Press Releases
Lineage Reports Second Quarter 2021 Financial Results and Highlights Additional Progress From Clinical Cell Therapy Programs
- OpRegen® Continued to Demonstrate Functional and Anatomical Improvements in Patients with Dry AMD
- Three Cases of Retinal Tissue Restoration Reported; Longest of Which Has Lasted 3 Years
- Company Added to Russell 3000® and Russell Microcap® Indexes
-
License Agreement Announced with
Immunomic Therapeutics Inc. to Develop New DC-Based Therapeutic - New Chief Financial Officer Appointed
-
Cash and Marketable Securities of$68.7M Expected to Support Operations Well Into 2023
“Lineage continued to make significant operational and developmental progress during the second quarter, providing additional reports of clinically meaningful outcomes in patients with dry-AMD with geographic atrophy, advancing our OPC1 program for spinal cord injury, and reaching a paid milestone under our new VAC platform alliance,” stated
Some of the significant events and milestones achieved to date this year include:
- Reported a positive interim clinical update from the ongoing Phase 1/2a study of OpRegen for the treatment of dry-AMD with GA: 83% of all Cohort 4 patients exhibited stable or improved Best Corrected Visual Acuity at least 6 months post-treatment, while visual acuity declined in the majority of untreated eyes; notably, the first retinal restoration patient, with confirmed atrophy growth at baseline has had zero progression for almost three full years;
- Reported two additional cases of retinal tissue restoration in dry AMD patients treated with OpRegen; restoration has now been observed in three of four patients who received OpRegen RPE cells across a wide area of atrophy;
- Hosted a webinar with key therapeutic area experts to discuss the reported evidence of retinal tissue restoration findings in detail, including a review of anatomical improvements, functional activity, and additional results of treatment with OpRegen;
- Reported that the Company has been added to both the Russell 3000® as well as the Russell Microcap® Indexes;
- Reported that OPC1 will return to clinical testing; a Phase 1 clinical study will evaluate a novel delivery system in partnership with Neurgain Technologies and will include treatment of chronic spinal cord injury patients. The Phase 1 study is intended to validate the delivery system for use in a late-stage clinical study, expected to begin in 2022;
- Entered into a worldwide license agreement with
- Announced an exclusive option agreement with Amasa Therapeutics for the supply and use of clinical-grade HyStem® for the development and commercialization of therapies for local treatment of solid tumors; and
- Announced the appointment of
Some of the events and milestones to look forward to include:
- OpRegen Program
- Presentation of additional interim data from the Phase 1/2a study, anticipated during the third and fourth quarters of 2021;
-
Meeting with the
U.S. Food and Drug Administration (FDA) to discuss further clinical development, anticipated in the fourth quarter of 2021.
- OPC1 Program
- Evaluation of the Neurgain Parenchymal Spinal Delivery (PSD) system in preclinical and clinical testing;
- GMP production of OPC1 via an improved manufacturing process and release testing to support a late-stage clinical trial;
- FDA interaction to discuss manufacturing improvements, anticipated around the end of 2021 or early 2022.
- VAC Program
- Completion of enrollment in the ongoing VAC2 Phase 1 non-small cell lung cancer study;
- Reporting results from the ongoing VAC2 Phase 1 study;
- Evaluation of opportunities for new VAC product candidates based on internally identified or partnered tumor antigens.
- Continued evaluation of partnership opportunities and expansion of existing external collaborations and identification of new collaborations.
Balance Sheet Highlights
Cash, cash equivalents and marketable securities totaled
Lineage added to its cash position during the second quarter of 2021 with approximately
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 Income/(Expenses), 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,” “look forward 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 funding runway, data presentations, clinical trial advancement and the timing thereof, Lineage’s ability to achieve value-creating milestones, meetings and interactions with the FDA, evaluation of the Neurgain PSD system, manufacturing improvements, enrollment in the VAC2 Phase 1 study, announcement of clinical study results, payments under the license agreement with
CONDENSED CONSOLIDATED BALANCE SHEETS (IN THOUSANDS) |
||||||||
|
|
(Unaudited) |
|
|
||||
ASSETS |
|
|
|
|
|
|
||
CURRENT ASSETS |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
62,001 |
|
|
$ |
32,585 |
|
Marketable equity securities |
|
|
6,745 |
|
|
|
8,977 |
|
Trade accounts and grants receivable, net |
|
|
326 |
|
|
|
4 |
|
Prepaid expenses and other current assets |
|
|
2,505 |
|
|
|
2,433 |
|
Total current assets |
|
|
71,577 |
|
|
|
43,999 |
|
|
|
|
|
|
|
|
||
NONCURRENT ASSETS |
|
|
|
|
|
|
||
Property and equipment, net |
|
|
5,008 |
|
|
|
5,630 |
|
Deposits and other long-term assets |
|
|
610 |
|
|
|
616 |
|
|
|
|
10,672 |
|
|
|
10,672 |
|
Intangible assets, net |
|
|
46,887 |
|
|
|
47,032 |
|
TOTAL ASSETS |
|
$ |
134,754 |
|
|
$ |
107,949 |
|
|
|
|
|
|
|
|
||
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
||
CURRENT LIABILITIES |
|
|
|
|
|
|
||
Accounts payable and accrued liabilities |
|
$ |
5,348 |
|
|
$ |
6,813 |
|
Lease liabilities, current portion |
|
|
790 |
|
|
|
746 |
|
Financing lease, current portion |
|
|
17 |
|
|
|
16 |
|
Deferred revenues |
|
|
613 |
|
|
|
193 |
|
Liability classified warrants, current portion |
|
|
- |
|
|
|
1 |
|
Total current liabilities |
|
|
6,768 |
|
|
|
7,769 |
|
|
|
|
|
|
|
|
||
LONG-TERM LIABILITIES |
|
|
|
|
|
|
||
Deferred tax liability |
|
|
1,907 |
|
|
|
2,076 |
|
Lease liability, net of current portion |
|
|
2,078 |
|
|
|
2,514 |
|
Financing lease, net of current portion |
|
|
16 |
|
|
|
26 |
|
Liability classified warrants, net of current portion |
|
|
384 |
|
|
|
437 |
|
TOTAL LIABILITIES |
|
|
11,153 |
|
|
|
12,822 |
|
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
||
Preferred shares, no par value, 2,000 shares authorized; none issued and outstanding as of |
|
|
- |
|
|
|
- |
|
Common shares, no par value, 250,000 shares authorized; 167,037 and 153,096 shares issued and outstanding as of |
|
|
428,046 |
|
|
|
393,944 |
|
Accumulated other comprehensive loss |
|
|
(3,051 |
) |
|
|
(3,667 |
) |
Accumulated deficit |
|
|
(300,282 |
) |
|
|
(294,078 |
) |
|
|
|
124,713 |
|
|
|
96,199 |
|
Noncontrolling deficit |
|
|
(1,112 |
) |
|
|
(1,072 |
) |
Total shareholders’ equity |
|
|
123,601 |
|
|
|
95,127 |
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
$ |
134,754 |
|
|
$ |
107,949 |
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (IN THOUSANDS, EXCEPT PER SHARE DATA) (UNAUDITED) |
||||||||||||||||
|
|
|
|
|
||||||||||||
|
|
Three Months Ended
|
|
Six Months Ended
|
||||||||||||
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
||||||||
REVENUES: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Grant revenue |
|
$ |
71 |
|
|
$ |
287 |
|
|
$ |
169 |
|
|
$ |
635 |
|
Royalties from product sales and license fees |
|
|
228 |
|
|
|
99 |
|
|
|
521 |
|
|
|
265 |
|
Collaboration revenues |
|
|
213 |
|
|
|
- |
|
|
|
213 |
|
|
|
- |
|
Total revenues |
|
|
512 |
|
|
|
386 |
|
|
|
903 |
|
|
|
900 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of sales |
|
|
(125 |
) |
|
|
(75 |
) |
|
|
(237 |
) |
|
|
(169 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Gross profit |
|
|
387 |
|
|
|
311 |
|
|
|
666 |
|
|
|
731 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
2,931 |
|
|
|
2,805 |
|
|
|
6,325 |
|
|
|
6,144 |
|
General and administrative |
|
|
4,536 |
|
|
|
3,908 |
|
|
|
8,471 |
|
|
|
8,427 |
|
Total operating expenses |
|
|
7,467 |
|
|
|
6,713 |
|
|
|
14,796 |
|
|
|
14,571 |
|
Loss from operations |
|
|
(7,080 |
) |
|
|
(6,402 |
) |
|
|
(14,130 |
) |
|
|
(13,840 |
) |
OTHER INCOME/(EXPENSES): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income (expense), net |
|
|
(3 |
) |
|
|
380 |
|
|
|
(1 |
) |
|
|
785 |
|
Gain on sale of marketable securities |
|
|
- |
|
|
|
2,470 |
|
|
|
6,024 |
|
|
|
3,728 |
|
Unrealized gain (loss) on marketable equity securities |
|
|
590 |
|
|
|
(4,146 |
) |
|
|
1,830 |
|
|
|
(5,484 |
) |
Gain on extinguishment of debt |
|
|
523 |
|
|
|
- |
|
|
|
523 |
|
|
|
- |
|
Unrealized gain (loss) on warrant liability |
|
|
35 |
|
|
|
(6 |
) |
|
|
52 |
|
|
|
29 |
|
Other income (expense), net |
|
|
970 |
|
|
|
1,174 |
|
|
|
(711 |
) |
|
|
(176 |
) |
Total other income/(expense), net |
|
|
2,115 |
|
|
|
(128 |
) |
|
|
7,717 |
|
|
|
(1,118 |
) |
LOSS BEFORE INCOME TAXES |
|
|
(4,965 |
) |
|
|
(6,530 |
) |
|
|
(6,413 |
) |
|
|
(14,958 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Deferred income tax benefit |
|
|
169 |
|
|
|
- |
|
|
|
169 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
NET LOSS |
|
|
(4,796 |
) |
|
|
(6,530 |
) |
|
|
(6,244 |
) |
|
|
(14,958 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss attributable to noncontrolling interest |
|
|
8 |
|
|
|
8 |
|
|
|
40 |
|
|
|
37 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
NET LOSS ATTRIBUTABLE TO LINEAGE CELL THERAPEUTICS, INC. |
|
$ |
(4,788 |
) |
|
$ |
(6,522 |
) |
|
$ |
(6,204 |
) |
|
$ |
(14,921 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
NET LOSS PER COMMON SHARE: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
BASIC |
|
$ |
(0.03 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.10 |
) |
DILUTED |
|
$ |
(0.03 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.10 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
BASIC |
|
|
162,914 |
|
|
|
149,821 |
|
|
|
160,831 |
|
|
|
149,814 |
|
DILUTED |
|
|
162,914 |
|
|
|
149,821 |
|
|
|
160,831 |
|
|
|
149,814 |
|
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (IN THOUSANDS) (UNAUDITED) |
||||||||
|
|
|
||||||
|
|
Six Months Ended |
||||||
|
|
2021 |
|
2020 |
||||
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
||
Net loss attributable to |
|
$ |
(6,204 |
) |
|
$ |
(14,921 |
) |
Net loss allocable to noncontrolling interest |
|
|
(40 |
) |
|
|
(37 |
) |
Adjustments to reconcile net loss attributable to |
|
|
|
|
|
|
||
Gain on sale of marketable securities |
|
|
(6,024 |
) |
|
|
(3,728 |
) |
Unrealized (gain)/loss on marketable equity securities |
|
|
(1,830 |
) |
|
|
5,484 |
|
Gain on extinguishment of debt |
|
|
(523 |
) |
|
|
- |
|
Depreciation expense, including amortization of leasehold improvements |
|
|
338 |
|
|
|
423 |
|
Amortization of right-of-use asset |
|
|
20 |
|
|
|
18 |
|
Amortization of intangible assets |
|
|
145 |
|
|
|
831 |
|
Stock-based compensation |
|
|
1,458 |
|
|
|
1,232 |
|
Common stock issued for services |
|
|
202 |
|
|
|
- |
|
Change in unrealized gain on warrant liability |
|
|
(53 |
) |
|
|
(29 |
) |
Write-off of security deposit |
|
|
- |
|
|
|
150 |
|
Deferred tax benefit |
|
|
(169 |
) |
|
|
- |
|
Foreign currency remeasurement and other gain |
|
|
692 |
|
|
|
236 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
||
Accounts and grants receivable, net |
|
|
(353 |
) |
|
|
125 |
|
Accrued interest receivable |
|
|
- |
|
|
|
(756 |
) |
Prepaid expenses and other current assets |
|
|
34 |
|
|
|
1,442 |
|
Accounts payable and accrued liabilities |
|
|
(955 |
) |
|
|
214 |
|
Deferred revenue and other liabilities |
|
|
422 |
|
|
|
51 |
|
Net cash used in operating activities |
|
|
(12,840 |
) |
|
|
(9,265 |
) |
|
|
|
|
|
|
|
||
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
||
Proceeds from the sale of OncoCyte common shares |
|
|
10,064 |
|
|
|
10,941 |
|
Proceeds from the sale of AgeX common shares |
|
|
- |
|
|
|
985 |
|
Proceeds from the sale of Hadasit common shares |
|
|
21 |
|
|
|
- |
|
Purchase of equipment and other assets |
|
|
(140 |
) |
|
|
(16 |
) |
Proceeds from the sale of equipment and other assets |
|
|
14 |
|
|
|
- |
|
Other deposits |
|
|
- |
|
|
|
48 |
|
Net cash provided by investing activities |
|
|
9,959 |
|
|
|
11,958 |
|
|
|
|
|
|
|
|
||
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
||
Proceeds from employee options exercised |
|
|
5,348 |
|
|
|
- |
|
Common shares received and retired for employee taxes paid |
|
|
(27 |
) |
|
|
(13 |
) |
Repayment of financing lease liabilities |
|
|
- |
|
|
|
(17 |
) |
Proceeds from Paycheck Protection Program (“PPP”) Loan |
|
|
- |
|
|
|
523 |
|
Proceeds from sale of common shares |
|
|
27,813 |
|
|
|
- |
|
Payments for offering costs |
|
|
(877 |
) |
|
|
- |
|
Net cash provided by financing activities |
|
|
32,257 |
|
|
|
493 |
|
Effect of exchange rate changes on cash, cash equivalents and restricted cash |
|
|
(43 |
) |
|
|
(38 |
) |
NET INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH |
|
|
29,333 |
|
|
|
3,148 |
|
CASH, CASH EQUIVALENTS AND RESTRICTED CASH: |
|
|
|
|
|
|
||
At beginning of the period |
|
|
33,183 |
|
|
|
10,096 |
|
At end of the period |
|
$ |
62,516 |
|
|
$ |
13,244 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20210812005745/en/
(ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
(Gogawa@soleburytrout.com)
(646) 378-2949
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242
Source: