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, 2022, Lineage Cell Therapeutics, Inc. (“Lineage,” “we,” “us,” “our,”
or the “Company”) issued a press announcing results from the ongoing Phase 1/2a
clinical study of RG6501 (OpRegen®), a retinal pigment epithelial cell therapy
currently in development for the treatment of geographic atrophy (“GA”)
secondary to age-related macular degeneration (“AMD”), that were presented at
the 2022 Association for Research in Vision and Ophthalmology Annual Meeting on
May 2, 2022. A copy of the press release is attached as Exhibit 99.1 to this
report.

The information provided under this Item 7.01, including the information 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, or otherwise subject to the liabilities of that Section or Sections
11 or 12(a)(2) of the Securities Act of 1933, as amended. The information
provided under this Item 7.01, including the information in Exhibit 99.1, shall
not be incorporated by reference into any filing with the Securities and
Exchange Commission (“SEC”) 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, 2022, Lineage announced results from the ongoing Phase 1/2a clinical
study of OpRegen that support the potential for OpRegen to slow, stop or reverse
disease progression in GA secondary to AMD. Twelve-month primary endpoint data
demonstrated that OpRegen was well tolerated in the study with an acceptable
safety profile. We also reported preliminary evidence of visual function and
outer retinal structure improvements observed in Cohort 4 patients with GA and
impaired vision. 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 subjects were enrolled into four cohorts. In all subjects, the worse
eye based on best corrected visual acuity (“BCVA”) was selected for OpRegen
subretinal delivery and the other eye was untreated. In Cohorts 1-3 (n=12), all
patients were legally blind at the outset of the trial (BCVA: ?20/200, with a
study eye mean of 23.5 letters, or approximately 20/320 (standard deviation
(SD): ±11.7; minimum-maximum: 0-39 letters)) and had significant progression of
GA (study eye mean GA area: 12.7 mm2 (SD: ±6.7; min-max: 6-30 mm2)). Cohort 4
(n=12) enrolled patients with impaired vision (BCVA: ?20/250 and ?20/64, with a
study eye mean of 44.8 letters, or approximately 20/125 (SD: ±7.5; min-max:
28-54 letters)) and smaller areas of GA (study eye mean GA area: 7.4 mm2 (SD:
±2.9; min-max: 1.4-11 mm2)). OpRegen was delivered subretinally via pars plana
vitrectomy and retinotomy (n=17) or, in Cohort 4 only, via suprachoroidal
cannula using the Gyroscope Therapeutics, Ltd. Orbit Subretinal Delivery System
(n=7). We completed enrollment in Cohorts 1-3 in the middle of 2018 and in
Cohort 4 in November 2020.

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 are to evaluate the potential activity of
OpRegen by assessing changes in visual function and retinal structure. The
primary objective and the secondary objectives were assessed at 12 months
following OpRegen subretinal delivery (“Month 12”) and subjects are followed for
up to five years.

Summary of Safety Results (data cutoff: January 18, 2022)



  ? All 24 treated patients reported at least one adverse event ("AE") and at
    least one ocular AE.

  ? The majority of AEs reported with OpRegen were mild (Cohorts 1-3, 87%; Cohort
    4, 93%), and the immunosuppressive regimen was well tolerated.

  ? The ocular AEs reported with OpRegen were mainly related to the surgical
    procedures used for subretinal delivery, with the most common being
    conjunctival hemorrhage/hyperemia (n=17) and epiretinal membrane (n=16).

  ? One patient discontinued the study due to an AE that was determined unrelated
    to treatment.

  ? No cases of rejection following OpRegen subretinal delivery have been
    reported.

  ? No acute or delayed intraocular inflammation, or sustained intraocular
    pressure increase following OpRegen subretinal delivery has been observed.




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Summary of Activity Results (data cutoff: January 18, 2022)



  ? Preliminary evidence of improvement in visual function using the Early
    Treatment Diabetic Retinopathy Study ("ETDRS") assessment of BCVA:




  ? Cohort 4 subjects (n=12) had an average 7.6 letter gain in the study (treated)
    eye and an average 1.7 letter gain in the fellow (untreated) eye at Month 12
    compared to baseline. Cohorts 1-3 subjects (n=11) had an average 4.7 letter
    gain in the study eye and an average 6.0 letter gain in the fellow eye at
    Month 12 compared to baseline.

  ? Three subjects in Cohort 4, or 25% of Cohort 4, and one subject in Cohorts 1-3
    had a 15 letter or greater gain in the study eye at Month 12 compared to
    baseline. None of the fellow (untreated) eyes had a 15 letter or greater gain.




  ? Five Cohort 4 subjects with OpRegen delivered to most or all of the GA area,
    including the fovea, had greater gains in visual function at Month 12 (average
    12.8 letter gain) as compared with subjects who did not receive OpRegen in a
    similar manner to most or all of the GA area, with evidence for regions of
    apparent improvement of outer retinal structure as assessed by spectral domain
    optical coherence tomography ("SD-OCT").

  ? SD-OCT imaging analysis of all subjects is ongoing.



These data support the potential for OpRegen to slow, stop, or reverse disease
progression in GA. Further assessment of the optimal disease stage for
intervention, surgical procedure for subretinal delivery, and target delivery
location of OpRegen in a larger, controlled clinical study is needed to confirm
these preliminary findings.

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,” “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 benefits of treatment with OpRegen in
patients with GA, the significance of clinical data reported to date, including
the findings of evidence of visual function and outer retinal structure
improvements, from the ongoing Phase 1/2a study of OpRegen. 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 report, including, but not limited to,
the risk 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; the risk that competing
alternative therapies may adversely impact the commercial potential of OpRegen;
the risk that Roche and Genentech may not be successful in completing further
clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in
any particular jurisdiction; the risk that Lineage may not be able to
manufacture sufficient clinical quantities of its product candidates in
accordance with current good manufacturing practice; 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
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.



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Item 9.01. Financial Statements and Exhibits.



(d) Exhibits



Exhibit No.   Description
99.1            Press release dated May 3, 2022
104           Cover Page Interactive Data File (embedded within the Inline XBRL
              document)




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