On November 8, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported financial results and business highlights for the third quarter ended September 30, 2018 (Press release, Tocagen, NOV 8, 2018, View Source;p=RssLanding&cat=news&id=2376312 [SID1234531164]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We conclude the eventful third quarter of 2018 having met important milestones, including early completion of enrollment and the first interim analysis of our ongoing Phase 3 Toca 5 trial. We’ve also further improved our balance sheet to advance our lead program and execute against our goals," said Marty Duvall, chief executive officer of Tocagen. "With the planned second interim and final analyses for Toca 5 anticipated in 2019, we are preparing for a potential rolling BLA submission and planning for commercial launch."

Third Quarter 2018 and Recent Highlights

First interim analysis of Toca 5 Phase 3 trial: In August 2018, Tocagen announced the Toca 5 pivotal Phase 3 trial evaluating Toca 511 (vocimagene amiretrorepvec) & Toca FC (extended-release flucytosine) in patients with recurrent high grade glioma (rHGG) will continue without modification following a pre-planned first interim analysis of data. An Independent Data Monitoring Committee completed its analysis at 50% of events occurring in the trial and recommended the trial continue without modification. Tocagen estimates the second interim analysis, at 75% of events in the trial, will occur in the first half of 2019 and that the final analysis will occur by the end of 2019.
Completed Toca 5 enrollment: In September 2018, Tocagen completed the planned enrollment of 380 patients in the ongoing Toca 5 Phase 3 trial approximately three months ahead of schedule.
Received milestone payment from ApolloBio: Completing the Toca 5 enrollment triggered a milestone payment of $2 million from ApolloBio, Tocagen’s licensee of Toca 511 & Toca FC within the greater China region.
Initiated commercial organization buildout: In September 2018, Mohamed Ladha joined Tocagen as vice president, head of commercial. Mr. Ladha will build, oversee and execute the global commercial strategies for Tocagen’s oncology products upon regulatory approval in the United States and other key markets.
Presented Toca 6 data: Tocagen presented new clinical data on Toca 511 & Toca FC in advanced solid tumors at the International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) in late September. Data showed favorable safety, vector deposition in "hot" and "cold" tumors and immune changes consistent with preclinical and clinical observations. Based on these data, Tocagen is now planning future safety and efficacy trials in select tumor types.
Publication of Toca 511 & Toca FC data: In October 2018, two peer-reviewed clinical data manuscripts appeared in print related to Toca 511 & Toca FC in rHGG. Data published by Timothy F. Cloughesy and co-authors in Neuro-Oncology demonstrated multiyear durable responses observed in rHGG patients treated in a Toca 511 & Toca FC Phase 1 trial. Data published by Daniel J. Hogan and co-authors in Clinical Cancer Research demonstrated Toca 511 & Toca FC treatment was not associated with concerning integration sites and clonal expansion. These manuscripts first published online May 12, 2018 and June 26, 2018, respectively.
Third Quarter 2018 Financial Results

License Revenue: License revenue was $18.0 million for the quarter ended September 30, 2018, compared to less than $0.1 million for the quarter ended September 30, 2017. The 2018 revenue was associated with a $16.0 million upfront payment recognized under Tocagen’s license agreement with ApolloBio and a $2.0 million development milestone earned upon completion of enrollment in the Toca 5 clinical study.

Research and Development (R&D) Expenses: R&D expenses were $12.3 million for the quarter ended September 30, 2018, compared to $7.6 million for the quarter ended September 30, 2017. The increase in R&D expenses in 2018 was primarily driven by higher costs to support the expanded Toca 5 Phase 3 clinical study and manufacturing activities related to Toca 511.

General and Administrative (G&A) Expenses: G&A expenses were $4.3 million for the quarter ended September 30, 2018, compared to $2.2 million for the quarter ended September 30, 2017. The increase in G&A expenses was primarily due to foreign non-income tax expense of approximately $1 million paid under Tocagen’s license agreement with ApolloBio and an increase in non-cash stock-based compensation expense.

Net Loss: Net loss was $0.4 million, or $0.02 per common share (basic and diluted), for the quarter ended September 30, 2018, compared to a net loss of $10.0 million, or $0.50 per common share (basic and diluted), for the quarter ended September 30, 2017. The reduction in net loss in 2018 was due to $18.0 million in revenue recognized under Tocagen’s license agreement with ApolloBio. Tocagen recognized $1.5 million in income taxes for the quarter ended September 30, 2018 related to the license agreement with ApolloBio. The 2018 calculation is based on 20.0 million average common shares outstanding for the third quarter of 2018, compared to 19.8 million average shares outstanding for the third quarter of 2017.

2018 Nine-Month Results

License Revenue: License revenue was $18.0 million for the nine months ended September 30, 2018, compared to less than $0.1 million for the nine months ended September 30, 2017. The 2018 revenue was associated with a $16.0 million upfront payment recognized under Tocagen’s license agreement with ApolloBio and a $2.0 million development milestone earned upon completion of enrollment in the Toca 5 clinical study.

R&D Expenses: R&D expenses were $35.5 million for the nine months ended September 30, 2018 compared to $20.8 million for the nine months ended September 30, 2017. Similar to the third quarter results, the R&D expenses primarily reflect increased costs to support the expanded Toca 5 Phase 3 clinical study, manufacturing activities related to Toca 511 & Toca FC and personnel and related costs due to increased headcount.

G&A Expenses: G&A expenses were $9.3 million for the nine months ended September 30, 2018 compared to $6.2 million for the nine months ended September 30, 2017. Similar to the third quarter results, the G&A expenses primarily reflect the foreign non-income tax expense paid under Tocagen’s license agreement with ApolloBio and an increase in non-cash stock-based compensation expense.

Net Loss: Net loss for the nine months ended September 30, 2018 was $29.4 million, or $1.47 per common share (basic and diluted), compared to a net loss of $28.1 million, or $2.19 per common share (basic and diluted), for the nine months ended September 30, 2017. This calculation is based on 19.9 million average common shares outstanding for the nine months ended September 30, 2018, compared to 12.8 million average shares outstanding for the same period in 2017.

Cash Position and Guidance
Cash, cash equivalents and marketable securities were $79.8 million at September 30, 2018 compared to $88.7 million at December 31, 2017. Tocagen refined its annual cash burn guidance and estimates the total cash used in 2018 to fund operations and capital expenditures will be approximately $50 million, resulting in a year-end cash balance of approximately $70 million, up from approximately $40 million implied in guidance provided in January 2018.

About Toca 511 & Toca FC
Tocagen’s lead product candidate is a two-part cancer-selective immunotherapy comprising an investigational biologic, Toca 511, and an investigational small molecule, Toca FC. Toca 511 is a retroviral replicating vector (RRV) that selectively infects cancer cells and delivers a gene for the enzyme, cytosine deaminase (CD). Through this targeted delivery, only infected cancer cells carry the CD gene and produce CD. Toca FC is an orally administered prodrug, 5-fluorocytosine (5-FC), which is converted into an anti-cancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU kills cancer cells and immune-suppressive myeloid cells resulting in anti-cancer immune activation and subsequent tumor killing.

On November 8, 2018 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that its Board of Directors has declared a quarterly cash dividend of $0.17 per common share, payable on January 15, 2019, to shareholders of record as of December 17, 2018 (Press release, Thermo Fisher Scientific, NOV 8, 2018, View Source [SID1234531163]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On November 8, 2018 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation, reported operating results for the third quarter ended September 30, 2018 and provided pipeline updates (Press release, AnaptysBio, NOV 8, 2018, View Source [SID1234531162]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continued to advance the clinical development of our wholly-owned etokimab and ANB019 programs for severe inflammatory disease indications during the third quarter of 2018," said Hamza Suria, president and chief executive officer of AnaptysBio. "Top-line data from our etokimab Phase 2a trial in severe adult eosinophilic asthma patients demonstrated rapid and sustained improvement in Forced Exhaled Volume In One Second versus placebo, with corresponding reduction in blood eosinophil levels. We look forward to further advancement of our wholly-owned pipeline with four additional readouts from ongoing clinical trials of etokimab and ANB019 during 2019."

Etokimab (ANB020 Anti-IL-33 Program)
•
In September, the Company announced positive topline proof-of-concept data for etokimab, its investigational anti-IL-33 therapeutic antibody, in an ongoing single dose Phase 2a clinical trial in adult patients with severe eosinophilic asthma. Patients administered with etokimab rapidly improved their Forced Exhaled Volume In One Second, or FEV1, which is a measure of lung function, with an eight percent FEV1 improvement over placebo at Day 2. FEV1 improvement was sustained through Day 64, with an 11 percent increase over placebo. Blood eosinophil reduction was sustained through the interim analysis period, with a 31 percent reduction at Day 2 and a 46 percent reduction at Day 64 over placebo, which was consistent with FEV1 improvement observed in this trial. Etokimab was generally well tolerated in all patients and no serious adverse events were reported as of this interim analysis. This Phase 2a trial is currently ongoing and the company plans to report full data from this trial at a medical conference in 2019 following trial completion. AnaptysBio plans to continue development of etokimab in eosinophilic asthma with a multi-dose Phase 2b randomized, double-blinded, placebo-controlled trial, which is expected to be initiated in 2019.
•
The Company is enrolling a Phase 2b randomized, double-blinded, placebo-controlled, multi-dose study in 300 adult patients with moderate-to-severe atopic dermatitis, also referred to as the ATLAS clinical trial, to assess different dose levels and dosing frequencies of subcutaneously-administered etokimab for a 16-week treatment period followed by an eight-week monitoring period, with data expected in the second half of 2019.
•
The Company has cleared an IND and initiated a randomized, placebo-controlled Phase 2 trial, also referred to as the ECLIPSE trial, in approximately 100 adult patients with chronic rhinosinusitis with nasal polyps. Patients will be treated with two multi-dosing frequencies of subcutaneous-administered etokimab or placebo, each in combination with mometasone furoate nasal spray as background therapy, for a treatment period of 16 weeks followed by an eight-week monitoring period. The Company anticipates top-line data from the ECLIPSE trial will be available in the second half of 2019.

ANB019 (Anti-IL-36 Receptor Program)
•
AnaptysBio has initiated a 10-patient, single arm, open-label Phase 2 trial of ANB019 in generalized pustular psoriasis, or GPP, also known as the GALLOP trial, and top-line data are anticipated in mid-2019.

All patients will be treated with an intravenous loading dose of ANB019 upon enrollment, followed by subcutaneously-administered monthly doses of ANB019 for a treatment period of up to 16 weeks post enrollment and followed by an eight-week monitoring period.
•
AnaptysBio has cleared an IND with the FDA and has initiated a randomized, placebo-controlled 50-patient multi-dose Phase 2 trial in palmoplantar pustulosis, or PPP, also known as the POPLAR trial, where top line data are anticipated in the second half of 2019. Patients will be treated with a (i) a subcutaneously-administered loading dose of ANB019 upon enrollment, followed by subcutaneously-administered monthly doses of ANB019, or (ii) placebo, each for a treatment period of 16 weeks post enrollment and followed an eight-week monitoring period.
Corporate Highlights
•
On September 28, 2018, the Company completed an underwritten public offering of 2,530,000 shares of common stock at a price to the public of $94.46, which included the exercise by the underwriters of their option to purchase an additional 330,000 shares of common stock. AnaptysBio, received net proceeds from the offering of $227.5 million, after deducting underwriting discounts and commissions.
Third Quarter Financial Results
•
Cash, cash equivalents and investments totaled $512.4 million as of September 30, 2018 compared to $324.3 million as of December 31, 2017, for an increase of $188.1 million. The increase primarily relates to net proceeds received by the Company of $227.5 million from the public offering, offset by operating cash outflow for clinical and manufacturing related expenses, as well as personnel costs.
•
Collaboration revenue was $5.0 million for the three and nine months ended September 30, 2018, related to a milestone for the first Phase 3 trial of TSR-042 by TESARO compared to no revenue and $7.0 million for two TESARO milestones for the three and nine months ended September 30, 2017, respectively.
•
Research and development expenses were $17.9 million for the three months ended September 30, 2018, as compared to $6.7 million for the three months ended September 30, 2017. The increase was primarily due to continued advancement of the Company’s etokimab and ANB019 clinical programs and additional personnel-related expenses including share based compensation during the three months ended September 30, 2018.
•
General and administrative expenses were $4.0 million for the three months ended September 30, 2018, as compared to $2.4 million for the three months ended September 30, 2017. The increase was primarily attributable to additional personnel-related expenses, including share based compensation, to support the Company’s growth.

Financial Guidance
AnaptysBio expects that its cash, cash equivalents and investments will fund its current operating plan at least through the end of 2020.
About Etokimab
Etokimab, previously referred to as ANB020, is an antibody that potently binds and inhibits the activity of interleukin-33, or IL-33, a pro-inflammatory cytokine that multiple studies have indicated is a central mediator of atopic diseases, which AnaptysBio believes is broadly applicable to the treatment of atopic inflammatory disorders, such as atopic dermatitis, eosinophilic asthma, chronic rhinosinusitis with nasal polyps, or CRSwNP, and potentially other allergic conditions. Following completion of a healthy volunteer Phase 1 trial of etokimab, AnaptysBio continued clinical development of etokimab into a Phase 2a trial for moderate-to-severe adult atopic dermatitis and a placebo-controlled Phase 2a trial in severe adult eosinophilic asthma patients. AnaptysBio is enrolling its ATLAS trial, a randomized, double-blinded, placebo-controlled multi-dose Phase 2b clinical trial of etokimab in 300 moderate-to-severe adult atopic dermatitis patients where data is anticipated in the second half of 2019. The company has also initiated its ECLIPSE trial, a randomized, double-blinded, placebo-

controlled Phase 2 trial of etokimab in approximately 100 adult patients with CRSwNP with data anticipated in the second half of 2019. AnaptysBio also plans to initiate a randomized, double-blinded, placebo-controlled, multi-dose Phase 2b trial of etokimab in patients with eosinophilic asthma in 2019.
About ANB019
ANB019 is an antibody that inhibits the function of the interleukin-36-receptor, or IL-36R, which AnaptysBio plans to initially develop as a potential first-in-class therapy for patients suffering from generalized pustular psoriasis, or GPP and palmoplantar pustulosis, or PPP. AnaptysBio conducted a Phase 1 clinical trial in healthy volunteers, where 54 subjects are dosed with ANB019 and 18 are dosed with placebo in single and multi-dose cohorts at various subcutaneous and intravenously administered dose levels. In May 2018, AnaptysBio presented data from this Phase 1 clinical trial, which demonstrated favorable safety, pharmacokinetics and pharmacodynamic properties that support advancement of ANB019 into Phase 2 studies. AnaptysBio is enrolling its GALLOP trial, a Phase 2 study of ANB019 in GPP where data is anticipated in the second quarter of 2019, and have initiated its POPLAR trial, a Phase 2 study in PPP where data is anticipated in the second half of 2019.

On November 8, 2018 Apollo Endosurgery, Inc. ("Apollo") (Nasdaq: APEN), a global leader in less invasive medical devices for bariatric and gastrointestinal procedures, reported financial results for the third quarter ended September 30, 2018 (Press release, Lpath, NOV 8, 2018, View Source [SID1234531161]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Third Quarter 2018 Highlights
• ESS contributed 37% of total sales in the quarter
• U.S. ESS sales increased 24% year-over-year in the quarter and 34% in the first nine months of 2018
• Worldwide ESS sales increased 40% in the first nine months of 2018
• Completed two gross margin improvement projects projected to contribute $2 million annually starting in 2019
Todd Newton, CEO of Apollo, commented, "ESS sales contributed 37% of overall revenue in the third quarter, showing solid progress despite a challenging comparable period in certain OUS markets in the prior year. We also achieved good IGB sales growth in the markets where Orbera365, our 12-month product is available. And finally, we are pleased to announce the completion of our two gross margin improvement projects that will add an estimated $2 million annually to our Endo gross margin beginning in 2019."
Third Quarter 2018 Results
Total revenues in the third quarter of 2018 were $14.1 million, compared to $16.5 million in the third quarter 2017, a decrease of 15%. Foreign currency fluctuations decreased total revenues $0.3 million for the three months ended September 30, 2018.
U.S. Endoscopic Suturing System ("ESS") product sales increased 24% to $2.5 million due to continuing new user adoption and greater product utilization in existing accounts. Outside the U.S. ("OUS") ESS product sales decreased 6%, to $2.7 million, due to lower third quarter 2018 sales in Australia and Brazil. Brazil ESS sales, in the third quarter of the prior year, included large initial orders with the launch of OverStitch in that country following regulatory approval in July 2017. In Australia, the third quarter of the prior year experienced elevated levels of ESS sales as providers used a gastroplasty code for ESG reimbursement before the Australian government warned against use of this code for obesity-related treatments at the end of 2017. These circumstances offset continued ESS growth during the third quarter in remaining OUS markets. In total, ESS product sales increased 6% to $5.2 million in the third quarter 2018 compared to $4.9 million in the third quarter 2017.
Total Intragastric balloon ("IGB") product sales decreased 8% to $4.1 million in the third quarter 2018 compared to $4.4 million in the third quarter 2017. OUS IGB product sales decreased 8%, to $2.9 million as higher unit sales and average selling prices of Orbera365 in Europe were offset by weaker six-month balloon sales in Brazil. In the U.S., IGB product sales decreased $0.1 million, or 7% to $1.2 million due to decreased consumer demand following the June 2018 FDA letter to Health Care Professionals ("HCPs").
Total Surgical product sales decreased $2.4 million, or 34% in the third quarter 2018 compared to the third quarter 2017 due to reductions in gastric banding procedures being performed worldwide.
Gross margin for the third quarter 2018 was 55%, compared to 64% for the third quarter 2017, resulting from a greater proportion of our overall product sales coming from our ESS products, which realize a lower gross margin than our other products. We have now completed two additional gross margin improvement projects related to the cinch component of OverStitch and the IGB delivery system, which on a combined basis will improve gross margin by approximately $2 million annually beginning in 2019.
Total operating expenses increased $1.0 million to $15.8 million in the third quarter 2018, compared to the third quarter 2017. The increase was due to higher research and development expenses in the third quarter primarily attributable to clinical study activities associated with our Endobariatric products, new product development activities, and margin improvement project activities.
Net loss for the third quarter 2018 was $9.8 million compared to $4.9 million for the third quarter 2017. The increased net loss was primarily due to lower gross profit and higher research and development expenses.

Cash, cash equivalents and restricted cash were $29.5 million as of September 30, 2018, which includes principal payments of $2.5 million on our credit facility during the quarter.
Conference Call
Apollo will host a conference call on November 8, 2018 at 3:30 p.m. Central Time / 4:30 p.m. Eastern Time to discuss Apollo’s operating results for the third quarter ended September 30, 2018.
To participate in the conference call dial (866) 393-4306 for domestic callers and (734) 385-2616 for international callers. The conference ID number is 3448713. A live webcast of the conference call will be made available on the "Events and Presentations" section of our Investor Relations website: www.ir.apolloendo.com.
A replay of the webcast will be made available on Apollo’s website, www.apolloendo.com following the event.

On November 8, 2018 BioTime, Inc. (NYSE American and TASE: BTX), and Asterias Biotherapeutics, Inc. ("Asterias") (NYSE American: AST), reported that they have entered into a definitive merger agreement whereby BioTime will acquire all of the remaining outstanding common stock of Asterias that are not currently owned by BioTime (Press release, BioTime, NOV 8, 2018, View Source [SID1234531159]). Asterias stockholders will receive 0.71 shares of BioTime common shares for every share of Asterias common stock and will own approximately 16.2% of the combined company. Subject to customary closing conditions, including approval by the respective shareholders of BioTime and Asterias, the transaction is expected to be completed in the first quarter of 2019.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our vision is to build BioTime into a premier cell therapy company and this acquisition can support that transformation as it not only diversifies our pipeline with two additional clinical-stage assets addressing high unmet medical needs, but also adds partnerships with notable institutions such as the California Institute for Regenerative Medicine and Cancer Research UK," stated Brian M. Culley, Chief Executive Officer of BioTime. "We believe this merger is an exciting opportunity for BioTime’s shareholders to benefit from the potential future value of a more differentiated pipeline as well as the opportunity to impact disease areas that are in desperate need of innovative therapeutic approaches."

"This transaction can create substantial value for our stockholders, employees and our clinical programs," stated Michael Mulroy, Chief Executive Officer of Asterias. "The stock merger structure provides Asterias stockholders the ability to continue their investment in our clinical programs in spinal cord injury and non-small cell lung cancer as part of a larger, more diversified company with greater resources."

Asterias’ Pipeline

OPC1 – Innovative Phase 2 Program for the Treatment of Severe Spinal Cord Injury

OPC1 is a cellular therapy utilizing oligodendrocyte progenitor cells (OPCs), which in preclinical testing has demonstrated potentially reparative functions that address the complex pathologies observed in demyelination disorders such as spinal cord injury and multiple neurodegenerative diseases, including multiple sclerosis and white matter stroke. The potential reparative functions of OPC1 include the production of neurotrophic factors, the stimulation of vascularization, and the induction of remyelination of denuded axons, all of which are critical for survival, regrowth, and conduction of nerve impulses through axons at the injury site.

Asterias is currently completing a Phase 1/2a clinical trial (the "SCiStar Study") for severe spinal cord injury where there currently are no approved therapies. The results from the SCiStar Study have been promising:

Safety Profile: Results-to-date for the SCiStar Study have shown no evidence of adverse changes in any of the subjects treated with OPC1. To date, there have been no serious adverse events (SAEs) related to the OPC1 cells.
Cell Engraftment: Over 95% of subjects in the SCiStar Study have magnetic resonance imaging (MRI) scans consistent with the formation of a tissue matrix at the injury site, which is encouraging evidence that OPC1 cells have engrafted at the injury site and helped to prevent cavitation.
Motor Function Recovery: Many of the patients in the SCiStar Study have shown promising upper extremity motor recovery in their arms, hands, and fingers.

An independent data review meeting was held recently to discuss the latest results from the SCiStar Study and positive feedback was received from the outside medical and scientific experts on the panel.
A meeting with the FDA under OPC1’s RMAT designation is scheduled for later this year to discuss the trial design of the next OPC1 study.
A final update on the SCiStar Study results is expected in the first quarter of 2019.
The SCiStar Study has been partially funded by a $14.3 million grant from the California Institute for Regenerative Medicine (CIRM) and there is the potential to obtain additional non-dilutive funding in 2019 to partially offset the cost of OPC1’s next phase of clinical development.

VAC2 – Phase 1 Program for the Treatment of Non-Small Cell Lung Cancer (NSCLC) Partnered with Cancer Research UK

VAC2 is a non-patient-specific, or "allogeneic," cancer immunotherapy candidate. VAC2 cells are engineered to express a protein widely expressed in tumor cells but rarely found in normal cells. The VAC2 antigen presenting dendritic cells instruct the immune system to generate responses against tumor cells.
VAC2 currently is being investigated in a Phase 1 study for the treatment of NSCLC and is sponsored and conducted by Cancer Research UK.

The safety data from the first three subjects has been reviewed by the study’s Safety Review Committee which found VAC2 to be safe and well-tolerated in those subjects.
The study currently is enrolling subjects in the advanced disease cohort of the study and immune response and survival data are expected during 2019 and 2020. The study design also includes a cohort of less advanced patients where tumors have been resected.

VAC2 is potentially complementary and synergistic with other immune therapies such as immune checkpoint inhibitors.
In addition to being investigated in NSCLC, a leading cause of cancer deaths, VAC2 is a platform technology that has the potential to be applied to other solid and liquid tumors and to deliver additional or different antigens depending on the cancer type.

About the Proposed Merger

Under the terms of the merger agreement, Asterias stockholders will receive 0.71 common share of BioTime for each share of common stock of Asterias they own upon closing of the merger. The merger agreement, the merger and the other transactions contemplated in the merger agreement have been approved by the board of directors of Asterias (by unanimous vote of the disinterested members of the Asterias board of directors, acting upon the recommendation of a special committee comprised of only disinterested and independent members of the board of directors of Asterias). The merger agreement, the merger, the issuance of the BioTime shares in the merger and the other transactions contemplated in the merger agreement have been approved by the board of directors of BioTime (by unanimous vote of the disinterested members of the BioTime board of directors acting upon the unanimous recommendation of the disinterested members of a special committee comprised of only independent directors of BioTime). The merger is expected to close during the first quarter of 2019, subject to approval of the merger by the BioTime and Asterias stockholders, and other customary closing conditions.

The combined company will be led by Brian M. Culley, President and Chief Executive Officer of BioTime. It is expected that, following closing of the transaction, BioTime’s Board of Directors will consist of nine members, with Don Bailey, Chairman of Asterias’ Board of Directors, joining the BioTime Board of Directors and Mr. Mulroy, Asterias’ Chief Executive Officer, remaining on the BioTime Board.

Pursuant to the terms of a "go-shop" provision in the merger agreement, between the date of the merger agreement and December 3, 2018, Asterias and its representatives may solicit, discuss or negotiate alternative proposals from third parties for the acquisition of Asterias. Following the expiration of this go-shop period, Asterias will become subject to customary "no shop" restrictions on its and its representatives’ ability to solicit, discuss or negotiate alternative acquisition proposals from third parties, subject to exceptions for acquisition proposals that the Asterias board of directors and the Asterias special committee has determined constitutes or is reasonably expected to constitute a Superior Proposal (as defined in the merger agreement), and further subject to compliance with certain conditions.

BioTime’s financial advisor in the transaction is Maxim Group LLC. Raymond James is acting as financial advisor to Asterias. Cooley LLP is serving as legal counsel to BioTime and Dentons LLP is serving as legal counsel to Asterias.