On November 3, 2016 Navidea Biopharmaceuticals (NYSE MKT:NAVB) reported financial results for the quarter ending September 30, 2016 (Press release, Navidea Biopharmaceuticals, NOV 3, 2016, View Source;p=RssLanding&cat=news&id=2219021 [SID1234516230]). Navidea reported total revenue for the third quarter of 2016 of $8.5 million, including Lymphoseek (technetium Tc 99m tilmanocept) injection sales revenue of $6.7 million. The income from operations was $3.4 million and the net loss attributable to common stockholders was $59,000.

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"We ended the third quarter with a clear plan for Navidea’s future. With our previously announced Letter of Intent with Cardinal Health, Inc., we believe that we have successfully identified an arrangement to extinguish the CRG (Capital Royalty Partners II L.P) debt and to focus Navidea on several attractive development efforts outside of lymphatic mapping, lymph node biopsy and the diagnosis of metastatic spread to lymph nodes for the staging of cancer in North America. The contemplated transaction with Cardinal Health, as well as the impending launch of Lymphoseek in Europe by our partner SpePharm AG (Norgine BV), should provide additional income for many years to come," said Dr. Michael Goldberg, Navidea President and CEO. "Our focus moving forward will be on expansion and development of Manocept-based diagnostic markets initially in rheumatoid arthritis and cardiovascular disease, as well as developing our immunotherapeutic platform with a strong preclinical pipeline for cancer, autoimmune, inflammatory and infectious diseases."

Specific events and milestones achieved since the beginning of the third quarter include the following:

Operational & Financial

Entered into Letter of Intent with Cardinal Health, Inc. for the sale of Lymphoseek in North America;
Operating activities provided cash of $1.3 million during the first nine months of 2016, compared to $14.9 million cash used in operations during the same period in 2015;
Reduced cash used in operations by over 100% for the first nine months of 2016 compared to the same period of 2015; and
Appointed Michael M. Goldberg, M.D. President and Chief Executive Officer, and Eric K. Rowinsky, M.D. Chairman of the Board.
Commercial

Achieved sequential quarter-on-quarter Lymphoseek sales revenue growth;
Earned a $500,000 milestone payment from Cardinal Health with the sale of the 100,000th Lymphoseek dose;
Received positive opinion in Europe for new Lymphoseek reduced-mass vial enabling a single injection per vial and triggering a $500,000 milestone payment by our partner, Norgine BV; and
Continued to support the projected Q4 launch of Lymphoseek in Europe by Norgine BV.
Immunodiagnostic & Immunotherapeutic Development Pipeline

Received both Institutional Review Board at University of California, San Francisco and Western Institutional Review Board approvals for a tilmanocept subcutaneous administration clinical trial protocol in rheumatoid arthritis, allowing subject enrollment to begin. To date, 17 of 18 patients have been dosed and imaged;
Received Institutional Review Board approval for a tilmanocept clinical trial protocol in Kaposi Sarcoma which is supported by an NIH grant;
Clinical trial results of tilmanocept in cardiovascular disease from Massachusetts General Hospital have been submitted for publication; and
Completed a number of additional preclinical animal studies and initiated additional studies with the MT 1000 and MT 2000 class of compounds.
Financials

"We are pleased with our financial performance despite the significant disruption in our organization caused by the ongoing litigation with CRG. Our results demonstrate our commitment to our commercial efforts and controlling our operating expenses," said Jed Latkin, interim Chief Operating Officer and Chief Financial Officer at Navidea.

Total revenues for the quarter ended September 30, 2016 were $8.5 million compared to $4.0 million in the third quarter of last year. Third quarter 2016 product revenues recognized from the sale of Lymphoseek were $6.7 million, compared to $4.2 million in the second quarter of 2016 and $3.0 million in the third quarter of 2015. During the third quarter of 2016, the Company also reported $1.8 million in licensing, grant and other revenue. For the nine months ended September 30, 2016, Navidea’s total revenue was $18.6 million compared to $9.0 million for the same period in 2015, an increase of 108%. The primary driver of this increase was revenues recognized by Navidea from the sale of Lymphoseek which exceeded $14.7 million for the nine months ended September 30, 2016 compared to $6.8 million for the same period last year. Third quarter 2016 revenue from the sale of Lymphoseek included $2.0 million of inventory purchases by Cardinal Health and $500,000 of additional revenue from a milestone related to the sale of the 100,000th Lymphoseek dose by Cardinal Health.

Third quarter 2016 margins also remained above 80%, contributing to a total gross profit of $7.6 million for the quarter, compared to $3.5 million for the same period last year. For the nine months ended September 30, 2016, total gross profit rose to $16.6 million versus $7.7 million for the same period last year, an increase of 115%. The increases in total gross profit in the third quarter and first nine months of 2016 was primarily due to $2.0 million of inventory purchases by Cardinal Health, a $500,000 milestone related to the sale of the 100,000th Lymphoseek dose by Cardinal Health, and receipt of a $500,000 milestone payment, and recognition of the remaining $500,000 of the upfront license fee received from SpePharm related to the positive regulatory opinion on a reduced-mass vial in Europe.

Research and development (R&D) expenses for the third quarter of 2016 were $1.3 million, compared to $3.9 million in the third quarter of last year. R&D expenses were $6.5 million for the nine months ended September 30, 2016 compared to $10.2 million in the same period of 2015. The net decreases in year-to-date R&D expenses were primarily a result of decreased headcount costs coupled with decreased project costs related to the Company’s neuro assets and Lymphoseek, offset by increased project costs related to the Company’s therapeutic programs. Selling, general and administrative (SG&A) expenses for the third quarter of 2016 were $2.9 million, compared to $3.9 million in the third quarter of last year. SG&A expenses were $9.9 million for the nine months ended September 30, 2016, compared to $13.5 million for the same period in 2015. The net decrease in year-to-date SG&A expenses was due primarily to decreased headcount coupled with decreased costs related to business development consulting services, contracted medical science liaisons, commercialization costs for Lymphoseek, license fees and investor relations, offset by increases in commercial and medical headcount costs related to the addition of our internal sales force and medical science liaisons coupled with increased legal and professional services. Total operating expenses were $4.2 million for the third quarter of 2016, compared to $7.8 million in the third quarter of last year. Operating expenses were $16.4 million for the nine months ended September 30, 2016, compared to $23.7 million for the same period in 2015.

Navidea’s income from operations for the quarter ended September 30, 2016 was $3.4 million compared to a loss from operations of $4.3 million for the same period in 2015. For the nine months ended September 30, 2016, Navidea’s income from operations was $210,000 compared to a loss from operations of $15.9 million for the same period in 2015. Navidea’s net loss attributable to common stockholders for the quarter ended September 30, 2016 was $59,000, or $0.00 per share, compared to net loss attributable to common stockholders of $8.1 million, or $0.05 per share, for the same period in 2015. For the nine months ended September 30, 2016, Navidea’s net loss attributable to common stockholders was $10.4 million, or $0.07 per share, compared to a net loss attributable to common stockholders of $25.1 million, or $0.17 per share, for the same period in 2015. Net losses attributable to common stockholders include fees paid to CRG (which the Company is disputing in court), the interest expense on our outstanding debt, as well as significant non-cash charges. For the nine-month periods ended September 30, 2016 and September 30, 2015, net loss attributable to common stockholders included $10.6 million and $9.1 million, respectively, in interest, debt-related fees, losses on extinguishment of debt, and changes in the fair value of financial instruments.

Navidea ended the quarter with $4.3 million in cash, $3.5 million of which was restricted related to the CRG debt.

On November 3, 2016 NantKwest Inc. (Nasdaq:NK), a pioneering, next generation, clinical-stage immunotherapy company focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and inflammatory diseases, reporteded several presentations at the upcoming 58th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in San Diego, CA, December 3-6, 2016 (Press release, NantKwest, NOV 3, 2016, http://ir.nantkwest.com/phoenix.zhtml?c=254059&p=RssLanding&cat=news&id=2220144 [SID1234516468]).

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"As these presentations demonstrate, since our IPO in July 2016, NantKwest continues to make significant progress in our preclinical and clinical development efforts," said Patrick Soon-Shiong, MD, Chairman and CEO of NantKwest. "We are honored to present these results at the upcoming annual ASH (Free ASH Whitepaper) meeting and remain focused on bringing our novel, natural killer cell based therapies to the routine clinical cancer setting for a broad range of cancer types."

Presentation Summaries

Combination Therapy with Daratumumab and CAR-NK Targeting CS1 for Multiple Myeloma

Abstract #1342, View Source
Presenter: Yibo Zhang, PhD, Comprehensive Cancer Center, Ohio State University, Columbus, OH
Saturday, December 3, 2016, 5:30 – 7:30 PM, Hall GH
This poster will review the combination of Daratumumab and CS1.taNK therapy targeting two different tumor-associated antigens, both with potent efficacy in multiple myeloma, which may have synergistic effects.

Phase 1 Clinical Trial of Adoptive Immunotherapy Using "Off-The-Shelf" Activated Natural Killer Cells (aNK) in Patients with Refractory/Relapsed Acute Myeloid Leukemia

Abstract #1649, View Source
Presenter: Michael Boyiadzis, MD, MHSc, University of Pittsburgh Medical Center, UPMC Cancer Center, University of Pittsburgh Cancer Institute, Pittsburgh, PA
Saturday, December 3, 2016, 5:30 – 7:30 PM, Hall GH
This poster will review a Phase I clinical trial of the safety and efficacy of "off-the-shelf" aNK cell therapy in heavily pretreated patients with refractory/relapsed AML

CD19 Target Activated Natural Killer (CD19.taNK) Cellular Therapy: A Novel Immunotherapeutic Approach to the Treatment of Non-Hodgkin Lymphoma (NHL)

Abstract #4174, View Source
Presenter: Ravi Dashnamoorthy, PhD, Molecular Oncology Research Institute, Tufts Medical Center, Boston, MA
Monday, December 4, 2016, 6:00 – 8:00PM, Hall GH
This poster will review the potent single agent anti-tumor activity against a range of NHL cell and ongoing activity into the biological mechanisms of activity of CD19.taNK therapy and potential combination therapy approaches.

On November 3, 2016 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the fields of cancer metabolism and rare genetic metabolic disorders, reported business highlights and financial results for the third quarter ended September 30, 2016 (Filing, Q3, Agios Pharmaceuticals, 2016, NOV 3, 2016, View Source [SID1234516180]).

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"We have made significant progress during 2016, establishing proof of concept with our lead pyruvate kinase-R (PKR) activator, executing late-stage clinical development for both of our lead isocitrate dehydrogenase (IDH) mutant inhibitors in hematologic malignancies and strengthening our balance sheet through our recent financing," said David Schenkein, M.D., chief executive officer at Agios. "As we head into year end, we are focused on supporting the enasidenib NDA submission with our partner Celgene and planning for our next steps in clinical development for our PKR and IDH portfolios based on data we will present at a number of upcoming medical meetings this quarter."

THIRD QUARTER 2016 HIGHLIGHTS & UPDATES
IDH Mutant Inhibitors in Hematologic Malignancies:
In September, Agios and Celgene announced plans to submit a new drug application (NDA) to the U.S. Food and Drug Administration for enasidenib (AG-221) in relapsed and/or refractory (R/R) acute myeloid leukemia (AML) with an IDH2 mutation by year-end. The NDA will be based on data from an ongoing Phase 1/2 trial in patients with relapsed and/or refractory AML and other advanced hematologic malignancies with an IDH2 mutation.

Agios plans to explore a similar regulatory path for AG-120, its wholly owned, first-in-class, oral, potent inhibitor of mutant IDH1, which could lead to a NDA submission in 2017 in the U.S.

Corporate:
In September, Agios completed an underwritten public offering of common stock for 3,876,403 shares at the offering price of $44.50 per share, resulting in gross proceeds of approximately $173 million.

Agios recently announced the appointment of Andrew Hirsch to chief financial officer. Mr. Hirsch has more than 20 years of experience in a range of strategic and operating roles. He most recently served as president and chief executive officer of BIND Therapeutics. Prior to joining BIND, he was chief financial officer at Avila Therapeutics until its acquisition by Celgene and held roles of increasing responsibility during his nearly 10-year tenure at Biogen.

UPCOMING MEDICAL MEETING PRESENTATIONS

• First data from the expansion phase of the ongoing Phase 1 study of AG-120 in advanced IDH1 mutant positive chondrosarcoma at the Connective Tissue Oncology Society (CTOS) Annual Meeting on November 10, 2016 in Lisbon, Portugal.

• Preliminary data from the expansion phase of the ongoing Phase 1 study of AG-120 in advanced IDH1 mutant positive low-grade glioma at the Society for NeuroOncology (SNO) Annual Meeting on November 18, 2016 in Scottsdale, AZ.

• Updated data from the AG-348 Phase 2 DRIVE-PK study, the AG-519 Phase 1 healthy volunteer study, the Natural History Study of pyruvate kinase deficiency (PKD), and new AG-348 metabolic data in PKD patients at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on December 3-6, 2016 in San Diego, CA.

• Updated follow-up and molecular data from the completed dose escalation portion of the AG-120 Phase 1 study in R/R AML at ASH (Free ASH Whitepaper).

ADDITIONAL 2016 EXPECTED MILESTONES
IDH Mutant Inhibitors in Hematologic Malignancies:

• Complete enrollment of the 125-patient expansion cohort for the Phase 1 study of AG-120 in patients with R/R AML
IDH Mutant Inhibitors in Solid Tumors:

• Initiate a randomized study of AG-120 in IDH1 mutant positive cholangiocarcinoma

Cancer Metabolism Research:

• Initiate preclinical development activities for the first molecule in a program focused on MTAP (methylthioadenosine phosphorylase) deleted cancers
Rare Genetic Metabolic Disorders:

• Provide a development strategy update for our PKR activator program, including molecule selection

• Outline the clinical development plans for our PKR activators in beta-thalassemia

THIRD QUARTER 2016 FINANCIAL RESULTS
Cash, cash equivalents and marketable securities as of September 30, 2016 were $622.6 million, compared to $375.9 million as of December 31, 2015. The increase in cash was driven by cash received from Celgene totaling $251.5 million, which includes a $200 million upfront payment from the May 2016 collaboration agreement, $25 million related to initiation of the enasidenib Phase 3 IDHENTIFY study and $26.5 million of program funding related to our collaboration agreements, and net proceeds of $162.1 million received from the company’s September 2016 public offering. These items were offset by a decrease in cash related to expenditures to fund operating activities of $161.7 million and purchases of fixed assets, net of reimbursements, of $4.3 million during the nine months ended September 30, 2016.

Collaboration revenue was $9.0 million for the quarter ended September 30, 2016, compared to $5.5 million for the comparable period in 2015.

Research and development (R&D) expense was $60.6 million, including $7.9 million of stock-based compensation expense, for the quarter ended September 30, 2016, compared to $36.0 million, including $4.9 million in stock-based compensation expense, for the quarter ended September 30, 2015. The increase in R&D expense was primarily due to increased costs to support advancement of the company’s lead investigational medicines toward later-stage development. Celgene is responsible for all development costs for enasidenib and certain development costs for AG-881 and reimburses the company for development costs incurred for these investigational medicines.

General and administrative (G&A) expense was $11.9 million, including $4.2 million of stock-based compensation expense, for the quarter ended September 30, 2016, compared to $9.9 million, including $4.5 million of stock-based compensation expense, for the quarter ended September 30, 2015. The increase in G&A expense was largely due to increased headcount and other professional expenses to support growing operations.

Net loss for the quarter ended September 30, 2016 was $62.8 million, compared to a net loss of $40.3 million for the comparable period in 2015.

UPDATED FINANCIAL GUIDANCE FOR THE FULL YEAR 2016
As a result of the recent financing, Agios now expects to end 2016 with more than $550 million of cash, cash equivalents and marketable securities. The anticipated year-end 2016 cash position does not include any additional program-specific milestone payments from Celgene. Based on its current operating plans, the company expects that its existing cash, cash equivalents and marketable securities as of September 30, 2016, together with anticipated interest income, and anticipated expense reimbursements under our collaboration agreements with Celgene, but excluding any additional program-specific milestone payments from Celgene, will enable the company to fund its anticipated operating expenses and capital expenditure requirements through at least the end of 2018.

On November 3, 2016 Argos Therapeutics Inc. (Nasdaq:ARGS) ("Argos"), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis technology platform, reported the publication of a Case Report in the Kidney Cancer Journal which details the clinical outcomes of two patients with intermediate risk metastatic renal cell carcinoma who had participated in a Phase 2 clinical trial of the company’s investigational immunotherapy AGS-003 in combination with sunitinib (Press release, Argos Therapeutics, NOV 3, 2016, View Source [SID1234516205]). These patients have obtained long-term control of metastatic disease that is ongoing seven years after initiation of treatment.

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"Our report discusses truly remarkable cases from a Phase 2 study, where two intermediate risk mRCC patients have sustained an immune response to their disease for many years," said lead author Gautam Jha, MD, medical oncologist at the University of Minnesota. "Perhaps most importantly, we have observed an increase in the number of effector memory T-cells associated with improved Overall Survival (OS) in 14 patients who received at least 5 doses of AGS-003. Considering AGS-003 is well-tolerated without significant additional side effects over single agent sunitinib, this investigational therapy remains promising for patients with advanced kidney cancer."

In the open-label Phase 2 clinical trial, 21 patients with newly-diagnosed, intermediate and poor risk mRCC were treated with AGS-003 plus sunitinib as a first-line therapy. Results demonstrated a median Progression Free Survival (PFS) of 11.2 months and median OS of 30.2 months for all patients. Five patients in the trial survived for more than five years, and two patients have maintained durable immune responses for seven years. According to the International mRCC Database Consortium, similar unfavorable risk mRCC patients have an expected OS of only 14.7 months. In addition, follow-up analysis of these Phase 2 data, approximately two years after database lock, demonstrated a median OS of 61.9 months for the intermediate risk patients in the study compared with 20.7 months for similar patients in the International mRCC Database Consortium.

Argos designed AGS-003 to capture the mutated and variant antigens that are unique to each patient’s tumor to induce a robust targeted immune response. This individualized immunotherapy is created using a small tumor sample and the patient’s own dendritic cells collected in a leukapheresis procedure. RNA is isolated from the tumor sample and used to program dendritic cells to target disease-specific antigens. Activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma, and administered via intradermal injection as an individualized immunotherapy.

"By capturing the array of known, unknown, and mutated antigens present in an individual patient’s specific cancer, AGS-003 appears to elicit a broad, individualized anti-tumor immune response," said Lee F. Allen, MD, PhD, chief medical officer of Argos. "We remain focused on aggressively advancing our development program through late-stage clinical research, and continue to be encouraged by the long-term outcomes from the Phase 2 study."

Argos is currently evaluating AGS-003 in combination with standard-of-care targeted therapy in the pivotal ADAPT Phase 3 clinical trial for the treatment of mRCC. Enrollment in this 462-patient study was initiated in February 2013 and completed in July 2015. The Independent Data Monitoring Committee (IDMC) for this study most recently recommended continuation of the study following a meeting in June 2016, with the next IDMC meeting planned for February 2017. In addition, AGS-003 is being studied in Phase 2 investigator-initiated clinical trials as neoadjuvant therapy for RCC and for the treatment of non-small cell lung cancer (NSCLC).

To read the full report in the Kidney Cancer Journal, visit View Source

About the Arcelis Technology Platform
Arcelis is a precision immunotherapy technology that captures both mutated and variant antigens that are specific to each patient’s individual disease. It is designed to overcome immunosuppression by producing a specifically targeted, durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to the treatment of a wide range of different cancers and infectious diseases, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized immunotherapies. The Arcelis process uses only a small disease sample or biopsy as the source of disease-specific antigens, and the patient’s own dendritic cells, which are optimized from cells collected by a leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease-specific antigens. These activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma, and administered via intradermal injection as an individualized immunotherapy.

On November 3, 2016 BioTime, Inc. (NYSE MKT and TASE: BTX), a clinical stage biotechnology company with a focus on pluripotent cell-based technologies, reported financial results for the third quarter ended September 30, 2016, and recent therapeutic program progress (Filing, Q3, BioTime, 2016, NOV 3, 2016, View Source [SID1234516259]).

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"Through the quarter, we continued to execute on our plan with great progress across all our programs within the BioTime family of companies. We are particularly encouraged by the early data reported on Renevia and OpRegen. Both Asterias and OncoCyte also reported promising data from their clinical trials," said Adi Mohanty, Co-Chief Executive Officer. "For the remainder of the year and into 2017, we expect to achieve a substantial number of value-enhancing milestones, including additional efficacy and safety data from the second and third patient cohorts in the OpRegen clinical trial, and pivotal data and potential CE mark approval for Renevia in Europe."

Third Quarter and Recent Accomplishments

Clinical Progress

OpRegen (retinal pigment epithelial cells)

The ongoing Phase I/IIa clinical trial is evaluating the safety of three different dosage regimens of OpRegen in the advanced form of dry age-related macular degeneration (Dry-AMD). Dry-AMD is a condition for which there is currently no FDA-approved therapy. Preliminary data from the first cohort of patients treated in this trial of OpRegen resulted in no serious adverse events. Imaging data from the first patient who completed one-year of post-treatment clinical assessment may indicate that the graft can survive for at least 12 months. These and other data will be presented at the International Symposium on Ocular Pharmacology and Therapeutics (ISOPT), on December 2, in Rome, Italy.
Enrollment in the second cohort, in which patients are receiving a higher and more clinically meaningful 200,000 cell dose, is expected to be complete by year end 2016, and data are expected early in 2017.
Additional data, from the third cohort, which is expected to commence before year end, is anticipated by the end of 2017.
US clinical trial sites are expected to be announced in early 2017.
Renevia (adipose cells + cell delivery matrix)

The Renevia pivotal clinical trial for HIV-related facial lipoatrophy continues to enroll new patients and is on track to complete patient enrollment by the end of 2016. The objective of the trial is to assess the safety and efficacy of Renevia in restoring normal skin contours in patients whose subcutaneous fat has been lost due to antiviral drug treatment for HIV. BioTime expects top-line efficacy data in the first half of 2017. If the data are positive, the company plans to submit an application for CE mark approval in Europe shortly thereafter.
Positive data from the pivotal trial could provide support for future studies of Renevia in certain broader applications of fat tissue deficits. These include various medical aesthetics applications, such as age-related and trauma-related facial fat loss.
AST-OPC1 (oligodendrocyte progenitor cells)

In September, BioTime’s affiliate Asterias Biotherapeutics, Inc. (NYSE MKT: AST), announced positive data from the AST-OPC1 SCiSTAR Phase 1/2a clinical study in patients with complete cervical spinal cord injuries. All patients in the initial cohort who received 10 million AST-OPC1 cells showed at least one motor level of improvement (regaining some function in their arms), while two of five patients achieved two motor levels of improvement (regaining some function in their arms, hands and fingers) on at least one side of their body. The data were presented at the Annual Scientific Meeting of the International Spinal Cord Society (ISCoS) in Vienna, Austria.
Six-month efficacy data on this first cohort are expected to be announced in January 2017. Enrollment is also ongoing in a new cohort in which patients are receiving a higher dose of 20 million cells.
OncoCyte (non-invasive cancer diagnostics)

In August, BioTime’s subsidiary OncoCyte Corporation (NYSE MKT: OCX) closed a financing with both new and existing investors, providing OncoCyte with gross proceeds of $10.55 million, before deducting placement agent fees and offering expenses.
Data was presented related to OncoCyte’s lead product, a confirmatory diagnostic for lung cancer screening. OncoCyte expects to complete the study by year end and, if successful, could launch the product by mid-year 2017.
Research and Development

In August, BioTime strengthened its regenerative medicine intellectual property portfolio with the issuance of 31 new patents. This included nine in the U.S. and 22 in Australia, Canada, China, India, Israel, and Japan. The new patents supplement the existing portfolio of more than 700 patents and patent applications owned or licensed by the BioTime family of companies worldwide.
Management Team

In October, BioTime strengthened its senior management team with the appointment of Jim Knight as Senior Vice President, Head of Corporate Development. Mr. Knight is a highly accomplished professional with an extensive skill set and knowledge that is applicable immediately, as the company has started reporting encouraging early clinical data on its key programs.
Third Quarter Financial Results

Cash Position and Equity Values: Cash and cash equivalents totaled $30.5 million as of September 30, 2016, compared to $42.2 million as of December 31, 2015, which included Asterias’ cash and cash equivalents of $11.2 million. Based on the September 30, 2016, closing prices of Asterias and OncoCyte common stock on the NYSE MKT, the shares of Asterias and OncoCyte owned by BioTime had an estimated market value of $92.2 million and $74.0 million, respectively, or an aggregate market value of approximately $166.0 million on that date.

Revenues: Total revenues were $1.5 million for the third quarter, compared to $2.3 million in the third quarter of 2015. Asterias’ total revenues included in the third quarter of 2015 were $1.4 million as shown in the table below (in thousands). BioTime’s operating revenues are currently generated primarily from research grants, licensing fees and advertising from the marketing of online database products.

Three months ended September 30, 2016 Three months ended September 30, 2015
Consolidated
Results of
Operations
Asterias Consolidated
Results less
Asterias
Consolidated
Results of
Operations

Asterias
Consolidated
Results less
Asterias
REVENUES:
Total revenues 1,499 - 1,499 2,306 1,423 883

R&D Expenses: Research and development expenses were $6.4 million for the third quarter, compared to $11.4 million for the comparable period in 2015. The 2015 expenses included $4.6 million attributable to Asterias’ research and development. The decrease year over year was primarily due to the deconsolidation of Asterias for financial reporting purposes commencing May 13, 2016.

G&A Expenses: General and administrative expenses were $4.6 million for the third quarter, compared to $7.5 million for the third quarter of 2015. The decrease was primarily due to the deconsolidation of Asterias financial results and reduced expenses incurred by OncoCyte.

Operating Loss: Loss from operations was $9.6 million in the third quarter compared with a loss of $17.1 million in the third quarter of 2015. The decrease was primarily due to the lower operating expenses as a result of the deconsolidation of Asterias operating results and reduced expenses incurred by OncoCyte.

Net Income (loss) attributable to BioTime: Net income attributable to BioTime was $31.2 million, or $0.30 per basic and diluted share for the three months ended September 30, 2016, due primarily to the gain on our interest in Asterias at fair value using the equity method of accounting. There was no deferred income tax provision or benefit recorded in the three months ended September 30, 2016. For the third quarter of 2015, net loss attributable to BioTime was $14.0 million, or ($0.18) per share. Net income (loss) attributable to BioTime includes losses from BioTime’s majority owned and consolidated subsidiaries based upon BioTime’s percentage ownership of those subsidiaries.