Lineage Cell Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Update
Lineage Cell Therapeutics (LCTX) reported strong financial results for Q1 2022, with revenues increasing to $5.2 million from $0.4 million YoY, attributable to a $50 million licensing payment from Roche. Operating expenses rose to $11.5 million, driven by a $3.5 million one-time expense related to litigation. The company completed patient enrollment for the VAC2 Phase 1 study and showcased promising clinical results for OpRegen in addressing geographic atrophy from AMD. As of March 31, 2022, cash reserves stood at $78.1 million, supporting ongoing clinical and regulatory efforts.
- Revenue rose to $5.2 million from $0.4 million YoY.
- Completion of enrollment in VAC2 Phase 1 study for NSCLC.
- Promising clinical results for OpRegen showing outer retinal structure improvement.
- Cash and cash equivalents totaled $78.1 million as of March 31, 2022.
- Operating expenses increased to $11.5 million, mainly due to a $3.5 million litigation expense.
- Net loss attributable to Lineage was $7.1 million, or $0.04 per share.
-
Reported RG6501 (OpRegen®) Clinical Results at 2022 ARVO Meeting; Outer Retinal Structure Improvement Observed in Five Dry
AMD Patients - Expanded Pipeline with Two New Cell Therapy Development Programs; Auditory Neurons and Photoreceptors
-
Announced Completion of Enrollment in VAC2 Phase 1 NSCLC Study by
Cancer Research UK -
Cash and Cash Equivalents of
as of$78.1 Million March 31, 2022
“The first quarter of this year was highlighted by the rapid launch of new cell therapy programs in hearing loss and vision disorders and conducting tech transfer activities to support our alliance with Roche and
Recent milestones include:
-
Reported RG6501 (OpRegen) Phase 1/2a clinical results at 2022
Association for Research in Vision and Ophthalmology , Inc. (ARVO) annual meeting: 12-month primary endpoint data support the potential for OpRegen to slow, stop or reverse disease progression in geographic atrophy (GA) secondary to age-related macular degeneration (AMD ); outer retinal structure improvement observed in five dryAMD patients; - Announced expansion of pipeline with addition of new cell therapy program: allogeneic photoreceptor neural cell (PNC1) transplants for the treatment of diseases which may lead to blindness; dynamic culturing process offers path to clinical- and industrial-scale production of photoreceptors; data generated further demonstrated that a single cell suspension of photoreceptor precursor cells has the potential to survive and mature post-transplantation in a rodent model of retinal degeneration;
-
Announced completion of patient enrollment in Phase 1 clinical study of VAC2 for the treatment of non-small cell lung cancer (NSCLC) by
Cancer Research UK ; Lineage has now assumed responsibility for further clinical development of VAC2 and any future development opportunities derived from the VAC platform; and - Announced expansion of pipeline with addition of new cell therapy program: auditory neuronal cells (ANP1) for the treatment of hearing loss; intellectual property filed covering composition and methods for generating auditory neuronal progenitors.
Some of the events and milestones anticipated by Lineage in the rest of 2022 include:
- Investigational New Drug (“IND”) amendment submission to enable clinical performance and safety testing of a novel parenchymal spinal delivery system for OPC1, in Q4 2022;
- FDA interaction to discuss recent manufacturing improvements made to OPC1, anticipated in Q4 2022;
- Clinical data update from the ongoing VAC2 Phase 1 non-small cell lung cancer study; anticipated from CRUK in 2H 2022;
- An IND submission for VAC2 to support US-based clinical testing in 2H 2022;
- Preclinical activities for both ANP1 and PNC1 programs; ongoing throughout 2022;
- Additional OPC1 publications, including full clinical study results from the SCiStar clinical study and an MRI findings paper; anticipated in 2H 2022;
-
Continued development of a cell-based therapeutic for glioblastoma with our strategic partner,
Immunomic Therapeutics ; ongoing throughout 2022; - Evaluation of opportunities for new VAC product candidates based on internally identified or partnered tumor antigens; ongoing throughout 2022;
- Evaluation of new funded partnership opportunities and/or expansion of existing collaborations; ongoing throughout 2022; and
- Continued participation in numerous investor and partnering meetings and medical and industry conferences to broaden awareness of our mission and accomplishments.
Balance Sheet Highlights
Cash and cash equivalents totaled
First 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
Interested parties may access today’s conference call by dialing (866) 888-8633 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 collaboration and license agreement with Roche and
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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(IN THOUSANDS) |
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ASSETS |
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CURRENT ASSETS |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
78,062 |
|
|
$ |
55,742 |
|
Marketable equity securities |
|
|
1,882 |
|
|
|
2,616 |
|
Accounts and grants receivable, net |
|
|
515 |
|
|
|
50,840 |
|
Prepaid expenses and other current assets |
|
|
1,413 |
|
|
|
2,351 |
|
Total current assets |
|
|
81,872 |
|
|
|
111,549 |
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|
|
|
|
|
|
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NONCURRENT ASSETS |
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|
|
|
|
|
|
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Property and equipment, net |
|
|
4,548 |
|
|
|
4,872 |
|
Deposits and other long-term assets |
|
|
639 |
|
|
|
630 |
|
|
|
|
10,672 |
|
|
|
10,672 |
|
Intangible assets, net |
|
|
46,789 |
|
|
|
46,822 |
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TOTAL ASSETS |
|
$ |
144,520 |
|
|
$ |
174,545 |
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LIABILITIES AND SHAREHOLDERS’ EQUITY |
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CURRENT LIABILITIES |
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|
|
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Accounts payable and accrued liabilities |
|
$ |
8,957 |
|
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$ |
27,969 |
|
Lease liabilities, current portion |
|
|
719 |
|
|
|
801 |
|
Financing lease, current portion |
|
|
31 |
|
|
|
30 |
|
Deferred revenues |
|
|
14,885 |
|
|
|
18,119 |
|
Liability classified warrants, current portion |
|
|
1 |
|
|
|
197 |
|
Total current liabilities |
|
|
24,593 |
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|
47,116 |
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|
|
|
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LONG-TERM LIABILITIES |
|
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|
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|
|
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Deferred tax liability |
|
|
2,076 |
|
|
|
2,076 |
|
Deferred revenues, net of current portion |
|
|
30,821 |
|
|
|
32,454 |
|
Lease liability, net of current portion |
|
|
1,781 |
|
|
|
1,941 |
|
Financing lease, net of current portion |
|
|
26 |
|
|
|
30 |
|
Liability classified warrants and other long-term liabilities |
|
|
5 |
|
|
|
30 |
|
TOTAL LIABILITIES |
|
|
59,302 |
|
|
|
83,647 |
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SHAREHOLDERS’ EQUITY |
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Preferred shares, no par value, authorized 2,000 shares; none issued and outstanding as of |
|
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- |
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- |
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Common shares, no par value, 250,000 shares authorized; 169,727 and 169,477 shares issued and outstanding as of |
|
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435,818 |
|
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434,529 |
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Accumulated other comprehensive loss |
|
|
(5,087 |
) |
|
|
(5,211 |
) |
Accumulated deficit |
|
|
(344,184 |
) |
|
|
(337,097 |
) |
|
|
|
86,547 |
|
|
|
92,221 |
|
Noncontrolling (deficit) |
|
|
(1,329 |
) |
|
|
(1,323 |
) |
Total shareholders’ equity |
|
|
85,218 |
|
|
|
90,898 |
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
$ |
144,520 |
|
|
$ |
174,545 |
|
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
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(IN THOUSANDS, EXCEPT PER SHARE DATA) |
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(UNAUDITED) |
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Three Months Ended
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2022 |
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2021 |
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REVENUES: |
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Collaboration revenues |
|
$ |
4,865 |
|
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$ |
- |
|
Royalties |
|
|
372 |
|
|
|
293 |
|
Grant revenues |
|
|
- |
|
|
|
98 |
|
Total revenues |
|
|
5,237 |
|
|
|
391 |
|
|
|
|
|
|
|
|
|
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Cost of sales |
|
|
(176 |
) |
|
|
(112 |
) |
|
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|
|
|
|
|
|
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Gross profit |
|
|
5,061 |
|
|
|
279 |
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OPERATING EXPENSES: |
|
|
|
|
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|
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Research and development |
|
|
2,988 |
|
|
|
3,394 |
|
General and administrative |
|
|
8,469 |
|
|
|
3,935 |
|
Total operating expenses |
|
|
11,457 |
|
|
|
7,329 |
|
Loss from operations |
|
|
(6,396 |
) |
|
|
(7,050 |
) |
OTHER INCOME/(EXPENSES): |
|
|
|
|
|
|
|
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Interest income, net |
|
|
1 |
|
|
|
2 |
|
Gain on sale of marketable securities |
|
|
- |
|
|
|
6,024 |
|
Unrealized (loss) gain on marketable equity securities |
|
|
(735 |
) |
|
|
1,239 |
|
Unrealized gain on warrant liability |
|
|
221 |
|
|
|
18 |
|
Other (expenses), net |
|
|
(184 |
) |
|
|
(1,681 |
) |
Total other income (expenses), net |
|
|
(697 |
) |
|
|
5,602 |
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LOSS BEFORE INCOME TAXES |
|
|
(7,093 |
) |
|
|
(1,448 |
) |
|
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|
|
|
|
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Deferred income tax benefit |
|
|
- |
|
|
|
- |
|
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NET LOSS |
|
|
(7,093 |
) |
|
|
(1,448 |
) |
|
|
|
|
|
|
|
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Net loss attributable to noncontrolling interest |
|
|
6 |
|
|
|
32 |
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NET LOSS ATTRIBUTABLE TO LINEAGE CELL THERAPEUTICS, INC. |
|
$ |
(7,087 |
) |
|
$ |
(1,416 |
) |
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NET LOSS PER COMMON SHARE: |
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BASIC |
|
$ |
(0.04 |
) |
|
$ |
(0.01 |
) |
DILUTED |
|
$ |
(0.04 |
) |
|
$ |
(0.01 |
) |
|
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WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: |
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BASIC |
|
|
169,647 |
|
|
|
158,725 |
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DILUTED |
|
|
169,647 |
|
|
|
158,725 |
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CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS |
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(IN THOUSANDS) |
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(UNAUDITED) |
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Three Months Ended
|
|
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|
2022 |
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2021 |
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CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
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Net loss attributable to |
|
$ |
(7,087 |
) |
|
$ |
(1,416 |
) |
Net loss allocable to noncontrolling interest |
|
|
(6 |
) |
|
|
(32 |
) |
Adjustments to reconcile net loss attributable to |
|
|
|
|
|
|
|
|
Gain on sale of marketable securities |
|
|
- |
|
|
(6,024 |
) |
|
Unrealized loss/(gain) on marketable equity securities |
|
|
735 |
|
|
(1,239 |
) |
|
Depreciation expense, including amortization of leasehold improvements |
|
|
150 |
|
|
|
174 |
|
Amortization of right-of-use asset |
|
|
(4 |
) |
|
|
10 |
|
Amortization of intangible assets |
|
|
32 |
|
|
|
112 |
|
Stock-based compensation |
|
|
1,106 |
|
|
|
539 |
|
Common stock issued for services |
|
|
- |
|
|
|
102 |
|
Change in unrealized gain on warrant liability |
|
|
(221 |
) |
|
|
(18 |
) |
Foreign currency remeasurement and other gain |
|
|
75 |
|
|
|
1,712 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts and grants receivable |
|
|
50,321 |
|
|
(135 |
) |
|
Prepaid expenses and other current assets |
|
|
573 |
|
|
(92 |
) |
|
Accounts payable and accrued liabilities |
|
|
(18,905 |
) |
|
|
(1,031 |
) |
Deferred revenue and other liabilities |
|
|
(4,865 |
) |
|
|
(86 |
) |
Net cash provided by (used in) operating activities |
|
|
21,904 |
|
|
(7,424 |
) |
|
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|
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|
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CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
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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 |
|
|
(46 |
) |
|
|
(11 |
) |
Net cash (used in) provided by investing activities |
|
|
(46 |
) |
|
|
10,074 |
|
|
|
|
|
|
|
|
|
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CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Proceeds from employee options exercised |
|
|
379 |
|
|
|
1,717 |
|
Common shares received and retired for employee taxes paid |
|
|
(8 |
) |
|
|
(13 |
) |
Proceeds from exercise of subsidiary warrants |
|
|
2 |
|
|
|
- |
|
Proceeds from sale of common shares |
|
|
148 |
|
|
|
19,873 |
|
Payments for offering costs |
|
|
- |
|
|
(614 |
) |
|
Repayment of lease liability |
|
|
(8 |
) |
|
|
- |
|
Net cash provided by financing activities |
|
|
513 |
|
|
|
20,963 |
|
Effect of exchange rate changes on cash, cash equivalents and restricted cash |
|
|
(42 |
) |
|
|
(80 |
) |
NET INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH |
|
|
22,329 |
|
|
|
23,533 |
|
CASH, CASH EQUIVALENTS AND RESTRICTED CASH: |
|
|
|
|
|
|
|
|
At beginning of the period |
|
|
56,277 |
|
|
|
33,183 |
|
At end of the period |
|
$ |
78,606 |
|
|
$ |
56,716 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20220512005185/en/
(ir@lineagecell.com)
(442) 287-8963
Solebury Trout IR
(jfrantz@soleburytrout.com )
(617) 221-9100
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242
Source:
FAQ
What were Lineage Cell Therapeutics' Q1 2022 revenues?
What is the current cash position of LCTX?
What clinical results were reported by LCTX for OpRegen?
What new developments were announced in Lineage's pipeline?