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Lineage Cell Therapeutics Reports Third Quarter 2019 Financial Results and Provides Business Update

November 12, 2019

CARLSBAD, Calif.--(BUSINESS WIRE)--Nov 12, 2019--

Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cellular therapies for unmet medical needs, reported financial and operating results for the third quarter ended September 30, 2019. Lineage management will host a conference call and webcast today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its third quarter 2019 financial results and to provide a business update.

“We are excited about our cell therapy programs and how they may benefit patients with serious medical conditions such as dry AMD, spinal cord injury, and cancer,” stated Brian M. Culley, CEO of Lineage. “We believe that Lineage has one of the largest and most comprehensive patent estates in cell therapy and that our clinical-stage programs are making important advances. We also recently implemented additional cost-cutting measures that will reduce our planned 2020 net operational spend to $16 million, $8 million to $12 million less than our previous estimate of $24 million to $28 million. Under this plan, our primary goal will be to complete enrollment in our Phase I/IIa clinical study of OpRegen early next year and collect the follow-up data to guide our late-stage study design and partnership discussions. We also have completed the transfer of OPC1 to our manufacturing facility and will continue our efforts to introduce manufacturing enhancements to OPC1 in preparation for the initiation of a randomized clinical study in 2021. We believe reducing our cash burn and focusing on OpRegen, our nearest-term high value asset, as well as on finding a strong marketing partner for Renevia, is the best way to create near-term shareholder value. In August 2020, we also are entitled to receive our final payment of $24.6 million in principal and interest for the 2018 sale of AgeX Therapeutics shares to Juvenescence, an amount which exceeds our anticipated cash needs from now through the end of next year.”

“Additionally, we are looking forward to hosting two therapeutic area experts in ophthalmology and spinal cord injury at Solebury Trout’s KOL Event for analysts and investors in New York City on November 15, 2019,” added Mr. Culley. “Our executive team will be joined by renowned experts Allen C. Ho, M.D. FACS, Wills Eye Hospital Attending Surgeon and Director of Retina Research, and John Steeves, B.Sc., Ph.D., Emeritus Principal Investigator at ICORD and Professor in the Department of Neuroscience at the University of British Columbia. We will be providing an update on our OpRegen and OPC1 clinical programs, as well as an update on the SCiStar Clinical Study for the treatment of spinal cord injury.”

Recent Significant Highlights

Near Term Milestones for 2019 and 2020

Balance Sheet Highlights

Cash, cash equivalents and marketable securities totaled $35.7 million as of September 30, 2019. Marketable securities include our remaining ownership stakes in OncoCyte, AgeX and Hadasit Bio-Holdings Ltd (Hadasit), which are now all under 20% of their respective total outstanding shares. Lineage sold 6,250,000 shares of OncoCyte’s common stock in the third quarter of 2019 for net proceeds of $10.7 million. Lineage also sold 651,839 shares of AgeX common stock in the third quarter of 2019 for net proceeds of $1.6 million and 647,397 shares of Hadasit common stock in July 2019 for net proceeds of $1.2 million.

Lineage’s promissory note due from Juvenescence Limited had an outstanding balance (principal plus accrued interest) of $23.2 million as of September 30, 2019. Unless earlier converted into Juvenescence ordinary shares, the promissory note is payable in cash, plus accrued interest at 7% per year, at maturity in August 2020. If Juvenescence completes an initial public offering (IPO) resulting in gross proceeds of not less than $50.0 million, the promissory note automatically converts into the Juvenescence securities issued in the IPO based on the per-share price to the public in the IPO, subject to an upward adjustment in the number of shares that would be issued to Lineage upon such conversion if the 20-day volume-weighted average trading price of one share of common stock of AgeX before the IPO is priced above $3.00. If the promissory note is converted, the Juvenescence ordinary shares will be a marketable security that Lineage may use to supplement its liquidity, as needed and as market conditions allow.

In summary, as of September 30, 2019, the value of the Company’s cash, marketable securities, and the balance of a promissory note due to it in August 2020 were in excess of $58.9 million.

Lineage expects to spend approximately $6 million in the fourth quarter of 2019. The Company has implemented significant cost savings initiatives and now anticipates that net operational spend for 2020 will be $16 million. This planned spending level represents a significant reduction from 2019 forecasted spending levels of $34 million and 2018 spending levels of $43 million for Lineage and Asterias Biotherapeutics, Inc. (Asterias) combined. Lineage acquired Asterias on March 8, 2019.

Third Quarter Operating Results

Note regarding AgeX: On August 30, 2018, Lineage deconsolidated AgeX from its consolidated financial statements due to the sale by Lineage of 14,400,000 shares of AgeX common stock to Juvenescence and the related decrease of Lineage’s ownership position in AgeX from 80.4% to 40.2%. Accordingly, Lineage ceased recognizing revenue and expenses related to AgeX and its programs on such date.

Revenues: Lineage’s revenue is generated primarily from research grants, licensing fees and royalties. Total revenues for the three months ended September 30, 2019 were $0.6 million, a decrease of $0.4 million as compared to the same period in 2018. The decrease was primarily related to a $0.4 million decrease in grant revenues, which is primarily based on the timing of grant-related activities.

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 September 30, 2019 were $8.9 million, a decrease of $2.4 million as compared to the same period in 2018.

R&D Expenses: R&D expenses for the three months ended September 30, 2019 were $4.3 million, a decrease of $0.6 million as compared to the same period in 2018. The decrease was primarily related to a $0.8 million decrease from the AgeX deconsolidation and the absence of AgeX R&D expenses incurred after August 30, 2018, offset by a net increase of $0.2 million in Lineage programs primarily related to: (1) an increase of $1.4 million in OPC1 and VAC2 expenses (these programs were acquired in the Asterias merger) offset by (2) decreases of $1.2 million in Renevia, OpRegen and other research-related expenses.

G&A Expenses: G&A expenses for the three months ended September 30, 2019 were $4.6 million, a decrease of $1.8 million as compared to the same period in 2018. The decrease was primarily attributable to a $0.8 million decrease in AgeX related general and administrative expenses, a $0.5 million reduction in legal and patent expenses, a $0.4 million decrease in salaries, benefits and severance costs primarily related to terminated personnel and a $0.3 million reduction in consulting expenses, offset by a $0.2 million increase in rent expense, which is primarily related to the implementation of ASC 842 Leases in 2019.

Loss from Operations: Loss from operations for the three months ended September 30, 2019 was $8.4 million, a decrease of $2.0 million as compared to the same period in 2018.

Other Income/(Expenses), Net: Other income/(expenses), net for the three months ended September 30, 2019 reflected other expense, net of ($9.1) million, compared to other income, net of $76.9 million for the same period in 2018. The variance was primarily related to the gain on the deconsolidation of AgeX in 2018 and the changes in the value of investments in marketable equity securities for the applicable periods.

Conference Call and Webcast

Lineage will host a conference call and webcast today, at 1:30pm PT/4:30pm ET to discuss its third quarter 2019 financial results and to provide a business update. Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside 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 November 19, 2019, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 1473397.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its proprietary cell-based therapy platform and associated development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally-differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed either to replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical assets include (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase I/IIa development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase I/IIa development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic cancer immunotherapy of antigen-presenting dendritic cells currently in Phase I development for the treatment of non-small cell lung cancer. Lineage is also evaluating potential partnership opportunities for Renevia®, a facial aesthetics product that was recently granted a Conformité Européenne (CE) Mark. For more information, please visit www.lineagecell.com or follow the Company on 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,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineage’s cost-savings efforts, manufacturing plans, enrollment activities, data presentations, clinical study advancement, drug evaluation, and anticipated net operational spend for the fourth quarter of 2019 and full year 2020. 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 risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the Securities and Exchange Commission (the SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. 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 Annual Report on Form 10-K filed with the SEC on March 14, 2019 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.

Tables to follow

LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(IN THOUSANDS)

September 30,
2019 (Unaudited)
(Notes 1 and 3)

 

December 31,
2018
(Notes 1 and 6)

ASSETS

 

 

 

CURRENT ASSETS

 

 

 

Cash and cash equivalents

$

14,366

 

 

$

23,587

 

Marketable equity securities

 

21,318

 

 

 

7,154

 

Promissory note from Juvenescence (Note 5)

 

23,238

 

 

 

-

 

Trade accounts and grants receivable, net

 

157

 

 

 

767

 

Receivables from affiliates, net (Note 10)

 

164

 

 

 

2,112

 

Prepaid expenses and other current assets

 

2,342

 

 

 

2,738

 

Total current assets

 

61,585

 

 

 

36,358

 

 

 

 

 

 

 

NONCURRENT ASSETS

 

 

 

 

 

Property and equipment, net (Notes 7 & 15)

 

8,844

 

 

 

5,835

 

Deposits and other long-term assets

 

826

 

 

 

505

 

Promissory note from Juvenescence (Note 5)

 

-

 

 

 

22,104

 

Equity method investment in OncoCyte, at fair value (Note 4)

 

-

 

 

 

20,250

 

Equity method investment in Asterias, at fair value (Note 3)

 

-

 

 

 

13,483

 

Goodwill

 

12,977

 

 

 

-

 

Intangible assets, net

 

48,746

 

 

 

3,125

 

TOTAL ASSETS

$

132,978

 

 

$

101,660

 

 

 

 

 

 

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

CURRENT LIABILITIES

 

 

 

 

 

Accounts payable and accrued liabilities

$

4,842

 

 

$

6,463

 

Financing lease and right of use lease liabilities, current portion (Note 15)

 

1,138

 

 

 

237

 

Promissory notes, current portion

 

-

 

 

 

70

 

Deferred grant revenue

 

182

 

 

 

42

 

Total current liabilities

 

6,162

 

 

 

6,812

 

 

 

 

 

 

 

LONG-TERM LIABILITIES

 

 

 

 

 

Deferred tax liability

 

6,343

 

 

 

-

 

Deferred revenues, net of current portion

 

240

 

 

 

-

 

Deferred rent liabilities, net of current portion

 

-

 

 

 

244

 

Right-of-use lease liability, net of current portion (Note 15)

 

4,087

 

 

 

1,854

 

Financing lease, net of current portion

 

87

 

 

 

104

 

Liability classified warrants, net of current portion, and other long-term liabilities

 

540

 

 

 

400

 

TOTAL LIABILITIES

 

17,459

 

 

 

9,414

 

 

 

 

 

 

 

Commitments and contingencies (Note 15)

 

 

 

 

 

 

 

 

 

 

 

SHAREHOLDERS’ EQUITY

 

 

 

 

 

Preferred shares, no par value, authorized 2,000 shares; none issued and outstanding as of September 30, 2019 and December 31, 2018

 

-

 

 

 

-

 

Common shares, no par value, 250,000 shares authorized; 149,790 shares issued and outstanding as of September 30, 2019 and 127,136 shares issued and outstanding as of December 31, 2018

 

386,454

 

 

 

354,270

 

Accumulated other comprehensive income

 

(357

)

 

 

1,426

 

Accumulated deficit

 

(268,940

)

 

 

(261,856

)

Lineage Cell Therapeutics, Inc. shareholders’ equity

 

117,157

 

 

 

93,840

 

Noncontrolling interest (deficit)

 

(1,638

)

 

 

(1,594

)

Total shareholders’ equity

 

115,519

 

 

 

92,246

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

$

132,978

 

 

$

101,660

 

LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(IN THOUSANDS, EXCEPT PER SHARE DATA)

(UNAUDITED)

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

2019

 

2018

 

2019

 

2018

 

REVENUES:

 

 

 

 

 

 

 

 

 

 

Grant revenue

$

350

 

$

718

 

$

1,628

 

$

2,985

 

Royalties from product sales and license fees

 

164

 

 

85

 

 

390

 

 

312

 

Subscription and advertisement revenues

 

-

 

 

119

 

 

-

 

 

691

 

Sale of research products and services

 

53

 

 

60

 

 

256

 

 

242

 

Total revenues

 

567

 

 

982

 

 

2,274

 

 

4,230

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales

 

(114

)

 

(35

)

 

(289

)

 

(250

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Gross profit

 

453

 

 

947

 

 

1,985

 

 

3,980

 

 

 

 

 

 

 

 

 

 

 

 

 

 

OPERATING EXPENSES:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

4,266

 

 

4,882

 

 

14,462

 

 

17,175

 

Acquired in-process research and development

 

-

 

 

-

 

 

-

 

 

800

 

General and administrative

 

4,609

 

 

6,422

 

 

19,527

 

 

17,585

 

Total operating expenses

 

8,875

 

 

11,304

 

 

33,989

 

 

35,560

 

Loss from operations

 

(8,422

)

 

(10,357

)

 

(32,004

)

 

(31,580

)

OTHER INCOME/(EXPENSES):

 

 

 

 

 

 

 

 

 

 

 

 

Interest income, net

 

399

 

 

174

 

 

1,278

 

 

278

 

Gain on sale of marketable equity securities

 

2,055

 

 

-

 

 

2,055

 

 

-

 

Gain on sale of equity method investment in OncoCyte

 

546

 

 

-

 

 

546

 

 

-

 

Gain on sale of equity method investment in Ascendance

 

-

 

 

-

 

 

-

 

 

3,215

 

Gain on sale of AgeX shares and deconsolidation of AgeX

 

-

 

 

78,511

 

 

-

 

 

78,511

 

Unrealized (loss) gain on marketable equity securities

 

(4,458

)

 

23

 

 

(3,134

)

 

635

 

Unrealized (loss) gain on equity method investment in OncoCyte at fair value

(8,287

)

(734

)

8,001

(31,550

)

Unrealized (loss) gain on equity method investment in Asterias at fair value

 

-

 

(1,087

)

 

6,744

 

(20,660

)

Unrealized gain on warrant liability

 

79

 

 

21

 

 

350

 

 

372

 

Other income (expense), net

 

582

 

 

(7

)

 

2,270

 

 

(1,021

)

Total other (expense) income, net

 

(9,084

)

 

76,901

 

 

18,110

 

 

29,780

 

(LOSS)/INCOME BEFORE INCOME TAXES

 

(17,506

)

 

66,544

 

 

(13,894

)

 

(1,800

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Deferred income tax benefit

 

991

 

 

-

 

 

6,623

 

 

-

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET (LOSS)/INCOME

 

(16,515

)

 

66,544

 

 

(7,271

)

 

(1,800

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss attributable to noncontrolling interest

 

10

 

 

181

 

 

44

 

 

762

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET (LOSS)/INCOME ATTRIBUTABLE TO LINEAGE CELL THERAPEUTICS, INC.

$

(16,505

)

$

66,725

 

$

(7,227

)

$

(1,038

)

 

 

 

 

 

 

 

 

 

 

 

 

 

NET (LOSS)/INCOME PER COMMON SHARE:

 

 

 

 

 

 

 

 

 

 

 

 

BASIC

$

(0.11

)

$

0.53

 

$

(0.05

)

$

(0.01

)

DILUTED

$

(0.11

)

$

0.53

 

$

(0.05

)

$

(0.01

)

 

 

 

 

 

 

 

 

 

 

 

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING:

 

 

 

 

 

 

 

 

 

 

 

 

BASIC

 

149,659

 

 

126,878

 

 

144,097

 

 

126,872

 

DILUTED

 

149,659

 

 

126,973

 

 

144,097

 

 

126,872

 

 

View source version on businesswire.com:https://www.businesswire.com/news/home/20191112006063/en/

CONTACT: Lineage Cell Therapeutics, Inc. IR

Ioana C. Hone

(ir@lineagecell.com)

(510) 871-4188Solebury Trout IR

Gitanjali Jain Ogawa

(Gogawa@troutgroup.com)

(646) 378-2949

KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: ONCOLOGY HEALTH STEM CELLS CLINICAL TRIALS PHARMACEUTICAL OPTICAL BIOTECHNOLOGY

SOURCE: Lineage Cell Therapeutics, Inc.

Copyright Business Wire 2019.

PUB: 11/12/2019 04:05 PM/DISC: 11/12/2019 04:06 PM

http://www.businesswire.com/news/home/20191112006063/en