On November 7, 2017 Celsion Corporation (NASDAQ:CLSN) reported that the Company will host a conference call to discuss financial results for the quarter ended September 30, 2017 and provide an update on its development programs for ThermoDox, its proprietary heat-activated liposomal encapsulation of doxorubicin and GEN-1, an IL-12 DNA plasmid vector formulated into a nanoparticle with a non-viral delivery system at 11:00 a.m. ET on Tuesday, November 14, 2017 (Press release, Celsion, NOV 7, 2017, View Source [SID1234521645]). To participate in the call, interested parties may dial 1-877-830-2649 (Toll-Free/North America) or 1-785-424-1824 (International/Toll) and ask for the Celsion Corporation 3rd Quarter 2017 Earnings Call (Conference Code: 3840213) to register ten minutes before the call is scheduled to begin. The call will also be broadcast live over the internet at www.celsion.com.

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The call will be archived for replay on Tuesday, November 14, 2017 and will remain available until Tuesday, November 28, 2017. The replay can be accessed at 1-888-203-1112 (Toll-Free/North America) or 1-719-457-0820 (International/Toll) using Conference Code: 3840213. An audio replay of the call will also be available on the Company’s website, www.celsion.com, for 90 days after 2:00 p.m. ET on Tuesday, November 14, 2017.

On November 7, 2017 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the third quarter ended September 30, 2017 (Press release, Nektar Therapeutics, NOV 7, 2017, View Source [SID1234521684]).

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Cash and investments in marketable securities at September 30, 2017 were $412.2 million as compared to $389.1 million at December 31, 2016. The cash balance includes the $150.0 million upfront payment from Nektar’s collaboration with Eli Lilly & Company for the development and commercialization of NKTR-358.

"Nektar’s immuno-oncology portfolio continues to expand as we add novel drug candidates to our growing pipeline," said Howard W. Robin, President and CEO of Nektar. "NKTR-214 is the first I-O agent to both increase tumor-infiltrating lymphocytes (TILs) and increase PD-1 expression on human immune cells, which uniquely complements checkpoint inhibition and other anti-cancer mechanisms. As the majority of cancer patients have tumors that do not express PD-L1 and these patients receive limited benefit from treatment with checkpoint inhibitors, the potential of NKTR-214 to help patients is significant. Finally, based on recent positive conversations with the agency regarding our regulatory plans for NKTR-181, we are now planning to submit an NDA for NKTR-181 by April 2018 with our data package of over 2,100 patients and healthy volunteers."

Revenue in the third quarter of 2017 was $152.9 million as compared to $36.3 million in the third quarter of 2016. Year-to-date revenue for 2017 was $212.2 million as compared to $128.0 million in the first nine months of 2016. Revenue in 2017 included recognition of $127.6 million of the $150.0 million upfront payment from Nektar’s collaboration with Eli Lilly & Company for the development and commercialization of NKTR-358.

Total operating costs and expenses in the third quarter of 2017 were $83.4 million as compared to $69.2 million in the third quarter of 2016. Year-to-date total operating costs and expenses in 2017 were $247.9 million as compared to $208.7 million for the same period in 2016. Total operating costs and expenses increased primarily as a result of increased research and development (R&D) expense.

Research and development expense in the third quarter of 2017 was $65.7 million as compared to $52.0 million in the third quarter of 2016. Year-to-date R&D expense for 2017 was $187.0 million as compared to $153.6 million for the same period in 2016. R&D expense was higher in the third quarter and first nine months of 2017 as compared to the same periods in 2016 primarily because of expenses for our pipeline programs, including Phase 3 clinical studies for NKTR-181, Phase 1/2 clinical studies of NKTR-214 and NKTR-358 and IND-enabling activities for NKTR-262 and NKTR-255.

General and administrative expense was $12.1 million in the third quarter of 2017 as compared to $10.3 million in the third quarter of 2016. G&A expense in the first nine months of 2017 was $40.0 million as compared to $31.5 million for the same period in 2016. G&A expense in the first nine months of 2017 includes a $3.3 million charge for a litigation settlement related to a cross-license agreement.

Net income in the third quarter of 2017 was $60.9 million or $0.39 basic income per share as compared to net loss of $43.2 million or $0.32 basic loss per share in the third quarter of 2016. Net loss in the first nine months of 2017 was $62.9 million or $0.41 basic loss per share as compared to $111.3 million or $0.82 basic loss per share in the first nine months of 2016.

The company also announced upcoming presentations at the following scientific congresses during the fourth quarter of 2017:

Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting, National Harbor, MD:

Oral Presentation: "PIVOT-02: Preliminary safety, efficacy and biomarker results from the Phase 1/2 study of CD-122-biased agonist NKTR-214 plus nivolumab in patients with locally advanced/metastatic solid tumors"
Presenter: Dr. Adi Diab, Assistant Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas
Session: Clinical Trials: Novel Combinations
Date: Saturday, November 11, 2017, 5:00 p.m. Eastern Time

Poster #P77: "The Novel IL-2 Cytokine Immune Agonist NKTR-214 Harnesses the Adaptive and Innate Immune System for the Treatment of Solid Cancers"
Presenter: Salah Eddine Bentebibel, University of Texas MD Anderson Cancer Center
Session: Biomarkers and Immune Monitoring
Date: Friday, November 10, 2017, 12:30-2:00 p.m. Eastern Time

Poster #P140: "NKTR-214 enhances anti-tumor T-cell immune responses induced by checkpoint blockade or vaccination"
Presenter: Meenu Sharma, University of Texas MD Anderson Cancer Center
Session: Cancer Vaccines
Date: Saturday, November 11, 2017, 12:30-2:00 p.m. Eastern Time

Poster #P274: "Combination of NKTR-214 and radiotherapy (RT) to reverse anergy and expand tumor-specific CD8 T-Cells"
Presenter: Joshua Walker, Oregon Health & Science University
Session: Combination Therapy
Date: Saturday, November 11, 2017, 12:30-2:00 p.m. Eastern Time

Poster #P275: "Harnessing the innate and adaptive immune system to eradicate treated and distant untreated solid tumors"
Presenter: Saul Kivimae, Nektar Therapeutics
Session: Combination Therapy
Date: Friday, November 10, 2017, 12:30-2:00 p.m. Eastern Time

Poster #P332: "Pre-clinical efficacy and tolerability of NKTR-255, a polymer-conjugated IL-15 for immuno-oncology"
Presenter: Peiwen Kuo, Nektar Therapeutics
Session: Combination Therapy
Date: Saturday, November 11, 2017, 12:30-2:00 p.m. Eastern Time

Poster #434: "Great Apes Adenoviral vaccine encoding neoantigens synergizes with immunomodulators to cure established tumors in mice"
Presenter: Anna Morena D’Alise, Nouscom srl
Session: Personalized Vaccines and Technologies/Personalized Medicines
Date: Saturday, November 11, 2017, 12:30-2:00 p.m. Eastern Time

American College of Neuropsychopharmacology 56th Annual Meeting, Palm Springs, CA:

Poster #T166: "Abuse potential of NKTR-181 in recreational opioid users: results from a randomized, double-blind crossover oral study"
Presenter: Snow Ge, Nektar Therapeutics
Session: Poster Session II
Date: Tuesday, December 5, 2017, 5:30-7:30 p.m. Pacific Time

Conference Call to Discuss Third Quarter 2017 Financial Results
Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time, Tuesday, November 7, 2017.

This press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through Monday, December 11, 2017.

To access the conference call, follow these instructions:
Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)
Passcode: 4677348 (Nektar Therapeutics is the host)

In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investor Relations page at the Nektar website as soon as practical after the conclusion of the conference call.

On November 7, 2017 MannKind Corporation (NASDAQ:MNKD) reported financial results for the third quarter and the nine months ended September 30, 2017. Third quarter highlights include (Press release, Mannkind, NOV 7, 2017, View Source [SID1234521715]):

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Afrezza net revenue grew 28% and 246% vs. 2Q 2017 and 3Q 2016, respectively
Cash burn of $23.3 million in 3Q 2017
Exchanged all outstanding Series A and B Common Stock Warrants for an aggregate of 1.3 million shares of the Company’s common stock
FDA approved label changes for Afrezza
Other recent highlights include:

Issued 10.2 million shares of the Company’s common stock in a registered direct offering resulting in receipt of net proceeds of $57.7 million
Exchanged senior convertible notes of $27.7 million due August 2018 for senior convertible notes of $23.7 million due October 2021 and 973,236 shares of the Company’s common stock
Extended the maturity of $10 million of the Deerfield obligation from October 31, 2017 to January 15, 2018
Allowed for certain outstanding principal under the Deerfield obligation to be converted into shares of the Company’s common stock (including the $10 million due January 2018). 4 million shares have been reserved for conversion.
Third Quarter Results

For the third quarter of 2017, Afrezza net revenue of $2.0 million grew 28% vs. the second quarter of 2017 and 246% vs. the third quarter of 2016 (the first quarter for MannKind sales and commercial support of Afrezza after the termination of the Sanofi agreement). As of September 30, 2017, the amount of Afrezza shipped to the wholesale and retail channels, but not yet recognized as revenue, was $3.0 million, an increase of $0.4 million from June 30, 2017. A reconciliation of gross to net revenues can be found in the Management’s Discussion and Analysis of Financial Condition and Results of Operations section of the Form 10-Q for the quarter ended September 30, 2017.

Cost of goods sold was $4.6 million in the third quarter of 2017 compared to (i) $5.1 million in the second quarter of 2017, a decrease of $0.5 million primarily related to a write-down of inventory in the second quarter, and (ii) $4.4 million in the third quarter of 2016, an increase of $0.2 million.

Research and development expenses were $4.4 million in the third quarter of 2017 compared to (i) $3.1 million in the second quarter of 2017, an increase of $1.3 million primarily related to starting the Time in Range ("STAT" study) and the pediatric study, and (ii) $4.0 million in the third quarter of 2016, an increase of $0.4 million, primarily due to increases in clinical trials partially offset by a decrease in compensation expense related to a reduction in workforce in the fourth quarter of 2016.

Selling, general and administrative expenses were $17.7 million for the third quarter of 2017 compared to (i) $18.6 million for the second quarter of 2017, a decrease of $1.1 million primarily from a reduction in commercial support expenses and (ii) $13.1 million in the third quarter of 2016, an increase of $4.6 million primarily due to scaling up the Afrezza commercial infrastructure during the first quarter of 2017.

The net loss for the third quarter of 2017 was $32.9 million, or a loss of $0.31 per share based on 104.7 million weighted average shares outstanding, compared to net income of $126.5 million, or $1.32 per share on 95.6 million weighted average shares outstanding in the third quarter of 2016. The net income in the third quarter of 2016 included net revenue – collaboration of $161.8 million related to the termination of the Sanofi agreement.

Nine Months Results

Due to the termination of the Sanofi agreement in early 2016 and MannKind’s commencement of commercial activities for Afrezza in the third quarter of 2016, a comparative analysis for sales and commercial support between the nine months ended September 30, 2017 and September 30, 2016 is not meaningful.

For the nine months ended September 30, 2017, total net revenue of $7.2 million was comprised of $4.7 million of Afrezza net sales, $1.7 million from the net sales of surplus bulk insulin to a third party, $0.6 million from the sale of certain oncology intellectual property, and $0.2 million from collaboration net revenue.

Cost of goods sold was $12.2 million for the nine months ended September 30, 2017 compared to $12.9 million for the same period in 2016, a decrease of $0.7 million.

Research and development expenses were $10.6 million for the nine months ended September 30, 2017 compared to $13.4 million for the same period in 2016, a decrease of $2.7 million or 21%, due primarily to a decrease in compensation expense of $5.1 million as a result of the reduction in workforce in the fourth quarter of 2016. This decrease was partially offset by a $2 million increase in clinical trial expense.

Selling, general and administrative expenses were $51.7 million for the nine months ended September 30, 2017 compared to $31.6 million for the same period in 2016, an increase of $20.1 million due to the change in the commercial support structure after termination of the Sanofi agreement in 2016.

The net loss for the nine months ended September 30, 2017 was $84.5 million, or a loss of $0.84 per share based on 100.1 million weighted average shares outstanding, compared to net income of $71.7 million, or $0.79 per share on 90.8 million weighted average shares outstanding at September 30, 2016.

Cash and Cash Equivalents

Cash and cash equivalents at September 30, 2017 decreased to $20.1 million from $43.4 million at June 30, 2017, primarily due to cash burn for the third quarter of 2017 of $23.3 million. The cash balance as of September 30, 2017 does not include $57.7 million of net proceeds received from the registered direct offering of the Company’s common stock completed in October 2017.

Afrezza Label Change

On September 29, 2017, the U.S. FDA approved an update to the Afrezza prescribing information for the inclusion of study data that describes the time action profile by dosage strength; clarity on "Starting" and "Adjusting" mealtime doses; and updated pregnancy and lactation guidance.

Conference Call

MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time. To view and listen to the earnings call webcast, visit MannKind’s website at View Source and click on the "Q3 2017 MannKind Earnings Conference Call" link in the Webcast section of News & Events. To participate in the live call by telephone, please dial (888) 771-4371 or (847) 585-4405 and use the participant passcode: 44096374.

A telephone replay will be accessible for approximately 14 days following completion of the call by dialing (888) 843-7419 or (630) 652-3042 and use the participant passcode: 4409 6374#. A replay will also be available on MannKind’s website for 14 days.

On November 7, 2017 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported the selection of its third drug candidate, BP1003, for the treatment of pancreatic cancer and provided an update on several of its preclinical discovery efforts (Press release, Bio-Path Holdings, NOV 7, 2017, View Source [SID1234521671]).

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"We are excited about the ways in which we continue to leverage our novel DNAbilize technology and are particularly pleased to be moving forward toward the treatment of solid tumors," said Peter H. Nielsen, chief executive officer of Bio-Path Holdings. "As we advance our current drug candidates into additional indications and add new targets, we continue to establish the DNAbilize platform as a premier RNAi nanoparticle technology for systemic treatment of disease."

Bio-Path’s third drug candidate, BP1003, targets the Stat3 protein and is currently in preclinical development in a pancreatic patient-derived tumor model. Previous preclinical models have shown BP1003 to successfully penetrate pancreatic tumors and to significantly enhance the efficacy of standard frontline treatments. Bio-Path intends to initiate IND enabling studies of BP1003 in 2018.

BP1002, Bio-Path’s second drug candidate, targets the Bcl2 protein and has demonstrated strong anti-non-Hodgkin’s lymphoma activity in cell lines and in an animal model. The company has completed IND enabling studies and expects to initiate a Phase 1 trial in lymphoma in 2018.

Prexigebersen, Bio-Path’s lead drug compound, targets the Grb2 protein and is currently in Phase 2 development for the treatment of blood cancers. In recently completed preclinical models, prexigebersen effectively penetrated ovarian tumors and has demonstrated clinical benefit both as a monotherapy and in combination with standard frontline therapies. Bio-Path plans to initiate a Phase 1 clinical trial of prexigebersen targeting several solid tumors types in 2018.

Verastem has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Verastem, 2017, NOV 7, 2017, View Source [SID1234521639]).

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