On November 7, 2016 Emergent BioSolutions Inc. (NYSE:EBS) reported financial results for the quarter and nine months ended September 30, 2016 (Press release, Emergent BioSolutions, NOV 7, 2016, View Source;p=RssLanding&cat=news&id=2220329 [SID1234516384]).

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FINANCIAL HIGHLIGHTS

The following financial highlights reflect Emergent’s financial performance from "Continuing Operations" and exclude the impact of the operations associated with the Company’s former biosciences business which was spun-off into a separate publicly traded company, Aptevo Therapeutics Inc., on August 1, 2016.

Total revenues from continuing operations: Q3 2016 of $142.9 million; nine months 2016 of $337.1 million
GAAP net income from continuing operations: Q3 2016 of $20.4 million, or $0.43 per diluted share; nine months 2016 of $30.2 million, or $0.68 per diluted share
Adjusted net income from continuing operations: Q3 2016 of $28.5 million, or $0.58 per diluted share; nine months 2016 of $44.0 million, or $0.90 per diluted share
EBITDA from continuing operations: Q3 2016 of $45.6 million, or $0.92 per diluted share; nine months 2016 of $82.2 million, or $1.68 per diluted share
Adjusted EBITDA from continuing operations: Q3 2016 of $50.2 million, or $1.02 per diluted share; nine months 2016 of $91.7 million, or $1.88 per diluted share
Note: For a reconciliation of the Company’s Statement of Operations for the Three and Nine Months Ended September 30, 2016 on a continuing operations basis to that on a combined basis, which takes into account the impact of the Aptevo-related discontinued operations, see "Reconciliation of Statement of Operations."

Q3 2016 AND RECENT BUSINESS ACCOMPLISHMENTS

Signed a five-year contract with the Biomedical Advanced Research and Development Authority (BARDA) for advanced development and procurement of NuThrax (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant), the Company’s next generation anthrax vaccine candidate, valued at up to $1.6 billion
Department of Health and Human Services issued a Sole Source Notification indicating its intention to award the Company a follow-on procurement contract with the Centers for Disease Control and Prevention (CDC) for the purchase of 29.4 million doses of BioThrax (Anthrax Vaccine Adsorbed), the Company’s licensed anthrax vaccine, for delivery into the Strategic National Stockpile (SNS); Company anticipates finalizing the contract in the coming weeks
Completed delivery of the full 44.75 million doses of BioThrax under current 2011 procurement contract as CDC exercised option to purchase all remaining doses
Achieved Food and Drug Administration (FDA) licensure for Building 55, the Company’s large-scale BioThrax manufacturing facility
Completed the spin-off of Aptevo Therapeutics Inc.
2016 FINANCIAL GUIDANCE

The Company continues to postpone its financial guidance for 2016 until the CDC follow-on BioThrax procurement contract has been finalized.

2016 FINANCIAL PERFORMANCE

Note: As a result of the August 1, 2016 spin-off of the Company’s biosciences business into a separate publicly traded company, Aptevo Therapeutics Inc., the financial statements and related explanatory sections for Emergent, exclusive of Aptevo, presented herein have been revised accordingly and are referenced as "continuing operations."

The results of operations and financial position of Aptevo are reflected on one line of the Company’s Statements of Operations for the three and nine months ended September 30, 2016 and 2015 as "Income (loss) from discontinued operations, (net of tax)." Please refer to "Reconciliation of Statement of Operations" for a reconciliation of the Company’s Statement of Operations for the Three and Nine Months Ended September 30, 2016 on a continuing operations basis to that on a combined basis, which takes into account the impact of the Aptevo-related discontinued operations.

(I) Quarter Ended September 30, 2016 (unaudited)

Revenues

Product Sales
For Q3 2016, product sales were $96.7 million, a decrease of 18% as compared to 2015. The decrease in BioThrax sales was primarily due to fewer doses delivered to the SNS. The decrease in other sales was primarily due to the timing of BATTM [Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine)] sales to the SNS.

(in millions) Three Months Ended
September 30,
2016 2015 % Change
Product Sales
BioThrax $ 94.1 $ 109.8 (14 )%
Other $ 2.6 $ 7.7 (67 )%
Total Product Sales $ 96.7 $ 117.5 (18 )%
Contract Manufacturing
For Q3 2016, revenue from the Company’s contract manufacturing operations was $14.7 million, an increase of 30% as compared to 2015. The increase primarily reflects the timing of fill/finish services.

Contracts and Grants
For Q3 2016, contracts and grants revenue was $31.5 million, an increase of 7% as compared to 2015.

Operating Expenses

Cost of Product Sales and Contract Manufacturing
For Q3 2016, cost of product sales and contract manufacturing was $39.6 million, an increase of 12% as compared to 2015. The increase primarily reflects an increase in costs associated with underutilized manufacturing capacity at the Company’s Winnipeg site and an increase in the BioThrax cost per dose sold associated with lower production yield in the period in which the doses sold were produced.

Research and Development
For Q3 2016, gross research and development (R&D) expenses were $27.2 million, a decrease of 20% as compared to 2015. The decrease primarily reflects lower contract service costs.

For Q3 2016, net R&D was fully funded, or a positive $4.3 million, versus an expense of $4.7 million in Q3 2015. Net R&D, which is more representative of the Company’s actual out-of-pocket investment in product development, is calculated as gross research and development expenses less contracts and grants revenue.

(in millions) Three Months Ended
September 30,
2016 2015 % Change
Research and Development Expenses [Gross] $ 27.2 $ 34.2 (20 )%
Adjustments:
– Contracts and grants revenue $ 31.5 $ 29.5 7 %
Net Research and Development Expenses (Income) $ (4.3 ) $ 4.7 –
Selling, General and Administrative
For Q3 2016, selling, general and administrative expenses were $40.7 million, an increase of 58% as compared to 2015. This increase includes costs associated with the Aptevo spin-off, restructuring activities at the Company’s Lansing, Michigan site, along with increased professional services to support the Company’s strategic growth initiatives.

Net Income from Continuing Operations
For Q3 2016, GAAP net income from continuing operations was $20.4 million, or $0.43 per diluted share, versus $42.1 million, or $0.90 per diluted share, in 2015.

For Q3 2016 and 2015, GAAP net income from continuing operations per diluted share is computed using the "if-converted" method. This method requires GAAP net income to be adjusted to reflect the impact of interest expense and amortization of debt issuance cost, both net of tax, associated with the Company’s 2.875% Convertible Senior Notes due 2021. As a result, GAAP net income from continuing operations per diluted share for Q3 2016 is adjusted in the amount of $1.1 million, from $20.4 million to $21.5 million, and diluted shares outstanding were 49.4 million. GAAP net income per diluted share for Q3 2015 is adjusted in the amount of $1.0 million, from $42.1 million to $43.1 million, and diluted shares outstanding were 47.8 million.

(II) Nine Months Ended September 30, 2016 (unaudited)

Revenues

Product Sales
For the nine months of 2016, product sales were $208.8 million, an increase of 2% as compared to 2015. The increase in BioThrax sales was primarily due to the timing of deliveries to the SNS. The decrease in other sales was primarily due to the timing of sales of BAT to the SNS and a one-time payment for AnthrasilTM [Anthrax Immune Globulin Intravenous (Human)] that occurred in the prior comparative period.

(in millions) Nine Months Ended
September 30,
2016 2015 % Change
Product Sales
BioThrax $ 193.3 $ 182.0 6 %
Other $ 15.5 $ 22.5 (31 )%
Total Product Sales $ 208.8 $ 204.6 2 %
Contract Manufacturing
For the nine months of 2016, revenue from contract manufacturing operations was $32.5 million, level with that in 2015.

Contracts and Grants
For the nine months of 2016, contracts and grants revenue was $95.9 million, an increase of 4% as compared to 2015.

Operating Expenses

Cost of Product Sales and Contract Manufacturing
For the nine months of 2016, cost of product sales and contract manufacturing was $93.0 million, an increase of 27% as compared to 2015. The increase primarily reflects an increase in the BioThrax cost per dose sold associated with lower production yield in the period in which the doses sold were produced along with increased costs associated with underutilized manufacturing capacity at the Company’s Winnipeg facility.

Research and Development
For the nine months of 2016, gross research and development (R&D) expenses were $81.2 million, a decrease of 13% as compared to 2015. The decrease primarily reflects lower contract service costs.

For the nine months of 2016, net R&D was fully funded, or a positive $14.7 million, versus an expense of $1.3 million in the comparable period in 2015.

(in millions) Nine Months Ended
September 30,
2016 2015 % Change
Research and Development Expenses [Gross] $ 81.2 $ 93.8 (13 )%
Adjustments:
– Contracts and grants revenue $ 95.9 $ 92.5 4 %
Net Research and Development Expenses (Income) $ (14.7 ) $ 1.3 –
Selling, General and Administrative
For the nine months of 2016, selling, general and administrative expenses were $108.3 million, an increase of 25% as compared to 2015. This increase includes costs associated with the Aptevo spin-off, restructuring activities at the Company’s Lansing, Michigan site, along with increased professional services to support the Company’s strategic growth initiatives.

Net Income from Continuing Operations
For the nine months of 2016, GAAP net income from continuing operations was $30.2 million, or $0.68 per diluted share, versus $48.9 million, or $1.11 per diluted share, in 2015.

Pursuant to the "if-converted" method, GAAP net income from continuing operations per diluted share for the nine months of 2016 is adjusted in the amount of $2.8 million, from $30.2 million to $33.0 million, and diluted shares outstanding were 48.8 million. GAAP net income from continuing operations per diluted share for the nine months of 2015 is adjusted in the amount of $3.1 million, from $48.9 million to $52.0 million, and diluted shares outstanding were 47.0 million.

(III) RECONCILIATION OF GAAP NET INCOME TO ADJUSTED NET INCOME, EBITDA AND ADJUSTED EBITDA ALL RELATED TO CONTINUING OPERATIONS

This press release contains three financial measures (Adjusted Net Income, EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization), and Adjusted EBITDA) that are considered "non-GAAP" financial measures under applicable Securities and Exchange Commission rules and regulations. These non-GAAP financial measures should be considered supplemental to and not a substitute for financial information prepared in accordance with generally accepted accounting principles. The Company’s definition of these non-GAAP measures may differ from similarly titled measures used by others. Adjusted Net Income adjusts for specified items that can be highly variable or difficult to predict, or reflect the non-cash impact of charges resulting from purchase accounting. EBITDA reflects net income excluding the impact of depreciation, amortization, interest expense and provision for income taxes. Adjusted EBITDA also excludes specified items that can be highly variable and the non-cash impact of certain purchase accounting adjustments. The Company views these non-GAAP financial measures as a means to facilitate management’s financial and operational decision-making, including evaluation of the Company’s historical operating results and comparison to competitors’ operating results. These non-GAAP financial measures reflect an additional way of viewing aspects of the Company’s operations that, when viewed with GAAP results and the reconciliations to the corresponding GAAP financial measure, may provide a more complete understanding of factors and trends affecting the Company’s business.

The determination of the amounts that are excluded from these non-GAAP financial measures are a matter of management judgment and depend upon, among other factors, the nature of the underlying expense or income amounts. Because non-GAAP financial measures exclude the effect of items that will increase or decrease the Company’s reported results of operations, management strongly encourages investors to review the Company’s consolidated financial statements and publicly filed reports in their entirety.

Reconciliation of GAAP Net Income to Adjusted Net Income

The following table provides a reconciliation of GAAP Net Income to Adjusted Net Income for the three month periods as indicated.

(in millions, except per share value) Three Months Ended September 30,
2016 2015 Source
GAAP Net Income From Continuing Operations $ 20.4 $ 42.1 NA
Adjustments:
+ Spin-off and acquisition-related costs (transaction & integration) 4.6 1.0 SG&A
+ Non-cash amortization charges 2.0 2.2 COGS, SG&A,
Other Income
+ Exit and disposal costs 7.9 – SG&A
+ Impact of purchase accounting on inventory step-up – 0.3 COGS
Tax effect (6.4 ) (1.1 ) NA
Total Adjustments 8.1 2.5 NA
Adjusted Net Income From Continuing Operations
Adjusted Net Income per Diluted Share $28.5
$0.58
$44.6
$0.93
NA
The following table provides a reconciliation of GAAP Net Income to Adjusted Net Income for the nine month periods as indicated.

(in millions, except per share value) Nine Months Ended September 30,
2016 2015 Source
GAAP Net Income From Continuing Operations $ 30.2 $ 48.9 NA
Adjustments:
+ Spin-off and acquisition-related costs (transaction & integration) 9.5 3.5 SG&A
+ Non-cash amortization charges 6.5 6.7 COGS, SG&A,
Other Income
+ Exit and disposal costs 8.7 – SG&A
+ Impact of purchase accounting on inventory step-up – 0.3 COGS
Tax effect (10.9 ) (3.2 ) NA
Total Adjustments 13.8 7.3 NA
Adjusted Net Income From Continuing Operations
Adjusted Net Income per Diluted Share $44.0
$0.90
$56.2
$1.20
NA
Reconciliation of GAAP Net Income to EBITDA and Adjusted EBITDA

The following table provides a reconciliation of GAAP Net Income to EBITDA and Adjusted EBITDA for the three month periods as indicated.

(in millions, except per share value) Three Months Ended September 30,
2016 2015
GAAP Net Income From Continuing Operations $ 20.4 $ 42.1
Adjustments:
+ Depreciation & Amortization 9.7 7.5
+ Provision For Income Taxes 13.2 20.1
+ Total Interest Expense 2.0 1.6
Total Adjustments 24.9 29.2
EBITDA From Continuing Operations
EBITDA per Diluted Share $45.3
$0.92
$71.3
$1.49

Additional Adjustments:
+ Spin-off and acquisition-related costs (transaction & integration) 4.6 1.0
+ Impact of purchase accounting on inventory step-up – 0.3
Total Additional Adjustments 4.6 1.3
Adjusted EBITDA From Continuing Operations
Adjusted EBITDA per Diluted Share $49.9
$1.01
$72.6
$1.52

The following table provides a reconciliation of GAAP Net Income to EBITDA and Adjusted EBITDA for the nine month periods as indicated.

(in millions, except per share value) Nine Months Ended September 30,
2016 2015
GAAP Net Income From Continuing Operations $ 30.2 $ 48.9
Adjustments:
+ Depreciation & Amortization 27.0 24.7
+ Provision For Income Taxes 19.9 23.6
+ Total Interest Expense 5.1 4.9
Total Adjustments 52.0 53.2
EBITDA From Continuing Operations
EBITDA per Diluted Share $82.2
$1.68
$102.1
$2.17

Additional Adjustments:
+ Spin-off and acquisition-related costs (transaction & integration) 9.5 3.5
+ Impact of purchase accounting on inventory step-up – 0.3
Total Additional Adjustments 9.5 3.8
Adjusted EBITDA From Continuing Operations
Adjusted EBITDA per Diluted Share $91.7
$1.88
$105.9
$2.26

(IV) RECONCILIATION OF STATEMENT OF OPERATIONS

The following table provides a reconciliation of the Company’s Statement of Operations for the Three Months Ended September 30, 2016 on a continuing operations basis to that on a combined basis, which takes into account the impact of the Aptevo-related discontinued operations.

Emergent BioSolutions Inc. and Subsidiaries
Consolidated Statements of Operations
(in thousands, except share and per share data)


Three Months Ended September 30, 2016
Continuing Operations Discontinued Operations Combined
Revenues: (Unaudited)
Product sales $ 96.7 $ 3.0 $ 99.7
Contract manufacturing 14.7 - 14.7
Contracts and grants 31.5 0.1 31.6
Total revenues 142.9 3.1 146.0

Operating expenses:
Cost of product sales and contract manufacturing 39.6 0.9 40.5
Research and development 27.2 2.5 29.7
Selling, general and administrative 40.7 7.5 48.2
Income from operations 35.5 (7.8 ) 27.7

Other income (expense):
Interest income 0.4 - 0.4
Interest expense (2.0 ) - (2.0 )
Other income, net (0.2 ) (0.1 ) (0.3 )
Total other expense, net (1.9 ) (0.1 ) (2.0 )

Income (loss) before provision for (benefit) from income taxes 33.6 (7.9 ) 25.6
Provision for (benefit from) income taxes 13.2 (8.9 ) 4.3
Net income $ 20.4 $ 1.0 $ 21.3

The following table provides a reconciliation of the Company’s Statement of Operations for the Nine Months Ended September 30, 2016 on a continuing operations basis to that on a combined basis, which takes into account the impact of the Aptevo-related discontinued operations.

Emergent BioSolutions Inc. and Subsidiaries
Consolidated Statements of Operations
(in thousands, except share and per share data)


Nine Months Ended September 30, 2016
Continuing Operations Discontinued Operations Combined
Revenues: (Unaudited)
Product sales $ 208.8 $ 21.2 $ 230.0
Contract manufacturing 32.5 - 32.5
Contracts and grants 95.9 0.2 96.1
Total revenues 337.1 21.4 358.5

Operating expenses:
Cost of product sales and contract manufacturing 93.0 11.6 104.6
Research and development 81.2 18.0 99.2
Selling, general and administrative 108.3 23.8 132.1
Income from operations 54.6 (32.0 ) 22.6

Other income (expense):
Interest income 0.8 - 0.8
Interest expense (5.1 ) - (5.1 )
Other income, net (0.2 ) (0.0 ) (0.2 )
Total other expense, net (4.5 ) (0.0 ) (4.5 )

Income (loss) before provision for (benefit) from income taxes 50.1 (32.0 ) 18.1
Provision for (benefit from) income taxes 19.9 (16.2 ) 3.7
Net income $ 30.2 $ (15.9 ) $ 14.4

On November 7, 2016 Dynavax Technologies Corporation (NASDAQ: DVAX) reported financial results for the third quarter and nine months ended September 30, 2016 (Press release, Dynavax Technologies, NOV 7, 2016, View Source [SID1234516383]).

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The Company had $109.6 million in cash, cash equivalents and marketable securities as of September 30, 2016, compared to $196.1 million at December 31, 2015. The net loss for the third quarter of 2016 was $34.7 million, compared to $30.1 million for the third quarter of 2015.

Recent Progress

HEPLISAV-B. In late August, the U.S. Food and Drug Administration (FDA) cancelled its previously scheduled Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the Biologics License Application (BLA) for HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)]. The FDA indicated that remaining questions on the BLA will be addressed between Dynavax and the FDA review team. The Company has since provided responses to information requests by the FDA related to remaining questions. The FDA also confirmed in August that it will not include in its review of the BLA the immunogenicity data submitted by the Company related to sub-populations, including results in individuals with diabetes. The Company plans to submit these data as a supplemental BLA.

The Prescription Drug User Fee Act (PDUFA) date for the HEPLISAV-B BLA is December 15, 2016.

In late October, we reported sub-group results from HBV-23, demonstrating that HEPLISAV-B, when administered as two doses over one month, induced significantly higher seroprotection rates than the approved hepatitis B vaccine Engerix-B, when administered as three doses over six months. This result was observed in all prespecified groups of study participants, including those with characteristics that are known to have a reduced immune response to currently licensed hepatitis B vaccines, including older age, high body mass index, diabetes mellitus, male gender and persons who smoke. In the total Phase 3 trial population, the rates of adverse events, serious adverse events and deaths were similar between the HEPLISAV-B and Engerix-B groups. The data were presented at the Infectious Diseases Society of America’s (IDSA) annual IDWeek 2016 meeting in New Orleans.

Preparations for launch of HEPLISAV-B are continuing, including pre-commercial activities, manufacturing of launch inventory and continued infrastructure spending related to commercial development and information technology capabilities and related increases in headcount.

Immuno-oncology. In October we announced at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress 2016 the first presentation of findings from an ongoing Phase 1/2 study evaluating SD-101, Dynavax’s intratumoral TLR9 agonist, in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 treatment. Early results evaluating five patients with metastatic melanoma for efficacy and 16 patients for safety were reported. In patients naïve to anti-PD-1 treatment objective responses were observed in three out of four (75%) including one complete response (CR) and two partial responses (PR’s). One patient with progressive disease while receiving anti-PD-1 therapy was observed to have stable disease (SD). The drug combination was well-tolerated. No dose-limiting toxicities of the combination were observed in any dose cohort, and a maximum tolerated dose (MTD) was not identified. No immune-related adverse events were reported. Additional results from this study will be presented at future scientific meetings.

Financial. In late October we secured a $100 million loan commitment from Deerfield upon FDA approval of HEPLISAV-B and satisfaction of other conditions. We intend to use the net proceeds for general corporate purposes, including the commercialization of HEPLISAV-B.

Financials

Total revenues for the third quarter of 2016 were $0.2 million compared to $1.2 million for the same period in 2015. The $1.0 million decrease was due to the conclusion of our work under the research collaboration and license agreement with AstraZeneca for the clinical development of AZD 1419.

Research and development expenses for the third quarter of 2016 were $23.2 million compared to $24.1 million for the same period in 2015. This $0.9 million decrease was primarily due to reduction in outside services expense associated with the completion of HBV-23 in the fourth quarter of 2015, partially offset by an increase in employee headcount and regulatory and manufacturing activities in preparation for the anticipated commercial launch of HEPLISAV-B.

General and administrative expenses for the third quarter of 2016 were $11.8 million compared to $5.5 million for the same period in 2015. This $6.3 million increase reflects expenses related to preparation for the commercial launch of HEPLISAV-B including additional headcount, information technology systems and infrastructure to support commercial development.

The net loss for the third quarter of 2016 was $34.7 million, or $0.90 per basic and diluted share, compared to $30.1 million, or $0.82 per basic and diluted share, for the same period in 2015.

On November 7, 2016 Compugen Ltd. (NASDAQ: CGEN), a leading predictive drug discovery company, reported its quarterly financial results for the third quarter 2016 and nine months ending September 30, 2016 (Filing, Q3, Compugen, 2016, NOV 7, 2016, View Source [SID1234516382]).

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As previously announced, the Company confirms that it has postponed its third quarter conference call to Wednesday, November 16, 2016 at 10:00 am ET, in order to include discussion of new CGEN-15029 program data to be presented this Friday, November 11, 2016, at the 31st Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper).

An abstract of Compugen’s presentation, selected by SITC (Free SITC Whitepaper) as a late breaking presentation, will be available tomorrow, November 8th, beginning at 8:00 am ET, on the SITC (Free SITC Whitepaper) conference website. In addition, the Company plans to issue a press release on November 11, 2016 with respect to the new data to be disclosed at the SITC (Free SITC Whitepaper) conference that day.

Anat Cohen-Dayag, Ph.D., President and Chief Executive Officer of Compugen, stated, "We are extremely pleased with our continuing progress in the pursuit of immuno-oncology programs addressing novel immune checkpoint target candidates identified by us in silico. These efforts have resulted in an exceptional pipeline of multiple novel targets, consisting of both T cell-based and more recently myeloid-based targets, potentially offering multiple first-in-class therapeutics with various mechanisms-of-action."

Dr. Cohen-Dayag continued, "Although advancing such novel target programs to therapeutic development requires longer target validation timelines than required for targets generally pursued by the industry, we believe that the medical and commercial potential presented by these multiple first-in-class programs more than justifies this additional time and effort."

Revenues for the three and nine months ending September 30, 2016 were $0.1 million and $0.7 million respectively, compared with $0.2 million and $1.0 million for the comparable periods in 2015, primarily reflecting changes in the non-cash amortization during each of these periods of the upfront payment related to the August 2013 collaboration and license agreement with Bayer.

R&D expenses for the three and nine months ending September 30, 2016 were $6.0 million and $18.2 million respectively, compared with $5.3 million and $15.4 million in the comparable periods in 2015. These increases primarily reflect expanded activities involving our pipeline program candidates, including initiation of certain pre-clinical activities and the hiring of additional professional employees and manufacturing and regulatory consultants to support these activities.

Net loss for the third quarter of 2016 was $7.8 million, or $0.15 per diluted share, compared with a net loss of $6.7 million, or $0.13 per diluted share, for the comparable period in 2015. Net loss for the nine months ending September 30, 2016 was $23.0 million, or $0.45 per diluted share, compared with a net loss of $19.7 million, or $0.39 per diluted share, for the comparable period in 2015.

As of September 30, 2016, cash and cash related accounts totaled $68.0 million. The Company has no debt.

On November 7, 2016 Cellectis (Alternext: ALCLS; Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), reported that abstracts regarding the Company’s allogeneic, off-the-shelf, CAR T programs have been accepted for presentation at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Cellectis, NOV 7, 2016, View Source [SID1234516381]). The meeting will be held December 3-6, 2016 in San Diego.
Oral presentations: • 765 Allogeneic Tcrα/β Deficient CAR T-Cells Targeting CD123 Prolong Overall Survival of AML Patient-Derived Xenografts
View Source Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation Program: Oral and Poster Abstracts Type: Oral Session: 616.

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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

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Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Emerging Immune-Based Therapies for AML Monday, December 5, 2016: 11:00 AM San Diego Ballroom AB (Marriott Marquis San Diego Marina)
Monica L. Guzman, PhD1, Mayumi Sugita, MD1*, Hongliang Zong, MD, PhD1*, Nathan EwingCrystal1*, Vicenta Trujillo-Alonso1*, Nuria Mencia-Trinchant, PhD1*, Linda Lam1*, Nicole M. Cruz, MD1, Roman Galetto, PhD2*, Agnès Gouble, PhD2*, Duane C Hassane, PhD1, Julianne Smith, PhD2 and Gail J. Roboz3
1Division of Hematology and Medical Oncology, Department of Medicine, Weill Cornell Medical College, New York, NY
2Cellectis SA, Paris, France
3Weill Cornell Medical College, New York, NY
• 381 Preclinical Evaluation of Allogeneic Anti-Bcma Chimeric Antigen Receptor T Cells with Safety Switch Domains and Lymphodepletion Resistance for the Treatment of Multiple Myeloma
View Source
Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy Program: Oral and Poster Abstracts Type: Oral Session: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Novel Immune Approaches for Myeloma Therapy Sunday, December 4, 2016: 12:30 PM Grand Hall B (Manchester Grand Hyatt San Diego)
Bijan Boldajipour, PhD1*, Roman Galetto, PhD2*, Cesar Sommer, PhD1*, Thomas Pertel, PhD1*, Julien Valton, PhD3*, Yoon Park, PhD1*, Annabelle Gariboldi2*, Amy Chen1*, Tao Geng1*, Hong H Dong1*, Gregory R Boucher1*, Thomas J Van Blarcom, PhD1*, Javier Chaparro-Riggers, PhD1*, Arvind Rajpal, PhD1*, Julianne Smith, PhD3, Tracy Kuo, PhD1* and Barbra Sasu, PhD1
1Pfizer Inc., South San Francisco, CA
2Cellectis SA, Paris, France
3Cellectis Inc., New York, NY

Poster presentation:
• 4039 Pre-Clinical Studies of Anti-CD123 CAR-T Cells for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
View Source
Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation Program: Oral and Poster Abstracts Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III
Monday, December 5, 2016, 6:00 PM-8:00 PM Hall GH (San Diego Convention Center)
Tianyu Cai, PhD1*, Roman Galetto, PhD2*, Agnès Gouble, PhD2*, Julianne Smith, PhD2, Antonio Cavazos, MS1*, Sergej Konoplev, MD, PhD3, Andrew A. Lane, MD, PhD4, Monica L. Guzman, PhD5, Hagop M. Kantarjian, MD1, Naveen Pemmaraju, MD1 and Marina Konopleva, MD, PhD1
1Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX
2Cellectis SA, Paris, France
3Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX 4Dana-Farber Cancer Institute, Boston, MA 5Division of Hematology an

On November 7, 2016 Novocure (NASDAQ:NVCR) reported that 38 abstracts focusing on Tumor Treating Fields (TTFields) will be presented at the 21st Annual Scientific Meeting of the Society for Neuro-Oncology (SNO) on Nov. 17-20, in Scottsdale, Arizona (Press release, NovoCure, NOV 7, 2016, View Source [SID1234516379]). Of the 38 abstracts, 28 were prepared by external researchers, representing a growing interest in Novocure’s proprietary TTFields therapy.

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"Every year at the SNO annual meeting, we observe an increased interest in TTFields, as is evident from a growing number of abstracts accepted along with an increasing number of institutions that are studying TTFields," said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. "Research conducted by external scientists strengthens our understanding of TTFields, often validating TTFields as a potential treatment for a number of solid tumors."

Abstracts span a variety of topics from preclinical and clinical data to treatment delivery and patient education. Notable topics to be presented include, amongst others, TTFields in combination with immunotherapy, radiation, triple chemotherapy and cytostatic agents, a case report on the use of TTFields in brain metastasis from ovarian cancer and a pilot study of Optune for recurrent atypical and anaplastic meningioma.

The long-term survival analysis of the full dataset from its phase 3 pivotal EF-14 trial of Optune in combination with temozolomide for the treatment of newly diagnosed glioblastoma (GBM) will be presented on Friday, Nov. 18, by Roger Stupp, M.D., Professor at the University of Zurich and Director of Department of Oncology at the Zurich University Hospital, Zurich, Switzerland, and EF-14 Principal Investigator. The long-term analysis confirms the interim analysis results published in the Journal of the American Medical Association (JAMA)1 in December 2015, showing significant extension of both progression free and overall survival in newly diagnosed GBM patients receiving Optune with temozolomide compared to temozolomide alone. The long-term analysis shows survival rates were significantly higher four years from randomization in patients receiving Optune with temozolomide compared to patients receiving temozolomide alone. The safety profile in the long-term analysis was consistent with the interim analysis of the EF-14 trial.

The following abstracts will be presented:

Preclinical

Human glioma cell migration and invasion properties are inhibited by exposure to tumor treating fields (TTFields) in vitro; RS Schneiderman et al; Saturday, Nov. 19; abstract: #EXTH-03

Tumor treating fields (TTFields) induce autophagy in glioma cells; Y Porat et al; Saturday, Nov. 19; abstract: #EXTH-30

Effects of tumor treating fields (TTFields) and temozolomide in MGMT expressing and non-expressing patient-derived glioblastoma cells; PA Clark et al; Saturday, Nov. 19; abstract: #EXTH-25

Tumor Treating Field (TTFields) effects on glioblastoma cells are augmented by mitotic checkpoint inhibition; AF Kessler et al; Saturday, Nov. 19; abstract: #EXTH-07

Cytostatic agents combined with tumor treating fields (TTFields) in glioma cell lines; M Groves et al; Saturday, Nov. 19; abstract: #NIMG-39 Tumor cells induce immune activation phenotype in immune cells following TTFields activation; T Holtzman et al; Friday, Nov. 18; abstract: #IMST-26 Evaluating the in-vitro effects of tumor treating fields on T cell responses; G Diamant et al; Friday, Nov. 18; abstract: #IMST-30 Clinical METIS: A phase III study of radiosurgery with TTFields for 1-10 brain metastases; M Mehta et al; Saturday, Nov. 19; abstract: #BMET-03 One year with Optune in routine use: first report on clinical experiences in Germany; M Misch et al; Friday, Nov. 18; abstract: #RARE-44 Analysis of glioblastoma physical characteristics in patients benefiting from tumor treating electric fields therapy; PP San et al; Friday, Nov. 18; abstract: #RTHP-19 Compliance and duration of treatment with tumor treating fields (TTFields) in adjuvant treatment for newly diagnosed glioblastomas (GBMs) improves progression-free survival (PFS) and overall survival (OS); SA Jeyapalan et al; Friday, Nov. 18; abstract: #RTHP-29 Pilot study of Optune (Novo-TTF-100A) for recurrent atypical and anaplastic meningioma; G Wu et al; Friday, Nov. 18; abstract: #ACTR-43 Classification of dermatologic adverse events and management strategies in patients receiving therapy with Optune for high grade gliomas; D Jennings et al; Friday, Nov. 18; abstract: #QLIF-11 The use of a programmable shunt in a patient, treated with Optune: feasibility report; L Schreiber et al; Friday, Nov. 18; abstract: #RARE-24 Survival benefit with triple chemotherapy and TTFields for glioblastoma; G Lu et al; Friday, Nov. 18; abstract: #PDCT-16 Patterns of glioblastoma recurrence in low field intensity regions during TTFields treatment; J Battiste et al; Saturday, Nov. 19; abstract: #NIMG-61 Patterns of compliance in the use of tumor treating fields (Optune) for brain tumors; M Pandey et al; Friday, Nov. 18; abstract: #ACTR-31 Use of tumor treating fields in brain metastases from ovarian cancer, a case report; M Pandey et al; Saturday, Nov. 19; abstract: #BMET-21 Imaging the early metabolic response during tumor treating fields (TTFields) therapy in recurrent glioblastoma; C Juhasz et al; Saturday, Nov. 19; abstract: #NIMG-37 Rates and impact of compliance with tumor treating fields therapy in a glioma cohort; Y Odia et al; Friday, Nov. 18; abstract: #RTHP-37 Rates and outcomes of combination tumor treating fields and immunotherapy in a glioma cohort; Y Odia et al; Friday, Nov. 18; abstract: #ATIM-34 A phase II, single arm study of Optune in bevacizumab-naive subjects with recurrent WHO grade III malignant glioma; D O’Connell et al; Friday, Nov. 18; abstract: #ACTR-41 Use of tumor treating fields in the first line treatment of glioblastoma; M Pandey et al; Friday, Nov. 18; abstract: #ACTR-28 Clinical experiences of tumor treating fields (TTFields) in pediatric GBM patients; J Crawford et al; Saturday, Nov. 19; abstract: #NIMG-66 Beneficial effect of tumor treating field therapy in Gliomatosis Cerebri; N Blondin; Friday, Nov. 18; abstract: #ACTR-08 Enhanced therapeutic benefits of tumor treating fields (TTFields) on superficially located glioblastoma multiforme (GBM); V Kumar et al; Friday, Nov. 18; abstract: #RTHP-30 Stability of shunt programmable valve settings with simultaneous use of the Optune transducer array; A Chan et al; Friday, Nov. 18; abstracts: #SURG-25 Treatment Delivery/Patient Education First report of user experience, compliance outcomes, and alarm states with the second generation Optune system; A Kinzel et al; Saturday, Nov. 18; abstract: #NIMG-50 Does personalizing tumor treating fields (TTFields) with NovoTAL in glioblastoma treatment planning make a difference? Insights from electric field simulation studies; D Garcia Carracedo et al; Saturday, Nov. 19; abstract: #NIMG-06 Compliance of tumor treating electric fields therapy and overall survival in glioblastoma; ET Wong et al; Friday, Nov. 18; abstract: #RTHP-17 Development of practice algorithms to guide treatment planning with TTFields for the management of glioblastoma; J Trusheim et al; Saturday, Nov. 19; abstract: #NIMG-23 Shared Care Model for glioblastoma patient management; J Battiste et al; Saturday, Nov. 19; abstract: #NIMG-52 Periodic transducer array shifting preserves both TTFields intensity in the gross tumor volume (GTV) and promotes scalp health during the course of glioblastoma therapy; A Naveh et al; Saturday, Nov. 19; abstract: #NIMG-26 Influence of 2 contrasting treatment planning approaches on tumor treating fields (TTFields) intensity in the gross tumor volume (GTV) and peritumoral brain zone (PBZ) in glioblastoma; D Garcia Carracedo et al; Saturday, Nov. 19; abstract: #NIMG-07 Placement of scalp electrodes (Novo TTF) does not significantly change radiation dosimetry when delivering cranial intensity modulated radiation therapy (IMRT); G Shukla et al; Friday, Nov. 18; abstract: #RTHP-34 Optimal Patient and Family Education Is Key to Improving the Efficacy of Tumor Treating Fields Plus Chemotherapy in Treatment of GBM; MG Saria et al; Saturday, Nov. 19; abstract: #NIMG-63 Tumor recurrence in areas of lower TTFields Intensity: A reverse simulation case study; J Battiste et al; Saturday, Nov. 19; abstract: #NIMG-29 Late-Breaking Oral Presentation Prospective multi-center phase III trial of Tumor Treating Fields together with temozolomide compared to temozolomide alone in patients with newly diagnosed glioblastoma; R Stupp et al; Friday, Nov. 18