On August 12, 2025 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel allogeneic, or "off the shelf", cell therapies for serious neurological and ophthalmic conditions, reported its second quarter 2025 financial and operating results and will host a conference call today at 4:30 p.m. Eastern Time to discuss these results and provide a business update (Press release, Lineage Cell Therapeutics, AUG 12, 2025, View Source [SID1234655157]).

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"Following the recent positive 36-month clinical data update with the OpRegen RPE cell therapy program, which is licensed by Genentech and Roche, we continue to remain confident in its potential to address a significant medical need, especially because long term clinical outcomes following a single administration of OpRegen cell therapy are challenging the long-held view that GA is an irreversible condition," stated Brian M. Culley, Lineage CEO. "It is notable that among patients who received extensive one-time coverage of OpRegen RPE cells across the area of atrophy, anatomical and functional benefits have lasted for at least three years, outcomes consistent with meaningful disease stabilization and even improvement."

"In addition to supporting our partners in advancing the OpRegen program, we are equally excited to have reached a milestone with our OPC1 program for the treatment of spinal cord injury, treating our first-ever chronic patient with a new parenchymal spinal delivery system. We also solidified our position as a leader in allogeneic cell process development and manufacturing by reporting in-house GMP production for each of two separate cell-based product candidates from a master and working cell bank system which, in its current form, can support a production capability of several million doses for a single-administration product. This is in addition to continuing to advance our ReSonanceTM program for the treatment of sensorineural hearing loss and evaluating other strategically selected early-stage initiatives. As our cell therapy platforms gain further validation, we believe our pipeline and cell manufacturing and related expertise continue to position us as a compelling partner and investment opportunity," added Mr. Culley.

Select Business Highlights

RG6501 (OpRegen Cell Therapy)
Positive RG6501 (OpRegen) Phase 1/2a Clinical Study 36 Month Results featured at Clinical Trials at the Summit (CTS) 2025. 2025 CTS highlights:
Gains in Best Corrected Visual Acuity (BCVA) in patients in Cohort 4 (less advanced GA) measured at month 12 remain evident through month 36 following subretinal administration of OpRegen cell therapy;
Mean change in BCVA among treated eyes for patients (n=10) completing 3-year follow up was +6.2 letters (compared to +5.5 letters at 24 months) (Early Treatment Diabetic Retinopathy Study (ETDRS) assessment);
Improvement in BCVA and outer retinal structure in patients with extensive OpRegen bleb coverage of their GA area was greater than in patients with limited coverage and persisted through month 36
Effects were greater on average in the five (5) patients with extensive OpRegen cell therapy coverage of atrophic areas at the time of surgical delivery
In these patients’ treated eyes, the mean change in BCVA was +9.0 ETDRS letters for those completing 3-year follow-up (compared to +7.4 ETDRS letters at 24 months) (n=5)
These data suggest that OpRegen cell therapy may counteract RPE cell dysfunction and loss in GA by providing support to the remaining retinal cells within atrophic areas, and these effects appear durable through at least 36 months after a single administration

Ongoing execution of Lineage’s contributions to its collaboration with Roche and Genentech across multiple functional areas, including support for the ongoing Phase 2a clinical study (the "GAlette Study") in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) at sites in the U.S. and Israel.
In addition to testing of other surgical parameters, Genentech currently plans to evaluate two proprietary surgical delivery devices that have potential advantages over available off-the-shelf devices in the GAlette Study.

Ongoing efforts to further support development of OpRegen RPE cell therapy under a separate services agreement with Genentech, signed May 2024, including: (i) activities to support the ongoing Phase 1/2a study long term follow-up and the currently enrolling Phase 2a GAlette Study; and (ii) additional technical training and materials related to our cell therapy technology platform to support commercial manufacturing strategies.

Manufacturing Capability
Successfully completed a production run for two different product candidates, each produced from a customized, two-tiered current Good Manufacturing Practice ("cGMP") cell banking system, highlighting the application of the Lineage platform across multiple programs.
This production process utilizes a genetically-stable master cell bank created from a single, well-characterized pluripotent cell line, to generate a working cell bank, which then provides the source material for a final cell-based product candidate.
This demonstrated cGMP production process should enable the ability to produce millions of doses of a cost-effective, scalable and consistent supply of an allogeneic, cell-based product derived from a single initial cell line, that can be applied across multiple programs.

OPC1
First chronic spinal cord injury patient treated in the DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) clinical study.
First chronic SCI patient treated in DOSED was a neurologically complete SCI injury (American Spinal Injury Association Impairment Scale [AIS] grade A), with a single neurological level of injury (NLI) from levels T1 to T10, and the novel delivery system successfully administered a one-time injection of OPC1.
Hosted the 3rd Annual Spinal Cord Injury Investor Symposium (3rd SCIIS) in partnership with the Christopher & Dana Reeve Foundation.
Balance Sheet Highlights

Cash, cash equivalents, and marketable securities of $42.3 million as of June 30, 2025, is expected to support planned operations into Q1 2027.

Second Quarter Operating Results

Revenues: Revenue is generated primarily from collaboration revenues, royalties, and other revenues. Total revenues for the three months ended June 30, 2025 were $2.8 million, a net increase of $1.4 million as compared to $1.4 million for the same period in 2024. The increase was primarily driven by more collaboration revenue recognized from deferred revenues under the Roche Agreement, as well as deferred revenues recognized upon termination of the VAC platform-related collaboration agreement.

Operating Expenses: Operating expenses are comprised of research and development ("R&D") expenses and general and administrative ("G&A") expenses. Total operating expenses for the three months ended June 30, 2025 were $22.5 million, an increase of $15.2 million as compared to $7.3 million for the same period in 2024. The overall increase was driven by the $14.8 million expense recognized for the loss on impairment for the intangible asset related to the VAC platform.

R&D Expenses: R&D expenses for the three months ended June 30, 2025 were $3.1 million, an increase of $0.2 million as compared to $2.9 million for the same period in 2024. The net increase was primarily driven by ongoing activities within our preclinical programs.

G&A Expenses: G&A expenses for the three months ended June 30, 2025 were $4.6 million, an increase of $0.2 million as compared to $4.4 million for the same period in 2024. The net increase was primarily driven by more costs incurred for services provided by third parties.

Loss from Operations: Loss from operations for the three months ended June 30, 2025 were $19.8 million, an increase of $13.9 million as compared to $5.9 million for the same period in 2024. This increase in loss was primarily driven by the impairment expense related to the VAC platform of $14.8 million, which is a non-recurring transaction.

Other Income/(Expenses): Other income/(expenses) for the three months ended June 30, 2025 reflected other expense of $10.6 million, compared to other income of $0.1 million for the same period in 2024. The net change was primarily attributable to the quarterly fair value remeasurement of the warrant liabilities of $12.7 million primarily due to an increase in our share price as compared to the prior quarter, partially offset by $1.7 million for exchange rate fluctuations related to Lineage’s international subsidiaries.

Net Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended June 30, 2025 was $30.5 million, or $0.13 per share (basic and diluted), compared to a net loss of $5.8 million, or $0.03 per share (basic and diluted), for the same period in 2024. The change was primarily driven by the loss on impairment expense related to a 2019 acquisition and the quarterly fair value remeasurement of the warrant liabilities.

Conference Call and Webcast

Interested parties may access the conference call on August 12, 2025, by dialing (800) 715-9871 from the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through August 19th, 2025, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 7788342.

On August 12, 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 provided financial results for the quarter ended June 30, 2025 (Press release, Immatics, AUG 12, 2025, View Source [SID1234655156]).

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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

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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.

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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.
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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.
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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.
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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.
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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

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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
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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
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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

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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.
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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.

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Phase 1a dose escalation in solid tumors is ongoing to evaluate higher doses of IMA203CD8 with and without IL-2.
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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.

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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.

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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.
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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

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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.
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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.
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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.

On August 12, 2025 Agendia, Inc., a leader in innovative genomic testing for breast cancer, reported the publication of new findings in JNCI Cancer Spectrum validating the predictive utility of the MammaPrint 70-gene assay for chemotherapy benefit in patients with hormone receptor-positive, HER2-negative (HR+HER2-) early-stage breast cancer (Press release, Agendia, AUG 12, 2025, View Source;Early-Breast-Cancer-Using-Real-World-Evidence-from-the-FLEX-Study [SID1234655152]). The peer-reviewed article, titled "MammaPrint Predicts Chemotherapy Benefit in HR+HER2- Early Breast Cancer: FLEX Registry Real-World Data," highlights how the MammaPrint Index predicts benefit from chemotherapy using a real-world, prospective, observational dataset.

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The findings are based on data from the ongoing FLEX Study (NCT03053193), a real-world data (RWD) study designed to collect whole transcriptome genomic data annotated with clinical data and outcomes from patients undergoing standard of care MammaPrint testing. This analysis included a propensity-score matched cohort of 1,002 patients with HR+HER2- breast cancer who received either chemotherapy with endocrine therapy or endocrine therapy only, with 5-year median follow-up. The results demonstrate that the MammaPrint Index is a strong continuous predictor of distant recurrence-free interval (DRFI) and chemotherapy benefit.

"This propensity-score matched population offers statistically robust evidence supporting the benefit of chemotherapy for patients with MammaPrint High Risk cancers. At the same time, it supports foundational results from MINDACT (NCT00433589) that showed no significant benefit of chemotherapy for patients with MammaPrint Low Risk breast cancer," said Adam Brufsky, MD, PhD, Professor of Medicine at UPMC and first author of the study. "These findings strengthen the evidence that MammaPrint is a chemopredictive comprehensive genomic test for guiding treatment decisions in early-stage breast cancer."

Key Findings:

The study showed that the MammaPrint Index was significantly predictive of 5-year DRFI for both endocrine therapy only (R²=0.99, p<0.001) and endocrine therapy + chemotherapy (R²=0.90, p<0.001).
Chemotherapy provided the greatest absolute benefit of up to 14.2% (average: 10.9%) to patients with MammaPrint High Risk 2 (H2) breast cancer, with an average 5.5% benefit for High Risk 1 (H1), and minimal benefit in Low or UltraLow Risk categories.
A multivariate Cox model confirmed a significant interaction between the MammaPrint Index and chemotherapy benefit (HR=0.15, p=0.047), independent of age, tumor stage, nodal status, or grade.
"This study marks a milestone in the large body of data supporting the predictive value of MammaPrint in breast cancer, and underscores Agendia’s commitment to providing robust, clinically actionable genomic insights that personalize care and improve outcomes for individuals diagnosed with breast cancer," said William Audeh, MD, MS, Chief Medical Officer at Agendia. "It also highlights the growing impact of the FLEX Study, which has now enrolled more than 20,000 breast cancer patients and continues to make meaningful contributions to the field of breast cancer research." The publication is available online in JNCI Cancer Spectrum.

On August 12, 2025 TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the "Company"), an oncology company integrating novel delivery technology with standard of care therapies, and its investigational immunotherapeutic to transform treatment for patients with solid tumors, reported financial results for the quarter ended June 30, 2025, and provides an operational update (Press release, TriSalus Life Sciences, AUG 12, 2025, View Source [SID1234655151]).

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"TriSalus continued to deliver strong commercial momentum in the second quarter, underscoring the growing clinical adoption of our TriNav product suite and proprietary PEDD platform across a broad range of solid tumor indications," said Mary Szela, President and CEO of TriSalus. "We are pleased to reaffirm our full-year revenue growth guidance of 50%, reflecting increasing market penetration within liver-directed therapies. We will continue to invest in clinical data to extend the benefits of our PEDD technology platform to new embolization applications. With a strategic shift toward partnering development of Nelitolimod and an expanded focus on liver-directed therapies and new applications, we are energized by the opportunity to bring our PEDD technology to a wider range of patients which will not only support improved clinical outcomes but also drive deeper physician engagement and commercial momentum, fueling our long-term vision."

Second Quarter 2025 Highlights

Generated $11.2 million in net sales, a 52% increase year-over-year, and sequential growth of 22% over the first quarter 2025.
Continued strong commercial momentum with expanded use of TriNav in liver embolization and continued to further develop new applications in new clinical settings focused on the interventional radiology specialty.
Expanded product portfolio with the successful launch of TriNav FLX, the latest advancement in Pressure-Enabled Drug Delivery (PEDD). Designed with a more flexible distal tip, TriNav FLX enhances navigability through tortuous vessels—providing an effective solution for physicians previously limited by anatomical barriers to PEDD adoption. Early market response has been strong, with sales surpassing internal projections.
Subsequent to the second quarter, the Company simplified its capital structure through the successful completion of an exchange offering of previously issued Series A Preferred stock.
Second Quarter 2025 Financial Highlights

Revenue, all from the sale of the TriNav system, was $11.2 million for the three months ended June 30, 2025, an increase of 52% compared to the same period in 2024 and 22% sequential growth. Revenue growth was driven primarily by increased selling resources and increased market share.
Gross margins were 84% in the second quarter, compared to 88% in the same period of 2024. The year-over-year decline was primarily driven by lower manufacturing efficiency associated with newly launched products, a dynamic we expect to improve as production scales and processes mature over the course of the year.
Research and Development (R&D) expenses were approximately $3.9 million, compared to $4.7 million for the same quarter of the prior year. The decline in R&D costs is primarily a result of a decline in clinical trial costs relating to Nelitolimod.
Sales and Marketing (S&M) expenses were approximately $7.2 million in the second quarter, compared to $6.0 million for the same quarter of the prior year. The year-over-year increase reflects continued investment in the expansion of our commercial organization.
General & Administrative (G&A) expenses were approximately $5.7 million, compared to $4.0 million for the same quarter of the prior year. G&A costs include non-cash stock-based compensation of $1.2 million and $0.7 million, respectively, for the same periods. The increase in G&A costs is primarily a result of professional services related to legal services and audit.
Operating losses were $7.3 million, compared to Operating losses of $8.2 million for the same period in 2024. Current reductions in operating losses are due to reduced research and development expenses associated with the ramp-down of Nelitolimod clinical trial spending.
Net loss attributable to common stockholders was $9.0 million, compared to $5.1 million for the same period in 2024, primarily due to non-cash adjustments to the fair value of our contingent earnout liability.
The basic and diluted loss per share was $0.27, compared to $0.21 for the same period in 2024.
As of June 30, 2025, cash and cash equivalents totaled $26.5 million providing sufficient runway to reach positive adjusted EBITDA in the first half of 2026.
The non-GAAP measure of adjusted EBITDA is reconciled in the table below as the Company believes it is an important measure of performance. Adjusted EBITDA losses were $5.3 million, compared to losses of $6.7 million for the same period in 2024. Currently, reductions in adjusted EBITDA losses are due to increased sales, reduced research and development expenses and increased stock compensation in 2025.

Conference Call

The Company will host a conference call and webcast today at 4:30 PM eastern time to discuss its financial results for the quarter ended June 30, 2025. Parties interested in participating by phone should register using this online form. After registering for the webcast, dial-in details will be provided in an auto-generated e-mail containing a link to the conference phone number along with a personal pin. The event will also be webcast live on the investor relations section of TriSalus’ website. A replay will also be available on the website following the event.

On August 12, 2025 Atossa Therapeutics, Inc. (Nasdaq: ATOS) (Atossa or the Company), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, reported its financial results for the second quarter ended June 30, 2025 and provided an update on recent company developments (Press release, Atossa Therapeutics, AUG 12, 2025, View Source [SID1234655150]).

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"Atossa continues to make meaningful and measurable progress across our pipeline, underscored by recent, highly constructive interactions with the FDA that further support our (Z)-endoxifen development strategy in metastatic breast cancer," stated Dr. Steven Quay, Chairman and CEO of Atossa Therapeutics. "With a strong balance sheet, we believe we are well-positioned to execute on our planned upcoming IND submission and advance our metastatic clinical program toward key value-creating milestones. We remain disciplined in our capital strategy and have deliberately chosen not to utilize our ATM facility at recent share price levels, which we believe significantly undervalue the true potential of our Company. As we progress toward multiple upcoming potential catalysts, we are confident that our focused execution, scientific rigor, and unwavering commitment to patients will demonstrate the substantial intrinsic value of Atossa and position (Z)-endoxifen to make a meaningful impact in the treatment of breast cancer."

Clinical & Regulatory Developments

Positive FDA Feedback on (Z)-Endoxifen Program – In July 2025, Atossa announced it received highly constructive written feedback from the U.S. Food and Drug Administration (FDA), supporting the Company’s proposed dose optimization trial in estrogen receptor positive, human epidermal growth factor receptor 2 negative (ER+/HER2-) metastatic breast cancer and allowing the Company to meet the requirements of Project Optimus. The FDA agreed that existing clinical and nonclinical data are sufficient to initiate the monotherapy arm (Part A) of the study and agreed with the scientific rationale for combination therapy arms (Part B) using standard-of-care agents, such as CDK4/6 inhibitors, PI3K inhibitors, mTOR inhibitors, and capecitabine. The Agency also indicated that no additional general toxicity or neurotoxicity studies are required and confirmed that Atossa’s cardiac safety assessment monitoring protocol is sufficient for the monotherapy portion of the trial. These developments support the Company’s plan to file an Investigational New Drug (IND) application with the FDA, which is expected in Q4 2025.
Clinical Trial Readouts & Scientific Validation

I‑SPY 2 Endocrine Optimization Sub‑Study Results (Monotherapy with Low-Dose 10 mg (Z)-endoxifen) – In May 2025, Atossa released full results from the Phase 2 pilot within the I‑SPY 2 trial. Among 20 women with stage II/III ER+, HER2‑ breast cancer.
Primary endpoint achieved with 95 percent of subjects completing at least 75 percent of planned dosing.
Median Ki‑67 dropped from 10.5 percent at baseline to 5 percent by Week 3, with 65 percent achieving Ki‑67 ≤ 10 percent. Ki-67 is a widely used biomarker in pathology to assess the extent to which cancer cells are dividing and is often correlated with tumor behavior and prognosis. The POETIC (Peri-Operative Endocrine Therapy for individualized Care) trial, a large phase 3 study conducted in the UK and sponsored by the Institute of Cancer Research and the Royal Marsden NHS Foundation Trust, demonstrated that early changes in Ki-67 are strongly prognostic. Published in 2020, the trial showed that women with ER+/HER2− breast cancer whose Ki-67 levels fell from >10 percent at baseline to ≤10 percent after just two weeks of neoadjuvant aromatase inhibitor therapy had a 5-year recurrence rate of 8.4 percent, compared to 21.5 percent in those whose Ki-67 remained above 10 percent.
Median functional tumor volume, as assessed by MRI, decreased by 77.7 percent from baseline to surgery, and the longest tumor diameter dropped by 36.8 percent from baseline to preoperative MRI.
Safety was favorable: adverse events were predominantly Grade 1; vasomotor symptoms (hot flushes) and fatigue were most common. Only three Grade 3 events (two skin infections, one post‑procedural infection) occurred in a single patient and were deemed unrelated to the study drug; no Grade 4 or Grade 5 events were reported.
I-SPY 2 – Endocrine Optimization Pilot Analysis (Combination therapy of 40 mg (Z)-endoxifen and Eli Lilly’s abemaciclib)
Patient recruitment continues at a faster rate than anticipated, with 41 patients initiated as of July 29, 2025.
Other ongoing Phase 2 Programs – Atossa continues to evaluate (Z)-endoxifen in two other Phase 2 trials: one in women with ductal carcinoma in situ (DCIS) and one in women with ER+/HER2- breast cancer, as previously disclosed.
Intellectual Property & Patent Portfolio

New U.S. Patents – In mid‑May 2025, Atossa announced the issuance of U.S. Patent No. 12,281,056, containing 58 claims relating to the enteric oral formulations of (Z)-endoxifen, including features of improved purity, stability, and bioavailability.
Recent Patent Challenges – Two of Atossa’s patents are currently the subject of post‑grant challenges (i.e., U.S. Patent Nos. 11,261,151 and 12,071,391), which may result in modification or invalidation of certain patent claims; however, such proceedings are common for high‑value pharmaceutical IP, and we remain confident in our ability to vigorously defend these patents. The majority of Atossa’s intellectual property is unaffected. Atossa holds four additional issued U.S. patents with claims to endoxifen—U.S. Patent Nos. 11,680,036, 12,201,591, 12,275,684, and 12,281,056—with over 200 total claims covering proprietary manufacturing methods, stable crystalline forms, and multiple sustained‑release and enteric oral formulations of (Z)‑endoxifen. We believe that these patents, along with pending applications worldwide, provide substantial additional protection for our lead program.
Strategic Outlook & Upcoming Milestones

Atossa remains focused on executing its breast cancer development strategy. Key upcoming deliverables include:

Announcement of Contract Research Organization (CRO) selected to execute the metastatic dose ranging study in coordination with Atossa clinical personnel.
Disclosure of dose-ranging trial design, including specifics on patient selection criteria and combination treatment backbone.
Targeting IND submission in Q4 2025, in alignment with feedback under the FDA Project Optimus initiative.
Advancing enrollment and data generation from ongoing Phase 2 trials.
Working with the FDA on regulatory strategies for breast cancer indications beyond metastatic breast cancer, including treating women in the adjuvant setting, patients with DCIS, and in reducing the incidence of breast cancer in high-risk women.
Comparison of Three and Six Months Ended June 30, 2025 and 2024

Operating Expenses. Total operating expenses were $9.0 million and $16.5 million for the three and six months ended June 30, 2025, respectively, which was an increase of $1.9 million and $2.4 million from total operating expenses for the three and six months ended June 30, 2024 of $7.1 million and $14.1 million, respectively. Factors contributing to the increased operating expenses in the three and six months ended June 30, 2025 are explained below.

Research & Development (R&D) Expenses. The following table provides a breakdown of major categories within R&D expenses for the three and six months ended June 30, 2025 and 2024, together with the dollar change and percentage change in those categories (dollars in thousands):

For the Three Months Ended June 30,

For the Six Months Ended June 30,

2025

2024

Increase (Decrease)

% Increase (Decrease)

2025

2024

Increase (Decrease)

% Increase (Decrease)

Research and Development Expense

Clinical and non-clinical trials

$

4,089

$

2,501

$

1,588

63 %

$

6,836

$

5,384

$

1,452

27 %

Compensation

856

679

177

26 %

1,736

1,305

431

33 %

Professional fees and other

557

373

184

49 %

1,087

613

474

77 %

Research and Development Expense Total

$

5,502

$

3,553

$

1,949

55 %

$

9,659

$

7,302

$

2,357

32 %

Clinical and non-clinical trial expenses increased $1.6 million and $1.5 million for the three and six months ended June 30, 2025, respectively, compared to the three and six months ended June 30, 2024, due to increases in spend related to our (Z)-endoxifen trials, including drug development costs.
The increases in R&D compensation expenses of $0.2 million and $0.4 million for the three and six months ended June 30, 2025, respectively, compared to the three and six months ended June 30, 2024, were due to increases in headcount.
The increases in R&D professional fees and other of $0.2 million and $0.5 million for the three and six months ended June 30, 2025, respectively, compared to the three and six months ended June 30, 2024, were primarily attributable to higher consulting fees in the 2025 periods related to our (Z)-endoxifen program.
General and Administrative (G&A) Expenses. The following table provides a breakdown of major categories within G&A expenses for the three and six months ended June 30, 2025 and 2024, together with the dollar change and percentage change in those categories (dollars in thousands):

For the Three Months Ended June 30,

For the Six Months Ended June 30,

2025

2024

Increase (Decrease)

% Increase (Decrease)

2025

2024

Increase (Decrease)

% Increase (Decrease)

General and Administrative Expense

Compensation

$

1,564

$

1,031

$

533

52 %

$

3,026

$

2,356

$

670

28 %

Professional fees and other

1,794

2,269

(475)

(21) %

3,408

3,949

(541)

(14 %)

Insurance

180

252

(72)

(29) %

361

479

(118)

(25) %

General and Administrative Expense Total

$

3,538

$

3,552

$

(14)

(0) %

$

6,795

$

6,784

$

11

0 %

The increases in G&A compensation expenses of $0.5 million and $0.7 million for the three and six months ended June 30, 2025, respectively, compared to the three and six months ended June 30, 2024, were primarily due to increases in non-cash stock-based compensation expense of $0.4 million and $0.5 million, respectively.
The decreases in G&A professional fees and other of $0.5 million for the three and six months ended June 30, 2025, compared to the three and six months ended June 30, 2024, were due to decreases in legal fees of $0.3 million and $0.2 million, respectively, related to higher patent-related activity as well as other legal matters in the prior year periods and decreases in investor relations costs of $0.1 million and $0.3 million, respectively, due to changes in the timing of investor outreach programs.
Interest Income. Interest income was $0.6 million and $1.4 million for the three and six months ended June 30, 2025, respectively, a decrease of $0.5 million and $0.8 million from interest income of $1.1 million and $2.2 million for the three and six months ended June 30, 2024, respectively. The decreases were due to decreases in the average balance invested in our money market account.

About (Z)-Endoxifen
(Z)-endoxifen is a highly potent Selective Estrogen Receptor Modulator (SERM) with demonstrated ability to inhibit—and potentially degrade—estrogen receptors. It has shown activity even in tumors that have developed resistance to other endocrine therapies. Beyond its anti-estrogenic properties, (Z)-endoxifen also targets protein kinase C beta 1 (PKCβ1), an oncogenic signaling protein, at clinically achievable blood levels. Importantly, (Z)-endoxifen seems to deliver comparable or superior bone-protective effects relative to tamoxifen.

Atossa is developing a proprietary enteric oral formulation of (Z)-endoxifen that bypasses stomach acid, which would otherwise convert the active (Z)-isomer to its inactive (E)-form. We believe this innovation allows for optimal bioavailability and therapeutic integrity. Clinical studies have shown Atossa’s (Z)-endoxifen to be well tolerated in both healthy women and those with breast cancer. In over 700 subjects (healthy volunteers and breast cancer patients), doses up to 360 mg/day have been administered with no maximum tolerated dose (MTD) identified, supporting continued dose-ranging exploration.

Atossa is prioritizing the development of (Z)-endoxifen for the treatment of metastatic breast cancer, where novel therapeutic options are urgently needed. The compound is currently being evaluated in three Phase 2 trials: one in women with ductal carcinoma in situ (DCIS) and two in women with ER+/HER2- breast cancer. Atossa’s (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including three recently issued U.S. patents and numerous pending applications worldwide.