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Healthcare

Biotechnology

Lineage Cell Therapeutics, Inc.

Investor Appraisal
OPC1 is a cellular therapy comprised of oligodendrocyte progenitor cells (OPCs) which are derived from a pluripotent cell line and injected into the patient&#8217;s spinal cord. OPC1 is the product candidate used for the treatment of acute spinal cord injury (SCI). SCI occurs when the spinal cord is subjected to a severe crush or contusion injury, such as that caused by a car or motorcycle accident, and typically results in severe functional impairment. OPC1 demonstrated: i) remyelinate axons, ii) remodel tissues: neovascularization and prevention of cavitation, iii) promote neurite growth, and iv) improve motor function. Twenty-five patients were enrolled, seven out twenty-two patients (32%) who were dosed with 10-20 million cells experienced motor level improvement. Some details to the program include:
<ul>
<li>Lineage&#8217;s cells are derived from an NIH-registered cell line </li>
<li>The cells are allogeneic (&#8220;off the shelf&#8221;) and not taken from the patient </li>
<li>Treatment for SCI occurs 3-6 weeks postinjury and includes short-course (60-day) immunosuppression </li>
<li>The cells are cryopreserved for &#8220;thaw and inject&#8221; use </li>
<li>OPC1 cells are manufactured from a single cell line </li>
<li>OPC1 is covered by multiple issued patents </li>
<li>OPC1 has RMAT Designation </li>
<li>OPC1 has Orphan Drug Designation </li>
<li>OPC1 has received &gt;$14M in support from CIRM (California Institute for Regenerative Medicine) </li>
<li>OPC1 could have application in other demyelinating conditions</li>
</ul>
 Exhibit 1. OPC1 prevents cavitation
<img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/lctx.2.22.21.png" style="width: 552px;height: 328px" />
Source: Company SEC filings
In the preclinical setting, OPC1 showed to prevent cavitation, enhanced myelination of the axons, and increased secretion of neurotrophic factors (Exhibit 1).
 
 Exhibit 2. Phase 1/2a SCiStar clinical trial
<img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/lctx.2.22.21.png_2.png" />
<img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/lctx.2.22.21.png_2.2.png" style="width: 524px;height: 291px" />
Source: Company SEC filings
Safety data was assessed 2 to 5 years on all 25 patients and no serious adverse events related to the OPC1 cells were observed. Four percent of the patients did not demonstrate any improvement in their motor functions. The two worst performing subjects had spinal cord compression. Thirty-two percent of the patients had two or more levels of improvement in their motor level, and 96% had motor recovery in at least 1 motor level gain on at least 1 side (Exhibit 3).
 
Exhibit 3. Motor function gains in SCiStar clinical trial
<img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/lctx.2.22.21.png_3.png" />
Source: Company SEC filings
Lineage also made significant progress on OPC1 manufacturing. Based on the December 2020 update:
<ul>
<li>A new ready-to-inject formulation was developed </li>
<li>Elimination of dose preparation achieved </li>
<li>10- to 20-fold increase in production scale </li>
<li>Significant reduction in product impurities </li>
<li>Improvements in functional activity </li>
<li>12 new analytical and functional methods developed </li>
<li>Elimination of all animal-based production reagents </li>
<li>Patent applications recently filed on the process and product which if allowed will have expiration dates of 2039 and 2040 </li>
</ul>
The company also recently entered into an agreement with Neurgain to utilize evaluate Neurgain&#8217;s novel Parenchymal Delivery Injection (PDI) system for the administration of cells to the spinal cord without stopping the patient&#8217;s respiration that is expected to reduce the complexity, risk, and variability of&nbsp;the procedure. The delivery technology is expected to provide; a) the ability for clinicians to directly deliver therapeutics agents straight to a segment or spinal site (Precision Neurology), b) an alternative to intravenous delivery, c) a more precise approach; both in dosage and site access. The delivery technology is at the preclinical stage and has not yet been tested in the clinic.
In our view, Lineage has made significant progress in three verticals: i) clinical: compelling safety and efficacy data; ii) manufacturing: a new ready-to-inject formulation (10-20x increase in production scale and reduced impurities; iii) administration (new device agreement for OPC1 administration). We like the progress and think the management is taking all the right steps. We foresee value expansion upon clinical data update, device adoption progress, FDA meeting, and identification of a path forward in the next 12-18 months. We are reiterating our Outperform rating and $4 price target. 
&nbsp;

Lineage Cell Therapeutics, Inc. (LCTX)

OPC1 Investor and Analyst Day Overview

Fundamental Analysis:

Rating: Log in to view

Dropping Coverage (LCTX)

OpRegen Collaboration Advances As Pipeline Products Move Toward INDs (LCTX)

1Q22 Reported With Clinical Program Review (LCTX)

New Program Added To The Development Pipeline (LCTX)

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