Lineage Cell Therapeutics acquires NeuroAirmid
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
Lineage Cell Therapeutics, Inc. (LCTX) completed its acquisition of NeuroAirmid Therapeutics on November 12, 2026, making it a wholly owned subsidiary and adding HUNT1, a Phase 1b/2a Huntington’s disease cell-therapy candidate. At closing, Lineage paid sellers $2.4 million in cash and issued 2.2 million common shares, paid $0.2 million into the sellers’ representative’s expense fund, and paid $1.7 million toward NeuroAirmid’s third-party obligations. Further payments include up to $5.4 million on the first anniversary and up to $48.0 million tied to clinical and regulatory milestones.
REGEN4HD is evaluating HUNT1 in up to 21 patients; 6 had been dosed. Lineage assumed responsibility for up to $3.1 million in study co-funding through February 2030. Third-quarter revenue was $1.434 million versus $3.681 million a year earlier, and operating loss was $7.314 million versus $3.786 million. Net income attributable to Lineage was $4.232 million, compared with a $29.781 million loss, primarily reflecting noncash warrant-liability remeasurement. Cash, cash equivalents and marketable securities were $45.2 million as of September 30, 2026, which Lineage expected to support planned operations into Q2 2028.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Minor pointNet income attributable was $4.2 million, primarily reflecting noncash warrant-liability remeasurement.
Negative
- Moderate pointQuarterly revenue fell by $2.2 million year over year.
- Moderate pointOperating loss widened to $7.3 million from $3.8 million.
Filing Explained
The acquisition issued 2.2 million shares, reducing existing holders’ ownership percentages; resale registration is a later filing, not another issuance.
The acquisition closed on
Lineage issued 2.2 million unregistered common shares at closing and agreed to file a resale registration within 60 days, using commercially reasonable efforts to have it effective within 90 days; this registration concerns resale of shares already issued, not another issuance.
The issued shares increase the total share count and reduce existing holders’ percentage ownership, absent offsetting changes.
A sublicense, collaboration or other strategic transaction completed before the tenth anniversary that provides at least
The license requires
8-K Event Classification
Key Figures
Key Terms
volume-weighted average price financial
IND sponsorship regulatory
minimum royalty financial
cGMP cell bank technical
maximum tolerated dose medical
warrant liabilities financial
Earnings Snapshot
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How much did LCTX pay at closing for NeuroAirmid?
What additional payment could apply to a future LCTX HUNT1 deal?
What doses will LCTX’s REGEN4HD study evaluate?
When will HUNT1’s IND sponsorship transfer to LCTX?
What development deadlines does LCTX’s NeuroAirmid license set?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 1.01 Entry into a Material Definitive Agreement.
NeuroAirmid Acquisition
On November 12, 2026, Lineage Cell Therapeutics, Inc. (“Lineage” or the “Company”), entered into a Stock Purchase Agreement (the “Purchase Agreement”) with all of the stockholders (the “Sellers”) of NeuroAirmid Therapeutics, Inc. (“NeuroAirmid”), and Leslie Thompson, as the representative of the Sellers, pursuant to which Lineage acquired from the Sellers all of the outstanding shares of NeuroAirmid common stock (the “Acquisition”). As a result of the Acquisition, which closed concurrently with the execution of the Purchase Agreement, NeuroAirmid became Lineage’s wholly owned subsidiary.
In connection with the Acquisition, NeuroAirmid entered into an Amended and Restated Exclusive License Agreement, effective November 12, 2026 (the “License Agreement”), with The Regents of the University of California (“The Regents”), related to a pluripotent stem cell derived, clinical-stage neural cell therapy program, (hNSC-01) which Lineage calls HUNT1, for the treatment of Huntington’s Disease (HD).
HUNT1 is currently being evaluated in a Phase 1b/2a clinical study known as the REGEN4HD clinical study (ClinicalTrials.gov ID NCT07451613). The REGEN4HD clinical study is evaluating the safety and tolerability of a single dose, one-time administration of HUNT1 for the treatment of HD. Up to 21 patients will be enrolled across 5 planned cohorts, which will evaluate various doses of hNSC-01. Phase 1b of the REGEN4HD study will enroll up to 12 patients, across 4 cohorts (Cohorts A – D), at dose escalations of 2 million, 4 million, 8 million and 16 million cells. Phase 2a of the REGEN4HD study will enroll up to 9 patients (Cohort 2A), with a maximum tolerated dose to be determined from Phase 1b of the clinical study. The first 3 Cohort A patients will undergo unilateral administration of hNSC-01, with an option to undergo a similar transplant following approval from the study’s Data Safety Monitoring Board (DSMB). The primary safety outcome measure is the number of participants with treatment-related adverse events, after 6 and 12 weeks following dosing. Safety is assessed 6 weeks following each surgery for Cohort A patients, and at 12 weeks following surgeries for each Cohort B - D patients. Secondary outcome measures at 12 months following treatment include: number of participants with treatment-related adverse events; change in Total Motor Score; changes in functional imaging and structural magnetic resonance imaging; changes in cerebrospinal fluid neurofilament light chain, a biomarker associated with neuronal injury and neurodegeneration; changes in plasma neurofilament light chain; changes in cognitive function measured using the Mini-Mental State Examination and Stroop Word Reading Test; changes in Total Functioning Capacity; and changes in behavioral symptoms associated with HD, measured using the Problem Behaviors Assessment–short version.
The HUNT1 program has progressed into clinical development with the support of $16 million of translational funding from the California Institute for Regenerative Medicine (“CIRM”). The REGEN4D clinical study is being supported by a CIRM award of up to $12 million issued in April 2026, of which Lineage is responsible for paying up to $3.1 million over the term of the grant, which is expected to be through February 2030, in respect of a co-funding obligation that Lineage assumed in connection with the acquisition of NeuroAirmid, replacing CIRM’s co-funding arrangement. Lineage will assume responsibility for clinical development of the HUNT1 program following completion of the REGEND4HD clinical study, as well as for all future cell manufacturing, process development, scale up and optimization activities, potentially utilizing aspects of its proprietary AlloSCOPE cell manufacturing platform.
At the closing of the Acquisition, Lineage (i) paid $2.4 million in cash to the Sellers, (ii) issued an aggregate of 2.2 million Lineage common shares to the Sellers (which was calculated by dividing $2.1 million by the volume-weighted average price of Lineage common shares over the 20 trading days ending two days before the closing), (iii) paid $0.2 million into an expense fund for use by the Sellers’ representative, and (iv) paid an aggregate of $1.7 million to satisfy NeuroAirmid’s obligations to third parties. Lineage also agreed to pay up to the following amounts to the Sellers and in respect of obligations of NeuroAirmid at the closing: (a) up to $5.4 million on the first anniversary of the closing; (b) up to $48.0 million in the aggregate contingent upon achievement of specified clinical development and regulatory milestones relating to the HUNT1 program; and (c) for each sublicense, collaboration or other strategic transaction involving the HUNT1 program or for the sale of NeuroAirmid or the program, in each case that is completed before the tenth anniversary of closing and provides at least $5.0 million in qualifying proceeds to Lineage (which excludes contingent consideration, including earn-outs, milestones and royalties), the greater of (i) a low seven-figure dollar amount and (ii) a single-digit percentage of those proceeds, which single-digit percentage increases depending on the program’s development stage at the time of the transaction. Lineage may pay up to approximately 50% of the value of each post-closing payment to the Sellers in Lineage common shares, with the balance payable in cash, subject to NYSE American limits on share issuances without shareholder approval. During specified periods of time, Lineage agreed to use commercially reasonable efforts to achieve certain of the milestones relating to the HUNT1 program.
The Lineage common shares issued and issuable under the Purchase Agreement were not, and will not be, registered under the Securities Act of 1933, as amended (the “Securities Act”), and were issued, or will be issued, in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated thereunder. Within 60 days following the closing, Lineage agreed to file a registration statement to register for resale the Lineage common shares issued to the Sellers at the closing, and will use commercially reasonable efforts to cause such registration statement to be declared effective within 90 days after the closing.
NeuroAirmid was founded to advance human neural stem cell technologies for the treatment of HD. It was co-founded by Leslie M. Thompson, Ph.D., Donald Bren Professor of psychiatry and human behavior as well as neurobiology and behavior at the University of California, Irvine, who is the principal investigator of the REGEN4HD clinical study. In 2024, NeuroAirmid received an exclusive license from The Regents under specified patent rights relating to neural stem cell compositions and methods to treat neurodegenerative disorders, and a nonexclusive license to associated technology, to develop, manufacture and commercialize licensed
products for neurological diseases, injuries and disorders, drug testing and diagnostics, and commercial in vitro assay uses, which license agreement has been amended and restated by the License Agreement (described below). NeuroAirmid has had nominal operations, does not have any employees, and has not generated any revenue. In connection with the Acquisition, Dr. Thompson and the other Sellers entered into customary consulting and noncompetition agreements with Lineage.
The Purchase Agreement contains customary representations, warranties, covenants and indemnification obligations of Lineage and the Sellers.
The foregoing summary of the Purchase Agreement does not purport to be complete and is qualified in its entirety by the full text of the Purchase Agreement, a copy of which is filed as an exhibit to this report and incorporated herein by reference. The Purchase Agreement is included solely to inform investors of its terms, not to provide factual information about the Company, NeuroAirmid or the Sellers or to modify or supplement any factual disclosures about the Company in its reports filed with the SEC. The representations, warranties and covenants of the parties set forth in the Purchase Agreement have been made solely for purposes of, and were and are solely for the benefit of the parties to, the Purchase Agreement, may be subject to limitations agreed upon by the contracting parties, and may be subject to standards of materiality applicable to the contracting parties that differ from those generally applicable to SEC filings, and may have been used to allocate risk among the parties to the Purchase Agreement. Certain schedules and exhibits to the Purchase Agreement have been omitted, and the representations and warranties may not reflect the actual state of affairs when made or at any other time, and investors should not rely on them as statements of fact.
The License Agreement
Under the License Agreement, NeuroAirmid and Lineage (which are together referred to as Lineage for purposes of this summary of the License Agreement) received an exclusive license under specified patent rights relating to neural stem cell compositions and methods to treat neurodegenerative disorders, and a nonexclusive license to associated technology, to develop, manufacture and commercialize licensed products for neurological diseases, injuries and disorders, drug testing and diagnostics, and commercial in vitro assay uses. The patent license covers territories where the licensed patent rights exist or may arise, and the associated technology license is worldwide. Lineage also received exclusive rights to use specified clinical trial data for regulatory filings, nonexclusive rights to use that data to develop and commercialize licensed products, and rights of reference to the investigational new drug application (“IND”) supporting the ongoing REGEN4HD clinical study and the related data pending transfer of IND sponsorship. IND sponsorship is to transfer to Lineage within six months after the last patient is dosed in the ongoing REGEN4HD clinical study, or earlier by agreement of the parties.
The Regents retain noncommercial research and educational rights, including rights to complete the ongoing REGEN4HD clinical study. Lineage also has rights to negotiate licenses to specified improvements and, if negotiations are unsuccessful, to accept terms offered to third parties before The Regents license those improvements to them. The licensed rights are subject to applicable CIRM requirements and provisions permitting The Regents to license certain undeveloped products to third parties if Lineage does not pursue development or sublicensing as required.
Lineage must pay quarterly royalties on net sales by Lineage and its sublicensees, determined by product and country, at percentages in the low single digits, with a higher rate while a licensed product is covered by a valid patent claim in the country of sale or manufacture and a lower rate when no such claim applies. Beginning in the calendar year after the first commercial sale, a single aggregate annual minimum royalty applies across licensed products. For products approved for an orphan disease, the minimum increases over the initial commercial years from the low-five figures to the mid-five figures annually; for other products, the minimum increases over the same period from the high-five figures to the mid-six figures annually. Minimum royalties are creditable against earned royalties for the calendar year in which paid.
Lineage must also pay The Regents a percentage of sublicensing income in the low double digits and must reimburse The Regents for patent prosecution and maintenance costs. Specified subsequent assignments to nonaffiliates would trigger a minimum assignment fee to The Regents in the low-six figures, plus an additional low-six figures fee for each $5 million of assignment consideration.
Lineage must diligently develop and commercialize licensed products, obtain regulatory approvals, comply with reporting and recordkeeping requirements, and maintain insurance and provide third-party indemnification, subject to specified exceptions. Remaining development objectives require diligent efforts to establish approved chemistry, manufacturing and controls manufacturing and a new cGMP cell bank within three years, dose a patient in a pivotal trial supporting a biologics license application within eight years, and submit a marketing application within 15 years after the License Agreement’s effective date. Failure to satisfy diligence requirements may result in termination or conversion of the exclusive license to a nonexclusive license following notice and an opportunity to cure.
Unless earlier terminated, the patent license continues until expiration or abandonment of the last licensed patent rights, and the associated technology and clinical trial data licenses continue for 25 years after the first commercial sale of a licensed product in the United States or Europe. Upon expiration, but not earlier termination, the licenses convert to perpetual, irrevocable, fully paid-up, royalty-free, nonexclusive licenses if all amounts due have been paid. In addition to customary termination rights, The Regents may terminate for a breach not cured within 90 days after notice.
The foregoing summary of the License Agreement does not purport to be complete and is qualified in its entirety by its full text, a copy of which Lineage intends to file as an exhibit to its next periodic report.
Item 2.01 Completion of Acquisition or Disposition of Assets.
The information in Item 1.01 of this report is incorporated by reference into this Item 2.01 to the extent responsive to the disclosure requirements of Item 2.01 of Current Report on Form 8-K.
Item 2.02 Results of Operations and Financial Condition.
On November 12, 2026, Lineage issued a press release announcing financial results for the quarter ended September 30, 2026, a copy of which is furnished as Exhibit 99.1.
The information under this Item 2.02 and in Exhibit 99.1 is being furnished and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and is not to be incorporated by reference into any filing of the registrant under the Securities Act or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in any such filing, except as shall be expressly set forth by specific reference in such a filing.
Item 3.02 Unregistered Sales of Equity Securities.
The information in Item 1.01 of this report is incorporated by reference into this Item 3.02 to the extent responsive to the disclosure requirements of Item 3.02 of Current Report on Form 8-K.
Item 7.01 Regulation FD Disclosure.
On November 12, 2026, Lineage issued a press release announcing the Acquisition, a copy of which is furnished as Exhibit 99.2 to this report.
The information in this Item 7.01 and in Exhibit 99.2 to this report is furnished and is not filed for purposes of Section 18 of the Exchange Act, and is not incorporated by reference into any filing under the Securities Act or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language, unless expressly incorporated by specific reference in that filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
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Description |
2.1*+ |
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Stock Purchase Agreement, dated as of November 12, 2026, by and among Lineage Cell Therapeutics, Inc., the stockholders of NeuroAirmid Therapeutics, Inc., and Leslie Thompson, as the sellers’ representative. |
99.1 |
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Press release issued November 12, 2026 (announcing financial results for the quarter ended September 30, 2026) |
99.2 |
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Press release issued November 12, 2026 (announcing the Acquisition) |
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+ Portions of this exhibit have been redacted in compliance with Regulation S-K Item 601(b)(2)(ii). |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Lineage Cell Therapeutics, Inc. |
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November 12, 2026 |
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/s/ George A. Samuel III |
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George A. Samuel III |
Exhibit 99.1
LINEAGE CELL THERAPEUTICS REPORTS THIRD QUARTER 2026 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
CARLSBAD, CA – November 12, 2026 - Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel, allogeneic, “off the shelf”, cell therapies for serious medical conditions, today reported its third quarter 2026 financial and operating results. The Company will host a conference call today at 4:30 p.m. Eastern Time to discuss these results and to provide a business update.
“While our collaboration with Roche and Genentech for the development of the OpRegen cell therapy program for dry AMD with geographic atrophy continues to advance, we are focused on using our platform to build a diversified portfolio of additional allogeneic cell transplant programs,” stated Brian M. Culley, Lineage CEO. “Today, we closed the acquisition of NeuroAirmid Therapeutics adding HUNT1, a third clinical-stage asset to our development pipeline. HUNT1 is a pluripotent stem cell derived, clinical-stage neural cell therapy program, with the potential to validate a new cell-based treatment modality for Huntington’s Disease. When we evaluated this opportunity, what stood out was the substantial development work that had been completed, external capital had been invested, and we believed our manufacturing expertise could create significant additional value for this program. This transaction reflects the disciplined approach to capital allocation and strategic fit that we believe our investors have come to expect from Lineage. HUNT1 was created on the same proprietary cell line that Lineage uses and is compatible with its AlloSCOPE “5D” technology, providing us with a head start on our planned contributions. Leveraging our experience with this line and our capabilities in cell manufacturing, process development, and scale-up, we intend to deploy our resources to migrate the HUNT1 process to our AlloSCOPE manufacturing platform and to support the evolution of HUNT1 onto a commercially viable and scalable production system more suitable to supporting late-stage registrational trials in parallel with its ongoing clinical development. In addition, the ongoing REGEN4HD clinical trial of HUNT1 is supported in part by a CIRM grant, reducing our out-of-pocket development costs.”
Mr. Culley continued, “In addition to this exciting acquisition, we also strengthened our proprietary manufacturing position through the issuance of a U.S. patent covering our AlloSCOPE 5D technology. 5D is an approach which we believe may provide a differentiated solution to one of the most important challenges facing the allogeneic cell therapy industry: enabling commercially-scalable and consistent manufacturing of pluripotent cell-derived therapies. We recently deployed AlloSCOPE 5D to COR1, our wholly owned corneal endothelial cell therapy program, and expect initial preclinical data in the first quarter of 2027, demonstrating the speed, scalability, and
versatility of our development platform. We also continued to employ 5D technology to advance our ILT1 program, which ultimately may become a treatment for Type 1 Diabetes.”
“In parallel with supporting the development of the OpRegen cell therapy program through the production, release, and delivery of multiple GMP batches of clinical trial material, we are prioritizing other programs that we believe can generate meaningful data in early clinical trials, and which supports our plan to optimize capital allocation and accelerate value creation. By combining strategic business development, proprietary manufacturing technologies, and internally generated innovation, we believe we are building a differentiated pipeline and positioning Lineage to create sustainable long-term value for our shareholders.” concluded Mr. Culley.
Select Business Highlights
Balance Sheet Highlights
Cash, cash equivalents, and marketable securities of $45.2 million as of September 30, 2026 is expected to support planned operations into Q2 2028.
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, 2026 were approximately $1.5 million, a net decrease of $2.2 million as compared to $3.7 million for the same period in 2025. The decrease was primarily due to lower collaboration revenue recognized from deferred revenues under the Roche Agreement, reflective of measured progress towards completion of the first performance obligation. Additionally, revenue from our research collaboration agreement with WDI was lower; both decreases were driven by fewer services provided in the current year.
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 September 30, 2026 were approximately $8.8 million, an increase of $1.3 million as compared to $7.5 million for the same period in 2025.
R&D Expenses: R&D expenses for the three months ended September 30, 2026 were $3.8 million, an increase of $0.5 million as compared to $3.3 million for the same period in 2025. The net increase was primarily driven by $0.8 million for our preclinical programs and other undisclosed programs and $0.5 million for our Resonance program, partially offset by $0.2 million for our OPC1 program and $0.6 million for our OpRegen program.
G&A Expenses: G&A expenses for the three months ended September 30, 2026 were $4.9 million, an increase of $0.7 million as compared to approximately $4.2 million for the same period in 2025. The net increase was primarily driven by personnel costs and stock-based compensation expense.
Loss from Operations: Loss from operations for the three months ended September 30, 2026 were $7.3 million, an increase of $3.5 million as compared to $3.8 million for the same period in 2025.
Other Income/(Expenses): Other income/(expenses) for the three months ended September 30, 2026 reflected other income of $12.0 million, compared to other expense of ($26.0) million for the same period in 2025. The net change was primarily attributable to the quarterly fair value non-cash remeasurement of the warrant liabilities driven by a decrease in our share price as compared to an increase in the prior year’s quarter.
Net Income/(Loss) Attributable to Lineage: The net income/(loss) attributable to Lineage for the three months ended September 30, 2026 was net income of $4.2 million, or $0.02 earnings per share (basic) and ($0.03) loss per share (diluted), compared to a net loss of ($29.8) million, or ($0.13) loss per share (basic and diluted), for the same period
in 2025. The change was primarily driven by the quarterly fair value non-cash remeasurement of the warrant liabilities.
Conference Call and Webcast
Interested parties may access today’s conference call by dialing (800) 715-9871
from the U.S. and Canada and should request the “Lineage Cell Therapeutics Call” (Conference ID: 6471629). 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 19, 2026, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 6471629.
About the AlloSCOPE (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) Platform
The AlloSCOPE (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) platform highlights the key attributes of Lineage’s in-house technology and describes a differentiation and production modality from which Lineage can manufacture millions of doses of an allogeneic, cell-based product derived from a single initial pluripotent cell line, conferring consistent, cost-effective, and scalable cell-based production and which can be applied across multiple programs. From our proprietary AlloSCOPE platform, we successfully completed a current Good Manufacturing Practice (“cGMP”) production run from a custom, two-tiered cell banking system, featuring a genetically-stable master cell bank (MCB) created from a single, well-characterized pluripotent cell line, which generated a working cell bank (WCB), which then provided the source material for two final cell-based product candidates. AlloSCOPE “5D” describes an application of AlloSCOPE with the goal of higher scale production with reduced manipulation.
Allogeneic cell therapy product manufacturing generally involves three basic steps: (i) expansion of pluripotent cells; (ii) differentiation of cells into the desired cell type, and (iii) further expanding those cells prior to harvesting, filling and cryopreserving the final product. In cell therapy manufacturing, how cells are grown and organized during differentiation and/or expansion can affect their scalability, phenotype, process control, manufacturing cost, and the characteristics of the final product. In a 2D process, cells are typically grown as an adherent monolayer on a flat, coated surface, such as a culture flask or multilayer vessel. This method allows for close control of cell growth and morphology, but scaling generally requires increasing the number of culture vessels, which can add labor, facility space, cost, and process complexity. In a 3D process, cells are grown in a three-dimensional environment, often as aggregates or spheroids within a bioreactor. This method can support automation, higher cell densities, and greater scale from a smaller footprint, but requires a tradeoff of less control and loss of synchronization. Lineage’s AlloSCOPE 5D technology is the Company’s innovative process of merging 2D manufacturing with 3D scale. By creating 2D-like growth conditions within a controlled, scalable 3D environment, AlloSCOPE 5D is designed to address one of the central manufacturing challenges in large-scale cell therapy manufacturing, by harnessing the precision and uniformity advantages of 2D culture with the scalability, efficiency, and automation capabilities of 3D bioreactor systems, while simultaneously avoiding the scale limitations of 2D methods and unresolved challenges associated with aggregate-based 3D culture.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel allogeneic, or “off the shelf”, cell therapies for serious medical conditions. Lineage’s programs are based on its proprietary cell-based technology platform, AlloSCOPE™ (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering), and associated development and manufacturing capabilities. From this proprietary AlloSCOPE platform, Lineage develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or substantially identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages, and in some instances may be designed to have additional beneficial properties. Cells derived from such
lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s pipeline currently includes: (i) OpRegen® cell therapy, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) HUNT1, a pluripotent stem cell derived, neural cell therapy in Phase 1b/2a development for the treatment of Huntington’s Disease; (iii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iv) COR1, a corneal endothelial disease cell therapy in preclinical development for the potential treatment of corneal endothelial disease; (v) ReSonance® (ANP1), an auditory neuronal progenitor cell therapy in preclinical development under a collaboration with William Demant Invest A/S for the potential treatment of auditory neuropathy; (vi) ILT1, an islet cell therapy focused on the issue of large-scale production of undifferentiated pluripotent cells, which if successful and applied to an islet cell differentiation protocol could be evaluated for the production of islet cells for the potential treatment of Type 1 Diabetes; (vii) RND1, a novel hypoimmune induced pluripotent stem cell line being evaluated for development under a gene editing partnership; and (viii) PNC1, a photoreceptor neural cell therapy research initiative being evaluated for development for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit www.lineagecell.com or follow the company on X/Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that this press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Lineage intends these statements to be covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, to the extent applicable. All statements, other than statements of historical facts, contained in this press release are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “suggest,” “goal,” “positioned,” “scheduled,” or the negative version of these words and similar expressions. The absence of these terms does not mean that a statement is not forward-looking. Such forward-looking statements include, but are not limited to, statements relating to: the potential benefits of the NeuroAirmid acquisition and HUNT1 as a cell-based treatment modality for Huntington’s Disease; plans to develop a commercially scalable production process for HUNT1 in parallel with its clinical development, including the application of Lineage’s cell-line experience and manufacturing, process development, scale-up and optimization capabilities and the use of AlloSCOPE for future HUNT1 manufacturing; the expected progress, enrollment, completion and funding of the REGEN4HD Phase 1b/2a study, including support from CIRM, and Lineage’s assumption of clinical development responsibility following completion of that study; plans and timing for development of COR1, including initial preclinical data expected in the first quarter of 2027; the potential safety and therapeutic benefits of COR1 for patients suffering from corneal endothelial disease, including FECD and bullous keratopathy; the benefits of a thaw-and-inject formulation and its combination with bioreactor-based precursor expansion and differentiation, and the potential for COR1 to demonstrate a superior product profile; the potential for Lineage’s AlloSCOPE manufacturing platform to enable large-scale production of COR1 in accordance with cGMP and other applicable manufacturing standards and requirements and reduce production costs; the ability of Lineage’s two-tiered cell banking system to generate millions of doses of final product; the potential of the AlloSCOPE platform, including based on our prior success in completing a production run for two product candidates, to manufacture 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; the potential for AlloSCOPE 5D to support large-scale production for high-dose indications such as Type 1 Diabetes and the anticipated speed, scalability and versatility of the platform; the expected June 9, 2043 expiration of the AlloSCOPE patent and the anticipated competitive benefits of the Company’s intellectual property; Lineage’s strategy of prioritizing programs that it believes can generate meaningful data in early clinical trials, thereby allowing the Company to evaluate opportunities and clinical potential earlier, optimize capital allocation, and accelerate potential value creation; Lineage's plans to, and its ability to, apply its manufacturing capabilities through its ILT1 initiative to establish an
expansion-through-differentiation production modality entirely in a 5D dynamic culturing system that, if successful and applied to an islet-cell differentiation protocol, could address production and commercialization hurdles for potential islet cell therapy product candidates for Type 1 Diabetes; the potential therapeutic benefits of OpRegen cell therapy in patients with GA secondary to age-related macular degeneration and the significance of the Phase 1/2a clinical study data reported to date, including the expectation that findings from the open-label, single-arm Phase 1/2a study may support continued evaluation; Genentech’s plans to evaluate proprietary surgical delivery devices that have potential advantages over available off-the-shelf devices in the Phase 2a GAlette Study; the ongoing open and active status of the Phase 2a GAlette Study at clinical sites in the U.S. and Israel and ongoing patient enrollment at such sites; the benefits of Lineage’s services agreement with Genentech and its impact on advancing the OpRegen cell therapy program; the plans and expectations with respect to OPC1, including the ongoing DOSED clinical study and enrollment of additional participants and expectations regarding continued study conduct and device design; expected funding, duration, activities and objectives of the WDI research collaboration for ReSonance (ANP1), including second-year preclinical advancement and functional testing using the established deafening model, manufacturing and release testing, and the planned fourth-quarter 2026 meeting with the Danish Medicines Agency to discuss development plans and seek scientific advice; Lineage’s expectation that its cash, cash equivalents and marketable securities are sufficient to support its planned operations into the second quarter of 2028; Lineage’s plans to advance and diversify its pipeline in 2026 and beyond, including its long-term strategy of creating a leading pipeline of cell-based transplant programs based on its core technology and AlloSCOPE manufacturing platform . Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that we may need to allocate our cash to unexpected events and expenses causing us to expend our cash, cash equivalents and marketable securities more quickly than expected; that cash runway projections are based on current operating assumptions and are subject to change based on business conditions, development activities, and other factors outside Lineage’s control, and that Lineage may need to raise additional capital before that time; that development activities, preclinical activities, and clinical trials of our product candidates may not commence, progress or be completed as expected due to many factors within and outside of our control; that Lineage's development strategy of prioritizing programs based on the potential for early meaningful data may not result in the generation of meaningful data, nor ultimately successful product candidates, and that the ability to generate meaningful data in early clinical trials is uncertain and may not be predictive of clinical success in later-stage studies; that early, exploratory, or interim findings in clinical and/or nonclinical studies of a product candidate may not be predictive of results in controlled, subsequent, or later-stage clinical and/or nonclinical studies of that candidate; difficulties transferring manufacturing processes and clinical responsibilities for HUNT1, maintaining necessary licenses and other rights, or achieving anticipated acquisition benefits, and the costs of deferred and contingent acquisition payments; the possibility that CIRM grant support may be delayed, conditioned, reduced or unavailable or insufficient to complete planned activities; delays or failures in the REGEN4HD study and dependence on collaborators, investigators, clinical sites, suppliers and service providers for that study; that Roche and Genentech may not successfully advance OpRegen cell therapy or be successful in completing further clinical trials for OpRegen cell therapy and/or obtaining regulatory approval for OpRegen cell therapy in any particular jurisdiction, and Genentech retains discretion over the advancement of OpRegen and Lineage cannot control Genentech's decisions; that competing alternative therapies may adversely impact the commercial potential of OpRegen cell therapy; that OPC1 clinical trials, including the DOSED study, may not be successful; that the DOSED study is evaluating device safety and utility and no safety or efficacy conclusions regarding OPC1 are available at this time; that COR1 is a preclinical asset and there is no assurance that preclinical data expected to be generated in the first quarter of 2027 will be positive or generated on the anticipated timeline, that COR1 will advance into clinical development, or that COR1 will demonstrate the same or superior efficacy, a superior product profile or disruptive potential relative to existing or competing therapies for corneal endothelial disease; that Lineage’s ILT1 development is in its early stages, and even if our AlloSCOPE 5D manufacturing initiative is successful in producing large scale production of undifferentiated pluripotent stem cells, that we may not be able to successfully or feasibly differentiate those cells into islet cells, and further, we may not successfully establish a production modality for large-scale islet cell production, and there is no assurance that undifferentiated pluripotent
stem cell manufacturing milestones will translate to clinical or commercial development or result in a viable product candidate for the treatment of Type 1 Diabetes; that the AlloSCOPE platform may not generate new programs with the speed, efficiency, or value creation potential that Lineage anticipates, and past development timelines may not be indicative of future results; that expected manufacturing scale, consistency, genetic stability, differentiation control, efficiency and cost advantages may not be achieved or maintained across programs or at clinical or commercial scale; that intellectual property protection may be challenged, limited or lost before its expected expiration; that the WDI collaboration may not achieve its intended objectives, that WDI may not contribute the full amount of anticipated funding, that the WDI anticipated funding may not be sufficient to complete the planned activities under the WDI collaboration and that additional funding may be required, and that the completed cGMP manufacturing run may not satisfy release testing requirements; that the planned Danish Medicines Agency meeting may be delayed or may not yield scientific advice supporting the anticipated development plans; that research initiatives, including PNC1 and RND1, may not result in viable product candidates or achieve their intended therapeutic or development objectives; that the ongoing 2026 Iran War and broader Israeli regional conflict may materially and adversely impact clinical activities at Israel trial sites participating in the GAlette study and/or our manufacturing processes, including cell banking and product manufacturing for our cell therapy product candidates, all of which are conducted by our subsidiary in Jerusalem, Israel; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in its filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports filed with the SEC, including its most recent Annual Report on Form 10-K filed with the SEC and its subsequent reports filed with SEC, which are available on the SEC’s website at www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Lineage undertakes no obligation to update any forward-looking statement to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(Nic.johnson@russopartnersllc.com)
(David.schull@russopartnersllc.com)
(212) 845-4242
Tables to follow
LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS)
(UNAUDITED)
|
|
September 30, 2026 |
|
|
December 31, 2025 |
|
||
ASSETS |
|
|
|
|
|
|
||
CURRENT ASSETS |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
26,499 |
|
|
$ |
40,791 |
|
Marketable securities |
|
|
18,677 |
|
|
|
14,990 |
|
Accounts receivable |
|
|
1,333 |
|
|
|
891 |
|
Prepaid expenses and other current assets |
|
|
1,265 |
|
|
|
2,485 |
|
Total current assets |
|
|
47,774 |
|
|
|
59,157 |
|
|
|
|
|
|
|
|
||
NONCURRENT ASSETS |
|
|
|
|
|
|
||
Property and equipment, net |
|
|
2,378 |
|
|
|
2,566 |
|
Operating lease right-of-use assets |
|
|
1,696 |
|
|
|
2,131 |
|
Deposits and other long-term assets |
|
|
583 |
|
|
|
558 |
|
Goodwill |
|
|
10,672 |
|
|
|
10,672 |
|
Intangible assets, net |
|
|
31,700 |
|
|
|
31,700 |
|
Deferred tax asset, net |
|
|
5,307 |
|
|
|
5,800 |
|
TOTAL ASSETS |
|
$ |
100,110 |
|
|
$ |
112,584 |
|
|
|
|
|
|
|
|
||
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
||
CURRENT LIABILITIES |
|
|
|
|
|
|
||
Accounts payable and accrued liabilities |
|
$ |
5,610 |
|
|
$ |
7,181 |
|
Operating lease liabilities, current portion |
|
|
954 |
|
|
|
816 |
|
Finance lease liabilities, current portion |
|
|
33 |
|
|
|
37 |
|
Deferred revenues, current portion |
|
|
1,422 |
|
|
|
3,333 |
|
Total current liabilities |
|
|
8,019 |
|
|
|
11,367 |
|
|
|
|
|
|
|
|
||
LONG-TERM LIABILITIES |
|
|
|
|
|
|
||
Deferred tax liability, net |
|
|
14 |
|
|
|
22 |
|
Deferred revenues, net of current portion |
|
|
12,339 |
|
|
|
12,377 |
|
Operating lease liabilities, net of current portion |
|
|
1,036 |
|
|
|
1,534 |
|
Finance lease liabilities, net of current portion |
|
|
6 |
|
|
|
32 |
|
Warrant liabilities |
|
|
12,753 |
|
|
|
43,906 |
|
TOTAL LIABILITIES |
|
|
34,167 |
|
|
|
69,238 |
|
|
|
|
|
|
|
|
||
Commitments and contingencies |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
||
Preferred shares, no par value, 2,000 shares authorized; none issued and |
|
|
— |
|
|
|
— |
|
Common shares, no par value, 450,000 shares authorized as of issued and outstanding as of September 30, 2026 and December 31, 2025, respectively |
|
|
537,420 |
|
|
|
515,467 |
|
Accumulated other comprehensive loss |
|
|
(4,261 |
) |
|
|
(3,920 |
) |
Accumulated deficit |
|
|
(466,096 |
) |
|
|
(466,998 |
) |
Lineage's shareholders’ equity |
|
|
67,063 |
|
|
|
44,549 |
|
Noncontrolling deficit |
|
|
(1,120 |
) |
|
|
(1,203 |
) |
Total shareholders’ equity |
|
|
65,943 |
|
|
|
43,346 |
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
$ |
100,110 |
|
|
$ |
112,584 |
|
LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE DATA)
(UNAUDITED)
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|||||||||||||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
|||||||||||||||
REVENUES: |
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Collaboration revenues |
|
$ |
1,349 |
|
|
$ |
3,544 |
|
|
$ |
3,867 |
|
|
$ |
7,346 |
|
|||||||||||
Royalties, license and other revenues |
|
|
85 |
|
|
|
137 |
|
|
|
361 |
|
|
|
602 |
|
|||||||||||
Total revenues |
|
|
1,434 |
|
|
|
3,681 |
|
|
|
4,228 |
|
|
|
7,948 |
|
|||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Cost of royalties |
|
|
5 |
|
|
|
5 |
|
|
|
5 |
|
|
|
80 |
|
|||||||||||
Research and development |
|
|
3,818 |
|
|
|
3,271 |
|
|
|
12,826 |
|
|
|
9,491 |
|
|||||||||||
General and administrative |
|
|
4,925 |
|
|
|
4,191 |
|
|
|
15,227 |
|
|
|
13,608 |
|
|||||||||||
Loss on impairment of intangible asset |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
14,840 |
|
|||||||||||
Total operating expenses |
|
|
8,748 |
|
|
|
7,467 |
|
|
|
28,058 |
|
|
|
38,019 |
|
|||||||||||
Loss from operations |
|
|
(7,314 |
) |
|
|
(3,786 |
) |
|
|
(23,830 |
) |
|
|
(30,071 |
) |
|||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
OTHER INCOME (EXPENSES): |
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Interest income, net |
|
|
376 |
|
|
|
366 |
|
|
|
1,159 |
|
|
|
1,298 |
|
|||||||||||
Gain (loss) on marketable equity securities, net |
|
|
(8 |
) |
|
|
6 |
|
|
|
16 |
|
|
|
(1 |
) |
|||||||||||
Change in fair value of warrant liability |
|
|
11,944 |
|
|
|
(26,557 |
) |
|
|
23,711 |
|
|
|
(36,992 |
) |
|||||||||||
Foreign currency transaction gain (loss), net |
|
|
(284 |
) |
|
|
219 |
|
|
|
430 |
|
|
|
1,666 |
|
|||||||||||
Other income (expense), net |
|
|
— |
|
|
|
— |
|
|
|
(17 |
) |
|
|
(159 |
) |
|||||||||||
Total other income (expenses) |
|
|
12,028 |
|
|
|
(25,966 |
) |
|
|
25,299 |
|
|
|
(34,188 |
) |
|||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
INCOME (LOSS) BEFORE INCOME TAXES |
|
|
4,714 |
|
|
|
(29,752 |
) |
|
|
1,469 |
|
|
|
(64,259 |
) |
|||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Income tax expense |
|
|
(484 |
) |
|
|
— |
|
|
|
(484 |
) |
|
|
— |
|
|||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
NET INCOME (LOSS) |
|
|
4,230 |
|
|
|
(29,752 |
) |
|
|
985 |
|
|
|
(64,259 |
) |
|||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Net (income) loss attributable to noncontrolling interest |
|
|
2 |
|
|
|
(29 |
) |
|
|
(83 |
) |
|
|
(125 |
) |
|||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
NET INCOME (LOSS) ATTRIBUTABLE TO LINEAGE |
|
$ |
4,232 |
|
|
$ |
(29,781 |
) |
|
$ |
902 |
|
|
$ |
(64,384 |
) |
|||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
NET INCOME (LOSS) PER COMMON SHARE |
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Basic |
|
$ |
0.02 |
|
|
$ |
(0.13 |
) |
|
$ |
— |
|
|
$ |
(0.28 |
) |
|||||||||||
Diluted |
|
$ |
(0.03 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.28 |
) |
|||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
WEIGHTED-AVERAGE COMMON SHARES USED TO |
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Basic |
|
|
252,907 |
|
|
|
228,853 |
|
|
|
249,174 |
|
|
|
227,765 |
|
|||||||||||
Diluted |
|
|
259,075 |
|
|
|
228,853 |
|
|
|
261,217 |
|
|
|
227,765 |
|
|||||||||||
LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
(UNAUDITED)
|
|
Nine Months Ended September 30, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
||
Net income (loss) attributable to Lineage |
|
$ |
902 |
|
|
$ |
(64,384 |
) |
Net income attributable to noncontrolling interest |
|
|
83 |
|
|
|
125 |
|
Adjustments to reconcile net income (loss) attributable to Lineage Cell Therapeutics, Inc. |
|
|
|
|
|
|
||
Issuance costs for common stock warrant liabilities |
|
|
— |
|
|
|
183 |
|
Loss on impairment of intangible asset |
|
|
— |
|
|
|
14,840 |
|
(Gain) loss on marketable equity securities, net |
|
|
(16 |
) |
|
|
1 |
|
Accretion of income on marketable debt securities |
|
|
(402 |
) |
|
|
(10 |
) |
Depreciation and amortization expense |
|
|
577 |
|
|
|
513 |
|
Change in right-of-use assets and liabilities |
|
|
66 |
|
|
|
(41 |
) |
Stock-based compensation |
|
|
4,476 |
|
|
|
3,654 |
|
Change in fair value of warrant liability |
|
|
(23,711 |
) |
|
|
36,992 |
|
Income tax expense |
|
|
484 |
|
|
|
— |
|
Foreign currency remeasurement |
|
|
(471 |
) |
|
|
(1,721 |
) |
Loss on disposal of assets |
|
|
31 |
|
|
|
— |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
||
Accounts receivable |
|
|
(371 |
) |
|
|
511 |
|
Prepaid expenses and other current assets |
|
|
1,461 |
|
|
|
1,077 |
|
Accounts payable and accrued liabilities |
|
|
(2,102 |
) |
|
|
(188 |
) |
Deferred revenue |
|
|
(1,949 |
) |
|
|
(5,593 |
) |
Net cash used in operating activities |
|
|
(20,942 |
) |
|
|
(14,041 |
) |
|
|
|
|
|
|
|
||
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
||
Purchases of marketable debt securities |
|
|
(29,796 |
) |
|
|
— |
|
Maturities of marketable debt securities |
|
|
26,520 |
|
|
|
2,000 |
|
Purchase of equipment |
|
|
(237 |
) |
|
|
(123 |
) |
Net cash (used in) provided by investing activities |
|
|
(3,513 |
) |
|
|
1,877 |
|
|
|
|
|
|
|
|
||
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
||
Proceeds from employee options exercised |
|
|
233 |
|
|
|
487 |
|
Proceeds from exercise of warrants |
|
|
5,388 |
|
|
|
319 |
|
Common shares received and retired for employee taxes paid |
|
|
(40 |
) |
|
|
(15 |
) |
Proceeds from sale of common shares under ATM, net of offering costs |
|
|
4,454 |
|
|
|
1,276 |
|
Proceeds from sale of common shares with warrants under registered |
|
|
— |
|
|
|
5,232 |
|
Payment of financed insurance premium |
|
|
— |
|
|
|
(684 |
) |
Payment of finance lease liabilities |
|
|
(31 |
) |
|
|
(44 |
) |
Net cash provided by financing activities |
|
|
10,004 |
|
|
|
6,571 |
|
Effect of exchange rate changes on cash, cash equivalents and restricted cash |
|
|
173 |
|
|
|
216 |
|
NET DECREASE IN CASH, CASH EQUIVALENTS AND |
|
|
(14,278 |
) |
|
|
(5,377 |
) |
|
|
|
|
|
|
|
||
CASH, CASH EQUIVALENTS AND RESTRICTED CASH: |
|
|
|
|
|
|
||
At beginning of the period |
|
|
41,324 |
|
|
|
46,354 |
|
At end of the period |
|
$ |
27,046 |
|
|
$ |
40,977 |
|
|
|
|
|
|
|
|
||
Exhibit 99.2
LINEAGE ANNOUNCES ACQUISITION OF NEUROAIRMID THERAPEUTICS AND CLINICAL STAGE PROGRAM FOR THE TREATMENT OF HUNTINGTON’S DISEASE
CARLSBAD, CA – November 12, 2026 – Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic, “off the shelf”, cell therapies for serious medical conditions, today announced that the Company has acquired NeuroAirmid Therapeutics, Inc. (“NeuroAirmid”) along with certain worldwide rights related to a pluripotent stem cell derived, clinical-stage neural cell therapy program, hNSC-01, which Lineage calls HUNT1, for the treatment of Huntington’s Disease (HD), and to the use of clinical data from the ongoing REGEN4HD study. The HUNT1 program represents the culmination of decades of research, led by Leslie M. Thompson, PhD, Donald Bren Professor of Psychiatry & Human Behavior, School of Medicine, Neurobiology and Behavior, School of Biological Sciences, and Co-Director, Sue & Bill Gross Stem Cell Research Center at the University of California, Irvine (UCI). HUNT1 is a pluripotent stem cell-derived neural stem cell therapy for the treatment of Huntington’s Disease, currently being evaluated at UCI in the REGEN4HD clinical study. HUNT1 has progressed into clinical development with the support of $16 million of translational funding from the California Institute for Regenerative Medicine (CIRM). UCI also recently received a CIRM clinical award of up to $12 million that is supporting the ongoing REGEN4HD clinical study. To date, 6 patients have been dosed with HUNT1 in the ongoing REGEN4HD clinical study.
“We are excited to announce the acquisition of NeuroAirmid and the addition of HUNT1 for the treatment of Huntington’s Disease (HD), which adds a third clinical stage asset to our development pipeline and which aligns with our advanced capabilities in cell manufacturing, process development, and scale up,” stated Brian M. Culley, Lineage CEO. “Recent efforts in Huntington’s disease have focused on reducing mutant Huntingtin protein (mHTT) or somatic expansion, but to date there are no approved therapies that change the course of disease. HUNT1 represents an entirely new approach to treating HD. This approach focuses on providing protective factors to the brain to establish and stabilize the neural networks that underlie the essential clinical symptoms of HD. We are taking a fundamentally new approach toward potentially alleviating the terrible symptoms and progression of HD by delivering cells and providing permissive growth factors to the milieu.”
“Another consideration supporting this acquisition was that HUNT1 was created on the same cell line that Lineage has utilized with its AlloSCOPE™ “5D” technology and for its COR1 program, meaning we have experience and confidence with this cell line. And while the REGEN4HD study enrolls, we intend to deploy our resources to migrate the HUNT1 process onto our AlloSCOPE manufacturing platform and to support its evolution into a commercially viable and scalable production system more suitable to supporting late-stage registrational trials. The REGEN4HD study of up to 21 patients is collecting not only safety data, but also exploratory biomarker and functional assessments, making it capable of generating meaningful treatment signals. Additionally, the majority of the clinical costs for the ongoing REGEN4HD clinical study are being provided by CIRM, allowing us to complete this acquisition without deviating meaningfully from our historic and disciplined levels of investment. I am also pleased to note that as we advance this program, in addition to guidance from Dr. Thompson and her team, we also will benefit from the extensive internal expertise we secured via our recently appointed Head of Clinical, Dr. Priyantha Herath, a U.S. Board-certified specialist neurologist, whose broad clinical experience in
neurodegenerative disorders, including caring for patients with HD, will be exceptionally relevant to the HUNT1 program,” concluded Mr. Culley.
Upon closing of the transaction, Lineage paid approximately $4.7 million to NeuroAirmid investors, approximately half in cash and half in shares of Lineage common stock. A second payment of up to $5 million will be due to NeuroAirmid investors upon the first anniversary of the closing of the transaction, payable, in Lineage’s discretion, approximately half in cash and half in shares of Lineage common stock. NeuroAirmid investors will also be eligible to receive up to $48 million in additional developmental regulatory and clinical milestones, tied to continued HUNT1 program advancement, including upon achievement of clinical and regulatory milestones, and a minimum of a low seven-figure payment in the event of a possible future licensing transaction.
Lineage will assume responsibility for certain clinical development costs representing a portion of the CIRM award, estimated to be $3.1M through February 2030, and clinical development of the HUNT1 program following completion of the study, as well as for all future cell manufacturing, process development, scale up and optimization activities.
About the HUNT1 Program
HUNT1 is a pluripotent stem cell derived, clinical-stage neural cell therapy product candidate currently being evaluated in the REGEN4HD Phase 1b/2a clinical study for the treatment of Huntington’s Disease (HD) being conducted at UCI Health. HUNT1 has progressed into clinical development with the support of $16 million of translational funding from the California Institute for Regenerative Medicine (CIRM). UCI also recently received a CIRM clinical award of up to $12 million, supporting the ongoing REGEN4HD clinical study. The unique properties of HUNT1 cells following stereotactic intrastriatal administration has been extensively studied in vivo in multiple models of HD. These cells were shown to undergo differentiation into neurons including striatal neurons, while showing activity and connectivity with host neurons, measurable release of trophic factors that are critical for cellular health, a reduction of HD associated behaviors and pathologies, and the reversal of some transcriptional dysregulation that is commonly seen in HD. In addition, the preclinical efficacy of HUNT1 intrastriatal administration was robustly demonstrated in: (i) the expression of neuronal markers 8 months post-administration; (ii) the expression of Brain-Derived Neurotrophic Factor (BDNF) and the reduction mutant HTT accumulation; a favorable safety profile; and (iii) no adverse events 9-months post engraftment in pivotal GLP tumorgenicity and toxicity studies. The HUNT1 cells also demonstrated engraftment, survival and safety in Non-Human Primates (NHPs).
About the REGEN4HD Clinical Study
REGEN4HD (ClinicalTrials.gov: NCT07451613) is a currently enrolling Phase 1b/2a clinical study, evaluating the safety and tolerability of a single dose, one-time administration of HUNT1 (hNSC01) for the treatment of Huntington’s Disease. Up to 21 patients will be enrolled across 5 planned cohorts, which will evaluate various doses of hNSC01. Phase 1b of the REGEN4HD study will enroll up to 12 patients, across 4 cohorts (Cohorts A – D), at dose escalations of 2 million, 4 million, 8 million and 16 million cells. Phase 2a of the REGEN4HD study will enroll up to 9 patients (Cohort 2A), with a maximum tolerated dose to be determined from Phase 1b of the clinical study. The first 3 Cohort A patients will undergo unilateral administration of hNSC01, with an option to undergo a similar transplant following approval from the study’s Data Safety Monitoring Board (DSMB). The primary safety outcome measure is the number of participants with treatment-related adverse events. Safety is assessed 6 weeks following each surgery for Cohort A patients, and at 12 weeks following surgeries of each Cohort for Cohort B - D patients. Secondary outcome measures at 12 months following treatment include: change in Total Motor Score (TMS); changes in functional imaging and structural Magnetic Resonance Imaging (MRI); changes in cerebrospinal fluid neurofilament light chain (NfL), a biomarker associated with neuronal injury and neurodegeneration; changes in plasma neurofilament light chain (NfL); changes in proenkephalin (PENK) in CSF; changes in cognitive function measured using the Mini-Mental State Examination (MMSE) and Stroop Word Reading Test; changes in Total Functional Capacity (TFC); and changes in behavioral symptoms associated with Huntington’s disease, measured using the Problem Behaviors Assessment–short version. The REGEN4HD clinical study was made possible by funding from the California Institute for Regenerative Medicine (CIRM), a state of California Agency that funds regenerative medicine, stem cell, and gene therapy research. (Grant Number CLIN2-18595).
About Huntington’s Disease
Huntington’s disease (HD) is a rare, inherited and progressive neurodegenerative disorder caused by a mutation in the HTT gene. The disease results in the progressive dysfunction and loss of neurons, with particularly pronounced effects in the striatum, a region of the brain involved in movement, cognition and behavior. HD is characterized by progressive motor impairment, cognitive decline, and psychiatric and behavioral symptoms, which can ultimately result in significant loss of independence. Symptoms most commonly emerge during adulthood and progressively worsen over time. HD causes deterioration in a person’s physical, mental, and emotional abilities, usually during their prime working years, and currently has no cure. Most individuals start developing symptoms during adulthood, between the ages of 30 to 50, but HD can also occur in children and young adults (known as juvenile HD or JHD). Most persons with HD experience problems with thinking, behavior, and movements. Symptoms usually worsen over the course of 10 to 25 years and affect the ability to reason, walk, and talk. People with advanced HD need full-time care to help with their day-to-day activities, and they ultimately succumb to pneumonia, heart failure or other complications. The symptoms of HD are sometimes described as having ALS, Parkinson’s and Alzheimer’s – simultaneously. Approximately 41,000 people in the United States are symptomatic with HD, while more than 200,000 are estimated to be at risk of inheriting the disease. There is currently no disease modifying treatment or cure for HD, and available therapies are primarily focused on managing symptoms. For more information, please visit: The Huntington’s Disease Society of America.
About NeuroAirmid Therapeutics, Inc.
NeuroAirmid was founded to advance human neural stem cell technologies for the treatment of Huntington’s disease, a devastating neurological disease that strikes in the prime of life with no disease-modifying therapy currently available. NeuroAirmid’s human neural stem cell technology was developed at the University of California, Irvine. HUNT1 (hNSC01) has progressed into clinical development with the support of $16 million of translational funding from the California Institute for Regenerative Medicine (CIRM). UCI also recently received a CIRM clinical award of up to $12 million, supporting the ongoing REGEN4HD clinical study. For more information, please visit: www.neuroairmid.com.
About the California Institute for Regenerative Medicine (CIRM)
The California Institute for Regenerative Medicine (CIRM) is a funding agency established by Californians to accelerate regenerative medicine research to deliver treatments for patients with unmet medical needs. Established in 2004 through the passage of Proposition 71, CIRM was initially funded with $3 billion from the state of California to support ongoing research, and in 2020, was funded again with another $5.5 billion through Proposition 14 to continue the Agency’s important work. CIRM has provided billions in funding to support stem cell, genetic research, and development programs in its portfolio. Through the Agency’s research, infrastructure, and education programs, CIRM aims to transform the field of regenerative medicine, stimulate economic growth, and improve the lives of diverse communities throughout the state. For more information go to cirm.ca.gov.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel allogeneic, or “off the shelf”, cell therapies for serious medical conditions. Lineage’s programs are based on its proprietary cell-based technology platform, AlloSCOPE™ (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering), and associated development and manufacturing capabilities. From this proprietary AlloSCOPE platform, Lineage develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or substantially identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages, and in some instances may be designed to have additional beneficial properties. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient’s functional activity. Lineage’s pipeline currently includes: (i) OpRegen® cell therapy, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) HUNT1, a pluripotent stem cell derived, neural cell therapy in Phase 1b/2a development for the treatment of Huntington’s Disease; (iii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iv) ReSonance® (ANP1), an
auditory neuronal progenitor cell therapy in preclinical development under a collaboration with William Demant Invest A/S for the potential treatment of auditory neuropathy; (v) COR1, a corneal endothelial disease cell therapy in preclinical development for the potential treatment of corneal endothelial disease; (vi) ILT1, an islet cell therapy focused on the issue of large-scale production of undifferentiated pluripotent cells, which if successful and applied to an islet cell differentiation protocol, could be evaluated for the production of islet cells to support a potential treatment of Type 1 Diabetes; (vii) PNC1, a photoreceptor neural cell therapy research initiative being evaluated for development for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (viii) RND1, a novel hypoimmune induced pluripotent stem cell line being evaluated for development under a gene editing partnership. For more information, please visit www.lineagecell.com or follow the company on X/Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that this press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Lineage intends these statements to be covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, to the extent applicable. All statements, other than statements of historical facts, contained in this press release are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “suggest,” or the negative version of these words and similar expressions. The absence of these terms does not mean that a statement is not forward-looking. Such forward-looking statements include, but are not limited to, statements relating to: the anticipated strategic, clinical, operational and financial benefits of the acquisition of NeuroAirmid and the addition of HUNT1 to Lineage’s pipeline, including the expected alignment with Lineage’s cell manufacturing, process development and scale-up capabilities; the potential of HUNT1 to provide protective factors to the brain, establish and stabilize neural networks, stabilize or alleviate Huntington’s disease, provide new neurons and improve patient function; Lineage’s plans to deploy resources to migrate the HUNT1 process onto the AlloSCOPE manufacturing platform and support its evolution into a commercially viable, scalable production system capable of supporting late-stage registrational trials; the planned enrollment, cohorts, dose escalation, dose selection, additional transplantation, assessments and follow-up in the REGEN4HD clinical study, and its potential to generate meaningful treatment signals; expectations regarding CIRM funding, the extent to which such funding will offset future development costs or provide the majority of the clinical costs for the REGEN4HD clinical study, and Lineage’s ability to advance HUNT1 without deviating meaningfully from its historical levels of investment; the anticipated contributions of Dr. Thompson and her team and Lineage’s internal clinical expertise to HUNT1 development; Lineage’s anticipated assumption of responsibility for HUNT1 clinical development following completion of REGEN4HD and for future cell manufacturing, process development, scale-up and optimization activities using AlloSCOPE. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that Lineage may not realize the anticipated acquisition benefits of NeuroAirmid or effectively allocate resources among its programs; that HUNT1 may not demonstrate safety, tolerability or efficacy in humans, and preclinical findings, early clinical observations, exploratory biomarkers or results in other diseases or with other product candidates may not predict HUNT1’s clinical outcomes, functional benefits, regulatory approval or commercial success; that neural stem cell transplantation may involve surgical, immune, tumorigenicity, graft survival, differentiation, connectivity or other safety and efficacy risks; that REGEN4HD study enrollment, retention, dose escalation, dose selection, additional transplantation, follow-up, data collection or study completion may be delayed, modified, suspended or terminated because of adverse events, patient availability, study site capacity, Data Safety Monitoring Board decisions, regulatory requirements or other factors within or outside Lineage’s control; that migration of HUNT1 to AlloSCOPE, technology transfer, process development, scale-up and optimization may encounter technical difficulties, contamination, variability, comparability or validation issues, require additional studies or regulatory review, or fail to produce sufficient quantities of consistent, potent product meeting current good manufacturing practice requirements at commercially feasible cost or scale; that disruptions affecting personnel, suppliers, clinical sites, collaborators, cell banks or manufacturing facilities, including geopolitical conflict affecting operations in Israel, may delay or impair development and manufacturing; that CIRM funding may be subject to conditions, milestones, restrictions, delays, reduction or termination, may not be available to cover the anticipated share of costs, and
that actual acquisition, integration, manufacturing and development costs or payment obligations may exceed estimates; that the assumptions underlying anticipated spending levels and available financial resources may prove incorrect, and that Lineage may need additional capital that may not be available on acceptable terms or at all, potentially resulting in dilution, delays, reductions or discontinuation of programs; that reliance on UCI, CIRM, licensors, collaborators, clinical investigators and other third parties may expose Lineage to delays, disputes, loss of access to necessary rights or resources, or failures to perform; that regulatory requirements, changes in laws or regulatory policies, or additional requirements relating to cell therapies, clinical trials, manufacturing or reimbursement may delay, increase the cost of, or prevent development, approval or commercialization; that patents and other intellectual property rights may be challenged, invalidated, circumvented or insufficient to protect Lineage’s programs, and third-party rights may restrict their development or commercialization; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in its filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports filed with the SEC, including its most recent Annual Report on Form 10-K filed with the SEC and its subsequent reports filed with SEC, which are available on the SEC’s website at www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Lineage undertakes no obligation to update any forward-looking statement to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(Nic.johnson@russopartnersllc.com)
(David.schull@russopartnersllc.com)
(212) 845-4242
###