis is not intended to be published to protect the integrity of the ongoing clinical trial.
The Company remains on track for planned BLA submission in 1H 2027 and launch of anzu-cel in 2H 2027. Given the event-driven nature of the clinical trial design and based on the clinical site activation timelines, the target number of clinical trial sites and the current strong enrollment rate, Immatics estimates that the interim and final analyses will occur in 2026.
Patient recruitment is currently ongoing in the US and Germany. The SUPRAME trial is planned to be conducted in more than 65 sites across North America and Europe, including the US, Germany, France, the Netherlands, the UK and Canada.
Phase 1b trial for anzu-cel (IMA203) PRAME cell therapy in patients with metastatic melanoma

On May 31, 2025, extended follow-up data from the Phase 1b trial of anzu-cel in metastatic melanoma were presented by Martin Wermke, MD, in an oral presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting. The data further substantiate Immatics’ global leadership in precision targeting of PRAME and the potential of anzu-cel to be the Company’s first PRAME product to enter the market. A one-time infusion of anzu-cel PRAME cell therapy in all melanoma patients demonstrated favorable tolerability and promising clinical activity: cORR of 56%; mDOR of 12.1 months at mFU of 13.4 months; mPFS of 6.1 months; mOS of 15.9 months
Cutaneous melanoma subgroup, all post-checkpoint inhibitor, showed cORR of 50%, mDOR not reached at mFU of 16.7 months; mPFS of 6.0 months
Uveal melanoma subgroup, majority post-tebentafusp and checkpoint inhibitor, showed cORR of 67%, mDOR of 11.0 months at mFU of 13.4 months; mPFS of 8.5 months

Anzu-cel (IMA203) PRAME cell therapy in patients with uveal melanoma

Immatics will continue to evaluate anzu-cel in patients with uveal melanoma through the ongoing Phase 1b clinical trial. In addition, a Phase 2 cohort for ~30 patients with uveal melanoma is planned to commence in 4Q 2025.
Uveal melanoma data from the Phase 1b trial that support the Phase 2 cohort will be presented by Sapna Patel, MD, in a proffered paper presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 on October 20, 2025.
IMA203CD8 PRAME Cell Therapy (GEN2) – Expansion to all Advanced PRAME Cancers
IMA203CD8 is the Company’s second-generation PRAME cell therapy product candidate being developed with the goal of expanding into all advanced PRAME cancers. Given its enhanced pharmacology profile, once the target dose is reached, the Company intends to pursue the clinical development of this product with a tumor-agnostic approach, starting with gynecologic cancers.

Phase 1a dose escalation in solid tumors is ongoing to evaluate higher doses of IMA203CD8 with and without IL-2.
The next clinical trial update, which will report on the continued dose escalation in multiple PRAME cancers, including ovarian cancer, melanoma and synovial sarcoma treated at relevant doses, is planned for 4Q 2025.
IMA402 PRAME Bispecific – Expansion to Early-Stage PRAME Cancers

To expand the PRAME opportunity to early-stage PRAME cancers, the Company is developing its off-the-shelf, next-generation, half-life extended TCR Bispecific, IMA402. Upon delivering clinical proof-of-concept ("PoC") in last-line melanoma, Immatics plans to explore its potential in gynecologic cancers, non-small cell lung cancer (NSCLC), breast cancer and other solid tumor indications as well as earlier treatment lines of solid cancers, such as first-line (1L) cutaneous melanoma.

Phase 1a dose escalation is ongoing, and the next update with clinical data at relevant dose levels with a focus on second-line or later (2L) melanoma is planned for 4Q 2025.

Beyond the PRAME Franchise

IMA401 MAGEA4/8 Bispecific – Driving Innovation Beyond PRAME
Immatics is driving innovation beyond PRAME by evaluating its off-the-shelf, next-generation, half-life extended TCR Bispecific, IMA401, targeting MAGEA4/8 in patients with NSCLC, head & neck cancer, bladder cancer and other solid tumor indications, with the primary goal of developing this product candidate in earlier treatment lines.

Dose refinement in the Phase 1a trial evaluating IMA401 as a monotherapy and in combination with a checkpoint inhibitor is ongoing with a focus on indications with high MAGEA4/8 target expression, such as lung and head and neck cancer.
The Company expects to report updated data with a focus on head and neck cancer in 4Q 2025. Data with a focus on NSCLC are expected in 2026.
Corporate Development

The Company’s Chief Financial Officer, Arnd Christ, has informed the Company that he intends to transition out of the Company to pursue other opportunities. Arnd Christ has served as Chief Financial Officer of Immatics since 2020 and has been instrumental in driving the Company’s maturation as a publicly listed entity. He will be stepping down as Immatics enters its next phase of development and transitions to become a commercial-stage organization. The Company is commencing a search for his replacement. Arnd Christ will remain as the Company’s CFO to ensure a smooth transition until the earlier of the appointment of his successor or the end of 1Q 2026.
Moderna Collaboration: Immatics generated regulatory support data for one of Moderna’s mRNA product candidates that leveraged Immatics’ XPRESIDENT and its bioinformatics and AI platform XCUBE. Pursuant to the 2023 Collaboration Agreement under the Database/Vaccine Program, Immatics received a milestone payment triggered by the initiation of the first Phase 1 clinical trial for the Moderna product candidate.
International Nonproprietary Name: The International Nonproprietary Names (INN) Expert Committee of the World Health Organization selected anzutresgene autoleucel (anzu-cel) as the INN for Immatics’ PRAME cell therapy, previously known as IMA203. Each INN, often called a generic name, is a distinct and globally recognized designation used to identify pharmaceutical substances or active ingredients.

Second Quarter 2025 Financial Results

Cash Position: Cash and cash equivalents as well as other financial assets total $560.5 million1 (€478.2 million) as of June 30, 2025, compared to $708.5 million1 (€604.5 million) as of December 31, 2024. The decrease is mainly due to ongoing research and development activities and includes unrealized foreign exchange translational losses of $41.7 million1 (€35.6 million), which do not impact the expected cash reach.

Revenue: Total revenue, consisting of revenue from collaboration agreements, was $5.5 million1 (€4.7 million) for the three months ended June 30, 2025, compared to $22.0 million1 (€18.8 million) for the three months ended June 30, 2024.

Research and Development Expenses: R&D expenses were $52.9 million1 (€45.1 million) for the three months ended June 30, 2025, compared to $41.3 million1 (€35.2 million) for the three months ended June 30, 2024. The increase mainly resulted from costs associated with the advancement of the product candidates in clinical trials.

General and Administrative Expenses: G&A expenses were $15.0 million1 (€12.8 million) for the three months ended June 30, 2025, compared to $11.8 million1 (€10.1 million) for the three months ended June 30, 2024.

Net Profit and Loss: Net loss was $82.4 million1 (€70.3 million) for the three months ended June 30, 2025, compared to a net loss of $21.1 million1 (€18.0 million) for the three months ended June 30, 2024. The increase mainly resulted from lower revenue recognized and higher unrealized non-cash foreign exchange rate losses.

Full financial statements can be found in our Report on 6-K filed with the Securities and Exchange Commission (SEC) on August 13, 2025, and published on the SEC website under www.sec.gov.

Upcoming Investor Conferences

Cantor Global Healthcare Conference, New York (NY) – September 3 – 5, 2025
Jefferies Global Healthcare Conference, London, United Kingdom – November 17 – 20, 2025
To see the full list of events and presentations, visit: View Source

About PRAME
PRAME is a target expressed in more than 50 cancers. Immatics is the global leader in precision targeting of PRAME and has the broadest PRAME franchise with the most PRAME indications and modalities. The Immatics PRAME franchise currently includes three product candidates, two therapeutic modalities and a combination therapy that target PRAME: anzu-cel (anzutresgene autoleucel, IMA203) PRAME cell therapy, IMA203CD8 PRAME cell therapy (GEN2), IMA402 PRAME bispecific and anzu-cel in combination with Moderna’s PRAME adaptive immune modulating therapy.

On August 13, 2025 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported an update on the CX-2051 Phase 1 study to address certain recent social media posts (Press release, CytomX Therapeutics, AUG 13, 2025, View Source [SID1234655194]).

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"Since our initial data disclosure in May 2025, Phase 1 enrollment has been rapid and is substantially complete. We are on track to provide a data update in the first quarter of 2026. Patient safety remains our top priority as we continue to advance CX-2051 for the treatment of CRC," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX.

CX-2051 Program Status:

CX-2051 dose expansions at 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg doses, administered every three weeks (Q3W) have each enrolled approximately 20 patients as planned.
A single Grade 5 treatment-related acute kidney injury occured in a patient with a complex medical history including having a solitary kidney. The Grade 5 event was believed to be secondary to nausea, vomiting and diarrhea. The Company was made aware of the event on July 11, 2025 and promptly reported the event to the FDA on July 18, 2025 in accordance with regulatory requirements.
The CTMX-2051-101 Safety Review Committee convened on July 14, 2025 and supported continued study execution and enrollment.
The CTMX-2051-101 study is ongoing. A Phase 1 data update is expected by Q1 2026.

On August 13, 2025 BeyondSpring Inc. (NASDAQ: BYSI), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, reported Q2 2025 financial results alongside clinical and corporate milestones (Press release, BeyondSpring Pharmaceuticals, AUG 13, 2025, View Source;utm_medium=rss&utm_campaign=beyondspring-reports-second%25e2%2580%2591quarter-2025-financial-results-and-provides-corporate-update-accelerates-momentum-with-promising-clinical-advances-and-strategic-leadership-appointment [SID1234655193]).

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"At the heart of BeyondSpring’s pipeline is Plinabulin, a first-in-class agent potentially redefining cancer treatment by harnessing the body’s own immune system," said Dr. Lan Huang, Co-Founder, Chair, and CEO. "Plinabulin’s ability to mature dendritic cells in human studies, bridges innate and adaptive immunity, offering potentially new hope to the 60% of NSCLC patients whose disease progresses after checkpoint inhibitor therapy. In our global Phase 3 trial (Dublin-3, published in LANCET Respiratory Medicine), plinabulin and docetaxel combination compared to standard of care docetaxel alone, delivered durable survival benefits alongside reduced chemotherapy-induced neutropenia — a combination with strong potential to influence standards of care."

Dr. Huang added, "BeyondSpring’s impact extends beyond Plinabulin. As SEED Therapeutics’ ("SEED") founding shareholder, BeyondSpring, along with cornerstone investors and research collaborators Eli Lilly and Eisai, has supported SEED’s pioneering work in targeted protein degradation. SEED’s oral RBM39 molecular glue degrader, ST-01156, recently received FDA clearance to enter clinical trials, targeting aggressive cancers including Ewing Sarcoma and KRAS-driven tumors, with U.S. leading cancer institutions driving development forward."

Key Milestones:

ASCO 2025 Presentation on Plinabulin Effect in Re-sensitizing Tumors Progressed on Prior PD-1/L1 Inhibitors: New data from a phase 2 study evaluating pembrolizumab in combination with Plinabulin and docetaxel in metastatic NSCLC patients who progressed on prior PD-1/L1 inhibitors, showed encouraging efficacy and safety data. The combination demonstrated median progression-free survival (PFS) of 6.8 months, confirmed objective response rate (ORR) of 18.2%, duration of response (DOR) of 7.2 months, disease control rate (DCR) of 77%, and overall survival (OS) of 78% at 15 months.
Med (Cell Press) Publication on Plinabulin Mechanism in Dendritic Cell Maturation in Human Studies with MD Anderson Collaboration: Plinabulin, when used in combination with radiation and a checkpoint inhibitor, rapidly induces dendritic cell (DC) maturation in multiple cancer types in patients who failed prior immunotherapy. The combination was associated with tumor responses across eight types of cancer in patients previously refractory to immune checkpoint inhibitor (ICI) therapy, including NSCLC, head and neck cancer, and Hodgkin lymphoma. The study reported an ORR of 23% and a DCR of 54%. Importantly, the research identified a potential predictive biomarker, baseline GEF-H1 immune signature, which may support patient selection and clinical response prediction.
SEED’s IND Clearance from US FDA for Lead Oncology Asset RBM39 Degrader ST-01156: The U.S. Food and Drug Administration (FDA) cleared SEED’s Investigational New Drug (IND) application for ST-01156, a brain penetrant, novel orally administered molecular glue degrader targeting RBM39.
AACR 2025 Presentation on SEED’s Two Key Preclinical Advancements: 1) ST-01156 demonstrated complete tumor regression in Ewing Sarcoma models, and its corresponding mechanism, and 2) a dual-degrader approach showed promising activity in KRAS G12D target degradation and KRAS G12D-driven tumors.

SEED Strengthened Leadership: Dr. Bill Desmarais, Ph.D., MBA, joins SEED Therapeutics as CFO and Chief Business Officer, bringing two decades of leadership in finance, business development, and strategic expertise in biopharma and biotech.
Second Quarter Financial Results1

Continuing operations:

Research and development (R&D) expenses were $1.0 million for the quarter ended June 30, 2025 compared to $0.8 million for the quarter ended June 30, 2024. The $0.2 million increase was primarily due to higher professional service fees in regulatory and CMC activities as well as increased costs for Plinabulin research.
General and administrative (G&A) expenses were $0.9 million for the quarter ended June 30, 2025, compared to $1.8 million for the quarter ended June 30, 2024. The $0.9 million decrease was primarily due to lower professional service costs in consulting for business development initiatives, and lower salary expenses driven by decrease in administrative headcount.
Net loss: $1.9 million for the quarter ended June 2025, compared to $2.7 million for the quarter ended June 2024
Cash and cash equivalents: $9.5 million as of June 30, 2025, compared to $2.9 million as of December 2024
Discontinued operations:

Net loss: $2.8 million for the quarter ended June 2025, compared to $1.4 million for the quarter ended June 2024
Current assets: $15.7 million as of June 2025, compared to $25.3 million as of December 2024
Year to Date Financial Results1

Continuing Operations:

Research and development (R&D) expenses were $1.9 million for the six months ended June 30, 2025 compared to $1.6 million for the six months ended June 30, 2024. The $0.3 million increase was primarily due to higher professional service fees in regulatory and CMC activities as well as increased costs for Plinabulin research.
General and administrative (G&A) expenses were $2.7 million for the six months ended June 30, 2025, compared to $3.1 million for the six months ended June 30, 2024. The $0.4 million decrease was primarily due to lower salary expenses resulting from decrease in administrative headcount, and lower company overhead expenses mainly due to decrease in investor relations services and D&O insurance related costs.
Net loss: $4.5 million for the six months ended June 2025, compared to $4.7 million for the six months ended June 2024
Discontinued operations:

Net income (loss): $1 million for the six months ended June 2025, compared to ($2.6 million) for the six months ended June 2024
Note 1: Accounting Update

Following definitive agreements in January 2025 to sell the majority of its Series A-1 Preferred Shares in SEED Therapeutics, BeyondSpring now reports SEED’s financial results as discontinued operations under ASC 205-20. BeyondSpring currently owns approximately 40% of SEED and upon completion of the future sale transactions BeyondSpring would own approximately 14% of SEED’s outstanding shares.

On August 13, 2025 Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function, reported financial results for the second quarter ended June 30, 2025, and provided recent business highlights (Press release, Aura Biosciences, AUG 13, 2025, View Source [SID1234655192]).

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"We continued to focus on execution in our clinical programs in the second quarter, including our ongoing global Phase 3 CoMpass trial in early choroidal melanoma and our Phase 1b/2 trial in NMIBC," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. "With the successful completion of our recent equity financing, we believe we are well positioned to advance the clinical development of bel-sar in our ocular and urologic oncology programs, where we believe our unique mechanism of action has the potential to meaningfully impact the lives of patients."

Recent Pipeline Developments

Early Choroidal Melanoma

Ongoing Phase 3 CoMpass Trial: CoMpass is the first registration-enabling study in early choroidal melanoma. The study is a global, Phase 3, randomized trial evaluating bel-sar treatment against a sham control arm utilizing an enrichment strategy to enroll approximately 100 patients with documented tumor growth.

The CoMpass trial is actively enrolling globally. To identify patients meeting the enrichment criteria of documented growth, the Company implemented a pre-screening ‘run in’ period. Investigators have registered over 240 patients in this pre-screening tool as having met initial enrollment criteria for the study, highlighting the global need for a frontline vision-preserving therapy. With this progress globally, the Company believes study enrollment may be completed as early as the end of 2025.

The Company previously received Orphan Drug Designation from the FDA and the European Medicines Agency and Fast Track designation from the FDA for the treatment of early choroidal melanoma. The CoMpass trial is under a Special Protocol Assessment agreement with the FDA.

Additional Ocular Oncology Indications

In addition to early choroidal melanoma, bel-sar is in development for metastases to the choroid and cancers of the ocular surface. These three ocular oncology indications have a collective annual incidence of greater than 60,000 patients in the United States and Europe.

Metastases to the Choroid

Metastases to the choroid is an indication with high unmet medical need and no approved therapies. Bel-sar has the potential to treat a wide variety of tumor types that metastasize from several primary tumors. The Company has initiated a Phase 2 clinical trial in metastases to the choroid from breast and lung cancer and have activated sites with patients in prescreening in the United States. The Company is currently implementing a protocol amendment for the Phase 2 trial to broaden the inclusion criteria beyond breast and lung cancer to include all metastases from different solid tumors, an approach supported by pre-clinical models that demonstrate robust efficacy across a range of solid tumors. The Company believes that this approach, in addition to advancing bel-sar in metastases to the choroid, can provide clinical insights into multiple tumor types that could be impacted by bel-sar. The Company expects initial data from this trial in 2025.

Metastases to the choroid represents the second potential ocular oncology indication for bel-sar, affecting approximately 20,000 patients annually in the United States and Europe. The Company previously received FDA Fast Track designation for bel-sar in this indication.

Cancers of the Ocular Surface

The Company’s third potential ocular oncology indication is cancers of the ocular surface, which affects approximately 35,000 patients in the United States and Europe annually and has no approved therapies. The Company’s pre-clinical activities in cancers of the ocular surface remain on track, and we plan to have initial data from an early proof of concept Phase 1 clinical trial in 2026.

Bladder Cancer

Ongoing Phase 1b/2 Trial: Based on the positive data from the Phase 1 window of opportunity trial, the Company is advancing the development of bel-sar in NMIBC. The ongoing Phase 1b/2 trial will evaluate additional doses and cycles of bel-sar in approximately 26 intermediate and high-risk NMIBC patients. The trial will evaluate two approaches: an immune ablative design and a multimodal neoadjuvant design. In the immune ablative approach, bel-sar will be administered in two cycles without the need for a transurethral resection of the bladder tumor (TURBT). In the multimodal neoadjuvant cohorts, bel-sar will be administered in two cycles ahead of TURBT. For both approaches, patients will be monitored for response assessments and recurrence at 3, 6, 9, and 12 months. This trial is actively enrolling and remains on track.

Patent Application Filed for New Formulation of Bel-sar for Use in Bladder Cancer: The Company has filed a patent application with the U.S. Patent and Trademark Office for a new formulation of bel-sar for use in urologic oncology, which if issued, would provide patent coverage for this formulation into 2046. This new formulation is designed to enable convenient in-office urologist procedures with enhanced storage and handling at refrigerated conditions (2-8 Celsius).

Second Quarter 2025 Financial Results

•
As of June 30, 2025, Aura had cash and cash equivalents and marketable securities totaling $177.3 million. The Company believes its current cash and cash equivalents and marketable securities are sufficient to fund its operations into the first half of 2027.

•
Research and development expenses increased to $22.9 million for the three months ended June 30, 2025 from $16.9 million for the three months ended June 30, 2024, primarily due to ongoing clinical and CRO costs associated with the progression of our global Phase 3 trial of bel-sar in early choroidal melanoma and manufacturing and development costs for bel-sar.

•
General and administrative expenses decreased to $5.7 million for the three months ended June 30, 2025 from $5.9 million for the three months ended June 30, 2024. General and administrative expenses include $1.8 million and $1.6 million of stock-based compensation for the three months ended June 30, 2025 and 2024, respectively. The decrease was primarily driven by reduced professional fees.

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Net loss for the three months ended June 30, 2025 was $27.0 million compared to $20.3 million for the three months ended June 30, 2024.