On March 11, 2021 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported financial and operating results for the fourth quarter and full year 2020 (Press release, BioTime, MAR 11, 2021, View Source [SID1234576501]). 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 fourth quarter and full year 2020 financial and operating results and to provide a business update.
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"Our goal is to build Lineage into the preeminent allogeneic cell transplant company, and we hit our stride in 2020, reaching significant clinical, manufacturing, and business milestones and creating substantial value for our shareholders. We also positioned ourselves for success in 2021 and beyond"
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"Our goal is to build Lineage into the preeminent allogeneic cell transplant company, and we hit our stride in 2020, reaching significant clinical, manufacturing, and business milestones and creating substantial value for our shareholders. We also positioned ourselves for success in 2021 and beyond," stated Brian M. Culley, Lineage CEO. "We know of no other company that possesses a comparable combination of cell therapy patent breadth, in-house manufacturing capabilities, and encouraging clinical evidence in three distinct disease areas, each with large unmet needs and billion-dollar commercial opportunities. We believe the field of cell therapy is poised for explosive growth in the months and years ahead. Our objective is to be positioned for that growth by continuing to provide evidence that allogeneic approaches can generate safety and efficacy data which leads to commercial and clinical advantages over alternate approaches. Importantly, Lineage also recently added $35.9 million in new capital through the timely sales of our equity and marketable securities. We believe this new capital will ensure we are funded to deliver additional significant milestones from our novel cell therapy pipeline and provide us with optionality in ongoing partnership discussions."
Some of the significant milestones we achieved during 2020 include:
– Completion of enrollment in a 24 patient Phase 1/2a clinical study of OpRegen for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA) with encouraging preliminary signs of tolerability and efficacy;
– Announcing the first known finding of retinal tissue restoration in a patient who received a retinal pigment epithelium (RPE) cell transplant which had persisted to 23 months with further improvements to visual acuity;
– Making major manufacturing improvements to our OPC1 acute spinal cord injury (SCI) program, including to the process, purity, and scale, and to the development of a "ready-to-inject" formulation, enabling use at a much larger number of treatment centers;
– The early exercise of our option with Cancer Research UK to bring the VAC immuno-oncology platform in-house;
– Reporting encouraging preliminary Phase 1 clinical study results with VAC2 for the treatment of non-small cell lung cancer with evidence of high levels of antigen-specific immunogenicity observed in all patients treated to date;
– Receiving a new research & development grant from the Israel Innovation Authority under their bio-convergence initiative, for the development of a novel bio-retinal patch for the treatment of retinal diseases in partnership with Precise Bio Ltd.;
– Announcing the extension of an OpRegen development grant from the Israel Innovation Authority;
– Receiving a $24.6 million payment from Juvenescence Ltd. for principal and interest due under a convertible promissory note issued as partial payment for the sale of common stock of AgeX Therapeutics, Inc.; and
– Successfully monetizing portions of Lineage’s non-core patent portfolio.
Some of the events and milestones that our shareholders can look forward to in 2021 include:
– Present new and accumulated OpRegen data from the ongoing Phase 1/2a clinical study on two occasions during the first and second quarters of 2021;
– Plan to meet with the FDA to discuss further clinical development of the OpRegen program, anticipated in the third quarter of 2021;
– Complete VAC2 patient enrollment in the ongoing Phase 1 clinical study for the treatment of non-small cell lung cancer, anticipated in the second quarter of 2021;
– Evaluate the Neurgain Parenchymal Spinal Delivery (PSD) system for OPC1, currently ongoing and throughout 2021;
– Plan to meet with the FDA to discuss plans to evaluate the Neurgain Parenchymal Spinal Delivery (PSD) system for OPC1, anticipated in the second quarter of 2021;
– Complete OPC1 process development to support a late-stage clinical trial, currently ongoing and throughout 2021;
– Introduce manufacturing enhancements to the VAC2 program, anticipated throughout 2021;
– Report results from the ongoing Phase 1 clinical study of VAC2 for the treatment of non-small cell lung cancer, anticipated in the fourth quarter of 2021;
– Plan to meet with the FDA to discuss further development of the OPC1 program and manufacturing improvements, including a late-stage clinical study, anticipated in the fourth quarter of 2021;
– Evaluate opportunities for new VAC product candidates based on newly discovered tumor antigens/neoantigens, throughout 2021; and
– Evaluate partnership opportunities and expansion of existing external collaborations and identification of new collaborations for OpRegen, OPC1 and VAC2, currently ongoing and throughout 2021.
Balance Sheet Highlights
Cash, cash equivalents, and marketable securities totaled $41.6 million as of December 31, 2020. Marketable securities as of December 31, 2020 include our remaining ownership of unrestricted securities in OncoCyte, and Hadasit Bio-Holdings Ltd (Hadasit).
During 2020, we funded our operations primarily by receiving payment in full for a total of $24.6 million on the Juvenescence promissory note, and by selling a portion of our marketable securities, resulting in net proceeds of approximately $13.1 million.
Additionally, during 2020, we selectively sold 3,094,322 of our common shares under the ATM offering for gross proceeds of approximately $5.1 million (which excludes $0.3 million of cash in transit related to 2020 sales that settled in 2021).
2021 fundraising activities
From January 1, 2021 through March 5, 2021, we sold an additional portion of our marketable securities, resulting in net proceeds of approximately $10.1 million and an additional $19.9 million in gross proceeds through sales of 7,941,122 of our common shares under the ATM offering (which includes $0.3 million in cash in transit related to 2020 sales that settled in 2021). As of March 5, 2021, the value of the Company’s cash and cash equivalents were in excess of $57 million.
As of March 5, 2021, we hold 1,122,401 shares of OncoCyte stock valued at approximately $4.2 million and 169,167 shares of Hadasit stock valued at approximately $330,000, in each case based on the closing prices of those shares on March 5, 2021.
The Company anticipates that net operational spend for 2021 will be approximately $20.0 to $22.0 million, which is similar to 2020 spending levels. The Company believes that it is well funded into 2023 as a result of sustained cost savings initiatives in 2020 and recent fundraising activities.
Fourth Quarter Operating Results
Revenues: Lineage’s revenue is generated primarily from research grants, royalties, and licensing fees. Total revenues for the three months ended December 31, 2020 were approximately $0.4 million, a decrease of $0.8 million as compared to $1.2 million for the same period in 2019. The decrease was primarily related to an approximate $0.6 million decrease in royalties and licensing fees, which was primarily driven by the absence of a $0.6 million upfront payment from a new license agreement in 2019, and a $0.2 million decrease in grant revenues due to 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 December 31, 2020 were $6.1 million, a decrease of $1.9 million as compared to $8.0 million for the same period in 2019.
R&D Expenses: R&D expenses for the three months ended December 31, 2020 were $2.6 million, a decrease of $0.9 million as compared to $3.5 million for the same period in 2019. The overall decrease was primarily related to decreases of $1.5 million in OpRegen and other ophthalmic application expenses, attributable primarily to a decrease in manufacturing activities in 2020 as compared to 2019, and $0.1 million in Renevia and HyStem related expenses, offset by an increase of $0.5 million in OPC1 expenses, attributable primarily to an increase in manufacturing activities, and a $0.3 million increase in VAC program expenses.
G&A Expenses: G&A expenses for the three months ended December 31, 2020 were $3.5 million, a decrease of $1.0 million as compared to $4.5 million for the same period in 2019. The decrease was primarily attributable to decreases of $0.4 million in legal and patent expenses, $0.3 million in rent expense, $0.3 million in expenses related to our merger with Asterias Biotherapeutics, Inc. (Asterias Merger) and $0.2 million in accounting and consulting expenses, offset by a $0.2 million increase related to the cessation of shared services reimbursements.
Loss from Operations: Loss from operations for the three months ended December 31, 2020 was $5.9 million, a decrease of $1.0 million as compared to $6.9 million for the same period in 2019.
Other Income/(Expenses), Net: Other income/(expenses), net for the three months ended December 31, 2020 reflected other income, net of $6.9 million, compared to other income, net of $1.5 million for the same period in 2019. The variance was primarily related to the gain on sale of marketable securities and changes in the value of marketable equity securities for the applicable periods, as well as foreign currency translation adjustments related to Lineage’s international subsidiaries.
Net Income/(Loss) attributable to Lineage: The net income attributable to Lineage for the three months ended December 31, 2020 was $2.0 million, or $0.01 per share (basic and diluted), compared to a net loss attributable to Lineage of ($4.5) million, or ($0.03) per share (basic and diluted), for the same period in 2019.
Full Year Operating Results
Revenues: Lineage’s revenue is generated primarily from research grants, royalties, and licensing fees. Total revenues for the year ended December 31, 2020 were $1.8 million, a decrease of $1.7 million as compared to $3.5 million for the same period in 2019. The decrease was primarily related to a $1.0 million decrease in grant revenue due to less grant-related activities, $0.4 million decrease in royalties from product sales and license fees, and a $0.3 million decrease in the sale of research products and services due to the cessation of such sales.
Operating Expenses: Operating expenses are comprised of R&D expenses and G&A expenses. Total operating expenses for the year ended December 31, 2020 were $27.9 million, a decrease of $14.1 million as compared to $42.0 million for the same period in 2019.
R&D Expenses: R&D expenses for the year ended December 31, 2020 were $12.3 million, a decrease of $5.6 million as compared to $17.9 million for the same period in 2019. The overall decrease was primarily related to a decrease of $6.5 million in OpRegen and other ophthalmic application expenses, attributable primarily to a decrease in manufacturing activities in 2020 as compared to 2019, a decrease of $0.8 million in Renevia and other related expense as we are spending less and actively looking for a commercialization partner, and a $0.5 million decrease in OPC1-related expenses, primarily driven by a return of unspent project funds of approximately $0.8 million from a former Asterias service provider, offset by a $2.2 million increase in VAC program expenses, primarily related to the accrual of the signature fee of £1.25 million ($1.6 million) to Cancer Research UK.
G&A Expenses: G&A expenses for the year ended December 31, 2020 were $15.6 million, a decrease of approximately $8.4 million as compared to $24.0 million for the same period in 2019. The decrease was primarily attributable to a $5.5 million decrease in Asterias Merger related expenses, a $2.1 million reduction in compensation costs as a result of headcount reductions in 2019, a $0.9 million reduction in accounting expenses, a $0.5 million reduction in rent and utilities, a $0.3 million reduction in travel expenses, a $0.3 million reduction in office and information technology related expenses and a $0.2 million reduction in consulting expenses, offset by a $0.9 million increase related to the cessation of shared services reimbursements and a $0.5 million increase in legal and patent expenses.
Loss from Operations: Loss from operations for the year ended December 31, 2020 was $26.4 million, a decrease of $12.5 million as compared to $38.9 million for the same period in 2019.
Other Income, Net: Other income, net for the year ended December 31, 2020 reflected other income, net of $4.5 million, compared to other income, net of $19.6 million for the same period in 2019. The variance was primarily related to the changes in the value of equity method investments and marketable equity securities for the applicable periods, gain on sale of marketable securities for the applicable periods, as well as foreign currency translation adjustments related to Lineage’s international subsidiaries.
Net loss attributable to Lineage: The net loss attributable to Lineage for the year ended December 31, 2020 was $20.6 million, or $0.14 per share (basic and diluted), compared to a net loss attributable to Lineage of $11.7 million, or $0.08 per share (basic and diluted), for 2019.
Conference Call and Webcast
Lineage will host a conference call and webcast today, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its fourth quarter and full year 2020 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 March 19, 2021, 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 4176568.