On November 6, 2025 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the third quarter ended September 30, 2025.

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Cash and investments in marketable securities on September 30, 2025 were $270.2 million as compared to $269.1 million on December 31, 2024. Nektar’s cash and marketable securities at September 30, 2025 includes $107.2 million of net proceeds from the secondary offering closed on July 2, 2025 and $34.3 million of net proceeds for the issuance of registered stock under the Company’s filed at-the-market, "ATM", offering. Following the end of the third quarter, an additional $38.3 million of net proceeds were also raised from the ATM offering in October 2025. We expect our cash and investments in marketable securities to support our operations into the second quarter of 2027.

"We have made tremendous progress advancing rezpegaldesleukin, and the emerging data from the REZOLVE-AD study continue to demonstrate a highly differentiated profile for this first-in-class, novel regulatory T cell mechanism in moderate-to-severe atopic dermatitis," said Howard W. Robin, President and CEO of Nektar. "We will present important new findings from REZOLVE-AD this weekend at the ACAAI Scientific Meeting highlighting the potential of rezpegaldesleukin to treat atopic dermatitis and co-morbid asthma, which occurs in about 25% of atopic dermatitis patients. These compelling data give rezpegaldesleukin a unique position in the competitive landscape as this efficacy signal has not been observed with other biologic mechanisms recently approved or in advanced development. Notably, this year’s Nobel Prize in Physiology or Medicine, was awarded for discoveries establishing FOXP3-positive Tregs as essential for peripheral immune tolerance, and we were humbled that rezpegaldesleukin data were referenced in the background documents from the Nobel Committee. Finally, we look forward to reporting in December the topline data for rezpegaldesleukin in patients with severe-to-very-severe alopecia areata, a chronic auto-immune condition that greatly impacts quality of life and mental health for these patients."

Summary of Financial Results

Revenue in the third quarter of 2025 was $11.8 million as compared to $24.1 million in the third quarter of 2024. Revenue for the first nine months of 2025 was $33.4 million compared to $69.3 million in the first nine months of 2024. Revenue has decreased year over year because we no longer recognize product sales due to the sale of the Huntsville manufacturing facility in December 2024.

Total operating costs and expenses in the third quarter of 2025 were $43.5 million as compared to $58.5 million in the third quarter of 2024. Total operating costs and expenses in the first nine months of 2025 were $145.9 million compared to $188.8 million in the first nine months of 2024. Operating costs and expenses for the third quarter and first nine months of 2025 decreased due to the elimination of cost of goods sold following the sale of the Huntsville manufacturing facility and deceases in research and development expenses, as well as non-cash impairment charges recorded in the first nine months of 2024.

R&D expense in the third quarter of 2025 was $27.3 million as compared to $35.0 million for the third quarter of 2024. For the first nine months of 2025, R&D expense was $87.6 million compared to $92.2 million in the first nine months of 2024. R&D expense decreased in the first nine months of 2025 primarily due to a decrease in expense for the development of NKTR-255, partially offset by an increase in expenses for the development of rezpegaldesleukin and NKTR-0165.

G&A expense was $16.1 million in the third quarter of 2025 as compared to $19.0 million in the third quarter of 2024. G&A expense was $57.5 million for the first nine months of 2025 compared to $59.6 million in the first nine months of 2024. G&A expense decreased for both the third quarter and the first nine months of 2025 due to decreases in facilities and stock-based compensation expenses offset by an increase in legal expenses.

Non-cash restructuring and impairment charges were not material in the third quarter and the first nine months of 2025. Non-cash restructuring and impairment charges were less than $0.1 million in the third quarter of 2024 and $14.3 million in the first nine months of 2024. These non-cash charges were related to the declining San Francisco commercial real estate market and real estate lease obligations held by Nektar.

In the first quarter of 2025, we began accounting for our investment in the new portfolio company, Gannet BioChem, under the equity method of accounting which calculates our gain or loss based on the change in our share of Gannet BioChem’s equity each quarter. This resulted in non-cash losses from the equity method investment of $0.5 million in the third quarter of 2025 and $7.4 million for the first nine months of 2025.

Net loss for the third quarter of 2025 was $35.5 million or $1.87 basic and diluted loss per share as compared to a net loss of $37.1 million or $2.661 basic and diluted loss per share in the third quarter of 2024. Net loss in the first nine months of 2025 was $128.0 million or $8.14 basic and diluted loss per share compared to a net loss of $126.2 million or $9.271 basic and diluted loss per share in the first nine months of 2024. Excluding the $0.5 million and $7.4 million non-cash loss from our equity method investment in Gannet BioChem, net loss, on a non-GAAP basis, for the third quarter and the first nine months of 2025 were $35.0 million and $120.6 million, respectively, or $1.85 and $7.67 basic and diluted loss per share, respectively.

Recent Business Highlights

· In October of 2025, Nektar’s abstract "Rezpegaldesleukin, Novel Treg-Inducing Therapy, Demonstrates Efficacy in Atopic Dermatitis and Asthma in Phase 2b Trial" was accepted for a late-breaking oral abstract presentation at the American College of Allergy, Asthma and Immunology’s 2025 Annual Scientific Meeting (ACAAI). These data will be presented at ACAAI on Saturday, November 8, 2025 at 5:33pm ET.

1 The per share amounts have been retrospectively adjusted to reflect a one-for-fifteen reverse stock split completed on June 8, 2025.

· In September of 2025, Nektar presented data from the REZOLVE-AD Phase 2b study of rezpegaldesleukin in atopic dermatitis in a late-breaker oral presentation at European Academy of Dermatology and Venereology (EADV) 2025 Congress.

· In July of 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for rezpegaldesleukin for the treatment of severe-to-very-severe alopecia areata (AA) in adults and pediatric patients 12 years of age and older who weigh at least 40 kilograms.

· In July of 2025, Nektar announced the successful closing of a public offering of its common stock including the full exercise of underwriters’ option to purchase additional shares, raising $115 million in gross proceeds.

Conference Call to Discuss Third Quarter 2025 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time on November 6, 2025.

This press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through February 6, 2025.

To access the conference call by phone, please pre-register at Nektar Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call.

(Press release, Nektar Therapeutics, NOV 6, 2025, View Source [SID1234659582])

On November 6, 2025 Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported business highlights and financial results for the third quarter ended September 30, 2025.

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"With three programs in clinical development and a highly productive drug discovery engine creating additional future opportunities, we are building a leading protein degradation company innovating in the molecular glue degrader space," said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. "In that context, our recently announced second collaboration with Novartis marks another major milestone for Monte Rosa, significantly expanding our potential impact on immune-mediated diseases. We believe this partnership further validates the breadth and versatility of our QuEEN discovery engine and underscores the growing recognition of MGDs as a distinct and potentially transformative therapeutic modality. Our cash runway extends beyond multiple anticipated Phase 2 readouts for MRT-8102, MRT-6160, and MRT-2359, and positions us to execute on our early-stage portfolio, including multiple undisclosed targets in Th1, Th2, and Th17-driven autoimmune conditions."

"In regard to our clinical programs, we are enrolling our Phase 1 study of MRT-8102, the only clinical-stage degrader targeting NEK7, which we believe offers a highly differentiated approach to potentially address a wide range of inflammatory and cardio-immunology indications driven by the NLRP3 inflammasome, IL-1β and IL-6. We have recently initiated dosing a cohort of subjects with elevated cardiovascular disease (CVD) risk to evaluate changes in well-validated biomarkers such as C-reactive protein. Initial MRT-8102 data from the healthy volunteer and elevated CVD-risk subject cohorts are on track for the first half of 2026. In addition, we continue to work with Novartis to advance MRT-6160, our VAV1-directed MGD, towards Phase 2 studies across multiple indications where alternative treatment options are urgently needed. Our recent preclinical data presentation at ACR Convergence provides further support for exploration of systemic lupus erythematosus, Sjögren’s disease, and rheumatoid arthritis, amongst others. In oncology, MRT-2359 continues to progress through expansion in mCRPC, and we plan to share additional data by year-end. We are also making strong progress with our programs targeting cyclin E1 and CDK2, two well-validated tumor drivers poorly addressed by conventional approaches, and we remain on track for an Investigational New Drug (IND) submission next year."

RECENT HIGHLIGHTS

Collaboration with Novartis for degraders to treat immune-mediated diseases

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In September 2025, Monte Rosa announced a second agreement to collaborate with Novartis to develop novel degraders for immune-mediated diseases. Monte Rosa’s publicly disclosed pipeline programs are outside the scope of this agreement.
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Under the terms of the agreement, Monte Rosa has received an upfront payment of $120 million. Monte Rosa will also receive payments to maintain the options. In total deal value, Monte Rosa is eligible to receive up to $5.7 billion, including upfront, option maintenance, preclinical milestone, option exercise, and development, regulatory, and sales milestone payments across programs, as well as tiered royalties on global net sales in the high single to low double-digit range.

MRT-8102, NEK7-directed MGD for inflammatory diseases driven by IL-1β, IL-6, and the NLRP3 inflammasome

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Monte Rosa continues to execute a Phase 1 study of MRT-8102, a first-in-class, NEK7-directed MGD for inflammatory diseases driven by the NLRP3 inflammasome, IL-1β, and IL-6. The ongoing study includes single ascending dose / multiple ascending dose (SAD/MAD) cohorts in healthy volunteers, as well as an additional Part 3 cohort designed to evaluate potential early proof of concept in subjects with increased CVD risk. The Company has initiated dosing in Part 3 of the study, evaluating subjects with high CVD risk. Initial Phase 1 data, including from the Part 3 cohort, are on track for H1 2026.

MRT-6160, VAV1-directed MGD for immune-mediated conditions

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Advancement of MRT-6160 toward multiple Phase 2 studies in immune-mediated diseases is ongoing, in collaboration with Novartis. Results from the Phase 1, SAD/MAD study in healthy volunteers (clinicaltrials.gov identifier NCT06597799) support a clear path into anticipated Phase 2 studies and broad potential applications in multiple immune-mediated diseases.
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In October, Monte Rosa presented additional preclinical data at ACR Convergence 2025, demonstrating that in a spontaneous autoimmune disease mouse model characterized by chronic inflammation, autoantibody production, and multi-organ involvement, MRT-6160 inhibited disease pathology, including proteinuria, lymphadenopathy, skin lesion formation, autoantibody production, and organomegaly. These results provide further support for MRT-6160’s potential across multiple immune-mediated diseases, including systemic lupus erythematosus, Sjögren’s disease, rheumatoid arthritis, and others.
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Monte Rosa has a global exclusive development and commercialization license agreement with Novartis to advance VAV1-directed MGDs, including MRT-6160. Monte Rosa is eligible to receive up to $2.1 billion in development, regulatory, and sales milestones, beginning upon initiation of Phase 2 studies. Novartis is responsible for conducting and funding Phase 2 studies. Monte Rosa will co-fund any Phase 3 clinical development and will share 30% of any profits and losses associated with the manufacturing and commercialization of MRT-6160 in the U.S., and is also eligible for tiered royalties on ex-U.S. net sales.

MRT-2359, GSPT1-directed MGD for MYC-driven solid tumors

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Monte Rosa continues to enroll and evaluate MRT-2359 in patients with mCRPC. The Company plans to present updated clinical results in 20 to 30 patients with mCRPC and in patients with hormone receptor (HR)+ breast cancer by year-end 2025.

Cyclin E1 and CDK2-directed MGD programs for treatment of solid tumors

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Monte Rosa continues to advance its cyclin E1 (CCNE1)- and CDK2-directed MGD programs for the treatment of CCNE1-amplified solid tumors and ER+ breast cancer toward clinical development. The Company remains on track to submit an IND application in 2026 for a CDK2 and/or cyclin E1-directed MGD.

QuEEN (Quantitative and Engineered Elimination of Neosubstrates) discovery engine

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In July 2025, Monte Rosa’s publication, featured on the cover of Science, showcased the Company’s proprietary QuEEN AI/ML-powered discovery engine. The findings significantly expand the targetable protein space for MGD drug discovery, unlocking new opportunities to address previously undruggable therapeutic targets.
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Monte Rosa continues to progress its strategic collaboration with Roche to discover and develop MGDs against targets in cancer and neurological diseases previously considered impossible to drug.

ANTICIPATED UPCOMING MILESTONES AND DEVELOPMENT PRIORITIES

Immunology and Inflammation disease programs

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Continue advancement of MRT-6160 toward Phase 2 initiation, in collaboration with Novartis.
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Share MRT-8102 Phase 1 results in H1 2026.
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Submit an IND application for a second-generation NEK7-directed MGD with enhanced CNS penetration in 2026.
Oncology programs

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Share updated MRT-2359 Phase 1/2 study data in heavily pretreated mCRPC patients and in patients with HR+ breast cancer by year-end 2025.
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Submit an IND application for a CDK2 and/or cyclin E1-directed MGD in 2026

THIRD QUARTER 2025 FINANCIAL RESULTS

Collaboration Revenue: Collaboration revenue for the third quarter of 2025 was $12.8 million, compared to $9.2 million for the third quarter of 2024. Collaboration revenue represents amounts earned from our collaboration and license agreements with Roche and Novartis.

Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2025 were $36.7 million, compared to $27.6 million for the third quarter of 2024. These increases were driven by the successful achievement of key milestones in our R&D organization, including the advancement of MRT-8102 to enter the clinic, the continuation of the MRT-2359 clinical study, continued program activities for MRT-6160 in preparation for Phase 2 studies, the progression of our preclinical pipeline, including research performed in connection with our collaboration with Roche, and the continued development of the Company’s QuEEN discovery engine. Non-cash stock-based compensation constituted $2.5 million of R&D expenses for the third quarter of 2025, compared to $2.6 million in the same period in 2024.

General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2025 were $9.1 million compared to $8.1 million for the third quarter of 2024. G&A expenses included non-cash stock-based compensation of $1.9 million for the third quarter of 2025, compared to $1.7 million in the same period in 2024.

Net Loss: Net loss for the third quarter of 2025 was $27.1 million, compared to a net loss of $23.9 million for the third quarter of 2024.

Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash, and marketable securities as of September 30, 2025, were $396.2 million, compared to cash, cash equivalents, restricted cash, and marketable securities of $295.5 million as of June 30, 2025. The increase of $100.7 million was primarily due to a $120.0 million non-refundable upfront payment the Company received from Novartis in September 2025. The Company also received from Novartis $9.7 million for value added taxes related to the transaction, which is included in the Company’s accounts payable balance as of September 30, 2025 and is expected to be remitted to the Swiss government in the fourth quarter of 2025. During October 2025, the Company sold 2,955,082 shares of common stock in an at-the-market offering for aggregate gross proceeds of $25.0 million, or aggregate net proceeds of $23.9 million after deducting sales agent discounts, commissions, and other offering costs.

Based on current cash, cash equivalents, restricted cash, marketable securities, and certain anticipated Roche and Novartis collaboration revenue, the Company expects its cash and cash equivalents to be sufficient to fund planned operations and capital expenditures through 2028.

About MRT-6160
MRT-6160 is a potent, highly selective, and orally bioavailable investigational molecular glue degrader of VAV1, which in preclinical studies has shown deep degradation of its target with no detectable effects on other proteins. VAV1 is a key signaling protein downstream of both the T- and B-cell receptors. VAV1 expression is restricted to immune cells, including T and B cells. MRT-6160 has shown promising activity in preclinical models of multiple immune-mediated conditions. In a Phase 1, single ascending dose / multiple ascending dose (SAD/MAD) study in healthy subjects (clinicaltrials.gov identifier NCT06597799), MRT-6160 demonstrated sustained, dose-dependent VAV1 degradation in peripheral blood T and B cells after single and multiple dose administration. MRT-6160 also substantially inhibited secretion of inflammatory cytokines from whole blood derived T and B cells following ex vivo stimulation. Under the terms of an agreement announced in October 2024, Novartis has exclusive worldwide rights to develop, manufacture and commercialize MRT-6160 and other VAV1 MGDs. Monte Rosa is eligible to receive up to $2.1 billion in development, regulatory, and sales milestones, beginning upon initiation of Phase 2 studies. Monte Rosa will co-fund any Phase 3 clinical development and will share any profits and losses associated with the manufacturing and commercialization of MRT-6160 in the U.S., and is also eligible for tiered royalties on ex-U.S. net sales.

About MRT-8102
MRT-8102 is a potent, highly selective, and orally bioavailable investigational molecular glue degrader (MGD) that targets NEK7 for the treatment of inflammatory diseases linked to NLRP3, IL-1β, and IL-6 dysregulation. NEK7 has been shown to be required for NLRP3 inflammasome assembly, activation and IL-1β release both in vitro and in vivo. Aberrant NLRP3 inflammasome activation and the subsequent release of active IL-1β and interleukin-18 (IL-18) has been implicated in multiple inflammatory disorders, including cardiovascular disease, gout, osteoarthritis, neurologic disorders including Parkinson’s disease and Alzheimer’s disease, and metabolic disorders. In a non-human primate model, MRT-8102 was shown to potently, selectively, and durably degrade NEK7, and resulted in near-complete reductions of IL-1β and caspase-1 following ex vivo stimulation of whole blood. MRT-8102 has demonstrated a considerable safety margin (>200-fold exposure margin over projected human efficacious dose) in GLP toxicology studies. MRT-8102 is currently being investigated in a Phase 1 study (clinicaltrials.gov identifier NCT07119125) in healthy participants and participants at elevated cardiovascular disease risk.

About MRT-2359
MRT-2359 is a potent, highly selective, and orally bioavailable investigational molecular glue degrader (MGD) of GSPT1. MYC transcription factors (c-MYC, L-MYC and N-MYC) are well-established drivers of human cancers that maintain high levels of protein translation, which is critical for uncontrolled cell proliferation and tumor growth. Preclinical studies have shown this addiction to MYC-induced protein translation creates a dependency on GSPT1. By inducing degradation of GSPT1, MRT-2359 is designed to exploit this vulnerability, disrupting the protein synthesis machinery, leading to anti-tumor activity in MYC-driven tumors. MRT-2359 is being investigated in an ongoing Phase 1/2 study (clinicaltrials.gov identifier NCT05546268) in solid tumors, including castration-resistant prostate cancer (CRPC). In heavily pretreated CRPC patients, a patient group characterized by widespread expression of c-MYC, MRT-2359 demonstrated encouraging early signals of clinical response.

(Press release, Monte Rosa Therapeutics, NOV 6, 2025, View Source [SID1234659581])

On November 6, 2025 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, reported that Eric Risser, President and CEO of MacroGenics, will participate in a fireside chat at the Stifel 2025 Healthcare Conference on Thursday, November 13, 2025, at 4:00 pm ET in New York, NY.

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A webcast of the presentation may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source The Company will maintain an archived replay of the webcast on its website for 30 days.

(Press release, MacroGenics, NOV 6, 2025, View Source [SID1234659580])

On November 6, 2025 Mabqi reported the formation of a strategic partnership with Abzena, the leading end-to-end integrated CDMO for complex biologics and bioconjugates. This collaboration will integrate Mabqi’s antibody discovery capabilities with Abzena’s development and manufacturing services, offering biopharma customers a more streamlined, end-to-end drug development solution.

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The partnership’s combined offerings will leverage Mabqi’s LiteMab Antibody Discovery Studio for hit screening, characterization, and hit selection by using universal & pH-sensitive libraries to identify top lead candidates, and utilize Abzena’s capabilities for developability, cell line development, process development, and GMP manufacturing. Both organizations have extensive expertise in supporting a broad range of modalities, including monoclonal antibodies (mAbs), mAb fragments, bi- and multi-specifics, and bioconjugates.

"Our strategic partnership with Abzena marks a significant milestone in offering an integrated antibody discovery-through-development solution by combining our complementary scientific expertise and advanced capabilities", said Sylvain Yon, CEO of Mabqi. "Beyond scientific excellence and innovation, what truly sets this collaboration apart is the exceptional human fit between our teams ensuring smooth cooperation, shared dedication to innovation and customer-focused relationship. Together, we are poised to accelerate the development of differentiated therapeutic antibodies that can make a meaningful impact for patients worldwide."

(Press release, Mabqi, NOV 6, 2025, View Source [SID1234659579])

On November 6, 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 medical conditions, reported its third 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.

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"It has been a productive third quarter for the Lineage team," stated Brian M. Culley, Lineage CEO. "Last quarter, I outlined five areas of focus through the end of this year, and I am pleased to report that we delivered on several of these during the third quarter, as outlined below.

We entered into a research collaboration with William Demant Invest A/S, which is designed to fund all currently planned preclinical development of our ReSonance program, demonstrating the ability of our technology platform to produce a partnered program with limited investment and in a short amount of time.
We solidified our position as a leader in allogeneic cell process development by reporting cGMP production for each of OpRegen and OPC1, from a master and working cell bank system which, in its current form, can support a production capability of millions of doses of a single-administration product, all from our in-house facility.
We launched a new cell therapy initiative, focused on islet cell transplants for the treatment of Type 1 Diabetes, with an initial focus on addressing the unsolved issue of large-scale production of islet cells, which if successful could potentially solve a major hurdle to commercialization of islet cell therapy product candidates."
"Looking ahead, we will continue to work on the other strategic initiatives I outlined, including activities designed to drive milestone revenue from our alliance with Roche and Genentech and pursuing grant funding from the California Institute for Regenerative Medicine (CIRM) for our OPC1 program. We also continue to plan for a successful future by seeking to capitalize on our investments in our cell transplant platform and to utilize our manufacturing achievements as a foundation from which additional programs can be strategically advanced via funded collaborations or independently," 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, suggesting evidence of sustained gains in visual acuity and structural support of the retina.
Ongoing execution of Lineage’s contributions to its collaboration with Roche and Genentech, including support for the ongoing Phase 2a GAlette Study.
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 Phase 2a GAlette Study.
Ongoing efforts to further support development of OpRegen 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.
ReSonance (ANP1)
Announced research collaboration with William Demant Invest A/S (WDI) to jointly advance development of ReSonance (ANP1) over a term of three years; up to $12 million of development costs to be contributed by WDI in a collaboration which covers preclinical development activities, including cell manufacturing, proof-of-concept studies, translational/functional models, delivery development, outcome measures, regulatory strategy, and market analysis.
Manufacturing Capability
Successfully completed a production run for each of OpRegen and OPC1, two of our 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.
ILT1
Launched new cell therapy initiative, focused on islet cell transplants for the treatment of Type 1 Diabetes; plans are to deploy the company’s manufacturing capability to address the issue of large-scale production of islet cells, with the initial goal of establishing a production modality that can support the entire production process in a dynamic culturing system, which if successful could potentially solve a major hurdle to commercialization of islet cell therapy product candidates.
OPC1
First chronic spinal cord injury participant treated in the DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) clinical study.
First treated participant 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.
No significant safety events have been reported sixty days following treatment in the first chronic SCI participant.
The California Institute for Regenerative Medicine (CIRM) continues to review Lineage’s application for a CLIN2 clinical grant to support our DOSED study of OPC1.
Balance Sheet Highlights

Cash, cash equivalents, and marketable securities of $40.5 million as of September 30, 2025, is expected to support planned operations into Q2 2027.

Third Quarter Operating Results

Revenues: Revenue is generated primarily from collaboration revenues, royalties, and other revenues. Total revenues for the three months ended September 30, 2025 were $3.7 million, a decrease of approximately $0.1 million as compared to $3.8 million for the same period in 2024. The decrease was primarily driven by lower royalty revenue and other service revenues recognized of $0.3 million, partially offset by more collaboration revenues of $0.2 million.

Operating Expenses: Operating expenses are primarily comprised of research and development ("R&D") expenses and general and administrative ("G&A") expenses. Total operating expenses for the three months ended September 30, 2025 were $7.5 million, a decrease of $0.1 million as compared to $7.6 million for the same period in 2024.

R&D Expenses: R&D expenses for the three months ended September 30, 2025 were $3.3 million, an increase of $0.1 million as compared to $3.2 million for the same period in 2024. The net increase was primarily driven by $0.2 million for our OPC1 program, $0.4 million for our preclinical programs and other undisclosed programs, partially offset by $0.5 million for our OpRegen program.

G&A Expenses: G&A expenses for the three months ended September 30, 2025 were $4.2 million, a decrease of $0.2 million as compared to $4.4 million for the same period in 2024. The decrease was primarily attributable stock-based compensation and services provided by third parties.

Loss from Operations: Loss from operations for the three months ended September 30, 2025 was $3.8 million, which was in-line with the comparative prior year period’s loss.

Other Income/(Expenses): Other income/(expenses) for the three months ended September 30, 2025 reflected other expense of $26.0 million, compared to other income of $0.8 million for the same period in 2024. The change was largely attributable to the non-cash quarterly fair value remeasurement of the warrant liabilities of $26.6 million primarily due to a change in our share price as compared to the prior year period, and $0.2 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 September 30, 2025 was $29.8 million, or $0.13 per share (basic and diluted), compared to a net loss of $3.0 million, or $0.02 per share (basic and diluted), for the same period in 2024. The change was primarily driven by the non-cash quarterly fair value remeasurement of the warrant liabilities due to a change in our share price as compared to the prior quarter.

Conference Call and Webcast

Interested parties may access the conference call on November 6, 2025, by dialing (888) 596-4144 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 November 14, 2025, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 3958367.

(Press release, Lineage Cell Therapeutics, NOV 6, 2025, View Source [SID1234659578])