# EDGAR Filing Document

**Accession Number:** 0000876343
**File Stem:** 0000950170-25-111319
**Filing Date:** 2025-8
**Character Count:** 15431
**Document Hash:** 5c301b2e99887d4f069f91b70050d3e3
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0000950170-25-111319.hdr.sgml**: 20250826

**ACCESSION NUMBER**: 0000950170-25-111319

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 12

**CONFORMED PERIOD OF REPORT**: 20250826

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250826

**DATE AS OF CHANGE**: 20250826

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Lineage Cell Therapeutics, Inc.
- **CENTRAL INDEX KEY:** 0000876343
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 943127919
- **STATE OF INCORPORATION:** CA
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-12830
- **FILM NUMBER:** 251252945

**BUSINESS ADDRESS:**
- **STREET 1:** 2173 SALK AVENUE
- **STREET 2:** SUITE 200
- **CITY:** CARLSBAD
- **STATE:** CA
- **ZIP:** 92008
- **BUSINESS PHONE:** 5105213390

**MAIL ADDRESS:**
- **STREET 1:** 2173 SALK AVENUE
- **STREET 2:** SUITE 200
- **CITY:** CARLSBAD
- **STATE:** CA
- **ZIP:** 92008

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** BIOTIME INC
- **DATE OF NAME CHANGE:** 19930328

?xml version='1.0' encoding='ASCII'? 8-K

**UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549**

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## FORM 8-K

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**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported):** August 26, 2025<br>

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Lineage Cell Therapeutics, Inc.

**(Exact name of Registrant as Specified in Its Charter)**

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| | | |
|:---|:---|:---|
| California | 001-12830 | 94-3127919 |
| **(State or Other Jurisdiction<br>of Incorporation)** | **(Commission File Number)** | **(IRS Employer<br>Identification No.)** |
| 2173 Salk Avenue, Suite 200 |  |  |
| Carlsbad**,** California |  | 92008 |
| **(Address of Principal Executive Offices)** |  | **(Zip Code)** |

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**Registrant's Telephone Number, Including Area Code:** (442) 287-8990<br>

**(Former Name or Former Address, if Changed Since Last Report)**

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

**Securities registered pursuant to Section 12(b) of the Act:**

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| | | |
|:---|:---|:---|
| **<br>Title of each class** | **Trading<br>Symbol(s)** | **<br>Name of each exchange on which registered** |
| Common shares | LCTX | NYSE American LLC |

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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. ☐

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## Item 7.01 Regulation FD Disclosure.
On August 26, 2025, Lineage Cell Therapeutics, Inc. ("we," "us," "our," the "Company," or "Lineage") issued a press release announcing that it entered into a multi-year research collaboration agreement with William Demant Invest 2 Aps ("WDI") to advance the preclinical development of Lineage's auditory neuronal cell transplant program, ReSonance<sup>TM</sup> (ANPI), for the treatment of hearing loss. A copy of the press release is furnished as Exhibit 99.1 hereto.

The information in this Item 7.01 and in Exhibit 99.1 to this report 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 of 1933, as amended, 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 8.01 Other Events.
On August 22, 2025, Lineage and WDI entered into a research collaboration agreement (the "RCA") to advance the preclinical development of Lineage's auditory neuronal cell transplant program, ReSonance (ANPI), for the treatment of hearing loss (the "Project"). WDI will fund up to $12 million in research collaboration costs over the approximate three-year term of the RCA. The main objective of the RCA is for the parties to complete a preclinical phase achieving readiness to potentially progress to human clinical trials under one or more separate clinical agreements, the terms of which would be negotiated in good faith before the expiration of the RCA.

All intellectual property owned by a party prior to the date of the RCA will remain their sole and exclusive property. The parties will jointly own all results, data, reports, know-how and patent(s) conceived or otherwise generated in the course of and resulting from the Project (the "Project Results"), other than discoveries or developments relating to Lineage's prioprietary platform technology.

If a party (the "abandoning party") informs the other party (the "continuing party") that it will not continue the research with the other party under a clinical agreement, the continuing party may purchase the abandoning party's ownership interest in the intellectual property resulting from the Project for exploitation for the treatment of hearing loss and a license to the abandoning party's background intellectual property to the extent necessary for such exploitation for an amount and on terms to be determined by the mutual agreement of the parties, and if such mutual agreement is not reached, by an independent third-party.

## Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | [<u>Press release issued on August 26, 2025</u>](lctx-ex9_1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

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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. |
| Date: | August 26, 2025 | By:  | */s/ George A. Samuel III* |
|  |  | Name:<br>Title: | George A. Samuel III<br>General Counsel and Corporate Secretary |

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## Exhibit 9.1

![img193828089_0.jpg](img193828089_0.jpg)

**LINEAGE ANNOUNCES RESEARCH COLLABORATION WITH WILLIAM DEMANT INVEST TO DEVELOP RESONANCE**<sup>™</sup> **(ANP1) FOR HEARING LOSS** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;●**Three-year term intended to advance preclinical development of ReSonance** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;●**Up to $12 million of development costs to be contributed by William Demant Invest**

**CARLSBAD, CA – August 26, 2025** - Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel allogeneic, or "off the shelf", cell therapies for serious neurological and ophthalmic conditions, today announced that it has entered into a research collaboration with and through an investment from William Demant Invest A/S (WDI). WDI is an evergreen investor and the holding company for William Demant Foundation's investment activities - a majority shareholder of the world-leading hearing healthcare company, Demant A/S.

The parties will jointly advance Lineage's auditory neuronal cell transplant, ReSonance (ANP1), for the treatment of hearing loss. The multi-year research collaboration covers preclinical development activities, including cell manufacturing, proof-of-concept studies, translational/functional models, delivery development, outcome measures, regulatory strategy, and market analysis, to support a potential IND/CTA filing. WDI will fund up to $12 million in research collaboration costs over the period, with development activities jointly conducted and managed by Lineage and scientists from Eriksholm Research Centre, part of Oticon A/S, which is a subsidiary of the Demant Group.

"ReSonance is our first internally-developed cell transplant program and highlights the efficiency and breadth of our technology platform. Over a short period of time and with a modest initial, incremental investment, we advanced the ANP1 product concept through successful manufacture of the desired cell type, generated new intellectual property, and advanced into initial preclinical testing. With this research contribution from WDI, which has a strong interest in hearing healthcare, we are taking the next step in the development of this exciting product candidate. This partnership will allow us to integrate the hearing loss research expertise of Eriksholm Research Centre with the manufacturing and cell transplant expertise of the Lineage team to explore the potential of a differentiated cell transplant, and position this therapy for initial clinical development," stated Brian Culley, Lineage CEO.

According to the World Health Organization (WHO), nearly 2.5 billion people are expected to experience some degree of hearing loss by 2025, ranging from mild to moderate to profound. In severe-to-profound cases, the condition may involve loss of auditory nerve cells, potentially leading to auditory neuropathy and significant hearing impairment.

Hearing relies on a series of steps that convert sound waves in the air into electrical signals, which are then relayed by auditory nerve cells to the brain. Auditory neuropathy is a challenging hearing disorder in which the auditory nerve cells are damaged or lost, meaning that the communication pathway from the ear to the brain is disrupted. Currently, auditory neuropathy remains a significant challenge in audiology, and treatment options are limited. However, one treatment approach is cell-based therapy, which aims to replace lost or damaged auditory nerve cells. By repopulating the cochlea with functional, transplanted auditory neurons, this approach may restore hearing and enhance the effectiveness of a cochlear implant in certain individuals with severe-to-profound hearing loss.

**About William Demant Invest** 

William Demant Invest is an evergreen investor and the holding company for William Demant Foundation's investment activities, focusing on investments in listed companies. The current market value for all companies in the portfolio is around DKK 150 billion. Founded in 2004, William Demant Invest is wholly owned by William Demant Foundation with an identical Board of Directors. The main purpose of William Demant Foundation is to

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secure and expand the hearing healthcare company Demant and to donate a share of its net income to charter-defined causes.

**About Eriksholm Research Centre**

Eriksholm Research Centre is part of Oticon A/S, a world leader in hearing healthcare and part of the Demant A/S group of companies. Eriksholm is committed to making audiological discoveries with the potential to significantly enhance end-user benefits in hearing healthcare. Eriksholm engages in close collaborations with world leading academic research institutions. By bringing experts together, Eriksholm is able to create mutually beneficial research synergies and open up new lines of inquiry in the broader research community.

**About Lineage Cell Therapeutics, Inc.** 

**Forward-Looking Statements**

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, 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," "tend to," or the negative version of these words and similar expressions. Lineage's forward-looking statements are based upon its current expectations and beliefs and involve assumptions that may never materialize or may prove to be incorrect. Such statements include, but are not limited to, statements relating to: the benefits of the research collaboration agreement with WDI and its impact on advancing the ReSonance (ANP1) program, including through a potential IND/CTA filing. 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 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 positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that the ongoing Israeli regional conflict may materially and adversely impact 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 Lineage's filings with the Securities and Exchange Commission (SEC). Further information regarding these and other risks is included under the heading "Risk Factors" in Lineage's periodic reports with the SEC, including Lineage's most recent Annual Report on Form 10-K filed with the SEC and its other subsequent reports, which are available from the SEC's website. You are cautioned not to place undue reliance

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on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. All forward-looking statements are expressly qualified in their entirety by these cautionary statements.

**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

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