Paulness
6日前
NEWS -- Lineage Cell Therapeutics Announces Closing of Second Tranche of Previously Announced Registered Direct Offering
January 27 2025 - 4:05PM Business Wire
Lineage Has Now Received $30 Million in Gross Proceeds and May Receive an Additional $36 Million in Gross Proceeds Upon the Full Exercise of OpRegen® Clinical Milestone-linked Warrants
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced the closing of the second tranche of its previously announced registered direct offering of an aggregate of up to $66 million. The Company had previously received $24 million in gross proceeds at the closing of the first tranche in November 2024. Today, the Company received an additional $6 million in gross proceeds at the closing of the second tranche. In addition, the Company may receive up to an additional $36 million of gross proceeds upon the exercise in full on a cash basis of the clinical milestone-linked warrants issued in the offering.
Lineage obtained shareholder approval of the issuance of the securities at the closing of the second tranche, in satisfaction of applicable NYSE American rules. Lineage shareholders approved the issuance of 7,894,737 common shares and accompanying warrant to purchase an aggregate of up to 7,894,737 common shares, at a combined purchase price of $0.76 per common share and accompanying warrant, to Broadwood Partners, L.P., an affiliate of Neal Bradsher, a member of Lineage’s board of directors. Such warrant is exercisable for one common share at an exercise price of $0.91 per common share commencing on May 21, 2025 and will expire on the earlier of (a) May 21, 2028 and (b) the 90th day following the date of the public disclosure of the intent to advance OpRegen (also known as RG6501) into a multi-center phase 2 or 3 clinical trial which includes a control or comparator arm, or if the date of such public disclosure occurs prior to May 21, 2025, then the 90th day following May 21, 2025.
The securities described above were offered and sold by Lineage in a registered direct offering pursuant to a “shelf” registration statement on Form S-3 (File No. 333-277758) filed with the Securities and Exchange Commission (the “SEC”) on March 7, 2024, and which was declared effective by the SEC on May 14, 2024. The offering of the securities in the registered direct offering was made only by means of a base prospectus and a prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the offering were filed with the SEC and are available on the SEC’s website at https://www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained from H.C. Wainwright & Co., LLC, who served as the exclusive placement agent for the offering, at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at mailto://placements@hcwco.com.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel, “off-the-shelf,” cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or 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. 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 neuroscience focused pipeline currently includes: (i) OpRegen, 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) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance™ (ANP1), an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Factor Bioscience Limited. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical fact, 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 total potential amount of proceeds from the offering, the exercise of the warrants in cash prior to their expiration, and the exercise of the warrants upon the achievements of the clinical milestone event or otherwise prior to their expiration. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from the results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the risks that the warrants may not be exercised or, if exercised, the exercise price may not be paid in cash, and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the 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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250127672835/en/
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
4週前
NEWS -- Lineage Cell Therapeutics Issues Letter to Stockholders
CARLSBAD, Calif., January 06, 2025--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today published a letter to shareholders highlighting the company’s recent achievements and outlook for 2025.
Dear Fellow Shareholders,
We hope you had a restful holiday season and wish you a happy new year. As we look at our plans for the new year, we want to update you on our recent progress and explain why we believe 2025 will be an exciting year for our company.
As many of you know, Lineage is an emerging cell therapy company, but we more accurately should be referred to as a cell transplant company. The term cell transplant is more accurate because we do not administer "stem" cells to patients. Instead, we deliver mature, differentiated cells, which are guided along a specific lineage to become functionally identical to the cells which an individual has lost due to disease or trauma. Those cells are then transplanted in a one-time procedure to treat conditions caused by the loss or dysfunction of a specific cell type. We summarize this approach as "replace and restore". In the setting of dry-age related macular generation (dry-AMD), our manufacturing team creates new retinal pigment epithelial (RPE) cells to replace the RPE cells that have been lost by an individual after decades of use. This allogeneic cell therapy program, OpRegen®, led to a global development and commercialization partnership with Roche and Genentech, a member of the Roche Group. Our partners are currently evaluating OpRegen in a Phase 2a clinical trial. We also have established a pipeline of earlier-stage product candidates, each utilizing a single, carefully selected and cultured cell line for the life of a product, which eliminates donor variability and reduces regulatory risk. We believe we are the only publicly traded, non-oncology cell transplant company, which is one reason why we believe Lineage is the leading entity in this rapidly growing field of medicine.
Often, the most important things we do occur behind the scenes. Actions which increase our programs’ probabilities of success do not always become press releases. And discoveries that we make may be more valuable to our shareholders as trade secrets than as patents. Last year was a great example of these circumstances; we made significant progress in many areas, advancing our programs, expanding collaborations, and strengthening our balance sheet to help reach important milestones in 2025 and beyond. However, these advances were masked by significant uncertainty in the biotech sector, which has continued for years, making value-creation in biotech increasingly difficult and, unsurprisingly, frustrating many investors.
This communication is intended to provide clarity and transparency into certain areas of our business and is an opportunity to provide relevant context and expectations for our audience which aren’t normally covered in a press release. Those areas are: financing strategy, manufacturing capabilities, and our plans for long-term success. I aim to address each of those topics for both existing and future potential shareholders.
Financing – A Strong Foundation
For the past 6 years, Lineage has been funded by diverse sources of capital, including business development deals, sales of non-core assets, and an ATM facility. At their respective times, we believe each of these offered a better cost of capital than traditional investment bank-led financings. But traditional financings sometimes have advantages, and in particular, the "milestone-warrant" structure employed in our November financing was an ideal fit for our unique situation. However, the structure of that deal is complex and invites some clarity.
As many shareholders know, the company’s future is tightly linked to whether our partners, Roche and Genentech, elect to advance OpRegen into its next phase of clinical development. A forthcoming "go/no-go" decision to conduct a controlled clinical trial of OpRegen will be a major event for Lineage and for OpRegen’s probability of commercialization, so we sought not only to secure immediate capital, but also created a path to future capital, contingent in part upon the successful advancement of OpRegen by our partners into a controlled clinical trial.
In November, we closed on an initial $24 million in gross proceeds, and we expect to close on an additional $6 million later this month, subject to stockholder approval. Based on our current operational plan, we expect this capital will provide Lineage with runway into Q1 2027. In addition, we issued warrants for up to an additional $36 million at a strike price of at least $0.91, which included an acceleration (i.e. "call") of the warrants if and when the advancement of OpRegen into a controlled trial is disclosed. In a single transaction, we raised more than a year of capital and provided a path to a second year of capital if OpRegen meets the milestone defined in the warrant. We believe establishing this line-of-sight to additional capital reduces a future financial overhang and puts Lineage in greater control of its future with respect to capital raises or strategic discussions we may conduct with new or existing partners.
In the short-term, we expected the dilutive impact of this raise, because it was conducted in highly unfavorable market conditions, but it is important to run the business from a position of optionality and strength. Notably, based on our historic spending rates, we have capitalized the company potentially into mid-2028, subject to receiving the $36 million of warrant capital. And if certain alliance milestones, grants, and/or business development transactions that we are currently evaluating successfully close, Lineage could even be funded for the next four years. With this recent financing, we believe we have set Lineage on its strongest financial foundation in its history.
Manufacturing – Achieving the Unprecedented
One of the challenges of working in cell therapy is that many people restrict their scope of cell therapy to cancer, but the CAR-T field is unsustainably crowded with many poorly differentiated assets. We believe the more compelling growth opportunity in cell therapy resides in diseases and conditions outside of cancer, or what we like to call "noncology". There are only a few companies that have reached clinical testing with a "noncology" asset, including Bluerock (acquired by Bayer) for Parkinson’s Disease, and Semma (acquired by Vertex) for Type 1 Diabetes. In fact, to our knowledge, Lineage is currently the only publicly traded company in which one can invest exclusively and directly in this exciting and increasingly validated branch of medicine.
A second challenge is that a focus on clinical outcomes often overlooks the difficulty, or in some cases the feasibility, of manufacturing a product using a commercially-viable and scalable process. Autologous products are expensive because each dose is made for just one person, which precludes affordability in all but the most serious conditions (i.e. cancer). Allogeneic therapies, for which the cells are sourced from one donor but delivered to many patients, offer a theoretical solution to the problem of scale, but in our view, a truly affordable allogeneic process has not yet been reduced to practice by any company. Our view is that making 10, 100, or even 1,000 doses from a single donor fails to deliver on the intent or power of an allogeneic therapy. In fact, we call those approaches "shallow-geneic" because they lack the depth of a scalable process. They may be allogeneic by definition, but they are not sufficiently more scalable than autologous cell therapies, and therefore, do not genuinely address the issue of cost.
We believe the full vision of an off-the-shelf allogeneic therapy comes from scaling production by ten million, or even a hundred million-fold. To our knowledge, no company has yet demonstrated they can manufacture thousands of doses of their product from a stable Working Cell Bank (WCB), which itself was generated from a stable Master Cell Bank (MCB), and yet the multiplication stemming from that sequence of expansions is necessary to reach the commercially-desirable cost of goods implied from a "true" allogeneic product. Lineage aspires this year to be the first company to demonstrate this multiplicative scalable capability, using actual production lots. If we are successful, we believe it will help establish our manufacturing team as proven and capable leaders in cell therapy manufacturing.
Strategy and Future Goals – Planning for Success
The third message is how our development and financing decisions are linked to a longer-term vision of success for Lineage. We understand there are significant expectations on the ongoing OpRegen trial. While we believe our phase 1/2a results are compelling, validation and affirmation of our findings in a larger trial conducted by an international pharmaceutical company can reasonably be expected to add substantial credibility to our initial findings and future expectations. If OpRegen continues to perform as it has to date, we believe it will reflect positively on our team’s capabilities, our technology platform, and the value of the company.
Lineage is primarily known for OpRegen, but we are capable of much more than making RPE cells. A clearly articulated product portfolio, especially one that is generated from an internally-owned platform, can offer a compelling foundation for value creation. For this reason, we are establishing a pipeline of closely-related neurological cell transplant product candidates, which each employ our core technology, including: OPC1 (oligodendrocyte progenitors), to improve mobility following a severe spinal cord injury, ReSonance™ (auditory neuronal progenitors) to improve hearing in people suffering from sensorineural hearing loss, and a third, as yet undisclosed program. If OpRegen advances into a later-stage trial and our manufacturing objectives are reached, we believe our cost of capital will improve and allow us to move faster and farther with these programs. Once the power of our platform is further demonstrated and validated, we believe that the pipeline of internally-owned assets that we are advancing will make us a desirable partner for pharma and an attractive opportunity for investors.
Looking ahead, we will continue to support our partners in the development of OpRegen. In parallel, our internal focus will be on conducting the DOSED clinical study of OPC1, advancing ReSonance for the treatment of hearing loss, and other carefully chosen initiatives.
We remain committed to acting in the best interests of our shareholders and will continue to implement a thoughtful and staged approach to product development. We believe that long-term value and appreciation can be created through the advancement of our clinical and preclinical pipelines, where we intend to apply our technology and expertise to validate our unique cell transplant approach.
We appreciate your support and belief in our vision. We invite you to stay engaged with our progress through regular updates, earnings calls, and announcements.
Replace and Restore,
Brian Culley, CEO
Lineage Cell Therapeutics, Inc.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel, "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or 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. 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 neuroscience focused pipeline currently includes: (i) OpRegen, 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) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance (ANP1), an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Factor Bioscience Limited. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
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 potential therapeutic benefits of OpRegen in patients with GA secondary to AMD, as well as the clinical advancement of OpRegen and its impacts on us; our ability to successfully manufacture OpRegen at scale; statements relating to the terms of the financing described herein, which do not purport to be complete and are qualified in their entirety by the full text of the financing documents, copies of which are attached as exhibits to our Current Report filed on Form 8-K on November 20, 2024, our ability to obtain stockholder approval to close on an additional $6 million in gross proceeds later this month and issue corresponding warrants, the acceleration of the expiration of the warrants in connection with the achievement of the OpRegen clinical milestone, or the exercise of the common warrants in cash prior to their expiration; that our cash, cash equivalents and marketable securities is sufficient to support our planned operations into 2027, or into 2028 assuming exercise of the warrants, or beyond 2028 assuming additional alliance milestones, grants, and/or business development transactions occur; the growth of cell therapy in diseases and conditions outside of cancer, relative to oncology cell therapy, or at all; the broad potential for Lineage’s regenerative medicine platform and our ability to develop additional product candidates, including the commencement of the DOSED clinical study for OPC1; and the potential of our pipeline, platform technology and/or manufacturing capabilities, independently and/or in connection with the clinical advancement of the OpRegen program, to validate our approach or create value. 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 use our cash, cash equivalents and marketable securities more quickly than expected; that we are unable to obtain shareholder approval to close on an additional $6 million in gross proceeds and issue corresponding warrants; that the warrants may not be exercised for cash, including if the price per share of our common stock never reaches or exceeds the warrant exercise price of $0.91 per share, or that we do not have an effective registration statement on file at the time of exercise, or if other conditions contained in the warrants are not met; 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 OpRegen may not clinically advance, and even if it does, that such advancement will not have a positive effect on us, our share price, our cost of capital, nor the overall success of the OpRegen program; that OpRegen may never be proven to provide durable anatomical functional improvements in dry-AMD patients; that competing alternative therapies may adversely impact the commercial potential of OpRegen; that Roche and Genentech may not be successful in obtaining regulatory approval for OpRegen in any particular jurisdiction; that the ongoing Israel-Hamas war and broader 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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250106031795/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
2月前
NEWS -- Lineage Cell Therapeutics Announces First Closing of up to $66 Million Registered Direct Offering
$30 Million Upfront With Up to an Additional $36 Million of Aggregate Gross Proceeds Upon the Exercise in Full of Clinical Milestone-linked Common Warrants
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced the first closing of its previously announced registered direct offering for the purchase and sale of up to an aggregate of 39,473,688 of Lineage’s common shares and accompanying warrants (the “common warrants”) to purchase an aggregate of up to 39,473,688 of Lineage’s common shares at a combined purchase price of $0.76 per common share and accompanying common warrant. Lineage issued an aggregate of 31,578,951 common shares and common warrants to purchase up to 31,578,951 common shares to certain healthcare focused institutional investors in the first closing. Each common warrant will be exercisable for one common share at an exercise price of $0.91 per common share and will be exercisable commencing six months following their date of issuance and will expire on the earlier of (a) the three-year anniversary of the initial exercise date, and (b) the 90th day following the date of the public disclosure of the intent to advance OpRegen® (also known as RG6501) into a multi-center phase 2 or 3 clinical trial which includes a control or comparator arm, or if the date of such public disclosure occurs prior to the initial exercise date of the common warrants, the 90th day following the initial exercise date.
H.C. Wainwright & Co. served as the exclusive placement agent for the offering.
The offering of the securities to Broadwood Partners, L.P. (“Broadwood”), an affiliate of Neal Bradsher, a member of Lineage’s board of directors, is expected to close upon obtaining shareholder approval to satisfy applicable NYSE American rules and to the satisfaction of customary closing conditions. The common warrants that may be issued to Broadwood pursuant to the definitive purchase agreement entered into between Lineage and Broadwood will not be exercisable until the later of (i) their date of issuance, which will be the date shareholder approval is obtained, and (ii) the six-month anniversary of the date of issuance of the common warrants to the unaffiliated institutional investors in the offering.
Lineage received $24 million in aggregate gross proceeds in the first closing of the offering, which was with respect to the investments by the unaffiliated institutional investors, and expects to receive approximately $6 million in additional gross proceeds from the offering with respect to the investment by Broadwood, in each case, before deducting the placement agent’s fees and other offering expenses payable by Lineage. The potential additional gross proceeds to Lineage from the common warrants, if fully exercised on a cash basis, will be approximately $36 million. No assurance can be given that Lineage will obtain the shareholder approval required to satisfy applicable NYSE American rules in order to sell the securities in the offering to Broadwood or that any of the common warrants will be exercised. Lineage currently plans to use the net proceeds from the offering for working capital and general corporate purposes, including research and development expenses and capital expenditures.
The securities described above were offered and sold by Lineage in a registered direct offering pursuant to a “shelf” registration statement on Form S-3 (File No. 333-277758) filed with the Securities and Exchange Commission (the “SEC”) on March 7, 2024, and which was declared effective by the SEC on May 14, 2024. The offering of the securities in the registered direct offering was made only by means of a base prospectus and a prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the offering were filed with the SEC and are available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at placements@hcwco.com.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel, “off-the-shelf,” cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or 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. 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 neuroscience focused pipeline currently includes: (i) OpRegen, 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) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance™ (ANP1), an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Factor Bioscience Limited. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical fact, 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 closing of the offering of the securities to Broadwood, the total potential amount and use of proceeds from the offering, the exercise of the common warrants in cash prior to their expiration and the exercise of the common warrants upon the achievements of such milestone events or otherwise prior to their expiration. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from the results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the risks that the offering may not close due to the failure to satisfy the applicable closing conditions, including, with respect to the offering of securities to Broadwood, obtaining shareholder approval to satisfy applicable NYSE American rules, and that the common warrants may not be exercised or, if exercised, the exercise price may not be paid in cash, and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the 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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241121738269/en/
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
3月前
NEWS -- Lineage Cell Therapeutics to Report Third Quarter 2024 Financial Results and Provide Business Update on November 14, 2024
CARLSBAD, Calif., November 07, 2024--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its third quarter 2024 financial and operating results on Thursday, November 14, 2024, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, November 14, 2024, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its third quarter 2024 financial and operating results and to provide a business update.
Interested parties may access the conference call on November 14, 2024, by dialing (800) 715-9871 from the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through November 21, 2024, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 2238934.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel, "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or 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. 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 neuroscience focused pipeline currently includes: (i) OpRegen®, 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) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance™ (ANP1), an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Eterna Therapeutics Inc. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241107087038/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
4月前
NEWS -- Lineage Cell Therapeutics to Present at the Maxim Group 2024 Virtual Healthcare Summit
CARLSBAD, Calif., October 14, 2024--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that Brian M. Culley, Lineage’s Chief Executive Officer, will be presenting at the Maxim Group 2024 Virtual Healthcare Summit, in a fireside chat hosted by Jason McCarthy, Ph.D., Senior Managing Director, Head of Biotechnology Research. Lineage’s fireside chat will be available for viewing on Tuesday, October 15, 2024, at 11:00 a.m. ET, for registered conference attendees.
About the Maxim Group 2024 Healthcare Virtual Summit
Maxim Senior Analysts will host a wide range of biotechnology, diagnostic, medical device, and healthcare information technology companies in a series of presentations and interactive discussions with CEOs and key management as well as several topical industry panels. For more information on the event and to register, please visit the conference website: https://m-vest.com/events/healthcare-10152024.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel, "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or 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. 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 neuroscience focused pipeline currently includes: (i) OpRegen®, 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) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance™ (ANP1), an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Eterna Therapeutics Inc. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241014461058/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://mailto://Nic.johnson@russopartnersllc.com)
(David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
4月前
NEWS -- OpRegen® (RG6501) Phase 1/2a Results to Be Featured at International Society for Stem Cell Research (ISSCR) 2024 Copenhagen International Symposium
CARLSBAD, Calif., September 25, 2024--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that Brian M. Culley, Lineage’s Chief Executive Officer, will be presenting at the International Society for Stem Cell Research (ISSCR) 2024 Copenhagen International Symposium, PSC-Derived Cell Therapies: Clinical Advances, NextGen Technologies, and the Path to Success. Mr. Culley has been invited to participate as part of a panel entitled "Clinical Trial Updates: PSC-Derived Therapies of the Eye," on Wednesday, October 2nd, 2024, from 10:30 am to 12 pm CEST. The panel is being chaired by Kapil Bharti, Ph.D., Senior Investigator and Scientific Director, Ocular and Stem Cell Translational Research Section at the National Eye Institute (NEI), and will also feature executive presenters from Vision Care and Regenerative Patch Technologies, Inc. The 2024 Copenhagen International Symposium will take place October 2 – 4, 2024 at The Black Diamond, Royal Danish Library, Copenhagen, Denmark, and is being presented by the ISSCR in partnership with Novo Nordisk.
RG6501 (OpRegen) is a suspension of human allogeneic retinal pigment epithelial (RPE) cells currently in development for the treatment of GA secondary to AMD. OpRegen subretinal delivery has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function. It is being developed under an exclusive worldwide collaboration between Lineage, Roche, and Genentech, a member of the Roche Group, and is currently being evaluated in a Phase 2a clinical study in patients with GA secondary to AMD (ClinicalTrials.gov Identifier: NCT05626114).
The 2024 Copenhagen International Symposium presentation, "OpRegen®️: A Suspension Of Allogeneic Retinal Pigment Epithelial (RPE) Cells In Patients With Geographic Atrophy (GA) Secondary To Age-Related Macular Degeneration (AMD)," will be available on the Events and Presentations section of Lineage’s website, following the conclusion of the ISSCR panel presentation.
About The 2024 Copenhagen International Symposium: PSC-Derived Cell Therapies: Clinical Advances, NextGen Technologies, and the Path to Success
Pluripotent stem cell-derived cell therapies are accelerating rapidly into clinical trials. The ISSCR, in partnership with Novo Nordisk, is pleased to invite attendees to Copenhagen, Denmark in October 2024 for an event that will gather pioneers at the forefront of ESC and iPSC-derived cell therapies. Here, world-renowned scientists and innovators will share the latest updates on ongoing clinical trials, as well as groundbreaking platforms and technologies that will revolutionize the next generation of cell therapies for devastating and intractable diseases. For more information visit https://www.isscr.org/upcoming-programs/2024-copenhagen-international-symposium/#program or follow the organization on X/Twitter: @ISSCR.
About the OpRegen Phase 1/2a Study
The Phase 1/2a study is an open-label, single-arm, multi-center, dose-escalation trial evaluating a single administration of OpRegen delivered subretinally in patients with bilateral GA secondary to AMD. Twenty-four patients were enrolled into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with a best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 patients with impaired vision (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new "thaw-and-inject" formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study was to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment-emergent adverse events. Secondary objectives include evaluating the preliminary activity of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance.
About Geographic Atrophy
GA is an advanced form of AMD characterized by severe loss of visual function. GA is a leading cause of adult blindness in the developed world, affecting at least 5 million people globally. There are two forms of advanced AMD: neovascular AMD and GA. GA and neovascular AMD can occur simultaneously in the same eye, and patients treated for neovascular AMD may still go on to develop GA. GA typically affects both eyes.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel, "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or 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. 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 neuroscience focused pipeline currently includes: (i) OpRegen, 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) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance™ (ANP1), an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Eterna Therapeutics Inc. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
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 potential therapeutic benefits of OpRegen in patients with GA secondary to AMD. 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 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 OpRegen may never be proven to provide durable anatomical functional improvements in dry-AMD patients, that the ongoing Israel-Hamas war 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; 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 reports, which are available from the SEC’s website. You are cautioned not to place undue reliance 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240925984921/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
5月前
NEWS -- Lineage Presents Preclinical Data on Its Auditory Neuronal Cell Transplant Program, ReSonance™, at the 59th Annual Inner Ear Biology Workshop
ReSonance is Manufactured by a Proprietary Process, Developed In-House, at Clinical Scale, with Relevant In-Vitro Functional ActivityImmediate-Use, Thaw-and-Inject Formulation Durably Engrafted in Multiple Preclinical Hearing Loss ModelsReSonance is Currently Being Evaluated in a Functional Model of Hearing LossCARLSBAD, Calif., September 18, 2024--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today reported that preclinical results with ReSonance (ANP1), the Company’s auditory neuronal cell transplant for the treatment of hearing loss, were presented at the 59th Annual Inner Ear Biology Workshop by Ofer Wiser, Ph.D. Senior Scientist, Technological Innovation at Cell Cure Neurosciences, Inc., the Company’s Israel-based subsidiary, which is responsible for research, process development, and good manufacturing practice (GMP) production.
"We are excited to report on the continued successful pre-clinical development of ReSonance, our first internally-developed cell transplant program, which we believe illustrates the efficiency and breadth of our technology platform," stated Brian Culley, Lineage CEO. "Building on the success of our OpRegen® RPE cell transplant candidate for dry AMD, our process development team generated new methods of differentiation which enabled us to create a new product candidate for hearing loss. We advanced from a product concept through the successful manufacture of the desired and specific cell type, generating new intellectual property, and thereafter advancing ANP1 into initial preclinical testing. An inherent aspect of our successful manufacturing efforts was the generation of a cryopreserved, ready to administer thaw-and-inject formulation at a clinically testable dose, which demonstrated successful engraftment and survival in a preclinical hearing loss model. Given the many challenges of reliably and affordably manufacturing cell and gene therapy product candidates, we are excited to highlight the progress Lineage has made in this area and believe our unique manufacturing capabilities will continue to provide us with a leading position in the cell transplant space."
Hearing loss is a significant unmet medical need and by 2050, nearly 2.5 billion people are estimated to be impacted by listening impairments across the globe. The loss of auditory nerve cells can lead to auditory neuropathy, even when hair cells and the cochlear nucleus remain intact. A cell-based therapy designed to replace lost or dysfunctional auditory neurons may restore hearing and enhance the degree of success of a cochlear implant procedure by repopulating the cochlea with transplanted, functional auditory neurons.
Preclinical testing of ANP1 is ongoing through a collaboration with the University of Michigan and Yehoash Raphael, Ph.D., The R. Jamison and Betty Williams Professor of Otolaryngology, Department of Otolaryngology-Head and Neck Surgery and Lab Director at the University of Michigan Kresge Hearing Research Institute.
Auditory neuropathy is a challenging hearing disorder in which the inner ear successfully detects sound but has a problem with sending signals from the ear to the brain, currently accounting for approximately 10% of cases of sensorineural hearing loss (SNHL) in children. Current state of the art medical knowledge suggests that auditory neuropathies play a substantial role in hearing impairments and deafness. Hearing depends on a series of complex steps that change sound waves in the air into electrical signals. The auditory nerve then carries these signals to the brain. Auditory neuropathy can be caused by a number of factors including damage to the auditory neurons or loss of these neurons. Researchers are still seeking effective treatments for those affected with auditory neuropathy.
The 59th Annual Inner Ear Biology Workshop presentation is now available on the Events and Presentations section of Lineage’s website.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel, "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or 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. 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 neuroscience focused pipeline currently includes: (i) OpRegen, 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) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ReSonance (ANP1), an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Eterna Therapeutics Inc. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
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 potential use of ANP1 to restore hearing or enhance the degree of success of a cochlear implant procedure; the broad potential for Lineage’s regenerative medicine platform and Lineage’s ability to advance and expand the same, including Lineage’s ability to manufacture new specific and differentiated cell types on anticipated timelines and budgets; the potential for Lineage’s investigational allogeneic cell therapies to generate clinical outcomes beyond the reach of traditional methods, including gene therapy, and provide safe and effective treatment for multiple, diverse serious or life threatening conditions; and the potential of our platform technology and/or manufacturing capabilities to create success in the cell transplant space. 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 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 OpRegen may never be proven to provide durable anatomical functional improvements in dry-AMD patients, that the ongoing Israel-Hamas war 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 reports, which are available from the SEC’s website. You are cautioned not to place undue reliance 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240918699918/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
7月前
NEWS -- Lineage Cell Therapeutics Added to Membership of 2024 Russell 3000® Index
CARLSBAD, Calif., July 02, 2024--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that the Company has been added as a member of the broad-market Russell 3000® Index, effective after the U.S. market opens on July 1, 2024, as part of the 2024 Russell indexes reconstitution. The annual reconstitution of the Russell US indexes captures the 4,000 largest US stocks as of April 30, 2024, ranking them by total market capitalization. Membership in the Russell 3000® Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000® Index or small-cap Russell 2000® Index as well as the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.
"We are pleased with Lineage’s continued inclusion within the Russell 3000, which can help continue to expand investor awareness, increase institutional ownership, and provide additional liquidity in our stock," stated Brian M. Culley, Lineage CEO, "This recognition of our progress comes during an exciting time, and we believe that a deeper understanding of Lineage’s near term and longer term strategic objectives can help increase support for our novel and exciting approach to cell transplant medicine."
Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. According to data as of the end of December 2023, about $10.5 trillion in assets are benchmarked against the Russell US indexes, which belong to FTSE Russell, a prominent global index provider.
Fiona Bassett, CEO of FTSE Russell, an LSEG Business, comments:
"Russell indexes–now in their 40th year–continue to evolve to reflect the dynamic US economy. Annual rebalancing plays a vital role in establishing accurate benchmarks, ensuring they correctly mirror their designated market segments and remain unbiased in terms of size and style."
For more information on the Russell 3000® Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel or "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or 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. 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 neuroscience focused pipeline currently includes: (i) OpRegen®, 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) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Eterna Therapeutics Inc. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
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. Such statements include, but are not limited to, statements relating to: the impacts to Lineage as a result of being added to the Russell 3000 Index; and the potential of our cell therapy 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 those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s 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. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. 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 and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240702244492/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
8月前
NEWS -- Lineage to Present at 2024 BIO International Convention
CARLSBAD, Calif., May 30, 2024--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that the Company’s CEO, Brian M. Culley, will present at the 2024 BIO International Convention, on Tuesday June 4th, 2024, at 2:30pm in Theater 3. Company representatives are also hosting meetings with potential partners and collaborators to discuss opportunities for strategic alliances across Lineage’s novel pipeline of cell therapy transplant programs. The BIO International Convention is the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world, and is taking place June 3-6, 2024, at the San Diego Convention Center in San Diego, CA.
About BIO
BIO is the world’s largest advocacy association representing biotechnology companies, academic and research institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. Corporate members range from entrepreneurial companies developing a first product, to Fortune 500 multinationals. BIO also represents state and regional biotech associations, service providers to the industry, and academic centers. Our members help foster a healthy economy by creating good-paying, biotechnology jobs. We also host the largest cost-savings program in the life sciences industry, BIO Business Solutions, which saves nearly $700 million in aggregate for 4,500+ companies every year. For more information visit https://www.bio.org or follow the organization on X/Twitter @IAmBiotech.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel or "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or 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. 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 neuroscience focused pipeline currently includes: (i) OpRegen, 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) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Eterna Therapeutics Inc. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240530288523/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
8月前
NEWS -- Lineage Announces Updates to 2nd Annual Spinal Cord Injury Investor Symposium
Persons with Lived Experience Session Expanded to Include Michaela & Kyle DevinsClinical Session Expanded to Include NeuralinkPreclinical Session Expanded to Include Axonis, Novoron, Sania & Rewire Medical
CARLSBAD, Calif., May 21, 2024--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced updates to its 2nd Annual Spinal Cord Injury Investor Symposium ("2nd SCIIS"). The 2nd SCIIS aims to accelerate development in SCI research and treatments by bringing together companies working in the development of treatments for SCI, with regulators, key opinion leaders, persons with lived experience, patient and community advocacy organizations, and the investment community, in order to discuss perspectives on current and future treatment alternatives, impact and support SCI disease awareness and clinical trial participation through the implementation of patient appropriate clinical endpoints, and broaden awareness of and investment of capital into SCI.
"Through our initiatives to raise awareness and increase collaboration in the field of spinal cord injury, we have encountered an enthusiastic response to this conference from a diverse and innovative group of companies and other stakeholders. While each of us has a preferred approach to how we can best support individuals living with SCI, common hurdles remain and this conference aims to provide a forum for collaborative problem-solving, as well serving as a one-stop educational opportunity for investors interested in this space," stated Brian M. Culley, Lineage CEO. "We are excited to add a BCI-focused clinical session this year with the inclusion of Neuralink and several additional corporate presenters. We invite investors and others to register to join us in person in San Diego on June 26 and 27 for this unique coming together of a forward-thinking group of leaders in SCI product development."
Current confirmed speakers and moderating healthcare analysts (subject to change):
Richard G. Fessler, M.D., Ph.D., Professor, Department of Neurosurgery, RUSH University Medical CenterJames D. Guest, M.D., Ph.D., Clinical Professor, Department of Neurological Surgery, The Miami Project to Cure Paralysis, Professor, University of Miami Miller School of MedicineSteven Kirshblum, M.D., Chief Medical Officer, Kessler Foundation, Professor of Physical Medicine and Rehabilitation, Rutgers New Jersey Medical SchoolMarco Baptista, Ph.D., Chief Scientific Officer, Christopher & Dana Reeve FoundationJerod & Hanna NiederMichaela & Kyle DevinsJack Allen, CFA, Senior Research Analyst, Biotechnology, R.W. Baird & Co., Inc.Joseph Pantginis, Ph.D., Director of Research, Managing Director, Equity Research, H.C. Wainwright & Co., Inc.
Current presenters (subject to change):
California Institute for Regenerative Medicine (CIRM)Clinical companies
AbbVie, Inc.Lineage Cell Therapeutics, Inc.Kringle PharmaNeuralinkNervGen Pharma Corp.ONWARD Medical N.V.
Preclinical companiesAxonis TherapeuticsInteligexNeuroHagana Ltd.Novoron BioscienceSania TherapeuticsReWire Medical
Additional presentersNorth American Spinal Cord Injury Consortium (NASCIC)Praxis Spinal Cord InstituteSpinal Cord Outcomes Partnership Endeavor (SCOPE)
The 2nd Annual Spinal Cord Injury Investor Symposium will be held in-person, on June 26 and 27, 2024, in the Duane Roth Auditorium at the Sanford Consortium for Regenerative Medicine in La Jolla, CA. Advance conference registration is required. For more information, please visit https://www.scisymposium.com or follow the event on X/Twitter @SCISymposium.
About Spinal Cord Injuries
A spinal cord injury occurs when the spinal cord is subjected to a severe crush or contusion and frequently results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. There are approximately 18,000 new spinal cord injuries annually in the U.S. The cost of a lifetime of care for a severe spinal cord injury can be as high as $5 million.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel or "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or 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. 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 neuroscience focused pipeline currently includes: (i) OpRegen, 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) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Eterna Therapeutics Inc. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
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. Such statements include, but are not limited to, statements relating to: the potential effect of the 2nd SCIIS, including accelerating development in SCI research and treatment, and raising SCI disease awareness. 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 engagement with patients and the advocacy community may not lead to improvements in patient outcomes; 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). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. 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 and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240521738549/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
9月前
OpRegen® (RG6501) Phase 1/2a Clinical Study 24-Month Visual Acuity Results Featured at 2024 Retinal Cell & Gene Therapy Innovation Summit
BCVA gains of +5.5 letters at 24 months in Cohort 4 patients (n=10)BCVA gains of +7.4 letters among Cohort 4 patients with extensive OpRegen bleb coverage of the GA lesion (n=5)Maintenance or increases in external limiting membrane (ELM) and retinal pigment epithelium (RPE) layers observed by optical coherence tomography (OCT) in patients with extensive bleb coverage of the GA lesionData suggests OpRegen may counteract RPE cell dysfunction and cell loss in GA by providing support to remaining retinal cells, with effects observed through at least 2 years following a single administrationCARLSBAD, Calif., May 06, 2024--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that 24 month visual acuity results from patients enrolled in a Phase 1/2a clinical study (ClinicalTrials.gov Identifier: NCT02286089) of RG6501 (OpRegen) in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD), were presented at the 2024 Retinal Cell & Gene Therapy Innovation Summit. The meeting was jointly organized by the Foundation Fighting Blindness and the Oregon Health & Science University Casey Eye Institute. The presentation, "OpRegen® Retinal Pigment Epithelium (RPE) Cell Therapy for Patients with Geographic Atrophy (GA): Month 24 Results from the Phase 1/2a Trial," was presented by David Telander, MD, PhD, Retinal Consultants Medical Group, on behalf of Roche and Genentech, a member of the Roche Group.
RG6501 (OpRegen) is a suspension of human allogeneic retinal pigment epithelial (RPE) cells currently in development for the treatment of GA secondary to AMD. OpRegen subretinal delivery has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function. It is being developed under an exclusive worldwide collaboration between Lineage, Roche, and Genentech, a member of the Roche Group, and is currently being evaluated in a Phase 2a clinical study in patients with GA secondary to AMD (ClinicalTrials.gov Identifier: NCT05626114).
"The products approved recently for the treatment of GA secondary to AMD have not demonstrated a compelling functional benefit, so there remains a need for treatments that can positively affect patient vision," stated Brian M. Culley, Lineage CEO. "We are encouraged by the apparent durability of visual performance being achieved by patients in this study, notably in the 5 patients who received a thorough coverage of OpRegen cells across the majority of their atrophic areas and who had experienced a cessation or reversal of their areas of atrophy, evidenced by outer retinal structural improvements on optical coherence tomography (OCT). Dry AMD has traditionally been considered to be an irreversible and progressively degenerative disease leading to vision loss. However, these data suggest that OpRegen RPE cells may provide a one-time treatment which could slow or even reverse this damage by way of direct support to the patients’ remaining retinal cells, including those near or within atrophic areas. We look forward to additional, future clinical data updates on the OpRegen program from our partners, Roche and Genentech."
2024 Retinal Cell & Gene Therapy Innovation Summit Highlights
Improvement in visual acuity and outer retinal structure in patients with extensive OpRegen bleb coverage of their GA area was present at 12 months (primary endpoint) and persisted through 24 monthsBCVA gains in Cohort 4 patients (less advanced GA than in other cohorts) measured at 12 months were sustained at 24 months following a single subretinal administration of OpRegenMean change in BCVA among treated eyes for patients (n=10) completing 2-year follow up was +5.5 letters (Early Treatment Diabetic Retinopathy Study [ETDRS] assessment)Effects were greater on average in the five (5) patients with extensive OpRegen coverage of atrophic areas at the time of surgical deliveryIn these patients’ treated eyes, the mean change in BCVA was +7.4 ETDRS letters for those completing 2-year follow-up (n=5)Maintenance or improvements in external limiting membrane (ELM) and RPE drusen complex (RPEDC) structure on OCT were observed in five patients in Cohort 4 with extensive OpRegen coverage of atrophic areas at the time of surgical deliveryMean improvement of RPEDC area compared with baseline was maintained in treated eyes from 12 months (+2.6 mm2; n=5) to 24 months (+2.6 mm2; n=4)In comparison, mean change in RPEDC area decreased in untreated fellow eyes from 12 months (-1.1 mm2; n=5) to 24 months (-2.8 mm2; n=4)Mean change in ELM area increased in treated eyes from 12 months (+0.4 mm2; n=5) to 24 months (+0.8 mm2; n=4)In comparison, mean change in ELM area decreased in untreated fellow eyes from 12 months (-1.3 mm2; n=5) to 24 months (-1.9 mm2; n=4)Overall, these data suggest that OpRegen RPE cells may counteract RPE cell dysfunction and loss in GA by providing support to the remaining retinal cells within atrophic areas and such effects are durable through at least 24 months after a single administrationDr. Telander’s presentation is now available on the Events and Presentations section of Lineage’s website.
About the Innovation Summit
The annual Retinal Cell and Gene Therapy Innovation Summit 2024 is jointly organized by the Foundation Fighting Blindness and the Oregon Health & Science University Casey Eye Institute. Representatives from the biotech and pharma industries will come together with members of the medical and research communities to discuss rapidly emerging ocular gene and cell therapies and strategize how to move the most advanced retinal diseases therapies toward clinical utility. The Summit features presentations by leading retinal disease experts on potential gene and cell-based therapies and how best to deliver them to patients. For more information visit: https://give.fightingblindness.org/event/retinal-cell-and-gene-therapy-innovation-summit-2024/e529485.
About the OpRegen Phase 1/2a Study
The Phase 1/2a study is an open-label, single-arm, multi-center, dose-escalation trial evaluating a single administration of OpRegen delivered subretinally in patients with bilateral GA secondary to AMD. Twenty-four patients were enrolled into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with a best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 patients with impaired vision (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new "thaw-and-inject" formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study was to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment-emergent adverse events. Secondary objectives include evaluating the preliminary activity of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance.
About Geographic Atrophy
GA is an advanced form of AMD characterized by severe loss of visual function. GA is a leading cause of adult blindness in the developed world, affecting at least 5 million people globally. There are two forms of advanced AMD: neovascular AMD and GA. GA and neovascular AMD can occur simultaneously in the same eye, and patients treated for neovascular AMD may still go on to develop GA. GA typically affects both eyes.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel or "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or 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. 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 neuroscience focused pipeline currently includes: (i) OpRegen, 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) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Eterna Therapeutics Inc. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
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. Such statements include, but are not limited to, statements relating to: the potential therapeutic benefits of OpRegen in patients with GA secondary to AMD; the significance of clinical data reported to date from the Phase 1/2a study of OpRegen, including the findings of retinal tissue restoration, durability and visual function improvements; and the timing and availability of clinical data updates on the OpRegen program. 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 positive findings in early clinical studies of a product candidate may not be predictive of success in subsequent clinical studies of that candidate; that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; that competing alternative therapies may adversely impact the commercial potential of OpRegen; that the ongoing Israel-Hamas war may materially and adversely impact our manufacturing processes, 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). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. 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 reports, which are available from the SEC’s website. You are cautioned not to place undue reliance 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240506017390/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
9月前
NEWS -- Lineage Announces Changes to Board of Directors
CARLSBAD, Calif., April 29, 2024 -- (BUSINESS WIRE) -- Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX) is saddened to report the passing of its long-serving Chairman of the Board of Directors, Mr. Alfred D. Kingsley, and offers its deepest condolences to Mr. Kingsley’s family for their loss. Mr. Kingsley served as Chairman of the Company’s Board of Directors since July 2009, and was a significant contributor in the evolution of the Company into a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs.
Effective as of April 27, 2024, Michael H. Mulroy, J.D., has been appointed by the Board of Directors to serve as the Chairman of the Board of Directors.
"We are incredibly saddened by Al’s passing and offer our thoughts, prayers, and support to the entire Kingsley family during this difficult time," stated Michael H. Mulroy. "Al was exceptionally committed to Lineage and its shareholders, and brought great innovation, leadership, and dedication to others to his work. Al was not only a key contributor to the company from the beginning, but also set an example for all of us through his generosity to the community. It has been a privilege to serve alongside him on the Board and we look forward to continuing to build upon his legacy."
Mr. Mulroy’s background includes experience as a biotech and biopharma corporate executive, and as a corporate attorney and investment banker. He has served as a member of the Board of Directors since 2014 and serves as Chair of the Compensation Committee and as a member of the Audit Committee and the Financial Strategy Committee. Mr. Mulroy brings extensive expertise across a number of operational and functional areas, including corporate finance and development, and clinical and strategic operations. He previously served as Chief Executive Officer and a member of the board of directors of Asterias Biotherapeutics, Inc. Prior to joining Asterias, Mr. Mulroy served as a Senior Advisor to CamberView Partners, LLC (now part of PJT Partners Inc.), which assists companies in connection with investor engagement and complex corporate governance issues. Prior to its sale in 2014, Mr. Mulroy served as Executive Vice President, Strategic Affairs and General Counsel of Questcor Pharmaceuticals, Inc. (QCOR), where he also previously served as Chief Financial Officer. Mr. Mulroy earned his J.D. degree from the University of California, Los Angeles and his B.A. degree in economics from the University of Chicago.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel or "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or 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. 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 neuroscience focused pipeline currently includes: (i) OpRegen, 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) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Eterna Therapeutics Inc. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240429858960/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
10月前
NEWS -- Lineage Announces Appointment of Charlotte Hubbert, Ph.D., as Vice President of Corporate Development
CARLSBAD, Calif., April 01, 2024--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced the appointment of veteran industry executive Charlotte Hubbert, Ph.D., as Vice President of Corporate Development. Dr. Hubbert has an extensive background in cell therapy research and venture investment across a broad range of therapeutic modalities and development stages, and has a proven ability to combine deep scientific expertise and business development acumen to identify innovative opportunities to drive both returns and impact. Dr. Hubbert previously served as Partner and Head of Gates Foundation Venture Capital, an initiative at the Bill and Melinda Gates Foundation Strategic Investment Fund, where she oversaw investing in innovative technologies that supported the foundation’s programs in global health and agriculture. Most recently, Dr. Hubbert served in the leadership team at NanoString Technologies. She currently serves on the Board of Directors of the Beckman Research Institute at the City of Hope, and is a Strategic Director at Madrona Venture Group.
"We are excited to add such a talented executive to our management team in the newly created position of VP Corporate Development. Dr. Hubbert’s decades of experience in cell therapy, strategic investment, and partnering make her a valuable and welcome addition to the Lineage team," stated Brian M. Culley, CEO. "Given her relevant expertise in regenerative medicine, she will be able to support multiple operational areas, including product development, market strategies, strategic partnering, and broaden awareness of the work we’re doing to create a leading cell transplant company."
Prior to joining the Bill and Melinda Gates Foundation Strategic Investment Fund, where she led investments and served on the Board of Directors of Synlogic (Nasdaq: SYBX), Sera Prognostics, Lodo Therapeutics, Agtech Accelerator, Vedanta, and Vir Biotechnology (Nasdaq: VIR), Dr. Hubbert was a vice president at H.I.G. BioVentures, investing broadly in healthcare, and began her career in early-stage biotech investing at Accelerator Corporation, where she was a part of the founding management team.
Dr. Hubbert earned a B.S. in microbiology from the University of Washington and a Ph.D. in cancer biology from Duke University for which she received the prestigious Harold Weintraub Award. She did her post-doctoral work in stem cells and regenerative medicine at the Institute for Stem Cells and Regenerative Medicine at the University of Washington. Dr. Hubbert is a member of the Kauffman Society of Fellows and is a Fierce Woman in Biopharma awardee which recognizes top executives in Biopharma. She previously served on the Board of Directors of Life Science Washington, and the steering committees of the Fred Hutch Cancer Institute’s Evergreen Fund, University of Washington Innovation Roundtable and Columbia University Lab-to-Market initiative.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel or "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or 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. 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 neuroscience focused pipeline currently includes: (i) OpRegen, 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) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Eterna Therapeutics Inc. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
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. Such statements include, but are not limited to, statements relating to: the anticipated or implied benefits of Dr. Hubbert’s employment with Lineage. 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, those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s 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. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. 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 reports, which are available from the SEC’s website. You are cautioned not to place undue reliance 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240401267142/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
glenn1919
10月前
LCTX,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,https://stockcharts.com/h-sc/ui?s=LCTX&p=W&b=5&g=0&id=p86431144783
Paulness
11月前
NEWS -- Lineage Cell Therapeutics and the Christopher & Dana Reeve Foundation Proudly Announce the 2nd Annual Spinal Cord Injury Investor Symposium
Event Scheduled for June 26 and 27, 2024
CARLSBAD, Calif., March 18, 2024--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, and the Christopher & Dana Reeve Foundation, a non-profit organization dedicated to advancing innovative research and improving quality of life for individuals impacted by paralysis, are proud to again collaborate to present the 2nd Annual Spinal Cord Injury Investor Symposium ("2nd SCIIS"). The 2nd SCIIS builds upon a successful inaugural event held on June 29, 2023, and will connect a diverse set of stakeholders in the field of spinal cord injury (SCI). This year’s event aims to accelerate development in SCI research and treatments by bringing together companies working in the development of treatments for SCI, with regulators, key opinion leaders, persons with lived experience, patient and community advocacy organizations and the investment community, in order to discuss perspectives on current and future treatment alternatives, impact and support SCI disease awareness and clinical trial participation through the implementation of patient appropriate clinical endpoints, and importantly, broaden awareness of and investment capital into SCI. The 2nd SCIIS will be held on June 26 and 27, 2024 at the Sanford Consortium for Regenerative Medicine in La Jolla, CA.
"We are excited to continue our collaboration with the Reeve Foundation on this event, which provides an excellent opportunity to highlight the important work being done by for-profit and non-profit organizations alike and to broaden awareness and impact for those affected by this debilitating condition," stated Brian M. Culley, Lineage CEO. "Our aim at Lineage is to improve recovery and mobility by replacing the cells which are destroyed following a spinal cord injury. We are encouraged by the initial clinical testing which has been performed with our approach and look forward to continuing our work. In certain rare disease settings, we have seen that raising investor awareness can lead to greater investment, which can help to accelerate new treatments. This year’s symposium aims to build on the success of last year’s event and to continue to foster open and collaborative dialogue among leading experts, companies, researchers, persons with lived experience, caregivers, advocacy organizations, regulators and members of the investment community."
"Real breakthroughs in SCI science require diverse stakeholders to start talking, sharing data and collaborating," said Marco Baptista, Ph.D, Chief Scientific Officer at the Reeve Foundation. "We are focused on propelling the field forward and incentivizing high-risk, high-reward projects that can be translated from the lab into the clinic and make a real impact on quality of life. Success necessitates more collaboration among industry and academia, informed by those with lived experience. We’re excited to again bring together all those who are impacted by SCI and paralysis to explore and learn from promising science in progress."
The 2nd Annual Spinal Cord Injury Investor Symposium will be held in-person, on June 26 and 27, 2024, in the Duane Roth Auditorium at the Sanford Consortium for Regenerative Medicine in La Jolla, CA. This event will bring together both public and private companies developing new treatment options for people with spinal cord injury, alongside leaders in the spinal cord injury medical and advocacy communities. A number of important topics will be discussed, including but not limited to preclinical and clinical SCI treatment approaches and the drug development process; racial, ethnic, socioeconomic, geographic vulnerabilities within SCI care and outcomes; hearing the person's with lived experience voice and ensuring patients' perspectives, needs and priorities are captured in the drug development process; and discussions of SCI clinical endpoints and the need for new and more precise assessment tools.
About Spinal Cord Injuries
A spinal cord injury occurs when the spinal cord is subjected to a severe crush or contusion and frequently results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. There are approximately 18,000 new spinal cord injuries annually in the U.S. The cost of a lifetime of care for a severe spinal cord injury can be as high as $5 million.
About the Sanford Consortium for Regenerative Medicine
The Sanford Consortium is a multi-disciplinary and collaborative community of scientists who share the goal to harness the potential of stem cells for the treatment and cure of human diseases. The Sanford Consortium marshals the intellectual resources of five world leaders in life sciences research: La Jolla Institute for Allergy & Immunology, the Salk Institute for Biological Studies, the Sanford Burnham Prebys Medical Discovery Institute, Scripps Research, and the University of California, San Diego. Each of the Collaborating Organizations has substantive complementary research strengths that combined create a synergistic research enterprise, the whole of which is substantially greater than the sum of its parts. The Collaboratory has served as a focal point for stem cell science and has catalyzed increased collaboration among the stem cell research community. For more information, please visit https://www.sanfordconsortium.com/.
About the Christopher & Dana Reeve Foundation
The Christopher & Dana Reeve Foundation is dedicated to curing spinal cord injury by funding innovative research and improving the quality of life for individuals and families impacted by paralysis. Additionally, through a cooperative agreement with the Administration for Community Living, the Reeve Foundation’s National Paralysis Resource Center (NPRC) promotes the health, well-being, and independence of people living with paralysis, providing comprehensive information, resources, and referral services assisting over 125,000 individuals and families since its launch in 2002. The Reeve Foundation is committed to elevating our community’s voices and needs to achieve greater representation and independence. We meet all 20 of the Better Business Bureau’s standards for charity accountability and hold the BBB’s Charity Seal. For more information, please visit ChristopherReeve.org or call 800-225-0292.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel or "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or 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. 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 neuroscience focused pipeline currently includes: (i) OpRegen, 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) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Eterna Therapeutics Inc. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
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. Such statements include, but are not limited to, statements relating to: the potential effect of the 2nd SCIIS, including accelerating development in SCI, broadening SCI disease awareness, or increasing clinical trial participation; and the ability of cell transplant therapy approaches, including OPC1, to improve recovery or allow a patient to regain more mobility than what could otherwise be expected. 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 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 engagement with patients and the advocacy community may not lead to improvements in patient outcomes; and that raising investor awareness may not lead to greater investment, nor accelerate new treatments; 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). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. 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 and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240318962645/en/
Contacts
Reeve Foundation Media Contact:
Julia Leonard
(mailto://jleonard@reeve.org)
(973) 933-7222
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
11月前
NEWS -- RG6501 (OpRegen®) Phase 1/2a Clinical Study 24 Month Results to Be Featured at 2024 Retinal Cell & Gene Therapy Innovation Summit
CARLSBAD, Calif., March 13, 2024--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that 24 month results from patients enrolled in a Phase 1/2a clinical study (ClinicalTrials.gov Identifier: NCT02286089) of RG6501 (OpRegen) in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD), will be presented at the 2024 Retinal Cell & Gene Therapy Innovation Summit. The meeting will be held May 3, 2024, at the Hyatt Regency Seattle, and is jointly organized by the Foundation Fighting Blindness and the Oregon Health & Science University Casey Eye Institute. The presentation, "OpRegen® Retinal Pigment Epithelium (RPE) Cell Therapy for Patients with Geographic Atrophy (GA): Month 24 Results from the Phase 1/2a Trial," will include anatomical and functional data from long-term follow-up in 10 of 12 patients and will be presented by David Telander, MD, PhD, Retinal Consultants Medical Group, on behalf of Roche and Genentech, a member of the Roche Group.
About OpRegen
OpRegen (RG6501) is a suspension of allogeneic retinal pigment epithelial (RPE) cells currently in development for the treatment of GA secondary to AMD. Subretinal delivery of OpRegen has the potential to counteract RPE cell loss in GA by supporting retinal cell health and improving retinal structure and function. OpRegen is being developed under an exclusive worldwide collaboration between Lineage, and Roche and Genentech, a member of the Roche Group, and is currently being evaluated in a Phase 2a clinical study in patients with GA secondary to AMD (ClinicalTrials.gov Identifier: NCT05626114).
About the Innovation Summit
The annual Retinal Cell and Gene Therapy Innovation Summit 2024 is jointly organized by the Foundation Fighting Blindness and the Oregon Health & Science University Casey Eye Institute. Representatives from the biotech and pharma industries will come together with members of the medical and research communities to discuss rapidly emerging ocular gene and cell therapies and strategize how to move the most advanced retinal diseases therapies toward clinical utility. The Summit features presentations by leading retinal disease experts on potential gene and cell-based therapies and how best to deliver them to patients. For more information visit: https://give.fightingblindness.org/event/retinal-cell-and-gene-therapy-innovation-summit-2024/e529485.
About the Foundation Fighting Blindness
The Foundation Fighting Blindness was established in 1971 by a passionate group of families driven to find treatments and cures for inherited retinal diseases that were affecting their loved ones. At that time, little was known about these blinding retinal diseases. Very little research was being done, and there were no clinical trials for potential treatments. Today, the Foundation Fighting Blindness is the world’s leading private funder of retinal disease research. That funding has been a driving force behind the progress toward cures, including the identification of more than 270 genes linked to retinal disease, and the launch of over 40 clinical trials for potential treatments. For more information, visit: https://www.fightingblindness.org/ or follow them on X/Twitter @FightBlindness.
About OHSU Casey Eye Institute
OHSU Casey Eye Institute is a premier academic medical center providing eye care for adults and children in the Pacific Northwest and beyond. Since 1945, OHSU Casey Eye Institute doctors and vision scientists have worked side by side to discover the causes of eye disease and find new treatments. For more information, visit: https://www.ohsu.edu/casey-eye-institute or follow them on X/Twitter: @CaseyEye.
About the OpRegen Phase 1/2a Study
The Phase 1/2a study is an open-label, single-arm, multi-center, dose-escalation trial evaluating a single administration of OpRegen delivered subretinally in patients with bilateral GA secondary to AMD. Twenty-four patients were enrolled into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with a best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 patients with impaired vision (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new "thaw-and-inject" formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study was to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment-emergent adverse events. Secondary objectives include evaluating the preliminary activity of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance.
About Geographic Atrophy
GA is an advanced form of AMD characterized by severe loss of visual function. GA is a leading cause of adult blindness in the developed world, affecting at least 5 million people globally. There are two forms of advanced AMD: neovascular AMD and GA. GA and neovascular AMD can occur simultaneously in the same eye, and patients treated for neovascular AMD may still go on to develop GA. GA typically affects both eyes.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel or "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or 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. 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 neuroscience focused pipeline currently includes: (i) OpRegen, 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) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Eterna Therapeutics Inc. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
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. Such statements include, but are not limited to, statements relating to: the potential therapeutic benefits of OpRegen in patients with GA secondary to AMD. 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 positive findings in early clinical studies of a product candidate may not be predictive of success in subsequent clinical studies of that candidate; that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; 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). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. 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 reports, which are available from the SEC’s website. You are cautioned not to place undue reliance 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240313697648/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
11月前
NEWS -- RG6501 (OpRegen®) Preclinical Engraftment Results to Be Presented at 2024 Association for Research in Vision and Ophthalmology Meeting
CARLSBAD, Calif., March 11, 2024--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that preclinical results as part of a surgical development study evaluating the survival and distribution of RG6501 (OpRegen) will be presented at the 2024 Association for Research in Vision and Ophthalmology Annual Meeting (2024 ARVO). The meeting will be held May 5-9, 2024, in Seattle, WA. The presentation, "OpRegen engrafts within the retinal pigmented epithelium (RPE) of Gottingen mini-pigs by 4-weeks post-administration via subretinal delivery," will be presented by Rachel N. Andrews, DVM, PhD, DACVP, Principal Scientist-Pathologist, Safety Assessment, Genentech, a member of the Roche Group, on behalf of Roche and Genentech.
About OpRegen[img][/img]
OpRegen (RG6501) is a suspension of allogeneic retinal pigmented epithelial (RPE) cells currently in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Subretinal delivery of OpRegen has the potential to counteract RPE cell loss in GA by supporting retinal cell health and improving retinal structure and function. OpRegen is being developed under an exclusive worldwide collaboration between Lineage, and Roche and Genentech, a member of the Roche Group, and is currently being evaluated in a Phase 2a clinical study in patients with GA secondary to AMD (ClinicalTrials.gov Identifier: NCT05626114).
About the 2024 ARVO Meeting
The ARVO Annual Meeting is the premiere gathering for eye and vision scientists from across the globe, at all career stages, students, and those in affiliated fields to share the latest research findings and collaborate on innovative solutions. The theme of the 2024 Annual Meeting addresses how vision research is continually being transformed by new information and technologies. Exponentially expanding computing power is giving rise to improved artificial intelligence and powerful big data. Increasingly sensitive and elegant molecular techniques, including CRISPR and mRNA technologies, as well as more sophisticated imaging modalities, virtual reality, and breakthroughs in gene therapy are catalyzing our research as we aim to treat, cure and ultimately prevent blinding eye diseases. For more information, visit https://www.arvo.org/annual-meeting/meeting-info/meeting-info/ or follow the Association on X/Twitter: @ARVOInfo.
About Geographic Atrophy
GA is an advanced form of AMD characterized by severe loss of visual function. GA is a leading cause of adult blindness in the developed world, affecting at least 5 million people globally. There are two forms of advanced AMD: neovascular AMD and GA. GA and neovascular AMD can occur simultaneously in the same eye, and patients treated for neovascular AMD may still go on to develop GA. GA typically affects both eyes.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel or "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or 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. 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 neuroscience focused pipeline currently includes: (i) OpRegen, 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) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Eterna Therapeutics Inc. For more information, please visit https://www.lineagecell.com or follow the company on X/Twitter @LineageCell.
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. Such statements include, but are not limited to, statements relating to: the potential therapeutic benefits of OpRegen in patients with GA secondary to AMD. 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 positive findings in early clinical studies of a product candidate may not be predictive of success in subsequent clinical studies of that candidate; that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; 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). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. 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 reports, which are available from the SEC’s website. You are cautioned not to place undue reliance 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240311914768/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
chrismiss_everyday
12月前
February 13, 2024 8:00 AM EST
Lineage Announces FDA Clearance of IND Amendment for OPC1 Cell Transplant for the Treatment of Spinal Cord Injury
The DOSED Clinical Study Will Evaluate a Novel Delivery Device in Subacute and Chronic Spinal Cord Injury Patients
CARLSBAD, Calif.--(BUSINESS WIRE)--Feb. 13, 2024-- Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today the clearance, by the U.S. Food and Drug Administration (FDA), of its Investigational New Drug amendment (INDa) for OPC1, an investigational allogeneic oligodendrocyte progenitor cell transplant for the treatment of spinal cord injury (SCI). Pursuant to the INDa, Lineage has initiated activities to open its first clinical site in the DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) study to evaluate the safety and utility of a novel spinal cord delivery device in subacute and chronic SCI patients. Initial site opening is expected to occur in the second quarter of 2024, following customary trial preparations and submission in the first quarter of a grant application to the California Institute for Regenerative Medicine (CIRM) for potential partial financial support of the DOSED clinical study.
“Lineage’s oligodendrocyte cell transplants are designed to replace or support cells that are absent or dysfunctional due to traumatic injury, with the goal of helping to improve the quality of life and restore or augment functional activity to persons suffering from traumatic cervical or thoracic spinal cord injuries. The clearance of our INDa and the initiation of OPC1 clinical testing under our sponsorship represents a significant milestone for this program, and reflects our commitment to developing modern cell therapy product candidates,” stated Brian M. Culley, Lineage CEO. “We are excited by the opportunity to build upon the promising results achieved with OPC1 in previous trials, and to continue to seek improvements in how our therapy is prepared and administered. The DOSED clinical study in particular is intended to evaluate the safety and performance of a new delivery device, which is compatible with our forthcoming immediate-use formulation, and which does not require cessation of patient ventilation during administration. We believe these improvements can lead to a safer surgical procedure for surgeons and patients. This study also will mark the first time that OPC1 is administered to chronic SCI patients, and we will be collecting efficacy assessments in addition to the primary outcome measures of safety. Completing this regulatory step also enables us to proceed with our planned CLIN-2 grant application to CIRM to request external financial support for the OPC1 program.”
OPC1 has been tested in two clinical trials to date: a five patient Phase 1 clinical safety trial in acute thoracic SCI, where all subjects have been followed for at least 10 years; as well as a 25 patient Phase 1/2a multicenter dose-escalation clinical trial in subacute cervical SCI, where all subjects were evaluated for at least two years, one of the first cell therapy clinical trials supported by the California Institute for Regenerative Medicine under Proposition 71. Results from both studies have been published in the Journal of Neurosurgery: Spine. The data from the Phase 1/2a clinical study of OPC1 in subacute cervical SCI is available here and the data from the Phase 1 clinical study of OPC1 in acute thoracic SCI is available here.
About the DOSED Clinical Study
The Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device (DOSED) clinical study is an open label, multi-center, device safety study, in approximately 3-5 subacute and 3-5 stable chronic subjects with complete (ASIA Impairment Scale A) or incomplete (ASIA Impairment Scale B), traumatic, focal SCI affecting either cervical (C4-C7) or thoracic (T1-T10) vertebrae. The primary objective of this study is to evaluate the safety of a novel spinal cord delivery device to administer OPC1 to the spinal parenchyma. The primary endpoint is safety, as measured by the frequency and severity of adverse events (AEs) through 30 days following OPC1 injection that are related to the injection procedure. Secondary endpoints are safety and tolerability, as measured by the frequency and severity of AEs, including AEs of special interest, through 90 days following OPC1 injection, that are related to OPC1 and/or the concomitant short-term immunosuppression. Safety parameters will be evaluated by magnetic resonance imaging (MRI) data evaluating evidence of deterioration or changes in the following: intramedullary hemorrhage, cerebral spinal fluid (CSF) leak, epidural abscess, infection; evidence of an expanding cyst or mass at the injection site or elsewhere in the central nervous system (CNS); evidence of inflammatory lesion(s) at injection site or elsewhere in CNS and evidence of CSF flow obstruction. Exploratory endpoints include: (1) potential improvements in neurological impairment, function, and pain, evaluated by changes from baseline on the following endpoints: changes in neurological function as measured by sensory and motor scores and motor level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations; changes in post-injection pain, defined as a worsening of pain or neuropathic pain of greater than 7 days duration from baseline levels, as assessed by the International Spinal Cord Injury Pain Basic Data Set or occurrence of allodynia; (2) changes from baseline at 30, 90 and 365 days post-OPC1 injection in: ISNCSCI, SCIM, International Spinal Cord Injury Pain Questionnaire; and (3) patient and clinician impressions of changes in quality of life as reported by changes from baseline at 30, 90, and 365 days post-OPC1 injection.
About OPC1
OPC1 is an oligodendrocyte progenitor cell (OPC) transplant therapy designed to provide clinically meaningful improvements to motor recovery in individuals with spinal cord injuries (SCI). OPCs are naturally occurring precursors to the cells which provide electrical insulation for nerve axons in the form of a myelin sheath. SCI most often occurs when the spinal cord is subjected to a severe crush or contusion injury and typically results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. There are approximately 18,000 new spinal cord injuries annually in the U.S. and there currently are no FDA-approved drugs or interventions specifically for the treatment of SCI. The OPC1 program has been partially funded by a $14.3 million grant from the California Institute for Regenerative Medicine. OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation from the U.S. Food and Drug Administration (FDA).
About the California Institute for Regenerative Medicine (CIRM)
CIRM, California's Stem Cell Agency, was created by the voters of California in 2004 with the passing of Proposition 71, which authorized $3 billion in funding for stem cell research in California. The agency funds stem cell research at institutions and companies throughout California (as well as institutions and companies outside of the state that conduct a portion of their research in California) with the goal of accelerating treatments to patients with unmet medical needs. In 2020, California voters approved to continue funding California's Stem Cell Agency through the passage of Proposition 14. CIRM’s mission is to accelerate world class science to deliver transformative regenerative medicine treatments in an equitable manner to a diverse California and world as well as to accelerate stem cell treatments to patients with unmet medical needs. By promoting and encouraging the growth of the stem cell biotechnology sector, the agency is also helping attract the best scientists to the state and establishing California as a global leader in stem cell research. For more information, please visit https://www.cirm.ca.gov/ and follow the agency on Twitter: @CIRMnews.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform, Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy 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 Twitter @LineageCell.
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. Such statements include, but are not limited to, statements relating to: the ability of cell transplant therapies, including OPC1, to improve recovery, allow a patient to regain more function than what could otherwise be expected, or improve a patient’s quality of life; the potential future achievements of our clinical, preclinical and development programs, the planned initiation of clinical trials, including the expected initial site opening for the DOSED clinical study in the second quarter of 2024; that the improvements in the delivery device for OPC1 can lead to a safer surgical procedure; and the timing and availability of clinical data updates related to our programs. 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 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; 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). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. 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 reports, which are available from the SEC’s website. You are cautioned not to place undue reliance 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240213332150/en/
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(Nic.johnson@russopartnersllc.com)
(David.schull@russopartnersllc.com)
(212) 845-4242
Source: Lineage Cell Therapeutics, Inc.
Paulness
12月前
Lineage Cell Therapeutics Announces Closing of $14.0 Million Registered Direct Offering
CARLSBAD, Calif., February 09, 2024--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced the closing of its previously announced registered direct offering for the purchase and sale of 13,461,540 of the company’s common shares at an offering price of $1.04 per common share. The price per share was the closing price of the company’s common shares on NYSE American on February 5, 2024. Broadwood Partners, L.P., which is affiliated with Neal Bradsher, a member of the Company’s board of directors, has purchased 6,730,770 common shares in the offering, and Don M. Bailey, a member of the Company’s board of directors, has purchased approximately 100,000 common shares in the offering.
"This offering strategically strengthens our balance sheet, which can aid us in reaching important milestones in the months ahead," stated Brian M. Culley, Lineage CEO. "This deal was priced at-market, without a discount or dilutive structural elements like warrants. It featured significant insider and pre-existing shareholder participation and was executed without an investment bank. We appreciate the contributions of all parties involved in this transaction and look forward to advancing our product candidates this year."
The aggregate gross proceeds to Lineage from the offering at the closing were $14.0 million before deducting estimated offering expenses payable by Lineage. Lineage intends to use the proceeds from the offering for general corporate purposes, which may include clinical trials, research and development activities, general and administrative costs, and to meet working capital needs.
The securities described above were offered and sold by Lineage pursuant to a "shelf" registration statement on Form S-3 (File No. 333-254167), including a base prospectus, previously filed with the Securities and Exchange Commission, or the SEC, on March 11, 2021, and declared effective by the SEC on March 19, 2021. Such securities were offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and an accompanying base prospectus relating to the securities was filed with the SEC. Electronic copies of the prospectus supplement and the accompanying base prospectus may be obtained by visiting the SEC’s website at http://www.sec.gov.
This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
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," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "objective," or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to the expected use of proceeds from the offering. 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 those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the 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. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. 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 reports, which are available from the SEC’s website. You are cautioned not to place undue reliance 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240209732533/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
12月前
NEWS -- Lineage Cell Therapeutics Announces $14.0 Million Registered Direct Offering
CARLSBAD, Calif., February 06, 2024--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it entered into a definitive agreement with certain investors for the purchase and sale of 13,461,540 of the company’s common shares in a registered direct offering at an offering price of $1.04 per common share. The price per share was the closing price of the company’s common shares on NYSE American on February 5, 2024. The parties entered into the definitive agreement before markets opened on February 6, 2024. The closing of the offering is expected to occur on or about February 8, 2024, subject to the satisfaction of customary closing conditions. Broadwood Partners, L.P., which is affiliated with Neal Bradsher, a member of the Company’s board of directors, agreed to purchase 6,730,770 common shares in the offering, and Don M. Bailey, a member of the Company’s board of directors, agreed to purchase approximately 100,000 common shares in the offering.
The aggregate gross proceeds to Lineage from the offering at the closing are expected to be $14.0 million before deducting estimated offering expenses payable by Lineage. Lineage intends to use the proceeds from the offering for general corporate purposes, which may include clinical trials, research and development activities, general and administrative costs, and to meet working capital needs.
The securities described above are being offered and sold by Lineage pursuant to a "shelf" registration statement on Form S-3 (File No. 333-254167), including a base prospectus, previously filed with the Securities and Exchange Commission, or the SEC, on March 11, 2021, and declared effective by the SEC on March 19, 2021. Such securities may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and an accompanying base prospectus relating to the securities will be filed with the SEC. Electronic copies of the prospectus supplement and the accompanying base prospectus may be obtained, when available, by visiting the SEC’s website at http://www.sec.gov.
This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
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," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," "project," "target," "objective," or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to the offering, the completion of the offering and the expected use of proceeds from the offering. 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, without limitation, risk and uncertainties related to: the satisfaction of the closing conditions related to the offering, whether Lineage will complete the offering on the anticipated terms, or at all, and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the 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. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. 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 reports, which are available from the SEC’s website. You are cautioned not to place undue reliance 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240206000006/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
Paulness
1年前
RG6501 (OpRegen®) Phase 1/2a Results Will Be Featured at 2024 Angiogenesis Exudation and Degeneration Meeting in Presentation by Allen Ho, MD, FACS, FASRS
CARLSBAD, Calif., January 16, 2024--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that results showing retinal structure improvements with RG6501(OpRegen) from a Phase 1/2a clinical study (ClinicalTrials.gov Identifier: NCT02286089) in geographic atrophy (GA) secondary to advanced age-related macular degeneration (AMD), will be presented at the 2024 Angiogenesis, Exudation, and Degeneration Meeting. The virtual meeting will be held February 3, 2024, and is sponsored by the University of Miami Health System Bascom Palmer Eye Institute. The presentation, "Retinal Structure Improvements with OpRegen RPE Cell Therapy in a Phase I/IIa Study in Geographic Atrophy," will be presented by Allen Ho, MD, FACS, FASRS, Co-Director, Wills Eye Retina Service and Director, Retina Research, Wills Eye Hospital on behalf of Roche and Genentech, a member of the Roche Group.
About OpRegen
RG6501 (OpRegen) is a suspension of human allogeneic retinal pigment epithelial (RPE) cells currently in development for the treatment of GA secondary to AMD. OpRegen subretinal delivery has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function. It is being developed under an exclusive worldwide collaboration between Lineage, and Roche and Genentech, a member of the Roche Group, and is currently being evaluated in a Phase 2a clinical study in patients with GA secondary to AMD (ClinicalTrials.gov Identifier: NCT05626114).
About Angiogenesis
The 21st Annual Angiogenesis meeting, entitled Angiogenesis, Exudation, and Degeneration 2024, will be held virtually on February 3, 2024. The program will feature an exceptional group of basic scientists, clinicians, and healthcare experts, all focused on understanding and treating neovascular, exudative, and degenerative diseases of the eye. The program will highlight the revolutionary pharmacotherapies now in development and clinical practice for the management of neovascular AMD, macular edema, diabetic retinopathy, retinopathy of prematurity, and inherited retinal degenerations with a special emphasis on the present and future financial impact of these drugs on clinical practices and Medicare. Angiogenesis 2024 follows the tradition of excellence established by Bascom Palmer’s widely acclaimed Angiogenesis programs between 2004 and 2023. Designed for retina specialists, general ophthalmologists and researchers, the current program will review the latest in imaging, translational research, and clinical trials with an emphasis on how these results will impact clinical ophthalmology. For more information visit: https://umiamihealth.org/bascom-palmer-eye-institute/healthcare-professionals/continuing-medical-education/angiogenesis.
About the OpRegen Phase 1/2a Study
The Phase 1/2a study is an open-label, single-arm, multi-center, dose-escalation trial evaluating a single administration of OpRegen delivered subretinally in patients with bilateral GA secondary to AMD. Twenty-four patients were enrolled into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with a best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 patients with impaired vision (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new "thaw-and-inject" formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study was to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment-emergent adverse events. Secondary objectives include evaluating the preliminary activity of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance.
About Geographic Atrophy
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD) characterized by severe loss of visual function. GA is a leading cause of adult blindness in the developed world, affecting at least 5 million people globally. There are two forms of advanced AMD: neovascular AMD and GA. GA and neovascular AMD can occur simultaneously in the same eye, and patients treated for neovascular AMD may still go on to develop GA. GA typically affects both eyes.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
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. Such statements include, but are not limited to, statements relating to: the potential therapeutic benefits of OpRegen in patients with GA secondary to AMD. 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 positive findings in early clinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; 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). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. 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 reports, which are available from the SEC’s website. You are cautioned not to place undue reliance 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240116211178/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://mailto://Nic.johnson@russopartnersllc.com)
(David.schull@russopartnersllc.com)
(212) 845-4242
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