Lineage Cell Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Update
Lineage Cell Therapeutics reported Q2 2022 financial results, with revenue of approximately $4.6 million, up from $0.5 million in Q2 2021, due to licensing fees from Roche. Despite increased R&D and G&A expenses totaling $8.6 million, the loss from operations decreased to $4.2 million from $7.1 million year-over-year. The cash position stood at $72 million, sufficient to fund operations through Q2 2024. Key developments included advancements in RG6501 (OpRegen) and ongoing regulatory preparations for OPC1 and VAC2. A conference call will provide further business updates.
- Total revenue increased to $4.6 million, significantly up from $0.5 million in Q2 2021, largely due to licensing fees from Roche.
- Cash and marketable securities of $72 million expected to support operations through Q2 2024.
- Progress in the development of RG6501 (OpRegen) in collaboration with Roche and Genentech.
- Net loss increased to $6.8 million, or $0.04 per share, compared to $4.8 million, or $0.03 per share in Q2 2021.
- Operating expenses rose to $8.6 million, a $1.1 million increase from Q2 2021.
-
Advanced RG6501 (OpRegen®) Development in Partnership with Roche and
Genentech -
Published OPC1 Phase 1/2a Clinical Study Results in
Journal of Neurosurgery : Spine - Completed Key Activities to Support Planned Regulatory Interactions for OPC1 and VAC2
- Expanded Collaboration with Advanced BioMatrix for HyStem® Cell Drug Delivery Technology
-
Cash, Cash Equivalents, and
Marketable Securities of as of$72.0 Million June 30, 2022 Expected to Provide Capital Through Q2 2024
“We are pleased with the progress on RG6501 (OpRegen) product development under our collaboration with Roche and
Second quarter milestones and activities included:
- RG6501 (OpRegen)
-
Continued execution under our collaboration with Roche and
Genentech across multiple functional areas, including:- Conducting additional OpRegen manufacturing runs and supporting Chemistry Manufacturing and Controls (CMC) activities.
- Continuing technology transfer activities.
- Actively participating in both Joint Advisory and Joint Manufacturing Committees, forums for discussion and planning with respect to next steps in clinical development and related activities.
-
Continuing long-term follow-up of patients from the Phase 1/2a clinical study of OpRegen:
- Enrolled patients have continued to do well, supporting multi-year durability of a treatment effect with RG6501 (OpRegen).
- OPC1
-
Results from a Phase 1/2a clinical study in subacute cervical spinal cord injury were published in the
Journal of Neurosurgery : Spine;-
OPC1 has demonstrated an excellent safety profile, and at one-year post-treatment,
96% of patients had recovered one or more levels of neurological function on at least one side of their body, and32% of patients had recovered two or more levels of neurological function on at least one side of their body.
-
OPC1 has demonstrated an excellent safety profile, and at one-year post-treatment,
- Preclinical testing of a new thaw and inject formulation of OPC1, manufactured via an improved and larger-scale process, has demonstrated functional recovery, improvement in gait coordination and motor performance with a reduction of the area of cavitation.
- A majority of the verification and validation activities for the novel parenchymal spinal delivery (PSD) system, and its preclinical testing in support of a regulatory submission have been completed.
- Preclinical activities to support upcoming regulatory interactions are near completion.
-
Engagement with the
California Institute of Regenerative Medicine (CIRM), as well as various patient advocacy organizations and patient advocates, is underway.
- VAC2
-
Following technology transfer of the program from
Cancer Research UK (CRUK) to Lineage and improvement of manufacturing processes, production scale was increased and accordingly the cost of goods has been reduced significantly, along with marked improvements in the purity and functionality of the manufactured material. -
CRUK continues to follow patients on the Phase 1 NSCLC clinical study; Lineage has received all necessary clinical information from CRUK required to support
U.S. , or other, regulatory interactions.
- ANP1 & PNC1
- Preclinical activities are continuing, including thought leader engagement to support future preclinical testing.
- Business Development
- Broadened collaboration with Advanced BioMatrix, a division of BICO Group AB (STO: BICO), for the HyStem delivery technology to include clinical/commercial GMP (Good Manufacturing Practice) material, increasing the milestone payments and royalty percentages due to Lineage upon ABM reaching certain development milestones and/or product sales.
-
Continued work under our collaboration with our strategic partner,
Immunomic Therapeutics (“ITI”); currently awaiting decision on next steps for ITI’s allogeneic cell-based cancer immunotherapy for the treatment of glioblastoma based on the VAC platform.
Some of the key upcoming milestones and activities anticipated by Lineage include:
- Planned interaction with FDA in Q4 2022 to discuss an OPC1 IND amendment submission to enable clinical performance and safety testing of a novel PSD system.
- A pre-IND regulatory interaction in Q4 2022 to seek feedback on a VAC2 CMC, nonclinical, and clinical package to support
- Submission of a grant application to the
- Clinical data update from the ongoing VAC2 Phase 1 non-small cell lung cancer (NSCLC) study, pending release from CRUK.
- Preclinical activities for both the ANP1 and PNC1 programs.
- Additional OPC1 publications, including preclinical study results utilizing a new thaw and inject formulation of OPC1, manufactured via an improved and larger-scale process.
- An additional OPC1 manuscript from a Phase 1/2a clinical study in subacute cervical spinal cord injury, focused on MRI data.
- Evaluation of new partnership opportunities and/or expansion of existing collaborations.
- Continued participation in investor and partnering meetings and medical and industry conferences to broaden awareness of our mission and accomplishments.
Balance Sheet Highlights
Cash, cash equivalents, and marketable securities totaled
Second 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 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: our ability to support our operations for at least two years with our existing cash, cash equivalents and marketable securities; our ability to create value and reduce risk across our portfolio; our ability to support multiple years of progress and achieve important milestones; our collaboration and license agreement with Roche and
CONDENSED CONSOLIDATED BALANCE SHEETS (IN THOUSANDS) |
||||||||
|
|
|
|
|
||||
|
|
|
|
|
||||
ASSETS |
|
|
|
|
||||
CURRENT ASSETS |
|
|
|
|
||||
Cash and cash equivalents |
$ |
70,857 |
|
$ |
55,742 |
|
||
Marketable equity securities |
|
1,173 |
|
|
2,616 |
|
||
Accounts and grants receivable, net |
|
707 |
|
|
50,840 |
|
||
Prepaid expenses and other current assets |
|
1,289 |
|
|
2,351 |
|
||
Total current assets |
|
74,026 |
|
|
111,549 |
|
||
|
|
|
|
|
||||
NONCURRENT ASSETS |
|
|
|
|
||||
Property and equipment, net |
|
3,869 |
|
|
4,872 |
|
||
Deposits and other long-term assets |
|
598 |
|
|
630 |
|
||
|
|
10,672 |
|
|
10,672 |
|
||
Intangible assets, net |
|
46,757 |
|
|
46,822 |
|
||
TOTAL ASSETS |
$ |
135,922 |
|
$ |
174,545 |
|
||
|
|
|
|
|
||||
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
||||
CURRENT LIABILITIES |
|
|
|
|
||||
Accounts payable and accrued liabilities |
$ |
8,684 |
|
$ |
27,969 |
|
||
Lease liabilities, current portion |
|
593 |
|
|
801 |
|
||
Financing lease, current portion |
|
29 |
|
|
30 |
|
||
Deferred revenues |
|
15,785 |
|
|
18,119 |
|
||
Liability classified warrants, current portion |
|
- |
|
|
197 |
|
||
Total current liabilities |
|
25,091 |
|
|
47,116 |
|
||
|
|
|
|
|
||||
LONG-TERM LIABILITIES |
|
|
|
|
||||
Deferred tax liability |
|
2,076 |
|
|
2,076 |
|
||
Deferred revenues, net of current portion |
|
25,774 |
|
|
32,454 |
|
||
Lease liability, net of current portion |
|
1,459 |
|
|
1,941 |
|
||
Financing lease, net of current portion |
|
19 |
|
|
30 |
|
||
Liability classified warrants and other long-term liabilities |
|
4 |
|
|
30 |
|
||
TOTAL LIABILITIES |
|
54,423 |
|
|
83,647 |
|
||
|
|
|
|
|
||||
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, 250,000 shares authorized; 169,748 and 169,477 shares issued and outstanding as of |
|
437,151 |
|
|
434,529 |
|
||
Accumulated other comprehensive loss |
|
(3,357 |
) |
|
(5,211 |
) |
||
Accumulated deficit |
|
(350,947 |
) |
|
(337,097 |
) |
||
|
|
82,847 |
|
|
92,221 |
|
||
Noncontrolling (deficit) |
|
(1,348 |
) |
|
(1,323 |
) |
||
Total shareholders’ equity |
|
81,499 |
|
|
90,898 |
|
||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
$ |
135,922 |
|
$ |
174,545 |
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (IN THOUSANDS, EXCEPT PER SHARE DATA) (UNAUDITED) |
||||||||||||||||
|
|
|
|
|
||||||||||||
|
|
Three Months Ended
|
|
Six Months Ended
|
||||||||||||
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
||||||||
REVENUES: |
|
|
|
|
|
|
|
|
||||||||
Collaboration revenues |
$ |
4,148 |
|
$ |
213 |
|
$ |
9,013 |
|
$ |
213 |
|
||||
Royalties |
|
405 |
|
|
228 |
|
|
777 |
|
|
521 |
|
||||
Grant revenues |
|
- |
|
|
71 |
|
|
- |
|
|
169 |
|
||||
Total revenues |
|
4,553 |
|
|
512 |
|
|
9,790 |
|
|
903 |
|
||||
|
|
|
|
|
|
|
|
|
||||||||
Cost of sales |
|
(215 |
) |
|
(125 |
) |
|
(391 |
) |
|
(237 |
) |
||||
|
|
|
|
|
|
|
|
|
||||||||
Gross profit |
|
4,338 |
|
|
387 |
|
|
9,399 |
|
|
666 |
|
||||
|
|
|
|
|
|
|
|
|
||||||||
OPERATING EXPENSES: |
|
|
|
|
|
|
|
|
||||||||
Research and development |
|
3,302 |
|
|
2,931 |
|
|
6,290 |
|
|
6,325 |
|
||||
General and administrative |
|
5,270 |
|
|
4,536 |
|
|
13,739 |
|
|
8,471 |
|
||||
Total operating expenses |
|
8,572 |
|
|
7,467 |
|
|
20,029 |
|
|
14,796 |
|
||||
Loss from operations |
|
(4,234 |
) |
|
(7,080 |
) |
|
(10,630 |
) |
|
(14,130 |
) |
||||
OTHER INCOME/(EXPENSES): |
|
|
|
|
|
|
|
|
||||||||
Interest income (expense), net |
|
51 |
|
|
(3 |
) |
|
51 |
|
|
(1 |
) |
||||
Gain on sale of marketable securities |
|
- |
|
|
- |
|
|
- |
|
|
6,024 |
|
||||
Unrealized (loss) gain on marketable equity securities |
|
(709 |
) |
|
590 |
|
|
(1,444 |
) |
|
1,830 |
|
||||
Gain on extinguishment of debt |
|
- |
|
|
523 |
|
|
- |
|
|
523 |
|
||||
Gain on revaluation of warrant liability |
|
2 |
|
|
35 |
|
|
223 |
|
|
52 |
|
||||
Other income (expense), net |
|
(1,892 |
) |
|
970 |
|
|
(2,075 |
) |
|
(711 |
) |
||||
Total other income/(expense), net |
|
(2,548 |
) |
|
2,115 |
|
|
(3,245 |
) |
|
7,717 |
|
||||
LOSS BEFORE INCOME TAXES |
|
(6,782 |
) |
|
(4,965 |
) |
|
(13,875 |
) |
|
(6,413 |
) |
||||
|
|
|
|
|
|
|
|
|
||||||||
Deferred income tax benefit |
|
- |
|
|
169 |
|
|
- |
|
|
169 |
|
||||
|
|
|
|
|
|
|
|
|
||||||||
NET LOSS |
|
(6,782 |
) |
|
(4,796 |
) |
|
(13,875 |
) |
|
(6,244 |
) |
||||
|
|
|
|
|
|
|
|
|
||||||||
Net loss attributable to noncontrolling interest |
|
19 |
|
|
8 |
|
|
25 |
|
|
40 |
|
||||
|
|
|
|
|
|
|
|
|
||||||||
NET LOSS ATTRIBUTABLE TO LINEAGE CELL THERAPEUTICS, INC. |
$ |
(6,763 |
) |
$ |
(4,788 |
) |
$ |
(13,850 |
) |
$ |
(6,204 |
) |
||||
|
|
|
|
|
|
|
|
|
||||||||
NET LOSS PER COMMON SHARE: |
|
|
|
|
|
|
|
|
||||||||
BASIC |
$ |
(0.04 |
) |
$ |
(0.03 |
) |
$ |
(0.08 |
) |
$ |
(0.04 |
) |
||||
DILUTED |
$ |
(0.04 |
) |
$ |
(0.03 |
) |
$ |
(0.08 |
) |
$ |
(0.04 |
) |
||||
|
|
|
|
|
|
|
|
|
||||||||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: |
|
|
|
|
|
|
|
|
||||||||
BASIC |
|
169,731 |
|
|
162,914 |
|
|
169,689 |
|
|
160,831 |
|
||||
DILUTED |
|
169,731 |
|
|
162,914 |
|
|
169,689 |
|
|
160,831 |
|
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (IN THOUSANDS) (UNAUDITED) |
||||||||
|
|
|
|
|||||
|
|
Six Months Ended
|
||||||
|
|
2022 |
|
2021 |
||||
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
||||
Net loss attributable to |
$ |
(13,850 |
) |
$ |
(6,204 |
) |
||
Net loss allocable to noncontrolling interest |
|
(25 |
) |
|
(40 |
) |
||
Adjustments to reconcile net loss attributable to |
|
|
|
|
||||
Gain on sale of marketable securities |
|
- |
|
|
(6,024 |
) |
||
Unrealized loss (gain) on marketable equity securities |
|
1,444 |
|
|
(1,830 |
) |
||
Gain on extinguishment of debt |
|
- |
|
|
(523 |
) |
||
Depreciation expense, including amortization of leasehold improvements |
|
296 |
|
|
338 |
|
||
Amortization of right-of-use asset |
|
(7 |
) |
|
20 |
|
||
Amortization of intangible assets |
|
65 |
|
|
145 |
|
||
Stock-based compensation |
|
2,341 |
|
|
1,458 |
|
||
Common stock issued for services |
|
- |
|
|
202 |
|
||
Gain on revaluation of warrant liability |
|
(223 |
) |
|
(53 |
) |
||
Deferred tax benefit |
|
- |
|
|
(169 |
) |
||
Foreign currency remeasurement and other gain |
|
2,331 |
|
|
692 |
|
||
Changes in operating assets and liabilities: |
|
|
|
|
||||
Accounts and grants receivable |
|
50,111 |
|
|
(353 |
) |
||
Prepaid expenses and other current assets |
|
594 |
|
|
34 |
|
||
Accounts payable and accrued liabilities |
|
(19,230 |
) |
|
(955 |
) |
||
Deferred revenue and other liabilities |
|
(9,005 |
) |
|
422 |
|
||
Net cash provided by (used in) operating activities |
|
14,842 |
|
|
(12,840 |
) |
||
|
|
|
|
|
||||
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
||||
Proceeds from the sale of OncoCyte common shares |
|
- |
|
|
10,064 |
|
||
Proceeds from the sale of HBL common shares |
|
- |
|
|
21 |
|
||
Purchase of equipment and other assets, net |
|
(143 |
) |
|
(126 |
) |
||
Net cash (used in) provided by investing activities |
|
(143 |
) |
|
9,959 |
|
||
|
|
|
|
|
||||
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
||||
Proceeds from employee options exercised |
|
388 |
|
|
5,348 |
|
||
Common shares received and retired for employee taxes paid |
|
(17 |
) |
|
(27 |
) |
||
Proceeds from exercise of subsidiary warrants, net |
|
99 |
|
|
- |
|
||
Proceeds from sale of common shares |
|
148 |
|
|
27,813 |
|
||
Payments for offering costs |
|
(57 |
) |
|
(877 |
) |
||
Repayment of lease liability |
|
(15 |
) |
|
- |
|
||
Net cash provided by financing activities |
|
546 |
|
|
32,257 |
|
||
Effect of exchange rate changes on cash, cash equivalents and restricted cash |
|
(161 |
) |
|
(43 |
) |
||
NET INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH |
|
15,084 |
|
|
29,333 |
|
||
CASH, CASH EQUIVALENTS AND RESTRICTED CASH: |
|
|
|
|
||||
At beginning of the period |
|
56,277 |
|
|
33,183 |
|
||
At end of the period |
$ |
71,361 |
|
$ |
62,516 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20220811005126/en/
(ir@lineagecell.com)
(442) 287-8963
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242
Source:
FAQ
What were Lineage Cell Therapeutics' revenues for Q2 2022?
What is the cash position of Lineage Cell Therapeutics as of June 30, 2022?
What are the key developments for RG6501 (OpRegen) reported in Q2 2022?
What was the net loss for Lineage Cell Therapeutics in Q2 2022?