10-Q 1 form10-q.htm
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 30, 2022

 

OR

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from _________ to ________

 

Commission file number 001-12830

 

Lineage Cell Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

California   94-3127919

(State or other jurisdiction of

incorporation or organization)

 

(IRS Employer

Identification No.)

 

2173 Salk Avenue, Suite 200

Carlsbad, California 92008

(Address of principal executive offices) (Zip code)

 

(Registrant’s telephone number, including area code) (442) 287-8990

 

Securities registered pursuant to Section 12(b) of the Act

 

Title of each class   Trading Symbol   Name of exchange on which registered
Common shares   LCTX   NYSE American

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒ Yes ☐ No

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒ Yes ☐ No

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer ☐ Accelerated filer ☐
Non-accelerated filer Smaller reporting company
Emerging growth company  

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No

 

The number of common shares outstanding as of November 4, 2022 was 169,976,335

 

 

 

 
 

 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q (this “Report”) contains “forward-looking statements” (within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) that involve risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this Report are forward-looking statements. In some cases, you can identify forward-looking statements by words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” “would,” or the negative of these words or other comparable terminology. These forward-looking statements include, but are not limited to, statements relating to:

 

the Collaboration and License Agreement we entered into with F. Hoffmann-La Roche Ltd and Genentech, Inc., a member of the Roche Group, activities expected to occur thereunder, and the potential to receive the developmental, regulatory, and commercialization milestone and royalty payments thereunder;

 

our plans to research, develop and commercialize our product candidates;
   
the initiation, progress, success, cost and timing of our clinical trials and product development activities;
   
the therapeutic potential of our product candidates, and the disease indications for which we intend to develop our product candidates;
   
our ability to manufacture our product candidates for clinical development and, if approved, for commercialization, and the timing and costs of such manufacture;
   
the potential of our cell therapy platform, and our plans to apply our platform to research, develop and commercialize our product candidates;
   
the size and growth of the potential markets for our product candidates and our ability to serve those markets;
   
the potential scope and value of our intellectual property rights; and
   
the effects on our operations of pandemics, including the COVID-19 pandemic, the war in Ukraine, rising inflation and interest rates.

 

Forward-looking statements reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed and referenced under Part II, Item 1A, “Risk Factors” of this Report. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

 

2 | Page
 

 

PART I – FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(IN THOUSANDS)

 

   September 30, 2022    December 31, 2021 
   (Unaudited)     
ASSETS          
CURRENT ASSETS          
Cash and cash equivalents  $24,752   $55,742 
Marketable securities (Notes 4 and 5)   41,603    2,616 
Accounts and grants receivable, net (Note 3)   434    50,840 
Prepaid expenses and other current assets   1,720    2,351 
Total current assets   68,509    111,549 
           
NONCURRENT ASSETS          
Property and equipment, net (Notes 6 and 14)   4,652    4,872 
Deposits and other long-term assets   591    630 
Goodwill   10,672    10,672 
Intangible assets, net   46,724    46,822 
TOTAL ASSETS  $131,148   $174,545 
           
LIABILITIES AND SHAREHOLDERS’ EQUITY          
CURRENT LIABILITIES          
Accounts payable and accrued liabilities  $9,807   $27,969 
Lease liabilities, current portion (Note 14)   543    801 
Financing lease, current portion (Note 14)   25    30 
Deferred revenues (Note 3)   12,364    18,119 
Liability classified warrants, current portion   -    197 
Total current liabilities   22,739    47,116 
           
LONG-TERM LIABILITIES          
Deferred tax liability   2,076    2,076 
Deferred revenues, net of current portion (Note 3)   26,544    32,454 
Lease liability, net of current portion (Note 14)   2,216    1,941 
Financing lease, net of current portion (Note 14)   16    30 
Liability classified warrants and other long-term liabilities   4    30 
TOTAL LIABILITIES   53,595    83,647 
           
Commitments and contingencies (Note 14)   -      
           
SHAREHOLDERS’ EQUITY          
Preferred shares, no par value, authorized 2,000 shares; none issued and outstanding as of September 30, 2022 and December 31, 2021   -    - 
Common shares, no par value, 250,000 shares authorized; 169,886 and 169,477 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively   439,148    434,529 
Accumulated other comprehensive loss   (3,184)   (5,211)
Accumulated deficit   (357,016)   (337,097)
Lineage Cell Therapeutics, Inc. shareholders’ equity   78,948    92,221 
Noncontrolling (deficit)   (1,395)   (1,323)
Total shareholders’ equity   77,553    90,898 
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY  $131,148   $174,545 

 

See accompanying notes to the condensed consolidated interim financial statements.

 

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LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(IN THOUSANDS, EXCEPT PER SHARE DATA)

(UNAUDITED)

 

   2022   2021   2022   2021 
  

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

 
   2022   2021   2022   2021 
REVENUES:                    
Collaboration revenues  $2,592   $293   $11,605   $506 
Royalties   406    1,909    1,183    2,430 
Grant revenues   -    68    -    237 
Total revenues   2,998    2,270    12,788    3,173 
                     
Cost of sales   (235)   (985)   (626)   (1,222)
                     
Gross profit   2,763    1,285    12,162    1,951 
                     
OPERATING EXPENSES:                    
Research and development   3,592    2,811    9,883    9,136 
General and administrative   4,422    5,317    18,160    13,788 
Total operating expenses   8,014    8,128    28,043    22,924 
Loss from operations   (5,251)   (6,843)   (15,881)   (20,973)
OTHER INCOME/(EXPENSES):                    
Interest income (expense), net   384    1    435    (1)
Gain on sale of marketable securities   -    -    -    6,024 
Unrealized loss on marketable equity securities   (233)   (2,450)   (1,677)   (621)
Gain on extinguishment of debt   -    -    -    523 
Gain on revaluation of warrant liability   -    53    223    105 
Other income (expense), net   (475)   393    (2,550)   (318)
Total other income/(expense), net   (324)   (2,003)   (3,569)   5,712 
LOSS BEFORE INCOME TAXES   (5,575)   (8,846)   (19,450)   (15,261)
                     
Income tax (expense)/benefit   (541)   1,012    (541)   1,181 
NET LOSS   (6,116)   (7,834)   (19,991)   (14,080)
                     
Net loss attributable to noncontrolling interest   47    11    72    51 
                     
NET LOSS ATTRIBUTABLE TO LINEAGE CELL THERAPEUTICS, INC.  $(6,069)  $(7,823)  $(19,919)  $(14,029)
                     
NET LOSS PER COMMON SHARE:                    
BASIC  $(0.04)  $(0.05)  $(0.12)  $(0.09)
DILUTED  $(0.04)  $(0.05)  $(0.12)  $(0.09)
                     
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING:                    
BASIC   169,786    167,624    169,722    163,120 
DILUTED   169,786    167,624    169,722    163,120 

 

See accompanying notes to the condensed consolidated interim financial statements.

 

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LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(IN THOUSANDS)

(UNAUDITED)

 

   2022   2021   2022   2021 
  

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

 
   2022   2021   2022   2021 
NET LOSS  $(6,116)  $(7,834)  $(19,991)  $(14,080)
Other comprehensive loss, net of tax:                    
Foreign currency translation adjustment, net of tax   323    (382)   2,177    234 
Unrealized loss on marketable debt securities   (150)   -    (150)   - 
COMPREHENSIVE LOSS   (5,943)   (8,216)   (17,964)   (13,846)
Less: Comprehensive loss attributable to noncontrolling interest   47    11    72    51 
COMPREHENSIVE LOSS ATTRIBUTABLE TO LINEAGE CELL THERAPEUTICS, INC. COMMON SHAREHOLDERS  $(5,896)  $(8,205)  $(17,892)  $(13,795)

 

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LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(IN THOUSANDS)

(UNAUDITED)

 

   2022   2021 
   Nine Months Ended
September 30,
 
   2022   2021 
CASH FLOWS FROM OPERATING ACTIVITIES:          
Net loss attributable to Lineage Cell Therapeutics, Inc.  $(19,919)  $(14,029)
Net loss allocable to noncontrolling interest   (72)   (51)
Adjustments to reconcile net loss attributable to Lineage Cell Therapeutics, Inc. to net cash provided by (used in) operating activities:          
Gain on sale of marketable securities   -    (6,024)
Unrealized loss on marketable equity securities   1,677    621 
Gain on extinguishment of debt   -    (523)
Depreciation expense, including amortization of leasehold improvements   441    504 
Change in right-of-use assets and liabilities   (24)   19 
Amortization of intangible assets   113    178 
Accretion of income on marketable debt securities   (186)   - 
Stock-based compensation   3,328    2,601 
Common stock issued for services   -    202 
Gain on revaluation of warrant liability   (223)   (105)
Deferred tax benefit   -    (1,181)
Foreign currency remeasurement and other gain   2,668    295 
Changes in operating assets and liabilities:          
Accounts and grants receivable (Note 3)   50,206    (104)
Prepaid expenses and other current assets   517    (1,229)
Accounts payable and accrued liabilities (Note 8)   (17,573)   354 
Deferred revenue and other liabilities (Note 3)   (11,591)   784 
Net cash provided by (used in) operating activities   9,362    (17,688)
           
CASH FLOWS FROM INVESTING ACTIVITIES:          
Purchase of marketable debt securities   (40,628)   - 
Proceeds from the sale of OncoCyte common shares   -    10,064 
Proceeds from the sale of HBL common shares   -    21 
Purchase of equipment   (429)   (194)
Net cash (used in) provided by investing activities   (41,057)   9,891 
           
CASH FLOWS FROM FINANCING ACTIVITIES:          
Proceeds from employee options exercised   506    6,269 
Common shares received and retired for employee taxes paid   (17)   (41)
Proceeds from exercise of subsidiary warrants, net   991    - 
Proceeds from sale of common shares   148    30,741 
Payments for offering costs   (95)   (980)
Repayment of lease liability   (23)   (13)
Net cash provided by financing activities   1,510    35,976 
Effect of exchange rate changes on cash, cash equivalents and restricted cash   (795)   (34)
NET CHANGE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH   (30,980)   28,145 
CASH, CASH EQUIVALENTS AND RESTRICTED CASH:          
At beginning of the period   56,277    33,183 
At end of the period  $25,297   $61,328 
SUPPLEMENTAL DISCLOSURES          
Cash paid for interest  $13   $12 

 

See accompanying notes to the condensed consolidated interim financial statements.

 

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LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(UNAUDITED)

 

1. Organization and Business Overview

 

Lineage Cell Therapeutics, Inc. (“Lineage,” “we,” “us,” or “our”) is a clinical-stage biotechnology company developing novel cell therapies to address unmet medical needs. Our programs are based on our proprietary cell-based technology and associated development and manufacturing capabilities. From this platform, we design, develop, and manufacture specialized human cells with anatomical and physiological functions similar, or identical to, cells found naturally in the human body. These cells which we manufacture are created by developmental differentiation protocols that we apply to established, well-characterized, and self-renewing pluripotent cell lines. These functional cells are transplanted into patients and are designed to (a) replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury, or (b) help the body mount a more robust and effective immune response to cancer or infectious diseases.

 

Our strategy is to efficiently leverage our technology platform and our development, formulation, delivery, and manufacturing capabilities to advance our cell therapy programs internally or in certain cases in conjunction with strategic partners to further enhance their value. As one example, in December 2021, we entered into a Collaboration and License Agreement (the “Roche Agreement”) with F. Hoffmann-La Roche Ltd and Genentech, Inc., a member of the Roche Group (collectively, “Roche”), wherein we granted to Roche exclusive worldwide rights to develop and commercialize retinal pigment epithelium (“RPE”) cell therapies, including our proprietary cell therapy program known as OpRegen®, for the treatment of ocular disorders, including geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Under the terms of the Roche Agreement, Lineage received a $50.0 million upfront payment and is eligible to receive up to $620.0 million in certain developmental, regulatory, and commercialization milestone payments. Lineage also is eligible for tiered double-digit percentage royalties on net sales of OpRegen in the U.S. and other major markets.

 

As of September 30, 2022, we have five allogeneic, or “off-the-shelf,” cell therapy programs in development, of which three have reached clinical testing:

 

  OpRegen®, a retinal pigment epithelium (“RPE”) cell replacement therapy currently in a Phase 1/2a multicenter clinical trial for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), also known as atrophic AMD. There currently are no U.S. Food and Drug Administration (“FDA”) or European Medicines Agency (“EMA”) approved treatment options available for patients with GA. The Phase 1/2a trial enrolled 24 individuals with dry AMD and GA. In December 2021, this program was partnered with Roche for further clinical development and commercialization.
     
  OPC1, an oligodendrocyte progenitor cell treatment currently in long-term follow-up for a Phase 1/2a multicenter clinical trial for cervical spinal cord injuries (“SCI”). To date, five (5) patients with thoracic spinal cord injuries and twenty-five (25) patients with cervical spinal cord injuries have been enrolled in clinical trials of OPC1. The clinical development of OPC1 has been partially funded by $14.3 million received under a grant from the California Institute for Regenerative Medicine (“CIRM”).
     
 

VAC, an allogeneic cancer immunotherapy comprised of antigen-presenting dendritic cells. One of the VAC product candidates, VAC2, is currently in a Phase 1 clinical trial in non-small cell lung cancer (“NSCLC”). This clinical trial is being funded and conducted by Cancer Research UK, one of the world’s largest independent cancer research charities. We also have another VAC-based product candidate in preclinical development with our partner, Immunomic Therapeutics, Inc. (“ITI”), for the treatment of glioblastoma multiforme (“GBM”).

     
 

ANP1, an allogeneic auditory neuron progenitor cell transplant currently in preclinical development for the treatment of debilitating hearing loss (“DHL”).

     
  PNC1, an allogeneic photoreceptor cell transplant currently in preclinical development for the treatment of vision loss due to photoreceptor dysfunction or damage.

 

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We have additional, undisclosed product candidates being considered for development, which cover a range of therapeutic areas and unmet medical needs. Generally, these product candidates are based on the same pluripotent platform technology and employ a similar guided cell differentiation and transplant approach as the five product candidates detailed above, but in some cases may also include genetic modifications designed to enhance efficacy and safety profiles.

 

In addition to seeking to create value for shareholders by developing product candidates and other technologies through our clinical development programs, we also may seek to create value from our large patent estate and related technologies through partnering and/or strategic transactions. In addition to the Roche Agreement, we founded two companies based on Lineage’s intellectual property that later became publicly traded companies: OncoCyte Corporation (“OncoCyte”) and AgeX Therapeutics, Inc. (“AgeX”). We continue to hold common stock in OncoCyte as of September 30, 2022.

 

2. Basis of Presentation, Liquidity and Summary of Significant Accounting Policies

 

The unaudited condensed consolidated interim financial statements presented herein, and discussed below, have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. In accordance with those rules and regulations certain information and footnotes normally included in comprehensive consolidated financial statements have been condensed or omitted. The condensed consolidated balance sheet as of December 31, 2021 was derived from the audited consolidated financial statements at that date, but does not include all the information and footnotes required by GAAP. These condensed consolidated interim financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in Lineage’s Annual Report on Form 10-K for the year ended December 31, 2021 ( “2021 10-K”), as filed with the Securities and Exchange Commission (the “SEC”) on March 10, 2022.

 

The accompanying condensed consolidated interim financial statements, in the opinion of management, include all adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of Lineage’s financial condition and results of operations. The condensed consolidated results of operations are not necessarily indicative of the results to be expected for any other interim period or for the entire year.

 

Principles of consolidation

 

Lineage’s condensed consolidated interim financial statements include the accounts of its subsidiaries. All material intercompany accounts and transactions have been eliminated in consolidation. The following table reflects Lineage’s ownership, directly or through one or more subsidiaries of the outstanding shares of its subsidiaries as of September 30, 2022.

Schedule of Lineage's Ownership of Outstanding Shares of its Subsidiaries 

Subsidiary  Field of Business 

Lineage

Ownership

   Country 
Asterias BioTherapeutics, Inc.  Cell based therapeutics to treat neurological conditions and cancer   100%   USA 
Cell Cure Neurosciences Ltd.  Manufacturing of Lineage’s product candidates   94%(1)(2)   Israel 
ES Cell International Pte. Ltd.  Research and clinical grade cell lines   100%   Singapore 
OrthoCyte Corporation  Research in orthopedic diseases and injuries   99.8%   USA 

 

(1) Includes shares owned by Lineage and ES Cell International Pte. Ltd.
   
(2) As of December, 31, 2021 our ownership percentage of Cell Cure was approximately 99%. In July 2022, Hadasit Bio-Holdings Ltd. exercised warrants to purchase 21,999 ordinary shares of Cell Cure. Lineage’s ownership percentage of Cell Cure decreased as a result of the warrant exercise. As of September 30, 2022, our ownership percentage of Cell Cure was approximately 94%.

 

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As of September 30, 2022, Lineage consolidated its direct and indirect wholly owned or majority-owned subsidiaries because Lineage has the ability to control their operating and financial decisions and policies through its ownership, and the noncontrolling interest is reflected as a separate element of shareholders’ equity on Lineage’s consolidated balance sheets.

 

Liquidity

 

On September 30, 2022, we had $66.4 million of cash, cash equivalents and marketable securities. Based on our current operating plan, we believe that our cash, cash equivalents and marketable securities, together with our projected cash flows, will be sufficient to enable us to carry out our planned operations through at least twelve months from the issuance date of our consolidated financial statements included elsewhere in this Report.

 

Capital Resources

 

Since inception, we have incurred significant operating losses and have funded our operations primarily through the issuance of equity securities, the sale of common stock of our former subsidiaries, OncoCyte and AgeX, receipt of proceeds from research grants, revenues from collaborations, royalties from product sales, and sales of research products and services.

 

Our projected cash flows are subject to various risks and uncertainties, including those described and referenced under Part II, Item 1A, “Risk Factors” of this Report. See the discussion in Management’s Discussion and Analysis of Financial Condition and Results of Operations under “Cash Flows” for additional information regarding our sources of cash during the reporting period.

 

As of September 30, 2022, $63.8 million remained available for sale under our at the market offering program. See Note 11 (Shareholders’ Equity) to the condensed consolidated interim financial statements included in this Report for additional information.

 

We may use our marketable securities for liquidity as necessary and as market conditions allow. The market value of our marketable securities may not represent the amount that could be realized in a sale of such securities due to various market and regulatory factors, including trading volume, prevailing market conditions and prices at the time of any sale and subsequent sales of securities by the entities. In addition, the value of our marketable equity securities may be significantly and adversely impacted by deteriorating global economic conditions and the recent disruptions to and volatility in the credit and financial markets in the United States and worldwide resulting from the ongoing pandemics, including the COVID-19 pandemic, the conflict in Ukraine, rising inflation and interest rates, and other macroeconomic factors.

 

Additional Capital Requirements

 

Our financial obligations primarily consist of vendor contracts to provide research services and other purchase commitments with suppliers. In the normal course of business, we enter into services agreements with contract research organizations, contract manufacturing organizations and other third parties. Generally, these agreements provide for termination upon notice, with specified amounts due upon termination based on the timing of termination and the terms of the agreement. The amounts and timing of payments under these agreements are uncertain and contingent upon the initiation and completion of the services to be provided.

 

Our commitments also include obligations to our licensors under our in-license agreements, which may include sublicense fees, milestones fees, royalties, and reimbursement of patent maintenance costs. Sublicense fees are payable to licensors when we sublicense underlying intellectual property to third parties; the fees are based on a percentage of the license fees we receive from sublicensees. Milestone payments are due to licensors upon our future achievement of certain development and regulatory milestones. Royalties are payable to licensors based on a percentage of net sales of licensed products. Patent maintenance costs are payable to licensors as reimbursement for the cost of maintaining of license patents. Due to the contingent nature of the payments, the amounts and timing of payments to licensors under our in-license agreements are uncertain and may fluctuate significantly from period to period.

 

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Significant Accounting Policies

 

Marketable Debt Securities

 

Lineage accounts for its holdings of U.S. Treasury securities in accordance with Accounting Standards Codification (“ASC”) 320-10-50, Debt Securities. All marketable debt securities have been classified as “available-for-sale” and are carried at estimated fair value. Unrealized gains and losses are excluded from earnings and are included in other comprehensive income or loss and reported as a separate component of stockholders’ equity or deficit until realized. Realized gains or losses on available-for-sale debt securities are included in other income (expense), net. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion, together with interest on securities, are included in interest income on the Company’s condensed consolidated statement of operations. In accordance with the Company’s investment policy, management invests in debt securities with high credit quality, including U.S. government securities.

 

Lineage reviews all its investments for other-than-temporary declines in estimated fair value. Our review includes the consideration of the cause of the impairment, including the creditworthiness of the security issuers, the number of securities in an unrealized loss position, the severity and duration of the unrealized losses, whether the Company has the intent to sell the security. If a credit loss does exist for available-for-sale debt securities and should be recognized, an allowance will be recorded rather than a write-down to the amortized costs basis. To date, no such credit losses have occurred or have been recorded. See Note 4 (Marketable Debt Securities) for additional information.

 

Marketable Equity Securities

 

Lineage accounts for the shares it holds in OncoCyte and Hadasit Bio-Holdings Ltd (“HBL”) as marketable equity securities in accordance with ASC 320-10-25, Investments – Debt and Equity Securities, as amended by Accounting Standards Update (“ASU”) 2016-01, Financial Instruments–Overall: Recognition and Measurement of Financial Assets and Financial Liabilities, further discussed below.

 

The OncoCyte shares have a readily determinable fair values quoted on the NYSE American under trading symbol “OCX”. The HBL shares have a readily determinable fair value quoted on the Tel Aviv Stock Exchange (“TASE”) under the trading symbol “HDST” where share prices are denominated in New Israeli Shekels (NIS). See Note 5 (Marketable Equity Securities) for additional information.

 

Revenue Recognition

 

Lineage recognizes revenue in accordance with Financial Accounting Standards Board (“FASB”) ASU 2014-09, Revenues from Contracts with Customers (Topic 606), and in a manner that depicts the transfer of control of a product or a service to a customer and reflects the amount of the consideration it is entitled to receive in exchange for such product or service. In doing so, Lineage follows a five-step approach: (i) identify the contract with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations; and (v) recognize revenue when (or as) the customer obtains control of the product or service. Lineage considers the terms of a contract and all relevant facts and circumstances when applying the revenue recognition standard. Lineage applies the revenue recognition standard, including the use of any practical expedients, consistently to contracts with similar characteristics and in similar circumstances.

 

In applying the provisions of ASU 2014-09, Lineage has determined that government grants are out of the scope of ASU 2014-09 because the government entities do not meet the definition of a “customer,” as defined by ASU 2014-09, as there is not considered to be a transfer of control of goods or services to the government entities funding the grant. In the absence of applicable guidance under GAAP, the Company’s policy is to recognize grant revenue when the related costs are incurred and the right to payment is realized. Costs incurred are recorded in research and development and general and administrative expenses on the accompanying statements of operations.

 

Deferred grant revenues represent grant funds received from the governmental funding agencies for which the allowable expenses have not yet been incurred as of the latest balance sheet date reported.

 

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Royalties from Product Sales and License Fees

 

For agreements that include sales-based royalties, including commercial milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, Lineage recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Lineage estimates and recognizes royalty revenues based on all available information, including estimates provided by the customer or licensee from which Lineage obtains such estimates directly for each reporting period. Actual revenues ultimately received may differ from those estimates recorded and are adjusted in the period when information to actuals is available to Lineage.

 

Collaborative Agreements

 

In December 2021, Lineage entered into the Roche Agreement for the development and commercialization of OpRegen. Under the terms of the Roche Agreement, Roche agreed to pay Lineage a $50.0 million upfront payment and Lineage is eligible to receive up to an additional $620.0 million in certain developmental, regulatory and commercialization milestone payments. Lineage is also eligible to receive tiered double-digit percentage royalties on net sales of OpRegen. See Note 14 (Commitments and Contingencies) for additional information regarding this agreement.

 

In April 2021, Lineage entered a worldwide license and collaboration agreement with Immunomic Therapeutics, Inc. for the development and commercialization of an allogeneic version of an immunomic oncology target utilizing the VAC platform. Under the terms of this agreement, Lineage is entitled to upfront licensing fees totaling up to $2.0 million, and up to $67.0 million in development and commercial milestones across multiple indications. Lineage also will be eligible to receive royalties up to 10% on net sales of future products.

 

As of September 30, 2022, we recorded $38.1 million and $0.8 million of deferred revenue on the condensed consolidated balance sheet, related to the collaboration agreements with each of Roche and Immunomic Therapeutics, Inc., respectively. For the three and nine months ended September 30, 2022, we recognized $2.6 million and $11.6 million of revenue, respectively, on the condensed statement of operations, related to the Roche Agreement. See Note 3 (Revenue) for additional information.

 

We review collaborative agreements to determine if the accounting treatment falls under Accounting Standards Codification, Topic 606, Revenue from Contracts with Customers (“ASC 606”), or Accounting Standards Codification Topic 808, Collaborative Arrangements (“ASC 808”). While these agreements may be within the scope of ASC 808, we may analogize to ASC 606 for some aspects of the agreements.

 

The terms of our collaborative agreements typically include one or more of the following: (i) upfront fees; (ii) milestone payments related to achievement of development or commercial milestones; (iii) royalties on net sales of licensed products; and (iv) reimbursement of cost-sharing of research and development (“R&D”) expenses. Each of these payments eventually result in collaboration revenues. When a portion of non-refundable upfront fees or other payments received are allocated to continuing performance obligations under the terms of a collaborative agreement, they are recorded as deferred revenue and recognized as collaboration revenue when (or as) the underlying performance obligation is satisfied.

 

To identify the performance obligations within the collaboration agreements, we first identify all the promises in the contract (i.e. explicit and implicit), which may include a customer option to acquire additional goods or services for free or at a discount. We exclude any immaterial promises from the assessment of identifying performance obligations. When an option is identified as providing a customer with a material right, the option is identified as a performance obligation. A portion of the transaction price is then allocated to the option and recognized when (or as) the future goods or services related to the option are provided, or when the option expires.

 

As part of the accounting treatment for these agreements, we must develop estimates and assumptions that require judgement to determine the underlying stand-alone selling price for each performance obligation which determines how the transaction price is allocated among the performance obligations. The following items are estimated in the calculation of the stand-alone selling price: forecasted revenues and development costs, development timelines, discount rates and probabilities of technical and regulatory success. We evaluate each performance obligation to determine if they can be satisfied at a point in time or over time, and we measure the services delivered to our collaboration partners each reporting period, which is based on the progress of the related program. If necessary, we adjust the measure of performance and related revenue recognition. Any such adjustments are recorded on a cumulative catch-up basis which would affect revenue and net income (loss) in the period of adjustment. In addition, variable consideration (e.g., milestone payments) must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price.

 

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Upfront Fees: If a license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize collaboration revenues from the transaction price allocated to the license when the license is transferred to the licensee, and the licensee is able to use and benefit from the license. When the license is determined to be non-distinct, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time, and, if over time, the appropriate method of measuring progress for purposes of recognizing collaboration revenue from the allocated transaction price. For example, when we receive upfront fees for the performance of research and development services, or when research and development services are not considered to be distinct from a license, we recognize collaboration revenue for those units of account over time using a measure of progress. We evaluate the measure of progress at each reporting period and, if necessary, adjust the measure of performance and related revenue as a change in estimate.

 

Milestone Payments: At the inception of each collaboration agreement that includes milestone payments (variable consideration), we evaluate whether the milestones are considered probable of being reached and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within our or the collaboration partner’s control, such as non-operational developmental and regulatory approvals, are generally not considered probable of being achieved until those approvals are received. At the end of each reporting period, we re-evaluate the probability of achievement of milestones that are within our or the collaboration partner’s control, such as operational developmental milestones and any related constraint, and if necessary, adjust our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaboration revenues and net income (loss) in the period of adjustment. Revisions to our estimate of the transaction price may also result in negative collaboration revenues and net income (loss) in the period of adjustment.

 

Royalties: For collaboration agreements that include sales-based royalties, including commercial milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, we recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).

 

Reimbursement, cost-sharing payments: Under certain collaborative agreements, we will receive reimbursement for a portion of our R&D expenses. Such reimbursements are reviewed for gross versus net reporting considerations and reflected either as a reduction of R&D expense or as reimbursement revenue in our consolidated statements of operations.

 

Accounts and Grant Receivable, net

 

Net accounts receivable amounted to $0.4 million and $50.6 million as of September 30, 2022 and December 31, 2021, respectively. Net accounts receivable include an allowance for doubtful accounts of approximately $0.1 million as of September 30, 2022 and December 31, 2021, for those amounts deemed uncollectible. Lineage establishes an allowance for doubtful accounts based on the evaluation of the collectability of its receivables on a variety of factors, including the length of time receivables are past due, significant events that may impair the customer’s ability to pay, such as a bankruptcy filing or deterioration in the customers operating results or financial position, and historical experience. If circumstances related to customers change, estimates of the recoverability of receivables would be further adjusted.

 

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Basic and diluted net income (loss) per share attributable to common shareholders

 

Basic earnings per share is calculated by dividing net income or loss attributable to Lineage common shareholders by the weighted average number of common shares outstanding, net of unvested restricted stock or restricted stock units, subject to repurchase by Lineage, if any, during the period. Diluted earnings per share is calculated by dividing the net income or loss attributable to Lineage common shareholders by the weighted average number of common shares outstanding, adjusted for the effects of potentially dilutive common shares issuable under outstanding stock options and warrants, using the treasury-stock method, convertible preferred stock, if any, using the if-converted method, and treasury stock held by subsidiaries, if any.

 

For the three and nine months ended September 30, 2022 and 2021, respectively, Lineage reported a net loss attributable to common shareholders, and therefore, all potentially dilutive common shares were considered antidilutive for those periods.

 

The following common share equivalents were excluded from the computation of diluted net loss per common share for the periods presented because including them would have been antidilutive (in thousands):

 

   Nine Months Ended
September 30,
(unaudited)
 
   2022   2021 
Stock options   17,972    17,207 
Restricted stock units   939    46 

 

Cash and cash equivalents

 

Lineage considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. As of September 30, 2022 and December 31, 2021, Lineage had $14.7 million and $52.3 million in U.S. Treasuries securities and money market funds, respectively, considered to be cash equivalents.

 

Restricted Cash

 

In accordance with ASU 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash, Lineage explains the change during the period in the total of cash, cash equivalents and restricted cash, and includes restricted cash in cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the condensed consolidated statements of cash flows.

 

The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the condensed consolidated balance sheet dates that comprise the total of the same such amounts shown in the condensed consolidated statements of cash flows for all periods presented herein (in thousands):

 

   September 30,
2022
   December 31,
2021
 
   (unaudited)     
Cash and cash equivalents  $24,752   $55,742 
Restricted cash included in deposits and other current assets (see Note 14 (Commitments and Contingencies))   545    535 
Total cash, cash equivalents, and restricted cash as shown in the condensed consolidated statements of cash flows  $25,297   $56,277 

 

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Stock-Based Compensation

 

Lineage follows accounting standards governing share-based payments in accordance with ASC 718, Compensation – Stock Compensation, which require the measurement and recognition of compensation expense for all share-based payment awards made to directors and employees based on estimated fair values.

 

For employee and director stock options, we utilize the Black-Scholes option pricing model for valuing share-based payment awards. Lineage’s determination of fair value of share-based payment awards on the date of grant using that option-pricing model is affected by the price of Lineage’s common shares as well as by assumptions regarding a number of complex and subjective variables. These variables include, but are not limited to, expected stock price volatility over the term of the awards, and the expected term of options granted, which is derived using the simplified method, which is an average of the contractual term of the option and its vesting period, as we do not have sufficient historical exercise data upon which to estimate expected term. The risk-free rate is based on the U.S. Treasury yield in effect at the time of grant for zero coupon U.S. Treasury notes with maturities similar to the expected term of the awards. Stock option forfeitures are accounted for as they occur.

 

For restricted stock unit awards (“RSUs”) subject to service and/or performance vesting conditions, the grant-date fair value is established based on the closing price of Lineage’s common shares on such date. Stock-based compensation expense for RSUs subject to only service conditions is recognized on a straight-line basis over the service period. Stock-based compensation expense for RSUs with both service and performance conditions is recognized on a graded basis only if it is probable that the performance condition will be achieved. Lineage accounts for forfeitures of RSUs as they occur in determining stock-based compensation expense. For RSUs subject to a market condition, the grant-date fair value is estimated using a Monte Carlo valuation model. The model is based on random projections of stock price paths and must be repeated numerous times to achieve a probabilistic assessment. Lineage recognizes stock-based compensation expense for RSUs subject to market-based vesting conditions regardless of whether it becomes probable that the vesting conditions will be achieved, and stock-based compensation expense for such RSUs is not reversed if vesting does not actually occur.

 

Although the fair value of employee stock options and RSUs are determined in accordance with FASB guidance, changes in the assumptions can materially affect the estimated value and therefore the amount of compensation expense recognized in the condensed consolidated interim financial statements.

 

Recently Issued Accounting Pronouncements Not Yet Adopted

 

The following recently issued accounting pronouncement that is not yet effective should be read in conjunction with the recently issued accounting pronouncements discussed in the 2021 10-K.

 

In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. ASU 2016-13 is intended to provide financial statement users with more decision-useful information about the expected credit losses on financial instruments and other commitments and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. ASU 2016-13 is effective for Lineage beginning January 1, 2023. We are currently assessing the new guidance and we believe this will not have a significant impact on our consolidated financial statements.

 

In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting. This ASU provides optional guidance for a limited period of time to ease the burden in accounting for (or recognizing the effects of) reference rate reform on financial reporting. This would apply to companies meeting certain criteria that have contracts, hedging relationships and other transactions that reference LIBOR or another reference rate expected to be discontinued because of reference rate reform. This standard is effective for us immediately and may be applied prospectively to contract modifications made and hedging relationships entered into or evaluated on or before December 31, 2022. In April 2022, the FASB proposed extending the sunset date of this guidance to December 31, 2024. We are currently assessing the impact the new guidance will have on our consolidated financial statements and disclosures.

 

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3. Revenue

 

Our disaggregated revenues were as follows for the periods presented (in thousands):

 

  

Three Months Ended

September,

  

Nine Months Ended

September 30,

 
   2022   2021   2022   2021 
Royalties  $406   $1,909   $1,183   $2,430 
                     
Grant revenues                    
Israel Innovation Authority (“IIA”)   -    68    -    237 
Total grant revenues   -    68    -    237 
                     
Revenues from collaborative agreements                    
Upfront license fees   2,592    36    11,605    72 
Event-based development milestones   -    72    -    72 
Reimbursements, cost-sharing payments   -    185    -    362 
Total revenues from collaborative agreements   2,592    293    11,605    506 
                     
Total revenue  $2,998   $2,270   $12,788   $3,173 

 

During the three months ended September 30, 2022, we recognized $3.0 million in total revenue, of which $2.6 million was recognized in collaboration revenues related to the $50.0 million upfront payment from Roche, which was included in deferred revenues at December 31, 2021.

 

During the nine months ended September 30, 2022, we recognized $12.8 million in total revenue, of which $11.6 million was recognized in collaboration revenues related to the $50.0 million upfront payment from Roche, which was included in deferred revenues at December 31, 2021.

 

We are recognizing the $50.0 million upfront payment under the Roche Agreement, utilizing an input method of costs incurred over total estimated costs to be incurred.

 

Accounts receivable and other receivable, net, and deferred revenues (contract liabilities) from contracts with customers, including collaboration partners, consisted of the following (in thousands):

 

  

September 30,

2022

  

December 31,

2021

 
   (unaudited)     
Accounts receivable and other receivable, net (1)(2)  $435   $50,640 
Deferred revenues (2)   38,908    50,500 

 

  (1) Accounts receivable and other receivable, net, decreased primarily due to the receipt of the $50.0 million upfront payment under the Roche Agreement, received in January 2022. See Note 14 (Commitments and Contingencies).
     
  (2) Excludes government grants as Lineage has determined government grants are outside the scope of ASU 2014-09 – Revenue from Contracts with Customers (Topic 606).

 

As of September 30, 2022, the amounts in the transaction price of our contracts with customers, including collaboration partners, and allocated goods and services not yet provided were $40.5 million, of which $38.9 million has been collected and is reported as deferred revenues, and $1.6 million relates to unfulfilled commitments related to the ITI collaboration (see Note 14 (Commitments and Contingencies) for additional information), the latter is currently estimated to be delivered by the end of the third quarter of 2023. Of the total deferred revenues of $38.9 million, approximately $12.4 million is expected to be recognized within the next 12 months.

 

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4. Marketable Debt Securities

 

The following table is a summary of available-for-sale debt securities in cash and cash equivalents or marketable securities in the Company’s condensed consolidated balance sheet as of September 30, 2022 (in thousands):

 

   September 30, 2022
(unaudited)
 
Financial Assets: 

Amortized

Cost

  

Unrealized

Gains

  

Unrealized

Losses

  

Fair

Value

 
U.S. Treasury securities  $48,646   $1   $(151)  $48,496 
Total   48,646    1    (151)   48,496 

 

The Company has not recognized an allowance for credit losses on any securities in an unrealized loss position as of September 30, 2022. We believe that the individual unrealized losses represent temporary declines resulting from changes in interest rates, and we intend to hold these marketable securities to their maturity.

 

As of September 30, 2022, the amortized cost and estimated fair value of the Company’s available-for-sale securities by contractual maturity are shown below (in thousands):

 

  

Amortized

Cost

  

Estimated

Fair Value

 
   (unaudited)     
Available-for-sale securities maturing:          
In one year or less  $48,646   $48,496 
Total available-for-sale securities   48,646    48,496 

 

The Company currently does not intend to sell these securities prior to maturity and does not consider these investments to be other-than-temporarily impaired at September 30, 2022.

 

As of September 30, 2022 the Company had $7.8 million in marketable debt securities which were classified as cash equilavents on the condensed consolidated balance sheet. As of December 31, 2021 the Company did not have any available-for-sale debt securities.

 

5. Marketable Equity Securities

 

As of September 30, 2022, Lineage owned 1.1 million shares of OncoCyte common stock, which had a fair value of $0.8 million as of that date, based on the closing price of OncoCyte common stock of $0.73 per share on that date.

 

As of December 31, 2021, Lineage owned 1.1 million shares of OncoCyte common stock, which had a fair value of $2.4 million as of that date, based on the closing price of OncoCyte common stock of $2.17 per share on that date.

 

For the three months ended September 30, 2022, Lineage recorded a net unrealized loss on marketable equity securities of $0.2 million related to changes in fair market value of OncoCyte common stock price during the quarter. For the three months ended September 30, 2021, Lineage recorded a net unrealized loss on marketable equity securities of $2.5 million related to changes in fair market value of OncoCyte’s common stock price during the quarter.

 

For the nine months ended September 30, 2022, Lineage recorded a net unrealized loss on marketable equity securities of $1.6 million related to changes in fair market value of OncoCyte common stock price during the period. For the nine months ended September 30, 2021, Lineage recorded a realized gain of $6.0 million due to sales of OncoCyte shares in the period. Lineage also recorded a net unrealized loss on marketable equity securities of $0.6 million related to changes in fair market value of OncoCyte’s common stock price during the period.

 

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All share prices are determined based on the closing price of OncoCyte common stock on the NYSE American on the last day of the applicable quarter, or the last trading day of the applicable quarter, if the last day of a quarter fell on a day that was not a trading day.

 

6. Property and Equipment, Net

 

At September 30, 2022 and December 31, 2021, property and equipment, net was comprised of the following (in thousands):

  

  

September 30,

2022

  

December 31,

2021

 
   (unaudited)     
Equipment, furniture and fixtures  $3,389   $3,472 
Leasehold improvements   2,338    2,539 
Right-of-use assets   4,737    4,163 
Accumulated depreciation and amortization   (5,812)   (5,302)
Property and equipment, net  $4,652   $4,872 

 

Property and equipment, net at September 30, 2022 and December 31, 2021, includes $79,000 in financing leases, which were fully amortized.

 

Depreciation and amortization expense amounted to $145,000 and $165,000 for the three months ended September 30, 2022 and 2021, respectively, and $441,000 and $504,000 for the nine months ended September 30, 2022 and 2021, respectively.

 

7. Goodwill and Intangible Assets, Net

 

At September 30, 2022 and December 31, 2021, goodwill and intangible assets, net consisted of the following (in thousands):

 

  

September 30,

2022

   December 31,
2021
 
   (unaudited)     
Goodwill (1)  $10,672   $10,672 
           
Intangible assets:          
Acquired IPR&D – OPC1 (from the Asterias Merger) (2)  $31,700   $31,700 
Acquired IPR&D – VAC (from the Asterias Merger) (2)   14,840    14,840 
Intangible assets subject to amortization:          
Acquired patents   18,953    18,953 
Acquired royalty contracts (3)   650    650 
Total intangible assets   66,143    66,143 
Accumulated amortization (4)   (19,419)   (19,321)
Intangible assets, net  $46,724   $46,822 

 

(1) Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired and liabilities assumed in the Asterias Merger (see Note 14 (Commitments and Contingencies) for additional information on the Asterias Merger).
   
(2)

Asterias had two in-process research and development (“IPR&D”) intangible assets that were valued at $46.5 million as part of the purchase price allocation that was performed in connection with the Asterias Merger. The fair value of these assets consisted of $31.7 million pertaining to the OPC1 program and $14.8 million pertaining to the VAC platform.

 

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(3)

Asterias had royalty cash flows under certain specific patent families it acquired from Geron Corporation. Such patents are expected to continue to generate revenue, are not used in the OPC1 or the VAC platform and are considered to be separate long-lived intangible assets under ASC 805.

 

(4)

As of September 30, 2022 acquired patents were fully amortized and the acquired royalty contracts had a remaining unamortized balance of approximately $184,000.

 

Lineage amortizes its intangible assets over an estimated period of 5 to 10 years on a straight-line basis. Lineage recognized approximately $33,000 and $33,000 in amortization expense of intangible assets during the three months ended September 30, 2022 and 2021, respectively, and $98,000 and $178,000 during the nine months ended September 30, 2022 and 2021, respectively.

 

Amortization of intangible assets for periods subsequent to September 30, 2022 is as follows (in thousands):

 

Year Ended December 31,  Amortization
Expense
 
2022  $      32 
2023   130 
2024   22 
Total  $184 

 

8. Accounts Payable and Accrued Liabilities

 

At September 30, 2022 and December 31, 2021, accounts payable and accrued liabilities consisted of the following (in thousands):

 

  

September 30,

2022

  

December 31,

2021

 
   (unaudited)     
Accounts payable  $2,865   $3,543 
Accrued compensation   1,914    2,162 
Accrued liabilities (1)   5,003    22,086 
Other current liabilities   25    178 
Total  $9,807   $27,969 

 

(1) The decrease in accrued liabilities was primarily due to a $21.0 million payment by Lineage in accordance with its obligations related to the Roche Agreement (see Note 14 (Commitments and Contingencies)), offset with accrual of litigation settlement amount of $3.5 million (see Note 14 (Commitments and Contingencies)).

 

9. Fair Value Measurements

 

Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. To increase the comparability of fair value measures, the following hierarchy prioritizes the inputs to valuation methodologies used to measure fair value (ASC 820-10-50), Fair Value Measurements and Disclosures:

 

  Level 1 – Inputs to the valuation methodology are quoted prices for identical assets or liabilities in active markets.

 

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Level 2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

 

  Level 3 – Inputs to the valuation methodology are unobservable; that reflect management’s own assumptions about the assumptions market participants would make and significant to the fair value.

 

We have not transferred any instruments between the three levels of the fair value hierarchy.

 

We measure our money market fund, marketable securities and our liability classified warrants at fair value on a recurring basis. The fair values of such assets were as follows at September 30, 2022 and December 31, 2021 (in thousands):

 

       Fair Value Measurements Using 
   Balance at
September 30, 2022
   Quoted Prices
in Active Markets
for Identical Assets
(Level 1)
   Significant Other
Observable Inputs
(Level 2)
   Significant
Unobservable Inputs
(Level 3)
 
Assets:                    
Money market fund (1)  $6,909   $6,909   $-   $- 
Marketable debt securities   48,496    48,496                 
Marketable equity securities   940    940    -    - 
Liabilities:                              
Warrants to purchase Cell Cure ordinary shares   4    -    -    4 

 

       Fair Value Measurements Using 
   Balance at
December 31, 2021
  

Quoted Prices
in Active Markets
for Identical Assets

(Level 1)

  

Significant Other
Observable Inputs

(Level 2)

  

Significant
Unobservable Inputs

(Level 3)

 
Assets:                    
Money market fund (1)  $52,324   $52,324   $-   $- 
Marketable equity securities   2,616    2,616    -    - 
Liabilities:                                   
Warrants to purchase Cell Cure ordinary shares   227    -    -    227 

 

(1) Included in cash and cash equivalents in the accompanying condensed consolidated balance sheet.

 

In determining the fair value of the warrants to purchase ordinary shares of Cell Cure, Lineage utilizes a Black-Scholes pricing model that maximizes the use of observable inputs and minimizes the use of unobservable inputs to the extent possible, and also considers counterparty credit risk in its assessment of fair value. The significant unobservable inputs used in the fair value measurement of such warrants are volatility and share value. A significant increase or decrease in these inputs could result in a significantly higher or lower fair value measurements.

 

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The following table sets forth the establishment of the fair value of these warrants, as well as a summary of the changes in the fair value and other adjustments (in thousands):

 

  

Cell Cure

Warrants

 
Balance as of December 31, 2021  $227 
Change in fair value and other adjustments   (223)
Expiration of warrants   - 
Balance as of September 30, 2022  $4 

 

Lineage’s marketable equity securities includes the shares of stock of OncoCyte and HBL. Both of these securities have readily determinable fair values quoted on the NYSE American or TASE. These securities are measured at fair value and reported as current assets on the accompanying condensed consolidated balance sheets based on the closing trading price of the security as of the date being presented.

 

The fair value of Lineage’s assets and liabilities, which qualify as financial instruments under FASB guidance regarding disclosures about fair value of financial instruments, approximate the carrying amounts presented in the accompanying consolidated balance sheets.

 

10. Related Party Transactions

 

In connection with the putative shareholder class action lawsuits filed in February 2019 and October 2019 challenging the Asterias Merger (see Note 14 (Commitments and Contingencies)), Lineage agreed to pay the expenses for the legal defense of Neal Bradsher, a member of the Lineage board of directors, Broadwood Partners, L.P., a shareholder of Lineage, and Broadwood Capital, Inc., which serves as the general partner of Broadwood Partners, L.P., all of which were named defendants in the lawsuits, prior to being dismissed. Through September 30, 2022, Lineage has incurred a total of approximately $620,000 in legal expenses on behalf of the foregoing parties.

 

11. Shareholders’ Equity

 

Preferred Shares

 

Lineage is authorized to issue 2,000,000 preferred shares, no par value. The preferred shares may be issued in one or more series as the Lineage board of directors may determine by resolution. The Lineage board of directors is authorized to fix the number of shares of any series of preferred shares and to determine or alter the rights, preferences, privileges, and restrictions granted to or imposed on the preferred shares as a class, or upon any wholly unissued series of any preferred shares. The Lineage board of directors may, by resolution, increase or decrease (but not below the number of shares of such series then outstanding) the number of shares of any series of preferred shares subsequent to the issue of shares of that series. As of September 30, 2022 and December 31, 2021, there were no preferred shares issued or outstanding.

 

Common Shares

 

Lineage is authorized to issue 250,000,000 common shares, no par value. As of September 30, 2022 and December 31, 2021, there were 169,886,335 and 169,477,347 common shares issued and outstanding, respectively.

 

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At The Market Offering Program

 

In May 2020, Lineage entered into a Controlled Equity OfferingSM Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co., as sales agent (“Cantor Fitzgerald”), pursuant to which Lineage may sell its common shares from time to time through an “at the market offering” (“ATM”) program under the Sales Agreement.

 

In March 2021, Lineage filed a prospectus supplement with the SEC in connection with the offer and sale of $25.0 million of common shares through the ATM program under the Sales Agreement (“March 2021 Prospectus Supplement”).

 

In December 2021, Lineage filed a prospectus supplement with the SEC in connection with the offer and sale of up to $64.1 million of common shares (which included $14.1 million of its common shares which then remained unsold under the March 2021 Prospectus Supplement) through the ATM program under the Sales Agreement (“December 2021 Prospectus Supplement”). No further sales will be made under the March 2021 Prospectus Supplement.

 

As of September 30, 2022, Lineage had sold 108,200 common shares under the December 2021 Prospectus Supplement at a weighted average price per share of $2.55 for gross proceeds of $0.3 million. As of September 30, 2022, $63.8 million remained available for sale under the December 2021 Prospectus Supplement. In the third quarter of 2022, no shares were sold through the ATM program.

 

The shares offered under the December 2021 Prospectus Supplement are registered pursuant to Lineage’s effective shelf registration statement on Form S-3 (File No. 333-237975), which was filed with the SEC on May 1, 2020 and declared effective on May 8, 2020, and Lineage’s effective shelf registration statement on Form S-3 (File No. 333-254167), which was filed with the SEC on March 5, 2021 and declared effective on March 19, 2021.

 

Lineage agreed to pay Cantor Fitzgerald a commission of 3.0% of the aggregate gross proceeds from the sale of shares under the Sales Agreement, reimburse its legal fees and disbursements, and provide Cantor Fitzgerald with customary indemnification and contribution rights. The Sales Agreement may be terminated by Cantor Fitzgerald or Lineage at any time upon notice to the other party, or by Cantor Fitzgerald at any time in certain circumstances, including the occurrence of a material and adverse change in Lineage’s business or financial condition that makes it impractical or inadvisable to market the shares or to enforce contracts for the sale of the shares.

 

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Reconciliation of Changes in Shareholders’ Equity

 

The following tables document the changes in shareholders’ equity for the three and nine months ended September 30, 2022 and 2021 (unaudited and in thousands):

 

   Shares   Amount   Shares   Amount   Deficit   (Deficit)   Income/(Loss)   Equity 
  

 

               Accumulated     
   Preferred Shares   Common Shares       Noncontrolling   Other   Total 
   Number of       Number of       Accumulated   Interest/   Comprehensive   Shareholders’ 
   Shares   Amount   Shares   Amount   Deficit   (Deficit)   Income/(Loss)   Equity 
BALANCE AT DECEMBER 31, 2021   -   $-    169,477   $434,529   $(337,097)  $(1,323)  $(5,211)  $90,898 
Shares issued upon vesting of restricted stock units, net of shares retired to pay employees’ taxes   -    -    10    (8)   -    -    -    (8)
Shares issued upon exercise of stock options   -    -    240    189    -    -    -    189 
Subsidiary warrant exercise   -    -    -    2    -    -    -    2 
Stock-based compensation   -    -    -    1,106    -    -    -    1,106 
Foreign currency translation gain   -    -    -    -    -    -    124    124 
NET LOSS   -    -    -    -    (7,087)   (6)   -    (7,093)
BALANCE AT MARCH 31, 2022   -   $-    169,727   $435,818   $(344,184)  $(1,329)  $(5,087)  $85,218 
Shares issued upon vesting of restricted stock units, net of shares retired to pay employees’ taxes   -    -    10    (9)   -    -    -    (9)
Shares issued upon exercise of stock options   -    -    11    10    -    -    -    10 
Subsidiary warrant exercise, net   -    -    -    97    -    -    -    97 
Stock-based compensation   -    -    -    1,235    -    -    -    1,235 
Foreign currency translation gain   -    -    -    -    -    -    1,730    1,730 
NET LOSS   -    -    -    -    (6,763)   (19)   -    (6,782)
BALANCE AT JUNE 30, 2022   -   $-    169,748   $437,151   $(350,947)  $(1,348)  $(3,357)  $81,499 
Shares issued upon exercise of stock options   -    -    138    118    -    -    -    118 
Subsidiary warrant exercise, net   -    -    -    892    -    -    -    892 
Stock-based compensation   -    -    -    987    -    -    -    987 
Unrealized loss on marketable securities   -    -    -    -    -    -    (150)   (150)
Foreign currency translation gain   -    -    -    -    -    -    323    323 
NET LOSS              -            -    -    -    (6,069)   (47)   -    (6,116)
BALANCE AT SEPTEMBER 30, 2022   -   $-    169,886   $439,148   $(357,016)  $(1,395)  $(3,184)  $77,553 

 

                   Accumulated     
   Preferred Shares   Common Shares       Noncontrolling   Other   Total 
   Number of       Number of      Accumulated   Interest/   Comprehensive   Shareholders’ 
   Shares   Amount   Shares   Amount   Deficit   (Deficit)   Income/(Loss)   Equity 
BALANCE AT DECEMBER 31, 2020   -   $      -    153,096   $393,944   $(294,078)  $(1,072)  $(3,667)  $95,127 
Shares issued through ATM   -    -    7,941    19,008    -    -    -    19,008 
Shares issued for services   -    -    78    202    -    -    -    202 
Shares issued upon vesting of restricted stock units, net of shares retired to pay employees’ taxes   -    -    10    (12)   -    -    -    (12)
Shares issued upon exercise of stock options   -    -    942    1,751                   1,751 
Financing related fees   -    -    -    (173)   -    -    -    (173)
Stock-based compensation   -    -    -    539    -    -    -    539 
Foreign currency translation gain   -    -    -    -    -    -    1,576    1,576 
NET LOSS   -    -    -    -    (1,416)   (32)   -    (1,448)
BALANCE AT MARCH 31, 2021   -   $-    162,067   $415,259   $(295,494)  $(1,104)  $(2,091)  $116,570 
Shares issued through ATM   -    -    2,824    7,874    -    -    -    7,874 
Shares issued upon vesting of restricted stock units, net of shares retired to pay employees’ taxes   -    -    10    (15)   -    -    -    (15)
Shares issued upon exercise of stock options   -    -    2,116    4,033    -    -    -    4,033 
Financing related fees   -    -    -    (26)   -    -    -    (26)
Stock-based compensation   -    -    -    919    -    -    -    919 
Shares issued for retirement of stock warrants   -    -    20    2                   2 
Foreign currency translation loss   -    -    -    -    -    -    (960)   (960)
NET LOSS   -    -    -    -    (4,788)   (8)   -    (4,796)
BALANCE AT JUNE 30, 2021   -   $-    167,037   $428,046   $(300,282)  $(1,112)  $(3,051)  $123,601 
Shares issued through ATM   -    -    1,049    2,667    -    -    -    2,667 
Shares issued upon vesting of restricted stock units, net of shares retired to pay employees’ taxes   -    -    10    (13)   -    -    -    (13)
Shares issued upon exercise of stock options   -    -    369    485    -    -    -    485 
Financing related fees   -    -    -    (79)   -    -    -    (79)
Stock-based compensation   -    -    -    1,144    -    -    -    1,144 
Foreign currency translation loss   -    -    -    -    -    -    (382)   (382)
NET LOSS   -    -    -    -    (7,823)   (11)   -    (7,834)
BALANCE AT SEPTEMBER 30, 2021   -   $-    168,465   $432,250   $(308,105)  $(1,123)  $(3,433)  $119,589 

 

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Warrants

 

Cell Cure Warrants – Liability Classified

 

In July 2017, Cell Cure issued to HBL a warrant to purchase 24,566 ordinary shares at an exercise price of $40.54 per share with an expiration date in July 2022. In March 2022, HBL was issued 50 shares following its cash exercise of a portion of that warrant, and an additional 50 shares were transacted as a net exercise. In April 2022, HBL was issued 2,467 shares followings its cash exercise of a portion of that warrant. In July 2022, HBL was issued 21,999 shares following its cash exercise of the remaining portion of that warrant, which resulted in net proceeds to Cell Cure of $0.9 million.

 

A warrant to purchase 2,000 ordinary shares issued to Cell Cure consultants with an exercise price of $40.00 per share and which expires in January 2024 is outstanding as of September 30, 2022.

 

12. Stock-Based Awards

 

Equity Incentive Plan Awards

 

In September 2021, our shareholders approved the Lineage Cell Therapeutics, Inc. 2021 Equity Incentive Plan (the “2021 Plan”), which became effective upon such approval. The 2021 Plan provides for the grant of incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock awards, RSUs, and other stock awards. All of our employees (including those of our affiliates), non-employee directors and consultants are eligible to participate in the 2021 Plan.

 

Subject to adjustment for certain changes in our capitalization, the aggregate number of our common shares that may be issued under the 2021 Plan will not exceed the sum of (i) 15,000,000 shares and (ii) the number of shares subject to awards granted under the Lineage Cell Therapeutics Inc. 2012 Equity Incentive Plan (the “2012 Plan”) that were outstanding when the 2021 Plan became effective and are not issued because such awards expire or otherwise terminate. As of September 30, 2022, there were 11,256,401 shares available for grant under the 2021 Plan.

 

As a result of the approval of the 2021 Plan by our shareholders, no additional awards will be granted under the 2012 Plan or the Asterias 2013 Equity Incentive Award (the “Asterias Equity Plan”).

 

A summary of activity under the 2021 Plan is as follows (in thousands, except per share amounts):

 

   Number
of Options
Outstanding
   Number
of RSUs
Outstanding
   Weighted
Average
Exercise Price
 
December 31, 2021   -    -   $- 
Options granted   6,258    -    1.40 
Options expired/forfeited/cancelled   (1,155)   -    1.40 
RSUs granted (1)   -    994    - 
RSUs forfeited   -    (55)   - 
September 30, 2022   5,103    939   $1.40 
Options exercisable at September 30, 2022   -        $- 

 

(1)On February 11, 2022, Lineage granted 694,424 RSUs to certain employees, including the Company’s executive officers, to further align management with the achievement of certain development milestones under the Roche Agreement. For each RSU, half of the common shares subject to the RSU will vest in four equal annual installments beginning on the first anniversary of the grant date. The other half of the common shares will vest in connection with the achievement of certain development milestones set forth in the Roche Agreement. Additionally, on March 10, 2022, Lineage granted 300,000 RSUs to Brian Culley, its Chief Executive Officer. 100,000 of these RSUs will vest on or prior to March 9, 2023, and 100,000 will vest on each of the second and third anniversaries of such date, upon the achievement of certain per share performance targets, calculated based on the trailing 20-day volume weighted average price of the Company’s common shares as of the date of determination.

 

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A summary of activity of the 2012 Plan and 2018 inducement option (issued outside of all equity plans) is as follows (in thousands, except per share amounts):

 

   Number
of Options
Outstanding
   Number
of RSUs
Outstanding
   Weighted
Average
Exercise Price
 
December 31, 2021   14,643    31   $1.84 
RSUs vested   -    (31)   - 
Options exercised   (389)   -    0.81 
Options expired/forfeited/cancelled   (1,385)   -    2.18 
September 30, 2022   12,869    -   $1.83 
Options exercisable at September 30, 2022   9,044        $1.82