Press Releases
Lineage Cell Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update
-
Enrollment Continues in Phase 2a Clinical Study of RG6501 (OpRegen®) in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) Under Management of
Genentech , a Member of the Roche Group -
Additional RG6501 (OpRegen®) Data Presented at 23rd Annual
EURETINA Congress and 2023 Eyecelerator Meetings -
U.S. Patent Issued Covering Manufacturing and Differentiation Process for Retinal Pigment Epithelial (RPE) Cells - Company On Track to Submit OPC1 Investigational New Drug Amendment in Q4 2023
-
Initiated Development Activities for Hypoimmune Pluripotent Cell Line for
Neurology Indications Under Partnership with Eterna Therapeutics
“The Lineage team has continued to advance our clinical and preclinical pipeline of differentiated cell transplant programs, supporting our alliances and working to establish new collaborations,” stated
“In addition, our team continued the necessary work to submit our Investigational New Drug amendment for OPC1 to enable us to initiate the DOSED clinical study in subacute and chronic spinal cord injury patients,”
Recent milestones and activities included:
-
RG6501 (OpRegen)
-
Continued execution under our collaboration with Roche and
Genentech across multiple functional areas, including support for the ongoing Phase 2a multi-center clinical study in patients with GA secondary to AMD. Additional sites expected to come online for the Phase 2a study. -
Results of imaging analyses demonstrating rapid improvement in outer retinal structure from patients enrolled in the prior Phase 1/2a clinical study, were presented at the 23rd
EURETINA Congress :-
All five patients who had extensive coverage of the GA lesion with the surgical bleb containing OpRegen in suspension demonstrated evidence of improvement in outer retinal structure as assessed by optical coherence tomography (OCT) within the first three months after treatment.
- Retinal structural improvements were initially observed on day 1 (n=1), day 14 (n=1), month 1 (n=2), and month 3 (n=1).
- Structural improvement on OCT was qualitatively defined as meeting all pre-specified criteria on at least two non-adjacent B scans including: 1) reduction in outer plexiform layer (OPL) and/or inner nuclear layer (INL) subsidence; 2) reappearance of external limiting membrane (ELM); and 3) increased hyperreflectivity and/or thickness of RPE and/or Bruch’s membrane or reduction of hypertransmission on at least two non-adjacent B scans.
- Structural improvement was only observed within GA lesions with extensive coverage with the surgical bleb, suggesting that OpRegen RPE cells provide support to the remaining retinal cells within atrophic areas.
- These five patients had an average of 4.4 letter best corrected visual acuity (BCVA) gain by 3 months and 12.8 letter BCVA gain by 1 year compared to baseline.
-
All five patients who had extensive coverage of the GA lesion with the surgical bleb containing OpRegen in suspension demonstrated evidence of improvement in outer retinal structure as assessed by optical coherence tomography (OCT) within the first three months after treatment.
-
U.S. Patent No.11,746,324 entitled “Large Scale Production of Retinal Pigment Epithelial Cells,” issued.
-
Continued execution under our collaboration with Roche and
-
Investigational New Drug (IND) amendment preparation for clinical testing of novel OPC1 spinal cord delivery system continues
- Company remains on track to submit IND amendment to FDA in Q4 2023 to enable initiation of the DOSED clinical study in subacute and chronic spinal cord injury patients.
-
Initiated Development Activities for Hypoimmune Pluripotent Cell Line for
Neurology Indications Under Partnership with Eterna Therapeutics-
Lineage evaluated its development strategy with a group of leading neurology experts in the
U.S. and abroad and following an assessment of the competitive landscape, finalized its selection of specific gene edits for the initial cell lines to be developed by Eterna.- The edits include: the targeted deletion of the B2M gene, designed to reduce the immunogenicity of product candidates derived from the lines by inhibiting rejection by CD8+ T cells; the targeted insertion of the HLA-E gene, designed to overexpress HLA-E and prevent the allogeneic NK cell response; and a third undisclosed edit intended to confer clinical differentiation and a competitive advantage in the applicable indications.
-
Lineage evaluated its development strategy with a group of leading neurology experts in the
-
Positive ANP1 initial proof of concept results from collaboration with the
University of Michigan - Initial results demonstrated delivery, engraftment, and survival of ANP1 cells into specific target areas.
- Results support advancement of the ANP1 program into functional preclinical testing.
Balance Sheet Highlights
Cash, cash equivalents, and marketable securities totaled
Third Quarter Operating Results
Revenues: Lineage’s revenue is generated primarily from licensing fees, royalties, collaboration revenues, and research grants. 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
Interested parties may access today’s conference call and webcast, by dialing (800) 715-9871 from the
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,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “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: the potential benefits of OpRegen and the expansion of the Phase 2a clinical study of OpRegen to additional clinical sites; that our cash, cash equivalents and marketable securities is sufficient to support our planned operations into the first quarter of 2025; the timing of anticipated regulatory submissions to the FDA related to our programs, the potential future achievements of our clinical, preclinical and development programs, the initiation of clinical trials and the timing and availability of clinical data updates related to our programs; plans and expectations regarding existing collaborations; and the potential of our cell therapy platform and our ability to provide an meaningful impact for patients. 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, but not limited to, the following risks: that we may need to allocate our cash to unexpected events and expenses causing us to use our cash, cash equivalents and marketable securities more quickly than expected; that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that OpRegen may never be proven to provide durable anatomical functional improvements in dry-AMD patients, that competing alternative therapies may adversely impact the commercial potential of OpRegen; that Roche and
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||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
||||||||
(IN THOUSANDS) |
||||||||
|
|
|
||||||
|
(Unaudited) |
2022 |
||||||
ASSETS |
|
|
||||||
CURRENT ASSETS |
|
|
||||||
Cash and cash equivalents |
$ |
31,474 |
|
$ |
11,355 |
|
||
Marketable securities |
|
9,858 |
|
|
46,520 |
|
||
Accounts receivable, net |
|
432 |
|
|
297 |
|
||
Prepaid expenses and other current assets |
|
1,717 |
|
|
1,828 |
|
||
Total current assets |
|
43,481 |
|
|
60,000 |
|
||
|
|
|
||||||
NONCURRENT ASSETS |
|
|
||||||
Property and equipment, net |
|
4,854 |
|
|
5,673 |
|
||
Deposits and other long-term assets |
|
552 |
|
|
627 |
|
||
|
|
10,672 |
|
|
10,672 |
|
||
Intangible assets, net |
|
46,594 |
|
|
46,692 |
|
||
TOTAL ASSETS |
$ |
106,153 |
|
$ |
123,664 |
|
||
|
|
|
||||||
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
||||||
CURRENT LIABILITIES |
|
|
||||||
Accounts payable and accrued liabilities |
$ |
5,030 |
|
$ |
8,608 |
|
||
Lease liabilities, current portion |
|
881 |
|
|
916 |
|
||
Financing lease, current portion |
|
55 |
|
|
36 |
|
||
Deferred revenues |
|
9,915 |
|
|
9,421 |
|
||
Total current liabilities |
|
15,881 |
|
|
18,981 |
|
||
|
|
|
||||||
LONG-TERM LIABILITIES |
|
|
||||||
Deferred tax liability |
|
273 |
|
|
2,076 |
|
||
Deferred revenues, net of current portion |
|
21,195 |
|
|
27,725 |
|
||
Lease liability, net of current portion |
|
2,047 |
|
|
2,860 |
|
||
Financing lease, net of current portion |
|
97 |
|
|
84 |
|
||
Other long-term liabilities |
|
- |
|
|
2 |
|
||
TOTAL LIABILITIES |
|
39,493 |
|
|
51,728 |
|
||
|
|
|
||||||
|
|
|
||||||
SHAREHOLDERS’ EQUITY |
|
|
||||||
Preferred shares, no par value, authorized 2,000 shares; none issued and
outstanding as of |
|
- |
|
|
- |
|
||
Common shares, no par value, 450,000 and 250,000 shares authorized
as of 174,987 and 170,093 shares issued and outstanding as of
|
|
450,282 |
|
|
440,280 |
|
||
Accumulated other comprehensive loss |
|
(2,084 |
) |
|
(3,571 |
) |
||
Accumulated deficit |
|
(380,081 |
) |
|
(363,370 |
) |
||
|
|
68,117 |
|
|
73,339 |
|
||
Noncontrolling deficit |
|
(1,457 |
) |
|
(1,403 |
) |
||
Total shareholders’ equity |
|
66,660 |
|
|
71,936 |
|
||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
$ |
106,153 |
|
$ |
123,664 |
|
|
||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||||||||
(IN THOUSANDS, EXCEPT PER SHARE DATA) |
||||||||||||||||
(UNAUDITED) |
||||||||||||||||
|
Three Months ended |
Nine Months ended |
||||||||||||||
|
2023 |
2022 |
2023 |
2022 |
||||||||||||
REVENUES: |
|
|
|
|
||||||||||||
Collaboration revenues |
$ |
957 |
|
$ |
2,592 |
|
$ |
5,949 |
|
$ |
11,605 |
|
||||
Royalties and license fees |
|
289 |
|
|
406 |
|
|
908 |
|
|
1,183 |
|
||||
Total revenues |
|
1,246 |
|
|
2,998 |
|
|
6,857 |
|
|
12,788 |
|
||||
|
|
|
|
|
||||||||||||
Cost of sales |
|
(169 |
) |
|
(235 |
) |
|
(415 |
) |
|
(626 |
) |
||||
|
|
|
|
|
||||||||||||
Gross profit |
|
1,077 |
|
|
2,763 |
|
|
6,442 |
|
|
12,162 |
|
||||
|
|
|
|
|
||||||||||||
OPERATING EXPENSES: |
|
|
|
|
||||||||||||
Research and development |
|
3,741 |
|
|
3,592 |
|
|
11,799 |
|
|
9,883 |
|
||||
General and administrative |
|
4,041 |
|
|
4,422 |
|
|
13,014 |
|
|
18,160 |
|
||||
Total operating expenses |
|
7,782 |
|
|
8,014 |
|
|
24,813 |
|
|
28,043 |
|
||||
Loss from operations |
|
(6,705 |
) |
|
(5,251 |
) |
|
(18,371 |
) |
|
(15,881 |
) |
||||
OTHER INCOME (EXPENSES): |
|
|
|
|
||||||||||||
Interest income, net |
|
433 |
|
|
384 |
|
|
1,225 |
|
|
435 |
|
||||
Loss on marketable equity securities, net |
|
(60 |
) |
|
(233 |
) |
|
(170 |
) |
|
(1,677 |
) |
||||
Gain on revaluation of warrant liability |
|
- |
|
|
- |
|
|
1 |
|
|
223 |
|
||||
Other expenses, net |
|
(826 |
) |
|
(475 |
) |
|
(1,253 |
) |
|
(2,550 |
) |
||||
Total other income (expenses), net |
|
(453 |
) |
|
(324 |
) |
|
(197 |
) |
|
(3,569 |
) |
||||
LOSS BEFORE INCOME TAXES |
|
(7,158 |
) |
|
(5,575 |
) |
|
(18,568 |
) |
|
(19,450 |
) |
||||
|
|
|
|
|
||||||||||||
Provision for income tax benefit (expense) |
|
- |
|
|
(541 |
) |
|
1,803 |
|
|
(541 |
) |
||||
|
|
|
|
|
||||||||||||
NET LOSS |
|
(7,158 |
) |
|
(6,116 |
) |
|
(16,765 |
) |
|
(19,991 |
) |
||||
|
|
|
|
|
||||||||||||
Net loss attributable to noncontrolling interest |
|
48 |
|
|
47 |
|
|
54 |
|
|
72 |
|
||||
|
|
|
|
|
||||||||||||
NET LOSS ATTRIBUTABLE TO LINEAGE CELL THERAPEUTICS, INC. |
$ |
(7,110 |
) |
$ |
(6,069 |
) |
$ |
(16,711 |
) |
$ |
(19,919 |
) |
||||
|
|
|
|
|
||||||||||||
NET LOSS PER COMMON SHARE: |
|
|
|
|
||||||||||||
Basic and Diluted |
$ |
(0.04 |
) |
$ |
(0.04 |
) |
$ |
(0.10 |
) |
$ |
(0.12 |
) |
||||
|
|
|
|
|
||||||||||||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: |
|
|
|
|
||||||||||||
Basic and Diluted |
|
174,868 |
|
|
169,786 |
|
|
171,880 |
|
|
169,722 |
|
|
||||||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS |
||||||||
(IN THOUSANDS) |
||||||||
(UNAUDITED) |
||||||||
|
Nine Months ended |
|||||||
|
2023 |
2022 |
||||||
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
||||||
Net loss attributable to |
$ |
(16,711 |
) |
$ |
(19,919 |
) |
||
Net loss allocable to noncontrolling interest |
|
(54 |
) |
|
(72 |
) |
||
Adjustments to reconcile net loss attributable to |
|
|
||||||
Loss on marketable equity securities, net |
|
170 |
|
|
1,677 |
|
||
Accretion of income on marketable debt securities |
|
(647 |
) |
|
(186 |
) |
||
Depreciation expense, including amortization of leasehold improvements |
|
419 |
|
|
441 |
|
||
Change in right-of-use assets and liabilities |
|
86 |
|
|
(24 |
) |
||
Amortization of intangible assets |
|
98 |
|
|
113 |
|
||
Stock-based compensation |
|
3,580 |
|
|
3,328 |
|
||
Gain on revaluation of warrant liability |
|
(1 |
) |
|
(223 |
) |
||
Deferred income tax benefit |
|
(1,803 |
) |
|
- |
|
||
Foreign currency remeasurement and other loss |
|
1,893 |
|
|
2,668 |
|
||
Changes in operating assets and liabilities: |
|
|
||||||
Accounts receivable, net |
|
(141 |
) |
|
50,206 |
|
||
Prepaid expenses and other current assets |
|
56 |
|
|
517 |
|
||
Accounts payable and accrued liabilities |
|
(3,456 |
) |
|
(17,573 |
) |
||
Deferred revenue and other liabilities |
|
(6,036 |
) |
|
(11,591 |
) |
||
Net cash (used in) provided by operating activities |
|
(22,547 |
) |
|
9,362 |
|
||
|
|
|
||||||
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
||||||
Proceeds from the sale of marketable equity securities |
|
196 |
|
|
- |
|
||
Purchases of marketable debt securities |
|
(16,403 |
) |
|
(40,628 |
) |
||
Maturities of marketable debt securities |
|
53,497 |
|
|
- |
|
||
Purchase of equipment |
|
(583 |
) |
|
(429 |
) |
||
Net cash provided by (used in) investing activities |
|
36,707 |
|
|
(41,057 |
) |
||
|
|
|
||||||
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
||||||
Proceeds from employee options exercised |
|
88 |
|
|
506 |
|
||
Common shares received and retired for employee taxes paid |
|
(37 |
) |
|
(17 |
) |
||
Proceeds from exercise of subsidiary warrants, net |
|
- |
|
|
991 |
|
||
Proceeds from sale of common shares |
|
6,625 |
|
|
148 |
|
||
Payments for offering costs |
|
(199 |
) |
|
(95 |
) |
||
Repayment of financing lease liability |
|
(41 |
) |
|
(23 |
) |
||
Net cash provided by financing activities |
|
6,436 |
|
|
1,510 |
|
||
Effect of exchange rate changes on cash, cash equivalents and restricted cash |
|
(532 |
) |
|
(795 |
) |
||
NET INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH |
|
20,064 |
|
|
(30,980 |
) |
||
|
|
|
||||||
CASH, CASH EQUIVALENTS AND RESTRICTED CASH: |
|
|
||||||
At beginning of the period |
|
11,936 |
|
|
56,277 |
|
||
At end of the period |
$ |
32,000 |
|
$ |
25,297 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20231109850473/en/
(ir@lineagecell.com)
(442) 287-8963
(daniel@lifesciadvisors.com)
(617) 430-7576
(Nic.johnson@russopartnersllc.com)
(David.schull@russopartnersllc.com)
(212) 845-4242
Source: