Press Releases
Lineage Cell Therapeutics Reports Second Quarter 2020 Financial Results and Provides Update on All Clinical Programs
- Announced First Known Reported Finding of Retinal Tissue Restoration Following OpRegen RPE Cell Transplant
-
Exercised Option with
Cancer Research UK for VAC Immuno-Oncology Cell Therapy Program and Initiated Process to Expand VAC Platform to Develop Coronavirus Vaccine - Provided Positive Update with OPC1 Program: Manufacturing Improvements Implemented in Production Process; Patent Position Strengthened to Protect the Processes, Product, and Methods of Use
“Lineage has continued to make significant progress across our entire cell therapy pipeline, with positive milestones on each of our three programs announced this quarter,” stated
We also recently exercised an option with
Lastly, we have made significant progress developing and implementing manufacturing improvements for our OPC1 program to treat spinal cord injuries. We now are working to develop a “thaw-and-inject” formulation and are evaluating a superior delivery system to enable an easier and faster surgical procedure and facilitate enrollment in a late-stage clinical study.
Our aim is to provide safe and sustained benefits of targeted cell-based therapies, alongside commercially relevant solutions with competitive advantages in areas of scale-up, production costs, and delivery techniques. We believe our holistic approach to designing new therapeutic solutions will allow us to position ourselves as the clear leader in the emerging field of cell therapy transplant medicine.”
Lineage has the following plans and objectives for the second half of 2020:
- Meet with
- Report initial VAC2 clinical data from patients treated in the ongoing Phase 1 trial in NSCLC (non-small cell lung cancer) run by
- Complete patient enrollment in the
- Present new and accumulated OpRegen data from the ongoing Phase 1/2a clinical trial at the
- Meet with the
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. In the six months ended
In conjunction with the sale of AgeX shares to
Net cash used in operating activities for the six months ended
Second 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, financing plans, enrollment activities, data presentations, clinical trial advancement, proposed expansion of the VAC platform in immune-oncology and infectious diseases, 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
|
||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
||||||||
(IN THOUSANDS) |
||||||||
|
|
|
|
|
|
|
||
(Unaudited) |
|
|||||||
ASSETS |
|
|
|
|
|
|
||
CURRENT ASSETS |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
12,676 |
|
|
$ |
9,497 |
|
Marketable equity securities |
|
|
7,575 |
|
|
|
21,219 |
|
Promissory note from Juvenescence |
|
|
24,372 |
|
|
|
23,616 |
|
Trade accounts and grants receivable, net |
|
|
193 |
|
|
|
317 |
|
Receivables from affiliates, net |
|
|
7 |
|
|
|
7 |
|
Prepaid expenses and other current assets |
|
|
1,377 |
|
|
|
2,863 |
|
Total current assets |
|
|
46,200 |
|
|
|
57,519 |
|
|
|
|
|
|
|
|
|
|
NONCURRENT ASSETS |
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
7,142 |
|
|
|
8,175 |
|
Deposits and other long-term assets |
|
|
649 |
|
|
|
864 |
|
|
|
|
10,672 |
|
|
|
10,672 |
|
Intangible assets, net |
|
|
47,417 |
|
|
|
48,248 |
|
TOTAL ASSETS |
|
$ |
112,080 |
|
|
$ |
125,478 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
CURRENT LIABILITIES |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
5,948 |
|
|
$ |
5,226 |
|
Financing lease and right of use lease liabilities, current portion |
|
|
1,241 |
|
|
|
1,223 |
|
Deferred revenues, current portion |
|
|
297 |
|
|
|
45 |
|
Liability classified warrants, current portion |
|
|
33 |
|
|
|
- |
|
Total current liabilities |
|
|
7,519 |
|
|
|
6,494 |
|
|
|
|
|
|
|
|
|
|
LONG-TERM LIABILITIES |
|
|
|
|
|
|
|
|
Deferred tax liability |
|
|
3,315 |
|
|
|
3,315 |
|
Deferred revenues, net of current portion |
|
|
- |
|
|
|
200 |
|
Right-of-use lease liability, net of current portion |
|
|
3,276 |
|
|
|
3,868 |
|
Financing lease, net of current portion |
|
|
62 |
|
|
|
77 |
|
Liability classified warrants, net of current portion |
|
|
215 |
|
|
|
277 |
|
TOTAL LIABILITIES |
|
|
14,387 |
|
|
|
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; 149,831 shares issued and outstanding as of |
|
|
388,271 |
|
|
|
387,062 |
|
Accumulated other comprehensive loss |
|
|
(486 |
) |
|
|
(681) |
|
Accumulated deficit |
|
|
(288,343 |
) |
|
|
(273,422) |
|
|
|
|
99,442 |
|
|
|
112,959 |
|
Noncontrolling deficit |
|
|
(1,749 |
) |
|
|
(1,712 |
) |
Total shareholders’ equity |
|
|
97,693 |
|
|
|
111,247 |
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
$ |
112,080 |
|
|
$ |
125,478 |
|
|
|||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
|||||||||||||
(IN THOUSANDS, EXCEPT PER SHARE DATA) |
|||||||||||||
(UNAUDITED) |
|||||||||||||
|
|
Three Months Ended
|
|
Six Months Ended
|
|||||||||
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|||||
REVENUES: |
|
|
|
|
|
|
|
|
|
|
|||
Grant revenue |
$ |
287 |
|
$ |
529 |
|
$ |
635 |
|
$ |
1,278 |
|
|
Royalties from product sales and license fees |
|
99 |
|
|
140 |
|
|
265 |
|
|
226 |
|
|
Sale of research products and services |
|
- |
|
|
110 |
|
|
- |
|
|
203 |
|
|
Total revenues |
|
386 |
|
|
779 |
|
|
900 |
|
|
1,707 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
(75 |
) |
|
(107 |
) |
|
(169 |
) |
|
(175 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
311 |
|
|
672 |
|
|
731 |
|
|
1,532 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
2,805 |
|
|
5,235 |
|
|
6,144 |
|
|
10,196 |
|
|
General and administrative |
|
3,908 |
|
|
6,258 |
|
|
8,427 |
|
|
14,918 |
|
|
Total operating expenses |
|
6,713 |
|
|
11,493 |
|
|
14,571 |
|
|
25,114 |
|
|
Loss from operations |
|
(6,402 |
) |
|
(10,821 |
) |
|
(13,840 |
) |
|
(23,582 |
) |
|
OTHER INCOME/(EXPENSES): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
380 |
|
|
437 |
|
|
785 |
|
|
879 |
|
|
Gain on sale of marketable securities |
|
2,470 |
|
|
- |
|
|
3,728 |
|
|
- |
|
|
Unrealized (loss) gain on marketable equity securities |
|
(4,146 |
) |
|
(607) |
|
|
(5,484 |
) |
|
1,324 |
|
|
(Loss)/gain on equity method investment in OncoCyte at fair value |
- |
(21,425 |
) |
- |
16,288 |
|
|||||||
Gain on equity method investment in Asterias at fair value |
- |
- |
|
- |
6,744 |
||||||||
Unrealized (loss) gain on warrant liability |
|
(6 |
) |
|
234 |
|
|
29 |
|
|
271 |
|
|
Other income (expense), net |
|
1,174 |
|
|
882 |
|
|
(176 |
) |
|
1,688 |
|
|
Total other (expense) income, net |
|
(128 |
) |
|
(20,479) |
|
|
(1,118 |
) |
|
27,194 |
|
|
(LOSS)/INCOME BEFORE INCOME TAXES |
|
(6,530 |
) |
|
(31,300) |
|
|
(14,958 |
) |
|
3,612 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred income tax benefit |
|
- |
|
|
1,248 |
|
|
- |
|
|
5,632 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET (LOSS)/INCOME |
|
(6,530 |
) |
|
(30,052) |
|
|
(14,958 |
) |
|
9,244 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to noncontrolling interest |
|
8 |
|
|
20 |
|
|
37 |
|
|
34 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET (LOSS)/INCOME ATTRIBUTABLE TO LINEAGE CELL THERAPEUTICS, INC. |
$ |
(6,522 |
) |
$ |
(30,032) |
|
$ |
(14,921 |
) |
$ |
9,278 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET (LOSS)/INCOME PER COMMON SHARE: |
|
|
|
|
|
|
|
|
|
|
|
|
|
BASIC |
$ |
(0.04 |
) |
$ |
(0.20) |
|
$ |
(0.10 |
) |
$ |
0.07 |
|
|
DILUTED |
$ |
(0.04 |
) |
$ |
(0.20) |
|
$ |
(0.10 |
) |
$ |
0.07 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: |
|
|
|
|
|
|
|
|
|
|
|
|
|
BASIC |
|
149,821 |
|
|
149,582 |
|
|
149,814 |
|
|
141,270 |
|
|
DILUTED |
|
149,821 |
|
|
149,582 |
|
|
149,814 |
|
|
141,270 |
|
|
||||||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS |
||||||||
(IN THOUSANDS) |
||||||||
(UNAUDITED) |
||||||||
|
|
Six Months Ended
|
||||||
|
|
2020 |
|
|
2019 |
|||
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net (loss) income attributable to |
|
$ |
(14,921 |
) |
|
$ |
9,278 |
|
Net loss allocable to noncontrolling interest |
|
|
(37 |
) |
|
|
(34 |
) |
Adjustments to reconcile net (loss) income attributable to |
|
|
|
|
|
|
|
|
Unrealized gain on equity method investment in OncoCyte at fair value |
|
|
- |
|
|
(16,288 |
) |
|
Unrealized gain on equity method investment in Asterias at fair value |
|
|
- |
|
|
(6,744 |
) |
|
Gain on sale of marketable securities |
|
|
(3,728 |
) |
|
|
- |
|
Unrealized (gain) loss on marketable equity securities |
|
|
5,484 |
|
|
|
(1,324 |
) |
Deferred income tax benefit |
|
|
- |
|
|
(5,632 |
) |
|
Depreciation expense, including amortization of leasehold improvements |
|
|
423 |
|
|
|
513 |
|
Amortization of right-of-use asset |
|
|
18 |
|
|
|
27 |
|
Amortization of intangible assets |
|
|
831 |
|
|
|
992 |
|
Stock-based compensation |
|
|
1,232 |
|
|
|
2,202 |
|
Change in unrealized loss on warrant liability |
|
|
(29 |
) |
|
|
(271 |
) |
Write-off of security deposit |
|
|
150 |
|
|
|
- |
|
Foreign currency remeasurement and other (gain) loss |
|
|
236 |
|
|
(1,461 |
) |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts and grants receivable, net |
|
|
125 |
|
|
|
(863 |
) |
Accrued interest receivable |
|
|
(756 |
) |
|
|
(756 |
) |
Receivables from OncoCyte and AgeX, net of payables |
|
|
- |
|
|
|
2,185 |
|
Prepaid expenses and other current assets |
|
|
1,442 |
|
|
(1 |
) |
|
Accounts payable and accrued liabilities |
|
|
214 |
|
|
(804 |
) |
|
Deferred revenue and other liabilities |
|
|
51 |
|
|
|
- |
|
Net cash used in operating activities |
|
|
(9,265 |
) |
|
|
(18,981 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Proceeds from the sale of OncoCyte common shares |
|
|
10,941 |
|
|
|
- |
|
Proceeds from the sale of AgeX common shares |
|
|
985 |
|
|
|
- |
|
Cash and cash equivalents acquired in the Asterias Merger |
|
|
- |
|
|
|
3,117 |
|
Purchase of equipment and other assets |
|
|
(16 |
) |
|
|
(364 |
) |
Security deposit paid and other |
|
|
48 |
|
|
(1 |
) |
|
Net cash provided by investing activities |
|
|
11,958 |
|
|
|
2,752 |
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Common shares received and retired for employee taxes paid |
|
|
(13 |
) |
|
|
(77 |
) |
Reimbursement from landlord on tenant improvements |
|
|
- |
|
|
|
744 |
|
Repayment of financing lease liabilities |
|
|
(17 |
) |
|
|
(14 |
) |
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 |
|
|
493 |
|
|
|
543 |
|
Effect of exchange rate changes on cash, cash equivalents and restricted cash |
|
|
(38 |
) |
|
|
83 |
|
NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH |
|
|
3,148 |
|
|
(15,603 |
) |
|
CASH, CASH EQUIVALENTS AND RESTRICTED CASH: |
|
|
|
|
|
|
|
|
At beginning of the period |
|
|
10,096 |
|
|
|
24,399 |
|
At end of the period |
|
$ |
13,244 |
|
|
$ |
8,796 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20200806005799/en/
(ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
(Gogawa@troutgroup.com)
(646) 378-2949
Source: