Press Releases
Lineage Cell Therapeutics Reports Third Quarter 2019 Financial Results and Provides Business Update
- New Data from Phase I/IIa Clinical Study of OpRegen® Presented at 2019 AAO Meeting; All Cohort 4 Patients Have Better Visual Acuity as of Last Visit
- Implemented Significant Additional Cost-Cutting Measures to Reduce Budget for 2020
- Received CE Mark Approval for Renevia®; Working to Identify European Commercial Partner
-
Conducted Sales of 6.25 Million Shares of
OncoCyte Corporation for$10.7 Million in Net Proceeds - Strengthened Extensive IP Portfolio with the Issuance of 3 New U.S. Patents
- Awarded Additional NIH Grant for Innovative Vision Restoration Program
“We are excited about our cell therapy programs and how they may benefit patients with serious medical conditions such as dry AMD, spinal cord injury, and cancer,” stated
“Additionally, we are looking forward to hosting two therapeutic area experts in ophthalmology and spinal cord injury at Solebury Trout’s KOL Event for analysts and investors in
Recent Significant Highlights
-
Provided an update of our Phase I/IIa clinical study of OpRegen in patients with dry age-related macular degeneration (dry AMD) with geographic atrophy at the 2019
American Academy of Ophthalmology Annual Meeting (AAO 2019) inSan Francisco, CA onOctober 14, 2019 . Data from the study demonstrated that treatment with OpRegen continued to be well tolerated and, at the furthest time point collected, all four Cohort 4 patients treated to date had better visual acuity on an Early Treatment Diabetic Retinopathy Scale (ETDRS) in the treated eye (range +8 to +19 letters) than in the untreated eye (range -2 to +7 letters). The largest increase recorded at any single timepoint in a Cohort 4 patient was +22 letters. Cohort 4 patients have better baseline vision and less advanced disease than Cohorts 1-3 patients, who were legally blind at baseline. Previously reported structural improvements in the retina and decreases in drusen density observed in some patients were maintained and there was evidence of the continued presence of transplanted OpRegen cells in patients treated in the first 3 cohorts, some over 3 years following administration. Of note, the first patient successfully dosed using the Orbit Subretinal Delivery System (Orbit SDS) as well as a new Thaw-and-Inject (TAI) formulation of OpRegen was also demonstrating signs of improved visual acuity, having gained 13 letters in the 3 months following administration as assessed by ETDRS. Overall, OpRegen appeared well tolerated with preliminary evidence of improved structural changes and potential improvement in visual acuity following treatment in some patients.
-
Announced that Renevia, the Company’s facial aesthetics product, has been granted a Conformité Européenne (CE) Mark. Renevia received a Class III classification with an intended use in adults as a resorbable matrix for the delivery of autologous adipose tissue preparations to restore and/or augment facial volume after subcutaneous fat volume loss for the treatment of facial lipoatrophy. The CE Mark provides Lineage, or its authorized agent, the authority to market and distribute Renevia throughout the
European Union (EU) and in other countries that recognize the CE Mark. The Company has engaged an EU-based business development agent to identify opportunities to partner this asset and has begun the process of engaging with commercially capable partners for Renevia.
-
Completed the launch of our new corporate brand and identity as well as a change in corporate name to
Lineage Cell Therapeutics, Inc. , reflecting our commitment to becoming an innovative, leading cell therapy company and highlighting our extensive cell therapy platform. In conjunction with the name change, the Company's ticker symbol was changed to "LCTX" onAugust 12, 2019 . The Company also relocated its corporate headquarters toCarlsbad, California , effectiveAugust 12, 2019 , a move which provides proximity to world-leading academic centers, public and private cell therapy peers, and offers more centralized decision-making, cost-savings, and access to an extensive network of experienced staff. The Company also terminated shared services withOncoCyte Corporation (OncoCyte , NYSE American: OCX) andAgeX Therapeutics, Inc. (AgeX, NYSE American: AGE) onSeptember 30, 2019 , an important step in our plan to simplify our business structure.
-
Converted approximately 43% of our investment in
OncoCyte into cash to support our operations with the sale of 6,250,000 shares ofOncoCyte common stock for net proceeds totaling$10.7 million . Lineage continues to own approximately 16% or 8.4 million shares of OncoCyte’s outstanding common stock. Based on the closing price of OncoCyte’s common stock onNovember 8, 2019 , the value of our remainingOncoCyte shares is approximately$14.1 million .
Near Term Milestones for 2019 and 2020
-
Complete patient enrollment in
the United States with the Orbit SDS in the ongoing Phase I/IIa clinical study of OpRegen for the treatment of dry AMD, expected in Q1 2020. -
Obtain VAC2 immunogenicity data from the initial patients in the ongoing Phase I study in NSCLC (non-small cell lung cancer) run by
Cancer Research UK , expected around year end. -
Present new OpRegen data from the ongoing Phase I/IIa clinical study at the
Association for Research in Vision and Ophthalmology Meeting (ARVO) inMay 2020 . - Advance the OPC1 manufacturing program by introducing enhancements to the manufacturing process in our GMP manufacturing facility, ongoing throughout 2020.
-
Meet with the
FDA to discuss the manufacturing and clinical development of OPC1, around the middle of 2020. -
Identify an external partner for commercialization of Renevia in
Europe , targeted for the first half of 2020. - Continue engagement with the investment and medical communities with participation at medical and healthcare industry conferences, ongoing throughout 2020.
-
Strengthen existing partnerships with the
National Institutes of Health , theIsrael Innovation Authority , theCalifornia Institute for Regenerative Medicine andCancer Research UK .
Balance Sheet Highlights
Cash, cash equivalents and marketable securities totaled
Lineage’s promissory note due from
In summary, as of
Lineage expects to spend approximately
Third Quarter Operating Results
Note regarding AgeX: On
Revenues: Lineage’s revenue is generated primarily from research grants, licensing fees and royalties. 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
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 cost-savings efforts, manufacturing plans, enrollment activities, data presentations, clinical study advancement, drug evaluation, and anticipated net operational spend for the fourth quarter of 2019 and full year 2020. 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
Tables to follow
LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (IN THOUSANDS) |
|||||||
September 30,
|
|
December 31,
|
|||||
ASSETS |
|
|
|
||||
CURRENT ASSETS |
|
|
|
||||
Cash and cash equivalents |
$ |
14,366 |
|
|
$ |
23,587 |
|
Marketable equity securities |
|
21,318 |
|
|
|
7,154 |
|
Promissory note from Juvenescence (Note 5) |
|
23,238 |
|
|
|
- |
|
Trade accounts and grants receivable, net |
|
157 |
|
|
|
767 |
|
Receivables from affiliates, net (Note 10) |
|
164 |
|
|
|
2,112 |
|
Prepaid expenses and other current assets |
|
2,342 |
|
|
|
2,738 |
|
Total current assets |
|
61,585 |
|
|
|
36,358 |
|
|
|
|
|
|
|
||
NONCURRENT ASSETS |
|
|
|
|
|
||
Property and equipment, net (Notes 7 & 15) |
|
8,844 |
|
|
|
5,835 |
|
Deposits and other long-term assets |
|
826 |
|
|
|
505 |
|
Promissory note from Juvenescence (Note 5) |
|
- |
|
|
|
22,104 |
|
Equity method investment in OncoCyte, at fair value (Note 4) |
|
- |
|
|
|
20,250 |
|
Equity method investment in Asterias, at fair value (Note 3) |
|
- |
|
|
|
13,483 |
|
Goodwill |
|
12,977 |
|
|
|
- |
|
Intangible assets, net |
|
48,746 |
|
|
|
3,125 |
|
TOTAL ASSETS |
$ |
132,978 |
|
|
$ |
101,660 |
|
|
|
|
|
|
|
||
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
|
||
CURRENT LIABILITIES |
|
|
|
|
|
||
Accounts payable and accrued liabilities |
$ |
4,842 |
|
|
$ |
6,463 |
|
Financing lease and right of use lease liabilities, current portion (Note 15) |
|
1,138 |
|
|
|
237 |
|
Promissory notes, current portion |
|
- |
|
|
|
70 |
|
Deferred grant revenue |
|
182 |
|
|
|
42 |
|
Total current liabilities |
|
6,162 |
|
|
|
6,812 |
|
|
|
|
|
|
|
||
LONG-TERM LIABILITIES |
|
|
|
|
|
||
Deferred tax liability |
|
6,343 |
|
|
|
- |
|
Deferred revenues, net of current portion |
|
240 |
|
|
|
- |
|
Deferred rent liabilities, net of current portion |
|
- |
|
|
|
244 |
|
Right-of-use lease liability, net of current portion (Note 15) |
|
4,087 |
|
|
|
1,854 |
|
Financing lease, net of current portion |
|
87 |
|
|
|
104 |
|
Liability classified warrants, net of current portion, and other long-term liabilities |
|
540 |
|
|
|
400 |
|
TOTAL LIABILITIES |
|
17,459 |
|
|
|
9,414 |
|
|
|
|
|
|
|
||
Commitments and contingencies (Note 15) |
|
|
|
|
|
||
|
|
|
|
|
|
||
SHAREHOLDERS’ EQUITY |
|
|
|
|
|
||
Preferred shares, no par value, authorized 2,000 shares; none issued and outstanding as of September 30, 2019 and December 31, 2018 |
|
- |
|
|
|
- |
|
Common shares, no par value, 250,000 shares authorized; 149,790 shares issued and outstanding as of September 30, 2019 and 127,136 shares issued and outstanding as of December 31, 2018 |
|
386,454 |
|
|
|
354,270 |
|
Accumulated other comprehensive income |
|
(357 |
) |
|
|
1,426 |
|
Accumulated deficit |
|
(268,940 |
) |
|
|
(261,856 |
) |
Lineage Cell Therapeutics, Inc. shareholders’ equity |
|
117,157 |
|
|
|
93,840 |
|
Noncontrolling interest (deficit) |
|
(1,638 |
) |
|
|
(1,594 |
) |
Total shareholders’ equity |
|
115,519 |
|
|
|
92,246 |
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
$ |
132,978 |
|
|
$ |
101,660 |
|
LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (IN THOUSANDS, EXCEPT PER SHARE DATA) (UNAUDITED) |
||||||||||||||||
|
Three Months Ended
|
|
Nine Months Ended
|
|||||||||||||
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
||||||||
REVENUES: |
|
|
|
|
|
|
|
|
|
|
||||||
Grant revenue |
$ |
350 |
|
$ |
718 |
|
$ |
1,628 |
|
$ |
2,985 |
|
||||
Royalties from product sales and license fees |
|
164 |
|
|
85 |
|
|
390 |
|
|
312 |
|
||||
Subscription and advertisement revenues |
|
- |
|
|
119 |
|
|
- |
|
|
691 |
|
||||
Sale of research products and services |
|
53 |
|
|
60 |
|
|
256 |
|
|
242 |
|
||||
Total revenues |
|
567 |
|
|
982 |
|
|
2,274 |
|
|
4,230 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of sales |
|
(114 |
) |
|
(35 |
) |
|
(289 |
) |
|
(250 |
) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Gross profit |
|
453 |
|
|
947 |
|
|
1,985 |
|
|
3,980 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
4,266 |
|
|
4,882 |
|
|
14,462 |
|
|
17,175 |
|
||||
Acquired in-process research and development |
|
- |
|
|
- |
|
|
- |
|
|
800 |
|
||||
General and administrative |
|
4,609 |
|
|
6,422 |
|
|
19,527 |
|
|
17,585 |
|
||||
Total operating expenses |
|
8,875 |
|
|
11,304 |
|
|
33,989 |
|
|
35,560 |
|
||||
Loss from operations |
|
(8,422 |
) |
|
(10,357 |
) |
|
(32,004 |
) |
|
(31,580 |
) |
||||
OTHER INCOME/(EXPENSES): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income, net |
|
399 |
|
|
174 |
|
|
1,278 |
|
|
278 |
|
||||
Gain on sale of marketable equity securities |
|
2,055 |
|
|
- |
|
|
2,055 |
|
|
- |
|
||||
Gain on sale of equity method investment in OncoCyte |
|
546 |
|
|
- |
|
|
546 |
|
|
- |
|
||||
Gain on sale of equity method investment in Ascendance |
|
- |
|
|
- |
|
|
- |
|
|
3,215 |
|
||||
Gain on sale of AgeX shares and deconsolidation of AgeX |
|
- |
|
|
78,511 |
|
|
- |
|
|
78,511 |
|
||||
Unrealized (loss) gain on marketable equity securities |
|
(4,458 |
) |
|
23 |
|
|
(3,134 |
) |
|
635 |
|
||||
Unrealized (loss) gain on equity method investment in OncoCyte at fair value |
(8,287 |
) |
(734 |
) |
8,001 |
(31,550 |
) |
|||||||||
Unrealized (loss) gain on equity method investment in Asterias at fair value |
|
- |
|
(1,087 |
) |
|
6,744 |
|
(20,660 |
) |
||||||
Unrealized gain on warrant liability |
|
79 |
|
|
21 |
|
|
350 |
|
|
372 |
|
||||
Other income (expense), net |
|
582 |
|
|
(7 |
) |
|
2,270 |
|
|
(1,021 |
) |
||||
Total other (expense) income, net |
|
(9,084 |
) |
|
76,901 |
|
|
18,110 |
|
|
29,780 |
|
||||
(LOSS)/INCOME BEFORE INCOME TAXES |
|
(17,506 |
) |
|
66,544 |
|
|
(13,894 |
) |
|
(1,800 |
) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Deferred income tax benefit |
|
991 |
|
|
- |
|
|
6,623 |
|
|
- |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
NET (LOSS)/INCOME |
|
(16,515 |
) |
|
66,544 |
|
|
(7,271 |
) |
|
(1,800 |
) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss attributable to noncontrolling interest |
|
10 |
|
|
181 |
|
|
44 |
|
|
762 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
NET (LOSS)/INCOME ATTRIBUTABLE TO LINEAGE CELL THERAPEUTICS, INC. |
$ |
(16,505 |
) |
$ |
66,725 |
|
$ |
(7,227 |
) |
$ |
(1,038 |
) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
NET (LOSS)/INCOME PER COMMON SHARE: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
BASIC |
$ |
(0.11 |
) |
$ |
0.53 |
|
$ |
(0.05 |
) |
$ |
(0.01 |
) |
||||
DILUTED |
$ |
(0.11 |
) |
$ |
0.53 |
|
$ |
(0.05 |
) |
$ |
(0.01 |
) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
BASIC |
|
149,659 |
|
|
126,878 |
|
|
144,097 |
|
|
126,872 |
|
||||
DILUTED |
|
149,659 |
|
|
126,973 |
|
|
144,097 |
|
|
126,872 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20191112006063/en/
Source:
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(510) 871-4188
Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@troutgroup.com)
(646) 378-2949