Press Releases
Lineage Cell Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update
- Completed Enrollment in Phase 1/2a Clinical Trial of OpRegen for the Treatment of Dry Age-Related Macular Degeneration
- Announced First Known Report of Human Retinal Tissue Restoration; Persisted to 23 Months with Improved Vision
- Made Significant Improvements to OPC1 Manufacturing, Including to Process, Purity, and Scale
-
Reacquired the VAC Immuno-Oncology Platform and Reported Initial Data in Ongoing Phase 1 Clinical Trial in Non-Small Cell
Lung Cancer -
Received
$24.6 Million Installment Payment fromJuvenescence Ltd. Related to Sale of AgeX Therapeutics - Current Cash Position Expected to Support Operations Well Into 2023
“Our goal is to build Lineage into the preeminent allogeneic cell transplant company, and we hit our stride in 2020, reaching significant clinical, manufacturing, and business milestones and creating substantial value for our shareholders. We also positioned ourselves for success in 2021 and beyond,” stated
Some of the significant milestones we achieved during 2020 include:
- Completion of enrollment in a 24 patient Phase 1/2a clinical study of OpRegen® for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA) with encouraging preliminary signs of tolerability and efficacy;
- Announcing the first known finding of retinal tissue restoration in a patient who received a retinal pigment epithelium (RPE) cell transplant which had persisted to 23 months with further improvements to visual acuity;
- Making major manufacturing improvements to our OPC1 acute spinal cord injury (SCI) program, including to the process, purity, and scale, and to the development of a “ready-to-inject” formulation, enabling use at a much larger number of treatment centers;
- The early exercise of our option with
- Reporting encouraging preliminary Phase 1 clinical study results with VAC2 for the treatment of non-small cell lung cancer with evidence of high levels of antigen-specific immunogenicity observed in all patients treated to date;
- Receiving a new research & development grant from the
- Announcing the extension of an OpRegen development grant from the
- Receiving a
- Successfully monetizing portions of Lineage’s non-core patent portfolio.
Some of the events and milestones that our shareholders can look forward to in 2021 include:
- Present new and accumulated OpRegen data from the ongoing Phase 1/2a clinical study on two occasions during the first and second quarters of 2021;
- Plan to meet with the FDA to discuss further clinical development of the OpRegen program, anticipated in the third quarter of 2021;
- Complete VAC2 patient enrollment in the ongoing Phase 1 clinical study for the treatment of non-small cell lung cancer, anticipated in the second quarter of 2021;
- Evaluate the Neurgain Parenchymal Spinal Delivery (PSD) system for OPC1, currently ongoing and throughout 2021;
- Plan to meet with the FDA to discuss plans to evaluate the Neurgain Parenchymal Spinal Delivery (PSD) system for OPC1, anticipated in the second quarter of 2021;
- Complete OPC1 process development to support a late-stage clinical trial, currently ongoing and throughout 2021;
- Introduce manufacturing enhancements to the VAC2 program, anticipated throughout 2021;
- Report results from the ongoing Phase 1 clinical study of VAC2 for the treatment of non-small cell lung cancer, anticipated in the fourth quarter of 2021;
- Plan to meet with the FDA to discuss further development of the OPC1 program and manufacturing improvements, including a late-stage clinical study, anticipated in the fourth quarter of 2021;
- Evaluate opportunities for new VAC product candidates based on newly discovered tumor antigens/neoantigens, throughout 2021; and
- Evaluate partnership opportunities and expansion of existing external collaborations and identification of new collaborations for OpRegen, OPC1 and VAC2, currently ongoing and throughout 2021.
Balance Sheet Highlights
Cash, cash equivalents, and marketable securities totaled
During 2020, we funded our operations primarily by receiving payment in full for a total of
Additionally, during 2020, we selectively sold 3,094,322 of our common shares under the ATM offering for gross proceeds of approximately
2021 fundraising activities
From
As of
The Company anticipates that net operational spend for 2021 will be approximately
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/(Expenses), Net: Other income/(expenses), net for the three months ended
Net Income/(Loss) attributable to Lineage: The net income 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
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 anticipated net operational spend for 2021, 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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CONSOLIDATED BALANCE SHEETS |
||||||||
(IN THOUSANDS) |
||||||||
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|
|
|
|
|
|||
ASSETS |
|
|
|
|
|
|
||
CURRENT ASSETS |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
32,585 |
|
|
$ |
9,497 |
|
Marketable equity securities |
|
|
8,977 |
|
|
|
21,219 |
|
Promissory note from Juvenescence |
|
|
- |
|
|
|
23,616 |
|
Trade accounts and grants receivable, net |
|
|
4 |
|
|
|
317 |
|
Receivables from affiliates, net |
|
|
- |
|
|
|
7 |
|
Prepaid expenses and other current assets |
|
|
2,433 |
|
|
|
2,863 |
|
Total current assets |
|
|
43,999 |
|
|
|
57,519 |
|
|
|
|
|
|
|
|
|
|
NONCURRENT ASSETS |
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
5,630 |
|
|
|
8,175 |
|
Deposits and other long-term assets |
|
|
616 |
|
|
|
864 |
|
|
|
|
10,672 |
|
|
|
10,672 |
|
Intangible assets, net |
|
|
47,032 |
|
|
|
48,248 |
|
TOTAL ASSETS |
|
$ |
107,949 |
|
|
$ |
125,478 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
CURRENT LIABILITIES |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
6,813 |
|
|
$ |
5,226 |
|
Financing lease and right-of-use liabilities, current portion |
|
|
762 |
|
|
|
1,223 |
|
Deferred revenues |
|
|
193 |
|
|
|
45 |
|
Liability classified warrants, current portion |
|
|
1 |
|
|
|
- |
|
Total current liabilities |
|
|
7,769 |
|
|
|
6,494 |
|
|
|
|
|
|
|
|
|
|
LONG-TERM LIABILITIES |
|
|
|
|
|
|
|
|
Deferred tax liability |
|
|
2,076 |
|
|
|
3,315 |
|
Deferred revenues, net of current portion |
|
|
- |
|
|
|
200 |
|
Right-of-use lease liability, net of current portion |
|
|
2,514 |
|
|
|
3,868 |
|
Financing lease, net of current portion |
|
|
26 |
|
|
|
77 |
|
Liability classified warrants and other long-term liabilities |
|
|
437 |
|
|
|
277 |
|
TOTAL LIABILITIES |
|
|
12,822 |
|
|
|
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, authorized 250,000 shares; 153,096 and 149,804 shares issued and outstanding as of |
|
|
393,944 |
|
|
|
387,062 |
|
Accumulated other comprehensive loss |
|
|
(3,667 |
) |
|
|
(681 |
) |
Accumulated deficit |
|
|
(294,078 |
) |
|
|
(273,422 |
) |
|
|
|
96,199 |
|
|
|
112,959 |
|
Noncontrolling interest (deficit) |
|
|
(1,072 |
) |
|
|
(1,712 |
) |
Total shareholders’ equity |
|
|
95,127 |
|
|
111,247 |
||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
$ |
107,949 |
|
|
$ |
125,478 |
|
|
||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||
(IN THOUSANDS, EXCEPT PER SHARE DATA) |
||||||||
|
|
Year Ended |
|
|||||
|
|
2020 |
|
|
2019 |
|
||
REVENUES: |
|
|
|
|
|
|
||
Grant revenue |
|
$ |
1,053 |
|
|
$ |
2,037 |
|
Royalties from product sales and license fees |
|
|
773 |
|
|
|
1,221 |
|
Sale of research products and services |
|
|
- |
|
|
|
257 |
|
Total revenues |
|
|
1,826 |
|
|
|
3,515 |
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
(385 |
) |
|
|
(412 |
) |
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
1,441 |
|
|
|
3,103 |
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
Research and development |
|
|
12,317 |
|
|
|
17,948 |
|
General and administrative |
|
|
15,571 |
|
|
|
24,031 |
|
Total operating expenses |
|
|
27,888 |
|
|
|
41,979 |
|
Loss from operations |
|
|
(26,447 |
) |
|
|
(38,876 |
) |
|
|
|
|
|
|
|
|
|
OTHER INCOME, NET: |
|
|
|
|
|
|
|
|
Interest income, net |
|
|
1,039 |
|
|
|
1,685 |
|
Gain on sale of marketable securities |
|
|
4,560 |
|
|
|
2,421 |
|
Gain on sale of equity method investment in OncoCyte |
|
|
- |
|
|
|
546 |
|
Unrealized loss on marketable equity securities |
|
|
(3,782 |
) |
|
|
(2,898 |
) |
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 |
|
Unrealized (loss) gain on warrant liability |
|
|
(174 |
) |
|
|
611 |
|
Other income, net |
|
|
2,880 |
|
|
|
2,532 |
|
Total other income, net |
|
|
4,523 |
|
|
|
19,642 |
|
LOSS BEFORE INCOME TAXES |
|
|
(21,924 |
) |
|
|
(19,234 |
) |
|
|
|
|
|
|
|
|
|
Income tax benefit |
|
|
1,239 |
|
|
|
7,407 |
|
NET LOSS |
|
|
(20,685 |
) |
|
|
(11,827 |
) |
|
|
|
|
|
|
|
|
|
Net loss attributable to noncontrolling interest |
|
|
36 |
|
|
|
118 |
|
|
|
|
|
|
|
|
|
|
NET LOSS ATTRIBUTABLE TO LINEAGE |
|
$ |
(20,649 |
) |
|
$ |
(11,709 |
) |
|
|
|
|
|
|
|
|
|
NET LOSS PER COMMON SHARE: |
|
|
|
|
|
|
|
|
BASIC AND DILUTED |
|
$ |
(0.14 |
) |
|
$ |
(0.08 |
) |
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: |
|
|
|
|
|
|
|
|
BASIC AND DILUTED |
|
|
150,044 |
|
|
|
145,533 |
|
|
||||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS |
||||||||
(IN THOUSANDS) |
||||||||
|
Year Ended |
|
||||||
|
|
2020 |
|
|
2019 |
|
||
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net loss attributable to Lineage |
|
$ |
(20,649 |
) |
|
$ |
(11,709 |
) |
Net loss attributable to noncontrolling interest |
|
|
(36 |
) |
|
|
(118 |
) |
Adjustments to reconcile net loss attributable to Lineage to net cash used in operating activities: |
|
|
|
|
|
|
|
|
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 equity securities |
|
|
(4,560 |
) |
|
|
(2,967 |
) |
Unrealized loss on marketable equity securities |
|
|
3,782 |
|
|
|
2,898 |
|
Income tax benefit |
|
|
(1,239 |
) |
|
|
(7,407 |
) |
Depreciation expense, including amortization of leasehold improvements |
|
|
823 |
|
|
|
1,002 |
|
Amortization of right-of-use assets |
|
|
72 |
|
|
|
129 |
|
Amortization of intangible assets |
|
|
1,216 |
|
|
|
1,998 |
|
Stock-based compensation |
|
|
2,227 |
|
|
|
3,580 |
|
Common stock issued for services |
|
|
119 |
|
|
|
- |
|
Change in unrealized loss (gain) on warrant liability |
|
|
174 |
|
|
(611 |
) |
|
Write-off of security deposit |
|
|
150 |
|
|
|
- |
|
Amortization of deferred license fee |
|
|
(200 |
) |
|
|
- |
|
Foreign currency remeasurement and other (gain) loss |
|
|
(2,957 |
) |
|
|
(2,367 |
) |
(Gain) loss on sale of assets |
|
|
(20 |
) |
|
|
273 |
|
Realized loss on warrant exercise |
|
|
44 |
|
|
|
- |
|
Dividend received |
|
|
- |
|
|
|
182 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts and grants receivable, net |
|
|
287 |
|
|
|
467 |
|
Accrued interest receivable |
|
|
(1,008 |
) |
|
|
(1,512 |
) |
Receivables from affiliates, net of payables |
|
|
7 |
|
|
|
2,105 |
|
Prepaid expenses and other current assets |
|
|
1,575 |
|
|
(260 |
) |
|
Accounts payable and accrued liabilities |
|
|
308 |
|
|
(2,885 |
) |
|
Deferred revenue and other liabilities |
|
|
132 |
|
|
|
- |
|
Net cash used in operating activities |
|
|
(19,753 |
) |
|
|
(31,947 |
) |
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Proceeds from sale of OncoCyte common shares |
|
|
10,941 |
|
|
|
10,738 |
|
Proceeds from the sale of AgeX common shares |
|
|
1,290 |
|
|
|
1,734 |
|
Proceeds from the sale of Hadasit common shares |
|
|
830 |
|
|
|
1,743 |
|
Cash and cash equivalents acquired in the Asterias Merger |
|
|
- |
|
|
|
3,117 |
|
Purchase of property and equipment |
|
|
(64 |
) |
|
|
(440 |
) |
Proceeds from sale of assets |
|
|
23 |
|
|
|
82 |
|
Security deposit paid and other |
|
|
18 |
|
|
(17 |
) |
|
Net cash provided by investing activities |
|
|
13,038 |
|
|
|
16,957 |
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Proceeds from payment of Juvenescence promissory note |
|
|
24,624 |
|
|
|
- |
|
Common shares received and retired for employee taxes paid |
|
|
(27 |
) |
|
|
(110 |
) |
Proceeds from sale of subsidiary warrants |
|
|
- |
|
|
(40 |
) |
|
Proceeds from sale of common shares |
|
|
5,127 |
|
|
|
103 |
|
Payments for offering costs |
|
|
(356 |
) |
|
|
- |
|
Repayment of financing lease liabilities |
|
|
(26 |
) |
|
|
(30 |
) |
Proceeds from Paycheck Protection Program (“PPP”) Loan (Note 8) |
|
|
523 |
|
|
|
- |
|
Reimbursement from landlord on tenant improvements |
|
|
- |
|
|
|
764 |
|
Repayment of principal portion of promissory notes |
|
|
- |
|
|
|
(70 |
) |
Net cash provided by financing activities |
|
|
29,865 |
|
|
|
617 |
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash, cash equivalents and restricted cash |
|
|
(63 |
) |
|
|
70 |
|
|
|
|
|
|
|
|
|
|
NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH |
|
|
23,087 |
|
|
(14,303 |
) |
|
At beginning of year |
|
|
10,096 |
|
|
|
24,399 |
|
At end of year |
|
$ |
33,183 |
|
|
$ |
10,096 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20210311005828/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: