On November 1, 2017 Calithera Biosciences presented the corporate presentation (Presentation, Calithera Biosciences, NOV 1, 2017, View Source [SID1234535273]).

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On November 1, 2017 Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, reported financial results for the quarter and nine months ended September 30, 2017, and provided updates on its development programs (Press release, Conatus Pharmaceuticals, NOV 1, 2017, View Source [SID1234521422]).

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Program Updates
In collaboration with Novartis under terms of the company’s Option, Collaboration and License Agreement with Novartis, which was executed in December 2016, Conatus is conducting four randomized, double-blind, placebo-controlled Phase 2b clinical trials designed to evaluate emricasan treatment in various patient populations, including three EmricasaN, a Caspase inhibitOR, for Evaluation (ENCORE) clinical trials in patients with fibrosis or cirrhosis caused by nonalcoholic steatohepatitis (NASH), and a fourth clinical trial in POLT-HCV-SVR patients:

POLT-HCV-SVR, initiated in the second quarter of 2014, in approximately 60 post-orthotopic liver transplant (POLT) recipients with liver fibrosis or cirrhosis post-transplant as a result of recurrent hepatitis C virus (HCV) infection who have successfully achieved a sustained viral response (SVR) following HCV antiviral therapy, with top-line results expected in the second quarter of 2018;

ENCORE-PH (for Portal Hypertension), initiated in the fourth quarter of 2016, in approximately 240 patients with compensated or early decompensated NASH cirrhosis and severe portal hypertension, with top-line results expected in the second half of 2018 followed by an integrated treatment extension period for clinical outcomes;

ENCORE-NF (for NASH Fibrosis), initiated in the first quarter of 2016, in approximately 330 patients with NASH fibrosis, with top-line results expected in the first half of 2019; and

ENCORE-LF (for Liver Function), initiated in the second quarter of 2017, in approximately 210 patients with decompensated NASH cirrhosis, with top-line results expected in the second half of 2019.
Results from the four ongoing emricasan clinical trials are expected to support the design of Phase 3 clinical efficacy and safety trials.

Pipeline Expansion Plans

In October 2017, the European Medicines Agency (EMA) granted Orphan Drug Designation in the European Union to the company’s pan-caspase inhibitor IDN-7314 for the treatment of primary sclerosing cholangitis (PSC), a disease affecting bile ducts in the liver, which can lead to cirrhosis and liver failure. In June 2017, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation in the United States to IDN-7314 for the treatment of PSC.

These orphan drug designations were based on previously reported data with IDN-7314 demonstrating reduction of relevant biomarkers in two preclinical models of PSC. New results, showing that IDN-7314 markedly diminished inflammasome activation and reduced liver injury in a preclinical model of PSC, were presented in October 2017 at The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases (AASLD). In a separate study, IDN-7314 reduced biochemical markers in a new acute preclinical model of PSC.

Conatus believes the orphan drug designations, along with the growing body of preclinical data, warrant further evaluation of IDN-7314 as a potential product candidate in PSC as a component of its initial pipeline expansion plans. The company’s ongoing pipeline expansion activities also include:

internal development of new preclinical product candidates leveraging its expertise with the caspase inhibition technology platform, and

evaluation for potential in-licensing or acquisition of external clinical-stage product candidates consistent with its product development and regulatory expertise.
Conatus may pursue the development of product candidates in liver disease and in other related disease areas.

Financial Results
The net loss for the third quarter of 2017 was $4.0 million compared with $6.9 million for the third quarter of 2016. The net loss for the first nine months of 2017 was $13.0 million compared with $20.6 million for the first nine months of 2016.

Total revenues were $9.6 million for the third quarter of 2017 and $26.6 million for the first nine months of 2017, compared with $0.0 million for the comparable periods in 2016. Total revenues for both periods in 2017 consisted of collaboration revenue related to the Option, Collaboration and License Agreement with Novartis.

Research and development expenses were $11.2 million for the third quarter of 2017 compared with $4.8 million for the third quarter of 2016. Research and development expenses were $32.3 million for the first nine months of 2017 compared with $13.8 million for the first nine months of 2016. The increases in research and development expenses were primarily due to the ramp up of our ENCORE-NF, ENCORE-PH and ENCORE-LF clinical trials.

General and administrative expenses were $2.4 million for the third quarter of 2017 compared with $2.1 million for the third quarter of 2016. General and administrative expenses were $7.4 million for the first nine months of 2017 compared with $6.9 million for the first nine months of 2016. The increases in general and administrative expenses were primarily due to higher personnel costs and professional fees.

Cash, cash equivalents and marketable securities were $85.2 million at September 30, 2017, compared with $77.0 million at December 31, 2016. Based primarily on lower than expected spending on in-licensing and internal pipeline development, the company is now projecting a year-end 2017 balance of between $70 million and $75 million. The company believes its current and forecasted financial resources are sufficient to maintain operations and ongoing emricasan clinical development activities through the end of 2019, as well as to fund anticipated pipeline expansion activities.

Conference Call and Audio Webcast
Conatus will host a conference call and audio webcast at 4:30 p.m. Eastern Time today to discuss the financial results and provide a corporate update. To access the conference call, please dial 877-312-5857 (domestic) or 970-315-0455 (international) at least five minutes prior to the start time and refer to conference ID 99505370. A live and archived audio webcast of the call will also be available in the Investors section of the Conatus website at www.conatuspharma.com.

On November 1, 2017 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that 18 abstracts featuring data from the broad ADCETRIS (brentuximab vedotin) development program have been accepted for presentation, including a plenary presentation, at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place from December 9-12, 2017 in Atlanta, Georgia (Press release, Seattle Genetics, NOV 1, 2017, View Source [SID1234521404]). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of Hodgkin lymphoma cells and several types of non-Hodgkin lymphoma. ADCETRIS is being evaluated globally as the foundation of care for CD30-expressing lymphomas in more than 70 corporate- and investigator-sponsored clinical trials.

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Data accepted for presentation at the ASH (Free ASH Whitepaper) Annual Meeting include the following:

Data from the phase 3 ECHELON-1 clinical trial evaluating ADCETRIS in combination with chemotherapy in frontline advanced classical Hodgkin lymphoma patients will be featured in the Plenary Scientific Session on Sunday, December 10, 2017 from 2:00 – 4:00 p.m. ET. Based on the positive results from the ECHELON-1 trial, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to ADCETRIS in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma. Seattle Genetics expects to submit in the fourth quarter of 2017 a supplemental Biologics License Application (BLA) to the FDA for approval of ADCETRIS in frontline advanced classical Hodgkin lymphoma.
Numerous oral and poster presentations highlighting additional progress within the ADCETRIS development program including:
Updated durability results from the phase 3 ALCANZA clinical trial in patients with CD30-expressing mycosis fungoides and primary cutaneous anaplastic large cell lymphoma, the most common subtypes of cutaneous T-cell lymphoma (CTCL). Based on the positive results from the ALCANZA trial, a supplemental BLA for ADCETRIS in CTCL was accepted for filing by the FDA. The FDA granted Priority Review for the application and the Prescription Drug User Fee Act (PDUFA) target action date is December 16, 2017. ADCETRIS previously received FDA Breakthrough Therapy Designation in this setting.
Updated results from a phase 1/2 study of ADCETRIS in combination with Opdivo (nivolumab) among patients with relapsed or refractory Hodgkin lymphoma
Final five-year survival and durability results in patients with CD30-expressing peripheral T-cell lymphomas who received ADCETRIS with cyclophosphamide, hydroxydaunorubicin, and prednisone (CHP) as frontline therapy
“At this year’s ASH (Free ASH Whitepaper) Annual Meeting, we will present data from 18 abstracts, highlighting several ADCETRIS clinical program advancements that support our plans to establish ADCETRIS as the foundation of care for CD30-expressing lymphomas,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “Importantly, the results of the phase 3 ECHELON-1 clinical trial evaluating ADCETRIS combination therapy in frontline advanced Hodgkin lymphoma patients was selected from over 6,000 abstracts submitted to be featured in the Plenary Scientific Session. These data are the basis for our planned supplemental biologics license application to the FDA requesting approval of ADCETRIS in this setting. The breadth of data being presented with ADCETRIS in CD30-expressing lymphomas demonstrates the power of antibody-drug conjugates with a goal of improving patient outcomes.”

ADCETRIS is currently not approved for the treatment of frontline Hodgkin lymphoma, CTCL, or as combination therapy for Hodgkin lymphoma or non-Hodgkin lymphoma.

Multiple corporate and investigator presentations will be featured at ASH (Free ASH Whitepaper). Abstracts can be found at www.hematology.org and include the following:

Saturday, December 9, 2017

Updated analyses of the international, open-label, randomized, phase 3 ALCANZA study: longer-term evidence for superiority of brentuximab vedotin versus methotrexate or bexarotene for CD30-positive cutaneous T-cell lymphoma (Abstract #1509, poster presentation)
A pilot study of weekly brentuximab vedotin in patients with CD30+ malignancies resistant to every 3 week brentuximab vedotin (Abstract #1528, poster presentation)
Brentuximab vedotin with R-CHP chemotherapy as frontline treatment for patients with CD30 positive primary mediastinal large B-cell, diffuse large B-cell, and grey zone lymphomas: results of a phase I/II multisite trial (Abstract #191, oral presentation at 3:00 p.m. ET)
Patient-reported distress in Hodgkin lymphoma patients on active therapy vs. long-term survivors (Abstract #2173, poster presentation)
Real world clinical and economic burden of patients with Hodgkin lymphoma who fail frontline therapy in the US (Abstract #2128, poster presentation)
Sunday, December 10, 2017

Brentuximab vedotin plus doxorubicin, vinblastine, dacarbazine (A+AVD) as frontline therapy demonstrates superior modified progression-free survival versus ABVD in patients with previously untreated stage III or IV Hodgkin lymphoma (HL): the phase 3 ECHELON-1 study (Plenary Scientific Session presentation from 2:00 – 4:00 p.m. ET)
Five-year survival results: frontline brentuximab vedotin in combination with CHP in patients with CD30-expressing peripheral T-cell lymphomas (Abstract #2790, poster presentation)
Radiographic and high-throughput sequencing (HTS)-based response assessment after brentuximab vedotin plus ifosfamide, carboplatin, and etoposide (ICE) for relapsed/refractory classical Hodgkin lymphoma: updated results of a phase I/II trial (Abstract #2806, poster presentation)
Patient and physician preferences for front-line treatment of advanced stage Hodgkin lymphoma (Abstract #4082, poster presentation)
Changes in serum TARC predict PET response among pediatric patients with relapsed or refractory Hodgkin lymphoma treated with brentuximab vedotin and gemcitabine: a report from the Children’s Oncology Group (Abstract #2798, poster presentation)
Phase 2 Study of Brentuximab Vedotin in Patients with Advanced Systemic Mastocytosis (Abstract #2909, poster presentation)
Monday, December 11, 2017

Results from a phase 1/2 study of brentuximab vedotin in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma (Abstract #649, oral presentation at 10:30 a.m. ET)
Sequential brentuximab vedotin before and after adriamycin, vinblastine, and dacarbazine (A-VAD-A) for older patients with untreated Hodgkin lymphoma: final results from a multicenter phase II study (Abstract #733, oral presentation at 2:45 p.m. ET)
About ADCETRIS

ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30 and is being evaluated broadly in more than 70 clinical trials, including four phase 3 studies: the ECHELON-1 trial in frontline classical Hodgkin lymphoma from which positive top-line results were recently reported and the FDA granted Breakthrough Therapy Designation in this setting, the ongoing ECHELON-2 trial in frontline mature T-cell lymphomas, the completed ALCANZA trial in cutaneous T-cell lymphoma that supported the supplemental BLA with a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2017, and the recently initiated CHECKMATE 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS for intravenous injection has received FDA approval for three indications: (1) regular approval for the treatment of patients with classical Hodgkin lymphoma after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (2) regular approval for the treatment of classical Hodgkin lymphoma patients at high risk of relapse or progression as post-auto-HSCT consolidation, and (3) accelerated approval for the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. The sALCL indication is approved under accelerated approval based on overall response rate. Continued approval for the sALCL indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-ASCT consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression.

ADCETRIS was granted conditional marketing authorization by the European Commission in October 2012 for two indications: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) the treatment of adult patients with relapsed or refractory sALCL. The European Commission extended the current conditional marketing authorization of ADCETRIS and approved ADCETRIS for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT.

ADCETRIS has received marketing authorization by regulatory authorities in 68 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See important safety information below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

On November 1, 2017 Vedanta Biosciences, an affiliate of PureTech Health (LSE: PRTC) developing a new category of therapies for immune and infectious diseases based on rationally designed consortia of human microbiome-derived bacteria, reported that it has exclusively sub-licensed key intellectual property from JSR Corporation to develop and commercialize microbiome-derived cancer immunotherapies based on live biotherapeutics (Press release, Vedanta Biosciences, NOV 1, 2017, View Source [SID1234521457]). These live biotherapeutics have been shown to activate CD8+ T cells, a type of white blood cell that is the predominant effector in cancer immunotherapy. The sub-licensed intellectual property is based on the pioneering research of Dr. Kenya Honda, Professor, of Keio University School of Medicine and his collaborators in the University of Tokyo in Japan. An IND filing for the lead product candidate is planned in 2018.

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“Dr. Honda’s research suggests an entirely new approach to cancer immunotherapy harnessing the human microbiome, which has the potential to significantly enhance the effectiveness of cancer therapies,” said Bernat Olle, PhD, Chief Executive Officer of Vedanta Biosciences. “We are actively developing product candidates containing defined bacterial consortia that activate CD8+ T cells and stimulate the immune system to fight cancer alone and in combination with checkpoint inhibitors. This license to additional intellectual property from Dr. Honda’s institution further strengthens Vedanta’s leading IP position in the microbiome field.”

In validated pre-clinical models of cancer, Vedanta’s orally administered product candidates containing defined bacterial consortia induced CD8+ T cells, potentiating the immune system’s attack of tumor cells. The tumor fighting effects of a variety of checkpoint inhibitors were significantly amplified when combined with the bacterial consortia, suggesting a potentially novel approach for combination cancer immunotherapy.

About Key Intellectual Properties
Keio University and The University of Tokyo joined the Leading Advanced Projects for Medical Innovation (“LEAP”), part of Advanced Research and Development Programs for Medical Innovation at The Japan Agency for Medical Research and Development (“AMED”), in 2016. Their research and development is focused on the development of therapeutic cocktails of bacteria isolated from the gut microbiota. The licensed intellectual properties were developed as a part of the AMED-LEAP Research Program and are exclusively licensed to JSR Corporation (TSE: JSR) from Keio University and The University of Tokyo.

On October 31, 2017 Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported its third quarter 2017 financial results and provided a corporate update (Press release, Iovance Biotherapeutics, OCT 31, 2017, View Source [SID1234521366]).

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“In the third quarter of 2017 we continued to make significant progress in the clinic as the first patient was dosed with LN-145 in the Phase 2 trial for cervical cancer. Regulatory progress was demonstrated with the FDA granting Fast Track designation for LN-144 for the treatment of advanced melanoma and approval of a CTA by the competent authority in the Netherlands for the Phase 2 trial of LN-145 in cervical carcinoma,” said Dr. Maria Fardis, Ph.D., MBA, President and Chief Executive Officer of Iovance Biotherapeutics. “On the corporate front, we successfully completed a common stock offering adding approximately $54.0 million in net proceeds to the cash reserves. In the fourth quarter of 2017, we look forward to sharing new clinical data from Cohort 2 of the C-144-01 metastatic melanoma trial and nonclinical data at the upcoming SITC (Free SITC Whitepaper) meeting.”

Third Quarter 2017 and Recent Highlights and Anticipated Milestones

Corporate News:

Appointed New Chief Financial Officer (CFO): In August, Tim Morris was appointed CFO of Iovance. Mr. Morris brings over 22 years of experience related to the biopharmaceutical industry.

Completion of Public Offering: In September, the Company completed a public offering of 8,846,154 shares of its common stock at a price of $6.50 per share, before underwriting discounts. The shares of common stock issued and sold in the offering at the closing include 1,153,846 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares. The net proceeds from the offering, after deducting the underwriting discounts and commissions and other estimated offering expenses payable by Iovance, are approximately $54.0 million.
Clinical Trial Progress:

C-144-01 Phase 2 Trial in Metastatic Melanoma: In October, preliminary data from Cohort 2 of the ongoing C-144-01 Phase 2 trial of LN-144 was accepted as a late-breaking abstract to be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2017 Annual Meeting.

First Patient Dosed in C-145-04 Phase 2 Trial in Cervical Cancer: In August, the first patient was dosed in the C-145-04 Phase 2 trial of LN-145 for the treatment of patients with recurrent, metastatic or persistent cervical carcinoma.
Manufacturing Updates:

Partnership with TrakCel for Personalized Patient Product Management: In September, Iovance commenced a partnership with TrakCel Ltd. to build a scheduling and logistics tool that automates the supply chain for Iovance’s adoptive cell therapy products that utilize its TIL technology. The TrakCel Solution will electronically link Iovance with clinical sites, contract manufacturing organizations and couriers to schedule and track TIL therapies for each patient. The TrakCel Solution is intended to help manage capacity utilization and throughput as well as providing efficiencies in the delivery of TIL treatment.
Regulatory Updates:

Fast Track Designation Granted for LN-144: In August, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for LN-144, the Company’s adoptive cell therapy using its TIL technology, for the treatment of advanced melanoma.
European Clinical Trial Applications (CTAs): Iovance initiated the submission of CTAs in multiple countries in Europe starting in August 2017 in support of Phase 2 clinical trials of LN-145 in cervical carcinoma and LN-144 in metastatic melanoma. In September, the Company received the first approval from the competent authority in the Netherlands, for LN-145 for the treatment of patients with cervical carcinoma. Subsequent to the end of the quarter, the Company received CTA approvals in Hungary for metastatic melanoma and the United Kingdom for cervical carcinoma and metastatic melanoma.
Research Update and Data Presentations:

Research Collaboration Agreement with Ohio State University: In September, the Company entered into a collaboration with the Ohio State University. The collaboration will initially focus on hematologic malignancies in areas of poor prognostic cancers with high unmet medical need, which include acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL).
Poster Presentation at European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper): In August, the Company announced a poster presentation at the ESMO (Free ESMO Whitepaper) 2017 Congress in September with data that demonstrates the ability to produce TIL from lymphoma that have similar functionality as TIL generated from melanoma.
Third Quarter 2017 Financial and Operating Results

As of September 30, 2017, the Company held $163.4 million in cash and cash equivalents and short-term investments, compared to $166.5 million as of December 31, 2016.

The Company is providing both GAAP and non-GAAP financial information. All non-GAAP information excludes amounts related to stock-based compensation. See “Use of Non-GAAP Financial Measures” below for a description of the Company’s non-GAAP Financial Measures. Reconciliation between certain GAAP and non-GAAP measures is provided at the end of this press release.

GAAP and Non-GAAP Net Loss Attributable to Common Stockholders

GAAP net loss attributable to common stockholders for the quarter ended September 30, 2017 was $22.1 million, or ($0.35) per share, compared to GAAP net loss of $68.2 million or ($1.15) per share for the quarter ended September 30, 2016.

Non-GAAP net loss attributable to common stockholders for the quarter ended September 30, 2017 was $19.5 million, or ($0.31) per share, compared to non-GAAP net loss of $10.1 million, or ($0.17) per share for the quarter ended September 30, 2016. The non-GAAP net loss for the quarters ended September 30, 2017 and September 30, 2016 excludes $2.6 million and $8.6 million of non-cash stock-based compensation, and a non-cash deemed dividend of $49.5 million which was recorded in the quarter ended September 30, 2016. The deemed dividend will only impact the prior years’ quarter’s financial statements.

GAAP net loss attributable to common stockholders for the nine months ended September 30, 2017 was $66.2 million, or ($1.06) per share, compared to GAAP net loss attributable to common stockholders of $86.7 million or ($1.64) per share for the nine months ended September 30, 2016. Non-GAAP net loss for the nine months ended September 30, 2017 was $57.0 million, or ($0.91) per share, compared to non-GAAP net loss of $21.4 million or ($0.40) per share for the nine months ended September 30, 2016.

GAAP and Non-GAAP Expenses

GAAP research and development (R&D) expenses were $17.8 million for the quarter ended September 30, 2017, an increase of $9.3 million compared to the quarter ended September 30, 2016. The increase in R&D expense is due to increased spending on clinical activities and manufacturing. In addition, R&D-associated stock based expenses were $1.1 million for the three months ended September 30, 2017 and $4.3 million for the nine months ended September 30, 2017. Non-GAAP R&D expenses were $16.7 million for the quarter ended September 30, 2017, an increase of $8.9 million, compared to $7.8 million for the quarter ended September 30, 2016.

GAAP general and administrative (G&A) expenses were $4.6 million for the quarter ended September 30, 2017, a decrease of $5.9 million compared to the quarter ended September 30, 2016. Non-GAAP G&A expenses were $3.0 million for the quarter ended September 30, 2017, an increase of $0.5 million, compared to $2.5 million for the quarter ended September 30, 2016.

Use of Non-GAAP Financial Measures

This press release contains non-GAAP financial measures, including expenses adjusted to exclude certain non-cash expenses. These measures are not in accordance with, or an alternative to, generally accepted accounting principles, or GAAP, and may be different from non-GAAP financial measures used by other companies. The items included in GAAP presentations but excluded for purposes of determining non-GAAP financial measures for the periods presented in this press release are: (i) the non-cash stock-based compensation expense which may fluctuate from period to period based on factors including the timing and accounting of grants for stock options and changes in the Company’s stock price which impacts the fair value of options granted, and (ii) the one-time non-cash deemed dividend related to the conversion feature of the Series B Preferred Stock. The Company believes the presentation of non-GAAP financial measures provides useful information to management and investors regarding various financial and business trends relating to the Company’s financial condition and results of operations. When GAAP financial measures are viewed in conjunction with non-GAAP financial measures, investors are provided with a more meaningful understanding of Iovance’s ongoing operating performance. In addition, these non-GAAP financial measures are among those indicators the Company uses as a basis for evaluating operational performance, allocating resources and planning and forecasting future periods. Non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. To the extent this release contains historical or future non-GAAP financial measures, the Company has also provided corresponding GAAP financial measures for comparative purposes. Reconciliation between certain GAAP and non-GAAP measures is provided at the end of this press release.

2017 Year End Guidance for Cash, Cash Equivalents and Short-Term Investments

Iovance anticipates the cash, cash equivalents and short-term investments as of December 31, 2017, to be in excess of $141.0 million.

Webcast and Conference Call

Iovance will host a conference call today at 4:30 p.m. ET to discuss these third quarter 2017 results. The conference call dial-in numbers are: 1-844-646-4465 (domestic) or 1-615-247-0257 (international). The conference ID access number for the call is 1423064. The live webcast can be accessed under “News & Events” in the “Investors” section of the Company’s website at View Source or you may use the link: View Source

A replay of the call will be available one hour after the end of the call on October 31, 2017 until 8:00 p.m. ET on November 30, 2017. To access the replay, please dial 1-855-859-2056 (domestic) or 1-404-537-3406 (international). The conference ID number for the replay is 1423064. The archived webcast will be available for thirty days in the Investors section of Iovance Biotherapeutics’ website at View Source