Press Releases
Lineage Cell Therapeutics Reports First Quarter 2023 Financial Results and Provides Business Update
- Additional RG6501 (OpRegen®) Phase 1/2a Clinical Study Results Presented at ARVO 2023
-
Enrolling Phase 2a Clinical Study of RG6501 (OpRegen) in Patients with GA Secondary to AMD Under Management of
Genentech , a Member of the Roche Group - Awarded CIRM Grant to Support 1st Annual Spinal Cord Injury Investor Symposium
- Signed Option and License Agreement with Eterna Therapeutics to Develop Hypoimmune iPSC Lines
- Initiated Preclinical Testing of ANP1 for Treatment of Hearing Loss
“During the first quarter of this year, the Lineage team executed on multiple fronts, advancing our clinical and preclinical cell transplant programs while continuing support of our existing alliances and establishing new ones,” stated
Recent milestones and activities included:
- RG6501 (OpRegen)
-
Continued execution under our collaboration with Roche and
Genentech across multiple functional areas, including support for the ongoing Phase 2a multi-center clinical study in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD):- Additional sites expected to come online this year.
-
Long-term follow-up of patients from the Phase 1/2a clinical study of OpRegen:
-
Preliminary evidence of durable anatomical and functional improvements following administration of OpRegen cells was presented at 2023
Association for Research in Vision and Ophthalmology Annual Meeting and other medical and scientific meetings.
-
Preliminary evidence of durable anatomical and functional improvements following administration of OpRegen cells was presented at 2023
- Received CIRM grant to support 1st Annual Spinal Cord Injury Investor Symposium
-
California Institute for Regenerative Medicine (CIRM) awarded Lineage an educational grant with a total award value of$50,000 , recognizing this event as an important mission-specific conference, which will allow for the exchange of scientific information, create opportunities to accelerate the development of stem cell therapies to patients, increase the likelihood of successful treatments reaching patients, addresses an unmet clinical need, and can be impactful to CIRM’s overall mission.
- Strengthened OPC1 intellectual property portfolio
-
United States Patent and Trademark Office has granted a patent for the Company’s
U.S. patent application No. 16/750,975, nowU.S. Patent No. 11,603,518, entitled “Dorsally-Derived Oligodendrocyte Progenitor Cells From Human Pluripotent Stem Cells,” with claims covering proprietary manufacturing processes developed by Lineage for its oligodendrocyte progenitor cell therapy candidate (OPC1) for the treatment of spinal cord injury. The patent has a term that would expire no earlier than 2040.
- Executed option and license agreement with Eterna Therapeutics
- Enables development of novel beta 2 microglobulin (B2M)-deficient iPSC lines, which Lineage will evaluate for development into differentiated cell transplant therapies, specifically for the treatment of certain central nervous system disorders and other neurology indications.
- Initiated preclinical testing of ANP1
-
Preclinical testing underway through a collaboration with the
University of Michigan andYehoash Raphael , Ph.D., The R. Jamison andBetty Williams Professor of Otolaryngology,Department of Otolaryngology-Head and Neck Surgery and Lab Director at theUniversity of Michigan Kresge Hearing Research Institute .
Some of the events anticipated by Lineage include:
- Type B Meeting with FDA to discuss a proposed amendment to the Investigational New Drug Application (IND) for OPC1 to enable clinical testing of a novel spinal cord delivery system.
- Amendment of an IND for OPC1 to enable clinical testing of a novel spinal cord delivery system.
- Submission of an additional OPC1 manuscript describing magnetic resonance imaging (MRI) findings from the subacute studies in both thoracic and cervical spinal cord injury.
- Updates from ongoing ANP1 preclinical testing at the
Balance Sheet Highlights
Cash, cash equivalents, and marketable securities totaled
First Quarter Operating Results
Revenues: Lineage’s revenue is generated primarily from licensing fees, royalties, collaboration revenues, and research grants. Total revenues for the three months ended
Operating Expenses: Operating expenses are comprised of research and development (“R&D”) expenses and general and administrative (“G&A”) expenses. Total operating expenses for the three months ended
R&D Expenses: R&D expenses for the three months ended
G&A Expenses: G&A expenses for the three months ended
Loss from Operations: Loss from operations for the three months ended
Other Income/(Expenses), Net: Other income (expenses), net for the three months ended
Net Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended
Conference Call and Webcast
Interested parties may access today’s conference call and webcast, by dialing (800) 715-9871 from the
About
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 significance of the Phase 2a clinical study of OpRegen; that our cash, cash equivalents and marketable securities is sufficient to support our planned operations into the third quarter of 2024; the timing and nature of events and milestones anticipated to occur in 2023, including plans and expectations regarding publications and presentations related to our programs, the timing of anticipated regulatory submissions to the FDA related to our programs, the potential future achievements of our clinical, preclinical and development programs, the initiation of clinical trials and the availability of clinical data updates related to our programs; plans and expectations regarding existing collaborations, including our plans to develop new cell lines into differentiated cell transplant therapies and potential product candidates, and the potential indications thereof as a result of the Agreement with Eterna; our ability to broaden awareness of our mission, programs and accomplishments; and the potential of our cell therapy platform and our ability to provide an meaningful impact for patients. 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 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 competing alternative therapies may adversely impact the commercial potential of OpRegen; that Roche and
CONDENSED CONSOLIDATED BALANCE SHEETS (IN THOUSANDS) |
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|
|
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||
|
|
(Unaudited) |
|
|
2022 |
|
||
ASSETS |
|
|
|
|
|
|
|
|
CURRENT ASSETS |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
15,451 |
|
|
$ |
11,355 |
|
Marketable securities |
|
|
31,363 |
|
|
|
46,520 |
|
Accounts receivable, net |
|
|
203 |
|
|
|
297 |
|
Prepaid expenses and other current assets |
|
|
2,638 |
|
|
|
1,828 |
|
Total current assets |
|
|
49,655 |
|
|
|
60,000 |
|
|
|
|
|
|
|
|
|
|
NONCURRENT ASSETS |
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
5,584 |
|
|
|
5,673 |
|
Deposits and other long-term assets |
|
|
635 |
|
|
|
627 |
|
|
|
|
10,672 |
|
|
|
10,672 |
|
Intangible assets, net |
|
|
46,659 |
|
|
|
46,692 |
|
TOTAL ASSETS |
|
$ |
113,205 |
|
|
$ |
123,664 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
CURRENT LIABILITIES |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
5,252 |
|
|
$ |
8,608 |
|
Lease liabilities, current portion |
|
|
912 |
|
|
|
916 |
|
Financing lease, current portion |
|
|
51 |
|
|
|
36 |
|
Deferred revenues |
|
|
11,009 |
|
|
|
9,421 |
|
Other current liabilities |
|
|
1 |
|
|
|
- |
|
Total current liabilities |
|
|
17,225 |
|
|
|
18,981 |
|
|
|
|
|
|
|
|
|
|
LONG-TERM LIABILITIES |
|
|
|
|
|
|
|
|
Deferred tax liability |
|
|
273 |
|
|
|
2,076 |
|
Deferred revenues, net of current portion |
|
|
24,017 |
|
|
|
27,725 |
|
Lease liability, net of current portion |
|
|
2,542 |
|
|
|
2,860 |
|
Financing lease, net of current portion |
|
|
133 |
|
|
|
84 |
|
Other long-term liabilities |
|
|
- |
|
|
|
2 |
|
TOTAL LIABILITIES |
|
|
44,190 |
|
|
|
51,728 |
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
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SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Preferred shares, no par value, authorized 2,000 shares; none issued and outstanding as of |
|
|
- |
|
|
|
- |
|
Common shares, no par value, 250,000 shares authorized; 170,174 and 170,093 shares issued and outstanding as of |
|
|
441,299 |
|
|
|
440,280 |
|
Accumulated other comprehensive loss |
|
|
(3,107 |
) |
|
|
(3,571 |
) |
Accumulated deficit |
|
|
(367,742 |
) |
|
|
(363,370 |
) |
|
|
|
70,450 |
|
|
|
73,339 |
|
Noncontrolling deficit |
|
|
(1,435 |
) |
|
|
(1,403 |
) |
Total shareholders’ equity |
|
|
69,015 |
|
|
|
71,936 |
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
$ |
113,205 |
|
|
$ |
123,664 |
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (IN THOUSANDS, EXCEPT PER SHARE DATA) (UNAUDITED) |
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Three Months Ended
|
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|
2023 |
|
|
2022 |
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||
REVENUES: |
|
|
|
|
|
|
|
|
Collaboration revenues |
|
$ |
2,121 |
|
|
$ |
4,865 |
|
Royalties |
|
|
265 |
|
|
|
372 |
|
Total revenues |
|
|
2,386 |
|
|
|
5,237 |
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
(119 |
) |
|
|
(176 |
) |
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
2,267 |
|
|
|
5,061 |
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
Research and development |
|
|
4,185 |
|
|
|
2,988 |
|
General and administrative |
|
|
4,724 |
|
|
|
8,469 |
|
Total operating expenses |
|
|
8,909 |
|
|
|
11,457 |
|
Loss from operations |
|
|
(6,642 |
) |
|
|
(6,396 |
) |
OTHER INCOME (EXPENSES): |
|
|
|
|
|
|
|
|
Interest income, net |
|
|
410 |
|
|
|
1 |
|
Unrealized gain (loss) on marketable equity securities |
|
|
40 |
|
|
|
(735 |
) |
Gain on revaluation of warrant liability |
|
|
1 |
|
|
|
221 |
|
Other expenses, net |
|
|
(16 |
) |
|
|
(184 |
) |
Total other income (expenses), net |
|
|
435 |
|
|
|
(697 |
) |
LOSS BEFORE INCOME TAXES |
|
|
(6,207 |
) |
|
|
(7,093 |
) |
|
|
|
|
|
|
|
|
|
Deferred income tax benefit |
|
|
1,803 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
NET LOSS |
|
|
(4,404 |
) |
|
|
(7,093 |
) |
|
|
|
|
|
|
|
|
|
Net loss attributable to noncontrolling interest |
|
|
32 |
|
|
|
6 |
|
|
|
|
|
|
|
|
|
|
NET LOSS ATTRIBUTABLE TO LINEAGE CELL THERAPEUTICS, INC. |
|
$ |
(4,372 |
) |
|
$ |
(7,087 |
) |
|
|
|
|
|
|
|
|
|
NET LOSS PER COMMON SHARE: |
|
|
|
|
|
|
|
|
BASIC |
|
$ |
(0.03 |
) |
|
$ |
(0.04 |
) |
DILUTED |
|
$ |
(0.03 |
) |
|
$ |
(0.04 |
) |
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: |
|
|
|
|
|
|
|
|
BASIC |
|
|
170,127 |
|
|
|
169,647 |
|
DILUTED |
|
|
170,127 |
|
|
|
169,647 |
|
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (IN THOUSANDS) (UNAUDITED) |
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|||
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|
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|
|||
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|
Three Months Ended
|
|
|||||
|
|
2023 |
|
|
2022 |
|
||
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net loss attributable to |
|
$ |
(4,372 |
) |
|
$ |
(7,087 |
) |
Net loss attributable to noncontrolling interest |
|
|
(32 |
) |
|
|
(6 |
) |
Adjustments to reconcile net loss attributable to |
|
|
|
|
|
|
|
|
Accretion of income on marketable debt securities |
|
|
(326 |
) |
|
|
- |
|
Unrealized (gain)/loss on marketable equity securities |
|
|
(40 |
) |
|
|
735 |
|
Depreciation expense, including amortization of leasehold improvements |
|
|
138 |
|
|
|
150 |
|
Amortization of intangible assets |
|
|
33 |
|
|
|
28 |
|
Stock-based compensation |
|
|
1,031 |
|
|
|
1,106 |
|
Deferred income tax benefit |
|
|
(1,803 |
) |
|
|
- |
|
Gain on revaluation of warrant liability |
|
|
(1 |
) |
|
|
(221 |
) |
Foreign currency remeasurement |
|
|
466 |
|
|
|
75 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable, net |
|
|
95 |
|
|
50,321 |
||
Prepaid expenses and other current assets |
|
|
(847 |
) |
|
|
573 |
|
Accounts payable and accrued liabilities |
|
|
(3,463 |
) |
|
|
(18,905 |
) |
Deferred revenue and other liabilities |
|
|
(2,121 |
) |
|
|
(4,865 |
) |
Net cash (used in) provided by operating activities |
|
|
(11,242 |
) |
|
|
21,904 |
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Purchases of marketable debt securities |
|
|
(7,718 |
) |
|
|
- |
|
Maturities of marketable debt securities |
|
|
23,332 |
|
|
|
- |
|
Purchase of equipment and other assets, net |
|
|
(188 |
) |
|
|
(46 |
) |
Net cash provided by (used in) investing activities |
|
|
15,426 |
|
|
|
(46 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Proceeds from employee options exercised |
|
|
51 |
|
|
|
379 |
|
Common shares received and retired for employee taxes paid |
|
|
(37 |
) |
|
|
(8 |
) |
Proceeds from exercise of subsidiary warrants, net |
|
|
- |
|
|
|
2 |
|
Proceeds from sale of common shares |
|
|
- |
|
|
|
148 |
|
Repayment of financing lease liability |
|
|
(13 |
) |
|
|
(8 |
) |
Net cash provided by financing activities |
|
|
1 |
|
|
|
513 |
|
Effect of exchange rate changes on cash, cash equivalents and restricted cash |
|
|
(100 |
) |
|
|
(42 |
) |
NET INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH |
|
|
4,085 |
|
|
|
22,329 |
|
CASH, CASH EQUIVALENTS AND RESTRICTED CASH: |
|
|
|
|
|
|
|
|
At beginning of the period |
|
|
11,936 |
|
|
|
56,277 |
|
At end of the period |
|
$ |
16,021 |
|
|
$ |
78,606 |
|
SUPPLEMENTAL DISCLOSURES |
|
|
|
|
||||
Cash paid for interest |
$ |
2 |
$ |
5 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20230511005135/en/
(ir@lineagecell.com)
(442) 287-8963
(daniel@lifesciadvisors.com)
(617) 430-7576
(Nic.johnson@russopartnersllc.com)
(David.schull@russopartnersllc.com)
(212) 845-4242
Source: