Lineage Cell Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update
Lineage Cell Therapeutics (LCTX) has announced its financial and operational results for the fourth quarter and full year ended December 31, 2022. The company reported total revenues of approximately $1.9 million for Q4, a net increase of $0.7 million from Q4 2021. The full year revenues reached $14.7 million, up $10.4 million year-over-year. Operating expenses decreased to $36.5 million from $52.1 million in 2021, reflecting a significant reduction in R&D costs. The net loss attributable to Lineage was $26.3 million for the year, down from $43.0 million in 2021. The company continues advancing its clinical programs, notably the Phase 2a study of OpRegen in partnership with Roche.
- Total revenues increased to $14.7 million for 2022, driven by collaboration agreements.
- Operating expenses decreased to $36.5 million, primarily due to reduced R&D expenses.
- Net loss improved to $26.3 million for 2022, down from $43.0 million in 2021.
- Operating expenses still totaled $36.5 million, indicating high cost structure.
- G&A expenses rose to $22.5 million, primarily due to legal and compensation increases.
-
Phase 2a Clinical Study of RG6501 (OpRegen®) in Patients with GA Secondary to AMD Initiated by
Genentech , a Member of the Roche Group - Submitted RMAT and Pre-IND Materials to Support OPC1 and VAC2 Programs in Spinal Cord Injury and Oncology, Respectively
- Launched Two New Cell Therapy Programs for the Treatment of Hearing and Vision Loss
-
Established
New R &D Facility and Expanded Existing cGMP Manufacturing Facility
“2022 marked a year of clinical and regulatory execution for the Lineage team, as we worked alongside our partners and internally to advance our clinical and preclinical programs,” stated
“We also completed key regulatory activities for our OPC1 and VAC2 programs, which help provide insights into their continued development,”
Other significant milestones achieved in 2022 include:
-
RG6501 (OpRegen)
-
Continued execution under our collaboration with Roche and
Genentech across multiple functional areas, including support for ongoing Phase 2a clinical study in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). -
Long-term follow-up of patients from the Phase 1/2a clinical study of OpRegen:
-
Positive clinical data presented at 2022
Association for Research in Vision and Ophthalmology Annual Meeting.
-
Positive clinical data presented at 2022
-
Continued execution under our collaboration with Roche and
-
OPC1
- Completed verification and validation and preclinical testing activities for a novel parenchymal spinal delivery (PSD) system to support planned regulatory submissions.
-
Key data from OPC1, a Phase 1 clinical study in acute thoracic spinal cord injury and a Phase 1/2a clinical study in subacute cervical spinal cord injury, were published in the
Journal of Neurosurgery : Spine. - Preclinical testing of a new thaw and inject formulation of OPC1, manufactured via an improved and larger-scale process, demonstrated functional recovery, improvement in gait coordination and motor performance with a reduction of the area of cavitation.
-
Engagement with the
California Institute of Regenerative Medicine (CIRM), as well as various patient advocacy organizations and patient advocates continued.
-
VAC2
-
Pre-Investigational New Drug (IND) application briefing package submitted to the FDA to support
U.S. clinical development for immuno-oncology. -
Reported completion of enrollment in VAC2 Phase 1 non-small cell lung cancer (NSCLC) Study by
Cancer Research UK . -
Following technology transfer of the program from
Cancer Research UK to Lineage and improvement of manufacturing processes, production scale increased and accordingly the cost of goods was reduced significantly, along with marked improvements in the purity and functionality of the manufactured material.
-
Pre-Investigational New Drug (IND) application briefing package submitted to the FDA to support
-
Launched two new cell therapy programs for the treatment of hearing and vision loss.
- Process development and related activities were ongoing in support of planned preclinical testing.
-
Established new
U.S. R&D facility and expanded current GMP manufacturing facility inIsrael . - Strengthened intellectual property portfolio with Notice of Allowance for various patent applications including but not limited to covering oligodendrocyte progenitor cells.
-
Announced appointment of
Jill Howe as Chief Financial Officer.
Some of the events and milestones anticipated by Lineage in 2023 include:
-
Results from imaging analyses of structural changes in addition to visual data from a Phase 1/2a clinical study of RG6501 (OpRegen), to be presented at the 2023
Association for Research in Vision and Ophthalmology Annual Meeting. - Type B Meeting with FDA to discuss our proposed amendment to the Investigational New Drug Application (IND) for OPC1 to enable clinical testing of a novel spinal cord delivery system, anticipated in the second quarter.
-
Clinical data update from the ongoing VAC2 Phase 1 NSCLC study, pending release from
Cancer Research UK , anticipated in the second quarter. - Amendment of an IND for OPC1 to enable clinical testing of a novel spinal cord delivery system.
- Initiation of DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) clinical study of OPC1.
- Submission of an additional OPC1 manuscript describing magnetic resonance imaging (MRI) findings from the subacute studies in both thoracic and cervical spinal cord injury.
- Submission of a grant application to CIRM for the continued support of the clinical development of OPC1.
- Development update on hypo immune induced pluripotent stem cell (iPSC) lines for neurology indications, under collaboration with Eterna Therapeutics.
-
Updates from ongoing ANP1 preclinical testing at the
University of Michigan Kresge Hearing Research Institute under a collaboration with theUniversity of Michigan . - Evaluation of new partnership opportunities and/or expansion of existing collaborations.
- Continued participation in investor and partnering meetings and medical and industry conferences to broaden awareness of our mission, programs, and accomplishments.
Balance Sheet Highlights
Cash, cash equivalents, and marketable securities totaled
Fourth Quarter Operating Results
Revenues: Lineage’s revenue is generated primarily from licensing fees, collaboration revenues, royalties, 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, Net: Other income, net for the three months ended
Net Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended
Full Year Operating Results
Revenues: Lineage’s revenue is generated primarily from licensing fees, collaboration revenues, royalties, and research grants. Total revenues for the year ended
Operating Expenses: Operating expenses are comprised of R&D expenses and G&A expenses. Total operating expenses for the year ended
R&D Expenses: R&D expenses for the year ended
G&A Expenses: G&A expenses for the year ended
Loss from Operations: Loss from operations for the year ended
Other Income/(Expenses), Net: Other income (expenses), net for the year ended
Net Loss Attributable to Lineage: The net loss attributable to Lineage for the year ended
Conference Call and Webcast
Interested parties may access today’s conference call 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, including the potential that it will be informative and increase the probability of success in future larger, comparative trials; 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 timing of the anticipated submission of a grant application to CIRM, the initiation of clinical trials and the availability of clinical data updates related to our programs, plans and expectations regarding potential new partnership opportunities and existing collaborations, and our ability to broaden awareness of our mission, programs and accomplishments; the potential of our cell therapy platform and our ability to become a leading cell therapy company. 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 competing alternative therapies may adversely impact the commercial potential of OpRegen; that Roche and
CONSOLIDATED BALANCE SHEETS (IN THOUSANDS) |
||||||||
|
|
|
|
|
|
|
||
ASSETS |
|
|
|
|
|
|
|
|
CURRENT ASSETS |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
11,355 |
|
|
$ |
55,742 |
|
Marketable securities |
|
|
46,520 |
|
|
|
2,616 |
|
Accounts and grants receivable, net |
|
|
297 |
|
|
|
50,840 |
|
Prepaid expenses and other current assets |
|
|
1,828 |
|
|
|
2,351 |
|
Total current assets |
|
|
60,000 |
|
|
|
111,549 |
|
|
|
|
|
|
|
|
|
|
NONCURRENT ASSETS |
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
5,673 |
|
|
|
4,872 |
|
Deposits and other long-term assets |
|
|
627 |
|
|
|
630 |
|
|
|
|
10,672 |
|
|
|
10,672 |
|
Intangible assets, net |
|
|
46,692 |
|
|
|
46,822 |
|
TOTAL ASSETS |
|
$ |
123,664 |
|
|
$ |
174,545 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
CURRENT LIABILITIES |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
8,608 |
|
|
$ |
27,969 |
|
Lease liabilities, current portion |
|
|
916 |
|
|
|
801 |
|
Financing lease, current portion |
|
|
36 |
|
|
|
30 |
|
Deferred revenues |
|
|
9,421 |
|
|
|
18,119 |
|
Liability classified warrants, current portion |
|
|
- |
|
|
|
197 |
|
Total current liabilities |
|
|
18,981 |
|
|
|
47,116 |
|
|
|
|
|
|
|
|
|
|
LONG-TERM LIABILITIES |
|
|
|
|
|
|
|
|
Deferred tax liability |
|
|
2,076 |
|
|
|
2,076 |
|
Deferred revenues, net of current portion |
|
|
27,725 |
|
|
|
32,454 |
|
Lease liability, net of current portion |
|
|
2,860 |
|
|
|
1,941 |
|
Financing lease, net of current portion |
|
|
84 |
|
|
|
30 |
|
Other long-term liabilities |
|
|
2 |
|
|
|
30 |
|
TOTAL LIABILITIES |
|
|
51,728 |
|
|
|
83,647 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Preferred shares, no par value, authorized 2,000 shares; none issued and outstanding as of |
|
|
- |
|
|
|
- |
|
Common shares, no par value, authorized 250,000 shares; 170,093 and 169,477 shares issued and outstanding as of |
|
|
440,280 |
|
|
|
434,529 |
|
Accumulated other comprehensive loss |
|
|
(3,571 |
) |
|
|
(5,211 |
) |
Accumulated deficit |
|
|
(363,370 |
) |
|
|
(337,097 |
) |
|
|
|
73,339 |
|
|
|
92,221 |
|
Noncontrolling deficit |
|
|
(1,403 |
) |
|
|
(1,323 |
) |
Total shareholders’ equity |
|
|
71,936 |
|
|
|
90,898 |
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
$ |
123,664 |
|
|
$ |
174,545 |
|
CONSOLIDATED STATEMENTS OF OPERATIONS (IN THOUSANDS, EXCEPT PER SHARE DATA) |
||||||||
|
|
Year Ended |
|
|||||
|
|
2022 |
|
|
2021 |
|
||
REVENUES: |
|
|
|
|
|
|
|
|
Collaboration revenues |
|
$ |
13,367 |
|
|
$ |
1,120 |
|
Royalties |
|
|
1,336 |
|
|
|
2,776 |
|
Grant revenues |
|
|
- |
|
|
|
445 |
|
Total revenues |
|
|
14,703 |
|
|
|
4,341 |
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
728 |
|
|
1,426 |
||
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
13,975 |
|
|
|
2,915 |
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
Research and development |
|
|
13,987 |
|
|
|
33,914 |
|
General and administrative |
|
|
22,508 |
|
|
|
18,212 |
|
Total operating expenses |
|
|
36,495 |
|
|
|
52,126 |
|
Loss from operations |
|
|
(22,520 |
) |
|
|
(49,211 |
) |
|
|
|
|
|
|
|
|
|
OTHER INCOME (EXPENSES): |
|
|
|
|
|
|
|
|
Interest income, net |
|
|
829 |
|
|
|
2 |
|
Gain on sale of marketable securities |
|
|
- |
|
|
|
6,024 |
|
Unrealized loss on marketable equity securities |
|
|
(2,194 |
) |
|
|
(2,299 |
) |
Gain on extinguishment of debt |
|
|
- |
|
|
|
523 |
|
Gain on revaluation of warrant liability |
|
|
225 |
|
|
|
205 |
|
Other income (expense), net |
|
|
(2,152 |
) |
|
|
1,486 |
|
Total other income/(expense) |
|
|
(3,292 |
) |
|
|
5,941 |
|
LOSS BEFORE INCOME TAXES |
|
|
(25,812 |
) |
|
|
(43,270 |
) |
|
|
|
|
|
|
|
|
|
Income tax expense |
|
|
(541 |
) |
|
|
- |
|
NET LOSS |
|
|
(26,353 |
) |
|
|
(43,270 |
) |
|
|
|
|
|
|
|
|
|
Net loss attributable to noncontrolling interest |
|
|
80 |
|
|
|
251 |
|
|
|
|
|
|
|
|
|
|
NET LOSS ATTRIBUTABLE TO LINEAGE |
|
$ |
(26,273 |
) |
|
$ |
(43,019 |
) |
|
|
|
|
|
|
|
|
|
NET LOSS PER COMMON SHARE: |
|
|
|
|
|
|
|
|
BASIC AND DILUTED |
|
$ |
(0.15 |
) |
|
$ |
(0.26 |
) |
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: |
|
|
|
|
|
|
|
|
BASIC AND DILUTED |
|
|
169,792 |
|
|
|
164,502 |
|
CONSOLIDATED STATEMENTS OF CASH FLOWS (IN THOUSANDS) |
||||||||
|
|
Year Ended |
|
|||||
|
|
2022 |
|
|
2021 |
|
||
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net loss attributable to Lineage |
|
$ |
(26,273 |
) |
|
$ |
(43,019 |
) |
Net loss attributable to noncontrolling interest |
|
|
(80 |
) |
|
|
(251 |
) |
Adjustments to reconcile net loss attributable to Lineage to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Gain on sale of marketable equity securities |
|
|
- |
|
|
(6,024 |
) |
|
Unrealized loss on marketable equity securities |
|
|
2,194 |
|
|
|
2,299 |
|
Accretion of income on marketable debt securities |
|
|
(501 |
) |
|
|
- |
|
Depreciation expense, including amortization of leasehold improvements |
|
|
582 |
|
|
|
663 |
|
Change in right-of-use assets and liabilities |
|
|
(35 |
) |
|
|
14 |
|
Amortization of intangible assets |
|
|
145 |
|
|
|
210 |
|
Stock-based compensation |
|
|
4,287 |
|
|
|
3,519 |
|
Common stock issued for services |
|
|
- |
|
|
|
202 |
|
Gain on revaluation of warrant liability |
|
|
(225 |
) |
|
|
(205 |
) |
Foreign currency remeasurement and other loss/(gain) |
|
|
2,272 |
|
|
(1,566 |
) |
|
Loss/(gain) on sale of assets |
|
|
(11 |
) |
|
|
24 |
|
Gain on extinguishment of debt |
|
|
- |
|
|
(523 |
) |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts and grants receivable (Note 3) |
|
|
50,314 |
|
|
(857 |
) |
|
Prepaid expenses and other current assets |
|
|
446 |
|
|
(72 |
) |
|
Accounts payable and accrued liabilities |
|
|
(18,702 |
) |
|
|
21,645 |
|
Deferred revenue and other liabilities |
|
|
(13,354 |
) |
|
|
380 |
|
Net cash provided by (used in) operating activities |
|
|
1,059 |
|
|
(23,561 |
) |
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Purchases of marketable debt securities |
|
|
(53,412 |
) |
|
|
- |
|
Maturities of marketable debt securities |
|
|
7,666 |
|
|
|
- |
|
Purchases of property and equipment, net |
|
|
(413 |
) |
|
|
(340 |
) |
Proceeds from sale of OncoCyte common shares |
|
|
- |
|
|
|
10,064 |
|
Proceeds from the sale of HBL common shares |
|
|
- |
|
|
|
21 |
|
Net cash (used in) provided by investing activities |
|
|
(46,159 |
) |
|
|
9,745 |
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Proceeds from employee options exercised |
|
|
648 |
|
|
|
7,240 |
|
Common shares received and retired for employee taxes paid |
|
|
(17 |
) |
|
|
(54 |
) |
Proceeds from sale of common shares |
|
|
148 |
|
|
|
30,865 |
|
Proceeds from exercise of subsidiary warrants, net |
|
|
991 |
|
|
- |
||
Repayments of financing lease liabilities |
|
|
(32 |
) |
|
|
(20 |
) |
Payments for offering costs |
|
|
(106 |
) |
|
|
(1,101 |
) |
Net cash provided by financing activities |
|
|
1,632 |
|
|
|
36,930 |
|
Effect of exchange rate changes on cash, cash equivalents and restricted cash |
|
|
(873 |
) |
|
|
(20 |
) |
|
|
|
|
|
|
|
|
|
NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH |
|
|
(44,341 |
) |
|
|
23,094 |
|
At beginning of year |
|
|
56,277 |
|
|
|
33,183 |
|
At end of year |
|
$ |
11,936 |
|
|
$ |
56,277 |
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: |
|
|
|
|
|
|
|
|
Cash paid during year for interest |
|
$ |
13 |
|
|
$ |
13 |
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL SCHEDULE OF NON-CASH FINANCING AND INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Receivable from sale of common shares in at the market offering |
|
$ |
- |
|
|
$ |
147 |
|
Receivable from exercise of stock options |
|
$ |
32 |
|
|
$ |
189 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20230309005324/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:
FAQ
What were the fourth quarter earnings for Lineage (LCTX) in 2022?
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What progress was made in clinical studies for LCTX in 2022?