On May 2, 2017 Nativis Inc., a clinical stage life science bio-electronics company developing non-invasive, safe and highly effective treatments for cancers and other serious diseases, reported the peer reviewed publication of a research paper in the Journal of Neuro-Oncology (JNO) on a novel technology to treat brain cancer Nativis Inc., a clinical stage life science bio-electronics company developing non-invasive, safe and highly effective treatments for cancers and other serious diseases, reported the peer reviewed publication of a research paper in the Journal of Neuro-Oncology (JNO) on a novel technology to treat brain cancer (Press release, Nativis, MAY 2, 2017, View Source [SID1234518797]).

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Leading the efforts behind the research paper were Charles Cobbs, MD, Chair of the Nativis Medical & Scientific Advisory Board and Director of the Ben & Catherine Ivy Center for Advanced Brain Tumor Treatment at Swedish Neuroscience Institute, and Michael Prados, MD, Director of Translational Research at the Department of Neurological Surgery at the University of California, San Francisco. The article in JNO provided data by the research team identifying the significance of using the Nativis Voyager technology electromagnetic fields (EMF) in the ultra-low radio frequency energy (ulRFE) range to affect brain cancer cells at the molecular level. This technology was used to demonstrate the specificity and cellular effects on human derived glioblastoma (GBM) brain cancer cells. It was shown that this technology can specifically knock down EGFR gene expression, with resulting biological effects, in human primary (GBM) cells by exposing these cells to physical-EGFR siRNA and RFE-siEGFR signal. EGFR is a commercially proven target with multiple bio-pharmaceutical products approved to treat several different types of cancer.
"Brain cancer is known to be one of the most difficult cancers to treat due to the blood-brain barrier that makes delivery of pharmaceutical treatment difficult and ineffective," said Dr. Cobbs. "The Nativis Voyager technology delivers treatment via electronic signal, therefore by-passing the problems of delivering standard chemotherapy, and other drug treatment and the accompanying harsh physical effects that patients suffer."
"We continue to be encouraged about our Voyager technology to treat brain cancer as this research paper demonstrates," said Chris Rivera, Chief Executive Officer of Nativis. "These findings are the first, to our knowledge, that demonstrate specific molecular gene knockdown using ulRFE energy. Our strategy is to replicate the biological effects of commercially approved drugs and other therapeutic agents with our ulRFE technology. We have several research collaborations in the US and globally for work on human health, as well as other markets and sectors, including veterinary and plant science. It appears that our technology may be utilized in many ways and over multiple platforms to treat disease and other maladies. With the successful development of our ulRFE technology for the treatment of glioblastoma multiforme (GBM), a very complex and difficult area to treat, the impact for patients with GBM and other diseases could be monumental."

Further comments were made by Nativis Medical and Scientific Board Member Victor Levin, MD, Founder of the Society of Neuro Oncology (SNO) and Emeritus Professor of Neuro-Oncology at The University of Texas, M.D. Anderson Cancer Center. "This research is very important as it provides additional support for the importance of this technology to patients with CNS cancers and other tumors. The application of this research provides, for the first time, the possibility of treating human diseases with low energy electromagnetic field technology that can reduce the production of signaling proteins within tumor cells. Given that new drug development is almost absent for CNS cancers and those available today are of limited efficacy and produce a wide range of side effects making creating effective drug combinations difficult, the RFE approach is truly a bright light for patients in the future. This is true for brain cancer and likely equally true for other diseases affecting the brain. The implications and possible uses of this novel approach cannot be underestimated," Dr. Levin added.

The abstract of this paper can be seen at View Source." target="_blank" title="View Source." rel="nofollow">View Source

Leading the efforts behind the research paper were Charles Cobbs, MD, Chair of the Nativis Medical & Scientific Advisory Board and Director of the Ben & Catherine Ivy Center for Advanced Brain Tumor Treatment at Swedish Neuroscience Institute, and Michael Prados, MD, Director of Translational Research at the Department of Neurological Surgery at the University of California, San Francisco. The article in JNO provided data by the research team identifying the significance of using the Nativis Voyager technology electromagnetic fields (EMF) in the ultra-low radio frequency energy (ulRFE) range to affect brain cancer cells at the molecular level. This technology was used to demonstrate the specificity and cellular effects on human derived glioblastoma (GBM) brain cancer cells. It was shown that this technology can specifically knock down EGFR gene expression, with resulting biological effects, in human primary (GBM) cells by exposing these cells to physical-EGFR siRNA and RFE-siEGFR signal. EGFR is a commercially proven target with multiple bio-pharmaceutical products approved to treat several different types of cancer.

"Brain cancer is known to be one of the most difficult cancers to treat due to the blood-brain barrier that makes delivery of pharmaceutical treatment difficult and ineffective," said Dr. Cobbs. "The Nativis Voyager technology delivers treatment via electronic signal, therefore by-passing the problems of delivering standard chemotherapy, and other drug treatment and the accompanying harsh physical effects that patients suffer."

"We continue to be encouraged about our Voyager technology to treat brain cancer as this research paper demonstrates," said Chris Rivera, Chief Executive Officer of Nativis. "These findings are the first, to our knowledge, that demonstrate specific molecular gene knockdown using ulRFE energy. Our strategy is to replicate the biological effects of commercially approved drugs and other therapeutic agents with our ulRFE technology. We have several research collaborations in the US and globally for work on human health, as well as other markets and sectors, including veterinary and plant science. It appears that our technology may be utilized in many ways and over multiple platforms to treat disease and other maladies. With the successful development of our ulRFE technology for the treatment of glioblastoma multiforme (GBM), a very complex and difficult area to treat, the impact for patients with GBM and other diseases could be monumental."

Further comments were made by Nativis Medical and Scientific Board Member Victor Levin, MD, Founder of the Society of Neuro Oncology (SNO) and Emeritus Professor of Neuro-Oncology at The University of Texas, M.D. Anderson Cancer Center. "This research is very important as it provides additional support for the importance of this technology to patients with CNS cancers and other tumors. The application of this research provides, for the first time, the possibility of treating human diseases with low energy electromagnetic field technology that can reduce the production of signaling proteins within tumor cells. Given that new drug development is almost absent for CNS cancers and those available today are of limited efficacy and produce a wide range of side effects making creating effective drug combinations difficult, the RFE approach is truly a bright light for patients in the future. This is true for brain cancer and likely equally true for other diseases affecting the brain. The implications and possible uses of this novel approach cannot be underestimated," Dr. Levin added.

The abstract of this paper can be seen at View Source

On May 2, 2017 Gilead Sciences, Inc. (Nasdaq: GILD) reported its results of operations for the first quarter ended March 31, 2017 (Press release, Gilead Sciences, MAY 2, 2017, View Source [SID1234518816]).

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The financial results that follow represent a year-over-year comparison of the first quarter 2017 to the first quarter 2016. Total revenues were $6.5 billion in 2017 compared to $7.8 billion in 2016. Net income was $2.7 billion or $2.05 per diluted share in 2017 compared to $3.6 billion or $2.53 per diluted share in 2016. Non-GAAP net income, which excludes amounts related to acquisition-related, up-front collaboration, stock-based compensation and other expenses, was $2.9 billion or $2.23 per diluted share in 2017 compared to $4.3 billion or $3.03 per diluted share in 2016.

Three Months Ended
March 31,
(In millions, except per share amounts) 2017 2016
Product sales $ 6,377 $ 7,681
Royalty, contract and other revenues 128 113
Total revenues
$ 6,505 $ 7,794

Net income attributable to Gilead $ 2,702 $ 3,566
Non-GAAP net income* $ 2,949 $ 4,274

Diluted earnings per share $ 2.05 $ 2.53
Non-GAAP diluted earnings per share*
$ 2.23 $ 3.03

* Non-GAAP net income and non-GAAP diluted earnings per share exclude acquisition-related, up-front collaboration, stock-based compensation and other expenses. A reconciliation between GAAP and non-GAAP financial information is provided in the tables on pages 7 and 8.

Product Sales

Total product sales for the first quarter of 2017 were $6.4 billion compared to $7.7 billion for the same period in 2016. Product sales for the first quarter of 2017 were $4.5 billion in the United States, $1.3 billion in Europe and $661 million in other locations. Product sales for the first quarter of 2016 were $4.4 billion in the United States, $1.6 billion in Europe and $1.7 billion in other locations.

Antiviral Product Sales

Antiviral product sales, which include sales of our HIV, chronic hepatitis B (HBV) and chronic hepatitis C (HCV) products, were $5.8 billion for the first quarter of 2017 compared to $7.2 billion for the same period in 2016.

HIV and HBV product sales were $3.3 billion compared to $2.9 billion for the same period in 2016. The increase was primarily due to the continued uptake of our tenofovir alafenamide (TAF) based products, Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg), Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg) and Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg).
HCV product sales, which consist of Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg), Sovaldi (sofosbuvir 400 mg) and Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg), were $2.6 billion compared to $4.3 billion for the same period in 2016. The decline was due to lower sales of Harvoni and Sovaldi across all major markets, partially offset by sales of Epclusa, which was launched in the United States and Europe in June and July 2016, respectively.
Other Product Sales

Other product sales, which include Letairis (ambrisentan), Ranexa (ranolazine) and AmBisome (amphotericin B liposome for injection), were $536 million for the first quarter of 2017 compared to $498 million for the same period in 2016.

Operating Expenses

Three Months Ended
March 31,
(In millions) 2017 2016
Research and development expenses (R&D) $ 931 $ 1,265
Non-GAAP R&D expenses* $ 889 $ 769

Selling, general and administrative expenses (SG&A) $ 850 $ 685
Non-GAAP SG&A expenses* $ 807 $ 638

* Non-GAAP R&D and SG&A expenses exclude acquisition-related, up-front collaboration, stock-based compensation and other expenses. A reconciliation between GAAP and non-GAAP financial information is provided in the tables on pages 7 and 8.

During the first quarter of 2017, compared to the same period in 2016:

R&D expenses decreased primarily due to the 2016 impact of up-front collaboration expenses related to Gilead’s license and collaboration agreement with Galapagos NV and impairment charges related to in-process R&D. These decreases were partially offset by expenses associated with Gilead’s purchase of a U.S. Food and Drug Administration (FDA) priority review voucher.
Non-GAAP R&D expenses* increased primarily due to expenses associated with Gilead’s purchase of an FDA priority review voucher.
SG&A expenses and non-GAAP SG&A expenses* increased primarily due to higher branded prescription drug fee expense.
Cash, Cash Equivalents and Marketable Securities

As of March 31, 2017, Gilead had $34.0 billion of cash, cash equivalents and marketable securities compared to $32.4 billion as of December 31, 2016. Cash flow from operating activities was $2.9 billion for the quarter. During the first quarter of 2017, Gilead utilized $565 million on stock repurchases and paid cash dividends of $687 million.

Full Year 2017 Guidance Reiterated

Gilead reiterates its full year 2017 guidance, initially provided on February 7, 2017:

(In millions, except percentages and per share amounts) Initially Provided
February 7, 2017
Net Product Sales $22,500 – $24,500
Non-HCV Product Sales $15,000 – $15,500
HCV Product Sales $7,500 – $9,000
Non-GAAP*
Product Gross Margin 86% – 88%
R&D Expenses $3,100 – $3,400
SG&A Expenses $3,100 – $3,400
Effective Tax Rate 25.0% – 28.0%
Diluted EPS Impact of Acquisition-related, Up-front Collaboration, Stock-based Compensation and Other Expenses $0.84 – $0.91

* Non-GAAP Product Gross Margin, R&D and SG&A expenses and effective tax rate exclude acquisition-related, up-front collaboration, stock-based compensation and other expenses. A reconciliation between GAAP and non-GAAP full year 2017 guidance is provided in the tables on page 9.

Corporate Highlights

Announced that Alessandro Riva, MD, joined the company as Senior Vice President and therapeutic area head for hematology and oncology.
Announced the recipients of Gilead’s HIV cure grants program, a fund totaling more than $22 million, which will support 12 new HIV cure research projects. These projects will be conducted by leading academic institutions, non-profit organizations and community groups from around the world, focusing on three key areas: translational research, efficacy studies in animal models and community perspectives of HIV cure.
Product and Pipeline Updates announced by Gilead during the First Quarter of 2017 include:

Antiviral and Liver Diseases Programs

Presented data at the 2017 Conference on Retroviruses and Opportunistic Infections which included the announcement of:
Positive results from a Phase 2 study evaluating the efficacy, safety and tolerability of a combination of bictegravir (75 mg) (BIC) and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) versus dolutegravir (50 mg) (DTG) and FTC/TAF in treatment-naïve, HIV-1 infected adults. Results found that the BIC+FTC/TAF and DTG+FTC/TAF regimens both demonstrated high virologic response rates at week 24 and week 48.
Positive findings from a preclinical study evaluating HIV capsid inhibitors (CAIs) for potential use as a long-acting antiretroviral (ARV) treatment. The study identified novel HIV-1 CAIs with highly potent antiviral activity and a favorable resistance profile to existing ARVs in vitro.
Positive 144-week data from two Phase 3 studies (Studies 104 and 111) evaluating the safety and efficacy of Genvoya for the treatment of HIV-1 infection in treatment-naïve adults. Through week 144, Genvoya demonstrated significantly higher rates of virologic suppression compared to Stribild (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg), based on the percentage of patients with HIV-1 RNA levels less than 50 copies/mL. Patients receiving Genvoya also demonstrated favorable renal and bone laboratory parameters compared to those treated with Stribild.
Announced that the marketing authorization application for the investigational, once-daily, single-tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of HCV-infected patients has been fully validated and is under assessment by the European Medicines Agency. Gilead also previously submitted a new drug application to FDA for SOF/VEL/VOX. Under the Prescription Drug User Fee Act, FDA has set a target action date of August 8, 2017.
Announced that the European Commission granted marketing authorization for Vemlidy (tenofovir alafenamide 25mg), a once-daily tablet for the treatment of chronic hepatitis B virus infection in adults and adolescents (aged 12 years and older with body weight at least 35 kg).
Non-GAAP Financial Information

The information presented in this document has been prepared by Gilead in accordance with U.S. generally accepted accounting principles (GAAP), unless otherwise noted as non-GAAP. Management believes non-GAAP information is useful for investors, when considered in conjunction with Gilead’s GAAP financial information, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Gilead’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in the same industry. A reconciliation between GAAP and non-GAAP financial information is provided in the tables on pages 7, 8 and 9.

On May 2,2017 Celyad (Euronext Brussels and Paris, and NASDAQ:CYAD), a leader in the discovery and development of cell therapies, reported a non-exclusive license agreement with Novartis for Celyad’s US patents for the production of allogeneic CAR-T cells (Press release, Celyad, MAY 2, 2017, View Source [SID1234518791]). This license agreement is related to two targets currently under development by Novartis.

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The agreement includes Celyad’s intellectual property rights under United States Patent No. 9,181,527 related to allogeneic human primary T-Cells that are engineered to be T-Cell Receptor (TCR) deficient and express a Chimeric Antigen Receptor (CAR). The granted claims are not limited to specific CARs or specific methods of generating allogeneic CAR T-cells, such as genome editing or genetic engineering.

Under the terms of the agreement Celyad receives an upfront payment and is eligible to receive success based clinical, regulatory and commercial milestone payments. If all success based milestones are achieved, Celyad is eligible to receive payments, including the upfront payment, totalling $96 million. In addition, Celyad will receive single digit royalties based on net sales of the licensed target associated products. Novartis has the option to extend the agreement to additional targets and/or to convert its license into an exclusive license. Celyad retains all rights to grant further licenses to third parties for the use of allogeneic CAR-T cells.

Celyad will not be involved in the development of Novartis’ CAR-T cells. Celyad will continue to focus on the development of its CAR-T pipeline, including its allogeneic NKR-2 T-cell immunotherapy in the EU and US territories and in collaboration with Ono Pharmaceuticals, its partner in Japan, Taiwan and Korea.

Dr. Christian Homsy, CEO of Celyad, said: "This non-exclusive agreement with Novartis recognizes the importance of our IP for companies developing allogeneic CAR-T therapies".

On May 2, 2017 Aduro Biotech, Inc. (NASDAQ:ADRO) reported financial results for the first quarter ended March 31, 2017 (Press release, Aduro Biotech, MAY 2, 2017, View Source [SID1234518790]). Net loss for the first quarter of 2017 was $21.8 million, or $0.32 per share, compared to a net loss of $28.8 million, or $0.45 per share for the same period in 2016.

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Cash, cash equivalents and marketable securities totaled $356.0 million at March 31, 2017, compared to $361.9 million at December 31, 2016.

"This will be an important year for Aduro, as we generate data in our ongoing ADU-S100/STING monotherapy trial and our planned Phase 2 trial in mesothelioma, as well as look for data from Janssen’s Phase 1 trials in lung and prostate cancers evaluating LADD therapeutic candidates," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "We also plan to advance our STING program into additional clinical studies in collaboration with Novartis, and the first antibody from our B-select platform, the novel anti-APRIL antibody, is expected to be cleared for clinical testing this year. With ten product candidates in our diversified portfolio and a healthy balance sheet, we are in a strong position to continue to advance our pipeline and build a leading immunotherapy company."

Key Recent Accomplishments

Established a clinical collaboration with Merck to evaluate the combination of Aduro’s LADD agent CRS-207 with Merck’s KEYTRUDA (pembrolizumab) in a Phase 2 study in gastric cancer
Entered into an exclusive license agreement with Stanford University for the use of neoantigen identification technology in therapeutics using modified Listeria for our personalized LADD program, pLADD
Expanded Aduro’s Scientific Advisory Board with leading immunotherapy and oncology experts
Presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting on BION-1301, anti-APRIL antibody, and ADU-S100 STING agonist
Presented at the Keystone Symposia on Cancer Immunology and Immunotherapy Conference on ADU-S100 and pLADD
Anticipated 2017 Milestones

Initiate Phase 2 mesothelioma trial with CRS-207 in combination with anti-PD1 in the first half of 2017 and report early results in the second half of 2017
Initiate Phase 2 gastric trial with CRS-207 in combination with anti-PD1 in the first half of 2017
Initiate Phase 1 pLADD (personalized LADD) trial in advanced gastro-intestinal cancers in the second half of 2017
Janssen expected to initiate Phase 1b/2 trial of ADU-214 in lung cancer and determine next steps for ADU-741 in prostate cancer in the second half of 2017
Report top-line findings from Phase 1 monotherapy trial of ADU-S100 in the second half of 2017
In collaboration with Novartis, initiate Phase 1b trial of ADU-S100 in combination with anti-PD1 in the second half of 2017
File Investigational New Drug Application for BION-1301, anti-APRIL antibody, in the second half of 2017
Initiate Phase 1 multiple myeloma trial with anti-APRIL antibody in the second half of 2017
First Quarter 2017 Financial Results
Revenue for the first quarter of 2017 was $3.8 million, compared to $4.0 million for the same period in 2016. The revenue recognized in both quarters primarily relates to deferred upfront payments under the Novartis collaboration agreement. In addition, revenue in the first quarter of 2016 included reimbursed research services of $0.2 million.

Research and development expenses were $20.6 million for the first quarter of 2017, compared to $20.9 million for the same period in 2016. Research and development expenses incurred in the first quarter of 2016 included GVAX Pancreas manufacturing and pancreatic cancer clinical trial expenses, which did not occur in 2017. The decrease in expenses was partially offset by increased costs to manufacture our B-select antibodies and increased research and development expenses for the STING platform, as well as higher personnel and facility related costs in first quarter of 2017.

General and administrative expenses were $8.3 million for the first quarter of 2017, compared to $9.0 million for the same period in 2016. This decrease was primarily due to lower consulting and professional fees.

Income tax benefit was $2.8 million for the first quarter of 2017, compared to a provision for income taxes of $3.2 million for the same period in 2016. The income tax benefit recorded for the first quarter of 2017 was due to the current benefit of federal income taxes paid in 2016.

On May 2, 2017 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported results for the three-month period ended March 31, 2017 (Press release, Spectrum Pharmaceuticals, MAY 2, 2017, View Source [SID1234518788]).

“We remain focused on our advanced stage pipeline and look forward to several important milestones in the near future,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. “Based on the preclinical results and clinical data from the first compassionate-use patient, treated at MD Anderson Cancer Center by Dr. John Heymach under a compassionate-use protocol approved by the FDA, enthusiasm is building in the scientific community about the potential of poziotinib in non-small cell lung cancer patients with exon 20 insertion mutations. There is immense need for effective therapies in this disease as the current progression free survival is under 2 months. In addition, I am delighted with the recent pace of enrollment of the ROLONTIS Phase 3 program. Since the beginning of this year, we have enrolled over 135 patients in the pivotal trial. We are looking forward to Phase 3 results and a BLA filing next year. With three advanced stage drugs being studied in multiple tumors, I believe Spectrum is poised for transformational growth.”

Pipeline Update:

ROLONTIS (eflapegrastim), a novel long-acting GCSF: A pivotal Phase 3 study (ADVANCE) was initiated under an SPA from the FDA in 2016 to evaluate ROLONTIS in the management of chemotherapy-induced neutropenia. Based on the amended SPA, the size of the ADVANCE study was reduced to 400 from 580 evaluable patients. The ADVANCE study is now 75% enrolled and the Company expects to complete enrollment in the second half of this year. To strengthen the regulatory package in the U.S. and Europe, the Company has initiated the 218-patient RECOVER study, which is expected to include sites not only from the U.S., but also from Europe, Canada and South Korea. For the RECOVER Study, sites have been initiated and first patient enrollment is imminent. The Company continues to expect to file the BLA next year.
Poziotinib, a potential best-in-class, novel, pan-HER inhibitor: An investigator sponsored trial has been initiated at the University of Texas MD Anderson Cancer Center in non-small cell lung cancer patients with EGFR exon 20 insertion mutations. The study is expected to yield interim results before year end. Spectrum is also conducting a Phase 2 breast cancer study in the U.S., based on promising Phase 1 study efficacy data in breast cancer patients who had failed multiple HER2-directed therapies. Further, multiple Phase 2 studies are being conducted in South Korea by Hanmi Pharmaceuticals and National OncoVenture to study breast, lung, head-and-neck and gastric cancer indications.
QAPZOLA, a potent tumor-activated drug being investigated for low and intermediate risk non-muscle invasive bladder cancer: The Company received a new SPA from the FDA for a new Phase 3 study incorporating learnings from the previous studies, as well as recommendations from the FDA. Compared to the previous program, this new Phase 3 study will include fewer evaluable patients (n=425 versus 1,557 patients), use a higher dosage of QAPZOLA (8 mg versus 4 mg), and will evaluate time-to-recurrence as the primary endpoint. The Phase 3 trial is expected to start enrolling patients in the third quarter.
Three-Month Period Ended March 31, 2017 (All numbers are approximate)

GAAP Results

Total product sales were $25.8 million in the first quarter of 2017. Product sales in the first quarter included: FUSILEV (levoleucovorin) net sales of $2.6 million, FOLOTYN (pralatrexate injection) net sales of $9.3 million, ZEVALIN (ibritumomab tiuxetan) net sales of $2.8 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $2.0 million, BELEODAQ (belinostat) for injection net sales of $2.9 million, and EVOMELA (melphalan) for injection net sales of $6.3 million.

Spectrum recorded net loss of $23.0 million, or $0.29 per basic and diluted share in the three-month period ended March 31, 2017, compared to net loss of $9.3 million, or $0.14 per basic and diluted share in the comparable period in 2016. Total research and development expenses were $14.7 million in the quarter, as compared to $15.5 million in the same period in 2016. Selling, general and administrative expenses were $18.6 million in the quarter, compared to $22.0 million in the same period in 2016.

The Company ended the quarter with Cash and Cash Equivalents of $137 million.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $11.4 million, or $0.14 per basic and diluted share in the three-month period ended March 31, 2017, compared to non-GAAP net income of $0.3 million, or $0.01 per basic share and less than $0.01 per diluted share in the comparable period in 2016. Non-GAAP research and development expenses were $14.3 million, as compared to $13.0 million in the same period of 2016. Non-GAAP selling, general and administrative expenses were $15.7 million, as compared to $16.7 million in the same period in 2016.