On November 12, 2019 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported financial results for the third quarter ended September 30, 2019, and provided an overview of recent developments (Press release, Atreca, NOV 12, 2019, View Source [SID1234550969]).

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 make strong progress this quarter with our Investigational New Drug (IND) application for our lead product candidate, ATRC-101 and expect to initiate a Phase 1b clinical trial in patients with solid tumors early next year," said John Orwin, Chief Executive Officer. "To highlight our progress we recently presented a poster at the annual SITC (Free SITC Whitepaper) meeting describing the discovery and preclinical evaluation of ATRC-101, underscoring both our ability to leverage the human immune response to find novel antibody-target pairs, as well as the potential of ATRC-101 to become an important treatment option for patients with a variety of solid tumor cancers."

Recent Developments and Highlights

Atreca presented a poster describing the preclinical evaluation of ATRC-101 at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2019). The poster included preclinical data highlighting ATRC-101’s robust and persistent anti-tumor activity as both monotherapy and in combination with PD-1 checkpoint inhibitors.

In August 2019, Atreca appointed Lindsey Rolfe, BSc, MB ChB, MRCP, FFPM, to the company’s Board of Directors, who brings more than 20 years of drug development experience to the company.
In August 2019, the period for centralized opposition of patent rights at the European Patent Office (EPO) ended with respect to European Patent EP2702146B1, entitled "Identification of Polynucleotides Associated with a Sample", which was granted by the EPO in November 2018. This patent is part of the portfolio of patents and patent applications exclusively licensed by the Board of Trustees of the Leland Stanford Junior University to Atreca that relates to Atreca’s proprietary Immune Repertoire Capture technology.
Upcoming Milestones

Atreca anticipates completion of the IND process with the U.S. Food and Drug Administration for ATRC-101 by late 2019 and expects to initiate a Phase 1b clinical trial in patients with solid tumors in early 2020.
Third Quarter 2019 Financial Results

As of September 30, 2019, cash and cash equivalents and short-term investments totaled $201.0 million.

Research and development expenses for the three months ended September 30, 2019 were $12.8 million, including non-cash share-based compensation expense of $920,000.

General and administrative expenses for the three months ended September 30, 2019 were $4.9 million, including non-cash share-based compensation expense of $958,000.

Atreca reported a net loss of $15.9 million, or basic and diluted net loss per share attributable to common stockholders of $0.57, for the three months ended September 30, 2019.

On November 12, 2019 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, reported a business update for the third quarter 2019 (Press release, Cue Biopharma, NOV 12, 2019, View Source [SID1234550968]).

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!

"The third quarter was marked by the dosing of the first patient in our Phase 1 clinical study of CUE-101, which represents a transformative milestone for the company as we continue to grow and develop as a clinical stage company," said Daniel Passeri, chief executive officer. "As part of this continued evolution, the promotion of Dr. Suri to President and CSO helps enhance our productivity and effectiveness by further integrating operational functions and fostering close coordination of preclinical translational studies with clinical development."

Dr. Suri stated, "We have made significant progress on several key programs in addition to CUE-101, including CUE-102, a program selected with our collaboration partner, LG Chem Life Sciences, as well as our early-stage program in auto-immune disease, through our collaboration with Merck. With our first immuno-oncology candidate now in the clinic and additional candidates in lead optimization, Cue Biopharma is well positioned for the potential of significant value inflection over the coming months."

Recent News & Business Updates

Recently initiated dosing a Phase 1 clinical trial to investigate the safety and efficacy of CUE-101 in the treatment of HNSCC. The trial is a multi-center, open-label, Phase 1 dose escalation and expansion study evaluating the safety, anti-tumor effect, and

immunogenicity of CUE-101 as a monotherapy in approximately 50 patients with confirmed HPV16-driven recurrent/metastatic HNSCC and HLA-A*02:01 serotype.

Extended cash runway through an at-the-market equity offering sales agreement for aggregate gross proceeds of up to $30 million with Stifel Nicolaus & Company, Inc. ("Stifel"), who acts as sales agent. As of September 30, 2019, the Company had sold 2,084,615 shares of common stock under the sales agreement for total proceeds of approximately $15.7 million, net of commissions paid, but excluding estimated transaction expenses.

Promoted Anish Suri, Ph.D., to the role of president in addition to his current role as chief scientific officer. As president, Dr. Suri will assume operational and management oversight of corporate functions, as well as research and development activities. Building upon the recent success of entering clinical development with its lead drug candidate CUE-101, the company plans to augment its senior management team with a number of key hires through 2020.

On Friday, November 8, 2019, Cue Biopharma presented a poster on its lead program, CUE-101, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting (SITC 2019) titled, "CUE-101, a novel HPV16 E7:pMHC:IL-2:Fc fusion protein, enhances tumor antigen specific T cell activation for the treatment of HPV16-driven malignancies."

Third-Quarter Results & Financial Highlights

The Company reported collaboration revenue of approximately $1.0 million and $0.4 million for the three months ended September 30, 2019 and 2018, respectively.

Research and development expenses were $5.3 million and $10.3 million for the three months ended September 30, 2019 and 2018, respectively. The decrease in research and development expenses of $5.0 million was primarily due to a reduction in headcount, operational efficiencies and a decrease in drug substance manufacturing cost as our full clinical supply for the CUE-101 Phase 1 monotherapy trial was manufactured during 2018.

General and administrative expenses were $2.8 million and $2.9 million for the three months ended September 30, 2019 and 2018, respectively. The decrease in general and administrative expense of $0.1 million was primarily due to a reduction in headcount.

As of September 30, 2019, the Company had approximately $31.3 million in cash and cash equivalents compared with $39.2 million as of December 31, 2018.

The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

About CUE-101

CUE-101, our lead program from the CUE-100 series, contains IL-2 and a pMHC composed of HLA-A*02:01 complexed with a dominant peptide derived from the human papilloma virus 16 E7 protein (HPV16-E7). The drug is a fusion protein designed to target and activate antigen-specific T cells present in the patient’s body to attack HPV16-driven cancers. CUE-101 is currently being tested in a Phase 1 clinical trial for the treatment of HPV16-driven recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). For more information about the trial, please visit clinicaltrial.gov.

About Immuno-STAT

Immuno-STAT biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drugs is designed using our proprietary scaffold comprising: 1) a peptide-MHC complex (pMHC) to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.

The simultaneous engagement of co-stimulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in highly targeted T cell modulation. Because our drugs are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, stimulated and expanded outside the body (ex vivo), and reinfused in an activated state.

On November 12, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO), an innovative biotechnology company focused on the discovery, development, and commercialization of synthetic DNA products for treating cancers and infectious diseases, reported financial results for the third quarter ended September 30, 2019 (Press release, Inovio, NOV 12, 2019, View Source [SID1234550967]). Inovio’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss financial results and provide a general business update.

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!

Inovio Highlights

VGX-3100/MEDI0457/INO-3107/HPV-Related Diseases
REVEAL 1 Phase 3 trial of VGX-3100 for HPV-related high-grade cervical dysplasia, which completed enrollment of 198 patients in the second quarter of 2019, is on schedule to read out top-line efficacy data by the fourth quarter of 2020. Enrollment for the second Phase 3 trial for this program, REVEAL 2, remains on track, with expanded sites both within the United States and globally, including new sites recently opened in Argentina, Lithuania, and Spain.

Inovio completed enrollment of 33 patients for its Phase 2 trial of VGX-3100 for HPV-related high-grade vulvar dysplasia (vulvar HSIL).

In addition, the company completed enrollment in its open-label, 24 patient, Phase 2 trial of VGX-3100 in patients with HPV-related high-grade anal dysplasia (anal HSIL).

Inovio plans to present interim results for both vulvar HSIL and anal HSIL clinical trials at a medical conference in the first quarter of 2020.

In a global partnership with AstraZeneca, MEDI0457 (formerly INO-3112) in combination with durvalumab, an anti-PD-L1 checkpoint inhibitor, continues to be evaluated in multiple Phase 2 studies in patients with HPV-related head and neck, cervical, anal, penile, and vulvar cancers. Inovio is eligible to receive future milestone payments and double-digit tiered royalties on MEDI0457 product sales.

Inovio continues to prepare to initiate a pivotal clinical trial of INO-3107 for HPV-caused recurrent respiratory papillomatosis (RRP), which the company plans to advance as a rare, orphan product, within the first half of 2020.

INO-5401/Glioblastoma Multiforme (GBM) Phase 2 Trial
Inovio reported positive interim data from its ongoing Phase 2 trial of newly diagnosed glioblastoma multiforme (GBM), which combines Inovio’s INO-5401, a T cell-activating immunotherapy encoding for three tumor-specific antigens (hTERT, WT1, and PSMA), and INO-9012, an immune activator encoding IL-12, in combination with Libtayo, a PD-1 blocking antibody produced by Regeneron Pharmaceuticals in collaboration with Sanofi.

Key interim data from the 52-patient clinical trial showed that 80% (16 of 20) of MGMT gene promoter methylated patients and 75% (24 of 32) of unmethylated patients were progression-free at six months (PFS6) measured from the time of their first dose, substantially exceeding historical standard-of-care data (approximately 60% of MGMT promoter methylated patients and 40% of unmethylated patients historically were progression-free at six months). The data was presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2019 Annual Meeting. Inovio will report 12- and 18-month overall survival data next year.

INO-5151/Prostate Cancer Combination Trial
INO-5151 was featured in a trial-in-progress poster at SITC (Free SITC Whitepaper) 2019. INO-5151, which is a combined formulation of INO-5150 (with SynCon antigens encoding for PSA and PSMA) and INO-9012, is being tested in one arm (Cohort C) of this exploratory platform study along with nivolumab, a PD-1 inhibitor (Bristol-Myers Squibb), and CDX-301 (Celldex). This study is being conducted and funded by the Parker Institute for Cancer Immunotherapy (PICI) and the Cancer Research Institute (CRI), as part of Inovio’s previously established clinical collaboration agreement (ClinicalTrials.gov Identifier: NCT03835533).

DNA-encoded monoclonal antibodies (dMAb)/DNA-encoded Bi-specific T Cell Engagers (dBTE)
Inovio and its collaborator, The Wistar Institute, received a $4.6 million grant from the National Institutes of Health (NIH) in support of innovative research of antimicrobial resistance (AMR) and continued development of Inovio’s DNA-encoded monoclonal antibodies (dMAb) platform.

Using direct local delivery into the body by the CELLECTRA platform, the synthetic genetic codes provided by the dMAbs instruct the body’s cells to become a customized patient-specific factory that manufactures its own therapeutic antibody products, enabling a major leap in antibody technology. Traditional monoclonal antibodies represent the largest segment of pharmaceutical markets today, accounting for more than $100 billion in pharmaceutical sales each year, with treatments spanning cancer, infectious diseases, inflammation, and cardiovascular diseases. With its synthetic design and in-patient production, dMAb products represent a disruptive and innovative entrant to this important class of pharmaceuticals. Collectively, dMAb and dBTE offer the opportunity to provide improved yet cost-effective therapeutic options across cancer and infectious diseases.

Earlier this year, Inovio advanced its first dMAb candidate INO-A002 (for preventing or treating Zika virus infection) to a Phase 1 dose-escalation trial to assess safety and tolerability and expression of dMAb-produced antibodies with full funding from the Bill & Melinda Gates Foundation.

Cash Position
As of September 30, 2019, cash and cash equivalents and short-term investments were $93.8 million compared to $81.2 million as of December 31, 2018.

In August, Inovio closed a private placement of 1.0% convertible bonds due 2024 with an aggregate principal amount of 18 billion Korean Won (KRW) (approximately USD $15.0 million based on the exchange rate on the date of issuance) issued to a group of institutional investors led by Korea Investment Partners (KIP), a global venture capital and private equity firm. These bonds are convertible into Inovio’s Korean Depositary Receipts (KDRs) assuming Inovio has completed a secondary listing of its securities on the KOSDAQ Market of the Korea Exchange in the form of KDRs, or otherwise shares of common stock if KDRs are not listed at the time of conversion. Net proceeds from the offering were approximately $14.5 million after deducting offering expenses payable by Inovio.

In July, Inovio implemented a strategic cost-reduction plan (including a 28% staff reduction and cessation of several R&D and clinical programs), which resulted in an approximately 25% reduction in annual burn. The reallocation of resources focuses the company’s commercialization efforts for its lead asset, VGX-3100, while also developing high-value, fast-to-market product candidates, such as INO-3107 to treat RRP and INO-5401 for GBM.

Dr. J. Joseph Kim, Inovio’s President & CEO, said, "Our recently presented INO-5401 data demonstrated promising efficacy results, in terms of progression-free survival rates, against a very difficult to treat cancer in GBM and highlighted the potential of our immunotherapies utilizing tumor-associated antigens in cancer treatments. Looking ahead, the next 12 months should be a transformational period for Inovio, as we expect to have data readouts from multiple Phase 3 and Phase 2 programs. With our sharpened focus on advancing and commercializing products for HPV-related diseases and fast-to-market opportunities, the company is uniquely positioned to bring multiple products to the market."

Dr. Kim further stated, "We continue to advance our HPV treatment capabilities, where we will have efficacy results from our Phase 3 VGX-3100 REVEAL 1 trial and Phase 2 VIN/AIN programs next year. Additionally, we plan to initiate a pivotal clinical trial of INO-3107 for HPV-caused RRP, which we expect to move forward rapidly as a rare, orphan product. In cancer, you can expect overall survival data from our INO-5401 cancer combination trial with Regeneron for GBM, building upon the promising PFS6 data. Finally, the fully enrolled head and neck cancer Phase 2 trial sponsored by our partner AstraZeneca, combining MEDI0457 with AstraZeneca’s checkpoint inhibitor should be completed by the third quarter. Collectively, these anticipated data readouts in 2020 all point to great promise for Inovio’s product pipeline, and further solidify Inovio as the leader in synthetic DNA immunotherapy."

Third Quarter 2019 Financial Results

Inovio’s total revenue was $867,000 for the three months ended September 30, 2019, compared to $2.0 million for the same period in 2018. Inovio’s total operating expenses were $24.8 million for the three months ended September 30, 2019, compared to $28.6 million for the same period in 2018.

Inovio’s net loss for the quarter ended September 30, 2019 was $23.1 million, or $0.23 per basic and $0.25 per diluted share, compared to $25.0 million, or $0.27 per basic and diluted share, for the same period in 2018.

Revenue

The year-over-year decrease in revenue under collaborative research and development arrangements was primarily due to a decrease in reimbursed drug manufacturing activities related to our partnership with AstraZeneca.

Operating Expenses

R&D expenses were $19.1 million for the three months ended September 30, 2019, as compared to $21.9 million for the same period in 2018. The decrease in R&D expenses was primarily related to decreases in employee compensation expense, drug manufacturing expense related to our partnership with AstraZeneca and engineering and lab supplies, among other variances. These decreases were offset by a personnel-related restructuring charge in connection with the one-time employee termination costs incurred during the third quarter of 2019.

Contributions received from current grant agreements and recorded as contra-R&D expense were $2.8 million for the three months ended September 30, 2019, compared to $2.6 million for the same period in 2018.

General and administrative (G&A) expenses were $5.7 million for the three months ended September 30, 2019, versus $6.8 million for the same period in 2018. The decrease in G&A expenses was primarily related to decreases in employee compensation, allocated depreciation expense, and legal expenses, among other variances.

Capital Resources

As of September 30, 2019, cash and cash equivalents and short-term investments were $93.8 million compared to $81.2 million as of December 31, 2018. As of September 30, 2019, Inovio had 99.0 million common shares outstanding and 129.5 million common shares outstanding on a fully diluted basis, after giving effect to the exercise, vesting and conversion, as applicable, of its outstanding options, restricted stock units, convertible preferred stock, and convertible debt.

Inovio’s condensed consolidated balance sheet and statement of operations are provided below. Additional information is included in Inovio’s quarterly report on Form 10-Q for the quarter ended September 30, 2019, which can be accessed at: View Source

Conference Call / Webcast Information

Inovio’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss Inovio’s financial results and provide a general business update.

The live webcast and a replay may be accessed by visiting Inovio’s website at View Source Telephone replay will be available approximately one hour after the call at 877-344-7529 (US toll-free) or 412-317-0088 (international toll) using replay access code 10136605.

On November 12, 2019 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that the Company’s management will present a Company overview and update, as well as host investor meetings, at the following November conferences (Press release, Supernus, NOV 12, 2019, View Source [SID1234550966]):

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!

Stifel 2019 Healthcare Conference
Date: November 19, 2019
Time: 1:50 p.m. ET
Place: Lotte New York Palace Hotel, New York

Jefferies 2019 London Healthcare Conference
Date: November 21, 2019
Time: 2:40 p.m. GMT / 9:40 a.m. ET
Place: Waldorf Hilton, London, UK
Investors interested in arranging a meeting with the Company’s management during these conferences should contact the respective conference coordinators.

A live webcast of the presentations can be accessed by visiting ‘Events & Presentations’ in the Investor Relations section on the Company’s website at www.supernus.com. An archived replay of these webcasts will be available for 60 days on the Company’s website after the respective conferences.

On November 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 (Press release, Lineage Cell Therapeutics, NOV 12, 2019, View Source [SID1234550965]). 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.

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 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

Provided an update of our Phase I/IIa clinical study of OpRegen in patients with dry age-related macular degeneration (dry AMD) with geographic atrophy at the 2019 American Academy of Ophthalmology Annual Meeting (AAO 2019) in San Francisco, CA on October 14, 2019. Data from the study demonstrated that treatment with OpRegen continued to be well tolerated and, at the furthest time point collected, all four Cohort 4 patients treated to date had better visual acuity on an Early Treatment Diabetic Retinopathy Scale (ETDRS) in the treated eye (range +8 to +19 letters) than in the untreated eye (range -2 to +7 letters). The largest increase recorded at any single timepoint in a Cohort 4 patient was +22 letters. Cohort 4 patients have better baseline vision and less advanced disease than Cohorts 1-3 patients, who were legally blind at baseline. Previously reported structural improvements in the retina and decreases in drusen density observed in some patients were maintained and there was evidence of the continued presence of transplanted OpRegen cells in patients treated in the first 3 cohorts, some over 3 years following administration. Of note, the first patient successfully dosed using the Orbit Subretinal Delivery System (Orbit SDS) as well as a new Thaw-and-Inject (TAI) formulation of OpRegen was also demonstrating signs of improved visual acuity, having gained 13 letters in the 3 months following administration as assessed by ETDRS. Overall, OpRegen appeared well tolerated with preliminary evidence of improved structural changes and potential improvement in visual acuity following treatment in some patients.
Announced that Renevia, the Company’s facial aesthetics product, has been granted a Conformité Européenne (CE) Mark. Renevia received a Class III classification with an intended use in adults as a resorbable matrix for the delivery of autologous adipose tissue preparations to restore and/or augment facial volume after subcutaneous fat volume loss for the treatment of facial lipoatrophy. The CE Mark provides Lineage, or its authorized agent, the authority to market and distribute Renevia throughout the European Union (EU) and in other countries that recognize the CE Mark. The Company has engaged an EU-based business development agent to identify opportunities to partner this asset and has begun the process of engaging with commercially capable partners for Renevia.
Completed the launch of our new corporate brand and identity as well as a change in corporate name to Lineage Cell Therapeutics, Inc., reflecting our commitment to becoming an innovative, leading cell therapy company and highlighting our extensive cell therapy platform. In conjunction with the name change, the Company’s ticker symbol was changed to "LCTX" on August 12, 2019. The Company also relocated its corporate headquarters to Carlsbad, California, effective August 12, 2019, a move which provides proximity to world-leading academic centers, public and private cell therapy peers, and offers more centralized decision-making, cost-savings, and access to an extensive network of experienced staff. The Company also terminated shared services with OncoCyte Corporation (OncoCyte, NYSE American: OCX) and AgeX Therapeutics, Inc. (AgeX, NYSE American: AGE) on September 30, 2019, an important step in our plan to simplify our business structure.
Converted approximately 43% of our investment in OncoCyte into cash to support our operations with the sale of 6,250,000 shares of OncoCyte common stock for net proceeds totaling $10.7 million. Lineage continues to own approximately 16% or 8.4 million shares of OncoCyte’s outstanding common stock. Based on the closing price of OncoCyte’s common stock on November 8, 2019, the value of our remaining OncoCyte shares is approximately $14.1 million.
Near Term Milestones for 2019 and 2020

Complete patient enrollment in the United States with the Orbit SDS in the ongoing Phase I/IIa clinical study of OpRegen for the treatment of dry AMD, expected in Q1 2020.
Obtain VAC2 immunogenicity data from the initial patients in the ongoing Phase I study in NSCLC (non-small cell lung cancer) run by Cancer Research UK, expected around year end.
Present new OpRegen data from the ongoing Phase I/IIa clinical study at the Association for Research in Vision and Ophthalmology Meeting (ARVO) in May 2020.
Advance the OPC1 manufacturing program by introducing enhancements to the manufacturing process in our GMP manufacturing facility, ongoing throughout 2020.
Meet with the FDA to discuss the manufacturing and clinical development of OPC1, around the middle of 2020.
Identify an external partner for commercialization of Renevia in Europe, targeted for the first half of 2020.
Continue engagement with the investment and medical communities with participation at medical and healthcare industry conferences, ongoing throughout 2020.
Strengthen existing partnerships with the National Institutes of Health, the Israel Innovation Authority, the California Institute for Regenerative Medicine and Cancer Research UK.
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.