On November 2, 2017 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported financial results for the third quarter ended September 30, 2017 (Press release, Sunesis, NOV 2, 2017, View Source [SID1234521490]). Loss from operations for the three months ended September 30, 2017 was $9.9 million. As of September 30, 2017, cash, cash equivalents and marketable securities totaled $12.5 million. Subsequent to the end of the quarter, the company raised approximately $6 million from sales of common stock through its at the market facility in October 2017 and $20 million in gross proceeds from concurrent underwritten public offerings on October 27, 2017, which together will provide sufficient funds for the operation of the company’s business into early 2019.

“In the third quarter, we advanced our lead program, a reversible, non-covalent BTK inhibitor, SNS-062, with the ongoing enrollment in our Phase 1b/2 study in patients with relapsed chronic lymphocytic leukemia (CLL) and other B-cell malignancies,” said Daniel Swisher, Chief Executive Officer of Sunesis. “We will provide a program update at an investor presentation and webcast during the American Society of Hematology (ASH) (Free ASH Whitepaper) Conference in Atlanta, Georgia in December 2017, and to present interim data from the study at a peer-reviewed medical conference in mid-2018. We believe SNS-062 has the potential to overcome the leading resistance pathway to ibrutinib, the predominant standard of care for the treatment of CLL. In addition, in October, we secured the financial resources from leading life science investors extending our operating runway into early 2019.

Mr. Swisher added, “Beyond SNS-062, we have made progress with our proprietary PDK-1 and Takeda-partnered pan-RAF inhibitor programs. We are pleased to announce today the nomination of our PDK1 (phosphatidyl-inositol dependent kinase1) inhibitor, SNS-510, as a Development Candidate and potentially first-to-clinic selective inhibitor in this pathway. PDK1 is a master kinase that activates other kinases important to cell growth and survival including members of the AKT, PKC, RSK and SGK families. In addition, we look forward to announcing future updates from the ongoing clinical studies of our Takeda-partnered TAK-580 program.”

Recent Highlights

Completed $20 million concurrent public offerings with leading life science investors. On October 27, 2017, Sunesis raised $20 million in gross proceeds in concurrent underwritten public offerings of common and preferred stock and warrants, with participation by new and existing investors, including Oncology Impact Fund managed by MPM Capital, BVF Partners L.P and Burrage Capital.

Continued Progress in Phase 1b/2 Study Evaluating Oral Non-Covalent BTK-inhibitor SNS-062 in Adults with Chronic Lymphocytic Leukemia (CLL) and other B-Cell Malignancies. In July 2017, Sunesis announced that the first patient was dosed at the Dana-Farber Cancer Institute in the Phase 1b/2 dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of its potent, reversible, non-covalent BTK-inhibitor, SNS-062, in adults with CLL, small lymphocytic leukemia, Waldenstrom’s macroglobulinemia, and mantle cell lymphoma. The Phase 1b/2 trial is an open-label, sequential-group study that is enrolling up to 124 subjects across leading sites in the United States. The Company plans to present interim data from this study in mid-2018.
Financial Highlights

Cash, cash equivalents and marketable securities totaled $12.5 million as of September 30, 2017, as compared to $42.6 million as of December 31, 2016. The decrease of $30.1 million was primarily due to $30.8 million of net cash used in operating activities and a debt restructuring payment of $7.6 million, partially offset by $8.3 million in net proceeds primarily from sales of common stock through the company’s at the market facility. An additional $24.6 million in net proceeds were raised in October, resulting in pro-forma September 30, 2017 cash, cash equivalents and marketable securities of $37.1 million. This capital is expected to fund the company into 2019.

Revenue for the three and nine months ended September 30, 2017 was nil and $0.7 million, as compared to $0.6 million and $1.9 million for the same periods in 2016. Revenue in each period was primarily due to deferred revenue recognized related to the Royalty Agreement with Royalty Pharma.

Research and development expense was $6.8 million and $17.9 million for the three and nine months ended September 30, 2017 as compared to $5.3 million and $18.1 million for the same periods in 2016, primarily relating to the SNS-062 and the vosaroxin development program in each period. The increase of $1.5 million between the comparable three month periods was primarily due to the $2.5 million milestone payment to Biogen under the license agreement, offset by decreases in professional services of $0.8 million and salary and personnel expenses of $0.2 million. The decrease in the comparable nine months periods of $0.2 million was primarily due to a decrease in professional services of $2.5 million, salary and personnel expenses of $0.2 million, and medical affairs expenses of $0.2 million, partially offset by the $2.5 million milestone payment to Biogen under the license agreement.

General and administrative expense was $3.2 million and $10.8 million for the three and nine months ended September 30, 2017, as compared to $3.9 million and $12.2 million for the same periods in 2016. The decrease of $0.7 million for the comparable three month periods was primarily due to decreases in salary and personnel expenses of $0.4 million and commercial expenses of $0.3 million, partially offset by increases of $0.1 million in professional services. The decrease in the comparable nine months periods of $1.4 million was primarily due to a decrease in salary and related expenses of $0.9 million, commercial expenses of $0.7 million, partially offset by increase of $0.4 million in professional services.

Interest expense was $0.3 million and $1.1 million for the three and nine months ended September 30, 2017, as compared to $0.5 million and $1.2 million for the same periods in 2016. The decrease in the 2017 periods was primarily due to the decrease in the outstanding notes payable.

Net other income was $0.1 million and $0.3 million for the three and nine months ended September 30, 2017, as compared to nil and $0.1 million for the same periods in 2016. The other income was primarily comprised of interest income from the short-term investments.

Cash used in operating activities was $30.8 million for the nine months ended September 30, 2017, as compared to $29.0 million for the same period in 2016. Net cash used in the 2017 period resulted primarily from the net loss of $28.8 million and changes in operating assets and liabilities of $4.6 million, offset by net adjustments for non-cash items of $2.6 million. Net cash used in the nine month period ended September 30, 2016 resulted primarily from the net loss of $29.5 million and changes in operating assets and liabilities of $3.6 million, including a final payment fee representing interest expense of $1.2 million under the Oxford Loan Agreement, partially offset by net adjustments for non-cash items of $4.1 million.

Sunesis reported loss from operations of $9.9 million and $28.0 million for the three and nine months ended September 30, 2017, as compared to $8.5 million and $28.4 million for the same periods in 2016. Net loss was $10.2 million and $28.8 million for the three and nine months ended September 30, 2017, as compared to $9.0 million and $29.5 million for the same periods in 2016.
Conference Call Information

Sunesis will host a conference today at 2:00 p.m. Eastern Time. The call can be accessed by dialing (844) 296-7720 (U.S. and Canada) or (574) 990-1148 (international) and entering passcode 1071001. To access the live audio webcast, or the subsequent archived recording, visit the “Investors and Media – Calendar of Events” section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the company’s website for two weeks.

On November 2, 2017 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported financial results for the third quarter ended September 30, 2017 (Press release, Sunesis, NOV 2, 2017, View Source [SID1234521490]). Loss from operations for the three months ended September 30, 2017 was $9.9 million. As of September 30, 2017, cash, cash equivalents and marketable securities totaled $12.5 million. Subsequent to the end of the quarter, the company raised approximately $6 million from sales of common stock through its at the market facility in October 2017 and $20 million in gross proceeds from concurrent underwritten public offerings on October 27, 2017, which together will provide sufficient funds for the operation of the company’s business into early 2019.

“In the third quarter, we advanced our lead program, a reversible, non-covalent BTK inhibitor, SNS-062, with the ongoing enrollment in our Phase 1b/2 study in patients with relapsed chronic lymphocytic leukemia (CLL) and other B-cell malignancies,” said Daniel Swisher, Chief Executive Officer of Sunesis. “We will provide a program update at an investor presentation and webcast during the American Society of Hematology (ASH) (Free ASH Whitepaper) Conference in Atlanta, Georgia in December 2017, and to present interim data from the study at a peer-reviewed medical conference in mid-2018. We believe SNS-062 has the potential to overcome the leading resistance pathway to ibrutinib, the predominant standard of care for the treatment of CLL. In addition, in October, we secured the financial resources from leading life science investors extending our operating runway into early 2019.

Mr. Swisher added, “Beyond SNS-062, we have made progress with our proprietary PDK-1 and Takeda-partnered pan-RAF inhibitor programs. We are pleased to announce today the nomination of our PDK1 (phosphatidyl-inositol dependent kinase1) inhibitor, SNS-510, as a Development Candidate and potentially first-to-clinic selective inhibitor in this pathway. PDK1 is a master kinase that activates other kinases important to cell growth and survival including members of the AKT, PKC, RSK and SGK families. In addition, we look forward to announcing future updates from the ongoing clinical studies of our Takeda-partnered TAK-580 program.”

Recent Highlights

Completed $20 million concurrent public offerings with leading life science investors. On October 27, 2017, Sunesis raised $20 million in gross proceeds in concurrent underwritten public offerings of common and preferred stock and warrants, with participation by new and existing investors, including Oncology Impact Fund managed by MPM Capital, BVF Partners L.P and Burrage Capital.

Continued Progress in Phase 1b/2 Study Evaluating Oral Non-Covalent BTK-inhibitor SNS-062 in Adults with Chronic Lymphocytic Leukemia (CLL) and other B-Cell Malignancies. In July 2017, Sunesis announced that the first patient was dosed at the Dana-Farber Cancer Institute in the Phase 1b/2 dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of its potent, reversible, non-covalent BTK-inhibitor, SNS-062, in adults with CLL, small lymphocytic leukemia, Waldenstrom’s macroglobulinemia, and mantle cell lymphoma. The Phase 1b/2 trial is an open-label, sequential-group study that is enrolling up to 124 subjects across leading sites in the United States. The Company plans to present interim data from this study in mid-2018.
Financial Highlights

Cash, cash equivalents and marketable securities totaled $12.5 million as of September 30, 2017, as compared to $42.6 million as of December 31, 2016. The decrease of $30.1 million was primarily due to $30.8 million of net cash used in operating activities and a debt restructuring payment of $7.6 million, partially offset by $8.3 million in net proceeds primarily from sales of common stock through the company’s at the market facility. An additional $24.6 million in net proceeds were raised in October, resulting in pro-forma September 30, 2017 cash, cash equivalents and marketable securities of $37.1 million. This capital is expected to fund the company into 2019.

Revenue for the three and nine months ended September 30, 2017 was nil and $0.7 million, as compared to $0.6 million and $1.9 million for the same periods in 2016. Revenue in each period was primarily due to deferred revenue recognized related to the Royalty Agreement with Royalty Pharma.

Research and development expense was $6.8 million and $17.9 million for the three and nine months ended September 30, 2017 as compared to $5.3 million and $18.1 million for the same periods in 2016, primarily relating to the SNS-062 and the vosaroxin development program in each period. The increase of $1.5 million between the comparable three month periods was primarily due to the $2.5 million milestone payment to Biogen under the license agreement, offset by decreases in professional services of $0.8 million and salary and personnel expenses of $0.2 million. The decrease in the comparable nine months periods of $0.2 million was primarily due to a decrease in professional services of $2.5 million, salary and personnel expenses of $0.2 million, and medical affairs expenses of $0.2 million, partially offset by the $2.5 million milestone payment to Biogen under the license agreement.

General and administrative expense was $3.2 million and $10.8 million for the three and nine months ended September 30, 2017, as compared to $3.9 million and $12.2 million for the same periods in 2016. The decrease of $0.7 million for the comparable three month periods was primarily due to decreases in salary and personnel expenses of $0.4 million and commercial expenses of $0.3 million, partially offset by increases of $0.1 million in professional services. The decrease in the comparable nine months periods of $1.4 million was primarily due to a decrease in salary and related expenses of $0.9 million, commercial expenses of $0.7 million, partially offset by increase of $0.4 million in professional services.

Interest expense was $0.3 million and $1.1 million for the three and nine months ended September 30, 2017, as compared to $0.5 million and $1.2 million for the same periods in 2016. The decrease in the 2017 periods was primarily due to the decrease in the outstanding notes payable.

Net other income was $0.1 million and $0.3 million for the three and nine months ended September 30, 2017, as compared to nil and $0.1 million for the same periods in 2016. The other income was primarily comprised of interest income from the short-term investments.

Cash used in operating activities was $30.8 million for the nine months ended September 30, 2017, as compared to $29.0 million for the same period in 2016. Net cash used in the 2017 period resulted primarily from the net loss of $28.8 million and changes in operating assets and liabilities of $4.6 million, offset by net adjustments for non-cash items of $2.6 million. Net cash used in the nine month period ended September 30, 2016 resulted primarily from the net loss of $29.5 million and changes in operating assets and liabilities of $3.6 million, including a final payment fee representing interest expense of $1.2 million under the Oxford Loan Agreement, partially offset by net adjustments for non-cash items of $4.1 million.

Sunesis reported loss from operations of $9.9 million and $28.0 million for the three and nine months ended September 30, 2017, as compared to $8.5 million and $28.4 million for the same periods in 2016. Net loss was $10.2 million and $28.8 million for the three and nine months ended September 30, 2017, as compared to $9.0 million and $29.5 million for the same periods in 2016.
Conference Call Information

Sunesis will host a conference today at 2:00 p.m. Eastern Time. The call can be accessed by dialing (844) 296-7720 (U.S. and Canada) or (574) 990-1148 (international) and entering passcode 1071001. To access the live audio webcast, or the subsequent archived recording, visit the “Investors and Media – Calendar of Events” section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the company’s website for two weeks.

On Noember 2, 2017 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported financial results for the third quarter ended September 30, 2017 (Press release, Sunesis, NOV 2, 2017, View Source [SID1234521490]). Loss from operations for the three months ended September 30, 2017 was $9.9 million. As of September 30, 2017, cash, cash equivalents and marketable securities totaled $12.5 million. Subsequent to the end of the quarter, the company raised approximately $6 million from sales of common stock through its at the market facility in October 2017 and $20 million in gross proceeds from concurrent underwritten public offerings on October 27, 2017, which together will provide sufficient funds for the operation of the company’s business into early 2019.

“In the third quarter, we advanced our lead program, a reversible, non-covalent BTK inhibitor, SNS-062, with the ongoing enrollment in our Phase 1b/2 study in patients with relapsed chronic lymphocytic leukemia (CLL) and other B-cell malignancies,” said Daniel Swisher, Chief Executive Officer of Sunesis. “We will provide a program update at an investor presentation and webcast during the American Society of Hematology (ASH) (Free ASH Whitepaper) Conference in Atlanta, Georgia in December 2017, and to present interim data from the study at a peer-reviewed medical conference in mid-2018. We believe SNS-062 has the potential to overcome the leading resistance pathway to ibrutinib, the predominant standard of care for the treatment of CLL. In addition, in October, we secured the financial resources from leading life science investors extending our operating runway into early 2019.

Mr. Swisher added, “Beyond SNS-062, we have made progress with our proprietary PDK-1 and Takeda-partnered pan-RAF inhibitor programs. We are pleased to announce today the nomination of our PDK1 (phosphatidyl-inositol dependent kinase1) inhibitor, SNS-510, as a Development Candidate and potentially first-to-clinic selective inhibitor in this pathway. PDK1 is a master kinase that activates other kinases important to cell growth and survival including members of the AKT, PKC, RSK and SGK families. In addition, we look forward to announcing future updates from the ongoing clinical studies of our Takeda-partnered TAK-580 program.”

Recent Highlights

Completed $20 million concurrent public offerings with leading life science investors. On October 27, 2017, Sunesis raised $20 million in gross proceeds in concurrent underwritten public offerings of common and preferred stock and warrants, with participation by new and existing investors, including Oncology Impact Fund managed by MPM Capital, BVF Partners L.P and Burrage Capital.

Continued Progress in Phase 1b/2 Study Evaluating Oral Non-Covalent BTK-inhibitor SNS-062 in Adults with Chronic Lymphocytic Leukemia (CLL) and other B-Cell Malignancies. In July 2017, Sunesis announced that the first patient was dosed at the Dana-Farber Cancer Institute in the Phase 1b/2 dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of its potent, reversible, non-covalent BTK-inhibitor, SNS-062, in adults with CLL, small lymphocytic leukemia, Waldenstrom’s macroglobulinemia, and mantle cell lymphoma. The Phase 1b/2 trial is an open-label, sequential-group study that is enrolling up to 124 subjects across leading sites in the United States. The Company plans to present interim data from this study in mid-2018.
Financial Highlights

Cash, cash equivalents and marketable securities totaled $12.5 million as of September 30, 2017, as compared to $42.6 million as of December 31, 2016. The decrease of $30.1 million was primarily due to $30.8 million of net cash used in operating activities and a debt restructuring payment of $7.6 million, partially offset by $8.3 million in net proceeds primarily from sales of common stock through the company’s at the market facility. An additional $24.6 million in net proceeds were raised in October, resulting in pro-forma September 30, 2017 cash, cash equivalents and marketable securities of $37.1 million. This capital is expected to fund the company into 2019.

Revenue for the three and nine months ended September 30, 2017 was nil and $0.7 million, as compared to $0.6 million and $1.9 million for the same periods in 2016. Revenue in each period was primarily due to deferred revenue recognized related to the Royalty Agreement with Royalty Pharma.

Research and development expense was $6.8 million and $17.9 million for the three and nine months ended September 30, 2017 as compared to $5.3 million and $18.1 million for the same periods in 2016, primarily relating to the SNS-062 and the vosaroxin development program in each period. The increase of $1.5 million between the comparable three month periods was primarily due to the $2.5 million milestone payment to Biogen under the license agreement, offset by decreases in professional services of $0.8 million and salary and personnel expenses of $0.2 million. The decrease in the comparable nine months periods of $0.2 million was primarily due to a decrease in professional services of $2.5 million, salary and personnel expenses of $0.2 million, and medical affairs expenses of $0.2 million, partially offset by the $2.5 million milestone payment to Biogen under the license agreement.

General and administrative expense was $3.2 million and $10.8 million for the three and nine months ended September 30, 2017, as compared to $3.9 million and $12.2 million for the same periods in 2016. The decrease of $0.7 million for the comparable three month periods was primarily due to decreases in salary and personnel expenses of $0.4 million and commercial expenses of $0.3 million, partially offset by increases of $0.1 million in professional services. The decrease in the comparable nine months periods of $1.4 million was primarily due to a decrease in salary and related expenses of $0.9 million, commercial expenses of $0.7 million, partially offset by increase of $0.4 million in professional services.

Interest expense was $0.3 million and $1.1 million for the three and nine months ended September 30, 2017, as compared to $0.5 million and $1.2 million for the same periods in 2016. The decrease in the 2017 periods was primarily due to the decrease in the outstanding notes payable.

Net other income was $0.1 million and $0.3 million for the three and nine months ended September 30, 2017, as compared to nil and $0.1 million for the same periods in 2016. The other income was primarily comprised of interest income from the short-term investments.

Cash used in operating activities was $30.8 million for the nine months ended September 30, 2017, as compared to $29.0 million for the same period in 2016. Net cash used in the 2017 period resulted primarily from the net loss of $28.8 million and changes in operating assets and liabilities of $4.6 million, offset by net adjustments for non-cash items of $2.6 million. Net cash used in the nine month period ended September 30, 2016 resulted primarily from the net loss of $29.5 million and changes in operating assets and liabilities of $3.6 million, including a final payment fee representing interest expense of $1.2 million under the Oxford Loan Agreement, partially offset by net adjustments for non-cash items of $4.1 million.

Sunesis reported loss from operations of $9.9 million and $28.0 million for the three and nine months ended September 30, 2017, as compared to $8.5 million and $28.4 million for the same periods in 2016. Net loss was $10.2 million and $28.8 million for the three and nine months ended September 30, 2017, as compared to $9.0 million and $29.5 million for the same periods in 2016.
Conference Call Information

Sunesis will host a conference today at 2:00 p.m. Eastern Time. The call can be accessed by dialing (844) 296-7720 (U.S. and Canada) or (574) 990-1148 (international) and entering passcode 1071001. To access the live audio webcast, or the subsequent archived recording, visit the “Investors and Media – Calendar of Events” section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the company’s website for two weeks.

On November 2, 2017 Seattle Genetics, Inc. (NASDAQ:SGEN) reported that it has submitted a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) based on data from the phase 3 ECHELON-1 trial evaluating ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma (Press release, Seattle Genetics, NOV 2, 2017, View Source [SID1234521489]). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical 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. ADCETRIS is currently not approved as a frontline therapy for Hodgkin lymphoma.

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“There have been no new treatment advances for frontline Hodgkin lymphoma in more than 40 years. Up to 30 percent of the patients diagnosed with advanced disease will experience disease progression after frontline treatment with the current standard of care chemotherapy regimen, representing a significant unmet need to improve the treatment outcome of these patients who are often young adults,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “Results from the ECHELON-1 study demonstrated superior activity of an ADCETRIS-containing regimen over standard of care, and resulted in FDA Breakthrough Therapy Designation for ADCETRIS in combination with chemotherapy for frontline advanced classical Hodgkin lymphoma. We believe these data represent a significant advance for the patient and physician community and look forward to working with the FDA to complete the review of this new treatment regimen as quickly as possible.”

The ECHELON-1 study evaluated a combination of ADCETRIS plus AVD (Adriamycin, vinblastine, dacarbazine) compared to a recognized standard of care chemotherapy regimen, ABVD (which also includes bleomycin), in previously untreated advanced classical Hodgkin lymphoma. The ECHELON-1 study met its primary endpoint of a statistically significant improvement in modified progression-free survival (PFS) of the ADCETRIS containing regimen versus the control arm as assessed by an Independent Review Facility (hazard ratio=0.770; p-value=0.035). The two-year modified PFS rate for patients in the ADCETRIS arm was 82.1 percent compared to 77.2 percent in the control arm. Interim analysis of overall survival, the key secondary endpoint, also trended in favor of the ADCETRIS plus AVD arm. The safety profile of ADCETRIS plus AVD in the ECHELON-1 trial was consistent with that known for the single-agent components of the regimen. Full data from the ECHELON-1 study will be presented in the Plenary Scientific Session at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on Sunday, December 10, 2017 from 2:00 – 4:00 p.m. ET in Atlanta, Georgia.

ADCETRIS was recently granted Breakthrough Therapy Designation by the FDA based on data from the phase 3 ECHELON-1 clinical trial. The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of promising drug candidates for serious or life-threatening conditions. It is based upon clinical evidence of substantial improvement over existing therapies on one or more clinically significant endpoints.

ECHELON-1 Phase 3 Clinical Trial Design

The randomized, open-label, phase 3 trial is investigating ADCETRIS plus AVD versus ABVD as frontline therapy in patients with advanced classical Hodgkin lymphoma. The primary endpoint is modified PFS per Independent Review Facility assessment using the Revised Response Criteria for Malignant Lymphoma. Modified PFS is defined as the time to progression, death or receipt of additional anticancer therapy for patients who are not in complete response after completion of frontline therapy per Independent Review Facility. This endpoint was chosen as it provides a clearer picture of the efficacy of frontline chemotherapy and eliminates the confounding impact of salvage and consolidation chemotherapies and radiotherapy. Secondary endpoints include overall survival, complete remission and safety. The multi-center trial was conducted in North America, Europe, South America, Australia, Asia and Africa. The study enrolled 1,334 patients who had a histologically-confirmed diagnosis of Stage III or IV classical Hodgkin lymphoma and had not been previously treated with systemic chemotherapy or radiotherapy. The ECHELON-1 trial is being conducted under a Special Protocol Assessment (SPA) agreement from the FDA and the trial also received European Medicines Agency (EMA) scientific advice.

Please see Important Safety Information at the end of this press release.

About Classical Hodgkin Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Classical Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell expresses CD30.

According to the American Cancer Society, approximately 8,260 cases of Hodgkin lymphoma will be diagnosed in the United States during 2017 and more than 1,000 will die from the disease. According to the Lymphoma Coalition, over 62,000 people worldwide are diagnosed with Hodgkin lymphoma each year and approximately 25,000 people die each year from this cancer.

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 2, 2017 Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) reported financial results and provided a business update for the third quarter of 2017 (Press release, Progenics Pharmaceuticals, NOV 2, 2017, View Source [SID1234521488]).

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“The recent completion of our NDA submission for AZEDRA represents a major achievement for our growing company,” said Mark Baker, Chief Executive Officer of Progenics. “AZEDRA offers a potentially transformative therapy for metastatic pheochromocytoma and paraganglioma patients who have no treatment options in the U.S. for this devastating condition. We are continuing to build the necessary team and infrastructure to support a rapid commercial launch of this important therapy following a potential approval.”

Third Quarter and Recent Key Business Highlights

AZEDRA, Ultra-Orphan Radiotherapeutic Candidate

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New Drug Application (NDA) for AZEDRA (iobenguane I 131) Submitted to the U.S. Food and Drug Administration (FDA) on October 31st
As announced earlier today, Progenics has submitted the NDA for AZEDRA in patients with malignant, recurrent, and/or unresectable pheochromocytoma and paraganglioma, rare neuroendocrine tumors for which there are currently no approved treatment options in the United States. The NDA remains subject to FDA regulatory review and approval. AZEDRA holds Breakthrough Therapy and Orphan Drug statuses, as well as Fast Track designation.

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Multiple Presentations of Additional Data from Phase 2b Trial of AZEDRA
Progenics has recently presented the positive results from its pivotal Phase 2b study evaluating AZEDRA at the 5th International Symposium on Pheochromocytoma and Paraganglioma (ISP), the North American Neuroendocrine Tumor Society (NANETS) 2017 Annual Symposium, and the 30th Annual Congress of the European Association of Nuclear Medicine (EANM). The Phase 2b trial met the primary endpoint evaluating the proportion of metastatic pheochromocytoma and paraganglioma patients who achieved a 50% or greater reduction of all antihypertensive medications for at least six months. The results further demonstrated that sustained reduction of antihypertensive medications was positively correlated with favorable tumor responses, including radiographic tumor responses, tumor biomarker response and overall survival. AZEDRA was shown to be safe and generally well tolerated.



Progenics Announces Third Quarter 2017 Financial Results
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PSMA-Targeted Prostate Cancer Pipeline

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Progress Continues for Clinical Studies of 1404, PyL and 1095
Progenics continues to enroll patients in: the Phase 3 trial of 1404, a SPECT/CT imaging agent; the Phase 2/3 study of PyL, a PET/CT imaging agent; and the Phase 1 open-label dose escalation study of 1095, a radiotherapeutic that selectively binds to PSMA.

RELISTOR, Treatment for Opioid-Induced Constipation (partnered with Valeant Pharmaceuticals International, Inc.)

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Third Quarter 2017 RELISTOR Net Sales of $17.1 Million
The third quarter 2017 sales, as reported to Progenics by its partner Valeant, translated to $2.6 million in royalty revenue for Progenics for the quarter. Oral RELISTOR prescriptions increased 40% over the preceding quarter.

Third Quarter 2017 Financial Results

Third quarter revenue totaled $2.7 million, down from $53.9 million in the third quarter of 2016, reflecting RELISTOR royalty income of $2.6 million compared to $3.3 million in the corresponding period of 2016. The prior year period included milestone revenue of $50.0 million for the approval of RELISTOR oral tablets as well as a non-recurring favorable sales return adjustment included in Valeant’s reported net sales of RELISTOR.

Third quarter research and development expenses increased by $0.5 million compared to the corresponding prior year period, resulting primarily from higher clinical trial costs for PyL, partially offset by lower manufacturing scale-up costs for 1095. Third quarter general and administrative expenses decreased by $1.3 million compared to the corresponding prior year period, which included an accrual for litigation with a former employee. Partially offsetting this decrease were higher costs associated with building commercial capabilities in preparation for a potential AZEDRA approval and launch. For the three months ended September 30, 2017, Progenics recognized interest expense of $1.0 million related to the RELISTOR royalty-backed loan.

Net loss attributable to Progenics for the third quarter was $15.4 million, or $0.22 per diluted share, compared to net income of $36.3 million, or $0.52 per diluted share, in the corresponding 2016 period. Progenics ended the third quarter with cash and cash equivalents of $98.3 million, a decrease of $40.6 million compared to cash and cash equivalents as of December 31, 2016.

Conference Call and Webcast

Progenics will review third quarter financial results in a conference call today at 8:30 a.m. ET. To participate, please dial (877) 250-8889 (domestic) or (720) 545-0001 (international) and reference conference ID 5589567. A live webcast will be available in the Media Center of the Progenics website, www.progenics.com, and a replay will be available for two weeks.