Lineage Cell Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update
Lineage Cell Therapeutics, Inc. reported positive financial results for Q4 and full year 2023, highlighting key developments in their collaboration with Roche and Genentech for OpRegen in AMD patients, IND clearance for OPC1, and initiation of a new clinical trial. The company also strengthened its balance sheet through a $14 million offering. Financially, Lineage saw a slight increase in revenues and a decrease in operating expenses for Q4, with a net loss of $4.8 million. For the full year, revenues decreased, but operating expenses also decreased, resulting in a net loss of $21.5 million.
Positive
Positive financial results reported for Q4 and full year 2023.
Key developments in collaboration with Roche and Genentech for OpRegen in AMD patients.
IND clearance for OPC1 and initiation of a new clinical trial.
Strengthened balance sheet through a $14 million offering.
Slight increase in revenues and decrease in operating expenses for Q4.
Net loss of $4.8 million for Q4.
Revenues decreased for the full year, but operating expenses also decreased.
Net loss of $21.5 million for the full year.
Negative
Decrease in total revenues for the full year compared to 2022.
Increase in R&D expenses for the full year.
Overall increase in loss from operations for the full year.
Net loss of $21.5 million for the full year.
The financial and operating results of Lineage Cell Therapeutics, Inc. for the fourth quarter and full year 2023 indicate a mixed performance. The company's total revenues for the year have decreased by $5.8 million, primarily due to lower collaboration and licensing revenue from Roche, which could signal a concern for revenue diversification and sustainability. However, the decrease in total operating expenses, particularly the $5.2 million reduction in G&A expenses, reflects effective cost management, potentially improving the company's operational efficiency.
The net loss for the year has decreased, which may be perceived positively by investors, suggesting a more controlled burn rate. The cash position, bolstered by the recent financing, is expected to support operations into Q3 2025, providing a relatively stable runway for continued development. This financial stability is crucial as the company progresses with its clinical trials and preclinical programs, which could lead to future value inflection points.
The clinical advancements in OpRegen for Dry AMD and the IND amendment clearance for OPC1 are significant milestones for Lineage Cell Therapeutics. The progression into Phase 2a for OpRegen, in collaboration with industry giants Roche and Genentech, not only validates the therapeutic potential but also suggests a strategic partnership that could facilitate future commercialization. The issuance of U.S. Patent No.11,746,324 for large-scale production of retinal pigment epithelial cells enhances the company's intellectual property portfolio, potentially increasing its competitive edge in the ophthalmology space.
For OPC1, targeting chronic and subacute spinal cord injury, the IND amendment clearance marks a critical step towards initiating the DOSED clinical study. The support from a CIRM grant and the collaboration with the Christopher & Dana Reeve Foundation may enhance the program's visibility and credibility. These developments could have long-term implications for the company's pipeline strength and market positioning within the regenerative medicine sector.
Lineage's inclusion in the Russell 3000® Index is a strategic advantage that could lead to increased visibility among institutional investors and potentially more liquidity in the stock. This, combined with the successful registered direct offering conducted without a discount or warrants, suggests investor confidence and a more favorable perception of the company's valuation and growth prospects.
The company's focus on developing a hypoimmune pluripotent cell line for neurology indications aligns with the growing interest in personalized medicine and could tap into a significant market opportunity. The preclinical programs, such as the collaboration with Eterna Therapeutics, highlight Lineage's commitment to expanding its therapeutic pipeline, which is essential for long-term growth and value creation in the biotechnology industry.
03/07/2024 - 04:01 PM
Advanced OpRegen® For Dry AMD in Phase 2a Study in Collaboration with Roche and Genentech
Closed $14 Million
OPC1 Investigational New Drug Amendment Cleared; New Clinical Trial Planned
Initiated Development of Hypoimmune iPSC Cell Line for Neurology Indications Under Gene Editing Collaboration with Eterna Therapeutics
Added to Russell 3000® Index
Established 1st Annual Spinal Cord Injury Investor Symposium
CARLSBAD, Calif. --(BUSINESS WIRE)--
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today reported its fourth quarter and full year 2023 financial and operating results and will host a conference call today at 4:30 p.m. Eastern Time to discuss these results and provide a business update.
“Throughout 2023, our team has continued to advance our clinical and preclinical pipeline of differentiated cell transplant programs,” stated Brian M. Culley, Lineage CEO. “The most important area of attention has remained our partnership with Roche and Genentech and the support we provide to the ongoing Phase 2a clinical study of OpRegen in patients with geographic atrophy secondary to AMD. With the recent clearance of our IND amendment for OPC1, we are excited for the opportunity to return this program back into the clinic in both subacute and, for the first time, chronic spinal cord injury patients. Following the closing of our recent financing, a transaction conducted without a discount or warrants, our balance sheet has been strengthened, which will help us advance our programs and reach important milestones this year that can help provide a meaningful impact for patients.”
2023 Select Development Highlights
RG6501 (OpRegen)
Continued execution under our collaboration with Roche and Genentech across multiple functional areas, including support for the ongoing Phase 2a clinical study in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Long-term follow-up of patients from the Phase 1/2a clinical study of OpRegen:
U.S. Patent No.11,746,324 entitled “Large Scale Production of Retinal Pigment Epithelial Cells,” issued .
OPC1
Submitted an Investigational New Drug Amendment (INDa) for OPC1 for the treatment of chronic and subacute spinal cord injury to enable initiation of DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) clinical study in subacute and chronic spinal cord patients. INDa clearance from the U.S. Food and Drug Administration announced in February 2024.
Received CIRM grant to support the 1st Annual Spinal Cord Injury Investor Symposium , hosted in partnership with the Christopher & Dana Reeve Foundation.
Preclinical Programs
Reported 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, supporting advancement of program into functional preclinical testing.
Initiated development activities for hypoimmune pluripotent cell line for neurology indications under collaboration with Eterna Therapeutics.
Balance Sheet Highlights
Cash, cash equivalents, and marketable securities of $35.5 million $13.8 million
Fourth Quarter Operating Results
Revenues: Lineage’s revenue is generated primarily from collaboration revenues and royalties. Total revenues for the three months ended December 31, 2023 were approximately $2.1 million $0.2 million $1.9 million
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 December 31, 2023 were $8.2 million $0.3 million $8.5 million
R&D Expenses: R&D expenses for the three months ended December 31, 2023 were $3.9 million $0.2 million $4.1 million $0.2 million $0.4 million $0.2 million $0.2 million
G&A Expenses: G&A expenses for the three months ended December 31, 2023 of $4.3 million
Loss from Operations: Loss from operations for the three months ended December 31, 2023 was $6.4 million $0.2 million $6.6 million
Other Income/(Expenses), Net: Other income/(expenses), net for the three months ended December 31, 2023 reflected other income of $1.6 million $0.3 million
Net Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended December 31, 2023 was $4.8 million $0.03 $6.4 million $0.03
Full Year Operating Results
Revenues: Lineage’s revenue is generated primarily from licensing fees, collaboration revenues, royalties, and research grants. Total revenues for the year ended December 31, 2023 were $8.9 million $5.8 million $14.7 million
Operating Expenses: Operating expenses are comprised of R&D expenses and G&A expenses. Total operating expenses for the year ended December 31, 2023 were $33.0 million $3.5 million $36.5 million
R&D Expenses: R&D expenses for the year ended December 31, 2023 were $15.7 million $1.7 million $14.0 million $0.4 million $1.2 million $2.0 million $1.9 million
G&A Expenses: G&A expenses for the year ended December 31, 2023 were $17.3 million $5.2 million $22.5 million $4.2 million
Loss from Operations: Loss from operations for the year ended December 31, 2023 was $24.7 million $2.2 million $22.5 million
Other Income/(Expenses), Net: Other income (expenses), net for the year ended December 31, 2023 reflected other income of $1.5 million ($3.3) million for the same period in 2022. The net change was primarily attributable to fluctuations in intercompany balances and related exchange rates applicable to Lineage’s international subsidiaries, as well as fair market value changes in marketable equity securities.
Net Loss Attributable to Lineage: The net loss attributable to Lineage for the year ended December 31, 2023 was $21.5 million $0.12 $26.3 million $0.15
Conference Call and Webcast
Interested parties may access the conference call on March 7th , 2024, by dialing (800) 715-9871 from the U.S. and Canada and should request the “Lineage Cell Therapeutics Call.” A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through March 14, 2024, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 8345585.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel or "off-the-shelf," cell therapies to address unmet medical needs. Lineage’s programs are based on its proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform, Lineage designs, develops, manufactures, and tests specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. These cells are created by applying directed differentiation protocols to established, well-characterized, and self-renewing pluripotent cell lines. These protocols generate cells with characteristics associated with specific and desired developmental lineages. Cells derived from such lineages are transplanted into patients in an effort to replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and to restore or augment the patient's functional activity. Lineage’s neuroscience focused pipeline currently includes: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development under a worldwide collaboration with Roche and Genentech, a member of the Roche Group, for the treatment of geographic atrophy secondary to age-related macular degeneration; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of spinal cord injuries; (iii) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage; and (v) RND1, a novel hypoimmune induced pluripotent stem cell line being developed in collaboration with Eterna Therapeutics Inc. For more information, please visit www.lineagecell.com or follow the company on X/Twitter @LineageCell .
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. Lineage’s forward-looking statements are based upon its current expectations and beliefs and involve assumptions that may never materialize or may prove to be incorrect. Such statements include, but are not limited to, statements relating to: the timing and availability of clinical data updates on the OpRegen program; the commencement of the DOSED clinical study for OPC1; that we will be able to continue to advance our business and programs in a responsible and fiscally conservative way; that our cash, cash equivalents and marketable securities is sufficient to support our planned operations into the third quarter of 2025; 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 clinical trials of our product candidates may not commence, progress or be completed as expected due to many factors within and outside of our control; 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 Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; that the ongoing Israel-Hamas war may materially and adversely impact our manufacturing processes, including cell banking and product manufacturing for our cell therapy product candidates, all of which are conducted by our subsidiary in Jerusalem, Israel ; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. All forward-looking statements are expressly qualified in their entirety by these cautionary statements.
LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS)
December 31,
December 31,
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$
35,442
$
11,355
Marketable securities
50
46,520
Accounts receivable, net
745
297
Prepaid expenses and other current assets
2,204
1,828
Total current assets
38,441
60,000
NONCURRENT ASSETS
Property and equipment, net
4,767
5,673
Deposits and other long-term assets
577
627
Goodwill
10,672
10,672
Intangible assets, net
46,562
46,692
TOTAL ASSETS
$
101,019
$
123,664
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable and accrued liabilities
$
6,270
$
8,608
Operating lease liabilities, current portion
830
916
Finance lease liabilities, current portion
52
36
Deferred revenues, current portion
10,808
9,421
Total current liabilities
17,960
18,981
LONG-TERM LIABILITIES
Deferred tax liability
273
2,076
Deferred revenues, net of current portion
18,693
27,725
Operating lease liabilities, net of current portion
1,979
2,860
Finance lease liabilities, net of current portion
91
84
Other long-term liabilities
—
2
TOTAL LIABILITIES
38,996
51,728
SHAREHOLDERS’ EQUITY
Preferred shares, no par value, 2,000 shares authorized; none issued and outstanding as of December 31, 2023 and 2022
—
—
Common shares, no par value, 450,000 and 250,000 shares authorized as of December 31, 2023 and 2022, respectively; 174,987 and 170,093 shares issued and outstanding as of December 31, 2023 and 2022, respectively
451,343
440,280
Accumulated other comprehensive loss
(3,068
)
(3,571
)
Accumulated deficit
(384,856
)
(363,370
)
Lineage's shareholders’ equity
63,419
73,339
Noncontrolling deficit
(1,396
)
(1,403
)
Total shareholders’ equity
62,023
71,936
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
$
101,019
$
123,664
LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE DATA)
Year Ended December 31,
2023
2022
REVENUES:
Collaboration revenues
$
7,588
$
13,367
Royalties, license and other revenues
1,357
1,336
Total revenues
8,945
14,703
Cost of sales
(671
)
(728
)
Gross profit
8,274
13,975
OPERATING EXPENSES:
Research and development
15,705
13,987
General and administrative
17,302
22,508
Total operating expenses
33,007
36,495
Loss from operations
(24,733
)
(22,520
)
OTHER INCOME (EXPENSES):
Interest income, net
1,629
829
Loss on marketable equity securities, net
(176
)
(2,194
)
Gain on revaluation of warrant liability
2
225
Other expenses, net
(4
)
(2,152
)
Total other income (expenses), net
1,451
(3,292
)
LOSS BEFORE INCOME TAXES
(23,282
)
(25,812
)
Provision for income tax benefit (expense)
1,803
(541
)
NET LOSS
(21,479
)
(26,353
)
Net (income) loss attributable to noncontrolling interest
(7
)
80
NET LOSS ATTRIBUTABLE TO LINEAGE
$
(21,486
)
$
(26,273
)
NET LOSS PER COMMON SHARE ATTRIBUTABLE TO LINEAGE
Basic and Diluted
$
(0.12
)
$
(0.15
)
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING:
Basic and Diluted
172,663
169,792
LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
Year Ended December 31,
2023
2022
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss attributable to Lineage Cell Therapeutics, Inc.
$
(21,486
)
$
(26,273
)
Net income (loss) allocable to noncontrolling interest
7
(80
)
Adjustments to reconcile net loss attributable to Lineage Cell Therapeutics, Inc. to net cash (used in) provided by operating activities:
Loss on marketable equity securities, net
176
2,194
Accretion of income on marketable debt securities
(679
)
(501
)
Depreciation expense, including amortization of leasehold improvements
562
582
Change in right-of-use assets and liabilities
91
(35
)
Amortization of intangible assets
130
145
Stock-based compensation
4,640
4,287
Gain on revaluation of warrant liability
(2
)
(225
)
Deferred income tax benefit
(1,803
)
—
Foreign currency remeasurement and other loss
602
2,272
Gain on sale of assets
(11
)
Changes in operating assets and liabilities:
Accounts receivable, net
(446
)
50,314
Prepaid expenses and other current assets
(418
)
446
Accounts payable and accrued liabilities
(2,295
)
(18,702
)
Deferred revenue
(7,645
)
(13,354
)
Net cash (used in) provided by operating activities
(28,566
)
1,059
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from the sale of marketable equity securities
196
—
Purchases of marketable debt securities
(16,403
)
(53,412
)
Maturities of marketable debt securities
63,330
7,666
Purchase of equipment
(674
)
(413
)
Net cash provided by (used in) investing activities
46,449
(46,159
)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from employee options exercised
88
648
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
)
(106
)
Repayment of finance lease liabilities
(54
)
(32
)
Net cash provided by financing activities
6,423
1,632
Effect of exchange rate changes on cash, cash equivalents and restricted cash
(250
)
(873
)
NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH
24,056
(44,341
)
CASH, CASH EQUIVALENTS AND RESTRICTED CASH:
At beginning of the period
11,936
56,277
At end of the period
$
35,992
$
11,936
View source version on businesswire.com: https://www.businesswire.com/news/home/20240307502626/en/
Lineage Cell Therapeutics, Inc. IR
ir@lineagecell.com )
LifeSci Advisors
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Russo Partners – Media Relations
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David.schull@russopartnersllc.com )
Source: Lineage Cell Therapeutics, Inc.
The company reported positive financial results with a slight increase in revenues for Q4 and a decrease in operating expenses.
Key developments included support for the ongoing Phase 2a clinical study of OpRegen in AMD patients.
Lineage received IND clearance for OPC1, enabling the initiation of a new clinical trial.
Lineage strengthened its balance sheet through a $14 million offering.
Lineage reported a net loss of $4.8 million for Q4.
Lineage reported a net loss of $21.5 million for the full year 2023.
