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 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.

•
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.
•
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
o
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
o
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.

On August 12, 2025 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported financial results for the second quarter 2025 and provided a business update for its oncology clinical programs CB-010 and CB-011 with data disclosures on track for H2 2025 (Press release, Caribou Biosciences, AUG 12, 2025, View Source [SID1234655130]).

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"Caribou is advancing allogeneic CAR-T cell programs to deliver off-the-shelf therapies designed for rapid treatment and broad patient access," said Rachel Haurwitz, PhD, Caribou’s president and CEO. "Our clinical programs, CB-010 for large B cell lymphoma and CB-011 for multiple myeloma, continue to generate encouraging Phase 1 results, reinforcing our conviction in the potential of these therapies. We remain on track to report robust datasets from both programs this year, which we expect to provide meaningful insights into the potential of our approach and the future of allogeneic CAR-T cell therapies."
Clinical highlights
CB-010, a clinical-stage allogeneic anti-CD19 CAR-T cell therapy for B cell non-Hodgkin lymphoma
•Caribou completed enrollment of the 20-patient confirmatory cohort using the Company’s partial HLA matching strategy in the ANTLER Phase 1 clinical trial for patients with second-line large B cell lymphoma (2L LBCL).
•To date, data continue to demonstrate that a single dose of CB-010 has the potential to drive outcomes that are on par with the safety, efficacy, and durability of approved autologous CAR-T cell therapies.

CB-011, a clinical-stage allogeneic anti-BCMA CAR-T cell therapy for multiple myeloma
•Caribou completed planned enrollment for the dose escalation portion of the CaMMouflage Phase 1 clinical trial for patients with relapsed or refractory multiple myeloma (r/r MM).
•Caribou continues to observe encouraging efficacy in patients treated with CB-011 at multiple active dose levels.

2025 anticipated milestones
•CB-010 ANTLER: Caribou plans to present data from both the additional 2L and prior CD19 relapsed LBCL patient cohorts in H2 2025 and is interacting with the FDA on a potential pivotal trial to be initiated following alignment. This update is expected to include:
▪Initial safety and efficacy data on the confirmatory cohort (20 patients) with partial HLA matching, with a minimum of six months of follow up for the majority of patients, as well as an update on the larger, maturing dataset presented previously.
▪Pivotal trial design and timeline, contingent on positive data and FDA alignment.
•CB-011 CaMMouflage: Caribou plans to present dose escalation data from its ongoing CaMMouflage Phase 1 clinical trial in r/r MM in H2 2025. This update is expected to include:

▪Initial safety and efficacy data on a minimum of 25 patients at multiple dose levels using the deeper lymphodepletion regimen with at least three months of follow up.
▪Recommended dose(s) for expansion and plans for dose expansion.
Second quarter 2025 financial results
Cash, cash equivalents, and marketable securities: Caribou had $183.9 million in cash, cash equivalents, and marketable securities as of June 30, 2025, compared to $249.4 million as of December 31, 2024. Caribou expects its cash, cash equivalents, and marketable securities will be sufficient to fund its current operating plan into H2 2027.

Licensing and collaboration revenue: Revenue from Caribou’s licensing and collaboration agreements was $2.7 million for the three months ended June 30, 2025, compared to $3.5 million for the same period in 2024.

R&D expenses: Research and development expenses were $27.7 million for the three months ended June 30, 2025, compared to $35.5 million for the same period in 2024. The decrease was primarily related to the previously announced strategic pipeline prioritization and related workforce reduction and lower costs associated with the ongoing CB-010 ANTLER and CB-011 CaMMouflage Phase 1 clinical trials.

G&A expenses: General and administrative expenses were $10.4 million for the three months ended June 30, 2025, compared to $11.5 million for the same period in 2024. The decrease was primarily due to reduced personnel-related expenses, including stock-based compensation, related to the previously announced strategic pipeline prioritization and related workforce reduction, lower patent prosecution and maintenance costs, and lower legal and other service related expenses. The decrease was partially offset by an increase in other facilities and allocated expenses.

Non-recurring, non-cash impairment charges: Non-recurring, non-cash impairment charges were $21.3 million for the three months ended June 30, 2025, and include charges related to the previously announced strategic pipeline prioritization and an impairment of the Company’s stock investment in a private company.

GAAP and non-GAAP net loss and net loss per share, basic and diluted: Caribou reported a net loss of $54.1 million, or $0.58 per share, basic and diluted, for the three months ended June 30, 2025, compared to $37.7 million, or $0.42 per share, basic and diluted, for the same period in 2024. Non-GAAP net loss for the three months ended June 30, 2025, excluding $21.3 million of non-cash impairment charges, was $32.8M, or $0.35 per share, basic and diluted.

About CB-010
CB-010 is an allogeneic anti-CD19 CAR-T cell therapy being evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL) in the ongoing ANTLER Phase 1 clinical trial. To Caribou’s knowledge, CB-010 is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to enhance CAR-T cell activity by limiting premature CAR-T cell exhaustion. The FDA granted CB-010 Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug, and Fast Track designations for B-NHL. Additional information on the ANTLER trial (NCT04637763) can be found at clinicaltrials.gov.

About CB-011
CB-011 is an allogeneic anti-BCMA CAR-T cell therapy being evaluated in patients with relapsed or refractory multiple myeloma (r/r MM) in the CaMMouflage Phase 1 trial. To Caribou’s knowledge, CB-011 is the first allogeneic CAR-T cell therapy in the clinic that is engineered to enable activity through an immune cloaking strategy with a B2M knockout and insertion of a B2M–HLA-E fusion protein to blunt immune-mediated rejection. CB-011 has been granted Fast Track and Orphan Drug designations by the FDA. Additional information on the CaMMouflage trial (NCT05722418) can be found at clinicaltrials.gov.

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 11, 2025 Azitra, Inc. ("Azitra") (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported financial results for the quarter ended June 30, 2025, and provided a business update (Press release, Azitra, AUG 11, 2025, View Source [SID1234655065]).

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Q2 2025 and Recent Business Highlights

Announced initial safety results and 50% enrollment of the Phase 1b clinical trial of the ATR-12 program in Netherton syndrome, demonstrating a promising safety profile
Announced acceptance of poster detailing the Phase 1/2 clinical trial of the ATR-04 program in EGFR inhibitor ("EGFRi")-associated rash at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting
Entered into a purchase agreement for up to $20 million to establish an equitly line of credit in partnership with institutional investor Alumni Capital LP, to fund clinical pipeline
"The first half of 2025 was a vital period for Azitra as we hit a key milestone in our first-in-class, precision, live biotherapeutic candidates designed for major undertreated dermatological diseases," said Francisco Salva, CEO of Azitra. "For ATR-12, our lead program targeting the rare, chronic and devastating Netherton syndrome, we announced promising safety data in the first five patients dosed with ATR12-351, and we believe this novel approach has potential to be life-changing for these patients. Netherton syndrome has a high unmet need with no approved treatment options."

Mr. Salva continued: "We also announced the design of our Phase 1/2 trial with our ATR-04 program at ASCO (Free ASCO Whitepaper), which is investigating a live biotherapeutic product candidate containing an isolated, naturally derived S. epidermidis strain being developed for the treatment of EGFRi-associated rash. EGFRi-associated rash is a dermatologic toxicity that often accompanies EGFRi treatments for cancer, impacting approximately 150,000 patients in the United States annually. We expect to dose the first patient in our Phase 1/2 trial in the third quarter of this year."

Mr. Salva concluded: "The remainder of 2025 is anticipated to be a milestone-rich period for Azitra during which we look forward to showcasing the potential of ATR-12 and ATR-04, as well as our unique, proprietary platform for delivering engineered proteins using topical live biotherapeutic products."

Pipeline and Anticipated Milestones

Q3 2025: First patient to be dosed with for EGFRi-associated rash in a Phase 1/2 trial for ATR-04
Q1 2026: Topline data of the Phase 1b trial with ATR-12 in Netherton syndrome patients
Financial Results for the Quarter Ended June 30, 2025

Research and Development (R&D) expenses: R&D expenses for the quarter ended June 30, 2025, were $1.4 million compared to $1.1 million for the comparable period in 2024.
General and Administrative (G&A) expenses: G&A expenses for the quarter ended June 30, 2025, were $1.5 million compared to $1.5 million for the comparable period in 2024.
Net Loss was $2.9 million for the quarter ended June 30, 2025, compared to $2.6 million for the comparable period in 2024.
Cash and cash equivalents: As of June 30, 2025, Azitra had cash and cash equivalents of $1.0 million.