Press Releases
Lineage Cell Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Business Update
- Reported Positive Data from Phase 1/2a Clinical Trial of OpRegen®; All Cohort 4 Patients Have Improved Visual Acuity at Twelve Months or as of Last Visit (Gained Between 8-25 Readable Letters)
- Entered into Agreements with Three Companies for Certain IP and Assets
- Provided Positive Clinical Update from SCiStar Trial of OPC1 for Spinal Cord Injury
-
Strengthened Extensive IP Portfolio with the Issuance of 3 New
U.S. Patents -
Awarded
$3.2 Million in Grants fromIsrael Innovation Authority andNIH -
Extended Anticipated Cash Runway by
Implementing Cost Savings Initiatives and Converting Securities into Cash Positions
“2019 was a transformative year for Lineage. We established Lineage as a leading cell therapy company with the goal to usher in a new branch of medicine based on transplanting intact cells into the body to restore activity lost to aging, injury, or disease,” stated
Significant events and data updates from 2019 and early 2020 include:
-
Successfully dosed two patients in our OpRegen Phase 1/2a clinical trial for the treatment of dry age-related macular degeneration (AMD) with a new thaw-and-inject formulation and a new delivery device, the 510(k)-cleared Subretinal Delivery System (SDS) developed by Gyroscope Therapeutics (Gyroscope). The Gyroscope SDS is designed to precisely and consistently deliver therapeutics to the sub-retinal space via a suprachoroidal route, avoiding: (i) the need for a vitrectomy; (ii) perforation of the retina (retinotomy); and (iii) loss of cells and adverse safety events due to efflux. We have to date reported on two patients dosed with the combination of the new device and formulation. The first patient demonstrated notable improvements in vision, having gained 25 readable letters (or 5 lines) 6 months following administration, as assessed by the Early Treatment Diabetic Retinopathy Scale (ETDRS). This represented an improvement in visual acuity from a baseline of 20/250 to 20/100 in the treated eye. The second patient showed a small improvement in visual acuity in the treated eye at just 14 days following treatment. Both patients had rapid healing at the surgical site with no unexpected complications or any serious adverse events. Improvements for patients in the trial have typically become most evident approximately three to six months after treatment. Treatment for all patients in the trial continues to be well tolerated and all five patients in Cohort 4 (who have better baseline vision and less advanced disease than Cohorts 1-3 patients) registered improvement according to the ETDRS eye chart assessment. Improvements ranged from 8 to 25 additional letters correctly identified for all patients with at least 6 months of follow-up as of
December 31, 2019 . We expect to dose a total of six patients with the Gyroscope SDS under our current agreement with Gyroscope. -
Acquired
Asterias Biotherapeutics, Inc. inMarch 2019 . As a result of this acquisition, we acquired two additional cell therapy product candidates, OPC1 and VAC2, along with their associated expansion opportunities and other assets. As we integrated the two companies, we reduced costs by about 50% by eliminating duplicate costs and rationalizing non-key projects. -
Rebranded as
Lineage Cell Therapeutics and relocated the corporate headquarters from theSan Francisco Bay Area toCarlsbad, California . We also hired experienced biotech professionals to fill critical management positions, including the Chief Financial Officer, General Counsel and Vice President, Business Development. -
Entered into agreements with three separate companies, with each agreement relating to different parts of Lineage’s intellectual property portfolio. All three companies have ongoing commercial operations in areas related to cell therapy. The aggregate up-front cash payment from the three transactions was greater than
one million dollars with additional cash and royalties due upon reaching certain development milestones or product sales. - Reported a positive clinical update from our ongoing Phase 1/2a clinical trial of OPC1 known as SCiStar for the treatment of acute spinal cord injury (SCI). The overall safety profile of OPC1 remained excellent with robust motor recovery in the arms/hands maintained through year 2 follow-ups to date. Gains in motor function for patients assessed to date continued, representing tremendously meaningful improvements to quality of life and independence.
-
Awarded
$3.2 million in grants from theIsrael Innovation Authority and theNational Institutes of Health and published or presented multiple papers and abstracts describing our work. - Obtained patents associated with the manufacture of our unique cell types, adding additional protections to all three of our clinical programs. Also obtained patent rights describing the use of induced pluripotent stem cells, an alternate option for generating differentiated cells for transplant and treatment of diseases, further broadening the potential application of our work.
-
Granted a Conformité Européenne (CE) Mark for Renevia®, the Company’s facial aesthetics product, with an intended use in adults for the treatment of facial lipoatrophy. The CE Mark enables us to sell Renevia in
Europe and we are actively pursuing a commercialization partner for this activity. -
Announced that after reviewing promising preliminary data from the ongoing OpRegen Phase 1/2a clinical trial, our independent data safety monitoring board removed the protocol-mandated treatment stagger. Accordingly, we are opening two new
U.S. clinical sites to accelerate patient enrollment and broaden surgical experience among dry AMD experts.
Potential key events for 2020:
-
Complete patient enrollment in the
U.S. with the Gyroscope SDS in the ongoing Phase 1/2a clinical trial of OpRegen for the treatment of dry AMD. -
Present new OpRegen data from the ongoing Phase 1/2a clinical trial in
May 2020 and as available throughout the year. -
Meet with the
U.S. Food and Drug Administration (FDA) to discuss the further clinical development of OpRegen. - Evaluate partnership opportunities for the OpRegen program.
- Enhance commercial utility of OPC1 program by introducing commercially enabling improvements to the manufacturing process in our GMP manufacturing facility.
- Meet with the FDA to discuss the manufacturing and further clinical development of OPC1.
- Provide further clinical updates from the SCiStar Trial for SCI.
-
Evaluate partnership opportunities for Renevia in
Europe . -
Evaluate VAC2 clinical data from the initial patients in the ongoing Phase 1 trial in NSCLC (non-small cell lung cancer) run by
Cancer Research UK and evaluate potential early exercise of option to acquire data. - 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
During 2019, we were able to fund our operations primarily by selling a portion of our marketable securities. We sold 6,250,000 shares of OncoCyte’s common stock for net proceeds of approximately
In conjunction with the sale of AgeX shares to
In summary, as of
The Company has implemented significant cost savings initiatives and anticipates that net operational spend for 2020 will be approximately
Fourth Quarter Operating Results
Revenues: Lineage’s revenue is generated primarily from royalties, licensing fees, research grants and the sale of research products. 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
Full Year Operating Results
Note regarding AgeX: On
Revenues: Lineage’s revenue is generated primarily from royalties, licensing fees, research grants and the sale of research products. 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/(Expenses), Net: Other income/(expenses), 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, manufacturing plans, enrollment activities, discussions with
CONSOLIDATED BALANCE SHEETS (IN THOUSANDS) |
||||||||
ASSETS |
2019 |
|
2018 |
|||||
CURRENT ASSETS |
|
|
|
|
|
|||
Cash and cash equivalents |
$ |
9,497 |
|
|
$ |
23,587 |
|
|
Marketable equity securities |
|
21,219 |
|
|
|
7,154 |
|
|
Promissory note from Juvenescence |
|
23,616 |
|
|
|
- |
|
|
Trade accounts and grants receivable, net |
|
317 |
|
|
|
767 |
|
|
Landlord receivable |
|
- |
|
|
|
840 |
|
|
Receivables from affiliates, net |
|
7 |
|
|
|
2,112 |
|
|
Prepaid expenses and other current assets |
|
2,863 |
|
|
|
1,898 |
|
|
Total current assets |
|
57,519 |
|
|
|
36,358 |
|
|
|
|
|
|
|
|
|||
NONCURRENT ASSETS |
|
|
|
|
|
|||
Property and equipment, net |
|
8,175 |
|
|
|
5,835 |
|
|
Deposits and other long-term assets |
|
864 |
|
|
|
505 |
|
|
Promissory note from Juvenescence |
|
- |
|
|
|
22,104 |
|
|
Equity method investment in OncoCyte, at fair value |
|
- |
|
|
|
20,250 |
|
|
Equity method investment in Asterias, at fair value |
|
- |
|
|
|
13,483 |
|
|
|
|
10,672 |
|
|
|
- |
|
|
Intangible assets, net |
|
48,248 |
|
|
|
3,125 |
|
|
TOTAL ASSETS |
$ |
125,478 |
|
|
$ |
101,660 |
|
|
|
|
|
|
|
|
|||
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|||
CURRENT LIABILITIES |
|
|
|
|
|
|||
Accounts payable and accrued liabilities |
$ |
5,226 |
|
|
$ |
6,463 |
|
|
Financing lease and right-of-use liabilities, current portion |
|
1,223 |
|
|
|
237 |
|
|
Promissory notes, current portion |
|
- |
|
|
|
70 |
|
|
Deferred grant revenue |
|
45 |
|
|
|
42 |
|
|
Total current liabilities |
|
6,494 |
|
|
|
6,812 |
|
|
|
|
|
|
|
|
|||
LONG-TERM LIABILITIES |
|
|
|
|
|
|||
Deferred tax liability |
|
3,315 |
|
|
|
- |
|
|
Deferred rent liabilities, net of current portion |
|
- |
|
|
|
244 |
|
|
Deferred revenues |
|
200 |
|
|
|
- |
|
|
Right-of-use lease liability, net of current portion |
|
3,868 |
|
|
|
1,854 |
|
|
Financing lease, net of current portion |
|
77 |
|
|
|
104 |
|
|
Liability classified warrants and other long-term liabilities |
|
277 |
|
|
|
400 |
|
|
TOTAL LIABILITIES |
|
14,231 |
|
|
|
9,414 |
|
|
|
|
|
|
|
|
|||
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, authorized 250,000 shares; 149,804 and 127,136 shares issued and outstanding as of |
|
387,062 |
|
|
|
354,270 |
|
|
Accumulated other comprehensive (loss) income |
|
(681 |
) |
|
|
1,426 |
|
|
Accumulated deficit |
|
(273,422 |
) |
|
|
(261,856 |
) |
|
|
|
112,959 |
|
|
|
93,840 |
|
|
Noncontrolling interest (deficit) |
|
(1,712 |
) |
|
|
(1,594 |
) |
|
Total shareholders’ equity |
|
111,247 |
|
|
|
92,246 |
|
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
$ |
125,478 |
|
|
$ |
101,660 |
|
|
CONSOLIDATED STATEMENTS OF OPERATIONS (IN THOUSANDS, EXCEPT PER SHARE DATA) |
||||||||||||||||
Three Months Ended
|
|
Year Ended
|
||||||||||||||
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
||||||||
REVENUES: |
|
|
|
|
|
|
|
|
|
|
||||||
Grant revenue |
$ |
409 |
|
$ |
587 |
|
$ |
2,037 |
|
$ |
3,572 |
|
||||
Royalties from product sales and license fees |
|
831 |
|
|
80 |
|
|
1,221 |
|
|
392 |
|
||||
Subscription and advertisement revenues |
|
- |
|
|
- |
|
|
- |
|
|
691 |
|
||||
Sale of research products and services |
|
1 |
|
|
91 |
|
|
257 |
|
|
333 |
|
||||
Total revenues |
|
1,241 |
|
|
758 |
|
|
3,515 |
|
|
4,988 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of sales |
|
(123 |
) |
|
(52 |
) |
|
(412 |
) |
|
(302 |
) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Gross profit |
|
1,118 |
|
|
706 |
|
|
3,103 |
|
|
4,686 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
3,486 |
|
|
3,780 |
|
|
17,948 |
|
|
20,955 |
|
||||
Acquired in-process research and development |
|
- |
|
|
- |
|
|
- |
|
|
800 |
|
||||
General and administrative |
|
4,504 |
|
|
7,033 |
|
|
24,031 |
|
|
24,726 |
|
||||
Total operating expenses |
|
7,990 |
|
|
10,813 |
|
|
41,979 |
|
|
46,481 |
|
||||
Loss from operations |
|
(6,872 |
) |
|
(10,107 |
) |
|
(38,876 |
) |
|
(41,795 |
) |
||||
OTHER INCOME/(EXPENSES): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income (expense), net |
|
407 |
|
|
433 |
|
|
1,685 |
|
|
711 |
|
||||
Gain on sale of marketable equity securities |
|
366 |
|
|
- |
|
|
2,421 |
|
|
- |
|
||||
Gain on sale of equity method investment in OncoCyte |
|
- |
|
|
- |
|
|
546 |
|
|
- |
|
||||
Gain on sale of equity method investment in Ascendance |
|
- |
|
|
- |
|
|
- |
|
|
3,215 |
|
||||
Gain on sale of AgeX shares and deconsolidation of AgeX |
|
- |
|
|
- |
|
|
- |
|
|
78,511 |
|
||||
Unrealized (loss) gain on marketable equity securities |
|
236 |
|
|
523 |
|
|
(2,898 |
) |
|
1,158 |
|
||||
Unrealized (loss) gain on equity method investment in OncoCyte at fair value |
|
- |
|
|
(16,435 |
) |
|
8,001 |
|
|
(47,985 |
) |
||||
Unrealized (loss) gain on equity method investment in Asterias at fair value |
|
- |
|
|
(14,789 |
) |
|
6,744 |
|
|
(35,449 |
) |
||||
Loss on equity method investment in AgeX at fair value |
|
- |
|
|
(4,181 |
) |
|
- |
|
|
(4,181 |
) |
||||
Unrealized gain (loss) on warrant liability |
|
261 |
|
|
(97 |
) |
|
611 |
|
|
384 |
|
||||
Other income (expense), net |
|
262 |
|
|
(677 |
) |
|
2,532 |
|
|
(1,699 |
) |
||||
Total other income (expense), net |
|
1,532 |
|
|
(35,223 |
) |
|
19,642 |
|
|
(5,335) |
|
||||
LOSS BEFORE INCOME TAXES |
|
(5,340 |
) |
|
(45,330 |
) |
|
(19,234 |
) |
|
(47,130 |
) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Income tax benefit |
|
784 |
|
|
346 |
|
|
7,407 |
|
|
346 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
NET LOSS |
|
(4,556 |
) |
|
(44,984 |
) |
|
(11,827 |
) |
|
(46,784 |
) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss attributable to noncontrolling interest |
|
74 |
|
|
32 |
|
|
118 |
|
|
794 |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
NET LOSS ATTRIBUTABLE TO LINEAGE |
$ |
(4,482 |
) |
$ |
(44,952 |
) |
$ |
(11,709 |
) |
$ |
(45,990 |
) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
NET (LOSS) PER COMMON SHARE: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
BASIC AND DILUTED |
$ |
(0.03 |
) |
$ |
(0.35 |
) |
$ |
(0.08 |
) |
$ |
(0.36 |
) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
BASIC AND DILUTED |
|
149,794 |
|
|
126,990 |
|
|
145,533 |
|
|
126,903 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20200312005759/en/
(ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
(Gogawa@troutgroup.com)
(646) 378-2949
Source: