Lineage Cell Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update
Lineage Cell Therapeutics (LCTX) announced an exclusive worldwide collaboration with Roche and Genentech for the development of OpRegen, a retinal cell therapy, valued at up to $670 million. This partnership underscores the validation of Lineage's technology platform. In Q4 2021, total revenues increased to $1.2 million from $0.4 million in 2020, primarily from royalties and licensing fees. However, operating expenses surged to $29.2 million due to OpRegen-related costs, leading to a net loss of $29 million for the quarter. Lineage held $55.7 million in cash and equivalents as of December 31, 2021.
- Entered a collaboration with Roche and Genentech worth up to $670 million, indicating strong market validation.
- Reported retinal restoration in four patients treated with OpRegen, enhancing the product's credibility.
- Fourth quarter revenues increased to $1.2 million, reflecting growing licensing and royalty income.
- Operating expenses increased significantly to $29.2 million in Q4 2021, primarily due to OpRegen-related accruals.
- Net loss attributable to Lineage was $29 million, a considerable increase from the prior year's profit.
-
Established Exclusive Worldwide Collaboration and License Agreement with Roche and
Genentech for the Development and Commercialization of RG6501 (OpRegen®) in Transaction Worth up to$670 Million - Retinal Tissue Restoration and Visual Improvements Reported in Four Patients Treated with RG6501 (OpRegen) for Dry Age-Related Macular Degeneration
- Non-Clinical Testing Initiated to Support New Delivery Device for OPC1 Clinical Trials
- Worldwide License Agreement Secured for a Cancer Immunotherapy Product Candidate Based on the Lineage VAC Platform
-
Cash and Cash Equivalents of Approximately
as of$83 Million January 31, 2022
“2021 was a transformative year for Lineage, in part because we entered into a worldwide corporate partnership with Roche and
Some of the more significant milestones we achieved in 2021 include:
- Established an exclusive worldwide collaboration and license agreement with Roche and
- Reported a fourth case of retinal restoration with OpRegen; notably, four patients with dry AMD were observed to have areas of GA which diminished or remained unchanged relative to baseline for a period of at least 12 months;
- Announced a worldwide license agreement with
- Entered into an exclusive agreement with Neurgain Technologies to evaluate a novel delivery system for OPC1 to treat Spinal Cord Injury;
- Expanded our management team with the additions of Chief Financial Officer,
- Expanded our Board of Directors with the appointments of Drs.
Some of the events and milestones anticipated by Lineage in 2022 include:
- Announcement of a new pipeline program from our regenerative medicine cell therapy platform anticipated in March;
- Completion of GMP production of OPC1 via an improved and larger-scale manufacturing process and a new thaw-and-inject formulation; anticipated in Q1 2022;
- FDA interaction to discuss recent manufacturing improvements made to OPC1, anticipated in Q3 2022;
- Initiation of clinical performance and safety testing of the novel Parenchymal Spinal Delivery system device for OPC1, with an anticipated Investigational New Drug (“IND”) amendment submission in Q3 2022;
- Updates from the ongoing VAC2 Phase 1 non-small cell lung cancer study; anticipated in Q2 2022;
- An anticipated IND submission for VAC2 in 2H 2022;
- Continued development of a cell-based therapeutic for glioblastoma with our strategic partner,
- Evaluation of opportunities for new VAC product candidates based on internally identified or partnered tumor antigens; ongoing throughout 2022;
- Evaluation of partnership opportunities and expansion of existing collaborations; ongoing throughout 2022; and
- Continued participation in numerous investor and partnering meetings and medical and industry conferences to broaden the knowledge of our work.
Balance Sheet Highlights
Cash and cash equivalents totaled
Fourth Quarter Operating Results
Revenues: Lineage’s revenue is generated primarily from research grants, royalties, and licensing fees. 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 Income/(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 research grants, royalties, and licensing fees. 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, Net: Other income, 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 the conference call by dialing (866) 888-8633 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 collaboration and license agreement with Roche and
Tables to follow
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CONSOLIDATED BALANCE SHEETS |
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(IN THOUSANDS) |
||||||||
|
|
|
|
|
||||
ASSETS |
|
|
|
|
||||
CURRENT ASSETS |
|
|
|
|
||||
Cash and cash equivalents |
|
$ |
55,742 |
|
|
$ |
32,585 |
|
Marketable equity securities |
|
|
2,616 |
|
|
|
8,977 |
|
Trade accounts and grants receivable, net |
|
|
50,840 |
|
|
|
4 |
|
Prepaid expenses and other current assets |
|
|
2,351 |
|
|
|
2,433 |
|
Total current assets |
|
|
111,549 |
|
|
|
43,999 |
|
|
|
|
|
|
||||
NONCURRENT ASSETS |
|
|
|
|
||||
Property and equipment, net |
|
|
4,872 |
|
|
|
5,630 |
|
Deposits and other long-term assets |
|
|
630 |
|
|
|
616 |
|
|
|
|
10,672 |
|
|
|
10,672 |
|
Intangible assets, net |
|
|
46,822 |
|
|
|
47,032 |
|
TOTAL ASSETS |
|
$ |
174,545 |
|
|
$ |
107,949 |
|
|
|
|
|
|
||||
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
||||
CURRENT LIABILITIES |
|
|
|
|
||||
Accounts payable and accrued liabilities |
|
$ |
27,969 |
|
|
$ |
6,813 |
|
Lease liabilities, current portion |
|
|
801 |
|
|
|
746 |
|
Financing lease, current portion |
|
|
30 |
|
|
|
16 |
|
Deferred revenues |
|
|
18,119 |
|
|
|
193 |
|
Liability classified warrants, current portion |
|
|
197 |
|
|
|
1 |
|
Total current liabilities |
|
|
47,116 |
|
|
|
7,769 |
|
|
|
|
|
|
||||
LONG-TERM LIABILITIES |
|
|
|
|
||||
Deferred tax liability |
|
|
2,076 |
|
|
|
2,076 |
|
Deferred revenues, net of current portion |
|
|
32,454 |
|
|
|
- |
|
Lease liability, net of current portion |
|
|
1,941 |
|
|
|
2,514 |
|
Financing lease, net of current portion |
|
|
30 |
|
|
|
26 |
|
Liability classified warrants and other long-term liabilities |
|
|
30 |
|
|
|
437 |
|
TOTAL LIABILITIES |
|
|
83,647 |
|
|
|
12,822 |
|
|
|
|
|
|
||||
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
||||
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; 169,477 and 153,096 shares issued and outstanding as of |
|
|
434,529 |
|
|
|
393,944 |
|
Accumulated other comprehensive loss |
|
|
(5,211 |
) |
|
|
(3,667 |
) |
Accumulated deficit |
|
|
(337,097 |
) |
|
|
(294,078 |
) |
|
|
|
92,221 |
|
|
|
96,199 |
|
Noncontrolling (deficit) |
|
|
(1,323 |
) |
|
|
(1,072 |
) |
Total shareholders’ equity |
|
|
90,898 |
|
|
|
95,127 |
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
$ |
174,545 |
|
|
$ |
107,949 |
|
|
||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||
(IN THOUSANDS, EXCEPT PER SHARE DATA) |
||||||||
|
|
Year Ended |
||||||
|
|
2021 |
|
2020 |
||||
REVENUES: |
|
|
|
|
||||
Royalties |
|
$ |
2,776 |
|
|
$ |
773 |
|
Collaboration revenues |
|
|
1,120 |
|
|
|
- |
|
Grant revenues |
|
|
445 |
|
|
|
1,053 |
|
Total revenues |
|
|
4,341 |
|
|
|
1,826 |
|
|
|
|
|
|
||||
Cost of sales |
|
|
(1,426 |
) |
|
|
(385 |
) |
|
|
|
|
|
||||
Gross profit |
|
|
2,915 |
|
|
|
1,441 |
|
|
|
|
|
|
||||
OPERATING EXPENSES: |
|
|
|
|
||||
Research and development |
|
|
33,914 |
|
|
|
12,317 |
|
General and administrative |
|
|
18,212 |
|
|
|
15,571 |
|
Total operating expenses |
|
|
52,126 |
|
|
|
27,888 |
|
Loss from operations |
|
|
(49,211 |
) |
|
|
(26,447 |
) |
|
|
|
|
|
||||
OTHER INCOME, NET: |
|
|
|
|
||||
Interest income, net |
|
|
2 |
|
|
|
1,039 |
|
Gain on sale of marketable securities |
|
|
6,024 |
|
|
|
4,560 |
|
Unrealized loss on marketable equity securities |
|
|
(2,299 |
) |
|
|
(3,782 |
) |
Gain on extinguishment of debt |
|
|
523 |
|
|
|
- |
|
Unrealized gain (loss) on warrant liability |
|
|
205 |
|
|
|
(174 |
) |
Other income, net |
|
|
1,486 |
|
|
|
2,880 |
|
Total other income, net |
|
|
5,941 |
|
|
|
4,523 |
|
LOSS BEFORE INCOME TAXES |
|
|
(43,270 |
) |
|
|
(21,924 |
) |
|
|
|
|
|
||||
Income tax benefit |
|
|
- |
|
|
|
1,239 |
|
NET LOSS |
|
|
(43,270 |
) |
|
|
(20,685 |
) |
|
|
|
|
|
||||
Net loss attributable to noncontrolling interest |
|
|
251 |
|
|
|
36 |
|
|
|
|
|
|
||||
NET LOSS ATTRIBUTABLE TO LINEAGE |
|
$ |
(43,019 |
) |
|
$ |
(20,649 |
) |
|
|
|
|
|
||||
NET LOSS PER COMMON SHARE: |
|
|
|
|
||||
BASIC AND DILUTED |
|
$ |
(0.26 |
) |
|
$ |
(0.14 |
) |
|
|
|
|
|
||||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: |
|
|
|
|
||||
BASIC AND DILUTED |
|
|
164,502 |
|
|
|
150,044 |
|
|
||||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS |
||||||||
(IN THOUSANDS) |
||||||||
|
|
Year Ended |
||||||
|
|
2021 |
|
2020 |
||||
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
||||
Net loss attributable to Lineage |
|
$ |
(43,019 |
) |
|
$ |
(20,649 |
) |
Net loss attributable to noncontrolling interest |
|
|
(251 |
) |
|
|
(36 |
) |
Adjustments to reconcile net loss attributable to Lineage to net cash used in operating activities: |
|
|
|
|
||||
Gain on sale of marketable equity securities |
|
|
(6,024 |
) |
|
|
(4,560 |
) |
Unrealized loss on marketable equity securities |
|
|
2,299 |
|
|
|
3,782 |
|
Deferred tax benefit |
|
|
- |
|
|
|
(1,239 |
) |
Depreciation expense, including amortization of leasehold improvements |
|
|
663 |
|
|
|
823 |
|
Amortization of right-of-use assets |
|
|
14 |
|
|
|
72 |
|
Amortization of intangible assets |
|
|
210 |
|
|
|
1,216 |
|
Stock-based compensation |
|
|
3,519 |
|
|
|
2,227 |
|
Common stock issued for services |
|
|
202 |
|
|
|
119 |
|
Change in unrealized (gain) loss on warrant liability |
|
|
(205 |
) |
|
|
174 |
|
Write-off of security deposit |
|
|
- |
|
|
|
150 |
|
Amortization of deferred license fee |
|
|
- |
|
|
(200 |
) | |
Foreign currency remeasurement and other (gain) |
|
|
(1,566 |
) |
|
|
(2,957 |
) |
Loss (gain) on sale of assets |
|
|
24 |
|
|
|
(20 |
) |
Realized loss on warrant exercise |
|
|
- |
|
|
|
44 |
|
Gain on extinguishment of debt |
|
|
(523 |
) |
|
|
- |
|
Changes in operating assets and liabilities: |
|
|
|
|
||||
Accounts and grants receivable |
|
|
(857 |
) |
|
|
287 |
|
Accrued interest receivable |
|
|
- |
|
|
|
(1,008 |
) |
Receivables from affiliates, net of payables |
|
|
- |
|
|
|
7 |
|
Prepaid expenses and other current assets |
|
|
(72 |
) |
|
|
1,575 |
|
Accounts payable and accrued liabilities |
|
|
21,645 |
|
|
|
308 |
|
Deferred revenue and other liabilities |
|
|
380 |
|
|
|
132 |
|
Net cash used in operating activities |
|
|
(23,561 |
) |
|
|
(19,753 |
) |
|
|
|
|
|
||||
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
||||
Proceeds from sale of OncoCyte common shares |
|
|
10,064 |
|
|
|
10,941 |
|
Proceeds from the sale of AgeX common shares |
|
|
- |
|
|
|
1,290 |
|
Proceeds from the sale of HBL common shares |
|
|
21 |
|
|
|
830 |
|
Purchase of property and equipment |
|
|
(354 |
) |
|
|
(64 |
) |
Proceeds from sale of assets |
|
|
14 |
|
|
|
23 |
|
Security deposit paid and other |
|
|
- |
|
|
|
18 |
|
Net cash provided by investing activities |
|
|
9,745 |
|
|
|
13,038 |
|
|
|
|
|
|
||||
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
||||
Proceeds from employee options exercised |
|
|
7,240 |
|
|
|
- |
|
Proceeds from payment of Juvenescence promissory note |
|
|
- |
|
|
|
24,624 |
|
Common shares received and retired for employee taxes paid |
|
|
(54 |
) |
|
|
(27 |
) |
Proceeds from sale of common shares |
|
|
30,865 |
|
|
|
5,127 |
|
Payments for offering costs |
|
|
(1,101 |
) |
|
|
(356 |
) |
Repayment of financing lease liabilities |
|
|
(20 |
) |
|
|
(26 |
) |
Proceeds from Paycheck Protection Program (“PPP”) Loan |
|
|
- |
|
|
|
523 |
|
Net cash provided by financing activities |
|
|
36,930 |
|
|
|
29,865 |
|
Effect of exchange rate changes on cash, cash equivalents and restricted cash |
|
|
(20 |
) |
|
|
(63 |
) |
|
|
|
|
|
||||
NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH |
|
|
23,094 |
|
|
|
23,087 |
|
At beginning of year |
|
|
33,183 |
|
|
|
10,096 |
|
At end of year |
|
$ |
56,277 |
|
|
$ |
33,183 |
|
|
|
|
|
|
||||
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: |
|
|
|
|
||||
Cash paid during year for interest |
|
$ |
13 |
|
|
$ |
20 |
|
|
|
|
|
|
||||
SUPPLEMENTAL SCHEDULE OF NON-CASH FINANCING AND INVESTING ACTIVITIES: |
|
|
|
|
||||
Receivable from sale of common shares in at the market offering |
|
$ |
147 |
|
|
$ |
269 |
|
Receivable from exercise of stock options |
|
$ |
189 |
|
|
$ |
- |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20220310005347/en/
(ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
(Mbiega@soleburytrout.com)
(617) 221-9660
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242
Source:
FAQ
What is the significance of the collaboration between Lineage Cell Therapeutics and Roche?
How much revenue did Lineage report for Q4 2021?
What were the net losses for Lineage Cell Therapeutics in Q4 2021?