Press Releases
Lineage Cell Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Update
- Presented Positive New Data from Phase 1/2a Clinical Study of OpRegen in Dry AMD at 2020 ARVO Virtual Meeting
-
Announced Early Exercise of Option with
Cancer Research UK for Immuno-Oncology Cell Therapy Program - Initiated Process to Expand VAC Cell Therapy Platform to Develop Coronavirus Vaccine
- Maintained High Degree of Continuity of Global Operations During COVID-19 Pandemic
-
Converted Portion of OncoCyte Shares into Net Proceeds of Approximately
$3.7 Million
“Lineage has adapted quickly to an unprecedented business environment. We ensured the safety of our teams while maintaining the continuity of our global operations and advancing our programs with meaningful clinical data and contractual arrangements,” stated
2020 Plans and Objectives:
- Present new OpRegen data from the ongoing Phase 1/2a clinical trial as available throughout the year.
- Complete patient enrollment in the
- Meet with the
- Evaluate partnership opportunities for the OpRegen program and other development assets.
- Report VAC2 clinical data from the initial patients treated in the ongoing Phase 1 trial in NSCLC (non-small cell lung cancer) run by
- Enhance commercial utility of OPC1 program by introducing commercially enabling improvements to the manufacturing process in our GMP manufacturing facility.
- Continue engagement with the investment and medical communities with virtual participation at medical and healthcare industry conferences, ongoing throughout 2020.
- Strengthen existing partnerships with the
- Seek non-dilutive support for certain programs, as may be available, including for coronavirus vaccine development.
Balance Sheet and Cash Flow Highlights
Cash, cash equivalents, and marketable securities totaled
We have continued to fund our operations primarily by selling a portion of our marketable securities. On
In conjunction with the sale of AgeX shares to
Net cash used in operating activities for the three months ended
First 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 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
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 manufacturing plans, enrollment activities, data presentations, clinical trial advancement, proposed expansion of the VAC platform to address coronaviruses, expected net operational spend, 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 |
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(IN THOUSANDS) |
||||||||
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|
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ASSETS |
|
|
|
|
|
|
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CURRENT ASSETS |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
9,832 |
|
|
$ |
9,497 |
|
Marketable equity securities |
|
|
15,933 |
|
|
|
21,219 |
|
Promissory note from Juvenescence |
|
|
23,994 |
|
|
|
23,616 |
|
Trade accounts and grants receivable, net |
|
|
253 |
|
|
|
317 |
|
Receivables from affiliates, net |
|
|
47 |
|
|
|
7 |
|
Prepaid expenses and other current assets |
|
|
2,225 |
|
|
|
2,863 |
|
Total current assets |
|
|
52,284 |
|
|
|
57,519 |
|
|
|
|
|
|
|
|
|
|
NONCURRENT ASSETS |
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
7,539 |
|
|
|
8,175 |
|
Deposits and other long-term assets |
|
|
637 |
|
|
|
864 |
|
|
|
|
10,672 |
|
|
|
10,672 |
|
Intangible assets, net |
|
|
47,750 |
|
|
|
48,248 |
|
TOTAL ASSETS |
|
$ |
118,882 |
|
|
$ |
125,478 |
|
|
|
|
|
|
|
|
|
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LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
CURRENT LIABILITIES |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
5,321 |
|
|
$ |
5,226 |
|
Financing lease and right of use lease liabilities, current portion |
|
|
1,240 |
|
|
|
1,223 |
|
Deferred revenues |
|
|
200 |
|
|
|
- |
|
Deferred grant revenue |
|
|
208 |
|
|
|
45 |
|
Total current liabilities |
|
|
6,969 |
|
|
|
6,494 |
|
|
|
|
|
|
|
|
|
|
LONG-TERM LIABILITIES |
|
|
|
|
|
|
|
|
Deferred tax liability |
|
|
3,315 |
|
|
|
3,315 |
|
Deferred revenues |
|
|
- |
|
|
|
200 |
|
Right-of-use lease liability, net of current portion |
|
|
3,527 |
|
|
|
3,868 |
|
Financing lease, net of current portion |
|
|
66 |
|
|
|
77 |
|
Liability classified warrants, net of current portion, and other long-term liabilities |
|
|
247 |
|
|
|
277 |
|
TOTAL LIABILITIES |
|
|
14,124 |
|
|
|
14,231 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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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; 149,818 shares issued and outstanding as of |
|
|
387,686 |
|
|
|
387,062 |
|
Accumulated other comprehensive income (loss) |
|
|
634 |
|
|
(681) |
|
|
Accumulated deficit |
|
|
(281,821 |
) |
|
|
(273,422) |
|
|
|
|
106,499 |
|
|
|
112,959 |
|
Noncontrolling interest (deficit) |
|
|
(1,741 |
) |
|
|
(1,712 |
) |
Total shareholders’ equity |
|
|
104,758 |
|
|
|
111,247 |
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
$ |
118,882 |
|
|
$ |
125,478 |
|
|
||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
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(IN THOUSANDS, EXCEPT PER SHARE DATA) |
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(UNAUDITED) |
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|
|
Three Months Ended
|
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|||||
|
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2020 |
|
2019 |
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REVENUES: |
|
|
|
|
|
|
||
Grant revenue |
|
$ |
348 |
|
|
$ |
749 |
|
Royalties from product sales and license fees |
|
|
166 |
|
|
|
86 |
|
Sale of research products and services |
|
|
- |
|
|
|
93 |
|
Total revenues |
|
|
514 |
|
|
|
928 |
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
(94 |
) |
|
|
(68 |
) |
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
420 |
|
|
|
860 |
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
Research and development |
|
|
3,339 |
|
|
|
4,961 |
|
General and administrative |
|
|
4,519 |
|
|
|
8,660 |
|
Total operating expenses |
|
|
7,858 |
|
|
|
13,621 |
|
Loss from operations |
|
|
(7,438 |
) |
|
|
(12,761 |
) |
OTHER INCOME/(EXPENSES): |
|
|
|
|
|
|
|
|
Interest income, net |
|
|
405 |
|
|
|
442 |
|
Gain on sale of marketable equity securities |
|
|
1,258 |
|
|
|
- |
|
Unrealized (loss) gain on marketable equity securities |
|
|
(1,338 |
) |
|
|
1,931 |
|
Gain on equity method investment in OncoCyte at fair value |
|
|
- |
|
|
37,713 |
|
|
Gain on equity method investment in Asterias at fair value |
|
|
- |
|
|
|
6,744 |
|
Unrealized gain on warrant liability |
|
|
35 |
|
|
|
37 |
|
Other (expense) income, net |
|
|
(1,350 |
) |
|
|
806 |
|
Total other (expense) income, net |
|
|
(990 |
) |
|
|
47,673 |
|
(LOSS)/INCOME BEFORE INCOME TAXES |
|
|
(8,428 |
) |
|
|
34,912 |
|
|
|
|
|
|
|
|
|
|
Deferred income tax benefit |
|
|
- |
|
|
|
4,384 |
|
|
|
|
|
|
|
|
|
|
NET (LOSS)/INCOME |
|
|
(8,428 |
) |
|
|
39,296 |
|
|
|
|
|
|
|
|
|
|
Net loss attributable to noncontrolling interest |
|
|
29 |
|
|
|
14 |
|
|
|
|
|
|
|
|
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NET (LOSS)/INCOME ATTRIBUTABLE TO LINEAGE CELL THERAPEUTICS, INC. |
|
$ |
(8,399 |
) |
|
$ |
39,310 |
|
|
|
|
|
|
|
|
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NET (LOSS)/INCOME PER COMMON SHARE: |
|
|
|
|
|
|
|
|
BASIC |
|
$ |
(0.06 |
) |
|
$ |
0.30 |
|
DILUTED |
|
$ |
(0.06 |
) |
|
$ |
0.30 |
|
|
|
|
|
|
|
|
|
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WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: |
|
|
|
|
|
|
|
|
BASIC |
|
|
149,807 |
|
|
|
132,865 |
|
DILUTED |
|
|
149,807 |
|
|
|
132,869 |
|
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||||||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS |
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(IN THOUSANDS) |
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(UNAUDITED) |
||||||||
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Three Months Ended
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|||||
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|
2020 |
|
|
2019 |
|
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CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net (loss) income attributable to |
|
$ |
(8,399 |
) |
|
$ |
39,310 |
|
Net loss allocable to noncontrolling interest |
|
|
(29 |
) |
|
|
(14 |
) |
Adjustments to reconcile net (loss) income attributable to |
|
|
|
|
|
|
|
|
Unrealized gain on equity method investment in OncoCyte at fair value |
|
|
- |
|
|
|
(37,713 |
) |
Unrealized gain on equity method investment in Asterias at fair value |
|
|
- |
|
|
|
(6,744 |
) |
Gain on sale of marketable securities |
|
|
(1,258 |
) |
|
|
- |
|
Unrealized loss (gain) on marketable equity securities |
|
|
1,338 |
|
|
|
(1,931 |
) |
Deferred income tax benefit |
|
|
- |
|
|
|
(4,384 |
) |
Depreciation expense, including amortization of leasehold improvements |
|
|
212 |
|
|
|
269 |
|
Amortization of right-of-use asset |
|
|
9 |
|
|
|
14 |
|
Amortization of intangible assets |
|
|
498 |
|
|
|
485 |
|
Stock-based compensation |
|
|
626 |
|
|
|
1,440 |
|
Change in unrealized gain on warrant liability |
|
|
(35 |
) |
|
|
(37 |
) |
Foreign currency remeasurement and other (gain) loss |
|
|
1,424 |
|
|
|
(839 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts and grants receivable, net |
|
|
66 |
|
|
|
(614 |
) |
Accrued interest receivable |
|
|
(378 |
) |
|
|
(378 |
) |
Receivables from OncoCyte and AgeX, net of payables |
|
|
(40 |
) |
|
|
2,129 |
|
Prepaid expenses and other current assets |
|
|
911 |
|
|
|
(66 |
) |
Accounts payable and accrued liabilities |
|
|
(138 |
) |
|
|
(241 |
) |
Deferred revenue and other liabilities |
|
|
167 |
|
|
|
- |
|
Net cash used in operating activities |
|
|
(5,026 |
) |
|
|
(9,314 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Proceeds from the sale of OncoCyte common shares |
|
|
4,963 |
|
|
|
- |
|
Proceeds from the sale of AgeX common shares |
|
|
258 |
|
|
|
- |
|
Cash and cash equivalents acquired in the Asterias Merger |
|
|
- |
|
|
|
3,117 |
|
Purchase of equipment and other assets |
|
|
(10 |
) |
|
|
(169 |
) |
Security deposit paid and other |
|
|
45 |
|
|
|
(2 |
) |
Net cash provided by investing activities |
|
|
5,256 |
|
|
|
2,946 |
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Common shares received and retired for employee taxes paid |
|
|
(2 |
) |
|
|
(74 |
) |
Reimbursement from landlord on tenant improvements |
|
|
- |
|
|
|
738 |
|
Repayment of financing lease liabilities |
|
|
(8 |
) |
|
|
(6 |
) |
Repayment of principal portion of promissory notes |
|
|
- |
|
|
|
(52 |
) |
Net cash (used by) provided by financing activities |
|
|
(10 |
) |
|
|
606 |
|
Effect of exchange rate changes on cash, cash equivalents and restricted cash |
|
|
73 |
|
|
|
53 |
|
NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH |
|
|
293 |
|
|
|
(5,709 |
) |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH: |
|
|
|
|
|
|
|
|
At beginning of the period |
|
|
10,096 |
|
|
|
24,399 |
|
At end of the period |
|
$ |
10,389 |
|
|
$ |
18,690 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20200507005819/en/
(ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
(Gogawa@troutgroup.com)
(646) 378-2949
Source: