Blog: LINEAGE CELL THERAPEUTICS, INC. : Regulation FD Disclosure, Other Events, Financial Statements and Exhibits (form 8-K) – marketscreener.com

Item 7.01. Regulation FD Disclosure.

On May 3, 2021, Lineage Cell Therapeutics, Inc. (“Lineage”), issued a press
release announcing that updated interim results from its ongoing, 24-patient
Phase 1/2a clinical study of its lead product candidate, OpRegen®, were reported
at the 2021 Association for Research in Vision and Ophthalmology Annual Meeting.
A copy of the press release is attached as Exhibit 99.1 to this report.

The information contained in this Item 7.01, including in Exhibit 99.1 to this
report, is being “furnished” and shall not be deemed “filed” for the purposes of
Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), or otherwise subject to the liabilities of that Section or Sections 11
and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”).
The information contained in this Item 7.01 and in Exhibit 99.1 shall not be
incorporated by reference into any filing with the Securities and Exchange
Commission made by Lineage, whether made before or after the date hereof,
regardless of any general incorporation language in such filing.


Item 8.01. Other Events.



On May 3, 2021, Lineage announced updated interim results from its ongoing,
24-patient Phase 1/2a clinical study of its lead product candidate, OpRegen.
OpRegen is an investigational cell therapy consisting of allogeneic retinal
pigment epithelium (RPE) cells administered to the subretinal space for the
treatment of dry age-related macular degeneration (AMD) with geographic atrophy
(GA).

The patients in the ongoing clinical study are 50 years of age or older, whose
dry AMD has advanced to the GA stage, with absence of additional concomitant
ocular disorders. The eye in which the disease has progressed the most is
treated, while their other eye serves as a measure of disease progression.
Following injection, the patients are followed for 12 months at specified
intervals to evaluate the safety and tolerability of OpRegen. Following the
initial 12-month period, patients are evaluated at longer intervals for up to an
additional five years following administration. A secondary objective of the
clinical study is to examine the ability of transplanted OpRegen to engraft,
survive, and modulate disease progression in the patients. In addition to
thorough characterization of visual function, several vision tests are used to
quantify stabilization or improvements in visual function. Anatomical evaluation
imaging is also performed to assess the restoration of the structure of the
retina.

The updated interim results included additional data on 24 patients enrolled in
the study, including all 12 patients treated in Cohort 4, which have better
baseline vision and smaller areas of GA than earlier cohorts, and included a
minimum of 4.5 months of follow-up in all 24 patients treated with OpRegen. Nine
of twenty-four patients were treated with the “thaw and inject” formulation of
OpRegen, two via a standard pars plana vitrectomy (PPV) and seven utilizing the
Orbit™ Subretinal Delivery System (Orbit SDS).

Overall, 10/12 (83%) of the Cohort 4 patients’ treated eyes were at or above
baseline visual acuity at their last assessment, based on per protocol scheduled
visits ranging from 4.5 months to approximately 3 years post-transplant.
Improvements in best corrected visual acuity (BCVA) for Cohort 4 patients
reached up to +19 letters on the Early Treatment Diabetic Retinopathy Study
(ETDRS) chart. In contrast, 10/12 (83%) of the patients’ untreated eyes were
below pre-treatment baseline values at the same time points. Among the newly
reported data, three (50%) of the more recently treated Cohort 4 patients
exhibited marked improvements in BCVA ranging from +7 to +16 letters at their
last scheduled assessments of at least 4.5 months. Two additional Cohort 4
patients experienced a gain of 2 letters from their baseline values. One Cohort
4 patient measured 7 letters below baseline. Previously reported structural
improvements in the retina, decreases in drusen density, and a trend toward
slower GA progression in treated compared to untreated eyes continued. Overall,
OpRegen has been well tolerated with no unexpected adverse events or serious
adverse events, and evidence of durable engraftment of OpRegen RPE cells have
extended to more than 5 years in earliest treated patients, supporting the
potential for OpRegen to be a one-time treatment.

A Cohort 4 patient with evidence of retinal restoration and confirmed history of
GA growth, which was first reported 9 months following treatment, continues to
demonstrate areas of retinal restoration as of their last assessment,
approximately 3 years after treatment.

Below are highlights of the updated interim results (as of April 16, 2021):

? In Cohort 1-3 patients (all legally blind at baseline), visual acuity

reductions occurred as expected due to progressive GA;

? In Cohort 4 patients, which collectively had smaller areas of GA and higher

baseline BCVA as compared to Cohort 1-3 patients, improved or sustained BCVA

has been observed in 10/12 (83%) patients as of their last visit prior to this

update (range of -7 to +19 letters on the ETDRS chart);

? OpRegen continues to be well-tolerated in all treated patients (N = 24);

? The majority of adverse events were mild (87%);

? Sustained subretinal pigmentation continues to suggest multi-year durability

of OpRegen transplants;

? Improved anatomy and function continue to be observed in some patients,

    including:




 ? Reduction in drusen;

? Photoreceptor and RPE layer restoration;

? Localized slowing of GA progression in treated areas;

? Better visual acuity via ETDRS scores and reading speed; and

? Improved National Eye Institute Visual Function Questionnaire (VFQ-25) scores.

? Post-treatment surgical interventions occurred in four cases (5 events in 4

    patients):



? Three epiretinal membranes (ERM) were surgically peeled. Mild to moderate ERM

were observed in an additional 12 out of 17 PPV operated patients. Most ERMs

were clinically insignificant.

? Retinal detachment (RD) was observed in 2 out of 17 patients, neither of which

appears to be attributable to OpRegen or any study related medications:

? The first case of RD, which occurred in a Cohort 3 patient, was an

unsuccessful repair of a post-surgical retinal tear; visual acuity did not

regain baseline levels; and

? The second case of RD, which occurred in a Cohort 4 patient, was successfully

repaired; post-surgical visual acuity has remained higher than baseline.

? Choroidal neovascularization (CNV) was observed in 3 out of 7 patients

receiving OpRegen via the Orbit SDS, all of whom received treatment with an

approved anti-VEGF;

? As previously reported, one PPV operated patient developed CNV, which was

identified more than two years following treatment.

As part of an ongoing effort to administer the minimally effective dose and
duration of immunosuppressive therapy, immunosuppression was utilized only
during the perioperative period of approximately 3 months in Cohort 4 patients.
One patient received a modified immunosuppressive regimen at baseline, which
included no tacrolimus and only mycophenolate mofetil. One patient was diagnosed
with COVID-19 shortly after treatment for whom all immunosuppression was halted
and reinstated once the patient was asymptomatic. Both patients showed no signs
of acute or delayed inflammation or rejection of OpRegen cells with 4.5 months
of post-transplant follow up. Other than the reduced regimens described above,
immunosuppressants have been discontinued as scheduled, typically within 90 days
post-operatively, and no cases of acute or delayed rejection or inflammation due
to OpRegen have been reported in any patients treated with OpRegen.

Cautionary Statement Regarding Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical
facts, contained in this report, 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,” “tend to,” or the negative version of these
words and similar expressions. Such statements include, but are not limited to,
statements relating to the expected clinical outcomes of treatment with OpRegen
in dry AMD patients with GA. 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 risks and uncertainties inherent in
Lineage’s business and other risks 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.

Item 9.01. Financial Statements and Exhibits.




(d) Exhibits



Exhibit No.   Description
99.1            Press release dated May 3, 2021.

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