Press Releases
Lineage Cell Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update
-
Reported Encouraging VAC2 Clinical Data in the Ongoing Phase 1 Trial in Non-Small Cell
Lung Cancer - Enrolled Additional Patients in Final Cohort of OpRegen Phase 1/2a Clinical Trial for the Treatment of Dry Age-Related Macular Degeneration (AMD)
-
Announced Extension of OpRegen Development Grant and New Grant for Development of a Bio-Retinal Patch from
Israel Innovation Authority
“Lineage moved all three of its clinical programs forward during the third quarter, particularly by reporting new data on VAC2 and by advancing closer to the completion of patient enrollment in the OpRegen trial,” said
Lineage has the following plans and objectives for the remainder of 2020 and early 2021:
- Present new and accumulated OpRegen data from the ongoing Phase 1/2a clinical trial at the AAO Annual 2020 Meeting in mid-November.
- Complete OpRegen patient enrollment in the
- Announce details of manufacturing improvements achieved with the OPC1 program by the end of 2020.
- Meet with the
- Complete VAC2 patient enrollment in the ongoing Phase 1 clinical trial for the treatment of non-small cell lung cancer by the end of the first quarter of 2021.
Balance Sheet and Cash Flow Highlights
Cash, cash equivalents, and marketable securities totaled
We continue to hold approximately 3.6 million shares of OncoCyte stock that are valued at
Net cash used in operating activities for the nine months ended
Third 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 (Expense) Income, Net: Other (expense)/income, 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
Lineage will host a conference call and webcast today, at
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,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “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 Lineage’s planned announcement of manufacturing improvements, expected enrollment in the Phase 1/2a clinical study of OpRegen and Phase 1 study of VAC2, data presentations, clinical trial advancement, planned meetings with the FDA and partnership evaluations. 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 risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the
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||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
||||||||
(IN THOUSANDS) |
||||||||
|
|
|
|
|
|
|
||
ASSETS |
|
|
|
|
|
|
||
CURRENT ASSETS |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
32,565 |
|
|
$ |
9,497 |
|
Marketable equity securities |
|
|
5,481 |
|
|
|
21,219 |
|
Promissory note from Juvenescence |
|
|
- |
|
|
|
23,616 |
|
Trade accounts and grants receivable, net |
|
|
276 |
|
|
|
317 |
|
Receivables from affiliates, net |
|
|
- |
|
|
|
7 |
|
Prepaid expenses and other current assets |
|
|
1,414 |
|
|
|
2,863 |
|
Total current assets |
|
|
39,736 |
|
|
|
57,519 |
|
|
|
|
|
|
|
|
|
|
NONCURRENT ASSETS |
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
4,849 |
|
|
|
8,175 |
|
Deposits and other long-term assets |
|
|
666 |
|
|
|
864 |
|
|
|
|
10,672 |
|
|
|
10,672 |
|
Intangible assets, net |
|
|
47,167 |
|
|
|
48,248 |
|
TOTAL ASSETS |
|
$ |
103,090 |
|
|
$ |
125,478 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
CURRENT LIABILITIES |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
7,214 |
|
|
$ |
5,226 |
|
Financing lease and right of use lease liabilities, current portion |
|
|
488 |
|
|
|
1,223 |
|
Deferred revenues |
|
|
46 |
|
|
|
45 |
|
Liability classified warrants, current portion |
|
|
3 |
|
|
|
- |
|
Total current liabilities |
|
|
7,751 |
|
|
|
6,494 |
|
|
|
|
|
|
|
|
|
|
LONG-TERM LIABILITIES |
|
|
|
|
|
|
|
|
Deferred tax liability |
|
|
3,137 |
|
|
|
3,315 |
|
Deferred revenues, net of current portion |
|
|
- |
|
|
|
200 |
|
Right-of-use lease liability, net of current portion |
|
|
1,800 |
|
|
|
3,868 |
|
Financing lease, net of current portion |
|
|
29 |
|
|
|
77 |
|
Liability classified warrants, net of current portion |
|
|
189 |
|
|
|
277 |
|
TOTAL LIABILITIES |
|
|
12,906 |
|
|
|
14,231 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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; 149,991 shares issued and outstanding as of |
|
|
388,190 |
|
|
|
387,062 |
|
Accumulated other comprehensive loss |
|
|
(821 |
) |
|
|
(681 |
) |
Accumulated deficit |
|
|
(296,103 |
) |
|
|
(273,422 |
) |
|
|
|
91,266 |
|
|
|
112,959 |
|
Noncontrolling deficit |
|
|
(1,082 |
) |
|
|
(1,712 |
) |
Total shareholders’ equity |
|
|
90,184 |
|
|
|
111,247 |
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
$ |
103,090 |
|
|
$ |
125,478 |
|
|
||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||||||||
(IN THOUSANDS, EXCEPT PER SHARE DATA) |
||||||||||||||||
(UNAUDITED) |
||||||||||||||||
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||||
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|||||||||
REVENUES: |
|
|
|
|
|
|
|
|
|
|
||||||
Grant revenue |
$ |
229 |
|
$ |
350 |
|
$ |
864 |
|
$ |
1,628 |
|
||||
Royalties from product sales and license fees |
|
342 |
|
|
164 |
|
|
607 |
|
|
390 |
|
||||
Sale of research products and services |
|
- |
|
|
53 |
|
|
- |
|
|
256 |
|
||||
Total revenues |
|
571 |
|
|
567 |
|
|
1,471 |
|
|
2,274 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of sales |
|
(102 |
) |
|
(114 |
) |
|
(271 |
) |
|
(289 |
) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Gross profit |
|
469 |
|
|
453 |
|
|
1,200 |
|
|
1,985 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
3,566 |
|
|
4,266 |
|
|
9,710 |
|
|
14,462 |
|
||||
General and administrative |
|
3,628 |
|
|
4,609 |
|
|
12,055 |
|
|
19,527 |
|
||||
Total operating expenses |
|
7,194 |
|
|
8,875 |
|
|
21,765 |
|
|
33,989 |
|
||||
Loss from operations |
|
(6,725 |
) |
|
(8,422 |
) |
|
(20,565 |
) |
|
(32,004 |
) |
||||
OTHER INCOME/(EXPENSES): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income, net |
|
252 |
|
|
399 |
|
|
1,037 |
|
|
1,278 |
|
||||
Gain on sale of marketable securities |
|
120 |
|
|
2,055 |
|
|
3,848 |
|
|
2,055 |
|
||||
Gain on sale of equity method in OncoCyte Corporation (“OncoCyte”) |
|
- |
|
|
546 |
|
|
- |
|
|
546 |
|
||||
Unrealized loss on marketable equity securities |
|
(2,003 |
) |
|
(4,458 |
) |
|
(7,487 |
) |
|
(3,134 |
) |
||||
Unrealized (loss)/gain on equity method investment in OncoCyte at fair value |
- |
(8,287 |
) |
|
- |
|
8,001 |
|
||||||||
Unrealized gain on equity method investment in Asterias at fair value |
- |
- |
- |
6,744 |
||||||||||||
Unrealized gain on warrant liability |
|
55 |
|
|
79 |
|
|
84 |
|
|
350 |
|
||||
Other income, net |
|
351 |
|
|
582 |
|
|
175 |
|
|
2,270 |
|
||||
Total other (expense) income, net |
|
(1,225 |
) |
|
(9,084 |
) |
|
(2,343 |
) |
|
18,110 |
|
||||
LOSS BEFORE INCOME TAXES |
|
(7,950 |
) |
|
(17,506 |
) |
|
(22,908 |
) |
|
(13,894 |
) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Income tax benefit |
|
178 |
|
|
991 |
|
|
178 |
|
|
6,623 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
NET LOSS |
|
(7,772 |
) |
|
(16,515 |
) |
|
(22,730 |
) |
|
(7,271 |
) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss attributable to noncontrolling interest |
|
12 |
|
|
10 |
|
|
49 |
|
|
44 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
NET LOSS ATTRIBUTABLE TO LINEAGE CELL THERAPEUTICS, INC. |
$ |
(7,760 |
) |
$ |
(16,505 |
) |
$ |
(22,681 |
) |
$ |
(7,227 |
) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
NET LOSS PER COMMON SHARE: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
BASIC |
$ |
(0.05 |
) |
$ |
(0.11 |
) |
$ |
(0.15 |
) |
$ |
(0.05 |
) |
||||
DILUTED |
$ |
(0.05 |
) |
$ |
(0.11 |
) |
$ |
(0.15 |
) |
$ |
(0.05 |
) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
BASIC |
|
149,973 |
|
|
149,659 |
|
|
149,868 |
|
|
144,097 |
|
||||
DILUTED |
|
149,973 |
|
|
149,659 |
|
|
149,868 |
|
|
144,097 |
|
|
||||||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS |
||||||||
(IN THOUSANDS) |
||||||||
(UNAUDITED) |
||||||||
|
|
Nine Months Ended
|
|
|||||
|
|
2020 |
|
|
2019 |
|
||
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net loss attributable to |
|
$ |
(22,681 |
) |
|
$ |
(7,227 |
) |
Net loss allocable to noncontrolling interest |
|
|
(49 |
) |
|
|
(44 |
) |
Adjustments to reconcile net loss attributable to |
|
|
|
|
|
|
|
|
Unrealized gain on equity method investment in OncoCyte at fair value |
|
|
- |
|
|
(8,001 |
) |
|
Unrealized gain on equity method investment in Asterias at fair value |
|
|
- |
|
|
(6,744 |
) |
|
Gain on sale of marketable securities |
|
|
(3,848 |
) |
|
|
(2,601 |
) |
Unrealized loss on marketable equity securities |
|
|
7,487 |
|
|
|
3,134 |
|
Income tax benefit |
|
|
(178 |
) |
|
|
(6,623 |
) |
Depreciation expense, including amortization of leasehold improvements |
|
|
623 |
|
|
|
766 |
|
Amortization of right-of-use asset |
|
|
47 |
|
|
|
59 |
|
Amortization of intangible assets |
|
|
1,080 |
|
|
|
1,500 |
|
Stock-based compensation |
|
|
1,733 |
|
|
|
2,961 |
|
Common stock issued for services |
|
|
59 |
|
|
|
- |
|
Gain on write-off and sales of assets |
|
|
(154 |
) |
|
|
- |
|
Change in unrealized gain on warrant liability |
|
|
(84 |
) |
|
|
(349 |
) |
Write-off of security deposit |
|
|
150 |
|
|
|
- |
|
Amortization of deferred license fee |
|
|
(200 |
) |
|
|
- |
|
Foreign currency remeasurement and other gain |
|
|
(116 |
) |
|
|
(1,911 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts and grants receivable, net |
|
|
44 |
|
|
|
634 |
|
Accrued interest receivable |
|
|
(1,008 |
) |
|
|
(1,134 |
) |
Receivables from OncoCyte and AgeX, net of payables |
|
|
7 |
|
|
|
1,948 |
|
Prepaid expenses and other current assets |
|
|
1,634 |
|
|
(136 |
) |
|
Accounts payable and accrued liabilities |
|
|
1,342 |
|
|
(2,788 |
) |
|
Deferred revenue and other liabilities |
|
|
- |
|
|
|
132 |
|
Net cash used in operating activities |
|
|
(14,112 |
) |
|
|
(26,424 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Proceeds from the sale of OncoCyte common shares |
|
|
10,941 |
|
|
|
10,738 |
|
Proceeds from the sale of AgeX common shares |
|
|
1,196 |
|
|
|
1,586 |
|
Proceeds from the sale of Hadasit common shares |
|
|
3 |
|
|
|
1,231 |
|
Cash and cash equivalents acquired in the Asterias Merger |
|
|
- |
|
|
|
3,117 |
|
Purchase of equipment and other assets |
|
|
(40 |
) |
|
|
(433 |
) |
Proceeds from sale of equipment |
|
|
18 |
|
|
|
- |
|
Security deposits and other |
|
|
18 |
|
|
(2 |
) |
|
Net cash provided by investing activities |
|
|
12,136 |
|
|
|
16,237 |
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Proceeds from payment of Juvenescence promissory note |
|
|
24,624 |
|
|
|
- |
|
Common shares received and retired for employee taxes paid |
|
|
(19 |
) |
|
|
(101 |
) |
Reimbursement from landlord on tenant improvements |
|
|
- |
|
|
|
750 |
|
Proceeds from sales of common shares |
|
|
- |
|
|
|
103 |
|
Payments for offering costs |
|
|
(53 |
) |
|
|
- |
|
Repayment of financing lease liabilities |
|
|
(24 |
) |
|
|
(20 |
) |
Proceeds from Paycheck Protection Program (“PPP”) Loan |
|
|
523 |
|
|
|
- |
|
Proceeds from sale of subsidiary warrants |
|
|
- |
|
|
|
(40 |
) |
Repayment of principal portion of promissory notes |
|
|
- |
|
|
(70 |
) |
|
Net cash provided by financing activities |
|
|
25,051 |
|
|
|
622 |
|
Effect of exchange rate changes on cash, cash equivalents and restricted cash |
|
|
(36 |
) |
|
|
128 |
|
NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH |
|
|
23,039 |
|
|
(9,437 |
) |
|
CASH, CASH EQUIVALENTS AND RESTRICTED CASH: |
|
|
|
|
|
|
|
|
At beginning of the period |
|
|
10,096 |
|
|
|
24,399 |
|
At end of the period |
|
$ |
33,135 |
|
|
$ |
14,962 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20201104005525/en/
(ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
(Gogawa@troutgroup.com)
(646) 378-2949
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242
Source: